Should we try harder to prevent humans from being subject to medical research experiments?

There are many pros and cons of testing medical therapy on human beings.
The best argument for, I think, lies in that testing drugs/procedures on the group of people who will actually be receiving that drug/procedure yields a lot more accurate result with a more realistic sense of potential side-effects. However, when testing stuff on humans, I suppose we undermine their autonomy and expose them to a lot of (potentially) unnecessary harm…?

So my question is as follows: if we know that few people actually benefit from medical research experiments (Therapeutic Misconception, Rebecca Dressler), but that the world benefits scientifically from testing on humans, SHOULD we do more to PROTECT people from being “ABUSED” in medical experiments?

I’d love to hear more of your pros and cons!

Thanks! I’m really not sure where I stand in this matter… :smack:

There is an argument form social contract.

If you have benefited from medical science, you have some level of moral obligation to repay.

There is probably a very significant misconception about the nature of, and the value of “medical experiments.”

It is impossible to logically progress unless there are human experiments. The only logical alternative is no human trials, and simply to bring a new therapy to mainstream use. This is a simple contradiction, these new patients are an experiment, since there is no clue that the therapy works, or what may go wrong until then. The logical conclusion is that no further medical progress can be possible.

Then what is this “ABUSE” ? We don’t round up truckloads of the poor and ship them off to some sort of gulag. Experiments are for the most part very carefully controlled, and are designed from the outset to do the absolute minimum hard. But, be clear, there are no certainties. The process may get messed up, or there will a totally unexpected bad outcome. We do not perform experiments where the intent is to gauge the harm done.

Without a clear idea what forms of harm are alleged to occur it is very hard to say much more.
and… reporting for forum change as this isn’t a GQ.

Well, for example, the amount of research projects which actually benefit the participant is very small. Again I refer to Rebecca Dressler. In many cases, the percentage of individuals recovering or improving their condition from a research experiment is virtually zero.

Also, when the experiment is conducted on very sick patients, in what could be considered ‘alternative treatments’ for some, MANY patients do not understand that the main goal of the researchers is to benefit FUTURE patients. No researchers explicitly want to benefit the individual patient participating - for example, if it is determined that a specific drug DID work for the patient, it might still be withheld from the individual after ended study.

This is what I meant with “abuse”. The participants are really not aware that they’re wasting their time and quite possibly also health for something which is not directly intended to benefit them.

So should we, as individuals, or governments, institutions or medicine in general do more to thoroughly inform the patient about the dangers and small chances of success, EVEN if this may impede scientifc progress?

Sorry for a long reply… Did you get what I meant? :confused:

Of only one thing am I certain here - the situation is better now than it was 50 or 100 or more years ago.

The biggest issue is informed consent. It is possible that some patients are will to be a human trial to benefit others (perhaps they feel it gives their suffering and eventual death some meaning if there is something to be learned from it), and some may be willing to gamble on a very, very small chance of success. That’s fine - provided the patients are truly informed and actually understand the circumstances. The biggest problem is effective communication.

Human experimentation is not all bad - my spouse is alive because of surgery that was experimental at the time of his birth (without it, his life expectancy would have been 6-8 weeks to maybe a few months at most). He walks because of additional experimental surgery. On the downside, he nearly lost his right leg to surgery that didn’t work out so well. He has on-going health problems from other surgery, some of which the doctors never asked permission to do or informed him or his parents of (which used to be allowed but isn’t anymore). Part of the problem was parents with little formal education, in poverty, with few resources and no medical insurance: “we’ll take care of your crippled child’s medical care for two years if you let us do X”. Coercion is a problem, and so it taking advantage of people in a bad spot. Likewise, terminally ill people in clinical trials - dying people are easy to take advantage of, intentionally or otherwise.

Now, a couple of the surgeries he underwent are routine for infants with his birth defect, and result in much better outcomes and lives than those people would otherwise have. Someone had to be first.

We need to reap the benefits of such experimentation and ground-breaking while minimizing the damages.

Which means it’s a complicated question with complicated answers and not a clear yes or no.

If no-one explained this, then they were negligent.

There is the social contract. If you have benefited from the results of experiments performed on others, why should you not wish to give back something. Maybe you don’t, and you are happy to be treated on the back of what others have put into society, but no-one is forcing you to participate.

Drug treatment trials are almost all double blind. What one does hera of are experiments with new drugs where the trial is terminated early because it is clear that the therapy is so valuable that it is unethical to withhold it from the group receiving the placebo.

