FDA

Kill the FDA (Before It Kills Again!): Dallas Buyers Club

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If you haven't seen The Dallas Buyers Club, which took home three Oscars last Sunday, you should. It's the most flat-out libertarian movie since Ghostbusters and one of the best message movies I can think of (of course, like all quality message movies, it's first and foremost a powerful piece of art).

Specifically, it shines a harsh light on the Food and Drug Administration's obstructionist role in approving life-saving medicines.

From my Daily Beast column on the topic:

During a good chunk of the AIDS epidemic in the 1980s, the federal government, in the guise of the Federal Drug Administration (FDA) did just about everything it could to keep dying patients and their caregivers from responding quickly and effectively to terminal illness. It was only after massive, coordinated pressure applied by gay-rights groups that the FDA made partial and selective exceptions to its lengthy and widely criticized drug-approval processes.

Worse still, the FDA continues to choke down the supply of life-saving and life-enhancing drugs that will everyone agrees will play a massive role not just in reducing future health care costs but in improving the quality of all our lives (in 2000, Columbia University's economist Frank Lichtenberg estimated that"increased drug approvals and health expenditure per person jointly explain just about 100 percent" of the seven-year increase in life expectancy at birth between 1960 and 1997). Little wonder, then, that the movie is "the libertarian favorite of the year," in the words of film critic Kyle Smith….

…the FDA's often arbitrary but always time-intensive requirements have created a system in which new drugs take somewhere around 10 to 15 years to come to market, at a typical cost of $800 million or more. As my Reason colleague Ronald Bailey has written, this means the FDA's caution "may be killing more people than it saves." How's that? "If it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime."

More, including lots of links to Reason.com stories, here.

Related in Reason: Peter Huber (interviewed here) lays out how to overcome "20th-century regulations to allow 21st-century cures."

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  1. Indeed, it reminded me of Atlas Shrugged.

  2. I haven’t seen the movie but I have a feeling that most of its audience will misinterpret any anti-FDA message as a call for more/better regulation.

    1. No. They will just walk away thinking that if it wasn’t for that God Damned Reagan hating gays, things would have been fine.

      1. BETA BLOCKERS!!!!

        Two can play that game, and I win (and I know you and SIV were mocking it, but I still win).

  3. the most flat-out libertarian movie since Ghostbusters

    What about Rain Without Thunder? Other People’s Money?

    1. Braveheart.

      1. Atlas Shrugged Part 1
        Atlas Shrugged Part 2
        The Incredibles

          1. What was particularly libertarian about Frozen? Psychopaths and death sentences?

            1. Maybe not libertarian as much as Randian. It’s a movie about suppression and sacrifice against one’s values, followed by self-realized empowerment and independence, followed by a return to the values while maintaining the empowerment.

              But on the libertarian front, note that all the bad actors are government agents, and the sisters never really wanted to be rulers. The only illiberal thing their administration does is impose trade sanctions on another nation’s population to punish that nation’s emissary.

              1. Great points. That part with the trade sanctions made me angry because of the suffering inflicted on the citizens of both polities. It could be justified by the emissary’s attempts to have someone murdered, but then he should have just been arrested!

        1. In The Incredibles, the bad guy was the libertarian. I love being the bad guy!!

    2. Legends of the Fall

    3. Actually most crime movies are libertarian, because they at least imply that crime (which is usu. victimful crime, stuff like murders & heists) is bad. The main point of slasher pix in particular seems to be that violence is really awful; war pix too.

    4. Serenity.

      1. There’s a whole libertarian series that precedes it, too. I know we’re talking about movies, but there’s a strong libertarian “feel” to the whole Firefly series.

  4. the message Nick believes people should grasp will be totally ignored in a few things – the setting is the 80s, so the FDA was Reagan’s gay-hating foot-soldier movement that wanted people to die; since AIDS was new and no one new a damn thing about controlling it, the FDA was just making sure people weren’t taken in by snake oil salesmen; and, some variant of the culture warz.

    Preach all you want to the Daily Beast crowd about how govt exacerbates existing problems and creates new ones far more often than it solves them, and you’re still talking to folks who believe we would be eating poisoned meat without the FDA, that no person with pre-existing condition was ever insured prior to O-care, and that libertarianism = Somalia. I guess TDB’s checks must be good but that crowd views individual liberty like a politician views term limits.

    1. Meh. People who might be persuaded could stumble across the article since it is on the internet and not in a print magazine, and you gotta start somewhere.

