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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Sunday, September 30, 2012

The Dangers of Uninformed Reporting: Clinical Trials in Russia

It’s way too easy to say “never believe what you read in the papers.”  But on the occasions when I read or hear something about which I know more than the reporter—a recent general example being whether the individual mandate had been upheld or not, it’s disconcerting to see how much they get wrong because they lack any context.  This is an especially serious issue when reporters without a background in science, medicine or law rely on too few sources.  Here’s the most recent example.  In an article in Friday’s New York Times entitled, “Russians Eagerly Participating in Medical Experiments Despite Risks.”  The reporter, Andrew E. Kramer, who has been reporting on Russia for the Times since 2005, has written what amounts to a press release touting the wonderful advantages of bringing drug development overseas.   The direct subjects of the article are Russian citizens delighted to have the opportunity to enroll in clinical trials to test drugs for which they would otherwise not have access.   The testing of pharmaceuticals intended for use in the United States using patients in countries with less developed laws regarding quality, monitoring and human safety is a topic of intense discussion and concern in the popular press, legal, industry, human rights and bioethical communities.  And by concern I mean in the sense of there being  “concern” in Israel about the Iranian nuclear program”  The article explains how the Russian government  is encouraging pharmaceutical companies into the country to conduct these trials by requiring that drugs sold in Russia be tested in Russia.  The reporter never considers how odd that is---we don’t have that requirement in the US nor does Japan, Switzerland, New Zealand, or the like.

JSB  

 “The law” he reports “ has the effect of compelling investment in clinical testing on Russians, trade groups say.”  And indeed the entire article is based on information from “trade groups.”  The article’s primary source, is “John Lewis, the vice president for the Association of Clinical Research Organizations.”  The reporter characterizes Russia’s laws, like those in Singapore, as having “benefits both for the local population and for the drug companies, although the association does not endorse that motive.”  This last sentence seems to come from the industry representative who is then quoted as stating that “Clinical trials should be viewed as experiments, as investigations, not as treatment.” Apparently conditions in Russia are so good that “A host of pharmaceutical companies operate in Russia, including Bayer, Bristol-Myers Squibb, Eli Lilly, Novartis, Novo Nordisk and Pfizer.”   Seemingly oblivious to the context of the story, the reporter gets to what he may not realize is the heart of his subject:  notes that “The companies use the results of trials in Russia, as elsewhere, to help win approval from the United States Food and Drug Administration.” 

The reporter continues, without apparent irony, that “Companies have turned to Russia in particular to test experimental psychiatric medicines, sometimes in the same mental health wards once used to confine Soviet dissidents.”  The good news, however, is that “there is no indication political detainees are used today in drug testing.”   As an afterthought, he does note that “there have been strange results. In 2007, an F.D.A. official wrote that the agency approved Eli Lilly’s top-selling antipsychotic drug Zyprexa for use by adolescents based on the results of a Russian test, even though trials in the United States showed the drug had no effect. Why tests differed in Russia and the United States was never explained. Doctors now routinely prescribe the drug for American adolescents.”   Obviously Mr. Kramer was not aware that this, too, has been a matter of significant “concern” here in the U.S.  In 2009 Eli Lilly plead guilty and paid a $515 million criminal fine and a total of $1.415 billion in civil penalties and fines for promoting the use of Zyprexa for adolescents without evidence that it was safe or effective.   Does the New York Times still have an active Google account?

The article concludes as uncritically as it began by reporting that:

“In March, Domain Associates, an American venture capital firm, agreed to jointly invest with the Russian government about $760 million in 20 biotechnology start-up companies in the United States. The investment was intended to help Russia transfer drug development expertise to its own, nascent biotech industry.

As an incentive for the American drug companies it will invest in, the joint venture offered to help these start-ups conduct “advanced stage clinical trials in Russia of new pharmaceuticals,” according to a statement.

In another example, VitaPortal, a Russian Web site analogous to WebMD, plans to profit by helping pharmaceutical companies find test subjects among visitors to the Web site who have searched for information about particular ailments.”While perhaps we wouldn’t expect analysis and criticism from a reporting piece in the business section, it is interesting that the article does conclude that the practice is ethical.  Although not directly attributed to Mr. Lewis, the industry spokesman, proximity makes clear that he is the source for the reporter’s sentence that “ethically, if a clinical trial will most likely improve a patient’s health — for whatever reason, including because the patient lacks access to standard, already accepted care — a doctor should admit the patient to the trial.”  Although I am not advocating a “full employment act for health law commentators” it wouldn’t have been difficult to find someone who could have noted the existence of, at least a difference of opinion on the ethics of asking citizens of countries with far fewer resources than the United States to take risks that would not be allowed here and on the safety concerns these practices generate.

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