Bring It On!

FDA Approved Anti-Smoking Drug Can Cause Lethal Heart Rhythm Disturbances, Heart Attacks, Seizures, Diabetes and Psychiatric Disturbances. Tell Me Again Why Pot Is Illegal.

May 22nd, 2008 | by Ken Grandlund |

Chantix has been hailed as a near miracle cure for smokers. By targeting certain receptors in the brain, it is supposed to reduce and then eliminate the pleasure associated with smoking. But apparently it can also wreak havoc on a persons mental state or cause other serious problems. And while smoking tobacco is easily one of the least healthy things a person can do, sometimes the cure is just as bad, or maybe worse, as the ill.

The FAA has banned the use of Chantix by licensed pilots, citing concerns that the drug can cause serious side effects that just aren’t compatible with piloting an aircraft filled with passengers. Things like hallucinations or heart attacks.

Is this just another case of rushing a designer drug to market so a pharmaceutical company can reap the profits before bad news hits the market?

Pfizer makes Chantix, and it is no newcomer to the “new drug approval” game. Like all drug manufacturers, Pfizer had to put Chantix through trials before it could get FDA approval. But Pfizer knows how the game works, and the studies used to show the efficacy and safety of Chantix were, shall we say, a bit skewed.

A total of 3,659 people were handpicked for the Chantix tests before it came on the market, an almost equal number of men and women, with an average age of 43. Nearly all were white, and the tests excluded anyone with a history of depression, panic disorder, heart disease, kidney or liver problems, alcohol or drug abuse, and diabetes. These exclusions aren’t mentioned in the original “Who Should Not Take Chantix” part of the patient-information sheet, which merely states that the drug wasn’t tested on people under 18.

“When they tested the drug, the sample they chose simply isn’t representative of the people they’re targeting,” says Dr. Daniel Seidman, the director of Smoking Cessation Services at Columbia University Medical Center. “By excluding drinkers, you’re artificially inflating your results.”

So Pfizer weeded out people from the study who were most like the people they targeted to buy their new drug. It is true that FDA guidelines say that test subjects should be healthy, but the fact is that most people have some kind of health issues to content with, and I would venture to say that smokers are more likely to have adverse health concerns than non-smokers. This very truth should seem to indicate that trials on otherwise healthy people (i.e. people whose only health problem up to that point was an addiction to nicotine) would not yield accurate study results for the general target of the drug. But hey- when we’re talking billions of potential profits, who’s worried about reality?

By many accounts, Chantix does a great job at getting people to quit smoking. But it also has its problems…

The institute’s findings, which were based on an analysis of adverse events reported to the F.D.A., said that from May 2006 through December 2007, there were 227 reports of suicide attempts or suicides, 397 cases of possible psychosis and 525 reports of hostility or aggression. Those reports included 28 suicides and 41 mentions of homicidal thoughts, 60 cases of paranoia and 55 cases of hallucinations.

And these are just the reported incidents.

Modern medicine has done wonderful things to fight human illness, prolong life, and combat disease. I’m a big fan, believe me. But increasingly, drug companies are rushing to market with miracle cures that may not be miracles at all-and federal regulatory agencies seem more and more complicit in allowing medically suspicious and frequently unneeded medications to be mass marketed to consumers who have no idea about drug safety trial results and often, no medical need for the drug anyhow. Doctors join the problem by peddling prescriptions to patients who harangue them for the latest miracle cure-whether they are right for the drug or not. And worse, without waiting for better information about a new drugs efficacy or safety.

As modern medicine becomes more target specific towards combatting disease and illness, we are seeing more and more designer drugs that will fix what ails us. But do they really? Or do they just create other problems while marginally alleviating the original one?

For the majority of pill poppers these negative side-effects may never occur. I mean, how many users of Cialis really are afflicted with the dreaded four hour erection? But the fact that they have to add such  disclaimers seems to indicate that these miracle drugs are more like Mr. Hyde than Dr. Jekyll.

Yet the federal government- that same entity that lets Chantix or Vioxx and many other questionable drugs to market-still insists that marijuana is as harmful as herion. And despite numerous studies to the contrary, it sticks to this assertion and uses it to continue a failed policy of incarceration and prohibition.

Meanwhile, big pharma gets rich “saving” lives with marginal medication and cancer patients go to jail for smoking pot to increase their appetites.

I thought government regulatory agencies were there to help prevent these kinds of problems, not exacerbate them. Oh, I forgot. Government agencies are political extensions of the ruling parties, who in turn are kept in power through big money donations from people like the pharmaceutical companies. I guess the ones being kept in check are the public-at their own detriment and to the favor of the money guys.

Ain’t that a great system?

 

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