Commission formed to collect data on drugs - C&EN Global Enterprise

A new commission charged with devising a nationwide reporting system for adverse reactions to prescription drugs and current trends in drug prescribin...
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keV. This concentration makes the x-ray beam the brightest ever achieved, so bright that the beam it­ self is visible as a pale blue helium fluorescence before it enters the monochromator. Synchrotron radiation has the im­ portant advantage over conventional x-ray sources of providing a continu­ ous spectrum through much of the x-ray region. In the six years of its active development, it has been ex­ ploited by analytical chemists par­ ticularly for its ability to determine the local environment surrounding heavy metal atoms in complex mole­ cules or alloys, for x-ray diffraction at previously unobtainable wave lengths, and for trace element deter­ mination by fluorescence analysis. The new high-intensity beam is expected to decrease by one or two orders of magnitude the concentra­ tion of heavy metal atoms needed to study the local atomic environment ill a technique called extended x-ray absorption fine structure analysis (EXAFS). This will bring sensitivity to one metal atom for every 106 or 107 other atoms in a sample, a ratio found in many important enzyme and pro­ tein molecules. And the new beam can focus on a crystal as small as 50 micrometers, a much easier size to grow than the larger crystals needed up to now. D

Commission formed to collect data on drugs A new commission charged with de­ vising a nationwide reporting system for adverse reactions to prescription drugs and current trends in drug prescribing was announced on Capi­ tol Hill last week at a press confer­ ence, sponsored jointly by Sen. Ed­ ward M. Kennedy (D.-Mass.) and the Pharmaceutical Manufacturers As­ sociation. The 18-member Joint Commission on Prescription Drug Use is neither a government nor an industry organi­ zation. The majority of its members are physicians, pharmacologists, and lawyers. Others are associated with universities and some with state or local government agencies or industry groups. Three public members have been appointed to represent the consumers of drugs. Commission members were picked by Kennedy; Dr. Theodore Cooper, assistant sec­ retary for health of the Department of Health, Education & Welfare; and Dr. David A. Hamburg, president of the National Academy of Sciences' Institute of Medicine. The commission will have three years in which to complete its job and 6

C&ENDec. 6, 1976

Velsicol Chemical's Bayport, Tex., plant during the years—1971 through 1975—that the company produced leptophos. Leptophos, an organophosphate insecticide [0-(4-bromo-2,5-dichlorophenyl) - Ο -methyl phenylphosphonothioate], has been used only experimentally in the U.S. but has been sold under the tradename Phosvel to Egypt for use in cotton fields and to other countries. Last January, Gunter Zweig, chief of the chemistry branch at the Envi­ ronmental Protection Agency's cri­ teria and evaluation division, sent a memo to a staff member at NIOSH, alerting him to the dangers of lepto­ Kennedy: important national experimentphos. In the memo, Zweig cited EPA studies and literature data that indi­ will hire its own staff and select its cated that leptophos can cause dis­ own chairman. To ensure its inde­ orders of the central nervous system. pendence its annual funding of about NIOSH officials immediately went to $250,000 will come from a trust fund Bayport to survey the plant and in­ set up by PMA. The funds cannot be terview employees. They were told by withdrawn for any reason and the company officials that Velsicol had commission may petition for addi­ just terminated production of lepto­ tional funds if required. phos because of a surplus of invento­ According to PMA, it is sponsoring ry· the new commission because of a NIOSH requested complete med­ challenge issued by Kennedy in a ical records of all employees—in­ speech to PMA last May, when he cluding those that had left—who were called on the industry to use its re­ working at the plant in the five years sources to initiate a drug data col­ that Velsicol manufactured lepto­ lecting mechanism. Kennedy points phos. Following months of corre­ out that up until now the regulation spondence, NIOSH says that it finally of prescription drugs has focused al­ got some limited information. It finds most exclusively on the premarketing that six employees are suffering ner­ phase. Once a drug is marketed, he vous disorders—three from enceph­ says, a physician may use a drug in alitis, two from multiple sclerosis, and any dosage for any purpose—whether one from permanent disability due to or not that purpose has been evalu­ spastic paralysis of the lower ex­ ated scientifically. tremities. What the institute didn't The Food & Drug Administration get was information on how many does have a voluntary adverse drug employees were examined by the reaction reporting system. But Ken­ company doctor during those five nedy says two years of hearings by his years and how many employees are Senate Subcommittee on Health has suspected of suffering nervous dis­ shown that very little detailed infor­ orders. Velsicol, the only company to have mation is available on the postmark­ eting use of drugs. " We simply don't made leptophos, says it first became know," he says, "how different kinds aware in 1975 of "the serious occu­ of doctors use different categories of pational health problem" associated drugs and we don't know the true in­ with the compound. At that time, cidence of adverse reactions." The according to a company spokesman, commission "must be viewed as an "we retained independent medical important national experiment." D experts to review the health of our employees." Since that time, he says, there have been no additional inci­ dents. He adds that the firm has "re­ Insecticide blamed ported fully" on the situation to ap­ propriate government agencies, and for nervous disorders that it is cooperating with them in A casual memo from one chemist to reviewing the matter. Velsicol had applied to EPA for another has led to the discovery of cases of pesticide poisoning reminis­ tolerances for the insecticide's use on cent of those in the Kepone incident lettuce and tomatoes, and had re­ a year ago. Officials of the National ceived a preliminary denial. It ap­ Institute for Occupational Safety & pealed this denial but later withdrew Health now are actively following up its appeal. EPA had terminated the on the health histories of more than experimental use permit three weeks 100 employees who had worked at ago. D