September 30, 2014

FDA About to Greenlight a Drug Banned in Other Countries

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

warning fda approved 300x222 FDA About to Greenlight a Drug Banned in Other Countries

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

Confessions 20of 20an 20Rx 20Drug 20Pusher FDA About to Greenlight a Drug Banned in Other Countries

Free Shipping Available for this book!


0 commentsback to post

Other articlesgo to homepage

Vaccine Scandals and Criminal Cases Increase in 2014

Vaccine Scandals and Criminal Cases Increase in 2014

Pin It

Criminal activities of pharmaceutical companies are frequently reported on in the mainstream media. The largest criminal settlements in U.S. history are cases against pharmaceutical companies, such as Johnson & Johnson’s $2.2 billion criminal settlement late last year for illegally marketing drugs to the elderly, children and the mentally disabled.

When it comes to criminal activities involved with marketing vaccines, however, there is a near total blackout in the mainstream media. So here at Health Impact News we will highlight a sampling of some of the biggest stories of fraud and criminal activities involved with marketing vaccines so far here in 2014.

Very few of these stories have been mentioned in the mainstream media, because the vaccine market is a multi-billion dollar market, and the vaccine industry does not like losing any market share. They are using their incestuous relationship to the U.S. government to take away personal rights and liberties in medical choices. They would like mandatory vaccine policies in place at the local, state, and national levels, because their products cannot survive in a free market. They need government collusion and coercion for this market to survive. And so far, with the help of the mainstream media generally not reporting on the corruption and criminal activity, they have a willing and compliant public.

The Flu Vaccine War: Healthcare Workers Fight Back

The Flu Vaccine War: Healthcare Workers Fight Back

Pin It

We have already established in previous articles that the flu vaccine is by far the most dangerous vaccine in the United States, injuring and killing many people every year based on settled court cases by the Department of Justice in the National Vaccine Injury Compensation Program.

And yet, hospitals across the country are mandating that healthcare workers receive the flu vaccine as a requirement to keep their employment. The main reason for this policy of forcing employees to receive the flu vaccine is not based on solid science that it protects patients (the science actually points towards no patient benefits), but based on funding requirements for medical reimbursements through Medicare and Medicaid, and through the Affordable Health Care Act, that require healthcare facilities to have a high compliance rate of employees receiving the flu vaccine.

Nurses, doctors, and other healthcare workers across the country are fighting back, however.

This week, he Massachusetts Nurses Association sued Brigham and Women’s Hospital in Boston to block a policy to require nurses to get flu shots as a condition of employment.

And this is not the first lawsuit in the country. Others have also taken action to protect their right to refuse medical treatments that are mandated as a condition to retain employment.

State Farm to Families of Vaccine-Damaged Children: We Don’t Need Your Business

State Farm to Families of Vaccine-Damaged Children: We Don’t Need Your Business

Pin It

Why would State Farm make such a controversial decision to pull one of their ads featuring someone who helped families with vaccine-injured children in private, knowing that they would lose customers over it? Could it be they were pressured to do so because they just jumped into the lucrative health insurance exchange business?

Learning When to Refuse Medical Treatment

Learning When to Refuse Medical Treatment

Pin It

Doctors today are over-prescribing diagnostic tests and drugs, and patients need to learn how to say “no” to their doctors. This message, surprisingly, is coming from the mainstream media. While this has been a clear message for many years now in the alternative media, that message is now going “mainstream.”

Whistleblowers Dent the ‘Deep State’ of the U.S. Vaccine Program

Whistleblowers Dent the ‘Deep State’ of the U.S. Vaccine Program

Pin It

In speaking with an autism lawyer, who represented three African-American boys at the turn of the century, he told me he ushered their cases through Vaccine Court, only to have them dismissed, like my son’s case of harm caused by Thimerosal, in one sweep.

The whistleblowers haven’t negatively impacted the Vaccine Deep State yet. But when their cases go to trial, combined with a CDC-sponsored Danish scientist turned-U.S.-Department- of-Justice-fugitive in Poul Thorsen—he was indicted of stealing $2 million from the agency —the harm to the U.S. vaccine program could become unwieldy, as irreparable as the Ray Rice domestic violence issue now threatening the NFL.

For that to happen, the U.S. DOJ would have to extradite Poul Thorsen from Denmark to stand trial. And if that unicorn coming out of the forest event ever took place, the bed the CDC made with the Dane a decade ago would shake the Vaccine Deep State to its core.

After three years of non-action, will Attorney General Eric Holder, who happens to be African-American, finally be spurred to extradite the most wanted man in the autism community?

read more


Get the news right in your inbox!