Drug Access

Abbott To Stop Launching New Drugs in Thailand in Response to Country's Compulsory License for Antiretroviral Kaletra

[Mar 14, 2007]

Pharmaceutical company Abbott Laboratories recently announced that it has withdrawn applications to sell seven new drugs in Thailand in response to the country's decision to issue a compulsory license for the company's antiretroviral drug Kaletra, Reuters reports. The seven withdrawn drugs include a new version of Kaletra; an antibiotic; a painkiller; and medicines to treat blood clots, arthritis, kidney disease and high blood pressure, Reuters reports. According to Reuters, Abbott's decision to stop introducing new drugs will not affect the sale of drugs currently on the market in Thailand (Schuettler, Reuters, 3/14). Thai Health Minister Mongkol na Songkhla in January signed the compulsory license, which allows Thailand to produce a lower-cost version of Kaletra, into law. World Trade Organization regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that provides treatment to more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. The compulsory license could save the country as much as $24 million annually. According to a joint statement released in February by the health ministry and Abbott, the two sides agreed in principle to reduce the price of Kaletra in Thailand to increase access to the drug among HIV-positive people who have developed resistance to other antiretrovirals. The lower price will apply only to Thailand's public health programs and will not apply to private hospitals, people with high incomes or foreign patients. Abbott offered to lower Kaletra's cost to $167 per patient monthly, although representatives from the health ministry said that was still too high. Abbott and the ministry agreed to meet for further negotiations (Kaiser Daily HIV/AIDS Report, 2/15).

Reaction

Abbott spokesperson Jennifer Smoter said that because the Thai government "decided not to support innovation by breaking the patents, Abbott will not submit applications or register new medicines and will withdraw current applications in Thailand until the government changes its position." According to an unnamed source, Abbott notified the Thai government about its decision a few weeks ago after talks between the two sides ended unsuccessfully, the Wall Street Journal reports. Thawat Suntrajarn, director-general of the health ministry's department of disease control, said that he had been unaware of Abbott's decision. He added that it is "not good for anyone, even the American company, because they will lose the market" in Thailand. According to Thawat, the Thai government will continue to seek out drugmakers able to produce a generic version of Kaletra. Paul Cawthorne, head of the Thailand operation of Medecins San Frontieres, said that Abbott's decision is "appalling," adding, "If they really are going to do this, it reflects so badly on the multinational companies." Cawthorne said that in recent months Abbott told him the new formulation of Kaletra would be made available in Thailand by this summer. Abbott has said that it will not pull the older version of Kaletra from the Thai market, adding that both the older and newer versions of the drug are equally effective. The primary difference between the two versions is that the newer one is more convenient to take, according to Abbott (Zamiska, Wall Street Journal, 3/14).

Related Editorial

Abbott's decision to withdraw the drug applications in Thailand is an "entirely rational business decision" a Journal editorial says. "In the long run, Abbott's withdrawal may have a salutary impact if it demonstrates to Thai officials and other governments that they will pay a price for stealing intellectual property," the editorial says. "In seizing the patents, Thailand is taking advantage of vague language" in the WTO regulations, the editorial says, adding that there is "no such emergency in this case." The editorial says that the World Health Organization's executive board meets in May, and unless WHO Director-General Margaret Chan and other officials start "publicly supporting intellectual property rights, there's a good chance Thailand's actions will be replicated elsewhere." The editorial concludes, "That's bad news for pharmaceutical companies -- and for everyone who cares about drug innovation and public health" (Wall Street Journal, 3/14).

Link to this story.

