Harvard’s Biederman And His Ties To J&J
25 CommentsBy Ed Silverman // November 24th, 2008 // 3:19 pm
Last June, when a Congressional investigation revealed Harvard University’s Joseph Biederman had earned far more money from drugmakers than he had reported to the school, the world-renowned child psychiatrist insisted his “interests are solely in the advancement of medical treatment through rigorous and objective study.” (Back story).
Now, e-mails and internal Johnson & Johnson documents made public in a court filing reveal Biederman pushed the drugmaker to fund a research center at Massachusetts General Hospital, and the point was “to move forward the commercial goals of J&J,” according to the documents, The New York Times reports. The documents also show J&J wrote a draft summary of a study that Biederman was said to author (here are the documents; this is a Word document, folks).
Biederman’s work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotics in children, the Times writes. Many of his studies are small and often financed by drugmakers, but Biederman has had outsized influence because of his position at one of the world’s most prestigious medical institutions. J&J makes Risperdal and more than a quarter of its use is in children and adolescents.
Last week, a panel of federal drug experts noted that meds such as Risperdal are prescribed improperly and the FDA must do more to warn doctors of the risks (back story). Other popular antipsychotics include Lilly’s Zyprexa, Pfizer’s Geodon, AstraZeneca’s Seroquel, and Bristol-Myers Squibb’s Abilify. Numerous lawsuits filed against J&J and other drugmakers over these issues.
Plaintiffs’ attorneys have demanded untold numbers of documents, and nearly all are under judicial seals, but a select few mentioning Biederman became public after a judge’s order was sought to require Biederman to be deposed. Biederman argued he shouldn’t be deposed because he is actively cooperating with the US Senate Finance Committee investigation (here is the deposition order).
In a motion filed two weeks ago, attorneys for the families argued they should be allowed to interview Biederman under oath because his work has been crucial to the widespread acceptance of pediatric usage of antipsychotics, the Times writes. To support this contention, the lawyers included more than two dozen documents, including e-mails from J&J that mentioned Biederman.
The documents, the Times correctly notes, offer an unusual glimpse into the delicate relationship between drugmakers and influential doctors. In one November 1999 e-mail, John Bruins, a J&J marketing exec, begs his supervisors to approve a $3,000 check to Biederman in payment for a lecture he gave at the University of Connecticut. “Dr. Biederman is not someone to jerk around,” Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.” (click e-mail to enlarge)
Bruins also wrote that Biederman was furious after J&J rejected a request Biederman had made to receive a $280,000 research grant. “I have never seen someone so angry,” Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.” He concluded that, unless Biederman received a check soon, “I am truly afraid of the consequences.”
A series of documents described the goals behind establishing the J&J Center for the Study of Pediatric Psychopathology, where Biederman is still 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, which expose children to potentially serious adverse events.”
In a February 2002 e-mail, Georges Gharabawi, a J&J exec, wrote that 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.
A June 2002 e-mail from Gahan Pandina, another J&J exec, to 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,” Pandina wrote. One problem with the study, 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 Pandina included in the e-mail, however, stated that only the children given Risperdal improved, while those given placebos did not. Pandina asked 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, the Times writes, do not make clear whether Biederman approved the final summary of the brief abstract in similar form or asked to read the longer report on the study. This would be an example of ghostwriting, by the way.
In June, a Congressional investigation revealed that Biederman failed to report to Harvard at least $1.4 million in outside income from J&J and other makers of antipsychotics. For instance, Biederman reported no income from J&J for 2001 in a disclosure report filed with the university. When asked by Senator Chuck Grassley of the finance committee to check again, Biederman said he received $3,500. But J&J told Grassley it paid Biederman $58,169 in 2001 (back story).
On Monday, David Cameron, a Harvard spokesman, told the Times the university is still reviewing the allegations against Biederman, and they had not seen the documents in question and that the university is not directly involved in the child psychiatry center at Massachusetts General Hospital. Calls to Biederman were not returned, the Times writes, and J&J did not immediately comment or make executives available for comment.
Philip Dawdy
great stuff ed. i’ve been writing about biederman and the child bipolar thing for a long time and have been soundly attacked for it. looks like i was right and so were others who were critical of the biederman-developed paradigm.
Lisa Van S
One has to question the sanity of J&J officials and Dr. Biederman. Their is nothing more grotesque than ones intentional harm towards Infants, Toddlers, children and teens for financial gain.
Ima Misfit
Small world!
I actually worked for John Bruins wife when she was a D.M. for Organon in 1999. At the time of she was very worried that her husband, a Science Liaison, might lose his job.
