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
http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm079097.htm
Pastner, Bruce. (2013) “Right to unapproved drugs”.
Law. Retrieved 1 July 2013 from
http://www.law.uh.edu/healthlaw/perspectives/2007/(BP)%20Fatal%20ill.pdf
Rubin, Rita. “Unapproved Drugs Spark Life and Death
Debate”. (2007). USA Today. Retrieved
1 July 2013 from http://usatoday30.usatoday.com/news/nation/2007-04-02-unapproved-
drugs_N.htm?csp=34
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