NIH Specialist Denied Whistleblower Status Over Reports Concerning Nevirapine Research Practices
A federal administrative law judge in November denied whistleblower status to Dr. Jonathan Fishbein -- a clinical research specialist hired by NIH who recently released documents allegedly showing problems with NIH-funded trials of the antiretroviral drug nevirapine -- because Fishbein was hired as a "special consultant" and therefore lacks standard civil service protections, the Washington Post reports. Although Fishbein said he believes NIH is attempting to fire him in "retaliation for his refusal to overlook [research] shortcomings," officials at the agency have said that Fishbein -- who is still in a two-year probationary period -- is "being let go because of poor performance," according to the Post (Lee, Washington Post, 12/29/04). Enacted more than a decade ago, the Whistleblower Protection Act allows legal protections to federal employees who fear retaliation for making accusations of wrongdoing against their employer (AP/New York Times, 12/25/04).
NIH in 1997 began studying the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to prevent vertical HIV transmission. The initial results showed that the drug prevented HIV transmission to newborns in as many as half of births. However, by early 2002, medical safety specialists and auditors with NIH as well as the drug's manufacturer Boehringer Ingelheim all cited "widespread" problems with the research in Uganda -- 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 for 15 months from spring 2002 to summer 2003 in order to review the trial and take corrective steps (Kaiser Daily HIV/AIDS Report, 12/16/04). The National Institute of Allergy and Infectious Diseases in a "Q & A" document regarding the trial said that nevirapine is a "safe and effective" treatment to reduce the risk of vertical HIV transmission and that reviews of the study data "have found only a very small number of serious adverse reactions that potentially might be due to nevirapine" (NIAID Q & A, 12/17/04).
Judge Raphael Ben-Ami of the Merit Systems Protection Board -- an independent, quasi-judicial federal agency that was created to ensure that federal employees are hired according to merit systems standards and "protected against abuse by managers" -- on Nov. 9 ruled that Fishbein could not seek a hearing before the board because it lacks jurisdiction over "special-status" employees, the Post reports. NIH hired Fishbein in 2003 under a provision in federal law that allow HHS departments to hire employees "without regard to the civil service laws," according to the Post. The provision -- Title 42 209(f) -- allows NIH to provide "high-level" scientists with larger salaries than allowed under the standard federal payroll system, the Post reports (Washington Post, 12/29/04). "Title 42 appointments of special consultants are made without regard to the civil service laws," Ben-Ami wrote in his ruling, adding that, for that reason, the "board lacks authority to consider the appellant's claims of discrimination or retaliation."
"This is a major setback for drug safety," Kris Kolesnik, executive director of the National Whistleblower Center, said, adding, "Many of these employees, such as Dr. Fishbein, hold sensitive health- and safety-related positions. Without protections, these employees will not blow the whistle" (Solomon, AP/Boston Globe, 12/25/04). Stephen Kohn, Fishbein's attorney, has appealed Ben-Ami's decision to the full board (Washington Post, 12/29/04).
Scientists, Advocates Support Tramont
Scientists and AIDS advocates so far are "standing by" NIAID Division of AIDS Director Dr. Edmund Tramont's decision to rewrite conclusions concerning the Ugandan nevirapine trial, according to the journal Nature (Check, Nature, 12/22/04). Tramont last month admitted to rewriting a safety report on the use of nevirapine in pregnant women in order to change its conclusions and remove negative information about the drug. A January 2003 report by Dr. Betsy Smith, a medical officer under Tramont, "urged" NIH not to make "sweeping conclusions" about nevirapine based on the research in Uganda. However, Tramont asked to review Smith's report before it was submitted to authorities, including FDA. The report was published and sent to FDA a few weeks later with a new conclusion and without Smith's recommendations. Tramont's version of the report concluded that the Ugandan study "has demonstrated the safety of single-dose nevirapine for the prevention of maternal-to-child transmission. Although discrepancies were found in the database and some unreported (adverse reactions) were discovered ... these were not clinically important in determining the safety profile." Tramont acknowledged he had written the report after his staff began inquiring how Smith's report was changed (Kaiser Daily HIV/AIDS Report, 12/15/04).
Nevirapine 'Key' Drug, Advocates Say
"Ed Tramont is a man of integrity and common sense, and he has probably done more than anybody at the NIH to improve the infrastructure for conducting these trials in developing countries," Brooks Jackson, a pathologist at Johns Hopkins Medicine who led the study in Uganda, said, adding, "There's no question in my mind that single-dose nevirapine is safe and efficacious, and now that's been supported by several other studies independent of ours." AIDS advocates who "often clash" with NIAID also have said that despite the Ugandan study's procedural flaws, the data were "correctly interpreted," according to Nature. "The data discrepancies don't alter the fundamental findings," Gregg Gonsalves of Gay Men's Health Crisis said (Nature, 12/22/04). Both Zackie Achmat, head of the South African treatment advocacy group Treatment Action Campaign, and Dr. Mark Dybul, deputy chief of the President's Emergency Plan for AIDS Relief, also have said that nevirapine "remains a key drug in saving the lives of newborns," the Boston Globe reports (Donnelly, Boston Globe, 12/26/04).
Wrongful Death Suit Filed
In related news, the family of Joyce Ann Hafford -- an HIV-positive pregnant woman who enrolled in an NIH study examining the ability of nevirapine to prevent vertical HIV transmission -- on Dec. 28 filed a $10 million wrongful death suit in Memphis, Tenn., against the doctors, hospitals and drug manufacturers involved in the study, the Memphis Commercial Appeal reports (Edmondson, Memphis Commercial Appeal, 12/29/04). Hafford died Aug. 1, 2003, from liver failure less than 72 hours after giving birth by emergency caesarean section to an HIV-negative infant. NIH documents obtained by the Associated Press show that Hafford could have survived if doctors had ceased administering nevirapine when her blood work indicated liver problems two weeks before her death (Kaiser Daily HIV/AIDS Report, 12/16/04). Hafford's mother and sister have filed the suit against several of the doctors and nurses who treated Hafford, the Regional Medical Center at Memphis and pharmaceutical companies Boehringer Ingelheim and GlaxoSmithKline (AP/Kansas City Star, 12/29/04). The suit claims that doctors were negligent in monitoring and treating Hafford and that the defendants did not receive her informed consent to participate in the study or warn her of the risks associated with nevirapine. The defendants' lawyers have declined to comment (Memphis Commercial Appeal, 12/29/04).