Chicago Tribune - January 28, 2005

The Food and Drug Administration early in the week approved the first generic "drug cocktail," giving hope to those in poor nations who couldn't afford the life-saving medications.

And it was reported on Thursday that the administration will request $3.2 billion from Congress for the 2006 installment of Bush's AIDS plan. No other president, or country, has done more to fight AIDS worldwide than Bush and the U.S.

Ever since Bush announced his plan in 2003, some have criticized the fine print that stipulates that taxpayer funds could be used to buy only brand-name drugs made in the U.S.

That precluded the plethora of far cheaper generic drugs made in the Third World, primarily in Brazil, South Africa and India, that often were knockoffs of those from Western countries.

"Drug cocktails" lower viral levels sometimes to undetectable levels, prolong life expectancy and lessen significantly the chance of infection of spouses and partners. Yet millions of people affected could not afford the drugs, which can cost $700 a year for the brand-name drugs, compared to $250 for the generics. The FDA decision is bound to change that.

That huge cost differential undermined the U.S. goal to distribute the drug to as many as 500,000 people in Africa by last September. Only about 170,000 have received it so far.

The U.S. contributes about a third of the funds for the Global Fund to Fight AIDS, Tuberculosis and Malaria--which can use the money to buy generics. But direct funding from the U.S. was constrained by the brand-name requirement. The drugs bought by the global fund are licensed by the World Health Organization, according to procedures some claim are every bit as stringent as those used by the FDA.

The way around these restrictions was for the American pharmaceutical companies to work with Third World firms effectively to share the patent. The FDA cannot approve a generic if the patent for the original drug is still in place.

The compromise worked out by the drug companies and the Bush administration is a sensible solution to a two-year impasse. Some drug manufacturers have agreed to work with Third World manufacturers. In this case, the FDA also waived its normal $500,000 licensing fee and sped up approval to two weeks, far faster than the normal six months.

Accordingly, Aspen Pharmacare, based in South Africa, will be allowed to produce a generic version of an AIDS cocktail that contains drugs developed by GlaxoSmithKline, a British firm with operations in the U.S., and Boehringer-Ingelheim, a German company. The FDA has granted "tentative approval" to the generic version, which limits its sale to poor countries.

So far, so good.

The question now is whether other drug companies will take similar action. An official at the president's Global AIDS Fund assures that we can expect similar arrangements by other firms.

Not everyone is enthralled with the developments of this week. Some say the full gamut of AIDS drugs won't be available--and must be because some people don't respond to certain medications or develop a resistance to them. Others wonder if the administration's latest move is but a token gesture.

Word of the $3.2 billion budget request, though, should help to allay any remaining doubts of Bush's commitment to this cause. The White House budget request, of course, is not the final word. That will come from Congress, and Congress is going to be under intense pressure--as it should be--to reduce the size of the projected deficit in the coming budget. This needs to be a lean budget year, but the U.S. should keep its commitment to fight the crisis of AIDS, which is having a devastating economic and social impact across the globe.

For all the criticism it has received, the Bush administration's plan to fight AIDS in the developing world is far more sweeping than anything else in play. No other country even comes close.

The increasing funding and wider access to cheaper generic medication should be enough to silence the critics. For his part, President Bush should push ahead with his strategy and as quickly as possible. Those affected by the disease haven't got time to spare.

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