Should we abolish the FDA?

In this thread, we were talking about Milton Friedman and I claimed Friedman was a nutbag for wanting to abolish the FDA among other things. Opus1 challenged me to back up my statement and make a cogent argument about why the Friedman is wrong. Not wanting to hijack that thread, I’ve decided to start another one.

The original interview is here. The relevant portion is here (this should fall under fair use):

In my mind, I view Friedman as having a bad case of Man with a hammer syndrome. Like Einstein and BF Skinner, he simply refuses to entertain evidence that refutes his pet theory and conflicts with his world view.

Lets start with Opus1’s main argument which is that the FDA has lead to the death of hundreds of thousands of people due to making bad decisions:

Well, my response to that is sure, of course they have. They wield a lot of power and, as a consequence, any mistake they make can have far reaching consequences. But everybody makes mistakes, all the time. You just have to live with that. The real question is would a free market approach cause the loss of more or less lives?

The fundamental assumption that Friedman is making is that the market will act in a rational manner because either all people are rational or the market contains some mystical voodoo that distills a rational decision from non-rational parts. However, what this completely fails to take into account is that human reasoning, especially on issues of risk, are grossly irrational on a huge and systematic basis. We overestimate small threats and underestimate big ones, overestimate gruesome looking threats, threats outside of our control and new threats. As a result, the “average person” is grossly unsuited to making judgements about the relative risks of drugs and whether the benifits outweigh the risks. Drug companies would be incredibly motivated to play on flaws of human judgement to maximise their return rather than do the most good for humanity. While the FDA isn’t perfect in this regard, anybody who has had at least some training on performing risk analysis and cost benifit analysis is almost always going to do far better than the layman.

As a result, Friedman’s tort based incentive program for keeping drug companies in line is ludicrious. Many of the currently benifical drugs would be sued off the market because of a few highly visible media stories and many harmful or useless drugs would flood the market based on similarly biased marketing. If you doubt this, look at the dietary supplement market which is NOT regulated by the FDA and see the results there.

Friedman seems to have fallen in love with the mathematical models and has simply refused to stick his head out into the world to see if they correlate properly and I think thats a very dangerous position to be in.

I’d consider seriously reconstructing it over simply abolishing it and hoping everything turns out all right. I agree there is a overly lengthy period, much like the patent office, between submission and the approval/denial decision. Throwing out what-ifs like the timolol question is quite obviously pointless, and a bit propagandist. Pointing out the flaws is helpful, but likening them to mass murder is pushing it.

Pardon my ignorance, but don’t European countries have the FDA to some degree?

I wouldn’t abolish the FDA, but I would gut their regulatory power to make it so that pharmaceuticals could still be sold without their approval. Yes, this could have harmful effects to society, but just as with recreational drugs, I think people have a right to do with their own body as they wish.

I think this would in effect abolish it. FDA approval is horrendously expensive to go through. If the FDA standard was made voluantary, drug companies would work as hard as they could to downplay the importance of it and promote their own “independant” scientific studies which would be not at all scientifically valid but much cheaper to run. It would be almost impossible to try and educate the population on the benifits of completely randomised, double blind clinical studies vs any other sort of study and why the billions of dollars spent doing them is worth it. What would end up happening is the drug market becomes exactly like the dietary supplement market where the standards of proof are incredibly lax. The number of people who would demand a higher standard is simply not large enough to matter.

The whole “right to do what they want with their own bodies” argument is a perculiarly American strain of liberty. In almost everywheve else in the world, and I think even in America, the general sentiment is that the government has some right to protect us against systematic stupidity against ourselves. We should regulate against nigerian scammers, people who sell deadly “herbal” remedies, unsafe architects and the like.

Given the unquestioning (and hence hugely lucrative) approval consumers give to so-called supplements, which are almost universally lacking in efficacy, at best, I’d say abolishing the FDA would be nothing short of a catastrophe. Just imagine what would happen when people start popping pills that actually do something. It’s difficult enough as it is to keep thousands from accidentally killing themselves with OTC analgesics every year, yet this mythical rational consumer I keep hearing about will then be entrusted to make informed judgements about, say, antibiotics and antiretrovirals? Chemotherapeutics? Opiate painkillers? It’s laughable on the face of it. Friedman demonstrated with one statement that he knows (or perhaps even cares to know) precisely zero about the realities of public health policy, or even the basics of human psychology when it comes to self-medication. The average patient is woefully uninformed about their own health and biology, and rational self-interest appears to be virtually absent among the great majority of the teeming millions, as evidenced in their burgeoning waistlines alone.

