OK, this is odd and journalistically lame. Three years ago, about.com flat-out censored an article written for it by Andy Behrman, author of Electroboy about how Abilify messed him up. As it happened, the site had tons of ads from Abilify running at the time. Behrman's piece appeared briefly and then down it came. Not long after, I posted the piece on this site, pretty much as an FU to about.com for being lame and lacking journalistic integrity. The site in owned by the New York Times Company and should adhere to some kind of standards of not letting advertising determine content.
I'm sure some of you are aware of a publication called bp Hope. A few years ago, I ran into one of the editors at a journalism awards banquet and he told me that the magazine did allow criticism of meds, but only if the author didn't refer to the drug by name. What else would you expect from a publication funded largely by Big Pharma dollars? There's no search function on the mag's website, but I'm willing to bet that there has never been word one of the Zyprexa scandal mentioned in its pages or on its site. What a fine public service to bipolars that is.
BTW, the most recent issue has an interview with Kay Jamison, an alleged profile in courage, says the mag's website. I would so love it if someone has a hard copy, if you'd scan it and send me the pdf. As it happens, the same folks who put out that mag are now publishing a depression and anxiety magazine called esperanza. It's interesting that they chose to have the Spanish word for hope in lower case. Just saying.
Anyway, here we are in 2009 and someone at about.com's bipolar blog has interviewed Behrman (there's no byline on the post, even though the author refers to herself in the first person), making no reference to the earlier censorship, on his views on the medication roller coaster plenty of people diagnosed with bipolar disorder can win up on and if there isn't a balance of some kind.
"In speaking with Andy about his new book, I asked him about his thoughts on how we, as consumers that simply cannot function without pharmacological interventions, can find a balance in sifting through slick promises and unrealistic hope being broadcast into our lives through every media outlet available. Andy has really been demoralized by his personal experience and his response is telling, 'I really don't think that consumers actually ever find a balance. I believe consumers just take what the company and the company sponsored doctors tell them to take. It's sad, but I have found that it's very true. This is what I learned as a spokesman.'"
I don't think that absolutely everyone with an alleged mental disorder is as naive as Behrman says, but I know a great number are very unquestioning when it comes to taking whatever a doc presses on them. We know why that's going on--doctors have a lot of power over patients and plenty of docs are not careful with how they use that power. It wasn't until I began being a lot more skeptical about what was going into my body and brain that my situation improved.
Speaking of Behrman's new book, it actually doesn't exist yet and he doesn't have a deal for it yet, but that ought to get straightened out soon. I cannot think of many publishers who wouldn't want a tell-all book on someone's experiences as a spokespatient for Big Pharma.
News is out that Eli Lilly today formally entered a guilty plea in court to criminal misdemeanor charges related to illegal off-label marketing of Zyprexa for dementia, a condition for which the diabetes-inducing atypical antipsychotic is not approved. The plea comes as part of a settlement Lilly reached earlier this month with federal prosecutors in Pennsylvania, wherein the Indianapolis-based drug maker also agreed to pay the feds and about 30 states $1.42 billion. So far, Lilly is on the hook for $2.7 billion in payouts over its nasty little mood pill and, as I noted earlier this week, the company could be forced to kick down another $4 billion to settle remaining states and class action lawsuits. Wouldn't Col. Lilly be proud?
Hell, things got so messed up around Zyprexa that the company was outed by its own employees.
Two thoughts: the company is getting off cheap--Zyprexa has killed more than 3,400 people and injured many thousands more. Second, I can now refer to Lilly from here on out as a criminal corporation or use the adjective criminal in almost any way I want in referring to the company. So can you, and I encourage you to do so. Perhaps it's time to get some T-shirts printed up. I wonder what size the CEO wears.
Meanwhile, Bloomberg reports that a Lilly executive yesterday apologized to investors in an analyst conference call (via BNET Pharma Blog):
"'The company deeply regrets the past actions covered by the plea,' said Phil Johnson, executive director of investor relations, in a call to investors."
Two thoughts for Phil: you are apologizing to the wrong people. You should be apologizing to the many thousands of people your company's drug has killed and maimed due to your company's strategy of lying about how Zyprexa should be used in order to keep the company afloat when Prozac went off-patent in 2001. You should also apologize to the taxpayers everywhere who picked up much of the tab for your company's rotten drug through Medicaid and Medicare. Anytime you criminals want to issue an apology to the public, you know where to find us. We're the ones who aren't on the analyst calls.
Two, you are a couple of letters short of a pretty decent first name.
This paper (pdf here) in the American Journal of Psychiatry should be a big wake up call to patients (your doctor simply isn't very thorough or doesn't have the time to be thorough) and doctors who prescribe atypical antipsychotics, a class of drugs that is well-known to cause diabetes and heart problems. That's because this study asserts that patients getting these drugs are barely being monitored for either blood glucose or lipids.
Roughly 10 percent of patients got lipids monitoring and about only 20 percent of patients got blood glucose monitoring. Outrageous.
I've long contended that psychiatrists are routinely lax when it comes to their patients' physical health (not once when I was on these awful atypicals did a doctor inquire as to my body weight or lipids, even though it was obvious my weight was ballooning on these drugs) and I'm sure some folks thought I was excessive in my assessment. Looks like some doctors agree with me.
Said lead study author Dan Haupt of Washington University (St. Louis):
"'Possibly many psychiatrists do not feel comfortable performing metabolic monitoring, because they were not trained to consider the effects of mental illness and treatment on the whole patient, and many practice in environments that are physically separated from the rest of the healthcare system,' he said."'However, this represents a missed opportunity for psychiatrists to reduce the impact of medical comorbidities in their patients,' he added."
I could care less whether or not psychiatrists feel comfortable performing such monitoring, they absolutely have got to do it if they are going to give patients these drugs and patients should demand such monitoring or tell the psychiatrist to go take the drug for themselves and see how it all work out.
It's worth noting that one of the study authors is John Newcomer of Washington University (St. Louis). It was he who back in 2004 was a consultant to Eli Lilly and had some thoughts about the company's attempts to discount links to diabetes for its drug Zyprexa:
"Lilly is playing a language game with the FDA pronouncements. Because the FDA class warning is about diabetes, Lilly can claim that there is no direct link with diabetes--which is true in one sense. But there is a direct link with weight gain, visceral fat, insulin sensitivity, and thus diabetes, stroke, and myocardial infarction. So while Lilly is technically correct, this is whitewash. They are, however, doing an outstanding job of politicizing and language games."
This news brought to you courtesy of the Zyprexa documents, which Rolling Stone apparently used in reporting its recent lengthy story on Zyprexa, but didn't attribute to the appropriate source. They are just referred to as "internal documents" in the article, completely ignoring the very substantial risks some folks went to to make those documents public.
Yes, the RS article is now online and I've read it. I want to re-read it before deciding whether to take out a plinging gun or a .50 caliber machine gun.
Despite giving the reporter loads of help for his story and going unmentioned and unattributed, one thing I'll tell you right now is that the article is entitled "Bitter Pill." Ironically enough, last year I wrote an article for Willamette Week on how negative anti-depressant clinical trials data had been suppressed for decades. The article's title was "Bitter Pill." While article titles are up for grabs, it just charms me beyond belief that RS chose, coincidentally I'm sure, a title I'd already used. Classic.
The Wall Street Journal's Health Blog is reporting that GlaxoSmithKline has set aside $400 million in its fourth quarter of 2008 to answer a federal inquiry into off-label marketing of nine unnamed drugs. The inquiry was led by the US Attorney's Office in Colorado. In a statement the company said:
"GlaxoSmithKline plc (GSK) today announced that it will record a legal charge in the fourth quarter of 2008 of $400 million (£278 million) relating to an ongoing investigation initiated by the US Attorney’s Office in Colorado into the Group’s US marketing and promotional practices for several products for the period 1997 to 2004."
Technically, the company is merely setting aside the monies to reflect the current status of the inquiry, but companies like GSK don't set aside monies they don't reasonably expect to pay out or their shareholders would be very testy.
It's not clear what the nine drugs are, but the Journal provided a smart clue. From Note 44 of Glaxo's most recent annual report (page 156 of the 2007 annual report. Thanks to the WSJ Health blog for the link, but don't press it unless you want to wait a long time for all of the pages to load):
"In February 2004, the Group received a subpoena from the US Attorney’s office in Colorado regarding the Group’s sales and promotional practices relating to nine of its largest selling products, for the period from January 1997 to the present. In particular, the government has inquired about alleged promotion of these drugs for off-label uses as well as Group sponsored continuing medical education programmes, other speaker events, special issue boards, advisory boards, speaker training programmes, clinical studies, and related grants, fees, travel and entertainment. Although the original subpoena was issued from the US Attorney’s office in Colorado, the scope of the inquiry is nationwide. The government is also inquiring about the Group’s response to an October 2002 letter from the FDA’s Division of Drug Marketing, Advertising and Communication requesting information on the Group’s alleged promotion of Wellbutrin SR for off-label use. The Group is co-operating with the investigation and providing the requested information."
Obviously, there is some connection between the $400 million charge and Wellbutrin SR, but I've got only a slim idea of what the other eight products might be. You could of course reasonably suspect that Paxil will be one of them, given that the company was aggressively marketing the still-on-patent drug in the late-1990s.
A study came out in The Lancet the other day and I held off writing about it, waiting to see how the media would handle it. It was a very large meta study of anti-depressant trials where one anti-depressant was trialed against another anti-depressant. I don't have access to full text of Lancet studies, but from the abstract it's apparent that the authors didn't report how those anti-depressants performed versus placebo in all these trials--it's possible of course that none of these studies had placebo arms or that only some did and some of the drug v. drug trials are bound to be small since the whole meta study included 25,928 people in 117 trials. Anyway, I point this out because I am highly suspicious of studies of psych meds that don't include placebo arms, since I don't think you can learn much about the value of an individual med without controlling for the placebo effect. That's just me, of course. Feel free to have your own opinion.
Just so folks know, I've taken six of these drugs and I pretty much hated them all.
What's interesting is that none of the media coverage I saw mentioned the placebo matter, so you really have to wonder about global efficacy of the drugs. I've read loads of anti-depressant studies over the years and generally speaking you end up with a fairly sizeable placebo effect and an effect size for the drugs that runs from 12 percent to about 30 percent. But this study was about trying to help patients (I guess) and doctors sort out which of the 12 modern anti-depressants are best, compared with other drugs in their class. (The study didn't look at extended release version of Paxil and Wellbutrin.)
The big winners were Zoloft and Lexapro, based upon their efficacy versus other anti-depressants and their tolerability versus other anti-depressants. The final nod went to Zoloft due to its being generic and inexpensive. With one exception, the researchers who authored this study had deep ties to pharma companies (see the above-linked abstract for disclosures).
ABCnews.com kindly produced a list of the rankings:
Efficacy:
1. Remeron
2. Lexapro
3. Effexor
4. Zoloft
5. Celexa
6. Wellbutrin
7. Paxil
8. Savella
9. Prozac
10. Cymbalta
11. Luvox
12. Vestra
Tolerability:
1. Zoloft
2. Lexapro
3. Wellbutrin
4. Celexa
5. Prozac
6. Savella
7. Remeron
8. Effexor
9. Paxil
10. Cymbalta
11. Luvox
12. Vestra
Interestingly, I didn't catch any press coverage of this study that noted that Savella is not approved in the US as an anti-depressant, but was only recently approved as a fibromyalgia treatment in the US. As for Vestra, it is not approved for any use in the US and in fact in May 2007, the FDA shot down its maker's application for the US. Obviously the study was aimed at a global market, but for US media to not catch that it was ranking two drugs not available for depression in the US is very, very sloppy reporting (and makes me extra cranky that some of these folks are getting a journalism paycheck while I am not).
What also interests me is the implicit assumption in the study and the press coverage that someone diagnosed with depression is going to head straight for the meds. That's just arrogant.
It is amusing however to see how poorly Cymbalta performed on all measures. You've got to expect that, Eli Lilly being Eli Lilly, its maker will have its sales reps out in the field pronto to somehow try and defang the effects of this study.
This from the AP, which has tracked this issue very aggressively:
"Suicides among U.S. soldiers rose last year to the highest level in decades, the Army announced Thursday. At least 128 soldiers killed themselves in 2008. But the final count is likely to be considerably higher because 15 more suspicious deaths are still being investigated and could also turn out to be self-inflicted, the Army said."A new training and prevention effort will start next week. And Col. Elspeth Ritchie, a psychiatric consultant to the Army surgeon general, made a plea for more U.S. mental health professionals to sign on to work for the military.
"'We are hiring and we need your help,' she said.
"The new suicide figure compares with 115 in 2007 and 102 in 2006 and is the highest since record keeping began in 1980. Officials calculate the deaths at a rate of roughly 20.2 per 100,000 soldiers - which is higher than the adjusted civilian rate for the first time since the Vietnam War, officials told a Pentagon news conference."
This is all so sad and I wish the Army luck with its efforts.
No word on suicides among Marines, Navy and Air Force personnel.
It's interesting that today the Pew Research Center released a study ranking Seattle as third among cities where Americans say they would like to live, placing behind Denver and San Diego. I know Denver and lived in San Diego for 10 years, so I can attest to the wondrousness of those cities, especially when it comes to having better weather (ie, actual sunshine) than Seattle (cloudiest big city in America, but not the wettest).
