Healthy Skepticism International News

October 2003

Garai’s challenge: The 40th anniversary of the inspiration for Healthy Skepticism

Introduction

by Peter R Mansfield This edition celebrates the 40th anniversary of a speech by advertising executive Pierre R. Garai at a 1963 meeting of the leaders on prescription drug issues in the USA.[1] Garai was Senior Writer at the Lennen and Newell agency in New York.  He died on 8 November 1963, a few days after the meeting. If anyone is able to give us more information about him we would be very grateful. Contact: .(JavaScript must be enabled to view this email address)

My favourite quotes are:

“…the medical profession is distressed to find its high opinion of itself not shared by writers of [prescription] drug advertising. It would be a great step forward if doctors stopped bemoaning this attack on their professional maturity and began recognizing how thoroughly justified it is. As an advertising man, I can assure you that advertising which does not work does not continue to run. If experience did not show beyond doubt that the great majority of doctors are splendidly responsive to current [prescription drug] advertising, new techniques would be devised in short order. And if, indeed, candor, accuracy, scientific completeness, and a permanent ban on cartoons came to be essential for the successful promotion of [prescription] drugs, advertising would have no choice but to comply.”

“Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it. The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.”

I became aware of Garai’s speech in the mid 90s when I read a quote of the last paragraph above in an article about logical fallacies in pharmaceutical promotion.[2] That quotation inspired changing the name of our organisation from the Medical Lobby for Appropriate Marketing to Healthy Skepticism.

This month we celebrate the anniversary of Garai’s November 1963 speech by reprinting it in full without editing.  Please note that 40 years ago it was common to refer to prescription drugs as “ethical drugs” because “ethical companies” limited themselves to promoting prescription drugs only to health professionals and not to the general public. Readers are welcome to comment. Comments will be considered for addition to this webpage. Garai spoke of drugs whose popularity is long gone. However the fundamental processes and problems have not changed so his comments on them remain fresh. Whilst I don’t agree with him entirely, I find Garai’s insights very helpful. I hope you do also.

Advertising and promotion of drugs

by Pierre R. Garai That underrated American sage, Calvin Coolidge, is said to have remarked, “America’s ideal is idealism.” If he didn’t, he should have. As a nation, we are irresistibly attracted by idealism, especially in the very young, who can do us no harm with it, and in the very successful, who may someday bequeath us something because of it. If, as I think is the case, the practice of idealism is at the heart of much that is great in our country, so is the maudlin misuse of it responsible for a frightening amount of foolishness. The tendency, for one, to oversimplify political, social, and economic phenomena into demagogic extremes which obscure reality and promote witch-hunts rather than solutions. The habit, for another, of charging controversial issues with so much emotional voltage and irrelevant moralizing that sober discussion becomes impossible and degenerates, on all sides, into special pleading, sloganeering, and headline-snatching.

These characteristics of the American forum are much in evidence in the continuing debate over the advertising and promotional practices of the pharmaceutical industry. Both on the government and the industry side, there has been so much huddling on the side of the angels that it has been years since any angel had room enough to strum his harp. Witness these two characteristic gambits. A Senate report, in a non sequitur fraught with the most sinister implications, contrasts the $750,000,000 the industry spends annually on promotion with the $200,000,000 available to medical schools for their educational programs.[3] If the medical schools need more money to fulfil their assignment, our society must certainly find ways of providing it, but what has that to do with the cost of drug promotion?

