Russians gladly participate in clinical trials, despite possible risks

The dream patient in a pharmaceutical company’s board room is a Russian babushka who readily accepts the risks of the medicines she uncomplainingly takes and gladly endures even extraordinary side effects.

As a subject in a Russian clinical trial studying an experimental weight-loss drug, Galina Ivanovna Malinina had to inject herself in the abdomen every day. “No problem,” she said. “The needle is thin and the dose is small.”

She did it the first time in a hospital, where a gloomy doctor in a white coat stood watching her closely. Soon after the injection Mrs. Malinina vomited. She then suffered daily vomiting for another two weeks but remained in the clinical-trial regimen — which companies value because patient recruitment is expensive.

“It’s wonderful,” she said of the investigational medication, a weight-reducing serum under development at Danish biotech giant Novo Nordisk. Not only did my weight drop by 10 kilograms in a year, but “I’ve become livelier, it’s easier to walk and I have energy.”

The readiness of Mrs. Malinina — and thousands of other Russians — to participate in drug studies has been surprisingly advantageous for international pharma companies facing high costs and difficulties recruiting subjects in the United States and Europe.

Russian regulators, doctors and even many patients are increasingly eager to seize any chance to take part in medical experiments.

Patients, as in the case of Mrs. Malinina, seek to be enrolled in clinical trials because it is often the only way to receive modern medical care.

This creates a pool of ready subjects. President Vladimir Putin’s government, seeking to diversify the Russian economy away from oil, welcomes new jobs and investment in high-tech industries — including clinical research — and has eased pharma companies’ access to Russian patients as an incentive.

Indeed, under a law passed in 2010, foreign pharmaceutical companies are required to run a drug trial in Russia in order to sell the drug in Russia.

According to trade-organization estimates, the law is bringing additional investment into the Russian clinical-research industry. The number of drugs being studied in Russia has shot up: Russian regulators approved 448 clinical trials in the first six months of 2012, compared with 201 for the same period a year earlier — 96% growth.

Russia is not alone in opening the doors of its national health-system hospitals to pharma companies seeking patients for international trials for better demographic representation.

Research in Russia is a net benefit for public health because hundreds of millions of dollars are invested in diagnostics and medical care. Most of the trials relate to reduced-risk testing aimed at replacing originators with generics.

Singapore, South Korea and China are among the countries that have offered incentives and/or requirements for pharma companies — they are now required to conduct clinical research locally, said John Lewis, vice-president of the Association of Clinical Research Organizations, in a phone interview from Washington.

From an ethical standpoint, if a clinical trial is likely to improve a patient’s health — regardless of reason, including because the patient has no access to the most effective drugs already approved — the doctor should enroll the patient.

“We know many governments encourage clinical research in terms of potential economic benefits, improvements in medical care and the innovation process,” he said.

Pharma companies also benefit, though the association does not endorse that motive. “A clinical trial should be viewed as an experiment, as research, not as treatment,” Lewis said.

Russia hosts many pharmaceutical companies, including Bayer, Bristol-Myers Squibb, Eli Lilly, Novartis, Novo Nordisk and Pfizer. The companies use results from Russia and elsewhere to obtain approval and market access from the US FDA.

Companies have turned to Russia in particular for trials of experimental psychiatric drugs — sometimes in the very psychiatric wards that once held Soviet dissidents. There is no indication today that political prisoners are being used for drug trials.