I'm not sure how crazy things get in Denver when it comes to absurd crimes, but I know San Diego has its share of bizarre happenings. Meanwhile, here in Rain City, there have been three bizarre incidents in recent days. In one, a man tried to make a human sacrifice of his girlfriend, who apparently hadn't realized how off-the-peg her beau was before. The guy was reportedly still chanting in a strange language when cops arrested him on assault charges. Hate crime charges were just filed against a man who tried to stab a lesbian in the eyes on a street in my neighborhood not too far from my soon-to-be-former apartment. Sometimes, I just don't understand my fellow primates.
Sadly, on Sunday night, a 22-year-old Microsoft employee fell to his death off a building in Bellevue (OK, not Seattle but right across Lake Washington). His death has been ruled a suicide and is not related to recently announced layoffs at the software giant, since the guy's job was not affected. Suicide at any age is tragic, but at 22, what can you say?
Seattle may be a place people desire to live, but it sure as hell can get strange around here.
AstraZeneca, maker of Seroquel, and Eli LIlly, maker of Zyprexa and Cymbalta, today both reported their 2008 financial results.
For AZ (pdf here), global Seroquel revenues were up 11 percent over 2007 to $4.452 billion. US Sales of the drug were $3.015 billion, a 5 percent increase over 2007.
For Lilly, Zyprexa revenues were down 1 percent (so essentially flat) at $4.696 billion versus $4.761 in 2007. The company's anti-depressant Cymbalta saw 2008 revenues jump 28 percent over 2007 to hit $2.697 billion after 2007 sales of $2.102 billion. Sales of the company's ADHD drug Strattera posted a modest 2 percent increase to $580 million after 2007 sales of $569 million.
Lilly reported a loss for 2008 of $2.072 billion due to charges related to illegal off-label marketing of Zyprexa and the acquisition of ImClone.
Yesterday, I wrote that the FDA was ordering AstraZeneca, maker of Seroquel, to update its labeling to reflect "significant weight gain" experienced by patients, a potential precursor to diabetes and other metabolic syndrome issues (the agency has still not answered my questions on this issue). In response, one reader left the following comment:
"No problems with weight, but prolonged massive back pains."
I replied:
"Me too on back problems that cropped up with taking this drug. Let me guess, you had sudden tightening of all the muscles in your back? Sorry you had that experience. Back pain sucks."
I feel terrible for the guy and believe his account. On Seroquel's package insert (pdf here), AZ notes that 3 percent of patients in the drug's schizophrenia and bipolar mania clinical trials experienced back pain while taking the drug as opposed to 1 percent who took a placebo. The PI also notes that 7 percent of patients in the same trials experienced pain versus 5 percent of those taking a placebo. The package insert also describes patients who experienced muscle twitching and muscle stiffness due to neuroleptic malignant syndrome and extra pyramidal symptoms. (Download the pdf for yourself and search for those terms.) NMS and EPS are well-known side effects of antipsychotics, particularly the first-generation drugs. The second generation antipsychotics were supposed to be largely free of these problems. Looks like Big Pharma and researchers and doctors were lying to patients once again.
I suspect that the percent figure for back pain and other problems could be higher in the real world, as in my experience clinical trials data on side effects usually understates the percent of patients who experience side effects on a particular drug, perhaps most infamously with sexual side effects and anti-depressants. The reality is that in three to 12 week clinical trials, there's only so many side effects that are going to crop up. Many side effects don't emerge until months, and sometimes years, later.
And, now I am going to let the cat out of the bag. As I've written before, I experienced tardive dyskinesia (trembling lips in my case) in 2005 while taking Seroquel. What I've not written about before is that I believe Seroquel to be directly responsible for the back problems I've experienced over the last four-plus years and I also believe the drug has caused jerking tremors in my legs and in my right arm and right shoulder that continue to this day. The tremors are somewhat sporadic, but I do worry about how they may develop over time, as they have not stopped even though I halted use of the drug in 2005. I had never had tremors in my limbs of any kind before taking Seroquel in 2004. I had never experienced back problems of any kind in my entire life until after I began taking Seroquel.
According to NIH, symptoms of TD can continue long after a patient stops taking an antipsychotic.
Although I have suspected a Seroquel connection with my back pain and limb tremor problems for a long time, I've not written about it at-length previously because I wanted to be reasonably sure of a connection before doing so. The thought that there could be a connection was simply too ugly to ponder overmuch. I did write about the TD I experienced and overall muscle tightness on the drug two years ago, plus my experience of having horrible dreams on the drug. What's more, during the time I took Seroquel--approximately 14 months--I would sometimes wake up with scratches all over my forehead, caused by my own fingernails while I was asleep. This has not occurred since I got off Seroquel in 2005.
Two weeks ago, a friend of mine arranged to have a doctor friend of his--a rehabilitative medicine specialist and a chronic pain doctor--examine me pro bono as a favor to my friend. I have no health insurance and no ability to pay out of pocket. My friend suspected that my chronic back problems (very painful ones, by the way) over the last few years likely had a deeper source than just sitting in front of a computer for too many years and so on, since I'd had a pain-free back until recent years and couldn't attribute the back pain to any injury. He was even more suspicious of a deeper cause when he saw my right arm jerk spontaneously when we were hanging out one evening not long ago.
So, anyway, the doctor examined my back and I told him about the tremors and jerking. I also told him about the back pain and how one night in late 2004 I reached for something on a coffee table in my apartment and all of a sudden I had a muscle tear in my right deltoid. Excepting a minor hamstring tear playing high school football and a groin pull (it's as bad as you've heard) while playing college hockey, I'd never experienced muscle tears or pulls of any kind. The tear in my deltoid was extremely painful and stuck around for several weeks. This cropped up about six months after I had begun taking Seroquel to address agitation and edginess which I thought was a hallmark of bipolar disorder (especially on the depressive side of things), but which, in retrospect, was likely connected with Depakote and Wellbutrin, drugs I was taking at the time I began Seroquel. I wasn't then as attuned to drug-induced akathisia as I am now. And, yes, I was basically prescribed Seroquel to treat the side effects of other drugs. Nice, eh?
I told him how I later experienced muscle tightness and, the next year, trembling lips (my mouth really), and then how that eventually devolved into severe muscle spasms in my back and, eventually, chronic back pain--sometimes the pain is so bad that I cannot walk or bend--and how that had all led me to his office. We also talked about how my body weight had ballooned 10 percent on the drug, even though I was following a fairly careful diet and was walking frequently.
He told me that Seroquel was a likely cause, although he couldn't rule out other causes until after I'd had X-rays, a procedure I simply have no money to pay for. He'd also like me to have a complete neurological exam. Again, that's something I simply cannot afford. But if I ever get health insurance again in my life, he'll be happy to write me a referral.
So there you have it. I'm not clear on how much these sorts of problems crop up for patients taking Seroquel. I'd like to hear from others who've taken this drug or other similar drugs. Have you run into similar problems or not? Did whatever problems popped up go away or hang around indefinitely? Fire away in comments.
And for the two or three people at AstraZeneca who will read this post, if you want to talk, you know where to find me. Otherwise, I guess you can read the adverse event report I plan on filing.
I'll be back later this morning with other posts, but for now I am a bit too frustrated after writing this post to write anything else.
Much as I've been saying since last summer, the Bloomberg wire service is reporting today that Lilly faces at least $4 billion more in settlement monies to shut down the remaining lawsuits brought against the company over its handling of Zyprexa, its $4 billion-plus selling antipsychotic. The remaining cases involve unions, insurance companies and pension funds who've sued the company in federal court in New York State plus remaining lawsuits by 12 states who were not part of last week's $1.42 billion settlement between Lilly and the feds plus about 30 other states.
Adding $4 billion to the $2.7 billion the company has already paid out would bring the total to $6.7 billion, or more than the $4 billion-plus that Merck is paying out over Vioxx, which is the current record holder for pharma settlements.
"Not part of the settlements were suits by 12 states and a class-action case brought by pension funds, insurance companies and labor unions seeking as much as $6.8 billion. Two state trials are set for this year. Settling all 12 might cost the company another $2 billion, and going to trial would cost more, said Patrick Burns, a spokesman for Taxpayers Against Fraud."'The total nut on this could be four or five billion' if the company settles, Burns, who tracks the suits, said in an interview. 'Their cheapest way of clearing the decks is to settle.'
"Burns’s Washington-based group promotes lawsuits to fight fraud against the U.S. government."
Whether Lilly ends up settling is another matter entirely, but the company has blustered before about meritless Zyprexa cases only to later settle them. Lilly had this to say to Bloomberg:
"'We believe their claims are without merit, and that’s why we’re prepared to go to court,' Marni Lemons, a spokeswoman for Lilly, said. She wouldn’t comment on how much more Lilly may spend to settle suits."
So we shall see. Hopefully, these cases will be wound up sometime this year.
I was pleased last week when President Barack Obama pledged to make the federal government more open, accountable and transparent to the American people. But, sadly, that message seems to be lost on one of the most opaque, we-work-for-industry-not-the-public agencies of them all, the FDA.
For example, in December I contacted an agency press officer because news had just come out that the FDA had caught AstraZeneca engaging in what the agency deemed off-label marketing of Seroquel, an atypical antipsychotic, for depression, a condition for which the drug is not approved. I asked the FDA to tell me what range of penalties and sanctions the company could face for engaging in such conduct. I was trying to provide readers with some context for understanding what penalties were possible.
I was given the usual FDA response of "I'll look into this and get back you." Days passed and I queried the agency again, after receiving no further reply. This time, I got no reply whatsoever. Yesterday, I renewed my request of the agency in conjunction with questions about the FDA now requiring AZ to update its label on the drug to warn the public and doctors about the likelihood of significant weight gain on the drug. I asked the fDA to provide me with a copy of whatever communique it had sent AZ so that I could include it in what I planned to write for today about the weight gain warning. No answer.
This whole stall-and-don't-answer business with the FDA is, of course, legendary and I am sick of it. The agency approves drugs with limited efficacy, then allows Big Pharma to hide negative data about the same drugs. The agency creates its own diagnoses of psychiatric disorders, even running counter to scientific disputes as it did with pediatric bipolar disorder last year, while one of its officials was entangled in helping academics and industry create the definition for that disorder and the same official would then later sit in judgement of drugs submitted for approval for that disorder--and then the agency won't answer questions about how that official was involved in the process to begin with (seriously, I've tried to get answers and get no response). Heck, those are just a few examples of the FDA's paranoid secretiveness. I'm sure there are many other examples in the drug and device side as well as on the food safety side of the FDA.
I know there are a number of federal agencies that are closed-off and secretive and which need to be forced into the sunshine, but I can think of no better place for the White House to begin pressing its new openness dictates than upon the FDA. After all, it's now a Presidential directive that the agency tell the public what's up.
Yesterday, the Bloomberg wire service reported that the FDA recently wrote to AstraZeneca, makers of Seroquel, and ordered the company to update its labeling for the drug to include a warning of "significant weight gain" due to use of the drug. This news came out not because the FDA suddenly made its request of AZ public, but because of documents that became public in a court case in Florida where AZ is being sued over various accusations about its handling of the drug, a $4 billion-plus seller in 2007.
I've asked the FDA to provide me with a copy of the letter it sent AZ, but so far nothing but the agency's usual silence.
The issue of weight gain is crucial because rapid and significant weight gain can lead to diabetes and a host of other maladies. It's not clear to me what data the FDA has that prompted the label change and it's not clear what kind of weight gain was being experienced by patients. I took this drug for about 14 months and saw an approximate weight gain of 10 percent of my body weight. When I began taking Seroquel in 2004 there was no warning on its label for weight gain, which kind of makes me roll my eyes at what the company told Bloomberg.
"Seroquel’s label has 'always provided accurate and appropriate information and warnings,' Tony Jewell, a spokesman for AstraZeneca in Wilmington, Delaware, said in an e-mailed statement. 'We continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.'"
I have reviewed the current package insert (pdf here) for Seroquel and cannot find where it reflects the FDA's order. As far as I am concerned, AZ is not providing "accurate and appropriate information and warning."
The court case is scheduled to begin Feb. 2.
Yesterday's post on getting dissed by Rolling Stone wound up generating over 16,000 visits for the day as well as loads of emails and comments from supportive readers. Thanks to all of you. My previous daily visits record was set one day last September when I got almost 8,000 visits one day. I'll try and catch up with emails today.
In addition, two people contributed money to this site, bringing in $50. Thanks. Heck, I'm not even beginning the next fundraiser yet. That will begin later in February. I appreciate the gesture and the contributions.
One of my goals for this year was to have a month with at least 40,000 visits in it, which would be 20 percent growth over my previous record month and seemed like a reasonable goal to shoot for. That goal was surpassed a few hours ago. I'm simply stunned that this occurred so early in the New Year. Guess I need a new goal of some kind.
Bristol-Myers Squibb today announced its 2008 financials and its atypical antipsychotic Abilify, the object of much TV advertising over the last year, saw its sales hit $2.15 billion, a 30 percent jump over 2007's sales of $1.66 billion. The company has been advertising Abilify on TV both as an add-on treatment for depression (i.e., for use in cases where an anti-depressant alone isn't enough) and for bipolar disorder, the first TV ads ever seen for an antipsychotic. So it's clear that advertising pays.
I've criticized both the ad and the drug in recent months, both in its bipolar version and in its more recent incarnation as an anti-depressant (and in a slightly newer version of the ad). I've noted that the drug is likelier to cause akathisia than it is to successfully treat depression. I've criticized the depression ads for craftily re-branding Abilify as an anti-depressant, when it is actually an antipsychotic. I've slammed the FDA for refusing to comment on BMS's attempt to advertise the drug as an anti-depressant, which in my mind has got to be in violation of the agency's marketing regulations. And I've written about adverse events experienced by children and teens and caused by Abilify. In 2007, I noted that Abilify ads were being pasted to phone booths around Seattle.
