A brief note to let you know that yesterday and so far today $590 has come in from 12 contributors, bringing the total raised so far to $2,252 from 54 contributors. That leaves $1,748 from 46 contributors to go to reach the overall goals of $4,000 from 100 contributors by the end of March 6. That's next Friday, so there's six day to go.
Thanks to all who've contributed so far. If you'd like to make a donation and help chip away at the remainder before Monday, the PayPal button is on the right or send me an email and I'll send you my mailing address.
BTW, I do now have the Seroquel documents released on Thursday in federal court in Orlando and am plowing through them over the weekend. I'll have news from them on Monday.
Another $485 came in yesterday from 10 contributors, bringing the total raised so far to $1,662 from 42 people. That leaves $2,338 from 58 contributors to go to reach the fundraiser's goal of $4,000 from 100 contributors on or about March 6. So there's one week to go.
Thanks to all of you who've contributed so far.
As usual, the PayPal button is on the right. Of if you prefer snail mail, send me an email and I'll send you my mailing address.
To make things more interesting, a psychiatrist who reads this site (Douglas Bremner of Emory University) has offered to contribute $10 per psychiatrist who contributes to the fundraiser after yesterday. He'll contribute $2 per psychologist, nurse or social worker and $1 per journalist. That's a great offer and I hope some of you MDs who read this site will take him up on his offer.
Thanks to all of you for your support.
I'll be taking it a bit slowly today, barring any big news, as I lost so much sleep Monday and Tuesday working on that story on AZ's former Seroquel medical director.
From this morning's Wall Street Journal:
" ORLANDO, Fla. -- AstraZeneca PLC instructed its U.S. sales representatives to tell doctors that its powerful psychiatric drug, Seroquel, didn't cause diabetes even though a company physician had at one point stated years earlier that such a link was probable in some individuals, documents unsealed in a federal court case here show."The documents -- ranging from unpublished study results to previously undisclosed depositions -- are among more than 100 the U.K. drug maker agreed to unseal Thursday in lawsuits brought by plaintiffs who allege they were harmed by the multibillion-dollar antipsychotic drug. Many of the cases have been consolidated ..."
The rest of the story is behind the subscriber firewall, so until someone passes it along to me or another paper covers those documents, that's all I've got for you. This document is out in the public realm because in federal court yesterday AZ agreed to release over 100 documents in the case, but fought to keep some others under seal.
So it sure looks like AstraZeneca took a page out of the Lilly playbook and had its sales force lie about Seroquel's propensity to cause diabetes.
I'm sure there's much more to come.
Well, someone passed it on to me:
"In an Aug. 15, 2005, voicemail message addressed to company salespeople, an AstraZeneca employee named Christine Ney followed up on a 'weight and diabetes sell sheet' they had recently been sent. The sales representatives should assuage doctors' fears about their patients' weight gains, she said in the voicemail, by telling them that data showed no causal link between diabetes and the drug."'Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile,' Ms. Ney said, according to a transcript of the voicemail message. She then instructed representatives to 'refocus the call' away from diabetes to the drug's tolerability, the transcript shows.
"The voicemail to the sales representatives raises questions about whether there was a contradiction between Ms. Ney's instructions and an AstraZeneca drug-safety expert's own assessment of Seroquel's link to diabetes years earlier. In a 2000 position paper about the safety of Seroquel sent to Dutch regulatory authorities, an AstraZeneca doctor named Wayne Geller wrote that there was a relationship between the drug and diabetes.
"'There is reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes melliutus in certain individuals,' Dr. Geller wrote."
Reportedly, Geller retracted his statement in a deposition last year.
"Among the unsealed documents, another set goes back to the late 1990s and raises further questions about whether AstraZeneca kept a lid on unflattering Seroquel studies."A document dated Feb. 12, 1997, describes internal company deliberations over how to report 'Study 15,' a study comparing Seroquel to Haldol, an older-generation psychiatric drug. In the document, an AstraZeneca employee named Richard Lawrence writes to his team that one of his colleagues had done a great 'smoke and mirrors job,' which 'should minimise (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.'
"It isn't clear what Mr. Lawrence's comments were referring to. He couldn't be reached late Thursday, and AstraZeneca declined to discuss the emails. Ed Blizzard, an attorney with the Houston law firm Blizzard, McCarthy & Nabers, who is one of the lawyers for the plaintiffs, says the document refers to the fact that 'the weight gain data was bad, and that's why we believe the study was buried.'
"In a series of emails in 1999, AstraZeneca executives discuss withholding the results of another Seroquel study, known as COSTAR. That study compared Seroquel to Risperdal, another antipsychotic drug made by Johnson & Johnson.
"On Dec. 6, 1999, an AstraZeneca employee named John Tumas, the publications manager for Seroquel, wrote to his colleagues, 'There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried' certain studies. Referring to COSTAR, he added: 'We must find a way to diminish the negative findings. But in my opinion we cannot hide them.'"
"Mr. Tumas couldn't be reached late Thursday. AstraZeneca's Mr. Jewell declined to comment about the 1990s emails and documents other than to note that the FDA 'vetted and substantiated the safety data for Seroquel,' including the data from both Study 15 and COSTAR. 'The FDA has approved the medicine as a safe and effective treatment for schizophrenia and bipolar disorder,' he says."
Speaking of Seroquel and weight gain data, I hear through the rumor mill that the reason for the much-delayed FDA decision on approving the company's applications to have the drug approved for depression and/or anxiety is because the clinical trials showed loads of weight gain in patients.
This came to me too late at night for me to do much poking around. From Bloomberg:
"Feb. 27 (Bloomberg) -- Unfavorable studies about the antipsychotic drug Seroquel were 'buried' by AstraZeneca Plc, according to an internal e-mail unsealed as part of litigation over the medicine."The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in 'cherry picking' of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients...."
"'The larger issue is how we face the outside world when they begin to criticize us for suppressing data,' John Tumas, an AstraZeneca publications manager, told colleagues in the e- mail."
More on Trial 15 which the Wall Street Journal also picked up on:
"One unsealed document showed AstraZeneca officials considered Trial 15, one of the studies Tumas described as 'buried,' to be a problem because it didn’t produce favorable results on the issue of weight gain for patients taking the drug. Gaining weight can be a factor in the development of diabetes."Richard Lawrence, an Astra Zeneca official, said in a February 1997 e-mail that the company had engaged in a 'great smoke-and-mirrors job' in dealing with U.S. and Canadian investigators on the trial’s results.
"'Adopting the approach Don has outlined should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study,' Lawrence said in the e- mail. It isn’t clear from the e-mail which person Lawrence is referring to."
"In his December 1999 e-mail, Tumas pointed out that AstraZeneca had 'buried trials 15, 31, 56,' and was considering a study listed as COSTAR. The focuses of the trials weren’t specified in the e-mail."He also noted 'there is growing pressure from outside the industry to provide access to all data from clinical trials conducted by industry.'
"Tumas chastised colleagues for using favorable data produced by Trial 15 without disclosing the full study results, according to his unsealed e-mail.
"'There has been a precedent set regarding "cherry picking of data," he said. The data was used in 'the recent Velligan presentations,' he noted. 'Thus far, I am not aware of any repercussions regarding interest in the unreported data.'"
I cannot find any references to a published COSTAR study online.
Velligan is likely a reference to University of Texas (San Antonio) psychiatry professor Dawn Velligan. She's done some Seroquel studies in schizophrenia. For example, this.
More:
"The publications manager indicated that AstraZeneca had a favorable reputation for engaging in 'ethical behavior' when it came to disclosing study results on its drugs."'We must decide if we wish to continue to enjoy this distinction,' he wrote.
"'The reporting of the COSTAR results will not be easy,' he added. 'We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.'
"Among the unsealed documents was a March 2000 e-mail from Tumas in which he noted a study comparing Seroquel to Risperdal, Johnson & Johnson’s rival antipsychotic drug, produced data 'that don’t look good.'
"The results showed that Seroquel failed to best Risperdal in at least five different categories and only out-performed the placebo used in the study, according to study data made public yesterday. Those categories included mood, anxiety and hostility, the documents showed."
Wow is all I can say.
"AstraZeneca officials have criticized lawyers for former Seroquel users for pushing to have documents in the case unsealed."'It is not surprising that plaintiffs’ lawyers have resorted to these tactics to distract attention from their lack of success on the merits of the claims,' Jewell said in his statement."
Separately, Tony Jewell, an AZ spokesman, said in a statement to Bloomberg, "None of the documents can obscure the fact that AstraZeneca acted responsibly and appropriately as it developed and marketed Seroquel."
With a first trial set for Delaware in April, it'll be interesting to see if AZ settles or goes to trial. AZ has settled none of the approximately 9,000 lawsuits it faces over Seroquel.
I've now seen a copy of the federal complaint against Forest Labs for allegedly illegally promoting Lexapro and Celexa for use in children, both uses for which the company has no approvals. It's the usual tale of ignoring negative clinical trials, pimping the heck out of a positive trial by none other than the University of Texas' Karen Wagner (already snared in one of Sen. Grassley's investigations, involving Paxil), and flat-out marketing the drug to docs for use in children, despite evidence of suicides and suicidality in one of the trials. Read the complaint for yourself. Forest Labs itself announced today that an unnamed 11 states and the District of Columbia will join in the federal suit.
Then this bombshell:
From 1999 through 2006, one pediatric specialist, Dr. Jeffrey Bostic, Medical Director of the Massachusetts Child Psychiatry Access Project at Massachusetts General Hospital, gave more than 350 Forest-sponsored talks and presentations, many of which addressed pediatric use of Celexa and Lexapro....Dr. Bostic became Forest's star spokesman in the promotion of Celexa and Lexapro for pediatric use. As one sales representative wrote, 'Dr. Bostic is the man when it comes to child psych!' Between 2000 and 2006, Forest paid Dr. Bostic over $750,000 in honoraria for his presentations on Celexa and Lexapro."
Bostic is an assistant clinical professor of psychiatry at Harvard. Harvard has been embroiled in these crazy scandals around psych meds over the last couple of years, most prominently involving Joseph Biederman, who is under investigation by Mass. General. It'll be interesting to see how the
hospital and university address these revelations around Bostic.
This is simply sickening. Numerous Forest execs knew exactly what was going on, according to the complaint.
There's more detail over at Bnet.com.
Another $120 came in yesterday from four contributors. That brings the total raised to $1,177 from 32 contributors and that leaves $2,823 and 68 to go by the end of March 6, which is next Friday. That leaves nine days.
Thanks to the 32 of you who've contributed so far.
I'd be dishonest if I didn't tell you that I am a bit worried about hitting that goal. Contributions are coming in slower than during other fundraisers. The reality for me is that if this fundraiser doesn't reach its goal, then I will have to back off my work here proportionately. I cannot justify doing work that the public doesn't appropriately support.
To put things into perspective, yesterday's post on the major conflicts of interest around Seroquel and AZ's former medical director was 2,100 words long. If I were getting $1 a word, the going rate at bigger magazines, then I would've made $2,100. But the big magazines simply don't care about stories like that one--Harper's, Mother Jones, the New York Times Sunday Magazine and so on. I've pitched them all vaguely similar stories about the intersection of human health and conflict of interest and pretty much been blown off and shot down. I don't even pitch them anymore. It's a complete waste of my time.
So I did the story on this site and was thinking in the back of my mind that it would jump start contributions. Obviously, it didn't. The article was widely-read and many of the readers were, aside from regulars, people from pharma companies (not the FDA though) and people from universities with major medical centers (Harvard, Columbia, Emory, Tufts, Stanford and so on all came through).
So my frustration is that I am sitting here doing professional quality work, but literally starving in the process. This site has between 5,000 and 6,000 regular readers and it should be an easy thing to get some of them to get together and contribute $5 to $50 and, boom, the fundraiser is over. But that's not how the new media we're making on the Internet works. Everyone counts on everyone else to support site X and site X goes unsupported. That's frustrating.
If you'd like to help end my frustration, the PayPal button is on the right. Of if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks for your support.
The Wall Street Journal is reporting that officials with the HHS inspector general's office are looking into questions of whether Emory University misled NIH about the work and consulting contracts of Charles Nemeroff, a professor of psychiatry there and recently removed as chair of the department.
"The probe by the inspector general for the Health and Human Services agency, which investigates fraud in NIH programs, concerns the work of Charles Nemeroff. From 2003 until last year, Dr. Nemeroff served as primary investigator on an NIH-funded research effort to study five GlaxoSmithKline PLC drugs for use as antidepressants. During that time, Dr. Nemeroff also received hundreds of thousands of dollars from Glaxo."A person familiar with the federal probe said investigators are examining whether Emory failed to tell the NIH about Dr. Nemeroff's potential conflicts of interest in conducting the research, and whether the university may have misrepresented the kind of work he did for Glaxo."
As I noted previously:
"Between 2000 and 2006, Nemeroff took in almost $1 million in consulting fees and whatnot from GlaxoSmithKline but copped to making less than $35,000 on university disclosure forms. And that's just for one company. Nemeroff was reportedly on the advisory boards of 12 pharma companies. He took in about $1.8 million between 2000 and 2007 from other companies for a total of $2.8 million. That works out to $400,000 a year."
If Emory is found to have violated NIH policies, the university could face a range of sanctions including losing its $251 million a year in NIH funding.
I know I'm merely a wee journalist on the West Coast and what I think about things doesn't matter very much to anyone, but the piece I wrote yesterday on a major conflict of interest around AstraZeneca's former Seroquel medical chief speaks to more than just how bizarre Big Pharma's behavior has gotten. It speaks to how bizarre things have gotten in the realms of Big Pharma--sexual relationships with a researcher who wrote positively of the drug along with yet another relationship with a ghostwriter who worked on published Seroquel studies that led to FDA approval of the drug--and just how weird the FDA is. The agency declined to respond to questions about the situation.
So as far as the FDA is concerned, you can pay off whomever you want in whatever fashion you desire and the FDA will approve your drug and won't do a thing to guarantee the data submitted to it about a drug's performance hasn't been fiddled with. That's how it looks at this point.
At a minimum, the FDA needs to review the October 2006 approval of Seroquel for bipolar depression. This was not an approval without consequence for AstraZeneca, despite having earlier approvals for schizophrenia and acute mania in bipolar disorder. In 2005, Seroquel sales were $2.76 billion. Sales hit $3.4 billion in 2006. The year after the bipolar depression approval, in 2007, Seroquel sales rocketed to $4.0 billion and hit $4.45 billion in 2008. That's 62 percent growth in less than four years.
That bipolar depression approval was a goldmine for AstraZeneca, but it had little to do with bipolar and much to do with depression. Last December, the FDA busted AZ for off-label marketing of Seroquel for depression. No sanctions against the company have been announced and the FDA still refuses to answer my inquiries as to what range of possible penalties the company might face. "We'll get back to you on that" has been the agency's basic response to me.
AstraZeneca currently has several applications for new indications for Seroquel currently before the FDA. Three of them are for depression.
Last month, the FDA ordered AZ to change its Seroquel label to warn of rapid weight gain on the drug, but the FDA refuses to tell me what data prompted them to order the change and refuses to offer details of what patients were experiencing. Bizarre.
Based upon former Seroquel medical director Wayne Macfadden's involvement with two women involved with the drug's approval, there are obviously serious questions floating around various studies of this drug and if the FDA is just going to ignore the conflicts, then you've got to wonder what it is exactly that the agency does. If the agency is interested in protecting public health and it already knows the company off-label markets its drug and that its drug cause rapid weight gain, a precursor to diabetes, then why wouldn't it look into the bipolar depression approval?
As it happens, none other than Tufts psychiatrist Danny Carlat agrees with me on how valuable the bipolar depression indication was:
"The drug’s approval for bipolar depression was particularly valuable, because it opened the door to off-label use in garden variety, unipolar depression—-a much bigger market than bipolar depression."
I have no idea how the FDA might resolve the conflict of interest issues around Seroquel--probably by ignoring them and hoping they go away--but for once I think it's time the public and legislators started demanding answers from the agency.
Straight from Reuters:
"The United States accused Forest Laboratories of inappropriately marketing the drugs Celexa and Lexapro for children and paying kickbacks to pediatricians who prescribe the drugs, the Justice Department said on Wednesday."Prosecutors said the antidepressant Celexa was no more effective than a placebo when taken by children or teenagers, and, in fact, more patients taking Celexa reported suicidal thoughts or attempted suicide."
From the DOJ itself:
"The Complaint alleges that a double-blind, placebo-controlled, pediatric trial found Celexa no more effective than the placebo for pediatric use and that, in the study, more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo. The negative efficacy data led the FDA to deny Forest’s request to approve Celexa for pediatric use. It is further alleged that, despite the FDA’s denial of a pediatric indication, Forest actively promoted pediatric use of the drugs and misled physicians and the public by failing to disclose the results of the negative study. The same study was among those later considered by the FDA when it mandated that Forest add a "black box" warning to both the Celexa and Lexapro labels."The Complaint alleges that Forest sought to induce physicians and others to prescribe Celexa and Lexapro by providing them with various forms of illegal remuneration, including cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment and other valuable goods and services, all in violation of the federal anti-kickback statute."
Oh, my, a federal agency admitting suicide and suicidality around SSRIs and alleging kick backs to doctors? Someone tell the FDA.
All joking aside, this is very serious stuff that's just breaking now and I'll hope to get more detail on it soon.
Another $80.74 came in yesterday from two contributors. That brings the total raised so far to $1,057 from 28 contributors. That leaves just under $3,000 to go from another 72 contributors by March 6. That's only 10 days to go.
Thanks to all who've contributed so far.
I've just labored long and hard over a major piece on conflicts of interest around the drug Seroquel. It's original reporting. You won't find it in any other media outlet. There are on the order of 6,000 regular readers of this site and I hope I can count on many of you to support this kind of work. I can assure you work like that doesn't come without lots of experience and expertise and it shouldn't come for free either. So please contribute today.
As usual, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll send you a mailing address.
There's been much news of conflict of interest between pharmaceutical companies and outside researchers possibly biasing the results of studies of psychiatric drugs over the last year. Notably, Sen. Charles Grassley (R-Iowa) has exposed researchers at Harvard University, Emory University and George Washington University, among others, as being locked in questionable alliances with companies such as Johnson & Johnson and GlaxoSmithKline. The researchers get hundreds of thousands of dollars and, then, perform research favorable to a company's drugs and often tout those drugs before their peers, claiming their research is independent of bias. The entire affair, along with revelations about how continuing medical education programs are funded, has given psychiatry a serious image problem and led to calls by everyone from the New York Times to this website to clean up the research system in America.
Now, a new tale of conflict of interest has cropped up, one involving a senior medical official at AstraZeneca responsible for the drug Seroquel who had sexual relationships with a British researcher, who studied the drug and wrote positively of it, and with an American medical ghostwriter, who among other things assisted in writing two published academic papers known as BOLDER I and BOLDER II, in the American Journal of Psychiatry in 2005 and the Journal of Clinical Psychopharmacology in 2006 that were at the heart of Seroquel's 2006 approval by the FDA for bipolar depression. According to court records, there is evidence Macfadden gave one of the women prescription painkillers and exchanged emails with them showing relationship of "control and dependence."
Simply put, I've never seen anything quite like these conflicts in my years of working the mental health beat.
"Anything like this clearly makes the data suspect if not dubious," says David Egilman, a Brown University professor and expert witness in one of the Zyprexa class action lawsuits (he was the initial leaker of the Zyprexa documents) and an expert on clinical trials and conflict of interest. "What are the journals, the FDA and the medical boards going to do when it becomes public?"
