December 14, 2004

In War on AIDS, Generics Give Poor a
Fighting Chance

Carol Adelman's claims about generic AIDS medicines ("Deadly Medicine," Dec. 9) are deliberately deceptive and dead wrong.

Doctors Without Borders, or Médecins Sans Frontières (MSF), treats 23,000 people in 27 countries, and does not prescribe "unproven and outmoded drugs." Our clinical results, published in peer-reviewed medical journals and presented at international conferences, parallel those in wealthy countries. After one year of therapy, patients' immune systems improved significantly, with CD4 cell counts increasing on average by 135. In Khayelitsha, South Africa, 84% of patients had undetectable amounts of the virus in their blood after one year.

MSF physicians, like doctors in wealthy countries, prescribe generic medicines every day. As the scandal with Merck's Vioxx illustrates, regulating brand-name drugs and generic medicines requires constant vigilance. True, several generic AIDS medicines were removed from the World Health Organization's prequalification list -- but to resolve important questions about the paperwork demonstrating the drugs' bioequivalence, not because of deadly side effects, as with Vioxx. New studies on two of these medicines provide indisputable proof of their therapeutic equivalence with brand-name versions.

Ms. Adelman, who is not a physician, may not realize that drug resistance is a fact of life with HIV, or that the majority of resistant strains are in the U.S. and Western Europe, not Africa. The best way to delay resistance is to maximize treatment adherence, and in MSF's projects, adherence rates often exceed those in wealthy countries. This is largely because of intensive counseling and the use of triple fixed-dose combinations -- one pill twice a day -- that are only available from generic sources because of patent barriers.

When brand-name drugs were the only option, AIDS was a death sentence in the world's most impoverished regions. No amount of distortion can change the fact that generic competition led to dramatic price drops -- from $15,000 per person per year to just $150 -- making treatment a reality for a small but growing number.

Like arsonists masquerading as firefighters, Ms. Adelman's Hudson Institute and other industry-funded groups pretend to have the best interests of patients at heart while treating their needs with contempt and blatantly disregarding medical ethics and evidence-based science. People with AIDS need affordable and effective treatment, not massive disinformation.

Dr. Rowan Gillies
President, Medecins Sans Frontieres International Council


Ms. Alderman is widely off the mark in her comments about the drugs used to fight AIDS in the developing world. On July 15, the New England Journal of Medicine published an article showing that one of the generic drug combinations used by Doctors without Borders made HIV disappear from the blood in 68% of patients. The same drug combination, purchased from brand-name manufacturers, made HIV disappear in 67% of patients, as reported in another prestigious medical journal, The Lancet, on April 17. Tell me, please, where is the evidence that Doctors without Borders recommends inferior drugs?

The complaint regarding generic drugs is not that they produce low blood levels, but that the tests have not been properly done. For instance, the WHO delisted two Cipla drugs in May because documentation regarding bioequivalence was insufficient. Tests have now been repeated, and Cipla passed with flying colors. On Nov. 30, the WHO reinstated the two drugs in its list of qualified medicines.

It's not surprising that some drugs made in developing countries fail U.S. Food and Drug Administration and WHO tests. It is patently unreasonable to expect that industries in developing nations can perform to Western standards each time, and on their first try. It would be nice if cows could sing, but unlikely. Until they learn, MSF reasonably suggests, the poor should be permitted to drink the milk.

Ms. Alderman wants to pour it out. She accuses MSF of favoring "poor drugs for poor people." Not true, but we all know what she and her ilk at Hudson Institute favor: extended patent protection, universal FDA standards and high drug prices.

In other words: no drugs for poor people.

Bernard Hirschel
Head, HIV/AIDS Division
Geneva University Hospital

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