The FDA is a manifestly flawed contraption, and the baby indeed must swim at times in a sewer of bathwater. Improvement is always warrented. But abolishment? Ridiculous.

You are ignoring the salubrious effects on the quality of the gene pool. :wink:

Those who have lived under the benevolent guidance of the FDA all their lives, it’s tough to imagine how anarchic the drug business was back at the start of the 20th century. In short, there was no such thing as a laboratory testing process until governments here and elsewhere stepped in and started implementing standards. Before the FDA, there was no shortage of classic stories, such as treatments for alcoholism that were mostly alcohol. However, the damage was relatively limited because the overall number of drugs taken was still fairly small. We have become a much more heavily drugged society over the last hundred years, and the consequences of having untested drugs on the market would be much more severe today than back then.

So no one has any stats on how many lives the FDA has saved? But we all just somehow know it would be a disaster to let people decide for themselves what drugs to put in their own bodies?

I’ll also present a freedom based argument. Let’s assume, for the sake of argument, that the FDA does indeed save more lives than it costs. But those lives belong to different people. There are certainly some consumers who are rational, do research on the drugs they are taking, and weigh risks and benefits accordingly. Suppose consumer X hears about a new drug that might save his life, but hasn’t been tested thoroughly yet. He decides the risk is worth it. But unfortunately, the FDA actively prohibits him from getting his hands on this drug. The FDA’s policy of not permitting the sale of untested drugs exists in order to save the lives of people may be benevolent, but is it moral to deny X a lifesaving treatment in order to prevent Y from doing something stupid to himself? This strikes me as even worse than a doctor who kills a healthy patient to harvest his organs to save five sick ones. The doctor has killed one to save others from something that isn’t their fault, but the FDA may be killing one to prevent others from killing themselves.

Final point, which always comes up in libertarian debates. Who here admits to being one of the great unwashed, who would put into his/her body anything on a drug store shelf that claims to cure what ails you? My guess is no one. It’s always someone else who’ll act stupid unless government protects them. I think people greatly underestimate the self-interest people have.

All this is true, but none of it adds up to an argument for having the FDA.

The fact that people are irrational at times simply does not constitute evidence that the FDA has provided a net benefit to American society. Friedman’s argument is being presented simplistically, and I’m sure if he were alive and we asked him he’d admit people can be suckers.

But, look, the FDA costs a LOT of money, and represents a minor imposition on the freedom of Americans. For all that cost, surely it’s reasonable to expect that someone can provide an argument **based on objective evidence ** that the FDA’s net effect has been a positive one?

And yet, industry often self-regulates with great efficiency. Look at the back of your monitor, right now; there’s likely a UL or CSA symbol there, right? That’s the certification that your monitor is tested (or, in most cases, that the way it is made and the prototypes thereof were tested) to ensure it won’t set your house on fire or electrocute you. That standard was completely voluntary to submit to, as are most such product standards; almost everything in your house with a UL or CSA label was so tested just out of the manufacturer’s sense of self-preservation. The general public hasn’t a damned clue about product certification, product testing, standards writing, or any of that… and yet that system works, and it works very well. It’s saved thousand upon thousands of lives.

Granted, drugs aren’t the same kind of product, but this out-of-hand dismissal of the idea of getting rid of the FDA is nothing more than a knee-jerk reaction. I’m not coming down hard on one side or the other because I haven’t studied it, but I can imagine the ungodly, expensive mess product certification would be if the government stuck its nose into it, and it’s reasonable to at least **think ** about the possibility that the FDA is similarly a mess.

I look forward to marketing 2,4 dinitrophenol as a diet aid.
It works, it really works!

And I look forward to a continuing stream of snarky one line responses that fail to respond to my arguments.

I, for one, will readily admit that my drug-buying procedure is to find the cheapest item in the store that claims to alleviate my symptoms. I do not do any research into the drugs I use. I do not have the slightest interest in hunting down nd reading dozens of scientific papers in order to determine whether cherry-flavored Nyquil is actually safe and effective. I much prefer that the government verify it for me.

