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Book Review - Deadly Medicine

Advice to authors

Lord Beaverbrook gave some punchy advice to his staff on writing book reviews (5 Feb 1957 - cited in Taylor AJP. Beaverbrook New York: Simon & Schuster; 1972, page 634).
  1. Name - author - publisher
  2. What the book is about. The story if possible
  3. The author and his idiosyncracies
  4. Is it worth reading
  5. Wisecracks if good. But not any clever quips if commonplace

Never Never Never Neglect News values if any - Critics must be Reporters First.

Deadly Medicine

Moore TJ. New York: Simon & Schuster; 1995.

Deadly Medicine describes in American investigative journalese the events which led up to the registration, marketing and consequent disaster with Class 1 anti-arrhythmic drugs, particularly encainide, flecainide and mexiletine. The drugs were investigated using their ability to suppress premature ventricular contractions (PVCs). This was a 'proxy' for preventing sudden cardiac death presumed to be due to dysrhythmia. When, after drug registration and marketing, a trial was mounted to study the real outcome, mortality, there were significantly more deaths in the treated group than in the placebo group.

The thought-provoking parts of the diatribe are the uneasy triangular relationship between academic medicine, the pharmaceutical industry and the drug regulation authorities, and the issue of using proxy outcome measures.

Eternal triangles

Taking these in turn there is nothing new in the triangular relationship, but the increasing 1990s unease about sleaze means that we have to be critical when the academics who do research funded by the industry turn up on the panel for the drug registration authority. Conflict of interest becomes the understatement of the decade.

To say, as was said to Bandolier, "Dear Boy, I am a consultant to 27 different companies. How can you accuse me of being in the pocket of any one company?", is not an adequate defence. One phrase in the book Bandolier had not heard before and loved, the description of professors speaking 'on behalf' of the industry at symposia as "marquee professors".

Proxy outcomes

The question of proxy outcomes, in this case the drugs' ability to suppress PVCs - thought to be the likely cause of sudden cardiac death- is vexed. The drugs did suppress PVCs. This was relatively easy to answer. To answer the more fundamental question, did the drugs reduce the incidence of sudden cardiac death, would have cost a great deal more and taken longer to do. If such trials had been done the drugs would not have been registered.

The fact that more patients died on the drugs than on placebo would have been apparent earlier. Such deaths were in fact seen in the proxy outcome trials, but, because they did not fit with the prevailing wisdom, they were ignored. Moore makes much of the fact that there was a stampede to prescribe drugs of this class, and that many people died as a result. He estimates 50,000 deaths over a two year period.

The moral has to be that there are no shortcuts, but that doing things properly takes time and money. Political pressure, for instance from the AIDS or cancer lobbies, is for rapid introduction of new drugs. The downside is first that proxy outcomes may say that a drug is effective when it is not, and second that safety problems may be obscured by unduly hasty processes.

Again there is nothing new here, but ever since the thalidomide disaster there has been escalating concern among the public and the professionals, and a tension for the politicians, between the economic benefits for the pharmaceutical industry of introducing new drugs and the risk to the patient. The flecainide story emphasises that the concern is justifiable and the checks and balances are not perfect. The story is well told in the book, but the journalistic style may make it more difficult for the professional reader.

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