Thursday, October 11, 2007

Memory Hole (11 October): Who will guard the guards?

Scientific Misconduct Blog Memory Hole: Events of October the 11th

Quote of the day

Sed quis custodiet ipsos custodes? (But who will guard the guards?)


70 years ago today: The Sulfanilamine disaster and regulation

11 October 1937 was a landmark day in the history of drug safety. On that day, the American Medical Association received reports from doctors in Tulsa suggesting that a formulation of sulfanilamide was responsible for the deaths of patients deaths. It was discovered that the Elixer contained large amounts of the toxin diethylene glycol. Elixir of Sulfanilamide eventually killed 107 patients. One doctor who had six patient deaths resulting from his prescribing of the Elixir stated "I have spent hours on my knees . . . I have known hours when death for me would be a welcome relief from this agony." Other doctors tried to avoid responsibility by denying they had prescribed the drug.

In fact, the company that produced the Elixer had not broken any laws and there was no basis for prosecution. The only charge that was possible was an obscure "mis labeling" charge (that the word "elixir" implied alcohol content, but that the Elixer contained no alcohol). In 2007, I am not sure that anything has changed, even when science is deliberately misrepresented. The chemist who had compounded the Elixer committed suicide. He had made a mistake.

Public outrage led to the signing of the USA Food, Drug, and Cosmetic Act on June 25 1938. There is a counter view that this connection between a crisis and regulation is overly simplistic. "Industry capture" explanations propose that established drug firms supported new regulation as a way of driving away competition and gaining control of the rules of regulation. There may be some merit in that view.

Sed quis custodiet ipsos custodes? (But who will guard the guards?)

Read more: FDA view of the incident, and another view

40 years ago today: Harold Wilson and the nude postcard

On 11 October 1967 the British Prime Minister won a libel case against the pop group The Move after they published a promotional postcard featuring a cartoon of the Prime Minister in the nude with his female assistant Marcia Falkender. Wilson also sued journalists for libel and Lady Falkender sued the BBC over other matters.

The only reason for including this here is that legal threats and UK libel law have a chilling effect on science. Prime Ministers should not sue for libel. After all, Wilson's election campaign was aided by another nude.

Oh what have you done cried Christine,
You've wrecked the whole party machine!
To lie in the nude may be terribly rude
But to lie in the House is obscene


Source: Harold Wilson and the nude postcard

Dump my body at the FDA

19 years ago today: AIDS activists challenge regulation

On 11 October 1988, the group ACT UP (AIDS Coalition to Unleash Power) held a public demonstration to voice "their concern about the availability of drugs and other therapies to combat AIDS". The FDA and clinical trials were perceived to be the roadblock in the way of access to AIDS drugs. Protesters held mock tombstones with inscriptions: "I got the placebo - R.I.P."

While there may have been merit in these concerns, the crisis was used by industry to create an argument that science should be abandoned, denying patients and doctors critical information that can only be obtained through properly conducted trials. The debate about sulfanilamide (above) applies here.

Read: FDA view of demonstration. This August 2007 court decision is also of relevance.

4 years ago: 200 000 euthanasia files from the Nazi regime made available

Around 11 October 2003 documents pertaining to Nazi euthanasia (medically approved murder) were made available. These had been concealed for half a century by the former German Democratic Republic. Victims were mostly mentally and physically disabled adults and children.

"Eighty eight year old Rosemarie Albrecht, former director of the Ear Nose and Throat Hospital and former dean of the medical faculty in Jena is accused of taking part in the killing of at least 159 women and 11 children when in 1940 she worked as a junior doctor in a psychiatric hospital in Stadtroda, Thuringia."

Sources: British Medical Journal 2003;327:832 (11 Oct), The central databank of the German Federal Archives

2 years ago today: Arrest of 4 Israeli doctors for research violations

On 11 October 2006 four Israeli doctors were arrested for carrying out illegal, non-consensual medical experiments on their patients.

"the hospitals in Gedera and Rehovot conducted illegal and unethical testing on thousands of elderly patients for years." "During one of the incidents described, twelve patients died either during the experiments or shortly after they took place, but these incidents were not reported".

Source: AHRP

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