Ban Avandia & Save Per Month 300 from Heart Failure & 500 from Heart Attacks!

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged.

http://blogs.healthfreedomalliance.org/blog/2010/02/22/once-again-big-pharma-lies-and-people-die/

Feb

22

Once Again Big Pharma Lies And People Die

Filed Under Big Medicine, Big Pharma, FDA, Medical Maiming

Bush lied people died, whoops wrong website. Big Pharma lied people died. There that’s better. In what should be a shocking report but now is all to common, Glasko Smith Kline got caught lying about the dangers of their blockbuster diabetes drug named Avandia. Health Freedom Alliance assumes the penalty will be a small fine and increased campaign contributions. Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.’s drug center, wrote that “there are multiple conflicting opinions” about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

“I await the recommendations of the advisory committee,” the agency’s commissioner, Dr. Margaret Hamburg, said Friday night. “Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

“Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”

In response, GlaxoSmithKline said that it disagreed with the Senate investigation’s conclusions. The company said that it could not comment on internal F.D.A. documents but that “the official ruling from F.D.A. is that Avandia remain on the market.”

In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.

But Dr. Graham and Dr. Gelperin, working in the F.D.A.’s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia’s use by precisely such patients, the reports note.

“Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable,” one of the reports concludes.

These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company’s patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.

http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?hp

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Antidepressant Romance Fuels “Premedicated” Murder

Note From Ann Blake-Tracy: I must say that in the 20 years I have been specializing in adverse reactions to antidepressants and lecturing and writing about these drugs this is possibly the best article I have ever read on the overall problem with antidepressants!! EXCELLENT WORK!!!
The only thing I might have added is that the hypothesis behind the serotonin THEORY (everyone keeps forgetting it is a theory and not a fact) is backwards. According to research serotonin is elevated in depression, anxiety, violence, mania, psychosis, etc. NOT low. What is low is the ability to metabolize serotonin.
Now enjoy the article! As I said, it is excellent!!
Dr. Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness

Website: www.drugawareness.org & www.ssristories.drugawareness.org
Author: Prozac: Panacea or Pandora? – Our Serotonin Nightmare
& CD or audio tape on safe withdrawal: “Help! I Can’t Get
Off My Antidepressant!”
Order Number:

August 17th, 2009

From The Desk of The People’s Chemist:

Are antidepressant’s a silent killer? Read more to learn how to avoid “Premedicated Murder.” Then visit my blog at http://www.thepeopleschemist.com/blog to leave your comments. I want to hear your voices on this! This is one of the most important articles I’ve ever written. Invest 6 minutes into your health by reading this.

Antidepressant Romance Fuels “Premedicated” Murder

By Shane “The People’s Chemist” Ellison

I wish medicine wasn’t so damn complicated. If it weren’t, people would see how Big Pharma cleverly plays prescription cupid to hook the masses into an antidepressant romance. Fueled by dreamy ads, sexy actors, and medical experts who get paid to give pharmaceutical fellatio, the romance has grown into a full-fledged orgy.

Antidepressants are among the best selling drugs, yet not one single diagnostic test supports their effectiveness. Romance makes for great business. But, are patients getting the love they deserve or are they facing another life threatening disaster akin to the Vioxx fiasco (killing an estimated 30,000 people who could have just used aspirin)? Perhaps the chemical facts behind antidepressants will give way to reality and help Americans sever ties to the deadly affair.

Life can be a bitch at times. Everyone knows it and Big Pharma profits from it. To answer our cries for happiness, they sell us a slew of molecules ripe with supposed happy atoms purported to elicit wanton pleasure. It’s a pipe dream. Like a parent who doesn’t like their daughter dating drug reps or psychiatrists, the FDA started using Black Box Warnings to inform us that, “Antidepressants, compared to placebo, increase the risk of suicidal thinking and behavior in children in short term studies.” Psychiatrists quickly refuted this.

Massaging our fears, Dr. McAllister-Williams of the Institute of Neuroscience at Newcastle University publicly insisted that “I believe they work and have an acceptable risk: benefit ratio for many patients.” Taking his cue, psychiatrists from around the world did what they do best: Ignore scientific ethics and get on their knees for Big Pharma.

In a vulgar display of medical ineptitude, prescribing habits surged. From 1996 to 2006, use of antidepressants increased 50% among children, 73% among adults and a ghastly 100% among the elderly – so much for Black Box Warnings. Why not rename them Profit Warnings? As prescribing habits have surged, so has antidepressant reality.

The so called disease of a “serotonin” chemical imbalance among depressed patients has never been proven. The Journal of Psychiatry and Neuroscience recently reminded doctors that, “Brain serotonin cannot be directly measured” and that even in the deceased, “Serotonin levels are unstable, within 24 hours of death.” Therefore, “direct evidence that serotonin is low in depressed persons is unavailable.”

Panicked, psychiatry hypothesized yet another cause of a chemical imbalance: Bad genes. Apparently, select people (basically anyone with a heartbeat) have a defective gene that makes them susceptible to depression – and drugs, drugs and more drugs can save them from the scourge of sadness. Bio-babble like “alleles” and “transporter genes” were thrown around like condoms at a high school pep rally. The jargon confused everyone. And in their dizzy stupor, most were convinced that it must mean one thing: antidepressants are the Holy Grail to attaining happiness. Psychiatry was once again renewed with the stench of pharmaceutical pheromones. But it didn’t last.

Thanks to scientific methodology, the industry was slapped with the facts. The New York Times delivered the blow and wrote, “One of the most celebrated findings in modern psychiatry – that a single gene helps determine one’s risk of depression in response to a divorce, a lost job or another serious reversal – has not held up to scientific scrutiny.”

You don’t need science to disprove the antiquated, reductionist propaganda surrounding the chemical imbalance theory. You only need the common sense of a child.

