Friday, January 25, 2008

Clinical Trial Inquiry

On Tuesday, I met with West Clinic, an American cancer treatment and research center with an office here in Singapore. They contacted me about participating in a clinical trial. It turns out that I'm not eligible for the trial, but I got a chance to ask a few questions.

The trial is for the drug Avastin, which is used for lung and colon cancer. Genentech, the company that makes the drug, recently tried to get it on the market for breast cancer as well. But in December last year, the U.S. Food and Drug Administration (FDA), rejected the use of Avastin for breast cancer.

The committee said Avastin slowed down the progression of cancer, but it did not improve overall survival rates. And patients taking the drug suffered more toxic side effects than those who did not. Worst of all, five of the 363 patients in the trial died from the drug itself.

So why is this drug that's been rejected by the FDA in the U.S. being tested again here in Singapore? And are the patients who volunteer for this drug trial going to be told that the drug has killed five patients and that the FDA has rejected it?

I asked the clinical research coordinator these questions and she said the side effects warnings are on the drug label. But she conceded that the drug label doesn't say the FDA has rejected the drug or that five patients died during the clinical trial in the U.S. She said volunteers would be told, but I'm not convinced that they will. I think I'll have to talk to my oncologist about this and see if she can find out for sure whether the patient volunteers are provide with all this information.

The volunteers for this trial are going to get two years of this cancer drug for free. These volunteers will be Stage IV breast cancer patients. This means the trial will probably attract women who are desperate for a chance at life and who have little money to spend on their treatment. And, most likely, not terribly well educated. This type of study seems to prey on uneducated, poor, desperate people.

I have no problem with doctors and researchers taking risks with patients' lives. This is unavoidable in cancer research, where so much is untested. But I absolutely insist that patients are given all the information they need to make intelligent decisions about their participation.

1 comment:

areillyus said...

Shin - I don't read your blog all the time but happened to try this evening. Part of my job at the hospital has been involved with research projects. It's my experience that each candidate has to read an informed consent form which lists all the possible risks involved in the study. The consent form for our project re to Alzheimers Dis was about 14 typed pages long. I would prefer to think that even outside of the US, research projects must have detailed consent forms that anyone in the project must read and sign. Another issue to consider is whether the deaths were the result of other complications of the person's illness or other conditions the person may have had. If they didnt do research on drugs not appvd by the FDA, would Herceptin have been available for you in Singapore when you needed it and wouldnt have gotten it in USA.
I'm sorry your illness has turned into such a drawn out struggle. Sometimes I feel guilty that I am so healthy when I hear about all the others I know right now who are having such difficult struggles. If ever I can do anything, please let me know. And thanks for the pleasure of babysitting your children, They were a delight. Take good care. Alice