A Harvard child psychiatrist whose work has helped fuel an explosion in the use of antipsychotics in children earned at least $1.6 million in consulting fees from drugmakers from 2000 to 2007 but for years did not report much of the income to university officials, according to information given Congressional investigators,The New York Times reports.
By failing to report income, the psychiatrist, Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Timothy Wilens, may have violated federal and university research rules governing conflicts of interest, US Senator Chuck Grassley, an Iowa Republican tells the Times, since some of their research is financed by government grants.
Grassley has been investigating the interplay between academics who receive grant money from both pharma and the NIH. Another recent example he uncovered involved a University of Cincinnati professor who received funds from AstraZeneca while studying one of their drugs, but allegedly failed to report the outside income to the university while also receiving NIH grants.
Like Biederman, Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Thomas Spencer, reported earning at least $1 million after being pressed by Senate investigators. But even these amended disclosures may understate their outside income because some entries contradict payment info from drugmakers, the investigators told the Times.
In one example, 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 J&J told Grassley that Biederman was paid $58,169 in 2001. The Harvard group’s consulting arrangements were already controversial because of their advocacy of unapproved uses of psychiatric meds in children.
"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," according to Grassley's statement in the Congressional Record. Want to see Biederman's lack of disclosure? How about Grassley's letters to the NIH and Harvard? Look at the Congressional Record (just search for 'Biederman' once you open the link).
In an e-mail to the paper, Biederman wrote: “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.” Wilens and Spencer wrote e-mails saying they thought they had complied with conflict-of-interest rules.
John Burklow, a spokesman for the National Institutes of Health, told the Times: “If there have been violations of NIH policy — and if research integrity has been compromised — we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and NIH will not tolerate it.”
The federal grants received by Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants, the Times writes, adding that the health institutes could place restrictions on the hospital’s grants or even suspend them altogether.
Alyssa Kneller, a Harvard spokeswoman, e-mailed the Times this statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.” She added that the docs had been referred to a university conflict committee for review.
The NIH last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, officials have insisted, the Times notes, so the government relies on universities. Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.
“It’s really been an honor system thing,” Robert Alpern, dean of Yale School of Medicine, tells the Times. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”
Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients, the Times writes. Although many of his studies are small and often financed by pharma, his work helped fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotics in children, the Times writes, adding that the Senate investigation did not address research quality.
In the past decade, Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults, the Times writes. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotics, which were invented to treat schizophrenia.
Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic use in children have soared, the Times notes and then cites data from Medco, the pharmacy benefits manager, showing about 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 younger than 6 years old.
162 Comments
I like Senator Grassley.
So do I Henry! Biederman and his "team" are responsible for the most aggregious use of antipsychotics in children. Even their colleagues question their methods.
http://www.boston.com/news/globe/editorial_opinion/oped/articles/2007/06/19/misguided_standards_of_care/
If left to their own devices this "team" would being drugging every aspect of childhood. It was Biederman who polydrugged Rebecca Riley until her death. It's time that Harvard took away this mans "distingished" Harvard title, for the sake of his patients.
Correction it was Biedermans research and recommendations, that Rebecca's psychiatrist followed.
Biederman's a very confused guy, I think. I came to the conclusion, long ago, that the people who work in the field of mental health are actually trying to repair themselves (but do so in secret, whilst pretending to be experts in repairing others). As I understand Biederman's conduct, he's been trying to crush certain kinds of apparently normal childhood behaviour.
I imagine that that is how he was treated, when he was a child, and that's how he's been programmed to behave. Which would be fine, except that, given his position, if his methods are incorrect (and I think they are), he will likely do a great deal of damage to his patients, when he is not treating them, but merely imposing his own reality.
Matt
I wonder if these folks who didn't accurately report this income to university officials accurately reported it on their taxes. . .