There are obviously all kinds of questions about conflict of interest in these relationships. Those questions, in my opinion, extend to the integrity of data, statistical methodology, study findings, publications, medical communications and drug approval applications tied to the BOLDER studies, as well as to many recent AstraZeneca-funded studies of Seroquel use in bipolar depression, as well as to several publications on schizophrenia and Seroquel.
The FDA did not respond to repeated requests for comment. I specifically pressed the FDA on the conflicts of interest, whether the agency had any regulations on these sorts of pharma exec/researcher relationships, and if the agency would launch a review of Seroquel's bipolar depression indication. The agency didn't even care enough to issue a "no comment," opting for silence instead.
Robert Freedman, editor the American Journal of Psychiatry, did not respond to a request for comment. The American Psychiatric Association, which publishes the AJP, did not respond to a request for comment. Richard Shader and David Greenblatt, editors of the Journal of Clinical Psychopharmacology, did not respond to a request for comment. I asked both journals' officials about how they would address the conflicts of interest and if they would review the published articles. But in an email from Greenblatt, which I was perhaps mistakenly copied on, Greenblatt wrote, "I suggest we say nothing further to this guy." All that anyone from the journal had written me was a brief email saying they get back to me if they had any comment.
I was unable to locate Macfadden for an interview.
"Any normal person hearing this story would question the validity of the data and would want it checked out independently," says Egilman. "The FDA should be in the catgeroy of normal people. But it wouldn't shock me if they don't do anything."
To its credit, AstraZeneca did respond to several questions.
"AstraZeneca had no knowledge of these relationships at the time," says Laura Woodin, an AstraZeneca spokeswoman in an email. Macfadden's relationships with the women ran from 2002 to 2006, according to court records. "Dr. MacFadden is no longer employed with the Company." Woodin added, "AstraZeneca has audited and stands behind the integrity of its Seroquel trial data."
Macfadden left AstraZeneca in 2006.
I'm not naming the women involved in this matter. They are not named in publicly-available court documents and there is argumentation in the court record that the relationships may have been ones of dependence for them.
A FLORIDA COURT FILING
Details for this story became available to me last week from a recent filing in open court, made available to me by a Florida reader of this site. The filing is from a federal court case in Orlando, Fla. involving accusations that AstraZeneca did not provide appropriate warnings about Seroquel and its tendency to induce diabetes in some patients. In the midst of pretrial motions in the case, attorneys for AstraZeneca filed a motion asking the court to exclude evidence of the personal and sexual relationships of Wayne Macfadden, a psychiatrist licensed in New Jersey, arguing they weren't relevant to the case. From 2001 to 2006, Macfadden was the US medical director for Seroquel and director of clinical research for central nervous system efforts by AstraZeneca. In a deposition in the case in 2008, given under oath, Macfadden admitted to a lengthy sexual relationship with a researcher at the Institute of Psychiatry, King's College in London, England and with a ghostwriter who worked at Parexel MMS (Medical Marketing Services) in the USs, according to court records. Neither woman is named in court papers, due to the obviously sensitive nature of their dealings with Macfadden. Both women were intimately tied to publications favorable to Seroquel and AstraZeneca, according to court records.
Officials at the Institute of Psychiatry did not respond to a request for comment. Parexel MMS did not respond to a request for comment.
Plaintiffs' attorneys filed their own motion last month, arguing that Macfadden's relationships with the women were "relevant and highly probative evidence of one high level AstraZeneca employee's determination to exploit his sexual relationships with these women in order to elevate Seroquel's status in the prescribing medical community through supposedly 'independent' publications of Seroquel safety and efficacy data," according to the plaintiffs' filing. "Moreover, the mere existence of these relationships calls into question the integrity of the scientific work product of those involved." You can read the plaintiffs' motion here (5 MB pdf).
THE BRITISH AFFAIR
The quality of the plaintiffs' filing that ought to make things easy for the federal court judge to rule upon are that most of the factual statements in the filing come directly from Macfadden's own deposition in the case. A hearing expected to be held in the case on Feb. 26. In addition to arguments on the AstraZeneca and plaintiffs' competing motions on Macfadden, the judge is also expected to take up AstraZeneca's earlier motion to have numerous other documents in the case sealed from public view and the Bloomberg wire service's counter-motion, fighting the proposed seal.
According to the plaintiffs' filing, Macfadden was responsible for a host of Seroquel-related activities at AstraZeneca during his five-year tenure. Macfadden planned Seroquel's clinical trials. He was involved in "ongoing diabetes discussions" at AstraZeneca. He advised the company on decision-making regarding the monitoring of glucose in clinical trials. He was "actively involved" in the marketing and promotion of the drug and sat on multiple marketing teams, including the so-called bipolar execution and strategy team (BEST). Macfadden was also a liaison to "key opinion leaders," researchers who promoted Seroquel to the medical community.
Also worth noting is that "In an effort to expand Seroquel prescribing beyond the field of psychiatry, Macfadden was consulted on the decision to market Seroquel to primary care physicians who treated patients with dementia," according to the plaintiffs' filing.
Sometime in 2002, according to the plaintiffs' filing, Macfadden "became involved in a sexual relationship with an IOP researcher who, as well as being involved in other Seroquel-related projects, participated in the clinical research and abstract preparation relating to the effectiveness of Seroquel for use in the treatment of schizophrenia."
There were also emails and other correspondence between the two as well as between Macfadden and the Parexel ghostwriter. The emails are currently under court seal, but details are alluded to in the filing.
"The IOP researcher suggested that Macfadden would 'punish' her if she even looked at studies that were favorable to Seroquel's competitors," reads the filing, referring to exchanges between Macfadden and the British researcher. "He actively encouraged her to conduct research the results of which would be favorable to Seroquel and AstraZeneca, and promised sexual favors in exchange for intelligence on Astrazeneca's competitiors."
According to the filing, during the time she was involved with Macfadden, the IOP researcher published several papers attesting to the effectiveness of Seroquel and of atypical antipsychotics in general. Her research was presented at unnamed conferences and was sent to American physicians in response to what are known as "physician information requests."
The British researcher mostly focused on schizophrenia, but it appears she may have written about Seroquel's use in other disorders.
THE AMERICAN GHOSTWRITER
As for the American ghostwriter, she worked for Parexel MMS where she was responsible for the Seroquel global publications business, "including the publication of BOLDER I and BOLDER II on which Macfadden was listed as an author," reads the plaintiffs' filing. She is openly credited on both studies as well as on other studies advancing Seroquel as a treatment for bipolar depression. What's more, she was responsible for posters and abstracts presented at medical conferences and medical association meetings, according to the filing.
Sometime in 2004, Macfadden and this woman became involved in a sexual relationship, according to the filing, at the same time that Macfadden was still involved with the British researcher. "In addition to his sexual involvement with the Parexel program manager, it appears he [Macfadden] also provided her with prescription painkillers."
Macfadden is a licensed physician in New Jersey.
Remember, it's the BOLDER I and II studies that were the basis of Seroquel's approval for bipolar depression. AstraZeneca says its hands are clean in regards to the two studies.
"We are not aware of a relationship any AstraZeneca clinical trial employee had with anyone outside AstraZeneca who was involved in the collection or analysis of any clinical data for the BOLDER studies," says AstraZeneca's Woodin in an email.
"CONTROL AND DEPENDENCE"
"The nature of their communications suggest a level of control and dependence between Macfadden and these women," reads the plaintiff's filing in part. "There is no doubt that Macfadden's relationships were never disclosed to the FDA or the medical community, though Macfadden agreed that sexual relationships between clinical researchers and management members of pharmaceutical companies can create bias which can affect the integrity of the science. Macfadden also acknowledged that sexual relationships can affect a person's judgment. Although Macfadden denies that his multiple sexual relationships with these women created a conflict of interest, he in fact teased the IOP researcher about the obvious conflict of interest as he reviewed drafts of her papers on Seroquel."
"Every time we think we've hit bottom [regarding the behavior of Big Pharma employees], we haven't," says Vera Sharav of the Alliance for Human Research Protection and a longtime critic of Big Pharma's alliance with academic psychiatry. "What is off-limits when it comes to the promotion of psychiatric drugs?"
In an email, AstraZeneca notes that its personnel work in teams, partly as a way to catch various oversights. Macfadden may have elevated the teamwork concept at AstraZeneca to new levels.
A footnote on page 10 of the plaintiffs' filing notes, "Macfadden has admitted to additional sexual affairs with a clinical researcher assistant at AstraZeneca and a clinical researcher in California also involved in the Seroquel clinical trials."
It is not clear what published studies, if any, these additional two women may have been involved in.
Two cases in the Florida federal court lawsuit were tossed out by a judge last month, but could be reinstated upon appeal. A plaintiffs' attorney did not respond to a request for comment.
Another $140 came in yesterday from three contributors, bringing the total raised so far to $976.26 from 26 contributors. I appreciate the contributions that have come in so far. The overall goal by the end of March 6 is $4,000 from 100 contributors, so there's $3,023.74 and 74 contributors to go.
If you'd like to support the work I do here, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll shoot you my mailing address.
For those of you asking for apparel and whatnot from this site, stay tuned. There will be a few items available, but not until April-ish as I'm still trying to finalize a design.
Christopher Schneck of the University of Colorado wrote an editorial in this month's American Journal of Psychiatry, attempting to sort out the treatment implications of two studies published in the same issue of the journal. The studies report on the problem of mania induction in patients given an anti-depressant who have a baseline diagnosis of bipolar disorder--I've already written about this study--and, separately, on how fully two-thirds of the patients in the STEP-BD study had subthreshold manic symptoms mixed with depression.
The big overarching question is who's having a genuine episode of depression and might warrant an anti-depressant versus who shouldn't be given an anti-depressant. Schneck's editorial mostly looks at the studies through the lenses of treatment and diagnosis, and makes a sensible recommendation.
"By reemphasizing the importance of evaluating racing thoughts, distractibility, psychomotor agitation, irritability, and pressured speech, clinicians may be able to better predict which patients have an underlying bipolar diathesis and thereby avoid giving them antidepressants."Recently, I evaluated three consecutive patients who presented nearly identical histories of long-standing refractory depression. All had been taking multiple antidepressants for many years, and all complained of irritability, crowded thoughts, and varying degrees of agitation. None had a history of clear hypomania or mania, with or without antidepressants, and none had a family history of bipolar disorder. The practitioners’ dilemma is apparent: are these cases of refractory unipolar depression that require more aggressive antidepressant treatment, or are there sufficient bipolar symptoms to introduce a mood stabilizer? Studies such as the two published this month help clarify these fundamental decisions. In light of the present findings, I was more inclined to consider my patients’ symptoms consistent with mixed depression, taper their antidepressants, and initiate treatment with mood stabilizers. Future controlled trials examining the efficacy of mood stabilizers in mixed versus nonmixed depression will further support or refute such treatment strategies.
"In addition, the findings from the Goldberg and Frye studies reemphasize the need to improve our current categorization of bipolar disorder, perhaps by including pure depression, mixed depression, mixed hypomania, mixed mania, and pure mania."
I've argued on this site for ages that what Schneck describes above often gets diagnosed as bipolar disorder 2 and that it strikes me that, absent true mania, it describes a state closer to agitated depression than it does classic manic-depression and I've wondered aloud why it merits the bipolar disorder label. It appears that Schneck agrees with me, at least in part.
My frustration with the bipolar disorder label, be it type 1 or 2 (or the possibly forthcoming type 3) is that people outside the clinical world of well-informed researchers and well-read patients--and that would be the general public--do not understand the distinction between subtypes of bipolar disorder and what those distinctions mean. So saying to someone that you are diagnosed with bipolar disorder type 2, especially a cautious employer, is tantamount to saying you have full-blown manic-depression because that's all the general public knows. You'll lose your job, or not get it in the first place, and that date you've got tonight will run for the hills. Some family members will make the same kinds of assumptions. So will the police, insurance companies and society as a whole.
The instant assumption people will make is that you are just like the manic guy they read about in the paper who went off his nut and shot a cop or stripped and ran naked down the street until the cops dragged him off to a psych unit. I don't care how many awareness-raising campaigns you or NAMI National or DBSA or whoever want to do on bipolar disorder. They simply won't cut ice with the public.
The sad fact is that people in America lose jobs, careers and their own little society each day due to being slapped with a diagnosis of bipolar disorder type 2 that should more properly be understood as "mixed depression," as the above author notes. It's time for psychiatrists, and especially those drawing up the forthcoming DSM-V, to realize that their diagnoses exist as much in a social context as in a medical context and that they need to be damn careful and extremely precise about labeling anyone with bipolar disorder (and some other disorders as well). It's time for these blasted 15-minute interview, first-visit diagnoses to go away.
I've had a flurry of emails involving others' experiences with this dynamic lately and I'm sick and tired of seeing this go on in our culture.
To the degree that this mixed depression diagnosis might help clear some of that up--let's face it, it'll be understood by most people as "depression"--I'm all in favor. I doubt that it would change much the treatments doctors would recommend, but you can only fight one war at a time, as it were. It would appear from the two other papers that treating someone with mixed depression with anti-depressants is a recipe for disaster and human suffering.
For those of you who think I am attacking you and your diagnosis of bipolar disorder type 2, I'm not. If you are comfortable with your diagnosis, then roll with it. I'm simply putting some things out into the Netosphere that must be asked and making points that must be made, or nothing will ever change.
Besides, where do you or anyone think all those false-positive diagnoses of bipolar disorder are coming from?
No matter where you stand on any of these issues, this is a pressing matter that demands sorting out and promptly.
"Madness Radio" is a fabulous interview program that delves into all manner of interesting and rarely-explored issues in mental health. It airs on a couple of Pacifica radio network stations and is available on the web. Back in December the show's host, Will Hall, interviewed Gianna Kali, author of Beyond Meds, and it's now available online. I listened to the first part and it's damn good. Those of you who know Kali's story will find it interesting listening, as she's really seen the horrors of psych meds and the mental health system and it's left her in very tough physical shape.
Kali offers her own update on her blog:
"Since December a few things have happened. I am indeed, now, completely housebound. I can no longer drive. I remain sane and stable mentally but am grossly physically disabled. I do trust that in time I will recover some of my physical health and wellbeing if not all of it."
I wrote about Kali's situation recently and her diagnosis of muscle damage due to 20 years or so of psych meds.
News is just out this morning that the parents of Rebecca Riley, a four-year-old diagnosed with alleged child bipolar disorder and ADHD who died in December 2006, are to have first-degree murder charges reinstated against them, after a ruling by a Massachusetts appeals court. Earlier first-degree murder charges had been reduced to second-degreee murder due to a judge's finding that no pre-meditation existed. Riley was on a host of serious medications, especially for a child, including Seroquel and clonidine. The latter is the drug that reportedly killed her in overdose.
"The Rileys say they were following the orders of Rebecca's psychiatrist, who had diagnosed the girl with bipolar disorder and attention deficit hyperactivity disorder. But prosecutors say the couple kept Rebecca and two older siblings loaded with psychiatric drugs to keep them quiet and to collect Social Security disability payments....""The appeals court called the evidence against the Rileys presented to the grand jury 'disturbing and graphic.'
"'Michael, who was abusive, preferred his car to the children,' the court said.
"The seven-page ruling also outlined evidence that Michael Riley directed his wife to give the children Clonidine, a blood pressure medication sometimes prescribed for attention deficit hyperactivity disorder, 'to quiet them down and make them "pass out."'
"'Whenever they began to annoy him, he told Carolyn to shut them up with Clonidine — telling her to "give them their pills" and "give them their meds",' the appeals court wrote.
"The defense maintains that Rebecca died of pneumonia."
We'll see where all this winds up.
The Riley case was a huge cause celeb and made its way to the New York Times, PBS and "60 Minutes." I've written about it, oh, many times.
An article in the UK's The Telegraph (London) poses that question in the wake of a well-known British philanthropist, Sir Peter Lampl, going through a change in anti-depressant medication (from what to what, the article does not say) and then going missing for several days. Sir Peter was later found at a train station. The case apparently got loads of attention in the UK and the fear among some was that regular Brits, learning of the story, might be scared away from taking their meds or away from visiting a doctor for a scrip.
Anyway, the answers to the question are interesting:
"Psychiatrist Dr William Shanahan, medical director at Capio Nightingale Hospital, London, is adamant that anti-depressants are safe. 'These drugs have their place. They work wonderfully for many people and lives have been transformed by them,' he says. He finds the case of Peter Stampl very unusual and difficult to explain without a full pharmaceutical history, but believes such an extreme reaction would probably be brought on by a combination of factors such as a build-up of medication, linked with another illness, stress or alcohol consumption."'This case may have scared people but these events are rare and often the result of other factors becoming involved,' says Dr Shanahan. 'You get interactions between substances, which leave the body in a state of toxicity and can create a feeling of confusion. And in this particular instance, there will be variables we know nothing about. It might be something unrelated to the depression.'
"But Dr Shanahan does warn of the 'normalisation' of taking anti-depressants, and that because they are so commonplace, we don't consider the risks. 'We are becoming too blasé about anti-depressants,' he says."
We are pretty darn blase about anti-depressants on this side of the pond as well. What amuses me about the doctors response is that he first defends them as safe, then admits there is much unknown about their interactions with other substances and their long-term build-up in humans (that kind of ignorance strikes me as being unsafe) and then says Brits are too blase about their use. That's barely a half-defense.
"Alison Cobb, senior policy and campaigns officer for Mind, the national association for mental health, believes that while the normalisation of anti-depressants is a good thing – 'depression is more acceptable; the taboo has been lifted' – there is a dangerous gap in public knowledge."'The names Prozac and Seroxat are so well known,' she says, 'that perhaps people don't recognise that they are serious drugs with side-effects, and the potential to cause withdrawal symptoms.'"
Mind is essentially like the US's NAMI National, except that it tends to be a bit more thoughtful in its pronouncements. You'd never hear NAMI describe anti-depressant as "serious drugs" with "withdrawal symptoms."
The only truly striking thing about the assessment of anti-depressant safety is this:
"There are real dangers in taking anti-depressants – notably the risk of death. Between 1993 and 2002, there were 4,767 deaths in England and Wales involving anti-depressant drugs, according to the Office of National Statistics."
The majority of those deaths--mostly due to overdose--were related to tricyclic anti-depressants, but about 10 percent involved SSRIs and other anti-depressants (ie, SNRIs and Wellbutrin), according to this study (pdf).
While I knew the old tricyclics were dangerous in overdose, who knew that about modern anti-depressants?
My own assessment of anti-depressant safety is that it's a mixed picture: Some people do roaringly good on the drugs and never have a problem. Others have horrible reactions to the drugs (heart attacks, suicide, suicidality, birth defects, incidences of violence, and so on and so on). And no one seems to be able to sort out why this dichotomy exists.
Not long ago, someone I know asked me to explain the wide range of responses to the drugs. I told her that the only analogy I could think of what alcohol: Some people take one drink and fall over and are drunks for life, crash cars, lose jobs and explode their livers. Others take a few drinks a day for life and nothing untoward happens to them.
Anti-depressants are weird like that. And just as with hooch, I doubt we ever get to a final answer.
A wave of contributions came in on Friday and over the weekend, bringing in $690 from 14 contributors. So far, the total raised is $836.26 from 22 contributors. The overall goal is $4,000 from 100 contributors on or about March 6, so that leaves $3,163.74 from 78 contributors to go.
Thanks to all of who've contributed so far.
My hope is that between now and the end of this Friday those remainders can be chipped away at significantly. So if you'd like to help with the chipping, the PayPal button is on the right. Or, if you prefer snail mail, drop me an email and I'll send you my mailing address.
