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Medical Forum / Diseases and Disorders / AIDS / December 2004Thirty-eight babies died. Sixteen on Nevirapine
The NIH Two-Step - Stepping Over Bodies on the Way to Market by Liam Scheff Saturday, Dec. 18, 2004 at 1:18 PM The major media is finally covering the toxicity of what pharmaceutical companies mislabel 'AIDS Drugs,' but they're four years and hundreds of deaths too late This week, Dr. Edmund Tramont, Head of the National Institutes of Health (NIH) AIDS division, was outed by fellow NIH AIDS researcher Dr. Jonathan Fishbein, for burying evidence of drug toxicity in an African drug trial. Tramont censored reporting of thousands of toxic reactions and at least 14 deaths in the ongoing Nevirapine study in Uganda. The media has seized on this like it’s news, but the truth about Nevirapine was known in 2000, when the FDA put a black-box label on the drug, warning of the drug’s ability to cause fatal liver damage and bloody rupturing of skin and flesh. The drug’s manufacturer, Boehringer Ingelheim, wanted to get the drug into the US market for use in pregnant HIV-positive women. But the drug’s toxicities were so great, they pulled it out of the FDA approval process. Then they did what all drug companies do with their garbage – dump it into impoverished foreign markets and tell the soft-headed liberal media that it’s an AIDS drug. The Ugandan study that Tramont helped bury was overseen by Dr. Laura Guay, a US doctor from Johns Hopkins University School of Medicine. Under Dr. Guay, the drug found its approval overseas. How does a drug that kills Americans save Africans? South African lawyer and journalist Anthony Brink scrutinized the study in "The Trouble With Nevirapine" first published in April 2002, and updated this year. Dr. Fishbein tracked down Brink, whose study he described as "an expertly written piece about this very dangerous drug." There’s not a word in the current NIH mea culpa that Brink didn’t outline in greater detail a year and a half ago. The Ugandan study started like all AIDS drug trials do. Dr.Guay discarded the study controls. There was no placebo group to compare the Nevirapine group to. Everybody was on one of two cell-killing drugs – Nevirapine or AZT. The study put pregnant women on one of the two pills at labor. Why at labor? The idea is to prevent transmission of HIV from mother to child. The mother’s HIV status is determined, of course, by what we call an HIV antibody test. Here’s a clever bit of information left out of the NIH report and the mainstream press coverage - HIV test inserts warn that pregnancy produces antibodies which cause the tests to come up positive. Pregnancy, on its own, creates positive HIV test results. You’ll find this over and over again in the medical literature. But it was ignored in Uganda (as it is in the US, every day). The other line of missing logic in the Ugandan study is that, according to the test manufacturers, no child can be tested for at least 18 months with any certainty, because of normal “passive transmission of maternal antibodies” that can trip up the hyper-reactive HIV tests. So, what are we trying to prevent transmission of? Antibodies? Pregnancy? Who knows. In order to get around the standard tests’ short-comings, the babies were instead tested with a genetic kit called PCR. But here’s the joke. PCR isn’t validated or approved to diagnose viral infection. PCR is irreproducible. In the lab, it gives wildly varying results for the same sample. There’s no standard to measure it against. PCR tests amplify scraps of unidentifiable genetic material in cells. Researchers like to pretend that this material represents some aspect of a virus – but the manufacturer warns specifically against using the test for this purpose: “The AMPLICOR HIV-1 MONITOR Test….is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection.” (Roche PCR HIV-1 Monitor Test) But that’s exactly how doctors and researchers are using it, to get infants into a drug study. Where’s the liberal media on this issue - Mother Jones, Democracy Now? I’ve presented it to DN, several times, and apparently, they can’t be bothered with it. After all, how could the medical establishment be wrong? But even if the tests were accurate, and the drugs weren’t biological weapons, there’s a terrible flaw in these studies. To paraphrase Brink - what’s the purpose of a last-minute drugging to prevent the passage of a retrovirus, when the child and mother have been sharing the same blood, tissue, cells and body for nine months? Adding insult to injury, the Guay study also became immediately unblinded. Everybody knew who was on Nevirapine, who was on AZT, and who tested positive. In the absence of a controlled, well-observed study, participants tend to give into panic, pill-sharing, over-consuming, and the mixing in of non-study drugs to try to get the HIV-antibody response to go away. The results of Guay’s study came in with an official recommendation for Nevirapine, but only after recording a 20% rate of “serious adverse events” in both the Nevirapine and AZT groups. Patients on the drugs