Showing posts with label PrEP. Show all posts
Showing posts with label PrEP. Show all posts

Sunday, May 29, 2016

AIDS War. Profiteering with PrEP



Abstract _____________________________________________________________________________
America’s AIDS czar for almost 30 years, Dr. Anthony Fauci has promoted and shepherded human experimental research that has exposed HIV negative Third World men and women to toxic chemotherapy, many already health-challenged from lack of clean water, poor sanitation, malnutrition and old diseases like tuberculosis and malaria. The experiments were to demonstrate “Pre-Exposure Prophylaxis” (PrEP) for the anti-viral drug Truvada. Like other nucleoside analogs, Truvada has well-assessed adverse (“side”) effects. Funded with tax dollars and non-profit grants, including tens of millions from Fauci’s National Institute of Allergy and Infectious Diseases, as well as from the CDC and USAID, studies have accrued to the sole benefit of a politically well- connected U.S. drug corporation, Gilead, the only company to “donate” pills for the clinical trials.
When PrEP was discussed initially in mainstream media, including in a New York Times article published January 22, 2006 (later critically reviewed by independent journalist Liam Scheff), human guinea pigs, almost all impoverished Third World subjects, were already in early phase trials, designed to produce results that would allow Gilead eventually to seek FDA approval for re- purposing its “Viread” but later only its “Truvada” chemotherapy for use by HIV antibody negative Americans, for theoretical protection from a virus proclaimed by the U.S. government in 1984 as a discrete pathogen responsible for the amorphous health condition described since 1982 as “acquired immune deficiency syndrome,” or “AIDS.” Under patent protection until 2021, Truvada remains more profitable for Gilead than Viread, for which a generic can be sold as early as December 2016.
Four main Phase 3 trials were initiated before the FDA approved the only drug studied in all four, Gilead’s Truvada--two with heterosexual Third World women, one with “discordant” (“one negative, one positive”) Third World heterosexual couples, but only one with the original “risk group,”gay men, over 90% of them in the Third World. Two of the heterosexual trials were halted early, when investigators began to see no difference between drugged and placebo cohorts. Reports on the gay male study, iPREX PrEP, and the discordant straight couples trial, Partners PrEP, grossly overstated drug prophylaxis, by using a spurious calculation technique. A valid methodology, dividing sero-conversions in each drug and placebo cohort by cohort size, would have resulted in slight percentage differences between those receiving Truvada and those getting “sugar pills.” [See below full article and summary chart, for a complete explanation.]

Sunday, October 5, 2014

Profiteering with PrEP (PreExposure Prophylaxis). Gilead pharmaceutical company's toxic Truvada for so-called HIV





by Terry Michael, September 30, 2014

I trace how a supplemental use for Gilead's HIV chemotherapy went from confirmation-biased clinical trials, funded by Dr. Anthony Fauci, NIH/NIAID director; to approval by the FDA, in a corrupt "user fee" (funded by Gilead) fast-tracked process, just in time for Fauci to announce it at the International AIDS Society "XIX AIDS Conference" in Washington, DC, in July 2012; to the CDC's  compliant  endorsement in May 2014; and now is being touted by a science-uninformed mass media and gay press, heavily promoted by the Gilead public relations machine.



America’s AIDS czar for almost 30 years, Dr. Anthony Fauci has promoted and shepherded human experimental research that has exposed HIV negative Third World men and women to toxic chemotherapy, many already health-challenged from lack of clean water, poor sanitation, malnutrition and old diseases like tuberculosis and malaria. The experiments were to demonstrate “Pre-Exposure Prophylaxis” (PrEP) for the anti-viral drug Truvada. Like other nucleoside analogs, Truvada has well-assessed adverse (“side”) effects. Funded with tax dollars and non-profit grants, including tens of millions from Fauci’s National Institute of Allergy and Infectious Diseases, as well as from the CDC and USAID, studies have accrued to the sole benefit of a politically well- connected U.S. drug corporation, Gilead, the only company to “donate” pills for the clinical trials. 

When PrEP was discussed initially in mainstream media, including in a New York Times articlepublished January 22, 2006 (later critically reviewed by independent journalist Liam Scheff), human guinea pigs, almost all impoverished Third World subjects, were already in early phase trials, designed to produce results that would allow Gilead eventually to seek FDA approval for re- purposing its “Viread” but later only its “Truvada” chemotherapy for use by HIV antibody negative Americans, for theoretical protection from a virus proclaimed by the U.S. government in 1984 as a discrete pathogen responsible for the amorphous health condition described since 1982 as “acquired immune deficiency syndrome,” or “AIDS.” Under patent protection until 2021, Truvada remains more profitable for Gilead than Viread, for which a generic can be sold as early as December 2016. 

