Thursday, 7 May 2015

A tough ethical issue

Businesses are often considered as machines without a heart. But even businesses face some gut wrenching ethical issues , where the "right" course of action is by no means obvious.  Take the case of the compassionate care issue face by pharmaceutical companies.

Drugs produced by pharmaceutical companies are marketed after years, and sometimes, decades of clinical trials. They have to be approved by a regulating body - in the case of the US, the FDA - before they can be made available for use by doctors and patients. This is a justifiably stringent process.

It is therefore obvious that at any point in time, there are a number of experimental drugs which are at various stages of testing or approval. They may or may not finally make it to the market place. But the fact of their existence, their performance in the trials, the stage of FDA approval (relevant since most drugs are discovered in the US) are all fairly common knowledge and often in the public domain.

The ethical issue comes when there is say a terminally ill patient who does not have much time left and where conventional approved forms of treatment have failed. The patient, or his family, makes the appeal to a pharmaceutical company for an experimental drug that is not yet fully tested and has not been approved by the FDA. Is it ethical for the company to release an experimental drug for such a patient ? They may not even be making the drug outside of the lab as yet. Should they actually produce it in a pilot facility to make it available ?

I learnt from this news article that hundreds of such requests actually come to the FDA every year . The regulator examines each such request and apparently they are mostly approved. But for any serious evaluation of a request, they need time and that is probably what the patient does not have. Even if there was a little time, the patient and the family would be understandably anxious to try the treatment tomorrow if possible. So, even with an FDA approval of the case, how does a company respond to such a request.

On one hand, it is absolutely cruel to withhold a possibility of a chance, however slim, from somebody who will otherwise die. The case for release of experimental drugs is very strong. It doesn't need any further elaboration.

But consider the risks. Doctors will be the first to tell you that there are many grey cases where it is not easy to determine if the patient is terminally ill. What if there are are horrendous side effects which are not yet known - at what stage of experimentation of a drug is it OK for it to be released to a live patient. What about the risks of lawsuits - after all we are talking about the US a notoriously litigious society. What about the risks that companies may simply use terminal patients as clinical trials if compassionate care becomes widespread. What about non terminal cases (say Parkinson's or Alzheimer's, which are non fatal but horrible diseases) where an experimental treatment might drastically alter the quality of life.

Thorny ethical issues. I would hate to be in a position making the decision. Johnson & Johnson, a famously ethical company has moved to set up an independent panel to be organised by the New York University to decide on each case. That is probably the best course of action, but each decision would be extremely difficult to make.

What do you think - in which direction would you lean ?

16 comments:

  1. My sister works on developing drugs for cancer patients, and she has first hand knowledge of how things work.

    I'll start by saying that I hope I am never in that situation to make such a decision.....

    I've been closely following the case of a 5 yr girl Anya from the bay area who has DIPG (a kind of brain tumor) and her parents chose not to enroll in the trial, primarily because of the risks. When it comes down to it, I resonate with the approach they are taking....data-based decision combined with their gut feeling....it is heart-wrenching to even read about it...I have no idea what her parents are going through.
    (https://www.facebook.com/prayforanya?fref=ts)

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    1. Oh God I can't bear to read it.

      Would be very interested to hear of your sister's view.

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  2. this is so tricky, especially the misuse part. But i would still support anything for a chance to live and a strong governance for curbing misuse

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    1. That's probably where many views will fall, but practically its very difficult to implement. Its incredibly tricky and its almost like playing God.

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    2. Anne in Salem8/5/15

      "Almost like playing God." I have taught my children my religious views, and we freely discuss ethical topics because we do not always agree. My 16 year old son recently asked if all medicine isn't playing God. If murdering someone is wrong because a person makes a decision that is rightfully God's (when to end a life), how is receiving cancer treatment or even taking antibiotics also not playing God? Perhaps we humans are extending a life that God decided should end with that cancer or that infection. I love having intelligent children, but sometimes they challenge me.

      Yes, a difficult, thorny, tricky issue. I would not be able to make a decision such as this. I suppose the crux of the matter is the definition of the word terminal. How does a doctor know for sure a patient is terminal until the person is truly beyond medical reach? Is a longer life necessarily better? I don't know how absolutes can be defined in such cases, and case-by-case decisions are fraught with many complications and possibilities for misuse.

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    3. Nice to have such a debate with children. Well, the issue raised by your son is not a valid argument for me. Yes, life is God's to take but that does not mean we must be passive and do nothing. It is in the order of nature that all living beings try their best to survive - by physical prowess in the case of animals and mental prowess in the case of man. It would be a sin, I think, for humans to not do otherwise. The fight for life is a basic aspect of nature and I see no theological conflict with life being God's will.

