Avandia

Avandia fraud explained: Why Big Pharma keeps lying about its drugs (opinion)

Wednesday, July 21, 2010
by Mike Adams, the Health Ranger
Editor of NaturalNews.com (See all articles...)
Tags: Avandia, fraud, health news

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(NaturalNews) Sometimes the degree of fraud that takes place in the drug industry is so mind-boggling that it's hard to determine whether drug regulators and the media are paying attention at all. For the past several months, drug giant GlaxoSmithKline (GSK) has been under scrutiny for tampering with clinical trial data for its diabetes drug, Avandia. Reports show that the company lied about Avandia's safety in order to get the drug approved and keep it on the market. But despite numerous pieces of credible evidence and witness testimonies that have all come forward -- all of which reveal GSK's deception -- an FDA advisory panel is still recommending that Avandia remain on the market.

Back in February, a Senate Finance Committee report revealed that not only is Avandia dangerous, but GSK knows this and has deliberately tried to hide this crucial information from the public. The report even goes so far as to openly name the FDA as a culprit in conspiring with GSK (and other drug companies) to deceive the public. (You can read the article I wrote about this report at: http://www.naturalnews.com/028233_GlaxoSmith...)

Right after this extensive report was released, an FDA advisory panel voted 22 - 1 in favor of keeping the drug on the market. And just a few days ago, another FDA panel did the same thing following official hearings that showed even further that GSK committed fraud in getting Avandia approved. (It has since been revealed that at least one expert on the FDA panel voting for Avandia's approval was on the take, receiving "speaking fees" from GSK. But no one seems to care about this disturbing fact...)

You can read the details of the report at the following link:
http://finance.senate.gov/newsroom/chairman/...

The lies and manipulation of GlaxoSmithKline

Pharmaceutical companies are notorious for skewing the truth in order to get their next blockbuster drug approved for sale. These companies are vicious, money-hungry, multi-national corporate monsters that will stop at nothing to make an obscene profit, even if it means exposing their customers to harm.

It's one thing for a company that sells, say, televisions, to lie about the quality of its product. Nobody ultimately dies from false claims about a poor quality TV and, if found guilty, the company that produced the TV will likely be held liable for any crimes it committed through deceptive marketing. But when it comes to drug companies that peddle dangerous toxins as medicine, it's a whole different story.

Sadly, Big Pharma is one of the most protected industries on the planet. Big Pharma gets away with murder (literally), and nobody really seems to care. You and I would be hauled off to jail immediately for doing even a small fraction of what Big Pharma does, but when Big Pharma does it, the blinders go up because observers falsely believe that drugs are "science-based", and that the wonderful drug companies would never do anything to harm us.

Such thinking is pure foolishness, of course, especially when you examine the plain facts in the GSK case.

Hiding the truth

First of all, internal documents reveal that GSK knew about the dangers of Avandia since the early days of its development, but didn't disclose any of this information to the public or to the FDA. And why would they? The FDA, according to the same reports, has been in collusion with GSK since the beginning to hide the truth, so GSK has had no reason to disclose anything.

Think about it. GSK created a diabetes drug that, at its high point, was raking in more than $3 billion a year in profits. GSK spent millions of dollars for research and development of the drug, paid for the clinical trials, and purchased approval from the FDA for the several million dollars it costs to complete the FDA drug application. And GSK did all this knowing full well that the drug causes a substantial increase in the risk of heart attacks and death.

With all of this in mind, do you really think that the company is now going to simply own up to the fact that it lied, and willingly agree to have the drug pulled from the market?

Truth be told, drug companies like GSK practically never tell the truth. They don't have to. Even when their racket gets exposed, it all gets glossed over and covered up by the bureaucrats in our government agencies.

GSK's flawed safety studies

It's amazing to me just how many people put their trust in the "safety studies" the drug companies conduct on their own drugs. That such studies are considered credible by anyone just goes to show you that critical thinking skills are severely lacking among both the public and members of the medical profession.

Drug companies spend millions of dollars on studies and clinical trials that are designed to show that their drug is safe, and with enough manipulation, they usually get the results they're looking for. These studies have little or nothing to do with actual science or unbiased inquiry; it's all about using "pretend science" to produce a result that will allow them to achieve FDA approval.

And this scenario is no different in GSK's trials for Avandia which, according to reports, didn't properly reflect the inherent dangers of the drug.

