/ 13 March 2006

Firms fail on pledge to deliver life-saving drugs

Major drug companies are still not making life-saving drugs available to millions of people with HIV/Aids in the developing world, according to the charity Médécins Sans Frontières (MSF).

Basic three-drug cocktails in a single pill are being slowly rolled out to some who need them, but doctors fear many of those people will die within a few years if they cannot get hold of alternative drugs that are widely available in Western countries.

In Khayaleitsha, a township on the edge of Cape Town, where MSF pioneered the treatment of poor people in South Africa, some have now been on a basic drug cocktail for four years. Long before that, however, resistance builds up — the virus in the body mutates to overcome the effects of the drug and the patient becomes sick again. In one of MSF’s programmes, 16% of patients now need what is known as ”second line” drugs.

But MSF says some of the drugs they need are not available in Africa because manufacturing companies have not registered them there. Until a drug is registered, it cannot be approved by government authorities for use in that country.

In South Africa and Zimbabwe, where treatment programmes have been in place for several years, there is a critical and growing need for the drug tenofovir. A manufacturer, Gilead, promised in December 2002 it would offer the drug at a reduced price in 68 developing countries and last March extended the list to a further 97. But the company has not registered the drug where it is needed, says Nathan Ford of MSF. As of October, almost three years after the price cut was announced, tenofovir was registered in only 10 of the 97 eligible countries, he writes in this week’s Lancet. The application was completed in South Africa in December. By February, Gilead had applied for registration in only 11 of 53 African countries.

”Companies gain good publicity for announcing discounts for the developing world, but their intentions have to be backed up by a proper commitment to actually make the drugs available,” writes Ford.

Tenofovir is important because it can replace stavudine — one of the widely used components of the basic three-drug Aids cocktail. Stavudine can cause life-threatening side-effects in some patients. This weekend, the World Health Organisation included tenofovir as both a recommended first-line and second-line drug its latest guidelines for Aids treatment.

It is only one example of what could be a growing problem unless the companies move to make their newer drugs available quickly, MSF’s doctors believe.

Another big research-based pharmaceutical company, Abbott, has just had a new version of its drug Kaletra licensed in the US. Instead of six pills a day, there are now four, patients can take them without food and the drug does not need to be refrigerated, which makes it perfect for Africa, where the lack of refrigeration is a big issue affecting treatment.

But, says MSF, although this drug is needed for second-line therapy in Africa, it is not available in any developing country and no price cut has been suggested. – Guardian Unlimited Â