October 20, 2014

FDA About to Greenlight a Drug Banned in Other Countries

pin it button FDA About to Greenlight a Drug Banned in Other Countries

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by Alliance for Natural Health

Is FDA About to Greenlight a Drug Banned in Other Countries?

If enough people raise their voices in protest, we can prevent it. Action Alert!

Remember the controversial diabetes drug Avandia? In 2010 we told you about two FDA drug safety reviewers who warned the agency that Avandia posed serious risks of heart attack and heart failure when compared with other diabetes drugs. Since then, the drug has been removed from the market in most countries and has been under severe restrictions in the US.

Last Thursday, in a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted to recommend removing or modifying Avandia’s highly restrictive label and distribution system. Five voted to keep the restrictions in place, while one panelist voted to remove the product from the market altogether.

There has been only one large, randomized trial for the safety of rosiglitazone, the drug that is marketed as Avandia. That trial—sponsored by GlaxoSmithKline (GSK), the drug’s manufacturer—was called RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes). Serious flaws were found in RECORD’s methodology, its results were questioned, and the trial was widely discredited.

In 2010, FDA required GSK’s RECORD results to be reexamined and re-adjudicated. What was the FDA’s motivation for reviewing Avandia? GSK didn’t request that the drug be reviewed. Could it be, as Steve Nissen suggests in Forbes, because FDA “is seeking to avoid accountability for its role in the Avandia tragedy”? FDA’s official position is that they asked for the re-adjudication because of “the public interest in Avandia, the extensive history of the product, and the continued uncertainty of the risk surrounding this drug.”

Duke University’s Clinical Research Institute (DCRI) was selected for the re-adjudication, and they found that the risk for cardiovascular death, myocardial infarction (MI), and stroke to be virtually the same as the original study concluded. Because these new results reaffirmed GSK’s findings that the drug was no more unsafe than other diabetes products in its class, Thursday’s panelists were sufficiently reassured that the drug was safe enough to lift restrictions.

Unfortunately, other data paint a very different picture:

  • In 2005 and 2006 GSK secretly conducted an analysis of cardiovascular safety of Avandia, and concluded that the drug increased the risk of heart attacks and related events by 30%. Since two-thirds of diabetics eventually die of cardiovascular complications anyway, this 30% hike is terrifying.
  • In 2006 GSK informed the FDA’s Center for Drug Evaluation and Research (CDER) of the secret analysis, but FDA and CDER agreed to conceal this hazard from patients and practitioners.
  • During a public hearing, independent FDA statisticians reported an 80% increased risk of heart attack. Avandia is estimated to have caused 83,000 heart attacks in the United States alone.
  • Adverse effects caused by the drug are currently the subject of over 13,000 lawsuits against GSK. As of July 2010, GSK has agreed to settlements on more than 11,500 of these suits.
  • Last year, GSK pled guilty of criminal conduct, partially for concealing the hazards of Avandia. The company paid a $3 billion fine—the largest in US history.

In addition, the re-adjudication process itself was biased. GSK prepared the study materials before submitting them to Duke for analysis, rather than allowing the university to review the raw data. (On the widespread problem of publication bias, see our article in this issue.)

On top of that, key members of the 2010 advisory committee that decided to place restrictions on Avandia in the first place were not part of the 2013 meeting. Of the twenty-seven member panel, fourteen of the experts were on the panel last time, and they were the people with a more favorable attitude toward Avandia. This is in contrast to the other experts who did not serve on the panel a second time—like Steven Nissen, who was one of the most outspoken critics on the panel. FDA claims all panelists were invited, it does not appear they made a huge effort to ensure their participation; Nissen says he was not re-invited. With all of the big nay-sayers out of the picture, it’s no surprise the panel voted to lift the restrictions on this dangerous drug.

FDA should focus more on advisory panelists who have true conflicts of interest. A 2007 law placed caps on the number of waivers that could be granted allowing experts with conflicts of interest; a 2012 law removed those safeguards. When there are no restrictions on experts with conflicts of interest serving on FDA advisory panels, more drugs with dangerous side effects could certainly enter the market.

Action Alert! The FDA is not obligated to follow its advisory committee’s recommendation, though they usually do so. Moreover, there is no regulatory deadline by which they have to make a decision. If there is enough public pressure, perhaps this will force the FDA to reject the advisory committee’s decision on Avandia—or at least postpone any action indefinitely.Please send your message to the FDA about the dangers of Avandia!

Take Action11 FDA About to Greenlight a Drug Banned in Other Countries

Read the full article here: http://www.anh-usa.org/fda-greenlight-drug-banned

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Boston Nurses Speak Out Against Mandatory Flu Shots

Boston Nurses Speak Out Against Mandatory Flu Shots

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Last month (September 2014) the Massachusetts Nurses Association sued Brigham and Women’s Hospital over a new policy that required nurses to receive the annual flu vaccine as a condition for employment.