Not to be outdone in romancing this question, industry executives have repeatedly struck an altruistic stance when asked to explain why so great a percentage of their sales dollar is plowed back into promotion. The reason, we learn, is that they spend such heavy sums to further “the postgraduate education of the doctor.” One such automatic student, Dr. Charles May, now at New York University, remains unconvinced. “The goal of promotion,” he writes, “even when travelling under a circuitous path under the guise of ‘education,’ is to achieve uncritical acceptance of a preconceived message -to captivate the mind; stimulation of skeptical thinking could block the purpose. This is in sharp contrast to the objective of true education, which seeks to cultivate the use of the mind for independent judgments. The success of promotion does not depend on the authenticity of the message but on the skill in manipulation of belief.”[4]

What are the facts about the cost of drug promotion, and what do these facts mean? On the basis of data supplied by the twenty-two largest drug companies to the Senate Subcommittee on Antitrust and Monopoly, drug receipts can be broken down as follows: 32 per cent of the sales dollar is made up by the cost of goods, 24 per cent by total selling expenses, including advertising and promotion, 13 per cent by taxes, 13 per cent by profit after taxes, 11 per cent by general and administrative expenses, and 6 per cent by research and development.1 These are only averages, of course, and the actual figures vary considerably not only from company to company but from product to product. More than half of this much defamed 24 per cent-13.5 per cent-goes into the compensation and expenses of detail men as well as into other selling costs. This leaves some 10.5 per cent as strict advertising and promotion outlays.! How does this adjusted figure compare with advertising and promotion expenditures in other industries? According to Advertising Age,3 the top one hundred advertisers maintained the following advertising-to-sales ratios in 1962:

Drugs and cosmetics, taken as a class and including both ethical and proprietary drugs, led the list with an advertising-to-sales ratio of 15.4 per cent. Bear in mind that, in all these categories, manufacturers incurred such additional selling costs as sales-force commissions, salaries, and expenses. The rule of thumb for estimating these other selling costs is to allow for them roughly 50 per cent of advertising and promotion budgets. The ratios of total selling expenses to sales are therefore some 50 per cent higher than those given here. Viewed in this light, the 10.5 per cent advertising-to-sales ratio of the ethical drug business is only fourth-highest in industry. High? Yes. Villainous? No.

The fact remains that, in absolute terms, approximately three-quarters of a billion dollars is spent every year by some sixty drug companies in order to reach, persuade, cajole, pamper, outwit and sell one of America’s smallest markets-the 180,000 physicians. Direct mail, medical journal advertising, paramedical publications, closed-circuit television, canned radio, exhibits at conventions, samples, premiums, visits by detail men-these make up the mighty promotional weaponry the drug companies use to bombard their market. And it is not too much to say that perhaps no other group in the country is so insistently sought after, chased, wooed, pressured, and downright importuned as this small group of doctors who are the de facto wholesalers of the ethical drug business.

It has been estimated that the average medical practitioner receives some four thousand promotional pieces a year. One observer points out that “it would take 2 railroad mail cars, 110 large mail trucks and 800 postmen to deliver the daily load of drug circulars and samples to doctors if mailed to 1 single city.“4 Another, formerly the medical director of a well-known drug company, speaks ruefully of “the triphammer effect of weekly mailings, the regular visits of the detail man, the two-page spreads, and the ads which appear six times in the same journal, not to mention the added inducement of the free cocktail party and the golf outing complete with three golf balls stamped with the name of the doctor and the company in contrasting colors.”[7]

All this adds up to a well-nigh stupefying concentration of promotional weight on the individual physician. Does it increase the industry’s cost of doing business? Substantially. Is it reflected in the cost of prescription drugs? Of course. Is it paid for by the eventual consumer? Certainly. In the ethical drug business as in all others without exception, promotional costs are borne by the public. Why all this drum-beating? The answer is quite simple. One, the drug companies cannot compete effectively without it. Two, it works. America’s ideal may well be idealism, but as the good gray Coolidge also observed, “The business of America is business.” In the current climate, this once unexceptionable tautology has assumed the ring of an indictment, with the astonishing results that there are many today who feel it necessary to defend the drug houses against the “taint” of being profit-seeking, against the “charge” that they assume the risks inherent in our economic system only because they also hope to reap its rewards. I, for one, have no intention of apologizing on their behalf.

