Winter Fundraiser Begins

As I do every three months, today I'm beginning this site's winter fundraiser. The goal is to raise $3,000 over the next two weeks. The fall fundraiser was a big success and ended early, and I hope that's the case this time. I know full well how badly the economy stinks right now--I can assure you that the market for freelance writing of any kind is a disaster right now. I have a thing or two in the works right now, but I won't be paid for them until February.

Meanwhile, several issues that I've pounded on on this site have come full circle in recent weeks. Fred Goodwin, host of "The Infinite Mind" radio show, was exposed for taking over $1 million in pharma payouts and for not revealing those conflicts and his show was cancelled. Some of you know that back in April I was the first to report on how during one episode of the show Goodwin and several of his guests openly lied about suicidality and anti-depressants, an issue in some ways more important than unreported financial conflicts. What's more, Harvard child psychiatrist Joseph Biederman was recently outed for his ties to J&J and for basically working the company for tons of money to start a "research" center to advance J&J's commercial goals. If there's one bad apple in psychiatry whom I've focused on on this site, it's Biederman, the prime architect of the bipolar child business and a huge pusher of ADHD diagnoses on kids. I've been writing about Biederman for two years. I've also been the one alerting the public to the deceptive Abilify for depression ads on TV and how the FDA refuses to comment on whether it has or ever will review them.

In addition, I'll have more news soon on one antipsychotic used in kids.

For me to continue to go after these issues, I need your support. Unlike John McManamy, I won't accept ads for Seroquel and other psych meds on my website. I'm sure he's making a pretty penny for those ads, but for myself I prefer to have clean hands in that regard.

Anyway, as always, the PayPal button is on the right. If you prefer using snail mail, drop me an email and I'll shoot you a mailing address.

Thanks for your support.

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Risperdal Causing Breast Development In Boys

As I noted two weeks ago, there are now solid reports of teen boys who developed breasts as a result of taking the atypical antipsychotic Risperdal. The WSJ Health blog reported on this last week as well:

"One particularly troubling side effect is the growth of breasts in some male patients taking Risperdal. Steve Sheller, a lawyer in Philadelphia, represents six teenage boys seeking compensation from J&J after they developed breasts while taking Risperdal. Sheller says their problems stem from prolactin, a hormone involved in lactation, that can be elevated in males and females who take the medicine. Two of the boys he represents required mastectomies to get rid of their bosoms.

"The company has denied in court papers that it is culpable for the plaintiffs’ injuries, has taken part in any 'misrepresentations, omissions, suppression or concealment' of negative information about possible side effects from the drug in their warnings to consumers."

I spoke with Sheller last week and he told me of some other side effects from Risperdal, one of which is such an explosive allegation that I'm going to wait for further evidence of its presence or for it to show up in a legal complaint before I write about it here. But, trust me, it will make your head spin.

I haven't the faintest as to when Sheller's clients were taking the drug or what J&J was describing as issues with the drug's use at the time.

The drug's package insert reports cases of gynecomastia--breast development in males--in 2.3 percent of kids and teens taking the drug (see page 9 of the insert). It's not clear me if this same phenomenon is present in adults, but the insert does note gynecomastia in some adults (see page 7 of the insert), or what the situation is with girls taking the drug.

What troubles me about all of this should perhaps be obvious: it isn't right, fair or appropriate to give boys a drug that can cause them to grow breasts. It's simply so against Nature and human development that I cannot even get into it. It's difficult to imagine the psychological trauma these boys must have experienced--and perhaps still are experiencing--in the name of treating ADHD, bipolar disorder or whatever else they were being given Risperdal for. If you assume that perhaps 500,000 male boys and teens are taking Risperdal--a number I'm using for illustration only--then you'd expect to see 11,500 boys developing breasts. That's a problem and as side effects percentages generally run even higher in the general population--as opposed to those in the clinical studies--it makes me wonder what the hell is going on out in America.

All in all, I see this issue with gynecomastia and prolactin levels and Risperdal as validating a lot of my concerns about giving antipsychotics to youngsters. One of my concerns is how these drugs can affect the physical and sexual organ development of youngsters.

If you think such concerns are excessive or misplaced (God knows, some people have dubbed me as a Scientologist and anti-psychaitrist for flagging these concerns), then consider this paper which identifies decreased bone density in patients diagnosed with schizophrenia who've taken antipsychotics long-term. A separate paper by the same researchers indicates that some women taking antipsychotics become hypogonadal, "a medical term for a defect of the reproductive system that results in lack of function of the gonads (ovaries or testes)."

Obviously there are differences in amount of medication taken and length of time on a medication, but if those kinds of mechanisms are at work in adults, then how could anyone possibly argue that they would not be a source of grave concern in kids and adults being given antipsychotics for non-psychotic disorders.

A I noted on this site recently, the best rule of thumb for approaching antipsychotic use is to not give them to kids for anything other than childhood schizophrenia and, perhaps, extreme autism. I'd argue that the same rule should be applied to adults, and I'm sure not very comfortable about the long-term use of these drugs in adult schizophrenia.

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New York Times Calls For Crack Down On Research Conflicts

On Sunday, the New York Times' editorial page went after the twin conflict of interest sagas of Harvard child psychiatrist Joseph Biederman and leading bipolar disorder researcher Fred Goodwin, conflicts that have been well-documented on this site as well. The editorial called for action:

"More evidence has emerged of appalling conflicts of interest that throw into doubt the advice rendered and the research performed by two prominent psychiatrists who have received substantial funding from the pharmaceutical industry. The revelations prove, once again, the need for universities and professional societies to crack down on conflicts of interest, and for Congress to pass legislation that will bring hidden conflicts into the open."

I don't have much to add here, except to note that it pleases me greatly that the paper has editorialized on this matter and that, all in all, these kinds of conflicts shouldn't only be in the open, they simply shouldn't exist. We've got to fund psychiatric research and all medical research in this country differently.

My own view is that no researcher taking over, say, $10,000 a year from pharma companies to do research or make speeches on behalf of their products should turn around and pass themselves off as unbiased scientists. Their papers should be rejected by professional journals and the media should decline to quote them and patients of every stripe should rebel against their evidence. Psychiatrists make plenty of money as it is already. If they can't live on $180,000, the average yearly earnings of a psychiatrist in the US, then they need to pursue another career.

Doctors are supposed to have their patients' best interests at heart, but it's clear to me that a discouragingly large number of psychiatrists have been more interested in their own bank accounts than in their patients' well-being. That's got to change.

I certainly hope that Congress, the various medical societies and research universities heed the call for a crack down on these conflicts of interest. The public has been fed enough bull already and it's got to stop.

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Thanks

This will be the only post today because it's pretty much getaway day and after doing this site for three years, I know that traffic craters today and tomorrow. I may be back on Friday, but maybe not.

Thanks to all of you for reading this site. For the third month in a row, it will clear 30,000 visits for the month, and in recent days something like 7,000 people have read the various posts on "The Infinite Mind" fracas and the Biederman/Harvard scandal. I'm not pointing this out to brag, but to let you regulars know that information we care about is finally penetrating the public mind.

Have a nice Thanksgiving Day.

