Section: Costa Rica
Published: July 2010
Costa Rica: Abbott Against Hetero with PLWA caught in the Middle
(Versión en Español disponible el Lunes 5 de Julio)
By Richard Stern*
During the past four to six weeks, an Abbott Laboratories HIV product representative has been contacting People Living with HIV/AIDS in Costa Rica, urging them to participate in a lawsuit to be filed with the Costa Rica Supreme Court, declaring that a generic version of Abbott’s ARV Kaletra(Lopinavir/Ritonavir) produced by Hetero drugs of India is unsafe and should not be used in Costa Rica.
Hetero drugs won a competitive bidding process in February of this year, and the drugs were legally approved by the Costa Rica Ministry of Health for purchase and are now in the country. Abbott by encouraging PLWA to participate in a lawsuit, is attempting to block their distribution. When the current stock of Abbott’s Kaletra runs out, in early July, the health care system will begin using the generic version, unless the Court rules otherwise.
Abbott’s price for Kaletra last year was approximately $2,808 per year per person and sales of Kaletra were over $2 million. I spoke with Abbott’s Director of International Affairs Dirk van Eeden while he was traveling in Singapore on June 29th, and he refused to indicate how much of this price was profit. Abbott has a tiered pricing policy but the policy does not apply to upper middle income countries such as Costa Rica. Price are negotiated individually with these countries.
However, the generic version purchased from Hetero which would be priced at about $2,140, still very expensive, would nonetheless result in a savings of about $450,000 to the Costa Rica Health Care system which provides Kaletra to approximately 750 PLWA.
I spoke to several Personas Living with HIV/AIDS (names are protected for confidentiality) who had in fact received these phone calls from the Abbott product representative, urging them to go to a meeting at the office of a local lawyer who will be taking the case to the Supreme Court. Although a local Abbott official has repeatedly denied that such calls were ever made, PLWA I spoke with were quite specific in providing details of the contents of these conversations.
Costa Rican PLWA Guillermo Murillo, the first Costa Rican to come out publicly as a person living with HIV/AIDS 14 years ago, and who has given permission to publish his name, also confirmed that he had spoken with several PLWA who had been contacted by Abbott and asked to attend the meeting at the office of the lawyer.
Abbott Denies Allegations
This is the second attempt at such a lawsuit. In early April, the Supreme Court had rejected a suit filed by a local AIDS association against the purchase of Hetero’s version of Lopinavir/Ritonavir (LPV/r), indicating that the suit should be filed by individuals and not by an organization.
Abbott’s Costa Rican Country Spokesperson, Martin Castro, interviewed Friday June 25th, denied that any Abbott representative had ever spoken to any Person Living with HIV/AIDS about the issue of a lawsuit. When confronted with the fact that several PLWA had confirmed receiving these phone calls from product representative Sary Rodriguez, he said that this would have been impossible, that it is against Abbott’s policies. In fact he was asked repeatedly if Sary Rodriguez had called PLWA about this issue, and he continued to deny this, even when this writer confronted him with the fact that he had spoken with PLWA who said that they had spoken with Ms. Rodriguez about this matter.
According to International Public Affairs Director, Van Eeden, in an e-mail received shortly after I spoke with him:
“Abbott adheres to the highest ethical standards. We do not condone any marketing practice that could create anxiety among patients. We investigate all allegations of this nature and are doing so in this case.”
But Van Eeden did not deny that Abbott staff in Costa Rica had contacted PLWA about participating in a lawsuit, and indicated that he was deeply disturbed by this possibility. He continued to emphasize that there is an extensive on-going investigation. He also would not respond to unsubstantiated allegations that Abbott had contributed US $940 toward the lawsuit filed in March. Abbott employees have been ordered to stop any direct contact with PLWA regarding this matter.
Abbott’s Vice President for External Communications, Melissa Brotz, was contacted Friday afternoon June 25th at Abbott Headquarters near Chicago. Brotz indicated that Abbott has a strong ethical policy of not directly contacting PLWA to encourage them to participate in lawsuits against competitors.
It is also important to point out that the generic version of LPV/r from Hetero drugs is, in fact, not pre-qualified by any of the normal regulatory bodies such as WHO, or FDA. It is not brokered by either the Clinton Foundation or the PAHO Strategic Fund for Anti-Retrovirals. In fact, in spite of extensive inquiries I could find no evidence that the Hetero version of LPV/r has been used anywhere else in the world. Hetero did apply for pre-qualification from the FDA in April of 2009, but the FDA has never followed through on the request to carry out the pre-qualification process. An FDA representative who received the application from Hetero in April of 2009 did not return my phone calls.