Global Challenges

E.U., Neighboring Countries Issue Joint Declaration To Fight HIV/AIDS Pandemic

[Mar 14, 2007]

Officials from 27 European Union nations and neighboring countries on Tuesday at the close of an HIV/AIDS conference in Bremen, Germany, issued a joint declaration to fight the HIV/AIDS pandemic, Xinhuanet reports. According to officials, the declaration primarily focuses on universal access to HIV prevention services, particularly in the context of mother-to-child transmission and sex education for young people. Officials also said that they will make efforts to improve cooperation to ensure access to affordable drugs and that discrimination against HIV-positive people and vulnerable groups will be "legally prohibited, if necessary" (Xinhuanet, 3/13). German Chancellor Angela Merkel on Monday at the conference called on the international community to take more effective measures to combat the spread of HIV worldwide, Deutsche Welle reports. "The struggle against the disease is a task for all of mankind and should not be treated as a problem for individual nations," Merkel said. She added that Germany -- which this year holds the presidency of the European Union and the Group of Eight industrialized nations -- will put the HIV/AIDS pandemic on the E.U. and G8 summit agendas in June (Deutsche Welle, 3/13). Merkel also has said that Africa will be among the focus points of Germany's G8 presidency (Reuters India, 3/11). While opening the two-day conference, German Health Minister Ulla Schmidt called on the European Union to do more to control the spread of HIV. European countries should aim to implement more effective preventive measures and affordable treatment across the continent, Schmidt said. HIV "doesn't stop at borders," she said, adding, "High rates of infection in one country have a knock-on effect in neighboring states." Access to prevention measures and affordable treatment should be ensured throughout Europe, and all people living with the disease should be able to live their lives without stigma or discrimination, Schmidt said. She added that increased efforts to develop an HIV/AIDS vaccine are needed and that she is in talks with pharmaceutical companies over the price of some HIV/AIDS drugs. Schmidt and German Development Minister Heidemarie Wieczorek-Zeul also called for increased cooperation among aid groups working to fight the disease. UNAIDS Executive Director Peter Piot, as well as health experts and representatives of nongovernmental organizations, took part in the conference (Deutsche Welle, 3/13).

Link to this story.

Brazil Officials Say Condom Distribution Effective Part of HIV Prevention Campaign; Church Officials Criticize Policy

[Mar 14, 2007]

An official from Brazil's Ministry of Health on Monday said that sex education and condom distribution are effective parts of the country's HIV prevention efforts after Roman Catholic church officials criticized the policy, the AP/Pravda.ru reports. President Luiz Inacio Lula da Silva last week said that sex education is the most effective method to prevent the spread of HIV and teenage pregnancy. Thirty percent of Brazilian girls ages 15 to 17 leave school because of pregnancy, Silva said, adding that sex education could help solve the problem. Educating people about the risks of sex also can combat the spread of HIV, Silva said. Cardinal Geraldo Majella Agnelo, president of the National Conference of Brazilian Bishops, said, "The use of the condom encourages people to have inconsequential and irresponsible sex," adding, "We cannot agree with the use of the condom." Some health experts have said the country's sex education and condom distribution programs have helped control the spread of HIV in Brazil. The World Bank in 1990 estimated that about 1.2 million people in Brazil would be HIV-positive by 2000; however, about 600,000 people in the country currently are estimated to be living with HIV, the AP/Pravda.ru reports. In a statement issued Monday in response to comments from church officials, Mariangela Simao, head of the health ministry's HIV/AIDS program, said that the "government cannot base its public health policies on moral and religious principles," adding, "Promoting the use of condoms is and will continue being one of the main pillars of Brazil's prevention policy" (Sequera, AP/Pravda.ru, 3/12).

Link to this story.

Uganda's HIV/AIDS Epidemic Concentrated Among Adults, Health Ministry Says

[Mar 14, 2007]