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J&J Called Clinical Trials Of Psychiatric Drugs For Kids "Growth Opportunities"

There was quite a bit of media coverage of revelations yesterday that controversial Harvard child psychiatrist Joseph Biederman, who is also at Massachusetts General Hospital and is the primary creator of the bipolar child paradigm and is one of the chief researchers of ADHD, had pressured Johnson & Johnson, makers of the atypical antipsychotic Risperdal, to contribute hundreds of thousands of dollars in research money to him and got the company to underwrite a center at Mass. General to study psychiatric medications in kids in order to "move forward the commercial goals of J&J," according to documents in a lawsuit released to the media. J&J gave the center $700,000 in 2002 alone.

Details of those documents are stunning. Here's a sampling of their contents from the Philadelphia Inquirer:

"The court papers show Johnson & Johnson:

"Budgeted $6.4 million to hold 'educational summits' and sponsor advisory panels in part to counter negative media reports on the research, diagnosis and treatment of children with mental illness;

"Was actively involved in drafting research that Biederman was to present at a medical conference and asked him how to deal with unfavorable research results suggesting that a placebo worked as well as Risperdal;

"Discussed clinical trials for drugs as 'growth opportunities' and tied trial proposals to sales potential."

According to the New York Times, Biederman was actually willing to slap his name on a J&J study of Risperdal in kids where placebo had performed as well as the drug, but a draft abstract of the paper said only that kids taking Risperdal improved.

Between a company that allegedly saw clinical trials as growth opportunities instead of the testing of a scientific hypothesis and a researcher who was allegedly willing to sell himself to J&J, is it any wonder that child psychiatry is such a controversial mess. And is it any wonder that lawmakers and the public have become very dubious of pharmaceutical companies and their compromised researchers.

As I noted yesterday, I wonder what proponents of the bipolar child paradigm now make of the "science" behind the paradigm. I'm still waiting to hear.

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Fred Goodwin's Strange History

Yesterday a reader informed me that Fred Goodwin, at the center of the recent controversy around "The Infinite Mind" radio show, had been involved in a very messy incident back in 1992. Goodwin, author of the primary medical text on bipolar disorder and the author of many papers on mental illness and a major consultant for drug companies, was reportedly at the center of a storm around questions of race, violence and genetics.

From the New York Times:

"Dr. Breggin said his accusations were based on remarks made by Dr. Frederick Goodwin, director of the National Institute of Mental Health, at a meeting of the National Mental Health Advisory Council on Feb. 11. Controversy over a statement by Dr. Goodwin at that meeting, which seemed to compare inner cities to jungles, led to his resignation as head of the Alcohol, Drug Abuse and Mental Health Administration.

"At the meeting, Dr. Goodwin spoke of planning for a 'violence initiative,' which, among other goals, would seek to find biological correlates of violence in males, detecting them early in life, and seeking to prevent their expression. He also asserted that adoption studies had shown that genetic factors in violence and aggression were 'very strong.' Dr. Goodwin declined to be interviewed."

This account by Breggin offers more explanation of what turned into a very complex situation with, reportedly, the Wall Street Journal and Washington Post editorializing in favor of Goodwin's free speech rights.

I find it very odd that one of the presumed good guys in psychiatry would make a proposal, however casual, to go after inner-city youths (ie, African-American males) in such a fashion. I wonder what his defenders such as John McManamy of mcmanweb.com and HealthCentral.com now make of Goodwin. You can read McManamy's defense of Goodwin here.

Meanwhile, Bill Lictenstein, who produced "The Infinite Mind" radio show, has released a statement about the show's demise in the wake of revelations of immense financial conflicts between Goodwin and various pharmaceutical companies who gave him well over $1 million to speak on behalf of their drugs. Goodwin did not reveal these conflicts, even in the midst of a March 2008 radio episode in which he and his guests claimed that there was no credible scientific evidence of a link between anti-depressants and suicide as well as other violent acts and suicidality.

Lictenstein stated:

"Dr. Goodwin’s acceptance of these fees was in direct violation of his written contract with LCM, which states, in part: 'You agree to disclose to LCM existing and any new business relationships as they occur that could potentially be perceived as representing a conflict of interest with your role as a public radio commentator or journalist. You also agree to disclose to LCM any business relationships that existed during your time as host since 1997 which may have presented a conflict of interest as defined above.' There was no gray area. Fred Goodwin was legally bound to inform LCM of any conflicts of interest. And he didn't."

I simply cannot understand why someone of Goodwin's standing in medical science wouldn't appropriately identify his conflicts to Lictenstein and his radio audience, especially when some of those conflicts were identified in various academic publications of Goodwin's. Then again, I am confused as to why Lictenstein hadn't read Goodwin's published articles and identified the conflicts for himself.

Two sordid affairs involving one of the key thought leaders in psychiatry inside of two decades.

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Harvard Child Psychiatrist Worked Closely With J&J

Gardiner Harris of the New York Times has done it again. In a piece just out on the paper's website, he details emails and other documents from an ongoing lawsuit against J&J over the use of its antipsychotic Risperdal in kids, which offers insight into how Joseph Biederman, a Harvard child psychiatrist, worked J&J for money. Biederman is of course the godfather of the whole pediatric bipolar disorder (aka, child bipolar disorder) business. The details are stunning.

"[E]-mails and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to fund a research center at Massachusetts General Hospital whose goal was 'to move forward the commercial goals of J&J,' the documents state. The documents also show that Johnson & Johnson wrote a draft summary of a study that Dr. Biederman, of Harvard University, was said to author."

Keep in mind that this is the researcher whose science the FDA said it was leaning upon when it decided that pediatric bipolar disorder was a valid diagnosis back in July.

"In one November 1999 e-mail, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman in payment for a lecture he gave at the University of Connecticut.

"'Dr. Biederman is not someone to jerk around,' Mr. Bruins wrote. 'He is a very proud national figure in child psych and has a very short fuse.'

"Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made to receive a $280,000 research grant. 'I have never seen someone so angry,' Mr. Bruins wrote. 'Since that time, our business became non-existant (sic) within his area of control.'

"Mr. Bruins concluded that, unless Dr. Biederman received a check soon, 'I am truly afraid of the consequences.'"

Sounds like Biederman is an adult version of the little boys he urges Americans to medicate.

But wait, there's more:

"A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, for which Dr. Biederman still serves as chief.

"A 2002 annual report for the center stated that its research must satisfy three criteria: improve psychiatric care for children, have high standards and 'move forward the commercial goals of J&J,' according to court documents.

"'We strongly believe that the center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children,' the report stated. 'Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics [ie, antipsychotics], which expose children to potentially serious adverse events.'"

More:

"A February 2002 e-mail from Georges Gharabawi, a Johnson & Johnson executive, stated that Dr. Biederman approached the company 'multiple times to propose the creation' of the center. 'The rationale of this center is to generate and disseminate data supporting the use of risperidone in' children and adolescents, the e-mail stated.

"Johnson & Johnson gave the center $700,000 in 2002 alone, documents show."

