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."That's one extract from an article filled with such passages.
. . .
Behind the scenes, Tramont asked to see Smith's report before it was submitted to medical authorities, including the Food and Drug Administration "I need to see the primary data--too much riding on this report," Tramont wrote Jan. 23, 2003.
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."
The current status of the drug? Well, they are now advising it not be used when there is another alternative because apparently it "may cause long-term resistance to AIDS drugs in the hundreds of thousands of African patients who received it, foreclosing future treatment options."
What they don't mention in that article, but they do mention in this one is that nevirapine can cause lethal liver damage, which is apparently the way Joyce Ann Hafford died when she was taking the drugs in the US on an experimental basis. NIH tried to cover up her death as well, but AP gave Hafford's family internal NIH memos.
In the category of inscrutable choices: Yahoo! News has her story filed in the "Parenting/Kids" subsection of the Health news. Can I tell you how glad I am that I don't have children so that when I die because I am taking unsafe drugs that the government gave me and failed to warn me about and then they try to cover up that fact, Yahoo will at least file my story in the "Oddly Enough" category.
Tramont's response to her death? This email: "Ouch! Not much wwe (we) can do about dumd (dumb) docs." [I say again: you can't make this shit up.]
Am I too much of an alarmist to be thinking of this?