Volunteers in Russia shrug at drug trial risks
09/30/2012 12:00 AM
09/30/2012 8:25 AM
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, 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." 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 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 past year. Russian regulators approved 448 clinical trials in the first six months of 2012, compared with 201 in the same period a year earlier.
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.
Singapore, South Korea and China are among countries offering incentives or compelling companies to conduct clinical trials locally, John Lewis, the vice president for the Association of Clinical Research Organizations, a trade group, said in a telephone interview from Washington.
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.
"We see a lot of governments encouraging testing for economic benefits, for health care benefits and for innovation benefits," he said.
Drug companies benefit, too, though the association does not endorse that motive.
"Clinical trials should be viewed as experiments, as investigations, not as treatment," Lewis said.
A host of pharmaceutical companies operate in Russia, including Bayer, Bristol-Myers Squibb, Eli Lilly, Novartis, Novo Nordisk and Pfizer. The companies use the results of trials in Russia, as elsewhere, to help win approval from the U.S. Food and Drug Administration.
Companies have turned to Russia in particular to test experimental psychiatric medicines, sometimes in the same mental health wards once used to hold Soviet dissidents. There is no indication that political detainees are used today in drug testing.
But there have been strange results. In 2007, an FDA 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 U.S. trials showed the drug had no effect. Why tests differed in Russia and the United States was never explained. Doctors now routinely prescribe it for American adolescents.
For Russian doctors, the benefits of the globalization of clinical trials are clear from cases like that of Albert V. Chupikov, a 75-year-old cardiac patient enrolled in a trial in Moscow who was referred for an interview by one of his doctors. He said he joined because he could not find treatment elsewhere.
"It was really, really hard to find a doctor," he said. "We couldn't find one." So he joined a trial to take an experimental medicine, a choice that worked well for him.
He credits the trial for keeping him alive.
"I understand I won't get any healthier," Chupikov said. "So it's important not to get worse. And it hasn't gotten worse. So I'm thankful."
Supporters of the expanding business in Russia note it has room to grow. For every 1 million people in the United States, drug companies are conducting 46.8 clinical trials, according to the National Institutes of Health, which keeps a running tally.
In the European Union the average is 11.5, and in Russia a mere 3.3. About 5 percent of global clinical trials are conducted in Russia, compared with about 50 percent in the United States.
"America is saturated with clinical trials," Svetlana Zavidova, the director of a trade group promoting the business in Russia, said in an interview.
The National Center for Preventive Medicine, a research hospital on a leafy back street in Moscow, is testing dozens of new drugs for U.S. and European companies this fall, with a range of promising uses and side effects.
The weight-loss medicine gets the pounds off, but patients often vomit or lose control of their bowels. A prostate medicine being tested here on young male volunteers can cause dizziness and spontaneous erections. Elderly patients are raving about the energy- elevating effects of one experimental drug, Dr. Svetlana N. Toppygina, a lead doctor on the studies, said.
That energy-enhancing substance, from a class of drugs banned as doping in sports, was once tested on soldiers to raise stamina and mood. So far the trial is going well with geriatric cardiac patients, who all seem spry after taking their pills.
Folya M. Gonopolsky, an 83-year-old retired engineer who is taking these pills with his wife, Margarita, said, "They told me I would feel better, and I do." At a recent appointment, the two received free electrocardiograms and consultations, then shuffled into a room to take the experimental medicine, laid out on a table in tiny plastic bags beside glasses of water.
"Take the pills," a doctor said, and they did.
Inevitably, tests sometimes do go awry.
Vera G. Belolipetskaya is the supervisor of the ward where patients are observed in early-stage trials. Here, a substance is tested on humans for the first time after animal trials. These studies are also done more cheaply and swiftly in Russia than the West, as volunteers, perhaps tapping Russians' deep sense of fatalism, are surprisingly forthcoming.
Once, an experimental antibiotic set off allergic reactions. Doctors stared in amazement at the students and migrant workers who had volunteered.
"It was like something from the cartoon 'Tom and Jerry,' when a character gets sick," Belolipetskaya said. "Red dots started appearing all over, right in front of my eyes. They appeared in just a few minutes. It was really shocking."
On a recent morning, Yevgeny Maksimov, a 32-year-old computer salesman, slouched in a chair and waited for his turn in drug trials. On offer: $180 to take the experimental prostate drug.
He would be enclosed in a ward under observation for 24 hours, then let go and asked to return two weeks later for a follow-up.
"Why not? I take risks every day," Maksimov said, noting that he recently flew on a Russian-made airplane.
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