had blood and tissue infection, pneumonia, blood cell death, severe rash and insufficient oxygen reaching their tissues. Thirty-eight babies died. Sixteen on Nevirapine, twenty-two on AZT. The drug was approved because the rate of PCR-inferred viral infection in the Nevirapine infants was 13.1%. Lower than that of the AZT group’s PCR rating. What’s PCR? A non-diagnostic test with no standard that gives different results for every sample. According to the medical/pharmaceutical establishment, it was enough to get a profitable, deadly drug into the international marketplace. (Dead babies don’t mean much there). If that doesn’t penetrate your skull, try this. A study was done in 1998 with 561 expectant African mothers to see what the rate of presumed HIV infection was with no drugs, no pills and no placebos. The result – 12%. Less than 13.1? Sure. But where’s the money in not drugging them? This summer in America, the same drug was being used in an NIH sponsored trial of US patients. Another expectant mother, Joyce Ann Hafford, had been dosed with Nevirapine (commercially sold here as “Viramune”) because she too had a reaction on an HIV test. Hafford was 33. Before entering the study, she was healthy and pregnant, but was convinced to go on the drug because of her HIV test result. In early August doctors knew that Hafford’s liver was failing. But they kept her on the drugs. She died two weeks later due to “drug-induced hepatitis” – fatal liver poisoning. An emergency cesarean-section was performed to get her baby out of her dying body. Neither she nor her family had been given the drug’s boxed warning label prior to her entrance into the study. If she had, she might be here today. The Nevirapine (Viramune) label: “Warning: Severe, life-threatening, and in some cases fatal hepatotoxicity [liver poisoning], including fulminant and cholestatic hepatitis, hepatitic necrosis [liver death] and hepatatic [liver] failure, has been reported in patients treated with VIRAMUNE [Nevirapine]…Patients with signs or symptoms of hepatitis must discontinue VIRAMUNE and seek medical evaluation immediately. Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis [skin death], and hypersensitivity reactions characterized by rash, constitutional findings and organ dysfunction. It is essential that patients be monitored intensively during the first 18 weeks of therapy with VIRAMUNE to detect potentially life-threatening hepatotoxicity or skin reactions….In some cases, hepatatic injury has progressed despite continuation of treatment. VIRAMUNE should not be restarted following severe hepatatic, skin, or hypersensitivity reactions.” Dr. Edmund Tramont, of the NIH, had these thoughtful words to offer on the subject. "Ouch! Not much wwe (we) can do about dumd (dumb) docs," he wrote, in an inner-office email, leaked to the Associated Press. “Ouch! Not much we can do about dumb docs?” Sure there is. We can take them to court. In droves. But maybe it’s time that the rest of us got smart, and began to regard the NIH with the same unblinking critical eye that we do any other money-driven corporate entity. The day that the Left stops pretending that the NIH is going to solve the world’s health problems, we might actually start saving some lives. For more on Nevirapine, see the 2001 European Study photos and link at Altheal.org http://www.altheal.org/toxicity/orphans.htm No where in what you post bellow says anything about 38 babies dying Paul, did you pull another number out of your a.s? In that no child is even given Nevirapine during the treatment to prevent mother to child transmission of HIV it would be impossible for any child whose mother was treated to prevent mother to child transmission of HIV to have any reaction to the drug what so ever. You also say; > If that doesn’t penetrate your skull, try this. A study was done in 1998 > with 561 expectant African mothers to see what the rate of presumed HIV > infection was with no drugs, no pills and no placebos. The result – 12%. > Less than 13.1? Sure. But where’s the money in not drugging them? I would be willing to bet that if the study you quote above exists at all it was a study simply of untested pregnant women thus there was no knowledge as to the HIV status of any of the participants. So most likely only 15% or so of them were infected with HIV witch would account for the 12% rate of mother to child transmission. Just so you know Paul not every HIV infected woman passes on HIV to her infant 2% to 3% of the children borne to HIV positive mothers manage to escape infection with no treatment. So unless you can produce a citation for the study you are purportedly quoting from the quote is simply meaningless as far as the debate about Nevirpine as used to prevent mother to child transmission of HIV. Gary Stein (snip the rest of Paul's lies and propaganda) You are correct. I posted the wrong story with the headline. I will go back and find the correct story. Thanks for pointing out the error. (I'm off now so it will have to wait until tomorrow) Paul's simply cutting and pasting from Liam Scheff's bullshit. Daft bastard doesn't have a