Participating In A Clinical Study? You're On Your Own

The FDA’s own parent department, the Department of Health and Human Services, just issued a report that says the FDA “does very little to ensure the safety of the millions of people who participate in clinical trials,” according to the New York Times. The FDA has 200 inspectors, some of whom are part-time, to monitor 350,000 testing sites—and even when they reported “serious problems,” their findings were downgraded 68% of the time by higher-ups in Washington.

The chairman of the department of medical ethics at the University of Pennsylvania says, “In many ways, rats and mice get greater protection as research subjects in the United States than do humans.”

Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said. Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been.

The Times article offers a quick, horrible illustration of where the lack of oversight can lead. A woman who agreed to an experimental drug treatment for bipolar disorder signed an agreement that said she could leave the study at any time, then was held against her will when, three days before the drug was to be administered, she tried to drop out. Her lawyer had to go to court, obtain a writ of habeas corpus, and then track down the doctor at another location because the staff wouldn’t let him serve the writ at the hospital. In the meantime, the woman was given the experimental drug anyway. Incidentally, this same doctor gave genital herpes infections to two other patients.

“Report Assails F.D.A. Oversight of Clinical Trials” [New York Times]
(Photo: Getty)

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  1. CumaeanSibyl says:

    So what this means is, we need an activist group to watch out for the rights of humans? Call it PETP — People for the Ethical Treatment of People.

    I’m no fan of PETA and Friends, but if their agitating has made animal subjects safer than human subjects, they must be doing something right.

  2. Dead Wrestlers Society says:

    I used to work with a guy who wasn’t the sharpest knife in the drawer. He was a bit quirky and had a lot of odd mannerisms. A few months after he was hired I found out in casual conversation that he volunteered for a lot of clinical studies in college to make money. Case closed.

  3. It’s nice to know that given the choice the government would rather treat it’s citizens with less regard than rats. Because, you know, it’s easier than doing the right thing.

  4. chinadoll724 says:

    If you’re going to do one, make sure it’s at a large hospital. I sat in on plenty of institutional review boards, which are required for any study/experiment involving human subjects, and the 3 hospitals that I sat in on were all pretty thorough in looking at the studies. I have to agree that it’s not close to perfect. They rely heavily on what the researchers/doctors tell them as they don’t have the manpower to do many inspections and how heavily things are discussed lies a lot in who is picked for reading over the study.

  5. synergy says:

    Considering I work for a doc that does clinical studies on bipolar patients, I think I should throw in that I’ve never known anything like this to happen. With him and all the other docs I’ve worked with are extremely paranoid about sticking to the letter of the law when treating with people. The people I worked with who handled mice and rats were more willing to do things that legally are now considered inhumane than the other people who work with people.