While I think it's been acknowledged for years that family physicians and other PCPs write the majority of scrips for psych meds, the scale to which that's going on, as reported in a new study, is pretty eye-opening and concerning:
"They found that general practitioners prescribed the bulk of prescriptions in two main categories -- 62 percent of antidepressants and 52 percent of stimulants."The stimulants were mainly drugs for treating attention deficit hyperactivity disorder, or ADHD. About 25 percent of all stimulant prescriptions examined were written by pediatricians, they reported in the journal Psychiatric Services.
"Family doctors also wrote 37 percent of prescriptions for drugs used to treat psychosis and prescribed 22 percent of anti-mania medications, the study showed."
Problems are common with these meds even when prescribed by a psychiatrist and a whole load of people I know personally who've had bad experiences with anti-depressants have had it happen at the hands of a PCP casually giving them whatever anti-depressant they felt like. You've also got to wonder if there's anything approaching adequate follow-up or if your average PCP is well-informed about problems with these drugs. (The study itself is not online yet.)
That said, I know PCPs here in Seattle who flatly refuse to prescribe psych meds of any kind for any reason.
The New York Times reported yesterday on an unpublished study of retired NFL players which shows a shockingly high rate of dementia in former players over 50 years of age. This comes on the heels of other research showing depression in former football players who'd suffered concussions during their playing days.
The prevalence of dementia in the 50 and above general population is a little over 1 percent. Among former NFLers over 50 researchers found it to be 6.1 percent, according to the paper. Players aged 30 to 49 had dementia at a 1.9 percent rate as opposed to the national average of .1 percent. The paper also notes that the study had some weakness in that it used a telephone survey method, but even if the numbers might be off a bit from what a harder scientific approach might show the results are very troubling.
I presume the dementia is related to concussions and that gives me a bit of concern for myself. I've experienced four full blown concussions in my life (one from skiing, one from hockey, one in a fight and one when I was attacked by a gang of 18-year-olds when I was 14) and I guess the time I saw stars at a high school football practice counts as a minor concussion. I guess I should start taking Aricept right now! Um, no.
I deeply love football (between college and the NFL, I watch seven games a week during the season), but it's clear something needs to be done about the number of concussions suffered, especially at the youth level, and the number of deaths (usually a few and we had one in Washington State this week) and paralyzations each year. I wouldn't begin to know what the solution is. Helmets are very, very good these days. The NCAA has banned head-to-head hits, but it's kind of hard to prevent what happens naturally in the course of tackling someone. It'll be interesting to see how the NFL addresses this matter or if it does at all.
I wrote about a spate of head injuries among high school football players in Oregon back in 2000.
The Fall fundraiser ended successfully after all, now that the USPS has caught up with me. Thanks to all of you who contributed. I appreciate your support.
Announced earlier today is a $25 million settlement between Eli Lilly and the State of Connecticut over allegations that the company illegally marketed Zyprexa for unapproved uses including dementia and ADHD. Lilly has already settled about $2.7 billion in other Zyprexa related claims.
News is out in the Boston Globe that Eli Lilly's recently-released list of payouts to docs includes 60 Massachusetts doctors, including some at Boston Medical Center--the main hospital for the Boston University School of Medicine. The university has ordered the docs in question to stop doing talks for industry. It's refreshing to see a university take these sorts of things so seriously and so promptly.
How much money were doctors getting? What products were they promoting?
"At Boston Medical Center, Dr. Brian McGeeney, a neurologist, received $30,000 during that period [first three months of 2009], and Dr. Elliot Sternthal, an endocrinologist, was paid $11,587.50, according to a faculty registry on Lilly’s website."
McGeeney was promoting Cymbalta, Lilly's anti-depressant, presumably for fibromyalgia.
I think readers of this site are fairly well aware of the respect I have for Tufts University psychiatrist Danny Carlat, who's led the fight in psychiatry to clean up the APA and pharma-sponsored CMEs. My respect for him now goes up by $170,000, the amount Schering-Plough reportedly (scroll down to the bottom of the linked page) offered him to go shill for its recently-approved atypical antipsychotic Saphris and the amount which Carlat turned down.
"In a letter to doctors, Schering-Plough says 'you must present the Schering-Plough approved materials provided to you.' The company offered one psychiatrist, Dr. Daniel Carlat, a Tufts University Medical School professor, up to $170,000 over two years to give 125 45-minute talks in restaurants, in his office, and by telephone and the Internet. A well-known critic of the drug industry, Carlat declined."
First, that's a ton of money for anyone to promote anything, especially a drug with pretty much no track record. Second, didn't S-P know who they were dealing with and that he'd very likely shoot them down and that their offer would become public? Lame.
For the uninitiated, Carlat's blog is here.
This is alarming: The UK press is reporting that a 14-year-old girl died soon after being given GlaxoSithKline's HPV vaccine Cervarix. A few other girls at her school took ill after getting the vaccine. Cervarix is not yet approved in the US, but GSK has submitted it to the FDA for approval, which is expected later this year.
What a terrible tragedy, exactly the kind of thing opponents of mandatory vaccinations for HPV feared could happen with Merck's Gardasil.
Via Sexorat Sufferers.
The fall fundraiser ended Friday with $215 from three people coming in that day. As things stand now, the fundraiser ended $554.25 short of its $4,000 goal. But I'll know more over the next few days as I know a few checks are still headed my way. So I'll update you all later.
Thanks to all of you who contributed.
Apparently the British blogosphere is nuttier than the American one, because rumors began circulating round the Net recently that Gordon Brown, the Prime Minister of Britain, was coming unhinged in private, had OCD and depression and was allegedly taking anti-depressants. The hubub on the issue became so great that an interviewer for the BBC pressed him on it during a radio show.
Here's the Guardian's account of what went on:
"Marr [of the BBC] said this morning: 'A lot of people in this country use prescription painkillers and pills to help them get through. Are you one of those people?'"Brown replied: 'No.' And when Marr asked him about the issue again later in the interview, he said that he had already dealt with the question.
"The prime minister seemed to object to Marr raising the matter, saying this was 'the sort of question that is all too often entering the lexicon of British politics.'"
Standards at the BBC have sure gone into the tank. I can't see where a bunch of half-baked Internet rumors should lead to a legitimate journalist pressing a public official about what pills they take. Unless there's something else going on that I don't know about. But it's basically no one's business I would think.
It all kind of reminds of lefty bloggers painting a psychological profile of President George W. Bush a few years ago. One psychologist even wrote a book about the President and his alleged maladies. I did not like Bush 43 much at all, but this sort of thing is just out of hand and is wildly disrespectful of the office and I hope that right wing bloggers and others don't attempt to play DSM game with President Barack Obama.
Yep, today marks the fourth anniversary of this website. I had no idea it would last this long or be as essential as it is to my journalism career or that it would garner such readership. There have been almost 2,500 posts in that time and over 20,000 comments. Kind of mind-numbing.
Thanks to all of you for reading and for your support.
Another $391.26 came in yesterday from seven people bringing the total raised so far to $3,230.75 from 68 people. That leaves $769.25 to go from 32 people to reach the overall goal of $4,000 from 100 people by the end of today. Thanks to all of you who've contributed so far.
Today is the final day of the fundraiser--I'm not going to extend it any further--and I'd like it to end successfully. It'll take a few days to determine whether it's reached its goal or not due to the vagaries of the US mail, of course.
You can help things end on a successful note by making use of the PayPal button on the right. If you prefer using snail mail, send me an email and I'll send you my mailing address.
A new study out in the BMJ yet again links anti-depressants to birth defects due to women taking anti-depressants in the first trimester of a pregnancy.
"Still, the authors said the absolute risk is relatively low: 246 women would have to take such medication in order to see one septal heart defect. And 62 mothers would have to take more than one SSRI to see a problem in one child."'A potential association with malformations must be considered in the choice of treatment of depression during pregnancy,' said Dr. Lars Henning Pedersen, lead author and a research assistant in the department of epidemiology at Aarhus University in Denmark. However, 'if our data is correct, the absolute risk is low, which must be balanced against the potential substantial risk of under- or untreated depression during pregnancy.'"
Oddly enough, the study didn't turn up problems with Paxil--usually thought to be the worst of anti-depressants for birth defects--and Prozac. The risks were seen with Zoloft and Celexa (and that would mean Lexapro too).
While the risk isn't high in an absolute sense--less than one-half of 1 percent--that's small comfort to a pregnant woman taking anti-depressants.
I've long considered the evidence of birth defects problems with anti-depressants to be mixed. Now, I'm more convinced than ever that something is going on here.
By which I mean that Bob Fiddaman of Seroxat Sufferers fame has gotten pdfs of opening arguments and the testimony of psychiatrist David Healy and another plaintiff's expert witness and put them online right here. More will come later as the trial, which is taking place in Philadelphia, continues. This will include some never-seen-before documents regarding what GlaxoSmithKline knew and when it knew it about birth defects problems with Paxil.
The opening arguments--both sides--are well worth a read.
The Federal Trade Commission is going to hold public hearings on creating regulations so that pharma companies can use social media (ie, Facebook, Twitter, networking sites) to promote their drugs. Like they don't have enough promotion opportunities already. I'd assume the FDA will also have to get involved in this somehow since drug promotion is also its regulatory bailiwick.
The folks at digidaydaily.com think it's a lovely idea--I don't--and have a suggestion:
"Create Fan Pages: It’s in the company’s best interest to supervise and add some credibility to a Seroquel community for bipolar adults, or a Paxil community for depressed patients. If you don’t agree go on Facebook and look at the unsupervised version."
Whomever wrote this is utterly clueless if he thinks Seroquel and Paxil are drugs that would generate a fan base. More like an anti-fan base. And would pharma companies allow criticism, even the honest kind, on their drugs' social networks? Probably not. And how would they keep kids under the age of 18 from viewing the pages?
Another $15 came in yesterday from two people bringing the total raised so far to $2,839.49 from 60 people. That leaves another $1,160.51 to go from 40 people to reach the overall goal of $4,000 from 100 people by the end of this Friday. Thanks to all of you who've contributed to date.
If you'd like to join them, there are only about 24 hours left. So the PayPal button is on the right. If you prefer snail mail, send me an email and I'll pass along my mailing address.
Thanks in advance for your support.
A reader passed along an article that ran last October in the MetroWest Daily News in Massachusetts, an article I'd not seen previously about the implementation of Yolanda's Law, named for a 16-year-old who committed suicide.
"The legislation, signed by Gov. Deval Patrick in August and backed by a coalition called the Children's Mental Health Campaign, encourages doctors to screen their young patients for disorders and seeks to have mental health assessments provided at day care and pre-K programs."
At day care and pre-kindergarten programs? Oh wow. They are really going after them young nowadays.
