267285 From development to withdrawal of Raptiva: A case study examining conflicts of interest in pharma-FDA relationships, inadequate safety studies, and circumvention of the physician intermediary

Tuesday, October 30, 2012 : 5:10 PM - 5:30 PM

David Egilman, MD, MPH , Department of Community Health, Brown University, Attleboro, MA
Caroline Lee, BS , Researcher, Never Again Consulting, Attleboro, MA
The FDA's drug review process is intended to be rigorous, thorough, and balanced in its evaluation of a drug's safety profile, benefits, and efficacy before, and sometimes after, it is approved to go to market. An agency-approved label is meant to communicate all of a drug's risks and relevant information which a prescribing physician can consider and accordingly relay to his patient. However, a pharmaceutical maker can increase the likelihood of its drug's approval and a consumer's continued use by taking steps to marginalize these regulatory mechanisms. This talk will explore psoriasis biologic Raptiva's road to market withdrawal with regards to Genentech's discussion of a bribe with a FDA official; the inadequacy of pre-approval and post-marketing studies evaluating the biologic's safety; and the corporate practice of medicine in Genentech's direct communications with patients.

Learning Areas:
Conduct evaluation related to programs, research, and other areas of practice
Ethics, professional and legal requirements
Public health administration or related administration
Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
(1) Identify how conflicts of interest can affect the drug review process during and after an FDA official’s tenure. (2) Assess the adequacy of studies which are meant to establish a drug’s safety profile and how the FDA regulates them. (3) Identify a direct-to-consumer marketing program whose design allows for the corporate practice of medicine and circumvents the physician intermediary between a drug maker and the patient.

Keywords: Accountability, FDA

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a practicing physician board certified in internal medicine and preventative occupational medicine. I have served as an expert witness for plaintiffs in litigation on this subject. I research and publish extensively on public health issues.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Never Again Consulting Internal medicine, preventative occupational medicine, epidemiology Serves as an expert witness/consultant in litigation involving toxic substances, occupational health, and pharmaceuticals.

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.