Bipolar researcher failed to disclose fees from drug companies

Discussion in 'General Parenting' started by Sara PA, Jun 8, 2008.

  1. Sara PA

    Sara PA New Member

    Anyone who has spent any time on will know who Joseph Biederman is. Not disclosing payments from drug companies when the rules require it is reason to question the reliability and/or validity of the research.

    Researchers Fail to Reveal Full Drug Pay

    A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.

    By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

    Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley's investigators. But even these amended disclosures may understate the researchers' outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

    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.' doctors. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.

    John Burklow, a spokesman for the National Institutes of Health, said: 'If there have been violations of N.I.H. 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 N.I.H. will not tolerate it.'

    The federal grants received by doctors. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital's grants or even suspend them altogether.

    Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed 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.'

    Ms. Kneller said the doctors had been referred to a university conflict committee for review.

    Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators' findings, and he placed the letters along with his comments in The Congressional Record.

    Dr. 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. Although many of his studies are small and often financed by drug makers, his work helped to 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 antipsychotic medicines in children. The Grassley investigation did not address research quality.

    Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children's lives over time, experts say.

    In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.

    To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.

    The health institutes 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, health institutes officials have long insisted. 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,' said Dr. Robert Alpern, dean of Yale School of Medicine. 'If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don't even know how to check on that.'

    Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.

    Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.

    Mr. Grassley asked Harvard for the three researchers' financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.

    'Basically, these forms were a mess,' Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. 'Over the last seven years, it looked like they had taken a couple hundred thousand dollars.'

    Prompted by Mr. Grassley's interest, Harvard asked the researchers to re-examine their disclosure reports.

    In the new disclosures, the trio's outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.

    In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. 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.

    At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.

    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.

    In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.

    Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

    Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

    'I consider Dr. Biederman a true visionary in recognizing this illness in children,' said Susan Resko, director of the Child and Adolescent Bipolar Foundation, 'and he's not only saved many lives but restored hope to thousands of families across the country.'

    Longtime critics of the group see its influence differently. 'They have given the Harvard imprimatur to this commercial experimentation on children,' said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.

    Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.

    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.

    Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.

    More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for 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.'

    Copyright 2008 The New York Times Company
  2. klmno

    klmno Active Member

    I don't doubt this at all, Sara. All I can say is that I feel sure there will be future repercussions from all the medications my difficult child is on- and they won't be good. I wish all the psychiatrists and tdocs stood up more for educating the public- school district, legal authorities, everybody- about how best to treat this kids instead of putting so much faith into medications when they all know that enough research hasn't been done and that they REALLY don't know the RIGHT treatment or even how to positively diagnosis it. They keep themselves out of it and leave it up to the parents to be the advocates and I personally find it very frustrating.
  3. TerryJ2

    TerryJ2 Well-Known Member

    Wow. I'm shocked ... but I'm not.
    What a catastrophe.
  4. Marguerite

    Marguerite Active Member

    Well, that's blown HIS credibility right out of the water.

    I really get cranky with this sort of thing. I thought only naive researchers who don't know the ropes or who think it's OK to rort the system (because they aren't sufficiently experienced) did this sort of thing. The last time I saw this, the researchers claimed naivety and although two of them were at least Associate Professor in rank (and, I would have thought, would have understood the way the research funding system worked especially when you're university-employed) they were believed.

    And they got away with nothing more than a "don't do it again."

    I watched - and although they did make changes in their research methodology to try to repair some of the damage, they continued to break the rules (just not so obviously).

    But that was a very minor research team whose work was invalid (for so many reasons, including fudged results) and the natural course of events occurred - they are no longer doing that research because nobody else was ever able to verify their results, nor demonstrate any value in continuing the study.

    It seems this sort of thing happens more than we would like to believe. Maybe it's a case of a researcher who thinks he is sufficiently high-profile to be able to get away with things due to nobody else daring to scrutinise his actions?

    So now what happens, with children he helped diagnose? Does everything he has done now get questioned? is it all going to get discredited? And of so, what then?

    Or if not, what if he really did get it badly wrong, and many children are taking medications that are not truly needed?

    If only these idiots would really think before they broke the rules, then there wouldn't be so much waste of time, resources, energy and credibility.

  5. susiestar

    susiestar Roll With It

    This will have a big impact on child psychiatry. The people who will be hurt are the kids.

    Some docs seem to think they are immune to the rules and laws because they are docs. Idiots.

    I wish I was shocked by this. But I am not.

    I wonder how much drug co's influenced the docs not to report?? told them that this or that didn't count??
  6. susiestar

    susiestar Roll With It

    I question the idea that there are too many researchers getting grants to scrutinize all of them. With computers that do research easily, I would think it would be possible to get the drug co reports adn teh doctor's reports and have them checked. At least for a substantial group of them.

    And ALL of Harvard's grant recipients. Cause who knows what Harvard officials told the docs informally?? And what these docs told other researchers at Harvard??
  7. Sara PA

    Sara PA New Member

    " Maybe it's a case of a researcher who thinks he is sufficiently high-profile to be able to get away with things due to nobody else daring to scrutinise his actions?"

    I think it's just plain arrogance. And I suspect this isn't new-found arrogance.
  8. Christy

    Christy New Member

    This is discouraging. It is hard enough to decide to use these medications without factoring in the fact that the current research in the field is biased by drug companies :(
  9. Sara PA

    Sara PA New Member

    FWIW, here's a list of studies under Biederman's name from the federal govenment's site:
    Because this site and the requirement that studies be registered is fairly recent, the completed studies only go back to 2004 (unless I missed something).

    Note the bipolar/bupropion SR (Wellburtin) study was terminated. That generally results when the outcome is so onesided (generally negatively, but not always) that it would be unethical to continue the study.