Emily's Post - The Saga Continues

[harmony gardens]

It has been known for at least 20 years that the depression associated with smoking cessation is not a temporary withdrawal symptom for a segment of the smoking population.

In "Smoking, Smoking Cessation, and Major Depression," published in the Journal of the American Medical Association on September 26,1990, Alexander H. Glassman, M.D., et al discussed the relationship. They used population-based data collected between 1980 and 1983. The lifetime prevalence of major depressive disorder in the entire sample was 5.1%. Among individuals who had never smoked the prevalence was 2.9%. Among those who had ever smoked on a daily basis for at least 1 month, the prevalence was 6.6%.



Remember, this article was published 20 years ago and used data collected up to 30 years ago. I believe the reason the smoking prevalence rate has remained static for the last several years is the a large proportion of the smoking population consists of folks who become unable to function when they are forced to give up nicotine.

Another article published around the same timeframe related an anecdote about a pateint hospitalized with depression. "If you let me smoke," the patient said, "I'll stop trying to kill myself."

Wow, and I just had anecdotal evidence of this. Do you think this might have something to do with the crazy behavior of some people using chantix???

 

[CJsKee]

Oh, I absolutely think so, HG. I took Chantix and was so depressed I could not get out of bed!!! As soon as I quit -- and went back to smoking!! -- the depression lifted.

 

[Stubby]

Oh, I absolutely think so, HG. I took Chantix and was so depressed I could not get out of bed!!! As soon as I quit -- and went back to smoking!! -- the depression lifted.

Chantix is nothing compared to what's coming up. The nicotine vaccine will make chantix look like a picnic

Nicotine vaccine effective in early tests - CNN.com

I can see mentally ill people being forced to us this... then watch them line up to jump off the highest building they can find. No way out of this one once you get the shot

 

[CES]

The vaccine is potentially really bad news. I've commented on it on a couple of other threads, so won't go OT here. But the vaccine is scary from the point of view of both potential effects and the possibility of loss of personal choice.

 

[Vocalek]

And notice that, once again, the very people who are most likely to see adverse effects on their health caused by nicotine abstinence are excluded:

•Organic neurological disorder or significant psychiatric disorder

There is an extremely long list of exclusion criteria for the Phase III trials.
http://clinicaltrials.gov/ct2/show/NCT00369616

And, of course, once the vaccine is FDA-approved, there will be absolutely no warnings to the prescriber that the product was never tested on folks with psychiatric disorders (or just about any other disease state you can think of).

There were no warnings provided for Chantix until after people started dying. And yes, psychiatric disorders were also exclusion criteria for Chantix clinical trials.

 

[CES]

Heck, we're lucky that women are included in clinical trials. They didn't used to be. Many populations still aren't included in clinical trials. While i understand the need to limit variables, those limits also mean the the results may not generalize. That's the part that gets left out. It's not until a product comes to market that effects on other populations or potential off-label uses are found.

 

[Vocalek]

Heck, we're lucky that women are included in clinical trials. They didn't used to be. Many populations still aren't included in clinical trials. While i understand the need to limit variables, those limits also mean the the results may not generalize. That's the part that gets left out. It's not until a product comes to market that effects on other populations or potential off-label uses are found.

And that's why I believe that we already know that -- at least for the first several years of use -- electronic cigarettes are safe. There have been no limitations on who gets to use them, and there have been no serious adverse health events. Many of us users would have been excluded from the clinical trials of any nicotine cessation product.

 

[CES]

Exactly. A strong body of anecdotal evidence can be pretty convincing. And, in the world of decent science, is the basis for more controlled research.

 

[PlanetScribbles]

Chantix is nothing compared to what's coming up. The nicotine vaccine will make chantix look like a picnic

Nicotine vaccine effective in early tests - CNN.com

I can see mentally ill people being forced to us this... then watch them line up to jump off the highest building they can find. No way out of this one once you get the shot

The effects of nicotine addiction cause nearly a half-million deaths annually in the United States, according to the American Cancer Society.

Hmmm. I thought it was the effects of smoking tobacco that caused all those deaths?
Using controlled doses of nicotine isn't at all dangerous, no more than controlled doses of caffeine.

