THE AMA'S PECULIAR STANDARDS ON DRUG ADVERTISING
Mintz, Morton
The AMA's Peculiar Standards on Drug Advertising by MORTON MINTZ THE FIRS T criminal prosecution un der the advertising provisions of the 1962 Kefauver-Harris amendments to the Food, Drug,...
...There was no apology to the members, and certainly none to patients...
...The basis for the claims was primarily a single, company-sponsored study by Dr...
...Four advertisements in JAMA—elaborate two-page affairs carried in successive weekly issues starting on June 1, 1964—were the basis for the criminal information filed against Wallace Laboratories on August 5, 1965, by the U.S...
...For even the slightest deviation from fact may be vital...
...The advertisements superimposed on lush color pictures—a hand reaching out to a rising sun, airborne seagulls, waves quivering on the sea—charts and text claiming that Peritrate kept more patients alive while they were in the hospital and, after they were discharged, decreased the likelihood of subsequent attacks...
...Identical except for one thing: where the phrase "Contra-indications: None known" had appeared, there was now white space...
...I t ran the advertisement in JAMA for weeks...
...suddenly there was a request to eliminate the claim...
...The government charged in two counts that the advertisements suppressed data on adverse effects that physicians must have if they are to prescribe intelligently, and that the advertisements falsely claimed, "Contraindications: None known...
...The Kefauver-Harris amendments contain no provision for prosecution of medical journals...
...The FDA's Dr...
...In them, helplessly, their patients trust...
...Two days later, FDA Commissioner James L. Goddard disclosed that six additional advertising cases had been prepared for transmittal to the Department of Justice for possible prosecution...
...Goddard said pretty much the same thing in a speech last spring...
...This amounts to between a quarter and a third of the $2.4 billion that the manufacturers gross from the sale of these products, a figure which even at the lower level averages out to $3,000 per doctor...
...The agency said the advertising was "false and misleading...
...Walter Modell said in 1961 in an editorial in Clinical Pharmacology and Therapeutics...
...Further comment was refused...
...An advertisement that misinforms the doctor, the Commissioner said, can be construed "to be a clear and present danger to the patient...
...In what FDA called Dr...
...Since JAMA was established in 1883, he told the Parenteral Drug Association on April 9, 1965, the AMA "has maintained screening boards to enforce high standards of advertising," one purpose of the screening being to limit "claims for useful products to those which can be documented by scientific fact" (emphasis added...
...In the July 16 issue, Harris told of the Physicians Committee for Health Care for the Aged through Social Security, which was formed by several distinguished doctors, including two Nobel laureates in medicine...
...The Kefauver-Harris amendments require drug manufacturers to give a true statement of adverse effects and contra-indications in "brief summary" in advertising...
...But no therapeutic effect was visible in the AMA hierarchy...
...Apparently the episode was therapeutic: Last April, Commissioner Goddard said that insofar as warnings to physicians are concerned, Wallace advertisements have become "among the best that I have observed...
...The advertisements claimed that the survival rate— after two years—among the patients given Peritrate was twenty-two per cent higher than among the patients given a placebo...
...The phrase had been chiseled off JAMA's printing plate...
...Robert S. McCleery, head of the agency's Medical Advertisement Branch, and an associate...
...He continued: "But you may not fool any of the people any of the time about drugs...
...By the estimate of Dr...
...Pree MT, the product involved in the criminal prosecution of Wallace Laboratories in New Jersey, was commonly prescribed for premenstrual tension, congestive heart failure, and high blood pressure...
...attorney in Trenton...
...One reason the advertising was deemed "false and misleading" was its reference to a study involving "148 elderly patients"—who in reality were men aged thirty-five to ninety-seven, and women aged thirty-three to eighty-nine...
...In the hospitalization period immediately following cardiac attacks, the advertisements indicated, two patients using the drug died—nine fewer than those given the placebo...
...Peritrate SA (penterythritol tetranitrate) was introduced in 1952 and has been prescribed since then to millions of coronary artery disease patients...