As I noted when I wrote about a slightly different law in Massachusetts requiring mental health screening for kids in the commonwealth's Medicaid program that was touted by the Boston Globe which included a handy checklist of kiddo mental disorder symptoms on its website:
"One of the symptom checklists on the paper's website contains a stunning array of non-symptom symptoms: teases others, refuses to share, is fidgety, acts younger than others, daydreams too much, is afraid of new situations. And so on. Many of these symptoms are hardly indicative of abnormal behavior or psychology."Could someone please let me know what is the objective standard for daydreaming?"
I wonder how these programs are working out and how many more Rebecca Rileys they'll create. Anyone from Massachusetts know?
Sometime last year, I was interviewed by a reporter from WFCR-FM, the public radio station in Amherst, about mental health screening for kids. I gave the reporter several reasons to be skeptical, much less against, screening for little kids. The reporter got quite frustrated with me--I could hear it in her voice--and told me how much doctors liked screening programs. I reminded her of the Riley case and she basically ended the conversation. I know that nothing I told her ended up on the air. That's some nice objective journalism by a publicly-supported radio station.
Last month, I wrote about a Long Island man who was allowed to use the Zoloft defense--an unusual move by a judge--in an assault/domestic violence case. The man had beat up his girlfriend and he was arguing that going off Zoloft a few days before had made him do it. As I noted then, I wasn't particularly sympathetic to his situation, because as real as withdrawal problems can be, I just can't develop sympathy for anyone who beats up his girlfriend. Period.
Yesterday, he was found guilty of felony assault, attempted assault and second-degree harassment charges. So the Zoloft defense did not sway a jury.
Oddly, Newsday notes:
"The FDA has not blamed such drugs for violent behavior."
That's kind of a BS line of thought since the FDA has never examined, as far as I know, that issue outside of the context of suicidality. The paper also reports that Pfizer paid an unnamed Harvard professor $7,500 a day to be an expert witness for the prosecution. The man was being prosecuted by the State of New York, so what the hell is a pharma company doing paying for an outside expert? That's just odd.
Another $150 came in yesterday from four people bringing the total raised so far to $2,824.49 from 58 people. That leaves another $1,175.51 to go from 42 people to reach the overall goal of $4,000 from 100 people by the end of this Friday. Thanks to all of you who've contributed to date.
If you'd like to join them, there are only about 48 hours left. So the PayPal button is on the right. If you prefer snail mail, send me an email and I'll pass along my mailing address.
Thanks in advance for your support.
Bloomberg is reporting that Eli Lilly has settled claims brought against it by seven states concerning the company's marketing of its antipsychotic Zyprexa. Right now, the settlements are confidential (details should come out later), so it's not possible to tell what states are involved or how much money Lilly is paying out. Most of the claims involved illegal off-label marketing of the drug for use in the elderly and children and the bilking of states' Medicaid programs.
Lilly told the wire service that it's in "advanced discussions" with the other states. A trial involving claims brought by South Carolina is set to begin in October.
Lilly has previously settled various claims brought by individuals, states and the feds for a whopping $2.7 billion.
On Monday, GlaxoSmithKline US announced that beginning next year it would no longer fund medical education companies to put on CME's for doctors, a practice that has come under increasing scrutiny by Congress, the press and physicians because the pharma-sponsored CME's are little more than advertisements for the company's drugs and leave docs with little information about competing products. GSK makes Paxil, Wellbutrin and Lamictal, although they likely do no CME's for any of the drugs since all three are now off-patent.
But Danny Carlat, a Tufts University psychiatrist who's policed this issue harder than anyone else, has gotten GSK to admit that it's carving a huge loophole into its new policy by claiming that 20 yet-to-be-named academic medical centers will run the GSK-funded CME's but are then free to go out and hire a medical education company to do the work. Seriously, the company admitted to this old-wine-in-new-bottles practice.
Don't GSK and others in Big Pharma get it? Academics (the serious ones), doctors (the ones who care) and the public (the ones who are paying attention) are sick and tired of your damn dog and pony show. You need to change your ways completely or people like Carlat and I will continue to work to expose your shoddy drug-touting science and biased information you spoon feed docs as the garbage it is. The choice is yours.
I cannot wait to see who the 20 medical centers are who are going to allow themselves to be used in such a fashion? How much does anyone want to bet that Harvard will be on the list?
Bloomberg is reporting today on documents recently unsealed in federal court in Florida in the ongoing case against AstraZeneca concerning claims that the company did not properly notify the public of risks (principally, diabetes and weight gain) associated with its antipsychotic Seroquel, now one of the top selling drugs in the world
"Nancy White, the saleswoman, and a colleague met in July 2006 with an unidentified doctor who reported 'getting a lot of flak' from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel 'where causality with the drug could not be ruled out.'"White said in the 2006 note that she told the physician that 'there has been no causative effect' found between Seroquel and diabetes. The doctor 'said he would not quit writing' prescriptions for Seroquel 'due to this at this time,' White reported."
Issuing a warning in Japan while not issuing one in the US probably won't play out really well for AZ at trial. The behavior is reminiscent of Lilly warning Japanese doctors of similar diabetes problems with Zyprexa in 2002 while months later in the US claiming the drug was perfectly safe as it rolled out a huge sales campaign aimed at PCPs.
Tufts psychiatrist Danny Carlat echoes what I wrote in 2007 about Zyprexa:
"'It’s pretty clear that if a drug poses a diabetes risk in one country, it poses that risk in others,' Dan Carlat, a psychiatrist at Tufts University in Boston who writes a blog about the health-care industry, said in an interview. 'I don’t think it’s ethical to warn doctors in Japan about this drug and then downplay or ignore the risk in the U.S.'"
Unethical? I'd say it should be illegal and the FDA ought to look into how it can reconcile US labeling to conform to warnings on the same drugs in other countries.
In other documents, AZ sales reps are reportedly working to downplay docs concerns about weight gain in Seroquel users, in effect flat out lying about the issue when Seroquel was known to be producing rapid weight gain in some patients, a potential precursor to diabetes.
An AZ spokesman told Bloomberg:
"'The heart of these cases are unproven claims that Seroquel caused diabetes,' Tony Jewell, an AstraZeneca spokesman in Wilmington, Delaware, said in an e-mailed statement. 'The evidence does not back up the allegations that Seroquel was responsible for the plaintiffs’ alleged injuries.'"
That remains to be seen.
Another $45 came in yesterday from two people bringing the total raised so far to $2,674.49 from 54 people. That leaves $1,325.51 from 46 people to go to reach the overall goal of $4,000 from 100 people by the end of this coming Friday, which is this site's fourth anniversary. Thanks to all of you who've contributed so far.
I know a couple of contributions are headed my way by mail, so I'm not pushing the panic button yet. But it'd be great if some more contributions came in today. As usual, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks in advance for your support.
This is one of the oddest studies I've seen in a while. It was published in the American Journal of Psychiatry earlier this month and it's literally an example of trying to pull the wool over the public's eyes concerning the efficacy of atypical antipsychotics used to augment an anti-depressant in the treatment of major depression. The study authors are J. Craig Nelson of UCSF and George Papakostas of Harvard/Mass General. Their stated purpose was:
"The authors sought to determine by meta-analysis the efficacy and tolerability of adjunctive atypical antipsychotic agents in major depressive disorder.trial, depression scale used, response and remission rates, and discontinuation rates for any reason or for adverse events."
They then focused on published studies or studies presented as posters at various conferences for the use of Zyprexa, Risperdal, Seroquel and Abilify as augmentation treatments. Oddly, only Abilify is approved for such use by the FDA. Seroquel's maker, AstraZeneca, is still awaiting FDA approval of its drug as an augmentation--and has been waiting for almost six months since an FDA panel recommended--quite gingerly--that the agency approve the drug. That's an unusually long wait and tells you that something odd is afoot.
Anyway, the researchers didn't report in their paper the efficacy of the four drugs. Instead, they pulled an odd trick and reported the odds ratio of all the studies of the four drugs as depression augmenters to placebo. In other words, they were telling readers the chance that this class of drugs beat placebo--not the efficacy of the drugs (except in a slippery manner I'll come to). That strikes me as a consumer and science dork as an utterly useless measure with little real world clinical significance, especially since several of the 16 studies were of only four weeks duration--some of the shortest depression treatment studies I've ever heard of.
They reported the odds of beating placebo as:
"Adjunctive atypical antipsychotics were significantly more effective than placebo (response: odds ratio=1.69, 95% CI=1.46–1.95, z=7.00, N=16, p<0.00001; remission: odds ratio=2.00, 95% CI=1.69– 2.37, z=8.03, N=16, p<0.00001). Mean odds ratios did not differ among the atypical agents and were not affected by trial duration or method of establishing treatment resistance. Discontinuation rates for adverse events were higher for atypical agents than for placebo (odds ratio=3.91, 95% CI=2.68–5.72, z=7.05, N=15, p<0.00001)."
Translation: atypicals as augmenters are 69 percent more likely to produce a response than is placebo and 100 percent more likely to produce remission than is placebo. Sounds awesome, right?
Now, here's why you should be very suspicious of the apparent epic victory over placebo:
"The odds ratio for remission was 2.00, with a number needed to treat of nine."
The NNT as it's known means the number of people who would have to try a treatment before one person would realize a treatment benefit. An NNT of nine people translates to an overall efficacy for atypical augmenters of about 11 percent. Staggeringly low. And hardly the victory researchers seemed to be claiming.
So why would such august researchers report an odds ratio that favored the drugs instead of reporting their individual and pooled lack of efficacy? I have no idea, but here are there conflicts of interest declarations from the paper:
"Dr. Nelson has received grant support from or served as a speaker on advisory boards, or as a consultant for Abbott Laboratories, Acadia Pharmaceuticals, AstraZeneca [maker of Seroquel], Biovail, Bristol-Myers Squibb [maker of Abilify], Corcept, Cyberonics, Eli Lilly [maker of Zyprexa], Forest Pharmaceuticals, GlaxoSmithKline, Health Resources and Services Administration, Janssen Pharmaceutica [maker of Risperdal], Medtronics, Merck, NIMH, Novartis Pharmaceuticals, Organon, Orexigen, Otsuka [creator of Abilify], Pfizer U.S. Pharmaceuticals Group, Sepracor, Shire, and Sierra Neuropharmaceuticals. Dr. Papakostas has received grant support from or served as a speaker, on advisory boards, or as a consultant for Bristol-Myers Squibb [maker of Abilify], Eli Lilly [maker of Zyprexa], Evotec AG, GlaxoSmithKline, Inflabloc Pharmaceuticals, Jazz Pharmaceuticals, Lundbeck, NIMH, Otsuka [creator of Abilify], PAMLAB LLC, Pfizer U.S. Pharmaceuticals Group, Pierre Fabre Laboratories, Precision Human Biolaboratories, Shire Pharmaceuticals, Titan Pharmaceuticals, and Wyeth."No external funding was received for the study design, trial search,
data analysis, interpretation of the data, writing of the paper, or the
decision to submit for publication."