BMS is, of course, the same company that in 2007 agreed to pay a $515 million settlement to the feds, much of it to answer allegations that the company had marketed Abilify off-label for use in kids and dementia in the elderly. I guess the big boost in sales in 2008 sort of helps cover that fine.
I'll leave it at that.
As I mentioned two weeks ago, the US military has determined that post-combat PTSD does not merit awarding of the Purple Heart, given to service members wounded or killed in action with an enemy. Yesterday, two separate writers responded to the finding.
First up is Simon Maxwell Apter writing in The Nation, who, once he gets done being snotty towards the military (you'd expect that from the lefty magazine), he expresses a sentiment with which I agree:
"A wounded soldier, whether he or she suffers from PTSD or from an RPG-shattered face, is a wounded soldier. By shining honor, and not shame, onto the psychological wounds of victimized soldiers, the armed forces can perhaps begin to update their decidedly old-fashioned vision of sacrifice and give their fighting men and women the credit and respect they deserve."
Yes, wounds are wounds, be they physical or psychological. The trouble is sorting out genuine cases of PTSD from what some would consider fakers, because there is much concern about the holy medal being debased, a legitimte concern.
Writing an op-ed in the New York Times, Tyler E. Boudreau, a former Marine captain and Iraq War veteran, offers a possible solution:
"I urge General Eric Shinseki, the new head of Veterans Affairs and former Army Chief of Staff, to work hand in hand with the Defense Department to bring about some form of official recognition for these wounded veterans. The current stigma of post-traumatic stress would likely prevent many soldiers from wearing the medal initially, but its mere existence would help crystallize in the American — and the American military — consciousness one of the more obscure human costs of war."I suggest we call this medal the Black Heart. Certainly the hearts of these soldiers are black, with the terrible things they saw and did on the battlefield. Certainly the country should see these Black Hearts pinned on their chests."
I truly don't know how to sort out this issue, but it seems to me only fair that service members struck down with post-combat PTSD deserve some form of official recognition and an appropriate decoration.
Update (2.40 p.m. PST, 1/27/09): To clarify for a few wondering souls, I have heard from numerous readers of the article at this point and the author himself. I am mentioned nowhere in the article and neither is this site.
Last week, science writer David Dobbs wrote that this blog was a fine example of a symbiotic relationship between old media and new media and specifically cited my work on the Zyprexa scandal in this regard. This week, Rolling Stone's article on the Zyprexa scandal appeared, authored by Ben Wallace-Wells. It's not online yet and it hasn't appeared on newsstands in Seattle, but I've heard now from several readers who've seen the article. They tell me that it's a good article and one even wrote to tell me that the author made several salient points about Zyprexa and the atypical antipsychotics and that they largely echoed views on these drugs which I have expressed on this site over the last several years.
I'm glad Wallace-Wells wrote a nice article and got a fat paycheck (RS pays really well or so I hear). I hope the article serves to inform RS's 1.4 million print readers and 1 million monthly web readers, and even works to keep some of them away from these awful drugs.
What torques me, however, is that the article makes no mention whatsoever of this site or the Zyprexa documents or of me, according to three people who've read the article already. Last August, I got an email from Wallace-Wells, a contributing writer at the magazine, soliciting my help as a source for his article on the "social history" of the atypicals. A few days later, he and I spent quite a bit of time on the phone and I did a complete brain dump on the atypicals, their history and development, the Zyprexa documents, the Zyprexa scandal, issues around mental health, issues around doctors handing these drugs out willy-nilly to adults and children, the FDA, my experiences on these drugs, and my view that the atypicals essentially amount to a repeat of America's attempt to treat its psychological complaints much as it did in the 1950s and 1960s with Milltown, benzos and downers (and Valium in the 1970s), all disastrous experiments. I pointed out that Big Pharma, doctors, research universities and the government all played a part in the Zyprexa scandal and in the ascent of the atypicals to a $14 billion-plus class of drugs. I covered the waterfront in other words. (We even talked about how screwed up the media world was and he acknowledged how lucky he was to have paying work at a time when very experienced journalists such as myself were out of work.)
I sent a few follow-up emails and brought to his attention other bits of news on atypicals. As recently as early January, I heard from Wallace-Wells, asking me to help him track down some documents for RS's fact-checkers.
I would've expected that in a very lengthy article such as he wrote that Wallace-Wells would've found a way to quote me, mention my work here, mention my website and so on. But no. No symbiotic relationship there.
In the last two years or so, I have been a source for or offered expert commentary to a lot of print reporters and to reporters at TV news networks in this and other countries. In the last two years, I have reviewed books by various authors on mental health issues and have promoted their columns and such (even where I sometimes disagreed with their points). With perhaps one small exception or two, not once have I or this site so many of you read each day been mentioned, credited, quoted, attributed to and so on. Not only would the occasional mention help build my reputation at a time when I am starving and largely out of work, but it would drive a few readers my way and, inevitably, some of them would contribute money to help support this site. But no. No symbiosis.
And, so now I am done helping my alleged colleagues in the media and book authors. None of them help me (Dobbs is the obvious major exception), so why the hell should I help them? For several years, I've taken the attitude that I needed to be altruistic and help reporters with stories so that no more Americans would wind up on the atypicals, or at least that the trend in their use would be reversed. But I simply cannot eat altruism, I cannot pay rent with altruism and altruism doesn't get attention for my labor or send me readers. I've been sleazed for the last time.
From here on out, if a major media organization (and that means any reporter getting a paycheck these days) approaches me for help, I'm going to do what I used to do when I worked at a newspaper (Seattle Weekly, Willamette Week) and reporters at NBC and the New York Times used to call me to try and get me to turn over my sources on a story so they could go off and look smart while trading on my labor. "Are you going to credit me and my paper?" I'd ask. They'd usually hem-and-haw and say "No." Then I'd tell them that I didn't have time to help them. Sound of phone hanging up.
The same thing now applies to this site. If you are in the media or are a book author and you want my help, then you find a way to credit me and this site, or you don't get the value of my expertise. If you are an author and want me to mention whatever it is you are writing, then you'd better find a way to scratch my back in return (one or two have and I appreciate it). If you agree to credit me and this site, then I'm all yours. But until then, no dice. (Obviously, if you are a blogger, etc., then I'll treat you the same as you treat me.)
As for Wallace-Wells, I simply cannot wait to flyspeck his article, because as one those who's read it wrote to me, "I wondered why it read like some of your positions/comments."
Update, Feb. 9, 2009: I've heard from various sources in Australia that this story may be a victim of data entry errors and that no ECT was given to small children Down Under. I'm working to clarify this with authorities in Australia.
On occasion, a bit of news comes my way that simply leaves me speechless (hat tip to Beyond Meds for putting me onto this) and this is one of those times: the Melbourne Herald Sun is reporting that it's uncovered government data establishing that ECT is being used on young children in the State of Victoria and elsewhere in Australia, in some cases on children younger than 4 years of age.
From the article, it is unclear what these youngsters could possibly have that might merit using ECT, a procedure that the State of Western Australia is considering banning for kids under 12. My sick hunch is that, given how rare psychosis is in young kids, this is the bipolar child business run amok, or at least it smells like it. But then who cares what disorder these kids allegedly have, ECT simply cannot be right to use on kids, whose brains are still forming.
"Federal Government statistics show the use of ECT--an electric shock delivered straight to the brain--in the state's private health system increased from 1,944 treatments in 2001-2002 to 6,009 in 2007-2008. [That's a 300 percent increase in six years!]"About 12,000 treatments were performed in the public health system last financial year.
"Medicare statistics record 203 ECT treatments on children younger than 14--including 55 aged four and younger. Two of the under-4s were in Victoria."
Although experts the paper contacted both wondered at the use of ECT in children and the vast increase in its use among adults, one person actually defended its use in children:
"Bioethicist Assoc Prof Nicholas Tonti-Filippini supported ECT on children, saying some toddlers were 'disturbed.'"
Those are some nice bioethics Tonti-Filippini, who teaches at the John Paul II Institute for Marriage and Family-Melbourne, has got there. One senses that even the late Pope John Paul II would be alarmed.
Let me offer my usual disclaimer on ECT, so readers know where I am coming from. I consider the use of forced, involuntary ECT to be barbarous and a form of torture. If someone wants to undergo the procedure voluntarily, then go right ahead. It's your brain.
As for its use in children, let me just go out on a limb here and say it ought to be banned.
I've never heard of ECT being used on youngsters (let's say under 12) in the US much less anywhere else. But here's an oldish web page describing its use in American kids. Oh, wow is all I can say.
Today marks something of landmark for this site, as this is the 2,000th post on this blog. Last May was the 1,500th post.
Although I had hoped to mark the occasion with a special post, my back is simply not up to it today. Yes, I'm learning to treat my back very gingerly as I come back from the realms of constant pain and muscles in spasm.
Two other bits. First, not many readers are commenting today although site traffic itself is pretty much normal for a Monday. Is something going on out there that I don't know about? Aside from the recession and cold, crappy weather (it's been quite cold in Seattle, but nothing to compete with the Midwest)?
Second, Rolling Stone is out with a lengthy article on atypical antipsychotics and their cultural history. I've not seen the article myself yet as it's not on the newsstands in Seattle and it's not online yet either (online posting usually lags publication by a week or so), but one person who's read the piece liked it a great deal. It'll be interesting for me to read since I spent a fair amount of time with the reporter last August, walking him through the history of the drugs, their immense legal problems, and how I think medical culture has lost its mind in regards to their use, as well as how these drugs screwed me up personally.
Anyway, I thought I'd give you all a heads-up.
A stunning report was out the AP wire yesterday: news that allegedly treated wastewater in the region where many American pharma companies manufacture generic drugs in India is filled with huge concentrations (the highest in the world, the reporter claims) of pharmaceuticals, especially antibiotics, but also including anti-depressants, heart drugs and so on. The big offender is ciprofloxacin, an antibiotic that's winding up in Indian wastewater and drinking water at a level of 150 times that seen in American drinking water (where it's presence is also unacceptably high). While the problem may be localized to India's pharma region, it's sure indicative of just how great the befouling reach of Big Pharma has gotten in this world and how lax the companies are overseas at cleaning up the messes they create while making anti-depressants for bummed-out Americans. We take drugs for literally every ailment under the sun and moon in the US ($250 billion or so each year) and because of the way global economies work now, the same drugs wind up in the drinking water of people in India. That's just crazy.
In addition to whatever concerns you ought to have about long-term exposure to various pharma products for the folks in India, another big concern is the possibility that having an antibiotic floating around the water is that it can create new strains of bacteria resistant to current antibiotics because of all the antibiotics in the water that actual humans drink. That's not good, but I'll point you to the article itself to see how that's fleshed out.
What amuses me is that both the branded and generic pharma manufacturers trade groups in the US basically declined to comment on the situation. Not to be too much of a cynic here, but I'd say these trade groups' members have a special responsibility to remedy this situation and so does the Indian government, which pulls in taxes from these companies.
BTW, when I wrote of the "pharma water" situation here in the US last year, several commenters basically acted as if the situation was benign and of no great import. I wonder if they'll say the same thing this time out.
Last year, I noted that Prozac in a water supply was found to make fish swim oddly and not eat. Also late year, the AP broke news on how psych meds and other pharma products were winding up in the water supplies of major metropolitan areas.
Congratulations to the AP for continuing to press this story in the US and elsewhere. It's further evidence of why America (and the world) need healthy news organizations and reporters paid a decent wage, otherwise stories such as this would never come to the fore and the public would go along in deluded ignorance.
And, this case has nothing to do with academic psychiatry, but involves women's health doctors at the University of Wisconsin School of Medicine and Public Health. Unearthed by two reporters at the Milwaukee Journal Sentinel is evidence that for several years researchers at the UW taught medical courses at the school touting the efficacy of hormone replacement therapy for women, even after other UW researchers participating in a major clinical study of HRT had cancelled the study due to grave safety risks that cropped up around the drugs, including breast cancer and heart disease. Of course, the first group of researchers downplayed those risks in their course and on an accompanying website, which was taken down earlier this month where reporters began asking the UW questions.
The course was funded by Wyeth Pharmaceuticals to the tune of $12 million. Wyeth makes HRT drugs such a Prempro and Premarin. The UW got $1.5 million of that and individual doctors got money as well, all to advance views which several experts quoted in the article say are out of touch with consensus views in women's medicine.
"The Journal Sentinel asked several doctors, including Jacques Rossouw, chief of the Women's Health Initiative branch of the National Institutes of Health, to review course material. The initiative is the largest clinical trial of hormone therapy drugs."He said the views expressed in the course are not those of the general scientific community and are not suitable for a university medical education course.
"'There is a history of this kind of thing from Wyeth,' Rossouw said. 'The materials regurgitate lines that I have heard and read many times, and I have come to believe (though I do not know) that this is part of an overall marketing strategy to the profession. It is not good science because it fails to strive for any kind of balance.'"
Remember the days when doctors were supposed to be ethical actors and a firewall against their patients being given dangerous treatments? Those days are gone it seems. I wonder if they will ever come back.
As troubled as psychiatry is, there is now growing evidence that these wild conflicts and unscientific drug pushing pervade academic medicine. That's not just my view. Marcia Angell, former editor of the New England Journal of Medicine makes that very point in this recent article.
It's time for medicine to have its head examined. Meanwhile, the article is further proof that America needs stout, healthy newspapers and reporters paid decent wages in order to have these sorts of stories continue to see public view.