The HIV/AIDS epidemic in Uganda is now concentrated among adults, and HIV prevention campaigns should be redesigned to target the population, the country's Ministry of Health said recently, the New Vision/AllAfrica.com reports. According to the ministry's data, the average age of an HIV-positive person in the country has increased from 22 in 1988 to about 35 currently. A study conducted in the country from 2004 to 2005 tested 30,000 people ages 15 to 59 nationwide for HIV. The study found that 0.3% of boys ages 15 to 19 and 2.3% of men ages 20 to 24 are HIV-positive, compared with more than 9% of men ages 35 to 44. "The epidemic has changed, but we have not kept the pace in our approach," Sam Okware, the commissioner of health services, said. He added, "We continue to focus our prevention messages more on youth. This is a grave mistake as the epidemic is now concentrated in adults. People in 30s and 40s are struggling with their sexual lives and getting infected in big numbers." He also said that HIV prevention messages should focus on groups that might be the primary sources of new HIV cases. Health experts believe that most men who contract HIV are married because the average age of marriage for men in the country is 22. Most HIV-positive women in the country contract the virus between ages 30 to 39, according to health ministry statistics. "Because the average age of marriage for females is 17.8 years, most women get infected a decade or more into marriage," Wilford Kirungi, an epidemiologist and study researcher, said (New Vision/AllAfrica.com, 3/12). Uganda AIDS Commission Chief Kihumuro Apuuli said, "We are not going to manage this epidemic if we are not focusing on where the problem is." Donna Kabatesi of the CDC/Uganda Virus Research Institute said HIV cases in Uganda easily could increase unless prevention messages target adults. According to research by the organization Parent Talk, most married couples in Uganda have never discussed how to prevent HIV (Xinhua News Agency, 3/12). "Since [couples] have had unprotected sex together for years, if their partner has HIV/AIDS, they assume that they do too," Cathy Watson, a co-director of Straight Talk Foundation, said (New Vision/AllAfrica.com, 3/12).

Link to this story.

Across The Nation

Los Angeles County Board of Supervisors Approves Needle-Exchange Program To Curb Spread of HIV

[Mar 14, 2007]

The Los Angeles County Board of Supervisors on Tuesday voted 3-2 to approve a needle-exchange program in an effort to curb the spread of HIV and other bloodborne diseases, the Los Angeles Times reports (Los Angeles Times, 3/14). The one-year program is expected to cost about $500,000, which will be paid for with tobacco settlement funds. According to Public Health Director Jonathan Fielding, there are an estimated 120,000 to 190,000 injection drug users in Los Angeles, 45% of whom share needles. The needle exchange program, which will target heroin users, will be available at the Asian American Drug Abuse Program, BIENESTAR, Common Ground-The Westside HIV Community Center, Public Health Foundation Enterprises and Tarzana Treatment Centers (CBS 2, 3/13). Supervisors Mike Antonovich and Don Knabe questioned the benefits of a needle-exchange program and said that money should be used for education and rehabilitation. Supervisors Gloria Molina, Yvonne Brathwaite Burke and Zev Yaroslavsky voted to approve the program (Los Angeles Times, 3/14).

Link to this story.

California Hispanic HIV/AIDS Organization Urges Lawmakers To Increase Awareness in the Community, Pass Legislation

[Mar 14, 2007]

California-based BIENESTAR, the nation's largest Hispanic HIV/AIDS organization, last week organized a briefing at the state capitol urging lawmakers to increase HIV/AIDS educational campaigns and treatment services in the Hispanic community, the Sacramento Bee reports. Lack of health care access and late HIV detection in the Hispanic community has resulted in Hispanics being more likely than any other ethnic group to progress to AIDS within 12 months of an HIV diagnosis, according to the Bee (Rojas, Sacramento Bee, 3/10). At the hearing -- which was co-sponsored by the California Latino Legislative Caucus -- caucus members and HIV/AIDS service and advocacy groups urged lawmakers to pass the Inmate and Community Public Health and Safety Act, which would allow organizations to distribute condoms in prisons, and a budget item that would fund an HIV awareness campaign aimed at minorities. Gilbert Cedillo, vice chair of the caucus, said, "Today, we took an important step by bringing these startling statistics to light and now we must make a commitment and pursue policies that will result in real change," adding, "We have a responsibility to ensure that race and ethnicity do not translate into an AIDS diagnosis" (BIENESTAR release). BIENESTAR CEO Oscar De La O said, "We also see [HIV/AIDS] as a social justice issue because poverty, lack of education, adequate medical care, immigration issues continue to impact HIV" (Sacramento Bee, 3/10).

Link to this story.