Outsourcing Clinical Trials

Iaşi, with a population of 320,000, lies in the Moldavian region of Romania. Mégrine is a town of 24,000 in northern Tunisia, on the Mediterranean Sea. Tartu, Estonia, with a population of 100,000, is the oldest city in the Baltic States; it is sometimes called “the Athens on the Emajõgi.” Shenyang, in northeastern China, is a major industrial center and transportation hub with a population of 7.2 million.

These places are not on anyone’s Top 10 list of travel destinations. But the advance scouts of the pharmaceutical industry have visited all of them, and scores of similar cities and towns, large and small, in far-flung corners of the planet. They have gone there to find people willing to undergo clinical trials for new drugs, and thereby help persuade the U.S. Food and Drug Administration to declare the drugs safe and effective for Americans…

Increasingly, companies are doing 100 percent of their testing offshore. The inspector general found that the 20 largest U.S.-based pharmaceutical companies now conducted “one-third of their clinical trials exclusively at foreign sites.” … A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000. In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials.

Full article on the dangers in overseas outsourcing of clinical drug trials.

Comments (8)

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  1. Neil H. says:

    What’s wrong with outsourcing clinical trials?

  2. Larry C. says:

    Voluntary exchange between two consenting adults. What else do you need?

  3. Bruce says:

    I agree with Larry and Neil. What’s the big deal?

  4. Devon Herrick says:

    I don’t have a problem with clinical trials performed off-shore. Outsourcing drug trials is primarily due to the FDA requiring larger (longer) drug trials with bigger populations. Firms cannot afford the cost of domestic trials with the populations required to gain approval.

  5. Tom H. says:

    It’s called free trade.

  6. Virginia says:

    I think the big moral concern is that these people might be forced to take dangerous drugs because they have no other way of making money.

    I certainly think that it is a concern. But, I’m not sure what should be done about it. On the one hand, they wouldn’t have the money (or the medicine) if they were working in a factory. On the other hand, their freedom of choice seems a little more limited: drug trial or eating? It’s not a real choice.

  7. Dennis says:

    There are always risks with clinical trials. If a particular drug is known to be safer and/or more efficacious then a trial is not required. Having said that, the people enrolled in a trial have an opportunity to receive treatment for a condition that may be more effective than anything currently available. Indeed it is generally shown that patients in clinical trials get better care overall even in the placebo arm because of the close observation for adverse events. If the FDA is as critical of overseas trial as they are of domestic ones, I suspect the subjects involved are getting far better care than they would otherwise in their home country.

  8. Bruce says:

    Also, I thought these companies used prisoners. Does that still happen?