November 08,2005

Chairman Grassley asks Inspector General to review system that governs human testing of pharmaceutical drugs

November 8, 2005

Via Electronic Transmission

The Honorable Daniel R. Levinson
Inspector General
Department of Health and Human Services
Office of Inspector General
330 Independence Avenue, SW
Washington, DC 20201

Dear Inspector General Levinson:

The Committee on Finance (Committee) has jurisdiction over the Medicare andMedicaid programs, among other matters. Accordingly, the Committee is responsible tothe more than 80 million Americans who receive health care coverage under thoseprograms, including payment for drugs and medical devices. As Chairman of theCommittee, I am greatly concerned by a special report published in the December 2005issue of Bloomberg Markets, entitled, “Big Pharma’s Shameful Secret” (Report). TheReport states that “[e]very year, drug companies spend $14 billion to test experimentalsubstances on humans. Across the U.S., the centers that do the testing—and theregulators who watch them—allow scores of people to be injured or killed.”

According to the Report, people who participate as patients in clinical drug trialsare not always warned adequately of the risks of those trials, are sometimes blatantlyendangered and harmed, and, although otherwise healthy, some are dying as a result ofthe trials. The Report suggests that these problems are arising from a lack of directFederal oversight and the reliance on largely unregulated private institutional reviewboards (IRBs) to monitor trials conducted by profit-driven testing centers staffed bypoorly trained, unlicensed clinicians. Not only is this treatment of participating patientsand their families alarming, but it also undermines the credibility of the pharmaceuticalresearch and development process and places the value of new pharmaceutical productsin question. The problems with how some clinical trials are being monitored andconducted may harm important efforts to encourage participation in properly conducteddrug trials, which could expand the availability of life-saving new drugs for this countryand the world. The more fundamental and important concern, however, is the lack ofprotections and respect for research participants who place their health and their lives inthe hands of clinical investigators and the entities that are expected to monitor andoversee the studies.

Therefore, as Chairman of the Committee, I request that the Office of InspectorGeneral (OIG) review the issues identified in this Report. Specifically, I ask that youassess the previous work undertaken by your office in this area and determine appropriateissues related to institutional review boards that your office can address, including but notlimited to FDA oversight of clinical trials. In particular, please advise whether or notadministrative, regulatory, and/or legislative corrective actions in this area are needed.

In addition, I note that over the last 10 years previous OIG reports have addressedmany of these issues and contained recommendations related to protecting humanresearch subjects, including but not limited to strengthening institutional review boards,improving recruiting practices for human research subjects, and strengthening FDAoversight of clinical investigators. Therefore, I request that the OIG forward acomprehensive list of its recommendations to the appropriate agencies of jurisdiction andto this Committee, along with the date of each recommendation and the OIG’s knowledgeof the status of each recommendation as of the date of this letter. Please be aware thatunder separate cover I am requesting that HHS, FDA and NIH provide an accounting tothis Committee of their actions taken in response to the OIG reports released in 1995,1998, 2000, and 2001.

Finally, as Chairman of the Committee, I request that your office keep theCommittee apprised of your review of the aforementioned matters. At the earliestopportunity, I would appreciate receiving a briefing from your office. We must takeevery possible step to ensure that our clinical trial system is in fact the “Gold Standard”that we expect it to be.

Thank you in advance for having your staff coordinate with my staff about thisletter by November 10, 2005. I would appreciate your response by November 29, 2005,unless it is available sooner. Any questions or concerns should be directed to DanDonovan, Senior Investigative Counsel, at (202) 224-4515, or All formal correspondence should be sent via facsimile to (202) 228-2131 and original by U.S. mail. Please do not hesitate to contact me if you have anyconcerns.


Charles E. Grassley