Glaxo quits HIV drug trial for third world

1.00pm

WASHINGTON - Giant international drugmaker GlaxoSmithKline Plc dropped out of an Aids drug trial after a rival company's drug was substituted for a Glaxo best-seller, a member of Congress said on Wednesday.

California Democratic Representative Henry Waxman said Glaxo's decision could doom the study, aimed at finding the most effective cocktail of drugs for use in developing countries hardest hit by the Aids epidemic.

"Your company's action is undermining efforts to determine how to treat millions of people infected with HIV around the world," Waxman, ranking Democrat on the House Government Reform Committee, wrote in a letter urging the British-based company to reconsider.

More than 40 million people globally are infected with the Aids virus and it has killed 25 million in 20 years. There is no cure but combinations of drugs can keep patients alive.

With 20-odd drugs on the market it is difficult to know which combination works best. Drug companies usually test their own drugs but also donate them to government-funded researchers.

A team sponsored by the US National Institutes of Health was going to compare three regimens, all using Glaxo's best-selling drug Combivir.

But later Emtriva, made by one of the four other companies taking part in the trial, Gilead Sciences Inc, was substituted for Combivir in one arm of the trial.

"According to a senior investigator involved with the study, your company attempted to pressure researchers to drop this comparison 'as a quid pro quo for providing the drug'," Waxman wrote.

Dr Robert Schooley of the University of Colorado said his team decided to try Emtriva because it will be part of a simple once-a-day combination pill using three drugs.

He also said people in developing countries may respond to strong HIV drugs differently than do people in rich countries, where drugs are typically tested first.

"You have to be careful how to translate research from Boston to Malawi," Schooley said in a telephone interview. "We really feel strongly that you have to be able to compare regimens that are used here with new regimens."

Glaxo spokeswoman Nancy Pekarek said the company dropped out of the trial when it was changed because it no longer conformed to World Health Organisation guidelines.

"We did not believe that it was any longer appropriate because it was not fulfilling any public health need for regimens in poor-resource settings," she said in a telephone interview.

It would cost US$6 million ($9.56 million) to pay for Combivir in the study at US retail prices, the researchers said.

Glaxo drugs make up 45 per cent of the HIV drug market. Waxman said Glaxo had earned more than US$1 billion from sales of Combivir from 2001 to 2003 in the United States.

Pekarek said the company took his letter seriously and would respond.

- REUTERS