Some of you are likely aware of the syndicated column "The People's Pharmacy," which I often find interesting, and which has often taken a deeply-skeptical stance on various psych meds. In this week's column, the authors go after atypical antipsychotics and note that they are used for a whole host of mental disorders that have nothing to do with psychosis.
"Despite the initial enthusiasm, there is growing consternation about the safety and effectiveness of these powerful mind medicines. A few years ago, a study found that the newer and far pricier drugs were no more effective or less likely to cause troublesome side effects than an older antipsychotic (New England Journal of Medicine, Sept. 22, 2005). A new study in the same journal (Jan. 15, 2009) reported an alarming rate of sudden cardiac death linked to the newer drugs."It’s no wonder that patients and families are nervous about these medicines, especially when you consider that they can cause other complications such as dramatic weight gain, diabetes, strokes and irregular heart rhythms. Children and older people may be particularly vulnerable."
I've been making this same basic point for over three years on this site and almost five years in print (albeit a bit more quietly)--the atypical antipsychotics are as lame as the first-generation drugs they replaced and their widespread use in our culture for non-psychotic disorders represents one of the biggest scams ever pulled by Big Pharma on the American people (and peoples of other lands as well).
To date, the companies foisting these drugs upon the public have largely remained unaccountable. Sure, Lilly has paid out--or is supposed to pay out--$2.7 billion in settlements (with more to come) and has pleaded guilty to a criminal misdemeanor charge, all of it related to Zyprexa. Bristol-Myers Squibb has paid a $515 million fine to the feds, some of that related to off-label marketing of Abilify. J&J/Janssen (Risperdal), AstraZeneca (Seroquel) and Pfizer (Geodon) have escaped unscathed so far. One hopes their days of reckoning are coming soon.
Of course, it's not just with antipsychotics where supposedly-safe new drugs have proven to be utter train wrecks in a pill. When SSRIs and other new anti-depressants were introduced in the late-1980s and 1990s, they were touted as being so much more effective and so much more safe than the older tricyclics and MAOIs. But they weren't.
In both instances, some of the chief cheerleaders for the drugs were doctors and mental health workers, and not just the ones who landed speaking gigs for the drugs themselves, but your average run-of-the-mill clinician and mental health worker. While it's nice to see continued skepticism about antipsychotics and anti-depressants from some quarters, I know there are still plenty of mental health workers out there who think these drugs are a boon.
Last week, I ran into a young man I know and he told me he'd recently developed sweats and shaking on Effexor. He told his psychiatrist about this and, no lie, the doctor told him he was either exaggerating or making the whole thing up.
According to this press release, three more lawsuits were filed in federal court in Florida earlier this week on behalf of patients who allege that they developed diabetes as a result of taking the atypical antipsychotic Seroquel.
In a separate case in Florida, it was reported last month that AstraZeneca knew of increased incidence of diabetes related to Seroquel going back as far as 2000.
What with Lilly settling $2.7 billion in cases relating to its antipsychotic Zyprexa and admitting guilty to a criminal charge, you have to wonder how matters will play out in court for AZ and Seroquel, which has over $4 billion in sales in 2007.
Peter Gott is one of a few doctors who does a syndicated Q&A type of column nationally and he recently took up a question from a reader about whether Seroquel should be given to elderly person with dementia and whether the drug was safe long-term. His answer:
"The long-term effectiveness (more than six weeks) has not been fully evaluated. All prescribing physicians should reevaluate patients on a regular basis."You are correct that the drug can be dangerous for elderly patients with dementia. I can only hope the prescribing physician fully researched all the options before prescribing it and that the dose is a reasonable one.
"All patients, regardless of age, that are treated with antidepressants or antipsychotics for any condition should be monitored carefully for negative alterations in behavior, especially during the early stages of a new medication."
I have serious questions about how safe the drug may be for elderly patients even short-term. Last week I heard from a reader whose elderly father had been admitted to a nursing home the week before and who was given a dose of Seroquel. The reader reported to me that within 24 hours their father became confused, began slurring his words and, then, died. While the Seroquel could possibly have not been the cause, it sure would have to be a leading suspect.
Many of you know that I am being kicked out of my apartment of six years come March 1 because I smoke cigarettes and my property manager got my lease changed (sneakily, in classic passive-aggressive Seattle style) to no-smoking allowed in order to chase me out. Yesterday, I ran into his wife, who co-manages the property with him, and asked her if the no-smoking rule would also apply to people in the building who smoke pot, as I know that several residents do (and I'm fine with them smoking weed).
"Of course not," she said.
I pointed out to her that smoke is smoke and smoking is smoking regardless of the plant involved, as well as that pot is illegal (except for medical marijuana patients in this state) and cigarettes are legal. I told her she was being hypocritical and she just laughed at me as I walked off. I'm being driven out of a place I've lived in longer than any place in my life because a group of new residents hate cigarettes (and the mere idea of someone smoking them since no smoke is going into their units), but are just fine with people hitting the Graffix bong to their heart's content. This is not an isolated situation in either Seattle or other big cities, but I'll come to that in a minute.
Some of you may wonder why I'm bringing this up on a mental health blog. Besides, the fact that all of this affects yours truly, it's well-known that there are high rates of cigarette smoking among people diagnosed with schizophrenia, depression and bipolar disorder. Nicotine and dopamine receptors love one another is supposedly the simple reason.
Whatever the impulse, I know of multiple cases of people with mental illnesses who smoke cigarettes and who have been forced from their housing in Seattle due to the excessive hatred for smoking in Seattle, where we have the toughest anti-smoking rules (in public) of any big city in America. In fact, last year Reason magazine ranked Seattle as the number two Nanny State city in America (behind Chicago) based upon a number of factors, but primarily due to the city's warrior stance on smoking (I wrote the piece on Seattle, but was not involved in the rankings). All of those I know who've been displaced due to smoking (so far) are low-income and disabled, usually the precise group of people whom good, diversity-embracing Seattle progressive-liberals claim to be extra concerned about. I've even seen otherwise all-loving liberals harass homeless people for smoking on a sidewalk. I'm only a click or two above these folks when it comes to income. I doubt that Seattle prog-libs give a damn about me either.
Last weekend, I ran into a guy I know who runs a low-income building for a public agency here in town that owns many buildings and he told me that his agency is going to ban smoking in its buildings very soon. This will affect about 1,000 people. "I don't know why," he said, "because when I walk through the halls all I smell is hella weed." We were smoking cigarettes, 15 stories below the party we were both at because that building had banned smoking as well. He told me that the agency would ask him to enforce the ban. I asked if he would. "Hell, no," was his answer and he explained that very few people in his building smoked cigarettes, but that a whole bunch smoked marijuana and that if he enforced the ban on smoking, he'd be required to kick a dozen or more residents out for smoking weed. We talked about the bizarre disconnect of all of this, finished our smokes and went back upstairs where, in an apartment reeking of marijuana, we were offered a joint. Seriously. Smoking is banned in that building, but that apparently means cigarettes not BC Bud.
The way all the smoker-hating is playing out in Seattle is bizarre, to say the least, and it would make me laugh if it didn't affect me so personally. If, come March 1, I smoke a cigarette in my unit, I will be evicted (I'll be moved by then or so I hope), but if I smoke a joint that's just fine with my property manager, even though the lease change sent around last week says no smoking. If I walked outside and smoked a cigarette within the gaze of a cop, I'd be fine, but if I smoked weed in front of a cop I could get in some trouble (not too much trouble, but you get my point).
I cannot claim to know how the whole war on smoking thing is playing out in every big city in America. I know that there have been various proposals floated in both San Francisco and Los Angeles to ban smoking in or around apartment buildings, but I know both cities well enough to know that no one would ever apply that to pot nor would they survive politically if they tried. Pot is very close to legal in San Francisco (under local laws) and I seriously doubt anyone is getting kicked out of apartments for smoking weed. But the city is virulently anti-smoking, at the same time. In fact, there are so many cities in California mulling bans on smoking in apartments and outdoors, that I know I will never live again in my native state. Clearly, there's a new cigarette in town and its name is marijuana.
How all of this is playing out in cities like Philadelphia, New York City and Chicago is not known to me. But I know Boston is about to institute some very tough rules on smoking and has already banned smoking in bars and whatnot, but something tells me that the inevitable drift towards kicking people out of apartments in that city over cigarettes--that's where the ban hysteria seems to now be leading--won't apply to marijuana. And yet pot is illegal while cigarettes, cigars and pipe tobacco are legal.
The reality is that federal laws on marijuana are wildly out of touch with the sentiments of tens of millions of Americans who do smoke weed. A few cities--Seattle, SF, Boulder, Colo., etc.--have relaxed local laws on marijuana enforcement and 13 states (including Washington State) have some form of medical marijuana laws and several states have largely decriminalized possession of small amounts of weed, but under federal laws and the laws of many states, you can still do hard time in prison for possessing marijuana, which makes zero sense to me (I think Paxil is arguably more harmful than pot and allegedly safe Zyprexa has led to over 3,000 deaths in the last decade while I don't know of any documented cases of deaths caused by marijuana). From what I hear from sources of mine, it wouldn't surprise me if Congress chose to re-examine federal laws on marijuana at some point in the next few years and it wouldn't shock me if President Barack Obama ordered the DEA and federal prosecutors to back off on medical marijuana, especially in California. Obama promised to do so during the election campaign last year (to a reporter friend of mine no less).
But wherever a possible rethink on marijuana ends up, the fact remains that pot is illegal and is a form of smoking (and therefore leads to instant death by the groupthink of public health types) and yet it suddenly enjoys greater rights and casual protections, especially when it comes to housing in America's big, largely liberal cities, than does smoking cigarettes, which is a legal activity. I simply cannot sort out this kind of disconnect except to point out that it represents a form of delusional thinking and policy making. When it comes to the housing disconnect, it's discrimination, straight-up and nasty.
It also represents a startling change to me in how liberal sorts think and treat their fellow Americans. I'm a moderate/Libertarian myself and have kicked around Seattle prog-libs pretty hard in this post, but that's because I am a recovering liberal myself and I cannot help but notice that the places in America where the anti-smoking jihad is the most intense is in big liberal cities--Seattle, San Francisco, Los Angeles and Boston. So far, I'm not hearing about people being chased out of their apartments for smoking in Nashville or Houston. What's more, it's in these big liberal cities where marijuana enjoys a preeminence that would've simply been unthinkable even a decade ago.
What intrigues me even more is how liberalism and liberals have changed over the last 10 or 15 years. When I was younger, liberals were very much the crowd that clung to respecting differences among humans, letting people make informed adult choices about adult behavior and go their own way out of respect for their individual rights (even if the behavior was deemed unhealthy or immoral), and so on. That sort of ethos is gone from liberalism now--at least where I sit in Rain City it is--and it makes me wonder what the hell happened. If all these alleged science-loving, reason-imbibing liberals took a long hard look at the various studies on secondhand smoke (this site run by a public health researcher who prefers honesty to religiosity in his science is a good place to start), they'd find that the evidence for the effects of secondhand smoke isn't as robust as they think. They'd also find that many of the anti-smoking advocacy groups (some funded by Big Pharma-related foundations) behind the smoking bans and smoker hatred in this country make claims that are excessive. I was pretty surprised myself when I began looking into all of this a few years ago, albeit somewhat casually.
But let's assume for minute that all the hysteria around smoking is true. Why aren't the same people who want me booted from my apartment calling for Obama to be booted from the White House? (Yes, the new President still smokes on occasion.) Why aren't they calling for all cars, buses, trucks and airplanes to be banned as well? Smoke is smoke, right?
And what are they going to do once someone gets around to doing a study on the effects of secondhand marijuana smoke?
Well, I know the answer. I am one person and am pretty much powerless. I'm easy to pick on and have kicked from my housing. So are all the folks I mentioned at the top of this post, who have no one to advocate on their behalf. It both disgusts and amuses me that this is what's going on in our country these days and I'll push back against it as best I can. But that may take a while. Discrimination takes time to turn around.
In the meantime, I'm beginning to think that the only way to work all of this out is for big cities like Seattle to embrace segregated rental housing, based on smoking preferences instead of race. I know that may strike some readers as odd, but given that 20 percent to 25 percent of adult Americans still smoke and given that that percentage seems to be a dialed-in hardcore band of smokers it strikes me as practical. I suspect like a lot of other people who smoke, I simply want a place to live and to be left alone by the smoker haters.
I'm not making this up: former French President Jacques Chirac was mauled by the family dog, which has been given anti-depressants. Said Chirac's wife: "The dog went for him for no apparent reason.... We were aware the animal was unpredictable and is being treated with pills for depression. My husband was bitten quite badly but he is certain to make a full recovery in weeks."
Apparently, anti-depressants can work a whammy on dogs as well as humans.
I'm not even sure what lede to write for this post, but the basic story is that a couple of days ago David Dobbs, a well-known science writer whose work I admire, wrote on his new blog "Neuron Culture" (separate from his old blog, "Smooth Pebbles") about this here blog. The occasion was Dobbs responding to critics of an earlier posting of his wherein he had defended the existence of what some call the dinosaur media--newspapers, mostly--and his hope that they don't disappear entirely. He noted:
"I too have been disappointed in the MSM's [mainstream media] failings the last few years. Yet there are times when the papers' sources and clout combine with the energy, quickness, and independence of BlogoMedia in a mutual amplification that serves the public well."
