I was wondering about medical research. Because of medical research we have advances in medicine and many cures, but it presents a danger to the people that participate in the research so:

1. is a person allowed to participate in medical research as a participant?
2. is a person allowed to conduct medical research - putting others in danger for the greater good?

Well today we have the helsinki protocols which is required for all medical research which requires informed consent.

The basic question is if cruelity to animals applies to humans. Since jews are voluntarily allowed to cause themselves suffering like fasting and immersing in ice cold water for religious reasons or money, then it appears that animal cruelity does not apply to humans since he can make a value judgement whether he wishes to suffer or not.
The question of medical research is first a matter of risk. If the risk is minor and their is benefit to other's health, it is permitted (how much risk is involved in cosmetic surgery is one of the determinants if is permitted). If the risk is major, the beneficiary must be known and in the immediate area. Donation of blood samples or urine samples (helsinki accord) would be permitted since the risk is mininal. Donation of a kidney is permitted if only if the recipient is immediately available.
If you are paid it is like any other job with acceptable risk. In the talmud people were permitted to do dangerous jobs like climbing out on tree limbs for money.
As for performing medical research on humans within the helsinki accords, Judiasm requires that the doctor is trained in what ever procedure he performs. The procedure in his hands at least three times.

Aryeh Shore

thanks for the answer aryeh.

How much risk is considered ok? Is one allowed to take more risk if one is getting paid for it?

Another question i have, is one allowed to be a firefighter - putting oneself in danger to save others? If yes, why? Doesn't it say 'chayecha kodem?'

quote:

Originally posted by Gila:
thanks for the answer aryeh.

How much risk is considered ok? Is one allowed to take more risk if one is getting paid for it?

Another question i have, is one allowed to be a firefighter - putting oneself in danger to save others? If yes, why? Doesn't it say 'chayecha kodem?'

Dear Gila,

Our rabbis were very reluctant to restrict the ability of people to make a living. Most people were poor and not having a way to make a living would endanger their life. They did not therefore object to dangerous jobs.

Risk is of course an estimation. For estimations, the jewish law requires using an expert, in most cases a doctor. More than one expert can be consulted and if opinions disagree and there is no consensus, then is up to yourself to decide. Possible loss of a limb would be the most clear criteria. This applies to military and political decisions as well. Whether a person can refuse a treatment, e.g., not eat on yom kippur in spite of the doctors advice, is a case by case decision.

However, we have one category where we ignore risk or pikuach nephesh, that is the army. Obviously, if the torah permits warfare (we are not pacifists), then there are situations were the individuals safety becomes a lesser consideration. This would probably also apply to firemen but I haven't seen it spelled out. The classic case is if a civilian can risk his life to save others. This, as we say, has used up a lot of ink and paper. However, most people cite the suicide of Saul so his men would stop fighting unnecessarily would indicate that it is permitted in some circumstances.

Aryeh Shore

Having worked in both basic research and clinical trials (please note, I no longer work in either area for a reason) that the risk one doesn't know may the risk that gets you. Laypeople and society often trusts the integrity of major researchers to give them the full scoop. Let me tell you ... where multimillions in dollars and deals are concerned, trust no one.

the race to patent rights often overrides the right to informed consent for "human subjects"

sorry to post again, but I just wanted to clarify my last post with the phrase - "fully" informed consent

Let me echo Lori's concern;
Today we have Institutional Review Boards that preside over what Aryeh is calling Helsinki Protocols. These institutional review boards take investigators through a rigorous process to make sure that the subjects' interests are covered.
I once had to appear before an IRB for an Insulin (Juvenile)Dependent Diabetes trial. The fact that it involved minors required an additional layer of oversight, even though I was not doing anything invasive with them. This additional layer was a bunch of attorneys and issues of confidentiality etc. So a lot of rigor goes into it.