When you've had recent research and consultant funding from the companies making the drugs is it any wonder that study resulted are measured in such a fashion that they sound totally wonderful when they are not? I'm just asking.
Another $308 from eight people came in since Friday's update bringing the total raised so far to $2,629.49 from 52 people. That leaves $1,370.51 to go from 48 people. Thanks to all of you who've contributed so far.
I'd hoped to end the fundraiser by the end of today, but that does not exactly look realistic. So I'm extending the fundraiser until the close of this Friday, September 25, which just so happens to be the fourth anniversary of this site and a seemingly symbolic time to close out the fundraiser.
If you'd like to help make things end successfully, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll pass along my mailing address.
Thanks in advance for your support.
Most of you are aware of a long-running campaign by Sen. Charles Grassley (R-Iowa) to ferret out undisclosed pharma company funding of academic researchers who also wind up taking federal research money. Well, it ain't the Senator who does all the digging that leads to him going after the likes of Emory University psychiatrist Charles Nemeroff and Harvard University psych researchers. Instead, it is Paul Thacker, a former journalist and an investigator for the Senator, who is making researchers' lives hell--and appropriately so. I've known this for a long time but have kept my yapper shut when writing about Sen. Grassley.
Anyway, Nature has a nice article on Thacker and it includes Nemeroff himself basically apologizing for his mess and claiming he was in compliance with disclosure rules plus other researchers defending Nemeroff. Please. In a political world filled with scum and manure, it's good to see one good guy in the fray. And since I'm such a good guy, I'm making a copy of the article (usually requires a subscription) available to all of you. I encourage you to download it and read it.
My Grassley back catalog is here.
Pro-ana means pro-anorexia and pro-mia is pro-bulimia and, yes, there are websites promoting the eating disorders, lots of them. I've seen them before (I won't link to them for you all) and they frighten me. The images of teen girls who've rendered themselves bone thin are simply disgusting. Apparently, the sites have a big following among some girls with eating disorders.
Now, the Royal College of Psychiatrists in the UK wants the British government to step in and:
"* Expand its definition of harmful web content to include pro-eating disorder websites. "* Extend its plans to moderate internet sites that promote harmful behaviour to include pro-eating disorder websites."* Specifically address pro-eating disorder websites in its plans to raise awareness of e-safety among parents and teachers."
I'm not quite sure of how this would all work under British law and I've got no idea what teen Internet culture is like in the UK. If it's anything like the US, then it's probably pretty free-wheeling, which makes me wonder where the hell these teens' parents are.
In the US, it'd likely be impossible for the government to regulate such sites, again putting the onus on teens' parents to regulate things themselves. I know parents have got a lot to contend with these days raising a kid in the Internet age, but just as with other content they don't want their kids to see, they've got to be the ones in charge or you'd get a slippery health website regulation slippery slope very quickly because there are likely all manner of websites that doctors don't approve of and which they could argue are damaging somehow.
Another $25 came in yesterday from two people and that brings the total raised so far to $2,321.49 from 44 people. And that leaves $1,678.51 from 56 people to go to reach the overall goal of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
Obviously, September 21 fast approaches and this fundraiser is going far more slowly than I could've projected and I've got to make a tough decision here over the next day or so. As I've noted in the past, if a fundraiser fails to make its goal, then I'll have to scale back my work here proportionately. So I need to figure out whether to end the fundraiser as planned on Monday and see how much things are short then or extend the fundraiser a few days. It has this D-Day feeling for me. This site's fourth anniversary is next Friday and it'd be like the bitterest pill of all to have to scale back when I ought to be celebrating.
You can help me figure out which way things are going by using the PayPal button on the right. Of if you prefer snail mail, send me an email and I'll shoot you my mailing address. Or, hell, send me an email and tell me to pound sand with a small hammer.
Thanks in advance for your contributions.
I've been wrestling with how to say something sensible about the Senate Finance Committee's health care reform bill, but what can you say when the country is literally ripping itself apart over the shape of the reforms and an unexpected side show has broken out over race and the contention that opposition to reform--and to President Barack Obama himself--is racially-motivated? There's damn little that's safe to say in that environment, especially when I myself have been a victim of racial discrimination (at UC Berkeley no less and at the hands of the New York Times and other media companies) and had that limit my career opportunities, my future earning potential and, yes, my dreams. I ain't making that up, but I'm not getting into it today.
It's not clear to me whether or not the Senate Dems have got the votes to get the bill approved and the whole thing is so big and complex that I'm not sure if it should be approved in its present form. But the bill authored by Sen. Max Baucus (D-Montana) does have one provision in it that I support 100 percent and that's the Physician Payments Sunshine Act, which is embedded in the bill. The Act has floated around the Senate for a few years and was authored by Sen. Charles Grassley (R-Iowa) and Sen. Herb Kohl (D-Wisc.). Simply put, it would require drug and device makers to report to the feds any payment or gift to a doctor or researcher of $10 or more or face a $1 million penalty. The reports would later become available to the public on the Internet.
Sounds good to me, although I wouldn't necessarily support the Baucus bill on the basis of its sunshine provision. I merely hope that whatever House or Senate bill eventually winds up being passed (assuming something can get passed in D.C.'s noxious environment) and heads to the President for his signature will contain the sunshine provision. I'm tired of waiting for the lawsuits to come out about Drug X or Y to find out about all the dough Harvard's Joseph Biederman was getting from Janssen/J&J and that Pfizer was paying for a psychiatrist's helicopter rides to go shill for Geodon and so on.
I expect we'll have some kind of answer on what health care reform will or won't look like by mid-October.
This is a good get by Jim Edwards at bnet.com: one of the whistleblower lawsuits that was part of the recent $2.3 billion settlement between the feds and Pfizer over Bextra, Geodon and other drugs contains some eye-popping claims. Prime among them is that Pfizer funded NAMI as a "Trojan Horse" that then specifically promoted on its website off-label uses of Geodon in the elderly and, yes, children. Go read Edwards' posting to see what Pfizer and NAMI were up to.
While it's not clear to me what constitutes promotion per se for NAMI, the reality is that NAMI is not supposed to promote specific drugs--although I've caught them promoting Invega in the past--and it sure shouldn't be promoting off-label uses of any drug.
Yet here's this from NAMI's website:
"While not approved by the FDA for other uses, ziprasidone may be used alone or with other medications to treat other symptoms such as agitation or other behavior problems in older persons with memory loss or people with developmental disabilities, children with mental illnesses like schizophrenia or bipolar disorder, or depression. It may also be used for long-term management of bipolar disorder."
Decide for yourself whether or not you consider that promotion.
The lawsuit also states that NAMI's Rhode Island affiliate had a president, James McNulty, who was getting money to speak on behalf of Pfizer. That was first reported by Allison Bass in her book "Side Effects."
In a separate post on the lawsuit, Edwards details how Pfizer was paying one psychiatrist $4,000 a day (the regular fee is about $2,000) to speak on behalf of Geodon and that it even paid for him to fly his personal helicopter to meetings with docs.
Another $50 came in yesterday from three people bringing the total raised so far to $2,296.49 from 42 people. That leaves $1,703.51 from 58 people to go to reach the overall goal of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
September 21 is fast approaching, so it'd be great if contributions picked up over the next day or so so that this fundraiser can end on time.
If you'd like to contribute, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks in advance for your support.
There's a smallish buzz around a new drug called Valdoxan (agomelatine), an anti-depressant recently approved in Europe that's being touted as more effective than Prozac and other commonly-used anti-depressants and as having virtually no side effects. To whit, from the Mirror:
"New research shows that agomelatine - the first antidepressant in over a decade - is more effective than Prozac in treating depression. And it is not associated with some of the common side-effects of antidepressant drugs such as weight gain, sleep difficulties and sexual problems."A study found the £30-a-month drug, also known as Valdoxan, helped 77.7 per cent of people with severe depression compared with 68.8 per cent on Prozac. The data was presented at the European Congress of Neuropsychopharmacology in Istanbul."
That study remains unpublished and I'm skeptical of it for one reason: I've never, ever seen Prozac relieve depression in over two-thirds of patients in an eight-week trial, so it makes me wonder what was going on here. Also, there is apparently no placebo arm to the study.
Even more, a few years ago the French company Servier submitted Valdoxan for approval to European regulators and the drug was rejected as not having sufficient efficacy. The company resubmitted the drug and it was approved for use in Europe this past February (it's been submitted for approval in the UK). I've heard little about the drug since its approval.
One sign that Valdoxan is not the greatest thing since sliced bread is that Servier licensed it in the US to Novartis and the company reportedly has no plans to submit it for FDA approval until at least 2012. If it were a hotter compound, Novartis would be banging down the FDA's doors for approval.
All of that said, what is interesting is that Valdoxan is a melatonergic antidepressant as it's an agonist to melatonin receptors in the brain and it apparently works to reset human sleep patterns and circadian rhythms.
It'll be interesting to see what plays out with this drug over the next few years.
My back started acting goofy last evening, so I couldn't sit down to write any posts. I'll play catch up later this morning.
Another $40 came in from two people yesterday bringing the total raised so far to $2,246.49 from 39 people. That leaves $1,753.51 to go from 61 people to reach the overall goal of $4,000 from 100 people on or about September 21. That's next Monday, so it'd be great if things picked up significantly today and tomorrow.
Thanks to all of you who've contributed so far.
If you'd like to help support this site, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll send you my mailing address. Thanks in advance for your support.
The National Center for Health Statistics recently released final mortality data for 2006 and the report shows that the age-adjusted suicide rate in America was 10.9 people per 100,000 people, the same as in 2005 and the same as in 2004. Interestingly, none of this has been reported by the media (suggested storyline: "Three years. No Change. What happened?")
The total number of people who committed suicide in 2006 was 33,300, about 50 percent by using a firearm. (2005 was originally reported at 11.0 per 100,000 but was revised to 10.9.)
There was a teensy improvement in the teen suicide rate (see page 30 of the report). There were increases of 4.2 percent and 4.3 percent, respectively, among people aged 45 to 54 and 55 to 64. The suicide rate remains quite high among older adults, but even there there was some improvement in older age groups.
Men, as usual, had four times the rate of suicide as did women (18 per 100,000 versus 4.5 per 100,000) with white males being the big driver of the rate amongst men (see page 76).
Wyoming was the worst state (21.9 people per 100,000) followed by Alaska (20), Montana (19.7), Nevada (19.5) and New Mexico (18). Washington, D.C. was the lowest (5.1 per 100,000) followed by New Jersey (6.5). (See page 104.)
