FDA: A stinging critique - Chemical & Engineering News Archive (ACS

The Food and Drug Administration's total science effort has received a stinging critique from an ad hoc science advisory committee at the invitation o...
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plant and took air samples. On May 20 one worker was hospitalized with suspected mercury poisoning; he is still undergoing tests. In addition, eight other workers have filed claims with the state of West Virginia for workmen's compensation for mercury exposure. Thomas Capps, plant manager for the Allied facility, says he believes the plant is in full compliance with the generally accepted standards referred to by the citation. Mercury found by the inspectors was the result of minute pipeline leaks that occurred when the mercury cell operation was closed down several hours for scheduled maintenance and equipment installation. He attributes the leaks to cooling and contraction of the pipelines during the shutdown. Following return to normal operations the same day, the mercury droplets were cleaned up, he says. The company has taken steps to tighten maintenance and housekeeping procedures and to make greater use of a mercury vapor depressant as recommended by the inspectors. Recent air sampling of the cell rooms and adjoining areas show that mercury vapor levels meet generally accepted standards. CANADA:

Similar science problems Unemployment among scientists and engineers; poor job outlook for graduating classes; national science policy—all are topics that could characterize an American Chemical Society meeting, or a meeting of most any other U.S. scientific society for that matter. Last week they were echoes from across the border, issues confronting the Chemical Institute of Canada at its 54th Canadian Chemical Conference in Halifax, N.S. No hard actions resulted from that confrontation. In moving to increase its involvement in the issues, however, CIC may have succeeded in better defining the dimensions of problems facing the Canadian chemical community. One of those problems is a shortage of employment opportunities for chemistry and chemical engineering graduates, at least in the short term. Layoffs of scientists and engineers have been taking place in Canada, as they have been in the U.S. A recent CIC survey shows that of some 1800 chemistry and chem-

ical engineering students graduating from 34 universities with bachelor's, master's, or doctor's degrees, about 40% up to that time had been unable to find employment in their fields of specialty (C&EN, April 26, page 26). CIC plans to conduct another survey in the fall to detail what happened to 1971 graduates. That there are as many students in science and engineering curriculums as there are people employed in R&D activities in Canada seems likely to keep the issue alive. Employment opportunity is also one of the factors behind CIC's desire to provide an input to the development of a national science policy in Canada. A draft position paper on science policy presented as a basis for initial discussion by the membership notes that the impact of government policies in other areas has had a profound effect on the utilization of science in Canada, much of it negative. Taxation policy, according to the paper, has left little money in the hands of corporations to use for developing new technology. Liberalization of trade has made export of raw materials more profitable and processing of them in Canada less attractive. Uncertainties regarding the government's position on Canadian ownership and the role of multinational corporations in Canada has also influenced business decisions on use of science and technology in Canada. Judging from discussion, it will be some time before CIC comes up with an official position. But with the appointment by the government of a minister of state for science expected shortly, some members feel a statement can come none too soon. FDA:

A stinging critique The Food and Drug Administration's total science effort has received a stinging critique from an ad hoc science advisory committee at the invitation of FDA commissioner Charles C. Edwards. The committee says FDA suffers from, among other things, poor morale, a poor reputation, and in some instances, poorly managed laboratories. To remedy the problems the committee makes some 50 recommendations. Only one—a call for abolishing the Bureau of

Veterinary Medicine—is unacceptable, Dr. Edwards says. Many have already been implemented. Dr. Edwards requested the study about a year ago to determine which aspects of FDA's scientific activities needed improvement. Dr. Roy E. Ritts, Jr., of the University of Minnesota's Mayo Graduate School of Medicine, chaired the committee of five academic scientists. The committee faced no restrictions, Dr. Edwards says, and was free to speak to anyone, look at any records, and inspect any facilities. The committee did just that, and spared few harsh words in reporting its thoughts. For instance, it C&EN: Fred H. Zerkel

FDA's Charles Edwards

says that certain FDA labs have advanced technology, good morale, and high productivity, but others are "so poorly managed that scientists seem to be unable to describe their work coherently." Some senior chemists have to perform "menial chores," the committee observes, in order to proceed with their work, partly because of inadequate numbers of technicians. The committee says conditions at certain labs are a disgrace to the agency. At Chicago and Philadelphia, for instance, FDA lab facilities are "antiquated, crowded, and unsafe," and at Denver are "only barely adequate." FDA regulatory actions also draw criticism from the committee, which notes that some regulatory decisions have been made apparently without adequate scientific input. For example, FDA's action on cyclamates illustrates JUNE 7, 1971 C&EN 13

