NEW YORK – Pharmaceutical industry executives, patient advocates, government officials and legal experts debated the ethical issues involved in drug development during a panel discussion in McNally Amphitheatre at Fordham University. Organized by Celia B. Fisher, Ph.D., director of the Center for Ethics Education at Fordham, the Jan. 10 public forum, titled Bio-Pharmaceuticals and Public Trust, 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 Energy and Commerce Committee, 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 effects, [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, 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 were also on hand. All the panelists participated in a summit at Fordham on Jan. 11 designed to develop recommendations for legislation involving clinical drug trial registries..
The Fordham University Center for Ethics Education, which is directed by Celia B. Fisher, Ph.D., was created in 1999 to contribute to Fordham’s commitment to cultivating lifelong habits of critical thinking, moral reflection and articulate expression. The Center sponsors activities that provide students, faculty, professionals and the public with knowledge and skills to study, inform and shape a just society that nurtures the full-flourishing of peoples of diverse faiths and cultures. The text of panel presentations for Biopharmaceuticals and Public Trust are available atwww.fordhamethics.org.