While it's hard to know what to take away from this data (things didn't get better or worse overall), I'm sure researchers will dissect all of the data and spin out a pharma-worthy paper on the benefits on anti-depressants. I bet you no one makes the point I did last year:
"One other point worth making is that in 1999, the feds announced a national goal of reducing the rate of suicide by 50 percent by 2010. The rate of suicide in 1999 was 10.5 per 100,000 people, so the rate has actually increased by about 5 percent during that time."
With four years of data left in this decade, it's pretty clear that the feds' 2010 public health goal will not come anywhere close to being met.
Earlier this month, I noted that Washington University psychiatry professor Joan Luby appeared to have possible unreported conflicts of interest on three separate papers, including one on "early childhood depression" that appeared in this month's issue of the American Journal of Psychiatry. I queried the AJP's editor and the American Psychiatric Association about the situation, asking if they look into the matter and make whatever correction was appropriate. I got no reply from either the editor or the APA's press office.
Luby had reportedly received monies from AstraZeneca in 2003 and 2004. AZ makes Seroquel, an atypical antipsychotic that is being widely used off-label in children (and adults) as a treatment for depression and agitation. Since Luby's research bailiwick is so-called preschool bipolar disorder and preschool depression the AZ monies would seem to be worthy of disclosure, as might be monies she also reportedly got from Shire (makers of Adderall) and Janssen/J&J, makers of Risperdal. When I queried Luby about all of this I got no reply.
Yesterday, I again queried the AJP's editor and the APA's press office on the matter. I also copied APA president Alan Schatzberg.
So far, I've gotten no answer from any of them.
What a contrast to the response from the editor of the Archives of General Psychiatry, who pledged to look into possible non-disclosure problems with a Luby paper published in his journal in August.
I'm not sure what the AJP and APA's problem is, but they appear to not care very much about the proper reporting of financial conflicts in their journal. Their silence speaks volumes.
After the first day of a trial against GlaxoSmithKline for allegedly hiding birth defects data from users of its anti-depressant Paxil, Bloomberg reports:
"An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced in trial."'If neg, results can bury,' Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of an injured child."
There will apparently be many more documents--ones unseen by the FDA and Congress--introduced at this trial, so stay tuned.
After several years of revelations around Paxil and GSK, I simply don't know what to say anymore.
The FDA today put out a list of drugs for which it ordered new warnings and other labeling changes in August. Among the drugs was Pristiq, Wyeth's newish anti-depressant that is a metabolite of Effexor.
Under "warnings" on the drug's package insert, the agency ordered the following update:
"Elevated Blood Pressure:"Has occurred with Pristiq. hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment."
Under "adverse reactions," the agency ordered the following update:
"Clinical Studies Experience:"Adverse reactions in patients in short-term fixed-dose studies (incidence ≥ 5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
The FDA adverse events database lists four reports of sexual dysfunction to date.
Sounds like yet another lovely anti-depressant.
This from Bloomberg today in the first court case against GlaxoSmithKline over allegations that the company's anti-depressant Paxil caused fatal heart defects in a newborn child whose mother had taken the drug while pregnant:
"U.S. District Judge Nancy Gertner in Boston today refused to block William Seale’s family from reviewing e-mails and other communications between Glaxo and Boston University researchers over Paxil’s birth-defect risks. The 1-year-old Seale, whose pregnant mother took the antidepressant, died in 2004 after three surgeries to address heart defects, according to court filings."Seale’s family contends officials at London-based Glaxo, which funded the birth-defect research, sought to influence the study’s results to help protect the company from lawsuits, Gertner said in her ruling."
It'll be interesting to see what these emails reveal once they are presented in open court.
Another $75 from three people came in yesterday bring the total raised so far to $2,206.49 from 37 people. Thanks to all of you for your contributions to date. There's another $1,793.51 from 63 people to go to reach the overall goal of $4,000 from 100 people on or about September 21, which is next Monday. I'd really like to hit that goal on time or pretty darn close to it.
If you'd like to contribute, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks in advance for your support.
A study out in the American Journal of Psychiatry this month asserts that irritability in adolescence as reported by parents is a "specific predictor of self-reported depressive and anxiety disorders 20 years later." This was a study done by NIMH researchers and involved assessing the kids for irritability when they were on average 13 years old and then surveying them 20 years later.
Researchers reported increased risks of major depression (33 percent increase), generalized anxiety disorder (72 percent increase) and dysthymia (81 percent increase). There was no association with bipolar disorder or personality disorders.
What did researchers mean by irritability?
"In psychiatric nosology, irritability is usually defined as a propensity to react with anger, grouchiness, or tantrums disproportionate to the situation."
Researchers did not note any implications for treatment of youths judged by their parents to be irritable nor do they get into claims of protective effects of any treatment viz. adult disorders, but I wouldn't be shocked if this very study winds up being referred to by other researchers in the future. They'll write something like: "Irritability in adolescents is a known predictor of depression and anxiety in adulthood" and it'll go from there into recommending treatment with an antipsychotic as "protective" against adult depression and anxiety. Maybe they'll even recommend "irritability screening" in junior high schools across the land. (Instead of Teen Screen would it be Grouch Screen?)
Then again, perhaps someone will examine how psychotherapy works in irritable youths.
Perhaps I'm being too cynical in what I've written here, but I've grown very weary of the way psychiatry is poking into youthful behaviors over the last decade or so--not that researchers weren't before then, but it's gotten incredibly aggressive of late. It makes me happy I'm not a youth, but it sure worries me on behalf of today's teens.
Hell, it makes me downright irritable.
This incident has my blood boiling: according to documents leaked to KATU-TV in Portland, Ore., hospital security staff at Oregon Health & Science University beat a handcuffed woman after she stormed out of the ER. Here's how the station describes the incident:
"Anna Marie Hartwick said she is bipolar, has post traumatic stress disorder, and a personality disorder. She said she has been in and out of the state mental hospital and on heavy medications since she was 12 years old."She said she’s on a cocktail of three medications: Geodon, Zoloft, and Trazodone, which led to infections and severe pain.
"On Sept. 1 the pain became intolerable while she was at the Central Library in downtown Portland. Someone called an ambulance to take her to OHSU. After waiting a long time to see a doctor and three hours without her medication, she admitted she blew up at hospital staff and left the emergency room with four security guards following behind.
"'That’s when they tackled me and threw me to the ground,' Hartwick said.
"In the incident reports, two officers said they witnessed another officer deliver 'focus blows to Hartwick.' The officer in question said in a supplemental report that Hartwick was 'handcuffed, [and] struck by focused blows' on the pavement outside the emergency room. Then in a car Hartwick was struck by 'a closed fist to the right side' of her face.
"'The first punch landed to the left side of my mouth,' Hartwick said. 'The second punch landed to the right side of my mouth. The third punch was when I was already in the car, and it landed on my left cheek.'"
While it's not clear to me if Hartwick was at the ER for physical pain or if something else was going on, there is no way OHSU security--they are licensed peace officers, meaning they are police--should have hit her, handcuffed or not. There's something cops everywhere operate under and it's called the use of force continuum and, under its precepts, cops cannot hit or strike a citizen unless that citizen has hit or struck them (there are exceptions but that's the basic deal). Once someone is in handcuffs, there should be no blows delivered unless a detainee is kicking or hitting the cops somehow.
What's more, it's not clear to me why security would be trying to arrest her in the first place (her offense would be what? yelling at ER staff?) much less employing a takedown.
I hope this woman, who suffered a black eye and likely another PTSD-deepening incident, gets a good lawyer and sues the hell out of OHSU.
The use of force is under review by OHSU authorities who are also trying to find out who coughed up internal police documents to the TV station. I have some experience with how OHSU can freak out when someone leaks documents to the press from my days as a reporter in Portland. Looks like they are acting as lamely as ever:
"OHSU said patient information is protected by federal HIPAA laws and someone broke the law and violated hospital policies by giving the documents to a news organization."
How a police incident report would constitute "patient information" protected by HIPPA is beyond me. Nice try OHSU!
I've long held that there's got to be a reason for why psychosis exists in the human makeup or evolution would've corrected it out of humanity's psychological genome eons ago. I don't know what the reason is, however.
Now, Al Galves, a retired psychologist, has written an interesting piece on Beyond Meds.
"What about psychosis, the most extreme and bizarre of 'mental illnesses?' The key symptoms of psychosis are hallucinations, delusions, disorganized speech and bizarre behavior such as talking to people who don’t appear to be there. What could be the value of that?"I believe that psychosis is a protective and life-affirming move of the psyche in response to extreme desperation, fear, terror about the prospect of having to live in the real world with real human beings. I’m not the only one. Psychologist John Weir Perry spent lots of time with many people who had been diagnosed with schizophrenia. He came to see that state of being as a deeply motivated move by the psyche to reconstitute itself. All of the people he came to know had suffered a severe blow to their self-concept and were experiencing a severe sense of negative self-image. The symptoms of psychosis were a compensating move."
The piece goes from there. Read on.
A new website, knowfibro.com, has popped up and interestingly its open and transparent about its sponsorship by Eli Lilly and the National Fibromyalgia Association, a California-based non-profit. NFA is in turn partially funded by Lilly, Forest Labs and other pharma companies. NFA claims that upwards of 10 million Americans suffer from the chronic pain condition, although fibromyalgia is controversial among some doctors who claim it doesn't exist. (I've got no opinion on that point.) So fibro sure could be big business for Big Pharma. Lilly's anti-depressant Cymbalta is approved in the US for fibromyalgia treatment, although it was rejected for that indication by European regulators.
Whatever anyone makes of fibro and whether anti-depressants do much to address it, it sure is interesting to see a pharma company being upfront about its astroturfing.
Another $1,085 from 10 people came in Friday and over the weekend and that brings the total raised so far to $2,131.49 from 34 people. Thanks to all of you who've contributed so far. There's still $1,868.51 from 66 people to go to reach the overall goal of $4,000 from 100 people on or about September 21, which is next Monday.
I sure appreciated the dramatic boost in contributions the last few days. If you'd like to join in the groundswell of support for this site, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address.
Thanks in advance for your support.
There was an op-ed in the Seattle Times over the weekend authored by Jeff Skolnick, a psychiatrist at an area psychiatric hospital called Navos, formerly known as Highline West Seattle Mental Health. Skolnick argues that Washington State's commitment laws need to be changed to give doctors and other staff much more leeway in involuntarily committing their fellow human beings to psychiatric institutions. His thinking is straight out of the Fuller Torrey/Treatment Advocacy Center playbook and pretty much echoes what conservative forces in psychiatry argue when they talk commitment laws. In fact, TAC highlighted the op-ed on its blog and dubbed it "Positive Movement in Washington State."