 

[Vocalek]

Hmmm. I thought it was the effects of smoking tobacco that caused all those deaths?
Using controlled doses of nicotine isn't at all dangerous, no more than controlled doses of caffeine.

Very good observation! I, too, have noticed that "tobacco-related" has been substituted for "smoking-related" in many documents put out by the Alphabet Soup Gang (and that includes Federal government agencies) and I assert that this substitution is being done on purpose. The tobacco control community knows full-well that not all tobacco use is equally hazardous.

It was easy to make a case that smoking is hazardous to health. So first they "denormalized" smoking. The next step is to denormalize (i.e., "demonize") all tobacco use, by substituting "tobacco" for "smoking" in their propaganda.

Next step, substitute "nicotine" for either "smoking" or "tobacco." Get a couple of doctors to pounce on the very skimpy evidence of nicotine harm, and voila! The evils of nicotine.

 

[Thulium]

They certainly like to play the equivocation game, but it is really very simple: Nicotine is addictive -> nicotine addiction makes you want to use tobacco -> using tobacco involves combustion. The known harms of combustion (fire hazards, toxins, carcinogens, offensive odors and allergens) are blamed on the use of tobacco which is blamed on the addiction to nicotine, therefore Nicotine is seen as harmful. However, if you take the combustion out of the equation, you eliminate the actual cause of about 99% of harm attributed to tobacco use.

The FDA is afraid that if the public thinks that using nicotine is okay, they will start smoking. They fail to account for the fact that the public might be smart enough to figure out that the problem with smoking is the smoke.

 

[rothenbj]

And notice that, once again......
There were no warnings provided for Chantix until after people started dying. And yes, psychiatric disorders were also exclusion criteria for Chantix clinical trials.

No problem, just a bit of collateral damage as they say in war. The FDA will fix everything. They'll have BP put a black box warning on it, plus add a few more lines on the list of warnings on the TV ad.

 

[ezmoose]

Seems Emily has developed a somewhat reasonable stance on E Cigarettes; however, she remains unconvinced that the obstacles E Cigarettes (Tobacco Harm Reduction) face extend beyond the FDA.

P.S. If anyone can point me to solid, unbiased evidence of organizations like the ALA and AMA, etc., working to squash smokeless alternatives and/or purposely creating ineffective tobacco cessation programs, go for it. So far I've found nothing. I'm willing to have an open mind about it, but many of those kinds of accusations strike me as pretty far-fetched and unsubstantiated.

 

[Posidon]

Seems Emily has developed a somewhat reasonable stance on E Cigarettes; however, she remains unconvinced that the obstacles E Cigarettes (Tobacco Harm Reduction) face extend beyond the FDA.

I posted this in another thread, but you can forward it to Emily if you like.

Information about the 2004 deal between Phillip Morris and Campaign for Tobacco Free Kids.

The Campaign for Tobacco-Free Kids - SourceWatch

Roll Call wrote that "The face-to-face negotiating sessions and conference calls were so sensitive that Philip Morris and the Campaign for Tobacco Free Kids refused to tell even their closest allies."

There is also this book which looks very interesting. I haven't had a chance to look into it yet.

.... Out! How Philip Morris Burned Ted Kennedy, the FDA & the Anti-Tobacco Movement

http://www.amazon.com/Philip-Morris-Kennedy-Anti-Tobacco-Movement/dp/061528597X/ref=sr_1_2?ie=UTF8&s=books&qid=1278906389&sr=8-2

 

[kristin]

Seems Emily has developed a somewhat reasonable stance on E Cigarettes; however, she remains unconvinced that the obstacles E Cigarettes (Tobacco Harm Reduction) face extend beyond the FDA.

I saw that post too and I know that there is evidence written in a book or articles of the public health groups opposing tobacco harm reduction - I have to find it again. I'm sure if she read Dr. Siegel's blog, spoke to bill Godashall, read anything by Brad Rodu or joel nitzkin she'd see the evidence. Unfortunately, most of it is first-hand accounts and I'm not sure how it can be "proven."

 

[kristin]

OK, I found good sources and posted them to her last blog post. If this isn't "unbiased proof" for her, then I give up.

