Revisions would speed drug approval process decades, judging from the outpour­ing of scientific discoveries and the variety of awards. These include a disproportionate share of Nobel Prizes going to Klug's colleagues, such as Max Perutz and Frederick Sanger.

Methodically during the past two decades, Klug and his many collabo­rators commandeered electron mi­croscopy, helping to correct many of the faults that had kept it from the realm of quantitative science. Opti­cal filtering techniques were adapted for use in electron microscopy, at first to enhance two-dimensional im­ages and to improve their fidelity, but eventually to furnish composite three-dimensional images of an object.

Improving the process involves the same two essential steps as in opti­cal filtering, according to Klug, namely the formation of a diffrac­tion pattern (Fourier transforms) and their recombination. Carried out by computer, such analysis is based on viewing an object at different angles using several pictures. Simi­lar enhancement techniques have been developed to minimize other distorting affects, allowing images to be made from unstained speci­mens.

These and other methods have been brought to bear on diverse problems, such as solving the struc­tures of transfer-RNA, TMV, chro­matin, and the molecular apparatus within the purple membranes from a particular bacterium. "I've spent 25 years working on the structure of TMV," Klug says. "We now know it in detail; this also is becoming true of chromatin."

For example, Klug and his collab­orators helped to rewrite an attrac­tive but misleading chapter in the chromatin story, in which histone proteins were described as "beads on a string" of DNA. The real pic­ture is more like string on beads: DNA is wound around globs of his­tone proteins, which act as a scaf­folding placed at regular intervals to permit packaging of a cell's ge­netic material.

Such matters lie at the heart of molecular biology inasmuch as his-tones must figure in which stretches of DNA are being read for genetic messages and when DNA is being copied for use in subsequent gen­erations. Thus Klug's contributions, important in their own right, set the stage for addressing the central ques­tions of how key genetic and devel­opmental processes are controlled in living tissues. D

The Food & Drug Administration has proposed a series of revisions to its new drug approval process that could reduce the processing time for these drugs by six months. Current applications take an average of two years to complete.

Basically, the revisions would cut the length of approval time by re­quiring less paperwork from the drug sponsors and less review time by FDA. Specific changes include elimi­nating the need to submit individ­ual patient report forms on each per­son using the drug, devising a more efficient appeals process to resolve differences between the drug firms and FDA, permitting the approval of a drug solely on foreign clinical investigations as long as they meet U.S. standards, and eliminating some recordkeeping and reporting require­ments for drug companies after the drug has been approved.

Two changes would increase mon-

Earnings continue drop a The third quarter is traditionally a time for slower business and poorer earnings than in the rest of the year for the chemical industry. And this year, the industry seems to be con­tinuing this tradition with a ven­geance.

The problems that have plagued the industry through the first two quarters are continuing—including poor markets in construction and automobiles. But some new prob­lems also have reared their heads, such as devaluation of the Mexican peso. This is having a big impact on U.S. chemical companies with large operations in that country. And the strength of the dollar against most other foreign currencies is having a chilling effect on chemical exports.

Thus, earnings for almost all of the companies that have reported third-quarter results so far are down—and in most cases down con­siderably—from their levels a year ago.

A sampling of chemical firms bears this out. For instance, Union Car­bide reports that its earnings for the third quarter dropped to $60.5 million, 61.2% less than in last year's third quarter (based on applying the same accounting method for foreign currency translation that it uses now to last year's figure). The third-quarter 1982 figure excludes a $10 million nonrecurring gain.

itoring of the drugs after marketing. One would require companies peri­odically to update the drug applica­tion with any new safety data dis­covered while the drug was under investigational review by FDA so the most recent data would be available for making the final decision. The second change would increase post-market surveillance of any adverse health effects caused by the drug. Companies would have 15 days to file an "alert report" if any serious problems were to be found with the drug, and 30 days to report any other adverse reactions discovered.

Most of these proposed changes were first outlined in July at a meet­ing of the National Pharmaceutical Council in Washington, D.C. (C&EN, July 12, page 18). Formal proposal of the changes, published in the Oct. 19 Federal Register, opens a 60-day period for public comment on the changes. Π

most companies For American Cyanamid, long one

of the more stable chemical compa­nies in profits performance, earn­ings dropped 48.2% from a year be­fore to $27.1 million. The company's sales slid 7.9% to about $861 million. Chairman James G. Affleck says that the company's third-quarter perfor­mance was affected seriously by the continuing worldwide recession, par­ticularly in the agricultural and For­mica brand products businesses. He

Affleck: hurt by global recession

Oct. 25, 1982 C&EN 5