Good job Mr. Sheff

http://nyp.org/news/hospital/263.html

“Freedom to Discover Grant”?

I wonder if the ’study subjects’ of the vaccine trial you described feel the ‘freedom of discovery’?

Orwellian…..

http://www.nature.com/nrmicro/journal/v1/n1/abs/nrmicro729.html

http://www.nature.com/nm/journal/v9/n3/abs/nm833.html

http://www.nature.com/nature/journal/v438/n7064/abs/nature04055.html

http://www.iavireport.org/Issues/0103/glendagray.asp

http://www.medicalnewstoday.com/articles/87409.php

http://jac.oxfordjournals.org/cgi/content/full/56/5/954
Long-term, controlled release of the HIV microbicide TMC120 from silicone elastomer vaginal rings R. Karl Malcolm*, A. David Woolfson, Clare F. Toner, Ryan J. Morrow and Stephen D. McCullagh

http://jac.oxfordjournals.org/cgi/content/full/52/6/890
Moore, et al: Preventing HIV-1 sexual transmission—not sexy enough science, or no benefit to the bottom line?

…. Jesus, get this guy a psychiatrist. Somebody, please send JP Moore some info on how hiv surrogate marker tests actually ‘test’ for, and how they work in reality.

“I thought the recent big failure was of a vaccine, not a microbicide, so I still don’t see how Moore was involved. I agree that microbicides have usually been shown to increase the risk of HIV surrogate markers developing, and now it seems that vaccines do too, but apart from that I don’t see a specific connection.”

Moore is the engine of the microbicide study in Nature, with Merck and BMS footing the bill, and supplying ingredients.

Moore has been pushing the microbicide issue long and hard, because he pushes the sexual issue. He’s obsessed with the sex life of Africans, and chooses to believe that the most important place for the West to go is to sexual intervention, for something that is not, as per Gisselquist, Padian, and everybody else who looks, not a problem of sexual conduction.

But there Moore goes, the Great White Hope, instead of to immuno-supportive therapies (like food and clean water, which a lot of African could really use to help them with their Immune Deficiencies).

As for the details, it seems that they’re all using old ‘hiv’ drugs, and shoving them in gels (like carageenan), into vaginas (and rectums).

http://jac.oxfordjournals.org/cgi/content/full/52/6/890?ijkey=7bfd3a6a4739e4bc7b540433ee77317a39b9e540&keytype2=tf_ipsecsha

and then on “negatively charged, sulphated polyanions”

http://www.nature.com/nature/journal/v438/n7064/abs/nature04055.html

Here’s fuzeon, and they seem to be focusing on the p120 that they manufacture in these SHIV constructs.

“The Nature study was led by John P. Moore, Ph.D., of the Weill Medical College of Cornell University in New York City, and Ronald S. Veazey, D.V.M., Ph.D., of the Tulane National Primate Research Center in Covington, LA. For the experiments, they used simian-human immunodeficiency virus (SHIV), a hybrid virus made in the laboratory from HIV and its cousin, SIV, which infects only non-human primates.

The researchers tested three microbicide gels alone and in combination. Two contained small molecules and the third featured a modified assembly of protein building blocks; each of the three was designed to block SHIV from entering specific cells in the vaginal area and thereby prevent the virus from invading the monkey’s body. The two small molecules were provided by Bristol Myers Squibb Inc. (BMS), based in Wallingford, CT, and Merck Research Laboratories, headquartered in Rahway, NJ. Weill Cornell Medical College supplied the third compound, which is similar to the approved anti-HIV drug Enfuvirtide (Fuzeon).”
http://pretoria.usembassy.gov/wwwhpr16f.html

“These compounds are BMS-378806, a small molecule that binds the viral gp120 glycoprotein and prevents its attachment to the CD4 and CCR5 receptors3, 4,”
http://www.nature.com/nature/journal/v438/n7064/abs/nature04055.html

This study referenced here is the 2005 Nature study:
http://www.nature.com/nm/journal/v11/n12/abs/nm1321.html

But Moore’s 2003 study, seems to be the starting point:
http://www.nature.com/nm/journal/v9/n3/abs/nm833.html

A topical microbicide reduces the probability of virus transmission when applied to the vagina or rectum of a person at risk of sexually acquiring HIV-1 infection1, 2, 3. An effective microbicide could significantly reduce the global spread of HIV-1, particularly if women were able to use it covertly to protect themselves. A microbicide could target the incoming virus and either permanently inactivate it or reduce its infectivity, or it could block receptors on susceptible cells near the sites of transmission1, 2, 3.

