Speaking of libertarians, reading the JCI this week I came across this wonderful review of Richard Epstein's new book, "Overdose: How excessive government regulation stifles pharmaceutical innovation".
We've discussed Epstein, and his ilk before. The libertarians that routinely attack the FDA as some kind of bogeyman, killing kids, eating babies, blah blah blah, when the market could be making all these drug decisions for us. David Ross, writing for JCI, sees through the nonsense.
Although Epstein terms Overdose a study, it's really a legal polemic that could be subtitled "What's good for pharma is good for America," his title for a 2006 newspaper opinion piece (1). Overdose raises questions but fails to persuade, largely because Epstein consistently fails to mention evidence that might inconvenience his argument.
First, he ignores the reality that patients and health care providers cannot acquire on their own the information they need to make rational choices about drugs. Without complete information, drug market failures, in the form of poor patient outcomes, are inevitable. Epstein dismisses this problem, proposing, for instance, surfing the Internet as a replacement for FDA-required information on drug efficacy and safety.
Second, Epstein seems unconcerned about the effects of market failure. He notes the Elixir Sulfanilamide disaster of 1937, which cost over a hundred lives, without explaining how his proposals would prevent such catastrophes. He posits the effects of safety issues on companies' reputations as a deterrent to the knowing marketing of unsafe drugs, ignoring repeated examples of manufacturers doing just that. He concedes that the average patient does not have the ability to tell whether a drug is contaminated yet assumes that judging clinical trial results is a simple matter.
Finally, Epstein repeatedly distorts clinical trial science. The most peculiar section of Overdose is Epstein's attack on randomized controlled trials (RCTs). Epstein seizes on the heterogeneity of responses to any therapeutic intervention as evidence that reliance on RCTs is flawed. He contends that drugs that are equivalent to (or even inferior to) placebo should still be approved, arguing that patient responses in the experimental arm that are greater than the placebo mean imply efficacy for the drug in those patients -- committing the blunder of rejecting the null hypothesis for a post-hoc subgroup. Epstein appears unaware, or indifferent, to the role of variations in natural history, drug response, and assessment, and the role of type 1 error. Under his scheme, patent medicine nostrums would be legal again.
...
Epstein's hidden agenda appears to be opposing more FDA-mandated information on drug efficacy and safety that might level the playing field between drug manufacturers and consumers.
I don't have much hope that we'll be able to keep these arguments out of the debate over the FDA forever. People have such a poor understanding of history (and everyone from that period is dead or soon will be - the drugs didn't help), that they may actually be convinced of this nonsense. But I can think of few suggestions more profoundly stupid and intellectually dishonest than to suggest that we can create this ideal market system in which omniscient consumers navigate through the vagaries of pharmacologic science and RCTs to find the best drug for their condition, or that the market will magically provide information to consumers when the evidence is that companies have already shown they are disinclined to do so.
The argument over whether or not we should have validation of safety and efficacy of drugs by non-partial government scientists is over. The only way one can argue for a return to a pre-FDA market regime is to argue dishonestly.
- Log in to post comments
More like this
What if, rather than being too stringent about drug approval, the FDA is not being stringent enough?
I am not a student of history, but I can recognize that some of the complaints raised in your excerpt of the article are themselves dismissing of evidence. Markets do not require all buyers to have perfect knowledge. If they did, we would find ourselves paralyzed and unable to make choices no matter what we shop for. Markets work quite well, despite their imperfections.
Additionally, I don't see any consideration of personal sovereignty in your discussion. What right, after all, does the government have in telling me what I may or may not put into my own body? To accept an argument that government interference is for my own good is to adopt the same rhetoric that permitted slavery and the subjection of women for the majority of human existence.
The comment about the FDA and baby-eating is completely innaccurate.
Babies are essentially an agricultural product, and therefore baby-eating has more to do with the USDA than the FDA.
I read comments like Matt's and I wonder, why don't the libertarians just move to Mexico. It sounds like their paradise. No prescriptions for drugs, nobody pays their taxes etc.
And personal sovereignity? That's the argument against the FDA? I don't think so, maybe the DEA. All the FDA does is make sure that drug claims are consistent with the evidence. That is not to say that I agree people should get drugs without a prescription. Libertarians act as if every man is an island, but this is nonsense. For one, people will end up diagnosing and treating themselves - something doctors shouldn't even do. The next thing they do is start experimenting on their children. I shit you not, just look at what the alties do with their kids. When you don't restrict this stuff people use it willy nilly, they use it on their kids, and they self-diagnose. All of which represent the worst possible outcome for public health.
Further, the idea that the market will solve this problem is naive. Historically, before the FDA, the market did not solve this problem, patent medications were at best worthless, at worst poison. And if you want a modern day example, look at the altie-med market. That's what happens when there is no accountability or oversight. Snake oil takes over.