That it appeared in a newspaper with a 300,000 daily circulation and many thousands of more readers on its website is significant. A lot of people have read Skolnick's op-ed and gotten the usual violence card arguments from the conservative wing of the psych world.
Here's Skolnick's lede:
"THIS should be a no-brainer. An idea that could save money for Washington State, make it a much safer state, and allow us to more adequately care for people with severe mental illness: Repair the broken legal system used to commit people with psychiatric illness."
A much safer state? Oh, here we go with the violence card yet again, a special fetish of some in the psych world. And what does he mean by "severe mental illness" since he doesn't say? Depression? Schizophrenia? Bipolar disorder? Preschool bipolar disorder? It's kind of weird that the paper's editors didn't insist upon some precision here, unless the sages over there think that there's a link between, say, depression and violence. In addition, it's odd that there's no news hook for this op-ed piece--no recent local dust-ups between humanity and someone diagnosed with schizophrenia and the rest of humanity; no bills before the state legislature. It sure makes me wonder what event prompted this op-ed.
And how much less safe am I as a citizen of the state under our current commitment laws? Skolnick offers no answer, making his fear-mongering look especially chicken shit.
More:
"In my hospital, at least half of all patients who are committed against their will are discharged by the court against medical advice. Many of these people are very ill, still psychotic and often likely to quickly become a danger to society, their families and themselves."
OK, how many people would that be? Sloppy editing there. My hunch is that Skolnick is not talking about a large number of people and yet he's using them to argue for specific changes to my state's commitment statutes, which I'll come to in a moment. Using small numbers of people to argue for wholesale legal changes that would affect many more people is a rotten way to do public policy.
"Quickly?" "Danger to society?" Skolnick offers not one drop of evidence for making this assertion, but he's a psychiatrist and I guess they are excused from the usual rules of op-ed land, especially when they are trying to appeal to deep-seated public fears. In all seriousness, if Skolnick were at all conversant with the scientific literature examining links between, for example, schizophrenia and violence, he'd find that while there is a slight uptick in violence associated with the disorder--especially among the severely psychotic--much of that increase is associated with substance abuse. He should try reading this recent study in JAMA.
And now:
"It's also an incredible waste of money. People discharged against medical advice are often back in the hospital within days if not weeks. This takes resources from law enforcement, jails, hospitals, ambulances and county mental-health professionals, but more than that, it exposes the community to senseless and unpredictable acts of harassment, vandalism and violence. Read the papers. We shouldn't have to wait for a tragedy to fix this system."
Ah, I do read the papers here in Seattle and they are not a catalog of offenses committed by the mentally ill. There are ugly incidents from time to time and quite often there are underlying drug abuse problems such as with Issac Zamora's shooting rampage last year. Diagnosed with schizophrenia, my sources tell me that Zamora had quite the crack habit.
Speaking of tragedies, why doesn't Skolnick alert the public to the many tragedies associated with the use of antipsychotics--the very drugs used to treat the severely mentally ill--that have gone on in our country, especially since he's interested in protecting people? You know, the deaths due to diabetes, the sudden heart attacks and so on. Why not tell the good people of Washington State about the findings of the CATIE study and how they show what a weak technology these drugs are in treating schizophrenia? Well, he's got an agenda to serve and clearly he values the lives of the non-mentally ill more than the very populace he serves otherwise he'd be barking for safer, more effective treatments.
Skolnick moves on from rabble-rousing to specific policy recommendations:
"First, stretch out the time of initial commitment from 72 hours to five days, as they do in Oregon, or even a week. Our system was set up as a zealous way to protect the civil rights of people with mental illness (or of those falsely accused of it). Yet, it seems to have gone overboard and is actually violating the rights of people who cannot think rationally in getting the help they need. The days of psychiatric hospitals readily housing the mentally ill against their will for years are as much a relic of the past as female nurses wearing white dresses and hats. The government would do better to involve themselves in overseeing hospital quality and lengths of stay, putting less emphasis on judges and prosecutors who are making what amounts to medical decisions."
While adding 48 hours to an initial involuntary commitment doesn't strike me as onerous, I'm puzzled that Skolnck offers no evidence of whether the Oregon five-day holds are demonstrably better. I'm doubly puzzled that apparently no one in op-ed edit land at the paper asked. Absent evidence that an extra 48 hours does much to improve things, I'd say Skolnick doesn't have much of an argument.
And he wants a government agency to control who gets committed? That is such a bad idea that it speaks for itself.
Finally, Skolnick argues:
"Third, change the criteria — the legal threshold — for civil commitment. For instance, make it less stringent to detain people with psychiatric illness who are dangerous to others, say if they are clearly dangerous but haven't made specific threats or if they kill an animal. Allow more flexibility and deference to treatment teams in hearings about whether to keep someone hospitalized longer, for example, if they are still hostile and potentially a menace but have made no specific threats or acts while in the hospital; or they cannot be discharged without a reasonable place to live or professional follow-up in order to prevent predictable decompensation. Also lessen the criteria for "grave disability" (where someone cannot care for their health and safety) so that they don't have to be so severely incapacitated, in such an immediate risk of death, to be detained."
Let me start with his last point: while working a shelter counselor at a huge shelter in Seattle (DESC's Morrison Hotel shelter to be precise), I saw several people evaluated for commitment and taken away under the "grave disability" portion of state commitment laws. In each case, the person was nowhere near death, but was unable to take care of themselves (couldn't bathe for months, couldn't eat for days, covered with lice, etc.), so I don't know where Skolnick is getting the "immediate risk of death" from.
While I'm sensitive to the idea of not discharging people with no place to live, I wonder how Skolnick would define "reasonable." A homeless shelter? An apartment? The Four Seasons? Joking aside, it's hardly the fault of people who've been hospitalized if they have no place to live and it seems a weak argument for limiting someone's basic human liberty and an argument that should be greeted with skepticism.
I completely agree with Skolnick on his "kill an animal" point, depending on how he would define animal. Cat? Dog? Snake? Rat? Spider?
I really don't know what to make of Skolnick's argument that "if they are clearly dangerous but haven't made specific threats" then the person involved needs to be detained because if someone is "clearly dangerous" then they've either made verbal threats against someone or they have hit someone. Unless clearly dangerous means Skolnick has hit upon some mysterious new rating scale that he's not telling the public about. Or do doctors and their staffs just "know" nowadays?
Globally, Skolnick's arguments are so ham-fisted and imprecise that one hopes that members of the legislature managed to not read his op-ed in Washington State's most influential newspaper.
Another $31.50 came in yesterday from two people bringing the total raised so far to $1,046.49 from 24 people. Thanks to all of you who've contributed so far. There's still $2,953.51 from 76 people to go to reach the overall goals of $4,000 from 100 people on or about September 21.
I know how badly the economy stinks right now--far more than I want to get into on a personal level--and I've heard from several readers by email about just how tough things are on their ends. I feel for all of us these days. The economy is horrific, competition for available jobs is tougher than I've ever seen in my life (I know this one intimately), and the nation seems primed to rip itself to shreds over health care reform (it's a subject that's grown so intense, poisonous and heated that I'm reluctant to even write about it). Times are way tough. Hell, the Sunday NY Times costs $6 in Seattle these days.
I'd like to think that every so often I'm worth the price of the Sunday Times or whatever magazines you read. That's why I'd like to ask all you regular readers out there--and that's about 5,000 people--to make a large number of small contributions. If that happens, this fundraiser will succeed. If it doesn't, I'm going to have to scale back dramatically in the work I do here and go do something else with my time.
If you've been following the mental health blogosphere lately, you probably don't want that to happen. Sadly, some popular blogs have gone on hiatus, their returns uncertain. Meanwhile, this is a critical time: yet another pharma company (Pfizer) has been found criminally liable for its psych meds and researchers continue to tout BS evidence and theories in papers while not disclosing their pharma ties. (There's more of course.) Someone has got to tell the public--meaning you--about this crap so it can someday be ended. That someone is me.
As usual, the PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll send you my mailing address. Thanks in advance for your support.
A new study out in Psychiatric Services asserts that a full 60 percent of antipsychotics prescribed in the VA system in 2007 were being prescribed off-label and, in my opinion, for conditions for which there is little scientific evidence supporting their use. These drugs are known to be dangerous, so you've got to wonder what the hell is going on at the VA and just how much illegal marketing pharma companies have engaged in to create this situation. The study most prominently identifies the off-label use of Seroquel and Risperdal.
Here's the stunner to me:
"The most common mental illness diagnoses among patients given prescriptions for antipsychotics off label were posttraumatic stress disorder (PTSD, 41.8%), minor depression (39.5%), major depression (23.4%), and anxiety disorder (20.0%)."
Seroquel and Risperdal simply aren't approved for those conditions. The study states that 279,778 people in 2007 got antipsychotic medication, 168,442 of them off-label. I know the VA gets deeply discounted prices and that the doses were on the small side, according to study authors, so let's assume that each of these 168,442 patients ran up $100 a month in antipsychotic expense to the VA system each month (that $100 might be low). That would work out to $202,106,400 in 2007 for off-label use of these drugs in the VA system. And people wonder why health care costs so much.
Over 168,000 people is a large group to give risky drugs to with little evidence of their effectiveness. That these are military veterans pisses me off immensely.
Even the study's authors conclude:
"Given that these drugs are expensive, have potentially severe side effects, and have limited evidence supporting their effectiveness for off-label usage, they should be used with greater caution."
Or maybe not used at all.
Someone has got to look into this situation because I smell a rat. The DOJ has pushed on the pharma companies over off-label marketing within the Medicare/Medicaid system, so it would stand to reason that they should have a look-see here as well. I know that Sen. Charles Grassley (R-Iowa) continues to look into off-label marketing, among other things. I hope he decides to press the appropriate parties for information on what's going on here. I think our veterans deserve that.
Most of you know that ABC's "Primetime" did a program on Mad Pride a few weeks ago and did the usual mainstream media thing when dealing with alternative approaches to mental health care and played the violence card. (Liz Spikol and I trashed the program here.) MindFreedom's founder and one of the biggest proponents of Mad Pride David Oaks was interviewed on the program but was out of the country when it aired, so he's only recently viewed it and offered some thoughts on it all.
In classic form, he points out that if ABC is going to tar Mad Priders with violence, then this is about how they'd handle other social movements.
"Let me try to find some parallels, as inexact as that might be:"* Islamic pride? It would be as if you talked with an Islamic leader at length about their pride in being Muslim, and the leader asked if you were going to focus on suicide bombers, and you replied no, no, no... but your piece ended up with a lurid focus on suicide bombers, with slow motion of bombs going off.
