FDA and Big Pharma blow smoke in your face over smoking cessation drug dangers

Wednesday, June 29, 2011 by: Paul Fassa
Tags: quit smoking, drugs, health news

(NewsTarget) Kicking the nicotine habit usually involves mental and emotional angst. It`s usually taken lightly, even humorously. After all, no frustrated smoker has ever climbed a building threatening to jump or shoot passers-by. Now we find that a popular drug sold internationally as a panacea for quitting smoking can put people over the top enough to kill or commit suicide. Dying to quit is for real, but the FDA doesn`t care.

The Drug

The drug is a real money maker for Pfizer. They have marketed it internationally under two different trademark names: one for the USA and another for 45 other countries. The FDA approved Pfizer`s patent for their smoking cessation drug in May 2006. Annual sales have reached well over a billion dollars.

The effectiveness was highly exaggerated by study results. And worse than the hype, many extreme adverse reports were camouflaged. This obscured the real figures for serious side effects that include suicidal and homicidal behavior, some of which resulted in death.

Hiding Stats to Appear Less Dangerous

It wasn`t until the non-profit organization Institute for Safe Medication Practices (ISMP) discovered and tracked the camouflaged serious adverse effect reports that a true picture emerged. After analyzing the data, ISMP scientist Thomas Moore noted that there was " ... a major breakdown in safety surveillance".

Serious adverse effects were camouflaged by mixing them in with the usual minor adverse reports of nausea, constipation, and rashes. Those hidden adverse effects were serious enough for some to commit suicide or violently attack others. There were almost 600 similar events buried among the 26,000 less serious adverse reports since 2006. Once the buried reports were isolated, the total suicide count went from 122 to 272.

Moore also commented in the September 2010 issue of Journal of Pharmacotherapy on how Pfizer`s smoking cessation drug tends to unleash something in people that can cause sudden violent reactions at anytime toward self or others. He based this on closer analysis of 26 episodes of violence formerly mixed within the obscurity of minor adverse events.

There were also several reported injuries from accidents, mostly automobile, which occurred during periods of fogginess or dizziness. Many others experienced deeper depressions than unusual while taking the smoking cessation drug.

The side effects listed in the consumer's box are far fewer and less serious than the information distributed to prescribing doctors (black box) in 2009, three years after FDA approval. One section warns of "Serious Neuropsychiatric Events", with the caveat that doctors should inform patients to report to them if they are experiencing extreme depression or thinking of suicide or murder.

There are over 1500 injury cases against Pfizer pending in Federal Court, including one where the parents of a murder/suicide married couple are suing. The plaintiffs claim that Pfizer knew of the extreme adverse effects since 2006 and obfuscated those statistics with their unethical reporting procedures.

This malfeasance did not surface until 2009 when the ISMP discovered the more serious adverse effects woven into the blur of thousands of minor adverse reports.

FDA Only Protects Big Pharma

The black box warning of suicide is the most serious mark against any drug. Despite admitting off the record that Pfizer`s smoking cessation drug`s side effects are worse than expected compared to Pfizer`s original trial study reports, the FDA is standing on its original approval.

In 2010, over 3 million smokers were prescribed two tablets daily of Pfizer`s smoking cessation drug for 12 weeks. The FDA`s hands-off shrug is from the same agency that continually harasses herbal and supplement providers for promoting safe and effective products.

Sources for this article include:

http://healthmaven.blogspot.com/2011/05/smok...
http://whyquit.com/pr/082506.html
http://labeling.pfizer.com/ShowLabeling.aspx...

About the author

Paul Fassa is dedicated to warning others about the current corruption of food and medicine and guiding others toward a direction for better health with no restrictions on health freedom. You can visit his blog at http://healthmaven.blogspot.com