November 9, 2006
FDA: One Step Forward?
Some good news in the Wall Street Journal today: "Election a bad dream, GOP keeps both houses." Well, no. The actual headline was FDA May Broaden Access To Experimental Drugs. Life and political battles go on. And the story starts out promising.
The Food and Drug Administration is moving to broaden access to experimental drugs for people with serious illnesses, with efforts that would represent a middle ground in the emotional debate over when unproven treatments should be available to patients with no other options.
Great news: some people will be allowed to buy drugs that will help them. If, they can prove that they will die. And there's nothing else. And they fill out the right form. And if their form is approved.
Two sides to a controversy, and the article points out the other side.
The FDA is preparing a proposal that would clarify how doctors and drug companies can make certain drugs, not yet FDA-approved, available to small groups and individual patients with dangerous diseases and no other treatment options, according to people with knowledge of the matter. Agency officials have also drafted a proposal that would lay out more situations in which companies could charge patients for access to experimental drugs, though not for a profit, these people said.Both proposals are subject to approval by the White House's Office of Management and Budget and could change before they are released.
The FDA proposals, which wouldn't represent a major revamping of the current system, don't go as far as the most aggressive patient activists wish. On the other side, some doctors warn that the agency needs to make sure there is reason to believe a drug could work before patients start taking something that may not help.
With apologies to James Taranto, "what would we do without 'some doctors?'" Where in the Constitution is government given the right to prevent the sale of treatment? People are suffering. If they know the risks, the government should not have the right to preclude access to treatment.
Better to let 99 snake oil shysters bilk some unfortunate people out of money for ineffective treatment than to let one person die because some bureaucrat thought the form was filled out incorrectly. 30,000 people died of colon cancer while Erbitux was forced to perform 24 more months of trials. Many though it was because Dr. Sam Waksal was "arrogant."
I’m happy for the small step, but still reject Government's having any authority in this ambit. Free markets could do better.