"* Gay pride? It would be as if you were doing an early piece on Gay Pride, promised the activists a positive portrayal, and instead focused on lurid and detailed tales of homosexual child molestation for much of the show, including weeping parents of the children."* Black pride? Not at all to compare ourselves to Rosa Parks, but it would be as if you did one of the first pieces on Rosa Parks, but instead focused on instances of where African American youth had beaten up or killed bus drivers, complete with an interview with a slain bus driver's widow."
Oaks is dead right about these parallels.
The show's producer sure flunked the classic Journalism 101 test because when you are comparing two things--Mad Pride and violence--then you need some evidence to back up your assertions. Yet the show provided no evidence of anyone in the Mad Pride movement being violent. Epic fail.
A new study out from the editors of JAMA, which I've not seen in full yet, conducted an online survey of authors with published work in six leading medical journals--JAMA and the NEJM included--and found a ridiculously high rate of ghostwriting going on.
"Among authors of 630 articles who responded to an online questionnaire created by the researchers, 7.8 percent acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed."According to the study, responding authors reported a 10.9 percent rate of ghostwriting in The New England Journal of Medicine, the highest rate among the journals."
This is simply outrageous and it's got to be pretty embarrassing for the journals involved. It's equally appalling that the researchers who put their names on these studies are letting this practice continue, because it calls into question the scientific integrity of their work.
Who do any of these people think they are fooling at this point by letting unnamed outsiders, paid for by pharma companies, massage and manipulate scientific data and findings?
This ghostwriting nonsense has simply got to stop.
Another $108.73 came in from five people bring the total so far to $1,014.99 from 22 people. That leaves $2,985.01 from 78 people to go to reach the overall goal of $4,000 from 100 people on or about September 21. Thanks to all of you for your contributions.
I get the sense that many readers are just getting back to their regular routines after the long weekend and end of summer vacations. But for this fundraiser to work, things really need to pick up. I know there's a day each and every fundraiser when 10 to 15 people contribute en masse and launch the beast on its way to success. Today needs to be that day or I am going to be eating cat food this weekend. I'm not exaggerating by much.
If you've not been around the last few weeks, I've been successful in getting a major medical journal to look into possible undisclosed conflicts of interest involving a fairly major psych researcher's published study and I'm pressing for another major journal to look into similar possible problems with the same researcher's work there. Knowing readers as I do, I suspect more than a few of you would think that's reasonably significant, so please consider supporting the work I do here with a contribution.
As usual the PayPal button is on the right. if you prefer snail mail, send me an email and I'll shoot you my mailing address.
Thanks in advance for your support.
Last week I wrote about possible undisclosed conflicts of interest involving Joan Luby, a Washington University psychiatry professor, and published studies of hers in the Archives of General Psychiatry, published by the AMA, and the American Journal of Psychiatry, published by the American Psychiatric Association. I brought the possible conflicts to the attention of the journals' editors and to Luby herself.
Yesterday, I received an email from from Joseph Coyle, editor of the AGP and a psychiatry professor at Harvard University:
"I apologize for the delay in responding to your inquiry, but I was on vacation and out of email contact. We take your allegations seriously and will look into the issue."
So the AGP is going to look into Luby's possible disclosures on a paper published in the journal last month and on one from December 2003. In each case, it appears that Luby neglected to mention pharma monies it appears she'd received in accordance with the journal's conflict of interest policies. I appreciate the journal and the AMA taking this issue seriously. At the end of the day, Luby's conflicts are likely not particularly egregious, but that doesn't matter: researchers have got to be rigorously transparent in reporting conflicts and biases, particularly if they are going to go around asserting that 3-year-olds experience chronic depression.
I look forward to whatever results the AGP comes up with.
To date, I've gotten no response from the editor of the American Journal of Psychiatry nor from the APA's press office. If the AGP and AMA can take questions of unreported conflict of interest seriously, then so can the AJP and the APA. Their silence is very telling and very discouraging. Have they no interest in properly reported conflicts?
I've heard nothing from Luby.
I suppose the standard response in the blogosphere when something like the AGP investigation gets kicked off by one's own blog is to pat oneself on the back repeatedly. Not going to happen here. That kind of blog self-love is so 2005.
Some of you will recall that earlier this year a huge ruckus broke out around unreported conflicts of interest in a Lexapro for stroke victims paper in JAMA. Things got very messy and JAMA's editor called Jonathan Leo, a neuroanatomy professor at Lincoln Memorial University, a "nobody," apparently because said editor was steamed that Leo had spoken to the press (me and the Wall Street Journal, as well as publishing a letter on the BMJ's website) while JAMA was looking into the conflict.
Leo has now written a paper in Society about the whole dust-up and in particular goes after JAMA for removing an editorial from its website that had taken him to task and then replacing it with a different piece explaining its new conflict of interest investigation policies. What's odd is that JAMA, as Leo notes, has gone from demanding that anyone bringing conflicts to its attention remain silent while the journal looks into matters to articulating a slightly different approach:
"We will explain to the person bringing the allegation that gaining full cooperation of all parties with knowledge of the facts is likely to be enhanced by maintaining confidentiality while the investigation is under way."
Leo sees this as a big problem for the media:
"The new policy also seems to put some burden on the press. Under the new policy, an investigative reporter who notices a problematic unreported conflict-of-interest in JAMA needs to first contact JAMA before writing about it....Is it in the public’s best interest for news organizations and journals to broker secret deals about when to write about something? Isn’t this just another conflict of interest? In a society that prizes freedom of the press, a policy that puts constraints on the open and free exchange of publicly available information needs to be carefully evaluated."
While it's not clear to me if JAMA's policy is intended to apply to the press or only to academics, there is simply no way that JAMA could apply it to the media and I hope the journal's editors have the good sense to not try and do so. There are not too many journalists who would agree to play by JAMA's rules anyway.
Leo's article is well worth a read.
To the AMA's credit, when I contacted its press office and the editor of the Archives of General Psychiatry last week in regards to possible unreported conflicts of interest by a researcher who'd recently published a study in the journal (a sister publication to JAMA published by the AMA), no one asked me not to write about the matter prior to the AMA/AGP giving me some kind of assent. In fact, as I was about to publish this post I heard from the AGP's editor who said the matter would be looked into.
I've not heard back from the researcher in question--Joan Luby of Washington University--or from the editor of the American Journal of Psychiatry, where another of the papers with possible reporting issues was published.
Leo also notes in his paper that the claimed implication of the original Lexapro study has some far-reaching implications:
"Following its publication, the authors were quoted in the media as saying that every stroke patient who could tolerate the medicine should be started on an SSRI. At the very least, the slippery slope comes to mind at this point. If we are going to try and prevent depression in one high risk group by treating everybody in the group before they are clinically depressed, then what about other high risk groups? Where do we stop? Should we medicate all the returning veterans (a 20% rate of depression), every pregnant woman (10% to 20%), the entire population of foster children (80% rate of psychopathology), and all the medical students in the country (20% rate)?"
Those are excellent questions, ones I've raised on this site for four years now and ones where I feel the obvious answer is a resounding "No."
Last night, NBC's "Tonight Show" host Conan O'Brien took a big jab at Pfizer's recent settlement of $2.3 billion with the feds for off-label marketing of Bextra and Geodon, among other drugs, and ran a spoof ad for a fictitious Pfizer Drug called Purposol, "the perfect drug." It treats everything from depression to werewolfism. Enjoy.
If You're Going Through Hell, Keep Going also has it online.
Another $36.36 from one person came in yesterday bring the total raised so far to 906.26 from 17 people. That leaves $3,093.74 from 83 people to go to reach the overall goals of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
There are about two weeks left in this fundraiser and I know there's a day during any fundraiser when it just takes off on a relentless march to the goal. It would please me greatly if today were that day. There are about 5,000 regular readers of this site--meaning everyday to several times a month readers--and it should be pretty darn easy to for 10 to 15 people to contribute today. Large or small really doesn't matter.
So if you'd like to contribute, the PayPal button is on the right. If you prefer snail mail, send me an email and I'll send you my mailing address. Thanks in advance for your support.
I really don't know what to do with a study from this month's Archives of General Psychiatry which asserts that deaths in study patients who had acute coronary syndrome (an umbrella term of heart problems resulting in ischemia or dead heart muscle) and who later died had their deaths related to persistent depression following the onset of ACS. Part of me says, "Well, duh, having a heart attack is likely damn depressing and recovery is likely pretty tricky if that depression lasts." But part of me thinks that's being a bit too dismissive.
Another part of me notes that one of the study authors (Michael Gaffney) is an employee of Pfizer and Pfizer makes Zoloft. What's more, the anti-depressant used in the study was Zoloft. The study was called the Sertraline Antidepressant Heart Attack Randomized Trial (SADHART) and was presumably unwritten by Pfizer. It was placebo-controlled but didn't include a psychotherapy arm.
So the skeptic in me says not to trust pharma trying to find yet another way to connect its depression treatments to another condition by claiming a protective effect of depression treatment. Not that the study claims a huge benefit from taking Zoloft. An initial six-month course of the drug following onset of ACS was not connected to long-term survival. Neither were previous episodes of depression. So it's not like this study is actively pimping for SSRIs for all post-heart attack.
Nonetheless, the authors still conclude that depression treatment is the way to go:
"Because persistent depression increases mortality and decreases medication adherence, physicians need to aggressively treat depression and be diligent in promoting adherence to guideline cardiovascular drug therapy."
What kind of depression treatment would that be since Zoloft wasn't associated with longer life spans?
As I said, I really don't know what to make of this study, but something in me tells me not to trust its conclusions, at least not wholesale.
A federal judge today ruled that the State of New York discriminated against the mentally ill by forcing them to live in crappy adult group homes--in effect, little more than replacements for shuttered state psych hospitals--when the state could've paid for them to live in apartments and likely would've saved money in the deal. The judge ordered the state to submit a remedial plan to fix this mess.
And quite a mess it is. Some of the homes house hundreds of people and are rundown and unsafe, and staffed by incompetent people, in some cases. That's what a NY Times series found back in 2002. I'd strongly recommend taking a look at it.
These kinds of adult homes are present all over the country and they've essentially become the new form of long-term institutionalization. Although most states regulate the homes, in my experience I cannot tell where regulations have helped patients. I visited one in Seattle several years ago and within about 30 seconds I could tell I was in a fire trap. It's since been torn down and replaced by expensive town homes, but not because of a state inspection but because the agency that owned the property could make a ton of money selling to a developer. I have no idea what they did with the proceeds.
This is maddening: court documents released today show details of so-called call notes made by Lilly sales reps of visits and golf games with doctors in South Carolina, where the company was working hard to get doctors to switch patients to Zyprexa, even for unapproved uses. There were basically payoffs going on, the State of South Carolina alleges in a lawsuit against Lilly, and some of that involved reps making bets with doctors during golf games. One doc agreed that for each time a sales rep made par during one outing that he'd start a new patient on Zyprexa, according to Bloomberg.
