Key vote next week on human gene therapy - C&EN Global Enterprise

Jul 23, 1990 - R. Michael Blaese and Kenneth W. Culver of the National Cancer Institute and W. French Anderson of ... disease (SCID) in as many as 10 ...
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Panel assails nuclear waste storage program Scathing criticism was fired last week at the U.S/s already controver­ sial plans for a permanent under­ ground geologic repository for spent nuclear fuel (containing depleted uranium-235) and high-level radio­ active wastes. A position statement by the Na­ tional Research Council's Board on Radioactive Waste M a n a g e m e n t charges that current policy, "as con­ ceived and implemented over the past decade, is unlikely to succeed," because it requires assurances of safety over thousands of years that science and engineering cannot pro­ vide. The program is "rigid" and "unrealistic," applies geologic mod­ els and other methods in a "scientif­ ically unsound" manner, and may prevent underground disposal in­ definitely unless the U.S. adopts ma­ jor legal and regulatory changes, the board says. The U.S. is using the approach re­ garded worldwide as the best and safest. This is to put the waste into a specially designed facility where lo­ cal geology and groundwater condi­ tions will permit isolation for tens of thousands of years. By law, the site must be licensed by the Nuclear Regulatory Commission and meet radionuclide release limits, set by the Environmental Protection Agen­ cy, that would result in less than 1000 deaths in 10,000 years. In 1987, Congress told the Depart­ ment of Energy to study just one site, Yucca Mountain, Nev. However, last December, the state of Nevada sued DOE, seeking to end site character­ ization actions. Nevada also had re­ fused permits DOE sought for two years for site testing. In January, DOE countersued for the permits. Even if proved acceptable, site operation has already been pushed back to at least the year 2010. The board says the U.S. program is unique in the world in its "rigid schedule," its "insistence on defining in advance the technical require­ ments for every part" of the contain­ ment system, and its requiring the site to be certified "safe" by EPA standards before waste is put in. The result is a "scientific trap . . . encour­

aging the public to expect absolute certainty about the safety of the re­ pository for 10,000 years"—which is "a time longer than recorded human history," it notes—and "encouraging DOE program managers to pretend that they can provide it." Waiting for complete certainty be­ fore interring the waste virtually guarantees that it will remain where it is now: "mostly at reactor sites at or near the Earth's surface." Thus, the board stresses, the choice is not between an "ideal" and a less than perfect underground facility, but be­ tween disposal underground and leaving it at the surface, with proba­ bly higher risks of public exposure. The board recommends instead a more flexible approach, permitting changes during repository construc­ tion and operation as new informa­ tion becomes available—modeled after Swedish and Canadian pro­ grams. "A realistic—and attain­ able—goal is to assure the public that the likelihood of serious un­ foreseen events . . . is minimal and t h a t t h e c o n s e q u e n c e s of such events will be limited." This new approach will require profound changes by Congress, regulators, and DOE. And, it admits, "a likely alternative is that the program will continue as at present." Peter B. Myers, the board's staff director, tells C&EN this is the first time the board has focused on over-

Yucca Mountain suitability for nuclear waste storage is probed with test cores all U.S. policy, after years of criticiz­ ing various aspects. "The board con­ cluded you can't get there from here, and to pretend otherwise is folly." However, Melinda Kassen, a se­ nior attorney with the Environmen­ tal Defense Fund in Boulder, Colo., tells C&EN that e n v i r o n m e n t a l groups believe current standards should continue in force. Until stan­ dards can be met, it is "more pru­ dent to rely on above ground dry cask storage at nuclear sites than to go ahead with an unsafe under­ ground repository," she adds. Richard Seltzer

Key vote next week on human gene therapy Climaxing a tortuous federal review process that has so far involved four committees and seven meetings, the National Institutes of Health's Re­ combinant DNA Advisory Commit­ tee (RAC) is expected to approve next week the first clinical trials of human gene therapy. If the vote is positive, final approvals will then be needed from the Food & Drug Ad­ ministration and the acting director of NIH to permit the study to begin, perhaps as soon as this fall. R. Michael Blaese and Kenneth W. Culver of the National Cancer Insti­ tute and W. French Anderson of the National Heart, Lung & Blood Insti­ tute are seeking clearance from RAC for a proposal to use recombinant DNA techniques to treat a form of

severe combined immunodeficiency disease (SCID) in as many as 10 af­ flicted children. SCID patients, the most well known of whom was the Texas "bubble boy," are severely de­ ficient in Τ lymphocytes. These blood cells are needed to fight infec­ tions, so their loss leaves the body open to opportunistic infections. Some SCID cases are caused by lack of a normal adenosine deami­ nase (ADA) gene. The proposed treatment would use a retroviral vector to insert normal ADA genes into Τ lymphocytes taken from each patient. The transduced blood cells would then be cultured to increase their numbers and injected back into the patient to provide a continuous source of ADA. July 23, 1990 C&EN 5

