This June the New York Times broke the story that two Harvard Professors, Dr. Joseph Biederman and Dr. Timothy Wilens, had only belatedly reported their considerable external financing from drug makers to their University. The evidence, revealed during a congressional investigation, may also cast suspicion on the dramatic increase in prescribed antipsychotics.

As AIA has documented, some groups remain skeptical of the expansive definitions surrounding Attention Deficit Disorder diagnoses. Others are concerned by the rapid expansion of the use of psychotropic drugs among children.

The investigation of the Harvard doctors, two of about 30 university-affiliated scientists under suspicion, is being spearheaded by Senator Chuck Grassley (R-Iowa), a Senator known for his fiery investigation into university endowments and transparency efforts.

“These physicians are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies and failed to report those payments accurately to Harvard and Mass General [Hospital],” Grassley said on the Senate floor on June 23. The Senator also said that he was looking into payments made to a “professor of psychiatry” at the University of Cincinnati, but gave no name.

Grassley is currently investigating financial conflicts of interests at 20 different universities and colleges, reports the Chronicle of Higher Education.

Senator Grassley and Senator Herb Kohl (D-Wisc.) introduced the Physician Sunshine Payments Act of 2007, which was referred to committee with no hearings last Fall. Notable cosponsors include Senator Hillary Clinton (D-NY) and Senator Ted Kennedy (D-MA).

The Act would establish a database of physicians and other researchers’ funding from pharmaceutical companies if payments exceed $500. Current National Institutes of Health (NIH) standards require grantees to self-report financial conflicts of interest if they exceed $10,000 annually or have 5% or greater equity ownership in a company.

On June 23, Senator Grassley also announced that he would be looking into the activities of a Stanford employee, Dr. Alan Schatzberg.

Schatzberg developed Mifepristone, an anti-depressant, using an NIH grant to Stanford University. Stanford later sold the patent rights to Corcept Therapeutics, a company Schatzberg co-founded in 1998.

In a letter to Senator Grassley, Stanford claims that they are “managing” the conflict—but Dr. Schatzberg continues to act as the “principal investigator” on the extended NIH research grant.

Dr. Schatzberg currently owns 2,738,749 shares of Corcept stock, potentially worth $6 million, according to Senator Grassley.

The Senator believes that Schatzberg’s ongoing conflict of interest displays a “pattern of behavior” and has demanded that Stanford release financial information regarding the University’s total NIH grant and its financial conflict disclosure policies.

Contention remains over whether Grassley’s investigations will uncover systematic conflicts of interest among medical researchers, but a January report issued by the Department of Health and Human Services remains troubling. The “NIH’s Institutes and [NIH Office of Extramural Research] were unable to provide us with the paper copies of all the actual conflict of interest reports received from grantee institutions,” reports the DHHS. “Some of the Institutes were also unable to provide an accurate count or even an estimate of the reports that they received during the 3-year period.”

11 of the 24 Institutes were able to provide exact numbers for FY 2004-2006, 10 provided an estimate count, and 3 of the Institutes could do neither.

This government-entity receives billions of dollars annually and may soon see an increase in revenues, despite its poor record and 2003 scandal. The 24 National Institutes of Health received $29.2 billion in fiscal year 2007, around 80% of which was distributed as medical research grants. The 2009 appropriations bill would increase NIH funding by another $1 billion, reports the Chronicle of Higher Education.

The NIH seems to suffer many of the same problems as the Food and Drug Administration (FDA), in that it relies heavily—if not solely—on grantee’s self-reporting of conflicts-of-interest. Even if grantees do report financial conflicts of interest, the NIH often does not investigate them further. The DHHS identified several key weaknesses in the NIH system:

1. inconsistent tracking of conflict-of-interest reports
2. “details are not required to be reported and most conflict-of-interest reports do not state the nature of the conflict;” and
3. “many Institutes’ primary method of oversight is reliance on grantee institutions’ assurances.”

In other words, the NIH accountability process is flawed at each stage, from reporting to tracking to investigation.

Stanford’s response to Senator Grassley’s investigation of Professor Schatzberg perhaps best exemplifies the culture surrounding NIH grants. “As a result [of Schatzberg’s disclosure], Stanford was fully aware of the value of his stock based on his disclosures to the University,” writes Stanford its June 25 statement.

The statement continues, 

“Before the patent was issued, Dr. Schatzberg did not have any financial interest in this drug. Once he was aware he was going to have a financial interest in mifepristone, he disclosed it, and Stanford University managed the conflict of interest. As part of that process, Dr. Schatzberg has not had responsibility for any aspect of the conduct of the grant’s research related to mifepristone.”

While Schatzberg “remains the principal investigator on the original NIH grant,” the university “would like to underscore that Dr. Schatzberg has not been involved in managing or conducting any human subjects research involving Mifepristone,” they write.

Whether Schatzberg has involved himself with the ongoing research is a matter of contention. In 2006, San Jose Mercury News writer Paul Jacobs reported that as principal investigator of the NIH grant, Schatzberg:

1. helped design studies of the abortion pill RU-486, of which Mifepristone is the main ingredient;
2. determines the salaries of those doing the experiments;
3. has control over the career advancement of those conducting the studies; and
4. continues to coauthor those papers analyzing the studies’ results.

All this is done, Jacobs reports, by a professor who a.) chairs Corcepts’ scientific advisory board, b.) serves on the board of directors, and c.) is one of the company’s largest shareholders. Jacobs article, “Science Critics Make Issue of Financial Ties,” focuses on how two medical statistics experts have criticized Schatzberg’s scientific methodology.

While Dr. Bernard Carroll and Dr. Robert Rubin, a UCLA Professor, have their own reasons to resent Schatzberg, they argue that the Stanford Professor has repeatedly exaggerated the therapeutic effects of mifepristone, writes Jacobs.

Stanford may not have remained as distant and impartial from the situation as the University maintains. In their June statement, they write “Stanford received a small amount of equity in Corcept under a technology license. Pursuant to its policy on institutional conflict of interest, Stanford divested itself of the stock.”

What they don’t mention is that Stanford waited 17 months before selling the stock—and then gave the proceeds to an affiliated hospital. “Another safeguard, put into place by Stanford in December 2002, requires that the university divest shares in companies like Corcept…It did not do so until May 2004—a few months after Corcept went public. The university gave the proceeds—about $100,000—to Lucile Packard Children’s Hospital, which is affiliated with Stanford,” writes Jacobs.

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