Thanks to all of you for your support.
BTW, I'll be back later this morning with more posts. I lost a good portion of last evening to helping a friend with some stuff.
On Friday, New York Times "op-extra" columnist/blogger/sometime pharma apologist Judith Warner offered her take on news that some of those kids dumped on the State of Nebraska last year, during that state's doomed "safe haven" law experiment, were mentally ill.
"Recently, The Omaha World-Herald acquired 10,000 pages of case files concerning these children from the state’s Department of Health and Human Services. They paint a portrait of desperation – of out-of-control kids, overtaxed parents and guardians, and an overstretched health care system – that really deserves more widespread national notice."Because even though the mentally ill 'safe haven' children had extreme needs, and some of their parents and guardians had extremely limited capabilities (one grandmother said her charge had 'demons inside of him'; a mother who dumped her two teenagers in an emergency room said they were 'mouthy,' 'too much work' and 'need to be voted off the island'), what their stories have to say about children’s mental illness, parental limitations and the paucity of care available in our country is altogether typical. They illustrate how a lack of good care early on can create much bigger problems, for families and for society, in the long run.
"Their example also serves as a necessary corrective to the popular view that children being labeled mentally ill today are just spirited 'Tom Sawyers' who don’t fit our society’s cookie-cutter norms, with parents who are desperate to drug them into conformity...."
"This problem of lack of access to care – and lack of access to truly good care – is the real mental health 'epidemic' affecting children in our time."
As out there as the Nebraska story is, only 36 children were left with state authorities, hardly the wave of kid dumping that was bandied about the press last year.
To use such a small subset of the population of children and teens in this country as one's argument for an epidemic is simply lazy thinking, lazy editing or a prime example of someone rushing out their weekly missive from the DC Beltway. Because what Warner is saying in her piece is that 36 kids were so mentally ill that it proves how wrong are the critics of the pathologization and psychopharmacologization of American childhood (myself included) and that we're guilty of being simple-minded. Hence, the Tom Sawyer gibe (I'd argue for Huck Finn myself).
The trouble is she's using a statistically small, self-selecting universe of particular problems (and lack of access to care to fix those problems) to argue for a much broader epidemic in the land. The Biederman camp and his defenders do much the same based on another self-selecting universe, again statistically-small, of children and teens with extreme problems, as if they were the norm of the abnormal. Theirs voices are loud and listened to because they write for the Times and are connected with Harvard and are well-plugged into major media in a way that loads of critics aren't.
It's also the voice of a firm believer in the prevention paradigm in mental health. Screen kids for problems early, detect problems early before they erupt into full-blown syndromes, pack the kids off to the doctor, get them medicated and future problems will be prevented. If only that were true in either children or adult psychiatry (it sometimes looks true though, but in my experience not over the long term).
Remember the 2007 ADHD studies that generated so much controversy--because one of them showed that even ADHD kids ended up with normal brain development over time regardless of whether they were on or off-meds--and led Warner to declare:
"But where I differ (now) from those eager to pile onto the anti-ADHD bandwagon is that I’m not willing — anymore — to sacrifice real children and their parents on the altar of ideology."
That's a fine sentiment and Warner would do well not to use these kids who were dragged to Nebraska as an excuse to sacrifice "real children and their parents" on the altar of extreme cases in Nebraska.
To the degree that Warner is pointing to limited access to mental health care for kids and teens in rural areas (some of the Nebraska dumpees were from Oklahoma and Georgia), she has a fine point. It's not much better in big urban centers. But the trouble is once you get a kid into see whomever, often the diagnoses and solutions offered are not particularly workable. Just ask Rebecca Riley's parents.
While obviously some of the Nebraska kids were way out of hand, does Warner really think that putting them in a psych unit is goign to solve things? Short-term, sure. Long-term, more questionable. As fouled up as some of these kids appear to have been, it's interesting to note that Warner isn't the least bit interested in what kid of home environment these kids came through and assumes instead that we've just got all these naturally-disordered brains and kids flying around. Sure, there are some, but argue that some kids in America who have "issues" aren't Tom Sawyers and that they are baby John Hinckleys based upon 36 very extreme cases is a bit much.
Just a brief note to let you all know that yesterday and so far today $510 came in from 11 contributors. That brings the total raised to $706.26 from 19 contributors. The overall goal is $4,000 from 100 contributors by the end of March 6. So that leaves $3,293.74 and 81 contributors to go.
Thanks very much to all of you who've contributed so far.
For those who'd like to contribute, the PayPal button is on the right or if you prefer snail mail send me an email and I'll pass along my mailing address.
Thanks again for your support.
Another $66.26 came in yesterday, bring the total raised so far to $146.26 from seven contributions. That leaves $3,853.74 and 93 contributions to go to reach the goal of $4,000 and 100 contributions by the end of March 6. I appreciate all the contributions to date, as well as the people who've pledged to send me checks.
All the same, I'd love to see the numbers climb significantly and I hope they do today and over the weekend. As usual the PayPal button is on the right, or if you prefer snail mail, send me an email and I'll send you my mailing address.
Those of you who've been around for a while would be staggered at the number of readers this site now has from pharma companies--and I'm talking people who read from their work site, not from home. The same is true of big law firms and PR agencies repping "America's pharmaceutical research companies." Charming as that may be, you and I both know that they won't be contributing, and neither will any of the two dozen folks who read this site from Massachusetts General Hospital. But they are paying attention.
I'm not making this up. Yesterday, California Attorney General Jerry Brown filed a criminal complaint against three officials at a Lake Isabella, California nursing home. From the Los Angeles Times:
"The state attorney general's office contended in a criminal complaint that more than 20 residents at a skilled nursing center run by the Kern Valley Healthcare District were drugged 'for staff convenience.' Many of them experienced side effects that included dramatic weight loss, slurred speech, tremors, loss of cognition and even psychosis, according to the complaint."
It's been a very long time since I've seen hospital officials charged with crimes. Expected to be arraigned later today are Hoshang M. Pormir, former medical director, former nursing director Gwen D. Hughes and former chief pharmacist Debbi C. Hayes. The three were arrested and jailed in Bakersfield on Wednesday. According to filings in the case, about two dozen patients were slammed with various psych meds, a few of them forcibly and without proper consent.
You can read the statement from AG Brown's office here. At the bottom, you'll find the felony complaint and its supporting declaration. Here's one ugly bit from the AG's declaration in support of the felony complaint (essentially a probable cause document):
"Opal Towery, who received Resperidol by intramuscular injection suffered harm. This medication stayed in her body for a month, and there was very good documentation by nurses of her adverse reactions, such as drooling, being noncognizant, being completely dependent of care, having severe tremors, and falling."
More:
"Lightner [a former nurse there] stated that KVHD was using psychotropic medications as chemical restraints such as Zyprexa, Depakote, Resperidol, and Seroquel, on many of their residents during the approximate time period of August 2006 through January 2007. The use of the psychotropic medications were ordered by former KVHD Director of Nurses (DON), Gwen D. Hughes.
"Lightner stated that Hughes ruled the nurses with an ‘iron fist’ at KVHD. Hughes did not tolerate any nonsense from the nursing staff or from any of the residences. Hughes created an extremely hostile working environment for the nurses by her stern management style. Hughes would order psychotropic medications for minor behavioral issues displayed by the residents. Many of the residents at KVHD suffered from Alzheimer’s or Dementia. Many of these residents were nonviolent, but moved around the hospital and were vocal. Due to their medical conditions, the nursing staff tolerated the residents moving around the hospital and talking among themselves. Most of the residents were innocent and not harmful to one another or to themselves. Hughes did not tolerate the behavior of residents who were vocal, loud, or being free to roam the hospital. She wanted to calm them. Hughes accomplished this by directing the KVHD Director of Pharmacy, Debbi Hayes, to write prescriptions for psychotropic medications to administer to these residents. This was done without a psychiatric or medical diagnosis performed by a psychiatrist or physician on the residents."
It gets worse, but one of the nurses tried to stand up for the patients:
"Shortly after Hughes became the DON in August 2006, she began ordering the residents to be put on these psychotropic medications. Lightner and the other nursing staff began to notice many dramatic changes in the behaviors of the KVHD residents. The residents were very lethargic, slept around the clock, some could not talk, some were not cognizant and were like complete “zombies.” Some of these residents became completely dependent for care, could not eat or drink, some became nonambulatory, and sat in geri chairs all day or were bedridden. Before the psychotropic medications were administered, most of these same residents, while at KVHD, were mobile in wheelchairs and were able to talk, eat, and drink, and bathe without assistance. Lightner believes that approximately over twenty residents were affected by the use of the psychotropic medications."Lightner began doing her own research on these psychotropic medications. Lightner
began informing the other nurses of what these medications were intended for and the risks they posed to the elderly. All of the nurses felt that it was wrong to administer these psychotropic medications to the residents and they voiced their disapproval to Hughes, Hayes, and Dr. Pormir. However, Dr. Pormir did not want to discuss the issue with the nurses."Hughes verbally threatened Lightner and all of the other LVNs and RNs that if they
refused to administer the psychotropic medications ordered to the patients, Hughes would report them to the State of California to have their nursing licenses taken away, and then they would be terminated by KVHD. All of the nurses were fearful of Hughes."Hughes ordered KVHD resident, Gayle Hamilton, be put on Depakote due to Hamilton
refusing to eat in the dining room. Hamilton had always eaten her meals in her bedroom prior to Hughes being hired. Depakote sprinkles were to be put into Hamilton’s food which was written on the doctor’s order. Lightner stated that this written order was in Hughes’ handwriting."KVHD resident, Opal Towery, threw her milk in the dining room, so she was injected
with Zyprexa by LVN Julie Aguirre. Aguirre told Lightner that Hughes had ordered her to inject the Zyprexa into resident Towery. Towery told Lightner that she did not know the injection was for Zyprexa, but was tricked to believe that the injection was for another drug, Ativan. Towery stated to Lightner that she had signed a consent form to be injected with Ativan, not Zyprexa."
Based upon that kind of evidence, it's no surprise that the three hospital officials face criminal charges and have been jailed.
So John McManamy has gone and done it--gone and called my writing "dumb antipsychiatry." Seriously, you can check out that humdinger right here. McManamy is the author of "Living Well with Depression and Bipolar Disorder," but one wonders how well he's living now that his blog at Health Central has been shit-canned (he was well-paid for his once-weekly posts, however) and his McManweb.com site is running ads for psych meds--there was one the other day for Concerta, when I swung through to see what the self-styled king of recovery was up to.
Anyway, McManamy has a new blog called Knowledge Is Necessity. As far as I can tell not many people read it or find it necessary. The other day, its author was talking anti-depressants and bipolar disorder and took a swipe at moi:
"Indeed, the possibility of a new 'bipolar III' diagnosis was the basis of a blog post last week from Furious Seasons, fairly typical of antipsychiatry sentiment:"'I think it's been a boon to doctors - who get a patient for life - and Big Pharma - which gets a long-term customer - but I have my doubts about how useful the depression-is-bipolar thing is for patients who wind up on an atypical and an anti-seizure drug when they are dealing with something that's not even in the ballpark of mania.'
"To respond in brief:
"Yes, big pharma would love a customer for life, but to make a case for a drug industry conspiracy one would have to bend time a hundred years."
Better to bend time than to bend human nature and moods for billions in sales and thousands of deaths and oodles of journal articles, eh, John?
I've wearied of the attacks my writing has gotten of late. Maybe I should be flattered that someone like McManamy feels the need to get attention for himself by throwing the anti-psychiatry barb at me, but here's why I don't feel especially charitable. McManamy has been one of the biggest defenders of the bipolar child paradigm out there. He's been a passionate defender of Fred Goodwin. And, yet, McManamy can never find it within himself to understand the level of corruption in the mental health world. Maybe that's why a little over two years ago, when I was making the Zyprexa documents available to the public and going up against Eli Lilly, McManamy was going on book tours, divorcing his wife who'd supported him while he wrote said book and moving off to the desert of San Diego County to find himself.
The truth is I've never seen McManamy lay it on the line for his fellow bipolars and depressives. Not a peep out of him on Seroquel, Abilify, Risperdal and so on. I guess he thinks these drugs are good for adults and kids and all those lawsuits against their makers and criminal pleas and a dead girl in Massachusetts and boys growing boobs on Risperdal and whatnot are nothing but "dumb antipsychiatry" and not even worth alerting his readers to. And as for schizophrenia, I've never read a word of his on the subject and would be scared if I did. So that's McManamy for you.
As for me, I've never had to find myself. I've been here all along. And, I sure as hell am not an anti-psychiatrist. In fact, I had to ban yet another one from this site last week for being way-too-over-the-top. Or was that "Smart antipsychiatry?"
Henry Nasrallah, a professor of psychiatry and neurology at the University of Cincinnati, is also the editor of Current Psychiatry. A reader of this site--a psychiatrist, as it happens--passed along an editorial by Nasrallah in the journal, purporting to map out psychiatry's promising future. The reader called some of the editorial "scary."
In it, Nasrallah describes six "trends that will shape how we practice psychiatry." It's aimed at clinicians in private practice.
"1. Earlier diagnosis and early intervention. The past decade has witnessed a surge of progress in identifying individuals at high risk for psychosis or mood disorders. The 'prodrome' has become a fertile area of research, with a focus on early 'treatment' even before the clinical syndrome of schizophrenia or mania appears. The goal is to try to delay, modify, or ameliorate incipient serious mental illness by using both pharmacotherapy and psychotherapy."
What Nasrallah is getting at is that some in psychiatry believe they can identify people at-risk for developing psychosis and zap them with antipsychotics and, then, they'll never develop schizophrenia. But the one big trial of this approach--the PRIME study at Yale--was a disaster. I wrote about it in 2006. About half the patients bailed from the study, mostly due to side effects of Zyprexa. Overall, only about one-quarter of the 60 original participants experienced psychosis, which perhaps calls into question the power of initial assessments.
"Study authors concluded that the drug didn't prevent psychosis, but perhaps only delayed its onset. But they couldn't--or wouldn't--say for sure whether that alleged delaying (a few months, tops) was the result of some patients taking the drug and getting a benefit from it. But, then, only 16 percent of the patients who took the drug received a benefit at all. That's just way too small a number to be enthusiastic about using Zyprexa for people believed to be at-risk of developing psychosis--schizophrenia, in other words."
Let me point out that the study led to an exchange of letters in one journal where one researcher openly questioned the ethics of giving teens Zyprexa.
Although a so-called psychosis prevention program based in Portland, Maine, has gotten some attention in the popular press, the reality is that none of that program's work or claims have been published or peer reviewed yet. So this whole prodrome thing is pretty dubious to me.
What spooks me about Nasrallah's cheerleading is that he and other researchers think they can actively identify psychosis before a first episode--so we're talking teens here--and if such thinking gains credence in the field, then we are going to see a raft of screening programs around the country targeting teens with lip piercings and dyed hair, and I simply don't want to see that day come. This determinism that Nasrallah and others in psychiatry seem wedded to spooks me.
Nasrallah's claim that this would work for mood disorders too is a new one on me.
"2. A tsunami of genetic discoveries. Almost weekly, psychiatric geneticists are discovering genes associated with serious psychiatric disorders. Neuregulin 1, dysbindin, DISC1, DAOA (G72), PRODH, and COMT are among the many odd-sounding genes located on various chromosomes. These discoveries confirm the 'complex genetics' of psychiatric disorders involving dozens—even hundreds—of susceptibility genes, in contrast to the '1 gene, 1 disease' Mendelian paradigm."
To date, all this gee-whiz talk about genetic discoveries and gene therapy had led nowhere--not a single treatment has resulted and I've not seen a convincing study that can identify one gene or region of genes and say that's where disorder X comes from. But that hasn't stopped docs for trying to devise blood tests for bipolar disorder and psychosis, the use of which would be very controversial, especially since the researchers cannot offer proof that those genes identified through such testing will result in bipolar or schizophrenia.
The reality that people like Nasrallah have a hard time facing is that bipolar disorder, to pick one example, is not the sole result of genetics.
Nasrallah does make interesting points about "Neuroplasticity as treatment target," "Neurostimulation for brain repair" (ie, deep brain stimulation, TMS), although none of these techniques are in anything approaching wide use yet. I do worry a bit about his claim here:
"Pharmacogenetic screening in clinical practice soon will become routine—it already is at a few U.S. academic hospitals—and will enable psychiatrists to customize drug treatment to achieve better efficacy and tolerability for each patient. This will help us adapt therapies to address genetic variations within our ethnically diverse society."
There's some reasonable evidence now that a huge percentage of Americans cannot respond to anti-depressants due to four genes they share. My worry isn't that a series of gene screen tests will come along to help tease out who might respond to what medication they might respond to (that might save someone a bad reaction to, say, Paxil), it's that this whole thing bespeaks genetic determinism and I've not seen where that's gotten us very far in mental health treatment.
So far, $80 from four contributors has come in to date, leaving $3,920 and 96 contributors to go before the fundraiser reaches its goal of $4,000 and 100 contributors sometime around March 6.
Thanks to all of you for the contributions to date. I know a couple of others are coming via USPS, but for the rest of you it would be great if you'd make a contribution, however large or small.
As ever, the PayPal button is on the right or if you prefer using snail mail, send me an email and I'll send you my mailing address.
BTW, I am in the process of doing some reporting for what promises to be a major bit of news and I hope to be able to write about it by the end of next week.
So yesterday, I got what's got to count as one of the most satisfying bits of reader feedback in 15 years of journalism:
"I would also like to thank you for Furious Seasons. My daughter was 13 when she received a diagnosis of 'bipolar.' The doctors never seemed to understand that before they started medicating her (26 medications in all) she had zero symptoms for the disorder. Your site gave me the information I needed to support my decision to withdraw her from all medication in spite of extreme opposition from her doctors. Within 2 weeks she said for the first time in two and a half years she did not feel depressed (which is what she was originally seen for) and she no longer acted psychotic. It took another year before she was completely recovered. She is now 19 and working. More importantly she is happy and healthy. Furious Seasons played a crucial role in restoring her health and happiness. I can only say thank you thank you,thank you,thank you."
I asked her for some more detail:
"Her original diagnosis was made by a social worker after a 45 minute conversation. The social worker immediately had her admitted to a psychiatric hospital. Once there a psychiatrist talked to her for about 10 minutes before he put her on Zyprexa. They did not ask for permission from her father or me to do this. Within 1 day her condition worsened dramatically. When we told the doctors we believed the medication was making her worse their position was that they had caught it just in time and without medication she would be much worse.Through 5 psychiatrists, 3 hospitalizations, 26 medications (in more combos than I could count), through daily episodes of rage or depression when she would sob for hours, even through watching her gain 80 pounds while at the same time losing her cognitive abilities and short term memory to the point where she had to drop out of school, her psychiatrists held firm to that opinion. While she was going through all this I was searching for every bit of information I could find about being bipolar and the medications they were giving her. Furious Seasons was the first site I found that logically and calmly exposed the lack of real scientific facts and evidence which would support the pharmaceutical treatment my daughter was receiving. It was when my daughter seemed to be developing T.D. (she had been on antipsychotics for 2 1/2 years at that point......I did not learn about the risk of developing movement disorders from medication from any of her doctors, I learned about it from your site) that we decided we had to stop listening to the doctors. It took about 2 months to withdraw her from the medications. It took another year for her metabolism, memory, and ability to learn to return to normal. She lost all her high school years and most of her friends. Thankfully she says she can't remember much of what she experienced. I remember almost every minute of it."
I'll leave it at that.