I agree with Dobbs, who writes for the New York Times and other media outlets and is the author as well of three books, that there are simply things that the MSM can do that the blogosphere cannot, primarily because of the MSM's reach and resources and the skills of individual reporters and editors. Frankly, I'd like to be back working for a major media outlet, but that's not likely to happen anytime soon and maybe never will. Newspapers are shedding reporters around the country, media companies are going into bankruptcy, the New York Times is reportedly in deep financial distress and, here in Seattle, the wonderful Seattle Post-Intelligencer is expected to be closed for good in March after being in business for 140-plus years. I can assure you that none of that bodes well for the blogosphere, but I don't want to belabor an obvious point.
What startles me is that the Craigslists, Monster.com's and Vehix.com's of the world who are directly responsible for the wounds suffered by newspapers in this country haven't put any money that I know of into producing a column inch of journalism. If you care about news and information that should trouble you immensely. If you care about the media's role as an essential check on governmental power and excess, then that should scare you as much as, say, the Patriot Act.
Anyway, Dobbs noted that I do the work I do here for low pay (oh, so true, not that I am not humbled by the donations of dozens of individuals come fundraiser time), no benefits (true, says my bad back) and minimal infrastructure (my G4 iMac is six years old and I work alone with no newsroom support or colleagues to lean on and bitch at) is somehow emblematic of blogging and how new media and old media oddly work together. He said a lot of other things as well.
"Dawdy has pressed the Zyprexa story hard since early 2006 -- it's possible no one has read or written more about it -- adding, synthesizing, and commenting on tons of information, and he pulled the sheets off in February 2007 by publishing, at what would seem to be frightening legal risk, the full set of court documents relating to Lilly's Zyprexa marketing. Presumably these are the same documents that were sent to the Times a couple months earlier, but which were not easily obtainable publicly until Dawdy posted them."How do you compare the contributions here? You can't get the scale to hold still. Yet it's clear that the combination of the Times expose and Dawdy's reporting and outing of the documents created a dual pressure that was crucial to the growing attention the case received, and ultimately to Lilly's extraordinary admission last week of criminal activity."
He's right that you cannot compare the contributions of the Times and myself, and it's pretty clear to me that outlets like the Times don't want you to make the comparison.
Dobbs notes elsewhere that I've not gotten hat tip one from the paper of record (plenty of credit from Timesfolk privately, however) for any of the work I've done on this site. Then again, sites like this are roundly ignored by the MSM (unless they are about politics, then they get tons of attention from the MSM) and while I get that the traditional media doesn't like to credit others, they need to accept that they and the blogosphere have a symbiotic relationship. Over the past two years, I have helped a dozen or so reporters at major media outlets with various Zyprexa stories and other stories on atypical antipsychotics (I helped another one just yesterday) and I don't think I've been credited once. It's gotten to the point where I don't even think about it much anymore and just help out the MSM unstintingly because if whatever work they end up doing results in X number of people not taking Zyprexa or Seroquel or whatever, then I've done my job.
Besides, as a former (and sometimes still-current) member of the MSM, I know what reporters are up against.
I simply have no idea now where things will wind up for me and this blog over the next year or so. The future of media in America is so very uncertain that I cannot hazard much of a guess as to where it's all going to end up or how reporters and editors and such are going to be paid an appropriate wage. But then so much in America is up in the air these days, even including hope, which I think our new President sometimes fails to recognize is still a thing with feathers.
BTW, many thanks to those of you who wrote me to alert me to Dobbs' post, which my Google alert did not pick up. And many thanks as well to Liz Spikol who offered her thoughts on this blog as well.
Over at US News & World Report's "On Women" blog, Deborah Kotz recounts a tale of a friend of hers, who along with her husband lost millions of dollars in the Bernie Madoff Ponzi scheme scandal. (BTW, like a lot of investors, they may have put their money with someone else, having no idea it was later invested with Madoff's firm.) She had a fairly natural grief reaction to all of this and developed fairly severe anxiety. She got put on Lexapro. Things did not turn out so well:
"Unfortunately, the Lexapro seemed to make things worse for Loren: 'I had horrible shivering and sweating and would curl up in a ball on my couch after breakfast and lie there until midafternoon,' she recalls. 'I felt like I was in a fog that I couldn't snap out of, like all the color went out of my world.' A psychiatrist friend of hers urged her to go off the medication, and within two days, Loren's fog lifted. She still feels anxious and occasionally has dry heaves but has found outlets to deal with her anxiety: talking to friends who are also Madoff victims; playing tennis; writing and illustrating a children's book (inspired by her Lexapro experience); and teaching art in a local high school. She and her husband also came up with a two-year plan for getting their family through the crisis."
As Kotz notes, there are other ways to deal with anxiety, even ones outside of therapy and medications. You can read her blog for that.
Separately, you've got to wonder how many new scrips for anti-depressants have been written in the last year due to this nation's financial crisis and in hopes of addressing people's natural depression and anxiety. I bet it's in the millions. You've also got to wonder how many of these same people have had nasty reactions to the drugs. I bet that's in the millions, too. Good business for Big Pharma and doctors though. Possibly quite pointless and painful for many Americans, who likely could've found other ways to address their responses to grief.
While I'm wondering aloud, I want to point out that in recent months several of you have written me to suggest that there may be an anti-depressant component to the financial crisis, but one of a different kind--i.e., that loads of people in the financial industry were basically high, or emotionally blunted, on anti-depressants the last decade or so and that their anti-depressant stupor led them to make insanely stupid financial choices for which we are all now paying a very hefty price. I suppose such a dynamic is possible--although I'm not sure you could ever reduce it to a simple Prozac effect--but I've not seen the kind and degree of direct evidence yet to convince me that anti-depressants are weirdly at the root of our financial crisis. But if I ever find such evidence, I can assure you I'll write about it.
At times, I've been deeply critical of some of psychiatrist Richard Friedman's work in the New York Times, but a column of his published Jan. 19 continues to intrigue me. The basic premise is that Friedman ran into a couple of otherwise-healthy patients who reported experiencing intense bouts of depression after sex (yikes). Friedman found little evidence of how to handle such cases in the medical literature--apparently such cases are rare--so he hypothesized that perhaps the patients were undergoing some kind of neurochemical change in their brains that caused the brief depressions.
He gave each an SSRI--he doesn't identify which--and it seemed to help the depressions abate. Friedman is quick to note that SSRIs commonly lead to sexual dysfunction, but he's intrigued by how these two outlier cases turned out. So am I. Even though I generally regard SSRIs as garbage and the chemical imbalance theory of depression as an unproven guess, I've never denied that there's a group of people for whom these drugs are worthwhile. How large that group is is hard to say--my hunch has usually been around 10 percent to 20 percent of people with depression--and who knows if people with post-coital blues would all respond similarly to an SSRI, but it sure is interesting.
Today marks my attempt to return to normal after both the inauguration of President Barack Obama and my bout of back miseries. My back seems to be semi-cooperative, so we'll see where this winds up.
As for the new President, I simply cannot wait to see his proposals on health insurance. We'll see where that winds up, too.
One of the interesting stories to come out of last week's record $1.42 billion settlement (and subsequent guilty plea to one criminal charge) between Lilly and the feds and about 30 states over claims Zyprexa was illegally marketed comes from Robert Rudolph, a Lilly sales rep who was one of several reps to blow the whistle on his own company.
"Why, he asked management, was the Indianapolis pharmaceutical company marketing its antipsychotic drug Zyprexa to elderly people when the drug was not approved for that group?"Why had the company violated privacy rules by culling patient lists at doctors' offices?
"Why was the company counting drug samples as sales, which would boost the stock price?
"He went on for about 10 minutes during a sales meeting in 2002. The other 25 Lilly sales representatives stared at him, stunned.
"'I'd just been wrestling with this stuff for so long,' he said in a telephone interview today. 'I was put in a position of breaking the law, in my view, or quitting....'
"He warned management of his concerns. Their response: 'You're not a team player.'
"He began talking to other sales representatives about the issue, including Hector Rosado, another whistle-blower in the case.
"As he pondered what to do, Rudolph's son, then 15, provided a moment of clarity:
"'He came up to me and said, "Dad, what's wrong is wrong." I had taught my kids that. It was wrong, and I wanted to make it right.'"
Good for Rudolph and his son. Rudolph and eight other Lilly whistleblowers will split from $78 million to $100 million of the settlement.
This is a classic case of poor reporting: yesterday a study comes out in JAMA and is written up the health news wire service Health Day News and it runs on the Washington Post's website (and presumably in the paper as well). Basically, the article claimed that elderly patients on Lexapro showed "significant improvement in symptoms" of generalized anxiety disorder. But the reality is the study showed that 69 percent of patients taking Lexapro improved while 51 percent on placebo did. That's an effect size of 18 percent, which is not especially robust or, to my mind, especially significant. (maybe it is to someone else, however.)
One researcher even touted Lexapro because it reduced patients' blood pressure.
Even more telling, however, is what was not reported in the article. From the study abstract:
"Adverse effects of escitalopram (P < .05 vs placebo) were fatigue or somnolence [41.1%]), sleep disturbance [14.1%]), and urinary symptoms [9.4%])."
How can 41 percent of patients on a drug experience a side effect and it doesn't end up mentioned in the article? I don't have an answer, except that the reporter must've left his make-me-non-lame pills at home. Either that or he's on Lexapro and half-asleep.
And why would doctors tout a drug that leaves a boatload of patients fatigued or asleep? While that might be therapeutic for a day or two, it'd be hard to make the case that it'd be dandy for patients longer term.
Tomorrow is the inauguration, so I think I'll just go silent out of respect for the event and the mood in this country right now (a mood that I hope improves dramatically and soon). Besides, you all are going to be paying attention to the events in DC and not whatever I post. And that's as it should be. Have a good day.
I'll be back at it on Wednesday.
Today is MLK, Jr. Day and I really have no idea how it affects readership, since some people have it off and some people don't. I'll likely just plod along with posts as the mood strikes me during the day. All of that is of course dependent on what my back allows. The beast seems to be better, but it's not fully-recovered yet so I'm having to be very careful about how much time I spend in front of the computer. It's sitting in front of the computer for long periods of time that really causes me problems and even short periods can be tricky still, so I'm forcing myself to be off the computer more than I'd care for. I hope things are vastly improved by the weekend.
In other news, I was informed by my evil property manager on Friday that my apartment building will ban smoking of any kind as of March 1. So I will be moving, to where I know not, when I know not, how I know not. With luck, I hope I can get through whatever move I have to do without too much disruption to the site (or to my back). It's sad to me personally, but the hate for smokers has become so huge in Seattle (and elsewhere in America) that we are now being booted from our housing. That sounds perfectly fair to me!
For those of you who wonder why I don't just go outside, the answer is that the same candy-assed yuppies who moved into my building recently and began to complain about me (and some others) will complain just as much if I smoke outside. Trust me. That's how hot the hatred is for smokers. I cannot wait until the Nanny Statists turn their pharma-funded weaponry to more aggressive assaults on food, alcohol and guns, then everyone else will know why I am feeling a bit put out these days.
Anyway, tomorrow is, of course, a special day in America and I haven't quite figured out yet whether I should post anything or just assume that everyone's attention is going to be somewhere else. Let me know what you think in comments.
I pass this along not because Fox News reporter Douglas Kennedy is breaking any new ground (he's not), but because none of the other TV news networks, cable or traditional, would touch the settlement Lilly reached with the feds and about 30 states last week. For whatever reason, Kennedy and the folks at FNC have kept tabs on all the lovely news around psych meds--especially anti-depressants and kids--the last few years. What's curious about Fox's coverage to me is that MSNBC, NBC, CNN, CBS and ABC didn't mention the $1.42 billion Zyprexa settlement, even though it was a record for cases of its kind and even though what's gone on with atypical antipsychotics represents the biggest scam Big Pharma has pulled in memory. The non-Fox networks simply don't seem interested (ABC has done a piece or two here and there) and you have to wonder why that is.
You'd think there might be one or two other reporters out there in TV land who could connect the dots on all of this and, perhaps, let their audiences know what's going on. But I guess not. Maybe their news directors are all on Prozac or something.
As a journalist, it sure does make me wonder, however. As a journalist, I also have to wonder why Fox feels the need to remind viewers that Kennedy was the first national TV reporter to report on anti-depressants and suicides back in 2004. That's five years ago, so if Fox wants people to be impressed perhaps they ought to go break some new stories in the lands of Big Pharma and psychiatry. Because the truth is out there.
I had a long day out of the office and away from the computer yesterday and my back is being temperamental this evening, so I'm going to decide that the better part of valor involves not sitting in front of a computer, but instead involves coming at you with posts late morning today. Ideally, next week things will be closer to normal. And Eli Lilly will still be admitted criminals!
News is out this morning that, as expected, Eli Lilly has settled claims against it by the feds and numerous states for illegal off-label marketing of its antipsychotic Zyprexa. The company also pleaded guilty to a criminal misdemeanor charge of violating the Food, Drug and Cosmetic Act by promoting Zyprexa as a dementia treatment. The total settlement comes to $1.42 billion, bringing the company's total Zyprexa settlements to date to about $2.7 billion. With more to come. Ten states have sued Lilly separately.
The settlement only covers off-label marketing of the drug for dementia. So what the hell happened to charges relating to the company's lies about the safety of its drug in on-label uses such as schizophrenia and bipolar disorder? I think the feds and the states walked away from this too easily because the company, which I can now safely dub "criminal," lied about the fact that its drug caused diabetes in all manner of patient populations. Surely, that's worth something to the feds and the states.
Lilly has issued a statement:
"'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.'"
Uh huh, just like with Prozac.
