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Guinea Pig Nation: Russia's booming business in clinical trials

Drug reps prepare their booth at a cardiology conference in Moscow.

Browse an interactive map of Russia's clinical trial industry growth over the past decade. And read more from Gregory Warner's special report.

TEXT OF STORY

Kai Ryssdal: Over the past month or so we've been bringing you a series of stories from Russia by our health care reporter Gregory Warner. Today, we're going to turn to clinical trials. Pharmaceutical and biotechnology companies spend $35 billion a year testing their products in those trials. And it's not a quick process. By the time they line up participants, meet regulatory requirements, and then actually test the drugs, we're talking years.

In other parts of the world, like Russia, things move more quickly. Quickly enough, that the business of clinical trials there is growing 15 percent a year. Here's Gregory.


Gregory Warner: Getting drugs to market is basically a race against the patent clock. You want to get your drug tested, approved and stocked on pharmacy shelves as fast as possible.

David Passov: The number one reason why companies come to Russia is that they can enroll patients in Russia three to 20 times faster than in America or Western Europe.

David Passov runs Clinstar, it's a company that organizes clinical trials in Russia for big drugmakers. And yes, he really did say:

Passov: Three to 20 times faster.

Meaning a trial that starts for example in October and has its Russian patients ready to roll by November, might only just be giving its American patients placebo pills by the following June.

Passov: In the West, people participate in clinical trials if they want to do something good for mankind, or that's their last resource.

Patients aren't paid for taking part. But in Russia, participating in a clinical trial could mean seeing that specialist you couldn't afford, or getting a diagnostic test you wouldn't have gotten.

Passov: They would actually get free treatment.

Galina is a 59-year-old diabetic in the northern Russian city of Yaroslavl. She already gets her insulin paid for by the state. But then her doctor offered her the chance to participate in a clinical trial.

Galina: I wanted to take part in it. There was a good chance that the insulin they were going to give me was of a higher quality than the insulin I was currently taking and I thought, well, maybe there's hope that I could get completely better!

She knew, at least the rational part of her, knew that you can't get completely better from diabetes. But she could still hope.

Galina: Well I think science generally moves forward.

Much of clinical trial work is not about breaking new scientific ground. It's usually seeking new uses for old brands or new brands to compete with drugs that already do a pretty good job. And in America, this kind of research is increasingly done not by top specialists but by doctors looking for extra cash. Not so in Russia.

Passov: Our investigators in clinical trials tend to be more prominent physicians because they get to be on the cutting edge of medicine.

Doctors like Andrei Koronov. He's the one that brought Galina into that clinical trial. But he's also tested drugs in cardiology, pulmonology, dermatology, gastroenterology, post-surgery drugs, anemia and endocrinology. Koronov tells me he does this research both for the cash and for professional pride. Out here in Yaroslavl's municipal center, far from the research centers of Moscow.

Andrei Koronov: Doctors here don't often get to work with novel drugs. Now we get to learn about these drugs before they get on the market. And we can let the doctors around us know about which way the science is heading.

And when Koronov talks about a drug to other doctors, its not just one or two colleagues in the break room. As a clinical pharmacologist in one of the city's largest hospitals, he gives the lectures to other doctors about which drugs they should use and when.

Koronov: Companies are naturally interested that we know about their drugs. So that we can give presentations to other doctors about those drugs.

This is where the clinical trial industry becomes as much about marketing drugs as about testing them. Drug companies even have a code name for these influential doctors in foreign countries.

Tatyana Boloshova: If we are speaking about opinion leaders?

We are speaking about opinion leaders. This, by the way, is Tatyana.

Boloshova: Tatyana Boloshova.

A Russian biochemist, who in the late 1990s was plucked from her job as a poorly paid university professor and hired as a sales rep for the drugmaker Sanofi Aventis, then called Sanofi.

Boloshova: I like Sanofi very much.

Bolshova tells me she owes her professional esteem to that company because it gave her what the Russian economy could not: a good salary, interesting work, and the respect of her scientific education. For years, her job as a drug rep was to find ways to make influential doctors feel about that company like she did.

Boloshova: We had a different budget for opinion leaders. His birthday for example; when a very important specialist had his birthday.

Drug companies would show up to pay their respects. They'd form a line in the morning, she says, so that by suppertime, they could come up and say happy birthday, and hand them a present. Sometimes the receiving line was longer.

Boloshova: It depends on the level of the doctor!

Those birthday parties are more muted now. Russia has passed laws similar to those in the states limiting the gifts that drug reps can offer. And the U.S. Department of Justice is investigating several major drug firms for their financial ties to Russian physicians.

But Tatyana Boloshova is still in the business of courting doctors -- not with swag, but with science. She's no longer works as a drug rep. She now works for Clinstar, organizing clinical trials across the country. And she knows that every time they line up another doctor to test out a new drug, they snag a potential spokesman.

Boloshova: It's obviously because they were involved in clinical trials, and now this when this drug is registered in Russia, they like to use it.

And hopefully, recommend it, to hundreds of their doctor friends.

In Russia, I'm Gregory Warner for Marketplace.


Ryssdal: You can check out a map of the spread of the Russian clinical trial business and hear the rest of our series.

About the author

Gregory Warner is a senior reporter covering the economics and business of healthcare for the entire Marketplace portfolio.

Browse an interactive map of Russia's clinical trial industry growth over the past decade. And read more from Gregory Warner's special report.

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Though I'm sure the US Medical Community is no different, it was shocking to hear Dr. Boloshova's description of "opinion leaders" and essentially turning doctors into spokespersons for pharmaceutical companies. This is a frightening issue in healthcare, whereby doctors may not necessarily give the best healthcare advice for their patients' health, but instead give the best healthcare advice for a pharmaceutical company's bottom line.