...Nor was the subject of false advertising in JAMA publicly mentioned at the First National Conference on Medical Ethics that the AMA held in Chicago last March...
...But Judge Lane imposed the maximum allowable penalty, a fine of $1,000 on each of two counts...
...The company also listed contra-indi cations in Physicians' Desk Reference (PDR), a compendium of entries on drugs prepared, edited, and paid for by the manufacturers, and distributed free to physicians, hospitals, and others in the medical field at a rate of almost half a million copies a year...
...Knotts went on soothingly about the staffing of the AMA's Office of Advertising Evaluation by "scientifically trained individuals" who use "comprehensive" procedures, who correspond with "approximately four hundred consultants," and who maintain "liaison with centers of research in medical schools, hospitals, industry, agencies of the government, and branches of the military services...
...The AMA was a party to this noncompli ance...
...This one was known as Serax...
...Goddard told Representative L. H. Fountain's House Intergovernmental Relations Subcommittee, were being developed by FDA...
...the ad was turned down as 'misleading...
...Compliance with government requirements, he said, "is fundamentally a matter for manufacturers...
...On February 28 the FDA invoked the same advertising provision, for the first time, to make a seizure of a prescription drug, Peritrate SA...
...The Committee, Harris wrote, "sent an advertisement stating its principles and its purpose to The Journal of the AMA...
...As long as the phrase appeared, the law was being violated by a lie...
...The "one-third" surely understates the reality because, as Dr...
...At this point someone in a position of re sponsibility at the AMA surely knew that there were contra-indications...
...It makes little difference if, under the impression that it is the best, a housewife buys the next best detergent," Dr...
...For example: One-Ordinary common sense might be expected to raise suspicions in "scientifically trained individua.ls" who see the bald claim, "Contra-indications: None known...
...JAMA "house ads" say that "every statement" made in the advertising it carries "must be backed by substantiated facts .. . or we won't run it...
...The net income of Carter-Wallace, the parent firm, in 1964, the year of the misdemeanor, was $11.3 million, or 5,650 times as much as the fine...
...The seizure was resorted to because of advertising which the agency described as "false and misleading...
...The AMA's peculiar standards are beautifully illustrated in an incident cited by Richard Harris in his recent New Yorker series on Medicare...
...Betterment of the public health is the last thing to be expected from an advertisement that misleads a physician about a drug...
...Half received Peritrate and half a placebo...
...It is enough to cite what Dr...
...Goddard to the Fountain Subcommittee, pharmaceutical manufacturers in the United States spend between $600 million and $800 million a year to advertise and promote prescription drugs to physicians...
...One must wonder how the AMA could, on one hand, claim that every statement in its advertising must be backed by "substantiated facts," while on the other hand it could disclaim a censorship program...
...Last December 6, Wallace Laboratories, long a major advertiser in JAMA, entered a plea of innocent...
...Goddard told the Fountain Subcommittee—that in 1965 "one-third of the members of the PMA (Pharmaceutical Manufacturers Association), for example, were found to have advertisements in violation of the regulation...
...The brochures and the entry in Physicians Desk Reference were by no means the only clues available to the Office of Advertising Evaluation of the AMA if it had wanted to bother to check on Pree MT...
...The four Wallace adver tisements cited by FDA had said there were no contra-indications...
...Two-While Pree MT advertisements claiming no contra-indications were running in JAMA, an advertisement for Merck, Sharp & Dohme's Cyclex, a drug of exactly the same formulation as Pree MT, was running, with contra-indications spelled out, in M odern Medicine, which has a circulation almost as large as the AMA's Journal...
...But the footnote failed to say, FDA noted, that the study was done in piglets, and "in a manner which in no way approx imates the human disease situations...
...The name had been Miluretic, but Wallace, a division of Carter-Wallace, Inc., changed it to Pree MT in January, 1964, and then launched a big promotional campaign—advertisements in The Journal of the AMA and other medical publications, and direct mailings to physicians...
...Oscharoff s "purportedly well-controlled clinical investigation" there were, initially, a hundred patients...
...A contraindication warns against use of a drug for patients with specified medical histories...