clue - he's referring to the HIVNET 012 study. The mothers were diagnosed by ELISA and WB, full CDC protocol so minimal false positives (well under 1% most likely). Kids were diagnosed NOT by PCR, but by multiple PCR, cultures and serology at 18 months of age. *sigh*. AZT kills cells at concentrations hundreds of times higher than what are virucidal, and NVP simply isn't a chain terminator so isn't cytotoxic. Mother and child don't share blood because the placenta actually gets in the way. If they did, the mother would reject the fetus as an "organ transplant" since half the genes wouldn't match the "host". Nothing like letting the facts get in the way of a good story. A half-arsed attempt to educate himself in medicine and the actual study he's criticising would have been nice. I dunno where the 12% story came from - it may well be a mixed cohort, or an immediately post-partum transmission rate, without taking into account the effects of breast feeding transmission - which would likely push it over 25%. I can't find the study with a Pubmed search, so maybe he's quoting something esoteric, or just misquoting. The NIH office memo was NOT in response to the Nevirapine toxicity, it was in response to a bunch of study docs not noticing the fact that the mother's liver tests from two weeks previously were bad. They should have _stopped_ the NVP, but they certainly weren't expected not to have given it at all (as implied in Liam's article). The family were given the study consent form which DID clearly state the drug's toxicity. If they didn't read it in the consent, who's to say they would have read it in the package insert? Bennett Paul's simply cutting and pasting from Liam Scheff's bullshit. Daft bastard doesn't have a clue - he's referring to the HIVNET 012 study. The mothers were diagnosed by ELISA and WB, full CDC protocol so minimal false positives (well under 1% most likely). Kids were diagnosed NOT by PCR, but by multiple PCR, cultures and serology at 18 months of age. *sigh*. AZT kills cells at concentrations hundreds of times higher than what are virucidal, and NVP simply isn't a chain terminator so isn't cytotoxic. Mother and child don't share blood because the placenta actually gets in the way. If they did, the mother would reject the fetus as an "organ transplant" since half the genes wouldn't match the "host". Nothing like letting the facts get in the way of a good story. A half-arsed attempt to educate himself in medicine and the actual study he's criticising would have been nice. I dunno where the 12% story came from - it may well be a mixed cohort, or an immediately post-partum transmission rate, without taking into account the effects of breast feeding transmission - which would likely push it over 25%. I can't find the study with a Pubmed search, so maybe he's quoting something esoteric, or just misquoting. The NIH office memo was NOT in response to the Nevirapine toxicity, it was in response to a bunch of study docs not noticing the fact that the mother's liver tests from two weeks previously were bad. They should have _stopped_ the NVP, but they certainly weren't expected not to have given it at all (as implied in Liam's article). The family were given the study consent form which DID clearly state the drug's toxicity. If they didn't read it in the consent, who's to say they would have read it in the package insert? Bennett AS A MATTER OF RECORD, THE POST OF A "DR" BENNETT IS THE SAME WHO IS EMPLOYED BY THE AIDS INDUSTRY. kjl And let's get all the facts on the table here... below is a clarification issued by the whistleblower, the honest and good Dr. Fishbein, a few days ago. It wasn't a small matter of record-keeping anymore than the Enron scandal was a minor detail of accounting. We are talking about compromised integrity; data which and researchers whom are now suspect. We don't assume safety and efficacy, they must be established. Without the evidence, it is assumed Nevirapine is not safe or is not effective. The hypocratic oath doesn't state, first do what you believe might help, it states: FIRST, DO NO HARM. << Without adherence to this standard, no honest assessment of the safety and efficacy of nevirapine in preventing the spread of HIV/AIDS from mother to child can be made from the HIVNET 012 data. NIH and the HIVNET 012 researchers have violated the public trust by ignoring rules and regulations designed to protect the well-being of vulnerable patient populations and the integrity of scientific research. Americans and Africans alike should be outraged by this behavior. >> In a message dated 12/21/2004 9:07:56 P.M. Pacific Standard Time, honestdoctor@comcast.net writes: HonestDoctor.org FOR MORE INFORMATION, CONTACT: Rand H. Fishbein, Ph.D. Tel: (301) 767-1691 Internet: _www.HonestDoctor.org_ (http://www.honestdoctor.org/) E-Mail: _HonestDoctor@comcast.net_ (mailto:HonestDoctor@comcast.net) FOR IMMEDIATE RELEASE Fishbein Clarifies Allegations: NIH Officials Betray Public Trust, Perpetuate Widespread Cover-up of Clinical Trial Data * * * * * Washington, D.C., December 22, 2004. There have been some incorrect assertions and