(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. Charles E. Grassley requested the financial disclosure reports that Drs. Joseph Biederman, Timothy E. Wilens and Thomas 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 Johnson & Johnson 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 Robert 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 John 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