Globalizing human experiments

    India, China, Ukraine, and others have become appealing trial sites to pharmaceutical companies.

    Every drug that gets approved has to go through lengthy and expensive human clinical trials. These experiments can last years and cost tens of millions of dollars. Like many American industries, pharmaceutical companies are now doing more of this work overseas. WHYY’s health and science reporter Kerry Grens looked into the trend. (Photo credit: e-magic/flickr)

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    Pharmaceutical companies often pay other companies to handle human clinical trials: recruiting patients, handling paperwork, making sure everything meets regulatory standards. MediciGlobal in King of Prussia has been in this business for nearly twenty years. Company President Liz Moench says seven years ago, 100% of the patients she enrolled were American.

    Moench: Today, about 50% of the clinical trials in which we work are global, and 50% are US based.

    India, China, Ukraine, and others have become appealing trial sites to pharmaceutical companies. A main driver of this trend, Moench says, is the difficulty of finding American patients who qualify for certain experiments.

    Moench: Sometimes the regulatory agencies are asking for studies to be conducted in patient populations where they’ve never been exposed to any therapy at all.

    Cost is another reason to go overseas.

    Schulman: Physicians in other markets make less money than they do in the United States. Hospitals might be less expensive.

    That’s Kevin Schulman. He’s a professor at Duke, and he recently wrote an article in the New England Journal of Medicine airing his concerns about overseas trials.

    Schulman: We don’t know at this point if drugs are developed around the world, whether they’re going to work the same in the United States. Whether the patients who are included in the clinical trials are as sick as the patients who might be getting that same therapy in the United States.

    Other researchers and advocates have raised concerns about how the Food and Drug Administration last year relaxed ethical standards for overseas clinical trials. Steve Zisson is the editorial director of Center Watch, a trade publication for the clinical trials industry. He says in 2007, 34% of trials were conducted overseas – and the number is rising.

    Zisson: It’s been going on for 10 years and it’s also, in our opinion, a desirable phenomenon.

    Zisson says the globalization of clinical trials will continue, in part because it helps get drugs approved for patients in the U.S. faster and cheaper. So US-based clinical trial companies need to respond to stay competitive.

    Zisson: If a particular company wants to do well it really has to have the global scale to meet the demand of pharmaceutical companies who are going overseas to do these trials.

    Moench at Medici says there will always be a need to do clinical trials in the US, especially for niche markets like orphan illnesses, which only affect a small number of people.

    Moench: You’ve got a number of companies that just do that in the US. And that’s not going to necessarily change.

    There’s also a rich source of patients available right here in the Delaware Valley, says Steven Glass at CRI Worldwide in Willingboro, New Jersey. Glass is the psychiatric medical director at CRI, which recruits and treats local patients in clinical trials.

    Glass: You’re talking about populations of well over 5 million. From rural to hard urban from communities with very young children to retirement communities.

    Glass says finding patients is easy, but competing with overseas trial sites is the company’s challenge. And it has had to adapt.

    Work harder, diversify, have more in the pipeline because the certainty with which a certain trial will get executed is less than it was five years ago.

    The competitive picture will only get worse. With imminent mergers of pharmaceutical giants such as Pfizer and Wyeth, and Merck and Schering-Plough, the industry analyst Center Watch predicts a tougher market ahead for American clinical trials.

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