The men behind the myth

David Lane

[David Lane]

[David Lane]

More Glaxo poison: -

GLAXO WELLCOME DECIDES TO WITHDRAW LOTRONEX FROM THE MARKET

Glaxo Wellcome, of Research Triangle Park, NC, has informed FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market. Lotronex is a prescription medication approved to treat Irritable Bowel Syndrome(IBS) in women.

The FDA is advising patients taking Lotronex to contact their healthcare providers to discuss treatment alternatives.

The company's action follows a meeting held earlier today with the Food and Drug Administration (FDA) where the agency discussed with Glaxo Wellcome risk management options that included restricting the distribution of the drug or marketing withdrawal.
Today's action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex.

Specifically, FDA has been concerned about reported cases of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured
bowels (complications of severe constipation).

As of November 10, 2000, FDA had received and reviewed a total of 70 cases of serious post-marketing adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation.
Of the 70 cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDA has received two additional reports of death that the agency did not classify as being cases of ischemic colitis or severe complications of constipation.

FDA has been closely monitoring the drug since approval on February 9, 2000. Prior to approval, four cases of ischemic colitis were observed in clinical studies and were discussed at a November 1999 meeting of FDA's

Gastrointestinal Drugs Advisory Committee. These cases were transient, mild-to-moderate in nature and reversible upon discontinuation of the drug.
Between approval and June 1, 2000, FDA received seven post-marketing reports of serious complications of constipation. This resulted in the hospitalization of six patients, three of whom required surgery. During the same time period, FDA received eight post-marketing reports of ischemic colitis. This resulted in four hospitalizations, four endoscopic procedures, and no surgeries.

On June 27, 2000, FDA convened a public advisory committee meeting where risk management options in response to the serious adverse event reports were discussed. No deaths were reported up to that date. The consensus of the advisory committee members was that both physicians and patients must be informed of the potentially serious adverse events associated with Lotronex.

Following the meeting, FDA updated the healthcare professional labeling for Lotronex and required the drug?s sponsor, Glaxo Wellcome, to distribute a Medication Guide that warned patients directly about the risks associated with the drug. In addition, at the request of FDA, Glaxo Wellcome issued "Dear Healthcare Professional" and "Dear Pharmacist" letters to advise these groups of the important new information.

FDA continued to receive severe adverse event reports of ischemic colitis and complications of constipation associated with Lotronex. In addition, FDA received reports of death and more serious complications of ischemic colitis that required blood transfusion or surgery.

Upon completing its recent analyses of the 70 cases, FDA's view of the options included marketing withdrawal or a restricted drug distribution program. The restricted drug distribution program would provide: (1) safe use of Lotronex in appropriately informed patients, (2) continued access to Lotronex by severely debilitated IBS patients under closely monitored conditions, and (3) continued clinical research into the benefits, risks, and safe and appropriate use of Lotronex. FDA recognized that the other available treatments for IBS may offer inadequate relief from a condition that can be severely incapacitating for some patients.

At the conclusion of today's meeting, Glaxo Wellcome informed FDA that it will voluntarily withdraw Lotronex from the market.

For more information on this subject, visit the Lotronex Information web page created by FDA's Center for Drug Evaluation and Research. The URL is
www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm.

[David Lane]

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