Last week, on his blog at Psychology Today Narris Ghaemi, a professor of psychiatry at Tufts University, wrote about the recent WHO study examining the question of anti-depressant use and suicide. I wrote about the WHO study here. The link to suicide is an important question because 30 million Americans take an anti-depressant each day and many tens of millions the world over do as well, and true believers in anti-depressants have fought back very hard against evidence of a link to suicide. As I've noted before, Ghaemi is no fan of anti-depressants.
Anyway, here he writes some of the most sensible words on the issue that I've ever seen come from a doctor.
"We psychiatrists have a problem with antidepressants; we have been so committed to giving them for so long that it is scary to think that they might be harmful. Side effects are bad enough, but suicide seems incredible to imagine. Yet the FDA came to that conclusion about 4 years ago."Since then a slew of studies have appeared in psychiatric journals challenging the FDA view; a recent WHO study put them all together, and could be interpreted as showing that clinicians were right all along: antidepressants are safe, at least in adults (the WHO study continues to find risk in children, but less in young adults, unlike the FDA analysis, which found risks of suicide in young adults as well)....
"The FDA review was based on randomized studies; the WHO review on observational studies. The former is more valid than the latter, and thus it still should be believed.
"This is a relatively simply matter, widely agreed upon by those who use statistics, so I do not think we can ignore it. Other arguments about the limits of the FDA analysis also fail: The studies in that analysis were not designed to assess suicide, indeed they excluded highly suicidal people. So much the worse for antidepressants: if suicidality is seen even in those at low risk for it then we really have a problem. Also, the claim that the FDA studies wrongly defined suicidality has been assessed already by a reanalysis of those data assessing truly suicidal behavior, conducted carefully by researchers at Columbia university, and the suicide risk persists.
"I think the link is real, though small, and not inherently due to something evil about antidepressants; rather the problem may be in us, rather than the drugs; it could be that we doctors are just using these drugs excessively or incorrectly."
Gee, I think some of us could've written this.
Today, I am beginning the spring fundraiser for this site. Yes, I know it's still technically winter, but the fundraiser in early December was dubbed winter, so this one shall be spring. I'm starting this fundraiser five days earlier than I'd originally planned simply because I am going to be moving somewhere between March 1 and March 15 due to my property manager changing my lease behind my back after six years in my apartment. I might delay moving until the end of March because, due to the economy, the rental market in Seattle is flooded with available rentals in a way no one has seen in this city in decades, but landlords have yet to realize that they are in a price war and bring down their rents accordingly. That's starting to happen but it needs to pick up steam before I sign a lease.
The goal for this fundraiser is $4,000 and I hope to hit that goal by March 6. During the last fundraiser, 70 people made contributions large and small. This time out, the goal is 100 contributions. This site currently has about 6,000 readers who Quantast pegs as addicts (several times a day readers) or regulars (several times a week readers), so these goals should be doable.
As usual, the PayPal button is on the right. For those who prefer sending checks, if you don't know my mailing address, send me an email and I'll send you my mailing address. Thanks to all of you for your support.
Ironically, I got a donation out of the blue on Monday, so the remainder to be raised now stands at $3,985. I know the economy stinks badly right now, but this is one of those times that when a bunch of people pull together in a small way, then things get done.
For the newer regulars amongst you, let me answer two inevitable questions that come up: why don't you have ads on your site? Why aren't you a non-profit?
I don't have ads for a few reasons. One is that those little text ads you see all over the Internet don't generate much more than $2 or $3 a day, in my experience, and the company's who offer the ads are very tricky with their payouts. For example, in late 2007, Google ripped me off to the tune of about $600. Two, I have little control over the content of text ads and many of those ads, in my experience, for sites like this turn out to be stealth ads for various psych meds. I simply don't want ads for psych meds on this site. Three, I've approached several of the companies who do run banner ad services (these pay better than text ads) for smallish web sites, but to date none have responded. My sense of things is that the contrarian nature of this site scares them off. No easy sales to Big Pharma through me!
So in attempting to keep psych meds ads off this site and tell what I consider to be the truth of their products and paradigm, I am paying a price.
As for the non-profit issue, in Washington State it runs about $1,000 to become a non-profit, or so I'm told, and that's simply not money I have right now.
For those of you who wonder about why you might give $50--or$5--to this site, consider the last few months: boys growing boobs thanks to Risperdal; defanging the half of college kids are mentally ill story; continuing to deal with the Fred Goodwin conflict of interest story; banging on the dangers of atypicals; revealing that Seroquel's diabetes problems were known back in 2000; the FDA busting AZ for marketing Seroquel off-label for depression; psychiatrist Gene Combs questioning his own profession; publishing a Christopher Lane op-ed the newspapers wouldn't touch on Prozac violence; waving the flag on post-combat PTSD; pointing out that Sanjay Gupta would make a poor Surgeon-General and pointing out that he lied about kids, suicide and SSRIs on CNN's airwaves; noting the huge placebo effect in kids' depression trials; celebrating Lilly's latest Zyprexa settlement and criminal plea; getting praise from elsewhere in the blogosphere; getting sleazed by Rolling Stone; pressing Lilly to half-apologize to some patients its drug harmed; pointing out how the rest of the world is skeptical about the bipolar child paradigm; being denounced by a defender of the bipolar kids who-ha; and probably some other things as well.
Thanks to all of you for reading this site and for supporting it.
As I noted yesterday, lawyers for AstraZeneca, makers of Seroquel, moved last week to seal numerous documents in a forthcoming federal court case involving the company and its $4.5 billion a year drug and to close an upcoming court hearing to the public. It's a move that runs counter to America's long tradition of open courts and the press' right to report on court proceedings. I had hoped at least one press organization would file a counter-motion to AZ's and indeed the Bloomberg wire service did last Friday. Thanks to a friend, I've now obtained both AZ's original motion and Bloomberg's motion and am making them publicly available. Please note that the AZ filing came to me in text form from a legal database, so the formatting and pagination isn't the best, even after I tried to clean it up. That motion is here.
Anyway, AZ lawyers argue, in part:
"Selective publication of these documents by Plaintiffs before trial, however, would present incomplete and out of context information relating to Seroquelís safety and efficacy to the public. This could mislead the public and healthcare providers and create a potential public health risk. To the extent this information is offered at trial, the documents will be placed in context and the whole story will be presented at once."Third, allowing plaintiffs to publicly disseminate a handful of cherry-picked documents containing out of context and incomplete information will present a misleading and unfairly negative image of AstraZeneca right before trial and taint the potential jury pool."
There are other reasons cited by the company's lawyers to seal the documents, but those are the gist--public health problem and tainting of possible jurors.
Keep in mind that many thousands of pages of Eli Lilly's internal corporate documents were under a court seal, but were leaked to the New York Times and, later, to me in late 2006. The paper and I (and others) reported on them extensively for the next two-plus years. I know of not one case of a public health problem erupting as a result or of oodles of patients going off their Zyprexa without consulting a doctor. If someone at AZ or on its legal team wishes to show me where the release of those documents into the public realm caused problems for patients, you know where to find me. But, as such, AZ's legal argument on this point is specious.
So, too, is its "tainted juror pool" line of reasoning. The media, for example, reports on murders and accused murderers all the time in advance of trial and I don't know of too many instances of juries not being able to sort through facts presented at trial because they were unduly influenced by pre-trial publicity.
The bottom line here is that the public has an absolute right to know the details of whatever hinkey-dinkey AZ may have allegedly been up to with Seroquel and it's the press' job to let the public know. Even Judge Jack Weinstein, who oversaw (and still oversees) Zyprexa litigation in federal court on New York and who originally was quite upset when the Zyprexa documents were leaked, later had a change of heart in 2008, a fact noted by Bloomberg's lawyers:
"'Public access' Judge Weinstein wrote, 'is now advisable because this litigation involves issues of great public interest, the health of hundreds of thousands of people, fundamental questions about our system of approval and monitoring of pharmaceutical products, and the funding for many health and insurance benefit plans. Public and private agencies and organizations have a right to be informed. At this stage public disclosure, congruent with our long tradition of open courts, is desirable'....""The plaintiffs’ allegations against AstraZeneca in this case are similar to the allegations made by the plaintiffs in the Zyprexa litigation. The world therefore is watching this litigation closely and with great concern that yet another pharmaceutical product may have been widely marketed without adequate warning of its health risks. Investors in AstraZeneca also are watching closely for fear that AstraZeneca will suffer a similar fate to that suffered by Eli Lilly. Many observers also are watching this litigation to assess how the Courts deal with claims that may have enormous impact on public health and welfare."
You can read the Bloomberg motion in its entirety here.
I hope the judge in this case rejects AZ's motion and rules in favor of the public's right to know.
Separately, the editorial board of the St. Petersburg Times opined yesterday on this case that:
"[T]he real public safety issue is one of public health and whether the company hid findings that Seroquel causes weight gain and diabetes. The legal system must put public health — and a patient's right to know — above a company's interest in secrecy...."There is altogether too much secrecy in court cases that implicate public health. If the records being held back contain information that the judge would like to know before taking Seroquel, then the public should know as well. No other interest should take precedence."
I agree.
I've been hammering on issues around children's mental health on this site for pushing three years now and have long made the point that much of the medicating of children in our culture (and I mean prepubescent here) is happening to boys. I've also made the point that kids in general, and boys especially, simply don't get enough play outdoors (for a bunch of reasons, obviously), don't play sports enough and so on compared with my generation. Now, there's a new book out that, in part, agrees with me and a few other braves souls in the realms of child psychology. It's called "The Trouble With Boys" and it's written by a Newsweek staffer, Peg Tyre.
According to Ars Technica:
"The idea for the book began when Tyre, a senior writer for Newsweek at the time, wrote a 2006 cover story for the magazine, called 'Boy Crisis.' The article focused on how boys were falling behind in school and what educational institutions were doing to address the issue. The figures are certainly worrying, according to Tyre: 'Boys get expelled from preschool at four times the rates of girls,' she writes. 'They are prescribed the lion's share of ADHD medication, they get most of the C's and D's in middle school, and they drop out of high school more than girls. Currently, only 43% of undergraduates in the United States are men." So what's the solution? Tyre's suggestion is simple enough: let boys be boys by simply letting them engage in the aggressive fantasies that come to them naturally.'"
What Tyre found was that violent video games, contrary to received wisdom, were actually beneficial to boys and didn't turn them into Columbine killers. Boys cogitate around violence. So do men, to lesser degrees, but it's generally just something in our internal mythologies and our hunter-gatherer cores that has got to be acted out in some fashion or we end up as lumps of mush or sociopaths. I don't claim that to be true for all boys and men, but it's true for plenty. Not everyone gets this. As the Ars Technica writer notes:
"If you've been around schools or youth organizations recently, you've probably seen how even playfully aggressive behavior is often demonized by both parents and other adults. A case in point from my own experience: when I served as an assistant scoutmaster for my Boy Scout troop at a summer camp in 2003, a number of parents complained about the fact that the Rifle and Shotgun Shooting merit badges were available as part of the camp's curriculum. They believed that teaching teenage boys the standard safety, care, and operation of firearms was wrong."Five years earlier, such complaints were unheard of, even in a suburb directly over the hill from Berkeley. This attitude, though, seems to have permeated the entire country."
Ah, how special the smarty-pants Bay Area can be.
I grew up miles away from that unnamed suburb in an age when kids of both genders played outside constantly and boys got in rock wars and dirt clod fights (when they weren't playing sports) and no one thought anything was particularly bad about that, even when their kid came home with a gashed scalp. Seriously. And boys of that early Gen-X time almost all knew how to use small guns, with or without a merit badge.
While some readers might think that sounds like a barbarous time, consider this: 6.6 percent of American boys now take psych meds of some kind, twice the rate among girls, compared with the 1970s when almost zero boys took a psych med of any kind (girls didn't take them either) and we were considered within behavioral norms. Now, we want our kids quiet and pliable, not that we didn't when I was a kid, but we used discipline and reinforcement then instead of Ritalin and Seroquel.
I'm not saying this to stigmatize the rush to turn kids into a generation of mentally-disordered kids, but to point out that we've made an epochal shift in our culture in how we regard childhood behavior, especially at school, and that it doesn't seem to be working out so swell for boys and young men. That males are so outnumbered by females among college graduates now worries me greatly. One commentator speculates that ADHD meds are making boys act like girls.
I suppose conservative critics would just ascribe all of this to feminism run amok and the "wussification of America," as a guy I know puts it, but I think these things are often more complicated than that. Besides, men are actually going along with this program--at least when they are present in a family--and I'm not sure why. Sure, there are post-whatever feminists such as the New York Times' Judith Warner who think all the fuss about kdis and boys being doped up is mere narrative.
But I can't see where steering boys away from contact sports, making sure they know nothing about guns and fishing, and keeping them away from violent video games while sticking them on Adderall and Prozac has produced an outstanding generation of young men. I almost never use the term epidemic, but I can assure you that there is an epidemic of young men in this country getting young women pregnant and then taking off on them and the kid. It's complete wuss behavior. That ought to tell you as much as the rate of psych med use. It ought to tell you that something has changed dramatically in our culture about being a man, and a boy.
I'm not silly enough to think video games are key to all of this--they are but an interesting measure of where culture stands--but it is an interesting thesis Tyre has there.
A bit of a row has cropped up in the UK over a paper in the Journal of Psychopharmacology, authored by David Nutt, a psychiatrist at the University of Bristol and head of the UK's Advisory Council on Drugs Misuse. In the paper, Nutt created a fictional addiction called "equasy," or addiction to riding horses, and detailed its risks. Apparently, 1 of every 350 horse riders will suffer a brain injury or death from riding horses whereas only 1 in 10,000 people exposed to Ecstasy (aka MDMA) will. Horse riding is legal, X isn't. Nutt's argument is that, viewed against culturally-acceptable activities such as rugby and motorcycling, illegal drugs aren't so dangerous.
It's a fair enough argument, as far as it goes, but a furor erupted both because Nutt is advising the British government on reclassifying classified drugs (they have a system similar to the US's drug scheduling system) and because, according to the BBC, he wrote the following in his paper:
"Drug harm can be equal to harms in other parts of life. There is not much difference between horse-riding and ecstasy."
Nutt was criticized for trivializing drug use and was the object of comment in the House of Commons. The only weird thing is that I cannot find such a statement in his paper (pdf here). It's there by analogy, but that precise quote is not. I wonder where the BBC got it from.
All the same, Nutt's argument is an interesting one, an approach I've used in the past when taking on Nanny Statists who want to ban risky activities such as smoking as a means of protecting citizens from themselves. Last year on KUOW-FM, I proposed a ban on mountain climbing because it's risky and we've got to protect the public from risk, even the risk of seemingly healthy activities. People do die and suffer serious injuries climbing in the Cascades each year. Sadly, the archive of my appearance on the radio is no longer live on the station's website.
I was being tongue in cheek, of course (I love hiking and mountain climbing and wouldn't want either banned), and so was Nutt. But it is interesting that his remarks stirred so much controversy. I wonder what would happen in the US if a doc authored a paper on the dangers of Ecstasy versus football.
Or if a doc wrote a paper comparing the risks of Zyprexa versus Ecstasy.
Just to be clear, I have no personal experience with X and am not advocating its use or trivializing anything. I do think, however, that MDMA is one of those molecules that merits further research into its possible benefits as a therapeutic drug. I've made similar noises about ketamine, marijuana, and mushrooms, which all seem to have some level of therapeutic purpose but are illegal.
(Via the ever-intruiging Before You Take That Pill.)
UPDATE, 2/17/09, 9:28 a.m. PST: Apparently, AstraZeneca reads this website as, this morning, Tony Jewell, a company spokesman, passed along a letter to editor of the St. Petersburg Times, which was published earlier today. Basically, the company claims that the paper relied on selective quotes from AZ's court filings and that AZ feels that information about the side effect profile of Seroquel should come from the FDA and not from a court proceeding. The letter is here.
A great article appeared in the St. Petersburg Times over the weekend, revealing that lawyers for AstraZeneca will argue in court later this month that the company wants documents introduced into a federal court hearing in a case over various allegations around Seroquel sealed and hidden from public view. They want an upcoming hearing in the federal class action lawsuit against AZ closed to the public as well. Lawyers argue that they are protecting patients and, oddly, the public at-large.
"This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm 'a vulnerable patient population.'"'This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,' lawyers for the drugmaker said in a recent filing in federal court."
This statement is bizarre and offensive. How would court documents even conceivably affect public safety? Are company lawyers arguing that everyone who takes its drug would go off the drug were the documents released and then patients would turn violent and run in the streets? That's what they appear to be implying and that's sickening. What's more, AZ is essentially advancing the same types of arguments that Lilly did when the infamous Zyprexa documents were leaked to the New York Times in late 2006 and were, later, made public by yours truly in early 2007--that is that the documents were distortions and served to confuse vulnerable people. AZ's argument is similarly lame.
But since I know some of AZ's outside lawyers read this site, let me offer you a thought: if you really believe that patients and the public would be harmed by unsealed documents, then you need to file a motion with the court to have the press banned from not just the Feb. 26 hearing, but from the proceedings at trial because reporters will be able to quote from documents introduced at trial, publish articles on the same and people will read those articles, and that could imperil a vulnerable population and threaten the public. Good luck with that argument.
In all seriousness, AZ doesn't give a rat's ass about patients. It wants as little publicity as possible for details of what it knew when about injuries caused by Seroquel and of how it may have marketed the drug for unapproved uses. This is about protecting AZ, no one else and one hopes the court will reject AZ's request. One hopes as well that the St. Petersburg paper--the trial is in Tampa--and the Bloomberg wire service, which has been covering the trial, will get their lawyers to file some kind of motion with the court on this matter.
"'They don't want anybody to know about the side effects of their drug, and they're keeping secret the results of studies from patients, their doctors and the FDA,' said Dr. David Egilman, clinical associate professor at Brown University's Department of Community Health."'Saying they're protecting the patient is a self-serving, fraudulent argument.'"
I agree with Egilman, who was the original leaker of the Zyprexa documents. AZ is embarrassing itself. The drug is so widely used (its 2008 sales were $4.5 billion) for conditions other than schizophrenia and acute mania--such as ADHD, sleep problems, depression and anxiety--that to keep documents from the public would actually work to keep doctors and many patients in the dark who have a legitimate right to know about the company and its drug.
Some interesting detail from the article:
"Dr. William C. Wirshing, a California psychiatrist, has lectured doctors on AstraZeneca's behalf and has prescribed Seroquel to as many as 5,000 patients. Though he has been a paid consultant for the drugmaker, in a pretrial deposition he left no question about the links he sees between the drug, weight gain and diabetes."'You literally just got to watch them get bigger...it was riveting to me,' said Wirshing who estimated that several hundred of his patients developed diabetes."
Several hundred of one doctor's patients? No wonder AZ wants those documents under wraps.
More details of what AZ wants to keep secret:
"The upcoming hearing is expected to focus on specific items that the plaintiffs' lawyers say have no legal right to secrecy. Among them: unpublished results of several drug studies, sales reps' notes on Seroquel's marketing strategies and letters from the FDA."The drugmaker also hopes to keep under seal information about sexual relationships that Dr. Wayne MacFadden, AstraZeneca's former U.S. medical director for Seroquel, had with an independent researcher as well as with a woman who wrote papers supporting the drug's safety and efficacy. Correspondence shows that MacFadden, who was also director of clinical research for neuroscience drugs, "promised sexual favors in exchange for intelligence on AstraZeneca's competitors."
"The plaintiffs say the affairs 'can create bias which can affect the integrity of the science.'
"Lawyers for the drugmaker counter that the affairs are not relevant to the lawsuits. Other disputed documents, they say, contain trade secrets, could taint the jury pool and could 'harm public health.'"
