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Science in Thrall to FDA


By Bill Frezza 

November 30, 2011 | The Skeptical Outsider | Risk aversion is the inherent enemy of progress. In a free society we can each seek our own balance, accepting the consequences. But when entrenched interests are allowed to thwart attempts by innovators and entrepreneurs to challenge the status quo, we all pay the price. As America slides into malaise and decline, nowhere is this more evident than in our passive acceptance of the absolute power of the U.S. Food and Drug Administration—even in the face of certain death. It need not be so. 

Forty years after President Richard Nixon declared War on Cancer—one of the most expensive and protracted wars in U.S. history—it’s hard not to be discouraged. If you should be unfortunate enough to be diagnosed with ovarian cancer, you are going to die. Same for pancreatic cancer. Or lung cancer. Not to mention a host of other metastatic sarcomas that medical science has not yet conquered. 

Who hasn’t lost a friend or family member to the Emperor of all Maladies? Who hasn’t watched victims struggle with false hopes raised by palliative remedies that a quick Google search will tell you can at best delay the inevitable? And who hasn’t imagined that if fate were to put them in a similar circumstance they would accept the risk of an experimental alternative on the chance of a cure, however slim? 

Yet standing between overburdened innovators and willing patients is an unaccountable agency determined to enforce a standard of safety completely disproportionate to the dire circumstances of the terminally ill. Exactly where in the Constitution did the people confer such power over life and death on unelected bureaucrats? 

Initially established by the Pure Food and Drug Act of 1906, the U.S. Department of Agriculture was granted the power to seize adulterated or misbranded food as well as mislabeled drugs when shipped across state lines. Note the constitutional foot in the door. In 1911, attempts to expand the USDA’s authority to regulate drug efficacy were struck down by the Supreme Court, slowing but not stopping the steady accretion of power. By the time the New Deal finished eviscerating most constitutional limitations, the FDA was born.  

A report recently released by the Milken Institute—“The Global Biomedical Industry: Preserving US Leadership”—documents how the wheels of progress have been slowly grinding to a halt as the FDA raises the bar for drug approval. The length of time required to complete clinical trials over the past decade is up 70%. The median number of procedures required per trial is up 50%, as is the total work burden per protocol. Meanwhile, volunteer enrollment and retention has been driven down by 21% and 30% respectively. And, of course, new drug approvals are down 50%. Keep this up and it won’t be long before clinical trials follow U.S. manufacturing to China, with other elements of the pharmaceutical industry trailing closely behind. 

Even as trials drag on with preliminary information kept blinded, new laboratory developments that could improve results are banned due to an insistence on maintaining rigid conformity to outdated protocols. In what other industry does this happen? The calls for “adaptive trials” that might be more suitable in an age of personalized medicine remain unheeded. And the shameful spectacle of denying Americans access to drugs that are approved and available in Europe and elsewhere defies justification. 

Is there an alternative? 

While wholesale FDA reform is needed, doing it right would entail a monumental effort that could take years. But there are modest steps we can take in the meantime. How about carving out one or more FDA-free Enterprise Zones where doctors, scientists, and volunteer patients can make their own decisions unfettered by the heavy hand of regulators? Imagine an experimental terminal-illness wing of the Cleveland Clinic where informed consent was the only law. How hard would it be to draft enabling legislation?  

Defenders of the FDA’s prerogatives would fight such proposals tooth and nail. But what kind of nanny state arguments can be made against conducting such a policy experiment when anyone who objects doesn’t have to be treated? Breakthroughs that emerge would still have to pass through the FDA gantlet before they would be generally available. The difference is that researchers could continue making improvements while treating volunteers during this long process. 

If we fail to arrest the regulatory assault on medical progress in the U.S., sooner or later out-of-the-box solutions like the one described above will pop up—elsewhere. And American patients will follow. The price of a plane ticket is trivial compared to the cost and consequences of cancer. Perhaps if enough patients start voting with their feet, pressure for change will build from those without the means to take care decisions into their own hands. 

But it should never come to that. There is no good reason we shouldn’t have access to the most advanced treatments at home. First, however, we need to exercise the political will to demand our right to choose. Are we up to the challenge? 

Bill Frezza is a fellow at the Competitive Enterprise Institute and a Boston-based venture capitalist. He can be reached at waf@acm.com.  

This article also appeared in the November-December 2011 issue of Bio-IT World magazine. Subscribe today! 
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