Saturday, June 26, 2010

Global health ... ARV supply interruption at Bristol-Myers Squibb

Dear Colleagues

On the face of it a supply interruption of antiretroviral (ARV) drugs is obscene. According to a writer with IRIN PlusNews a Bristol-Myers Squibb (BMS)factory supplying essential life-prolonging ARV drugs for infants will close in France this month and a new factory to continue production or the drug will be approved for manufacturing in the USA in February next year. Available stocks will run out probably in December, the article reports. Activists think it will be April before production of the drug goes back on stream.

This is the URL ... the text of the IRIN article is at the end of the post.

The story raises a number of questions about the nature of the global health sector. There are periodic observations that the major drug companies put profit before people and are in the business of making money more than they are committed to global good health. There are all sorts of pieces of evidence that this is the case, including the constraints on allowing low cost manufacturing of life saving drugs.

Over the years, there have been many initiatives to make drug supplies available to help poor people in developing countries. An initiative of the ExIm Bank of the US during the Clinton Administration was rejected by developing countries as being nothing more than a way of funding the transfer of wealth from poor countries to big pharmaceutical companies ... and the more recent initiative of the Clinton Foundation related to drug procurement that is referred to in the IRIN article has some of the same characteristics.

Big pharmaceutical companies have become very profitable because of high prices and high margins ... which are not obviously related to high investment in research and development, but more, I would argue to the restraint of competition through the patent regime and regulation. In the meantime, the science and the products are available technically for the treatment of disease in poor economies, but not affordable at prevailing big pharma prices. The ongoing fights against generics are understandable ... but the cost in terms of human health is unacceptable. There is a better way, but no political will to address business model of big pharma as important suppliers to global health.

A system of metrics that includes not only the profit but also the value of what companies do would change the nature of the corporate playing field. Much great work is done by researchers ... but only work that creates corporate profit gets corporate support while anything that has merely value through saving lives in poor countries is getting left on the shelf ... the so-called orphan drugs! Appalling state of affairs ... but what one should expect with a system of metrics that only takes profit into account!

Here is the text of the original post:
Factory closure could leave 7,000 babies without ARVs. Activists say the drug could be out of production until April 2011
NAIROBI, 9 June 2010 (PlusNews)

Civil society activists are protesting the closure of a factory that produces the only UN World Health Organization-pre-qualified version of a life-prolonging antiretroviral (ARV) drug for infants.

Pharmaceutical giant Bristol-Myers Squibb (BMS), which owns the French factory that produces didanosine, a second-line ARV for babies weighing less than 10kg, will shut down the plant in June 2010, stopping production of the drug until at least February 2011, when regulatory approval of a new United States-based manufacturing site is expected.

"Closing this factory means that 4,000–7,000 babies currently enrolled in treatment plans in developing countries through UNITAID [a funding mechanism for HIV treatment] could be left without the medicines they need," said the authors of a letter to BMS chief executive officer Lamberto Andreotti.

Didanosine is the last therapeutic option for these babies, and without it they could die ... there is likely to be a shortage of about 15,000 packs of didanosine 25mg across all UNITAID beneficiary countries between now and when production is expected to resume in April 2011," the letter, published in The Lancet, read.

UNITAID, the main buyer of didanosine for distribution to developing nations, issued a statement urging BMS to take all measures to ensure the continued supply of didanosine 25mg and 50mg during the transition of its manufacturing site, so as to avoid interrupting treatment of the children whose lives depend on it.

BMS said unforeseen demand had put a strain on the supply of didanosine, but they had taken steps to ensure uninterrupted supply of the drug until the US factory opened. The product would become available immediately upon regulatory approval of the US site.

"We preventively built up inventory to twice the level of 2009 demand," BMS spokeswoman Sonia Choi told IRIN/PlusNews. "We are actively working with procurement agencies to provide didanosine to patients in need, and to ensure minimal disruption."

Didanosine is the last therapeutic option for these babies, and without it they could die
However, UNITAID spokeswoman Daniela Bagozzi told IRIN/PlusNews that the Clinton Health Access Initiative, through which UNITAID distributes the medication, reported that existing stocks would last only until December 2010, and that regulatory approval of the new BMS site was unlikely to be received before April 2011, extending the period of likely shortages.

"At the moment we are still in talks with BMS but we are also looking at other solutions. We are asking manufacturers of generic versions of didanosine to seek WHO [World Health Organization] pre-qualification, and are in talks with WHO to expedite the pre-qualification of alternatives," Bagozzi said.

"By having alternatives we bridge the current gap, but we also ensure that should the same thing happen in the future, the lives of young children are not jeopardized."

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