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Tuesday, July 2, 2013

Argumentative Essay against the Use of Unapproved Drugs

Instruction: Should Unapproved Drugs Be Made Available?

Argumentative Essay against the Use of Unapproved Drugs
            Every day, there are thousands of patients suffering from incurable and life-threatening conditions. More often than not, these patients are often without or very little options as they run out of treatments that are approved by the Food and Drug Administration. And in desperation, some of them turn to drugs and treatments that have not been approved by the FDA. Most of these patients argue that they are willing to take the risk because they really have nothing to lose.

            Although such arguments make a valid point, both researches and experts suggest that using drugs that are unapproved is not only dangerous by it is also unlikely to be of significant benefit for the patient. This is because most of the drugs being questioned here are still under Phase I. This means that it is the drug’s first testing in humans and is typically carried out to a very small number of patients. In other words, the effect of the drugs to human remains unknown. For instance, a recent study regarding the benefits and risk of a newly developed anti-cancer agent showed that 1 out of 100 patients die as a result of using the experimental drug (Rubin 1). 

In addition to this, less than four percent of the volunteer patients show response to the Phase I drug. Doctors and researchers also point out that there is still no verifiable data that correlates response rates to better control or management of the symptoms (FDA 1). Despite of these discouraging findings, many patients are willing to participate in this testing as they are motivated by hopes of improvement and even cure. However, the active and voluntary participation of these patients could mean that they are either not accurately informed by the experimenters or they are willingly ignoring the possible consequences of the untested drugs (Pastner 2).

Accordingly, it is important to point out that there are no current legal issues in terms of receiving medications that still under experiment. This “right” is the crux of the Abigail Alliance, an organization that advocates for the access of developmental drugs. The group calls for the access to any experimental drug without having the need to undergo administrative requirements as this could be seen as potential delays (Pastner 3).  

Last 2003, the organization filed a case against the United States FDA because of a young woman named Abigail who passed away at age 21 while battling her right to receive an experimental drug. The suit claimed the inefficiency of the FDA and therefore called to enforce a policy allow the sale of Phase I drug. The federal court however, dismissed the complaint because of their failure to state the claim that “denying such drugs meant depriving patients of their right of self-defence”. In addition to this, the court noted that ‘to accept the proposition that the safety and efficacy standards of the Act have no relevance for terminal patients is to deny the Commissioner’s authority over all drug, however toxic or ineffectual, for such individuals”. This means that in the eyes of the law, the notion of “right” overruled by the importance of safety. Numerous medical professionals similarly agreed with the decision of the federal court as many believed that Phase I drugs are not designed to show any efficacy in terms of results or cure (Pastner 4). 

The case of Abigail only suggests that although experimental drugs offer a glimmer of hope for dying patients, the safety and efficacy of such drugs are still undetermined.  More than this, allowing the patient to access such drugs could also cause harm to the possibility of furthering and developing effective drugs as it deters their participation in new clinical trials.

Works Cited
“FDA’s Actions Against Unapproved Drugs”. (2013) FDA. Retrieved 1 July 2013, from
Pastner, Bruce. (2013) “Right to unapproved drugs”. Law. Retrieved 1 July 2013 from
Rubin, Rita. “Unapproved Drugs Spark Life and Death Debate”. (2007). USA Today. Retrieved
1 July 2013 from

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