According to Jill Bruins, her husband sponsored a meeting with a group of “key opinion leaders.” At some point during the meeting, John got up and spoke to the doctors about the value of pharma companies in educating doctors about their drugs.
Jill said that one very influential doctor spoke up and lambasted John. This very important doctor went off on an angry rant in which he insisted that pharma companies should have no role whatsoever in educating doctors.
Word of the incident quickly got back to J&J execs, who were very unhappy.
I’m guessing that this very important doctor was Dr. Biederman, and that this “research center” was J&J’s way of paying off Biederman to keep him from disparaging Risperdal.
Ed,
If you want to verify my information, you know how to get in touch with me.
sally
WhoCanWeSue.com???
laurie
I believe the term “sociopath” fits here.
Justice in MI
Once again, I genuinely ask those in industry how they understand the Biederman saga,and whether they view it as within the parameters of appropriate relationships between KOL-academics and industry.
Lisa Van S
I agree with laurie, individuals who behave in this manner are sociopaths and that label can also be placed on those who make a lame attempt to defend them. These sociopaths include the Special Interest Groups like NAMI and MHA who receive million of dollars to promote the Bipolar epidemic. These individuals need a mental health evaluation!!
Justice in MI
A true sociopath genuinely doesn’t get it. Missing conscience, like Hannibal the Cannibal.
A severe narcissistic character disorder “gets it,” but feels entitled to ignore it because of how “special” they are.
So sociopaths “simply” destroy. Severe narcissists destroy in the service, especially, of voracious self-aggrandizement.
Lisa Van S
Justice in MI
Wonderfully Stated!
Ima Misfit
The current pharma “leaders” have adopted a business model that fosters a sociopathic corporate culture.
Healthy corporations foster a culture of creativity, honesty, and an entrepreneurial spirit.
People who work in healthy corporate cultures are builders. They create new products, new ideas, and new services. They take pride in building their company.
Sociopathic corporate cultures are found in companies that are acquirers. They buy companies, take from them what they want, and then dismantle them. The leaders of these companies are demagogues who preach ethics and values and point to their strong corporate policies as proof of their morality. But in fact, they have built a culture of corruption. The behavior within sociopathic companies, if known by the public, would be condemned. Employees of these companies do not feel a sense of pride towards their company.
Justice in MI
Ima - May I ask if you are in such a company or have been? If so, what do you think makes the difference - how much leadership, how much external sanctions, how much public exposure, etc.?
In this case, the “company” obviously includes Harvard, one with which I have some familiarity. I believe the narcissistic model on an institutional level - or the synergy between institutional niches and certain character types - has relevance.
Ima Misfit
Justice,
I did work for such a company. Unfortunately it seems that all large institutions, public and private, foster sociopathic cultures. They run bureaucratic systems, and they set unrealistic goals that can only be achieved through fraudulent means and collusion.
Our politician’s feckless efforts to “regulate” corporations consist of legislation like Sarbanes Oxley, which is not enforced. In fact, industries such as pharma and banking are asked to “self regulate.” This policy of self-regulation, adopted by HHS, SEC, and DOJ has allowed private industry to evolve completely into organized criminal enterprises.
I don’t see any will from political and judicial leaders to enforce our laws. RICO violations and criminal activities are now settled behind closed doors.
We don’t need more regulations to reign in these criminal enterprises; we just need our laws enforced. But since the institutions responsible for enforcing the laws are bought and paid for by corporate institutions, the current system will continue.
The constitution has been discarded along with capitalism. Since more than 50% of revenues in major industries like Pharma and Defense come from the government, I think we can safely say that our system is a corrupt version of socialism.
Former Marketing Exec
This isn’t surprising and that in and of itself is surprising, because this should be a surprise, but it is becoming such the norm that it is no longer surprising. What does that say about us and humanity?
JIM, thank you for your very good definition of Sociopath versus narcissists. You’ve done a great service, people need to understand the difference.
In one case I have worked for a company that was completely controlled by an entire executive team full of narcissists. It was brutal, they wanted to know only what was the least they could do to be ethically approved but still maximize return. Since it was a private company on the fringe of healthcare, the profits went back to the executive, the middle managers and lower staff never got to share in the fruits of their hard work.
What is despicable about this is the years of research into bona-fide solutions that was diverted because of this.
The full extent of the harm to patients and individuals needs to be carefully assessed.