Wednesday, July 16, 2014

WHO IWorld Health Organization) now wants ALL gay men to take antiretroviral drugs for the rest of their life

"Among men who have sex with men, pre-exposure prophylaxis (PrEP) is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package. NEW RECOMMENDATION"


In this new consolidated guidelines document on HIV prevention, diagnosis, treatment and care for key populations, the World Health Organization brings together all existing guidance relevant to five key populations – men who have sex with men, people who inject drugs, people in prisons and other closed settings, sex workers and transgender people – and updates selected guidance and recommendations.

These guidelines aim to:
  • provide a comprehensive package of evidence-based HIV-related recommendations for all key populations;
  • increase awareness of the needs of and issues important to key populations;
  • improve access, coverage and uptake of effective and acceptable services; and
  • catalyze greater national and global commitment to adequate funding and services

Wednesday, June 18, 2014

A New York Times opinion section "debate" about Truvada and so-called "Pre-Exposure Prophylaxis" or "PrEP."

In one of their "Room for Debate" features, The Opinion Pages of The New York Times 

June 17 chose five mostly HIV-AIDS Industry likely suspects to "debate" use of Gilead's toxic chemotherapy Truvada for so-called "PrEP."
Is a Pill Enough to Fight H.I.V.?http://www.nytimes.com/roomfordebate/2014/06/17/is-prep-a-good-way-to-fight-hiv-infections?hp&rref=opinion
It wasn't much of a "debate," more akin to: "French fries: possibly fattening, pretty much OK, or really f'king great?"  The missing position:"You're poisoning yourself, stupid!"

Sunday, September 16, 2012

TERRY MICHAEL INTERVIEW WITH ROBERT GALLO at the XIX International AIDS Society Conference

posted by Terry Michael:
I did with Dr. Robert Gallo at the XIX International AIDS Society Conference in Washington, DC, July 22, 2012. I had to transcribe it, because it's a poor quality audio, and Gallo is a hard interview. His syntax makes it difficult to follow him on the audio, but it should be easier with this transcript:

Here's the audio file you can download, as Windows Media Audio (.WMA):

And here it is (much larger file) as an .MP3:

I asked Gallo mostly about Luc Montagnier, and what he (Gallo) thought of his one-time colleague's views on "HIV co-factors" and Montagnier's assertion that we can rid ourselves of HIV "in just a few weeks if you have a good immune system," in the interview from the film "House of Numbers"

I also asked Gallo about his views on use of so-called "ARV's" for PrEP, or "pre-exposure prophylaxis," on which he equivocated, but said he was "not on that bandwagon."

At one point, Gallo tried to go "off-the-record"--even though his press aide early in the interview cautioned him that "you're on the record."  Gallo attempted to go off-the-record in what I regarded as an attempt to slander Montagnier by suggesting he (Montagnier) was trying to personally profit from his theories on nutrition and AIDS. As a journalist, I believe an interviewee has the right to ask if he can go off-the-record, during the course of an interview.  But, in this case, he did not ask to change the on-the-record condition; he just asserted he was doing it. In any case, I don't believe an interviewee should be able go off-the-record to engage in an ad hominem attack. That quote, in context, is copied below.

Monday, September 3, 2012

Sean Strub, Poz magazine, challenges Julio Montaner,Director of the British Columbia Centre for Excellence in HIV/AIDS, on AIDS "treatment as prevention"

POZ magazine founder Sean Strub, on Julio Montaner and so-called "treatment as prevention," XIX Intnl AIDS Conf., Washington, July 23, 2012. Strub believes in single pathogen theory, but leads against "over use" of chemo "anti-retrovirals," opposing "test-and treat" and "PrEP" or "pre-exposure prophylaxis." Montaner has fed toxic ARV's to Vancouver IV drug users for years--immune suppressive poison to people already pumping poison into their veins. Includes Montaner's weasel word response. Video from Kaiser foundation. (3-second drop-out at point 1:43 into video.)

  • We are not about mandatory anything but testing!
  • Yes, mandatory testing to capture more "postives" and then destroy their health with immediate poisoning with highly toxic chemotherapy. Universal testing is The HIV-AIDS Industry's government's and non-profits' collusion with Gilead Sciences and the other BigPharma producers of the poison.

What will DC AIDS office be advising physicians on prescribing "anti-retrovirals" to "HIV negatives" for so-called pre-exposure prophylaxis (PrEP)?

Challenging the District of Columbia AIDS bureaucrats on "pre-exposure prophylaxis", or "PrEP"--feeding toxic "anti-retroviral" chemicals to those who have not even tested "positive" on the so-called "HIV test."

On the opening day, Sunday, July 22, of the XIX International AIDS Conference, Terry Michaels questioned the director of the Washington, DC HIV-AIDS bureaucracy about what his agency will be advising physicians on use of ARV's as a prophylaxis against HIV "infection." It was at the end of a panel in which Dr. Robert Gallo participated.  It was the only venue at the 6-day conference to which Gallo was invited. The conference was funded and tightly controlled by NIAID director Dr. Anthony Fauci, with a $7 million U.S. NIH grant to the Swiss-based advocacy organization that produced the conference.  Millions more U.S. tax dollars were spent on conference registration fees, airfare, hotels and expenses for the mostly university contractors who benefit from Fauci's HIV research grants.

