Medical research grants under investigation

In recent months, Senator Chuck Grassley of Iowa and ranking Republican on the Senate Finance Committee has been leading an investigation into the policies of universities that regulate how medical researchers report conflicts of interest.

Earlier this month, the National Institutes of Health (NIH) halted a $9.3-million grant to Emory University, based on allegations that the coordinator of the project receiving the funds, Charles Nemeroff, failed to disclose income that he received from the drug company GlaxoSmithKline (GSK), thus violating federal regulations.

"The issue is transparency," Grassley said in an e-mail. "Patients rely on their doctors' advice and have a right to know about financial relationships."

The Iowa Senator emphasized that the reporting of a conflict is his main concern.

"The major issue in my work is compliance with conflict of interest reporting requirements and achieving greatly expanded disclosure of financial relationships," he said.

According to Grassley, the industry's substantial support for continuing medical education and the use of the industry's money to pay for articles that present a scientific point of view are two worrisome tenets of medical research.

According to the Hopkins Medical Institute Web site, Hopkins defines a conflict of interest as "a situation where you are conducting research that is sponsored by, or involves a product of, a company for which you are consulting or providing other outside services, in which you have a personal financial interest, in which your spouse/domestic partner and/or minor dependent has a financial interest, [or] for which you can influence purchasing decision."

The Medical Institute Web site also explains another situation that creates a conflict of interest.

"Similarly, conflicts of interests can also occur in situations where you are conducting research involving a product for which you are named an inventor on a related license."

Hopkins has a specific definition of conflict of interest with regards to its medical research.

"Under Hopkins School of Medicine and other academic medical center policies - and federal (NIH) regulations - having a conflict of interest in itself is not a problem and does not imply wrongdoing," Julie Gottlieb, assistant dean for policy coordination at the Johns Hopkins Medical Institute, said. "Rather, failing to report a conflict of interest is a problem."

"Many conflicts of interest can be managed," she said. "They are allowed to exist, subject to conditions such as requirements for disclosure of the financial interest."

"I would characterize the leadership as being committed to ensuring that Hopkins has robust policies and procedures for identifying and addressing financial interests in research that may create risks to data integrity, safety of human research subjects, openness and collegiality in research and protection of students' interests," Gottlieb said.

Hopkins administrators feel that many conflicts of interests can be managed.

"The risks associated with some conflicts of interest cannot be managed so arrangements must be modified (e.g. lower or eliminate certain financial interests; limit the research role of the investigator who has the financial interest) or prohibited," Gottlieb said.

Grassley, however, feels that more needs to be done.

"Universities have been lax about collecting and auditing reports of financial relationships that their research doctors have with industry," he said. "It also looks like the NIH has been lax about verifying information it collects from institutions receiving grants and lax about enforcement generally."

The chairman of the department of bioethics at the NIH agrees that more needs to be done.

"The safeguards aren't working. They're onerous to those who do adhere, and they don't work for those who don't adhere," he told the Chronicle of Higher Education.

According to the Chronicle of Higher Education, federal regulations define conflicts of interest as "receiving more than $10,000 a year or owning more than 5 percent of an entity that might bias their work."

According to Megan Columbus, the acting director of communications and outreach at NIH, the NIH believes that the process with financial conflicts of interests could be improved.

"Therefore, we plan on releasing an Advanced Notice of Proposed Rule Making (part of a formal process to change regulations which requires the Department of Health and Human Sources level and Office of Management and Budget approval) to give the research community and the public the opportunity to weigh in on the necessary changes to the financial conflict of interest regulation," she wrote in an e-mail.

"Conflicts of interest are inherent in the conduct of science," she added.

Grassley has sent letters requesting information on conflict of interest polices to over 20 universities in his investigation.

"I haven't released the names of all the places that I'm seeking information on, in order to keep the investigation as effective as possible," he said when asked whether Hopkins was one of the universities being investigated.

Yet Grassley believes that more needs to be done.

In September 2007, he introduced the Physicians Payments Sunshine Act, which would require companies to disclose any payments of more than $500 that they made to researchers.

Although it did not pass, Grassley say he plans to introduce it again.

Hopkins's stance has yet to be determined.

"The University has not taken a formal position.?However, in general, there is support for transparency and openness, and the Sunshine Act will go a long way toward establishing transparency," Gottlieb said.