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[e-drug] Low-Key Recall of viracept Hits World's Poor

E-DRUG: Low-Key Recall of viracept Hits World's Poor
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[From the NY Times; copied as fair use. Thanks to Leela for spotting. WB]

July 23, 2007
Low-Key Recall of AIDS Drug Hits World*s Poor 
By ELISABETH ROSENTHAL
New York Times, July 23, 2007


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 scope of Roche*s recall is extraordinary, if not unprecedented, in the 
battle against the human immunodeficiency virus that causes AIDS, global health 
officials say. Dr. Lembit Rago, an official at the World Health Organization, 
said tens of thousands of people take Viracept worldwide, many of them poor 
people with H.I.V. in developing countries. The recall has left those patients 
with the painful choice of discontinuing a lifesaving medicine, or using a drug 
that might contain a dangerous contaminant.

Officials at the W.H.O. 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 costs.*

So far, in some countries like Panama, patients or treatment programs have had 
to make up the difference in cost between Viracept and far more expensive 
alternatives. For some patients in other countries, like Venezuela, 
alternatives to Viracept are unavailable.

Roche said the recall affected *Europe and some other world regions* but has 
not been more specific. The recall does not affect the United States, Canada or 
Japan, where a version of Viracept is made by Pfizer. Roche has been in 
discussions with Pfizer about supplying Pfizer*s version to some affected 
countries, but regulatory and licensing issues could take *some time,* said 
Martina Rupp, a Roche spokeswoman.

Roche sells Viracept for use in low-income countries at the discounted median 
price of about 28 cents a dose, according to the W.H.O.*s 2006 global price 
reporting system for AIDS medicine. The drug, also known as nelfinavir, is a 
member of the class of AIDS drugs known as protease inhibitors. It is 
considered an important defense against H.I.V., but it has fallen out of favor 
in Europe in recent years compared with newer medicines that are more 
convenient and cause fewer side effects. 

In some places, newer substitutes are not available to patients, either because 
they are not licensed or are much more expensive, said people with H.I.V. and 
international health experts. In Panama, for example, a substitute drug, 
Kaletra, costs three times as much as Viracept.

*Roche has provided information, but there has been much less support in terms 
of who is going to pay the additional cost,* said Dr. César Nuñez, the United 
Nations AIDS program*s coordinator for Latin America, who is based in Panama.

A more limited recall might have been possible had Roche been more forthcoming 
about the countries affected and the lots that were suspect, said Dr. Rago, the 
W.H.O. coordinator of quality assurance and safety for medicines. *It*s fine 
for Roche to say *withdraw and replace,* but there may not be much else at hand 
to substitute* in many places, he said. *This is not just about Europe.*

In response to questions sent by e-mail, Ms. Rupp said Roche had shipped *at 
least one packet of Viracept with high levels of the impurity to 35 countries.* 
But she declined to say which countries because Roche regards such information 
as proprietary. High levels of the contaminant *were observed in batches of 
Viracept that had been released to countries since March 2007,* she said.

The company made the recall worldwide *in order to avoid confusion,* she said. 
Roche estimates that about 45,000 patients were affected by the recall. Ms. 
Rupp said the toxic substance, ethyl mesylate, should be called an *impurity* 
rather than a contaminant because it was created in the manufacturing process 
and because that type of chemical can be found in very low levels in other 
medicines, although it was not supposed to be present in Viracept.

The company was performing studies on the issue, but the results would not be 
available for *some months,* she said. At high doses, ethyl mesylate has been 
shown to cause cancer in animals, and at lower levels it can cause genetic 
mutations, which means children and fetuses are particularly vulnerable.

Asia Russell, the coordinator of international advocacy for Health Gap, a 
nongovernmental organization based in New York and Philadelphia that focuses on 
medical care in the developing world, said, *It seems that Roche has abandoned 
these patients, since in many places there aren*t ready alternatives.*

In Venezuela, 3,000 people were on Viracept, paid for by the national health 
service, and the effect of the recall was *severe,* because many had no other 
options, said Edgar Carrasco, an advocate on issues relating to AIDS in Caracas.

Alberto Nieve, another advocate, said Roche had promised to make a donation of 
another medicine. *Most people are still waiting,* he said. *They have not 
switched yet, especially outside Caracas.* 

In the month since the recall, officials at the European Medicines Agency and 
the W.H.O. said that they, too, would like more information from Roche about 
the dose of the contaminant and where exactly the medicine was sent.

*We have not gotten information, not even an order of magnitude,* said Martin 
Harvey-Allchurch, a spokesman for the European agency. *I understand sales 
figures are confidential, but I would have thought by now we would have this 
information.*

Viracept was sold in 49 countries since 2004, according to the W.H.O., with 
more than 12 million units sold in 2006 and 2 million in 2007. Tido Von 
Schoen-Angerer, director of the essential medicines campaign at Doctors Without 
Borders, said about half of the 400 patients who received therapy supplied by 
the group in Africa were on Viracept. The alternate from Abbott is not yet 
available, he said.

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