November 18, 2000
Clinical Trials Are Needed
Love both of your articles from patient and doc point of view - sorry I didn't have time to respond to your question but thanks for asking. Think both sides very well done. Only thing I would have added is that the FDA will not allow any new drug to go on the market with out a clinical trial.
No antibiotic, no arthritis medication, no diabetic drug, no cancer drug - no drug will be available - with out first going through a clinical trial.
All new drugs can have problems - so all clinical trials carry risks - but cancer trials are the most dangerous at this point in time because we are still really only testing cytotoxic drugs which by definition kill cells. No person without cancer would ever take them.
I still am not sure if even cancer patients should - you would be a better spokesperson for their benefits then me. I do know that new cancer treatments can't be made available to the public with out going through trials. Phase one is of course the most dangerous because the whole purpose is to find the level that causes more harm than good. Someone is volunteering to provide that data.
With out that volunteer the drug will not be made available. The FDA decided it is better to subject a small number of people to this danger than to put drugs on the market with out this information. If that where to happen, many people would die because the Dr. would not know how much drug to give. On the other side they are also finding out the smallest amount of drug to give to achieve a positive benefit. Without that number people would be taking drugs and suffering possible side effects but no benefit, because not enough drug was given to help.
It would be wonderful if all of this could be modeled on computers but right now we don't know how to do this. Maybe T. will be the one to figure out how to simulate a persons absorption system while picking up toxicity's to cells and organs?
I loved both of your articles because they point out how very important it is to remember that a very sick person is volunteering to take a very toxic treatment and needs allot of emotional support as well as very close medical monitoring. The systems in place do not allow enough money to make this possible.
Maybe advocates need to push drug companies to pay Dr's even more, with specific guidelines that it will be used to hire more medical and emotional support staff for the patients in the trial.