And apparently Biederman was willing to slap his name on a ginned-up study of Risperdal in kids:

"A June 2002 e-mail from Dr. Gahan Pandina, a Johnson & Johnson executive, to Dr. Biederman included a brief abstract of a study of Risperdal in children suffering disruptive behavior disorder. The study was intended to be presented at the 2002 annual meeting of the American Academy of Child & Adolescent Psychiatry, the e-mail stated.

"'We have generated a review abstract, but I must review this longer abstract before passing this along,' Dr. Pandina wrote. One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly, 'so, if you could, please give some thought to how to handle this issue if it occurs.'

"The draft abstract that Dr. Pandina included in the e-mail, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as author so the company could present the study to the conference, according to the e-mail.

"'I will review this morning,' Dr. Biederman responded, according to the documents. 'I will be happy to sign the forms if you could kindly send them to me.' The documents do not make clear whether Dr. Biederman approved the final summary of the brief abstract in similar form or asked to read the longer report on the study."

Biederman is the gift that keeps on giving. I wonder what apologists for the bipolar kids paradigm make of these revelations.

Posted by Philip Dawdy at 11:00 AM | Comments (16) del.icio.us Digg it reddit

Judith Warner Tries To Go Moderate, NIMH Head Makes Dumb Joke

Some of you may remember that earlier this year, New York Times columnist Judith Warner accused critics of slamming kids with psych meds of engaging in "narrative," which I suppose means that they were making up stories of overmedicated kids in our culture and flapping their arms about nothing. Now, it appears that Warner, in her most recent piece, is engaging in some narrative of her own, or at any rate trying to back away from her accusation that people such as myself were exaggerating what was afoot in American culture, even when folks like me were presenting actual solid evidence of what was going on such as 50 percent of antipsychotic use in kids in Florida being tied to ADHD diagnoses and all that stuff I totally made up about side effects of these meds in kids.

Warner's shift comes because last week an FDA panel of outside experts slammed the FDA and, by implication, American doctors for overusing atypical antipsychotics in kids and stating that something needed to be done about this situation.

The other day, Warner opined on "tough" kids:

"[T]hinking hard about these kids — instead of merely moralizing about them and their psychotropic drug use — may well lead to a situation in which atypical use can be greatly reduced....

"It won’t solve the problem of the drug companies’ predatory marketing practices, or of thought leaders in psychiatry renting out their minds for the sake of fancy vacations and top-flight meals. But the fact that efforts are being made, in a concerted way, to figure out what lies behind the scary-sounding statistics about drugs like Risperdal argues, I think, for hope. After a period in which drug companies have had way too much power in determining how children with psychiatric issues are treated, the pendulum may be swinging back."

Well, no shit, Judy. Welcome to the show, although calling a small blowback by a few docs hope is a bit of a stretch. Besides, I'm not sure what "hard thinking" needs to be done here. Psych meds are rough on adults, rougher on children, and strip them of their souls in many cases, as they do adults too. (Don't believe me, Judy? Go take some Zyprexa!) Diagnostic criteria is often a joke--one Warner continues by refusing to call BS on pediatric bipolar disorder, or even hint that anyone in psychiatry has--and we've gone from a culture where 20 years ago, say, kids with behavioral problems that required psychiatric intervention were few and now, a generation later, they suddenly are mentally ill, suffering from brain damage if they don't get medicated and there are millions of them.

This isn't just as a result of drug companies marketing away or a few key opinion leaders saying it's so, it's because doctors have bought into this nonsense, almost across the board. And it's because the parents of these kids have accepted their views. So while I appreciate Warner suddenly getting all concerned about the FDA panel's warning and kids with ADHD being slapped with Risperdal, she's so late to the party that the drinks have all been drunk. Interestingly, I gather than Warner has a book coming out next year on children's mental health issues, a book she wrote earlier this year. Something tells me it won't reflect her recent backing away from a feminist-says-it's-cool-to-medicate-little-boys approach to hard thinking. Can't wait to read it.

Not that Warner can get beyond her earlier prejudices in her column the other day:

"This will not satisfy the critics of today’s biological psychiatry for whom no drug use is good drug use, nor the critics of today’s culture of parenting who are sure that all the aggression, irritability and out-of-control behavior that psychiatrists call mental illness is actually nothing more than a state of 'toddlerhood in perpetuity' caused by ineffective parenting practices, as the conservative family psychologist and writer John Rosemond and his coauthor have asserted in his new book, 'The Diseasing of America’s Children.'"

Interesting.

Even more interesting, in her column Warner quotes NIMH director Thomas Insel as saying psychiatry is:

"'[T]he only field where the doctors are more stigmatized than the illness.'"

While I assume Insel was trying to be amusing, I'm not sure I can appreciate his humor. Psych docs make on average $180,000 a year, some of them far, far more than that. Psych docs have tons of power with peoples' lives and often offer them treatments that don't work very well and hurt them. Psych docs often ignore evidence in the field of problems with treatments. Meanwhile, patients are regularly denied employment, romance and the fruits of American life based upon their psychiatric diagnoses. Last time I checked that's not what psychiatrists were experiencing.

It's time for Insel to stop making dumb jokes.

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Making Sense Of "The Infinite Mind" Mess

I have corrected this post at NPR's request as I had incorrectly identified "The Infinite Mind" as being NPR-distributed when in fact it was only on NPR's Sirius channel. I've changed the description to "NPR-connected." To clarify further for readers, the show was not funded in any way by NPR, even though it is strongly associated in the public's mind with NPR by dint of the fact that it aired on some NPR-affiliated stations. I regret the error.

As many of you know, news came out on Friday that the plug had been pulled on the NPR-connected "The Infinite Mind" radio show, which reached as many as 1 million listeners a week. Controversy erupted around the show this past Spring when the show, produced by Bill Lictenstein and hosted by Fred Goodwin, who among other things authored the principal medical text on bipolar disorder with Kay Redfield Jamison, aired an episode on anti-depressants and suicide, claiming that there was no evidence of a connection between anti-depressants and suicidality much less violence of any kind. These claims, which I consider to be lies (and I called them that back in April when I was the first to report on this show's BS), were made by Goodwin and several guests, all of them with complicated ties to pharmaceutical funding, on a show that was receiving funding from pharma companies. None of these conflicts were disclosed on the show, but were made public by an article on Slate.com in May.

Matters spiraled from there and last week Sen. Charles Grassley (R-Iowa) went after Goodwin for taking pharma money and not revealing those conflicts while presenting his show as scientific and unbiased on public airwaves. Soon after, Lictenstein pulled the plug on the show, ending its long run. This led to an article in the New York Times in which Lictenstein claimed he'd asked Goodwin about conflicts and was told he had none and in which Goodwin pretty much defended his actions by claiming this is what doctors all do, plus that he took funding from all kinds of pharma companies so that canceled out his conflicts.

I'm tempted to be kind to Goodwin. I know some of his current patients and they revere him. I know one of his former patients who dislikes him intensely. John McManamy, who authors the Mcmanweb.com website on bipolar disorder and depression (which now features a prominent ad for Seroquel) and does a blog for HealthCentral.com, has written a very spirited defense of Goodwin and attacked the Times. Among other things (such as once again defending the bipolar child nonsense), McManamy offers evidence that Goodwin is openly critical of pharmaceutical companies and is suspicious of anti-depressants and overmedicating patients. News to me.

