The Problems With Drug Testing 166
gallifreyan99 writes: Every drug you take will have been tested on people before it—but that testing process is meant to be tightly controlled, for the safety of everyone involved. Two investigations document the questionable methods used in many studies, and the lack of oversight the FDA seems to have over the process. First, drugs are increasingly being tested on homeless, destitute and mentally ill people. Second, it turns out many human trials are being run by doctors who have had their licenses revoked for drug addiction, malpractice and worse.
Nonsense (Score:2, Interesting)
Look, none of this is common place. It's very rare. Why? Because if this happens, then the multi-million dollar trial you paid for is worthless and would have to be redone. I'm working on setup of the data handling for a phase 1 clinical trial right now and there is no way in hell we would let a doctor with issues (ethical or otherwise) anywhere near the trial. Any data they collect would be suspect and could not be used. Homeless person that is taking a lot of meds already? I don't think so. I don't want to deal with trying to figure out which drug was doing what. Ideally, they would only be on our drug or a placebo (sugar pill), nothing else. Bottom Line: There is just too much money tied up in an already risky clinical trial to not do it right.
True (Score:5, Interesting)
So my mother has a Ph.D in experimental psychology and knows a thing or two about how to design experiments, how to avoid systematic bias, how to distinguish that from random error, and in the admittedly non-objective opinion of her son, is quite sharp about identifying sources of those in methodologies. After raising three children she tries to restart her career. At first the only work she could find was a lowly temp job entering survey responses from a drug trial into a database. Turns out that the forms completed by the doctors and patients surveyed left answers to many questions blank. So how is she instructed by those managing the data entry to handle those cases? She is told to systematically select particular answers to particular questions. And which answers? The answers consistent with the drug being effective and harmless.
Now you do not have to be a Ph.D. to spot a problem with that. Hell, my German Shepherd could probably do that. But maybe as a scientist herself the violation of scientific integrity stung too strongly and my mother insistently raised complaints within the company. And how far did those go to correct the "mistaken" guidelines for data entry? Absolutely nowhere.