Jaynesday
Ima, Justice and all,
And what better enabler of sociopathic behavior could there be than FDA preemption? It’s like the mother that refuses to admit that their child is capable of wrong and who defends them even as they go to jail. Preemption is that mother. Preemption refuses to admit that a company/industry can be wrong and deserves correction.
Neil Manowitz, PhD,
What is a key opinion leader? Generally it is an academic doctor who is in academia because he/she couldn’t hack it if they actually tried to take care of real patients. In psych, it often means using poorly validated rating scales to get a new drug approved for a bogus child psych disorder. It means squeezing pharma companies for every dollar or else they will run to the competitors. Unfortunately most doctoral level clinicians in drug companies are not specialists in their therapeutic areas and cannot intellectually challenge the KOL’s. They rush the money request through the company under fear of reprisal from the KOL. Most of the time a rigorous ROI analysis would show that the KOL’s do not deliver the bang for the buck but merely pad their coffers. I would much rather trust the opinion of a psychiatrist who actually sees real world patients than any one of the ivory tower KOL’s.
atlex
Neil,
Your statement, coming from a psychologist, sounds highly biased. Wouldn’t an equivalent statement from an academic psychiatrist who disagrees with you be that the reason that psychologists become psychologists is because they couldn’t hack medical school?
Atlex
Salmon
Key opinion leaders are not only psychiatrists and in Universities.
Look at Goodwin, Tom Insel, and Kathleen Merikangas from NIMH. For more details on Merikangas and Insel on bipolar and especially pediatric bipolar see my post under:
http://www.pharmalot.com/2008/11/14-meds-widely-used-off-label-need-more-study/
Neil as for people in industry not being specialists in their fields, this is not entirely true and there may be a mixture. However at top companies many M.D.’s and Ph.D.’s (especially the specialists) are incredibly sharp. They know the KOL’s are hacks but they use them as it’s a part of the marketing puzzle and how the system works.
The companies just don’t want to get into a position where a particular KOL gets overly powerful and can overcharge them. But this goes in phases and what’s a hot therapeutic area now may not be in a few years and a different group of KOL’s with rise and fall.
Salmon
Neil Manowitz, PhD,
Atlex:
First of all, I’m not a PHD psychologist. My opinion comes from 25 years in Phase III and Phase IV clinical research in several pharmaceutical companies, mostly in CNS clinical research. I’ve dealt first hand with figures such as Dr Biderman, and know how psychiatric rating scales are developed, used and misused. What are your credentials? Let’s compare.
Texan
“What is a key opinion leader? Generally it is an academic doctor who is in academia because he/she couldn’t hack it if they actually tried to take care of real patients.”
I may not be an expert in much of anything but that seems to be a rather broad brush you have chosen. Please guide me where I go astray, but is it not the trials that draw people to academic medicine? Don’t KOLs draw from their experiences, exposure, expertise through these trials to create a picture of the scientific landscape ahead that is typically larger than a private practitioner would see? To be a KOL seems to follow the model set forth by academic medicine: presence in the national and international communities of your respective field(s).
From the NYT article: “Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.”
It sounds like KOLs convey the comfort of credibility not easily obtained from any technical expert within the company that may have equal or greater expertise in the agent or device.
Justice in MI
Does anyone work in a large institution (industry or otherwise) that they believe is essentially not corrupt?
BPW
Not me. It’s unbelievable how much of this “bribery” goes on. Why is it that Big Pharma can’t keep their money away from the KOLs? They continue to lavish huge sums for these KOLs. It’s rampant at Harvard, Yale, Columbia, Duke and others. The KOL academics get paid hundreds of thousands of dollars to do their “pet” projects and support the company’s drugs. Corruption rules because greed and money run the show.
Lisa Van S
Jaynesday,
It would be very much appreciated if you kept your opinions about mothers to yourself, a “Parent’s Unconditional Love” has nothing to do with preemption, and she never be compared as such.
Michael S. Altus, PhD, ELS
In conducting a Janssen-supported adolescent bipolar study with 30 participants, Dr. Biederman did not use Janssen-specific consent forms. He said that he would conduct another study with 30 participants in which he would use the Janssen-specific consent forms.
I find this troubling. Clinical trials should serve a worthwhile purpose. I question whether repeating a study simply because the wrong consent forms had been used previously serves a worthwhile purpose. Did the protocol for the repeat study note that a rationale for doing it was to use Janssen-specific consent forms? Did an institutional review board approve a repeat study whose rationale was to use the appropriate consent forms?
Person
What is the correct chemical balance? they have discovered the imbalance so surely the balance will come soon.
By the way what did they originally compare to, to work out what an imbalance is?
Person
Guys?