Again it isn’t clear that patients are not so informed. Nor is it inevitable that the chances of success are small. Indeed I think it is rather naive to suggest they are relative to the risk and effort required. A clear example of what you consider to be a poor balance would be useful. Most people are happy to put back in to society. Whether a government should make efforts to encourage the converse on the back of an ill defined idea of a different balance of dangers/success. A bland assertion that the success/danger trade-off is poor, with no justification, isn’t going to do much to make people take interest.

By definition, the main goals of all research are always in the future.

Why would an efficacious drug be withheld from a sick person after a study had ended, when there isn’t even experimental integrity to protect? I’ve actually heard of the opposite: a study wrapped quicker than planned, when it was found that a treatment was making such a difference for the experimental group, it was deemed unethical to withhold it any longer from the controls.

Moving this one to Great Debates from General Questions.

samclem, moderator.

That seems like an inherent impossibility. Unless you abandon advancing medicine altogether, there always has to be a first time you use a new treatment on a human being.

There is a myth that humans have souls, and as far as I know, there is no scientific evidence to prove this (since this is a question about science), nor even a plausible argument in its favor. Nevertheless, this myth pervades the underlying approach to any scientific method that might be applied to medical research.

The soul is taken for granted from a very early stage of human development, and obstructs research on infants and even on foeti, which would otherwise have no conscious sense that anything extraordinary was happening to them. Life for all organisms is certain to expose them to a certain amount of discomfort, regardless of pampering.

The second part of your statement isn’t supported by the first. The concept of a soul has little to do with why medical experimentation on infants and fetuses is considered unethical.

I’d take issue with the notion that anyone is being “Abused” at all. I’m well aware that in the past there were places like Holmesburg Prison where the concept of consent vs. coercion was dubious, at best. Yet, as others have pointed out, medical ethics have been refined to the point where test subjects are probably treated better than at any point in history.

OP’s argument doesn’t make much sense to me:

What are you basing this on? In what way is their autonomy undermined? If they were informed of the risks and made a conscious, independent decision to participate, and have the right to stop participating if they choose, then how is there autonomy undermined? The only way we could say this is true is if they have *not *given their informed consent, which would be a violation of medical research ethics. You are starting from an unsupported assumption.

How so? In your own post you stated that testing yields more accurate results and that the world benefits from testing on humans. That doesn’t sound very “unnecessary” to me. The only way this claim holds up is if the chance of harming the patient exceeds the benefits of the research (a somewhat subject and hard-to generalize notion). Understanding the side effects of a drug is EXTREMELY necessary, and there have been disastrous consequences when a drug is released without adequately rigorous testing (re: thalidomide). Therefore, if a test subject is injured by the drug, but in the process we learn that an otherwise useful drug poses unacceptable risks, then that harm can hardly be called “unnecessary.”

This statement makes no sense. It is self-contradictory. You say “few people actually benefit” but in the very next clause you say “the world benefits.” The world contains about 7.3 BILLION people last I checked, so I would say “7.3 billion people actually benefit” from the research. And that’s not a number to be taken lightly.

From what I gather from your second post, you meant to say, “Few research subjects will actually benefit from the research they participate in.” And this is a good point. Even a great drug requires placebo group patients who will not benefit. If you have a better way to maintain a control group, let us know.

… according to who? Are you quoting Dressler here? Who says “MANY patients do not understand” the goals of research? Who says “No researchers” want to benefit individual patients? These are all unsupported statements. Unless you expect me to run out and purchase Dressler’s book, it would help your argument to summarize the supporting facts. Did a survey indicate many patients didn’t understand the goals? Did someone poll researchers to identify who they “want” to benefit?

Seconded. Well…thirded.

It’s a very interesting article written by her for the Social Philosophy and Policy Foundation, I believe. It’s not too long to read and definitely worth checking out if you’re interested in this topic.

I feel we do, to some extent, undermine patients’ autonomy when they aren’t truly giving their informed consent. I believe there are many patients who aren’t fully informed. Dressler lists the following about patients who participated in a psychiatric treatment in the 1980’s (as conducted by Appelbaum who coined the term “therapeutic misconception”, and who interviewed them prior to starting the treatment):
The amount of participants who failed to understand the randomization process (some get placebo, some the real deal) = more than 50%
Thinking research would be optimal for them = 33%
Unaware that placebo-drugs were included in the project = 44%
Thinking their dosage was individualized (in restricted-dosage studies) = 50%

Clearly a good amount of people aren’t giving their informed consent.

From 1 particular research project, hardly any of the participants benefit. I believe in the article, she claims that in a specific phase I cancer-related drug study, the chance of benefitting at ALL was about 5%. Naturally, when you have many experiments, the compilation of results is what aids researchers in discovering and creating new drugs.

