development of medicines and its exploits - industry that claims to save lives, is but purely profiteering, unethically at that.
share your thoughts around this if you like.
Best,
Dushwari
Source: N.Y. Times
URL: http://www.nytimes.com/2008/06/08/us/08conflict.html?em&ex=1213070400&en=
9971013dfd33290a&ei=5087%
0A
Date published: June 8th 2008
Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY
Published: 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
.
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. Grassleys
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 groups 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 hospitals 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 fields 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 childrens 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
.
Its 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 dont 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. Grassleys interest, Harvard asked the researchers to re-
examine their disclosure reports
.
In the new disclosures, the trios 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. Grassleys 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 hes 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
cant 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
.