If that's the case, then I have to question Goodwin's sense of proportion. He does a show in which he is religiously defensive of anti-depressants yet criticizes them in other quarters. He's critical of pharma companies yet took $329,000 from Glaxo in 2007 for doctor talks on behalf of Lamictal, according to the Times. He reveals his pharma funding in academic papers, but won't do it on a publicly-aired radio show. Something doesn't add up here, but it sure does display how unthoughtful Goodwin has been on these matters.

Something else doesn't add up. Lictenstein claims that he didn't know of Goodwin's conflicts, but I was able to easily identify them by searching through Goodwin's published papers. It makes me wonder about his other claims.

As I noted in May:

"Here's Goodwin's financial disclosure from a 2004 paper in the Journal of Clinical Psychiatry (.pdf here) touting Lamictal:

'Dr. Goodwin has received research support from Abbott, GlaxoSmithKline, Solvay, Janssen, Pfizer, Eli Lilly, Forest, Sanofi and Bristol-Myers Squibb; has received honoraria and participated in speakers/advisory boards for Solvay, GlaxoSmithKline, Pfizer, Janssen, Eli Lilly, AstraZeneca, and Bristol-Myers Squibb; and has been a consultant for GlaxoSmithKline, Eli Lilly, Pfizer, Bristol-Myers Squibb, Solvay and Novartis.'"

What's more, Goodwin had openly helped Eli Lilly promote Zyprexa when it was approved as a maintenance med for bipolar disorder in 2004 (so much for McManamy's claim that Goodwin loves Lithium alone). I doubt that he said "It is good news that the FDA has now approved Zyprexa as a new tool for physicians to use to delay relapse and prolong periods of stability and wellness" for free. It's amazing to me that Lictenstein couldn't find the statement for himself.

In fact, I informed Lictenstein in a May 2008 email exchange that Goodwin had revealed his pharma ties in academic articles. Why he didn't do some poking around at that point is far beyond me, especially when he now says he pressed Goodwin on the matter.

But what really blows my mind is that Lictenstein did nothing to rectify the false information put forth on the "Prozac Nation" episode in March. I know that a few readers from this site wrote to him and so did I. At length, I walked him through the evidence for problems with anti-depressants and suicidality and violence. The implicit push I was making was that he should take up the issue again on his program and do it in a more nuanced manner. His replies to me were short and polite, but dismissive.

At this point, it's clear to me that either Goodwin or Lictenstein are lying about the disclosure issue. Possibly both of them are. You can make your own decision. What's more, it's clear to me that both of them don't care about having put false information into the public realm because they have issued no correction or clarification of the March program.

So while I am tempted to feel bad for both of them losing their show--and for NPR ending up with some mud on its face--nah: They are getting what they deserve.

Speaking of deserving, the Times has updated its original article to appropriately reflect that Slate.com had first reported the show's pharma ties (I added even more on Goodwin soon after). Unfortunately, the paper failed to note that a certain website was first to raise the issue of the show's misinformation on anti-depressants, an issue that is even more important than financial conflicts.

Posted by Philip Dawdy at 12:03 AM | Comments (12) del.icio.us Digg it reddit

"American Idol" Contestant OD'd On Seroquel

This story is way beyond sad in just about every sense of the word. Sandra May McIntyre, who grew up in Maine and later changed her name to Paula Goodspeed, had an obsession with singing and becoming a star and was apparently obsessed with Paula Abdul, one of the weirdo judges on "American Idol." Goodspeed, who moved to Los Angeles to follow her dream, had some issues, shall we say. She was diagnosed with bipolar disorder and an eating disorder--a very tricky psychological combination--and had her two kids taken away by the State of California.

She'd also been a contestant on "Idol" where she was trashed for being a lousy singer and wearing braces (gee, I'm guessing that nasty Simon picked up on that). Goodspeed was also obsessed with being in contact with Abdul for some reason, sent her flowers and so on.

On Nov. 11, Goodspeed was found dead in her car, which was parked near Abdul's home. According to Goodspeed's family:

"He doesn't believe Goodspeed knowingly would cause her own death. She may have been taking too much prescribed medicine -- Seroquel and Prozac -- for her body size, he said.

"'They said she OD'd on Seroquel. They said it slowed her heart right down till it stopped. They did do a blood test and that's how they found out it was an overdose.'"

Whatever anyone wants to make of someone with Goodspeed's obsessions, it sure doesn't speak highly of the allegedly safe Seroquel that someone could OD on the drug.

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Senate Probe Snares Major Bipolar Researcher, "Infinite Mind" Radio Show

Today's New York Times has news that Sen. Charles Grassley has caught yet another researcher in his conflict of interest probe. This time out, it's Fred Goodwin--perhaps the most influential researcher and writer in the world of bipolar disorder--and the well-known radio show "The Infinite Mind." As a result of these new revelations, the show is going off the air.

"Dr. Goodwin’s radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, Dr. Goodwin warned that children with bipolar disorder who are left untreated could suffer brain damage, a controversial view [Pretty much bull, as far as I know.]. 'But as we’ll be hearing today,' Dr. Goodwin reassured his audience, 'modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.'

"That very day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. Indeed, Glaxo paid Dr. Goodwin more than $329,000 that year for promoting Lamictal, records given Congressional investigators show.

"In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting activities but that neither he nor Mr. Lichtenstein thought that 'getting money from drug companies could be an issue. In retrospect, that should have been disclosed.'

"But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drug makers and that he called Dr. Goodwin earlier this year 'and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, "No."'"

"'The fact that he was out on the stump for pharmaceutical companies was not something we were aware of. It would have violated our agreements,' Mr. Lichtenstein said in an interview."

NPR is pulling the show from its satellite service next week. Lictenstein told the paper that the show is going off the air, although no notice of such a move is on the show's website at the moment.

I wouldn't pretend to know who's right about who knew what when and who disclosed what to whom--I assume all involved are honorable human beings!

Here's some more on Goodwin:

"Dr. Goodwin has authored an influential textbook on bipolar disorder and is an adjunct professor at George Washington University. In an extensive interview, Dr. Goodwin blamed a changing ethical environment for any misunderstandings between himself and Mr. Lichtenstein about his consulting arrangements.

"'More than 10 years ago when he and I got involved in this effort, it didn’t occur to me that my doing what every other expert in the field does might be considered a conflict of interest,' Dr. Goodwin said.

"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias.

"'These companies compete with each other and cancel each other out,' he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments.

"In the fine print of a study he authored in 2003, Dr. Goodwin reported consulting or speaking for nine drug makers. Mr. Grassley only asked for payment information from Glaxo. Dr. Goodwin said that in recent years Glaxo paid him more than other companies.

"He said that he has never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled 'Prozac Nation: Revisited' that he introduced by saying, 'As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.'

"That same week, Dr. Goodwin earned around $20,000 from Glaxo, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors."

