Healthy Skepticism Library item: 20540

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

The FDA's Ambitious New Chief - the Schwartz commentary
Scrip 1991 July 19; 1635:16-18

Abstract:

It is still much less than a year since Dr David Kessler took over direction of the US Food And Drug Administration, but he is already in the public eye in a way none of his predecessors has been for a very long time. His ability to win headlines and friendly media attention – for example a
front pace article in the widely circulated Sunday Magazine edition headlined “A Shot in the Arm for the FDA” – is by now beyond doubt. An admiring commentator has called
him a combination of “ambition and righteousness”.

What remain to be seen are the longer term consequences of his whirlwind chances in the FDA for the agency, for the consumers it seeks to protect, and for the numerous providers of food and drugs regulated by the agency. Not surprisingly, opinions differ.

There is little disagreement that the FDA needed shaking up when he took over late last year. Mired in a sea of bureaucratic sloth, it was also under the heavy shadow of the disgrace brought on by the public exposure of FDA internal corruption with respect to generic drugs and the various deceptions and bribery policies followed by some generics manufacturers. Meanwhile food seemed to get only sporadic attention from the FDA. Even then the occasional high spot of action seemed of questionable wisdom, as in last year’s case of the tiny number of Chilean grapes the FDA found to contain poison. That finding provoked draconian action which devastated the Chilean industry but was thought by American observers to be based on questionable evidence.

As for the innovative pharmaceutical industry, it bore with ill-concealed resentment the burden of excessively long and delayed FDA examinations of new drugs, large numbers of which were regularly approved years earlier in other countries whose drug regulation systems few would maintain are less careful and scrupulous than is the FDA.

. . . speedier approvals
Dr Kessler has just turned 40 and is perhaps the most important member of the Yuppie generation now making a noticeable splash on the Washington scene. He has clearly charted what he regards as an across the board revitalisation of the FDA, and some of its positive fruits have already been felt by the innovative pharmaceutical industry.
The old traditional 10 month near-hiatus in FDA approvals of new drugs following the end of each year has abruptly changed. The new Kessler FDA has approved a relatively large number of NDAs in the first half of 1991, for example Bristol-Myers Squibb’s second ACE-inhibitor, Monopril (fosinopril). Dr Kessler himself proudly told an anecdote last month of amazing a major pharmaceutical company executive by telling him one of his company’s new drugs would be approved within a year, an eventuality the company had thought so unlikely that it had made no manufacturing preparations to meet that time schedule.

Yet on balance, to date Dr Kessler seems to have raised many more forebodings of trouble ahead in the executive suites of major pharmaceutical companies than of expectations of more future goodies. The basic reason is his apparent decision that his initial emphasis must be upon enforcing the strict letter of the law behind the FDA. He seeks to end the image of the organisation as a “paper
tiger” and make even the largest corporations fear the new Kessler FDA as the bringer of disaster if any deviations from the straight and narrow path of the law are allowed. It is his tactics in this direction which have won him most newspaper headlines and at least initial media celebrity
status and approval.

His most publicised combat here was with the huge Procter & Gamble (P&G) conglomerate. This crystallised in his order to seize 2,000 cases of P&G’s Citrus Hill orange juice on the
ground that it was mislabelled because its carton carried the word “fresh” though it also revealed the juice was reconstituted from concentrate. P&G surrendered with alacrity immediately after the seizure. He has also clamped dawn on labelling of foods claiming “no cholesterol” or the like even though they may contain saturated fats.

. . . labelling and promotion

But it is his attitude on drug labelling and drug promotion that is causing the most worry. This has been increased by reports that Dr Kessler and the well known anti-industry guru Sidney Wolfe have now become very close and are working together. Here is how the well-informed liberal Washington commentator for The Lancet, Daniel S Greenberg, put it in the June 22nd issue:

“Among [Kessler’s] strongest supporters is an ancient blood-feudist of the FDA, Dr Sidney Wolfe, Director of the Public Citizen Health Research Group, medical wing of the Ralph Nader empire. Over many years, Wolfe’s organisation has repeatedly sued FDA and its officials on charges of neglect of statutory responsibilities, particularly in assuring the safety and efficacy of pharmaceutical drugs. Before Kessler’s arrival at the agency, Wolfe’s contacts with the FDA took place either in courts of law or in surreptitious relations with clandestine allies working inside the agency.
Under the new regime, Kessler and Wolfe meet monthly for lengthy private discussions, the protocol of their sessions provides for alternating the meeting sites between their offices”.

What is most alarming about this is that many of Dr Wolfe’s demands upon the FDA are actions for which the decisions are ultimately the responsibility of the FDA Commissioner – for example his demand several years ago that Pfizer’s Feldene he banned front the market place. The Commissioner Frank Young personally conducted the hearings which ended with his decision to reject the Wolfe demand, Will Dr Kessler now automatically approve all of Wolfe’s demands, or will he make the Wolfe programme his own agenda for the agency? Little wonder that, as a senior PMA official told me recently, the foreheads of many industry CEOs are now “furrowed”.

