June 09, 2008

Senate Probe Snares Harvard ADHD, Bipolar Child Researchers' Pharma Payouts

Some of you are aware that yesterday the New York Times had a front page article detailing multi million dollar payouts from pharmaceutical companies to Joe Biederman, Timothy Wilens and another Harvard/Massachusetts General psychiatrist. These researchers are the chief proponents of the bipolar child paradigm and the leading researchers of ADHD in children. Their influence on child psychiatry in the US and elsewhere has been vast over the past 15 years and has resulted in millions of children being diagnosed with mental disorders and placed on aggressive medication protocols, a social experiment without parallel in American history. This is the same group of researchers who last week declared that teens who smoke and drink should be screened for bipolar disorder.

Vast too has been the amount of money they've been paid by pharma companies, which they have apparently underreported to both Harvard and a Senate committee looking into all manner of tangled relationships between pharmaceutical companies and academic researchers. They may well have violated university reporting requirements and NIH research regulations, according to the Times, and that could place future research grants at risk for the university. The paper also indicates that the university and NIH are investigating the researchers.

What's stunning to me is just how much money these researchers were pulling in.

Biederman: $1.6 million from 2000 to 2007

Wilens: $1.6 million from 2000 to 2007

Thomas Spencer: $1 million from 2000 to 2007.

The paper notes that these figures may understate how much these researchers pulled in from Big Pharma because, in some cases, the companies reported to the Senate committee that they'd actually paid them more.

"In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked to check again, he said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.

"The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

"In an e-mailed statement, Dr. Biederman said, 'My interests are solely in the advancement of medical treatment through rigorous and objective study,'and he said he took conflict-of-interest policies 'very seriously.' Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules."

It's entirely possible that they have complied with conflict rules because of how complex all of the various accounting systems are. But one has to wonder why they were so wildly understating their earnings and what should be done about this sort of thing. Sen. Chuck Grassley (R-Iowa) has his own thoughts:

"Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world."

No matter what the outcome, this is a huge blow against Biederman who has done much to popularize the alleged child bipolar disorder among fellow psychiatrists. Since I first started challenging the disorder in November 2006, I've been criticized by defenders of the disorder for being, in effect, a mental illness denier. In truth, I've never questioned that these kids who wind up being diagnosed with child bipolar disorder are distressed and that something untoward is going on. But distress doesn't prove bipolar disorder, which classically requires the presence of manic features. From the Times, we learn how some kids were being classed as having manic episodes:

"The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale — well below the 50 percent change that most researchers now use as the standard."

That's simply outrageous and one has to wonder what Biederman's motivation was to upend mania measures to make a drug look good when it wasn't. Even Fuller Torrey, an infamous psych researcher himself, recognizes that this puts a huge black eye on the field of psychiatry:

"'The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,' said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. 'In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.'"

I agree with Torrey. The industry money needs to be out of this kind of research.

Meanwhile, the Biederman group continues to pound away on doing clinical trials of bipolar disorder and ADHD in children. Here's his rundown from clincialtrials.gov and Wilens'.

I've written much in the past about Biederman and the alleged bipolar disorder. It's an ongoing point of controversy in medicine and it'll be interesting to see where these recent revelations steer things.

Posted by Philip Dawdy at June 9, 2008 12:03 AM
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Comments

that is exactly the point that needs to be made over and over again by responsible physicians: Behavior like this need to be condemned and refuted so it does not give any appearance this is the standard of operations by all psychiatrists. I really hope by this story running in the NY Times gives it more ammunition to pursue further.

Keep up the good work, FS. I sent you a check yesterday, and you keep doing this reporting, I guarantee funds quarterly.

Anyone who is invested in these issues should pay something to help this gentleman, even if it is $5. Everyone expects a free ride. Well, there are "fuel" costs for the internet too. By definition, an investment means you have to pay something to get a benefit, even if the expense is time and energy. Sort of goes along with what I preach to patients.

Posted by: therapyfirst at June 9, 2008 08:17 AM

http://www.hms.harvard.edu/integrity/conf.html

Instances of deliberate breach of policy, including failure to file or knowingly filing an incomplete, erroneous, or misleading disclosure form, violations of the guidelines or failure to comply with prescribed monitoring procedures, will be adjudicated in accordance with applicable disciplinary policies and procedures of the Faculty of Medicine and of the affiliated hospitals. Possible sanctions will include the following:
1. Formal admonition;
2. The inclusion in the Faculty Member's file of a letter from the Office of the Dean indicating that the individual's good standing as a member of the Faculty has been called into question;
3. Ineligibility of the Faculty Member for grant applications, Institutional Review Board (IRB) approval, or supervision of graduate students;
4. Non-renewal of appointment;
5. Dismissal from the Faculty of Medicine.

Posted by: AuK at June 9, 2008 09:23 AM

As the mother of two diagnosed with bipolar at age 17 (the average age of onset for this illness), and as an active mental health writer, speaker and advocate, I, too, agree with Torrey. When financial gain of this magnitude drives research, credibility is ultimately questioned. For the sake of my children and the 17 million Americans like them, I want medical advances more than most; and I want those advances to be right and true, not skewed toward one pharmaceutical solution.
Ethics.
Integrity.
Commitment.
VITAL!
www.katemclaughlin.net

Posted by: Kate McLaughlin at June 9, 2008 09:54 AM

Kate, it's been skewed longer than this,and about more than this too. Ghost written articles,withheld data (for example Paxil&Zyprexa)the list goes on and on where integrity has been lost in the scientific world, and gained hold of by pharma. NAMI also is funded by pharma, and the sutble influence to medicate, medicate, medicate is based on a paradigm of treatment based out of Harvard's crew. It's all questionable now; even the criteria for bipolar in a 17 year old was based on adult criteria and medications approved for age 18 and older, --only until recently have some of those medications been FDA approved for use in children, and yet the data has no long term studies to prove they are efficacious vs.risk long term.

