XPost: alt.society.mental-health, alt.psychology.personality   
   From: pjbrass@uswest.net   
      
   New York Times   
      
   Child Experts Fail to Reveal Full Drug Pay   
   By Gardiner Harris and Benedict Carey   
      
   June 8, 2008   
      
   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.   
      
   Senator Charles E. Grassley pushed three experts in child psychiatry   
   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 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   
      
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