Ethics and "the Good of the Many..."

Polio vaccination in the 1950's

There are some interesting articles around on "ethics" - in particular the ethics of what you would experiment on with humans if there were no ethics.

First of all, what does that mean "experiment without ethics".

Well, for one thing many experiments, such as testing the toxicity of various chemicals or injecting humans with viruses modified to perform certain functions, is never done on humans because it might harm them.

So they're done on rodents instead.

So I started to think about this.

What about something like a polio vaccine?  What about the discovery of vaccines in general?

Without violating ethics and trying something on humans never done before we would not have these things.

On the other hand things like new drugs are tested, at least in my opinion, at almost an amateurish level before being released into the wild where they cause serious problems.

Take Vioxx (and Celebrex) and the way it increases risk for heart attach (see this on Celebrex).  These drugs were approved by the FDA in the late 1990's. 

After the drugs were released clinical studies began (see this PDF) to determine if there were significant side effects.  A study, run immediately after Vioxx's approval, discovered that out of 8,000 patients, 50% taking Vioxx and 50% not in a blind study, there was a significant increase in cardiovascular events in those taking Vioxx.

Talk about closing the barn door after the horses escape.

Now how is this ethical - to perform tests on humans with an unknown toxic substance?

For one thing, if you read the history of this you will see that in the case of polio money was not the primary reason for the release of the vaccine.  Prior to its eradication polio was a serious killer - as a child you often saw pictures of kids on crutches or in "iron lungs". 

However, the rise of polio in the 1900's may have been due, ironically, to improvements in sanitation.  Prior to the 1900's polio antibodies were passed between mother and child through breast milk providing infants immunity - even though they were commonly exposed to the polio virus through poor sanitation.  As sanitation increased and breastfeeding decreased infants were left exposed to the virus.

Jonas Salk developed the first polio vaccine (there are actually three types of viruses and several different types of vaccines) at the University of Pittsburgh starting in the lat 1940's.  As far as I can tell, unlike Vioxx, for example, it was not developed in order for the University to make a profit (though it undoubtedly did after the fact).

In think few would argue that the introduction of the vaccine for polio was a mistake.

So what was the role of the FDA in the polio vaccine era?

According to its own web site this: The hiring of 48 investigators to ensure that no black market vaccines were produced.  Something which required (the hiring) congressional approval.

So it seems that the ethics model has changed quite a bit in the last 60 or so years. 

Polio vaccines were developed at universities and were based on research interests for the good of everyone.  Things like Vioxx are developed by businesses in order to make money.

The FDA worked to ensure that polio vaccines were not created on the black market.  Today the FDA approves things like Vioxx for reasons known only to them and then lets the companies who make it conduct post-release studies to see if the drug is safe (which it obviously is not).

Where did we as a country go wrong?

I think the FDA link says it all - 48 investigators to insure that face vaccines for polio were not being made.  That was their job.

Today the FDA's job is not so clear cut, nor is the process, nor is its ability to distinguish between good and bad.

Do we imagine that Salk was concerned over the risk of widespread use of his vaccine?

Of course (see this).  The initial trial involved some six hundred thousand school children.

I think that today there is an unholy alliance between the FDA and "big pharma".  I believe that the clinical trial model used by the FDA is far, far too simple in terms of the testing it performs before drugs are released.

While some argue that the FDA is too restrictive the problem there is one of responsibility.  If I use an experimental drug and something bad happens who's fault is it?

The fundamental "ethics violation" here is A) the replacement of "the good of humanity" with "money" by big pharma, and B) the implicit blessing FDA gives that substitution.

Did Vioxx kill some 55,000 people as various sources allege?

Where those deaths worth the "reduced pain" experienced by the remaining millions of Vioxx takers?

This is the real ethics question.

If one child dies a horrible death because of a pool drain cover outrage ensues requiring an entire industry to retool for a accident caused by other factors (the fact that no one was watching the child).

Yet in the case of the FDA and big pharma most of this goes by as just another news story...