FDA misdirection endangers lives of adolescents (and others)

by Elaine Keller

The most subtle and possibly most effective form of propaganda from a single exposure is the use of misdirection as a way to impact an audience’s Subconscious. Like “smoke and mirrors” used by magicians, this form of propaganda requires focusing the audience’s Conscious attention in one place while the real impact is made in the Subconscious. — Melanie Anne Phillips & Chris Huntley

Here are some interesting facts about Pfizer’s smoking cessation medication, varenicline, sold under the brand names of Chantix in the US and Champix in Canada and Europe:

  • Linked to an increased risk of suicides, suicide attempts, aggressive and unusual behavior.
  • In 2009, the FDA began requiring a boxed warning for serious mental health effects.
  • Suspected of causing serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, and psychosis.

Despite all the bad news highlighted above, Pfizer will be testing Chantix on 12 to 16-year old adolescents. Here are some examples:

Central KY Research. Up to $805 for completion
Mid-America Clinical Research.
Clinical Trials Gov

How in the world did we get from “this drug is unsuitable for first-line use in smoking cessation” to the idea that it might be a good thing to try the drug out on adolescent smokers?

Perhaps this headline on WebMD provides a clue: Stop-Smoking Drug Doesn’t Raise Risk of Psychiatric Hospitalization, Study Shows

The WebMD article describes two FDA-sponsored studies that looked at the medical records of 14,000 VA patients and 20,000 DoD patients that were prescribed Chantix. “Overall, the studies found no increased risk of psychiatric hospitalization in Chantix users,” states the article.

So where is the propaganda technique in all this? The misdirection lies in the word “hospitalization.” The average person doesn’t realize that the majority of serious, even deadly, psychiatric problems do not involve hospitalization.

Curt D. Furberg, M.D., Ph.D., professor of Public Health Sciences at Wake Forest Baptist, commented, “The FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression and assaults. These can be catastrophic events but do not normally result in hospitalization.”

Is it ethical to expose children between the ages of 12 and 16 to a drug linked to depression, suicide, aggression, assaults, and serious accidents? An indication that doing so might be asking for trouble is found in a 2007 report from The National Center on Addiction and Substance Abuse at Columbia University (CASA).

The CASA analysis also found that among teens ages 12 to 17, twice as many smokers as nonsmokers suffered from symptoms of depression in the past year. Teens who reported early initiation of smoking were more likely to experience serious feelings of hopelessness, depression and worthlessness in the past year. The report also notes that smoking at a young age is related to panic attacks, general anxiety disorders and post-traumatic stress disorder.

So if you take a group of smokers that already has a tendency to experience depression, panic, anxiety, etc., and give them a drug that has been known to trigger these experiences even in adults with no previous history of mental illness, what should you expect will happen?

In fact, nicotine’s documented beneficial effects include relief from depression and anxiety as well as improvements in attention, concentration, and memory. If an adolescent has been using nicotine as a form of self-medication for these problems, it stands to reason that abstinence will exacerbate their situation.  The harmful effects of Chantix have been known to continue even after discontinuing the medication. Thus, there is a possibility that nicotine, or new medications based on nicotine, will be rendered ineffective for treatment of mood and/or cognitive impairments by exposure to Chantix.

The $805 payment for participation in the clinical trials is a serious ethical concern.  Presumably this amount is paid to the parents, rather than to the adolescent participant. To some families, this amount is a substantial sum that might represent enough incentive to participate in a harmful study against his or her better judgment.

It is entirely foreseeable that some parents of 12 to 16 year old smokers interested in an $805 reward might not be able to understand all of the warnings, disclaimers, and legal release papers required for participation in the research project. Imagine how they will feel if their child develops a serious mood disorder, injures someone else, or commits suicide.

There are much less risky ways to quit smoking.  If the standard treatments leading to abstinence have been ineffective, there are THR products with a proven record  of minimal health risks. Unfortunately, the Tobacco Control Industry (TCI) appears to be dedicated to the concept of “complete nicotine cessation at all costs.”  Given the Chantix track record of serious illnesses, injuries, and deaths, the costs can be astronomically high.

The TCI is so intent on pursuing their myth that everyone wants abstinence that they will violate the norms of medical ethics and human decency in hopes of achieving their goal of prohibition.

4 responses to “FDA misdirection endangers lives of adolescents (and others)

  1. I tried Chantix and it was awful!!!! It made me go into a panic mode that still affects me this drug should be taken off the market. It is dangerous. In fact I think we should bring a lawsuit against this company. I sent them all my receipts when I told them what had happened they partially refunded my money but I had to go to a doctor to get medication to counter act what this Chantix did and they have not bothered to refund me the major cost that this drug caused to me.

  2. PS… I have tried the smokeless cigarette’s and have been extremly happy with the results!!! It works, it’s geat, it’s cheaper, you don’t have an oder. Not only that it’s cleaner for the enviroment, no butts left around to pick up or ash trays to empty, nothing thrown out the window that could start a fire which can occur and cause major damage, no hole burnt in your car, in your clothes and it doesn’t bother those around you who don’t smoke. I think this is the greatest thing and who ever came up with it kudo’s to you because it’s a wonderful product. Unlike Chantix with it’s major side effects. It has cost me way more and did not help me quit smoking.

  3. Pingback: Kentucky Lab asking for adolescent smokers 12 to 16 for Chantix Study - Page 3

  4. Pingback: US government to require tobacco companies to correct “lies”, and to lie | Anti-THR Lie of the Day

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