|In her keynote address, Rep. Diana DeGette (D-Colo.), noted that surveys gauging the public’s trust in the FDA and pharmaceutical companies indicate that fear has replaced confidence regarding the safety of new prescription drugs.
Photo by Jessica Chornesky
Top executives from pharmaceutical companies, the federal government and patient advocacy groups gathered at Fordham for a two-day summit designed to address the most controversial issues regarding the development, approval and marketing of new drugs. A steering committee of those stakeholders will ultimately develop a white paper to help guide federal lawmakers as they debate legislation regarding clinical registries and clinical-trial results databases.
“Biopharmaceutical research and development have produced lifesaving and life-enhancing treatments. Yet there is cynicism and skepticism about the intentions of the biotechnology and pharmaceutical companies,” said Celia B. Fisher, Ph.D., director of the Center for Ethics Education at Fordham, who organized the summit along with Falguni Sen, Ph.D., professor of management at Fordham Schools of Business. “This forum provides an opportunity to begin the creative dialogue essential to the construction of sound policy.”
The summit launched with a Jan. 10 public forum in the McNally Amphitheatre titled “Bio-Pharmaceuticals and Public Trust.” A panel of biopharmaceutical stakeholders highlighted various controversial issues, including potential conflicts of interest in drug research, mandatory clinical trial registries, transparency in reporting trial results and full disclosure to research subjects.
“The complexity of the public’s interaction with biopharmaceuticals can be overwhelming,” said Rep. Diana DeGette (D-Colo.) during her keynote address. “Public loss of confidence often stems from questions of motives.”
DeGette, who, as a member of the House Committee on Energy and Commerce, has jurisdiction over healthcare and consumer protection, said citizens have difficulty trusting the motives of for-profit drug companies that they believe could value the bottom line above public safety.
The most impassioned presentation among the panelists came from Alan C. Milstein, a lawyer with Sherman, Silverstein, Kohl, Rose & Podolsky in Pennsylvania, who shared the story of Jesse Gelsinger, an 18-year-old who died as a result of experimental gene therapy. Milstein, who represented Gelsinger’s family in a suit against the University of Pennsylvania, where the experiment took place, successfully argued that Jesse had not been informed about potential dangers.
“There were numerous violations of protocol, and this is at the top gene therapy institution in the world,” said Milstein. “After Jesse’s death, researchers reported 691 prior adverse affects [including the deaths of two monkeys].” Jesse’s family was only informed about 39 negative reactions, according to Milstein.
Such high-profile cases have seriously damaged the public’s trust, and the panelists agreed that greater transparency of the drug development process is needed to restore confidence in the industry and federal government, which has been accused most recently of slack oversight of approved drugs such as Vioxx.
Some patient advocates are lobbying for mandatory clinical trial registries, which would require drug companies to make public details of research and trials that weren’t previously disclosed. Drug companies, however, question the practicality of such registries in a competitive environment, where proprietary data and research are a company’s most valued assets.
“Merck has serious concerns about intellectual property and the impact of mandatory registrations,” said Laurence Hirsch, M.D., executive director of medical communications for Merck Research Laboratories, which manufactured and marketed Vioxx. The arthritis medication has been linked to stroke and heart disease and has been pulled from the market.
Other panelists included Theresa Toigo, director of the Office of Special Issues for the Food and Drug Administration (FDA), who noted that complaints from patient advocacy groups in the 1980s led to faster FDA approval of new drugs. Representatives of the National Health Council and the Office of Human Research Protections also participated.