Dr Kessler’s intentions in the area of pharmaceutical labelling wore most fully discussed by him on two occasions, in testimony before Rep Theodore Weiss’ subcommittee on June 11th and in a speech to the Drug Information Association on June 17th. In the latter he announced that prevention of drug promotion in the “guise of scientific exchange” is FDA’s top priority in the drug advertising
area. In the earlier speech, he had declared bluntly: “Physicians may not, under the guise of scientific exchange, involve themselves in the manufacturer’s promotion of unapproved uses … We intend to act against instances of clearly violative behaviour, whether by product
producers or healthcare professionals, which present a public health hazard (see Scrip No 1628, p 16).

…seminars
In the DIA speech Dr Kessler took aim at the growing use of seminars by the pharmaceutical industry to reach doctors, implying that these seminars were flagrant instances in many cases of illegal promotion in the guise of scientific exchange. He declared that FDA guidelines in this area will be ready by the end of this year, but added: “I do not expect companies -to wait until this guidance becomes final to put their advertising and promotional houses in order”.

He was particularly insistent that such seminars be conducted by impartial organisations, and suggested at one point that seminars might he confined to those proposed by the American Medical Association and other medical associations, though presumably paid for by pharmaceutical companies. Executives at a major pharmaceutical company who apparently had caught early traces of Dr Kessler’s thinking told me at the end of May that the American Medical Association was hoping to get all
of the industry’s promotional money and spend it as it pleased. In this connection it is perhaps significant that earlier this year the AMA – traditionally a conservative organisation which formerly had no truck with medical radicals – publicly announced it had opened amicable
contact with Dr Sidney Wolfe, apparently implying it would co-operate with him in the future.

But Dr Kessler’s still early campaign has already drawn opposition from a significant figure in the government, Dr Bruce Chabner, Director of the National Cancer Institute’s Division of Cancer Treatment. Dr Chabner was moved to comment by the FDA’s early banning of Bristol-Myers’ publication “Oncology Commentary `90” lamely on the ground that it promoted unapproved indications for anticancer drugs.

Dr Chabner defended much of the contents of the commentary as accurately and usefully summarising “the best of current cancer research”. He added that “therapeutic research, by its very nature, encourages the off-label use of approved drugs”. He attacked the slowness of FDA’s approval of drugs for new indications, declared that many package inserts “bear little relationship to the current use of the agents”, and concluded: “It seems to me to be anti-intellectual, unrealistic and inhibitory to technology transfer to restrict the dissemination of valid research results
concerning a new use for an approved drug”.
In his June 17th speech, Kessler noted three cases of what he saw as violations of his proposed criteria: Collagen Corporation’s promotion of collagen injections for unapproved uses; Johnson & Johnson’s alleged promotion of Retin-A to prevent wrinkling, and Ciba-Geigy’s use of former baseball star Mickey Mantle to promote the NSAI, Voltaren, before television audiences which did not know Ciba-Geigy was paying him. I might note that I know of nobody in the industry apart from Ciba-Geigy who defends the last example of promotion.

It has been reported that Dr Kessler has referred the case of Johnson & Johnson to the Justice Department which has already initiated an investigation. it may be that the new FDA head thought that the threat of criminal prosecution would cause J&J to surrender quickly. So far that has not
happened, but who knows.

The core of the issue, it seems to me, is that Dr Kessler who has three degrees, in medicine, law and business administration, and who was an administrator for years before his present job, has had little involvement in patient care, and does not bring to his present job the point of view of a physician with long experience of treating patients.

…off-label use
According to an AMA estimated in The New York Times on June 29th, about a quarter of all prescriptions are for drugs intended to be used for unapproved indications.
This does not mean that physicians do not respect FDA regulations. Rather, those regulations give every physician the right to use drugs for his patients as he sees fit. And it is common knowledge that many drugs give important and useful employment for purposes the FDA has never approved. An old and important example is the use of the anti-epilespy drug, Dilantin, for cardiac arrhytmias. In that case as in many others the drug’s manufacturers discovered that trying to go through the FDA labyrinth to get formal approval was too expensive and too time consuming, and needless because physicians and their textbooks all know of Dilantin’s use for this purpose.

Late in the 1980s, during the Washington discussions on Medicare’s and other third party payments for drugs, it was openly recognised that it made no sense to try to restrict payment for drugs only to those prescribed for FDA-approved indications. Instead there seemed to be general agreement that payment should be made for all drugs used for purposes approved in various general purpose drug compendia, including the AMA’s own volume.

Dr Kessler, it seems to me, is making a mistake in acting as though upholding the honor, prestige, and fear of FDA are the most important objectives of his job. He and the FDA exist after all only to help physicians do their job of protecting and curing patients. In many aspects of medicine, physicians practise pragmatically, trying different drugs in the hope that they will find one which will help the patient. They can be helped only if they are guided in their searches by knowledge about the latest advances in research. Why does he suppose physicians read those clinical trials reported in Lancet, JAMA and The New England journals among others? Does Dr Wolfe want to open himself to the charge that he is anti-patient, and would rather see a patient die than get a drug for a use the FDA still has not approved?

I had throught that the AIDS crisis and the highly effective work of ACT-UP and its sympathisers had taught the FDA that its highest priority must be the speediest approval of drugs that will help patients with minimum risk. Dr Kessler’s current stance proves I was wrong, since he would shut doctors off from the supply of much current research information those doctors badly need. I hope the industry fights back with all the energy, resources and ingenuity at its disposal. But that advice, of course, is subject to the usual caveat that a product manager’s lust for more sales and profits must not be the chief force deciding a company’s policy in this important and sensitive field.