Fri Apr 07, 2006

Costs versus benefits of new drugs

The FDA and the Tort system give little weight to the benefit side of the ledger

Tigerhawk has a post discussing the case of Tysabri, a very effective drug for treating MS. He writes:

An example of this is the FDA's hanky-twisting over the multiple sclerosis drug Tysabri, which is orders of magnitude more effective against that nerve-killing disease than existing therapies. Unfortunately, Tysabri has been "linked" -- tenuously, at best -- with a rare brain infection in fewer than five patients out of the many thousands who have taken it. The FDA pressured Biogen and Elan to pull the drug last year, and it has not cleared the drug for relaunch notwithstanding the unanimous recommendation of a non-binding expert advisory panel. Why? Because it fears the quick death of one or two people more than it values the lifespans of hundreds of thousands of people.

Tigerhawk goes on to reprint a WSJ editorial on the subject. It concludes:

One lesson is that Tysabri should never have been withdrawn in the first place, when a "Dear Doctor" warning letter would have sufficed. But the possible side effects came to light at the height of the Vioxx panic (another relatively small risk, by the way), and then-acting FDA chief Lester Crawford wasn't going to take any difficult stands while he was awaiting confirmation. We hope Andrew von Eschenbach, the latest nominee to head the FDA, won't follow Mr. Crawford's lead. The FDA badly needs public leadership to explain that almost all live-saving and life-improving drugs do have some risks.

The Tysabri story is also further evidence of the need for Congress to pass "Kianna's Law" -- legislation introduced by Senator Sam Brownback (R., Kan.) that would require the FDA to move faster on drugs for terminal and degenerative disease. The tendency of FDA bureaucrats is always to delay decisions on drugs that might turn out to have some nasty side effects. But as Audrey Greenfield, Bartira Tibertius and thousands of other MS patients have had to learn over the past year, too much caution can have nasty side effects too.

It is strange how so much attention is paid to the possible deaths of a few people and so little to the lives lost that otherwise would have been saved. The same sort of lunacy has greatly reduced the number of vaccine manufactures, as this Wharton article notes:

Lawsuits filed against vaccine makers alleging their products have harmed patients are another reason drug makers have become wary of vaccine production, says Wharton health care systems professor Scott Harrington. With vaccines that can potentially reach millions of patients, the odds of a bad outcome in the courts could ruin a firm, he notes. In the case of widely distributed vaccines, "a firm is engaging in a bet-the-firm risk if things go bad. That discourages research and development on certain types of vaccines and discourages production and marketing."

In 1986, Congress created the Vaccine Injury Compensation Program (VICP), which established a no-fault system for compensating those who may have been injured by routine childhood vaccines. The program was designed to streamline and limit vaccine makers' liability. But Harrington says lawyers continue to bring suit against vaccine companies by using opt-out provisions in the legislation that created the VICP.

The biggest obstacle vaccine makers face, Harrington adds, is little payback for their risk because many of their products are purchased in bulk by governments and other public health authorities, including humanitarian agencies. These large buyers are able to negotiate low prices. "In the U.S., the government is paying for over half of all vaccines for children, and vaccine makers are more or less forced to take prices that are very low. It might be difficult to pursue research and development without worrying that you could get a very low price," says Harrington.
...
David also suggests that some of the vaccine shortages in recent years may have come as a result of stepped-up Food & Drug Administration review of vaccine manufacturers' plants. "The more serious the FDA got, the more shortages we got."

According to Danzon's vaccine study, Wyeth produced influenza vaccine for the U.S. market for more than 20 years, but in October 2000 the company was fined $30 million for manufacturing violations and an additional $15,000 for every day that it remained out of compliance. In November 2002, Wyeth announced it would exit the flu market, leaving only two manufacturers of injectable influenza vaccine.

David says the role of government in the vaccine market cannot be overlooked. Assertions that a market-driven system has failed in the vaccine industry are wrong, he suggests. "We do have private firms providing vaccines, but it's not like we have ever given this market a chance to be a free market. This type of production is among the most heavily regulated industries we have."

Excessive government regulation and rapacious lawyers are a potent combination if your objective is to destroy the pharmaceutical industry. The price we pay for the few lives saved are a thousandfold more dying and suffering the ravages of diseases like MS.

Posted by: Pat on Apr 07, 06 | 9:07 pm |

http://www.asininity.com/weblog/P2653/