Right Thinking From The Left Coast
We didn't lose the game; we just ran out of time. - Vince Lombardi

Monday, August 16, 2010

The FDA Moves

You know I do sometimes get tired of being right all the time:

Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope.

The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?

The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.

Now there may be good reasons for rescinding the Avastin approval.  The recent studies have muddied the waters considerably as to whether this drug is a benefit or a hazard.  Avastin is also extremely expensive, running from $50-100,000 to extend life by a few months.

In a consumer-controlled healthcare system, it would be up to patients to decide whether to spend a lot of money on it (although, even in the major medical insurance scenario that I envision, Avastin costs would still be mostly, if not entirely, born by insurers).  In our insurance-company-controlled and increasingly government-controlled system, Avastin becomes a political football.  It was approved because of political pressure.  And this repeal is running into a firewall of political pressure from the government and private insurance companies that don’t want to pay for it on one side and congressmen and patients who think there should be no limits on healthcare spending on the other.  In short, science has become the least of the concerns here.

This is going to happen more and more.  As more expensive treatments come down the pipe, every one is going to become a political war between those who want the treatment and those who are paying for it.  Because those two groups are not the same people, it will be fought out in the FDA, in the halls of Congress and almost certainly in an eventual federal agency that will do cost-benefit analysis.

Welcome to the future.

Posted by Hal_10000 on 08/16/10 at 04:37 PM in Health Care  • (0) TrackbacksPermalink
Page 1 of 1 pages