And then there was this:
"Lawyers for the state pointed to a sales note from Sullivan in which he tells another salesman to tie a doctor’s Zyprexa prescriptions to participation in a speakers’ program."The company paid doctors and psychiatrists to address physician gatherings about the benefits of the antipsychotic. 'If his numbers go up, maybe he can talk,' Sullivan said in the August 2001 note."
The state's case against Lilly could go to trial later this month. Lilly told Bloomberg that the notes were taken out of context. Yeah, right.
At this point a question has got to be asked: why the hell are the doctors who keep taking payoffs from pharma companies--a la last week's Pfizer settlement--not named publicly? Why are they still practicing medicine? Why are they facing no discipline of any kind?
I hope you all had an enjoyable holiday.
Another $100 from one person came in over the weekend and that brings the total raised so far to $870 from 16 people. That leaves $3,130 from 84 people to go to reach the overall goals of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
If you'd like to help support the work I do here, the PayPal button is on the right. Or send me an email and I'll send you my mailing address.
For those of you who might be sitting on the fence about making a contribution, take a look at this series last week on a major researcher with some major disclosure problems with recent studies on "preschool depression" and "preschool bipolar disorder."
Thanks in advance for your support.
A new study in the British Journal of Psychiatry aims to understand the emotional side effects--ie, the infamous blunting effect--of taking SSRIs. Many in psychiatry and the mental health industry have long downplayed the stoned effect SSRIs (and other types of anti-depressants) can cause, so it's refreshing to see the phenomenon examined in a leading psych journal.
The study was actually a survey underwritten by the French pharma company Servier. Unfortunately, I don't have access to the full study, which concludes:
"Emotional side-effects of SSRIs are a robust phenomenon, prominent in some people’s thoughts about their medication, having a demonstrable impact on their functioning and playing a role in their decision-making about antidepressant adherence."
No kidding. Study findings are further described by the blog psychiatryupdate.com.au:
"Patients should be warned about emotional side effects of antidepressants when they start treatment, British psychiatrists suggest. The qualitative study of patients taking SSRIs found that the majority of patients experienced a reduction in positive and negative emotions, emotional detachment, changed personality and a feeling of indifference. Most described a general reduction in the intensity of emotions, so that all their emotions felt flattened or evened out. Others felt they experienced their emotions as thoughts rather than feelings. Most participants described feeling emotionally detached or disconnected and attributed this to their SSRI. This emotional detachment sometimes extended to a detachment from other people. Specifically, they felt reduced sympathy and empathy and a sense of detachment during social interactions. Almost all participants described not caring about things that used to matter to them, and some felt that their personality had changed in some way."
Ah, how well I remember the detachment I experienced on Prozac. When I began taking the drug in March 1990, my then-psychiatrist had me check in with him by phone a week later. I cannot remember what I told him, but he said to me, "If you feel as if your personality is changing, don't think about it too much. It's still really you."
The next summer I went to an opening night party for a musical that the big theatre I worked at in San Diego had just revived (and would later continue to Broadway). It was a wild party and several of the women in the cast were openly hitting on me. I was too zonked on Procaz--too removed--to care and went home alone (what I wouldn't give to have that night back, sans Prozac). It was a problem I fought with other anti-depressants as well, especially Zoloft and Wellbutrin, and I know it's a very tricky problem for many patients.
While I don't think the BJP study breaks any new ground, it's nice to see some psych researchers being publicly honest.
It's literally raining cats and dogs in Seattle this morning, which hopefully doesn't mean we've switched to November weather this early (although I've seen it before). Anyway, another $190 from two people came in on Friday and that brings the total raised so far to $770 from 15 people. That leaves $3,230 from 85 people to go to reach the fundraiser's overall goals of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
If you'd like to help chip away at the goal over the weekend, I'd appreciate it. The PayPal button is on the right. Or if you prefer snail mail, send me an email and I'll pass along my mailing address.
Enjoy the holiday weekend.
Another $50 came in from one person yesterday bringing the total raised so far to $580 from 13 people. That leaves $3,420 to go from 87 people to reach the overall goals of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
I knew things would slow down around the holiday weekend, but it would be great if the total raised were much closer to $1,000 raised so that there's not nearly as much to raise over the fundraiser's last couple of weeks.
If you'd like to contribute, the PayPal button is on the right. Of if you prefer snail mail, send me an email and I'll shoot you my mailing address.
Thanks to all of you for your support. Enjoy the holiday weekend.
A new study out in the American Journal of Psychiatry asserts that there is a risk, however small, of sudden death associated with the use of ADHD stimulants in youths. The study examined state vital statistics from across the country for the years 1985 through 1996 and, according to the authors, was mostly looking for methylphenidate (Ritalin) use. That time frame would largely exclude the years that Adderall has been on the market, so it'd be interesting to know what kind of results they would've gotten through 2006 or so.
Anyway, what researchers found was that in 564 cases of unexplained sudden death that 10 of the cases--or 1.8 percent--involved ADHD stimulant use. They compared this group with a control group of youths who had died in auto accidents and concluded:
"This case-control study provides support for an association between the use of stimulants and sudden unexplained death among children and adolescents. Although sudden unexplained death is a rare event, this finding should be considered in the context of other data about the risk and benefit of stimulants in medical treatment."
Interestingly, the journal published an accompanying editorial by Benedetto Vitiello who's one of NIMH's big shots on ADHD and Kenneth Towbin, also of NIMH. The pair pretty much try to pooh-pooh the study--while praising its methodology!--while offering this takeaway:
"However, it is equally clear that 1) sudden unexplained death is a rare event, 2) this is only the first such study, 3) it relies on small numbers, and 4) it is not possible to quantify the risk beyond estimating that it is very small. A full estimate of the risk-benefit ratio of ADHD treatment cannot be properly conducted at the population level because sudden unexplained death is so rare and we lack controlled long-term data on the effectiveness of these medications for reducing the risk for other adverse health outcomes, such as accidents, medical hospitalizations, unsafe sex practices, antisocial behavior, and substance abuse, which have been associated with ADHD."
It's fine for them to point out the rarity of sudden unexplained deaths and so on, but given that the average age in the study group was 15.76 years and ages ranged from about 13 to 17 years of age, it's kind of weird--at least to me--that they would try to use a backdoor justification of ADHD stimulant use related to accidents, unsafe sex, anti-social behavior and so on. Who the hell do these guys think Americans with ADHD are anyway? Is that what they really think of America's teens? That's some nice stigmatization there.
Earlier last evening I approved this site's 20,000th comment. That this site has gotten so many comments--on average 8.2 comments per post--and has survived long enough to get them blows my small mind. I sure do appreciate all the comments.
Oh, yes, the 20,000th comment was from "JJ."
Another $120 from four people came in yesterday and that brings the total raised so far to $530 from 12 people. That leaves $3,470 from 88 people to go to reach the overall goals of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
If you'd like to join them, the PayPal button is on the right. If you prefer using snail mail, send me an email and I'll send you my mailing address.
Thanks to all of you for your support.
On Tuesday I wrote of a possible non-disclosure of pharma monies by Joan Luby, a Washington University psychiatry professor, in an August 2009 paper in the Archives of General Psychiatry. In that paper, which asserted that child as young as three can and do experience chronic depression, Luby appears to have failed to disclose monies she'd received with the last five years from AstraZeneca, Shire and Janssen/J&J.
Luby is interested in more than depression in preschoolers. She has also authored papers on "preschool bipolar disorder," written that anitpsychotics are a suitable treatment and ranks with Harvard child psychiatrists Joseph Biederman and Washington University's Barbara Geller as one of the prime proponents of the bipolar child paradigm--a controversial paradigm to say the least.
Now, it's apparent that she has similar possible disclosure problems with a paper on "Early Childhood Depression" in this month's American Journal of Psychiatry and with a 2003 paper in the Archives.
At the AJP paper's end, Luby only notes under disclosures that she receives royalties from a book. While the AJP does not specify any particular time window within which an author must disclose possible conflicts, it does require that authors note relevant conflicts. Seeing as Luby received monies from AstraZeneca, a company that's quite interested in its antipsychotic Seroquel being used for depression, in 2003 and 2004, it's baffling that she wouldn't list the AZ monies as well as monies from Janssen/J&J, another company interested in seeing its antipsychotic, Risperdal, used for depression.
I've brought this matter to the attention of the AJP's editor and the press office at the American Psychiatric Association, which publishes the journal. In addition, I've contacted Luby, asking her to account for this apparent discrepancy. None of the parties replied to my requests for comment.
Luby's paper examines treatment considerations for preschoolers with depression, a controversial assertion even within psychiatry itself. To be fair, Luby isn't pushing meds for tots in the paper. She discusses psychotherapeutic approaches and states that:
"The use of antidepressant medications is not recommended as a first- or second-line treatment at this time."
All the same, as wild a claim as toddlers with depression sounds, Luby should be a lot more upfront about to what degree pharma companies may be biasing her assertions.
A December 2003 paper by Luby entitled "Alterations in Stress Cortisol Reactivity in Depressed Preschoolers Relative to Psychiatric and No-Disorder Comparison Groups" raises similar questions. Luby often cites this article in her subsequent work on depression in kiddos as establishing the mechanism of depression in their cases. In the paper, she asserts that she's detected hypothalamic-pituitary-adrenal (HPA) reactivity in depressed preschoolers. HPA reactivity is far from settled science in establishing a cause of depression.
In this paper, Luby discloses that she's gotten funding from the National Institute of Mental Health and the National Alliance for Research on Schizophrenia and Depression. NARSAD is a non-profit foundation. What Luby fails to disclose is that in 2003 she received monies from AstraZeneca. It's not clear if she was receiving monies from Shire and Janssen/J&J in 2003 or at any earlier date that would've triggered disclosure in the journal.
Nonetheless, it would stand to reason that she should've listed the AZ monies on her paper, especially since she was at the same time receiving federal research funding.
I've contacted Luby asking her to explain this apparent discrepancy. Luby has not responded to my request for comment.
So far, I've heard back from only the AMA's press office and only to the effect that the AGP's editor is out until next week. Stay tuned.
BTW, much credit to Jim Edwards at Bnet.com's Pharma Blog for this all started last week.
The Geodon portion of Pfizer's record $2.3 billion criminal and civil settlement with the Department of Justice yesterday was much larger than I'd thought. What's more, now that details of the settlement are out, it is clear that the company was paying kickbacks to doctors to prescribe Zoloft which is the company's now off-patent anti-depressant.
