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The Audacity of Freedom: Government Regulation of the Pharmaceutical Industry Harms More Than Helps

By J. Edward Nelson

stosselOn the February 25, 2010 episode of Stossel, a weekly Fox Business News program hosted by long time investigative reporter John Stossel, the issue of whether the designations made by the FDA, which determine through force of law the accessibility within the marketplace of all pharmaceuticals, would better serve the public in a voluntary capacity was discussed at length.

Stossel expressed the novel idea that “free” people should decide what goes into their bodies because they, not the government, own their bodies.

The simplicity and audacity of such sentiment – “we own our bodies” – may come as a surprise to many Americans who have grown accustomed to a post 9/11 environment in which civil liberties have become diminished in favor of heightened security precautions by the government. The perception that the principle function of the federal government is to protect its citizens first, and guard against encroachments upon civil liberties as an after thought, has become prevalent within the brave new world carved out by the untimely collapses of WTC buildings 1, 2 & 7.

The repercussions of this “brave new world” arguably reverberate most in the lives of the least among us – the terminally ill. I say “least among us” because in many instances, terminally ill patients are unable physically to advocate on their own behalf – unlike other marginalized communities such as ethnic minorities, homosexuals and women, who can ably employ numerous tactics, such as public demonstrations, in order to express displeasure with unfair treatment by government – and are forced to rely on loved ones and their personal doctors for advocacy (individuals who just happen to have lives of their own IN ADDITION to caring for someone with a serious or terminal illness).

Since the turn of the century, the upward trend of terminally ill communities being denied access to experimental drugs by the FDA has been well documented by the media. Add to this disturbing trend the FDA approval process which is a daunting task, to say the least, for those drug companies who lack the requisite hundreds of millions of dollars necessary to complete all three phases of a clinical drug trial.

It’s interesting to note that advances in technology allow new chemical compounds to be identified by drug companies a great deal faster and in higher quantities than in previous decades, subsequently lowering the cost of research and development on the front-end, and were it not for the high cost of FDA approval potentially life altering therapies would enter the marketplace much sooner, saving countless lives.

Therein lies an interesting conundrum: the net loss of life when you factor in the potentially lethal side effects of unapproved drugs which the FDA approval process protects the general public from, and the lives lost waiting for prospective drugs to be approved (on average, 10 – 15 years).

A Phase I trial consisting of stem cell treatments for 13 ALS patients has been approved by the FDA. The other 30,000 or so ALS patients in the continental United States have to wait 18 months for the Phase II trial (I was informed by a doctor working on the Phase I trial) and hope to be one of a lucky dozen or so chosen. But because of the high death rate of ALS, within two to five years from diagnosis, most ALS patients diagnosed even recently will die well prior to this treatment ever being approved by the FDA (if it is approved at all).

Proponents of this slow, totalitarian system (the government literally choosing who lives and who dies) contend that agencies like the FDA not only protect Americans from “rogue” drug manufacturers, but that individuals lack the resources necessary to thoroughly research the abundance of experimental drugs manufactured by pharmaceutical companies, and in those instances where patients are so bold as to identify experimental drugs which they want to try because no therapeutic currently exists for their condition, the FDA protects these individuals from THEMSELVES.

Most people – aside from certain decision-makers at the FDA – would find it difficult to argue against granting people dying of incurable diseases access to experimental drugs irrespective of the potential side effects. The rationale being, “he or she already has one foot in the grave,” so who does it hurt?

Stossel’s contention is much more broad than that. “WE own our bodies.” These simple words engender the force of a mission statement. ALL Americans, not just those who happen to be terminally ill, should be free to access any pharmaceutical product, for any ailment (life threatening or relatively insignificant), unfettered by the need for government acquiescence. What would this mean in a practical sense?

In practice, the designations made by the FDA would not have the force of law behind them. Thus patients, doctors and pharmaceutical companies could interact in the marketplace more fluidly with FDA approval being a voluntary “guideline,” not a giant red “stop-sign.” “FDA approved” would have the same significance in the pharmaceutical world as “USDA” has in the food industry. Approved drugs would still occupy the apex of the drug industry hierarchy, but sick people with few options would no longer be restricted from experimental therapeutics.

Whether you agree with Stossel or not depends upon how you answer the following question: Who owns your body?


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