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Biotech Experts Debate Gene Therapy, Regulation

By Naveen Sunkavally
NEWS EDITOR

Two days after the 3000-strong Biodevastation protest rocked Boston, a group of high-profile pundits on biotechnology gathered in a public forum to discuss gene therapy and its implications.

Tuesday night’s Technology and Culture Forum featured panelists with a variety of perspectives. James Heywood ’91, whose ailing brother inspired him to found the ALS Therapy Development Foundation, was pitted against George Annas of the Boston University School of Public Health, who favors a moratorium on gene therapy.

Claudia Mickelson, chair of the Recombinant DNA Advisory Committee in the National Institutes of Health, spoke about the government’s role in oversight of biotechnology, while Professor Sheldon Krimsky in Urban and Environmental Policy at Tufts University blasted the lack of government regulation and the hype about biotechnology.

Panelists speak about issues

Mickelson began the evening with a speech about the differing roles of various government oversight committees, including the Food and Drug Administration (FDA), the Office of Protection of Research Risks (OPPR), the Institutional Review Boards (IRBs), and the Institutional Biosafety Committees (IBCs).

Mickelson pointed out that number of requests for gene therapy trials in recent years has skyrocketed -- 91 last year, and 23 in the first two months of this year. Of those trials, 61 percent are related to cancer, she said.

In response, Annas said, “We need heavy-duty oversight, which is non-existent in the United States. Review boards can’t function. The FDA has no staff or oversight.”

Annas called the current lack of accountability and lack of penalties appalling.

Annas decried the use of children in experiments. “Babies can’t consent. Children can’t be used as guinea pigs,” he said. Annas said that humans also should not be participating in Phase I tests, because they are uninformed and do not realize that the tests are merely for toxicity.

Heywood, on the other hand, said that current government regulation was slowing down the process of finding cures. He likened the situation to a burning building, in which scientists are firemen trying to save the lives of the diseased.

“Gene therapy is treatment,” Heywood said. It is not cloning, genetic engineering, or playing God, he said. “Patients should make the decision” about whether they want to participate in tests, “not some attorney at Harvard,” he said, looking at Annas.

Sheldon Krimsky, the last speaker, allied himself with Annas with his observation that scientists in the private sector, blinded by commercial possibilities, tend to hype biotechnology to outrageous extremes.

Researchers are less likely to report the adverse effects of their experiments, Krimsky said. And in journals, such as Scientific American, research scientists write about biotechnology without revealing their affiliations to biotechnology companies.

Two emotionally charged moments

Two dramatic emotionally charged moments occurred later in the question-and-answer period of the forum.

One woman, whose 5-year-old child is suffering from a rare disease and is seeking gene therapy, denounced Annas, saying she could judge what was best for her child. “I am a physician and my husband has a PhD in biochemistry,” she said.

Stephen Heywood, the ailing brother of James Heywood, who was a member of the audience, also railed against Annas. “What makes [gene therapy] not real science?” Heywood asked.

Later, a woman affiliated with Biodevastation 2000 asked the panel why gene therapy was receiving so much funding when there are so many solvable diseases in the third-world related to diet and nutrition. Mickelson responded by saying that only 65 percent of gene therapy was funded by the government.