Shameless

A couple of months ago, a friend complained that my columns were too focused on AIDS. He told me to mix it up more. Well, I’ve tried, and I’ve failed—the Bush administration’s recent efforts to block access to cheap generic AIDS medications are simply too shameless to ignore. But I don’t want to pigeonhole this story as just an “AIDS” issue. Think of it as the ultimate Bush administration case study: an inside look at how a cynical White House policy is undermining a prestigious multilateral institution, wasting taxpayer dollars, and jeopardizing thousands—potentially even millions—of lives by subordinating good science to corporate special interests.

Our story begins last year, when President Bush announced the creation of the President’s Emergency Plan For AIDS Relief (PEPFAR). One of PEPFAR’s central planks is treatment, namely putting 2 million people onto anti-retroviral AIDS medicines by 2008. But not all anti-retrovirals are created equal. Today, the administration faces a critical choice—whether to allow PEPFAR grantees to purchase generic three-in-one fixed dose combination (FDCs) therapies.

By all rights, the choice should be simple—generic FDCs have significant advantages over the brand-name alternatives. First and foremost, they are much cheaper. The group Médecins Sans Frontières currently procures generic FDCs for its treatment programs at a cost of about $280 per patient per year. By contrast, the cheapest brand name anti-retrovirals sell for $562, or twice as much. This gap will soon double—the Clinton Foundation last month negotiated an agreement with generic manufacturers to supply FDCs to developing nations for as little as $140 per year. If these price differentials don’t seem like a big deal, consider the human cost: PEPFAR has a tightly capped budget, so buying more expensive brand-name drugs means buying fewer drugs—two to four times fewer drugs. That means two to four times fewer individuals will receive access to lifesaving drugs; they’ll be given a death sentence instead.

FDCs are also preferable from a therapeutic perspective. Where brand names drugs require patients to adhere to a complicated regime of six pills per day, FDCs allow for a simplified regime of two pills per day. This increases rates of adherence which in turn reduces the risk of viral mutation and the emergence of drug-resistant strains of HIV.

Yet despite these compelling advantages, the Bush administration refuses to authorize the purchase of FDCs. This is a little suspicious—the pharmaceutical industry is a huge contributor to and close ally of President Bush, and they stand to lose big if he green-lights generic FDCs. In addition to losing lucrative contracts, they fear that their long-term profit margins will suffer if generic manufacturers continue to gain greater international legitimacy and clout.

But let’s not get carried away by conspiracy theories. The administration’s opposition to FDCs is surely driven by nobler aims. Testifying before Congress, the President’s Global AIDS Coordinator Randall L. Tobias, asserted that generic AIDS drugs “may well be perfectly safe and perfectly effective...and then again, they may not be. The problem is, there is no process, no principles, no standards in place today, from a regulatory point of view, to make that assurance.” A compelling argument, if only it were true. Tobias’ testimony conveniently ignores the World Health Organization’s (WHO) expert drug review and prequalification system, which, as Rep. Henry Waxman, D-Calif., aptly put it, “constitutes a process, includes principles, and sets standards.” What’s more: the two generic FDCs in question, Triviro and Triomune, have both been approved through the WHO’s pre-qualification process.

The administration now maintains that WHO certification is not satisfactory and has busied itself erecting onerous regulatory obstacles to block FDC approval. The irony is that for years, the U.N., the World Bank, the Global Fund to Fight AIDS, Tuberculosis and Malaria and even the U.S. government itself have used WHO certification as a basis for their drug procurement policies. That’s because the WHO approval process is extremely rigorous. In fact, the additional regulatory conditions proposed by the administration exceed current FDA protocols.

The FDCs controversy is quickly becoming a black-eye for the White House. When the United States convened an international conference in Botswana to discuss the issue last month, the European Union’s leading drug regulatory authority boycotted the meeting. Congresspersons, including independent-minded Republican sens. John McCain, R-Ariz., Lincoln Chafee, R-R.I., and Olympia Snowe, R-Maine, have signed open letters criticizing the administration’s stance.

Now that it’s beginning to feel some heat, the administration is reassessing its alternatives. The latest news is that they’re working to construct an expedited FDA approval process that could sanction FDC procurement in a matter of months. We’ll see. It is unlikely that any such process will be set up before September, at the earliest. In any case, establishing a parallel approval process to the WHO’s is not the solution. This would just pave the way for political interference in future scientific decisions and, as Waxman notes, lead to “conflicting international standards, confusing countries and donors.”

The Bush Administration needs to end this deadly charade. I’d have more respect for Tobias and the President if they dropped all the pretense about “safety and efficacy,” stopped trying to undermine the WHO and just admitted that they’re really acting to protect pharmaceutical industry interests. Then the American people could see the issue as it really stands, and they could decide for themselves whether to put drug company profits before human lives.

Sasha Post ’05 is a social studies concentrator in Adams House. His column appears on alternate Thursdays.