You gotta love the concept of 'self-regulation' and medical 'ethics.' Where are his outspoken 'brethren'? Do they not recognize that they get smeared with the same broad paintbrush of contempt when misdeeds come to light? Do doctors endorse an unacknowledged code of silence when they enter the medical brotherhood? That code has served another organization quite well, hasn't it?
Here's some good footage of Biederman on 60 Minutes. The title of the program is "What killed Rebecca Riley?"
http://www.cbsnews.com/stories/2007/09/28/60minutes/main3308525_page2.shtml
ol cranky, I think the pharma companies send in tax forms on what they pay docs, so the individuals concerned better have reported accurately to the IRS!
Just another whore for Big Pharma. Harvard should be ashamed. I, as a physician, am ashamed.
HC is correct. All consultants, speakers, researcher, etc. receiving payment from pharma companies receive a Form 1099 with income information. This information is also sent to the IRS.
Not wanting to make excuses for not reporting income to the University or in other places, it is important to put this in context to the era. For much of the era, there was not much emphasis on reporting this and reporting was very lax. It has only become a hot topic in the past 2 or 3 years. This is still not an excuse for not reporting, but does put it into context.
One final note...whether this was reported or not, anyone involved in this issue was very aware of Biederman's support from pharma in terms of research grants and consulting fees. It doesn't excuse his lack of transparency, but let's not act as though this is "new" news.
Atlex
While this may not be "news" to those who are well aware of funding, this is huge news when put together with the controversial nature of Biedermans "research" and influence.
If Biederman claims that the money had no influence over his research, then comes the question....why not be completely honest and open about those sources of funding?
This line in the article is especially disturbing:
" Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated."
This statement highlights how it wasn't about the financial gain(4000 dollars isn't going to make someone rich), yet he purposely lowered that amount to conceal the violation of the disclosure rules. If he was willing to do that over $4000, what else was he willing to cover up? It comes down to integrity, which IMO he has none.
This happens all the time, I'm afraid. Check out Side Effects: A Prosecutor, A Whistleblower, and a Bestselling Antidepressant on Trial, a new book by Alison Bass:
http://www.amazon.com/Side-Effects-Whistleblower-Bestselling-Antidepressant/dp/1565125533/ref=pd_bbs_5?ie=UTF8&s=books&qid=1212946585&sr=8-5
I have never voted Republican, but this guy Grassley is getting a big "thank you" email from me today. Not only is he uncovering Harvard's and others criminal behavior, but he also found out UCLA has been doing liver transplants for Japanese gangsters while poor folk are dying. From this mornings NY Times:
http://www.nytimes.com/2008/06/08/washington/08transplant.html?th&emc=th
I have been going crazy, and now have taken my ex to court because my 7 year old doctors have been feeding here amphetamines, antidepressants, anti-anxiety meds and things to help her sleep. They have just started her on Respirdal, an atypical anti-psychotic!! They started these constantly-changing drug cocktails when she was 6 years old! This medication of masses of our children can clearly be blamed on big pharma and the unscrupulous doctors that take their money. They should all be put in jail.
Hooray for Sen. Grassley!!!
johnd
Sen. Grassley rocks!
Senator Grassley DOES rock. I am especially proud that he exposed the unscrupulous Biederman, busy disease-mongering and harming thousands upon thousands of children with a made-up illness and giving them lethal drugs. Grassley is Mr. Drug Safety in the Senate - not many more like him there.
Ed's link for the Congressional Record isn't working. Try this:
http://frwebgate3.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=96306823720+0+1+0&WAISaction=retrieve
or
http://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=96319827735+0+0+0&WAISaction=retrieve
or go to http://www.gpoaccess.gov/crecord/index.html
and search for "Biederman"
Biederman has been one of the worst Big Pharma Hos ever... but what makes him and his ilk particulalry evil is that they take money and destroy innocent, helpless children. Sen. Grassley should have these guys tax returns audited; hopefully they can be prosecuted for tax evasion. At the very least NIH should strip Biederman and Harvard of its grants.