      Yes, your views on the dilemma I presented are closely reflective of mine too. But I would be falling more into the camp of allowing compassionate care through an independent decision making process like what J&J have done.

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  3. I would take a chance and try the drug! but thats just me :)

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    1. Most would decide that way, but consider all the risks and grey areas and it becomes a not so clear cut decision.

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  4. Right to Life is fundamental right of humanity. If a medicine can extend it, it should be supported. Its a matter of risk beyond imagination for the person undertaking the trial and such people should be worshipped as martyrs.

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    1. Yes, Gils, the Right to Life is a primary right but equally so is the Right to Live with dignity. What is the use of prolonging a life when you are simply a living vegetable. I suppose it is an individual decision as to when to want to live and when not to.

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  5. As long as the patients are fully informed about it and as long as the providers are overseen by a regulated structure.
    However, the information asymmetry that will exist means that the chances are pretty darn good that the providers might know something that they might hold back, and the patient could easily be tempted when grasping for anything that could potentially be a treatment.

    While in the context of the post, this atheist could easily go off on the fixation that we humans seem to have on "life extension," he decides to resist that urge.

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    1. "Full information" is an oxymoron when it comes to medicine. I wonder if a layman pateint can ever be truly well informed enough to make a decision. We have to rely on the doctor. And as Nancy says below, people in fear of dying will always grasp at anything, however toxic that might be.

      Well, I wish you had argued against life extension. I would have bashed you back :):) Only us, who have been fortunate (blessed?) with good health can indulge in that debate. There are many many instances when life is tragically cut short - in such cases life extension IS a holy grail.

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    2. We will have to agree to disagree.

      Nancy writes:
      "If you give an option to the masses they will take it, ignoring the consequences. And in the history of healthcare, no doctor or drug company has ever taken responsibility for anything unfortunate that has happened to their patients. "
      The only thing I am happy about is that the "Nancy" that christened Deepa has stuck around for a while and she even posts as Nancy now ;) Wait, or is that a real Nancy?

      Because Nancy writes both about the FDA and India, am not sure if she is referring to the US or India or both when she comments about the responsibilities. Here in the US, doctors and hospitals and pharma companies get sued every day for negligence and malpractice. It is not any unregulated world in which the experimental drug could be made available for a terminally ill patient. And, btw, because of the potential for lawsuits, the insurance companies are not going to cover expenses related to the experimental treatments. The experimental drugs for the terminally ill will be only after making ultra-sure that the patient and designated proxies understand the risks.

      BTW, it is we people who are lucky with good health who should actively engage in these discussions. To a large extent, we are the "jury" who are far removed from the case and we can be as objective as we possibly can. It is like how we should draft our own advance directives or the final will when we are healthy. In fact, no doctor would even sign off on the advance directives if the person is seriously ill.

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  6. Anonymous9/5/15

    We enter dangerous territories when we let a company panel decide whether they should make a drug available as an experimental drug. And also scientists who research these things sometimes are fanatically, single mindedly trying to get to the end result. There have been cases where they have ignored even some basic consequences due to dosing in order to see the outcomes and gotten rapped on the knuckles by FDA. I would question the objectivity of the person who is on the panel if he/she is part of the study.

    Let's say they even agree to administer something which is really in the final stages of approval and ready to be cleared out of the door, one has created an option of a backdoor preapproval. If a governing body has a process in place to finally declare a drug sellable and everyone has agreed to it, why not stick to it. If there are flaws or bottlenecks in the process, those need to be fixed not the process itself.

    A person oscillating between life and death is desperate and may jump at any faintest option given to him/her to live. More than the love of life, people are afraid of death. People who come to terms with death will not want to live a life worse than what they already have thanks to some side-effect that nobody knew about.

    In India, just because healthcare and drugs are so cheap, people like to take a pill for every trivial reason. I have friends who have done a C-section only because they didn’t even want to deal with the thought of labor and doctors provide you that option. If you give an option to the masses they will take it, ignoring the consequences. And in the history of healthcare, no doctor or drug company has ever taken responsibility for anything unfortunate that has happened to their patients.

    If someone ended up signing up for clinical trials for these drugs, good for them, as they are doing a greater good to humanity as well. But otherwise, one has to respect life and the loss of it.

    -Nancy

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    1. Thanks Nancy for a beautifully reasoned and articulated point of view. You have summed up the risks so very well.

      To protect against exactly the sort of issues you have brought out, I think J&J has taken away the decision from individual scientists and put it in the hands of an independent panel which is to be constituted and run by the New York University. In any case the FDA approval is a pre requisite ; so there is regulatory authority. I feel this is a step in the right direction.

      But as I said, I would hate to be in a position where I would have to decide.

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    2. You are welcome Ramesh! 😊

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