Child Experts Fail to Reveal Full Drug Pay

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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

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 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 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

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 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. "