Operating under the profit system, the drug industry has made enormous contributions to our society. Not only has the successful marketing of individual drugs tended to reduce their price over the years. It has created the capital and the corporate motivation to which we owe the variety and plentiful supply of useful drugs from which the therapist may choose. Indeed, had the pharmaceutical industry never availed itself of the mass-marketing techniques we now hear so bitterly assailed, few of the drugs on which modem medical practice depends would be affordable at all.

In some future Utopia, it may be that non-commercial motivations will yield the same results, and without side-effects. Splendid. Until then, we shall have to make do with the world as we know it, and, in that world, they seldom do. It is easy to decry this state of things in quotable, gratuitous oratory and extremely popular these days to call on the drug companies to lead us into the promised land of economic selflessness. The market for drugs, it is said, is a captive market, and the cost of drugs is borne primarily by those least able to afford it, the ill and the old. That this is also the prime market for physicians is conveniently forgotten by medical critics who accuse the drug industry of seizing on the public health as “a commercial plum.”[8]

Can there be any doubt that the cost of health is a national scandal? I think not. Is much to be gained by singling out the drug industry for a place in the pillory? I think not. We will not find viable solutions for the contradictions inherent in our economic system by making scapegoats or by advocating unilateral economic disarmament. The drug business, like the medical business, like every business in a free enterprise system, must operate at a profit or die. As an industry spokesman quite accurately reminds us, “The basic responsibility of service to the people and to the medical and allied professions is certainly not the pharmaceutical industry’s only accountability. There is the responsibility to conduct a profitable enterprise to protect and enhance shareholders’ equity.”[9]

Are these profits excessive? This is a question not easily answered in a free economy. The Senate Subcommittee contends that they are. Many doctors and laymen agree. The industry, while granting that profits are high, denies they are excessive. And, in a dispassionate study of the matter. The George Washington Law Review concludes that while certain products have been maintained at arti­ficially high price levels through patent and license manipulations, the price of most drugs is a fair reflection of their value.[10]

Whatever the merits of these various conclusions, restrictive legislation is, I submit, the least healthy way of lowering the price of prescriptions. There is a far better one at hand. Indeed, most of the excesses with which the drug companies are charged can be corrected without any external intervention or official control of the marketing process that now exists.

The fact is that no ethical drug can reach the public, at any price, without the consent of the doctor. No drug, however aggressively promoted, can survive economically unless it gains and keeps the endorsement of the doctor. Between the manufacturer and the patient stands a jury of the most highly trained men and women in the professions. Why, then, do drugs of questionable value survive? Why do unnecessary and expensive modifications of existing drugs succeed so well? Why is the public not better protected by those who have not only the duty and competence to do so but the absolute power with which to do it? In my opinion, this, and no other, is the useful question here.

It is naive to expect any commercial enterprise in our society to devote itself solely to the common weal. Inevitably, business considerations dominate. The drug companies, their protestations notwithstanding, are no exception. Indeed, if they mean to stay in business, they cannot afford it. No manufacturer of drugs can afford to restrict his production to genuinely significant pharmaceutical innovations. There simply aren’t enough of these around in any given fiscal year or, for that matter, in any dozen fiscal years. It should therefore surprise no one that we find slight modifications of existing products marketed by the bushel, a veritable blizzard of parity products slugging it out as each company strives to extend its share of the market, endless polypharmaceutical combinations of dubious merit, and a steady outpouring of new chemical entities whose advantages, to say the least, remain to be established.

A particularly serious by-product of this driving competition for the doctor’s prescribing arm is that new products are often rushed into the market place before their side-effects are fully understood. Another is that razzle-dazzle promotion has come to play a more decisive role than scientific evaluation of drugs in determining the career of pharmaceutical products.