...This income was tax-exempt on the ground that it was substantially related to the AMA's professed purpose, "to promote the art and science of medicine and the betterment of public health...
...Six weeks after pleading innocent, and a year after taking Pree MT off the market, Wallace Laboratories went before Federal District Judge Arthur S. Lane to switch its plea from inno cent to nolo contendere...
...Among them the number of deaths in Peritrate and placebo patients was identical—ten...
...He told me that the advertisements were "distasteful," that he had "nothing to do" with them, and that after seeing them he had objected to the manufacturer...
...Serax (oxazepam) is a tranquilizer introduced in mid-1965 by Wyeth Laboratories, a division of American Home Products Corporation...
...This, an FDA official said, was the company's concept of "a correction," although it was not made until after word of impending FDA action may have leaked to Wallace...
...Hydrochlorothiazide, incidentally, is also in Caplaril, another Wallace product that was, but is no longer, advertised in the AMA Journal with the claim, "Contra-indications: None known...
...During 1965, according to FDA, the Warner-Chilcott Laboratories Division of the Warner-Lambert Pharmaceutical Company spent $1 million to promote it in medical journals, an expenditure exceeded for only two other prescription products...
...As part of my coverage for The Washington Post, I telephoned the AMA in Chicago to put some of the obvious questions: How had the Pree MT advertisements slipped by the AMA's elaborate screening apparatus...
...How could the AMA have failed to discover contra-indications that had been printed probably millions of times...
...This advertising, along with direct mail promotion for which $250,000 was budgeted for six months, "has been consistently characterized by misleading statements and excessive claims," Commissioner Goddard has said...
...By way of a footnote referring physi cian readers to a research study, the advertisements claim that Peritrate stimulates collateral circulation...
...But the adver tisements condemned in the seizure pap ers last February, including those ap pearing in JAMA in the five weekly issues starting last December 6, and in the issue of February 7, made claims that FDA said were "false and mislead ing," lacked "fair balance," and failed "to show fairly the effectiveness of the drug under the conditions for which it is promoted...
...When the phrase was removed, an act that created a new advertisement, the law was violated by noncompliance...
...Because the invalidity of the claim had been recognized...
...But no sophistries about "a correc tion" could explain the conduct of the AMA, even if one assumes it was so laggard as to have been unaware of the listing of contra-indications in the package brochure, PDR, New and Nonofficial Drugs, and in advertising for Cyclex...
...The initial sixmonths budget for advertising in medical journals was $350,000...
...There is far more of hypocrisy than of Hippocrates in the way that the AMA, through its Journal, has harvested money from drug companies and used it in its costly battle against Medicare...
...Most of the thirty-one cases involved advertisements in JAMA...
...Peritrate is perfectly all right as a drug for the treatment of angina pec toris," the heart condition distin guished by a massive chest pain, Dr...
...Did the AMA's Office of Advertising Evaluation have access to "approximately four hundred consultants" and "centers of research" but not to the AMA's own New and Nonofficial Drugs...
...FDA said his study had been "falsely represented" in the advertising...
...The AMA's Peculiar Standards on Drug Advertising by MORTON MINTZ THE FIRS T criminal prosecution un der the advertising provisions of the 1962 Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act was initiated by the Food and Drug Administration against Wallace Laboratories of Cranbury, New Jersey...
...At first the Company pleaded innocent, but six weeks later, on January 17 this year, it entered a plea of nolo contendere in Federal Court in Trenton, thus choosing not to contest the charge of "false and misleading" advertising of a Wallace prescription drug known as Pree MT...
...It was a combination of meprobamate, the sedative most widely sold as Miltown and Equanil, and hydrochlorothiazide, which removes excess fluid from the tissues...
...FDA termed the claim "false and misleading," saying the study had not established that Peritrate was responsible for the higher survival rate...
...Every issue of JAMA reassures some 200,000 Association members that the advertisements therein "have been reviewed to comply with the principles governing advertising in AMA scientific publications" (JAMA and ten medical specialty journals...
