Kaiser Daily HIV/AIDS Report Summarizes Opinion Pieces on NIH Studies of Nevirapine Use in Pregnant Women

Several newspapers have published editorials and opinion pieces in response to a recent series of Associated Press articles concerning NIH-funded research into the use of the antiretroviral drug nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to reduce the risk of vertical HIV transmission. The initial results from the research, which began in 1997, showed that the drug helped prevent HIV transmission to newborns in as many as half of the births. However, by early 2002, medical safety specialists, an auditor with NIH and the drug's manufacturer, Boehringer Ingelheim, all cited "widespread" problems with the study protocol, including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays in reporting and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research from spring 2002 to summer 2003 to review the trial and take corrective steps. Last month, Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, admitted that he altered a safety report on the use of nevirapine in pregnant women to change its conclusions and remove negative information about the drug (Kaiser Daily HIV/AIDS Report, 12/21/04). NIH officials also did not inform the White House of the risks associated with the drug's use in pregnant women before President Bush in 2002 announced a three-year, $500 million initiative to reduce mother-to-child HIV transmission in Africa and the Caribbean, although they were warned that the Ugandan trial was "flawed" months before the announcement (Kaiser Daily HIV/AIDS Report, 12/14/04).

NIAID Statement
However, NIAID in a Q & A document regarding the trial said that there "is no truth to the allegation that NIH officials chose not to inform the White House" about safety issues regarding nevirapine because an initial review of the study data "did not identify safety issues" associated with the drug. NIAID did say that the review identified "procedural problems related to recordkeeping" in the study. Therefore, NIH officials did not "directly" inform the White House of the procedural problems "because they had no bearing on the safety and efficacy of single-dose nevirapine used to prevent mother-to-infant transmission of HIV," according to the Q & A (NIAID Q & A, 12/17/04). Summaries of the opinion pieces written in response to the issue appear below.

Editorials

• Hartford Courant: Although "part of the answer" to combating the HIV/AIDS pandemic "lies in the development of new medicines," that is "not a reason to turn healthy babies into human guinea pigs" or use them as "foils to promote a political agenda," a Courant editorial says. Tramont's "manipulation of scientific data for political reasons is indefensible, even more so when the well-being of healthy babies is compromised," the Courant concludes (Hartford Courant, 12/27/04).
  
  
• Minneapolis Star Tribune: The "upshot" of the recent debate over the nevirapine trials could be a "reflexive swing away from the drug's use" in South Africa -- the "country with the world's greatest number of AIDS patients," a Star Tribune editorial says. Although claims of NIH misconduct concerning the trials are "serious and merit investigation," any "slips" made by the agency cannot "overshadow the lifesaving value of nevirapine," according to the Star Tribune. Doctors using the drug "to good effect" throughout Africa "rightly fear the NIH fumbles could spur pressure to stop using the drug before alternatives are available," the editorial says, concluding, "That could spell disaster for a multitude of African children -- and deprive a struggling continent of an undeniable blessing" (Minneapolis Star Tribune, 12/28/04).
  
  
• Palm Beach Post: The Bush administration's $500 million initiative "to push" nevirapine use is an "attempt to fight AIDS in Africa on the cheap and has undermined credible efforts and furthered distrust about AIDS prevention," a Post editorial says. In order to combat the HIV/AIDS pandemic "ethically and effectively, the Bush administration must insist on thorough, honest studies," the editorial says, concluding, "One cheap, dangerous drug should not be the only choice" (Palm Beach Post, 12/29/04).
  
  
• San Francisco Chronicle: The "benefits" of nevirapine have made it a "frontline drug in the AIDS fight, especially in Africa, where its relatively low cost can benefit a large population of infected women," a Chronicle editorial says. However, the recent reports about the problems in the Ugandan study have done "serious damage" to the "essential AIDS drug," while a "sad display of politics has crept into the debate," according to the Chronicle. "In South Africa and elsewhere, canceling a drug based on one reported problem isn't an option. That's why private AIDS group[s] have announced they will continue to use the drug, which shows demonstrable benefits when used correctly. It's completely understandable and supportable," the editorial concludes (San Francisco Chronicle, 12/29/04).
  

Opinion Pieces

• Celia Farber, New York Press: By "refusing to lament" the death of Joyce Ann Hafford -- an HIV-positive pregnant woman who died of liver failure likely caused by nevirapine while participating in an NIH study -- as well as the "scores of Ugandan deaths," the "AIDS establishment has shown itself to be lost, with a broken compass, on the map of medicinal ethics," columnist Farber writes in a Press opinion piece. "Once it becomes acceptable to kill patients in experimental clinical trials and cover it up, without consequence, you might argue that all is lost," Farber concludes (Farber, New York Press, 12/28/04).
  
  
• Frank Harris, Hartford Courant: The concerns about the nevirapine trials have confirmed the "fear that even today has many blacks in America -- and now Africans -- distrustful of the American medical community and government," Harris, chair of the journalism department at Southern Connecticut State University, writes in a Courant opinion piece. "Out of Africa and from the descendents of Africans have come wonders and discoveries in many fields -- including medicine," Harris writes, concluding, "When one group is suspicious of another's medicine, the best thing is for that group to do its own research and develop its own medicine" (Harris, Hartford Courant, 12/27/04).
  
  
• Sam Okuonzi, New Vision: Press reports on the safety of nevirapine are "deceptive, insincere and meant to mislead," Okuonzi, secretary general of the National Council of Children, writes in a New Vision opinion piece. Organizations painting a "bleak picture" of nevirapine's potential risks have "suddenly" become interested in AIDS, compared with established AIDS organizations that support the continued use of nevirapine in resource-poor areas where the drug is the only "safe, feasible and available [option] for preventing the infection of millions of babies with HIV by their HIV-positive mothers," Okuonzi concludes (Okuonzi, New Vision, 1/1).