From HHS's press release, the $1 billion combined federal and states civil settlement contains $301,462,065 attributable to illegal off-label promotion of Geodon, the company's weak-selling antipsychotic. The painkiller Bextra made up $502,524,316 of the $1 billion, so it's clear that Geodon was a big piece of the settlement.
Specifically, the settlement covers off-label promotion of Geodon for the following unapproved conditions:
"Depression, Bipolar maintenance, Mood disorder, Anxiety, Aggression, Dementia, Attention Deficit Hyperactivity Disorder, Obsessive compulsive disorder, Autism, Posttraumatic stress disorder, Unapproved patient populations (including pediatric and adolescent patients), Dosages above approved maximum."
That's a slew of off-label marketing and it's nonsense that it was going on. I'm not aware of any documents in the public realm related to all that activity. but if Pfizer settled claims connected with it, then you know they did it.
What's even more impressive is that the $1 billion portion of the settlement also included $49,844,714 for paying kickbacks to health care providers in connection with the marketing of a number of other Pfizer drugs including Zoloft.
The settlement doesn't include any sanctions against doctors who took kickbacks, but I have to question why these doctors aren't being named and why their medical licenses aren't in jeopardy, at a minimum.
Both Eli Lilly and Bristol-Myers Squibb have in recent years settled charges brought by the Department of Justice for the illegal off-label promotion of antipsychotics. Lilly even pleaded guilty to a federal criminal misdemeanor earlier this year.
In addition to now being able to call Lilly a criminal company, we can now apply the same terminology to Pfizer, although that behavior seems to have been mostly in relation to Bextra.
I'm curious, given all this criminal behavior, as to why companies like Lilly, BMS and Pfizer as well as their lobbyists are allowed to have any role whatsoever in negotiating health care reform.
In an eye-popping move, pharma giant Pfizer has agreed to pay $2.3 billion to settle charges of illegal marketing brought by the Department of Justice involving the painkiller Bextra, the antipsychotic Geodon, Zyvox, an antibiotic, and Lyrica, an anti-epileptic. The settlement includes a $1.2 billion criminal fine, a record, and a $105 million criminal forfeiture.
"Authorities said Pfizer's salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages."
Pfizer is also paying $1 billion to reimburse Medicaid.
Just anther day in the realms of Big Pharma.
Another $185 came in yesterday from four people, bringing the total raised so far to $410 from eight people. That leaves $3,590 from 92 people to go to reach the overall goals of $4,000 from 100 people on or about September 21. Thanks to all of you who've contributed so far.
If you'd like to join them, the PayPal button is on the right. Or if you prefer snail mail, shoot me an email and I'll send you my mailing address.
Thanks in advance for your support.
An interesting article appeared in Wired last week and I assume it's in the current issue of the magazine. It concerns the placebo effect and the pharma industry's attempts to capture it somehow since that would be major money for them. While much remains murky around the effect, there are some startling facts in the article:
"By the late '90s, for example, the classic antianxiety drug diazepam (also known as Valium) was still beating placebo in France and Belgium. But when the drug was tested in the US, it was likely to fail. Conversely, Prozac performed better in America than it did in western Europe and South Africa."
What's more, even tightly-controlled clinical trials still had placebo effect all over the place. And the color of a medication matters too.
The article's author, Steven Silberman, interviewed me many months ago and I walked him through what I knew about the placebo effect in depression: very powerful in teens and kids, long lasting in adults and possibly accounting for 80 percent or so of the long-term effect of anti-depressants. I explained that regardless of where the effect was coming from, it had huge implications for depression treatment. Why give people tons of meds with big problems of their own when it's clear something else may be at work?
I also pointed out that there are also plenty of clinical trials for schizophrenia treatments in which there's a placebo response of 20 percent or so. That's very striking for a disorder where there's not supposed to be much of a placebo effect at all. What could possibly account for that? What could we learn from it about treating psychosis without using harsh medications?
None of that really made its way into the article, but it's such a big topic and such a poorly-understood phenomenon that I know an article looking into it all can end up in all kinds of places. It's well-worth reading.
Yesterday, I wrote of an apparent undisclosed conflict of interest in a paper where a researcher had asserted that 3-year-old kids experience chronic depression--"preschool depression" so called--but the same researcher had received monies from AstraZeneca and possibly others with the last five years. The paper appeared in the Archives of General Psychiatry last month which requires disclosure of all pharma payouts and the like within the past five years.
I emailed both the journal's editor and the press office of the American Medical Association to ask what they would do to look into the non-disclosure and if they would issue a correction in the journal. I got no reply.
Apparently a copy of Forest Labs marketing plan to Lexapro has been circulating through the US Senate and the New York Times has an article on it. Lexapro racked up $2.3 billion in sales in 2008, even though there are substantial questions about whether it works any better than Celexa (much less other anti-depressants), another Forest anti-depressant from which it is derived and which is now available as a generic drug.
The marketing plan is linked on the NYT's website, but I've not been able to download it yet as the paper's website is having some hiccups today. so from the NYT article itself:
"Forest’s 2004 plan for marketing Lexapro offers detailed information about how the company planned to direct this money to doctors."Under 'Rep Promotional Programs,' the document said the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers over the course of one year.
"'These meetings may be large-scale dinner programs with a slide presentation, small roundtable discussions or one-on-one advocate lunches,' the document states.
"Under 'Lunch and Learns,' the company intended to spend $36 million providing lunch to doctors in their offices. 'Providing lunch for a physician creates an extended amount of selling time for representatives,' the document states.
"An entire section of the marketing plan, titled 'Continuing Medical Education,' outlines how the company intended to use educational seminars for doctors to teach them about Lexapro. The Senate’s Special Committee on Aging held a hearing in July on whether industry funding of medical education classes leads to tainted talks."
Forest is in hot water with the Department of Justice, which earlier this year alleged the company had engaged in illegal kickbacks to doctors to entice them to prescribe Celexa and Lexapro and that it had illegally marketed the drugs for use in kids. The company has already set aside $170 million in anticipation of a fine from the feds.
Despite having two failed clinical trials and unimpressive efficacy over placebo in two other trials, the FDA approved Lexapro earlier this year for the treatment of major depression in 12 to 17 year olds.
As many of you no doubt know, a trickle of documents from class action cases against Eli Lilly over its antipsychotic Zyprexa have been flying around lately. These documents are in addition to the Zyprexa court documents leaked to the public in late-2006. You can access the new documents here. The court ordered them unsealed, so their use and distribution is unrestricted as far as I know.
My own collection of the earlier Zyprexa documents is here.
From my review of the new documents so far, I can tell you that there are no smoking guns but that they do add more detail and texture to what's already known about Lilly's behavior. Lilly has settled about $2.7 billion in claims already, has pleaded guilty to a criminal misdemeanor charge and is expected to settle other outstanding cases in the near future.
Summer is rapidly waning and it's time to begin this site's fall fundraiser. The overall goal is $4,000 from 100 contributors by about September 21. Four contributors have already donated $225 over the last week or so--unsolicited by me I should add--and so that leaves $3,775 from 96 contributors to go. As usual, the PayPal button is on the right or shoot me an email and I'll send you a mailing address if you prefer snail mail.
This site is one the verge of several interesting milestones. Later this month will mark its fourth anniversary, it's on the verge of its 20,000th approved comment, it's nearing its 2,500th post and sometime in October it'll have had its 750,000th visit. All kind of amazing to me. What's more, the recently-launched and very good blog healthlifeandstuff.com listed this blog as one of its top investigative blogs in healthcare.
But what have I done for you all lately? Over the last three months, I've written about the continued controversy around suicide warnings on anti-depressants; the creepy Pristiq TV ad; the death of a 3-year-old allegedly bipolar child in Kansas; an FDA panel's recommendation to approve three antipsychotics for adolescents and teens; health care questions that President Obama needed to address; doctors criticizing long-term anti-depressant use on CNN and Fox News; antipsychotic use exploding in Canadian kids; the controversial case of a young girl allegedly with schizophrenia whose father admitted to hitting and starving the girl; the Boston Globe taking up my challenge to cover Seroquel's street drug life; placebo beating Seroquel in teen bipolar depression; the doubling of anti-depressant use in the US over the last decade; a study showing anti-depressants double suicide risk in young adults; how antipsychotics might be a potential treatment for certain cancers; how many over-diagnosed bipolars actually have depression; and trying to make sense of all the new antipsychotics coming to market. And just moments ago I posted on possible undisclosed conflicts of interest around a researcher who had proclaimed that small child have chronic depression.
If any of that is compelling to you, I'd appreciate your support. Thanks.
A few of you will recall that earlier this month I wrote of a new study in the Archives of General Psychiatry asserting that 3-year-olds can and do suffer from chronic depression, a controversial notion to many people. The published study specifically stated that the lead author, Joan Luby of the Washington University School of Medicine, had no financial conflicts to report. To whit:
"Financial Disclosure: None reported."Funding/Support: Funding for this study was provided
by grant MH64769-01 from the National Institute of
Mental Health (Dr Luby)."
The journal's instructions for authors specifically state:
"Authors are expected to provide detailed information about all relevant financial interests and relationships or financial conflicts within the past 5 years."
As reported by Jim Edwards at Bnet.com's Pharma Blog, Luby was receiving money from AstraZeneca in 2003 and 2004. Edwards reporting came in connection with a separate Luby paper published earlier this year on "pre-school bipolar disorder" wherein Luby revealed no conflicts. Luby's depression article was submitted to the AGP in August 2008 and was published last month, so it would appear that she failed to properly disclose her relationship with AstraZeneca. What's more, Edwards also reported that Luby had previously disclosed in another publication that she had also received monies from Shire, makers of Adderall and Vyvanase, and Janssen/J&J, makers of Risperdal.
Shire told Edwards that the company and Luby had no relationship in 2008 and 2009. J&J didn't respond to Edwards' request for comment about the nature of its relationship with Luby.
The upshot is that AGP likely needs to issue a correction for Luby's August 2009 article to account for her relationship with AZ and may well have to add Shire and J&J as well. At a minimum, journal personnel need to look into whether or not Luby made an appropriate disclosure. I'll try to get some kind of comment from the journal and/or its publisher, the American Medical Association. The AMA's flagship journal JAMA was embroiled in a controversy around undisclosed financial conflicts of interest earlier this year.
While I'm sure many readers have wearied of these kinds of stories--much less the underlying conflicts themselves--I want to point out that it is important for researchers to appropriately reveal conflicts with pharma companies so that readers know how many grains of salt with which to interpret particular research conclusions. I would say that it's doubly important in child psychiatry where researchers are making profoundly controversial conclusions about the psychological make-up of small children.
In the context of Luby's assertion that tiny tots experience chronic depression as well as her assertion elsewhere that antipsychotics are an awesome treatment for kids, it would seem imperative that she be 100 percent upfront on any possible conflicts of interest.