The doctors make much of their distaste for ethical advertising. They deplore its character, its quantity, its commercialism. In a recent survey, 35 per cent of the doctors responding urged that it be more scientific, more accurate, more factual, yes, and please, more informative, too; 10 per cent requested that advertising directed to them assume a higher level of intelligence on the part of the reader and frankly tell both the advantages and the disadvantages of drug products; 8 per cent called for more honesty, less puffery; 7 per cent asked for clear statistics and data; and 6 per cent pleaded for more dignity, less emotion, and no cartoons.[11] Wrote one offended physician, “Does a doctor, who has a professional education, require so much repetition to get across to him the idea of a new drug, or push an old one?“4 And another protested, “Matters would improve if the ethical drug industry shook off the exuberant promoters who have drawn them into the use of techniques customary in the sale of commodities but highly questionable for application to promotion of medical remedies.”[12]

What these howls of outrage and hurt amount to is that the medical profession is distressed to find its high opinion of itself not shared by writers of ethical drug advertising. It would be a great step forward if doctors stopped bemoaning this attack on their professional maturity and began recognizing how thoroughly justified it is. As an advertising man, I can assure you that advertising which does not work does not continue to run. If experience did not show beyond doubt that the great majority of doctors are splendidly responsive to current ethical advertising, new techniques would be devised in short order. And if, indeed, candor, accuracy, scientific completeness, and a permanent ban on cartoons came to be essential for the successful promotion of ethical drugs, advertising would have no choice but to comply.

I see little to suggest that such changes will be required in the near future. The trade journal, American Druggist, reports a nice recovery from the medical skepticism engendered by the late Senate hearings. For 1962, it notes a 6.3 per cent increase in new prescriptions, a 9.1 per cent increase in refills, an all-time record total of 702,016,000 prescriptions. “This,” comments the publication, “is of utmost importance to Pharmacy because it provides assurance that the source of all prescription activity-the doctor’s pen-not only has not dried up, but instead is flowing more freely than ever.”[13]

Some observers find hope in the growth of the bi-weekly Medical Letter, an independent, non-profit newsletter which provides reliable, continuing evaluation of drugs, especially new drugs. By drawing on an advisory board and on consultants of unquestioned integrity and distinction, by bringing together in a single, easily available source the best-founded, most objective findings about new drugs, and by publishing these evaluations at the very time the drugs are being intensively promoted. The Medical Letter is making a unique contribution whose value simply cannot be overstated. Though, as might be expected, it has drawn the fire of the drug industry for presuming to pass on advertising claims, the validity of supporting evidence, and the inherent merit of drugs, reaction in medical and scientific circles has been enthusiastic.

For the physician, harassed by relentless promotional efforts, confused by the sometimes bloated and often conflicting product claims he finds in advertising and by the unbounded optimism of detail men, here, surely, is an ideal way to keep abreast of informed opinion about a subject that vitally affects the soundness of his practice and the welfare of his patients. No longer need he be a sitting duck for color spreads until he can hunt down the reports on drugs of the National Research Council and of the Councils of the American Medical Association. For $12.50 a year-less than the price of his daily newspaper-he can avail himself of The Medical Letter and use its concise, timely, authoritative reports to steel himself against confusion, ignorance, and error. After four and a half years of publication, what is the circulation of this indispensable adjunct to conscientious practice? There are 180,000 physicians in North America. To date, 25,000 have seen fit to subscribe.

In the light of this kind of response, is it any wonder that drug advertisers should be unimpressed by the professional maturity of the bulk of their audience or that campaigns for ethical drugs should sometimes seek to manipulate physicians rather than communicate with them? And is it surprising that such campaigns should work?

