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by ikitat 6081 days ago
Ethics are not ridiculous. Randomized placebo controlled double-blinded studies have the potential to cause harm to humans.

A fantastic post on the issue can be found here http://www.sciencebasedmedicine.org/?p=467

1 comments

Well, let's keep things in perspective. We're talking about the ethics of asking some 1000 volunteers _not_ to get a flu jab in one winter. ([edit] not about nazi death camps as the article you posted does)

And I think it is ridiculously un-ethical to vaccinate hundereds of millions of people with a vaccine that has never been tested properly (and I mean the seasonal flu, not the exceptional swine flu situation). These people go out and take risks that may cost them their lives because they have a false sense of safety.

Did you read the article? The ethical issue is the fact that you are _not_ preventing a vaccine preventable disease.

What information do you have that the flu vaccine is not tested properly?

edit to your edit: You clearly didn't read the post I linked to above if you think it's about nazi death camps above the ethical considerations of randomized, placebo controlled, double blinded studies.

Look, I don't doubt that there are difficult ethical situations. But the flu situation is not one of them. The danger of not getting a flu jab just isn't severe enough to throw Dr. Mengele into the debate.

And to answer your question, I gather that seasonal flu vaccines have never been tested using a controlled, randomized, double-blind study. If that is not the case, then what are we talking about?

And I fail to see how it can be an ethical problem not to use a vaccine of which we don't know whether it prevents anything or not.

Perhaps an analogy would help:

Most car accidents don't kill people.

Seat belts have been proven as an effective defense against injury and death in automobile accidents.

It would be unethical to perform a study in which you ask humans to undergo a car accident without a seatbelt.

Anyway, that's how I understand it. I guess you could read up on the Tuskegee syphilis experiment, Belemont Report, Declaration of Helsinki and Nuremburg Code to learn more.

Making people not use something that is proven to prevent death and injury is unethical.

Making people not use something that is _not_ proven to prevent death and injury is _not_ unethical.

None of your examples for unethical procedures have any similarity with that second situation. The syphilis sufferers were not treated with penicillin even though it was proven to be effective. The nazis used prisoners, not well informed volunteers.

And your car accident analogy involves making people have accidents that they would not otherwise have, not using preventive measures proven to work. We're not talking about infecting people with the flu, are we?

I wanted to give a more thorough response, I was attending a birthday party earlier.

Remove "making people have an accident" from the car analogy and it is still unethical since seat belts are proven effective. In order to make the study double blinded with a placebo control you'd have to have something of a mock seat belt that fails to restrain the occupant in a crash or an abrupt maneuver.

The flu vaccine has been proven effective as well. The flu kills approximately 36,000 Americans a year. Therefore, a study which involves a placebo flu vaccine to determine who catches the flu and who doesn't is unethical, since those that received a placebo could potentially die or become injured. It doesn't matter if the study infects the participants or if they become infected by general human contact.

You may argue that the participants fully understand their risks and therefore a trial is ethical, but that is only part of the requirement. Again, you can find it outlined in the documents mentioned above.

don't shoot the messenger