In my opinion, this exposing of the millions of dollars here is a slap in the face to all Americans, and innocent children have been harmed by this group--based on their influential status they've created themselves.

Torrey finally said something worth quoting here today, but let's not forget he believes in forced treatment, and that all Schizophrenics are violent. He represents his own base of evil, the same as Biederman does.

Posted by: Stephany at June 9, 2008 12:51 PM

Kate, you mentioned 'not one pharmaceutical solution'.

I agree, and what needs to happen is medication needs to go back to an origin of 'last resort' use, most especially with children, because there are far too many different types of therapy one can try, before drugs in my opinion.

This is just my opinion, but NAMI doesn't go that route. Housing offered by them is always on a contract offered to the client to remain on medications. That's what I mean by the using the word 'subtle'.

It's an influence the same as Harvard, TAC, (Fuller Torrey, and yes I've heard him speak in person and he called himself 'delusional' so many times in his lecture it was ridiculous).

The sincere wishes and hard efforts of/from ppl who work for NAMI are not to be underestimated; I've seen their work first hand, and they truly care.

But, where I draw the line based on personal experience, is when I saw an older woman sew curtains for a home, give her loving care to ones (like my daughter)to have a place to live, independently.The woman is a kind and caring individual, and knows Fuller Torrey.

BUT, the fine print was, an application has to be filled out by the client, and the very fine print was an agreement to remain on medications to live in the home.

There are many aspects to this entire paradigm,and this Harvard scandal is the core of it's beginning--the Childhood Bipolar Disorder dx that has grown out of control, and now has filtered down to toddlers being medicated as a result.

When one understands how, who and what influenced and created this paradigm/diagnoses explosion, one can only want what I do: accountability, honesty, integrity, truth and high moral standards--in other words--take the Oath seriously or don't take the job.

Posted by: Stephany at June 9, 2008 04:49 PM

"Torrey finally said something worth quoting here today, but let's not forget he believes in forced treatment, and that all Schizophrenics are violent. He represents his own base of evil, the same as Biederman does."

Stephany, I detest Torrey too but I agree with you that he said something valuable here. But, you're right, it's important to keep in mind that he's the principal spokesman for forced drugging. He promotes this for bipolars, too, not just schizophrenics. The man's an odious turd.

Posted by: Francesca Allan at June 9, 2008 05:55 PM

This from Bloomberg.com yesterday:

"Biederman is currently recruiting 4- to 6-year-olds with bipolar disorder to test London-based AstraZeneca Plc's Seroquel, and 6- to 12-year-olds with the condition to test Equetro, developed by U.K.-based Shire Ltd., according to a U.S.-run registry of clinical trials."

The man should be put in jail.

Posted by: johnd at June 9, 2008 09:44 PM

http://www.cafepress.com/efullertorrey

Did someone say something about Torrey?
=)

Posted by: The man's odious at June 10, 2008 12:17 AM

Dear The man's odious,

I'm having trouble deciding between the E Fuller Torrey is an Odious Turd Hoodie, cap, and/or coffee mug. Of course as one of the labeled, my income is limited so I can't just get all three. Wow and now I see the doggie t. I hope someone is making a good living selling this stuff.

Posted by: Sally at June 10, 2008 03:58 AM

What an embarassing mess this is. Dr Carlat is bizarrely charitable on his blog, I think: this looks like full-on corruption, to me.

I have no idea which "clubs" Biederman belongs to, but I strongly suspect nothing whatsoever will happen, and Reamed Nib (anagram), will continue to be paid large sums of money to trial drugs that we already know don't benefit anybody, aside from those who manufactured and promoted them. Beaned Rim (anagram), will continue to "write" 30 papers a year, and will continue to be lauded by those who have an interest in pretending that Bared Mine (anagram), has even the first idea about the thing that he's supposed to be expert in.

Matt

Posted by: Matthew Holford at June 10, 2008 03:30 PM

CABF and others that proudly receive funding from many of the big Pharma companies need to come up with another source of funding if the appearance of impropriaty is to be avoided. Melissa DelBello, Joe Biederman, timothy Wilens, Keller, are just the tip of the iceberg. Their research is flawed, their statistics are horrible and they hedge their findings to make things look far better than they are. The way they do research, one could prove that peanut butter and jelly is better than placebo for the treatment of bipolar disorder.

Posted by: William at June 14, 2008 04:04 PM

When will we as a culture begin holding parents responsible for their quality of interaction with their children? I DO NOT mean blaming parents. Parents are a product of our culture and are a reflection of that culture. I do mean that we need to ask parents to become aware of their interactions, to become conscious of their reactions to their children's behavior and see that in so many cases, their children's behavior should not be medicated but be listened to. In all of the blogs i have read about the Biederman scandel, so little has been said about parents' taking responsibility for their behavior and what messages it sends to their children who do not know what to do with it. Their only option is to react in anger and sometimes in rage and hostility when they cannot absorb the shame they feel. I am a parenting specialist (connectiveparenting.com)and have spent my career in empathy for parents responses to their children. In wanting the best, we can unintentionally teach children the worst to which the children must react to. Taking responsibility for the interaction and learning how to communicate with these very strong willed, often angry, children can eliminate a large percentage of bipolar and even ADHD diagnoses.

Posted by: Bonnie Harris at July 6, 2008 02:50 PM
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