GOVERNMENT
Drug information sources attacked Sen. Nelson charges industry exaggerates drug differences, influences doctors' drug choices The latest round of hearings before Sen. Gaylord Nelson's Subcommittee on Monopoly on problems of the prescription drug industry was billed as an analysis of the recent report of HEW's Task Force on Prescription Drugs (C&EN, Sept. 23, page 15). But the report was barely mentioned. Instead, the Wisconsin Democrat launched a vigorous attack, joined in by a H E W witness, on two specific drug problems. These were: the equivalence of generic and brandname drugs, and the accuracy of information physicians receive on drug properties.
HEW's task force and principal witness at the hearing, said, "Lack of clinical equivalency among chemical equivalents meeting all official standards has been grossly exaggerated as a major hazard to the public health." In a statement issued after the hearing, PMA president C. Joseph Stetler denounced the attack made at the hearing. "The charges made by Sen. Gaylord Nelson . . . with respect to the PMA "Bibliography on Biopharmaceutics" and the release covering it issued last month are false," Mr. Stetler said. "The bibliography and all other evidence developed to date es-
DRUG WATCHER. Dr. Philip Lee, Assistant Secretary of HEW and a physician himself, feels that the massive amount of drug advertising, detailing, and other forms of drug promotion can't help but confuse doctors when prescribing drugs
Early in August, the Pharmaceutical Manufacturers Association issued a "Bibliography on Biopharmaceutics" accompanied by an explanatory press release. The press release indicated that the bibliography of 501 published citations showed that there is a difference between generic and brand-name drugs. Sen. Nelson charged that only two or three of the 501 citations showed a lack of equivalence between the types of drugs and that the press release distorted the contents of the bibliography. "My guess is," Sen. Nelson said, "that PMA thought that nobody would bother to read the bibliography to ascertain whether the press release, in fact, did summarize its contents or whether it was the usual PMA propaganda line." Dr. Philip Lee, head of 50 C&EN OCT. 7, 1968
tablishes that product formulation does make a difference, and it does this so completely that it is astonishing that Sen. Nelson and representatives of H E W could argue to the contrary." On the other major topic—physicians' information on drug propertiesSen. Nelson charged that most doctors get their information from drug company advertising or from drug firms' detail men. Doctors have great faith in the veracity of drug makers' claims, Sen. Nelson said. "I don't blame the physician for having confidence in the claims of the companies," the Senator continued, "but their confidence has been misplaced and the doctors don't know it." He charged that the American Medical Association refuses to do anything significant about giving its members
proper information about drugs. "AMA has been grossly derelict in failing to notify physicians about misleading drug advertising," Sen. Nelson said. Dr. Lee, assistant secretary of H E W and a physician himself, told the committee that in medical school "pharmacology, it seems, is the stepchild of medical education." Result: The doctor's training in the clinical aspects of drug therapy is scanty. Although there are a few publications which contain the objective data on drugs that are needed, they are largely ignored or unknown to the majority of practicing physicians, Dr. Lee said. Although the quality of drug advertising is steadily being improved, Dr. Lee said, "It concerns me that many, if not most, physicians rely on the companies' promotional material and on the detail men for drug information. The prime function of advertising is to sell drugs, and, therefore, one cannot and should not expect such advertising to be fully objective." Sen. Nelson's comment: "This is a fine commentary on the source of information that the distinguished medical profession uses in prescribing drugs for its patients. The AMA seems to be unconcerned about education in drug therapy." Dr. Lee's reply: "We share your concern." Immediately after the hearing, AMA's Chicago headquarters issued a statement rebutting the charges. AMA says that throughout its history one of its major concerns has been to obtain and disseminate to physicians timely and accurate information on drugs. "AMA disseminates information on drugs through its prestigious weekly Journal of the American Medical Association (in which drug advertising is carefully evaluated), through its 10 monthly specialty journals, through the weekly AMA newspaper (AMA News), and through specialized publications like its annual new drugs book," the AMA spokesman said. AMA has a large department of drugs in its Chicago headquarters. This department disseminates information on the untoward effects of drugs and other chemicals as part of its duties, he said. Dr. Lee told the committee that
HEW's task force had made three recommendations in its recent report that are designed "to help restore some balance to the provision of drug information." These are: • Establish a Federal Drug Compendium which would list and accurately describe all drug products and would provide doctors with some indication of relative costs. This is a project that Sen. Nelson is pushing hard in the Senate to no avail. • Have the Federal Government either publish or support publication of a journal which would provide upto-date guidelines on drug therapy. Although federal money would be used, articles would be written by experts acting independently. • Provide federal support for the efforts of local medical societies, medical schools, foundations, and others to support continuing education courses for practicing physicians, emphasizing current applications of drug therapy. Sen. Nelson said that all the evidence shows that doctors need a federal compendium to get accurate information on current problems in drug therapy. He noted that an opinion poll of physicians, sponsored by the Pharmaceutical Manufacturers Association, showed that doctors preferred present sources of drug information and saw no need for the proposed compendium (C&EN, July 22, page 11). "The probable reason for the doctors' negative attitude [on the compendium]," Sen. Nelson said, "is that they think they are getting correct information from drug firms, which they are not." On the issue of clinical equivalence of generic and brand-name drugs, Dr. Lee detailed the analysis of the H E W task force on PMA's "Bibliography of Biopharmaceutics." The group finds that of the 501 references, only 221 of the tests were conducted on human beings. Of these 221, only 76 were—"by the authors' own evaluation"—adequately designed or controlled. And of these 76, only 12 represented comparisons between what might seem to be differant brands of the same chemical equivalents. Of the final 12, most compared different dosage forms, different salts, or different coatings. Some of the products studied failed to meet U.S. Pharmacopeia or National Formulary standards and, thus, would be illegal in U.S. markets. "Accordingly," Dr. Lee said, "only two or three demonstrated statistically significant lack of clinical equivalency." The long-running hearings will continue subject to the exigencies of Sen. Nelson's campaign for re-election. However, it has not been decided when they will be held or who will be heard.
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