|
Townhall...
A Killer Agency
By Walter E. Williams
Sam Kazman’s “Drug Approvals and Deadly Delays” article in the Journal
of American Physicians and Surgeons (Winter 2010), tells a story about
how the U.S. Food and Drug Administration’s policies have led to the
deaths of tens of thousands of Americans. Let’s look at how it happens.
During the FDA’s drug approval process, it confronts the possibility of
two errors. If the FDA approves a drug that turns out to have
unanticipated, dangerous side effects, people will suffer. Similarly,
if the FDA denies or delays the marketing of a perfectly safe and
beneficial drug, people will also suffer. Both errors cause medical
harm.
Kazman argues that from a political point of view, there’s a huge
difference between the errors. People who are injured by incorrectly
approved drugs will know that they are victims of FDA mistakes. Their
suffering makes headlines. FDA officials face unfavorable publicity and
perhaps congressional hearings.
It’s an entirely different story for victims of incorrect FDA drug
delays or denials. These victims are people who are prevented access to
drugs that could have helped them. Their suffering or death is seen as
reflecting the state of medicine rather than the status of an FDA drug
application. Their doctor simply tells them there’s nothing more that
can be done to help them.
Beta-blockers reduce the risks of secondary heart attacks and were
widely used in Europe during the mid-’70s. The FDA imposed a moratorium
on beta-blocker approvals in the U.S. because of the drug’s
carcinogenicity in animals. Finally, in 1981, FDA approved the first
such drug, boasting that it might save up to 17,000 lives per year.
That meant as many as 100,000 people might have died from secondary
heart attacks waiting for FDA approval.
In the early 1990s, it took the FDA more than three years to approve
interleukin-2 as the first therapy for advanced kidney cancer. By the
time the FDA approved the drug, it was available in nine European
countries. The FDA was worried about the drug’s toxicity that resulted
in the death of 5 percent of those who took it during testing trials.
This concern obscures the fact that metastatic kidney cancer has the
effect of killing 100 percent of its victims.
Kazman says that if we estimate that interleukin-2 would have helped 10
percent of those who would otherwise die of kidney cancer, then the
FDA’s delay might have contributed to the premature deaths of 3,000
people. Kazman asks whether we’ve seen any photos or news stories of
the 3,000 victims of the FDA’s interleukin-2 delay or the 100,000
victims of the FDA’s beta-blocker delay.
These are the invisible victims of FDA policy. In the 1974 words of FDA
commissioner Alexander M. Schmidt: “In all of FDA’s history, I am
unable to find a single instance where a congressional committee
investigated the failure of FDA to approve a new drug. But, the times
when hearings have been held to criticize our approval of new drugs
have been so frequent that we aren’t able to count them. ... The
message to FDA staff could not be clearer.”
That message is to always err on the side of overcaution where FDA’s
victims are invisible and the agency is held blameless.
Kazman’s day job is general counsel for the Washington, D.C.-based
Competitive Enterprise Institute that’s done surveys of physicians and
their views of the FDA. On approval speed, 61 to 77 percent of
physicians surveyed say the FDA approval process is too slow.
Seventy-eight percent believe the FDA has hurt their ability to give
patients the best care.
But so what? Physicians carry far less weight with the FDA than “public
interest” advocates and politicians.
When the FDA announces its approval of a new drug or device, the
question that needs to be asked is: If this drug will start saving
lives tomorrow, how many people died yesterday waiting for the FDA to
act?
Read it in Townhall
|
|
|
|
