David R. Henderson  

Wolfe in Safety's Clothing

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In my latest Forbes.com article (co-authored with my book co-author Charles Hooper), I (we) take on Naderite Sidney Wolfe's views on safe drugs and on conflicts of interest. We point out that despite Wolfe's view that consultants to drug companies should not be involved as advisers to the FDA, a study that found no biased effect of such consultants was done by none other than . . . Sidney Wolfe.

Unfortunately, the FDA has appointed Wolfe to an important position with its Drug Safety and Risk Management Committee.


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COMMENTS (3 to date)
El Presidente writes:

David,

You write:

One single disease, lung cancer, kills more Americans each year than the combined U.S. casualties from combat in the Revolutionary War, the War of 1812, the Mexican War, the Spanish-American War, World War I, the Korean War, the Vietnam War and the Persian Gulf War.

And your solution is . . . ? Are you saying that we need to find a way for these people to become dependent on the products of pharmaceutical companies? I'm all in favor of curing illness, but maybe prevention is a more efficient alternative; one for which we would receive a greater return on investment. Of course, that might involve attempting to influence personal decisions through government. Just a thought.

How can we explain that, from 1963 through 2003, while pharmaceutical research and development expenditures grew by an inflation-adjusted factor of 20, the number of new drugs approved each year in the U.S. only doubled?

The Law of Diminishing Marginal Utility.

Their findings? None of the 76 voting outcomes would have changed had voters with supposed conflicts of interest been excluded. That didn't stop the authors from making a conclusion that contradicts their findings: "Ideally, all panels of scientific experts advising a federal decision-making body would be free of financial conflicts of interest with the affected companies." So much for the scientific method.

Saying that their connections would not have changed the vote is not the same as saying their connections had no influence over the approval process. While the formal voting threshold may be lower than the actual margin of victory, do you want a medicine cabinet full of drugs that were approved by a margin of one vote? Strong support is a valuable commodity in this industry, and margins may matter more than procedural rules would suggest. Influence would not be influence if it didn't actually influence anything. Industry reps get paid to lobby and presumably because their employers believe it works . . . unless you're saying that pharmas are spending money for nothing and passing the cost on to consumers.

David R. Henderson writes:

El Presidente,
You write:
Influence would not be influence if it didn't actually influence anything. Industry reps get paid to lobby and presumably because their employers believe it works . . . unless you're saying that pharmas are spending money for nothing and passing the cost on to consumers.
You're begging the question. That is, you're assuming that Pharmas are buying influence rather than expertise. That's why it makes sense to test the hypothesis, which is what Wolfe and his co-researchers did. If any of those 76 drugs had been approved by a one-vote margin and if that one vote had been due to a person who had been paid by the Pharma company whose interests had been directly at stake, that result would have shown up in their study. There was not even one such result in 76 cases studied. That's why we highlighted the fact in our article.
Best,
David

El Presidente writes:

David,

Thank you for your response.

If any of those 76 drugs had been approved by a one-vote margin and if that one vote had been due to a person who had been paid by the Pharma company whose interests had been directly at stake, that result would have shown up in their study. There was not even one such result in 76 cases studied. That's why we highlighted the fact in our article.

I understand what you're saying, and begging the question is not the highest form of debate (my apologies). You're saying that there were no 1-vote margins. I'm saying that something other than voting rules may be determining the socially required approval threshold. This is why I made the point that final votes which do not procedurally affect the outcome (those in excess of the required majority) are not necessarily irrelevant to the process or the outcome and do not disprove the presence of purchased influence. The final vote is not the whole of the process, and a voting requirement that lets you win by one does not guarantee you will get an audience if your margin is really that slim.

I agree that measuring the effect I am suggesting is much harder than measuring the formal votes for approval. What we can easily measure does not always tell us what we need to know. This is why it concerns me that you took Wolfe's study as presumptively demonstrating that there is no purchased influence rather than merely failing to prove there was. There is a lot of daylight between those distinct propositions.

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