Chemical world This week are also attempting to Chemical world This l they their academic personnel "forced and hurried judgment with inadequate, premature or uncon­ firmed scientific input admixed with political and industry pres­ sures." To remedy this the committee calls for an agencywide understand­ ing that good science is the funda­ mental basis for effective decision making by a consumer protection agency. Other recommendations on the committee's long list include the need for better science plan­ ning, improved management and communication practices, and wider use of outside scientists on councils and committees. On balance, committee member Willard Krehl points out that the agency fundamentally is doing a sound job within the budget avail­ able. The committee itself notes that the agency is doing an extra­ ordinary job in many ways. It adds, however, that FDA faces "enormous responsibilities for con­ sumer protection and the public health but with limited resources, constricted perspective, and little solid constituency in the public and medical and scientific establish­ ments." CHINA:

No theoretical research

bring into closer contact with ordinary work­ ers, he says. Within the context of their work, for example, this might mean that scientists "would have to accept suggestions about techni­ cal matters, when appropriate, from untrained laymen." It also means that scientists spend part of their time at unskilled labor. Most of the research work the U.S. biologists saw was either bio­ logical or medical—primarily be­ cause that is what they asked to see, but also because most Chinese R&D is in these fields. Agriculture con­ sumes about 80% of the total labor force, Dr. Galston points out, "so, clearly, that is where they have to put their major emphasis." Research in North Vietnam is similar in quality and direction to that in China, Dr. Signer notes, al­ though North Vietnamese scien­ tists "haven't had that explicit push to shift the focus" from theoretical to applied research. The most im­ pressive thing about North Viet­ nam's research, he believes, is that there is any research at all, consid­ ering the country is at war. The most notable difference in scien­ tific research between China and North Vietnam, Dr. Galston adds, is that the Vietnamese have had to disperse their universities because of aerial bombing. In sum, the travelers found the scientific establishments of both countries to be relatively sophisti­ cated. For example, the research centers have good, modern (Chi­ nese-produced) equipment and the libraries are well stocked and up to date. To an American, Dr. Gal­ ston says, "it is perfectly clear that basic science as we understand it is proceeding slowly while they at­ tend to practical questions," but "one has to give them a lot of points for attacking their problems very straightforwardly."

"There is now no such thing as purely theoretical research" in the People's Republic of China, says Dr. Arthur W. Galston. Instead, most university curriculums have been restructured so that the research of every department deals with practical problems, such as indus­ trial and agricultural production. All the work, he says, is develop­ mental or is short-term research aimed at specific, applied goals. Dr. Galston, professor of biology at Yale University, is in a unique position to discuss the status of Chinese science. He and Dr. Ethan Signer, associate professor of bi­ ology at Massachusetts Institute of Technology, have just returned EMPLOYMENT: from a 32-day visit to China and Drug screen for job seekers North Vietnam. Traveling at their own expense, the two biologists It's not news to chemistry and visited scientific, academic, agricul­ other science graduates that job tural, and industrial facilities. prospects are dimmed this year by They also talked with the leaders the depressed state of the economy and lower levels of research spend­ of both Communist countries. The strongest impression of the ing. For many new graduates, a trip, Dr. Signer says, was the effect history of drug use that is turned of the cultural revolution on sci­ up in pre-employment investiga­ ence. Not only are the Chinese tions may close the doors remain­ making academic work more rele­ ing open. This warning comes vant to the problems of society, but I from George R. Wackenhut, presi14 C&EN JUNE 7, 1971

ι dent of Wackenhut Corp., Coral Gables, Fla., one of the three larg­ est security companies in the U.S. "These college students have worked and studied for years for the day when they can leave school and start their careers. Now they may find that in the desire to keep step with their peer group, they have seriously damaged their ca­ reer potentials by experimenting with and using drugs," he says. Together with Pinkerton, New York City, and William J. Burns In­ ternational Security Services, Briarcliff Manor, N.Y., Wackenhut specializes in the security guar*d business, but the three companies also provide clients with pre-em­ ployment security checks. Wackenhut Corp. estimates that 80°/o of medium- and large-size com­ panies in this country have prob­ lems with employee drug abuse. As a result, the company says, many companies have issued strict guidelines in dealing with employ­ ment and drug use. In particular, pre-employment screening intensi­ fies as companies try to detect his­ tories of drug use. Because indus­ try now recognizes the large in­ crease in the use of drugs on cam­ pus, particular attention is paid to college graduates, Wackenhut says. Interviews with neighbors and associates are one source of infor­ mation. Occasionally, a polygraph examination is useful to determine truthfulness of the applicant about drug use, the company says. A Wackenhut spokesman points out the potential temptation for drug-using employees to sell pro­ prietary information of chemical processes or details of bids on en­ gineering projects, for example, to raise money for buying drugs. The firm says it has encountered among client companies some un­ derstanding in cases of drug experi­ mentation, but at many companies there is a policy to summarily re­ ject applicants with drug use his­ tories. This policy is easier to en­ force this year because companies have so few positions to fill. Burns International notes that use of interviews with third parties for pre-employment checks are limited by recent legislation de­ signed to restrict credit checks. The company stresses that poly­ graph examinations can pick up his­ tories of drug abuse, though recent drug use can be detected in pre-em­ ployment physical examinations.