...The criminal information listed additional contra-indications and side effects omitted from Wallace's JAMA advertisments, including a warning that patients on the dehydrating ingredient should be carefully watched for signs of serious and sometimes fatal blood disease...
...Unlike the housewife and her detergent, it is clearly immoral if the physician is even slightly misled by claims made for the drugs he is importuned to use on the sick...
...But, said an AMA spokesman, the advertisements "met our standards...
...In AMA they trust...
...What will be spelled out in what follows is the special role of the "largest publisher of prescription drug advertisements in the world," which was the boast the American Medical Association was proud to make for itself in 1963 in the statement it filed in all-out opposition to the regulations FDA had proposed to control abuses in advertising of prescription drugs...
...Not surprisingly, then, physicians in large numbers assume that the high standards the AMA once enforced still prevail...
...if, under the misapprehension that it is the best, a doctor prescribes something less than the best, it may be the difference between life and death...
...In thirteen additional cases violations had been found but administrative decisions had been made not to prosecute...
...All of this, and more, was readily ascertainable...
...What did the New Jersey company know to be the truth about Pree M T (Miluretic) ? From the time its product won FDA approval for marketing, in October, 1960, Wallace Laboratories listed contra-indications in the FDAapproved instruction brochure enclosed in every package...
...It is not my purpose to dwell here on what the late Senator Estes Kefauver, and others, have made abundantly clear—that such fantastic expenditures are wasteful and shot through with deception and dishonesty, nonsense, and non-science...
...In court, William L. Hanaway, counsel for Wallace, asked that the sentence be suspended, saying the advertising was "a mistake" that would not be allowed to recur...
...It had been advertised in JAMA...
...Speeches to the same effect have been made by Glenn R. Knotts, the AMA's Director of Advertising Evaluation...
...In promoting itself, the AMA tries to show that the advertising in its publications will not misinform the doctor...
...What about the removal of the no-contraindications claim...
...In the Miluretic entry for the 1964 edition (supplied by Wallace in late 1963) this is found: "CONTRA-INDICATIONS: Progressive renal impairment, some cases of advanced cirrhosis, previous toxic reactions to hydrochlorothiazide, or previous allergic or idiosyncratic actions to meprobamate...
...In its seizure action last May, the FDA charged misbranding in a Serax advertisement carried in the April 25, 1966, issue of JAMA, and in earlier issues of the American Journal of Psychiatry and Medical Economics...
...Much of the money paid for five-page and even ten-page advertisements in The Journal of the AMA...
...Goddard pointed out, it represents merely those violations actually detected during 1965 by an FDA professional staff of only two men—the brilliant, dedicated Dr...
...Oscharoff has acknowledged that the advertisements failed to cite the results of a repetition of his study involving a second group of a hundred patients, similar in all major respects to the first...
...Goddard said last April...
...Last year the advertising revenues of The Journal of the American Medical Association were an estimated $10.5 million...
...Hours later, a spokesman told me that although the AMA "exercises caution in acceptance of advertisements . . . we do not attempt to operate a censorship program...
...He termed Wallace Laboratories "a highly reputable pharmaceutical concern...
...In the June 29, 1964, issue of JAMA -which was the first issue subsequent to the four cited in the criminal information-and in some issues thereafter, there were Pree MT advertisements that were identical to those condemned by the government...
...Three-Among the medical publications that for years had listed contraindications for Pree MT (Miluretic) or separately for its ingredients, was New and Nonofficial Drugs, which was issued by the Council on Drugs of the American Medical Association...
...Alexander Oscharoff, a New York cardiologist...
...By deciding not to contest the government charge the company avoided the publicity that might have accompanied a trial, although it should be noted that leading news media, including The New York Times, ignored the case...
...The advertising had been carried by The Journal of the AMA or JAMA, as it is commonly called...
...But Dr...
...The advertisements cited in the criminal information had been published in the Journal of The American Medical Association during 1964...
...On May 23, again under the advertising provisions of the amendments, FDA made its second seizure of a prescription drug...
...Twelve other cases, Dr...
Vol. 30 • October 1966 • No. 10