The anti-depressants and suicide show in March is what started steering attention to conflicts of interest around the show. In April, I was the first media outlet to report on the show's bogus claims of no linkage between anti-depressants and suicidality. In May, first Slate.com and then I rolled out evidence that Goodwin and the show's producer had not been revealing pharma funding and conflicts of interest. Lictenstein defended the program to me and others. Soon after, Slate.com responded to Lictenstein.

I'm completely blown away that such immense conflicts of interest made their way onto a public radio show and for so many years. I'll have some more thoughts on Goodwin soon.

Sen. Grassley has his own thoughts on this whole business:

"'We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where,' Mr. Grassley said. 'Now it looks like the same thing is happening in journalism.'"

Well put, but such conflicts won't be appearing on this website, which as ever is pharma-free and reader supported.

Posted by Philip Dawdy at 08:29 AM | Comments (168) del.icio.us Digg it reddit

Three Examples Of Why The FDA Needs Fixing

Although there are likely many, many examples of lamery on the part of the FDA--this year's salmonella outbreak, for example, which it took the agency months to track down--I wanted to point readers to some recent examples of inanity at the agency which merit a thorough housecleaning by incoming President Barack Obama. Two are biggies, one is a small hassle.

1. Earlier this week, it came out that FDA scientists are accusing agency managers of engaging in "serious misconduct" in approving medical devices for sale where the devices were unsafe or ineffective. It's not clear what devices are in question, but it's so unusual for scientists to voice their concerns that you know something serious is up.

2. In late July, the FDA determined on its own that pediatric bipolar disorder was a valid diagnosis, despite much controversy within psychiatry about the alleged disorder and the fact that it's not even in the DSM. The move is one of the most bizarre I've ever seen from the agency, diagnosis by government decree. Earlier, the agency's psychiatry products chief had been involved in helping academic researchers--many with pharma funding--to design clinical trials to measure the disorder. A very weird conflict.

3. Recently, the FDA told me if wouldn't comment on whether it had or would review a questionable TV ad for the drug Abilify, an antipsychotic being marketed to consumers as an anti-depressant. I then asked an FDA press official where I could file my concerns about the ad. I was told to write one arm of the department or call an 800 number. I did both. The woman at the 800 number told me to go online and file out a form (I did). After a few days, someone at the email address wrote me to tell me they weren't the right branch of the agency, but to write a separate department altogether. When one of the agency's main press officers has no clue as to where to point the public to simply air concerns about a drug TV ad, then you've got an agency with some problems, big and small.

I hope people in the new administration are planning on making big changes at the agency such as possibly returning it to its mission as a consumer agency, not one that works for pharma companies.

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Fox News Criticizes Antipsychotics In Kids, Slams FDA Official

I happened to be watching Fox News yesterday afternoon--relax readers, I watch all the news networks--and there was reporter Douglas Kennedy, virtually the only national TV journalist to take on suicidality and anti-depressants, reporting on the recent blow up at an FDA committee hearing. That happened Tuesday, when outside researchers decried the overuse of antipsychotics in kids--especially for conditions like ADHD and alleged child bipolar disorder--and said the FDA needed to provide tougher label warnings about the use of these drugs in kids.

Sadly, I've not been able to run down a video or transcript of Kennedy's piece, but it also included comments from a lawyer in Pennsylvania who's sued J&J on behalf of kids who got messed up by Risperdal (some boys apparently developed breasts) and then Kennedy went after FDA psychiatry products chief Thomas Laughren. Kennedy accused him of, in the past, ghost-authoring studies for pharma companies and of working hand-in-hand with his "friends" at pharmaceutical companies. I wish I had the exact copy because it's certainly one of the most heated and opinionated pieces of reporting I've ever seen directed at an FDA division head (usually criticisms by name are aimed at the commissioner in charge).

I'm glad to see Kennedy going after these issues. What's interesting to me is that I have never (as in ever) seen MSNBC, NBC, CNN or CBS go after psych meds and their misuse in our culture. ABC has before. It's interesting that it's the two most conservative news networks that are while the more liberal ones are virtually silent. I don't want to conclude too much from that, but it sure does make you wonder.

If anyone stumbles across a video or transcript, let me know.

UPDATED: A reader located the video and passed it along. Thanks.

Posted by Philip Dawdy at 12:03 AM | Comments (7) del.icio.us Digg it reddit

Effexor Linked To Murder Of Arkansas Dem. Chair

Some of you may remember a horrific murder in Arkansas in August--a man stormed into the office of the state's Democratic Party and killed the party chairman, Bill Gwatney, apparently choosing him at random. Through some back channels at the time, I learned that the murderer--who was killed by police later that day--had been taking Effexor. I didn't write about the incident at the time because I wanted to wait for a final inquiry, which came out yesterday. From the AP:

"A police report said an autopsy found Effexor, an antidepressant, in [Timothy Dale] Johnson's blood. Investigators said the drug may have played a part in his 'irrational and violent behavior....'

"Johnson had first been prescribed Effexor in 2005 after complaining of anxiety and sleeplessness. He saw his doctor two months before the attack but there was no notation of any side effects from the drug."

I'll leave it at that, except to note that Effexor is well-known as causing erratic behavior in some people who take the drug.

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Electroboy Author To Write New Book, Film About Being Spokesman For Abilify?

Some of you may know of Andy Behrman, who wrote Electroboy, which was published in 2002. It's a good memoir of mania, bipolar disorder and craziness and his rough experiences undergoing ECT. A few years later, Behrman began taking Abilify and even became a paid spokesman for Bristol-Myers Squibb, the drug's maker. Then Behrman, in 2006, ran into serious problems with the drug and, somewhere in there, severed his relationship with BMS.

Since then, he's been working in Los Angeles to get Electroboy made into a movie. Yesterday, I learned that there's some interest in Behrman writing a book about his experiences as an Abilify spokesman. According to the New York Daily News, actors Brad Pitt and Matt Damon are interested in movie possibilities.

I talked to Behrman briefly yesterday, but he couldn't tell me much about his plans for the Abilify thing, as he's still under a non-disclosure agreement with BMS.

"I traveled around the country" for BMS, he said, to states like Florida and Texas. He did talks for doctors and nurses, focusing on his experiences with bipolar disorder and then-experiences with Abilify. He says he even made videos for the company. All very interesting, especially since he no longer takes the drug. The details of all of this will have to wait for the expiration of his agreement with BMS on Dec. 31.

Behrman did remind me of his experience writing for About.com about bipolar disorder. He had a few articles under his belt when, in May 2006, he wrote an article that was critical of Abilify. About.com posted the article, but then quickly took it down. I found out about this through the grapevine and asked Behrman to let me post it on my site, as a bit of a protest against his handling by About.com. Here are a couple of excerpts:

"The first disastrous side effect I noticed on Abilify was a serious bout with akathisia, a frequent and common adverse effect of treatment with antipsychotic drugs. The clarity that I first felt on Abilify had progressed to an edgy agitation which could not be quieted. I felt a terrible feeling of inner restlessness and an urge to constantly stay moving, as well as "kicking my legs around" (whether it be underneath my desk or while I was trying to fall asleep in bed). All of this eerily reminded me of the darkness of my old mania."

