If Russians nix loan, TB fund might dry up

Nation’s drug makers said to fear squeeze-out

If the Russian government turns down a $150 million loan from the World Bank intended to fight the country’s TB epidemic, the move could imperil other potential public health loans targeted for the country, says an expert on Russian TB.

"The current trend in global health is toward [the commitment of] more and more funding," says Alex Goldfarb, PhD, TB program director of the New York-based Public Health Research Institute (PHRI). "But if this — the first major international effort to combat TB in Russia — should fail, then additional funding from other international agencies may not follow."

Representatives of the Russian Health Ministry surprised observers with a sudden about-face, announcing they no longer wished to accept the funding. The Health Ministry has been negotiating the loan with the World Bank for two years. The loan had reached the final stages and seemed poised for approval. Suddenly, the ministry announced it had changed its mind and refused to sign.

The culprit is the Russian pharmaceutical industry, says Goldfarb. Members of the industry fear their products won’t meet the tough Good Manufacturing Practice (GMP) standards imposed by the World Bank on medications the loan would be used to purchase. "Because they’re worried they’ll be excluded from loan purchases, they’ve been lobbying heavily against the loan," he says.

None of the Russian firms have gained the GMP seal of approval yet, though a few are close to completing the application process and may soon be approved, adds Goldfarb. In other instances, though, the industries’ fears could be well-founded, he says.

"From the [Russian drug industry’s] perspective, I suppose it’s a legitimate complaint," says Goldfarb. "But that’s small consolation to the Russian TB patients who are dying for lack of drugs."

Even though Goldfarb calls the Health Ministry’s announcement "a serious threat" to the loan, he adds that there are other forces at work that may turn the situation around.

The Russian Ministry of Justice, which runs the country’s crowded prisons, is among those lobbying hard for accepting the loan, because TB is concentrated heavily in the prisons. Regional public health departments also want the loan to go through because they bear the brunt of treating people with TB. In any case, the final decision will be made by the Russian prime minister, not the Ministry of Health, adds Goldfarb.

Russian TB case rates have soared to 100 per 100,000 people. That is triple the rate of a decade ago and fifteen times the rate in the United States Each year, 30,000 Russians die of TB, with two million patients registered at overcrowded clinics.

One in 10 inmates in the country’s overcrowded prison system is infected with the disease; in some prisons, a fifth of TB patients are infected with multidrug-resistant (MDR) strains. Because few inmates seek treatment after they leave prison, international TB experts say the prisons function as "epidemiological pumps," working efficiently to spread the epidemic into civilian populations.

Exacerbating the TB epidemic is the fact that AIDS and HIV rates in the nation doubled between 1997 and 1999, according to World Bank officials. The bank estimates that by 2005, AIDS and TB together will cost the country 1% of its gross national product.

So far, only about 6% of TB cases across the country are currently receiving DOTS, the TB treatment strategy approved by the World Health Organization. A host of non-governmental agencies and other organizations have DOTS pilots up and running in various provinces. Recently, the first DOTS-Plus pilot — jointly administered by Harvard Medical School TB experts, the British nongovernmental organization Merlin, and PHRI — won approval from the WHO’s "Green Light Committee" for their second-line drug regimen.

That means the Tomsk project, which aims to treat prisoners suffering with MDR-TB, should be under way soon. The project will be the first DOTS-Plus project launched in Russia. Initially, 100 prisoners in Tomsk will get expensive second-line drugs, obtained at sharply reduced costs following negotiations with American drug companies.