UNITED STATES; AFRICA: Top US Officials Warned of Concerns Before AIDS Drug Sent to Africa

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

UNITED STATES; AFRICA: Top US Officials Warned of Concerns Before AIDS Drug Sent to Africa

Associated Press (12.13.04) - Tuesday, December 14, 2004
John Solomon

Weeks before President Bush announced a $500 million plan to protect African babies from HIV using the AIDS drug nevirapine, the National Institutes of Health was warned that its research on the drug in Uganda was flawed and potentially underreported serious adverse events including deaths. NIH did not inform Bush of the research problems; dismissed concerns as overblown; and were slow to report safety concerns to the Food and Drug Administration, according to documents obtained by the Associated Press.

Less than a month following Bush's June 2002 announcement, the federal Department of Health and Human Services notified Ugandan officials that NIH research "may have represented a failure to minimize risk to the subjects." NIH stopped the Ugandan research from the spring of 2002 to summer 2003 to review the science and take corrective actions. Records were so poor that agency investigators had to sample study participants' blood samples to determine who received the drug, the government documents show.

"Everyone recognized the enormity that this decision could have on the worldwide use of nevirapine to interrupt mother- baby transmission," NIH's AIDS research head, Dr. Edmund C. Tramont, reported March 14, 2002, to his boss, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Dr. H. Clifford Lane, NIH's second-highest ranking infectious disease official, said NIH officials knew of the upcoming White House announcement on nevirapine but did not notify Bush aides because they were confident - even before reviewing the Ugandan research - that the underlying science was valid.

NIH officials initially sought to postpone an FDA review of nevirapine's US application; then top FDA and NIH officials arranged for Boehringer to withdraw its US application rather than risk rejection and frighten African countries looking for US guidance with respect to nevirapine's use. NIH determined in subsequent reviews that poor patient health was responsible for all the deaths and the majority of adverse events in the Uganda study.

NIH officials acknowledge the research in Uganda failed to meet US standards, but are confident in reviewing the research that single-dose nevirapine is safe for use to prevent vertical HIV transmission during birth. However, one unexpected finding is that single-dose nevirapine therapy can confer instant resistance, and so should not be a first-line choice if other options are available, said Lane.

Two years after Bush's announcement, after hundreds of thousands of nevirapine doses had been distributed to African patients, FDA recommended NIH stop using the drug with certain patients and demanded stronger warnings to doctors and patients. In July, South African officials recommended ending the single-use treatment because of concerns over drug resistance. Some African doctors remain comfortable administering the drug to HIV-positive mothers with few other options to protect their babies. Boehringer is no longer seeking FDA approval to use nevirapine with US infants, as better treatments have emerged, according to company AIDS specialist Dr. Patrick Robinson.

Lessons learned from the review "will help us do our clinical research, both domestically and internationally, much better," said Lane.
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