News of the Week our spectra with their measurements, they're identical," he tells C&EN. "More important is the fact that their spectra were measured over a very limited energy range so they were unable to see the same features we found." Ruoff and Vanderborgh's theory is incorrect, he adds, because "when one has very low amounts of ruby one sees the same onset of reflectivity." Hemley says a paper of his to be published in April could help clarify the issue. Ruoff, who has seen this paper, says, "It makes it look as if they're backtracking and heading toward agreement with our results," but Hemley calls this "patently false." Research on H 2 metallization continues, with the latest results to be presented at the American Physical Society meeting in Cincinnati later this month. Stu Borman
Anti-clot drug study may hurt biotech sales Results of a massive study of blood clot-dissolving drugs, issued last week at an American College of Cardiology meeting in Atlanta, could have a major impact on sales of highly competitive thrombolytic agents. ISIS-3 (3rd International Study of Infarct Survival) surveyed 46,000 heart attack patients in 16 countries, directly comparing three versions of the agents. The agents were streptokinase from Behringwerke, Eminase (a streptokinase/plasminogen activator complex) produced by SmithKline Beecham, and duteplase [a genetically engineered version of tissue plasminogen activator (TPA)] produced by Wellcome. SmithKline Beecham and Wellcome funded the 18-month study, which was designed by a group at Oxford University. No difference in mortality was found among the drugs. But a key finding was a slight increase in the risk of stroke with Eminase or duteplase. This increased risk, attributed to "probable cerebral bleeding," was about 0.4% higher than for streptokinase. Similar results were found in an Italian study last year, in which the bioengineered drug— in that case, Genentech's recombi6
March 11, 1991 C&EN
nant TPA—faced the decades-older streptokinase. The ISIS-3 results, coupled with growing pressure to trim soaring medical costs, are likely to cause a second look at use of the drugs. Streptokinase costs about $200 per treatment; Eminase about $1700; and TPA, as sold by Genentech, about $2200. Genentech is the only firm to hold U.S. marketing approval for TPA so far, and it dominates the thrombolytic market with $210 million in sales, about a two-thirds
share. However, rising competition from the other two products and results of the Italian study are slowing its sales growth. Genentech stresses that its TPA differs from Wellcome's duteplase used in ISIS-3, which, it notes, is an experimental TPA variant not yet approved for sale. Genentech has gone so far as to sue SmithKline Beecham for implying in advertising that ISIS-3 compares Eminase to Genentech's TPA (C&EN, March 4, page 7). Ann Thayer
Objections to proposed plant safety rules aired Late last week, the Occupational Safety & Health Administration wrapped up eight days of public hearings in Houston on its proposed safety standard for the petrochemical industry. Most witnesses backed the concept of the standard, but many raised objections concerning its implementation. The regulation, proposed last July, aims to provide a systematic approach to accident prevention at facilities that handle flammable, explosive, or highly toxic chemicals. More than 50 companies, industry associations, unions, and public interest groups testified on many of the same issues that surfaced during OSHA's Washington, D.C., hearings on the standard last November (C&EN, Dec. 17, 1990, page 12). The latest hearings made it easier to collect testimony from people in the Houston area—the site of both the October 1989 Phillips 66 plant blast and the July 1990 Arco Chemical explosion, which together killed 40 workers. The hearings were prompted in part by those accidents. At the heart of the standard is the requirement that employers conduct process hazard analyses (PHAs) in their plants. These may enable an employer to "determine where problems may occur, take corrective actions that would be necessary if there were, for example, a failure of safety controls or a failure of redundant systems," says OSHA. Many participants expressed concern over the implementation time frame and costs for performing PHAs. "Implementing and maintaining an effective process safety
management program requires a major commitment of limited resources, both capital and human," said Ramon Lopez, manufacturing and technical vice president for Shell Oil. Texaco Chemical's coordinator of health and safety, Irene L. Jones, testified that the firm "supports the American Petroleum Institute in requesting seven years to complete the initial PHAs." And the Texas Chemical Council pointed out that the cost of such compliance would extend beyond that of the initial PHA to include documentation and training costs, which might involve plant downtime. The hearing also became a forum for debate over the use of subcontractors by petrochemical companies, and how to ensure that they work safely on site. The Oil, Chemical & Atomic Workers International Union reiterated its worry that increasing use of contract labor makes refineries and petrochemical plants more dangerous places to work, and it recommended that the host company take responsibility for training contract workers. Participants commented on many other aspects of the proposed standard, such as its requirements that employers maintain safe operating procedures; maintain mechanical integrity of equipment; manage changes to the processes; conduct incident investigations; develop emergency action plans; and conduct compliance safety audits. OSHA says it expects to publish the final regulation before the end of the year. Susan Ainsworth
