24 - 26 April 2017 | San Francisco, CA

Tuesday, July 31, 2007

FDA's Chang and Eng: Benefit vs. Risk

As reported in the Wall Street Journal, "A Food and Drug Administration advisory committee found that GlaxoSmithKline PLC's diabetes drug Avandia is tied to a risk of heart attacks, but it stopped short of voting to pull the medication off the market."

Behind that story, however, is the open discord between FDA's Office of New Drugs (OND), which approved Avandia for sale in the US, and the Office of Surveillance and Epidemiology, which is responsible for monitoring drug safety.

"At the meeting," WSJ reports, "officials of the FDA publicly clashed over what the evidence said about Avandia. Before the votes, two drug-safety officials -- David Graham and Gerald Dal Pan, who oversees the safety office -- said evidence signaling Avandia's risk outweighed its apparent benefits. But Robert Meyer, director of the FDA office that reviews diabetes drugs before they are approved, said he hadn't yet made up his mind and acknowledged a 'fundamental disagreement' among FDA staff."

It's as if the FDA had two heads!

FDA's Chang and Eng
But just like Chang and Eng Bunker, the original "Siamese Twins," the two heads are not equal. Like Chang, the OND side of FDA, is the stronger one -- only it has the power to force a drug off the market. It, of course, has a vested interest in keeping a drug on the market once it's reputation is at stake for having approved it for sale in the first place!

Just like Chang and Eng, the two heads of FDA have, until now, lived together in the same house with their wives -- or, in the case of the FDA, their staffs.

Eventually, however, the wives of the twins complained about the arrangement and Chang-Eng were forced to set up two homes and the twins would alternate spending three days at each home.

That is precisely the kind of arrangement Congress would like the FDA to adopt by giving more power to the Eng of FDA; specifically, more power to recall drugs for safety reasons.

I am not clear about the details of Chang's and Eng's sexual lives. All I know is that they had a total of 22 children -- 10 attributable to Chang and 12 to Eng!

See, that's what worries the drug industry about making FDA's Chang and Eng more equal -- Eng -- FDA's Office of Surveillance and Epidemiology -- may be more prolific than Chang! They fear that for every 10 drugs approved by Chang, 12 would be black-boxed or taken off the market by Eng. Can't have that!

It's interesting that Chang -- the stronger twin -- died first. It was said that he had a drinking problem, perhaps due to his insecurity about fathering fewer children than Eng. Who knows?

In the end, Eng refused to acquiesce to an emergency separation from Chang and he died just a few hours after Chang did.

According to some, separation of Chang and Eng would have been extremely easy, even with 19th century medical technology. But that never happened and both Chang and Eng were destined to live and die together.

That makes for a fascinating human interest story that will someday be brought to a movie screen near you. Unfortunately, FDA's Chang and Eng story does not make for good entertainment, just frustration over a dysfunctional agency that can't seem to agree on how to both serve and protect the public good.

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