26Feb15 A Faster Way to Try Many Drugs on Many Cancers - NYTimes.com
http://mobile.nytimes.com/2015/02/26/health/fast-track-attacks-on-cancer-accelerate-hopes.html?emc=edit_th_20150226&nl=todaysheadlines&nlid=25414714&_r=1&referrer
Does this situation comport with our ethical guidelines? What other concerns might you have about like situations?
After reading this article, I was impressed with the cancer research that has taken place. I was a little confused with all the terminology. Based on what I can comprehend, this cancer drug trial is on the fence of being considered ethical. In a sense the trial is ethical because they are trying to do the greatest good for the cancer population. The drugs in return will be used to save other cancer patients. On the other hand, the trial isn't ethical because there isn't a control group. So the researchers don't know if a side effect is from the drug, the cancer or another disease process. I don't think that is bonus in curing cancer.
ReplyDeleteI am concerned that the FDA let the trial run but they didn't "approve" it's use for the future. That doesn't make sense to me. The FDA should either allow the trial and support it's medication administration or deny the use of the cancer treatments. I thought the FDA would be more black and white about the matter and not so much in a gray area. I am all for curing cancer and helping people in any way, shape or form, but if the trial drug has the potential to do more harm than good, then the trial should end.
I know personally I see all this money donated to cancer and I am not familiar with the research and discoveries that are going on. This was interesting to see what is happening and that things are actually working.Cancer is very scary and something that I am very thankful I haven't had to have a close experience with. I agree with the arguments on the FDA approving this.If this is going to work that's awesome but then we need to make sure that it is going to grow. We need to start thinking a lot more about the future.
ReplyDeleteThese basket studies are tricky because there is no control group. When everyone gets the new drug, it can be hard to know if a side effect is from the drug, a cancer or another disease. However, many of these cancers and diseases are simply too rare to conduct large phase III studies. Thus, I think these basket studies are necessary and potentially groundbreaking. The FDA spokesman said it best when he said "“Is the American population going to be better off with this drug than without it?" The fact is that not everyone in these studies will survive or be cured; however, success rates of 50-60% cannot be ignored. The research companies are relatively new and need to develop a long-term plan with these drugs, demonstrate that wide spread availability is possible if there is success, and show that benefit outweighs potential harm. If true informed consent if received (as in an ethical imperative and shared decision making between provider and patient), I see no objection to these studies.
ReplyDeleteTo me, while these basket studies are capable of showing large amounts of success, they are still very risky and the outcomes are still so sketchy and unsure that it seems a little scary to just rush into this hoping for the best. The researchers have a good basis for their study, focusing on mending the mutations that cause the cancer instead of just treating the organ in which it originated. The fact that they can manipulate the treatment to be so precise is incredible, and the promising results that they have seen from doing these treatments are also incredible. However, as I previously mentioned, rushing into using these treatments with no control groups and only a vague idea of how the whole experiment is going to turn out in the end. I believe the phrase used in this article was that the "researchers are GAMBLING on finding huge effects."
ReplyDeleteI agree with your concerns however, since these cancers are so rare that the participants are willing to gamble their lives in hope of finding some relief from these rare cancers. Another reason to think that the researcher must move fast to try and treat these cancers the rare cancers spoken about could progress quickly and the participants with the cancers do not have much time. Sometimes gambling might be necessary within these literally dyer circumstances.
DeleteWhen cancer is involved in any ethical situation the lines can get blurred easily of what is ethical and what is not because of the desperation most suffers feel. I believe this method of research is ethical because it is helping parts of the cancer population that is often over look because it is so rare. Of course the common diagnosis of cancer are getting researched such as breast cancer for example. However, since these rare cancers only effect a very limited number of people it is hard to come up for treatments for them and often go unheard of because so few have them. These poor people are given a death sentence. I think these basket studies are an excellent idea of how medication can help the most desperate of people for a type of treatment. With such rare cancer i can imagine that most of these people are at the point within their illness they are willing to try anything even if it kills them. I think it is unethical not to look into these studies because these people have no hope or options like other people suffering from cancer what have a more common case. A concern is that these rare cancers are not able to be teated with even this medication that is specific for each patients mutation. If this process is a failure it is just another let down within the community of people trying to find a cure for such a horrible illness. Another concern is desperation that these people have yes it would drive them to be apart of the study but this desperation could skew results if a blinded study were to be performed. Overall, i think any cancer research is beneficial in anyway to help people suffering throughout the world. I hope these researchers are successful.
ReplyDeleteThis article was very interesting. It is amazing that some participants in these studies are having such quick and successful results. But, on the other hand, some participants are having no luck, and eventually die after having no success. I think this situation is scary and pretty risky, even with all of the good results that have occurred. However, if the individual would like to try this drug, knowing all of the risks that are associated with it, I think that it is ethical. What concerns me is that the FDA did not approve the researchers to start Phase 3 of their study, which is when the drug is tested on larger groups of people to monitor side effects, confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.
ReplyDeletelike I mentioned before we have to look at our risk tolerance level when it comes to evaluating medical studies or advancements. Cancer which effects so many is often considered the worlds biggest fear. People seem so strong in their ability to communicate their disdain for this disease and their commitment to ridding the world of it. However, if we are always looking at the ethics behind everything and the safety to everything to a significant degree absolute riddance of cancer is most likely impossible. " In life there are pestilences and then there are victims. It should be our goal as much as possible to never join forces with the pestilence" This means that sometimes there are victims of such medical studies however if it helps the collective then its worth the risk.
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