[From Joel]At my local philosophy club we experience a downturn during the summer months. It becomes even harder than usual to find topics and speakers. In exploring possibilities for breaking the barriers that people have in preparing a talk, I devised this possibility and used myself for the guinea pig. I presented several ethical dilemmas that have appeared on the television show "Boston Legal," prefacing them with a short general view of ethics as viewed by Aristotle. The audience response was excellent. Watching a television show and reporting on the ethical dilemma presented doesn't seem like too difficult a chore. Unfortunately, we aren't in the early days of television when E.G. Marshall and "The Defenders" was popular. That would have made it quite simple.
The first dilemma concerns a powerful person (PP) being sued by a not powerful person (NPP). They are both dying of cancer and participating in a drug study. It turns out that the PP has used his influence to assure that he is part of the 50% getting the real drug, while the NPP takes his chances with the rest of the study group. Not actually being a fan of the TV program, I didn't hang around to find out the ultimate result, but it looked like there was going to be an out-of-court monetary settlement. Be that as it may, I asked our club to discuss, not the specific question of whether or not PP and the doctor acted unethically, but rather whether or not the use of placebos as a statistical tool in research studies is moral and ethical. What do you say? with respect -Joel
The first dilemma concerns a powerful person (PP) being sued by a not powerful person (NPP). They are both dying of cancer and participating in a drug study. It turns out that the PP has used his influence to assure that he is part of the 50% getting the real drug, while the NPP takes his chances with the rest of the study group. Not actually being a fan of the TV program, I didn't hang around to find out the ultimate result, but it looked like there was going to be an out-of-court monetary settlement. Be that as it may, I asked our club to discuss, not the specific question of whether or not PP and the doctor acted unethically, but rather whether or not the use of placebos as a statistical tool in research studies is moral and ethical. What do you say? with respect -Joel
5 comments:
Thanks Joel for a new Topic.
IMHO it is certainly ethical to use placebos in statistical studies for new drugs. That is the ONLY way to determine if a drug that appears promising based on animal tests is really safe and effective for humans.
This type of testing can help determine optimal dosage to reduce bad side effects and still get the intended benefit, interactions with other drugs, different effects on men and women and people of different ages and medical complications, etc., etc.
However, the results should be statistically monitored as the study unfolds. If statistically significant bad side effects are greater than expected the study should be cut short. On the other hand, if statistically significant benefits are proven earlier than expected, the patients on placebos should be switched to the real drug immediately. I believe this is how it is done in practice.
I am not a fan of "Boston Legal" but if I were writing the episode where the Powerful Person (PP) used his influence to get the real drug while the Not PP ended up with the placebo, I would have it turn out that the drug was actually dangerous, perhaps because the unethical drug company faked the animal tests, and I would have the PP die a terible death and have the NPP attend his funeral!
Ira Glickstein
PS: Did anyone at your Philo Club say placebos were unethical?
Ira asked: Did anyone at your Philo Club say placebos were unethical?
Joel answers: Just one or two. Most said that one knows what one is doing when one signs up for the tests.
There appears to be some general argument in the medical community about individual treatment with placebos. I've looked at a lot of of large scale drug testing and think that the use of placebos is statistically unnecessary in life and death cases. The placebo effect appears to be large for pain relief, but small for deadly diseases not involving the nervous system. To the extent that placebos are effective we should study the hell out of it and understand the mind-body interaction rather than just trying to statistically account for it. A body of research does exist.
It would be better and more ethical to compare a new treatment with the best of the old treatments to see if there is an an improved effect. People should not have zero treatment for the sake of a test.
As for the signing up part and understanding the risk of no treatment: The is a principle of contract law which I believe applies here; "unconscionable provision." The classic case involves a large gasoline company and a service station owner. Even though the owner had signed a contract, an onerous provision was found not to be valid by the court, because of the vastly unbalanced power that the gasoline company had to force anyone who wanted to be a retailer to sign an unfair contract.