The human brain floats in thousands, billions or maybe even trillions of brain chemicals – all working in orchestra like unison to confer proper brain function. Even serotonin exists not as a single molecule, but instead as an ever changing chemical cascade of 5-htp, niacin, L-tryptophan, quinolinate, kynurenine and more. You’d have to be Paris Hilton or a psychiatrist to miss this logic and adhere to the simplistic serotonin imbalance theory.

With no such thing as a chemical imbalance or “depression inducing genes,” psychiatry did what any organization would do in the face of impending demise: Get the U.S Government to do their dirty work.

Today, an insidious collusion between Big Pharma and Big Government is doling out drugs paid for by our tax dollars to foster children, to our U.S. Troops, and to the elderly at breakneck speeds. With so many being drugged, a harsh reality is emerging: Antidepressant romance fuels “premedicated murder.”

While researching my upcoming book, Over-The-Counter Natural Cures (SourceBooks, October), I uncovered stories of horrific suicide and rage that occurred after being medicated with antidepressants. But none more disturbing than the Chris Wood story. Doped up on his prescribed cocktail of antidepressants – all three of them – he shot his 33 year old wife Francie and their three children – Chandler, 5, Gavin, 4, and Fiona, 2. Shockingly, in his drug damaged mind, they weren’t “dead enough” and gruesome decapitation followed. Afterwards, he picked up a shotgun and killed himself. This isn’t an isolated incident.

Among our US troop, suicide and rage is at an all time high – in direct correlation to mass prescribing. The same trend exists among teens as seen by the ever growing act of spraying classmates with bullets. Psychiatrists don’t seem to be alarmed with these trends, or at all interested in seeing the obvious correlations. In an attempt to “leave no American un-medicated,” they encourage subjective mental screening tests for the rest of us as a means of converting healthy people into psychiatric patients.

Psychiatry wants to position antidepressants as the cure for the premedicated violence. So to counter the growing evidence that their drugs are the cause, they insist that, “The only evidence that would be acceptable is the demonstration in a double blind trial that a difference in suicide rates was consistently seen. There is no evidence at all for a differential suicide attempt rate with antidepressants. Suicidal thoughts are an integral part of depression.” Here comes the backhand.

Writing for the Journal of American Physicians and Surgeons, Dr. Joel Kauffman elucidates that combined clinical trials on antidepressants show five times the risk of suicide among the treated compared to placebo.

The suicide/aggression trend is not inexplicable from a chemistry viewpoint. Using the latest cloning techniques and laboratory methods, it’s been shown that antidepressants elicit “neurotransmitter hijacking.” This may be partially responsible for the mental state that causes a person to gruesomely murder their loved ones, then put a shotgun to their chin and pull the trigger.

Once swallowed, antidepressants sail past the blood brain barrier and congregate on top of “neurotransmitter recyclers.” This can prevent the cellular “recycling factories” from activating previously used neurotransmitters like serotonin or any of its chemical cousins. With nowhere to go, the inactive brain compounds get “hijacked” by recycling facilities found in other regions of the brain. This would be similar to a square peg being shoved into a round hole. As shown by Baylor College of Medicine, the recycling facilities of key neurotransmitters, like dopamine (round), begin to retrieve serotonin (square) into dopamine vesicles. A dastardly consequence ensues.

Commenting on the hijacking, CNN publicized that, “Antidepressant drugs actually create a perilous brain imbalance.” And Psychiatric Times hypothesized that blocking transporters on cell bodies could drop neurotransmitter levels in the synapse. Is it true?

To measure if neurotransmitter hijacking leads to an empty synapse, you can simply look for clinical manifestations of poor neurotransmitter function (like Parkinson’s disease, which is due to poor output of dopamine) among antidepressant users. As far back as 1995, the American Journal of Medicine showed that 37% of all prescriptions for the treatment of Parkinson’s disease are due to Psychiatric drug use. Case closed. These antidepressant actions are the exact opposite of the claimed “neurotransmitter boosting” actions purported by most doctors!

Once neurotransmitter hijacking takes place, pharmacopossession (due to poor neurotransmitter function) may also set in. As patients come fully under the spell of antidepressants, the brain can become so scrambled that all normal reality and reason are overwritten by a new confusing and violent agenda. A new personality arises – one with homicidal and suicidal tendencies. And for an ever increasing number of antidepressant users, these tendencies are manifesting as premedicated murder – the deliberate killing as a result of being medicated in advance.

Unbalanced by drugs, the brain of an antidepressant user faces a slew of mind altering outcomes. What kind? What was Chris Wood thinking and feeling prior to committing premedicated murder of his family while pharmacopossessed? To answer these questions just go back to the beginning of this article and read the “profit warning” that comes with every Prozac prescription. It’s all there in black and white.

Even though the FDA “compels” drug companies to warn the public about antidepressant risks, their “death grip” on the medical industry has kept doctors and patients from knowing the real extent of the danger. Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association said that “Pharma’s influence on medicine is so blatant now you’d have to be deaf, blind and dumb not to see it.” I guess psychiatrists are all three since they continue to ignore science and romance the masses with promises of happiness courtesy of antidepressants.

Before your doctor gives you an antidepressant, ask him to read you the Black Box Warning that comes with your prescription. This will ensure that the potential romance quickly gives way to reality and that you don’t succumb to premedicated murder.

About the Author

Shane Ellison’s entire career has been dedicated to the study of molecules – how they give life and how they take from it. He was a two-time recipient of the prestigious Howard Hughes Medical Institute Research Grant for his research in biochemistry and physiology. He is a best selling author, holds a master’s degree in organic chemistry, and has first-hand experience in drug design. Learn to get lean fast like is Mom (photos included) at http://www.ampmfatloss.com

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