Urgent need in the developing world for Abbott Laboratories' new version of lopinavir/ritonavir, a drug that does not require refrigeration
Lagos/Berlin/New York, March 15, 2006 — People living with HIV/AIDS in developing countries can't get new and/or improved drugs that can make a critical difference, said the medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF). MSF also said that it refuses to accept the standard practice of drug companies to market less adapted drugs to African, Asian and Latin American countries while reserving improved or newly developed drugs for countries that can pay more. For this reason MSF is placing an order directly with the worldwide headquarters of Abbott Laboratories in Chicago for a new heat stable version of the drug called lopinavir/ritonavir, which the company right now only sells in the US at a price of US$9,687 (average wholesale price) per patient per year.
"With temperatures regularly rising to nearly 40 Celsius, over 100 Fahrenheit, and with the numerous daily electrical blackouts, our patients can't use the old version of this drug," said Dr. Helen Bygrave, who works at MSF's AIDS treatment program in Lagos, Nigeria. "It's a cruel irony that although this drug — with no need for refrigeration — seems to have been designed for places like Nigeria, it is not available here."
In November 2005, Abbott launched a new version of their boosted protease inhibitor, lopinavir/ritonavir in the US. Unlike the old version, this new one no longer requires refrigeration, making it much more suitable for use in the hot climates of many developing countries where MSF works. But when MSF inquired about the price and availability of this new product for its patients, Abbott responded that it would wait until the product was available in Europe before requesting marketing approval in developing countries. This means a potential delay of years before this drug reaches the people who can benefit from it most.
The drug lopinavir/ritonavir is a crucial component of antiretroviral therapy for patients that need to be switched to a newer 'second-line' treatment regimen when drug resistance naturally develops after a few years on their first set of medications. World Health Organization (WHO) experts recommend this drug for use in second-line AIDS treatment.
At MSF's program in Khayelitsha, South Africa, 16% of the patients needed a new regimen after four years of treatment. Such data underline the acute and growing need for newer drugs. With over 60,000 patients on antiretroviral treatment, MSF says that its efforts to treat some patients that need access to newer drugs are being thwarted by drug company policies that take a "go slow" approach to making these new drugs available in developing countries.
Ibrahim Umoru, who receives treatment at the MSF clinic Lagos, has been taking the old version of LPV/r for five weeks but his drugs need to be refrigerated at a clinic that is far from his home. "I can't afford the diesel fuel for a generator to run a refrigerator. And without a refrigerator, these temperatures turn the capsules into clumps that look like used chewing gum. I need the newer version."
Because Abbott is not making the drug available in developing countries, MSF today placed an order for its projects in Cameroon, Guatemala, Kenya, Malawi, Nigeria, South Africa, Thailand, Uganda, and Zimbabwe. Armed with evidence from industry experts that the new formulation is less expensive to make than the old one, they also demanded the lowest possible price, one that would be no more than the amount Abbott charges some developing countries for the old version.
In a letter to the CEO of Abbott, prominent doctors, researchers and AIDS organizations from around the world urged Abbott to make new lopinavir/ritonavir available "immediately" to patients in developing countries.
Abbott has been marketing this drug as Kaletra since 2000 — but the old version is a soft-gel capsule, which means more pills per day, meal restrictions, and need for refrigeration in hot climates.
The current crisis of access to lopinavir/ritonavir is a clear illustration that the drug access problem in developing countries is still acute. While the price of first generation ARV medicines has decreased considerably because of generic competition, the price of new life extending drugs which are likely to be patented in producing countries are dramatically higher than older drugs. This blocks access in poorer countries where most people suffering from AIDS reside. If drug access depends on the marketing policies of pharmaceutical companies, then the lives of millions of patients will remain threatened.