Dr. Biederman obviously didn't want to disclose the degree to which he is enriched by pharma, even though such disclosure is required. It is more than an oversight, it is a deliberate effort to conceal material facts related to his work. If Dr. Biederman is so ethically challenged that he can't or won't disclose his compensation from pharmaceutical manufacturers, how honest is his work?
If Dr. Biederman won't tell the truth to NIH and Harvard, how can he be trusted to conduct ANY research or to practice medicine? He should have his license revoked.
Henry, You may like Chuck Grassley, but why do have so much corruption in our government? Maybe it is time Chuck Grassley and Congress, Federal and state elected should be honest and truthful, especially when it it is our health. I speak erience and when it happens to you and member of your dies because of our corruptive health system you will feel differently.
Atlex, I agree,.. Bierderman isnt news. His ties to Industry are well known to those who follow this issue. In other words this guy is a bum,.. no doubt about it!!!!!!
johnd, Sounds like you have more of a problem than "pharma drugging your child." No pharma company has ever taken a child to a doctor or written a prescription--your ex has something weird going on, if you think your child is perfectly fine and she thinks she needs medication. Child docs rely a lot on what parents report about behavior, so strange stuff is going on with your ex for her to be telling the doctor anything to get your daughter medicated.
Sounds like you and your ex need to hash some things out--no way should she be taking your child to a psychiatrist without your knowledge and input. Obviously, you already know that, because you are taking her to court. I am sorry it has to come to that--that is so damaging to you and to your child. I hope you already have joint legal custody and can put a stop to this--do you have visitation? I guess you can't steal her while you get it hashed out in court, that would damage your standing. I hope you get it taken care of; in the meantime, don't stop the meds suddenly. Get that court order and take your daughter to another psych with the explicit intention of tapering her off the drugs. Good luck!
HorusCat - thanks for the support. I'm looking for a psych in the SF Bay Area I can have my daughter see, and as well maybe provide expert testimony in support of therapy and parent training instead of this insanity of using antipsychotics on children who are not mentally ill. The whole thing seems pretty unreal.
Laurie wrote: "...It comes down to integrity, which IMO he has none."
I agree with that, wholeheartedly: it points to a bigger issue than a few grand.
It's a different field, but in the UK, when one is licensed as an "competent person" within the financial services regulatory environment, one is required to disclose any criminal convictions. A traffic offence means absolutely nothing, and won't impact on one's application for Approval, but not reporting a traffic offence most certainly will...
Matt
That $4000 difference not reported was a blatant attempt to circumvent the mandatory $10,000 limit for reporting. That's what's so disturbing about this whole situation. While some will argue that full disclosure of funding sources isn't a true indicator of corruption of research....I think this situation highlights the fact that if an individual is willing to go to these lengths to decieve, then their ethical practices are in question.
johnd, This will sound crazy, but if you know any reps in the area, ask them. Reps know who the good, thoughtful docs are--even though they often aren't the ones prescribing our drugs! My middle son is autistic, and I recently wanted to change doctors. Sadly, the list was very short of psychiatrists who would also spend the time I wanted them to just talking to my son. Fortunately, I found one--she spends at least 45 minutes with him every time we see her. Additionally, we found a psychologist who specializes in kids on the spectrum, and she spends weekly time with us helping to problem-solve social situations and anger/impulsivity issues (like why you can only ask a person to explain a decision once, and after that they get annoyed!).
Another resource might be a local autism society--not that your daughter is autistic, but because those folks are really plugged in to the counseling community. They may have a list of psychologists who do behavioral/family counseling, much like I do with my son. They may also have insight into the legal situation. Hang in there!
For an SF Area child psych, I would recommend you do some research on Kiki Chang, MD. A very progressive and highly respected doc.
I believe Kiki Chang is also part of the Biederman gang that believes in medicating children as young as possible.
