Translated material
Bad smelling treatment
The drug purchased for HIV-infected people turned out to be defective
For the second time in the last six months, Russians infected with the human immunodeficiency virus are sounding the alarm. Yesterday, the Association of People Living with HIV distributed a letter saying that some patients risk being left without the necessary treatment, since one of the main antiretroviral drugs is being withdrawn from the market by the manufacturing company. Pharmaceutical company F.Hoffman-La Roche Ltd. (ZAO Roche-Moscow) announced that it doubted the quality of its drug Viracept and was withdrawing it from all markets. except American, Canadian and Japanese.The problem appeared on May 23, when several patients in different countries complained of a strong foreign odor emanating from the usual drug. The company immediately began an investigation. The very first tablets subjected to rapid testing revealed a huge content of methyl sulfonic acid ethyl ester, a substance used in production to clean containers where substances are mixed. “This is an obvious technological failure,” the head of the virology department of Roche-Moscow CJSC explained to a Vremya Novostey correspondent. Without waiting for the outcome of the investigation, the company decided to recall the entire batch produced at the company's European plant.
The scandal is international in nature, but on the Russian market it highlighted the unpleasant specifics of the program for providing drugs to carriers of the deadly virus. On the one hand, HIV-positive patients are a huge expense item for the state budget , and on the other hand, they are the most “expensive” and desired consumer for pharmaceutical giants. Therefore, it is not surprising that from time to time, government-funded programs end up with drugs that are not exactly what patients need. Thus, in January it turned out that the new standard of treatment for HIV and AIDS prepared by the Ministry of Health and Social Development was not aimed at the majority of those infected. But it was certainly beneficial to one Western drug manufacturer and its Russian supplier. After the scandal, the standard was revised.
Now Mikhail Zurabov's department will have to urgently adjust the drug procurement program . According to the Federal AIDS Center, Virasept, which also turned out to be defective, was purchased three times more than required for 2007. “We have a maximum of 1,500 people in need of such treatment, but we purchased for 4,000. Why? This is a question for our authorities,” deputy head of the center Oleg Yurin told Vremya Novostey.
In addition, according to him, the once popular Viracept is now obsolete. “At one time it was considered the best in its class, but now there are much more effective and safe analogues. They have already practically ousted Viracept from the Western market - there it is used only in isolated cases, and in Russia the number of patients who are prescribed this particular medicine is decreasing every year,” says Mr. Yurin. The supply volumes of this drug have indeed been significantly reduced compared to previous years. The analytical company Pharmexpert told a Vremya Novostei correspondent that in 2005 the volume of imports of Virasept amounted to 500 thousand packages, and in 2006 - only 10 thousand packages.
However, those who receive it are seriously concerned - deviation from the course of therapy is fraught with the development of the disease. “HIV-positive patients will be left without treatment, since there will simply be nothing to replace this drug,” says the appeal of the “Community of People Living with HIV” to officials of the Ministry of Health and Social Development.
Officials have so far refused to comment on the situation, but experts say that analogues of Viracept will not be difficult to find. Funds spent on the purchase of a defective batch, the company F. Hoffman-La Roche Ltd. promises to reimburse, but this, as well as the purchase of new drugs, will take months. And time for HIV carriers is sometimes worth even more money.