One of AZ's officials was having sex with a researcher studying the drug? Oh, wow. I wonder who it was.
It'll be interesting to see how this all turns out.
Keep in mind that even the FDA has lost its patience with AZ. Last December, the agency busted the company for off-label marketing of Seroquel for depression. The agency has still not answered my repeated inquiries about what possible sanctions AZ could face for the transgression. In January, the FDA ordered AZ to update its warnings on the drug to reflect risks of rapid weight gain.
Between 1992 and 2006, the prescribing of anti-depressants to pregnant women in the UK went from 0.8 percent to 3.3 percent, according to the Times of London. What's more, 4.8 percent of pregnant women received anti-depressants at some point during their pregnancy. That's a dramatic increase from the early-1990s, of course, and mirrors what's gone on in the US. One American study found that 13 percent of a cohort of pregnant moms in one state's Medicaid program received anti-depressants.
The paper notes, based upon a conference presentation by British researchers:
"The researchers found many pregnant women did not take antidepressants for the full course of medication, and less than one woman in five continued to take the drugs for the entire duration of pregnancy."They said that the high rate of discontinuation carried its own risks, because of the possibility women might be left at risk of post-natal depression, which had to be balanced against the potential for birth defects.
"When taken by pregnant women, SSRIs can cross the placenta and have the potential to affect newborn babies. Drugs such as Seroxat (paroxetene) have been associated with congenital malformations. Some evidence suggests that SSRIs are associated with neonatal complications such as neonatal abstinence syndrome and persistent pulmonary hypertension."
If only one in five women who get the drugs continue them for the course of their pregnancy, then that's an epic amount of withdrawal going on. There were 669,601 lives births in England and Wales in 2006, according to the UK's National Statistics. That works out to about 22,000 pregnant women who were prescribed anti-depressants, using the 3.3 percent number.
Beyond questions of possible birth defects (the evidence seems mixed, but there are enough cases to believe that something is afoot), there's a huge disconnect between doctors and patients on anti-depressant use during pregnancy. A group called Society for Women’s Health Research (sponsored by a huge array of pharma companies) claimed in 2007 that 10 percent of women think it is safe for women to take meds for depression while they are pregnant while 68 percent of doctors think it's safe. That's kind of a wide gulf. I wonder how wide it is in the UK.
Yesterday, the Wall Street Journal published an article on a European meta-study showing that St. John's Wort was as effective as standard anti-depressants. It focused on a study published in the Cochrane Collaboration last October, which I wrote about last October. I'm not sure why the paper is just getting around to writing about the study now--the news hook was what in February?--but it's interesting that they paid attention to it at all. As far as I know, no one else in the major media has touched the study.
Some of the commentary was interesting.
"[A] review published late last year by the Cochrane Collaboration concluded that St. John's Wort is better than a placebo for major depression and 'similarly effective' to standard antidepressants, with fewer side effects."While St. John's Wort flopped in the two U.S. trials, "the overall evidence looks a little different," says the Cochrane review's lead author Klaus Linde, a physician at the Center for Complementary Medicine Research at the Technical University of Munich. The Cochrane Review looked at 29 trials with 5,489 patients, mostly from non-U.S. countries. Side effects of the extract were generally not worse than placebo, Dr. Linde says."
The article also noted that some researchers were skeptical of the study because, in it, Zoloft failed to outperform placebo, making them suspect methodological errors. (I've still not seen the study or a published abstract and am working to remedy that.) Of course, American doctors aren't exactly fans of St. John's Wort, for reasons that escape me since there's enough evidence at this point showing the wildflower extract is somewhat effective for mild to moderate depression.
"Many physicians remain skeptical of St. John's Wort, even for minor depression, because many positive studies on it come from German-speaking countries, such as Germany, Austria and Switzerland. The reasons for the more positive results in those countries aren't known, says Dr. Linde. He says the German patient populations may be different, perhaps depressed for less time than U.S. patients. Most of the trials in German-speaking countries also were funded by makers of St. John's Wort products, while the two major U.S. trials weren't, Dr. Linde says."'It's hard to totally discount the evidence out of Europe, but it's a bit puzzling that we haven't been able to replicate the results here,' says Sheila G. Jowsey, assistant professor of psychiatry at the Mayo Clinic in Rochester, Minn."
What Jowsey means is that US studies of the extract have been complete failures for St. John's Wort. Personally, I've never given St. John's Wort much of a try, so I have no personal opinion of its effectiveness. But I should note that it's generally regarded as side effect free, which ought to increase researchers' interest in studying the extract, given how nasty anti-depressants have turned out to be.
Here's a 1998 Linde paper in which he found St. John's Wort outperformed placebo in treating major depression. Here's a 1996 BMJ paper where similar results were found for mild to moderate depression. Here's a slideshow presentation Linde gave recently on various St. John's Wort studies.
Today is a holiday, so I'll be back to regular posting tomorrow.
I've given the comment situation on this site some thought over the weekend. Several readers wrote to suggest that since this is primarily a news site and not a chat forum, then I should just let comments run wild and let whoever is offended fend for themselves. To a degree, I agree with this, but I cannot handle seeing how wounded some people wind up getting and I sure don't like seeing longtime readers and commenters driven away. And I sure don't cotton to reading comments where people accuse one another of murder and so on. But those are the obvious examples, ones easy for me to address if I catch them in moderation.
What's less easy for me to figure out are the more subtle jibes that people leave in a comment that strike me as bland but end up wildly offending someone else. My senses are likely not as finely tuned as those of some other readers, so if you sense a thread or a commenter is getting out of hand, then I need you to write to me directly by email, not in comments, and tell me what's up. For now, I'll stick with that as a method of trying to keep a lid on things. I need your help to do this because there are simply too many commenters and comments for me to micro-inspect each and every one.
Meanwhile, I did ban a commenter over the weekend, someone who then went to another IP address and left me and all of you some of the vilest hate I've seen on this site. While I understand, intellectually, some of the anger of anti-psychiatrists, I just do not get their level of hatred for other patients with whom they disagree. It makes me shake my head. I actually had to send this person a cease-and-desist email. I've only had to do that two other times in three and-a-half years.
BTW, for those of you who haven't figured out my email address format over on the top left, I've changed the usual @gmail.com format to ATgmail.com, so you can have to put the @ sign in it manually. This helps prevent against spam.
See you tomorrow.
OK, so someone has succeeded in driving off yet another longtime reader and supporter of this site, the second time this has happened in a month. Folks, you need to understand that it is very difficult for me to monitor each and every word left by commenters on each and every thread. There are too many commenters and too many threads and I simply cannot sit in front of a computer all day. Some people write lengthy comments, much more than I can skim through.
Some of you need to learn to behave like adults and stop seeking to put a knife into someone because you disagree about psychiatry and mental health care. Some of you also need to stop looking for an opportunity to feel wounded and that your personal experience is being attacked when someone disagrees with you. Commenters disagree with me all the time and lash out at me and I keep on chugging. Why can't you? I'm just as wounded as some of you are by psych "care," so why can't you just blow it off? I understand how frustrated everyone is, but I simply cannot have this kind of conflict where people who have supported this site for years feel driven off by newcomers. Some of you newcomers, especially some Aussie ones (what is it about the English language in the hands of some Aussies that pisses people off so?), need to be a bit more gracious and temper your language and consider that there just might be a terrifically wounded person on the other end of what you say and be more considerate.
I'm simply done with getting angry, sad emails in the night from people telling me how hurt they are by other commenters. Even I cannot handle that anymore.
Once again, I am now faced with a choice of turning off comments altogether or stopping doing this site. Trust me, there are other things I can do with my life. They'll pay much better, too.
If you'd like neither of these things to happen, then I suggest that everyone chill out and behave like adults.
This is one of the most disgusting stories I've seen in my life: two judges in Pennsylvania have pleaded guilty to taking kickbacks in exchange for sentencing juveniles to stays in privately-run detention facilities, often over complete BS offenses. I cannot even summarize this story. It disgusts me so much. Read the above article for details.
The other day, I heard from a new reader who ran into a post from last May on a study asserting that bipolar disorder is overdiagnosed (or perhaps misdiagnosed) 43.4 percent of the time, at least according to the data in that study which appeared in the Journal of Clinical Psychiatry.
"I have suffered from mild depression on and off throughout my life and have seen numerous doctors about it. Antidepressants have been helpful to me although they do have some unpleasant side effects. The other day I went to a new doctor who specializes in bipolar disorder and was told that I have bipolar disorder 'without the mania' part, whatever that means! I was told I had been misdiagnosed all of these years by many doctors. Needless to say, I am looking for a new doctor. Do I think bipolar is overdiagnosed? I do now!"
From a distance, it sounds as if this person was being told they had bipolar disorder type 2--the no mania required bipolar disorder--which certainly has a decent amount of overlap with depression. But to get from mild depression to bipolar 2 in one appointment is quite the leap. This reader is going to check in with another doctor, which seems sensible. It's good to see someone who knows themselves well enough to be appropriately suspicious.
I'm posting this because I think it's indicative of what's going on out there in the land and representative of the hyped theory of "You've been diagnosed with depression all these years but it's really bipolar disorder" that's been pushed quite hard the last few years. I think it's been a boon to doctors--who get a patient for life--and Big Pharma--which gets a long-term customer--but I have my doubts about how useful the depression-is-bipolar thing is for patients who wind up on an atypical and an anti-seizure drug when they are dealing with something that's not even in the ballpark of mania.
I'm drawing attention to this as well because I am concerned about the likelihood that we could get an even-newer and softer form of bipolar disorder--which is to say the old manic depression--in the forthcoming DSM-V due in 2011/2012. That would be subthreshold bipolar disorder or bipolar type 3, which would essentially amount to bipolar type 2 "without the hypomania." I think that BP2's introduction in 1994 was an epic opening of the gate for the pharma companies, as evidenced by Eli Lilly's push in 2002 to market Zyprexa, an antipsychotic, for women with mild agitation and mild depression (code for bipolar 2). That hasn't worked out too well has it? I worry about what could happened with a BP3. (See this from 2007 on how NIH proponents of BP3 had to correct an article on "treatment" of the alleged disorder.)
Feel free to tell me I'm off-base in comments.
Passed along by one of this site's Irish readers is the sad story of an Irishman with polio who, experiencing depression, was given Lexapro. Nine days later, he shot and killed himself with a homemade pistol. He'd complained to his doctor that Lexapro wasn't working:
"He returned to the practice three days later on September 22, and told Dr Hickey that he was still feeling very down. The doctor told him that 'it takes 10 days to kick in.'"Anthony Kelly told the court that the family are concerned that Dr Hickey failed to stress to Patrick that 'it's a well known fact Lexapro makes your symptoms worse for seven days.'"
A sad, tragic story.
In a ruling that's bound to get a ton of press coverage, a special Department of Justice court today found that autism is not linked to various childhood vaccines and denied compensation to people who asserted their children developed autism as a result of vaccinations. The court will take up the issue of whether autism may be linked to thimerosal separately.
This is obviously a major blow to those who believe vaccines are at the root of an explosion in autism cases in recent decades. Nonetheless, it was a court ruling, so who knows what this actually "proves."
"But the head of one consumer group that questions vaccine safety, the National Vaccine Information Center, said the court's ruling will do little to change the minds of most parents who suspect a link between vaccines and autism. She said more studies are needed."'I think it is a mistake to conclude that, because these few test cases were denied compensation, it's been decided vaccines don't play any role in regressive autism,' said Barbara Loe Fisher, the center's president."
Meanwhile, doctors wrapped themselves in the flag of Science:
"'It's a great day for science, it's a great day for America's children when the court rules in favor of science,' said Dr. Paul Offit of the Children's Hospital of Philadelphia."
I'm always a bit suspicious, perhaps too much so, when doctors claim they've got Science on their side in establishing mental disorders of many kinds when they can offer no firm scientific proof for their Science-based theories. I'm not denying their theories. I'm saying that absent some real proof, the whole game remains dubious.
Certainly, there are plenty of theories of what leads to autism, so many that I doubt God can sort them out. Some are anecdotal, some come wrapped in the cloak of Science. I'm neutral on the question of what's driving autism, but it's pretty clear that something weird has gone on in America's human environment over the last few decades to produce so many kids with autism (and spectrum disorders) when the disorders hardly existed in America in the 1960s and 1970s. I'm sure you've seen the PSAs on TV advertising the claim that autism will affect 1 out of 150 children in the US. Something tells me that this prevalence isn't simply a matter of diagnosis is better nowadays. Something else happened and, neutral though I am, I can't help but think that human genetics and brain theories don't explain it.
Autism is that mysterious.
There was a fairly alarming article in the New York Times about how some allegedly natural diet pills are turning out to have all manner of drugs in them. One celeb who mouthed support for StarCaps was Kathie Lee Gifford, another was an NFL player.
"And StarCaps are not the only culprits. In a continuing investigation that has prompted consumer warnings and recalls by some distributors, the F.D.A. has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs. In the coming weeks, the agency plans to issue a longer list of brands to avoid that are spiked with drugs, an F.D.A. spokeswoman said."
The FDA's current list is here. I expect we'll be hearing more on this in coming weeks.
I'll just never understand what drives some people to stick undeclared ingredients into products of any sort. I mean, I know it's money and greed, but there's a certain heartlessness there that I just don't get.
I've noted before that Seroquel's raw ingredients come from China and last November the Times had a spectacular article on the FDA's bumbling attempts to inspect drugmakers in China. No disrespect to anyone from China, but with what's gone on with tainted toys, tainted milk products, tainted Heparin and now tainted diet pills emanating from China, I think it's time for the FDA to consider banning pharma products and supplements from that country, absent some guarantee of purity by a reliable source. I'm no fan of banning much of anything, but this is simply getting out of hand.
After putting up the original post, I went back and slightly changed the portion where I discuss RS's handling of patient accounts in the article. I had overstated something and wanted to correct it. PD
Two weeks ago, I noted that a just-published Rolling Stone article had detailed the scandal around the atypical antipsychotic Zyprexa and delved into how its maker, Eli Lilly, had engaged in deceptive marketing of the drug off-label for some psychiatric conditions. Regular readers of this site know that I gave a lengthy interview to Ben Wallace-Wells, a contributing editor for RS, but that he failed to credit me or this site in any way. At the time, I hadn't read his article yet, as it was unavailable on newsstands or online. I've now read the article (now online) several times. I've held off on writing about the article until now because I wanted to separate my own frustrations with how the help I gave Wallace-Wells was uncredited from the article itself.
Overall, it's a good article, but there are some odd slip-ups, including a factual error, and globally it's odd how its author and RS chose to ignore people who acted heroically in warning the public about the dangers of this drug and who provided evidence of how the company had behaved.
There is no mention in the article of either David Egilman or Jim Gottstein, both of whom worked to leak to the public and the media court documents from a federal court case against Lilly. Egilman was later fined $100,000 for violating a court seal on the documents. Gottstein was also found in violation of the seal, although he wasn't a party to the case, and faces unspecified sanctions. Gottstein is currently appealing the court's finding against himself and Lilly has continued to go after Gottstein in court over his role with the documents. I know that Wallace-Wells interviewed both men, as Wallace-Wells told me he spoke with Egilman and Gottstein told me he'd been interviewed by the RS author. Given their central roles in getting the documents into the public realm, it's astonishing that Wallace-Wells didn't mention their service and courage. (Wallace-Wells also didn't mention the reporting done by the New York Times' Alex Berenson, to whom the documents were given in late-2006 and whose reporting truly pissed off a federal court judge in the case.) Even stranger, there is nary a mention of a single patient who took Zyprexa and the ones who are present are there as brushstrokes in a long article. A story about a drug and a company that victimized people that doesn't have some of the actual victims in it doesn't exactly make for compelling journalism, in my journalistic opinion.
What's even more striking and journalistically perplexing is that throughout his article, Wallace-Wells quotes doctors who say they knew early on that Zyprexa caused serious weight gain in patients and that they were astonished by Lilly's attempts to market the drug off-label. But there is no evidence I can find that any of these doctors did a thing to warn the public about the dangers of Zyprexa, that they contacted the FDA with their concerns or that they contacted anyone in the media. That's such an odd choice for a journalist to make with a story like this where real heroes took real risks that it makes me shake my head.
Throughout the article, Wallace-Wells mentions that Zyprexa is but one of a number of atypical antipsychotics. However, he never mentions these other drugs (Seroquel, Risperdal, Abilify, Geodon, Invega), never mentions that at least two of these drugs (Seroquel and Risperdal) have been documented as causing many of the same problems as caused by Zyprexa and that their respective makers are facing numerous legal claims similar to those faced by Lilly (for causing diabetes and hiding that fact, as well as for off-label marketing). Risperdal and Seroquel each generate about as much in sales as does Zyprexa and are used about as widely, so it's odd that the author didn't note this, even in brief in a 10,000-word article.
An uninformed reader could read the RS article and walk away with the impression that Zyprexa is the only bad atypical antipsychotic when clearly there are huge issues surrounding the other drugs. Neither is there any mention of Bristol-Myers Squibb's $515 million settlement with the feds over charges of off-label marketing of Abilify. In the issue the week before Wallace-Wells' article appeared (the one with former President George W. Bush on the cover), there is a prominent ad for Abilify toward the front of the magazine (obviously, I cannot reproduce it here). I'm not inferring a connection, but it sure is an odd coincidence.
The bottom line is that the entire class of atypicals is flawed and dangerous. When Wallace-Wells tries to briefly get at the idea, he commits an error of fact:
"But some medical researchers who have studied the atypical antipsychotics say that, in the final tally, the drugs, which have already been linked to some deaths, may eventually be responsible for tens of thousands of cases of diabetes and other potentially fatal diseases."
Some deaths? My jaw just about hit the floor when I read this. "Some" means just a few, but there is clear evidence that this class of drugs can be tied to the deaths of between 5,000 to about 7,000 people. Zyprexa alone is believed to be responsible for the deaths of 3,455 people, according to an FDA document. Taken together, the number of deaths caused by the atypicals exceeds those caused by Vioxx, generally considered one of the worst drugs in recent history for causing deaths of patients.
To describe the deaths caused by the atypicals as "some" is a flat-out error of fact or a wild distortion of reality, one the magazine should address in an appropriate fashion.
What's more, there is a curious omission in how the author characterizes Lilly's various legal settlements, including last month's $1.4 billion settlement with the feds and more than two dozen states:
"Lilly has already agreed to pay $2.6 billion to settle charges that it built the market for Zyprexa first by concealing its side effects, and then by marketing it 'off-label,' for diseases for which it had not been approved."
There is no mention of the fact that last month Lilly, as part of its settlement with the feds, agreed to plead guilty to a criminal misdemeanor charge. Pharmaceutical companies--like corporations in general--almost never plead guilty to anything and it's odd that RS would fail to mention this fact, given the rarity of such a plea and given the right of RS's readers to know the full scope of sanctions Lilly has faced to date over its handling of the drug.
Wallace-Wells makes much hay throughout the article that rules changes at the FDA over the last two decades and particularly under the recent Bush Administration worked to help make the Zyprexa scandal possible. While the FDA's laxity didn't help matters, it's an easy out to hang this on the agency when thousands of psychiatrists knew about problems with Zyprexa and how Lilly was marketing the drug and did very little to warn the public or alert the media to these problems.
While I have some thoughts on places in the article where Wallace-Wells' writing reflects information I gave him in an interview last August and where it's fairly obvious to me he's using documents and evidence obtained from this site, I'll leave my critique at the above.
There's been a lot of news out lately about how Wall Street bankers are pulling down millions in bonuses despite running their banks into the ground, and now it's Big Pharma's turn to look just as brilliant.
