Russia has long been infamous for its punitive approach to illegal drugs. Now legislation is threatening the availability of legal medications, forcing citizens to wait for unnecessary clinical trials in order to get access to lifesaving treatments.
Middle income countries like Russia are prime growth markets for European and North American companies that produce expensive, brand name medicines. In a move meant to drive funds to the rapidly growing Russian clinical trials industry (and to send the message that business in Russia will be done on Putin’s terms), the government has added a new twist: a requirement that all medicines sold in Russia be first tested in Russia. This will mean millions of dollars in expenditures to test medicines—whether branded or generic—already known to be safe and effective. The availability of many medicines will be delayed, and costs passed on to the patients—while the Russian clinical trial industry profits. The requirement also underscores one of the most corrosive features of Russian health policy: the claim that only Russian knowledge can answer the question of what is good for Russian health.
Past history raises multiple alarms about Russian scientific standards and practices. In the field of addiction medicine, for example, Russia has banned the use of methadone and buprenorphine—claiming bluntly that the medicines do not work, ignoring worldwide evidence proving their effectiveness. In tuberculosis diagnosis, Russia has long insisted on fluoroscopy to detect disease—even where microscopy would work better. Soviet era medical literature is full of parallel universe science where the interventions recommended (like radon baths and ultraviolet light machines) are accorded standard-of-care status while the rest of the world finds no evidence of effectiveness, or has documented outright harm.
Russian clinical trials may not work so well either. As detailed in a recent New York Times story about how people turn to clinical trials in Russia to get desperately needed health care, the results of a Russian trial of the psychotropic medication Zyprexa were instrumental in securing approval for its use by adolescents in the United States. The Russian data showed effectiveness—while US trials did not. Several years after approval, the Food and Drug Administration had to issue a warning about the potential harmful effects of the drug in young people. Another pharmaceutical company used a single Russian trial to secure approval in the US for an injectable, extended release form of the medicine naltrexone—claiming that it effectively helped heroin users to abstain. As noted in a Lancet article (and an earlier blog post), the trial not only raised ethical concerns but recorded no fatalities from overdoses among any trial participants. Since past studies have documented overdoses among those given placebos in such studies, the findings call the reliability of the Russian data into question.
Russia is not the only country to funnel millions to a domestic clinical trials industry, or to require country-specific drug trials. A number of Asian countries—most notably, Japan—have similar provisions, arguing in some instances that biological differences between Asians and Caucasians may change drug impact. Russians do not bother with a biological argument, instead going with a scientific version of “my way or the highway.”
Multiple brand-name manufacturers are going along, hoping to catch a share of the $15.3 billion pharmaceutical market (which is expected to grow by double digits in the next years). As the Times notes, clinical trials in Russia skyrocketed by more than 100 percent in the first six months of 2012 compared to 2011. So long as current laws require that Russian scientists reinvent the wheel, the gaps in Russian health care will continue to widen. Patients—forced to endure placebos and years of waiting when what they really need is greater access to affordable and effective medicines—will pay the price.