Controversial AIDS vaccine trial backed - C&EN Global Enterprise

Nov 30, 1992 - In a move arousing widespread criticism, Congress voted in October to give the Army $20 million to expand its testing of gpl60, a genet...
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nology policy. The report recommends creating a broad new national policy responsive to the needs of society, and going beyond science and engineering to include technology and its applications in the post-Cold-War era. NSF, with its emphasis on research and engineering, would have a role to play in this policy. But the panel says that role should be in basic research, and not the industrial and economic role some in Congress envision. David Hanson

Monsanto, Occidental plan major reductions Monsanto and Occidental Petroleum have separately announced plans for major retrenchments and reductions in force, entailing millions of dollars in charges against earnings, with both companies blaming expectations of a continued sluggish economy. Monsanto plans to eliminate 3200 jobs, or 10% of total employment. Hardest hit will be its G. D. Searle & Co. pharmaceutical subsidiary, which will cut 2250 jobs, or 20% of total employment. Many workers are expected to accept early retirement and severance packages. In addition, Monsanto plans to consolidate, close, or sell a number of nonstrategic businesses and facilities. Only one has been named so far, its Simple Pleasures frozen dessert business (see page 9). These moves will result in a one-time charge against earnings of $425 million and are expected to generate $200 million in annual savings when completed in 1995. Monsanto also plans to make some whopping accounting changes that will significantly affect earnings. It will take a charge against earnings of $658 million for medical and postretirement obligations to employees. However, it will gain $118 million from an accounting change for income tax obligations. Monsanto's earnings in this year's third quarter fell 50% from third-quarter 1991 to $53 million on a 3% sales gain to $1.9 billion. Meanwhile, Occidental plans a companywide 2% reduction in its work force, or 500 jobs, by the end of 1993. It §ays it also will cut capital expenditures in 1993 to $750 million from its 1992 level of $900 million. These actions, plus a salary freeze for all employees earning over $40,000 a year, will generate savings of $300 million in 1993. The result is

expected to be charges of about $25 million against earnings, including $15 million already set aside from an earlier reorganization. Occidental's earnings in the third quarter of 1992 from all sources, including chemicals, dropped 53% from last year's third quarter to $69 million, and sales fell 3% to $2.3 billion. Ray R. Irani, Occidental's chairman, president, and chief executive officer, explains the retrenchments by saying: "We must continue to operate on the assumption that our performance in the near term could very well remain under the influence of a sluggish economy." The sluggish economy affects not only Occidental's oil and gas operations, but also its commodity chemicals. The chemical operations, says Irani, "are currently out of favor because they are at the bottom of the cycle." However, he adds, "Our chemical operations have tremendous upside potential in a healthy economy." Monsanto's chairman and chief executive officer, Richard J. Mahoney, explains the company's cutbacks in terms not only of the world recession, but also of global competition: "Consumers worldwide are

demanding products and services at dramatically lower prices. We must respond in this fiercely competitive environment by significantly reducing our cost of doing business In our view, these conditions are a permanent shift in requirements, rather than simply a reflection of currently depressed economic conditions." Monsanto's cost-cutting steps include realignment of "selected research investments," by refocusing efforts on pharmaceutical projects with near-term paybacks. Analysts point out that Searle soon will lose patent protection on a popular cardiovascular drug, Calan, and that the company has no products in the pipeline with the potential to quickly replace Calan's revenue. Under the costcutting program, other Monsanto operating units will make a similar effort to focus only on the most commercially viable research programs. The cutbacks were welcomed on Wall Street. Monsanto's stock rose $1V8 to $56% on the New York Stock Exchange, and Occidental's gained HVi cents to $17V&, following their announcements. Marc Reisch

Controversial AIDS vaccine trial backed An advisory panel of AIDS experts convened by the National Institutes of Health recommended last week that the Army proceed with a controversial large clinical trial of a vaccine designed to boost the immune systems of people infected with the AIDS virus. But the trial must test all available vaccine candidates, the panel voted—not just the particular product specified by Congress in the Defense Department's 1993 appropriation bill. In a move arousing widespread criticism, Congress voted in October to give the Army $20 million to expand its testing of gpl60, a genetically engineered vaccine manufactured by MicroGeneSys Inc., a biotechnology research firm based in Meriden, Conn. The biomedical research community reacted angrily, charging Congress with bypassing the usual scientific review process by earmarking funds in response to the company's lobbying. "I have concerns and reservations about the process by which gpl60 was selected by Congress for the proposed efficacy trial," said NIH director Bernadine P. Healy earlier this month. "Not only is this a case of law preempting science and scientific judgment, it is pre-

empting science in the context of a clinical trial involving human subjects." However, the legislation includes an escape clause: If the Secretary of Defense, NIH director, and Food & Drug Administration commissioner agree that gpl60 does not merit the proposed clinical trial, the money can be spent on other AIDS research. Healy convened the panel—composed primarily of AIDS researchers and representatives from AIDS advocacy groups—to advise her on the issue. DOD officials and FDA representatives, including commissioner David A. Kessler, took part in the discussions. MicroGeneSys's gpl60 vaccine is based on a protein from the outer shell of the human immunodeficiency virus (HIV). Other biotech firms and research organizations also are working on vaccines derived from this or other HIV envelope proteins. Small-scale trials of gpl60 in humans have shown it is safe and stimulates the immune system. Whaf s not yet clear is whether the immunological changes it provokes actually help AIDS patients. According to Anthony S. Fauci, head of NIH's AIDS effort and chairman of the advisory panel, only a large-scale clinical trial can show whether such NOVEMBER 30,1992 C&EN

