> New York Times
>
> ChildExperts Fail to Reveal Full Drug Pay
> By Gardiner Harris and Benedict Carey
>
> June 8, 2008
>
> A world-renowned Harvardchildpsychiatrist 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.
>
> Senator Charles E. Grassley pushed three experts inchildpsychiatry
> at Harvard to expose their income from consulting fees.
>
> Dr. Joseph Biederman belatedly reported at least $1.6 million in
> consulting fees.
>
> 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 recently to check again, he reported receiving $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.” 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.”
>
> The federal grants received by Drs. 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 inchild
> 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 ofchildpsychiatristsin 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.
>
> Fewpsychiatriststoday 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 theChildand 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
> u

>> 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 toppsychiatrists...
>
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