Physicians Express Concerns
A coalition of Costa Rican physicians with a long track record of supporting generic medications has also sent a letter to the National Health Care system, expressing their concern about using a medication where no evidence is currently available regarding its history of quality control. Costa Rica’s own abilities to independently examine complex anti-retrovirals are considered by local Physicians as inadequate, due the inability of the local laboratory to carry out complex tests necessary for product approval, and have described the process of manufacturing the non-refrigerated version of Lopinavir/Ritonavir as “extremely complex” due to need for a process known as Meltrix to be integrated into the original product.
Data submitted by Hetero to the Costa Rican Health Ministry was minimal but, because Hetero also submitted the lowest bid, the Ministry was, by law, required to accept their bid, which was a few dollars lower than the bid by the Indian company Matrix, which does have a pre-qualified version of LPV/r. Hetero has a long track of producing pre-qualified generic ARVs, but in this case local physicians and other key actors are in fact, asking for more information about this particular product. Since 750 PLWA in Costa Rica take Kaletra, and there is no 3rd line back-up available, there is concern about what would happen if treatment failures were to occur, no matter how small the probability.
Apparently when contacted by the Health Care system and asked to provide more data about its use in other countries as well regulatory information, Hetero replied by stating that this was unnecessary since they had already been awarded the contract, and, in fact the product has been purchased and delivered. Costa Rican officials described this response as evasive and perhaps counterproductive.
Lack of Clarity about Hetero’s Regulatory Situation
Rightfully, Costa Rica PLWA have concerns about the situation. It is not clear to me why Hetero will not provide data about possible regulatory approval and/or provide information about countries where the product is already in use and what the results have been. Or, in fact, if Costa Rica is the first country worldwide where they have been awarded the contract to distribute this product.
Abbott may have behaved unethically in helping to coordinate participation by PLWA in a lawsuit, however Hetero has not provided the evidence related to accepted standards of quality control, directly or by means of appropriate regulatory authorities . In the past few years, resistance to generic use by some PLWA associations and other special interest groups was mitigated by the acceptance of external, “neutral” pre-qualification by Agencies such as WHO and the FDA, as a standard for acceptable quality. These standards were endorsed by the Global Fund as well as UNAIDS, and this seemed to go a long way toward alleviating fears and concerns of PLWA in this region.
Also generally considered to be acceptable are the standards utilized by the Clinton Foundation and the Pan American Health Organization’s Strategic Fund for Anti-Retrovirals, but the Hetero product complies with none of the standards of these two organizations at this moment. It is not clear as to why the FDA has not acted on Hetero’s request for an evaluation of this product. The Global Fund requires that drugs purchased with its funds be cleared by at least one of these Agencies, therefore if Global Fund resources were involved, a country would not be allowed to purchase Hetero’s version LPV/r. But Costa Rica does not utilize Global Fund resources for anti-retroviral purchase. Five of seven Central American countries do, and would not have been permitted to purchase the Hetero product. Costa Rica does not require pre-qualification from companies bidding on anti-retrovirals at the present time, but is expected to implement this pre-requisite by the time the next bidding process occurs, in order to avoid a similar problem in the future.
PLWA Leaders Urge Calm
Another unanswered question is why Hetero is charging $2,100 per year for a generic product that is sold in other parts of the world for as little as $500 per year? While Costa Rica will save $450,000 by using the Hetero product, it seems clear that Hetero can manufacture the drug at a much lower price and decided to send in a lower bid than what Abbott has been charging, not a fair bid that would reflect reasonable profit based on production costs.
Gustavo Chinchilla, President of the Costa Rica Association of People Living with HIV/AIDS has been urging his constituents to remain calm during the situation. “We should remain united and follow the advice of our physicians, pharmacists, and social workers,” he said in a written statement.
Some PLWA had indicated that they would refuse take the generic version of Kaletra, due to rumors that have been circulating that the Hetero product is dangerous. “This would be very dangerous (to not take the product) and possibly resistance to treatment could occur in some cases,” added Chinchilla. Obviously, although the product is not pre-qualified there is a very high probability, based on Hetero’s history of production, that it will be safe.
Costa Rican physicians have recommended that for PLWA who begin to take the new product, Viral Load tests be performed at an accelerated rate of every month, just be sure that there are no harmful effects taking place. PLWA will also receive a note explaining that they should immediately report any unexpected side effects of this medication to their physician, even though risks are expected to be minimal.
Agua Buena Human Rights Association
San Jose, Costa Rica