Thursday, December 16, 2004

This Week's
Backside
Of The
Bell Curve

Winner!


Chief of the
National Institutes of Health's
AIDS Division


Dr. Edmund Tramont




Dr. Edmund
GeorgeWIsComingLookBusy
Tramont


AP Exclusive: AIDS Research Chief Rewrote Safety Report, Restarted Research Over Objections

By John Solomon Associated Press Writer

WASHINGTON (AP) - The government's chief AIDS researcher removed some negative safety conclusions from a subordinate's report on a U.S.-funded drug experiment, then ordered the research to resume over objections from his staff, memos show.

--snip--

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. These problems had forced a 15-month halt to the research into using a single dose of nevirapine to prevent African babies from getting AIDS from their mothers.

--snip--

Now, officials have new concerns the lone dose of nevirapine may cause long-term resistance to AIDS drugs in the hundreds of thousands of African patients who received it, foreclosing future treatment options.

--snip--

Tramont dismissed the safety monitors' concerns, saying he didn't believe they fully understood AIDS.

--snip--

Bush visited the continent a few days after Tramont ordered the clinics reopened.

--snip--

Dr. Betsy Smith's report, finished in January 2003, said the Uganda trial suffered from "incomplete or inadequate safety reporting" and records on patients were "of poor quality and below expected standards of clinical research."

--snip--

A few weeks later, the safety report was published and sent to FDA without Smith's concerns and with a new conclusion.

The study "has demonstrated the safety of single dose nevirapine for the prevention of maternal to child transmission," Tramont's version concluded. "Although discrepancies were found in the database and some unreported AEs (adverse reactions) were discovered ... these were not clinically important in determining the safety profile."

In disbelief, Tramont's staff began inquiring how Smith's report got changed. An answer came back from the top.

"I wrote it," Tramont responded. LINK

George W.'s Recipe For AIDS Success:

Survive Idi Amin.

Trust the USA's AIDS medicine.

Die a horrible, lifesaving drug-resistant death
because George W. is coming for a photo op.

Decrease the surplus population.

Any questions?


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