We describe here how vaginal administration of the broadly neutralizing human monoclonal antibody b12 can protect macaques from simian-human immunodeficiency virus (SHIV) infection through the vagina. Only 3 of 12 animals receiving 5 mg b12 vaginally in either saline or a gel and then challenged vaginally (up to 2 h later) with SHIV-162P4 became infected. In contrast, infection occurred in 12 of 13 animals given various control agents under similar conditions. Lower amounts of b12 were less effective, suggesting that protection was dose dependent. These observations support the concept that viral entry inhibitors can help prevent the sexual transmission of HIV-1 to humans.

Antibody Microbicides Can Prevent HIV Infection, Weill Cornell Scientist Discovers
http://www.nyp.org/news/hospital/112.html

“New York, NY (Feb 13, 2003) A team headed by a Weill Cornell Medical College scientist has shown that a virus-inhibiting antibody applied vaginally as a topical microbicide can prevent SHIV infection in a monkey model. A National Institutes of Health (NIH)-funded study provides evidence that microbicides can prevent virus attachment and entry into the vagina and its associated tissues, a useful step in the development of an effective method to prevent the spread of HIV.

Our findings are encouraging because several viral entry inhibitors are currently being developed as antiviral drugs. They should now be evaluated as microbicides to prevent infection, and not just as drugs to treat established infection, said Dr. John P. Moore, lead author of the article and Professor of Microbiology and Immunology at Weill Cornell Medical College. Our next step is to continue to evaluate several other entry inhibitors, to determine which are the most effective in the monkey model. An emphasis will be to identify compounds that are cheap enough to be used in the real world cheap, safe, and effective.”

///

And this based on his theory of binding, ‘invasion’, etc:

http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&uid=15040177&cmd=showdetailview&indexed=google

Moore: “Defining the mechanisms of HIV-1 transmission, the target cells involved and how the virus attaches to and fuses with these cells, could reveal ways to block the sexual spread of the virus.”

………..

This, because Moore’s (and too much of Aids research) obsession is sexual, but not about helping people actually improve their health.

Will post more as I find it.

http://www.newscientist.com/article/dn11081.html

It is the second spectacular failure of a microbicide gel or a cream designed for women to use vaginally to prevent infection with HIV. Microbicides were hailed as an important new weapon in HIV prevention (see Protect and survive).

Trials of the spermicide nonoxynol-9 were stopped after it was found to raise the risk of HIV infection, although it is still unclear why the product did not work.

http://www.iht.com/articles/2007/02/01/healthscience/web.0201aids.php

Efforts to develop a topical microbicide to prevent H.I.V. infection during sex suffered a surprising setback Wednesday when researchers announced that they had stopped two full-scale trials for safety reasons.

The trials, in Africa and India, involved a chemical, cellulose sulfate or Ushercell, and were the second failure of a potential microbicide in a full-scale trial in recent years. In one of the latest trials, a standard check by an independent scientific committee found an increased risk of H.I.V. infection among women who used cellulose sulfate compared with those who used a placebo gel.

In 2000, a large full-scale trial showed that the only other microbicide candidate, nonoxynol-9, was unsafe when it had been expected to be effective. Subjects in that trial developed a higher incidence of H.I.V. infection, presumably through ulcers caused by chemical irritation.

Wednesday, AIDS researchers at the World Health Organization, the United Nations AIDS program and other organizations expressed hope that at least one of three other potential microbicides undergoing full-scale testing would prove to be safe and effective. The others are Pro 2000 by Indevus Pharmaceuticals, BufferGel by ReProtect and Carraguard, whose trademark is held by the Population Council.

http://www.ebar.com/news/article.php?sec=news&article=1548

The trial involved 1,333 female volunteers in South Africa, Benin, Uganda, and India who were randomized to receive either cellulose sulfate or a placebo. When an independent data monitoring committee saw that more women using cellulose sulfate were becoming infected with HIV, it recommended that the trial be stopped.

http://pda.physorg.com/lofi-news-women-hiv-infection_84113989.html

Moscicki said that the safety trial is important because earlier spermicidal microbicides like nonoxynol 9, which was an ingredient in a variety of contraceptive products from condoms to contraceptive creams and gels, was eventually found to increase rather than decrease HIV infection rates.

“Nonoxynol 9 was used commonly and was thought to be an extremely safe type of anti-microbial spermicide. But researchers found that it actually increased the rate of HIV infection in women. So now we realize that we must approach new microbicides a little more carefully,” Moscicki said.

