April 09, 2006

By Jens Wenkel, MD

History is threatening to repeat itself for AIDS patients in the developing world. In Lagos, Nigeria, and many other parts of Africa, the next crisis has already arrived.

Even as AIDS treatment programs are belatedly expanding around the world, more and more of the fortunate few on life-prolonging antiretroviral (ARV) therapy for years are beginning to experience treatment failure — a natural occurrence even when medicines are taken exactly as prescribed.

In fact, 10% of the 1,200 AIDS patients treated in our program in Lagos will need a new regimen by the end of this year. In South Africa, the situation is even more acute, with therapy beginning to fail in 16% of the patients on treatment for more than four years. In the coming years, this number will only grow.

If our patients lived in the United States, they would be switched to a second-line therapy that might include the new heat-stable version of the boosted protease inhibitor lopinavir/ritonavir, marketed by Abbott Laboratories as Kaletra. The new formulation was approved by the FDA in October 2005, and has significant advantages over the previous version: fewer pills to take, no meal restrictions, and most important, it does not require refrigeration.

But patients throughout the developing world are told to settle for less effective drugs like nelfinavir or Abbott's older formulation of lopinavir/ritonavir, one that degrades in a matter of weeks when exposed to high temperatures. One of our patients in Lagos, Ibrahim Umoru, has been taking the old version for five weeks, but his drugs need to be refrigerated far from his home at the clinic. He can't afford fuel for a generator to run a refrigerator, and without a refrigerator, the heat in Lagos — often near or above 100° F — turns the capsules into clumps that can't even be take out of the box. It is a cruel irony that people are denied a drug seemly designed to meet their circumstances.

The real cruelty is why they don't have access. The new formulation is only being marketed in the United States at an average wholesale price of nearly $10,000, and Abbott has shown little willingness to have it registered in Asia, Africa, or Latin America. The company says they are doing everything they can, but this is far from true

Abbott incorrectly claims that the drug needs to be approved in Europe and receive a European Certificate of Pharmaceutical Product (CPP) before registering it in African countries. Some countries — like Uganda and South Africa — do not even require a CPP before beginning the registration process. Those that do, ask the exporting country to issue it, which in this case could mean the United States. If Abbott were serious, they would file for registration immediately in those countries that do not require a CPP and would have already obtained a CPP from the US Food and Drug Administration in order to file in the others.

Other companies have blamed delays in registering new drugs on red tape in developing countries. Bureaucratic waste and even corruption can certainly cause inexcusable delays, but where there is a will there is a way. Tamiflu, for example, was registered in South Africa in just a matter of months. And with the profits of pharmaceutical giants exceeding the GDP of many countries, is there anyone who really believes that Abbott somehow cannot navigate Malawi's drug regulatory agency?

Because Abbott's new formulation is so crucial, my colleagues and I from several Doctors Without Borders AIDS treatment programs around the world ordered 5,000 pills directly from the company's Chicago headquarters. We asked Abbott to sell them to us at a price no greater than what the company charges for the older soft-gel formulation — $500 per patient per year — because industry experts say that the new heat-stable version actually costs less to manufacture at high volumes. In the absence of registration, Doctors Without Borders will be responsible for obtaining the necessary special authorizations from respective regulatory authorities, as we have done for other medicines.

So far, though, the company has not committed to fill our order, and simply repeats that they are working as fast as they can. While their assurances may buy them time and good PR, our patients are told to wait — a luxury they don't have.

The price of first-generation ARV medicines has decreased considerably — mainly because of generic competition and years of pressure by people living with HIV/AIDS — making treatment possible in some of the world's most impoverished regions. This was too little, too late for the millions who lost their lives and the millions who still don't have access. And unless urgent action is taken now, people still alive because of ARV therapy will be denied the newer life-extending drugs they need to survive.

As physicians, my colleagues and I refuse to take part in repeating such contemptible recent history. We respect all of the research and development that goes into creating essential medicines. But we refuse to accept that the marketing policies of pharmaceutical giants are allowed to threaten the lives of our patients.


Jens Wenkel, MD, is a doctor at the MSF AIDS treatment program in Lagos, Nigeria