After working in international clinical trials since 1998, I recently had the privilege of working with Mr. Passov, Dr. Balashova and their extended ClinStar team in Russia (Moscow, Siberia) and Ukraine. It was my experience that ClinStar’s concern for the protection of human subjects, regulatory compliance (FDA and the applicable in-country health authorities) in addition to their solid business practices are second to none in the developed or developing world.

Unfortunately, in the US, our gummed up health delivery and reimbursement systems coupled with inefficient clinical site start up (institutional contracts, budgets and multiple Institutional Review Boards (IRB) approvals ) severely and negatively impacts the ability to conduct time-efficient domestic clinical trials.

Based on my experience, Mr. Warner’s story is spot on.

As a participant in phase-1 clinical trials I was interested in the report regarding pharma companies choosing Russian for clinical trials.
Tough I address a different area of the clinical trial process it is relevant to what eventually happens on a long term and wide scale basis. Phase-1 trials is where studies begin testing in humans. Phase-1 trials are to test the safety and tolerability of medications. Phase-1 participants are always paid volunteers whom do not have the medical condition that they will be taking a medication for. I don't think I have ever heard of unpaid phase-1 studies. Phase-1 volunteers tend to participate for money which sometimes can be an astronomical amount. Few are motivated to help humankind. The most common type of phase-1 volunteers are people who need a quick easy way to earn cash such as people out of jail, homeless people, and jobless people besides people for whom clinical trials are a living . Some phase-1 volunteers are college students trying to earn tuition money, or perhaps save up for necessities. Phase-1 clinical trials tend to involve long spans of time in a dormitory being dosed with medication and having blood draws to determine how much of the medication absorbs into the body. These studies are designed so that the volunteers must sleep a certain amount of time and eat a certain diet besides following other restrictions, but volunteers whom are pursuing money and whom are unconcerned with doing their part to test a medication that will help sick people, are known to do things such as avoid eating the boring food provided to them, and they stay up late at night in their dorms talking, or playing cards thus affecting the preciseness of the studies. And these infractions may be mild compared to the fact that many phase-1 volunteers are supposed not to have had a history of substance abuse but a great deal of former drug abusers deceptively enroll. Research staff rarely eject such ineffective volunteers and neither are there any strict guidelines in place to prevent former prisoners, and persons from homeless shelters (etc) from volunteering because there is a dearth of healthy, drug-abuse free, altruistic, educated, volunteers. Phase-1 volunteers are medically tested but rarely if ever screened for having a legally desirable background.. Also, a lot of altruistically motivated volunteers are discouraged from volunteering because they know they will have to share space with ex-cons, gang members and other dangerous types. So a research facility that conducts phase-1 research studies very often resembles a penitentiary and from what I have witnessed, there are fights, harassment, and a resultant lack of integrity in medical research . The idea that vulnerable populations are not supposed to be given incentive to do what they would not otherwise do, allow themselves to be experimented on, is given lip service by pharmaceutical companies and research facilities, but then again the people who choose to risk their health to make money this way are not the ones whom are ultimately the disadvantaged group.

It takes years for a drug to make it to market. The pharma establishment needs rapid enrollment of volunteers for all phases or clinical trials, but one of the main reasons that wrongly-motivated people tend to be assigned to do a very important job which often only results in inaccurate test-results which can cause longer testing phases in clinical trials, and which can even ultimately mean that a drug will have to be recalled from the shelf after it had been approved for the marketplace, is because there is an industry-wide practice of barring most females from clinical trials especially phase-1 clinical trials. As a female phase-1 research participant I have observed that barring most females ( for the fear that an experimental drug can affect a female’s reproductive capacity in some way) shrinks the pool of benevolently- motivated, healthy, dedicated volunteers whom care to carry out the study the right way. It is a convenience for pharma companies to replace volunteers whom they cannot accept, ( women), with volunteers whom there is no official restriction on, male volunteers whom are in it for the money.

What concerns me about emerging markets for clinical trials is the ease with which potentially compromised subjects may be enrolled in a clinical trial. The ability of participants to give informed consent to participate in a trial is based on the idea that the consent is given free of coercion. In areas of the world where the economy is depressed and healthcare inadequate, does access to competent physicians and medical care that isn't otherwise available constitiute coercion? I work in clinical research here in the US, and there are special steps that must be taken to enroll vulnerable populations into clinical trials. Also, in the US clinical trial participants are compensated for time and travel for trials in every phase of clinical research, I-IV (post-market). Why not in Russia? Is there a regulatory prohibition, an industry-imposed ban on reimbursement to prevent the type of coercion I discussed above, or is it just another way to save money?

Unfortunately, I believe that Mr. Warner did not investigate the claim "3-20 times faster" from the representative of ClinStar (CRO-contract research organization). He ought to investigate other CRO's just as Covance, Quintiles, etc. to determine if this information is correct. Also, other emerging markets such and India and China might boast a similar claim. One should consult with the major pharmaceutical companies to see if they would confirm the information as well. One also needs to explore in depth more of the ethical issue of participating in a clinical trial in these emerging markets. One also needs to explore the quality of the date that is being generated as well. In short, a very superficial and misleading article. I expect more from your organizaqtion

Please be more careful in your assumptions. You said "you can't get completely better from diabetes." This is not true. Type 2 diabetes can be completely eliminated for many by changing their diet. My 70 year old neighbor did it.

Your carelessness just reinforces this mistaken belief. It is better to delete such text since it adds nothing to the story, and can do harm.

I heart this commentary on the radio while driving home. The big open questions is what can you do with a trial in Russia if your market is the USA and the European Union?

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