Kaisernetwork.org (Washington, DC)
2 April 2008
Politics and Policy
House Rules Committee Takes Action on PEPFAR Reauthorization Bill Ahead of Floor Consideration
[Apr 02, 2008]
The House Rules Committee on Tuesday took action on a bill (HR 5501) that would reauthorize the President's Emergency Plan for AIDS Relief ahead of floor consideration of the measure, which is scheduled for Wednesday, CQ Today reports (Graham-Silverman, CQ Today, 4/1). The measure, which was approved in February by the House Foreign Affairs Committee, would allocate $50 billion for PEPFAR over the next five years. President Bush had called on Congress to authorize a $30 billion, five-year extension of PEPFAR. The bill also would remove a requirement that at least one-third of HIV prevention funds that focus countries receive through PEPFAR be used for abstinence-until-marriage programs. It would require "balanced funding" for abstinence, fidelity and condom programs based on evidence in each PEPFAR focus country. In addition, the bill would retain the requirement that PEPFAR recipients pledge opposition to commercial sex work.
The bill would allow groups to use PEPFAR funding for HIV testing and education in family planning clinics but not for contraception or abortion services. The bill also would require reports to Congress if abstinence and fidelity programs compose less than half of country-level spending on programs aimed at preventing sexual transmission of the virus. In addition, the bill would allocate about $9 billion to fight tuberculosis and malaria, which often affect HIV-positive people in Africa. That amount also would underwrite food supplements for people living with HIV/AIDS. The bill would provide loans to women widowed by the disease or ostracized because of their HIV-positive status (Kaiser Daily HIV/AIDS Report, 3/31).
The Rules Committee on Tuesday approved by voice vote a structured rule (HR 1065) for floor consideration of the bill. During the Rules Committee consideration, Reps. John Campbell (R-Calif.) and Dave Weldon (R-Fla.) attempted to decrease the $50 billion funding amount allocated in the bill to $15 billion and $38 billion, respectively. The committee ruled the representatives' amendments out of order. Any changes to funding levels would "unravel" compromises, Foreign Affairs Committee Chair Howard Berman (D-Calif.) said, adding, "Part of the balance that was achieved with this bill was the funding level."
Rep. Betty McCollum (D-Minn.) attempted to gain Rules Committee approval to offer an amendment during floor consideration to eliminate a phrase in the bill that some advocates say could remove funding for family planning groups that currently receive PEPFAR money. According to CQ Today, 45 HIV/AIDS groups last week sent a letter to lawmakers in support of such efforts. "The effect of the language as it is could be interpreted to actually restrict access to those services," Jennie Quick -- the government affairs manager at Population Services International, one of the groups that signed the letter -- said. The Rules Committee did not allow the amendment, CQ Today reports.
The Rules Committee also rejected an amendment that would have changed a reference to "health care professionals and workers" to "health care professionals." The committee did approve four amendments to:
The White House in a policy statement said that it supports the PEPFAR reauthorization bill but hopes to resolve some concerns about provisions in the bill that it says would limit the president's authority to conduct foreign policy (CQ Today, 4/1).
Link to this story.
Science & Medicine
Examination of Antiretrovirals Abacavir, Didanosine's Potential Link to Increased Risk of Heart Attack Continues
[Apr 02, 2008]
GlaxoSmithKline's antiretroviral drug abacavir could nearly double the risk of heart attack, according to a study released at a meeting in February and published on Tuesday in the online version of the Lancet, the San Francisco Chronicle reports (Russell, San Francisco Chronicle, 4/2).The study also found that Bristol-Myers Squibb's antiretroviral didanosine might be associated with a 50% increased risk of heart attack, the AP/International Herald Tribune reports (AP/International Herald Tribune, 4/2). According to the researchers, the increased risk of heart attack could be the result of a cardiovascular inflammatory response to the drugs, but they added that more research is needed. GSK in a letter published alongside the study said its own analysis of 54 pooled studies did not suggest an increased risk of heart attack associated with abacavir (Berton, Dow Jones/CNNMoney.com, 4/1).
For the study, Jens Lundgren of the University of Copenhagen and colleagues examined more than 33,000 HIV-positive people who had been followed from 1999 to 2005 at clinics in Australia, Europe and North America. The researchers looked for heart issues that occurred until February 2007 (AP/International Herald Tribune, 4/2). The researchers analyzed the risk of heart attack among those who had used or were using abacavir, didanosine and lamivudine. The researchers found that an increased risk of heart attack was only found in participants currently receiving abacavir and didanosine. Abacavir was associated with a 90% increased risk of heart attack, and didanosine use was associated with a 49% increased risk, the study found. An increased risk was not found among past users of the drugs. According to the study authors, the findings suggest that the risk of heart attack associated with the two drugs is reversible if use is stopped (Kaiser Daily HIV/AIDS Report, 2/6). The study found that the people most likely to experience heart problems with abacavir were those with underlying medical conditions, such as high blood pressure and diabetes, that also place them at an increased risk of heart attack (San Francisco Chronicle, 4/2). The company said that an analysis of its database of about 14,600 HIV-positive people did not support the conclusions of the Lancet study.
Reaction, Comments
"We were unable to show any increased risk in heart attacks," Gwenan White, a GSK spokesperson, said, adding that the Lancet study results are "inconclusive" (AP/International Herald Tribune, 4/2). In a linked comment to both the study and GSK's response, James Stein of the University of Wisconsin School of Medicine and Public Health and Judith Currier of the University of California-Los Angeles David Geffen School of Medicine disagreed with GSK's analysis. They wrote that although findings from observational studies should not lead to changes in clinical practices, the increased risk of heart attack cannot be ignored. "Alternatives to abacavir and didanosine in high-risk patients should be considered," they said (Dow Jones/CNNMoney.com, 4/1).
Steven Deeks, a professor at the University of California-San Francisco, said the study was thorough and large-scale but not definitive. He added that although the study shows an increased risk of heart attack, it does not show why. "The concerns it raises are legitimate," he said, adding that until a plausible biological explanation can be ascertained and the findings are confirmed, he would be reluctant to recommend that patients switch to another antiretroviral. John Pottage, vice president for GSK, said the company is taking the results seriously. He added that although the risk of heart attack appears to double with abacavir, such risk is relatively low to begin with. "Obviously, the study is provocative, and people are trying to dig into it and understand it," Pottage said (San Francisco Chronicle, 4/2).
According to the AP/Herald Tribune, the study's findings could affect how people living with HIV/AIDS are treated worldwide. Charlie Gilks, director of AIDS treatment and prevention at the World Health Organization, said, "These antiretrovirals are wonderful and lifesaving, but they do have toxicity problems." He added, "It may be that we can continue to use them, but we need to be aware of their long-term problems." According to Gilks, physicians in wealthy nations have "24 different antiretrovirals to choose from if one isn't appropriate. But if that happens in resource-poor countries, it's not so simple." He added that WHO will "have to review what the likely implications of using these drugs is on a large scale and if we should consider alternatives." Lundgren said, "No drug is risk-free." He added, "For all patients, it's a matter of finding the right balance" (AP/International Herald Tribune, 4/2).
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