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'Our Children Aren't Lab Rats': Russian Transplant Patients Warn Of Dangers Of Generic Drugs


Six-year-old Masha Khlopotovaya from the Far Eastern city of Blagoveshchensk underwent a liver transplant in Moscow in 2013. Her mother was the donor. "I have never given Masha a generic because I cannot conduct such experiments on my child," Lyudmila Khlopotovaya says.

MOSCOW -- Russian lawmakers are currently considering a bill imposing countersanctions on the United States that includes a controversial provision banning the import of pharmaceuticals produced in the United States or its allies for which analogues can be obtained.

The bill's sponsor, Duma speaker Vyacheslav Volodin, said that Russia currently imports 1,019 medicines from the United States and all but 90 of them would fall under the ban if the legislation passes. He added that the Duma intends to push the government to adopt a program that would eventually lead to the complete replacement of all imported medications with Russian equivalents.

Activists and patients, though, are speaking out against the proposal.

Human rights ombudswoman Tatyana Moskalkova issued a statement on April 29 urging deputies to remove the medicines passage from the bill, saying the state's desire to make a political point should not "put people's health in danger."

But one group in Russia has already run into the problem of being compelled to use substitute medications: organ-transplant patients.

Following such surgeries, patients must take immunosuppressants for the rest of their lives to prevent organ rejection. Without the antirejection medications, patients face numerous complications, including potentially fatal ones. In recent months, however, Russian health officials have been pushing doctors and patients to use generic substitutes as a budget-cutting measure.

In 2018, the government stopped purchasing the immunosuppressant Prograf, which is produced in Ireland, altogether. And patients say the results have been disastrous.

Roman Tarasov with his daughter, Natasha, 6, who had a kidney transplant when she was 6 months old. When she was given a generic medicine, she broke out in a rash. "My child is not a laboratory rat," Roman Tarasov says.
Roman Tarasov with his daughter, Natasha, 6, who had a kidney transplant when she was 6 months old. When she was given a generic medicine, she broke out in a rash. "My child is not a laboratory rat," Roman Tarasov says.

Natasha Tarasova is a 6-year-old patient who had been taking Prograf since her kidney transplant at the age of 6 months. Her parents were pushed to use a substitute.

"We gave her, as usual, two capsules in the evening -- not the ordinary medicine but a generic," Natasha's father, Roman Tarasov, told RFE/RL. "She was instantly covered in a rash, although the instructions said nothing about that kind of reaction. Two weeks later, we tried again. This time her eyes, throat, and lips became swollen.

"After that, I said we are not going to experiment anymore," he concluded. "My child is not a laboratory rat."

The Russian company that produced the drugs his daughter took purchased the ingredients from companies in the Czech Republic, India, and China, Tarasov told RFE/RL.

I have never given Masha a generic [drug] because I cannot conduct such experiments on my child. I am constantly appealing to foundations and searching for sponsors. Otherwise, we can't make it."
-- Lyudmila Khlopotovaya

"No matter how hard I tried to find any trace of that company on the Internet," Tarasov said of the Chinese firm, "it turned out to be impossible."

"Moreover," he added, "the secondary ingredients in [the generic drug] were significantly different from the secondary ingredients in the Prograf. In order to reduce the cost of the end product, they replace [ingredients] with the cheapest possible alternatives."

After Tarasov was able to document that his daughter was allergic to the substitute, health authorities in Saratov Oblast approved an exception for her to obtain Prograf.

More than 32,000 people have signed a petition urging Russian President Vladimir Putin to change the government's policy and to allow at least children to receive Prograf.

Masha Khlopotovaya, a 6-year-old from the Far Eastern city of Blagoveshchensk, underwent a liver transplant in Moscow in 2013. Her mother, Lyudmila, was her donor. After her surgery, Masha spent nearly a year in the Shumakov Transplant Research Center.

In recent months, pharmacies have stopped selling Prograf, offering instead a Russia-produced substitute called Tacrolimus. But Masha's doctors in Moscow insist that Masha takes only Prograf.

"The doctors told me if you want to treat your daughter, just give her the original prescription," Lyudmila Khlopotovaya told RFE/RL. "I have never given Masha a generic because I cannot conduct such experiments on my child.

"I am constantly appealing to foundations and searching for sponsors," she added. "Otherwise, we can't make it. After all, not only do I have to pay for Prograf, but we also have to fly to Moscow four times a year for the tests. They have canceled subsidies on airplane tickets for sick children. Now they only subsidize train tickets. But from our home, it is six full days of travel, which is impossible for a sick child."

Heart-transplant recipient Lyudmila Pimenova (center) poses with her mother and the Indian surgeon who performed the operation.
Heart-transplant recipient Lyudmila Pimenova (center) poses with her mother and the Indian surgeon who performed the operation.

Lyudmila Pimenova, from the village of Ilek in Orenburg Oblast, spent several years waiting for a donor for a heart transplant in Russia. Eventually, she had the operation in India and now she takes Prograf -- "six to eight packages a month, depending on my tests."

Like other patients in her situation, she scrambles to find the money to buy Prograf, as well as to find the drug itself. But this situation is becoming increasingly difficult for her.

"But I can't take the risk," she told RFE/RL. "I simply might not get a second chance at life -- like hundreds of other patients who have had transplants."

She argues that the government's effort to push patients onto unproven substitute drugs is a false economy.

"If you look at it from the financial point of view, the government -- having spent huge sums on financing transplant operations -- is now spending more on additional examinations, keeping patients in hospitals, and on treating them from the complications of taking unproven analogues," she said.

The problem of unproven or substandard generics is not unique to immunosuppressants, says Aleksei Romanov, a psychiatrist from Saratov.

"Call me unpatriotic, but Russia has major problems with the production of pharmaceuticals," Romanov said. "The medicines that are produced often don't use original ingredients. I mean, the production is only partially in Russia -- the labels and the packaging. But the ingredients are imported from various countries. A little is produced in Russia, but only very little. Major problems arise when we are talking about new and technically complex formulas."

Babies at the Shumakov Federal Research Center await organ transplants. Russian transplant patients say they're being used as "lab rats" as the government cuts costs by buying unproven generic drugs. (file photo)
Babies at the Shumakov Federal Research Center await organ transplants. Russian transplant patients say they're being used as "lab rats" as the government cuts costs by buying unproven generic drugs. (file photo)

Dmitry Yanin, head of the International Confederation of Consumer Protection Societies, agreed.

"Although many medicines have been brought into local production, unfortunately this localization has been very uneven," Yanin said. "And for patients suffering from very serious illnesses, any attempt to change medications is a very serious issue. When the regions were forced for budgetary reasons to stop buying foreign medicines, the patients took this very badly. There have been both protests and real family tragedies.

"I think [in the end] they will strike out the part about medicines [from the countersanctions bill]," he added, "because this is a very serious issue. They will never be able to explain to mothers why their children can no longer get high-quality medicines."

Written by RFE/RL senior correspondent Robert Coalson based on reporting by RFE/RL Russian Service correspondent Yelizaveta Mayetnaya, with additional reporting by RFE/RL Russian Service correspondent Mikhail Sokolov and RFE/RL Tatar-Bashkir Service correspondent Katerina Mayakovskaya
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