Cool! Wanna buy some Badger milk? It’ll help your industry ‘self regulate’.[sup]*[/sup]

[sup]*[/sup]Actually Badger milk, unlike 2,4 dinitrophenol, does not work. You may as well buy snake oil.

Never mind hypothetical arguments, let’s have some reality-based scenarios. Are there any industrialized (or otherwise comparable to the U.S. in terms of pervasiveness, availability and importance of drugs) countries which have no equivalent to the FDA? And if so, what have been the practical effects of that lack on public health?

My argument is not “hypothetical.” It is based on reality–certain people can’t take drugs that might save their lives due to the FDA. Even if you deny that this is the situation, I fail to see what makes you think you can dodge a legitimate argument just by labeling it hypothetical. We don’t need an actual doctor killing a person for his organs to have a spirited debate on whether such a practice is ethical.

As to your question, I doubt it, but I’m not sure. I also doubt that there’s a single industrialized nation in the world that doesn’t have tariffs either, which hardly proves that they’re a good idea.

Many of see a special need for regulation of drugs, and this example will make it clear why. With monitors, it’s easy to see whether the thing works or not. If my monitor explodes, I’m going to be on the phone to Dell demanding a refund in about twenty seconds. Dell knows this, and thus has a motivation to only sell working monitors. Since their engineers can presumably fix the problem easily, self-regulation will work in that case.

Drugs are different. Let’s say a pharmaceutical company sinks $50,000,000 into developing a new chemical compound to fight cholesterol, which we’ll call Wioxx. Testing begins, and soon the testers are back with some bad news. Wioxx causes heart attacks in a small but non-trivial percentage of users. Now what does the company do?

From a financial perspecitve, the choice is clear. Sell the drug and you’ll make a lot of money. If the number of Wioxx-induced heart attacks is small, it probably won’t ever be noticed because it won’t stand out from random noise in the heart attack statistics. On the other hand, you probably can’t fix the problem with a minor change to Wioxx. If you don’t sell the drug, then your entire $50,000,000 goes down the drain.

In such a case, the profit motive would drive the company to bury the bad news about Wioxx and sell it anyway. The only way to solve the problem is to have an outside regulatory agency that isn’t concerned with profits.

Yes, there is. Iraq. An example that goes a long way towards proving they’re a good idea.

I can give you lots of arguments for banning the FDA. Let’s list them:

Absent the FDA, the market will develop alternatives
Rickjay Mentioned UL - Underwriter’s laboratories is an arm of the insurance industry. Insurers are one of the larger regulatory bodies in a free market. I can easily see, for example, a drug testing agency set up by a consortium of malpractice insurers, which demands that doctors who want malpractice insurance may only prescribe UL-Approved drugs.

How is this different than government regulation? Because it maintains a better balance between risk and reward. And it retains choice - doctors are free to opt out of the system, people are free to make their own choices.

Drugs are introduced more gradually, controlling risk
In the current system, FDA approval is a doctor’s ‘get out of a jail free’ card. If the FDA says it’s good, you’re free to prescribe it without risk to your practice. As a result, when a drug obtains FDA approval, it becomes widely used overnight by millions of people. So if the FDA screws up (and they have), the effects can be far reaching.

Without the FDA, doctors would have to be more cautious. Different people have different levels of risk aversion. The new diet drug would first only be prescribed to people who are at the highest risk of dying from obesity, because the drug risk is overshadowed by the other health risk. If drugs enter the market slowly (by ‘early adopters’), we have a real-world drug trial going on that can be stopped before the drug is taken by millions. Almost every other industry has this phenomenon - high-risk activities or extremely expensive activities are undertaken by early adopters who have great incentive to use it, and they help refine the product and shake out the bugs and expose hidden risks before the general public sees it.

The FDA, being a political agency, responds to political pressure
That means its not immune to adjusting its standards and procedures based on pressure from politicians, rather than the needs of science or the needs of patients. If you’re a liberal, wouldn’t you be worried that a Bush-appointed FDA head might manipulate the agency to delay introduction, of say, a drug developed from embryonic stem cells? In the past, ‘activist’ FDA heads have attempted to push the agency into regulating all sorts of politically incorrect things, such as second-hand smoke. Let’s not put our medicine in the hands of partisan politicians from either side of the aisle.

