Tuesday, April 8, 2014

Dallas Buyers Club Nails the FDA

by Bretigne Shaffer

Libertarians are raving about Dallas Buyers Club and with good reason. One of our biggest frustrations is the near-universal tendency of human beings to form political opinions not through a rational examination of the facts and theories, but through emotional attachments. Many of these attachments are derived from stories and mythology that no amount of scholarly journal articles or sound arguments can ever successfully refute.

So it is exciting when someone comes along and
distills all of the work that has been tirelessly cranked out for years by free-market analysts, and turns it into a compelling story about the indisputable evil that is the FDA.

The film is based (with a few liberties) on the life of Ron Woodroof, an electrician and rodeo enthusiast who was diagnosed with AIDS in 1985. In the film, he spends most of his time drinking, snorting coke and engaging in unprotected sex. He has no visible aspirations or humanitarian sentiments, he’s interested in nothing more than his hedonistic pursuits, and is kind of a jerk.

None of that changes when he is diagnosed with AIDS and is given approximately 30 days to live. After clarifying with the medical staff that he “...ain’t no faggot!”, Woodroof storms off into a booze and coke-filled orgy of denial. Only as the 30-day deadline approaches does he admit to himself that he is sick and decide to do something about it. He begins by bribing a hospital employee to get him a supply of AZT, then learns that the FDA-approved-for-trials drug is actually harming patients more than helping them, and ultimately finds out about some unapproved treatments that seem to be helping.

As Woodroof then struggles to first get these unapproved treatments into the US from other countries, and out to paying customers, something changes. He is transformed. Not into something warm and cuddly, but into something more believable and in a way, more moving. He is still rough and crude, still a jerk to those around him, including his transgendered business partner. He is still kind of an asshole. But he’s an asshole on a mission, and there is something beautiful about that.

Throughout, the film is clear about who the bad guys are: The FDA and its agents who forcibly prevent people from having access to treatments they believe may help them. This is something libertarians have been screaming about for decades - mostly to deaf ears.

The Independent Institute, for example, has done great work analyzing the costs vs. the benefits of the FDA. The Institute’s Daniel B. Klein offers empirical examples to demonstrate that the agency is entirely unnecessary, that drug quality and safety could easily be provided through voluntary institutions and the tort system. He writes:

“How is safety assured in other industries? In electronics, manufacturers submit products to Underwriters’ Laboratories, a private organization that grants its safety mark to products that pass its inspection. The process is voluntary: manufacturers may sell without the UL mark. But retailers and distributors usually prefer the products with it.

“Suppose someone proposed a new government agency that forbade manufacturers from making any electronic product until approved by the agency. We would think the proposal to be totalitarian and crazy. But that is the system we have in drugs...”


“The FDA was much less powerful before 1962. The historical record-decades of a relatively free market up to 1962—shows that free-market institutions and the tort system succeeded in keeping unsafe drugs to a minimum. The Elixir Sulfanilamide tragedy (107 killed) was the worst in those decades. (Thalidomide was never approved for sale in the United States.) The economists Sam Peltzman and Dale Gieringer have made the grisly comparison: the victims of Sulfanilamide and other small tragedies prior to 1962 are insignificant compared to the death toll of the post-1962 FDA.”

That death toll is estimated to be in the hundreds of thousands. According to drug regulation expert Dale Gieringer, “The benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios. In comparison … the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade.”

It is astounding to think that the FDA is not widely recognized as the threat to public health that it is. What is so wonderful about Dallas Buyers Club is not that it expresses what so many of us already knew, but that it turns reams of policy analysis into a compelling story line with characters we care about in a way that might actually get the message through to a wider audience - including many who aren’t the least bit interested in reading policy papers.

The film also articulates the more central point about drug regulation: That nobody has the right to dictate to anyone else (with obvious exceptions such as children) what they may or may not put into their own bodies. And in one brief statement, the protagonist is able to sum up the corrupt relationship between the regulatory agency and the pharmaceutical companies it purports to regulate. Says Ron Woodroof in the film:

“Oh I’m a drug dealer? No, you’re the f***ing drug dealers! I mean goddam, people are dying. And y’all are all up there afraid that we’re gonna find an alternative without you! See, the pharma companies pay the FDA to push their product. So f*** no, they don’t want to see my research! I don’t have enough cash in my pocket to make it worth their while!”

