GMU, GW IN PATENT, ETHICS DISPUTE



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Last Updated

17 Sep 2003

Source: Washington Post, September 17, 2003

GMU, GW in Patent, Ethics Dispute

AIDS Immunity From Smallpox Vaccine Suggested, Not Vetted

By Avram Goldstein, Washington Post Staff Writer

A small-scale study that suggests people receiving smallpox vaccine might also gain immunity from HIV has ignited an ethical tiff and a patent dispute between the two Washington area universities that collaborated on the work.

George Washington University scientists are seething because George Mason University issued a news release on the study last week -- even though no peer-reviewed medical journal has accepted the research team's report -- and because it filed a patent application that does not recognize GW's work.

The researchers, using blood samples given by 10 recently vaccinated and 10 unvaccinated U.S. Marines, reported a statistically significant difference in resistance to HIV infection. HIV failed to grow or grew at substantially reduced levels in the cells from the vaccinated group when compared with the unvaccinated group.

But the study was so tiny that people on all sides say no one is sure whether the results would be the same on a large scale. GW researchers said the "premature" publicity could cause misguided people to seek a smallpox vaccination for illusory HIV protection and could hamper efforts to win scientific legitimacy.

The only scientific journal that reviewed the article, the Journal of the American Medical Association, rejected it this month. Now it is under consideration by the Lancet, a British medical journal, said GMU Provost Peter N. Stearns.

"It's dangerous to bypass the peer-review process," said Peter Hotez, chairman of microbiology at GW. "The George Mason people are deliberately creating a situation where people who engage in high-risk behavior that could expose them to HIV might seek out and receive smallpox vaccine, erroneously believing that this might protect them."

The vaccine is available only through government programs for first responders, health care workers and the military.

"Smallpox vaccine is actually dangerous because it's a live viral vaccine," Hotez said. "If someone engages in high-risk behavior and has HIV, this could cause a very dangerous or even a disastrous situation."

Stearns said the news release may not have been the wiser course. "It was a decision made after careful thought, but like many decisions, it could have been made the other way," he said. "If they want to throw around scientific insults, I guess that's their privilege."

An HIV vaccine would be enormously valuable in fighting a disease that has ravaged the world, said Raymond S. Weinstein, the Dale City family practitioner and GMU professor who conceived and supervised the study.

"Imagine what we could do in Africa, where they have a huge AIDS crisis, to be able to start vaccinating people and reduce new cases," Weinstein said. "It would have a huge social and economic and human impact."

Weinstein brought the idea for the experiment to Ken Alibek, a bioterrorism expert at George Mason, and Alibek arranged for the collaborative lab work with George Washington microbiologist Michael Bukrinski.

Stearns, said the university made the announcement Sept. 11 because GW and George Mason researchers had already conducted a briefing for officials at the Department of Health and Human Services.

A federal health official who spoke on condition of anonymity said, "This is not peer-reviewed stuff in the scientific literature that's subject to scrutiny. The implication that it actually will produce protection against HIV at this point in time is highly speculative. The government eagerly awaits confirmation of the data and explanation of the protective mechanism and some evidence of how long it might last."

When George Mason issued its news release last week, shares of Acambis, the British company with an exclusive $428 million contract to sell smallpox vaccine to the U.S. government, were "overheated" on the London Stock Exchange, said Acambis spokeswoman Lyndsay Wright. Acambis may collaborate with GMU on larger-scale tests, she said.

Meanwhile, patent lawyers have filed competing provisional patent applications for each university. George Mason's did not credit GW, but GW's credited George Mason.

"The vaccine is already out there," said John F. Williams Jr., GW's provost and vice president for health affairs. "I don't know if [the application is for] a process or a mechanism. . . . The key thing from my point of view is that the two institutions are going to continue to collaborate. HIV is a major public health issue that I don't want to get lost."

On that, Stearns agrees. "I hope the importance of the scientific possibility isn't overshadowed by the dispute," he said.