Sack the FDA -- Before It Kills Again

I've been reading persuasive, market-oriented critiques of the insanely expensive, bureaucratically ham-handed and glacially-slow FDA drug approval process for decades. This enormous body of literature leaves little doubt that the FDA's "safety and efficacy" regime is one of the most misbegotten regulatory enterprises ever concocted by our beltway nannies and their Big Pharma crony capitalist allies. But the fog of statist propaganda regarding the FDA's bally-hoed success in protecting the public from dangerous drugs is so thick that mere analysis---no matter how cogent----has been to no avail whatsoever.

Then came Matthew McConaughey storming into our Big Nanny's face in The Dallas Buyers Club. His righteous attack on the FDA's mindless bureaucracy was worth a thousand libertarian pamphlets.

And just in the nick of time, too. As Nick Gillespie spells out below, the fundamental FDA process is obsolete because it is based on one size fits all----that is, the review of drugs for large populations based on average effects. But in the dawning age of precision molecular engineering, cures and interventions can be tailored to the specific genetics and specific disease biochemistry of one patient at a time. In that context, a drug approval process that costs $800 million and 10 years is not simply a stone age legacy---it will prove to be a killer not unlike what the real life Ron Woodroof was up against a quarter century ago.


Source: Nick Gillespie, "Kill the FDA (Before It Kills Again)," Daily Beast, March 9, 2014.

Kill The FDA (Before It Kills Again)

Forget Oscars for Matthew McConaughey and Jared Leto. The lasting significance of The Dallas Buyers Club is its righteous attack on drug approval procedures

For a grim, low-budget ($5 million) movie about a rodeo rider and a transgendered prostitute dying of AIDS, The Dallas Buyers Club has had a helluva run. Matthew McConaughey and Jared Leto took home Oscars for best actor and best supporting actor. Robin Mathews, reportedly working on a budget of just $250, earned a statue for best makeup.

But before the inspired-by-real-life flick fades from memory and is reduced to future trivia questions about who won what Academy Award when, it’s worth remembering the big message of the flick. 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.

McConaughey plays Ron Woodroof, a boozey roughneck who is given 30 days to live after being diagnosed with AIDS. Faced with such a death sentence, he schools himself on a wide variety of treatments for AIDS, first in Mexico and then all over the world. With the help of Rayon (Leto), Woodruf skirts FDA prohibitions against importing, using, and selling unapproved drugs by creating a “buyers club,” in which members pay a monthly membership and assume all risks (“You croak, you croak,” Woodroof tells members. “Not our problem”).

As the club grows in numbers and publicity, Woodroof is targeted by the FDA and law enforcement. “These fuckers are coming at me, man, from all angles. I wanna file a restraining order,” he tells his lawyer at one point. “Against who?” asks his sympathetic but exasperated counsel. “Against the government and the fucking FDA, that's who.” At another point, he shouts down a panel of bureaucrats, researchers, and drug-company reps: “Y’all up there are afraid that we’re gonna find an alternative without you.”

Though the movie takes more than a few liberties with the story of the real Ron Woodroof, its depiction of the drug-approval process is worth taking seriously. Most of the time, the FDA is considered as an unalloyed good, the only thing keeping us from constantly being poisoned by, say, baby-deforming drugs such as Thalidomide. That was the morning-sickness treatment whose effects in Europe gave rise in the early 1960s to the modern FDA, with its nearly dictatorial control over prescription drugs and, eventually, medical devices. Curiously, these expanded powers came despite the agency’s demonstrated ability to keep Thalidomide out of the United States.

Despite rare exceptions for “compassionate use” and “orphan drugs” secured in the wake of AIDS activism, the FDA’s drug-approval process is still widely recognized as being ultra-conservative in weighing the risks versus the benefits of various pharmaceuticals. It is also increasingly facing challenges based less on cost-benefit analyses and more self-ownership principles. “Right to Try” legislation – which proceeds from the presumption that there “is a fundamental right to save your own life” – is currently under discussion in Arizona and other states.

A 2006 Government Accountability Office (GAO) study found that the number of new drug applications submitted to the FDA between 1993 and 2004 increased by just 38 percent despite an increase in research and development of 147 percent. The mismatch, said GAO, was the result of many factors, ranging from basic issues with translating discoveries into usable drugs, patent law, and dubious business decisions by drug makers. But the problems also included “uncertainty regarding regulatory standards for determining whether a drug should be approved as safe and effective,” a reality that almost certainly made pharmaceutical companies more likely to tweak old drugs rather than go all in on new medicines.

In fact, 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.” Yet it’s easy to understand why bureaucrats remain slow-moving. "Officials know they will be punished by the public and politicians more for underregulating -- approving a harmful drug, say -- than for tightening the approval process, even if so doing so delays a useful innovation," wrote Harvard’s Regina Herzlinger in 2006.

That perverse calculus is made even worse given that dwe are at “the Dawn of Precision Molecular Medicine,” in which cures and interventions can be tailored to the specific genetics of specific patients. As the Manhattan Institute’s Peter Huber explains in The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine, we’re fast arriving at – and are already there in certain cases – the point in which we can take “full advantage of modern pharmacology's power to develop a vast array of precisely targeted rugs.” The early experiments in this sort action involved things such as “cocktails” of a variety of AIDS drugs mixed up for individual patients (some of this comes through in The Dallas Buyers Club).

Now, writes Huber, oncologists are “Oncologists...routinely take advantage of the...loophole that allows doctors to prescribe licensed drugs off label. They work out, one patient at a time, how best to use these treatments, which they do by fitting the molecular logic of the targeted drug to the biochemistry presented by the patient's cancer. Genetic matching is becoming as routine as matching a blood transfusion to blood type.” Yet the FDA drug approval process is predicated upon drug trials involving large numbers of participants and searching for the average response to a drug or treatment regimen.

The best way to accelerate progress, argues Huber, is to fundamentally rethink drug-approval procedures that date back to the Thalidomide scare that took place during John F. Kennedy’s presidency. "The search for one-dimensional, very simple correlations - one drug, one clinical effect in all patients - is horrendously obsolete," he says, and that’s only going to get worse as genomic sequencing of humans, tumors, and everything else moves forward. “The FDA should allow other drugs aimed at other complex diseases to follow the trail that HIV and, to a lesser extent, cancer drugs have already blazed.”

If The Dallas Buyers Club plays any role in sparking that sort of policy change, it will have scored a triumph that far outstrips the movie’s Oscar haul.

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