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Healthy Skepticism Library item: 18824

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

Rawlins M
The FDA and the black arts of drug regulation
The Lancet 2010 Oct 30; 376:(9751):1455 - 1456
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61979-4/fulltext


Abstract:

I enjoy reading political histories, especially those spiced with intrigue and gossip. But this is the first time I have read a political history on a subject about which I have been intimately acquainted; covering issues with which I have been personally involved; and about people with whom I have had more than a passing acquaintance. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA is about the rise in the power and influence of the US Food and Drug Administration (FDA) during the latter half of the 20th century; and its decline in the first decade of the present one. Political scientist Daniel Carpenter has written a voluminous account of the politics and personalities that have made the FDA both reviled and respected in the USA and beyond.
Carpenter’s central thesis is that the FDA’s power, in its halcyon days, stemmed not from its legal authority but from the reputation that it had earned with the public; and the fear that it instilled in the pharmaceutical industry. During the 1940s and 1950s, its legal powers to control the entry of new drugs onto the US market dated back to the Food Drug and Cosmetics Act of 1938. This had been passed by Congress, in the light of the sulfanilamide disaster, and empowered the agency to require evidence of a product’s safety before licensure. As Carpenter points out, however, safety is a nebulous concept in the absence of evidence of efficacy; and the agency pressed Congress to extend its legal mandate. Senator Estes Kefauver made valiant efforts to persuade Congress to do so during the 1950s, but was thwarted by the combined efforts of the US pharmaceutical industry, the American Medical Association, and the Republican members of the Senate. Then, suddenly, everything changed.
The tipping point was, of course, the thalidomide disaster. Introduced into Europe during the late 1950s, the entry of thalidomide onto the US market was blocked by a young FDA medical reviewer called Frances Kelsey. What caused Kelsey to prevaricate, in agreeing for thalidomide to get onto the US market, has always puzzled me. Her review started well before any significant safety issues had been encountered; and there could have been no doubt that it was an effective hypnotic. So what was the problem?
Carpenter believes that it was as much Kelsey’s animosity towards its US sponsors (Richardson-Merrill) rather, at least initially, than particular concerns over either its safety or efficacy. Certainly the company tried to bully her by, for example, threatening to make a complaint about her to more senior staff in the agency. She herself did not believe that the company’s officials were either honest or trustworthy. And when Kelsey later discovered that Merrill had concealed reports of neuropathy from her, her suspicions must have been confirmed. At any event, Kelsey’s delay meant that thalidomide never made it onto the US market; and that children in the USA avoided the teratogenicity experienced by an estimated 10 000 others elsewhere in the world. As a consequence, the FDA’s reputation with the public skyrocketed; and Senator Estes Kefauver saw his amendments sail through Congress without opposition. Kelsey, herself, became-and remains-a national hero; and President Kennedy presented her with the Distinguished Civilian Service Medal at a ceremony in the White House.
The FDA’s reputation, in the latter years of the 20th century, grew steadily. Its authority was unchallenged by the industry, the courts, or the medical profession. And its power and influence increased proportionately. It deftly handled the problems with oral contraceptives; and was sensitive to the needs of those with HIV/AIDS who demanded swifter access to treatments.
But over the past decade Carpenter argues that the FDA’s reputation and power have declined. The agency’s reputation has suffered badly over its mishandling of a number of safety issues (such as the COX-2 inhibitors); and from its persistent refusal, during the Bush years, to allow postcoital contraceptives to be marketed. The very public disagreements within the agency’s staff have also undermined the confidence of the public and Congress. In Carpenter’s view, the agency’s reputation and power are but a shadow of what they were in its heyday. And polling data confirm the public’s distrust.
Although Carpenter’s central thesis, of the interconnection between power and reputation, is surely correct, there are aspects of the book that disappointed me. First, he claims that in the mid-1960s the emerging UK and European Union regulatory authorities merely copied the FDA in generally demanding evidence from randomised controlled trials before agreeing to allow a new product to be marketed. This is untrue. The emerging UK regulatory authority, in the 1960s, wanted to ensure that drug development was based on the best available science. Carpenter seems to be unaware that Austin Bradford Hill, the architect of the randomised controlled trial, was a founder member of the UK’s Committee of the Safety of Drugs, together with such clinical pharmacological luminaries as Desmond Laurence and Colin Dollery. They didn’t need the FDA to tell them “how to suck eggs”.
Carpenter also ignores the FDA’s orphan drugs programme; nor does he make any mention of its remarkable first director Marlene Haffner. The world really does owe the FDA a debt for the way it advanced the cause of drugs for rare diseases. As a result of the agency’s orphan drugs programme, patients across the world with rare diseases, such as Gaucher’s disease, have access to therapeutic agents that would otherwise be unavailable to them. The European Union does, now, have its own programme; but owes everything to the example of the FDA and to the advice that Haffner gave to the European Commission.
As far as the gossip goes, much of it is entertaining. But Carpenter’s depictions of some clinical pharmacologists are egregiously unflattering. For example, Sir Derek Dunlop did not, on his retirement from chairing the Committee on Safety of Drugs, join the Association of the British Pharmaceutical Industry; and Carpenter’s caricature of my old friend Lou Lasagna as some right wing industry cheerleader is cruel to his memory.
Reputation and Power is, nonetheless, an authoritative and a well researched book. Political scientists will admire Carpenter’s scholarship. It will make an interesting read for those who are, or have been, professionally involved in the black arts of drug regulation either in the pharmaceutical industry or in a national drug regulatory authority. And many others who wonder how drugs get onto the market will enjoy it too. It is, indeed, a good mix of history, politics, gossip, and intrigue.

 

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