“[John P.] Moore’s team used a human antibody called b12 that binds an HIV coat protein and stops it latching onto cells. Applied two hours before sex, the antibody prevented 9 out of 12 monkeys from getting infected with a version of HIV; 12 out of 13 monkeys were infected without the antibody1.”

[again, they're not talking about an "hiv particle," they're talking about surrogate marker proteins, but they're not honest enough, or bright enough, to tell the audience the difference]

http://www.ipm-microbicides.org/news_room/english/press_releases/2005/2005_1031_bms.htm
31 October 2005

“New York – In a first-of-its-kind joint announcement, two of the world’s leading pharmaceutical companies, Merck & Co., Inc. and Bristol-Myers Squibb have each announced today that they have signed separate license agreements with the International Partnership for Microbicides (IPM) to develop new antiretroviral compounds as potential microbicides to protect women from HIV. Under the two separate agreements, Merck and Bristol-Myers Squibb will each grant the non-profit group a royalty-free license to develop, manufacture and distribute their compounds for use as microbicides in resource-poor countries.

Announced on the eve of the TIME Global Health Summit, this agreement marks the first time a pharmaceutical company has licensed an anti-HIV compound for development as a microbicide when the class of drugs is so early in development. The compounds are part of a new class of antiretrovirals known as “entry inhibitors.” Some of the compounds bind directly to HIV; others bind to the CCR5 receptor. They are designed to prevent HIV from efficiently entering host cells, thus preventing infection.

A study published in this week’s Nature will report that entry inhibitor compounds developed by Merck (CMPD 167) and by Bristol-Myers Squibb (BMS-378806), when used as vaginal microbicides, protected some macaque monkeys from infection with a virus similar to HIV. The research team was led by Dr. John Moore of the Weill Medical College of Cornell University and Dr. Ronald Veazey of the Tulane National Primate Research Center, and the study was funded primarily by US National Institutes of Health and other groups. Merck and BMS are providing IPM with royalty-free licenses to these drugs or other closely related compounds.”

“Trials of two vaginal microbicide gels to prevent HIV led to more infections among those using the products instead of placebos.”
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/24/AR2007102402514.html

http://www.clinicaltrials.gov/ct/show/NCT00385554

Botswana Study of UC-781 Vaginal Microbicide

This study is not yet open for participant recruitment.

Verified by Centers for Disease Control and Prevention October 2006

Sponsors and Collaborators:

Centers for Disease Control and Prevention
CONRAD

Information provided by: Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier: NCT00385554

Purpose

This study will test the safety, side effects, and acceptability of two strengths of UC-781 gel when used by women and men in Botswana for two weeks.

Condition
HIV Infections [surrogate marker results]

Intervention

Drug: UC-781 carbomer gel, 0.1% and 0.25%

Phase I

http://www.clinicaltrials.gov/ct/show/NCT00213083?order=12

Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:
Population Council
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation

Information provided by: Population Council

ClinicalTrials.gov Identifier: NCT00213083

Purpose
The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

HIV Infections
AIDS
Sexually Transmitted Diseases
HIV Seroconversion

Drug: Carraguard (PC-515)

Phase III

http://www.clinicaltrials.gov/ct/show/NCT00441298

Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV

This study is currently recruiting participants.

Verified by Centre for the AIDS Programme of Research in South Africa July 2007

Sponsors and Collaborators:

Centre for the AIDS Programme of Research in South Africa
Family Health International
United States Agency for International Development (USAID)
CONRAD

Information provided by: Centre for the AIDS Programme of Research in South Africa

ClinicalTrials.gov Identifier: NCT00441298

Purpose
This proposed phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 980 young women at risk of sexually transmitted HIV infection. Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.

[Will any of them receive any immunosupportive therapies? Or is it just the failed surrogate markers you want to test you failed cream on? No, Thanks, Aids Incorporated.]

http://www.nature.com/nm/journal/v9/n3/abs/nm833.html

http://www.nature.com/nm/journal/v9/n3/fig_tab/nm833_F1.html

http://jac.oxfordjournals.org/cgi/reprint/dkh011v1.pdf

Moore opines:

“Where do we go from here [with the monkey-vagina microbicide]?… The combined expertise of many sectors of the infectious disease research community will be required to develop an urgently needed product. ”

[A product for who? For Africans - of course! Just like Nevirapine...]

“New compounds to evaluate and more knowledge of the sexual transmission would certainly help.”

["More knowledge?" I think there's plenty, and to goes to - treat the immune deficiency, leave the surrogate markers behind.]

“And perhaps, above all, the involvement of the major pharmaceutical companies will be essential.”

But of course. Who else is going to do this noble work, but the major pharmaceutical companies.

