Hawking Up Hairballs

Tuesday, December 16, 2008

We Don't Need No Stinkin' Clinical Trials

"The U.S. Food and Drug Administration plans to use new computer technology to simulate how some drugs in development are supposed to work, helping researchers and regulators spot safety and effectiveness issues before late-stage tests on humans are completed.

"Entelos Inc., a Foster City, Calif., company that has developed the technology, said it will enable researchers to obtain computer-generated test results in a matter of days or weeks, compared with years required for most major clinical trials. Far more 'simulated patients' also can be tested than in conventional human trials."

The above item comes from The Wall Street Journal. I found it on the Pharmalot web site. My eyes fluttered when I first read it. That couldn't be right, I thought, and I went to get my caffeinated beverage of choice to help wake me up so that I could see straight. I sat down at the computer and read again. Damned if I hadn't gotten it right the first time, and it was indeed the Pharmalot site. I hadn't inadvertently found my way to a satirical Onion page. The FDA is indeed going to simulate the testing of drugs on a frigging computer. The Pharmalot folks went on to explain.

"Entelos says its technology, called the Cardiovascular PhysioLab, uses a mathematical model to simulate how cholesterol functions in the human body and how deposits of fatty material called plaque develop in the artery walls and become prone to rupture, the Journal writes. By running certain chemical characteristics of drugs through the model, the hope is to be able to predict whether the compounds might cause cardiovascular problems and, if so, in what types of patients."

You don't have to have a degree from Harvard Medical School to see what bullshit this is. The mathematical model referred to above was developed by people based upon our current knowledge of how cholesterol functions in the body. Uh-huh. Like we have a complete understanding of the biochemistry of cholesterol, as well as any other compounds that might interact with it in the body. Not only that, but someone in the Pharmalot's comment section claimed that he'd been involved in the development of such products and that they were skewed toward the assumption of safety. Of course they are. Don't get me wrong. Software like this could be valuable, but it's proper use is in research. For example, it could be part of the decision process in trying to decide whether or not to proceed to clinical trials. However, to use such software to substitute in any way for clinical trials is not only irresponsible, but reprehensible.

I have two guidelines that I use when deciding to accept a drug prescribed by a doctor. One, I won't take it unless it's been in widespread use for several years so that any nasty side effects have had a chance to become apparent. Two, I do as much research as I can to determine whether or not I think the drug is effective and safe. The fact is that you can't just take your doctor's word for it when he or she suggests a prescription. You have to do your own due diligence, and don't be afraid to tell him or her that you don't want that new drug that's just hit the market. In most cases, there older and better understood alternatives.


Blogger David Matthews said...

Good points. No matter how low you set the bar, some folks will try to slither under it when there's profit to be made.

11:32 AM  

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