There is another point to the film, one that was likely exaggerated for dramatic effect but is nonetheless valid. In the film, Ron Woodroof did not create the Dallas Buyers Club in order to help other AIDS victims, he created it to help himself, and in the process also ended up helping a great many other people with AIDS. The story brings to life the critical point made so long ago by Adam Smith: That one need not be motivated by a love of one’s fellow humans or concern for their welfare in order to benefit them, that free markets enable people to make each others’ lives better regardless of whether they care about each other or of what they think of each other. It is a point that those who insist that promoting liberty and free markets is “not enough” would do well to take to heart.

Bretigne Shaffer blogs at On the Banks.


  1. FDA head says agency’s work has helped shorten time needed for drug approval

    “For those products where there was early engagement ... that we thought that three to five years was actually taken off the development process because of this working together to shape the research needs and agenda in a much more formal and constructive way,” she said.

    However, in a press conference after the speech, Hamburg faced questions about a potential drug for Duchenne’s, which confines its victims to a wheelchair by the age of 12 and typically kills them in their 20s. Patient advocates have criticized the agency in recent months for not acting quickly enough to make promising new drugs available. While Hamburg did not specifically mention the name of any companies, Cambridge-based Sarepta Therapeutics has been the focus of efforts nationwide for its drug, eteplirsen. The drug has shown effectiveness in a small sample of boys for stopping progression of the disease.

    Hamburg said of efforts by her agency to work with patient advocates that it “has been one of the most intensive efforts in terms of high-level FDA engagement that I’ve seen during my tenure.” A petition to the White House last week reached 100,000 signatures, seeking a response that urged the FDA to use accelerated approval to significantly shorten the amount of time before “safe, effective therapies” for DMD can be made available to patients.

    Hamburg said that she can’t estimate how soon a drug for the disease might be approved, repeatedly saying that the agency does not currently have an application for one. The reason it doesn’t have one, however, is largely the fault of the agency itself: Last summer, Sarepta CEO Chris Garabedian said FDA officials had told him the agency would be open to considering an application for eteplirsen based on the small trial underway, and that he hoped to submit one in coming months. A few months later, however, he said the FDA had changed its mind and would now require a larger trial, delaying potential approval of the drug for at least a couple years.






  2. The FDA like most other federal agencies, is for the purpose of employing otherwise unemployable bureaucrats. Although the FDA has the additional mission of being an unofficial lobbying organization for the pharmaceutical industry (much like the ED is an unofficial lobbying organization for the teachers' unions).

    For the record I will agree that there are probably some very hardworking people at the FDA who do view themselves as being dedicated to public health. I imagine they must be heartsick seeing what the agency has become.

    It is amazing to me that most Americans think the FDA "have their back". They don't realize that the FDA gets a large amount of their funding from the industries it purports to regulate.

  3. I love articles like this. When gay people say stupid shit- "libertarians and conservatives hate gays"- I like to point out that many Rothbardians and conservative catholic libertarians have praised this film, as well as "12 Years A Slave", in glowing reviews.

    They separate their belief that homosexuality is a sin (I disagree, as a gay man I don't think God makes mistakes) from their praise of people overcoming government oppression.

    The current standoff in Nevada by a rancher that is fighting the government....LITERALLY, like getting ready to shoot...for restricting access to government land is just another facet of this- government is out of control and needs to be stopped.

  4. There is no regulation and control anymore and the food and the FDA is running a muck. They are just in it for profit and nothing else. The doctors are working hand and hand with the FDA to push these untested drugs off to their patience. They advertise these new drug on TV like it is god send. What is so bad is the side effects are worse than your ailment. When side effects are death, suicide, or aneurysms you know they can sell poison and get away with it. I think the Government is making all these diseases so they can treat you with their so called miracle drugs to manage your ailments and not cure them. Please don't go to the doctor and try to heal yourself. From one human being to another I just want help my fellow humans. Herbs can cure all and that is all you need with a little positive thinking you can't go wrong. Look up your ailment on line and find the herb to cure what ails you. Remember you have an Oracle at your finger tips your computer so ask that right question and you will get the answer. Their so evil and like to prey on our young and old and hope their so naive like most are. Please help yourself and pass it on to people you love and we can stop this atrocity from happening. Thanks for listening and stay safe.