They must be really ticked right now, JP Moore. You’ve lost them millions, and you’ve ruined the lives of the people who signed up for this fictional study. All for nothing.

Thanks again, Aidstruth.org, for the denial of competition in science and medicine. I think we’re going to be trying something new, from now on.

are you ready??

…female monkey vaginas (and then imagining that this is what we should do to African PEOPLE):

with the following result:

“Trials of two vaginal microbicide gels to prevent HIV led to more infections among those using the products instead of placebos.”

http://www.nyp.org/news/hospital/112.html

Antibody Microbicides Can Prevent HIV Infection, Weill Cornell Scientist Discovers

[from the NewYork Presbyterian Hospital press article]:

“A team headed by a Weill Cornell Medical College scientist has shown that a virus-inhibiting antibody applied vaginally as a topical microbicide can prevent SHIV infection in a monkey model. A National Institutes of Health (NIH)-funded study provides evidence that microbicides can prevent virus attachment and entry into the vagina and its associated tissues….”

“Our findings are encouraging because several viral entry inhibitors are currently being developed as antiviral drugs. They should now be evaluated as microbicides to prevent infection, and not just as drugs to treat established infection,” said Dr. John P. Moore, lead author of the article and Professor of Microbiology and Immunology at Weill Cornell Medical College. Our next step is to continue to evaluate several other entry inhibitors, to determine which are the most effective in the monkey model. An emphasis will be to identify compounds that are cheap enough to be used in the real world cheap, safe, and effective.

[...]

Dr. John Moore is also a member of the International AIDS Vaccine Initiative’s (IAVI) Neutralizing Antibody Consortium (NAC), a team working on the development of a preventive AIDS vaccine.

[end article]

Oh yeah, you mean these vaccines?

“South African AIDS researchers have begun warning hundreds of volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV…”

That is, to have a surrogate marker response, a non-specific, non-predictive response on either a molecular cloning assay (PCR), or an antibody assay (EIA testing).

More on Moore, of the monkey vagina fascination:

http://lib.bioinfo.pl/pmid:17428517

http://www.popcouncil.org/projects/BIO_Microb1RI.html

http://www3.niaid.nih.gov/news/newsreleases/2005/monkeymicrob.htm

video interview!!:
http://www.medscape.com/viewarticle/509678

Well, now you’re just talking crazy talk, Liam.

What would “treating immune deficiency” actually entail?

It probably wouldn’t involve the use of protease inhibitors, AZT and it’s chemical cousins. So, how would the drug companies make their money? Huh? Didn’t really think this through now, did you?

Sarcasm aside, yours is one of the most (if not the) most rational, reasonable approaches to solving what often gets called “AIDS”.

What a great shift in thinking. Rather than attacking surrogate markers with toxic drugs; treat people who’s immune systems have been ravaged by drugs, poor sanitation, poverty, malnutrition and starvation by reversing these conditions which negatively impact a person’s health. Crazy talk!

As far as I’m concerned “AIDS” is allopathic medicine’s last stand. They screwed themselves like they never have before. The “kill” something approach to the human body has, oddly enough, killed a lot of people in the process. I suppose there’s a certain degree of success in that. They killed the pathogen…along with the person. Oh well.

It is impossible no to laugh as you read how point by point you actually expose JP Moore and his AIDS cabal for what they are: Scared.

AIDS is over as pandemic and they know it. As long as they are there it is just a means towards human oppression and nothing more. When we expose them for that it really gets to them more than anything else.

(Note: when they talk about “infections”, they’re talking about surrogate marker tests, and non-specific, poly-reactive antibody tests, but they’re not bright enough to figure that out just yet):

Warning Is Sent to AIDS Vaccine Volunteers

South Africans Among Recipients Who May Be at Higher Risk of Contracting Virus

By Craig Timberg
Washington Post Foreign Service
Thursday, October 25, 2007; Page A20
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/24/AR2007102402514.html

JOHANNESBURG, Oct. 24 — South African AIDS researchers have begun warning hundreds of volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV in the midst of one of the world’s most rampant epidemics.

The move stems from the discovery last month that an AIDS vaccine developed by Merck & Co. might have led to more infections than it averted among study subjects in the United States and other countries. Among those who received at least two doses of the vaccine, 19 contracted HIV compared with 11 of those given placebos.

Researchers shut down the trial on the grounds that the vaccine was proving ineffective, but the surge in infection among vaccinated volunteers prompted intense scientific debate and anxiety among researchers. The failure of the Merck vaccine is the latest in a series of disappointing results for research projects aimed at curbing AIDS.