It got worse:

"Another horrible side effect for me were the problems that I experienced with my cognitive skills, which actually reminded me so much of my experience after electroshock therapy. One day while at lunch, I gazed blankly at a friend and could not for the life of me remember her name although I had known her for more than a couple of years. I was often confused and agitated over simple things: a misplaced piece of paper, whether I had taken my dogs out for a walk or not, and even focusing on a simple conversation. Abilify, my new "wonder drug" was failing me and I was embarrassed to tell anyone, even my wife (because we had an infant) and frighteningly, my own psychopharmacologist. What would he say? Because Abilify was relatively new, I figured it just had to work for me. But soon, after doing my own research, hearing from other people whose experiences were similar to mine as well as other mental health care professionals, and conferring with my own psychopharmacologist, it was clearly time to get off Abilify."

While Behrman may not be able to say much for his writing plans next year, I'm guessing that whatever book and, maybe, movie comes out of his experiences with Abilify and speaking on behalf of BMS won't make the pharma company very happy. But I bet it'll be a good read.

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Best Thought By A Psychiatrist Ever

OK, maybe not ever, but this from Emory University psychiatrist Goug Bremner is pretty good on the topic of educating other doctors on the use of antipsychotics in kids:

"OK, here's your education:

"Stop giving antipsychotics to kids who don't have the diagnosis of childhood schizophrenia."

That was in response to the FDA saying on Tuesday that it couldn't do much about the wild overuse of the drugs in kids--hm, maybe the agency should stop making up diagnoses for kids then--by doctors and suggesting that it was up to medical societies to educate its membership about all of this.

Of course, there are cases where the use of these drugs is justifiable, and Autism Vox points to the case of the author's own son, who was banging his head against walls:

"I really didn’t want to put Charlie on medication. And truly, it’s not the “answer” in and of itself for addressing aggressive or “problem behaviors.” Even as he wrote the first prescription for Risperdal for Charlie, our pediatric neurologist told us sternly that Charlie also had to have behavior therapy; that we had to keep his education in mind first.

"Charlie was 7 1/2 when he started taking Risperdal — since then, mostly via this post, I’ve heard of younger and younger children being prescribed Risperdal. The federal panel’s concern seems very much justified."

I'd wager that a very small percentage of kids being given these drugs are anywhere close to Charlie's situation.

Posted by Philip Dawdy at 12:01 AM | Comments (10) del.icio.us Digg it reddit

FDA Panel Slams Antipsychotic Use In Kids, Teens

As I noted on Monday, an FDA committee of outside experts was set to review the use of the atypical antipsychotic Zyprexa in teens. The meeting, according to the New York Times, turned into quite the affair with doctors denouncing safety labeling for the Lilly drug and Risperdal, a similar J&J product, "saying that far more needed to be done to discourage the medicines’ growing use in children, particularly to treat conditions for which the medicines have not been approved."

It's really heartening to hear this kind of talk from researchers on an FDA committee, since I've been making this same basic point on this site and in print for over three years (in adults and kids) and plenty of readers have attacked me as a loon. I assume they'll be warmer to the same criticism coming from researchers. Perhaps, they'll also stop calling me an anti-psychiatrist and Scientologist. Or is that what they are going to start calling members of the FDA panel?

As I've noted before, a lot of this antipsychotic use in youngsters seems to be going on with ADHD, at times a proxy diagnosis for child bipolar disorder (which doesn't exist in the DSM or insurance codes and so ends up being officially coded as ADHD).

"More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.

"But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.

"'This committee is frustrated,' said Dr. Leon Dure, a pediatric neurologist from the University of Alabama School of Medicine who was on the panel.'And we need to find a way to accommodate this concern of ours.'"

I'd suggest they start by reaching out to their peers who give kids Risperdal, Zyprexa, Seroquel, Abilify and the whole shooting gallery of antipsychotics and ask them what the hell they are thinking and to justify taking these kinds of risks with kids (or adults, for that matter). In my opinion, this isn't so much a matter of a labeling issue with the FDA (the committee wants stronger label warnings, but there's good evidence that docs ignore these), as it is a medical culture issue and a problem with our broader culture.

The problem with medical cultural is currently under investigation by the US Senate, including the roles of prominent psychiatric researchers at Harvard, Emory University, the University of Texas and the University of Cincinnati. Exhibit A when it comes to antipsychotic use in kids would be Joseph Biederman, a professor of psychiatry at Harvard and inventor of child bipolar disorder, who's been pimping for the use of these drugs in kids way beyond their approved indications for years. At the same time that he's barking for pharma companies, he's been taking NIH research money, possibly in violation of federal research rules.

Meanwhile, the FDA this summer decided to declare pediatric bipolar disorder a valid diagnosis all on its own, one of the most bizarre moves I've ever seen at that agency.

And for anyone who wants to argue that these drugs are actually OK and I am spreading misinformation about their use and how block-headed doctors are in prescribing them, read this:

"From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal."

I've also identified other deaths and serious problems with anti-psychotic use in kids and teens.

"Dr. Dure said he was concerned that doctors often failed to recognize the movement disorders, including tardive dyskinesia and dystonia, that can result from using these medicines.

"'I have a bias that extra-pyramidal side effects are being under-recognized with these agents,' Dr. Dure said.

"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects."

That's some really interesting talk from Thomas Laughren, director of the FDA's psychiatry products division, who was in charge of deciding that pediatric bipolar disorder was valid and who, as it turned out, had been working hand-in-hand with some researchers (who of course run trials for Big Pharma) to develop clincial trials for pediatric bipolar disorder several years ago, while employed at the FDA. Laughren has refused to answer questions about pediatric bipolar disorder and his role in its development and the agency has ignored repeated requests for information about Laughren's participation in the same.

As I did recently in regards to forced, involuntary ECT, if anyone wants to write something defending the use of antipsychotics in kids for non-psychotic disorders, send it to me and I'll post it.

I'll be back later this morning with some thoughts on just how screwed up things are at the FDA.

Posted by Philip Dawdy at 12:03 AM | Comments (25) del.icio.us Digg it reddit

The VA Only Offering Drugs To Iraq War Vets With PTSD

Thanks to a reader for passing along this fascinating and saddening article from Chicago about an Iraq War veteran who's wound up homeless due to PTSD and for whom the Veteran's Administration has had a classic, All-American response:

"Larson has been treated at Veterans Administration medical centers in Monterey, Calif., and Raleigh, N.C., and has sought treatment at the Jesse Brown VA Medical Center in Chicago.

"However, he claims, not a single one of these facilities has offered him the care he needs.

"'All the psychiatrist was ever there to do was to give me this prescription paper and tell me to go to the pharmacy,' he said, adding that VA psychiatrists had put him on a battery of pharmaceuticals, including Geodon, Zoloft, Zyprexa, Seroquel and Lithium, but nothing helped.

"'I didn't want pills,' he said. 'I just wanted someone to hold my hand and tell me it was going to be OK. I know it sounds weird, but I just needed to talk to someone.'

"Larson is one of a growing number of young veterans who, faced with record-high levels of depression, post-traumatic stress disorder and traumatic brain injury, are suffering invisible but often debilitating scars and, according to emerging reports, are all too often falling through the cracks of a system unable-or unwilling-to provide them with care."

