NIH changes COI policy in response to scrutiny

Here’s a quick look at new initiatives

As National Institutes of Health (NIH) officials learned the hard way, sometimes it takes little more than the suggestion of a conflict of interest to cause a major upheaval and media scandal.

IRBs and institutions might take away two important thoughts from the NIH’s recent experience: First, it doesn’t take more than the appearance of a conflict to harm one’s reputation. Secondly, some of the measures NIH has taken in response might guide institutions in their own conflict of interest (COI) policy-making.

On Dec. 7, 2003, the Los Angeles Times published a report that led to public concern over NIH’s ties to research companies and resulted in a hearing before the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education on Jan. 22, 2004.

The article raised questions about consulting activities on the part of Stephen I. Katz, MD, PhD, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases at NIH. Specifically, the article showed ties between Katz’s consulting activities and a research sponsor of a lupus nephritis study in which one subject died.

Katz testified to the Senate Subcommittee that he followed all NIH rules and regulations regarding consulting work and other outside activities, including having made no decisions affecting any company for which he consulted.

In one instance, he had not recused himself from matters relating to one subsidiary of Schering AG, from which he had accepted consulting fees, because he and other NIH officials were unaware that the subsidiary, Berlex, was affiliated with Schering AG, Katz testified.

Berlex was the company that supported the lupus study.

"Notwithstanding this gap in the system and despite the sensational and wholly inaccurate impression the LA Times sought to create, I did not make any substantive decisions which affected Berlex or the lupus trial conducted on its drug," Katz told the Senate subcommittee.

John I. Gallin, MD, director of Warren G. Magnuson Clinical Center at NIH, also was mentioned in the newspaper article. The alleged COI that resulted in Gallin being forced to testify before the senate subcommittee was that he was an author on a study about a vector prepared by Somatix Therapy Corp. to be given to patients as gene therapy. In June 1997, 18 months after the gene therapy last was administered and after the manuscript was ready for submission, Somatix Therapy was purchased by Cell Genesys.

Several months later, Gallin was asked to join the Scientific Advisory Board of Abgenix Inc., a spinoff of Cell Genesys. Gallin testified that he was unaware that Abgenix and Cell Genesys had an affiliation when he accepted the advisory board position.

"But I should note again that Somatix Therapy Corporation and Cell Genesys were not affiliated at any time during our gene therapy study," Gallin testified. "Therefore, there was no conflict between my consulting work for Abgenix Inc. and the clinical research study that my laboratory did with Somatix Therapy Corporation."

Both these examples show how wrong public impressions can be created based on tenuous financial ties to research sponsors.

New policies an outgrowth

NIH’s response has been to develop new policies and initiatives with regard to financial COIs includes the following:

• NIH employees are required to submit outside activity approval packets for any outside activity they wish to pursue that involves consultative or professional services; these include teaching, speaking, writing, and nonfederal board service.

• NIH employees who already are engaged in such activities are required to complete these packets, listing the information regarding the amount and type of compensation they receive and expect to receive.

• Supervisors will be required to review and approve or deny these requests, seeking advice from deputy ethics counsel when needed.

• In considering requests for approval of outside activities, supervisors should consider whether a conflict will arise between the relationship the employee has with the outside organization and his duty to the NIH and whether the conflict will require a disqualification that will effectively prevent the employee from performing critical duties and thereby harm the efficiency of NIH.

• NIH has created the NIH Ethics Advisory Committee (NEAC), composed of members within NIH, to review certain activity requests where an NIH employee will receive compensation from an outside entity.

Activities reviewed by NEAC primarily will involve employees who are directors, and they will include one of the following:

— cash awards where compensation exceeds $2,500;

— outside activities with biotechnology or pharmaceutical companies;

— outside activities where total anticipated compensation exceeds $10,000 or is expressed as future income stream;

— activities for which the compensation proposed is stock, stock options, or other equity position.

NEAC’s review criteria will include these questions:

— Does the proposed activity conflict with the employee’s official duties?

— Does the proposed activity use the employee’s government position for private gain?

— Does the proposed activity influence the employee in the performance of an official act, or induce the employee to take or omit an action in violation of the employee’s official duties?

— Does the proposed activity use nonpublic information?

— Does the proposed activity involve the inappropriate use of government property?