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John Stossel's Plan to Abolish the FDA Should Be Laughed Out of Town

Fox Business News firebrand John Stossel argued on his show last week that the FDA should be abolished and replaced with ... nothing. Americans should be allowed to take whatever medicines they like, whenever they like, for any symptom they please, he argues, and we'll all be safer for it.

As with all arguments made by Stossel, he takes a libertarian position that contains a grain of sense and blows it completely out of proportion. His cartoonish exaggeration of that position makes the drug company lobbyists standing on the sidelines, who would like to see a watered-down version of his rantings become law, look more realistic.

In this case, there's a debate in the drug business about whether terminal cancer patients should have access to unproven, experimental drugs. The patients say they should because they have nothing left to lose and even their deaths could advance research.

On the other hand, the FDA and others -- including me -- believe that allowing unfettered experimental use of cancer drugs will more likely lead to companies cynically selling useless drugs to desperate patients who are more likely to die than sue. This happened recently to Fred Baron, the Democratic fundraiser who died of cancer despite finagling access to Biogen's Tysabri. Even Biogen didn't want him to get it!

And you can see how thin the "evidence" has to be before thousands of people begin to believe that someone has stumbled on a miracle cure. Medarex's stock went through the roof after it announced in a single press release that just three patients had been cured of cancer with its drug, ipilimumab. (It may well be that the drug is a blockbuster, but press releases don't prove that.)

We'll know which drugs are safe and which aren't, Stossel says, because over time "trustworthy" private actors will emerge who will do a much better job than the FDA:

Why, in our "free" country, do Americans meekly stand aside and let the state limit our choices, even when we are dying ?
Competition leads both drug companies and private regulators to be trustworthy. If they are not trustworthy, they die.
Well, Merck (MRK) was "untrustworthy" on Vioxx, and guess what? It's alive and well and has since acquired Schering-Plough.

Stossel appeared on The O'Reilly Factor to make his case, which led to this surreal exchange in which Bill O'Reilly ends up defending big government. The pair start by agreeing that the FDA saved America from Thalidomide -- the sleeping pill that causes babies to be born deformed:

O'REILLY: look, this whole thing started -- and you remember this, when you were a little kid because I certainly do -- with thalidomide, where it started, where they came up with a drug and they gave it to pregnant women and babies came out with no arms and legs.
STOSSEL: It didn't happen in America because of the FDA.
O'REILLY: Right. When that happened, the government said, "Whoa, we have to make sure that these things don't happen." And then recently we have had a number of drugs come on the market that have caused all kinds of horror to people who took them. So surely you can't want that protection to be evaporated?
STOSSEL: Yes, I can.
Thalidomide proves the benefit of the existence of the FDA -- essentially, one doctor warned the agency that he believed the drug was dangerous to fetuses, the FDA investigated and the drug never made it to market. But Stossel believes that the FDA should be replaced by a series of free-market watchdogs:
STOSSEL: Consumer Reports, Underwriters Laboratory. Take away the government's monopoly, and private groups will do it better.
Next, O'Reilly goes on to make a cogent case in favor of regulation, based on the fact that most of us are completely unqualified to assess drugs or the science behind them:
O'REILLY: All right. You've got a point there. Suzanne Somers on this program last week, she wants supplements to be unregulated, OK? Again, you take a supplement. You don't know how it's going to react. I took this red yeast. I told her -- red yeast is supposed to bring down bad cholesterol. Well, it had a terrible impact on my liver. I didn't know that. Should I have known it? Maybe. But I think you've got to have labels on this stuff. You've got to know what you're taking.

STOSSEL: But you're assuming government would protect you from all this.

O'REILLY: I am assuming that.

STOSSEL: If you weren't such a meek, passive person trusting government to do that, you would have read up before you took red yeast.

O'REILLY: I did read up on it, but it didn't say, "It's going to hurt Bill's liver." It said it would bring my cholesterol down, which it did, but I'm running around the living room with my liver. Yes, I have low cholesterol, but here's my liver on a stick, all right? The trade-off wasn't worth it.

Look, you know what I'm talking about. That's impossible for the consumer to know what's in these things and whether it's going to adversely affect them. There's got to be some kind of central authority.

STOSSEL: No. Central authority is bad. The bias should be for freedom. And without a central authority, there are lots of little authorities, and we learn which ones to trust.

O'Reilly's point is even more compelling in relation to the terminally ill or the mentally ill. People who are very sick or who have lost their grasp on reality are likely to be very poor judges of what they most need, and they have very good reasons -- illness -- for being "meek" or "passive."

So why would Stossel make such a crazy argument? Here's one way to think about it: Public policy is often a result of an amalgam of public opinion, a compromise that attempts to please pressure groups. Drug companies want less regulation by the FDA, and their executives have previously endorsed stalking horse groups such as the Washington Legal Foundation which has argued and litigated the case that the off-label marketing of unapproved drug uses is a violation of companies' First Amendment rights. No one believed the courts or the government would adopt that policy wholesale, but the FDA did eventually relax its regulations to allow certain off-label materials to be distributed by companies.

In that light, Stossel's out-there position makes those who want unproven cancer drugs on the market seem a lot more reasonable.

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