    2. Forget about the proggies. This is about culture.

    3. the setting is the 80s, so the FDA was Reagan’s gay-hating foot-soldier movement that wanted people to die; since AIDS was new and no one new a damn thing about controlling it,

      Actually, the way they structured the film you’d have to work pretty hard to come up with that message. The movie really drags you kicking and screaming to the conclusion that he FDA itself is the problem and that it uses the enforcement of the courts and the IRS to bully people into compliance. There’s also enough of an anti-corporatism message that liberals won’t find the anti-regulatory message revolting.

      the FDA was just making sure people weren’t taken in by snake oil salesmen

      Some people are going to come to this conclusion or that we just needed better top men by the end of the movie, but they’d be hard cases anyway. The movie funnels you away from these conclusion with prejudice.

  5. This movie also shows the ability for free market commerce to rival over racism/homophobia/etc.. Wasn’t a bad flick.

  6. “I want to file a restraining order.”

    “Against who?”

    “Against the government and their fuckin’ FDA, that’s who.”

  7. OT but related to liberal cluelessness over the effects of the regulatory state:

    I met this gal at a mixer last night who was applauding zoning regulations that would prevent chain restaurants from opening in certain areas. “You don’t want an Applebee’s on every corner.” No, you don’t want an Applebee’s on every corner. She excused it with “that’s what the people in that area voted for” type logic. I didn’t bother to push the point that people could vote with their dollars, or that voting on property rights can lead to things like blocking abortion clinics from opening unless they’re near a hospital.

    The fucking kicker of it all was that not 10 minutes later she was bemoaning the lack of Chipotle’s, Krystal, and Jimmy John’s in her neighborhood (and had waxed nostalgic about Krispy Kreme earlier in the evening).

    The saddest part is that I’m still going to ask her out since she’s one of the best candidates I’ve met in a long time.

    1. The saddest part is that I’m still going to ask her out since she’s one of the best candidates I’ve met in a long time.

      If she’s the best your area has to offer, fucking move or get well acquainted with your right hand.

      1. This. Unless you’re just looking for a hookup.

        1. Yeah. Wouldn’t get too invested. When I was a young man I dated this airhead because she was crazy hot. Made it two weeks. Just wasn’t worth it.

          1. You already don’t respect her so why waste your time.

            1. what is this ask reason?
              you’re a libertarian I’m assuming, so the answer is simple; you’re going to do what you do regardless, cuz that’s how we roll

      2. Eh, she’s not religious and she’s a homebrewer. Trade-offs.

        1. She’s also apparently unable to connect dots. … But she probably has boobs. Gotta weigh all the pros and cons here.

  8. Part of the problem with the FDA lies with us, the citizens. We have developed an expectation of perfection in the medicines provided to us. They will have no side effects and work every time, or the FDA’s approval will come under fire from all sides. And without the approval to back them up in case someone is harmed, the medicines will not come to market. When the legal system changes, the FDA will be less important.

    1. “I’m Bob Goldwater, and if you took this pill, you may be entitled to financial compensation.”

  9. Pretty good movie; I hesitated to watch it, but was rewarded for my risk.

  10. It isn’t just life-saving drugs that are being held back by the FDA’s stranglehold. There are whole areas of medicine that are basically abandoned because of the FDA’s rules.

    Perhaps due to sports related issues, research into life-enhancing drugs used in an “elective” manner is pretty much sealed off. Plenty of people are using HGH and steroids to enhance their health – but only in an off-label use that may or may not actually be effective, or dangerous. We don’t really know because nobody can do the science to follow up on all of these patients because the feds will crack down on the doctors.

    I’d love to have the option of taking some sort of cocktail of drugs that has been clinically shown to increase muscle mass, decrease body fat and increase the elasticity of aging tendons and ligaments. But even though there are claims of such benefits in back-channel medical communities, you won’t find the science to back it up because the feds don’t like it.

    Meanwhile, the unregulated world of supplements and CAM makes all sorts of claims along the same lines that are verifiably false and it takes years for the feds to act. Stupid, but that’s the world of “regulations” for you.

    1. Do you have proof that the feds don’t like it? Know of any research projects that’ve been nixed? AFAIK, FDA would be very happy to approve an IND for a life-enhancing claim, it’s just that the market isn’t thought to be big enough to justify such research for a drug that could simply be used off-label for that purpose. However, apparently it was big enough for Rogaine.

      In fact, lots of drugs have had “lifestyle” indications licensed for marketing: birth control pills, penis erection drugs, antiperspirants, dandruff treatments, and abortifacients. Probably lots of others I’ve forgotten.