Doctors struggle to understand the indications and functions of drugs, and which patients will benefit most despite over a decade of graduate and post-graduate education. People simply are not competent to decide what drugs go into their body, even if they are knowledgeable one should never self-diagnose or self-prescribe, people will make decisions based on advertisement - not knowledge - and finally the inevitable result will be people poisoning themselves and their kids from incompetence.
Mark, both the DEA and FDA are targets of my argument. Simply because the DEA is responsible for enforcement does not exempt the FDA from the responsibility of its regulations.
Your "think of the children" argument is a straw man. Allowing adults to control their own chemical intake does not force one to sit passively while an adult harms a child. But even then, the government's intervention is justified by the harm principle, not the furtherance of public health. Public health pertains to matter of infectious disease and the like, not the aggregate health of the population.
What is wrong with responsibility, both personal and corporate? If I choose to take a substance known to cause harm, I should be prepared to deal with the possibility of unpleasant consequences. Likewise, if a company makes false claims about the efficacy of its product, it should be prepared to deal with legal ramifications which would result.
I don't need the government to tell me what food to eat or how much sugar to put in my coffee. Likewise, I do not need its assistance when I determine what drugs to use. It would be foolish of me to attempt self-treatment. The advice of a doctor is indispensable in determining what treatment I should seek when afflicted with disease. But this does not mean I should ultimately be denied the liberty to make my own decision.
And finally, I feel compelled to address your childish suggestion that I relocate to Mexico. I am quite happy with my life in this country; I enjoy the culture, being near my friend and family and falling under the umbrella of protection afforded to me by our marvelous constitution. My overall happiness does not mean I must therefore accept all the practices of my country. Instead, I feel the duty to argue for principles that I believe would make this already great country even better. If we were bound to condone all our country's endeavors by our continued citizenship, all of us not expatriating when the Abu Ghraib atrocities were announced would, by the same logic, be complicit in those acts. Instead, we retain our membership in this democracy and fight for the redress of our grievances.
Adults address problems, children run away.
The inclusion of the FDA is a mistake. It does not tell you what you can take or not. It is responsible for making drug companies provide proof of claims of drug efficacy.
Before the FDA included drugs, there was an episode alluded to in the review, that of the poisoning of over a hundred children, by their parents, with a patent medication containing ethylene glycol (or a close analog). The medication purported to treat the flu. It did not. Instead it killed. This lead to drugs being regulated for claims of efficacy requiring actual proof. Essentially, the initial role of the FDA was simple, fraud prevention. To include an indication on the label of a bottle, you had to demonstrate actual efficacy. The importance of this development can not be understated. The simple rule that drugs had to demonstrate efficacy created a necessity for efficacious drugs. Pharmaceutical science was essentially born in that moment, the pharmacopoeia which was described by contemporary writers at the time as essentially useless disappeared almost overnight, and a revolution occurred in drug efficacy. Many makers of patent medication survived by starting to make drugs that actually did something.
Did you know Lysol was originally recommended as a douche? That Listerine was ingested as an antimicrobial agent? That was the unregulated market at work. The companies that survived did so by investing in research in drugs with actual efficacy, and found real uses for their existing products.
The children argument is not a straw man. It is a critical element of proper public health. Parents don't think they're harming their kids when giving them drugs, they believe the advertisements and the labels, and its important the information they are given is accurate. These libertarian arguments are truly weak for their complete disregard for prevention. The evidence that the market reacts to should be determined in labs, and in a clinical research setting, not the deaths of a hundred kids from the carelessness or greed of a drug company.
Further, you ignore the altie market. How is this a demonstration of market efficiency? There is essentially billions of dollars in the US and more worldwide spent on cures that do absolutely nothing. How is this the sign that markets solve this problem? Why do people spend money on substances that have no benefits, no value for the treatment of disease? How would creating a similar disregulated system for pharmaceuticals be of benefit? Isn't it cheaper to sell a drug without proving efficacy, spending millions of dollars on trials? Why do science when one can spend 1/100th as much on advertising and accomplish the same thing? The biggest problem won't be poisoning, pseudoscience selects against physiological activity of substances. The problem will be a rash of worthless remedies being sold as legitimate pharmaceuticals. The example of what you want already exists, and I think we can do without making real pharmaceuticals mimic altie meds.
And how will doctors determine efficacy? How will we know what treatments to give patients, and what is safe without the required clinical trials? Doctors are susceptible to advertisement too (as imaginary dictator of the US I would ban all prescription drug advertisement as it leads to irrational use of drugs).
We've tried this, it has failed.
Libertarianism is a utopianist ideology. Adherents to this doctrine are immune to logic or facts that are antithetical to their creed.
<.blockquote>(as imaginary dictator of the US I would ban all prescription drug advertisement as it leads to irrational use of drugs it leads to irrational use of drugs)
Well at least Australia has one thing going for it. Direct to consumer marketing is still banned in Australia.
Without the FDA enforcing evidentiary standards, how do you make the judgment that an adult is harming a child (before it's too late)?
Libertarians act as if every man is an island
They talk as if every man is an island. It's their blindness to the fact that nobody (short of marooning) acts that way that makes their ideology so useless.