According to FiercePharma.com, Lilly's top six execs pulled down $48 million last year in pay and bonuses. This came in a year in which the company lost $2.072 billion due to acquiring ImClone and settling Zyprexa cases. I wonder what Lilly stockholders and employees think of this. I simply cannot fathom how such a few people at the top of the company make so much money when they are losing money for the company. I guess this is the new capitalism or something.
Topping the list was new CEO John Lechleiter, who raked in $13 million in 2008, up 39 percent from 2007. Chairman emeritus Sidney Taurel, who was in charge of the company during much of the Zyprexa scandal, also made $13 million and also gets a $40 million retirement package. Stunning.
Lechleiter, some may recall, was the Lilly exec who in 2003 reportedly pushed for the company to market Zyprexa off-label to kids. It's only fitting that he's paid so well.
Almost two weeks ago, I saw a news story on TV one night reporting that someone had jumped into Lake Washington, cried for help, but that police had been unable to locate the person. The lake is damn cold this time of year, so you pretty much knew what the outcome would be. And, sadly, a body turned up later. Yesterday, the Seattle Times reported that Larry Stephenson, a 27-year-old man from the Seattle area, had drowned in Lake Washington.
According to the paper, he'd developed schizophrenia about a year ago, was apparently quite smart (lots of people with schizophrenia are), married and somehow made a living as a gambler. Who knows what drove him to dive into a cold lake? His father thinks he knows:
"Now his father, a well-known Tri-City [about 200 miles inland from Seattle] attorney, wants to get the message out that people need to be more accepting of mental illnesses."'To me, the real tragedy of people like my son is so many of them — I've had them in my practice — somehow, some way don't believe that they need to take their medication and they invariably end up with future problems. That is definitely what happened here,' Stephenson said...."
"Stephenson said he spent a great deal of time researching the mental disorder, and learned that his son's future was dependent on his following a regimen of medicines.
"'If he would do that, he could have a decent life,' Stephenson said. "'However he, like so many in that situation, he was so bright that he thought he had it figured out. He believed it was lack of rest or staying up late or working late that would trigger that.'"
It's, of course, very sad to read about the family's pain here and the father may have a legitimate point in this case, but unfortunately the medicines are very rough on patients and it's fairly understandable why someone would go off them. The stigmatization of people with schizophrenia makes matters worse. I know families who read about the illness and its treatment walk away with the message that "All my son or daughter needs to do is take their medicine and all will be well, or at least manageable."
If only it were so simple.
A year ago, when I worked for a time at a homeless shelter in Seattle, I dealt with several dozen people each day who had schizophrenia. Some were med-compliant, others weren't. Staffers didn't force people to take meds at this place, which is generally a hands-off, be-who-you-are joint.
One 30-something man with schizophrenia and I developed a rapport. He liked to draw (I brought him a new pen each day) and play a recorder and was quite knowledgeable about math. He was also living at the shelter because he'd been kicked out of his group home (and family home previously) because he was off-meds and fought with other residents. One evening when I was working, he became disruptive at the shelter, pulled down his pants in front of several women (the main part of the shelter is co-ed, the sleeping facilities aren't) and, later on, stood talking to a wall.
The shift supervisor told me that if the guy didn't get calmed down, she'd have to kick him out for the night. You simply cannot have a male resident running around and basically sexually-harassing women (most of who were rape victims), but there would be nowhere for the guy to go that night except the streets. She gave me the task of getting him to take his evening meds--it was literally our only option at that point, as we had 200 other residents to see to, many of them in worse shape that this guy (I can assure you that this shelter takes on people who even other homeless shelters won't let through the door, but there are limits to what can be handled behaviorally). Neither of us wanted to see him on the streets. It was maybe 34 degrees out and raining and he didn't even have a proper jacket.
So I got him to sit down. I knew he was supposed to take a 300 mg slug of Seroquel in the evening (another in the morning) and as readers of this site are well aware, I am no fan of Seroquel at any dose. I asked him why he wasn't taking his meds.
"Because it's cooking my brain," he said.
I told him I understood (I truly did), but told him that if he didn't get a handle on himself, then the boss would likely kick him out for the night (he'd been kicked out one night the week before and I'd ended up in a shouting match with the same supervisor over the incident). I needed to get him through the night. I knew his own family wouldn't have him back. He was fairly lucid by this point and told me he couldn't sleep, hated Seroquel and wanted to switch to another med. My loose guess, as I sat there, was that with 15 years or so under his belt with schizophrenia (he'd developed it as a teen), he'd tried numerous other meds and they had proved no more tolerable and no more effective. I suspected he was one of those unfortunate folks with schizophrenia--perhaps 10 percent to 20 percent of them--for whom nothing works at all, side effects or not.
I explained to him that there was no way I could switch his meds. That would be up to a doctor, but maybe he could see one tomorrow (not likely, the ones who serviced this shelter were overwhelmed, and this guy got his care through a different mental health agency and the agency I worked for would have to send him there because that's where his funding was. Nice system, eh?). We could only give them the meds they were currently prescribed.
After a few minutes, he decided that he'd go get a 300 mg pill of Seroquel and break it in half and take that. He did all that and about 30 minutes later he was dozing in his bunk. I was relieved to keep him off the streets, but frustrated that I couldn't do anything else for the guy.
Take this with the downing noted above and you've got to ask yourself: when are we going to have a revolution in addressing schizophrenia because what's going on isn't working? I doubt there's a new magic medication on the way that will improve things. And while I'm asking, why don't antipsychotics work in the first place? Why aren't we trying something new in this culture, literally anything, to make this work better? I'm really tired of watching people I know who have schizophrenia getting hammered by meds and being reduced to slow-thinking bundles of mush while people say that's what works. Frankly, I'm sick of the media painting this "All they need is meds" picture of things. I'm tired of doctors doing it as well. If they think these meds are so super and seamless to take, then why don't they go take some Zyprexa or Seroquel for a few weeks and get back to me on how they feel and how easy it all is.
A new reader wrote me yesterday to compliment me on this site and to ask a question:
"I know your site basically dissects the shortcomings of the pharma-medical complex that is failing the masses, but I am wondering if you found any cures or relief for your own condition."
That would depend on what condition I have. I've not written about this publicly yet, but I'm convinced at this point that I no longer have bipolar disorder after being off-meds (at my psychiatrist's direction) for almost 19 months and after being essentially non-syndromal for about two years before that. I think three and-a-half years is enough time to declare myself in the clear. I'll write about this more later when I have a chance to write a more extensive post.
Obviously, I have huge questions about how I ever got diagnosed with bipolar disorder in the first place and whether I ever actually had it and was a bad diagnosis or if I represent the case of a medical freak or if bipolar disorder isn't a lifetime disorder, but instead wanes over time. I'll try to pin this down more some other day.
I wouldn't know whether to replace my old diagnosis with major depression or dysthymia, especially since I currently don't meet the diagnostic criteria for either. Ain't life funny?
But certainly over the years I have experienced depression, major and minor, going back to my teens.
As for cures, no, I haven't found any, except my own force of will on bearing down and pushing through life and by paying close attention to things and thoughts that trigger depressive cycles and avoiding them and by kind of just accepting life and my place in it and not fighting it. You cannot get that in a pill of any kind. You can't get it from a therapist either (they can help some people, but were useless for me). You can only get it from yourself.
Depression is tricky stuff and you have to be smarter than it is. I wish I knew how to explain how you do that, but the reality is that it can be done. Anyone who tells you otherwise is lying.
J&J announced late today that its long-acting injectable Risperdal CONSTA, an atypical antipsychotic, was not approved by the FDA, but that the agency had instead sent a letter to the company requesting additional information about the drug. The company is seeking approval for the injectable for frequently-relapsing bipolar disorder (whatever the hell that is exactly) and also for bipolar disorder in general. It's not clear what information the agnecy is seeking, as it's up to J&J to release the FDA's letter and all the company is saying is that the agency didn't request extra studies.
Earlier in the day, The Motley Fool investment news site had essentially predicted smooth sailing for the drug through the approval process. "Candy and Roses from the FDA" was the site's title for its reporting:
"Johnson & Johnson's (NYSE: JNJ) Risperdal Consta is already approved [for schizophrenia], but this month the company should have an opportunity to expand sales of the antipsychotic. The long-lasting version of Risperdal, which was developed using technology from Alkermes (Nasdaq: ALKS), is being reviewed as a treatment for frequently relapsing bipolar disorder."Patients in this subset make up only 10% to 20% of patients with bipolar disorder, but approval would be just the first step for J&J. The company has already submitted a marketing application for general bipolar disorder, which is scheduled to be acted on by the FDA later this year.
"An approval seems pretty likely. The drug’s short-acting older sibling, Risperdal, is already approved to treat bipolar disorder, and unlike Eli Lilly's (NYSE: LLY) long-acting version of its antipsychotic, Zyprexa, which the FDA has been reluctant to approve, Risperdal Consta is already approved, making safety issues less likely."
Looks like the fool was motley indeed.
As for the claim that the potential market for this drug would be 10 percent to 20 percent of people diagnosed with bipolar disorder, that doesn't even pass the smell test. Somewhere between 6 million to 9 million American adults are diagnosed with bipolar disorder and from what I know there aren't anything close to 600,000 to 1.8 million people with the disorder who need anything approaching an injectable. Perhaps that prevalence number comes from a study that was done in a very tough public health hospital population, but it sure as hell doesn't add up with the reality I know of.
J&J today announced that its premature ejaculation drug dapoxetine (to be marketed as Priligy) was just approved in Sweden and Finland. The drug was rejected for US approval by the FDA three years ago for reasons that remain under wraps. The company is pursuing approvals worldwide. One analyst expects the drug to generate $575 million in sales in 2011.
As tempting as it is to snigger at the problem the pill is supposed to address, Bloomberg reports that from 4 percent to 30 percent of men experience premature ejaculation. Which must just suck. The idea of having to take a pill to address this must suck even worse.
If the drug ever gets approved in the US, I simply cannot wait to see J&J's ad campaign. Maybe they can give the drug a snappy name like Delayzac.
UPDATE:
As it turns out, this drug is actually a short-acting SSRI. According to its Wikipedia entry:
"Dapoxetine was created by Eli Lilly and Company and is credited to biochemist David T. Wong. Originally known as LY 210448, it was being developed by Lilly as an antidepressant. Eli Lilly sold the patent to Johnson & Johnson for $65 million dollars and future royalties in December 2003."
There are all kinds of reasons to be concerned about a drug from the SSRI class being widely-prescribed such as suicidality, so one expects this drug's, um, performance will be closely watched.
On Sunday, the Philadelphia Inquirer ran a profile of Sen. Charles Grassley (R-Iowa), longtime thorn in the side of government waste, the FDA and the pharmaceutical industry, and friend to whistleblowers. His thoughts on the FDA's relationship with drug and device companies:
"'The pharmaceutical industry feels it's got a seat at the table, whereas the only person that should have a seat at the table across from the FDA is John Q. Public,' he said in an interview in his Senate office."
No kidding.
While the profile doesn't offer much that readers of this site don't already know or can't guess at, there was this classic bit:
"When Hustler publisher Larry Flynt sent free subscriptions of his magazine to members of Congress, Grassley skipped the moralizing speeches his colleagues gave in response and sent a letter:"'Dear Larry: Since you have sent me a slice of your mind, I'd like to send you a slice of mine. You will shortly receive your first installment of an annual subscription to Christianity Today.'"
The Senator apparently has a sense of humor. I suspect that's needed in large doses as an elected official in Washington, D.C.
I've previously written about Grassley's various investigations of Big Pharma and psychiatry here.
On Sunday, Reuters had a piece on its wire (OK, is there even a wire in wire service anymore or is it all Web-based now?) concerning a push by Daniel Carlat, a Tufts University psychiatrist, to have the American Psychiatric Association stop allowing pharmaceutical companies to fund continuing medical education programs, sometimes at lavish resorts, for psychiatrists. Carlat, who began making noise about industry-funded CMEs on his blog in 2007 (and possibly earlier in his newsletter), was asked by the APA last year to be on a panel to make recommendations to the APA board on how to handle the CME issue. The scope of the panel's recommendations are not known to me, but it's clear that some kind of change is afoot:
"Carlat and other psychiatrists have been studying the issue and have proposed that the American Psychiatric Association cut back on medical education seminars funded by drug companies."Dr. Nada Stotland, president of the group that represents 38,000 doctors, said the proposal is one of several the association's board will take up next month to address concerns that psychiatrists have become too cozy with drugmakers...."
"Stotland has heard a range of opinions on whether to ban industry-sponsored talks but she said the APA board will likely cut out at least some of the seminars during their meetings.
"'There are still those who feel strongly that they can hear things but it doesn't influence their practice,' she said. 'But the evidence points the other way.'"
It'll be interesting to see how far the APA goes in strangling its baby, so to speak.
Carlat deserves a lot of credit for pressing so hard on this issue, because it took some guts to stand up to the establishment in his own profession even though what he's asking his field to address probably seems self evident to us in patient land. Does it make any sense for pharma companies to sponsor CMEs (at which docs get credit towards their annual license requirements) which basically just amount to promotional exercises for their drugs and often omit any less-than-rosy details of research around those same drugs? Well, it makes sense for industry but not for doctors or patients. (Carlat's efforts also say a lot about the reach of blogs, but that's another story.)
Marcia Angell, a former New England Journal of Medicine editor, has pounded on similar medicine-in-bed-with-pharma issues in recent years. She's quoted to great effect in the Reuters piece:
"'It is self-evidently absurd to look to a company for information about a product it makes,' Dr. Marcia Angell of Harvard Medical School and former editor of the New England Journal of Medicine, said in a telephone interview."'Why can't doctors, who are among the most privileged members of society, pay for their own continuing medical education?' Angell said. 'Why have they abdicated that responsibility to the companies who make drugs?'"
Those are some great questions.
Regular readers know that I've been hammering on the use of anti-depressants in bipolar disorder and how the drugs cause mania and hypomania in some patients. My view is that these drugs should go from being standard treatment in bipolar disorder to being used as rarely as possible. Some researchers such as Tufts' Nassir Ghaemi have been brave enough to write about this as well, and during the recent NIH-funded STEP-BD study, we learned that placebo outperforms anti-depressants in treating bipolar depression and that the drugs increased manic symptoms severity. All of these points run counter to what most psychiatrists and doctors think they know about anti-depressant use in bipolar disorder. Hell, as I noted yesterday, there are docs who uses drug-caused mania to diagnose bipolar disorder (crazy, but true).
Last week, a new study came out in the American Journal of Psychiatry and made it crystal clear that there's drug-induced mania and hypomania in the land. The study was lead-authored by Mark Frye of the Mayo Clinic and you should check out his and his co-authors' reported pharma funding at the end of the study, because it's a long list.
That said, the study found that in a trial of anti-depressants in 176 adults, 44 people (25 percent) developed treatment-emergent mania, 44 people (25 percent) had no response whatsoever to anti-depressants used during the 10-week trial while 84 had some level of response to anti-depressants. Drugs used were Wellbutrin, Zoloft and Effexor. One wonders if the treatment-induced mania number wouldn't have been higher had Paxil been used. Patients were also on a mood stabilizer of some kind or an antipsychotic. There was no placebo control arm.
Two things leap out at me. A 50 percent chance of having an anti-depressant be ineffective or cause mania is a stunningly high rate as is the 25 percent mania induction figure. A one in four chance of inducing mania in patients for a drug regimen that doesn't work really well doesn't strike me as a risk most informed patients would want to take.
But to each, their own.
By the way, nothing I've written here argues that depression (or bipolar depression) doesn't exist or that people shouldn't take it seriously (they should). It's just pointing out yet again that anti-depressants are a weak technology and simply aren't getting the job done.
Vicente Navarro, a professor of Health Policy at Johns Hopkins University and editor-in-chief of the International Journal of Health Services wrote on CounterPunch.org yesterday that Sanjay Gupta, a neurosurgeon and CNN's chief medical correspondent, is a lousy choice for Surgeon-General and that President Barack Obama should look elsewhere for a better choice. I agree. As I wrote last month, Gupta has struck me as little more than a journalistic lightweight, a shill for Big Pharma, and someone who's had his facts wrong on anti-depressants and children, to cite one example. And to cite two others, Gupta pimped for Gardasil and downplayed the risks of Vioxx, the latter an issue on which he was clearly very wrong.
The President has not yet formally nominated Gupta (the President is apparently otherwise occupied) and things have been quiet on the S-G nominee front lately but one assumes this will all rise to the surface again soon enough. Hopefully, we can all avoid another income tax ruckus with this likely-nominee.
After criticizing the role CNN and other news organizations played in the run-up to the Iraq War, Navarro drops this:
"It is the war carried out by forces in the U.S. that, in defense of their interests, fight to prevent the establishment of one of the basic human rights: access to medical care in time of need – a right, found in all other developed countries but still denied to the citizenry of the U.S. sixty years after President Truman tried to establish it. As a consequence of this, many thousands of people die in the U.S. each year – from 18,000 to more than 100,000, depending on how one defines preventable death – due to lack of medical care. Even if we take the lower figure of 18,000 (given by the conservative Institute of Medicine), this is six times the number of people killed in the World Trade Center on 9/11. That event outraged the entire nation (as, indeed, it should), but the death toll due to lack of medical care seems to go unnoticed. These deaths are not reported on the front pages (or any other pages) of the mainstream newspapers."
What Navarro seems to forget is that because of very strict privacy laws enacted under HIPPA, it's extremely difficult for the media to report on these deaths and I think it's a bit disingenuous to claim that the media is ignoring death in plain sight. Reporters' hands are pretty much tied unless family members reach out to us and tell all.
Be that as it may, Navarro's point about Gupta being a poor choice for Surgeon-General due to his apparent opposition to a single-payer health insurance system is well-taken. From where I sit, I'm not sure that I care who winds up running whatever newfangled health insurance system we get under the Obama Administration as long as we get something that works and that is affordable and accessible to all. It would be nice, as well, if it didn't reward the same health insurance companies and pharma companies who've helped to get us into our current mess of wildly expensive health care and 47 million Americans without some kind of health coverage. As one of those 47 million Americans, I'm kind of sick of the situation.
I agree with Navarro that Gupta hardly seems an apt choice to help draw up a new health care system, although one assumes that HHS will have a bigger hand in shaping what winds up going before Congress than will the US Public Health Service.
Just as a reminder, the Sanjay Gupta under discussion here is not the same as the Sanjay Gupta who is a psychiatrist at the University of Buffalo (and also has some odd lapses on the anti-depressant front and whose conflicts of interest went unreported by the New York Times when it interviewed him in 2007).
That's what the AP asked over the weekend in a piece detailing the many millions Eli Lilly and Pfizer have spent to fund nonprofit groups and advertising for drugs to treat fibromyalgia. The drugs are Lilly's anti-depressant Cymbalta and Pfizer's Lyrica, the latter pointedly advertised as not being an anti-depressant. The companies reportedly spent $6 million in the first three quarters of 2008 on medical conferences and the like and $125 million advertising Lyrica (lots of TV ads) and $128 million on ads for Cymbalta (lots of TV ads, but mostly for the drug's use as an anti-depressant from what I've seen). Both drugs have seen huge sales gains.
Meanwhile, as the wire service notes:
"Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments."Experts differ on what to call and how to treat patients' pain.
"Many doctors and patients say the drug makers are educating the medical establishment about a misunderstood illness, much as they did with depression in the 1980s [um, that would mostly be in the 1990s, dear AP]. Those with fibromyalgia have often had to fight perceptions that they are hypochondriacs or even faking.
