Russians Eagerly Participating in Medical Experiments, Despite Risks

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The New York Times
Thursday, September 27, 2012

Russians Eagerly Participating in Medical Experiments, Despite Risks

By ANDREW E. KRAMER

MOSCOW — Like a dream patient conjured up in the boardroom of a pharmaceutical company, the Russian grandmother accepted the risks of the drug she was taking without complaint and cheerily endured even extraordinary side effects.

As a test subject in a Russian clinical trial for an experimental weight loss drug, Galina I. Malinina had to inject herself in the stomach daily. “No problem,” she said. “The needle is thin and the dose is small.”

The first time she did this at a hospital where long-faced, white-robed doctors stood by and observed her intently, Ms. Malinina soon vomited. After that, she threw up every day for two weeks, yet stuck to the regimen, something valued by companies, as dropouts are expensive.

“It’s wonderful,” she said of the test substance, a weight loss serum under development by the Danish biotechnology giant Novo Nordisk. In addition to losing 22 pounds in a year, she said, “I became more lively; I walk easier and I have energy.”

Ms. Malinina’s willingness, like that of thousands of other Russians, to take part in drug trials illustrates a remarkably advantageous development for the international pharmaceutical industry, which is running up against high costs and recruitment difficulties in the United States and Europe.

Russian regulators, Russian doctors and even many patients are increasingly embracing any chance they can get to take part in medical experiments.

Patients, as was the case with Ms. Malinina, are eager to join trials because often it is the only way to receive modern medical care.

That creates a pool of willing test subjects. The government of President Vladimir V. Putin, eager to diversify Russia’s economy away from oil dependence, welcomes the jobs and high-tech investment associated with clinical trials, and has eased access for drug companies to the Russian patients as an incentive to lure in these benefits.

In fact, under a law passed in 2010, ostensibly on health grounds, foreign drug companies must test medicine on Russians for it to be marketed in Russia.

The law has the effect of compelling investment in clinical testing on Russians, trade groups say. And it is working. The number of drugs tested on Russians has shot up over the last year. Russian regulators approved 448 clinical trials in the first six months of 2012, compared to 201 in the same period a year earlier — an increase of 96 percent.

Russia is not alone in opening the doors of hospitals in the national health system to drug companies looking for test subjects, in a quid pro quo with the international industry that conducts tests globally for a better demographic representation.

Testing in Russia is a net benefit to public health, pouring hundreds of millions of dollars into diagnostic work and doctor care that would not have been here otherwise. Much of the business swirls around lower-risk testing of generic replacements for brand-name drugs.

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