However, the reason we are doing a trial is because we are trying to find out something. That means we are "ignorant". So giving informed consent is really a stretch for most subjects. The best people to give informed consent are the investigators and doctors. Characteristically, they minimize it when recruiting subjects. Often, as Lori hinted, information is not divulged, that can harm a subject/patient years in the future. Dethylstibesterol is a good example. Women exposed to it "in utero" showed up with vaginal cancer 25 years later. Pharmaceutical companies are seldom forthright. They tend to minimize findings that shouldn't be minimized.

So Jewishly speaking is this a limb? I don't know. Would I do it? I would stay away from clinical trials of substances. Unless they are known to be benign and have been in use for a long time and only a new use for them is being investigated. Otherwise, I would stick with epidemiologic studies that evaluate and measure or procedural trials etc.

Having said that; if the trial is on terminal cases of a given condition that's different. You might just save your own life in situation like this.

I think many of the medical investigators involved in the field trials working with actual patients do an excellent job of providing informed consent - with the information they themselves have been provided by the pharmaceutical company. That is not where my primary concern lies. Don't think there aren't data doctors who work the data for the benefit of the company, not for the safety of patients. Vioxx is not an isolated case. Drug candidates that cause cardiovascular collapse in 60% of the animals of pre-human phases of clinica trials can still be pushed through to human clinical trials if a major patent right that could save company from a merger is at stake. How would a medical investigator know that kind of inside data unless a pharmaceutical company gave it straight up to them?

There are medical doctors and there are data doctors and the aims of them are not the same.

The medical world in the US has become incestuous. I've been both a clinician and a researcher. And both sides have very good people and bad people who are "on the take" from pharmaceutical companies. It doesn't matter how highly regarded a physician or researcher may be, money comes from pharmaceutical companies in different ways...from funding of research, to junkets to being co-opted into representing and giving lectures, to supporting residents etc. There is a lot of money involved. I have personal colleagues who ended up leaving their practices to work for the pharmaceutical companies. Pharmaceutical companies start with us in medical school, through residency and beyond. Is what they do bad? It's business. It's unfortunate that it takes this much to bring drugs to the market but much of the blame lies with the consumer's expectations. We receive a lot of free samples from drug reps. There are many elderly people who rely on these for their medications. That's a good thing, but it's done the wrong way.

I'm of the view that if it does not hurt anyone it's okay. But invariably it ends up hurting someone because someone got too greedy and hid important information.

About Vioxx; I think the lack of safety has been overblown. The risks associated with Vioxx had been articulated as with any other drug. Vioxx showed problems like other cox 2 inhibitors about which every physician warns a patient when prescribing and with which every pharmacist includes a checklist when dispensing. If Vioxx is found to be the bad drug it's supposed to be, we are all in big trouble because the same can be done with Tylenol or Aspirin. No drug is benign, but most of us have come to expect them to be. Dose and physiology for a rat do not necessarily extapolate to humans linearly. Heart collapse in 60% of rats could be simply due the dosage not physiologically appropriate for rats. Pharmacodynamics for the rat are quite different from human. The physiology of rats cannot be extrapolated to humans in a linear fashion. No drug is tested on humans only after rat studies. An appropriate animal model of a higher order has to be used. Many drugs used for humans will kill many animals at the right doses. In fact, we used rat poison in humans to prevent blood clotting. That could be a very good reason NOT to use it in humans but it's the very reason we use it in humans. The ace inhibitors used for blood pressure and heart failure was originally derived from snake venom...etc. So the fact that a rat has untoward effects from a drug does not mean it's bad for humans.

These weren't rats and the safety issue had nothing to do with pharmacodynamics. In my example, the safety issues causing the cardiocvascular collapse (in higher animals, including primates) were 2-fold: contamination and construct. The particlar drug candidate I am have in mind was a construct of recombinant genetic technology. The former issue could be easily dealth with. The latter required more investigation before moving on to human clincal trials. And I will leave it at that. Everything you say is true.

Lori;
I'm sorry, I thought you had said rats, but on examining your post you simply said animals. ooops!

No problem. I just didn't want to say too much more about the specific issue I had in mind - for legal/ethical reasons.