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squash court under the stands of the University of Chicago's football stadium. Scientists led by Enrico Fermi tensely watch from a balcony (at left) as a colleague below withdraws the final cadmium control rod from the world's first nuclear reactor, creating a self-sustaining chain reaction. A "liquid-control squad" of three scientists on a platform above the uraniumgraphite pile (at right) stands ready to flood it with cadmium salt solution if the mechanically operated control rods fail. The first chain reaction was a critical step toward making the atomic bomb, as well as opening the way to other nuclear development. The university is commemorating the anniversary with a historical exhibit and two symposia. The anniversary was also celebrated two weeks ago at meetings in Chicago sponsored by the American Nuclear Society, European Nuclear Society, and U.S. Council for Energy Awareness (a nuclear power trade association).

50th birthday of nuclear age celebrated in Chicago A series of events in Chicago this week will celebrate the birth 50 years ago of the nuclear age—achievement of the first controlled, self-sustaining nuclear chain reaction, depicted here

vaccines can stop the progression of AIDS toward death. That's because to date there are no reliable physical indicators to use as surrogate markers to judge if a vaccine is working. The panel warmed to the idea of studying the vaccines' effects in as many as 30,000 people with AIDS drawn from the entire U.S. population—with more detailed studies simultaneously on the disease's course in a smaller subgroup. "I vote we spend this money," says Jesse

in a painting by artist Gary Sheahan. No photographs were taken at the time, but the painting, made in 1957 after four months' research, reconstructs the scene on Dec. 2,1942, in a

Norman of Project Inform, a San Franicisco-based AIDS advocacy group. "Lef s try to get good science out of this so theree will be some benefit even if there's noo therapeutic effect." Healy will make a decision only after»r meeting this week with the NIH direc-:tor's advisory committee. FDA andd DOD appear to support the panel's rec-:ommendations, but must still formallyy decide whether to endorse the trial. Pamela Zurer er "

Groups send energy plans to Clinton, Congress Reports abound that President-elect Clinton plans to give the Department of Energy a major role in creating new jobs, protecting the environment, promoting energy efficiency, and developing renewable energy sources. Now, environmental, sustainable energy, and labor groups have weighed in with their own policy and budget proposals designed to influence Clinton and Congress. A coalition of several dozen energy, environmental, consumer, and industry groups issued a "Sustainable Energy Blueprint" with four goals: pumping up the economy, saf^guarding the environment, preserving public health, and strengthening national security. These are the same goals candidate Clinton outlined in his book "Putting People 8

NOVEMBER 30,1992 C&EN

First." The coalition includes the Naturald Resources Defense Fund, Friends of thee Earth, the American Wind Energy Asso-y ciation, the National Association of Ener-:gy Service Companies, and the Solar En-tergy Industries Association. The coalition says at least 1 millionn new jobs would be created by year 20000 through investments in sustainable energy technologies and policies—mainlyy energy efficiency and alternative energyy sources. It says such programs could cutit energy use at least 10% by 2010, reducee greenhouse gases 25% from 1990 levelss by 2005, and substantially cut produc-:tion of long-lived radioactive waste. One of its 50 recommended steps callss on the new Administration to publishh within six months an action plan to first>t

stabilize and then cut greenhouse gas emissions. Another step creates a White House Commission on Competitiveness & Energy Productivity. A third redirects DOE's 1993 or 1994 budget from nuclear R&D, oil and coal R&D, and the Superconducting Super Collider to renewable energy, energy efficiency, and natural gas programs. A fourth step, parallel to the third but aimed at the private sector, ends tax subsidies to mature, conventional energy technologies, and redirects them to new, emerging resources and technologies. Also, last week Greenpeace, which is not a member of the coalition, issued a report in alliance with the Oil, Chemical & Atomic Workers International Union (OCAW) calling for achievement of similar goals. Their proposal, "Energy for Employment," calls on Clinton to shift about $15 billion a year (5% of the current annual defense budget) to a program to create jobs in clean energy technologies. Such defense fund redirection could yield a net employment increase of more than 1 million new jobs, say Greenpeace and OCAW. But it could also produce severe economic dislocations. So they propose a Superfund for, Workers, modeled after the post-World War II G.I. Bill of Rights, to fund job reeducation while providing full income support to displaced workers. Lois

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