"But critics say the companies are hyping fibromyalgia along with their treatments in a textbook example of how drug makers unduly influence doctors and patients."
I simply don't have the expertise to sort out any of the controversies around fibromyalgia and have no opinion of its validity as a diagnosis. But if these campaigns resemble what went down with depression "education" (and bipolar awareness raising and so on) over the last 20 years, then it's hard to know who to trust. Big Pharma has a lot to gain from convincing people they have X disorder and that they also happened to have Drug Y which just so happens to treat X disorder. Consider the source is all I'm saying.
Late last week, the federal Department of Justice issued a report following its investigation of the psych unit at the Kings County (Manhattan) Hospital Center. As the New York Times reported:
"After a yearlong investigation, the Department of Justice portrayed the unit at Kings County Hospital Center as a nightmarish place where patients were not treated for suicidal behavior, were routinely subdued with physical restraints and drugs instead of receiving individualized psychiatric treatment, and were frequently abused by other patients."
I'm too disgusted to delve into the details, so please read the paper's article for yourself. There's also a copy of the DOJ report linked on the paper's website. Yes, this is the same place where a woman was left to die on a floor last year.
I find a couple of things striking, however. One, if there were doctors and nurses working at this unit--and there surely were--then they are likely in breach of their state licenses and ethical charges (that whole first, do no harm thing) and someone ought to hold them to account for standing by while this barbarity went on. Two, if society is going to employ its right to detain people in psych units, then it simply has to provide them with an abuse-free environment, at a minimum, or that society loses its right to detain people. The snake pit has got to become a thing of ancient history.
Separately, in the Australian state of Victoria, last week dozens of former patients spoke at a public hearing on mental health laws and pointed to many instances of patients having no rights in a system that often employs forced ECT, seclusion as punishment and "guesswork pharmacology." Although the system and its rules are under review there, you've got to wonder why some of these things even need review. Patients should have an absolute right to at least protect their own brains and bodies and the system over there should find a way to incorporate reasonable precautions to protect patients.
I'm not sure they can look to America for an example of how to do so.
Most of you are well aware of the controversy around child bipolar disorder and of how some of its key proponents have become enmeshed in controversy. I won't restate any of that here.
What I will note, however, is that in Australia several child psychiatrists have gotten vocal on the issue, perhaps in an attempt to preempt the controversial diagnosis' invasion of their nation.
Anyway, there was a good article on all of this in the Sydney Morning Herald today (actually Jan. 10 over there) and Peter Parry, who's a reader of this site, was quoted.
"The British National Institute for Health and Clinical Excellence rejects as theory the suggestion that children suffer bipolar disorder. It warns it could lead to overmedication."In Australia the increase in childhood diagnosis worries Peter Parry, an Adelaide child psychiatrist who published a paper with Stephen Allison in last April's issue of Australasian Psychiatry. This prompted letters in the August issue, with one contributor arguing it is 'currently one of the most active and controversial areas of clinical and research interest in child psychiatry.'
"Parry and colleagues recently surveyed 199 Australian and New Zealand child psychiatrists for future publication in Child And Adolescent Mental Health. Ninety per cent thought bipolar disorder was overdiagnosed in the US, 53 per cent said they had never encountered a case in a prepubescent child and another 29 per cent said they had seen only one or two cases.
"'If you'd told me three years ago that two-year-olds were being diagnosed with bipolar disorder my reaction would have been "that's impossible," Parry said.
"'Most of us in the psychiatric profession consider it extremely rare prior to puberty, let alone in a two-year-old.'"
Isn't it interesting that in Britain NICE considers the bipolar child stuff to be "theory" while in the US the nice folks at Harvard consider it rock solid science? Isn't it telling that all these kids are getting diagnosed in the US when Down Under docs say they've never seen a case or very few? Australia isn't different enough from the US for anyone to argue huge differences in genetics as being the difference. It seems to me that their medical culture is a lot more conservative when it comes to addressing child behavior.
Just so we are all clear, the article is discussing bipolar disorder in children, not teens. It's fairly clear to me that bipolar disorder can pop up in teens--hence the pediatric bipolar disorder label being bandied about, although who knows what the appropriate prevalence would be--but when it comes to kids younger than, say, 12 years old, I am very, very skeptical of its presence. I know there are some skeptics within child psychiatry in the US, but their voices have been effectively crowded out.
Over the weekend, I got an email from a reader asking what I knew about people being diagnosed with bipolar disorder after having a bad reaction to an anti-depressant and whether that was a legitimate way to diagnose someone. I told her that it wasn't and that I keep hearing of this same sort of phenomenon, especially in regards to people having awful reactions to Paxil and then being diagnosed with bipolar disorder on that basis. I actually know people who were diagnosed with bipolar this way. Crazy.
In my case, my own bad reactions to Prozac certainly hardened my then-newish diagnosis of bipolar disorder in the early 1990s. Simply put, the drug made me batty and so I became convinced that I actually was bipolar and needed to be on lovely medications for the remainder of my life. I never thought to be suspicious of the Prozac I was on. I sure wish I had been.
Anyway, the reader's story was interesting and she let me share it all with the rest of you, for which I thank her. It's crazy stuff, and sadly more common than you'd think.
"I was in counseling for depression and anxiety. The talk therapy wasn't really changing things so I finally was sent to see a pdoc. She put me on the Paxil saying it would help both my anxiety and depression. I went totally nuts and for three days I didn't sleep. I cleaned everything in sight including breaking into my friends apartment while she was out of town to alphabetize her cd collection. I went back into the pdoc and was very honest with her, I told her I was feeling great but knew this was not what it was supposed to do."First she tried to peg me with ADHD. I have no idea why. She asked me a ton of questions about how I was as a kid, if I could concentrate. Was I able to stand in lines? She really wanted to peg me with ADHD but I wasn't giving her the answers she wanted. So she began to ask more, "Were you moody as a teenager?" Well, yes, who wasn't? I see this now, years later, as her fishing for a dx. At the time I was so in shock with my behavior I didn't realize she was just looking to peg me with something. I don't know, I guess social anxiety wasn't interesting enough for her, because that is certainly what I had back then and still suffer with to this day.
"So, after a three day drug induced mania I walked out of that office, into a psych ward with a bipolar diagnosis and a whole host of new shiny pills. I was 26 or 27 years old (sorry, bad memory these days [from med withdrawal]).
"I asked lots of questions. No one in my family has bipolar. There is no history of it at all. My grandfather, who was a POW, was depressed (umm, duh) so they latched onto that. They also latched onto the fact that my father was an alcoholic which usually means an undiagnosed mental illness so he had to have been bipolar (sigh). My mother and brother are the most stable people you could ever meet.
"I asked my next pdoc about how I got the dx and he didn't want me to focus on the dx. He thought I had an unhealthy obsession with not wanting to have a mental illness so he didn't want to talk specifics with me. He just wanted to treat what was going on. But what was going on by the time he got me was I was half the person I used to be. I was a zombie mess dealing with a host of side effects I couldn't handle. He was good in that he did decrease a lot of my meds and he did listen to me (except about when I wanted to talk about where the bloody dx came from in the first place)."He retired and it took that for me to finally come off all this shit by myself (friends and family know and are being supportive). I've only been off my meds a few weeks. I did slowly come off them. I am having some withdrawals but it's to be expected.
"I am depressed, but I have been my whole life and it's ok, I can deal with it and I can live with it and it isn't always there. If I do something stupid like drink to excess I may risk getting manic (again drug induced mania). So hey, I don't drink, heh. I have anxiety. I wish someone would pay attention to my anxiety. I have trouble leaving the house and when I do make it to appts. they are so bloody interested in that Axis 1 Bipolar. The anxiety always takes a second seat and it's always been my number one complaint, and disability."
While I'm sure most psychiatrists would blanche at this story and say they'd never heard of such stuff, I'd remind them that this is a story I've heard in different variations over the last few years. Remember this from last year, a woman who was diagnosed with bipolar disorder after having a bad reaction to an anti-depressant and then being nervous with the doctor?
This kind of BS has got to stop, not just for the integrity of the mental health system but because patients are being given treatments they simply don't require. And that ain't right.
You read that right. According to the US Army, 24 soldiers killed themselves in January, a staggeringly high and tragic statistic, reportedly outpacing combat deaths that month. The Army openly admits it doesn't know what's going on, but one Army official at least partly pointed the finger at anti-depressants.
From cnn.com:
"Col. Kathy Platoni, chief clinical psychologist for the Army Reserve and National Guard, said that the long, cold months of winter could be a major contributor to the January spike."'There is more hopelessness and helplessness because everything is so dreary and cold,' she said.
"But Platoni said she sees the multiple deployments, stigma associated with seeking treatment and the excessive use of anti-depressants as ongoing concerns for mental-health professionals who work with soldiers....
"The anti-depressants prescribed to soldiers can have side effects that include suicidal thoughts. Those side effects reportedly are more common in people 18 to 24."
I don't want to make too much of Col. Platoni's statement--I suspect the dynamic is more complex than simple SSRI use--but there you have it.
UPDATE, 10.50 a.m., Feb. 6, 2009. Below the FDA responds to my overnight query of what prompted the label changes and how many cases the agency is seeing. Thankfully, NMS does appear to be rare, but it is intertwined with serotonin syndrome, which is more prevalent.
This is major stuff. Yesterday, the FDA ordered that makers of several anti-depressants change their labels to warn patients and doctors that the drugs can cause neuroleptic malignant syndrome. So far, the only press I've seen on this is on the Los Angeles Times' "Booster Shots" blog. I'd not known before of a connection between anti-depressants and NMS, which has largely been linked to antipsychotics in the past.
NMS involves muscle rigidity, fever and can cause delirium. While I don't know the details of what prompted the FDA's ruling, one assumes the agency must've been receiving adverse events reports. According to the LAT's post, NMS seems to be cropping up in the first few weeks of anti-depressant use and upon dose changes. I'll try to find out more of what's going on from the agency later today.
Keep in mind that 30 million people take anti-depressants each day in this country, so this obviously could effect a lot people. NMS is generally uncommon, but it sure is a worry as it can be fatal in extreme cases. Isn't it interesting that drugs marketed as safe and touted by doctors as side-effect free, especially back in the early-1990s, have turned out to have so many side effects and problems? It's all kind of stunning for the most-prescribed class of drugs in America.
Drugs covered by the change include Cymbalta, Effexor, Prozac, Paxil, Zoloft, Celexa and Lexapro. Most of the notices only cover brand name versions of the drugs, but one assumes the generic versions will be covered as well. Wellbutrin is not affected by the change.
You can read the FDA's letter to Eli Lilly, maker of Cymbalta and Prozac, here. You can read the new labeling for Cymbalta here. The letters to other drugmakers are likely the same. On the new label, it states on page 7:
"Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including Cymbalta treatment, but particularly with concomitant use of serotonergic drugs (including triptans [migraine medications]) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms."
On a personal level, this bit of news is certainly making me think back over my experiences with and reactions to anti-depressants over the years. I don't like what I'm thinking.
Updated with FDA response:
"The labeling changes regarding neuroleptic malignant syndrome (NMS) for the SSRIs and SNRIs were based on 28 U.S. adverse event reports and several literature reports for these 8 drugs. These labels already had language regarding the occurrence of serotonin syndrome for these drugs, and the labeling change was done to clarify that event, very much like NMS that is seen with many antipsychotic drugs, can be seen with these drugs as well, sometimes with the drug alone and sometimes in combination with an antipsychotic drug. The new labeling language makes clear that these two events, i.e., serotonin syndrome, especially in its most severe form, and NMS are overlapping with regard to the findings seen, and may not be distinguishable."
The other day I noted a newspaper article in Boston in which defenders of controversial Harvard child psychiatrist Joseph Biederman voiced their support for the embattled doctor. I thought what I wrote was pretty tame and non-critical of either the doctor or his supporters' views. Yesterday, one of Biederman's defenders swung through this site to lash out at me and those of you who read this site.
"This will be my one and only comment to this egregious blog. Clearly you and those that comment on your blog are either in desperate need of neuropsychological evaluations and suffer from neuropsychiatric brain disorders - OR - you are the ones who are members of a cult called - Scientology -. It is insulting and disturbing beyond measure to live among a citizenship that believes the brain is not an organ in the human body. Do you also believe the heart is mechanical and not in need of medical treatment?"The comments on this blog and respective to the Globe article and Dr. Biederman's many supporters; reflect an illiterate understanding and misconception of the brain, familial heritability and genetic loading. Dr. Biederman's supporters did not "just" pop-up. Dr. Biederman is recognized by countless individuals in the United States and around the globe, as the modern father of child psychiatry. He will be remembered and cherished in history and medical books for decades and centuries to come...And long after we are all six feet under ground.
"As long as I am alive, I will fight for my family members, my son and those around me that suffer from brain disorders. As advocates for mental health parity, research and targeted treatments...none of us will be thwarted by narrow-minded and contentious individuals like those of you on Furious Seasons. Marcie Lipsitt"
I seriously doubt that Biederman will be cherished in "history and medical books." He's more likely to be reviled, but Lipsitt is welcome to her opinion.
Lipsitt describes herself on this website as:
"I am also a state and national advocate for mental health parity and have an almost 19 year old son with pediatric bipolar disorder, AD/HD, obsessive-compulsive disorder, anxiety disorders, Asperger's Syndrome, executive functioning deficits, learning disabilities and additional medical morbidities. I am a proud member and actively participate on the Pediatric Psychopharmacology Advisory Council at the Massachusetts General Hospital."
It's sad to learn that her son is in such tough shape, but one wonders when his mom might stop describing him as having pediatric bipolar disorder since he's now older than 18. Or is it once a bipolar child, always a bipolar child?
I cannot find any information on that advisory council, but it sure smells like something associated with the pediatric pharmacology research center at Massachusetts General that was funded to the tune of $700,000 by J&J in 2002. That reporting was courtesy of the New York Times. One wonders if Lipsitt has lashed out at them as well. Or perhaps at Jack McClellan, a University of Washington child psychiatrist who considers the bipolar child paradigm to be mostly nonsense.
Anyway, just thought I'd share.
BTW, Marcie, I'm not a Scientologist or an anti-psychiatry believer and I don't need a check-up from the neck up, as you so calmly suggest. I'm merely skeptical as hell about psychiatry and what it's doing with kids and adults in this country. So are my readers. Also, if any Biederman defenders happen upon this post, they need to know that if they refer to me again as a Scientologist, then I will consider it slander. You've been warned.
Here's a report from the CBC's website on what's going on with Chantix, Pfizer's much-advertised stop-smoking drug, in Canada. Known as Champix up north, the drug has generated over 800 complaints to health authorities in Canada. Most of the complaints mirror those in the US and UK: suicide, depression, personality changes, suicidality, etc. What a lovely drug Pfizer has given the world.
One of these days I imagine I'll quit smoking, but when and if the time comes, I'll steer wide of this drug, which is clearly as nasty as Paxil. I've written oodles about Chantix before. Those posts are here.
The FDA announced yesterday that it is reviewing the safety of a bunch of drugs, including Abilify and several anti-depressants. As usual, I cannot find notice of this on the FDA's website (it's supposed to be here, but it's not yet), so going from Reuters' account of things, here's what's up:
Abilify is being reviewed by the FDA due to reports of liver toxicity and "other issues." I have no idea what the other issues are at the moment. You can go to the lovely fdable.com website and look at specific liver issues related to Abilify use. You can go here and see about 200 pages of adverse events reports filed with the FDA over Abilify.
As for anti-depressants:
"In addition, the agency said evaluating the risk of birth defects with widely-used SSRI and SNRI antidepressants, which already carry strong warnings about suicidal behavior."Well-known antidepressants include Eli Lilly and Co's Prozac, Pfizer Inc's Zoloft, GlaxoSmithKline Plc's Paxil and Forest Laboratories Inc's Lexapro and Celexa."
It's not clear from this which anti-depressants the FDA is looking at, but it's a safe bet one of them is Paxil. The company already faces lawsuits over birth defects allegedly related to Paxil use during pregnancy.
As usual, the fact that the FDA is reviewing the safety of these drugs doesn't mean that the FDA has concluded the drugs have that problem. That will come later. Ought to be interesting to see where the agency goes with all this.
This is a very alarming new paper--a literature review actually--just out in Psychiatric Services and asserting that people with bipolar disorder are at a very heightened risks of premature death due to death from general medical conditions. The basic range of premature death versus the general population runs from a 35 percent greater chance to a 200 percent greater chance of early death. The paper is by Wayne Katon and Babak Roshanaei-Moghaddam, psychiatrists at the University of Washington.
The authors don't indicate what constitutes early death--one year less than the average life span? A decade?--or the range of life spans for people with bipolar disorder. So it's unclear whether people with bipolar disorder are dropping dead at 40 or 75 years of age. Either way, the news is not comforting and the deaths appear to be mostly as a result of cardiovascular issues.
They note:
"Patients with bipolar spectrum disorders are more likely to smoke and to smoke heavily and might have higher exposure to second-hand smoke. In addition, bipolar disorder is highly comorbid with alcohol and other substance abuse. These patients are more likely to have a poor diet and sedentary lifestyle with resultant weight gain and obesity, which is more prominent during the depressive phase of the disorder and can further jeopardize health and increase mortality."
I've long suspected that one of the reasons people with bipolar disorder smoke so much is because nicotine excites dopamine receptors that are deadened by various medications. That's my opinion.
What amuses me is that the authors note peoples' diets are crappy, that they don't exercise and wind up overweight, but fail to connect this with the many meds people with bipolar disorder are coaxed into taking that make them sluggish and drive off their basic psychological energy, which you kind of need in order to exercise and eat properly. Speaking of diets, I'm not necessarily convinced that people with bipolar disorder have diets that are wildly at variance from the general population. I say this for two reasons. One, I've known dozens and dozens of people with the disorder fairly closely over the years and I've not observed anything away from the norm in terms of diet (nothing startling at any rate). Two, this nation is supposedly experiencing an obesity epidemic, so it's not like that general population's diet (and exercise) are so swell to begin with.
The authors don't entirely ignore problems that patients may be caused by meds, however:
"Most patients with bipolar disorder are treated with mono or polypharmacy, including at least one mood stabilizer with or without a second-generation antipsychotic. Most mood stabilizers are associated with weight gain. Most second-generation antipsychotics (with the exception of ziprasidone and aripiprazole [Geodon and Abilify]) are also associated with increased risk of weight gain, diabetes mellitus, and impaired glucose and lipid metabolism, all of which can increase mortality from cardiovascular disease. Increased weight gain and change in body fat distribution can lead to insulin resistance, type 2 diabetes mellitus, and dyslipidemia, all of which may result in increased mortality from cardiovascular disease. Second-generation antipsychotics can also increase triglycerides via 5-HT2 receptor blockade and further impair lipid metabolism."
Well, what a lovely picture this all is. The authors don't address whatever contribution to ill health that anti-depressants might be making, but this is as close as I've seen psych docs come to asserting a connection between medications and life spans of people with bipolar disorder. Not bad for a doc who, in Katon's case, lists honoraria from Eli Lilly, Pfizer, Forest Labs and Wyeth. He's also on a Lilly advisory board. His co-author lists no conflicts.
But, in the end, the authors aren't really blaming the meds at all. They suggest that, among other things, doctors monitor their patients with bipolar disorder for unhealthy habits and metabolic syndrome, but don't recommend that docs specifically look for problems generated by medications. So the elephant remains in the room, but no one will say it's there.
And as we know, it's highly unlikely that psychiatrists will monitor patients to whom they give medications.
I'll offer some personal thoughts on this issue later today.
