Lewis A. Fein

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The search for a cure

http://www.jewishworldreview.com | Typically, I write columns about politics or foreign policy, issues that generate passionately supportive or vehemently oppositional feedback.

But I am also a person who feels - yes, feels - deeply concerned about an attitude that affects not only my life but the lives of millions of people nationwide. This forum thus enables me, because of my shared religious heritage and ethnic background, to make an important confession, which is itself a plea.

I have Crohn's Disease, a chronic condition that causes physical pain, weight loss, fever and fatigue. (Crohn's disproportionately strikes Ashkenazi Jews, and - though fatalities are no longer as common as decades before - it requires a lifetime of prescription medication and a doctor's care.) Yet, my case has its own political message, a metaphor for regulatory change and economic action.

First, let me praise the very existence of an institution like the Food and Drug Administration (FDA). The agency performs a valuable public service, bestowing its credibility upon - or withdrawing its support for - products that grace pharmacies and store shelves throughout the country. The agency provides consumers with needed information about a drug's safety, efficacy, trial history or side effects. A delicate balance nonetheless exists between the FDA's authority and people's medical needs, which alarmism or media extremism must not upset.

Think, for a moment, about the consequences of this brand of regulatory fear and journalistic hysteria. The manufacturers of the MS treatment Tysabri, which also has excellent clinical results for patients with Crohn's, stands before the FDA's imperial whims. Despite this medication's impressive history, the public may not purchase this new drug. Awaiting the results of a comprehensive data review -- encouraged by the culture of indecision (or negative action) that predominates throughout the FDA -- punishes the sick.

Perhaps I should mention the consequences of inaction, something I can recount with vivid detail: The unavailability of new drugs for Crohn's left me hospitalized and prepped for surgery, a long procedure that required the supervision of a pancreatic specialist and a team of nurses.

After more than a month in a quarantined room, and with a surgical scar across my lower torso, I slowly began to regain my strength. This operation, which newer and more effective medication could have prevented, was necessary because of an absence of choice; regulatory hurdles prevented me from using more successful remedies.

Patients with MS also appreciate these comments because Tysabri represents a major breakthrough in treatment of this disease, focusing on halting its progression rather than merely providing symptom relief. And, given the degenerative nature of their condition, submission before the altar of regulatory "wisdom" is something few MS patients can afford. These individuals deserve improved quality of life, not legalistic obstacles or bureaucratic delays. Absent a compelling scientific reason to the contrary, we should elevate informed consent above the government's false protection.

People with MS, Crohn's, arthritis and other inflammatory diseases routinely deal with serious chronic conditions that require extensive treatment options. If a drug like Tysabri works, which MS patients can confirm and my fellow sufferers of Crohn's fervently believe, then we have an ethical responsibility to remove any restrictions toward scientific progress. Patients and physicians deserve choice, the greatest preserver of life.

It is rare that we directly sense the power of government, its ability to complicate or terminate (indirectly) life. The FDA has such power, an awesome responsibility that transcends its regulatory dominion over beef or aspirin or cough syrup. The existence of a drug like Tysabri, medication that can greatly improve the lives of my own friends and family, is reason for action. We need a vigilant government, but we must not have an intrusive government. Let patients and physicians decide these issues for themselves. Government, heal thy self.

JWR contributor Lewis A. Fein is a writer and Internet entrepreneur in Los Angeles. Comment by clicking here.