Gilead Criticized for AIDS Drug Supply

Wednesday, February 8th 2006, 10:37 am

By: News On 6

SAN FRANCISCO (AP) _ An international humanitarian group on Tuesday accused the biotechnology company Gilead Sciences Inc. of breaking its promise to make its effective AIDS drug widely available throughout the Third World.

Medecins Sans Frontieres, or Doctors Without Borders, said the Foster City-based company's vow to make the virus-fighting pill Viread widely available has turned out to be an ``empty promise.''

The company has touted its Gilead Access Program in several press releases since it was unveiled nearly three years ago. In April 2003, Gilead said it would make the drug available in all of Africa plus 15 other developing nations ``at no profit.''

The company has since announced it has expanded its access program to a total of 97 countries. In August, Gilead slashed the price of Viread in those countries to $208 per patient annually, compared with the nearly $5,000 annually the drug costs in the industrialized world.

Gilead Chief Executive John Martin said in April 2003 that because the drug had fewer side effects than most AIDS treatments and needed to be taken only once a day that ``Viread will be a particularly important treatment option for physicians and patients in these regions.''

But the humanitarian group said Gilead has yet to garner regulatory approval in 91 of those countries, making it nearly impossible to widely distribute the drug in those regions. The group alleged that company inaction is making it difficult for doctors to supply their patients with the drug, which is used in two popular ``cocktails'' to treats AIDS infections.

Gilead spokeswoman Amy Flood said Tuesday the company has applied for regulatory approval in about half the covered countries and expects to apply for the rest sometime this year.

``The process for approval has been more time-consuming than we had anticipated,'' Flood said. ``This is a commitment that Gilead takes very seriously.''

Flood said Gilead had initially hoped to ship the drugs without winning regulatory approval to the developing world on a ``temporary import'' basis, but found that process too difficult.

Flood said Gilead has supplied the drug at the reduced cost to about 20,000 patients.

AIDS affects about 40 million people worldwide, with nearly 30 million infections in Africa.

The U.S. Food and Drug Administration approved the drug in October 2001 and European regulators approved it in February 2002. Viread accounted for $779 million in sales last year.