Friday, April 01, 2005

"Bioshield" Boondoggle


Whole industries have sprung up based upon our fear of terrorism. And it's being funded in large part by the U.S. government to the detriment of other urgent needs.

Some sectors of the pharmaceutical industry hope to be the latest beneficiaries of this largesse. According to an article in today's Wall Street Journal:
Less than a year after Congress provided the pharmaceuticals industry with incentives to develop drugs for terrorism-related illnesses, a fight is brewing over efforts to offer more goodies -- including the chance to extend patent rights on medications that have nothing to do with homeland security.

Last year's legislation, signed by President Bush in July, provided $5.6 billion for the government to buy and stockpile medications to combat bioterrorism agents such as anthrax and smallpox. Now some lawmakers, convinced the measure didn't go far enough, are developing bills that go far beyond the Bioshield law.
An idea being pushed by Senator Joe Lieberman and likely to lead to a bipartisan bill co-sponsored by Orin Hatch is called "wild-card exclusivity."

"Under his plan, a drug maker that successfully develops a product to prevent or treat a bioterrorism illness or emerging infectious disease could get six months to two years of additional patent life for any product it chooses." (WSJ)

At least one drug company - Pfizer - backs the wild-card proposal as a way to "induce large companies to invest capital and divert the necessary resources to develop promising compounds for countermeasure uses," says company spokesman Jack Cox. Last year's Bioshield law "isn't enough to spur the development of new drugs to counter bioterrorism attacks."

$5.6 billion isn't enough, some want more!

Given the "chronic dysfunction inside American intelligence agencies" (see
NYT Times article "Bush Panel Finds Big Flaws Remain in U.S. Spy Efforts"), how can we trust the intelligence that a real threat actually exists?

Profiting from our fear of terrorism is not a smart PR card for the pharmaceutical industry to play. For an industry that prides itself on innovation, this gambit is a cheap shot to maintain marketing exclusivity despite its failure to be innovative.

I don't blame Pfizer and other drug companies for trying to extend the patent life of their products, but to do so simply by passing legislation and creating drugs that will likely expire in stockpiles is unconscionable.

A Better Way to Extend Patent Life
Some time ago I mentioned a much better way for drug companies to extend the patent life of their products and do it in a way that will address a REAL threat to the health of Americans -- death due to adverse drug side effects.


Here's my suggestion:
"Restricting DTC should be tied into (1) a requirement that drug companies perform more post launch surveillance studies to prove the safety of their drugs in the marketplace -- the restriction on DTC can be provisional upon completion of those studies; (2) increase the patent life of drugs so that drug manufacturers can make up for lost income due to lack of DTC after launch; and (3) make it much harder for "Me Too" drugs to be launched, especially during and immediately after the provisional period of the first-to-market drug where DTC is restricted -- this would prevent the copy cat from taking advantage of the groundwork established by the first-to-market drug, especially with regard to the safety studies." -- See "How the FDA Can Fix DTC"
This plan might actually save lives and at the same time REWARD INNOVATION rather than reward what the industry should be doing in the first place!

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