In some legal circles there is a belief that if someone entices someone to do something not legal or not ethical, the enticer is just as guilty as the person who did something wrong.
All consultants, speakers, researcher, etc. receiving payment from pharma companies receive a Form 1099 with income information. This information is also sent to the IRS, but this latest news report clearly shows that PHARMA is the enticer.
The money given to these so-called respected, highly regarded physicians is not as important as the motive for giving these physicians the money. It has been reported that these new psychotropic drugs accounted for $10 Billion in 2006.
Even more important is the fact that parents of young children and other adults were prescribed these drugs unnecessarily in many cases for FDA approved use and off label uses. How many patients suffered from side effects of these drugs - in some cases age restricted was ignored. A couple of years ago, it was reported tha Zyprexa reps did not tell physicians that the use of the drug caused patient to gain from 20 to 100 pounds, in many cases causing patients to become diabetic.
If PHARMa funded these research physicians in a honest and ethical manner and not as a marketing tool, every one would gain. But one has wonder, how many more unethical situations is still not known?
kiki chang is indeed part of the biederman mafia and has spoken for them on pbs when biederman refused to answer questions.
Just sent the following letter to Harvard Medical School. Made me feel a bit better. Maybe if they get swamped with mail and calls they won't languish in their decisions. "I am a psychiatrist who trained at NYU. There I was taught that honesty was integral to the practice of good medicine. I'm sure that's what you teach at your institution as well. Please do not just discipline but fire Biederman et al. as quickly and publicly as possible. Their moronic greed is going to have hideous ramifications in medicine for some time but the quicker that we all publicly denounce what they did and begin to take steps to correct our imperfect system, the sooner we will begin to earn our patient's trust back. That is of course, unless we just want to go back to a laying of the hands and stop prescribing drugs altogether."
P.S. I also think that their licenses should come under review for revocation for unethical conduct.
Bravo docf! Every Psychiatrist and the APA should be sending letters just like the one you wrote instead of trying to justify these doctors behavior by stating they may not have known it was drug money such as Danny Carlat.
Thanks Jane. I'm rather shocked there's not more discussion going on about it in the medical community. It really puts a lot of off label research we depend on for prescribing (especially in psychiatry) at risk. I know if I have to wait for the the FDA to approve a use a drug for a particular indication, usually I'm doing my patients a tremendous disservice. I do hope more docs get upset by this.
Sam, As far as I can tell from the NY Times article, it appears that the pharma industry acted entirely within ethical and legal guidelines. This appears to be a failure on the part of the medical establishment at Harvard. Disagree?
If the academic docs reported all of the income from pharma, the sheer amounts would shock the country. Research amounts are relatively small compared with consultant and speaking fees. I've worked in the cardiovascular area for years and can tell you that millions have gone to Harvard and Duke physicians who carry the label "Key Opinion Leader." Yes, millions! Did all of this get reported? Highly doubtful. These large university centers all have their own research groups whose physicians are very well rewarded. Not only that, the amounts thrown around in cardiovascualr dwarf what is spent in psychiatry.
CV MD is right on target. Grassley is just seeing the very tip of an extremely large iceberg. If he started to look at cardiologists who work for drug companies at the major academic institutions, he would find much, much more. I also agree that harvard and Duke have been extrtemely active for years.
More power to Sen. Grassley. he's one of the few that is trying to do something about the corruptness that is Big Pharma.
I think that the research should be closely scrutinized. There will be an inquiry, but I'm not sure it will involve reviewing all the studies in detail. That would take a long time.
CV MD, Do you mean that pharma pays these KOLs money for *personal* use or are you talking about research sponsorships & unrestricted grants? Unrestricted grants are a great way that pharma is funneling money into research institutions. It provides very necessary money at a time when federal funding is drying up. At my level, I'm completely unaware that pharma is personally funding the bank accounts of these KOLs. I always thought we were primarily funding their research groups.
