This week, a major manufacturer of generic AIDS drugs announced that it’s removing some medications from the World Health Organization’s list of approved drugs. At the same time came word that the maker of a new class of malaria medication said it would not be able to meet the demand for its drug. The humanitarian group, Doctors Without Borders, has reacted to the situations.
Ranbaxy Laboratories of India announced this week it was removing seven drugs from what’s known as the World Health Organization’s list of pre-qualified medicines. Generic drugs on that list are certified by the WHO – based on data it receives – that they are as potent as the brand name originals. Ranbaxy says it can no longer guarantee the potency, so it’s taking the action until a new, reliable study is done.
The anti-retroviral drugs, or ARVs, can still be used. But the move could raise questions about the effectiveness of generic drugs. That’s been a hot topic when it comes to spending US money in the fight against HIV/AIDS.
Rachel Cohen of Doctors Without Borders says the Ranbaxy announcement should not cast doubt on valuable medicines.
She says, "For us, we just don’t want this to be misrepresented or manipulated in a way that will make people feel that generics in general should not be trusted. That’s not the case. We know that quality generic medicines are safe, effective and can save lives. The question is that we just don’t have unequivocal proof that these particular drugs are bio-equivalent with the originator products. But we expect that, and even WHO said that they expect that we should have that assurance again probably by the end of the year."
Ms. Cohen also says there are alternative and pre-qualified suppliers for most of the Ranbaxy drugs that have been withdrawn from the WHO list.
She says Doctors Without Borders AIDS treatment programs should not be severely affected.
She says, "For the 23,000 people that we have on anti-retroviral therapy through our field programs, it’s not going to be a huge dramatic effect. A large number of our patients are the fixed dose combination of D-4-T, 3-T-C and Nevirapine from CIPLA (of India), which has been validated as meeting all of the international standards of WHO’s prequalification system. So, in terms of actual effects on our patients, I think it will be quite minor."
Ms. Cohen rejects any criticism of the WHO’s pre-qualification system, saying it was the system itself that caught problems with Ranbaxy data.
On the issue of malaria, Novartis, manufacturer of a top malaria drug, says there’ll be a shortage of the medication. Coartem is part of the new class of drugs that is much more effective against the disease. Novartis says it destroys parasites within 48 hours.
Coartem contains Artemisinin, which is derived from a wormwood plant being grown in Vietnam and China. The World Health Organization says a surge in demand is responsible for the shortage. But Doctors Without Borders says the shortage derives from a failure to grow enough of the plants, even though the WHO forecast last spring a growing demand for Coartem.
Margrit Den Boer is a pharmacist for Doctors Without Borders.
She says, "They could have prepared for that. They knew that the demand was rising a very long time already. They have actively promoted their product in Africa. On the other hand, they have not taken enough measures to make it available."
Ms. Den Boer says the plants used to make Coartem are usually planted in December and January and harvested in August. The drug is usually available for market several months later. Since planting will begin next month, adequate supplies of Coartem are not expected until March of next year.
"Lots of countries have switched to the new therapy containing Artemisinin, made from the plant Artemisia Anima, because they were stimulated by the WHO, the World Health organization, and also a lot of money was made available by the Global Fund (to Fight AIDS, Tuberculosis and Malaria). So, they had all reasons to choose that superior drug and want to introduce it as soon as possible," she says.
She estimates it will cost up to 50 million dollars to plant enough Artemisia Anima to meet demand.
The WHO is recommending that all countries facing shortages “increase their procurement of a second-line anti-malarial treatment, which is generally quinine.” But quinine treatment takes longer.
The UN agency says it will also offer technical assistance to any country facing an interrupted supply of Coartem – and will provide details of available quantities and delivery schedules.