The Potential of Gene Therapy Threatened by Early Tragedies
The vaccine program at Baylor remains on hold, and patients who participated are being carefully followed, says a spokeswoman.
In March, the FDA shut down a gene therapy study aimed at growing new blood vessels in patients with severe heart disease at Boston's St. Elizabeth's Hospital. The issue still being negotiated is whether the researchers properly reported two patient deaths to the FDA, according to a hospital spokeswoman there.
And in July, the newly created Office for Human Research Protections, established to help the government oversee all human clinical trials, stopped federally funded medical research at the University of Oklahoma College of Medicine in Tulsa over concerns about the safety of a vaccine to treat melanoma. An audit revealed a number of manufacturing flaws in the product, raising questions about whether patients with the deadly skin cancer understood the risks involved in the trial.
Not long after, the dean of the College of Medicine resigned, along with two other high-ranking officials involved with the institution's research program. Termination proceedings are underway against the vaccine's lead investigator, Michael McGee, MD, and his research has been restricted.
"We felt like it was a very serious problem and obviously one that needed to be addressed," Ken Lackey, president of the University of Oklahoma Tulsa programs, tells WebMD. The rapid action may signal a new mentality in the research community.
"All agencies have been jolted. They all are now proactive," Inder Verma, PhD, president of the American Society of Gene Therapy, tells WebMD. "They're all becoming more active in making sure that there are preventive measures before anything reaches that point."
Verma says that the University of Pennsylvania's Wilson was probably running more trials than he could reasonably handle but that the field of gene therapy will be stronger because of Jesse Gelsinger's death. "The expectations have been high. The delivery has been low, and, therefore, the field suffered ... a backlash," says Verma.
And that backlash may be at the detriment of both the field and those who could benefit from its progress. Recent reports indicate that some trials are now having a hard time recruiting patients in the midst of all the negative publicity about gene therapy. While the news media have been enthralled by the story of a much-ballyhooed technology in trouble, the pieces often miss the point, according to medical ethicist Arthur Caplan, PhD, of the University of Pennsylvania.