What Falsified Data? Ranbaxy And PEPFAR

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pepfarGeneric drugmakers, many of which are based in India, now dominate President George Bush’s program to provide AIDS treatment in poor countries, The Wall Street Journal writes.

Generics accounted for 57 percent of the $131 million spent by the US on the program in fiscal 2007, which ended September 30, according to the Office of the US Global AIDS Coordinator. In 2005, generics accounted for 11 percent. At that time, the US approved few generics for the program, so most money went to buy more expensive brand-name drugs, the paper continues.

The President’s Emergency Plan for AIDS Relief, or Pepfar, spent more than $39 million on Aurobindo Pharma products, making it the biggest player. India’s Cipla received more than $15 million, and Ranbaxy Laboratories received nearly $9 million. “The key is having affordable and accessible medicines, and I think the generic industry has made a contribution in a very positive way to Pepfar,” Chuck Caprariello, a Ranbaxy spokesman, tells the paper.

However, US authorities recently raised serious questions about the caliber of Ranbaxy meds distributed through the Pepfar program. Federal prosecutors allege Ranbaxy falsified records that resulted in the production and sale of meds that didn’t meet FDA standards. The allegations under investigation include fabricating bioequivalence and stability data to support AIDS drugs to be paid for by the Pepfar and distributed to foreign countries.

This revelation emerged only days before Bush signed a $48 billion, five-year expansion of the program, which the paper writes now draws widespread praise and is viewed as a major part of his legacy. “It’s pretty clear that the system is working well, and it protects African families just like American families are protected,” Ambassador Mark Dybul, the US global AIDS coordinator, tells the paper.

Apparently, no one asked him about Ranbaxy drugs.

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  1. “…it protects African families just like American families are protected,” Ambassador Mark Dybul, the US global AIDS coordinator…”

    Apparently no one asked them about the new study showing African PWAs get better treatment than black Americans either.

  2. Ed,

    Thank you for the follow up.

    Anne

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