When challenged about her concerns over the quality of GSK's safety data for Avandia, Dr. Nancy Geller, a member of the FDA advisory committee and director of the Office of Biostatistics Research at the National Heart, Lung, and Blood Institute, responded by explaining that clinical trial data is "not [reliable] if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death."

In other words, drug companies change all sorts of things during a trial in order to achieve a desired result (which makes them anything but trustworthy). This includes removing people from the clinical trial right before they die in order to avoid having a death statistic show up in the final data. Oh look, is Mary about to expire? Hurry, kick her out of the testing group before she ruins the safety record of our drug!

These are the types of things GSK was doing to hide the truth about Avandia. To call these clinical trials "scientific" is an affront to the entire science community. And yet, somehow, the scientists continue to go along with all this...

According to a leaked internal GSK email, study results from a 1999 trial of Avandia that found the drug to be dangerous were intentionally kept "under the radar". Dr. Martine Freed, a GSK company executive, explained in that same email that none of the data from that particular study should "see the light of day to anyone outside of GSK."

Bloomberg's BusinessWeek has the full report on the FDA Panel's evaluation prior to its Wednesday vote: http://www.businessweek.com/lifestyle/conten...

FDA orders GSK to do another trial

The funny thing about all this is that, in light of the concerns over GSK's trial tampering, the FDA actually ordered the company to conduct another trial to reevaluate Avandia's safety. How this was expected to accomplish anything productive is anyone's guess, considering that GSK lied about the previous trials. What makes the FDA think that a new trial is going to be beneficial? (But remember, insanity is doing the same thing repeatedly and expecting different results, and the FDA isn't anything if not insane...)

But that's the way the game is played between the FDA and Big Pharma. It's a never-ending circus of so-called investigations and busywork designed to fabricate the results they're looking for. Nobody asks the tough questions, and nobody ever states the obvious which, in this case, is that GSK committed fraud and must be held criminally responsible. The two entities work hand-in-hand to fulfill an agenda that's based on greed and nothing more. Science is abandoned from the start.

FDA panel refuses to support pulling Avandia from the market, let alone prosecute GSK

So after witness testimonies (one of which you can read about here: http://www.businessweek.com/news/2010-07-10/... ) and a pile of credible evidence presented as part of the mounting case against GSK, an FDA advisory panel voted last Wednesday to recommend that Avandia remain on the market, according to a Wall Street Journal report. Twenty of the 33 members ultimately voted against pulling Avandia from the market, and the FDA is expected to make its final decision about the drug soon, based on this recommendation.

You can read the full Wall Street Journal article here: http://online.wsj.com/article/BT-CO-20100714...

Members of the panel who voted against pulling Avandia from the market explained to reporters that they believe there isn't strong enough clinical data to show that Avandia is dangerous. But how much more evidence do these panel members need to conclude that there's a problem?

If evidence of falsified study data and reports showing that Avandia is dangerous isn't enough, it's difficult to say whether any amount of evidence would ever be enough for these people. According to the BusinessWeek article, the FDA itself even posted official remarks on its website stating that GSK mishandled its earlier Avandia trials, but apparently even that isn't enough for some of the FDA advisory panel members to put two and two together.

It seems that even if GSK came right out tomorrow and admitted that Avandia is dangerous (which the company's leaked internal emails basically reveal on their own), some members of the FDA advisory panel would argue with the company itself, saying that there's not enough evidence and that the drug should stay on the market.

And what about the potentially 100,000 heart attacks and deaths that may be linked to Avandia? Aw, just sweep that under the rug. Pretend it doesn't exist. Dead people don't talk, and they don't sue corporations either, so that's nothing to be concerned about.

All diabetes drugs are dangerous, Avandia is just more dangerous

Oddly enough, the primary issue with Avandia in this case isn't just that it causes heart attacks or that the company lied about its research, but rather that Avandia trials show the drug appears to be more dangerous than competitor's drugs like Actos. In fact, the main focus at the hearing was whether or not GSK had falsified study data to make it look as if Avandia isn't any worse than Actos.

In reality, both Actos and Avandia can cause heart failure. They both come from the thiazolidinediones family of diabetes drugs, and they're both potentially dangerous. In fact, both drugs bear the FDA's "black box" warning label, which is the agency's most extreme warning label.

So you've really got these two drug companies arguing over which of their drugs kills fewer people. And achieving that requires distorting a lot of clinical trials, burying other trials, spreading the money around to FDA panel experts and other similar criminal activities which now seem to typify Big Pharma.

