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. Last Updated: 07/27/2016

Drug Giants Turn to Russia for Tests

MTA statue of poet Vladimir Mayakovsky seemingly gazing at a couple on a billboard near the Mayakovskaya metro station. Rainshowers are forecast for Friday.
Tatyana's breast cancer seemed to be in remission after an operation three years ago. But her condition rapidly deteriorated in January, and she was placed on a waiting list for chemotherapy.

Not wanting to wait at least four months for treatment, Tatyana did what tens of thousands of other people do each year: She signed up for a clinical drug trial.

"In my local clinic, no one really examined me. Now doctors are actually paying attention to me," said Tatyana, 53, who spent more than half her life offering tours at what is now the All-Russia Exhibition Center.

Some 37,000 patients across the country took part in clinical drug trials last year, and the number of trials ordered by foreign pharmaceutical giants such as Novartis Pharma, Pfizer and GlaxoSmithKline is growing.

Ethical concerns over the clinical trials are being raised after Volgograd prosecutors charged three doctors with failing to safeguard the health of infants who were given an unregistered vaccine produced by a division of Glaxo during a clinical trial.

But patients such as Tatyana are more than willing to take the risk. As a cancer patient in a country with a dysfunctional medical system, Tatyana feels her best hope is the doctors, new drugs and high standard of care that the clinical trial provides.

Foreign pharmaceutical companies conducted 324 clinical trials in Russia last year, up from 252 in 2004, according to the Federal Health and Social Development Agency, a health care oversight body.

In contrast, 10,675 clinical trials are currently under way in the United States, 1,180 in Germany, 886 in Britain, 641 in Italy, 245 in India and 230 in China, according to ClinicalTrials.gov, a web site developed by the U.S. National Institutes of Health. The site says 250 trials are now being conducted in Russia.

Russia is the third most attractive country for Western pharmaceutical companies seeking to conduct clinical trials, behind China and India, consulting firm AT Kearney said in a report last year.

As long as Russia remains "a cost effective country" for drug companies, the number of trials will continue to grow, said Pavel Tverdokhleb, a quality control director with Pfizer.

Recruiting patients in Russia is quick and easy, enabling companies to cut three to six months off a trial and bring a drug to the market that much faster, said Dmitry Dmitriyev, a representative for PharmaNet, a U.S. contract research organization in Moscow. It takes an average of one day to recruit a patient in Russia, compared with 13 days in Italy and 75 days in Germany, according to Quintiles, another U.S. contract research organization with offices in Moscow.

And when it comes to putting a medication in drugstores, time is money. Releasing a drug on the market a month earlier can mean tens of millions of dollars in additional profits.

Russia has other advantages as well for drug companies. A clinical trial can require tests on up to 7,000 people with similar symptoms, and it is essential that the patients not be resistant to new drugs from years of antibiotic treatment, Tverdokhleb said. Recruiting such patients in those numbers is virtually impossible in smaller countries or countries where primary care plays a much larger role.

"This aspect is very important for accurate scientific results," Tverdokhleb said.

Doctors, patients and drug companies say clinical trials in countries with poor health care systems like Russia benefit everyone involved.

"Almost 70 percent of our patients are involved in clinical trials," said Mikhail Lichinitser, head of the chemotherapy and combined therapy department at the Russian Cancer Research Center, where Tatyana is being treated. "We are currently testing about 15 new drugs, and everyone benefits: Our patients get the best possible treatment for free, and our doctors have their benefits and grow as researchers."

Lichinitser said he typically received proposals for new trials from contract research organizations, which carry out research on behalf of pharmaceutical companies. The organizations usually subcontract the job of finding patients to an administrator like Lichinitser, who in turn farms out the work to doctors at his clinic.

All drug trials in Russia must be authorized by Federal Health and Social Development Agency, which determines whether they are scientifically valid and properly designed. An independent review board must also decide whether the research is in the patients' best interests.

One doctor at Linchinitser's clinic said that by handling 10 patients for a 10-month clinical trial, doctors can make around $1,000 per month on top of their $200 monthly salary. Treating 20 patients over the same period would mean an extra $2,000, but the doctor said it was not exactly easy money.

"Only if his research was accurate and accepted by international bodies does he get his money," said the doctor, speaking on condition of anonymity.

With clear financial motives for those involved in testing new drugs, clinical trials in developing countries have raised concerns about ethics and oversight. Russia is no exception.

Last week, Volgograd prosecutors charged three doctors with failing to safeguard the health of infants who were given the unregistered vaccine produced by the division of Glaxo, the British pharmaceutical giant.

Prosecutors opened the investigation in response to a complaint from the parents of Vika Geraskina, who was 1 year old when she was purportedly given the vaccine in November 2005. They maintain that Geraskina should not have been included in the list of 112 participants in the vaccine trial because she suffers from cerebral hypoxia, a lack of oxygen supply to the brain.

After receiving the vaccine, which is designed to protect against chicken pox, measles and rubella, Geraskina's health deteriorated, prosecutors said.

Investigators concluded that both the law and the pharmaceutical company's contract with the hospital were contravened, resulting in the inclusion of children with neurological disorders and chronic illnesses in the trial.

Parents also believed that their children were receiving proven vaccines and were not informed about the trials, prosecutors said.

Juntra Karbwang, clinical quality assurance coordinator for the World Health Association, said transparency in clinical trials was essential.

"Every trial should be available for public review so that potential problems can be identified and avoided," Karbwang said.

Dr. Inna Ganshina, who is treating Tatyana, said she always informs her patients about risks involved in a drug trial and possible side effects.

"I usually give them several days to make a decision, but most of them are ready to sign at once," Ganshina said.

There are 50 patients in Tatyana's ward, and 20 to 30 others come each day to receive chemotherapy under the auspices of the clinical trial. Tatyana shares a room with two other women. Yulia, 37, an engineer, also signed the consent form.

Yulia said she signed up for the trial because every time she went to her local clinic to get her free chemotherapy, she was forced to wait long periods for her paperwork to be processed.

"Sometimes it takes more than a month to get a drug and it interrupts the course," Yulia said.

She said signing up for the trial was "not a choice, but a necessity."

"The doctors said it's up to me, but really there is no alternative."