Kester Kenn Klomegah
MOSCOW, Jan 26 2007 (IPS) – Health NGOs and experts are accusing Russia s health and social development ministry of endangering the lives of tens of thousands of infected Russians by altering the list of anti-retroviral drugs the government plans to buy this year.
The activists and experts say government officials surreptitiously replaced cheaper, more effective drugs with more expensive, less effective medications. They allege that negligence and corruption might be behind the changes in the deal.
In a decree, the health ministry quietly replaced some of the so-called first-line drugs -for patients who have not been undergoing treatment for very long with third-line and fourth-line drugs designed for patients who have had the virus for years and have built up resistance to other medications. The critics say this change will jeopardise the lives of more than 30,000 HIV patients slated for treatment.
Two international organisations that have been working in Russia for several years, and have played an advisory role to the appropriate ministries, criticised the deal.
However, in Dec. 2006, WHO and UNAIDS were provided with a copy of the approved Prikaz (Order) 785 Regarding Adoption of Standards of Medical Services in Specialised Care for People with Illness Caused by HIV .
The order outlines standards of medical care for people with HIV-related illnesses in specialised settings. The standards are recommended for all specialised facilities in the Russian Federation, Dr. Corinna Reinicke, coordinator of the WHO HIV/AIDS programme in Russia, wrote IPS in an email.
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UNAIDS and WHO submitted a joint letter to the Minister of Health and Social Development expressing our concern that Prikaz 785 is not in line with international standards as recommended by the World Health Organisation in its most recent Clinical Protocols for HIV Treatment and Care, nor the evidence-based best practices in other developed industrialised countries in Europe or elsewhere, she told IPS.
In the letter, we also expressed our concern that HIV patients in the Russian Federation would not have access to effective and rational first- and second-line regimes for highly active anti-retroviral treatment, she added.
The ARV combinations ATV Combivir (ZDV+3TC), Trizivir (ZDV+3TC+ABC), and Reataz (ATV) were included in the previous Prikaz 612, issued in August 2006, but they are not in the new Prikaz 785, she pointed out.
The World Health Organisation feels it is imperative to include those fixed-dose combination drugs for better adherence to the regime, which also result in less pill intake. However, ZDV, 3TC and ABC are only listed as separate drugs in Prikaz 785. Darunavir is a drug for a salvage regime, and we suggested having salvage regimes according to the estimated number of MDR (multi-drug resistant) cases, Dr Reinicke added.
Russian health authorities have registered two cheap drugs produced by Indian pharmaceutical company Hetero, Roman Dudnik, an advisor with the Aids Foundation East-West (AFEW), told IPS.
It is a generic version of the original Norvir produced by Abbott Laboratories, he explained. The only danger I see is that this particular drug cannot be the same quality as the original one. Furthermore, as I heard, this drug is not pre-qualified by WHO. The official distributor of Hetero in Russia is Matiz Pharma, a Russian pharmaceutical company.
Another drug is Stag (Stavudin), made in Russia again by Matiz Pharma, he said.
The reason for the scandal was that the ministerial order is made especially for the benefit of one particular company Matiz Pharma, Dudnik said. To avoid such situations in future, the Russian government should consider, first of all, the needs of patients and the quality and safety levels of drugs they plan to use for their people, instead of financial benefits for some authorities.
Activists working closely with HIV patients put forth similar criticism.
The new standards concerning medical aid to people living with HIV were hurriedly approved by the Ministry of Health and Social Development directly before a tender to procure anti-retroviral drugs was to be held, have not passed expert appraisal, and contradict international regulations concerning the provision of medical aid to people living with HIV, the regional public organisation Community of People Living with HIV spokeswoman Anastassia Makryashina told IPS.
The prescription of anti-retroviral therapy in accordance with these new standards could lead to the development to resistant forms of the virus and increased morbidity and mortality. Moreover the drugs listed in the new standards are far more expensive than the drugs recommended by international protocols, she argued.
In an email to IPS, Makryashina said deputy Minister of Health and Social Development Vladimir Starodubov signed Prikaz 785, which also regulates the procedures for rendering help to people living with HIV in specialised institutions (AIDS Centres).
The approval of Prikaz 785 on Nov. 11, 2006, just three months after approval of the previous version and on the eve of the tender for procuring drugs for 2007, should provide grounds for oversight bodies to conduct an investigation into the agencies and officials involved in making such decisions, as well as the commercial structures that are directly connected to these government decisions, she strongly suggested.
She said her organisation is extremely concerned about the fact that several drugs have been excluded from the list of medicine for patients, including fixed-dose combinations that are optimal for adherence and have been successfully applied in treating HIV infection in Russia.
The absence of these drugs in the standard, she added, will lead to the following negative consequences: About half of the patients who are already undergoing treatment will be forced to change their regime of ARV therapy; new patients are very likely to be prescribed inappropriate regimes of drug treatment; patients will have much more complicated regimes; and the number of pills and the frequency with which they must be taken will increase significantly, which will have a negative effect on patients adherence to treatment.
All of this can lead to the rapid development and spread of forms of the virus resistant to the drugs, said Makryashina. This in turn will lead to increased morbidity and mortality related to AIDS as well as to a sharp rise in the cost of the treatment of HIV infection.
Also according to the new standard, she said, more than half of all patients will be treated with drugs that are more toxic and are accompanied by more frequent and stronger side-effects than first- and second-line drugs.
World over, these more toxic drugs are prescribed only when patients have resistance to the more simple and less toxic regimes. The wide use of the more complicated and more toxic treatment regimes will lead to lower adherence, which in turn leads to viral resistance, as well as increased morbidity and mortality.
Moreover, the new standard lacks one of the most important diagnostic tools used to monitor treatment effectiveness and health status identification of the viral load. Without conducting analyses for the viral load it will be difficult to identify whether the treatment is effective and whether patients are developing resistance to the drugs they take, she added.
In connection with the above, we think it is necessary to cancel and review the order No. 785 as soon as possible in accordance with the needs of Russia and international standards. The tender for procurement of anti-retroviral drugs must not take place until a new standard is developed. To ensure transparency, representatives of civil society and HIV patients must be involved in the development and adoption of the national standards for HIV treatment, Makryashina said.
According to the head of the Federal AIDS Centre for Treatment and Prevention, Professor Vadim Pokrovsky, purchasing the quantities of drugs recommended in the new standard will cost up to 30 million dollars one-sixth of the entire federal AIDS budget.
It s very scandalous indeed, a leading AIDS expert at the Centre told IPS. We really don t know how such a measure can be taken after it was discussed collectively by medical experts. This unilateral step by the government will put precious lives at stake and in serious danger.
Makiz Pharma s marketing director Yury Boryan told IPS in an interview that no purchasing order from the ministry for the delivery of drugs for treatment of AIDS/HIV patients came to us. As far as I know, today there is no official declaration about the conducting of similar purchases, conditions or volumes of similar medical deliveries.