I've argued before on this site that we've got to do a better job of addressing the needs of our returning vets, 20 percent or so of whom are returning with PTSD or some level of psychological distress. What's more, it's got to be a comprehensive psychological approach, not just meds, meds, meds. But that's what soldiers are getting:

"Hughes, who has met hundreds of veterans of the wars in Iraq and Afghanistan in recent years, says it is an all-too-common response.

"'They are doping people up instead of treating them,' he said.

"Brett Keen, an Afghanistan veteran and former Army reservist, echoed Hughes' criticisms. After he 'hit rock bottom,' Keen said, he went to the Elgin VA clinic and was only offered a monthly, 15-minute session with an online psychiatrist.

"'And all he wanted to do was give me drugs,' Keen said. 'He didn't want to talk about anything useful, like how's it going or are you trying to kill yourself. They just kept changing the dosage or adding new meds.'"

Sigh. There's only so much one can say about this situation, but as our nation goes around rescuing banks and, maybe, automakers and homeowners who took out insane loans, you'd think we could put some resources and effort into helping these folks out. But, then, this is America, isn't it?

Given the number of cases of vets killed or wounded all over again by some of the meds the VA is passing out for PTSD, we've simply got to do better.

Posted by Philip Dawdy at 10:53 AM | Comments (12) del.icio.us Digg it reddit

Medical Group Releases Anti-Depressant Guidelines, Admits Little Differences Between Drugs

The American College of Physicians, the big internal medicine group, yesterday released its clinical practice guidelines for the treatment of depression with anti-depressants. Non-psychiatrists prescribe about 80 percent of anti-depressants and most of those would be written by internists and GPs and family medicine docs, so these guidelines are important in that presumably a high percentage of the docs who prescribe anti-depressants might actually read them.

They are important in another regard: the guidelines assert that there is virtually no difference in efficacy among second generation anti-depressants (SSRIs, SNRIs, etc.), so in other words the differences among anti-depressants are pretty much like the differences between brands of gasoline; and, the guidelines assert that there is solid evidence for suicidality in some people taking anti-depressants, something that come as a shock to members of the American Psychiatric Association.

First, I do want to point out what I consider some omissions in the guidelines. One, while I know the title is "Using Second-Generation Anti-Depressants to Treat Depressive Disorders," there is no recommendation for psychotherapy or CBT, which is odd considering that Britain's NICE has determined that there is plenty of evidence to make CBT a first line treatment (after diet, exercise and watchful waiting). The ACP guidelines do state that the psychotherapies are effective, but leave it at that (then again, what do you expect from MDs?). But it is 2008 now, not 1993.

There is also no discussion whatsoever in the guidelines of withdrawal or how to get patients off of anti-depressants. That's an interesting omission considering that the ACP guidelines do not call for lifetime treatment of depression with anti-depressants. More on that in a bit.

As to anti-depressant efficacy, the guidelines state:

"The results of individual studies showed no significant differences between SSRIs or between SSRIs and SNRIs, SSNRIs, or other second-generation antidepressants. Some evidence from meta-analyses showed statistically significant differences between treatments; however, the effect sizes were small and the results were probably not clinically significant."

After two decades of companies trying to carve out comparative advantages for their anti-depressants, that's a stunning bit of news.

"Studies evaluating the risk for suicidality (suicidal thinking or behavior) in patients showed no differences among second-generation antidepressants (90–94). However, 1 meta-analysis showed that although no evidence indicated an increase in the risk for suicide with SSRIs (odds ratio, 0.85 [CI, 0.20 to 3.40]), the risk for nonfatal suicide attempts did increase (odds ratio, 1.57 [CI, 0.99 to 2.55]) (91). Another meta-analysis of published data (95) showed similar results, with SSRIs associated with an increased risk for suicide attempts compared with placebo (odds ratio, 2.25 [CI, 3.3 to 4.6])."

So there you have it: a fairly learned group of doctors has determined that, based upon the scientific evidence available to them, anti-depressants can cause suicidality. Someone ought to alert the producer of "The Infinite Mind" radio show, after this year's show where several docs claimed there is no evidence for suicidality.

Feel free to review the guidelines yourself and see what they say about other problems associated with anti-depressant use. I'm sure some readers, who I know truly hate anti-depressants, will find their assessments incomplete, but it's fairly honest document, as these sorts of things go.

As far as how long doctors should treat a patient with anti-depressants, the guidelines state:

"Patients who achieve remission with acute-phase treatment should continue receiving antidepressant therapy for 4 to 9 months to prevent relapse. No evidence indicates differences among second-generation antidepressants in preventing relapse (loss of response during continuation-phase treatment) or recurrence (loss of response during maintenance-phase treatment). Patients who have had 2 or more episodes may benefit from a longer duration of therapy (years to lifelong)."

While I appreciate that the guidelines do leave open the possibility of lifetime treatment with anti-depressants, it's clear to me that this isn't the emphasis. That's a huge change from generally-accepted principles circa-1995. It's not perfect, but it's sure better.

What puzzles me, however, is that since the ACP guidelines admit that patients will want to go off anti-depressants and that that would be clinically desirable, there is no discussion or advice whatsoever relating to how to get patients off anti-depressants.

I wonder why.

Posted by Philip Dawdy at 12:03 AM | Comments (5) del.icio.us Digg it reddit

The Almost Useless FDA Refuses To Comment On Antipsychotic Being Advertised As Anti-Depressant

Most of you are aware that for the last few weeks I've been noting the presence of the Abilify for depression TV ad, which has been running late nights. Abilify is an atypical antipsychotic, carries black box warnings for all manner of problems associated with that class of drugs, and yet nowhere in the ad is it mentioned that the drug is an antipsychotic. Instead, throughout the ad it's only referred to as an anti-depressant.

Last week, I asked the FDA if the agency had reviewed the ad or if it had plans to. The reply I got this morning from Sandy Walsh (who I know is doing her job within institutional constraints), the agency's spokeswoman for psychiatry products, speaks volumes about just how useless the FDA has become and how it clearly represents the needs of industry but not of consumers:

"We don't comment publicly about currently running ads, so there's nothing we can say specifically about Abilify's TV ads.

"Generally, individual ads for prescription drugs are not required to include information about all of a drug's indications, but may instead be limited to promotion of one of the drug's approved indications.

"And, generally, if the FDA were reviewing an ad and the agency is going to take action against a company for a certain advertisement, we would not be able to discuss that publicly until after the agency took an action.

"For more information on the regulation of prescription drug advertisements, please see our DDMAC web site at http://www.fda.gov/cder/ddmac/faqs.htm

"For information about warning letters that have been issued to companies about their ads, please see our Warning Letters site at http://www.fda.gov/cder/warn/warn2008.htm"

It's not clear to me if the agency's no comment is a result of federal law or of agency policy. Walsh hasn't answered my question on that point nor did she or anyone at the agency address the sticky issue of an antipsychotic being marketed as an anti-depressant. So how is the public to tell the difference between an Abilify TV ad and a Cymbalta TV ad? Surely, the FDA ought to be concerned about that, especially since the approval trials for Abilify as an add-on treatment for depression make it clear that the drug causes akathisia in about 25 percent of patients.

