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New Standards of HIV Treatment to Deprive Patients of Drugs

Russian Ministry of Public Health might become involved in a new corruption scandal. This time, it might be provoked by the Ministrys order concerning the new state standard of treating HIV and AIDS. The Federal AIDS Center said it might disrupt the program of treating HIV-positive patients because it drastically changes the list of anti-retroviral drugs. Doctors believe that the new standard, which appeared on the eve of the state tender for supplying HIV/AIDS drugs, was written specially for certain companies international Janssen Cilag and its Russian partner Makiz-Farma.

Deputy Minister of Public Health and Social Development Vladimir Starodubov signed the order containing a new list of state-approved HIV/AIDS drugs in November. The new standard does not have some vital drugs which were on the list before, such as Combivir, a first-line drug most widely used in Russia, and second-line Trizivir, Reataz and Fuzion given to patients resistant to Combivir. Instead, the list now includes Darunavir, which is suggested for being widely used, and Ritonavir, which is always used together with Darunavir.

The Community of People Living with HIV were the first to give feedback on the Ministrys order. The organizations chairman Mikhail Rukavishnikov said the changes will lead to mass death of patients, because the new standard violates all recommendations of the World Health Organization (WHO) on treating HIV-related deceases. The order surprised leading HIV experts as well. Vadim Pokrovsky, head of the Federal AIDS Center, said: The new standard is almost a copy of the outdated standard of 2003. For instance, it includes Amprenavir, a drug which was removed from production long ago. Pokrovsky is convinced the matter is in replacing cheap drugs with expensive ones.

The expert estimated that Darunavir will set the state back $30 million (which is a sixth part of the budget allocated for HIV treatment in 2007): It is the most expensive drug, and it should be used after all other drugs. Moreover, doctors believe such therapeutic regimen might simply harm HIV patients. Darunavir is a new, expensive, under-examined drug. It was registered in Russia quite recently just this year, said Pokrovsky. If the state buys it, at least one quarter of registered patients will be deprived of therapy, because will simply not have enough money left to buy other drugs.

The order came somewhat before schedule. In August 2006, the Ministry had already adopted new standards for HIV/AIDS treatment, which underwent medical expertise. A tender for supplying HIV/AIDS drugs was scheduled for early December. That is why doctors think that a before-schedule order changing the drug list was timed for the tender for suppliers. They suspect the standard was written specially for certain companies.

The only producer and creator of Darunavir in the world is Swiss-Belgian company Janssen Cilag. Ritonavir drug is produced by Indian company Hetero. The only partner of these two companies in Russia is large pharmaceutical producer Makiz-Farma. Members of the market believe that its owner is Igor Rudinsky, director general and co-owner of SIA International, the largest distributing company in Russia.

RosZdravNadzor, Russias Public Health watchdog, supervising the supply of drugs to the people, yesterday refrained from giving comments about the new standard and its possible connection to the tender. However, the State Duma is already interested in the situation. I have all grounds to think that the order was written for the sake of specific companies, said Mikhail Glushankov, head of the Dumas anti-corruption commission.

I will address the top officials of the presidents staff, who supervise national projects, and Dmitry Medvedev personally, promised the deputy.


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