News of the Week Lymphocytes have a limited lifetime in the blood, so the treatment would have to be repeated periodically and is not a cure. However, if successful, it could open the door to gene treatment for other diseases. Foreign genes were also transferred into humans in tests completed earlier this year by Steven A. Rosenberg of NCI, Blaese, and Anderson, but that procedure was not designed to be therapeutic. Anderson, Blaese, and Culver contend that the gene therapy procedure is safe. The retroviral vectors being used do not pose a public health risk, even in the event of accidental exposure, and "there is virtually no danger of exposure of germline cells . . . or risks to offspring. Therefore, no special precautions need to be taken," they say. Stu Borman

Two companies offer early retirement In what might be signs of a chemical industry slowdown, two large chemical firms have revived the use of early retirement incentives in an effort to reduce their work forces. Pharmaceuticals manufacturer Schering-Plough has announced a program for which 900 people, or 6% of its domestic work force, are eligible. Hoechst Celanese is offering incentives to 220 salaried employees at its polyester textile fibers operations in Spartansburg, S.C.; its polyester film operation in Greer, S.C.; and its polybenzimidazole fiber operations in Charlotte, N.C., with the goal of reducing employment by 117. The Labor Department's seasonally adjusted data show that chemical industry employment, essentially flat over the past six months, declined by 1000 in June to 1,106,000. Industry capacity utilization has remained essentially flat this year at about 82%, following previous highs in the 1988-89 period of 86.8%, according to t h e Federal Reserve Board. Housing construction, a major chemical industry customer, is now considered in recession, according to Department of Commerce figures, as housing starts have dropped 6

July 23, 1990 C&EN

to an annual rate of 1.18 million in June, following four months of consecutive declines. Until recently, chemists and chemical engineers appeared largely unaffected by the industry slowdown of the past six months. In a March survey by the American Chemical Society of its members, of 39,000 respondents, only 1.1% of chemists were without a job and were looking for work (C&EN, July 9, page 37). But recently the society's Committee on Professional Relations has been pursuing what a staff member says is a flood of 12 unconfirmed multiple termination reports. Only six mass terminations were confirmed last year. According to a Schering-Plough spokesman, the early retirement program is available to all employees including chemists. He says the goal of streamlining personnel is secondary to satisfying employees' request for such a program. He says the company plans to hire new employees during the remainder of the year, but he declines to indicate how many new employees might be hired.

Employees with at least 10 years of service who are 55 years of age or older must respond by Aug. 10 to participate. Robert P. Luciano, chairman and chief executive officer of Schering-Plough, says the program will have no material impact on earnings and adds that the company continues to project that 1990 earnings will increase 18 to 20% per share. Whereas Schering-Plough's offer is not obviously forced on the company by deteriorating business conditions, Hoechst Celanese's offer is predicated on deteriorating textile industry conditions. Industry shipments of man-made fibers have declined this year compared with last year. Polyester fiber producers Du Pont and Wellman have recently cut their fiber p r i c i n g . Hoechst Celanese has not yet cut its prices, but a spokesman says it needs to effect employee reductions to run more efficiently. Salaried employees 50 years or older with at least five years of service must notify the company they will participate by Sept. 16. Marc Reisch

ICI consolidates specialties operations Five years ago, British chemicals giant ICI reorganized its commodity and polymers business into one cohesive unit. Encouraged by results from that move, the company has just done the same with its various specialty interests. The new unit will be called ICI Specialties and will bring together a staff of 12,000 around the world, 3000 of whom are in the U.S. Yearly sales are about $2.7 billion. ICI's new operations are as diverse as colors and fine chemicals, surfactants and other specialties that have been part of the commodities and polymers group, resins, and biological products, which include the company's DNA profiling technology and biodegradable plastics. "We think these businesses will flower under entrepreneurial management," says Ronnie C. Hampel, ICI executive director responsible for specialties. Rodney Brown, who will head the new group, adds that the new focus will accelerate growth

and enable the company to put more research and technical work into the product areas. He says it will also cut down on overlapping areas—for example, in surfactants. The company expects to see 45% of sales in Western Europe, 30% in the U.S., 11% in the Asia/Pacific region, and 14% elsewhere. Commenting on the fragmented nature of the industry, Hampel says, "We will be one of the top three or four specialty c h e m i c a l c o m p a n i e s in t h e world," but will have "only about 1.5 to 2% of the world market." Hampel says new jobs will be created by the restructuring—news that likely comes as a relief to ICI's labor negotiators, who have just had a 9.8% pay offer rejected by the company's 24,000 workers. The U.K. inflation rate has hit 9.8% through June. The unions had asked for a 14% raise; their officials must now take a vote among members about a strike or other industrial action. Patricia Layman