The US government's chief of AIDS research rewrote a safety report on a US-funded drug study to change its conclusions and delete negative information. Later, he ordered the research resumed over the objections of his staff, documents show.
Dr. Edmund Tramont, chief of the National Institutes of Health's (NIH) AIDS Division, took responsibility for both decisions. He cited his four decades of medical experience and argued that Africans in the midst of an AIDS crisis deserved some leniency in meeting US safety standards, according to interviews and documents obtained by AP.
Tramont's staff, including his top deputy, had urged more scrutiny of the Uganda research site to ensure it overcame record-keeping problems, violations of federal patient-safety safeguards and other issues that forced a 15-month halt to the research into using nevirapine to prevent African babies from getting AIDS from their mothers.
AP reported on Monday that NIH knew about the problems in early 2002 but did not tell the White House before US President George W. Bush launched a plan that summer to spread nevirapine throughout Africa. Now, officials have new concerns the drug may cause long-term resistance in the hundreds of thousands of African patients who received it, foreclosing future treatment options.
"I am not convinced that the site is indeed prepared to become active," Dr. Jonathan Fishbein, an expert NIH hired to improve the agency's research practices, wrote Tramont in July last year.
Fishbein contended he should be given time to review Uganda's capabilities and safety monitoring before letting the site reopen, or NIH would risk being "toothless" in its new efforts to clean up sloppy research practices. He added that professional safety monitors hired by NIH had reservations about the site.
Tramont dismissed the safety monitors' concerns, saying he didn't believe they fully understood AIDS.
"I am convinced that this site is ready to resume given the limitations of doing research in any resource-poor, underdeveloped country," Tramont wrote on July 8 last year, in response to Fishbein.
"I want this restriction lifted ASAP because this site is now the best in Africa run by black Africans and everyone has worked so hard to get it right as evidence [sic] by the fact that their lab is now certified," he wrote.
NIH officials acknowledge Tramont rewrote the report and overruled his staff on the reopening, but said he did so because he was more experienced and had an "honest difference of opinion" with his safety experts. They noted he had no financial interest in nevirapine and that the troubled study began well before he joined NIH in 2001.
Those who raised objections "were part of a large team of which Dr. Tramont was the head, and it is important that the people involved in that team should express their opinion and there should be discussion," said Dr. H. Clifford Lane, the NIH's No.2 infectious disease specialist and one of Tramont's bosses. NIH designated Lane to speak to AP on Tramont's behalf.
Lane said an internal NIH review concluded Tramont had not engaged in scientific misconduct. Separately, the National Academy of Sciences is investigating whether the Uganda research is valid.
CONFRONTATION: The water cannon attack was the second this month on the Philippine supply boat ‘Unaizah May 4,’ after an incident on March 5 The China Coast Guard yesterday morning blocked a Philippine supply vessel and damaged it with water cannons near a reef off the Southeast Asian country, the Philippines said. The Philippine military released video of what it said was a nearly hour-long attack off the Second Thomas Shoal (Renai Shoal, 仁愛暗沙) in the contested South China Sea, where Chinese ships have unleashed water cannons and collided with Philippine vessels in similar standoffs in the past few months. The China Coast Guard and other vessels “once again harassed, blocked, deployed water cannons, and executed dangerous maneuvers” against a routine rotation and resupply mission to
GLOBAL COMBAT AIR PROGRAM: The potential purchasers would be limited to the 15 nations with which Tokyo has signed defense partnership and equipment transfer deals Japan’s Cabinet yesterday approved a plan to sell future next-generation fighter jets that it is developing with the UK and Italy to other nations, in the latest move away from the country’s post-World War II pacifist principles. The contentious decision to allow international arms sales is expected to help secure Japan’s role in the joint fighter jet project, and is part of a move to build up the Japanese arms industry and bolster its role in global security. The Cabinet also endorsed a revision to Japan’s arms equipment and technology transfer guidelines to allow coproduced lethal weapons to be sold to nations
Thousands of devotees, some in a state of trance, gathered at a Buddhist temple on the outskirts of Bangkok renowned for sacred tattoos known as Sak Yant, paying their respects to a revered monk who mastered the practice and seeking purification. The gathering at Wat Bang Phra Buddhist temple is part of a Thai Wai Khru ritual in which devotees pay homage to Luang Phor Pern, the temple’s formal abbot, who died in 2002. He had a reputation for refining and popularizing the temple’s Sak Yant tattoo style. The idea that tattoos confer magical powers has existed in many parts of Asia
ON ALERT: A Russian cruise missile crossed into Polish airspace for about 40 seconds, the Polish military said, adding that it is constantly monitoring the war to protect its airspace Ukraine’s capital, Kyiv, and the western region of Lviv early yesterday came under a “massive” Russian air attack, officials said, while a Russian cruise missile breached Polish airspace, the Polish military said. Russia and Ukraine have been engaged in a series of deadly aerial attacks, with yesterday’s strikes coming a day after the Russian military said it had seized the Ukrainian village of Ivanivske, west of Bakhmut. A militant attack on a Moscow concert hall on Friday that killed at least 133 people also became a new flash point between the two archrivals. “Explosions in the capital. Air defense is working. Do not