The nurses were, of course, criticized by the medical establishment. They were accused of putting their own interests above the needs of patients. Lynn Nicholas, president of the Massachusetts Hospital Association, stated that the nurses were: “putting a pet peeve of theirs above the safety and well-being of the patients they serve, their families, visitors to the hospital, and their colleagues.”

Pet peeve? Really?

When nurses all across the United States and Canada are willing to sacrifice their jobs and careers to avoid the annual flu shot, it is time to sit up and take notice. This is obviously something much more than a “pet peeve.”

Trish Powers, representing Brigham nurses in Boston fired back a comment that The Boston Globe published. It is titled “Brigham nurses know flu vaccine can do harm.”

Gardasil: The Day Our Daughter’s Life Changed

Gardasil: The Day Our Daughter’s Life Changed

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The Gardasil vaccine has changed Skylee’s life in so many ways and we do not know how many more symptoms will show up and change her life even more than it has already done. Our whole family has been affected by this vaccine and all of our lives have been turned upside down that terrible day in 2013.

If only the doctors would recognize Skylee has gone from being a healthy young girl to an invalid when the only major change in her life occurred on the day she had that single shot of Gardasil.

Will There Be An Ebola Outbreak in America?

Will There Be An Ebola Outbreak in America?

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So here is what inquiring minds want to know:

Why did U.S. health officials in Atlanta and on the ground in Africa ignore the exploding Ebola epidemic last spring?

Why did U.S. government officials fly American aid workers infected with Ebola to the U.S. rather than treating them with experimental drugs at hospitals in Africa?

Why did the U.S. government press the United Nations to adopt a resolution calling for no restrictions on international travel from Liberia and other Ebola-stricken countries?

Why did the Centers for Disease Control, supposedly the world’s leading infection control agency, fail to immediately assist Texas health officials when the first case of Ebola was diagnosed on US soil to guarantee that, at a minimum, the kind of infection control measures used in most nursing homes in America would be carried out?

Why has the Director of the CDC repeatedly stated that the only way a person can transmit Ebola is if they have a fever and said that people cannot get Ebola unless they have direct contact with the body fluids of an infected person – but that under no circumstances is Ebola airborne – when he knows, or should know, those statements could be false?

And why are experimental Ebola vaccines being fast tracked into human trials and promoted as the final solution rather than ramping up testing and production of the experimental ZMapp drug that has already saved the lives of several Ebola infected Americans?

A logical conclusion is that some people in industry, government and the World Health Organization did not want the Ebola outbreak to be confined to several nations in Africa because that would fail to create a lucrative global market for mandated use of fast tracked Ebola vaccines by every one of the seven billion human beings living on this planet.

Similarities Between 1976 Swine Flu Hoax and Ebola?

Similarities Between 1976 Swine Flu Hoax and Ebola?

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Read this before you consider purchasing a hazmat suit to protect yourself from Ebola!

Are we facing an Ebola pandemic that will kill millions, or is this just a marketing plan of the pharmaceutical industry to sell more drugs and vaccines? Is the current strain of the Ebola virus a secret creation of pharmaceutical company scientists, biological warfare researchers, or the fruit of Monsanto’s product development team?

Was Ebola created, or did it just accidentally spill over into humans from an animal host such as African fruit bats?

Is the US government intentionally not taking strong action to prevent Ebola from spreading or is there really minimal risk to Americans? Are there groups that want to decrease the world population through spreading contagious diseases such as Ebola, or is this just another imaginary plan that is being reported by certain conspiracy theory groups?

Is the Ebola virus a local epidemic, a global pandemic, or a hoax? Is life in America as we have known it about to collapse into chaos and martial law, or will we be safe and secure once we take the Ebola vaccine?

Will more people die from the Ebola vaccine than would have died from the disease itself?

All these questions have been circulating through the media over the last few months. The situation with Ebola is certainly a complex muddle of contradictory facts, opposing interpretations, and political intrigue. It reminds me very much of the 1976 Swine flu hoax — commonly called the swine flu fiasco or the swine flu debacle. More:

6 Reasons I Won’t Give My Kids The Nasal Flu Vaccine

6 Reasons I Won’t Give My Kids The Nasal Flu Vaccine

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It’s flu season again, and the push to get everyone in America vaccinated for the flu vaccine is in full swing. Please be aware that those who want you to receive the flu vaccine admittedly do not want you to know about the risks associated with the vaccine. They actively try to suppress information that would educate people on the dangers and risks of the flu vaccine and decrease their sales.

To hear the other side of the vaccine debate from a medical doctor the media would like to censor, please watch the video by Dr. Suzanne Humphries here: Dr. Suzanne Humphries on Vaccine Safety: “They Don’t Want You to Hear the Other Side”

Secondly, please look at the settled cases for vaccine injuries and deaths due to the flu vaccine the U.S. government pays out to victims: Flu Vaccine is the most Dangerous Vaccine in the U. S. based on Settled Cases for Injuries. This information is not published in the mainstream media.

This year, there is a heavy push on to give kids the nasal flu vaccine. Celeste McGovern, writing for GreenMedInfo.com, gives 6 reasons why she will not be giving this vaccine to her children.

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