Harvard Docs Disciplined For Conflicts Of Interest
40 CommentsBy Ed Silverman // July 2nd, 2011 // 9:03 am
Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.
In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”
And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).
The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.
The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.
For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).
And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.
At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).
But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”
“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”
How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.
“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).
pic thx to jerome kassirer
Discover and Recover
Ed,
As you know, our son got caught up in the ‘Bipolar Juggernaut’ (article in Bloomberg that you posted on Pharmalot).
It was nice to read the news about Joseph Biederman, M.D. The reprimand could not have happened to a nicer guy!
The question in my mind is how could so many shrinks have fallen for the work of this Bozo?
And, what a Bozo is Biederman!
An “illness”that has traditionally had an onset of first symptoms in the late teen or early twenties… suddely appearing in people much younger…. And the NIMH doesn\’t walk away from this stuff either… “Bipolar Disorder” a supposedly ‘genetic’ disorder… suddenly goes from 1 to 1.5 percent of the population to
3 or 4 percent of the population…. A question for the brilliant folks at NIMH: “How?”
Some of us were born at night.
But we weren’t born ‘last’ night.
A note to parents:
When is it a good idea to turn the keys to your child’s brain over to a psychiatrist?
Never!
Thank you for your blog, Ed
Duane Sherry, M.S.
discoverandrecover.wordpress.com
Discover and Recover
Another quick-note to parents:
Our son was placed on an antidpressant (paxil) which induced the “manic episode” months later.
Robert Whitaker, author of ‘Anatomy of an Epidemic’, addresses this reaction to antidepressants…. which is quite common, both in children and adults, and can often be the root cause of a false ‘bipolar disorder’ diagnosis.
My best,
Duane
gia
Duane, was it a \"shrink\" who put your son on Paxil initially, or was it the pediatrician? The Bloomberg article was a bit confusing. Thanks.
original industry insider
Biederman is on the pharma payroll, thus eligible for deferred compansation. He will cash in next year.
Discover and Recover
It was an MD who specialized in digestive health.
His diagnosis was ‘irritable bowel syndrome’.
Apparently, Paxil (like so many others) is used regularly off-label, for children; also off-label for other conditions (in this case irritable bowel).
The psychiatrist, Arnold Mech, M.D. is under watch by the Texas State Medical Board for some issues.
IMO, he (like many other child psychiatrists) ought to be charged criminally for what he’s doing. As Ed has pointed out on this blog, there is a massive over-drugging of children in this country.
Zombies.
These shrinks are turning young kids into zombies.
Duane
gia
Duane, now I’m even more confused. Why are you angry at psychiatrists, and not with the digestive health specialist? Was he a gastro-enterologist? I’ve just never heard of Paxil being used for IBS.
SteveM
oii has it right, Biederman will still get his bucks via a back door work-around.
And if he doesn’t like the MGH restrictions, Biederman can always bail to another university like Charlie Nemeroff. I.e. get all fat and happy with a new department chairmanship and a clean slate. “Scandal!? What scandal!?”
BTW, you know what kind of professional sanction Biederman will receive from his psychiatrist pals? None, Zero, Nada, Zilch.
Like Nemeroff, Biederman will continue to be a featured speaker at conferences and politely applauded. When in fact, any psychiatrist with integrity would get up and walk out when those guys get up to speak. Never gonna happen.
Psychiatry is messed up multi-dimensionally.
Justice in MI
“We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones.”
LOL
Elliot Spitzer could not have said it better.
Bernard Carroll
@ Steve M: Since you bring up the subject of Nemeroff, he did receive a sanction from one of the major professional organizations. This happened in late 2009, in the wake of the Grassley inquiries and Nemeroff’s demise at Emory. Nemeroff was banned from involvement in committees and programs for 2 years. But then, as I heard it, the members were instructed that nobody was allowed to talk about it, so to the outside world it’s like it never happened. Completely bizarre! But that’s what you get when you want to appear ethical and you want to help your crony at the same time. I have to assume that Pascal Goldschmidt at Miami wasn’t informed about these adverse proceedings until he had already hired Nemeroff. That would make two strikes against transparency.