My back is somewhat improved. I'll see how it feels in the morning and hopefully play catch up on some posts during the day.
I keep wondering when the many pieces of bad news around the atypical antipsychotics will finally wake up patients and doctors to the unacceptable dangers of these drugs and lead to decreases in their use. Now comes this study from the New England Journal of Medicine identifying that people who take atypicals have a more than 200 percent greater chance of a fatal heart attack than people who don't take the drugs. That really ought to make doctors (and parents) think twice about giving these drugs to children, the elderly and anyone who doesn't have a psychotic disorder. A doubling of cardiac death risk is kind of hard to ignore.
When these drugs were introduced in the 1990s (Abilify came in the 2000s), they were touted as wonder drugs, antipsychotics that were risk free and safe for one and all. Now, it's clear these drugs cause all kinds of metabolic problems, diabetes, heart problems, prolactin problems and on and on the list goes. They've killed thousands, more than Vioxx. So widely-used are these drugs for a myriad of conditions that their sales in 2007 were $14.5 billion, a huge increase from the $2 billion in antipsychotic sales rung up in 2000. The growth was because these drugs were supposed to be good for absolutely every psychological malady and their were prominent psychiatrists saying so.
I wonder how they all feel now. I wonder how they now explain away giving these drugs to someone. Here's what one of the study authors said:
"'Any prescription is a balancing of risks and benefits. This is more information on the risks that needs to be taken into account,' [Wayne] Ray [study author] said in a telephone interview."'Many people thought the "atypicals" would be much, much safer. Our study suggests that they are not at all safer in regards to this serious end point,' said Ray."
I've only been saying this for three years now.
I swear the atypicals have turned out to be one of the biggest scams Big Pharma has ever pulled on Americans. They also represent a big black eye for psychiatry, which worked so hard to adopt their use and defended the drugs to the hilt.
That headline about says it all. A Wisconsin man died earlier this week after walking out into sub-zero weather in the night while sleepwalking on Ambien. Tragic. And one of many who've done odd, and sometimes tragic, things while on the sleeping pill.
Ambien has certainly turned out to be one weird pill.
News is just out now that Eli Lilly is expected to finalize a settlement with the feds over accusations of off-label marketing of its drug Zyprexa and ripping off Medicaid and Medicare. According to the New York Times, the settlement will be for $1.4 billion, a record in a whistleblower case (because Lilly employees apparently reported their own company to the feds). So far, Lilly has settled civil class action lawsuits and some states' claims for about $1.3 billion. Many more claims remain outstanding.
Due to my bad back, I am not going to sit here and type out all the background and context to all of this. Please go read the article. And remember as well that this site somehow played a significant role in the Zyprexa scandal.
Just a short note to let you all know there will likely be no posts today, barring a miracle of some kind. My back worsened on Monday evening and was completely gone on Tuesday. To answer inevitable questions, no I haven't seen a doctor. I have no health insurance and no money to pay for a doctor out of pocket. Yes, I have stretched. Doesn't help. No, I am not using a heating pad. The pain and disablement I am experiencing right now are too much for that. No, ibuprofen doesn't help at any dose. No, I don't have pain pills.
Thanks for your patience. I hope I am back to semi-normal soon.
Over the last few days, I've run into some gut-churning pieces written by two youngish people, each wrestling separately with demon medications (or at least they are for them). First up is Zachary Taylor (God, I love that name), who's having a very rough go of it getting off Lexapro, which he was put on for panic issues not depression. His doctor told him he'd have no trouble getting off 5 mgs. Taylor ran into loads of problems including:
"For the first time in my life I feel like I could just die. Like, not really kill myself, but kind of just let something bad happen to me, maybe take risks, like drive my car of the road or walk out into an intersection. Never had any thoughts like this ever before, and don’t plan on acting on them either!"
He's back on the med short-term and I think hopes to get off it again in the future. I've noted before that the whole issue of psych med withdrawal needs to be appropriately researched so that other can avoid Taylor's experience. It's an issue of medical ethics, I'd say.
Then comes "Hannah," an 18-year-old student at the University of Manchester, who writes:
"I am back to the darkness, teary, nothingness, the existence. I’m being medicated to hell with olanzapine [Zyprexa] and an appointment has been made for me when I get back to Manchester to talk about returning to Seroquel. They don’t want life to be in me, they don’t want me to follow my plans, to be a someone and not a no one. They bundle me up every time, would rather have me in bed and fat on olanzapine than allowing free thought that they see as socially unacceptable. They see my promise and they kill it, repeatedly, and when it happens again they will repeat it, and of course it will happen again because thats the very nature of this illness. I get up there, I am up and they crash me down with a sledgehammer not caring what I will land on. They think my parents are wonderful for getting me help, they think my thoughts are wrong, they think I am wrong, that I need to be fixed."
There's more to it and you should go read it. She's a good writer and describes herself as:
"On good days I deny that I have manic depression and on bad days I deny that I have manic depression. Occasionally I believe that my diagnosis is correct but most of the time I am angry, bitter and twisted."
I pass these along to you all for what they may be worth to you.
Time has a piece on its website and, I presume, in its print edition (not sure how the whole print/Web thing works with the mag these days) on borderline personality disorder. As these sorts of article go in the major media, it's not a bad article. It steers clear of all the gender and sex issues that are sometimes associated with the disorder and focuses on cutting and self-harm and notes that far too many borderlines wind up on tons of medication, often to no good effect. Why the hell are they on meds in first place?
Other than that, the article is a big wet kiss for dialectical behavior therapy (good stuff, I'm told) and its developer, Marsha Linehan, a psychology professor at the University of Washington. She explains BPD thus:
"'Borderline individuals are the psychological equivalent of third-degree-burn patients. They simply have, so to speak, no emotional skin. Even the slightest touch or movement can create immense suffering.'"
None of the controversy around the diagnosis itself is explored, but that would likely require an entirely different article, yet it biugs me a bit that issues of diagnostic accuracy weren't at least mentioned. What also bugged me is that the author cites a prevalence figure of 5.9 percent of American adults (about 18 million people) and that strikes me as so much BS that it's difficult to remain calm. The author references a paper in the Journal of Clinical Psychiatry from 2008, but the only paper I can find in JCP from that year referencing BPD and prevalence rates uses the figure of 5.9 percent to refer to personality disorders in general, not BPD specifically. If someone has better insight into that 5.9 percent prevalence number, please let me know.
It strikes me as an excessive claim, right up there with claims that bipolar disorder affects 11 percent of American adults.
What the reporter got largely right was this:
"As many as 75% hurt themselves, and approximately 10% commit suicide — an extraordinarily high suicide rate (by comparison, the suicide rate for mood disorders is about 6%)."
While I don't know about the absolutes of self-harm and suicide, I can tell you that my experiences in the mental health world and of borderlines in my personal life would tend to support those numbers. But that's just what I've encountered. Your mileage may vary.
What pleased me was that the author actually got pretty close to what I think the actual suicide rate is for mood disorders (depression and bipolar disorder mostly). As I've discussed before, the usual 10 percent to 20 percent suicide rate bandied about by well-meaning advocate and doctors simply does not compute and winds up being used as a scare-people-onto-meds tactic.
That's the conclusion of a report out today from the HHS Office of the Inspector General (pdf here). From the AP:
"'We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators,' the report said...."In all, 42 percent of the applications lacked complete financial information and less than 1 percent of researchers disclosed possible conflicts. Such limitations 'could result in FDA being unaware of a clinical investigator's financial interest, and thus unable to gauge its potential bias on clinical trial results,' the report said."
It confuses the hell out of me that the FDA lets this go on and doesn't go back to the drug companies and investigators and demand proper financial disclosures before a drug is approved. I'd love to get the FDA's view on why this is the case, but as I've learned recently, it's next to impossible to get the simplest of answers out of the FDA concerning some of the simplest aspects of its regulations.
A new study is out in Lancet Neurology asserting that antipsychotics used to treat Alheimer's and dementia in the elderly may double the risk of death in patients. Use of these drugs in treating the elderly is off-label, but is nonetheless a huge proportion of antipsychotic sales, especially in the US, and has led to numerous lawsuits.
In the study, researchers found that of 83 patients receiving antipsychotics, 39 were dead within one year, while of 82 receiving placebo, 27 were dead within one year. And:
"After two years, 46 percent of Alzheimer's patients taking the anti-psychotics were alive, versus 71 percent of those not on the drugs. After three years, only 30 percent of patients on the drugs were alive, versus 59 percent of those not taking drugs."
That's pretty startling and so was the assessment of one of the study authors:
"'For the vast majority of Alzheimer's patients, taking these drugs is probably not a worthwhile risk,' said Clive Ballard, the paper's lead author, of the Wolfson Centre for Age-Related Diseases at King's College London."'Would I want to take a drug that slightly reduced my aggression but doubled my risk of dying? I'm not sure I would,' Ballard said."
This kind of evidence lines up with other recent studies and assessments of antipsychotics use in the elderly, including studies finding that treating patients with placebo was more effective than with an antipsychotic and studies showing an increased risk of stroke on these drugs.
Simply put, these drugs should be used very little in the elderly, if at all. Sadly, there's evidence that, at least in Canada, doctors are ignoring the various black box warnings on these drugs.
Although I'm still in a decent amount of pain, my back is at least functional and improving, so I should be back to something approaching normal today. The tricky part is I do best when I'm not sitting in a chair, so that ought to make things challenging.
BTW, thanks to all of you who wrote and commented on my situation. I can assure you that I was in very bad shape for a couple of days, wat beyond what a heating pad could address.
Just a quick note to let you all know that "Madness Radio," hosted by my friend Will Hall, has a new website. Shows cover a range of mental health issues, often from fairly radical and alternative angles, and run about one hour a piece and are archived on the site. The program has been around for three years and in that time Hall has hosted 100 shows. He's a busy guy.
Last week, the Pentagon decided, after reviewing the matter, not to allow the Purple Heart to be awarded for combat-related PTSD. While the decision is no doubt disappointing to some, the military does what it does.
"But a Pentagon advisory group decided against the award because, it said, the condition had not been intentionally caused by enemy action, like a bomb or bullet, and because it remained difficult to diagnose and quantify."'Historically, the Purple Heart has never been awarded for mental disorders or psychological conditions resulting from witnessing or experiencing traumatic combat events,' said Eileen Lainez, a Pentagon spokeswoman. 'Current medical knowledge and technologies do not establish PTSD as objectively and routinely as would be required for this award at this time.'"
I certainly get the point of those who'd like to see the award bestowed on people whose lives have been ripped apart by combat PTSD, but I also understand the Pentagon's trouble with making it fit military rules for the award.
This morning my back went into spasms and then locked up on me, completely without warning. I've been pain free for two months or so since my last go-round with back trouble, so this setback is a real surprise, especially since my rehab had been going so well. Making things more complicated is that I have no health insurance, so pain pills are completely out of the question right now--and the pain is so great I can barely walk. I hope I can turn this around quickly. I don't know how, but I will.
In the meantime, posts may be very sporadic since I cannot sit in a chair for long without feeling real pain.
News is out that the FDA has yet again said it's not prepared to approve the long-acting Zyprexa injectable, sister to the short-acting, diabetes-causing pill and short-acting injectable.
It's not clear when the FDA will approve this drug or when Lilly might give up on it (likely never!), but this back-and-forth has been going on for at least a year now.
This comment came in today, in response to yesterday's post on the huge placebo response in kids in depression treatment trials. I should note the study I wrote about was published in the American Journal of Psychiatry, a peer-reviewed journal.
"You know, Phil. I wonder how many people are going to die because of this site. Think about it. Someone is going to die because of your need to be the center of things. And to you that would be OK because it still leaves you at the center of things."
The person who left this unapproved comment sometimes goes by the handle "A Believer." S/he doesn't leave valid email addresses, so there's no way I can write s/he and let him/her know s/he's been banned from this site.
Just thought I'd share.
The former editor of the New England Journal of Medicine, Marcia Angell, has a piece in a recent issue of the New York Review of Books talking about the various crazy news around psychiatry, corruption in the medical field and discussing Alison Bass' Side Effects (Paxil book), Christopher Lane's Shyness (about the craziness of the DSM and social anxiety disorder) and Melody Peterseon's Our Daily Meds (how Big Pharma creates new disorders of every kind.
It's a fine article which breaks no new ground, but nonetheless reaches an extremely influential dorky intellectual audience in the progressive-liberal world who could probably benefit from knowing all of this. So read it for yourself.
Yesterday, I noted that CNN's chief medical correspondent Sanjay Gupta, a neurosurgeon, was expected to be named Surgeon-General of the US by President-Elect Barack Obama. I noted that I had concerns because Gupta struck me as a lightweight as a reporter--and I am in a position to make that kind of judgment--and that he had openly supported the use of the HPV vaccine Gardasil, well in advance of its FDA approval, and that he downplayed the risks of Vioxx, months before the drug's maker took the drug off the market and months before thousands of lawsuits erupted around the drug and how its risks were hidden by Merck.
I noted that I didn't want Gupta anywhere around mental health issues if he had such a track record of being wrong and intellectually incurious, but I hadn't been able to track down how Gupta had handled issues like depression and anti-depressants and suicide while at CNN. I've now rectified that and it is clear that Gupta screwed up his reporting on anti-depressants and suicide in 2004, ignoring evidence that was available to him before he went on-air.