I can't figure out who made this YouTube video, but it is a very angry attack on Cymbalta, Eli Lilly's star anti-depressant, and toys with Lilly's "Depression Hurts" ads. It was brought to my attention by If You're Going Through Hell, Keep Going, whose author is on the drug and tells me she's going through absolute hell on Cymbalta. Second only to Haldol amongst bad drugs for her, she writes.
Here's the video:
Yesterday, President Barack Obama gave a ton of interviews to the big news networks, trying to ramp up public support for his stimulus package that's currently stuck in the Senate. CNN's Anderson Cooper, host of "AC 360" and son of Gloria Vanderbilt, used time at the end of his interview with President Obama to quiz the Commander-In-Chief about his family's search for a dog (nothing yet!) and asked if the President had smoked any cigarettes at the White House so far.
President Obama basically answered the question by saying he hasn't smoked at the White House itself.
"COOPER: Have you had a cigarette since you've been to the White House?B. OBAMA: No, I haven't had one on these grounds. And I -- you know, sometimes it's hard, but, you know, I'm sticking to -- sticking to it.
COOPER: You said, on these grounds. I'll let you pass on that."
Former First Lady Hillary Clinton banned smoking at the White House in the 1990s, a ban her husband regularly ignored (President Clinton likes his cigars), and President Obama has admitted to smoking a few cigarettes a week, although one guesses that it's got to be more than that. (Word on the street is that he smokes Parliament Lights or chews nicotine gum.)
I just don't understand why some alleged reporter on TV--Cooper, Tom Brokaw last December--are so insistent on bugging President Obama about smoking. Who the hell cares? Maybe they think it's cute and folksy somehow, but if they really want the guy to quit, then perhaps they ought to stop hassling him. Personally, I'm kind of sick of all of the Nanny State carping about President Obama lighting up. He is a grown man, after all, and can make his own choices. Hell, if he fixes the economy, he can smoke bong hits in the White House with Michel Phelps and banned Cuban cigars with Castro for all I care. I bet the President is tired of the nags, too.
Maybe next time Cooper tries to nag him about smoking the President can ask Cooper how staying in the closet is working out for him. Cooper wants his personal adult choices to be respected and so he should respect the President's. It's really quite simple.
Meanwhile, I'm going to go have a smoke for the President. Since he can't do as he pleases lest someone photograph him inhaling, then I must represent, as it were.
There's a new study out in the Canadian Medical Association Journal delving once again into the question of whether there is a connection between SSRI use and suicide and suicidality, the latter only measured as a suicide attempt not suicidal ideation. It is a meta-study of eight large observational studies--so these aren't clinical trials.
The short answer to what the study found is that SSRI use increases the risk of suicide in children, is allegedly "protective" in adults aged 18 to 64, and decreases the risk of suicide in people 65 and older. This study has not received much press yet--probably because there aren't many fulltime journalists remaining who specialize in medicine--and the press that it has gotten stressed the good news on adults pretty uncritically and didn't make much hay about the troubling news on children. The study was accompanied by a disingenuous editorial, co-authored by Robert Gibbons. He authored a paper in 2007 claiming that a decrease in SSRI use earlier this decade had led to an increase in suicides when, in fact, that wasn't the case (and he was making his case based upon one year's worth of data). Gibbons has testified on behalf of Pfizer, makers of Zoloft, on the matter of SSRI use and suicide. I'll come back to his editorial in a moment.
The main study is by Italian researchers affiliated with the World Health Organization. I'm not shocked that a WHO study would come back with at least partially-positive results for anti-depressants. You can read the study for yourself to see where the data came from and decide for yourself whether it's good or bad. (Interestingly, one the studies the WHO authors pulled data from was a Gibbons-led study.)
Conclusion:
"Although exposure to SSRIs increased the risk of completed or attempted suicide among adolescents (odds ratio [OR] 1.92, 95% confidence interval [CI] 1.51–2.44), the risk was decreased among adults (OR 0.57, 95% CI 0.47–0.70). Among people aged 65 or more years, exposure to SSRIs had a protective effect (OR 0.46, 95% CI 0.27–0.79). Sensitivity analyses did not change these findings. In particular, for studies that used completed suicide as an outcome, exposure to SSRIs was associated with increased risk among adolescents (OR 5.81, 95% CI 1.57–21.51) and decreased risk among adults (OR 0.66, 95% CI 0.52–0.83) and older people (OR 0.53, 95% CI 0.26–1.06)."Interpretation: Based on data from observational studies, use of SSRIs may be associated with a reduced risk of suicide in adults with depression. Among adolescents, use of SSRIs may increase suicidality."
So the basic takeaway from the study is SSRIs are bad for kids and teens but are good for adults and seniors, as measured in terms of suicide or suicide attempts. I know that may run counter to what some readers know about these issues, but, like I've said for a long time, the evidence for suicide and SSRI use is mixed in adults. I've seen evidence in both directions. A lot of the studies use competing patient populations so there's a certain amount of apples-to-oranges going on. As for suicidality, the study's use of an actual suicide attempt as a proxy for suicidality doesn't really tell us much, given the broad range of behaviors and thoughts that comprise suicidality.
I think that there is enough evidence--anecdotal, scientific and clinical--to where only a fool wouldn't acknowledge that there is a significant link of some kind (however strong or weak) to suicide among adults using SSRIs, and that the evidence is very strong for a connection between suicide and SSRI use and kids and teens up to 18 years of age. Need evidence? Check out the FDA black box warning on anti-depressants in kids 0 to 14 from 2004 (and its extension to young adults in 2006) and the British ban on the use of anti-depressants (except Prozac) in kids 0 to 17 from 2003. Check out David Healy's Let Them Eat Prozac. And so on.
Which brings me to a fool.
The editorial accompanying the study is authored by the aforementioned Gibbons of the University of Illinois and John Mann of Columbia University. They use the WHO study to justify a call for more study of the question of kids and SSRI-induced suicide and suicidality. I'd say at this point that this issue really doesn't merit a lot of further study, especially given that the British ban forced down anti-depressant use while Britain's suicide rate was also dropping. It appears that Gibbons in particular will never let this sleeping dog lie. Why it appears to be his central life purpose to defend anti-depressants to the death is beyond me.
Of course, there is the tricky question of what the heck might be driving suicide risk and suicidality for kids and teens who take SSRIs while there's less of signal in adults. I don't even have a guess, but something is surely going on.
The editorial gets even more fun:
"Alarmingly, concerns about the risk of suicide in youth have led not only to fewer SSRI prescriptions without substitution of alternative medications or psychotherapies, but also to a decrease in predicted rates of diagnosis of mood disorders."
Using a shortfall in diagnoses to claim alarm is a bit much. Perhaps, the predictions by some in psychiatry of rates of mood disorders (meaning depression and bipolar disorder) in youth were wrong. What with arguments about the overdiagnosis of depression in adults and the misdiagnosis of bipolar disorder in adults (at almost a 50 percent rate), you have to wonder about the judgment of someone who would cry about rates of diagnosis in children and teens as not being high enough. What makes him think that misdiagnosis might not be a gigantic issue in children and teens? One of the peer reviewers didn't challenge the authors on this point?
One other fun bit:
"The conclusion by Barbui and colleagues that SSRIs are protective against suicidality among young adults challenges the justification of a 'black box' warning about the risk of suicide with the use of SSRIs."
The authors refer to the 2006 black box decision by the FDA which extended warnings on anti-depressants to 15 to 24 year-olds. I don't think it's fair for them to claim that the WHO study's findings challenge the warning. It's a different result from a different set of data and adds to a mixed evidence base. What's more, Gibbons and Mann failed to be specific in their age groups. By young adults, they meant 18 to 24 years olds, but the 2006 warning also covered 15 to 17 years olds. That's an error that I am surprised got by peer reviewers and journal editors.
News is just out that former South Dakota Senator Tom Daschle, a Democrat, has withdrawn his name as President Barack Obama's nominee to become secretary of Health and Human Services, and to lead the charge on reforming health insurance in the US. Reform of health insurance and extending coverage to tens of million of uninsured Americans was a key promise of President Obama's during his campaign last year, so losing Daschle is a blow, especially a day after the President publicly supported Daschle.
Dascle's problem, of course, is that he either screwed up--or cheated--on his taxes and that revelation was becoming a huge distraction heading into confirmation hearings in the US Senate. Earlier today, another nominee of President Obama's, Nancy Killefer, withdrew her name as nominee for chief White House performance officer. Killefer also had a tax problem.
Yesterday I filed an adverse event report with the FDA related to my 14 month use of the atypical antipsychotic Seroquel. Here's what I told the FDA:
"I began taking Seroquel at 25 mgs. a day in April 2004 for bipolar disorder/depression. I developed rapid weight gain from approximately 220 pounds to 245 pounds. I experienced muscle tightening in my legs and back, muscle tears in my right deltoid, back pain and severe nightmares. I had no history of muscle problems and nightmares before taking this drug. I also experienced jerking and convulsions in my legs and right arm, especially when at rest. I had no prior history of this before taking this drug. In addition, in May 2005 I experienced tardive dysknisia as a result of taking this drug. My lips began trembling and my mouth began moving. This was observed by work colleagues and reported to me. I stopped taking the drug soon after. I still experience jerking and convulsions in my legs and right arm. I have been diagnosed by a physician with sleep tremors and chronic back pain as a result of taking this drug. I have been unable to date to lose the weight I put on while taking this drug, despite careful attention to diet."
I've written about damage caused by Seroquel before. I could've filed this report long ago, but held off until being examined by a physician. I also checked the box on the FDA's form that reveals my identify to AstraZeneca, the drug's maker. How much do you want to bet that they don't have the guts to contact me?
Then again, you do have to wonder about the value of filing such reports. I fear that reports like mine go into a memory hole at the FDA and no one at the agency reviews them.
Ugh, I need to go lose some weight. At six-foot-two, I carry it OK and am at about 230 pounds now, but I'm simply tired of it. I'd really like to get back down to 200 pounds or so (I've always run bigger than the BMI for my height due to many years of weightlifting and competitive sports). First, though, I need to get my back fixed. Thanks, Seroquel!
Many of you are aware of the blog Beyond Meds and its author Gianna Kali. For those of you who aren't, the short story is that Kali was diagnosed with bipolar disorder in the 1980s and was hammered with high dose psych meds, especially the rotten atypical antipsychotics, for two decades or so. Eventually, she began questioning her diagnosis, undiagnosed herself publicly and has been struggling for a couple of years or so to get off the last of her meds on which she had become physically dependent (or addicted to, if you prefer). She has clearly suffered physical damage as a result of all the years on meds and is at the point where she is sometimes so weak she can hardly move. So much for assertions that psych meds are totally safe for one and all.
Perhaps most appalling was that last week a study came out asserting that most psychiatrists don't even do basic metabolic monitoring of their patients on atypical antipsychotics.
Kali's seen numerous doctors in recent years, some of whom were dubious that meds did this to her. Now, she writes of a recent visit with a doctor--not a psych doc--in North Carolina who openly acknowledged that meds had injured her and even gave her a diagnosis related to that damage:
"The diagnosis he gave me was something akin to 'muscle weakness and atrophy secondary to chronic medication usage.' He also documented the severe nausea, the convulsive/neurological like symptoms, the migraines, the noise and light sensitivity, the severe flu-like aches and pains, etc."He also told me I had great courage and said he realized that most people with my history ended up with deadened spirits. He seems to really get what I’m up to and truly appreciate it. He understands that the psychiatrized often end up not believing in themselves and he clearly sees my fighting spirit and acknowledges it in a profound sense."
It's very frustrating to read this sort of thing, especially since Kali was a dutiful compliant patient for many years, like me, who, like me, has wound up physically damaged by many years of meds. She and I are not the only ones. One reader of this site is on dialysis and needs a kidney transplant due to damage caused by Lithium. There are other readers who've had family members killed by meds, others who've developed diabetes and so on. Kali now needs homecare.
Compared to Kali and others, I am lucky despite the fact that I am physically wounded by drugs I took which psychiatrists and Big Pharma assured me were safe for long-term use (even though they had zero evidence to support their belief). I can walk, I am alive, I can write, I can work. I think I was somehow lucky enough to keep meds doses on the low side over the years and was somehow fortunate enough to begin to question why I was on-meds at all, prompted by my then-psychiatrist. But I can assure you that I am thoroughly pissed-off on their, and my own, behalf. I know that everyone responds to meds somewhat differently and some people seem to have no problem with using these drugs for years and years, but at some point we all need to wake up to the fact that a good number of people have wound up injured, profoundly so.
If I can offer one general principle I've learned over the last few years of living life and reporting on mental health issues it's that long-term use of psych meds (particularly use for many years) has got to be carefully evaluated by patients and doctors. Absent psychosis, it's hard for me to argue in favor of chronic use of psych meds, especially of antipsychotics, typical or atypical. (I have a hard time arguing for chronic use of meds with psychosis, too.)
I know those of you who dislike the controversial Harvard child psychiatrist Joseph Biederman, creator of the bipolar child paradigm among other things, won't especially care for this Boston Globe article from the other day wherein Biederman is defended by the families of some of his patients and by a couple of his patients. Biederman is, of course, enmeshed in much controversy and an investigation by Massachusetts General Hospital.
If people want to defend Biederman, then that's fine. One person, however, who wants to slam Biederman man again is Stephany at Soulful Sepulcher, whose daughter's experiences as a bipolar child receiving very aggressive medications are the polar opposite of the Biederman supporters own experiences. She writes about all of this here.
You always have to wonder who prompted these folks to contact the paper, something any reporter wonders when someone who's taken harsh criticism in the press suddenly has supporters pop up in his email and on his phone.
"Asked to comment for this article, his lawyer, Peter Spivack, wrote in an e-mail that Biederman 'did not initiate any efforts by patients to provide support for him and his work, but patients have expressed their support verbally and in writing.' What has meant the most to Biederman, his lawyer said, is that he has been able to help patients with serious mental illness 'normalize their lives and function in society.'"Adler, Lipsitt, and Tesher are among about three dozen parents on an advisory council that keeps abreast of work in Mass. General's pediatric psychopharmacology department and helps it raise funds. They and several of Biederman's roughly 400 patients contacted the Globe to defend the psychiatrist in response to recent news reports about him."
Who knows who got the ball rolling on this.
An interesting parallel is that late last year I know some of Fredrick Goodwin's patients were contacted and asked to write letters of support for the former "The Infinite Mind" radio host who's facing all manner of allegations around conflict of interest. I know these patients weren't contacted by Goodwin himself--which would likely be a huge ethical breach--but by someone who works with him. I don't know if any letters were written or published anywhere, but I do know that someone tried to organize patients in support of Goodwin. Which is fine, but curious.
I wanted to quickly note that two lawsuits against AstraZeneca over claims that the company's drug Seroquel caused the plaintiffs to develop diabetes were thrown on by a federal judge last week. The two cases were part of a class action suit that was set to go to trial this week. As was the Maryland Injury Lawyer Blog, I'm a bit mystified as to what happened here, especially so close to trial, but the judge found scientific evidence in the case didn't "meet the standards" to go forward.
According to Bloomberg:
"It is unclear how Conway’s ruling in the first cases set for trial would affect the remaining suits consolidated before her in Florida, said Richard Laminack, a Houston-based lawyer for Guinn and Haller."'This ruling basically means that there were some glitches in how these two cases were prepared for trial,' Laminack said in an interview. He will appeal Conway’s ruling, he said."
There are roughly 9,000 lawsuits filed against AZ over Seroquel.
Last week, I noted a press report indicating that the FDA had asked AstraZeneca, makers of Seroquel, to update its labeling to indicate risks of "significant weight gain" experienced by some patients taking the drug. The weight gain issue is important and linked to risks of developing diabetes.
I contacted the FDA and asked for a copy of its letter to AZ and for other information concerning its labeling change request. Here's the answer I got:
"Under federal laws to protect trade secret and commercial confidential information, the FDA is prohibited from publicly discussing or acknowledging labeling change requests until the changes are approved by the agency. (With the exception of class labeling changes where the agency may publicly announce the labeling change request since all drugs in the class are getting the same request.) "The FDA cannot disclose any information about a letter to AstraZeneca mentioned in the news this week. The company would have to disclose information in this case."
I love how federal rules are designed to protect Big Pharma and other businesses but not regular Americans. It's one of the many things I hope President Barack Obama cleans up.
As I noted on Friday, last week Eli Lilly and company specifically apologized to investors for act covered by its guilty plea to a criminal misdemeanor charge. The charge concerned Zyprexa and the company's illegal off-label marketing of the drug for dementia.
I was frustrated that the company, in my view, had apologized to its investors (who do deserve an apology, of course), but not to patients, so I contact Lilly by phone and email asking why it hadn't apologized specifically to patients and whether it planned to do so. For the first time ever, Lilly responded to a query of mine.
From Phil Belt, the company's director of product media relations comes this:
"On the day the settlement was announced Lilly issued a press release that expressed deep regret for our past actions covered by the guilty plea. That statement was repeated on the company's earnings call with investors and the media this past Thursday. Lilly's expression of regret, as voiced by our CEO John Lechleiter on both the earnings call and in the press release, was intended for ALL of our constituencies, and was certainly not specific to investors only. We take seriously our responsibilities to the patients we serve, to their caregivers, to payers, to health care professionals, and to our investors, and our communications regarding this issue have been intended for all of them."
Fair enough. I appreciate the response.
The trouble here from where I sit is that this is kind of a half apology and is only specific to the criminal plea and actions connected to it. As I understand things, that means the company is only apologizing for off-label marketing and not for lying about Zyprexa's diabetes-inducing qualities and not for any of the damage that drug and the company's actions caused people taking it for FDA-approved uses.
Here's what the company's CEO said last month:
"'We deeply regret the past actions covered by the misdemeanor plea,' said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly. 'At Lilly we take seriously our responsibilities to abide by all the laws governing our business practices, and we realize that we have a tremendous responsibility to the patients and healthcare professionals we serve. Every day and with every interaction we strive to operate in a responsible and compliant manner. Doing the right thing is non-negotiable at Lilly, and I remain personally committed to all of us at Lilly maintaining the highest standards of conduct.'"
I don't read that statement as applying to people diagnosed with schizophrenia and bipolar disorder. Does anyone else? Did any of you who read this site and got settlements from Lilly also get an apology of any kind from the company? I think you can tell me without violating the gag order the company put you under.
Perhaps, Lilly is somehow not apologizing to all patients who took the drug due to ongoing legal proceedings, but it strikes me that it needs to broaden the scope of its apology beyond dementia cases and off-label marketing. If Lilly truly believes that doing the right thing is non-negotiable, then I simply don't understand why it cannot apologize for lying about the safety of its drug, which it hasn't done to the best of my knowledge. Or am I being too tough here?
That was a hell of a Super Bowl and I am utterly exhausted from having watched it. I ate a bunch of fine food at a friend's party, drank water only and am wiped out. Great game. Too bad the Cardinals didn't win. I certainly congratulate any Steelers fans who read this site. Hey, at least the refs didn't give the "Stealers" this one! (Sorry, bitter Seahawks fan here.)
I'm always a bit bummed when the football season is over. During the season, I watch three to five pro games a week and at least a couple of college games as well. Thank God baseball is two months away (I love it even more than football), but my sports junkiedom will have to shift to the NHL and NBA for a while, although neither game is as fun on TV as it is live (they move too fast for TV in my opinion, especially hockey) and since Seattle no longer has an NBA team (oh thank you, Howard Schultz), TV will have to do.
I'll only have one other post for you early readers, as my back is telling me I need to be nice to it and not sit in a chair for long tonight. More will come later in the morning.