    2. increase the elasticity of aging tendons and ligaments

      I am curious what drug you might be talking about in this particular case. You know, uh, for a friend.

  11. that will everyone agrees will play a massive role not just in reducing future health care costs but in improving the quality of all our lives (in 2000, Columbia University’s economist Frank Lichtenberg estimated that”[SPACE NEEDED]increased

    Do I get the job?

  12. T’was the time when Luc Montaignier/Institut Pasteur/France found the AIDS virus, then Robert Gallo/NIH/US tried to grab the limelight by telling everyone that they were first, grabbing Luc’s photographs and samples. Even tried to retcon “HTLV” (Human-T-Cell Lymphotrophic Virus) to “Human-T-Cell Lymphadenopathy Virus”. No-one knew anything about this complex piece of signalling error. Interesting times.

    1. The HTLV does NOT cause AIDS! That’s HIV!

      Interesting no one ever mentions HTLV. It’s the STI that no one knows about.

  13. “, this means the FDA’s caution “may be killing more people than it saves.””

    “May be”? How many people do you think the FDA saves anyway? Do you think there is a large market for drugs that are ineffective or will kill you? The entire alternative medicine industry is about equal to Pfizer’s janitorial budget.

    Elixir Sulfanilimide killed 100 people and led to the FDA as we know it. The delay in approving beta blockers, AFTER they were widely used in Europe, killed approximately 70,000 people. (14,000 annually x 5 years)

    Expensive medicines? You better believe it. Drug companies have to recoup a billion dollars for every new medication to cover the outrageous R&D expenses the FDA forces.

    Put simply, the FDA has killed more Americans by delaying drug interactions that any enemy the US has ever fought.

  14. Seems like a faulty logic. What is the hidden cost approving a medicine right away? If it turns out that the medicine kills more than it saves then you would again blame fda. The moralist position against fda is actually better in the sense that it follows from its premise and does not rely on faulty logics, e.g., “no one has the right to stop me selling medicine to whoever is willing to buy” … etc.

    But from a pragmatic point of view, I think it is better to be honest and agree that we don’t know which way is strictly better. If medicine approval is accelerated, it would definitely decrease some known deaths. But there might be some hidden cost due to letting anything go. Not that fda has the best intention in that regards.

    1. I think it is better to be honest and agree that we don’t know which way is strictly better.

      You think wrong. I have the absolute right to put whatever I want into my own body; whether that substance is “approved” by the FDA or not is entirely irrelevant.

      The fact that they actively attempt to bar me from doing what I already have a natural right to do puts them in the “worse” camp.

      1. FDA would say you still have that right, and that all they regulate is what claims can be made for products for sale. For example, if you think sawdust will cure your acne, you can buy & ingest sawdust all you want, it’s just that nobody is allowed to sell you sawdust that is intended by them to treat acne.

        1. Access to home remedies and witchcraft to the exclusion of drugs that you would purchase on a voluntary basis does not a lack of rights violation make. That isn’t even decent sophistry. You still have the right, as you retain all of your rights regardless of whether the government recognizes them, but being completely prevented from exercising it means that it is, in fact, being violated.

      2. You have that absolute right so long as no one will be held accountable for an unexpected consequence of the substance taken.

      3. “The fact that they actively attempt to bar me from doing what I already have a natural right to do puts them in the “worse” camp.”

        I would rather call it a moralist position, (e.g., I have an absolute right of taking whatever I want irrespective of its outcome as long as the consequence is confined within me) which I already agreed to be a more consistent position. But this article is rather taking a “common good” or over all social good approach. And I am saying that the arguments given here in favor of their position are not holding well. Fda may as well argue that they are denying fast approval of drugs for the greater good of the society (by thwarting any evil attempt to introduce harmful drugs). The moralist position avoids this better/worse debate by simply asking “why do you care if I die taking a harmful drug”. It is important to distinguish between these two kinds of positions.

  15. Make drug manufacturers criminally and civilly liable for deaths, they can do their own testing. the FDA could be re-purposed and downsized to inspectors that approve the testing is following ethical and moral standards rather than being the agency for testing. better yet make this an optional thing to add to a label so that “FDA approved” becomes a marketable label and the free market can decide if they will pay more for regulated medicine or not at the same time mitigating the burden this agency imposes at it currently exists

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  17. There’s a new YouTube series called EconPop that explores economic idea in film, Dallas Buyers Club is the first episode: http://ctt.ec/aq74d

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