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The Potential of Gene Therapy Threatened by Early Tragedies

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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.

Caplan tells WebMD that even though some researchers have financial interests in gene treatments, money is not the main issue, as some news coverage suggests. "Ambition, arrogance, laziness, hubris are all much more important, and so is the drive to succeed and win -- be the first," says Caplan.

Some of the reform efforts, which typically involve more regulations and more federal oversight, no matter how well intended, are also off the mark, says Caplan. "Oddly enough, it's the ethics of the scientist that count, [and] you can't be there in the lab -- you can't be there with every patient," says Caplan.

One major issue for scientists is the multiple layers of regulation. Before human trials can begin, the investigators must win approval from local institutional review boards (IRBs), the safety boards that monitor human trials at individual institutions, then get an approval from the FDA, and in many cases, the National Institutes of Health.

And that's just the tip of the iceberg. "There are four reviews that go on for every study before [an IRB] ever sees the trial, and then it's reviewed by 35 [IRBs] around the country at each of our sites before a human subject ever enters a trial," Robert Schooley, MD, head of infectious diseases at the University of Colorado School of Medicine, tells WebMD of his AIDS research.

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