Friday, March 17, 2006

Titled:      Human guinea pig 'in coma for a year'

As we read of things going wrong on another medical trial, it is time to consider the methods and motives behind the use of human volunteers for medical testing. Drug development is a costly and time-consuming affair and this is often used as a defense for the cost of drugs when they reach the consumer.

Pharma spend many years sifting through existing compounds and creating new chemicals to search for likely candidates. This is followed by lab testing and further study to weed out the most promising candidates. The next step is usually animal testing, which is conducted under great secrecy and security and finally human trials. These come in two flavors: firstly, tests to see which level of dose is safe to administer, which is done by giving increasingly higher doses to healthy volunteers until adverse side effects are seen. Secondly, it is given to those volunteers with the targeted disease or condition, to see how effective a cure or treatment it is.

With increasing pressure to reduce animal testing and political moves to reduce the costs of drugs, it is more likely, not less, that drugs will be tested on humans earlier in the process than traditionally done, despite careful oversight.

In this case everything looked great up until the time human dose testing began:

"Now we're being told that Ryan might be in this coma for six to 12 months. He can't even breathe on his own."

Yesterday it was reported his head had ballooned immediately after being given the drug and his limbs turned purple.

The previously healthy men had volunteered to test a drug designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.

Dr Suntharalingam, clinical director of intensive care, said: "There is an inflammatory process going on that seems to have been triggered by something."

I would guess that "something" that caused his head to balloon and body to turn purple would be closely linked to the administration of an experimental drug?

We need more treatments, we need more volunteers and we need the best testing procedures available to make sure drugs are safe and effective.

Putting undue pressure on drug companies is not going to make it any easier.


Posted by Dave