AIDS activists shout slogans during a demonstration Sunday, July 11, 2004, on the opening day of the 15th International AIDS Conference in Bangkok, Thailand. Credit: AP Wide World/ Sakchai Lalit

Responding to pressure groups, the Cambodian government halted an important clinical trial scheduled to start in September, to test whether the Gilead AIDS medicine, tenofovir (Viread), approved to fight HIV infection, might also prevent the transmission of HIV. Biotech companies may think twice about entering drug development for diseases that fuel controversy and may need to spend more time analyzing the politics surrounding their patient groups, and more effort gaining the support of pressure groups before going ahead.

Two years ago when the University of California, San Francisco, and University of New South Wales in Sydney, Australia, first started designing the placebo-controlled trial for the Gilead drug, the collaborators knew they were up against a vexing scientific challenge. What surprised California-based Gilead is that this study proved to be fraught with more politics than they had anticipated. Before the study even began, it became a focal point for AIDS activists like ACT UP and Oxfam, which very much dislike the company's choice of trial locations and participants: 960 prostitutes in Cambodia.

Even though ethics committees in Cambodia and America, as well as the union that represents these sex workers, had signed off on the trial, activists charged exploitation. At the World AIDS Conference in Bangkok in July, activists took their complaint to the media. There, the firm was even chided by the non-governmental organization (NGO) Doctors Without Borders for charging too much for tenofovir; the price had been discounted by 37% just two days before. If the trial proves successful, the company has guaranteed the trial participants will receive the drug for free for two years and give the drug away at cost to developing countries after the two year post-marketing surveillance has taken place.

Cambodia's subsequent intervention in closing the trial, and the political passions that precipitated it, come across for some as an ominous foretoken. “There are so few drug companies that even risk it with diseases like AIDS and markets like those in the developing world that I can understand why some in the industry are asking, 'Why bother?'” says Raj Bawa, of Bawa Consulting, a Washington, DC-based biotech consultancy that works in places like India and Thailand.

This [tenofovir] trial was starting to draw attention to a group that most drug companies and governments don't typically pay much attention to--sex workers--who have a growing role in the spread of HIV-AIDS. Staffan Hildebrand, Face of AIDS

Gilead felt that it was doing a good thing by going to a developing country like Cambodia, where HIV infection and transmission—particularly among sex workers—is soaring. “It's really too bad because this [tenofovir] trial was starting to draw attention to a group that most drug companies and governments don't typically pay much attention to—sex workers—who have a growing role in the spread of HIV-AIDS,” says Staffan Hildebrand, a Swedish filmmaker with the Face of AIDS in Stockholm who has spent 18 years documenting the AIDS pandemic. “It took years to convince companies to develop drugs for AIDS and now some activists are doing their best to chase them away.”

Now, pharmaceutical companies are no longer the only ones to bear the brunt.

“Biotech companies have spent all these years—and capital—getting this very complex science right to treat diseases in complex markets only to discover that their best efforts might not be good enough,” points out Steven Burrill, CEO of investment firm Burrill & Co. in San Francisco. No firm has dropped product plans because of controversy just yet. “It's hard to quantify, but I do feel that political uncertainty is increasingly having an adverse effect on investment and product focus in biotech firms,” says Bjorn Odlander, founding partner of the venture firm HealthCap, which is based in Stockholm.

There are no fail-safe ways to avoid political controversy, but Cambridge, Massachusetts-based Vertex Pharmaceuticals benefited from the lessons that partner GlaxoSmithKline, which sells Lexiva, a protease inhibitor for HIV, learned the hard way several years ago when it attempted to put its AIDS medicines into the standard drug pricing model. They have thus far avoided the wrath of activists with some careful maneuvering, including pricing its drug at a discount from the highest priced drug in its class and, early on, forging links with patient advocacy groups. In fairness to Gilead, the company originally priced tenofovir on the high end in part because the drug has the best safety profile in the market, and it took pains to do the right thing on these new tenofovir trials.

However, there are limits to what can be done to avoid backlash. “It doesn't matter whether you're talking about stem cells, GMOs, AIDS trials,” notes Ortwin Renn, professor at the University of Stuttgart and director of Dialogik, a think tank, who was speaking at the EuroScience Open Forum in Stockholm on August 28, adding: “Some people want the risk factor to be reduced to zero—and will not trust or accept anything that falls short of this ideal.”

In this context, biotechs could, as some think is already happening, simply ditch products whose clinical trials and pricing might prove controversial. Or, as one commentator after another suggested at the EuroScience forum, to do a better job anticipating backlashes, the industry could start to expand links with activists, patient groups and foreign health officials in developing nations. Improving communication with politicians and community leaders would also help. Until then, much will be lost in translation between the biotech industry and its detractors.