NEWS OF THE WEEK

No major announcement of the devel­opment has been made, and no detailed research reports have been presented to a scientific audience. But Mistry—who left Imperial College, London, before ob­taining a degree—presented his work last August at the National Institute of Standards & Technology. He also de­scribed it last month at a diamond film conference in Barcelona, Spain.

The work drew the attention of sci­entists at the Materials Research Labo­ratory at Pennsylvania State Universi­ty, a leading center for research on dia­mond film technology. Penn State's Rustum Roy has arranged for the lab to study the mechanism. An agreement was about to be signed last week.

"It is absolutely one of the biggest developments in materials synthesis in a generation," says Roy. "And the amazing thing is that it was done entire­ly as part of a production, not a research, process." A memo by a consultant for the Pentagon's Institute for Defense Analysis says government support for research on Mistr/s work should pro­ceed "aggressively, optimistically, and rapidly."

Two leading diamond film research­ers contacted by C&EN would not comment on the development for lack of information. However, an official at the Office of Naval Research, who vis­ited QQC, tells C&EN that the office intends to support research on the pro­cess. Test results that he saw confirmed that the coatings were diamond films.

Mistry's achievement is one of those serendipitous developments that occa­sionally results from an error. In 1994, while working for another company, Mistry was supervising the titanium di-boride coating of a die used for extru­sion of aluminum tubing. The work in­volved "shrouding" the laser-induced coating environment in nitrogen gas. By mistake, nitrogen was replaced by carbon dioxide. When the coating pro­cess was finished, Mistry, to his aston­ishment, found that the die was coated with something resembling diamond film—much superior in properties to the intended titanium diboride.

The deposition mechanism is not yet known. But Roy says the laser pulses likely raise the temperature at the sub­strate surface to about 10,000 °C, creat­ing the plasma needed to produce the diamond crystal arrangement and to interlock it with the substrate surface.

Soon after his accidental achieve­

ment, Mistry met Manuel Turchan, president of Turchan Inc., who was looking for cheaper and more environ­mentally benign ways of machining aluminum engine blocks for the auto industry. The process at the time in­volved continuous application of toxic lubricants to cool the areas where car­bide-coated belts and drills met the metal. Mistry coated the carbide spin­dles and milling cutters with diamond film using the C02-laser technique, re­sulting in excellent performance with­out the lubricant complications.

While the breakthrough in machine tool technology is significant, it is in the diamond film field where the current excitement lies. Mistry says the new process undoubtedly could replace the vapor deposition methods industry currently uses for diamond coating.

Turchan Inc. has big plans for its di­amond-coated machine tools business. The company has already applied for 63 patents on various aspects of the process. Last week, QQC and the Del­phi Division of General Motors signed an agreement to coat brake rotors with diamond film. And Gillette is examin­ing the process for application to razor blades. In all, more than 1,000 compa­nies and organizations have expressed interest.

Wil Lepkowski

Drugmakers seek reform in drug approval U.S. pharmaceutical manufacturers say they are pleased with recent progress by the Food & Drug Administration in speeding up its drug approval process, but the system is not yet good enough. Further reforms are needed, and drug-makers are supporting legislation to mandate those changes.

In its annual review of new drug ap­provals, held last week in Washington, D.C., the Pharmaceutical Research & Manufacturers of America (PhRMA) challenged FDA's claim that its drug approval process is not a problem. "FDA's progress in reducing overall re­view time and the reforms it has an­nounced the past year should not be allowed to obscure the fact that drug regulations in the U.S. must be reengi-neered," said PhRMA President Gerald J. Mossinghoff.

FDA Commissioner David A. Kessler

Mossinghoff: enact fundamental reform

has said there is no "drug lag" between the U.S. and other developed countries when it comes to new drug approvals. Kessler's assertion that the lag is a "myth" supports his contention that ma­jor reforms are not needed at the agency.

Mossinghoff said FDA has reduced its review time for new drugs from an average of 19.7 months in 1994 to 19.2 months in 1995. "But this is still more than one year longer than the statutory standard enacted 30 years ago," he pointed out. He attributed the im­provement in review times to user fees paid by the pharmaceutical companies, which gave FDA the funds to hire more reviewers. The user fee legisla­tion was passed in 1992.

The problem is, he stressed, that more than 50% of new drug discoveries are made in the U.S., but about two-thirds of the drugs approved in the U.S. were approved first abroad. PhRMA figures show that of 28 new drugs approved in the U.S. in 1995, only 10 were ap­proved there first. Over the past six years, 66% of new drugs approved in the world were first approved outside the U.S.