Consider the case of the buffered tetracyclines. The promotion on behalf of these drugs continued for several years, drawing ever renewed strength as various companies entered new candidates. And it succeeded perfectly, finally driving most of the older tetracyclines from the market and indirectly fostering undue and often ill-advised reliance on these new products at the expense of other antibiotics.[14] This marketing triumph had its origin in claims of appreciably faster absorption and higher antibiotic blood levels, even though, as one writer has pointed out, “no sound evidence was ever brought forth that the levels and speed of absorption claimed for the widely heralded derivatives offered any clinical advantage or therapeutic superiority.”[15]

More disturbing still, the evidence on which these claims depended was shown to be totally specious shortly after the start of the promotion. Instead of potentiating the action of the basic drug as claimed, the various buffering agents in the new formulations were merely neutralizing the retardant effect of the calcium salts originally used as fillers in tetracycline capsules. Though this gross error in the supporting studies was pointed out time and time again in medical journals, as were statistical curiosities in later studies, this expert criticism had no visible effect on the tenor of promotional literature or on the industry’s ]oie de vendre. The addition of a buffering agent was typically described as allowing “more competent control of the disease under treatment” and as introducing “an entirely new concept in broad-spectrum therapy.” In short, as a major breakthrough. It proved, of course, a major bonanza for the industry.

Tranquilizers provide a second and particularly telling illustration of the ability of sustained, aggressive promotion to obscure valid evidence not favorable to product claims, bury dissent, sidestep questions, and take the market by storm. Generally promoted as anti-depressants, tranquilizers are said to have fewer side-effects than barbiturates and to be significantly more effective in the relief of anxiety and tension. One, Librium (a brand name for chlordiazepoxide), lays additional claim to special virtues in the treatment of acute and chronic alcoholism. What does the medical literature have to say about all this? A great deal has been written about meprobamate (Miltown, Equanil), the first of these prestigious drugs to achieve broad commercial success. As early as 1956, a year after its introduction, a controlled study by Dr. Louis Lasagna suggested that the drug was not “qualitatively different in its clinical effects from a number of other hypnotics including barbiturates.”[14] Not long after, allergic reactions were noted and the possibility of addiction indicated.[14] And a careful review of nearly a hundred papers on the drug concluded by seriously questioning whether smaller doses of meprobamate were appreciably more effective than a placebo in relieving anxiety.[15] More recently, controlled studies have given conflicting testimony, some finding in favor of meprobamate over placebos and barbiturates, some not.[16] On balance, however, there does not appear to be clear-cut evidence to support the large claims made for this drug. What is known for certain is that it is considerably more expensive than appropriate doses of barbiturates. It has not been convincingly demonstrated that it is either safer or more effective.

Though they have been expressed many times in reputable medical forums, these findings have yet to make a serious dent in the number of prescriptions issued daily for meprobamate or to restrain Wallace and Wyeth, the two companies involved, from pushing their star performer as hard as they are able. The latest advertisement for Equanil offers us an exquisite parallel between the virtues of the doctor, caught here at the sacramental moment of signing a prescription, and of the tranquilizer. In part, the copy reads as follows; “Your signature here means that your professional integrity, experience and knowledge stand behind the efficacy and quality of the drug prescribed. The same meaning is inherent in this signature; Equanil, meprobamate, Wyeth.”

Wallace has not only held its own in dithyrambs. It has also been conspicuously active in deploying the drug into related new preparations, of which the most popular is probably Deprol. This marriage of meprobamate and benactyzine claims exceptional usefulness in the treatment of neurotic and psychotic depression. Again, however, convincing evidence is lacking. What is indisputable is that the dosage range recommended by the manufacturer calls for the ingestion of twice as much meprobamate as is generally considered safe and that the side-effects of the anticholinergic and putatively antiphobic ingredient benactyzine have not yet been demonstrated to have compensating therapeutic advantages.[17]

What of Librium, the late entry in the tranquilizer derby that has recently become the best seller in the field? What is its special place in therapy? How much is reliably known about its properties now that three and a half years have passed since its introduction was so enthusiastically acclaimed by the medical profession? The jury is still out. True, Librium is widely believed to be superior in the relief of anxiety and tension not only to the barbiturates but to meprobamate as well. Superior in effectiveness, free of the side-effects, essentially different in its action. Moreover, this drug has won a sizable medical following as a valuable agent in the treatment of alcoholism. Future studies may validate some or all of these impressions. In the opinion of serious observers, however, past studies controlled and uncontrolled, chiefly the latter, have yet to do so in decisive fashion.[18] And the overriding fact is this. Tranquilizers have become big business in the past eight years, a new national habit. They may or may not be superior to barbiturates or meaningfully different from them in clinical effect.

