MEDICAL HISTORY


“ There is something absurdly crass about linking Marilyn’s, albeit manufactured, beauty with the monstrosity of thalidomide’s effects”


foresee in the forthcoming legislation. Te only one of these concerned scientists


to be named in the piece was Louis Lasagna who offered “a way out”. He is quoted as calling for “academicians and industrial scientists...to serve in advisory capacities to help draſt sensible provisions to safeguard the American people”.


Thalidomide “too valuable” Perhaps Lasagna had himself in mind for this role, together with his “industrial scientist” colleagues at Merrell, for he went on to argue that “thalidomide is too valuable a drug to lose. It is the safest sedative yet discovered; it will not kill animals or humans even in heavy overdoses”. Tat Lasagna should still be rooting for thalidomide in August 1962, when reports of several thousand birth defects in Europe had already been received, is difficult to understand and perhaps betrays either a lack of judgement or a too cosy relationship with his industrial sponsors. He went on to defend his position by


linking the thalidomide tragedy with the other headline of the hour—Monroe’s premature death. Osmundsen reports: “Lasagna observed that, if Marilyn Monroe’s physician had been able to prescribe thalidomide instead of barbiturates, the movie star might be alive today”. Lasagna’s claim is undoubtedly true, for in


overdose thalidomide is a much safer drug than the Nembutal taken by Marilyn. But Lasagna failed to appreciate, or perhaps just failed to acknowledge, the likely outcome if thalidomide had been available on prescription (or even over-the-counter, as Merrell had wished) in 1960s America. Te United States at the time was a much more medicated population than the UK or Germany, with a considerably larger population than both countries combined. Te numbers of thalidomide-associated birth defects would likely have been proportionately greater in the US than elsewhere and would certainly have run into the tens of thousands.


What if…? Yes, Marilyn may have been saved, she may have completed Something’s Got to Give, her final doomed movie, and, who knows, even gone on to live long enough to receive her honorary Oscar one day, but the associated


14


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costs would have been enormous. Marilyn would not have been the only victim of barbiturate poisoning saved by the availability of a “safer” alternative. In New York City alone, between 1957-63 there were over 1,100 deaths due to barbiturate overdose. But those were not the lives Lasagna chose to balance against the use of thalidomide. It was Marilyn’s, the screen goddess, whose death at the age of 36 had made the front page of every newspaper and magazine in America only three weeks before. Te symbolism of his statement was


powerful, and the counterfactual it presented was tempting. What if thalidomide had been prescribed instead of Nembutal, would Marilyn still be smiling her perfect inviting smile in Technicolor; would the fantasy still be alive? Tere is something absurdly crass about linking Marilyn’s, albeit manufactured, beauty with the monstrosity of thalidomide’s effects and Lasagna’s use of this imagery seems insensitive and misplaced. Lasagna was, however, right when he


predicted that thalidomide was “too valuable a drug to lose” but not, as he thought, because it was a useful sedative. In 1998, the FDA approved the drug for the treatment of erythema nodosum leprosum, a severe and debilitating complication of leprosy. Although thalidomide offered some benefit to patients with this condition it still possessed its teratogenic effects and the FDA took the unprecedented step of tightly controlling the drug’s marketing and insisting on a robust patient education programme, the maintenance of a patient registry and even mandatory pregnancy testing for sexually active women of childbearing age. At the age of 80, Frances Kelsey, still


working for the FDA, served on their Working Group to develop and implement uniform standards of safety for clinical studies using thalidomide. Her experience with the drug was, understandably, seen as a great advantage. While she was acutely aware of the potential benefits that thalidomide may offer certain patient groups, Kelsey remained


cautious. “We need to take precautions,” she said, “because people forget very soon”. Perhaps when we recall her meeting with


Louis Lasagna, some 37 years earlier, and the position he maintained aſterwards we might be forced to conclude that some fail to learn in the first place.


n Dr Allan Gaw is a clinical researcher and writer in Glasgow


Sources


Bren L. US Food and Drug Administration FDA Consumer Magazine March-April 2001 Lasagna L. Journal of Chronic Diseases 1960 11: 627-31.


Carpenter D. Reputation and power. Organizational image and pharmaceutical regulation at the FDA (Chapter 4) Princeton University Press, Princeton, 2010.


López-Muñoz F, Ucha-Udabe R, Alamo C. Neuropsychiatric Disease and Treatment 2005 December; 1: 329–43.


SUMMONS


Above: child with thalidomide-associated birth defects. Below: Frances Kelsey receiving award from President Kennedy.


pHoto: NAtIoNAL LIBRARY oF MEDICINE/SCIENCE pHoto LIBRARY


pHoto: oMIKRoN/SCIENCE pHoto LIBRARY


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