Low-Key Recall of AIDS Drug Hits World’s Poor
ROME - 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.
Copyright 2007 The New York Times Company
Sometimes I look at an incident like this and I ask myself if what is happening is neglect, or is in some way intentional.
Me, too, key89. Especially, since these incidents hardly ever happen to a population that would have the platform to express its outrage, and the clout to get something done about it.
Wow, “key89″ and “meg”- I had the same mental flash, when I read this- hmmm…
It’s all part of a plan to depopulate the poorer parts of the world by inflicting disease and withholding medications from those who cannot afford them. Depopulation has been a Rockefeller Foundation objective for decades. AIDS itself was deveoped as a bioweapon at the biowarfare labs st Ft Detrick, MD. This, as part of the Pentagon’s viral cancer program of the late 60s and early 70s. There are some evil forces behind Big Pharma that go back to eugenics programs of the early 20th century and to companiess like I.G. Farben.
Give me a break. If they HADN’T recalled the drug and people started dying you would have been all over them for intentionally killing people.
The solution to this is very simple–India, Japan, or PRC have competent pharmaceutical chemists. They need to take the Roche and other formulations and mass produce them and distribute them throughout Asia, Africa, and anywhere else they are needed by poor peoples abandoned by the likes of Roche.
The Catholic church and other religions share the blame for the AIDS epidemic in Africa for not allowing the use of condoms. The racist Republican Party also shares the blame for de-funding programs like Planned Parenthood who provide condoms for free in Africa.
aardvark … had they not pulled the drug, the issue would be the same — these things do not happen in empowered communities. look at what is happening with the poison housing FEMA supplied to the poor folks of the katrina disaster.
It’s still depopulation. There’s NO EXCUSE for the DEADLY SUBSTANCE being IN it, to BE found, to begin with.
Yes, since it WAS there they “had no choice” but to recall it. But all of the sudden it’s there, and was NOT there year after year before now?
And only since this specific drug became critical to parts of the world that are seriously over populated?
How extremely coincidental, that is.
At SOME level, it is a depopulation issue.
Is it not possible the HIV/AIDS was made to happen on purpose?
Viracept is fairly easy to replicate and manufacture. All a competent chemist needs are the chemical abstracts available at any library. If Roche wants to withdraw from producing the drug for poor people in Africa, it’s about time someone told them to fuck themselves and start cranking out Viracept in massive quantities.
I agree with Poet,
“India, Japan, or PRC …They need to take the Roche and other formulations and mass produce them and distribute them throughout Asia, Africa…”
The problem is that those countries are also devotees of the free markets mantra, respect for private and intellectual property, and will continue behaving as “good members of the international community”, in the meantime millions of their own people die of neglect.
Only Socialism will stop and eliminate these problems, hoping for a solution within a greedy and profits driven World is worthless wishful thinking.
What Asia, Africa and the rest need is to find decent leaders, people like Chaves in Venezuela to stamp out all these Capitalist leeches from the face of the Earth.
Good points Ezeflyer and Ragnarok. As for Dave Pepper’s assertion there are precedents: 1. EPA lies about safety of NY air after 911 2. US govt assertion the art was fine after nuclear tests done in SW desert (now there’s the downwinders organization fighting all the cancers their families have endured) 3. That big pharma managed to get life saving drugs in under an “intellectual copyright law” that protects their profits so egregiously over the lives of 3rd world poor. 4. Tuskegee (?) incident where prisoners were given a placebo to “fight” Syphillus. (Spelling?) 5. LSD experiments done unknowingly on US servicemen in Viet nam. 6. Agent Orange and denial of its effects 7. Depleted uranium and denial of its link with “Gulf War syndrome” etc. I’m sure others can add MANY numbers to this conservative list of what authorities SAY is safe versus the TRUTH that’s somewhere out there!
Back in the early l990’s I read a fascinating story in ROLLING STONE that cited how the Salk Polio vaccine ran amok and led to the AIDS epidemmic. Originally it was the population of SW Africa (I believe) that took the trial drug.
woops.. the air (not art) was fine…
Yes, an unlicensed version of the drug must be manufactured and distributed - but, the source is far more likely to be Canada or Northern Europe. Just in case it escaped your radar, Racism is a major issue in the treatment of Aids in Africa, and neither China, Japan, nor India are very interested in dealing with Black Africa for much of anything but cheap oil.
The recall, as well as the poverty in Africa are directly related to the Racism of many governments. Something the US government would like to ignore, given its own track record.
“The problem is that those countries are also devotees of the free markets mantra, respect for private and intellectual property, and will continue behaving as “good members of the international community”, in the meantime millions of their own people die of neglect. ”
All true but the cost of AIDS drugs from India is about a 10 to 20 times cheaper than that from the western pharmaceutical companies. Irrespective of who profits from it these drugs need to be made avialable to the vast majority of people. As for ‘intellectual prop’ rights , the real rights belong to us taxpayers as weve been subsidizing ‘big pharma’ for decades.
“China, Japan, nor India are very interested in dealing with Black Africa for much of anything but cheap oil.”
I think Indian and Brazilian AIDS drug manufacturers are not really concerned with the color of someones skin when it comes to selling their drugs !! It has to do with the big pharm companies preventing them from doing so …