At least MGH and Harvard went public with their sanction against Biederman.
headshrinker
This is merely a slap on the wrist for Biederman, and I don’t buy his explanation. He grossly underestimated his income from Big Pharma before the Senate Finance Committee and I hope Senator Grassley is not done with him yet. The arrogance and/or idiocy of that gaff per se is impossible to sugar coat in an insincere apology. If Psychiatry doesn’t do a better job policing itself of such charlotans, we will be finished soon. When all the damage is said and done from the childhood bipolar myth, for which Biederman can almost singlehandedly take the blame, we made be done regardless of what corrective action the profession takes to dissociate itself from esteemed academic leadership.
SteveM
Dr. Carroll,
Thanks for the update on Nemeroff. But he was a featured speaker at the Georgia Psychiatric Physicians Association CME meeting last August. Probably got a “Standing O” when he sashayed up to podium.
Apart from Charlie’s wet-noodle sanctions, I’m sure it was just like old times with the Georgia boys at the Ponte Vedra Inn & Club …
P.S. I don’t know who Pascal Goldschmidt is, but if he wasn’t aware of Nemeroff’s shenanigan before he hired him, he may be a candidate for whatever psychotropics are used to treat delusions.
Discover and Recover
The anger for the psychiatrist comes from the subjective guesswork on his part… His quick diagnosis (based on nothing scientific), and his placing our son on a cocktail of drugs.
The other part is what I’ve learned in the past 5 years, about how often this is done, and how psychiatrists rarely look for underlying physical and/or emotional root causes… Their diagnoses are based upon nothing.
And the psychiatric labels and drugs cause enormous injury to children, youth, families. None of it is necessary… The drugs do nothing to ‘cure chemical imbalance’, in fact, their long-term use ’causes chemical imbalance.’
‘Compliance’ is part of the psychiatric protocol… “A diabetic needs insulun” is one of their favorite lines… Again, based on nothing!
IMO, recovery takes place when a person rejects the lables, slowly tapers off the drugs (see Peter Breggin’s, ‘Your Drug May Be Your Problem: How and Whay to Stop Taking Psychiatric Medication); and begins to find the things (tools) needed to address underlying conditions that are at the root of pscyhiatric symptoms.
Disclaimer -
http://discoverandrecover.wordpress.com/warning
Duane
My Oh My
What frightens me is, these are physicians that pretend to know a lot about mental problems. All they have to do is, read a couple impressive experts books and voila, an overnight sage. It\’s got to be the easiest specialty, as it\’s just \"guess work\"!
For a psychiatrist to say they don\’t know what the rules are, I wonder how much they know about taking the time to make a well thought out diagnosis and some deep thinking as to the future effects. Quack, quack, quack !
John M. Nardo MD
Great coverage. And good for Harvard - it’s a start…
Evelyn Pringle
Hey Doctor Carroll - give it up.
Which group sanctioned Nemeroff? Don’t throw something like that out there and not tell me who. How am I supposed to sleep when I’ll be wondering about that all night. LOL.
Bernard Carroll
Um, all I can say is that I can’t say it wasn’t ACNP. LOL.
cliffintokyo
Overdue house cleaning by Harvard U and MGH.
Biederman et al were obviously in denial, over confident that the boys will protect them, living in the past, and a disgrace to a bygone era of trust in the ethics of professionals.
Whatever happened to ‘first do no harm’?
child psychiatrist
There is more child psychiatrists than just Biederman to take the blame for the disastrous false epidemic of pediatric bipolar disorder. But speaking as a child psychiatrist (not from USA) most of my colleagues are appalled by the PBD phenomenon and have never seen a true case of mania under about age 14 (though extremely rare younger cases probably do exist but you’d be unlikely to see one in a full career).
The journals have to take some of the blame for publishing so much of the research without more vigorous peer review and without allowing for the widespread dissenting views of many clinicians who never bought into it.
susan
Happy Happy Joy Joy.