In late 2003, Britain banned the use of anti-deperssants, excepting Prozac, in children under 18 years due to reports of suicides and suicidality. But nine months later, here's our Surgeon-General-to-be claiming children haven't committed suicide on these drugs. From Sept. 15, 2004 on CNN's "American Morning:"
"[HEIDI] COLLINS [CNN ANCHOR]: ... this pamphlet will come once you get the drugs from the pharmacy -- they'll be in the bag, right?[SANJAY} GUPTA: That's right. I mean, it's more stuff to read, but it's going to talk specifically about the studies, specifically about the increased likelihood of suicidal behavior.
COLLINS: So, how do these drugs end up going from depression to suicide? Quickly.
GUPTA: You know, it's interesting, because the disease itself, depression, can be linked to suicide. So, it's been a real battle for people to try and distinguish between the two.
The way they think it works is that if you are severely depressed, you take the medication, it may make you feel well enough to feel suicidal -- you know, where you have enough energy to actually commit -- carry out a suicide. No one has committed suicide on these drugs, children-wise, but they think about it a lot.
COLLINS: All right. Dr. Sanjay Gupta, thanks so much for that.
GUPTA: Thank you." (Emphasis mine.)
As I noted yesterday, as a reporter Gupta strikes me as a lightweight outside of neuroscience and neurosurgery, who either gets his information straight from pharma companies and establishment doctors or is too incapable or incurious as a reporter to look for contrary information. Or his producers at CNN are totally misserving him by not doing an appropriate amount of digging on his behalf.
If Gupta was referring to the oft-used argument by SSRI-suicidality deniers that there were no recorded suicides in clinical FDA approval trials of SSRIs and other modern anti-depressants, then he'd be correct. But Gupta doesn't cite his evidence base, clearly doesn't care about other anecdotal evidence, doesn't care about studies like the infamous Paxil Study 329 (which was in children, and included instances of profound suicidality that Brown University psychiatrist Martin Keller, the study's lead author, worked to cover up) which was published in 2001 and had a storm of controversy around it not long after (someone vaguely attentive to the medical press should've been semi-aware), and simply handled the story in a pharma-friendly, journalistically-lazy manner. I dislike lazy journalists, especially when they are making big TV money and have reams of producers and interns working under them who can do the digging someone like Gupta doesn't have the time for.
Besides evidence has been trickling out since Gupta's 2004 piece on how GlaxoSmithKline, Paxil's maker, worked to cover up suicides and suicidality from FDA approval trials. From the New Scientist in February 2008:
"However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra "placebo" suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults."
Of course, Gupta couldn't have known about those documents in 2004, but why wouldn't he choose to do a piece about new evidence that had emerged around suicides and SSRIs since? It's kind of hard to imagine why he wouldn't unless he flat out wasn't interested or was, inexcusably for a medical reporter, unaware of the efforts of Sen. Charles Grassley (R-Iowa) and others to reveal the real issues afoot here, including suicides on SSRIs and other anti-depressants plus all the other hubub of news around psychiatry these days. He could've reported on the 2004 suicide of healthy volunteer Traci Johnson, a 19-year-old woman who hanged herself at an Eli Lilly clinical trials facility while taking Cymbalta in a trial of the drug for stress urinary incontinence (Johnson didn't have a history of depression). That would've made for some interesting TV news.
If Gupta's going to handle such complex, tricky issues in such a careless manner, then how's he going to handle other public health matters? With 30 million people a day in America taking an anti-depressant of some kind for some reason, the issue of suicide, suicidality and anti-depressants is an actual public health issue. If Gupta and CNN don't get that, then they need to have their heads examined.
Anyway, in addition to the British ban, by the time Gupta went on-air in September 2004, there were several known cases of anti-depressant-induced suicides among children and, in fact, some of those parents had already spoken out publicly and would've been available for an interview.
Here are a few:
July 1997 suicide of Matt Miller, 13, in Kansas. He was taking Zoloft. His father blamed the drug.
July 2003 suicide of Julie Woodward, 17, of Pennsylvania. She hanged herself, seven days after beginning Zoloft. Parents blamed the drug and testified at FDA hearing.
January 2004 suicide of Candace Leigh Downing, 12, of Virginia. She hanged herself soon after a dosage increase of Zoloft. Parents blamed the drug and testified before the FDA.
January 2000 suicide of Caitlin McIntosh, 12, of Texas. She hanged herself weeks after being started on Paxil and, then, switched to Zoloft. Parents blamed the drug and testified at a February 2004 FDA hearing.
What's more, British psychiatrist David Healy had, by 2004, estimated that 500 American children had killed themselves on SSRIs. Healy is an authority on these issues. Given Gupta's account of no suicides of kids on anti-depressants, it's obvious neither he or anyone at CNN could have spoken with Healy.
I simply believe that someone who displays such a lack of curiosity as a reporter and alleged medical expert offers much to worry about as Surgeon-General. As I noted yesterday, Gupta has openly pimped for Gardasil and was dead wrong about Vioxx and now it is clear that he was very wrong about anti-depressants and suicide.
His appointment as Surgeon-General should be reconsidered.
Gianni Kali, the author of the Beyond Meds blog, has begun hosting a social networking group online for people who want to discuss all manner of issues around psychotropic medications and alternatives to psychiatry. It has several dozen members already. I pass it along to those of you who may be interested.
There's a new study out in this month's American Journal of Psychiatry, attempting to account for large placebo responses seen in earlier meta studies of kids taking anti-depressants, because, of course, researchers want to design future trials where anti-depressants perform better than placebo. OK, perhaps I am being a bit uncharitable about the motivation of the researchers who authored the article--they are researchers who want to understand what likely struck them as an anomaly--but when they start tossing around assertions like "major depressive disorder in children and adolescents is common,' as they do in their paper (pdf below), I tend to get a wee bit testy.
The big bits of news from this study are that the placebo effect in clinical trials of children and teens taking anti-depessants is huge; the effect size of anti-depressants is ridiculously small; anti-depressants seem to work better on severely-depressed kids and teens than on the moderately or mildly-depressed; researchers attribute the high placebo response rate to--drum roll--multicenter clinical trials with more centers involved than in other trials and younger subjects in some trials. That last bit--essentially blaming study design for placebo response rates--is the kind of prestidigitation that passes for science in psychiatry these days.
So how big was the placebo response rate? The anti-depressant response rate?
Overall, researchers analyzed 12 studies (including the infamous Paxil Study 329, led by Brown University's Martin Keller) which included 2,862 patients (median age 12.3 years) who were randomized to either an anti-depressant or placebo. The medications in those 12 studies were Prozac, Paxil, Zoloft, Lexapro, Celexa, Effexor, Remeron and Serzone. Taken together, 49 percent of patients responded to placebo while 57 percent percent responded to an anti-depressant. That makes for a global effect size of 8 percent, meaning a doctor would have to give anti-depressants to 10 kids before seeing a response in one of them.
That placebo response rate is huge, and should really give any parent, patient, advocate or clinician much pause when considering whether or not to give a child an anti-depressant. You have a roughly 10 percent chance of helping a child versus a, at minimum, 4 percent chance of inducing suicidality (see the FDA's black box warnings on anti-depressants for that bit) and an even high likelihood of giving that child some other side effect of the medication. You know, like akathisia and withdrawal. In other words, this paper ain't exactly a ringing endorsement of anti-depressant use in children and teens. If you read the paper and accompanying editorial, you can see researchers desperately trying to maintain their justification for using anti-depressants in kids. I won't even begin to go after that.
It's time for researchers and clinicians to face facts: the day of using anti-depressants in kids is drawing to a close and continued use of these drugs in kids and teens must cross some high hurdles or you are coming damn close to engaging in malpractice. That's my opinion and it may be overdrawn, but you know what? I don't care. I'm tired of seeing kids needlessly ripped apart by drugs that harm more than they help.
So how did individual anti-depressants perform?
In one study, Prozac had an effect size of 26 percent (and that looks suspiciously high compared to the other studies) and in another study Celexa had a 2 percent (yes, that's two percent) effect size. The rest fall somewhere in between, but pretty much hover around a 10 percent effect size. Effexor, for example, had a 9 percent effect size. For a drug with such a prominent and well-documented withdrawal syndrome and with such suicidality attached to its use, 9 percent may as well be 0 percent.
There are any number of implications to be drawn from the study, but I think the main one is that, as a culture, we are running serious risks by giving children and teens underperforming meds and perhaps we ought to be treating depression--particularly its mild and moderate forms--differently. Like with psychotherapy and proper diet and exercise.
Fell free to read the paper yourself and offer your own thoughts in comments.
And, if you are wondering about placebo response rates among adults, feast your eyes on this, a study from last summer that found a placebo response rate of 79 percent versus a 93 percent response rate from taking an anti-depressant in clinical trials lasting at least 12 weeks. That's a 14 percent effect size. Draw your own conclusions.
So the polls opened yesterday in Medgadget's annual Medical Weblog Awards. This is the fifth year of the awards which are based strictly upon vote totals. Furious Seasons is a finalist for Best Patient Weblog, as is Soulful Sepulcher, a blog I'm sure many of you already know. So vote for mine or Stephany's blog. Thanks.
A link to the list of finalists in all manner of categories is here. You can vote over the next couple of weeks and you can only vote once from a specific IP address.
Yesterday, news came out that CNN's chief medical correspondent Sanjay Gupta was being considered by President-Elect Obama to become the next Surgeon-General of the US. Gupta, who would become probably the first SG to actually be a surgeon (he's a neurosurgeon, mostly spinal, and on the staff at Emory University, so there goes that old joke), strikes me as a dubious choice for a number of reasons, some of them quite substantial, including Gupta's on-air pimping for Gardasil, the so-called HPV vaccine, and his dismissal of concerns about Vioxx.
Gupta is, by the way, not to be confused with the University of Buffalo psychiatrist of the same name, who I cut up in 2007 for lying in a New York Times Q&A wherein he claimed that there was no evidence of suicidal thinking linked to SSRIs and, then, cut up the paper for failing to reveal that Gupta has received monies from Eli Lilly.
Obama is clearly trading on Gupta's celebrity and instant public appeal, which has been carefully shaped by CNN over the last seven years. A few years ago, there was that whole "Isn't Sanjay cute and sexy?" ad campaign, which is an extremely odd way for a news organization to gain recognition for one of its reporters. Sorry, but I'm old-fashioned when it comes to that sort of thing--journalists should gain their credibility through their work not their smile. What bothers me here is that there is a certain tendency in the Obama camp to go for gloss over substance--remember those Obama's face in a sunbeam images the campaign floated last year? Remember Obama's meaningless line, "We are the change we seek"? (If we were all just seeking ourselves, then how does that represent change? Or are we changed simply because we sought ourselves?)
Gupta, who publishes journal articles on neurosurgery, nonetheless has little public health experience, something that reportedly bothers many in the public health service. The office of Surgeon-General isn't exactly one of policy-making, but is in essence nag-in-chief. Stop smoking. No unprotected sex. Watch your diet. And so on. Of some interest to readers of this site is that in 1999, then Surgeon-General David Satcher issued a voluminous report on mental health in America, asserting that a full 20 percent of Americans had a mental disorder of some kind. The report claimed that it relied upon scientific evidence, an evidence base that in recent years has been ripped apart as being wrong and driven by the interests of pharmaceutical companies and certain academic researchers.
I've seen Gupta reporting on various medical matters on CNN, commonly explaining how things like autopsies work and what head trauma is all about. Sadly, I didn't catch his appearance in 2005 when he openly pimped for Gardasil, eight months before the drug was approved by the FDA, according to CounterPunch.org. That's utterly bizarre and completely inappropriate for a journalist.
Then in 2006, according to CounterPunch.org:
"Here's an excerpt from the "Anderson Cooper 360 Degrees" broadcast on June 29, 2006:"GUPTA: 'Now there is a way to prevent the virus from ever taking hold in the first place. It's a vaccine. Typically, you think of vaccines for the measles or chicken pox. But Gardasil protects you against cancer. Trials showed the vaccine could lower cervical cancer rates by 70 percent.'
"The clinical trials for Gardasil showed no such thing. Even Merck is not making this wild and unsupported claim.
"On May 17, 2007, CNN aired an interview between Dr. Gupta and First Lady Laura Bush. The First Lady endorses mass inoculations of children with Gardasil on the basis that it will protect them later in life against cervical cancer. Gupta does not challenge her on the fact that there is zero evidence that the vaccine provides such long-term protection. The vaccine's own researcher acknowledges this."
It's weird that, as a journalist, Gupta wouldn't at least acknowledge some of the many controversies around Gardasil and attempts at forced inoculation laws, whatever his views of the scientific evidence. You almost have to worry what he'd do if he ever went out in public to discuss depression treatments.
Just as worrisome is that in 2003 he dismissed concerns of heart problems attached to use of Vioxx, which, like Gardasil, is made by Merck.
Again from CounterPunch.org:
"Here's how he responded to Miles O'Brien on CNN's "American Morning" on October 30, 2003:"Miles O'Brien: 'Let's talk about Vioxx. Some indication it might increase the risk of heart attack?'
"Gupta: 'This stat has been around since August of 2001. They talked about the increase of heart attack with Vioxx. The numbers are very small. Perhaps a small percentage increase in the overall risk of heart attacks with Vioxx. They say 37 percent to 39 percent but that's of a very small number. After 90 days, no increased risk.'"
In September 2004, Merck took the drug off the market. The company wound up the subject of thousands of lawsuits for hiding dangers of the drug and in 2007 agreed to settle class action lawsuits for just under $5 billion, a record settlement for Big Pharma. Some cases continue, however.
