Redefining clinical trials out of existence
This is my site Written by Alex on September 24, 2010 – 10:56 am   

I was flying home to Arizona from Charlottesville, VA when I read the story in the New York Times, New Drugs Stir Debate on Rules of Clinical Trials, about a controversy over using a trials drug to treat cancer patients. I had been in Charlottesville for my yearly overnight checkup as part of a clinical trial to cure diabetes. I had received an infusion of islet cells four years earlier and each year I returned to the University of Virginia and they ran more tests than they would on an astronaut. By the time I got on my plane my arms were black and blue, I had not slept in 36 hours, my blood sugar had spiked over 500 as part of the testing and I had nine hours of flying to get through before I could lay down at home.

That’s was partly why when I read in the NYT article that some cancer experts thought a new wave of experimental cancer drugs should be used for treatment before they’re approved I sat stunned. I read the article three times. “Experts” are actually arguing that patients should have increased access to drugs not yet tested and that this should be done on compassionate grounds. This article, by the way, came out a few days before the FDA decided to restrict Avandia, a drug that HAD ALREADY BEEN APPROVED because it increased the likelihood of heart attack

The very first time I saw the words “therapeutic misconception” in the New York Times was just one month ago. In an article by Gina Kolata, What to Tell the Patient After a Trial Goes Awry. “Most patients entering clinical trials believe they are getting a new treatment that may benefit them, Dr. Brody [director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine¬†said]said. Ethicists call that a ‘therapeutic misconception,’ he said, adding, ‘No one should ever assume that in a clinical trial.”

Gosh, ya think?

Like most media outlets, the Times treats trials as another medical option available to patients. This is because patients consider trials a medical option; as if they’re getting to buy wholesale rather than retail. That’s because doctors and researchers encourage patients to think of them as an option so they can recruit subjects to trials. It’s one vast belief but it’s not true. It’s built on statistics: If enough people believe it, eventually it’s true. I used to believe that truth was not statistical, that popularity didn’t make a thing real. And, of course, in an activity as rigorous about process and facts as medical research, truth was surely an inflexible concept. But after reading the NYT article I realized some researchers want the truth to be flexible, based on the whims of doctors and patients. And that’s a great way to make the truth disappear.

One Response »

  1. When you consider that the current clinical trial protocols don’t address the issue of long-term use of powerful pharmaceuticals for chronic conditions as it is, suggesting physicians should be allowed to bypass them altogether on “compassionate” grounds suggests to me that someone has a very odd definition of compassion.

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