It’s a start. Happy 4th Ed and readers
SteveM
Re: Dr. Nardo “And good for Harvard - it’s a start…”
Dr. Nardo, here’s a contiguous, well articulated set of entries that provide a nice integration of J&J’s PBD market gaming with Biederman’s analytical oiliness:
http://1boringoldman.com/
Bierderman is the Charley Rangel of Psychiatry. I.e. he gets an administrative love tab in spite of egregious professional malfeasance and then it’s business as usual.
Biederman still holding his position at Harvard is a disgrace. Psychiatry tolerating the Biedermans in its mist, even more so.
original industry insider
Agree with child psychiatrist on overdiagnosis of PBD. Kids are being labeled with DSM diagnoses these days to the extend that inn the US one in five matriculating college freshman meet DMS criteria for a diagnosable disorder. University clinical psychologists are overwhelmed, and their job has turned into referrals to outside psychiatrists.
In terms of underdiagnosis, perhaps because of the abdication of parental authority I see a vast increase in what you might label as conduct disorder. However, psychiatrists are reluctant to make the diagnosis for fear labeling children as nascent sociopaths, such as the kids who spent years planning the murdera at Columbine HS.
Lana Keeton
The entire health industry is no longer about wellness. It is a business pure and simple.
The entire focus is how to increase sales by selling adult meds to children…particularly, maintenance meds.
Ray Moynihan labeled it beautifully,”Disease Mongering”…selling sickness to the worried well. This is the reason the cost of “healthcare” is 1/6 (or more) of the nation’s economy.
Psychiatry is certainly not the only specialty with corrupt doctors pushing unnecessary meds and/or medical devices. Thousands are harmed daily by unnecessary “healthcare”.
Sam
Harvard finally buckled under pressure and negative publicity and did act. Yes, a tap on the wrist, but better than nothing for this arrogant little man.
Let’s hope that psychiatry starts to belly up to the bar, and show some honesty in the face of glaring evidence about the phenomenon of pediatric bipolar. The same flipping into mania caused by antidepressant use happens in adults as well as children (see Grace Jackson’s “Rethinking Psychiatric Medication”).
The refreshing news is in Whitaker’s “Anatomy of an Epidemic”. Though it is crammed full of real evidence of the abject and broad failure of the psychopharmacological abuse raining down on so many American heads, it also contains the future, as described in its chapter “Blueprints for Reform”. The real ethical and thoughtful psychiatrists, and there are a few out there, are learning (though not in medical school) that an individual approach to each person, and quite often minimal, short-term, or no drug use, can have the best outcome for both children and adults.
Let’s hope it’s widely read and taken to heart - the sooner the better.
D Bunker
GIA;
You\’ve never heard of Paxil used for IBS?
My Mom took her Cat to the Vet: who promptly poisoned the animal with the Tricyclic Amytriptiline under a diagnosis of IBS.
The cat circled Pluto for 3 days, terrified of its own shadow, and upon detox returned to just being a cat. There\’s No End of the idiot excuses used to sell psych drugs, even at the Vets.
Evelyn Pringle
Hey Doc Carroll
Nemeroff is so lucky to have a discreet pal like you.
What the hell good does it do to sanction someone secretly?
By now, I’m convinced that most of these organizations can’t dare come out publicly against any of these crooked quacks because if truth be known their leaders are guilty of the same misdeeds.
Doc
It is my understanding that Barney Carroll and his sidekick Robert Rubin were sanctioned (also secretly) a few years ago by the American College of Neuropsychopharmacology (ACNP), arguably the most prestigious professional organization in psychiatry. Perhaps, in the spirit of full disclosure, Carroll would like to admit or deny this.
Bernard Carroll
Doc, it’s no secret at all. Under the presidency of Kenneth Davis, the ACNP leadership went out of their way to leak this information to the attorney for Alan Schatzberg’s company, Corcept Therapeutics. Corcept wanted to block publication of an exposé of Schatzberg’s junk science by the journalist Paul Jacobs. All of this information has been in the public domain since PJ’s article appeared July 9-10, 2006 in the San Jose Mercury News.