I find it interesting - and disturbing - that I cannot find any references in the reporting on this story to the specific drugs which may have benefited from Biederman's suborned endorsements. It would seem to me that the public should be informed about which drugs, or drug regimens, that Biederman endorsed are manufactured by companies that subsidized Biederman's research activities.
The failure to "name names" with respect to the specific medications involved raises questions about the mendacity of the news media itself. My guess is that the management of the New York Times saw a potential law suit emerging if they were to identify the medications in question, and simply steered clear of the question.
Imagine how much more potent this story would be if it were connected to the specific drugs that Biederman has recommended. It would also have been a better service to the community to let the public know which drugs fall into this category so that they can reconsider any treatment regimen that includes these medications.
Ah ha! There was a reference to a specific drug, all the way down on page two of the Times article, but there was a reference to only one drug out of the unknown number of drugs in question. I reiterate my concern about the inadequate reporting, and the absence - still - of a full disclosure about which drugs may have been recommended by doctors receiving compensation from the companies that manufacture those drugs.
This kind of thing is rampant in the industry... It's corrupt to the core..
"At my level, I’m completely unaware that pharma is personally funding the bank accounts of these KOLs. I always thought we were primarily funding their research groups"
You should read up on "Martin Keller" of Brown university Nathan and "Study 329" ...
If corruption, abortion of ethics and pharma whoring is the accepted status quo at the top of the psychiatric profession, you can only imagine what happens further down..
You raise a good point, Atlex, but don't you wonder if the lax reporting is what has led to it becoming a hot topic?
Nathan,
You're kidding, right? Advising, Consulting and Speaking fees have gone through the roof over the past few years, with some "KOLs" commanding up to $5000/day! Many speak several times a month and consult for multiple companies. Not only that, they sit on a number of advisory boards at the same time. And then there's the research, where they charge outrageous amounts for their own personal time! How do you think these guys live in the most extravagant houses and drive the most incredible wheels? It's not from their day job at an academic institution. They don't get paid that much! If the government starts to look at who pays who what and who didn't report side income, then the lid will be blown off of Pandora's Box.
CV MD, Sure - speaking fees. We generally pay $1000-$2000 for academic speakers to come in for a day. That is "pay for work" -- not just "pay for hell of it". These guys won't speak for free!
You said in your prior message that "millions have gone to Harvard and Duke physicians who carry the label Key Opinion Leader.” If it is all in <$5000 increments, for speaking, consulting, etc, so what? We need academic speakers and consultants in order to keep up with advances in technology. These guys don't offer thier services (speaking and consulting) for free!
Nathan, your "academic" speakers charge you for speaking services because they understand that in those situations (where they are using the corporate written presentations) they are promoting a product.
I know a fellow (more senior) academic who was always delighted to give talks around the state. For one product, he expected $1,500 per talk, and would only do local area events not more than an hour away. He also liked to be picked up at the office, driven there and back. Lots of times he was "speaking" to two or three other physicians. I think he did around a dozen of these, but it might have been more. The really odd thing was although he is a pediatric subspecialist, the product he was speaking for products had no approved use (or studies) in children. About a year later, the product was pulled due to safety issues (which were signalled in the original studies).
I'm an academic, and I speak often locally on a variety of topics. I've given talks to family medicine meetings, pediatrics and psychiatry grand rounds, a state respiratory therapy meeting, as well numerous meetings for our Medicare/Medicaid quality improvement organization. I make my own presentations - which is a great deal more difficult and time consuming than attending a speaker training session (followed by golf). I don't take honoraria. Academicians will speak for free. It is called teaching.
CV, MD is absolutely correct on this point. The KOL's (who are usually deemed such by PhRMA)are simply leveraging their academic positions to get supplemental income.