We may someday learn the answers to these questions, or we may not. The matter is largely academic. Effective promotion, heavy promotion, sustained promotion has carried the day. The physicians have been sold. So has the country. During the golden fifties, the drug industry marketed an average of four hundred new products a year. Last year, only 78 new drugs were launched, but one can reasonably expect that the yearly birthrate will return to its previous size as the echoes of the Senate hearings die down and attention is focused on a new national whipping boy.

To continue to thrive in the highly competitive sphere in which they exist, the drug companies will have to remain essentially in the business of new products. That is where the greatest profit opportunities lie. And new products, since they represent so important a commitment of capital and productive facilities, will continue to call forth the most intense kind of promotional fervor. By definition, a new drug is one about which a great deal is unknown. The advertiser is usually euphoric about its merits and still unaware of any serious side-effects it may have, or he would not have launched it. His advertising reflects this mood, and that, not bad faith, is what makes it dangerous to the uncritical mind.

Cases of willful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in agate type, you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it. The best defense the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.

On this matter, as on so many others, the advice of The Medical Letter will stand him in good stead: “Except in serious disorders where older and safer drugs are ineffective, no new drug should be employed in practice unless controlled clinical trials and extensive experience have clearly established its effectiveness and safety. Most new-drug applications are made effective by the Food and Drug Administration on the basis of a company’s safety data provided by animal experiments, very limited human toxicity studies, physicians’ testimonials and usually uncontrolled clinical trials. Even when controlled clinical trials have been performed, the frequency and severity of toxic, allergic and other injurious effects are not fully defined until the drug has been in use for several years. All promotion statements that a new drug has few, mild or no side effects should be ignored.”[19]

In criminal cases, Scottish juries sometimes render a verdict of “not proven.” Affirming neither guilt nor innocence, this unique and uncommonly rational verdict merely expresses the jury’s conclusion that guilt, though likely, has not been demonstrated beyond reasonable doubt. And the defendant is freed because the burden of proof lies not on him but on the prosecution. Doctors might do worse than to render this Scottish verdict themselves when a new drug’s effectiveness and safety, even though likely, have not been demonstrated beyond reasonable doubt. And, in such cases, they should withhold their endorsement because the burden of proof lies not on them but on the manufacturer.

No conceivable form of government regulation can do half so much to raise the standards of the pharmaceutical industry and of ethical advertising as the growth of intelligent, disciplined medical skepticism. This is no pious hope. It is a statement of plain economic fact. In our society, the market place may be unresponsive to idealism. It is never unresponsive to sales curves. Let the sales of any product decline sharply and remain down and that product will die. Let the doctors but withhold their approval of new drugs until conclusive evidence has been presented in support of claims, and it will cease being economically feasible to market new drugs without this evidence. Whatever waste and cynicism may be charged to the profit system, it has no equal in creativity, in productivity, and, above all, in responsiveness to the mandates of the market.

Detroit didn’t abandon its mastodons for compacts because it wanted to but because the public gave it no choice. The Edsel didn’t die because it was poorly promoted but because the public just wouldn’t buy it. How much easier it would be for doctors to have their way, when theirs is the sole and absolute power to determine drug sales. Without their agreement, not a single milligram of any ethical drug can reach the public. Not a cent of profit can be earned. Not a single drug company can stay in business. There is no parallel to this situation in any other industry. If doctors will express their wishes audibly-that is, on prescription pads as well as at conferences and hearings their wishes will be heeded. And quickly. Ask any drug manufacturer. The drug business is today, and will be tomorrow, what the doctors cause it to be. Drug advertising, too. We know what the doctors are today. What will they be tomorrow?

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