inferences in the press regarding the exact nature of my allegations against the National Institutes of Health (NIH) and its officials. This statement clarifies my position. My sole criticism of the HIVNET 012 clinical trial rests with the issue of scientific integrity. It is my contention that NIH-sponsored researchers knowingly failed to abide by the most fundamental tenets of Good Clinical Practice (GCP) when studying the effects of the drug nevirapine on African research subjects. GCP is an internationally recognized standard for conducting clinical research. Its purpose is to assure the public that test data is credible and that the safety, well-being, and rights of clinical trial subjects are protected. The failings of the HIVNET 012 researchers were compounded by NIH officials, who not only deceived the public, but knowingly withheld critical information from the President, necessary for him to make an informed decision about a major foreign policy initiative. Publicly, they have trivialized the deficiencies in the trial by calling them "procedural". The integrity of the HIVNET 012 study has been compromised in a number of ways. Some of the more egregious include: 1· failure to record thousands of adverse events, 2· failure to obtain proper informed consent, 3· failure to maintain satisfactory clinical and pharmacy records, and 4· failure of the investigators to assess adverse events through direct observation. Furthermore, the Office for Human Research Protections (OHRP) cited serious issues of non-compliance with regulations that assure the protection of human research subjects. This was the judgment of auditors from Boehringer-Ingelheim, and Westat Corporation. It also was the finding of the DAIDS Remonitoring Team before their conclusions were rewritten by Edmund Tramont, Director, Division of AIDS, NIAID to cover-up the gross errors in the researchers. GCP is essential to assuring that clinical trial data is true and accurate. Without adherence to this standard, no honest assessment of the safety and efficacy of nevirapine in preventing the spread of HIV/AIDS from mother to child can be made from the HIVNET 012 data. NIH and the HIVNET 012 researchers have violated the public trust by ignoring rules and regulations designed to protect the well-being of vulnerable patient populations and the integrity of scientific research. Americans and Africans alike should be outraged by this behavior. Faulty scientific research, disguised through government deceit, exacts a high cost on the public and the credibility of American medical research. Without the preservation of high research standards and intellectual honesty in clinical research, the health and safety of the public is placed in grave jeopardy. The issue I chose to bring to the fore is not nevirapine, but the issue of misconduct in the NIH research establishment. All NIH employees have a mandatory duty under law and regulation to report waste, fraud, and abuse to the appropriate authorities: All NIH employees have a responsibility to assist in efforts to combat fraud, waste, and abuse in all NIH programs and have the responsibility to report such matters to the appropriate official following the procedures described in Section F of this chapter, ˜Procedures for Reporting Allegations. NIH Policy Manual, Chapter 1754, Part C (Policy); 45 CFR Part 73, Subpart M. Adding to this tragedy is the fact that NIH senior management failed in their role as guardians of the public trust to address the allegations of wrongdoing when I reported them. It is they who should have recognized these lapses in procedure and ethical judgment when I stepped forward. Instead, they chose to shoot the messenger. To this day they persist in denying that any wrongdoing took place. As a result, the NIH has fueled suspicions about the intentions of American scientists around the globe and has set back the cause of AIDS research years, if not decades. Reform and new leadership can not come soon enough to NIH. Countless lives depend upon it. Today, I call upon the Congress of the United States to direct that a full and independent investigation into the misconduct at NIH be carried out. Those responsible for covering up scientific misconduct must be held accountable. At stake is nothing less than the credibility of American medical research and with it a critical element of American foreign policy. Jonathan M. Fishbein, M.D. == Heatlthfully and Hopefully, Kelly Jon Landis HIV/AIDS ALTERNATIVE VIEWS http://forums.delphiforums.com/innocuous LOL! If you can find any evidence of any "AIDS industry" money coming my way, please let me know, because I think they've been depositing it in the wrong bank account. I'm currently employed solely by a charitable research organisation (I have a 403(b), not a 401(k)). Any why the quotes around the Dr bit? I mean, I have two "doctor" degrees, so if you're uncertain about one I can always bring out the other! Note that Fishbein's clarification actually supports what I said...so where am I supposed to be misleading anyone, hmm? Cheers Bennett |
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