You've got to wonder where Gupta was getting his information, because both his medical judgment and reporting skills were clearly lacking. I don't want this guy anywhere near policy-making or advocacy on mental health issues. He simply doesn't have the kind of skepticism you'd want from either a journalist or doctor (not that you often get that from either on mental health matters). But he does an awesome job of upholding establishment views of some drugs, especially marijuana.
In 2006, he opined in Time that:
"It can impair your cognitive ability (why do you think people call it dope?) and lead to long-lasting depression or anxiety. While many people smoke marijuana to relax, it can have the opposite effect on frequent users. And smoking anything, whether it's tobacco or marijuana, can seriously damage your lung tissue."
There's evidence to argue otherwise on marijuana: a 2005 Canadian study showing that pot causes brain cells to grow in rat and may have anti-depressant properties; a 2005 study showing that a cannabanoid compound has anti-depressant effects; a 2006 study showing no connection between marijuana use and lung cancer; claims that upwards of 30 percent of medical marijuana patients in California use cannabis to treat depression and anxiety.
What would he say about evidence that psilocybin helps treat depression or NIMH research showing the anti-depressant properties of ketamine?
My point isn't that he should enthusiastically embrace marijuana, mushrooms and ketamine--each has its problems, but then so do Gardasil, Vioxx and anti-depessants--but that he should have an open mind and not be dismissive of that which doesn't dovetail with his received beliefs.
One wonders where he receives his beliefs from outside of his specialty field, because outside of neuroscience he strikes me as a lightweight and pharma shill.
Gupta and CNN headline News anchor Robin Meade, host a monthly show for AccentHealth, a production of CNN, which is aired in doctors' offices around the country and which features oodles of ads from pharmaceutical companies, reportedly including ones from Merck.
And then there was a huge blow-up between Gupta and Michael Moore in 2007, over an assertion Gupta made on-air that Moore had fudged facts in his documentary "Sicko." I won't even attempt to sort that one out.
All in all, it'll be interesting to see where Gupta's possible appointment ends up and, if appointed, what he ends up doing with the office of Surgeon-General. If Obama wants every girl in America on Gardasil and every grumpy person in the country on Prozac, then it sounds like he's found his guy.
Interesting little Q&A on CNN.com today. A reader wrote in to ask if it was OK to take anti-depressants during pregnancy. Charles Raison, a psychiatrist at Emory University, fielded the question and came right out and said Paxil should be avoided during pregnancy and then hemmed-and-hawed a bit and said research showed that mothers who become significantly depressed or anxious during pregnancy are more likely to have more complicated deliveries and possibly pre-term babies. And this:
"Although it hasn't been definitively proven yet, there are a number of reasons to suspect that depression and anxiety damage fetal development because these are conditions in which the body is flooded with stress hormones, as well as changes in the immune system."It can't be good for a developing fetus to get a constant message that it exists in a dangerous environment. Animal studies have shown that a single injection of a stress hormone in the uterus changes the way the animal functions for its entire lifetime, and, worse, changes how its genes are expressed in a way that can be passed from mother to offspring for several generations.
"If the same thing is true for humans, it suggests that a mother's depression may be physiologically passed on not just to her daughter, but to her granddaughter through changes in gene expression."
I'm ever so fond of the way doctors will hypothesize in such a fashion in public even though something hasn't been "definitively proven" yet. I cannot think of too many other fields of expertise that a mainstream media outlet would let opine thus, especially when it sounds as if the doctor is trying to help humanity prevent some future ill. I'm know very little about gene expression changes in pregnancy and how they might later be passed along, but something about this strikes me as dubious.
Anyway:
"What do I recommend in general?"I think that taking antidepressants while pregnant is overall better than having a terrible depression. But pregnancy is one time in which it is especially useful to consider other options, especially psychotherapy. Getting sleep, limiting stress exposure (good luck!), eating a healthy diet and exercising can also all help milder depressions.
"A final point: There are other medications frequently used for mood disorders that are far more dangerous than antidepressants.
"I can't list them all here, but many of the drugs used for bipolar disorder (also called manic depression) can regularly cause a number of serious birth defects. If you are taking lithium or any type of mood stabilizer and you are pregnant or thinking of becoming pregnant, it is extremely important that you discuss with your doctor and/or psychiatrist."
The bipolar drugs he refers to are, of course, the anti-seizure drugs; i.e., Depakote, Tegretol, Topamax, Lamictal, Neurontin and so on. I wish the good doctor had spelled out what his precise concerns were about these drugs. At a minimum, we know Depakote has been linked to an increased incidence of ovarian cysts. And, last month, a report in Neurology linked Depakote use among pregnant women to an increased prevalence of autism in children. Interestingly, last year University of North Carolina researchers reported that there was no scientific evidence whatsoever for the use of Topamax and Neurontin in treating bipolar disorder, pregnancies aside.
While I'm not sure I buy all of the doctor's views on anti-depressant use in pregnancy, it strikes me that he's at least being judicious--or more judicious than other opinionators I've read in the past who pretty much claim that anti-depressant use while pregnant is just fine and that anyone who says different is trying to scare people off their meds.
All of this got me to wondering: let's assume I got married, my wife got pregnant and then she became depressed during the pregnancy. Let's assume she wanted to take an anti-depressant and I was against it, arguing about all the associations with birth defects and the like. Whose view would have greater legal weight? Ethical weight?
Last week, the New York Times had an interesting article on a large number of violent incidents, including murder, involving Iraq War vets stationed at Fort Carson, Colo. It's the usual story of post-combat stress--or PTSD, if you prefer--and an Army that doesn't seem to know what to do about the situation mixed with a new base commander who's looking into all the incidents to see if he can find common threads and figure out a solution. His son, you see, was an ROTC cadet who killed himself several years ago.
All the usual elements are at work: sergeants who discourage clearly-troubled troops from getting mental health evaluations, a mental health system that doesn't seem to produce good results when soldiers get "help," and soldiers popping pills and drinking themselves into oblivion (understandable enough).
I've noted before on this site that America needs to get its arms around all the combat stress dogging our troops in Iraq (and Afghanistan) because not only are we ending up with soldiers killing themselves, we are winding up with soldiers killing their wives and girlfriends--yes, we've had those incidents out here in the Fort Lewis area--and that's simply unacceptable on every level. Not only that, but an estimated 20 percent of returning vets are experiencing PTSD (the rate may have even been higher last year), a shockingly high percentage. I'm no expert on PTSD levels among vets of WWII, the Korean War and the Vietnam War, but I suspect they weren't similarly high. What's more, I don't recall stories of rafts of violent incidents committed by returning vets of those wars--stray incidents, yes, but not what we are seeing now.
I don't even pretend to know what the answer is--there are enough reported deaths and bad outcomes for soldiers being dosed on Seroquel and the like for me to think that meds-only isn't such a brilliant idea--but there's got to be an answer. And the service these folks have performed in Iraq certainly merits finding an answer, because our country sent them into a war that made little sense to me in 2003 and makes even less sense to me now.
Of course, you could argue that there is something qualitatively different about the Iraq combat experience--urban warfare and IEDs everywhere it seems--and the generation fighting that war, one raised on video games and hyper-violent movies and how all of that plays out. But, at the end of the day, everything I've just written is pretty much a guess.
You'd hope that some very smart researchers are doing some interesting research on these issues.
I'm sure most of you are aware of the tragic death of Jett Travolta, 16, on Jan. 2 in the Bahamas, apparently as the result of a grand mal seizure. He was the son of actor John Travolta. An autopsy is planned for today. It's difficult to feel anything but awful for the Travolta family.
One interesting bit of news that's come out of this was reported by TMZ.com, which notes that Jett was taking anti-seizure medication--namely Depakote--despite long-standing rumors that Travolta, a Scientologist, didn't let his kid take meds, in keeping with CoS practices. The medication reportedly lessened the frequency of Jett's seizures for a time, but then failed to work, so the family took him off Depakote. No one, myself included, is blaming the drug for Jett's death or implying that it had anything to do with his demise.
I simply pass this along for what it's worth to readers. (Via If You're Going Through Hell Keep Going.)
This is sad: Today, Ed Silverman, the longtime Star-Ledger of New Jersey reporter, who began the Pharmalot blog two years ago and faithfully detailed pharma news and broke loads of news in the process, announced that he's leaving the paper and Pharmalot as of now. Silverman took a buyout offered by the paper last year, which was designed to eliminate about 40 percent of the paper's editorial budget. Over the last year, I've told readers how sickened I was watching good reporters being forced into the sunset by the economic ill winds of the newspaper industry, but this departure sickens me more than most. There are other pharma-related news sites out there, but no one is even in Pharmalot's ballpark.
I know that I am not the only regular reader of Pharmalot who will now find a sudden gap in their daily reading. Thanks to Craigslist and the Monster.coms of the world for making this possible. Yes, the advent of content on the Internet is doing so, so much to expand the knowledge base of the world and have now contributed to eliminating one of the best watchdogs of Big Pharma. One of these days, the Web 2.0 propagandists will choke on their rhetoric.
Sad, sad, sad.
On Dec. 31 news came out that Joseph Biederman, the controversial Harvard child psychiatrist, had agreed to forego any industry funding of his work while various conflict of interest allegations against him are being investigated by officials at Massachusetts General Hospital. The move would not affect any government-funded research. The previous week controversial Emory University psychiatrist and top dog depression researcher Charles Nemeroff was permanently stripped of his position as chair of the psychiatry department at Emory. He also was found in violation of university policies and will face restrictions on future research.
The two researchers were in the news recently due to conflicts on interest wherein they took vast sums from pharmaceutical companies while also taking federal research dollars and while allegedly not revealing their pharma monies from their respective institutions, potentially in violation of NIH rules. As for Biederman, in November it was reported that he'd taken hundreds of thousands from J&J/Janssen, basically shaking the company down in the process, to fund a child psychopharmacology center at Mass. General.
I've written extensively about both Biederman and Nemeroff in the past.
What's interesting to me about the move with Biederman is that, according to press accounts, he lawyered up to handle whatever pressure he was under from Mass. General, so it gives you a sense that this wasn't just a casual agreement with his department chair. It's also interested that Biederman had defended his behavior in a letter to the Boston Globe earlier in December, claiming that he was only out to advance science not J&J's business interests, as some court documents had suggested.
Presumably, the restrictions on Biederman will be short-lived and Mass. General will conduct its investigation and mete out whatever punishment it deems appropriate in fairly short order. It's hard for me to believe that the hospital will treat Biederman harshly, as he is a major rainmaker there. Here's a list of his 29 ongoing or recently completed clinical trials, many of them sponsored by Big Pharma. I have no idea how much money he makes from these studies.
As for Nemeroff, while the loss of his department chairmanship may sound like a mere wound to his prestige, the university won't allow him to apply for NIH grants for two years and any outside income he's to make will have to be reviewed and approved of in advance by university officials. That's actually fairly serious stuff.
But, whatever you make of the sanctions against the two researchers, I've simply never before heard of two psychiatrists being hammered so hard by their institutions. So, maybe, some of the in-bed with Big Pharma research institutions are finally getting the message that this kind of nonsense cannot go on unquestioned.
I'm back from my break and will be back to regular posting over the next couple of days. Early January is usually slow for readership--people are just getting back into their routines after all--so posting will be a bit light the next few days.
Happy New Year too all of you. Let's hope 2009 is a hell of a lot better than 2008.
I just approved the 15,000th comment on this site, a number that simply stuns me. But then I am stunned by much in the last 24 hours as last night my dear alma mater, the University of Utah, destroyed Alabama in the Sugar Bowl and ended the season a perfect 13-0. Due to the stupid BCS system, the Utes will be denied a shot at a national title, even though they clearly deserve better treatment.
OK, back to watching football.
I couldn't wait until Jan. 5 to pass along a bit of news and wish you all a Happy New Year, so here goes.
My one-time employer Willamette Week has posted its most-viewed web stories of 2008 and, flatteringly enough, an article I wrote for them back in April on how negative anti-depresant trial data had been hidden from the public for decades (wildly overstating efficacy of the drugs as a result) checked in at #15. That's not bad considering that WW (where I was a reporter from 1999 to 2002 and have freelanced for them sporadically in the years since) is a well-read site in and out of Oregon (it's consistently in the top 15,000 websites in the world and the paper itself won a Pulitzer Prize in 2005) and considering that most of the top 10 stories involved breasts, a vegan strip club in Stumptown (one of Portland's amusing nicknames) and Chelsea Clinton hanging out with gays. Like almost any newspaper, any story that touches upon boobs and sex gets vast readership, so it's nice to see that some folks are almost as interested in issues around anti-depressants as they are breasts.
The original article, "Bitter Pill," is here.
Speaking of such things, when I recently wrote about teen boys allegedly developing breasts as a result of taking the drug Risperdal, the post somehow wound up on page #1 of Google searches for "boys breasts"--and apparently there is a decent number of people doing searches under that term. God, the Internet is so weird.
Weird, too, was my attempt at a two-week vacation. My flight out of town was cancelled about 15 minutes before passengers were to board, and United Airlines couldn't get me on another flight until after Christmas, so I got a refund and slinked back into snow-bound Seattle with hopes of flying to Arizona to see my parents early in 2009. There was so much snow here that I was literally stuck within a three-block radius of my apartment much of the time--and that's all because the City of Seattle refuses to use salt on its streets to address infrequent snow and ice (a policy our mayor reversed the other day). As a result, the city was damn near shut down until several days after Christmas. And New Year's Eve was one of the biggest disappointments I've had in years. People simply weren't into it this year. Like I said: weird.
Anyway, I hope you all had more joyful holiday seasons than did I. I'll be back to regular posting on Jan. 5.