T-DM1 clinical trials

I believe that clinical trials, whether randomized or not, have a huge role in playing in the development of new drugs and medicines and I would and have participated in one. They especially are needed for the verification of results on humans. You can test a drug on a mouse or a chimp over and over again but when it comes down to it if it can not achieve the same results in humans than all of the research and time was spent in vain. I think that the randomization of the trials should not be necessary for all trials such as cancer medication trials. When a person has a disease they are entitled to the best diagnostics and treatment available, but along with breakthroughs in medical science come the possibilities of new more effective treatments. Bridget Spence had a particularly aggressive strain of breast cancer but a new treatment on trial was able to shrink the cancer area. The drug was called T-DM1 and it was under study against the standard protocol of a medley of different drugs that were not doing the job. An unproven drug with great possible advantages saved her life and quote "the best part is it was very tolerable," she said. "I've lived a completely normal life. I worked full-time, was able to buy a house and walked 60 miles in three days while on the drug" (Corollo, 2012).

There is always the possibility that the drug on trial will fail or not work and the patient is made well ware of the consequences. You do not have to participate but if you do I think you have the right to know what is going into your body no randomized participation at this level. Everyone should be made well aware of the risk they are putting themselves in. “Rather, the appeal to dignity reflects a real concern about the need to promote respect both for the intrinsic worth of human beings and for the integrity of the human species” (Andorno, 2009). This means that everyone has their value and should be treated equally as humans and respect each others rights as humans too. Every one should have the right to choose to enter a trial knowing its possible consequences and be respected for the sovereignty of choice. Do I think that clinical trials are needed, yes, but I do not believe that there should be any randomized selections everyone should have an equal opportunity to choose what they want to do to their bodies.


Corollo, K. (2012, June 3). Experimental drug t-dm1 clinical trials encouraging against aggressive breast cancer. Retrieved from [Only admins are allowed to see this link]

Andorno, R. (2009). Journal of medicine and philosophy: Human dignity and human rights as a common ground for a global bioethics. (3rd ed., Vol. 34, pp. 223-240). Zurich, Switzerland: Retrieved from [Only admins are allowed to see this link]

Matt, you had a great post! I think its fantastic that you have participated in a clinical drug trial. You made some really great points! Your last paragraph about having the right to know goes along with informed consent and hospital accreditation. Before trials are approved, they are analyzed by an IRB (Institutional Review Board) and the Joint Commission (Unknown, 2012). All of these precautions are put in place to assure the health and safety of all participants. At any time, volunteer participants are free to remove themselves from the trial, for example, if they feel they are being harmed by the medication provided.

Unknown. (2012, March 13). Are clinical studies for you? . Retrieved from [Only admins are allowed to see this link]

Matt I totally agree with you. I especially like how you actually went through with a trial. If anyone knows what goes on with such trails, it would have to be you. I feel that being part of scientific and medical research is great for a person to do. It's especially great when they can help others and help themselves. You make such a great point about how we can't achieve the results by testing a rat and a chimp. That is so true, though those animals may have similar anatomical features that does not mean they are a perfect substitute for the real thing. I read an article as to which I found the true effectiveness of these trials. The article stated that "Results of the first clinical drug trial for children with a rapid-aging disease, known as Progeria, has shown successfulness with a farnesyltransferase inhibitor (FTI), a drug first used to cure cancer" (First Successful Treatment for Progeria, Rare Childhood Disease, 2012). To me that shows a great advancement in the medical field to be able to do something like this. I would feel totally safe doing these trials, especially if it is proven by the FDA to be ethical and safe (Learn About Clinical Studies, 2012). And as Morgan said and researched, they can always back out of it whenever they want.

Resources:
Unknown. First Successful Treatment for Progeria, Rare Childhood Disease. (2012, September 26). Retrieved September 28, 2012, from Medical News Today : [Only admins are allowed to see this link]

Unknown.Learn About Clinical Studies. (2012, August). Retrieved September 25, 2012, from clinicaltrials.gov: [Only admins are allowed to see this link]