A Clinical Trials Litigation Web Site

A Clinical Trials Litigation Web Site

Alan Milstein is the king of U.S. clinical trials lawyers. He has pursued several high-profile cases, including those brought against the Fred Hutchinson Cancer Research Center (Seattle, WA), the University of Pennsylvania (the Jesse Gelsinger case), and the University of Oklahoma Health Sciences Center. Click on his law firms Web site (sskrplaw.com/gene/) for clinical trials litigation, and you will be introduced to the actual lawsuits for these cases. They are fascinating examples of the myriad good clinical practice problems that can occur at a clinical study site.

Much more about good clinical practice (GCP) can be found at this Web site. It features numerous documents and commentary on studies and experiments:

• Regulations and governing documents such as the Code of Federal Regulations, Nuremberg Code, Declaration of Helsinki, Belmont Report, and the IRB Guidebook
• Tuskegee Study
• Nazi experiments
• U.S. government radiation experiments
• Willowbrook and Fernald School experiments
• Documents related to the deaths of Ellen Roche (Johns Hopkins), Jesse Gelsinger (University of Pennsylvania), Nicole Wan (Rochester, MIT), Gage Stevens (Propulsid), and James Quinn (artificial heart)
• Anthrax vaccine (FDA warning letters and inspection reports)
• Muckraking articles in the popular press on clinical studies that were dangerous.

The site has links to bioethics organizations, a bioethics chronology prepared by Milstein, and a section on the Gelsinger case that describes three popular myths of human experimentation (according to Milstein):

Risk. The purpose of a clinical trial is to benefit medicine and science at little or no increased risk to the subject.

Oversight. Somebody is watching. Investigators are watched by institutional review boards (IRBs); IRBs are watched by the Office for Human Research Protections (OHRP); the OHRP is watched by the Food and Drug Administration (FDA); the FDA is watched by the Department of Health and Human Services (DHHS); and the DHHS is watched by Congress.

Informed consent. The informed consent document shows evidence that informed consent was given.

This Web site should be mandatory reading for those being trained in GCP, as it includes more material on the topic than most books do. Although there is a decided slant to the coverage, its selection and inclusion of historical events and documents makes it a valuable tool for understanding how and why we have instituted various protections, imperfect as they are, for conducting clinical studies.

Douglas R. Mackintosh, DrPH, is president of GCPA, Inc., 12208 Fairfax Station Road, Fairfax Station, VA 22039, (703) 988-9080, fax (703) 988-9082, email: GCPAudits@aol.com, hometown.aol.com/GCPAudits.