There is no questioning the fact that
the pros and cons of human experimentation has been one of the most
important debates of the twenty-first century. While thousands of
people involved in clinical trials, legal or illegal, have suffered
from severe health deterioration including instant death, millions of
people have received vaccinations for arguably incurable ailments
such as polio, now on the verge of eradication. And the issue is
becoming increasingly complex with time, as indicated by the
following recent examples.
On 12th April 2006, six
volunteers at the North-wick Park Hospital in London were
administered weakened doses of a drug called TGN1412 in the first
human clinical trial conducted by researchers at a leading
biotechnology firm called TeGenero. The drug was being explored as a
potential treatment to auto-immune diseases like multiple sclerosis,
in which the body's own immune system causes harm to the body's
organs. Minutes after the infusion, all volunteers had to be
transferred to intensive care as they faced life-threatening
conditions which involved multi-organ failure. The United Kingdom’s
Medicines and Healthcare Products Regulatory Agency immediately
conducted an investigation, but did not find any flaws in the
execution of the procedures in the research protocol initially
submitted by TeGenero. Hence, it was ruled that this disaster was the
result of unexpected behavior of the drug.
On the other hand, on 16th
July 2012, the U.S. Food and Drug Administration approved the market
use of Truvada, a drug that reduces the risk of HIV infection in
uninfected individuals who are at a high risk of catching the disease
due to being engaged in sexual activity with HIV-infected partners.
One of the events that lead to the eventual approval of this drug was
a large, randomized clinical trial conducted by Gilead Sciences, the
manufacturer of the drug, in 4,758 heterosexual couples where exactly
one partner was HIV-infected. Truvada's safety and efficacy was
demonstrated by the fact that the drug reduced the risk of being
infected by 75 percent, with only mild side-effects such as diarrhea,
nausea, headache etc.
The primary reason behind narrating
these examples is to highlight the fact that human experimentation
has 'huge' advantages and 'huge' disadvantages. Hence, an intelligent
and powerful framework is essential to control the approval of these
experiments. Intelligent, because the greater the expertise of the
people who comprise this framework, the better the decisions made
while reviewing experiments for approval. Powerful, because unless
the framework has the authority to force its laws upon research
groups/individuals, it cannot control the experimentation that takes
place.
One way of implementing such a
framework, as observed in many countries, is the establishment of
government-funded agencies that adhere to a strict
cost-benefit-analysis approach when evaluating experiments. Research
without informed consent should not be permitted, not because it is
ethically wrong, but because it would cause uncontrollable public
unrest, resulting in people losing faith in their government. On the
other hand, research which offers monetary benefits to volunteers
should not be discarded without any further consideration based on
ethical grounds, because the benefits of the same research to the
society, if successful, might far outweigh the costs to the
volunteers. Policies such as these might sound too radical at first,
but the fact remains that the job of the government is to look after
the betterment of the public. Experiments for which expected social
benefit outweighs expected social cost, as determined after
meticulous evaluation by experts (from fields beyond biology if
necessary), must be approved and vice versa, because this is the only
way of reducing the future occurrence of events such as the TGN1412
tragedy while also increasing the future occurrence of events such as
the Truvada breakthrough.
Sources:
1. http://www.nature.com/nature/journal/v440/n7086/full/440855a.html
2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964774/
3. http://seattletimes.com/html/businesstechnology/2018699860_apushivdrugfda.html
4. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm312264.htm
1 comment:
I agree with what you have said about these huge risks and huge benefits associated with medical testing. The nature of improving medicine as a field has always been weighing these risks versus these benefits. Without this balance there would be no medical breakthroughs or no new discoveries that lead to a greater understanding and overall health for the public.
As you pointed out these tests do not always go exactly as planned. In cases such as TGN1412, which is the extreme of what can go wrong in one of these studies, terrible things do happen. The goal of researchers is obviously to try their best to make sure these kinds of outcomes rarely happen but the truth is that it is impossible to be one hundred percent sure of what a drug will do during its first human trials. Sure there are animal trials that can predict the outcome but they are not the same. Animal models can be great predictors, but they are not the real things and drastic changes can happen when humans are giving the same drug or treatment. The troubling question becomes, when tragedies like the one that occurred with TGN1412 do occur, and they will, who is to blame?
I think the only logical answer, as unsatisfying as it may seem, is no one. It is not anyone’s fault for these drug tests, as long as there were no flaws in the regulations and procedures of drug trials. It is just an extremely unfortunate event that occurred and is really the nature of medical advances. In order for there to be huge leaps forward like what Truvada accomplished, there must be some drugs that fail. It is the unfortunate truth in medicine.
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