Saturday, May 12, 2012

Panel recommends approving Truvada to prevent HIV infection

By Saundra Young, CNN
KEY FROM THIS ARTICLES:
Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication.


Did the Government listen?


A drug already approved for treatment of AIDS might one day be approved for prevention of the deadly disease in individuals at high risk.

Unlimited insanity: Truvada to prevent HIV

A U.S. Food and Drug Administration advisory committee recommended Thursday that the agency approve the drug, Truvada, for pre-exposure prophylaxis, or PrEP.
The committee voted 19-3 in favor of approval for the prevention indication -- PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus.
Truvada, manufactured by Gilead Sciences, Inc., is a once-a-day pill used in combination with other HIV drugs. The nucleoside reverse transcriptase inhibitor does not rid the body of HIV. Instead, it prevents the virus from replicating in the body.
The FDA doesn't have to follow the recommendations of its advisory committees, but it often does.
Most of the more than 40 health care professionals, AIDS advocates and patients who addressed the committee implored its members not to recommend the drug for the new indication.
"There is no question that, if efforts on using PrEP is widespread, condom use and other means of preventing HIV infection will decrease," said Robert Elliott, a registered nurse. "At this point we simply don't know enough about how to increase adherence rates to work with the PrEP or how to counteract the risk compensation and the use of PrEP. Until then, PrEP is not and cannot be considered safe and effective for preventing HIV infections."
AIDS Activist Miki Jackson agreed. "A recommendation for the use of Truvada as PrEP is akin to issuing an engraved invitation for lawsuits," she said. "To knowingly recommend a drug as powerful as Truvada with such serious serious side effects and given to people who are perfectly healthy is frightening."
Michael Weinstein, president and founder of the AIDS Healthcare Foundation, said he was concerned that approval could lead a decrease in condom use. "Approving PrEP would be a reckless act," he said.
The FDA panel looked at safety and efficacy data from three clinical trials:
-- iPrEx, a study of men who have sex with men, found 43.8% fewer infections in men who got the drug versus those who got placebo;
-- in a Truvada study carried out by the Centers for Disease Control and Prevention in Botswana, infection rates were reduced by 63% overall in healthy men and women considered to be at high risk of infection;
-- the University of Washington's Partners in PrEP study of serodiscordant couples in Kenya saw 62% fewer infections in those taking Truvada and a 73% reduction in those who took a combination of Truvada and the HIV drug tenofovir.
Committee members also heard concerns about the drug's side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density.
But, after assessing the data, they concluded that Truvada is safe for men and women and effective in preventing infection.
And they had supporters. "What we need currently is additional tools for our powerful tool box," said Dr. Richard Elion, director of clinical research at the Whitman Walker Clinic in Washington. "We are not winning the battle. Please, were asking today to allow a modality that's still being developed to be added to our toolbox."
Kirk Myers, founder and CEO of Abounding Prosperity Inc., made a plea on behalf of African-Americans. "People need to be given the option to choose," said Myers, who is HIV-positive. "This drug is wanted. Another tool we can use. The right thing to do. Without this option, desperation will continue to drive up statistics of new incidents."
Chris Collins, vice president and director of public policy for the American Foundation for AIDS Research, said the data on the drug's prophylactic use were compelling and urged the committee not to limit access to it. "We need new tools to fight this epidemic that include treatment, condoms and education," Collins said. "PrEP is certainly not for everyone, but it may have a role in bringing HIV-infection rates down. It's time to learn how PrEP may be useful in the real world."
According to Dr. Peter S. Miele, a medical officer in the agency's Center for Drug Evaluation and Research, Truvada's safety and efficacy for the prevention of HIV-1 infection in high-risk individuals is supported by two large clinical trials. "Regular HIV testing, adherence and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP," he said.
Truvada is not cheap. A month's supply costs about $1,200.


Thursday, February 23, 2012

Is an “HIV Prevention Pill” Worth It? - AHF SPEAK OUT



In the United States, the Centers for Disease Control and the Federal Drug Administration (FDA) have expressed interest in establishing guidelines for the use of PrEP. Under the current regulations, a medical provider is allowed to prescribe ART to a HIV negative person. This is called ‘off-label use’ – use of an HIV/AIDS medication for purposes other than treatment of HIV— effectively constitutes PrEP. However, as long as PrEP is not officially sanctioned by the FDA, drug companies cannot market ARTs as a preventative measure to the public. If PrEP is eventually approved by the FDA, pharmaceutical companies stand to make a lot of money catering to a new market in the developed world instead of providing cheaper—and much needed—drugs in the developing world.