Somehow, I think time and circumstances ruin the market based argument.
As I'm laying on the table in the ER, in pain, bleeding, exercising personal responsibility and reviewing the available information so I can make an informed choice is not the first thing on my mind.
In the longer term, I don't have the time, as my cancer spreads, to spend the years educating myself (assuming I have the skills to do so) so I can again make an informed choice.
Finally, drug companies generally spend far more marketing drugs than they do on developing them. A major part of that marketing is manipulating the information that is available. The object of that manipulation is to encourage the doctor and/or the patient to make the "correct" decision. "Correct" here doesn't mean most effective. "Correct" means the drug from my company.
So I would think that the trick is to figure out which drugs work best in which situations before they are needed by real people. That takes a trusted agent to do the testing. That agent needs access to accurate information. That agent is expected to evaluate drugs based on what is best for the patient.
As near as I can tell, the market is not structured to be that agent. The market is driven and manipulated by drug companies whose primary interest is profit. Effective drugs are just a means to profit. In addition, the drug companies have enough capital that they can manipulate the perception of their products in the marketplace. In other words, they lie in order to make money.
Sometimes the market is the wrong tool.
Actually, the USDA only regulates specific meats (cows, pigs, chickens). Seafood and "Exotic" meats (i.e. humans) are the jurisdiction of FDA.
Modest Proposals aside:
It's probably important to recognize is that a powerful corporation may very well be indistinguishable from a government when it comes to effects on the market.
A corporation can create barriers to entry (e.g. lawsuits against generics), institute price controls (they do set the prices, after all), provide authoritative information regarding relative values of products (advertising), and through professional societies they can make rules to control the behavior of the industry.
Well, I'd like to make one final stab at getting my point across before letting this thread die.
I understand your argument and I agree that some level of governmental regulation for safety might be called for. However, I don't think that it is necessary for the government to control the certification of efficacy. I read your blog, not as a masochist who disagrees with all of your ideas, rather, as someone who generally agrees with most of your writings, especially when it comes to altie madness. But, no matter how crazy we think it is for someone to want to use a substance for which there is no proof of positive effect, that does not therefore imply that the government should regulate away their rights. This is a philosophical point, so it may be more difficult for us to reach agreement.
I don't see why it would not be possible for a non-governmental agency similar to the Underwriters Laboratories to certify the efficacy of drugs. Markets can solve these problems and they can do it in a way that does not create large government nor infringe upon our liberties. The key is to create a system that allows for innovation.
I appreciate that you respond to these comments and your writing certainly provokes thought. Though we might not now agree, I think only by being forced to defend our ideas do we ensure that we are not deceiving ourselves.
"I don't see why it would not be possible for a non-governmental agency similar to the Underwriters Laboratories to certify the efficacy of drugs. Markets can solve these problems and they can do it in a way that does not create large government nor infringe upon our liberties. The key is to create a system that allows for innovation."
Well, the first problem is that if the market would favor such a strategy, such a private certification agency would already exist. It's the fact that market has been demonstrated to fail in internalizing these problems that necessitates the FDA.
The other problem that Underwriters Labs largely performs a service for professionals in its area, much like the ACM and the IEEE for computing and electrical engineering, respectively. The FDA, on the other hand, has to perform a service for the broader public. It's comparing apples to oranges.
Tyler DiPietro said:
Not necessarily. The existence of the FDA as the sole agency that's allowed, statutorily, to rate a drug's effectiveness before it goes on the market keeps other private certification companies from existing. If private firms could provide pharmaceutical efficacy rating services, then there would be a proliferation of companies doing just that, like there are firms that rate for auto safety, business or charity transparency, or the authenticity of organic or fair-trade food. Having multiple firms with different levels of risk tolerance (and differing strengths in their disclaimers, presumably) would lead to be fewer type II errors where drugs or procedures that pose acceptable risks for some patients are rejected (like RU-486 or the Berlin Heart).
I think you're right that non-governmental entities couldn't provide credible rating services when the FDA was initially brought into being. Snake-oil peddlers could just close shop and move down the road, so having government provide this service was helpful since it couldn't just pick up and run away. And without an easy way to verify the authenticity of a seal of approval or to learn what criteria were used to judge efficacy, it would be helpful to have just one monolithic rating entity whose brand could almost always be trusted. But in the era of the internet, customer service hotlines, bar codes, and RFD tags, it's much, much easier to know exactly what you're buying and from whom, what agency rated it in what way and why. So having the FDA be the only rating agency might not be such a necessity any more.
And before you say "but with all those rating agencies, how will the plebians know who to trust?", consider what Matt said:
Rating services would distinguish themselves from one another -- indeed, it would be in their interest to do so -- and people would come to understand pretty quickly the differences between them, just like they quickly came to understand that everyone could love MS Paint but only a few people with specific needs should buy CAD software. And of course, people will always be able to just ask their doctor which medicine is best.