Moreover, the time to bring a new drug from lab to marketplace has in­creased from about eight years in the 1960s to nearly 15 years today, accord­ing to a study by Tufts University. This increase has been accompanied by con­tinued expansion of R&D costs. PhRMA reports that drugmakers invested $14.4 billion in R&D in 1995, up from $13.4 billion in 1994. This year, PhRMA pre­dicts, companies will spend a record $15.8 billion for R&D, 19% of estimated 1996 pharmaceutical sales.

The U.S. will lead the world in drug approvals "only when we enact funda­mental FDA reform legislation," Moss-

8 JANUARY 22,1996 C&EN

inghoff said. The industry backs a bill, S. 1477, introduced last year by Sen. Nancy L. Kassebaum (R-Kan.). One provision of the legislation would require a single clinical trial to prove a drug's safety and efficacy, rather than the current two tri­als. Kassebaum has promised to push for FDA reform legislation this year. In addition, PhRMA seeks establishment of an independent oversight commission for FDA to help resolve problems.

David Hanson

Warning of infectious disease threat issued Health experts issued a warning last week at a press conference in Washing­ton, D.C., about the reemerging threat worldwide of infectious diseases.

Global warming, drug resistance, overpopulation, and the evolution of mi­crobes are creating new health threats and rekindling some diseases that it was believed had been conquered. To stress the threat's severity, 36 medical journals in 21 countries, including the Journal of the American Medical Association, coordi­nated publication of 242 articles on the problem this month.

Infectious diseases were in decline until about 1980. Robert W. Pinner, special assistant for surveillance at the Centers for Disease Control & Preven­tion, said at the press conference that the U.S. death rate from infectious dis­eases increased 58% from 1980 to 1992. Such diseases are now the third leading cause of death in the U.S. However, if deaths from AIDS are excluded, the in­crease in mortality is 22%.

Joseph F. Plouffe, professor of internal medicine at Ohio State University, Co­lumbus, found that the incidence of drug-resistant strains of Streptococcus pneumoniae—the most common cause of pneumonia—increased from 1991 to 1994. "Excessive antibiotic use appears to be the driving force behind the spread [of drug-resistant strains]/' he said.

Global climate change is likely to sig­nificantly increase the range of many in­fectious diseases in both the U.S. and around the world, said Jonathan A. Patz, research associate at Johns Hopkins School of Hygiene & Public Health. Ma­laria, dengue fever, and viral encephali­tis are among the diseases most sensitive to climate, he noted. Warmer tempera­tures cause malaria-carrying mosquitoes

to move to higher elevations and to bite more frequently, and also make the ma­laria virus multiply faster in the mosqui­to. For example, in 1987, a high-altitude region of Rwanda where malaria had never penetrated experienced many cas­es after a period of record-high tempera­tures and rainfall. Patz estimated that global warming in the next century may increase global mortality from malaria— which now kills about 2 million people each year—by 1 million annually.

Paul R. Epstein, professor of tropical medicine at Harvard Medical School, told C&EN that if s not just warmer tem­peratures that expand the range of infec­tious diseases, but the increase in weath­er extremes that accompany global warming. Prolonged droughts remove predators that control disease vectors, and torrential rains supply more breed­ing places for mosquitoes.

The world's population has never been more vulnerable to the threat of in­fectious diseases, said Joshua Lederberg, professor and president emeritus at Rockefeller University. The most impor­tant changes that led to this situation, Lederberg said, are the unprecedented movement of people and the "sheer ex­pansion of our species," with high pop­ulation densities "egregiously stratified" economically.

To combat disease threats, Lederberg urged concerted global and domestic surveillance of disease outbreaks, vec­tor management, and the provision of safe food and water supplies. He also urged the pharmaceutical industry, which has developed very few new an­tibiotics in recent years, to become ful­ly involved in creating new antibiotics and vaccines.

Bette Hileman

Federal shutdown and blizzard bury NSF in mail The National Science Foundation had to put its mailroom technicians on over­time last week as it returned to work to find thousands of backlogged research proposals jamming its offices. Normally, NSF receives about 240 proposals per day. So the 22-day federal furlough followed by four days of blizzard-induced closings left some 4,000 research proposals stacked in the mailroom and in doz­ens of mail carts lining the corridors and filling other rooms. With its mailroom staff working 12-hour shifts, NSF predicts it will take at least two weeks just to eliminate the mail backlog, and the 2,000 research institutions that rely on NSF funding may still be feeling the impact in six months. NSF says each day the government was shut down meant lost or delayed support to some 200 scientists, engineers, students, and teachers. Moreover, during the shutdown many con­tinuing grants ran out of money, and funding gaps are expected for some renew­als as well as substantial delays in funding new awards.

David Hanson

JANUARY 22,1996 C&EN 9