The FDA is not your doctor. It can not respond to personal requirements.
For example, the FDA will not approve a cancer drug until it can be shown to have minimal risks to the widespread population of people who might take it. It has to be less risky than alternative medicines and procedures that are available to the average patient who might take the drug. But what if you’re 100% terminal with a cancer that will kill you in weeks? Isn’t your condition special? Wouldn’t you be willing to take a drug that has, say, a 20% chance of making you blind, or that could possible kill you, but just might cure your cancer?

Your personal physician can look at your case and weigh those risks. The FDA can’t.

This happened years ago with drugs for HIV and AIDS. Eventually, the FDA had to modify its own policy to expedite the approval of HIV drugs, because so many people were dying waiting for the laborious standard approval process to run its course. And as I recall, the government even legally allowed AIDS patients to do a complete end-run around the system and import unapproved drugs for their personal use. AIDS got this exemption because it was a very politically-correct disease that had huge political pressure behind it, forcing the government’s hand. Too bad people with prostate cancer don’t have the same option. Sucks to be them.

The FDA approval process drives up the price of drugs
Big time. A patent on a drug lasts for 17 years. A drug has to be patented before it enters the expensive and publically visible trial process. The FDA approval process can take more than a decade, and cost the company hundreds of millions of dollars. And when the drug is finally approved, the company has maybe five, six, or seven years to make back its R&D costs, plus the cost of the FDA trials, plus profit, before the patent expires and generic drugs flood the market and drive down the price.

The result of this is that new drugs are horribly expensive, putting them outside the reach of the poor and uninsured. So the rich get the new drugs and the poor suffer for years until generics become available.

Another effect of this is that manufacturers have to target their R&D at drugs that have mass appeal. If you’ve got a rare disease that only a few hundred or a few thousand people have, well, you’re just out of luck. No one’s going to go through a 12 year drug trial to make a drug they can sell to 500 people.

A third effect is that it can be almost impossible for new drug startups to enter the market. The regulatory process is so heavyweight that new companies can’t break in. So a handful of drug giants like Merck and Pfizer own a huge chunk of the market. How much innovation are we losing as a result of this?

The FDA approval process undervalues the risk of delayed entry of drugs to needy patients
The AIDS example above illustrates the cost of keeping drugs away from people when they really need them. A classic example is beta blockers - they save many, many lives by preventing recurring heart attacks in people with heart problems. They become available in Great Britain years before they were available in the U.S., because the FDA, fresh from its PR triumph over Thalidomide, was being ultra-cautious.

Here’s an interesting article (google cached version - can’t find the current one): Death by Regulation - The Price We Pay for the FDA

From the article:

(emphasis mine)

Ugh. I hate to get off topic again, but I don’t even know where to begin on this one. Economists have known that tariffs are a bad idea for two centuries. They exist largely because they benefit small, discrete groups with large political power at the cost of large, diffuse groups without such power. The fact that you can even argue for tariffs with a straight face given all the harm they’ve done to mankind for centuries undermines pretty much any credibility you might have on economic matters. Do you also think that machines and immigrants cost jobs?

Anyway, I’ve yet to see anyone provide any evidence that the FDA has saved more lives than it has cost. Sam Stone has provided yet more evidence showing the opposite.

If you do sell the drug, you face millions of dollars in lawsuits. You seem to implicitly refute this premise by claiming that the heart attacks from this drug won’t be noticed in the general population. So, how were they noticed in the clinical testing?

Assuming a functioning legal system (a big if) in which consumers are permitted to recover damages for injuries from defective drugs, companies actually have the exact correct motivation. If they don’t sell a potentially useful drug, they lose profits. If they sell a potentially harmful drug, they risk lawsuits. As such, they are constantly searching for the “sweet spot” of testing. Too little --> lawsuits and lost $; too much --> lost profits.

Contrast the FDA. The FDA gets hit hard in the press, by congresspeople, and by the public at large if it approves a drug prematurely that later turns out to be dangerous. But what is consequence for taking too long to approve a drug? As has been demonstrated several times already in this thread, FDA delays in drug approval have cost hundreds of thousands of lives, and yet no one is calling for the FDA members to be indicted for crimes against humanity. The FDA has asymmetrical motivation, and as such will constantly error on the side of delays, denials, and further testing.