The "advisory boards" are especially absurd. There is just no way that an "advisory board" member can provide any useful direction to a company on how to research or market any product. The research folks, and the marketing teams have a much more intimate understanding of the strengths, weaknesses, opportunities and threats for their product group than any outside "advisor." These boards exist (I believe) to buy some goodwill from the attendees, and to plant some off-label use seeds. Having worked in PhRMA marketing, I know exactly why we had "advisory boards," and the degree to which anyone internally paid any attention to them. Payments to "advisors" are little more than bribes and ego-stroking.
CV, MD - Can I get an AMEN?
CV MD and M Helm, I guess I'm in a different area of research. What you say may be true in clinical R&D. I'm in pre-clinical R&D. We bring in academic consultants ("advisors") and speakers several times a year and pay them $1000/day for their services. They provide useful information to our project teams. They also bring an "outside the box" perspective. Sometimes we get "tunnel vission" from looking at the same project for so long. Often an academic might see something totally obvious, but because we've been so intimately involved in the day-to-day research, we've missed something obvious to someone with a fresh perspective.
My only point is that not ALL payments by pharma to academics are made with bad intentions. We fund basic research (with unrestricted grants) and we bring in speakers/consultants to educate our scientists about new work going on in academia. Just like physicians, we (in the lab) don't always pay as much attention to primary literature as we should. Academic speakers and consultants are an important part of continuing education for pharmaceutical researchers.
M Helm and CV, You are a little behind the times. No more golf, at least not with my company. Speaker training programs are a real pain in the patootey now; no free time whatsoever. We do most of the training over the internet, anyway. Ad boards are few and far between with the big companies; the smaller companies still get away with them. (Biogen comes to mind, as a matter of fact.)
Most speakers are not divas and don't command fees of $5,000 per day. In fact, I am having one in a couple of days. He is driving himself--even using MapQuest! He did ask for two talks for the day, which will pay him about $2,500, but since he is driving four hours and giving up a day's work in his office, I don't think that's unreasonable. His speaking cap for us is not very high--$20,000 or so total for all speaking for the year. He's not a huge KOL, but he uses my drug and is passionate about the disease state. To me, that kind of speaker is more valuable than some big name from Duke--often those guys are out of the office so much they don't have any real clinical experience to offer. My docs want someone who actually treats patients and uses different medications.
Another speaker I've used a bit is local; he speaks not just because he is passionate about the disease state and uses my drug, but because he can draw attention to current research, network with local doctors and talk about interventions that can occur if medications fail. I think that benefits all concerned.
The vast majority of speakers for pharma are local or regional level docs who do maybe ten or so talks a year. They don't have the reputation or desire to do national tours. The Duke, Harvard, Cleveland Clinic types get lots of press, but they are a small minority of speakers. We don't do a lot of dinner talks anymore, because no one wants to come out at night. That's why we do talks with a few doctors--we can do lunch or breakfast. It's a lot cheaper, food-wise, too. And reps have kids and lives, too. The worst thing in the world is to have one of those big names in and get no one at your program!
My point is that you get in high dudgeon over what is a small part of the speaker process. What goes on most of the time is pretty small potatoes.
Also--some academic centers require that physicians turn over speaking fees to the university.
Three (3) men make between them 'at least' $4.2 million dollars from drug companies in return for persuading physicians that children should be prescribed drugs with known toxic properties.
That should be considered criminal activity on both sides, bribers and takers.
Amen to M. Helm! Nathan - you are sheltered in pre-clinical and have no idea what goes on in the commercial side of the Big Pharma companies. The business bozos are the ones throwing around the money, not the research groups! Trsut me - many are paid $5000 per day and bill door to door! many KOLs are on "retainers" to pharma for $50,000 - 100,00 per year!! Advisors and consultants are paid ridiculous sums for very little work. It happens all the time! Horuscat - perhaps your company follows the rules, but most don't. just look at all the bad press lately. It's at least once or twice a week that Big Pharma is in the news for another stupid move. Wait until the democrats get elected in November - then Pharma will not know what hit them. They will be royally toasted. Please wake up!
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