Rubin and I were privately admonished for alleged personal attacks on Schatzberg and Nemeroff. The alleged personal attacks consisted in our pointing out their pitifully weak science regarding Corcept’s drug in juxtaposition to their (often undeclared) conflicts of interest. Schatzberg had a hissy fit and brought an ethics charge against us. The ethics committee process under chairman David Rubinow and ACNP president Dan Weinberger was deeply flawed.
In contrast, the sanction of Nemeroff by ACNP was unprecedented in its severity, but ACNP still kept the lid on it. You will have to ask them why. The complaint that Dr. Rubin and I filed against Dr. Nemeroff that led to his sanction in 2009 essentially stated that his institution (Emory University) determined he had violated the letter and the spirit of NIH regulations concerning conflict of interest, and that Dr. Nemeroff’s behavior, which resulted in widely publicized institutional and NIH sanctions, injured the reputation and dignity of the entire field of academic clinical research, which includes ACNP.
By the way, Dr. Rubin is not my sidekick. We are equal opportunity critics of corruption in academic psychiatry. There is no shortage of deserving targets nowadays. What about you, Doc? You come across like an ACNP insider. You wouldn’t be Carol Tamminga would you – one of the people who appointed Nemeroff editor of the ACNP journal?
John M. Nardo MD
This thread is iterating around a central point that ought to be stated explicitly. It’s time for the illusionists to either come clean or be exposed. Dr. Biederman’s story has it all - conflict of interest, unreported personal income, ghost-writing, inappropriate outside influence, arrogance, etc - in short corrupt science. We’re all aware that it’s the real epidemic - corrupt science.
Organizations that try to cover it up are becoming as vulnerable as the perpetrators. If the ACNP is protecting it’s members from appropriate scrutiny, sooner or later the college itself will make the same kind of headlines Biederman is now enjoying.
Some of us would’ve liked to see Harvard fire these Doctors, but we can at least be pleased that they publicly censured their behavior, and that they revised the university policies. If the scientific organizations can’t feel the wind changing, they’re not paying attention…
gia
D Bunker,
You’re kinda making the point I was trying to make. When a drug is prescribed for IBS or at the vet’s office — why hate on psychiatrists?
Sam
As Dr. Nardo says, the wind is changing at last! One day, not soon enough, incredulous duped ones (most of America) will look back on this terrible period and count up the bodies and ruined lives and be appalled. There is a real urgency, as many are still dying/being maimed, and the families are waiting for justice.
Here’s hoping Congress and the Federal Government step up to the plate (unfortunately, the voices are few - Senator Grassley and a few others here and there) with the integrity to stand up to pharma and academic psychiatry pressure - and seek the truth, despite the giant bribes they are paid annually. In this time of alleged government shortfall, think of the billions wasted by our tax dollars for flawed “science”, in the name of mental health care. Perhaps next year, when PDUFA comes up for reauthorization, the bill won’t be stripped of reform, as it was in 2007.
Evelyn Pringle
By now I kind of get a kick out of listening to people try and defend these indefensible quacks. Especially when they try to use the by now older than dirt tactic of trying to switch the blame onto the truthful and honest medical professionals, liked Doc Carroll, who have worked for years to expose the wrongdoings.
However, as I’ve said many time, I detest drive by attacks by anonymous bloggers. If I had my way people who refused to reveal their true identity wouldn’t be allowed to attack other commentators.
I wouldn’t expect anyone to allow me to make anonymous accusations that slander and defame people without letting people know it was me.
But then again, I’d never do such a thing.
shocked
Don’t you think it’s interesting that Biederman came out with a public acknowledgment of the sanction by Harvard? Of course, he may well have had his arm twisted to do so but still, he did it. Segue now to ACNP and Nemeroff. Why couldn’t ACNP have given Nemeroff the expectation that he would make a public announcement of his sanction? When you think about his abject groveling promises to do better after being outed by Grassley….
Celeste
Coming in on tail end of this and this is not regarding a child but an adult.