It seems to me that in a life and death situation, when a person is desperate to have life saving treatment they will sign anything. The fact that they are aware that they may receive no treatment at all is not an excuse for unconscionable neglect even if it is for the sake of "science." With respect -Joel
Good point Joel, if there is a generally recognized efective treatment and the new treatment (e.g., a drug) is only an improvement, none of the study participants should receive a placebo. Half should get the best current treatment and the other half the new treatment, and a statistical comparison should be made to prove or disprove the relative quality of the new treatment.
However, in the case you mentioned from "Boston Law", you said both the Prominent Person (PP) and the Non-PP had cancer and signed up for the new treatment test. I assumed they both had an inoperable form of cancer and the alternatives of chemo and radiation had been exhausted.
Why else would the PP sign up and use his influence to get the new drug while (presumably) abandoning further treatment using current menthods?
Ira Glickstein
PS: Has anyone seen the whole episode? What happened? If I were writing it, I would have the doctor who accepted money under the table from the PP to give him the real drug be the very same doctor who faked the animal testing that falsely showed the drug was safe and effective. Poetic justice!
I asked my wife Vi if she had seen that episode of "Boston Legal" and she had not, but she had two points to add to our ethical discussion:
(1) If the Prominent Person knew he was on the real drug, that would invalidate the purity of the "double-blind" test methodology. Neither the patients nor their attending physicians should know if they are on the real drug or the placebo because that could change their perceptions of the success of the real drug. In general, knowing you are on a new drug will enhance the perceived benefits and make it more likely the patient and the doctor will report that it works better than it actually does.
(2) Placebos are ethical and necessary even if there is an existing treatment that is somewhat effective, as long as the patient signs a paper saying he or she knows they may get the placebo. If a study is done of the old vs new drug, the doctor and/or the patient will know which they are on. That will raise perception issues that will probably favor the new drug.
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My opinion differs from Vi's on the use of placebos. If there is a currently accepted treatment and it is still possible that it will be beneficial for a given patient, I think it is NOT ethical to take them off of it and put them on a placebo for the sake of the purity of the test. I think they should keep half the people on the old drug and put half on the new drug and use that for comparison. They may want to adjust the statistics a bit to compensate for the perception issues that favor the new drug.
Ira Glickstein
Joel responds: Here's an excerpt from an interesting website discussing placebo ethics (http://www.childrens-mercy.org/stats/plan/placebo.asp) It demonstrates that the ethical considerations are very variable. It seems to me that a lot of studies I've seen just routinely use a placebo as a statistical tool without much thought to other alternatives. At this point we should have enough data about placebos to define classes in which they are and are not of significance. For example, they are significant in analgesic studies. They aren't much good for severed spinal cords. -Joel
Excerpted material: Others believe instead that is the individual doctor's beliefs and not community consensus that determines whether a trial is ethical.
An ethical physician must do what is best for his or her patients. She cannot participate in a controlled trial if she is certain that one arm is superior to the others and that some of her patients will receive an inferior treatment by participating in the trial. It does not matter whether her certainty is based on formal scientific studies, on personal experience, on anecdote, on tacit understanding, or rules of thumb. Whether her certainty is in accord with or diverges from the view of the medical community is irrelevant. Uncertainty is a moral prerequisite for a controlled study. If we know what we should do, we should do it, not study it. Controlled studies are possible and necessary, however, because even though clinicians usually have hunches that one treatment arm is more effective than another, they are often not certain that their hunches are correct. The boundaries (confidence interval) on their hunch may range from much better, through marginally better, down to ineffective, or even frankly harmful. When this is the case "it is time for a trial, and that trial is ethical." -- Wejer et al (2000).
A patient can be entered if, and only if, the responsible clinician is substantially uncertain which of the trial treatments would be most appropriate for that particular patient. A patient should not be entered if the responsible clinician or the patient are for any medical or non-medical reasons reasonably certain that one of the treatments that might be allocated would be inappropriate for this particular individual (in comparison with either no treatment or some other treatment that could be offered to the patient in or outside the trial). -- Peto and Baigent (1998).
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