Scripps defends research deal with Sandoz - C&EN Global Enterprise

portrayed it as stifling free enterprise and restricting the free exchange of ideas. ... on Small Business' Subcommittee on Regulation, Business O...
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The new investigation confirms intestinal lesions in 39 of the 42 victims it studied. But these were mostly beneath the surface of the tissue and so likely caused by transmission of the infection A new interpretation of evidence from by blood, not by ingestion. But all 42 victhe 1979 anthrax outbreak in the then- tims showed lesions of the thoracic Soviet city of Sverdlovsk supports the lymph nodes, an observation leading to contention that it was caused by an ac- the conclusion that the victims died from cidental release of airborne anthrax inhalation of aerosols containing anthrax spores from a nearby military facility. spores. However, the paper points out that there is a paucity of information on At least 65 civilians died. In a paper just published in the Pro- the pathology of intestinal anthrax for ceedings of the National Academy of Sci- comparison with the Sverdlovsk data. ences [90, 2291 (1993)], David H. WalkThe new findings do not clear up all er, a University of Texas, Galveston, pathologist and three Russian coauthors conclude from an examination of slides and preserved organs from 42 of the victims that they died from inhala- The Scripps Research Institute says Nation of anthrax spores. The Soviets tional Institutes of Health director Berclaimed at the time that they died from nadine P. Healy mischaracterized a eating anthrax-tainted meat. Anthrax is proposed research agreement between indigenous to the Sverdlovsk area. Scripps and Swiss-based Sandoz PharThe incident became a major Cold maceuticals Corp. when she portrayed War issue. The U.S. charged that the it as stifling free enterprise and restrictSoviets should have been more forth- ing the free exchange of ideas. coming in explaining the incident that Scripps, located in La Jolla, Calif., is indicated a likely violation of the 1972 the U.S/s largest independent nonprofit Biological Warfare Convention (BWC). biomedical research institution. NIH This treaty bans the development and provides the bulk of its $100 million anpossession of biological weapons. nual funding. Last December, Scripps The Soviets subsequently acknowl- negotiated an agreement with Sandoz edged they were developing an anthrax under which the East Hanover, N.J., firm vaccine, a legal activity under the treaty, would have the right to patent Scripps' at a military epidemiological facility in discoveries from 1997 to 2007 in exSverdlovsk in 1979. Russian President change for $300 million over that period. Boris Yeltsin said last May that the now NIH had no input into the agreement, defunct KGB indicated that the facility Healy testified at a recent hearing before was involved in the incident. However, the House Committee on Small Busithe Russian military to date has not admitted to an accidental release of anthrax. The latest study was conducted last . June in Sverdlovsk, now renamed Ekaterinburg. The three Russian authors are medical personnel involved, in 1979, in handling the outbreak. The study was funded in part through a MacArthur Foundation grant to Matthew Meselson, a Harvard biochemist. He was instrumental in developing the Biological Warfare Convention and has long been trying to shed light on the Sverdlovsk incident. In 1988, Meselson arranged for three Soviet public health officials to present data on the episode at the National Academy of Sciences in Washington, D.C. They showed photographs and slides they claimed were from autopsies of the victims that indicated extensive intestinal lesions and supported the tainted meat theory. Healy: deal stifles free exchange

New study links anthrax deaths to Soviet military

the medical mysteries concerning what happened in Sverdlovsk in 1979. For instance, if an accidental release was the cause, why was the incidence of new cases of the disease, which typically kills within three or four days, spread over a period or more than a month? An unsubstantiated theory is that the incubation period was longer for those exposed to only a very small dose of the spores. Also, why were no children among the dead, who all apparently lived or worked near the military facility? The youngest victim was 21. Michael Heylin

Scripps defends research deal with Sandoz ness' Subcommittee on Regulation, Business Opportunities & Technology. Subcommittee chairman Ron Wyden (D.Ore.) asked NIH in February to look into the deal, saying he was concerned about the potential for drug companies to charge excessive prices for products whose initial discovery had been financed by U.S. taxpayers. Contrary to Heal/s testimony, Scripps scientists will still be able to publish their work and freely exchange results, research materials, and ideas with other researchers, says Scripps senior vice president William H. Beers. Nor is Scripps becoming a federally funded Sandoz laboratory as Wyden has charged, he says. "Sandoz has no control over our research. All it can do is look over our shoulder and have first rights of refusal to develop any promising medical products." Both Scripps and Sandoz say the agreement complies with both the spirit and the letter of the Bayh-Dole Act of 1980. Designed to encourage rapid commercialization of products, the act gives universities and research institutions the rights to inventions discovered under federal grants. They may sell the patents rights to private companies on an exclusive basis. Congress has eagerly championed such technology-transfer mechanisms in the past. But Wyden's current investigation reflects growing fears that the federal government and consumers are being shortchanged under exclusive marketing arrangements. Beers, meanwhile, is afraid the intense scrutiny may cause Sandoz to call off the deal. "After all this," he says, "I think there is a real chance it may not go through." Pamela Zurer MARCH 22,1993 C&EN 7