NEWS VOLUME
38, NUMBER 24
T h e Chemical W o r l d T h i s W e e k
DAY IN COURT. Arthur S. Hemming (on right at witness table) Secretary of HEW, and FDA Commissioner George P. Larrick tell
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Kefauver committee that investigations will probe charges leveled against FDA, new rules will prevent conflicts of interest
HEW Probes Charges of FDA Laxity NAS scientists check safety of new drug approvals; HEW team investigates alleged pressure tactics by drug industry Charges of laxity and improper activities in the Food and Drug Administration, aired before Sen. Estes Kefauver's Subcommittee on Antitrust and Monopoly, have brought on a twopronged investigation of FDA. Arthur S. Flemming, Secretary of Health, Education, and Welfare, told the committee last week that the National Academy of Sciences will appoint a group of scientists to check FDA approvals of new drugs. He also will appoint a group of doctors and law-
yers within H E W who have had no connection with FDA to check on charges of improper administration. The group of three to five scientists to be appointed by NAS will have these jobs: • Review FDA's actions and policies in approving new drugs. • Review all approvals of antibiotics made by Dr. Henry Welch during the time he was simultaneously serving as head of FDA's Division of Antibiotics
and receiving large sums from antibiotics publications. "This is a matter of great urgency," Secretary Flemming said. He told the committee the investigation would start immediately and a preliminary report should be ready within 60 days. The H E W investigating group will investigate charges that FDA yielded to pressure applied by drug makers, held "back door" conferences with drug representatives, and acted as a JUNE
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committee he will weigh the evidence turned up by this group and make his conclusions public. Secretary Flemming also announced that FDA plans to crack down on misleading claims made by drug manufacturers in promoting new drugs. And he suggested some changes in the Food, Drug, and Cosmetic Act which would improve law enforcement. Pressure. "A compliant agency acting as a service bureau for drug manufacturers" is the way Dr. Barbara Moulton described the Food and Drug Administration to the committee. Until her resignation last February, Dr. Moulton had spent five years in FDA's Bureau of Medicine. She charged that FDA employees were subjected to pressure from drug companies seeking approval of new drugs, that FDA has approved new drugs despite objections from its medical staff, and that drugs have been approved before all necessary tests have been completed. Representatives of drug companies have ready access to FDA chemists, pharmacologists, and doctors who are working on applications for new drugs, Dr. Moulton said. And, she said, FDA workers who turn down industry requests for conferences are reprimanded by their superiors and the appointments are made anyway. Occasional conferences with industry, 'particularly about technical details in new drug applications, are valuable, she said, but at FDA these conferences are the rule rather than the exception. "When a company representative spends three or four days a week in the New Drug Branch offices, arguing each point step by step, wanting to know and being told exactly where the application is at all times and which chemists and pharmacologists are assisting in its review, the medical officer responsible for making a wise decision in the interest of the public is suffering under an almost insurmountable handicap," Dr. Moulton said. New drugs have been approved before tests have been completed and when medical evidence showed the drug might be unsafe, she charged. As an example, she cited the way a new tranquilizer had been approved. According to Dr. Moulton, the new drug application was incomplete. Chronic toxicity studies in animals were said to be under way but would not be complete for several months. 32
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There were unexplained reports of deaths; the recommended intravenous dose was higher than any single dose given in the reports submitted; there were apparent discrepancies in interpretation of the pharmacologic data. In response to repeated phone calls from the manufacturer's representative, she said she would not release the drug without more data. At a prearranged conference, four representatives of the company appeared, Dr. Moulton said. "The chief of the New Drug Branch joined the conference, unexpectedly as far as I was concerned," she stated, "and informed the firm that FDA would release the drug without proof of safety for chronic use and without waiting for completion of the pharmacologic studies." And, Dr. Moulton charged, once a medical officer recommends that a new drug be held off the market, he is usually taken off the case and not allowed to take part in further discussions between FDA officials and the drug company. Profit. At earlier hearings the committee staff developed information showing a serious conflict of interest in the case of Dr. Henry Welch. Until his resignation was demanded by Secretary Flemming, Dr. Welch was head of FDA's Division of Antibiotics. In 1950, Dr. Welch received permission to do outside editorial work in return for the "usual honoraria" received by editors of scientific journals. The committee revealed that Dr. Welch had received more than $285,000 for his editorial work with Antibiotics and Chemotherapy, Antibiotic Medicine and Clinical Therapy, and MD (Medical News) Magazine. These publications derive most of their income from drug advertising and sale of reprints of articles for use by drug companies in promoting their products. According to the committee, Dr. Welch received a share of the profits from the sale of advertising and reprints. "It is clear that Dr. Welch deliberately misled his superiors in receiving compensation far beyond what is the commonly accepted concept of an honorarium for editorial services," Secretary Flemming told the committee. "If I had known at any time what I learned on May 18,1 would have taken action looking toward Dr. Welch's discharge." Secretary Flemming said that
work. As Secretary Flemming sees it, the situation resulted from misplaced confidence in the integrity of a trusted employee. H E W is taking steps to see that such a situation never arises again, Secretary Flemming told the committee. H E W now has a policy governing outside activities which should prevent the occurrence of a situation "even slightly analogous to the Welch case." Although no drug was or could be approved solely on the recommendations of Dr. Welch,' Secretary Flemming said, the committee of scientists appointed by NAS will check, as a safety measure, every drug—especially antibiotics—he approved.
Better Enforcement. FDA plans to step up its campaign against misleading statements in promoting new drugs, Secretary Flemming said. Medical advertising is not subject to FDA jurisdiction, but promotional material mailed directly to doctors and druggists is. FDA plans to use some of the extra money in its budget for the coming fiscal year to scrutinize more promotional material than ever. In the past FDA has merely asked drug companies to correct misleading statements in promotional material. Sometimes the suggested changes were not made for a long time, Secretary Flemming said. .Under the new plan, FDA will set a time limit for making the requested changes. If the deadline is not met, FDA will suspend the new7 drug application. FDA could do a better job of protecting the public if changes were made in the Food, Drug, and Cosmetic Act, Secretary Flemming told the committee. FDA should have broader authority to inspect manufacturing plants. The law should be amended to permit FDA to inspect safety and purity controls, production formulas, qualifications of personnel performing laboratory control and manufacturing operations and to obtain reports made to manufacturers on adverse reactions produced by their drugs. Another amendment: Manufacturers should be required to report to FDA adverse reactions to new drugs as soon as they get this information. Under the present system of voluntary reporting, Secretary Flemming said, numerous reports of serious adverse reactions may accumulate in a drug company's files without FDA knowing that a problem exists.
