Low-Key Recall of AIDS Drug Hits World’s Poor

While I think about it, the Kaiser Foundation site is hosting webcasting of the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention. If it’s your thing. Play it in your cubicle instead of ESPN; see what happens around you..

This story, courtesy of an email from a former colleague:

ROME, July 21 — A total recall of an important AIDS drug widely used in developing countries has disrupted treatment for tens of thousands of the world’s poorest patients, with no clear word from the manufacturer on when shipments will resume.

The recall of the drug, Viracept, by Roche Pharmaceuticals of Switzerland, went largely unnoticed in the developed world when it was announced in early June, after the company had discovered that some batches made at its Swiss plant contained a dangerous chemical. But the recall has caused growing concern among global health officials and in AIDS programs in many poor nations. They say the company did an inadequate job of informing patients and officials about the potential risks and helping them find affordable access to newer alternative drugs.

Roche said that it had been actively working with health officials across the globe and that the risk from the affected batches was low.

The Precautionary Principle applies strangely, here. The IHT has considered it already:

Just when it looked like things were getting better for carriers of HIV in poor countries, old-fashioned negligence has thrown a monkey wrench (or spanner, if you prefer) into the works.

Perhaps erring on the side of caution, Roche recalled the drug worldwide after discovering that lots containing a cancer-causing chemical were shipped to at least 35 countries. Some countries might have received untainted lots, but their doctors have no way of knowing; even if Roche knows, it won’t say.

This is a problem because alternatives to the low-cost drug aren’t easily available. So doctors in poor countries – mostly in Latin America, Africa and Asia – may be sending back a perfectly good treatment, leaving their patients with nothing.

One side dictates the global recall; the other dictates, what? Less-than-global, I suppose. A warning, without a recall, and then some very fast and clever work on engineering some test, to detect the ‘bad’ drugs? It depends upon how ‘harm’ was defined. One gets the impression that harm to Roche was, naturally, a big consideration. Better to be criticised by these (poor) countries for treating them badly, than be known for sending out drugs that did more harm than good. I think. Honestly, would we even care? Our newspapers barely mention train wrecks that kill hundreds, and can anyone even name the places where the Asian Tsunami hit (Prof. Gunter is disqualified from answering)?

I’m being cynical, if with good cause.

Back at the New York Times:

Officials at the WHO in Geneva and the European Medicines Agency in London said Roche had not provided information they consider essential for safeguarding public health: which countries the tainted medicine was shipped to, the concentration of the contaminant and what the company will do for its patients. The European agency, which regulates drugs for the European Union, has canceled Roche’s license to market the drug.

Dr. Rago called the recall “sort of a disaster” for patients in very poor countries. He said of Roche, “They failed in communication.” Roche has denied the accusation. The company, which had revenue of $35 billion last year, said it promptly notified health providers in the affected countries to discontinue use of the drug, which is dispensed in both pill and powder form. It also said it would cover the “reasonable costs” of the recall. It did not define “reasonable co

I like the “sort of a disaster” although, to be fair, developing countries can give the rest of us lessons is disasters. Like cover-ups and crimes, it seems Roche is suffering less for the problem, or the recall, than how bloody badly it has managed the affair, and how little it is sharing with self-declared (but broadly agreed-upon) organisations of oversight. Losing the European license for their HIV/AIDS drug hardly bodes well for the company that has a license for Tamiflu, there – for those who fear avian influenza (I would remind you that God promised fire, not bird ‘flu, and that’s how we measure risks in the USA).

One benefit of a global recall is that it prevents a targeted recall being sent to hell by grey or black markets in these drugs. It is possibly better to assume all drugs are bad, than have good drugs in your country after your country’s allotment was already recalled. Again, allow for the fact that I’ve lived in only very highly-developed countries, disease free. For which I’m more and more grateful.

Seriously, though, what a mess. As the IHT’s blog asks, though, who can call Roche to account?

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