What's now obvious to us all is that GSK lied about the safety of Avandia, and it has harmed untold numbers of people as a result. According to a statistical analysis in the Senate Finance Committee report, more than 83,000 heart attacks have been caused by Avandia. Several hundred people reportedly die every month because of Avandia.

So removing Avandia from the market is only a very small part of the equation. True justice will be served when GSK is held criminally responsible for lying to the FDA and deceiving the public. GSK's greed is harming and killing thousands of people every single year, and regulators are bickering over whether or not Avandia is a little more dangerous than Actos. Something is seriously wrong with this picture.

I've mentioned this before in previous articles, but there actually is a cure for diabetes, and it doesn't involve either Avandia or Actos. You won't hear about it from the mainstream media or the medical industrial complex, but we've got some great resources here on NaturalNews that talk all about it, and you can find those at: http://naturalnews.com/diabetes.html

The truth is no person needs to take Avandia or Actos. Both drugs are needless, irrelevant and entirely outmoded. Simple foods and nutrition can cure diabetes, especially when tied to small doses of regular physical exercise. Rather than pushing dangerous, deadly drugs onto patients, our nation's doctors should be well versed in nutrition and exercise physiology. They should be recommending radical changes in the diets of diabetic patients to get them off all refined, dead foods and onto fresh, living foods and superfoods.

This is the true answer to our nation's diabetes pandemic. But of course teaching patients how to take care of their own health never made a dime for Big Pharma. And sending a patient home with the knowledge they need to stay well and avoid hospitals and doctor visits never made any money for the doctors.

America's health system isn't designed to keep you well, or cure your disease, or even prevent disease. It's designed to sucker you into a system of pharmaceutical dependency that's fronted by drug-pushing physicians who for the most part believe that patients have virtually no role in their own health or disease -- and only doctors know what they're talking about.

That might carry some weight if the doctors themselves weren't dying of cancer, heart attacks and strokes -- all at a rate much higher than the general public. There are a lot of sick, dying conventional MDs out there. They're all on pharmaceuticals. They all believe in the "science" of Big Pharma. And they're all paying for that foolish gullibility with their lives.

Don't you make the same mistake.

And just for the record, there are also some really good MDs who don't buy into Big Pharma's lies and who actually follow a more holistic, natural lifestyle. If you can find one of those, stick with them!

Additional sources for this story include:
http://www.aboutlawsuits.com/fda-avandia-pan...

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About the author:Mike Adams (aka the "Health Ranger") is the founding editor of NaturalNews.com, the internet's No. 1 natural health news website, now reaching 7 million unique readers a month.

In late 2013, Adams launched the Natural News Forensic Food Lab, where he conducts atomic spectroscopy research into food contaminants using high-end ICP-MS instrumentation. With this research, Adams has made numerous food safety breakthroughs such as revealing rice protein products imported from Asia to be contaminated with toxic heavy metals like lead, cadmium and tungsten. Adams was the first food science researcher to document high levels of tungsten in superfoods. He also discovered over 11 ppm lead in imported mangosteen powder, and led an industry-wide voluntary agreement to limit heavy metals in rice protein products to low levels by July 1, 2015.

In addition to his lab work, Adams is also the (non-paid) executive director of the non-profit Consumer Wellness Center (CWC), an organization that redirects 100% of its donations receipts to grant programs that teach children and women how to grow their own food or vastly improve their nutrition. Click here to see some of the CWC success stories.

With a background in science and software technology, Adams is the original founder of the email newsletter technology company known as Arial Software. Using his technical experience combined with his love for natural health, Adams developed and deployed the content management system currently driving NaturalNews.com. He also engineered the high-level statistical algorithms that power SCIENCE.naturalnews.com, a massive research resource now featuring over 10 million scientific studies.

Adams is well known for his incredibly popular consumer activism video blowing the lid on fake blueberries used throughout the food supply. He has also exposed "strange fibers" found in Chicken McNuggets, fake academic credentials of so-called health "gurus," dangerous "detox" products imported as battery acid and sold for oral consumption, fake acai berry scams, the California raw milk raids, the vaccine research fraud revealed by industry whistleblowers and many other topics.

Adams has also helped defend the rights of home gardeners and protect the medical freedom rights of parents. Adams is widely recognized to have made a remarkable global impact on issues like GMOs, vaccines, nutrition therapies, human consciousness.

In addition to his activism, Adams is an accomplished musician who has released ten popular songs covering a variety of activism topics.

Click here to read a more detailed bio on Mike Adams, the Health Ranger, at HealthRanger.com.

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