I asked Walsh where readers could direct their concerns about the Abilify for depression ad. You can direct whatever comments you wish to make to:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Information
5600 Fishers Lane, HFD-240
Rockville, MD 20857
Telephone number: (301) 827-4573 or 1-888-INFOFDA (463-6332).
E-mail address: druginfo@fda.hhs.gov

At a minimum, the agency should review this ad, which I consider to be highly deceptive. The reality is that antipsychotics are not anti-depressants, pure and simple.

UPDATE: If you call the above number/s, the nice person on the other end will ask you to fill out a Med Watch report. You can do that at www.fda.gov/medwatch and press on "begin." You don't need to include patient information or date of event since you are complaining about a TV ad. Or you can just send email to the above email address.

Seems like a rather complex system for the public to report concerns about a TV ad.

Posted by Philip Dawdy at 11:33 AM | Comments (14) del.icio.us Digg it reddit

FDA Finds Zyprexa Has Killed 3,400 People, Worse Than Vioxx

I was reviewing an FDA staff document this morning, wherein FDA staffers recommend additional warnings for Zyprexa for pediatric cases (ie, teens) and ran across a startling statistic. According to the agency's own adverse events database summarized in the report, the controversial atypical antipsychotic has killed 3,455 people (see page 7 of the above document) between 1997 and early 2008.

Roughly half of the deaths are known to have occurred in the US while the remainder are from unidentified locations (likely a mix of US and foreign deaths).

What startles me is that last fall I reported on a study of the FDA's adverse events database in which researchers reported that Zyprexa had killed 1,005 people from 1998 to 2005, so this new accounting represents a large increase in deaths associated with the drug. Even more, according to that same study, Vioxx had killed 932 people. So why do Vioxx cases get all the media attention while Zyprexa does not? Why is Zyprexa still on the market and raking in $4 billion or so a year in sales while Vioxx is off the market?

Why on earth has this drug been marketed for casual use far beyond its initial use as an antipsychotic?

As of now, Zyprexa is not approved for use in children and teens, but Eli Lilly has an application before the FDA to gain approval for its use in teens diagnosed with schizophrenia. Amazingly, one published study of Zyprexa in teens found that in a three-week trial of the drug patients gained an average of eight pounds, which is a lot for such a short time period. That's why the FDA staff in the above document is recommending additional warnings about weight gain in pediatric populations.

(Via Pharmalot.)

Posted by Philip Dawdy at 09:51 AM | Comments (12) del.icio.us Digg it reddit

Minnesota Man Gets Reprieve From Involuntary ECT

From MindFreedom I learned yesterday that Ray Sandford, whom I wrote about last week, has been given a one-week reprieve from the forced, involuntary ECT treatments he's had to endure in recent months. The bad news is that he's scheduled for another go-round next Wednesday, the day before Thanksgiving.

Nice touch.

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DSM-V Criticized In LA Times Op-Ed For Lack Of Transparency

Christopher Lane, a professor of English at Northwestern University and author of last year's "Shyness: How Normal Behavior Became a Sickness," had an excellent op-ed in yesterday's Los Angeles Times, flagging for the public just how contentious matters have become around the development of DSM-V.

"The bone of contention: whether the next revision of America's psychiatric bible, the "Diagnostic and Statistical Manual of Mental Disorders," should be done openly and transparently so mental health professionals and the public could follow along, or whether the debates should be held in secret."

DSM-IV, which came out in 1994, was rife with researchers flush with pharma funding devising new psychiatric disorders, none more prominent than bipolar disorder type 2, introduced in that edition of psychiatry's so-called Bible. DSM-V is due in 2012 or 2011 (depending on which account one is reading at what time) and it's now come out that Robert Spitzer, a professor of psychiatry at Columbia University, is hopping mad about what he characterizes as a closed door around the creation of DSM-V. It's already been reported that DSM-V's creators have deep ties to Lord Pharma.

When someone like Spitzer gets riled-up about the DSM, then you know something goofy is going on. Spitzer was the main creator of 1980's DSM-III, which introduced the concept of disorders to mental illness and tried to cast the whole thing as science-based, and has remained influential in the psych establishment ever since.

As it turns out the current DSM writing crew is refusing to let Spitzer have a look-see at their deliberations and minutes. Perhaps that's because word is the APA-assembled crew is considering some wacky new disorders to become fully enfranchised as mental illnesses. As Lane notes:

"Hanging in the balance is whether, four years from now, a set of questionable behaviors with names such as "Apathy Disorder," "Parental Alienation Syndrome," "Premenstrual Dysphoric Disorder," "Compulsive Buying Disorder," "Internet Addiction" and "Relational Disorder" will be considered full-fledged psychiatric illnesses....

"Behind the dispute about transparency is the question of whether the vague, open-ended terms being discussed even come close to describing real psychiatric disorders. To large numbers of experts, apathy, compulsive shopping and parental alienation are symptoms of psychological conflict rather than full-scale mental illnesses in their own right. Also, because so many participants in the process of defining new disorders have ties to pharmaceutical companies, some critics argue that the addition of new disorders to the manual is little more than a pretext for prescribing profitable drugs."

Those are some very odd disorders indeed and sure are consistent with a push I've seen in other quarters of psych research to have 50 percent of Americans diagnosed with some form or other of mental illness--at which point the term abnormal psychology will have lost all meaning.

I'm pleased Lane flagged this squabble within the academy because as goes the DSM so goes psychiatry, courts, social work and education the world over. What's going on with the new DSM deserves much more media attention then it's gotten to date, but unfortunately with 5,000 or so journalists in the US having been laid off in the last few months there may not be anyone around to bird dog the process in the press. That'd kind of suck because it sounds like it's going to be a grand show.

Like Lane, I'm not interested in embarrassing anyone, but apathy disorder? Really? Once that's defined, "treated" and "cured," where will the world look for a source of literature and popular music? What's the need to have one and all in line with the mainstream social order and all hyper-effecient at work? Strikes me as a boring arrangement.

One small nit I have with Lane's op-ed--and this is really more addendum than nit--is that he didn't mention that bipolar disorder is once again going to be on center stage in debates around the new DSM. Serious consideration is being given to including a new bipolar disorder type 3 or subthreshold bipolar disorder. Also up for inclusion is child bipolar disorder, which is a very controversial diagnosis. This summer, you may recall, the FDA went off on its own and declared pediatric bipolar disorder a valid diagnosis, and then offered a very sloppy set of consensus statements by researchers to support its conclusion. What's more, the FDA's chief of psychiatry products had been intimately involved in helping researchers and pharma companies design the diagnosis--and that's the kind of conflict of interest that no one should support.

It will be interesting to see where the APA takes concerns like Spitzer and Lane's (and mine and yours). You can read the original exchange of letters between Spitzer and APA President Nana Stotland--who incidentally doesn't believe that anti-depressants can induce suicidality--here and here.

I interviewed Lane about his book last year.

Posted by Philip Dawdy at 12:03 AM | Comments (13) del.icio.us Digg it reddit