U.S. Admitted AIDS Research Violated Rules

[Khephra]

WASHINGTON -- U.S. health officials told Uganda's government that a U.S.-funded study there on using an AIDS drug to protect babies violated federal safety rules even though they didn't tell President Bush before he authorized shipping the drug to Africa.

The Department of Health and Human Services' Office for Human Research Protections identified nearly nine-pages of problems with the National Institutes of Health research project on nevirapine in Uganda in a July 2002 letter that pointedly identified several violations of federal patient protection rules.

The letter also proposed numerous corrective actions.

"OHRP find that the ARC (the project's oversight committee) failed to conduct continuing reviews of the above-referenced research as required by HHS regulations," the letter to Uganda's National Council of Science and Technology said.

The letter identified problems that included lowering, without permission, the standards for disclosing bad reactions during the drug research, and giving patients information about the risks "that may not have been understandable."

http://www.newsday.com/news/politics/wire/sns-ap-aids-drug-letter,0,2401179.story?coll=sns-ap-politics-headlines

[bobbieinok]

1. letter from July 2002..JUST FINDING OUT ABOUT IT NOW?!?!?!?!?!?!

[maddezmom]

2. more incompetence

:eyes:

[struggle4progress]

6. Not incompetence but contempt for the health and safety of the peasants.

[daleo]

3. Notice the implied apology to Bush

"...even though they didn't tell President Bush before he authorized shipping the drug to Africa."

He must maintain is error-free status at all costs.

[maddezmom]

4. Grassley calling on Justice for an investigation

Senate Finance Committee Chairman Charles Grassley, R-Iowa, has asked the Justice Department (news - web sites) to investigate NIH's conduct. In a letter released Monday, Grassley said he was compelled to do so by "the serious nature of these allegations and the grave implications if the allegations have merit."

http://story.news.yahoo.com/news?tmpl=story&cid=544&ncid=693&e=1&u=/ap/20041213/ap_on_go_pr_wh/bush_aids_drug

[maddezmom]

5. Drug Expert Seeks Whistleblower Status

WASHINGTON - The expert hired by the National Institutes of Health (news - web sites) last year to improve its research practices after problems in an AIDS (news - web sites) drug study surfaced is seeking whistleblower protection after disagreements with management have left him on the verge of being fired.



Dr. Jonathan Fishbein, a 10-year expert on safe drug research practices in the private sector before joining NIH in summer 2003, has met with congressional investigators and provided extensive information about problems in NIH research.


NIH officials declined to discuss Fishbein, citing personnel privacy, except to say the move to fire him is based on his performance.


Fishbein, who is represented by the National Whistleblower Center, was told earlier this year he is being fired before he completes his two-year employment probation after a series of disputes with NIH managers over safety concerns in various AIDS research projects, according to his lawyer.


In one instance, Fishbein refused to discipline an employee for reporting safety concerns to the Food and Drug Administration (news - web sites), and another time he was overruled when he objected to restarting problematic research, documents show.

more: http://story.news.yahoo.com/news?tmpl=story&cid=542&ncid=693&e=7&u=/ap/20041213/ap_on_go_ca_st_pe/aids_drug_whistleblower

[justjones]

7. This is no isolated incident. There's all kinds of research going on....

in so-called "third world" countries sponsored by researchers in the United States that couldn't/wouldn't pass the sniff test here.

Since they got busted for The Tuskegee Syphillis research project where they were using African-Americans as human guinea pigs, I guess they decided to "outsource" such research to the so-called "third world" where they can go on exploiting and using brown people as guinea pigs, except these brown people will have no recourse against such treatment.

I know...I work in research and this is one of THE biggest problems I have with the research community. It makes my blood boil.

:grr:

[Rose Siding]

8. Soon Africa will begin to hate us for our "freedom"

Not discounting the moral issue in ANY way, but as hard as it is for the US to learn from its own mistakes, you'd THINK that the concept of an asymetrical threat is fresh enough to make an impression!

But that would involve THINKING and a sense of RESPONSIBILITY for your actions.

Just yesterday, some article asked "can dems handle nat'l security?". At least they seem to be able to CONNECT nat'l security with policies BEFORE the INVASION.

This blunder is shameful and chilling.