Other than that, I completely agree with you, as well. I too would argue that human experimentation is necessary, but I was hoping someone would be very strongly against it just to hear how the other side would argue it. Very interesting thoughts, though! :slight_smile:

The first sentence is quite correct.

Assuming we are talking about sick people (not healthy volunteers in it for the money)…

It is fair to recognize that many patients will participate in a research trial ***hoping **to personally benefit from some wondrous new treatment. This will remain true even when the concept of control arms and placebos are explained. Many patients also harbor altruistic attitudes. (They may be paid small amounts of money for inconveniences, mostly to encourage them to continue whatever followup and testing the research protocol demands; too much money is frowned upon, as it is considered ‘coercive’ in its own way.)

However, in America, unless the drug is already FDA approved, once the trial you participate in (whether closed early or not), it is quite likely that you will no longer receive the study drug until it is formally FDA approved (unless somehow provisions were made for this in originally writing up the study- I’ve never seen this, although my experience is not vast).

*In modern studies, when a disease is deadly (eg cancer) and a treatment exists, the control arm is generally ‘standard’ therapy, not nothing. We are supposed to have moved past the old “randomized to death” protocols. But drug companies hoping to market new “me-too” meds that duplicate older treatments prefer placebo trials, because efficacy is easier to demonstrate than superiority to an existing treatment.

There have been significant advances in the consenting process over the past 20 years.

It is more common today to see expressions such as, “You may not personally benefit from participating in this research study.” rather than “Your participation may benefit future patients.”

It is more common to ask for the consenting patient to initial each page of the consent and you may see initials required for each subsection.

It is more common today to see at least some mention of the benefits accruing to the researcher from your participation, although this is usually rather light and hardly ever mentions financial arrangements.
The biggest problem is not that written consents withhold negative information, but that the consents can get long enough to daze the reader, especially if they are feeling desparate.
Which is not to say that every investigator will do a good job of consenting, even with a very good consent form…

“I’ve got this new study drug for baldness you should try. It could make your teeth fall out, but that won’t happen to you…” :slight_smile:

A quaick google of "Rebecca Dressler’ brings up a page of “Social Network” links. Adding “wiki” gets me all kinds of things.

This is probably NOT a published bio-ethicist nor a medical testing expert.

Why is whatever she has to say worth a debate?

I know three people who have been directly involved with human drug experiments. Two were experimental subjects for cancer treatments, and one was the lead researcher on testing an old drug for a new use.

One of the cancer patients got no benefit, and was perhaps made more uncomfortable by the drug. But he had known that was possible going in, had no chance of survival without the drug, and wanted to help expand human knowledge even if he didn’t personally benefit. Neither he nor his family felt he was mistreated by the experiment.

The other cancer patient benefited substantially from her access to experimental drugs. She ultimately died of the cancer, but lived longer than originally expected, with a better quality of life.

The lead experimenter had accidentally stumbled on a promising treatment for a previously-always-deadly condition. After seeing two patients improve, he organized a study. When the study was fabulously successful (most of the patients getting the active drug improved, none of the ones taking the placebo did) he agonized over how much data he needed to gather to make the results valid, and at what point it became unethical to withhold the drug from the other patients. He ended the study earlier than the published protocol had laid out, when he felt the data was significant enough to convince others. As the drug was an old drug, and doctors are allowed to prescribe drugs “off label” without waiting for explicit approval for a new use, all the patients in that study got the effective drug as soon as the study ended. Many of them benefited, and none were hurt by the study.

Maybe my experience is biased, but I am all in favor of carefully executed human drug experiments, so long as the risks and potential benefits are clearly disclosed to the subjects, and they agree. I am also grateful for all the past human experiments that allow me to take better drugs than existed in the past.

So no, I do not think we should we try harder to prevent humans from being subject to medical research experiments. I think we should make sure that human subjects are carefully informed, and that only subjects who give informed consent participate in experiments. But I don’t see that as a barrier to medical research.

As long as the subjects volunteer, and the risks are explained to them, I’m cool with experimenting on people. I mean, you have to for medicine to progress at all.

I do wonder if taking only voluntary subjects might skew the results. Like telephone polling, you’re missing everyone who doesn’t have a phone, and that group may behave differently in the study, if only they were included. Sampling bias, basically.

This is probably not a big problem at the outset of a trial, especially if selection criteria and randomization are handled appropriately. However, people do drop out of trials, and this is expected to more likely happen with “dissatisfied customers”. Many studies (but not all) try to correct for this.

Rebecca Dresser.