> On Sep 18, 10:00 pm, Thetaworks uswest.net> wrote:
>

>> 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

>
> nnecessarily, 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

>
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