“This is my worst nightmare,” said Glenda Gray, the lead South Africa investigator for the vaccine study. “I haven’t slept for days. I have a headache. I’m ready to resign from trials for the rest of my life.”

[Great! While you're at it, please take your lousy surrogate markers with you, and start treating the Immune Deficiency, not the failed antibody/pcr technologies.]

Researchers in Soweto, Cape Town, Durban and two other sites began contacting South Africa’s 801 trial participants on Tuesday, mainly by cellphone text message. The goal is to tell each one individually whether they had received a placebo or the vaccine, a process called “unblinding” the trial. Researchers are telling the roughly half who received the vaccine that it might have increased their risk of contracting HIV.

“It’s quite shocking,” said Nelly Nonoise, 26, who had received three injections of the vaccine in her left shoulder.

She added, “I probably wouldn’t have joined the study knowing there’s a risk.”

Another participant, Nonhlanhla Nqakala, 22, said she thought the text message urging her to visit the vaccine test site meant she had tested positive for HIV. Her brother and a close friend had the disease and died, she said.

Nqakala said she was relieved when a doctor explained that she was not infected, but the news of a possible problem with the vaccine — she had received three doses, not placebos — left her distressed. “I thought the trial would help us find a cure for HIV,” she said.

Merck developed the vaccine in conjunction with the U.S. National Institutes of Health, and until September’s announcement, researchers worldwide considered it the most promising candidate yet in a multibillion-dollar quest for an AIDS vaccine dating to the 1980s.

Scientists crafted the vaccine by genetically altering a common virus to include elements of HIV. They hoped that it would trigger an immune response that would make recipients less likely to contract HIV, or at least delay the onset of full-blown AIDS.

["A common virus." Do you hear the question? "Why don't they use the "virus" they're trying to evoke antibodies to?" The answer is - There is no purified reference particle (no single, particular, particulate "hiv"), only proteins siphoned out of TCell and other cancer cultures, and cloned bits of white blood cell RNA and DNA, nothing from which to make an actual "vaccine".]

The vaccine could not have caused infection, researchers say, but it could have caused immunological changes that made it easier for the virus to take hold during a later exposure.

[No, what happened was this. You injected people with proteins that caused antibody [protein] production. You then tested them for a response to these proteins. Voila, they test “positive” (reactive), to the multilateral soup you shoved into their musculature. ]

The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men.

[Right, because we love to imagine that homosexual sex causes Aids, but heterosexual sex doesn't (unless you're Black, of course. (see "Africa" in this story).]

In South Africa — where an estimated 5.5 million people are infected with HIV, more than in any other country — the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual.

["Estimated." What does this mean? It means that blood samples drawn from pregnant girls (who'd left blood to be tested for syphilis), are then tested with a non-specific test that comes up positive for pregnancy, syphilis, and every other condition known to human kind. The results of the non-specific testing are then extrapolated to the entire COUNTRY, male, female, young and old. That's one terrific, "Estimate." ]

The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck.

Continuing research could be compromised, he said, if participants were told immediately whether they received the placebo or the vaccine. Vaccine researchers are scheduled to meet in Seattle on Nov. 7.

“Given the complexity of the issue, we feel the best conclusions will be reached when all the data are analyzed in their entirety,” Feinberg said from Atlanta, where he was traveling.

He added that individual participants who want to know whether they received the vaccine will be told. Researchers also are counseling all study participants that the vaccine may have increased HIV risk for those who received it.

Other AIDS studies also have had unexpected results. Trials of two vaginal microbicide gels to prevent HIV led to more infections among those using the products instead of placebos. A massive study in Zimbabwe of the ability of HIV counseling and testing to prevent the spread of the epidemic found more infections among those with expanded access to testing.

[end article]

I think John P. Moore might have had a hand in some of these trials…I’ll have to look and see.

The moral of the story?

The Aids cabal must stop trying to treat/affect/suppress the surrogate markers, and start dealing with the immune deficiency, and we’ll begin to turn this around. Stick with the surrogate markers, and you’re going to invite failure after failure.

So the Aids industry had now given all those people death sentences. I suppose the next tactic is to ply them with the poisonous drugs and condoms?

Makes you wonder what these people are playing at, in reality? Hey Aidstruth, how about next time, staying the f- out of people’s sex lives?

More on treating Immune Deficiency, not surrogate markers:

Treating Immune Deficiency, Not Surrogate Markers.

It’s a simple concept: Look for success, not failure, to be your guide. The Aids machine has racked up failure after failure. Time for them to move their fat asses over on the research bench, and let a little competition in for a change.