The Situation of Medical Research
Posted by The Situationist Staff on June 15, 2008
Gardiner Harris and Benedict Carey wrote an article in last week’s New York Times includes, titled “Researchers Fail to Reveal Full Drug Pay.“ In it , they describe yet another instance of industry influence over what research and manipulation of the marketplace of ideas. We’ve included a few excerpts from the story below.
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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 . . . .
The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.
In an e-mailed statement, Dr. Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.
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.”
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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.”
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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.
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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.”
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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.
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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.
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“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.”
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The entire article is here.
For a sample of related Situationist posts, see “The Situation of University Research,” “The company ‘had no control or influence over the research’ . . . .,” “Deep Capture – Part VII,” “Promoting Smoking through Situation,” “Industry-Funded Research,” “Industry-Funded Research – Part II,” and “Captured Science.”