Harvard Psychiatrists Hide Millions of Dollars Received from Drug Companies

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Harvard Psychiatrists Hide Millions of Dollars Received from Drug

Companies

Friday, November 07, 2008 by: Gutierrez

Key concepts: NIH, Psychiatrists and Antipsychotics

Natural News.com - Phoenix,AZ,USA

http://www.naturalnews.com/024737.html

NaturalNews) A congressional investigation has revealed that a group

of Harvard psychiatrists, instrumental in pushing the diagnosis of

bipolar disorder in children and its off-label treatment with

antipsychotics, concealed from university officials the millions of

dollars they earned in consulting fees for the companies that make

those drugs.

Iowa Sen. E. Grassley requested the financial disclosure

reports that Drs. ph Biederman, E. Wilens and

Spencer had filed with Harvard University between 2000 and 2007. He

then asked a handful of pharmaceutical companies for their own

records on how much had been paid to the researchers in that time.

The numbers reported by the drug companies were much higher than

those on the researchers' forms.

" Basically, these forms were a mess, " Grassley said. " Over the last

seven years, it looked like they had taken a couple hundred thousand

dollars. "

Upon being confronted with the discrepancies, the researchers

admitted to having concealed certain consulting fees and upped their

estimates. These new numbers still fell short of those reported by

the drug companies.

Biederman, for example, originally told Harvard that he had received

no money from & in 2001. When Grassley asked him to

double check, Biederman admitted to receiving $3,500. The drug

company's records, however, recorded payments of $58,169 to

Biederman in that year alone.

A more thorough investigation revealed that Biederman and Wilens had

received at least $1.6 million from the pharmaceutical industry

between 2000 and 2007, while Spencer had received at least $1

million.

The researchers' concealment may have violated both university and

federal conflict-of-interest rules.

The National Institutes of Health (NIH) requires researchers who are

receiving federal money to report any earnings of $10,000 or more

per year from a single source. This information is reported to the

researchers' university, which is then responsible for dealing with

potential conflict of interests. The NIH expects universities to

take this on because it would be logistically impossible for the

agency to do directly.

The NIH gave out a total of $23 billion in grants in 2007,

distributed among more than 325,000 researchers at more than 3,000

universities.

But federal and university officials admit that they have no way to

check the accuracy of the reported numbers.

" It's really been an honor system thing, " said Yale School of

Medicine Dean Alpern. " If somebody tells us that a

pharmaceutical company pays them $80,000 a year, I don't even know

how to check on that. "

Each university has different rules to avoid conflicts of interest.

Some of them require that study participants be alerted that

researchers have received money from the makers of the drug being

studied, for example. In 2000, Harvard banned researchers from

testing any drugs made by companies that had paid them more than

$10,000 in a single year.

In that year, Biederman told Harvard that he had been paid less than

$10,000 by Eli Lilly, when in fact he had received more than

$14,000. This allowed him to conduct a study of Lilly's attention

deficit disorder drug Strattera in children, using money from an NIH

grant.

" The information released by Sen. 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, " Harvard spokesperson Alyssa Kneller said.

According to Kneller, a Harvard university conflict committee is

reviewing the professors' cases. The NIH is also investigating.

" If there have been violations of NIH policy, and if research

integrity has been compromised, we will take all the appropriate

action within our power to hold those responsible accountable, " NIH

spokesperson Burklow said. " This would be completely

unacceptable behavior, and NIH will not tolerate it. "

Biederman and Wilens' NIH grants were administered by Massachusetts

General Hospital. If the hospital is found to have been involved in

the doctors' violation of conflict of interest rules, NIH could

restrict or suspend future grants. Massachusetts General Hospital

received $287 million worth of NIH grants in 2005.

Due to the widely acknowledged holes in university and federal

conflict-of-interest rules, a number of states require

pharmaceutical and medical device companies to report all the money

that they pay out to researchers, and Grassley is leading an effort

to establish a national registry of such information. He said that

the recent revelations only underscore the need for such a measure.

Yet the implications of the Harvard scandal go far beyond conflict-

of-interest rules, because Biederman and colleagues have been

instrumental in the controversial trend to diagnose more children

with bipolar disorder, and to treat those children with

antipsychotics designed for adults with schizophrenia.

The diagnosis of pediatric bipolar disorder increased by 40 times

between 1994 and 2003.

Advocates of this diagnosis claim that it has a different diagnostic

profile than the adult disease, with changes in mood occurring much

more rapidly. But many critics have questioned whether pediatric

bipolar disorder is even a real condition, or whether it is being

too widely diagnosed.

Adding to the debate, the Harvard researchers have also pushed for

the aggressive treatment of the disease with antipsychotics, which

are not licensed for such a use. The discovery that those same

researchers concealed massive payments from the drug industry has

cast further doubt on their motivations, and has led many to wonder

if too many children are now being diagnosed and treated with

potentially dangerous drugs.

There are no long-term safety data on the effects of antipsychotics

in children, but the young are known to be more susceptible to

metabolic side effects and weight gain.

" [These researchers] have given the Harvard imprimatur to this

commercial experimentation on children, " said Vera Sharav, president

of the Alliance for Human Research Protection.

Sources for this story include: www.nytimes.com.