Kaisernetwork.org (Washington, DC)
8 August 2007
Drug Access
European Commission Suspends Roche's License To Market Antiretroviral Viracept
[Aug 08, 2007]
The European Commission on Tuesday suspended Swiss pharmaceutical company Roche's license to market its antiretroviral drug Viracept because of contamination with the substance ethyl mesilate in certain lots of the drug, Reuters reports (Reuters, 8/7). According to the AP/International Herald Tribune, ethyl mesilate can damage DNA and lead to cancer (AP/International Herald Tribune, 8/7).
The European Medicines Agency in June recalled Viracept because of contamination. Roche in a statement said that it recalled all batches of the drug in Europe and other undisclosed countries in cooperation with EMA and Swissmedic, Switzerland's drug regulator. According to Roche, the drug was recalled after tests indicated that certain batches were contaminated with higher-than-normal levels of methane sulfonic acid ethyl ester -- a chemical normally used in the drug in small quantities.
William Burns, CEO of Roche's pharmaceutical division, said the impurity had been caused by the interaction of two chemicals in a vessel where the drug is produced. Roche later announced that it plans to establish patient registries to monitor the health of HIV-positive people who were taking the drug (Kaiser Daily HIV/AIDS Report, 7/24).
According to the European Commission, the suspension was based on scientific conclusions from EMA and consultations with members of the European Union. Roche expects to be able to market Viracept, which is known generically as nelfinavir, again in the European Union beginning in September or October, after EMA has examined new safety data, according to a spokesperson (Reuters, 8/7). Roche spokesperson Claudia Schmitt said the company is in "intensive discussions" with EMA "to validate the new manufacturing process for Viracept." Roche does not expect the suspension to affect the company's financial outlook for this year, the AP/Tribune reports (AP/International Herald Tribune, 8/7).
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Global Challenges
Niger's Religious Leaders Form Alliance To Prevent Spread of HIV
[Aug 08, 2007]
Catholic, Muslim and Protestant religious leaders in Niger have formed an alliance to teach youth in the country about HIV/AIDS, Reuters reports. The alliance aims to help the government fight the spread of the virus by promoting HIV tests and through better integration of HIV-positive people into society.
According to Reuters, 95% of Niger's population is Muslim, and Islamic leaders have a large influence over the country's population. Religious Affairs Minister Labo Issaka said that religious groups are "ideally placed to influence people's values and behavior" because of "their impact on communities and households, and the way they are organized and present on the ground."
According to Reuters, about half of Niger's population is under age 15. About 1% of the population ages 15 to 49 is HIV-positive, according to United Nations estimates. Although Niger's HIV prevalence is low in comparison to many other sub-Saharan African countries, the country's population is growing rapidly, which could lead to an increase in HIV cases, and government officials have pledged not to be complacent.
Earlier this summer, government officials set up 40 medical centers in the country's capital, Niamey, where people can receive no-cost HIV tests. About 9,000 young people came forward to be tested, but authorities had anticipated 22,000, according to Reuters. HIV/AIDS prevention education is difficult in Niger because less than half of children attend school, and eight in 10 adults are illiterate, Reuters reports (Massalatchi, Reuters, 8/6).
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Kenyan Government Developing Policy To Address HIV/AIDS in Workplace, Official Says
[Aug 08, 2007]
The Kenyan government plans to develop a policy to address HIV/AIDS in the workplace, Mark Bor, secretary of the Ministry of Labour and Human Resource Development, said on Sunday at the opening of a two-day seminar in Mombasa, Kenya, Kenya's Daily Nation reports. According to Bor, a series of workshops are scheduled to be held to develop the policy.
Bor said the government is committed to ensuring that no employee is discriminated against on the basis of his or her HIV status. He added that there is no justification to compel job applicants or employees to disclose their HIV status and other personal information about co-workers. "Access to personal data relating to a worker's HIV status should be bound by rules of confidentiality, consistent with" the International Labour Organization "code of practice on protection of workers' personal data," Bor said.
According to Bor, all employees, including those who are HIV-positive and their dependants, are entitled to affordable health care and access to benefits from statutory social security programs without fear of discrimination. Five bills -- the Labor Institutions, Employment, Labor Relations, Work Injury Benefits, and Occupational Health and Safety measures -- that aim to restructure the labor sector are before Parliament awaiting debate, Bor said, adding, "The bills have gone through the first and second reading, and they are awaiting the third reading before being finally approved" (Daily Nation, 8/6).
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Across The Nation
Montana's HIV/AIDS Names-Based Reporting System Preserving Privacy, Official Says
[Aug 08, 2007]
The privacy of people living with HIV/AIDS in Montana has been preserved since the state last year switched from a code-based reporting system to a names-based reporting system, Laurie Kops, section supervisor of the state's HIV prevention and surveillance division, said recently, the AP/Bozeman Daily Chronicle reports (AP/Bozeman Daily Chronicle, 8/6). CDC in 1999 endorsed names-based reporting and in 2005 recommended that states use names-based reporting systems. Beginning this fiscal year, the funding formulas used by HHS to calculate Ryan White Program grants include only HIV data from states that use names-based reporting systems. All U.S. states and Washington, D.C., by the end of 2007 will begin recording HIV cases using names-based reporting systems rather than code-based reporting systems (Kaiser Daily HIV/AIDS Report, 4/3).
Montana began names-based reporting in September 2006, according to Kops. If the state had not switched to names-based reporting from its code-based system, it risked losing a significant portion of the $2.1 million in federal funds it receives for HIV/AIDS programs, the AP/Daily Chronicle reports. Officials have said the system has been effective in tracking the number of HIV/AIDS cases, as well as protecting records that could identify Montana residents living with the disease.
"In trying to make sure we report the true numbers of cases," names-based reporting is "one of the best ways to accomplish that," Kops said. She added that only summary data on the number of HIV/AIDS cases is given to CDC. "When there is a report to CDC, it's only by the numbers, and not by name," Kops said, adding, "That seems to be people's greatest fear -- that their information will be released by name" (AP/Bozeman Daily Chronicle, 8/6). Erin Barnes -- the department's HIV surveillance specialist, who has access to the names -- said Montana has "very strict confidentiality guidelines," adding, "It's a big deal for CDC and for us." David Herrera, a state HIV prevention contractor and member of the Montana Gay Men's Task Force, said, "Coupled with the fact there hasn't been a breach in that confidence at the state health department with HIV data, I think people felt confident the information would be safeguarded" (Richardson, Bozeman Daily Chronicle, 8/4).
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