Correction to Abbott's False Assertions
From Abbott's Greed
 Correction to Abbott’s False Assertions
Abbott recently put out a press release maintaining that information contained in our press release, “Coalition of AIDS Activists: Abbott Pediatric Formulation Leaves Thai Kids Out – Delays Expected for Others in Developing Countries” was inaccurate. We stand by the information contained in our press release; below is a list of points that Abbott made, and our corrections to them.
1st point made by Abbott: Abbott will file the pediatric version of Kaletra/Aluvia in Thailand, pending the government's acceptance of that application.
Our Response: SGAC welcomes this news, which is a reversal of Abbott's previous position. In March, Jennifer Smoter said that because of the entirely legal compulsory licenses in Thailand, "Abbott will not submit applications or register new medicines and will withdraw current applications in Thailand until the government changes its position." (http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=43558 ) We commend your alteration of this unjust practice. However, as it stands, the parents of these children are being denied access to lifesaving drugs because of a patent dispute. When will you be resubmitting the adult version of heat stable Kaletra/Aluvia?.
2nd point made by Abbott: Abbott has the most widely registered HIV drug in the world so to characterize the company as having "no true commitment" is just not true. The lopinavir/ritonavir tablet has been filed or approved in 135 countries (it has been approved in 89 of the 135). The lopinavir/ritonavir capsule has been the most widely registered HIV medicine in the world at 118 countries, and the company is on track to make the tablet even more widely registered at the targeted 150 countries. While we cannot force governments to approve the tablet formulation, and cannot publish a timetable for approvals if those approvals are not within our control, we have filed in 135 countries, more than any other HIV medicine. We have also provided the tablet on waiver in many places where it is not yet approved.
Our Response: We are pleased to learn that registration has reached 135 filings -though it is a year and a half after registration was approved in the U.S. What would have been truly impressive is if Abbott had filed immediately in all countries for new Kaletra, and worked assiduously to get it registered in Africa, Asia, and Latin America, as it has in the U.S. and Europe where profits are higher. As Abbott well knows, it dragged its feet for half a year (see, e.g. Thailand http://www.medicalnewstoday.com/articles/42833.php or South Africa http://www.medicalnewstoday.com/articles/41555.php) before even beginning to register in the Global South. Therefore, we maintain that our announcement is correct: Abbott has not published the past dates of its registration applications in developing countries either for Kaletra capsules or for the heat stable formulation despite multiple requests that it do so. It is announcing that it will register promptly, but similar promises have not been transparent or reviewable in the past.
3rd point made by Abbott: For filing of the pediatric tablet beyond the developed world, most developing world countries require European approval before a company can file. We explained this to the community, including the Student Global AIDS Campaign, more than a year ago -- and our press release reiterates that, as well as our commitment to work to expedite those filings. This group in particular continues to mischaracterize the regulatory process. Our Response: We are familiar with Abbott's claim that it cannot register until it gets European approval, Despite the fact that the company itself filed for registration in places like South Africa WITHOUT European approval; MSF did an excellent job of debunking the myth of the "CPP": http://www.doctorswithoutborders.org/news/hiv-aids/kaletra_cppdoc.cfm It is deeply disturbing that Abbott is yet again repeating this rhetoric, suggesting that children in the global South will have a long time to wait before they have access to it.
4th point made by Abbott: Abbott's prices for the lopinavir/ritonavir tablet (adult or proposed price on pediatric) are lower than any generic or potential generic -- in any least developed or developing world country. This can be verified by the MSF report (Untangling the Web of Price Reductions, July 27, 2007) that shows that lopinavir/ritonavir is the lowest priced protease inhibitor in any developing world country. Our philosophy on pricing can also be found on our website.
Abbott's commitment to our work in the pediatric community -- and the HIV community more broadly -- is important to us and, as you can imagine, we cannot condone or let misinformation be spread about our work. Please do refer to our website if you would like further information on our tablet filings or approvals (you can find the information at http://www.abbott.com/global/url/content/en_US/40.5.10:10/general_content/General_Content_00327.htm) or alternatively do not hesitate to call me if you would like to discuss Abbott's work in person.
Our Response: To generalize price globally is inaccurate, since price depends upon where an HIV+ individual lives. The $500 price is indeed available in Ghana, but not in Guatemala, which most certainly qualifies as a poor country (ranked number 118 on the human development index and over 4 million people --30% of the population -- live on less than $2 a day). Currently, for countries such as Guatemala, it is the Clinton Foundation which offers the lowest price ($695, or 30% lower than the Abbott price for middle income countries like Guatemala). Why not give HIV+ children in Guatemala, Ukraine, and Sri Lanka access to the $500 price? On this point, then, we maintain that it is Abbott rather than activists who are misleading the public.