Monday, February 10, 2014

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by Kathy Chow


Before any drug reaches the sales counter, the Federal Drug Administration (FDA) must approve it via a three-phase process to ensure that it is safe for consumers. This is a long and arduous process that usually takes several years.

The question of whether we should allow terminally ill patients to gain access to non-FDA-approved drugs is one that has surfaced repeatedly in recent years. In 2008, the Supreme Court justices dismissed Abigail Alliance v. von Eschenbach. As a result, a divided federal appeals court made the decision instead, ruling that terminally ill patients do not have the right to use experimental medications. More recently, during the 112th Congress (2011-2013), Senator Ron Paul attempted to introduce the Compassionate Freedom of Choice Act, which would prevent the FDA from restricting access to experimental medication for terminally ill patients. However, the bill died in committee.

Despite the continuous rejection from various branches of the United States government of this policy, several compelling arguments may be made in its favor.

First, there is the issue of bodily autonomy. The ability to make independent choices gives human life meaning. If you woke up one day and somehow realized that your brain is hooked up to a machine that generates your perceived “reality”, your life would have a lot less meaning. Why? Because the decisions that you think you made were not actually made by you, but were instead predetermined by the machine. Therefore, you will realize that what you once perceived as a journey involving choices at several intersections that lead you to a destination you choose for yourself is in fact a single road the destination of which has already been determined. In sum, the more choices you have, the more meaning you have in your life. Consequently, what we see with this proposal is an increase in the quality of life in general for terminally ill patients because it allows them to exercise the right of bodily autonomy.

Furthermore, the terminally ill deserve respect and trust, which are closely correlated with how much autonomy we give people. For example, the government incarcerates criminals because we cannot trust these people with their autonomy and their ability to make choices that don’t negatively impact society. However, in the situation of the terminally ill who are innocent and have not shown any tendencies to make poor choices that cause harm to others, the government removal of such an important and potentially life-saving choice from their lives essentially tells them that we do not trust or respect their abilities to make their own life decisions. Consequently, the government would be grossly overstepping its role.

In addition to the moral arguments, a persuasive case can be made from a pragmatic perspective as well. To begin, the FDA takes an extremely long time to approve a drug. This occurs because there is strong incentive for them to be as thorough as possible: to minimize the risk of wrongfully approving a drug that is in fact more harmful than helpful and inspiring mass criticism from the public. At first glance, the meticulousness of the FDA may appear beneficial for society because it ensures that only the drugs with proven benefits that far outweigh any possible negative side effects will enter the market. However, one must realize that in the case of terminally ill patients who essentially have no other choice, the extreme length of time taken by the FDA to approve a drug is essentially a death sentence for them. Thus, by giving terminally ill patients access to non-approved drugs, the government at least gives these people a chance to live.



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