Have suffered from depression most of my life, since the teens. As a younger person I went on short stretches of antidepressants when things were very bad (an assault and the aftermath, a divorce at a young age). I would go on them short-term and then go long periods of time without them.
As an older adult, I have been on antidepressants for longer stretches and find that if I try to wean myself off, I get rock bottom depressed very quickly. The kind of depressed that only happened occasionally for most of my life. Now it\’s commonplace without my medicine. I would not try to go without antidepressants now for any length of time for fear of a really bad crash.
I would say that for people with profound depression, antidepressants are heaven sent. If you have moderate depression and can get by with other treatments, try to avoid long stretches. I am not the only person I know dependent on antidepressants just to function. The lows some of us face are scary. I highly advise against it.
Bernard Carroll
Celeste, you are one of those for whom antidepressants really are effective, and there are a lot like you out there. For your kind of depression, the mood episodes often are recurrent. In the classic Pittsburgh studies done 20 years ago the relapse rate was 50% within 6 months. As the years go by, the duration of the well intervals between episodes shortens noticeably, too. That’s why many patients are given the antidepressant medication long term. It helps to prevent the relapses, as you have observed for yourself.
The cross cutting issue nowadays is that antidepressant drugs are used for a great many people with over-broadly defined ‘depression’ who will not obtain specific benefit from them. How we got to this point is too long a story for a comment on Pharmalot. I have written more about it here:
In Defense of Psychiatric Diagnoses and Treatments 04-02-2009
http://hcrenewal.blogspot.com/2009/04/in-defense-of-psychiatric-diagnoses-and.html
It is important that the experience of persons like yourself be validated amidst all the current questioning of antidepressant drug prescribing and marketing.
harpy
1) prescribing antidepressants for trauma or mild depression is off-label and hasn\’t been proven safe or effective
2) it is also possible that Celeste developed a dependency on the drugs, leaving her unable to function without them. when someone finds his/herself unable to function without a drug, it is called “addiction”
3) counseling has been shown to be as or more effective than antidepressants for the types of depression Celeste describes, and with no side effects
Judy
It is possible to get off antidepressants after longterm use. I know; I did it. Having been put on them, then told by an array of psychiatrists that I had a lifetime condition, I didn’t question the situation for many years. After longterm use of, say, 20 years, I was flipped into a manic state and told I had bipolar. I was put on lithium. So when I weaned off two years ago, I had manic rebound to contend with, as well as a bad array of other withdrawal effects. But I had the support of my psychologist and a number of friends who looked out for me, and I made it.
Never needed them in the first place. And am now doing better than ever. It’s nice to know that I own my own emotions, at last. There are a few places to go to get help getting off these pernicious drugs, including Soteria House in Alaska.
D Bunker
Gia;
Ed’s kind enough to invite us All in to His home for civilized discussion over the banquet He prepares, and my gripes with psychiatry in general, in specific, and in Toto would - aside from being far too voluminous to enumerate here - I feel be transgressing upon Ed’s generosity.
But you’re more than welcome to visit my page if you wish clarification of my dissatisfaction with the whole psychiatric con game.
AA
Sorry for this off topic post but Celeste, you might be one of those folks who might have tapered too quickly which resulted in withdrawal symptoms that looks like a relapse but isn’t.
Many people have been very successful in getting off of antidepressants tapering at the rate of 10% of current dose every 4 to 8 weeks after not being able to taper according to “standard” protocol. I was one of those folks and got off of 4 meds after long term use.
If you decide in the future to make another attempt at getting off of meds, you might want to visit http://survivingantidepressants.org/index.php?/index for support. It is supported by donations and not affiliated with any group. Commercial links are not allowed.
truthman30
Diagnosing any child with a \’psychiatric\’ condition is criminal. It should be a human rights abuse, because that\’s what it amounts to…
Hey Hey GSK How many kids did you kill today?
Nemeroff, Biderman in the pockets of Big Pharma? They should be hung! That, or left alone in a room with the parents of the children they treated and were forced to deal with the results of that treatment!