What would you consider "unbiased?" Would the first-hand experiences and opinions of actual tobacco control experts, doctors and anti-smoking advocates convince you? How about an unbiased book about tobacco control in the U.S. written by a British author?

I gave you these links before, but you must not have read them yet or you would already have your "proof."

Here is some reading for you by those people - people who were and are a part of tobacco control and the anti-smoking movement, whistleblowers on how the movement has gone astray. These reports, comments, opinions, white papers and books are what convinced me.

Dr. Michael Siegel
Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. The Rest of the Story: Tobacco News Analysis and Commentary: Insanity of the Modern-Day Tobacco Control Movement: Approve and Protect Existing High-Risk Cigarettes; Get Rid of Everything Else

The Rest of the Story: Tobacco News Analysis and Commentary: Why is the American Lung Association Not Even Willing to Look at the Scientific Evidence?

Dr. Joel Nitzkin, AAPHP
Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians
Current Federal Tobacco Legislation S.625/H.R. 1180
"The Campaign for Tobacco Free Kids has as their only concern keeping children and teenagers from initiating tobacco use. In their minds all tobacco and tobacco related products are evil and any time you add any new product to the marketplace you increase the risk of teens initiating tobacco use. So they are therefore unalterably opposed to the addition of any new tobacco or tobacco related products to the market place, because in their minds until proven otherwise the impact of that product will be to dramatically increase teen use of nicotine. I know of no research that has been done on this point. Every one of the e-cigarette companies I have talked to have claimed that they do not market their product to teenagers but neither are our cigarettes ostensibly marketed to teenagers, so there would have to be some other studies done to determine the extent to which teenagers use e-ciagrettes or any of these other products."
Nitzkin E Cigarette Interview 2

Prominent Public Health Physicians and Tobacco Researchers Expose Double Standard in the FDA's Recent Study of Electronic Cigarettes and Challenge the FDA's Alarmist Attitude Toward the Devices - Standard Newswire


Dr. Carl V. Philips
PhD in public policy from Harvard University, did a post doctoral fellowship in public health policy and the philosophy of science, professor of public health and medicine, most recently at the University of Alberta and currently directs an independent research institute.
http://en.scientificcommons.org/52309861

THR2010. (tobaccoharmreduction.org)

Tobaccoharmreduction.org

Dr. Brad Rodu
Professor of Medicine at the University of Louisville who holds an endowed chair in tobacco harm reduction research, and a member of the James Graham Brown Cancer Center at U of L. For the past 15 years he has been involved in research and policy development regarding tobacco harm reduction (THR). THR advocates acknowledge that there are millions of smokers who are unable or unwilling to quit with conventional cessation methods involving tobacco and nicotine abstinence, and we encourage them to use cigarette substitutes that are far safer.
Tobacco Truth

For Smokers Only

Quote from "Tobacco harm reduction: an alternative cessation strategy for inveterate smokers"
by Dr. Brad Rodu and William T Godshall, president of Smokefree Pennsylvania
"It is not clear how Americans have become so confused about tobacco risks. But it is clear that misinformation about ST products is available in copious quantities from ostensibly reputable sources, including governmental health agencies and health-oriented organizations. Phillips et al have made some of the most pointed comments about this phenomenon:
"Certain health advocates believe it is acceptable to mislead people into making choices they would not otherwise make...Through the use of various tactics, advocates who oppose the use of ST as a harm reduction tool have managed to convince most people that the health risk from ST is several orders of magnitude greater than it really is. The primary tactic they use is making false or misleading scientific claims that suggest that all tobacco use is the same. . . . Apparently motivated by their hatred of all things tobacco, they are trying to convince people to not switch from an extremely unhealthy behavior to an alternative behavior that eliminates almost all of their risk"
http://www.aaphp.org/special/TobcHarmReduction_RoduGodshall.pdf

Christopher Snowden
An adjunct scholar at the Democracy Institute. Velvet Glove, Iron Fist was his first book. He is an independent researcher and author and has no affiliation or financial ties with the tobacco industry or any anti-smoking group.
Velvet Glove, Iron Fist: A History of Anti-Smoking

Velvet Glove, Iron Fist

These are just some sources available. These are respected people, some of whom have been heavily involved in tobacco control and the anti-smoking movement. They have no finbancial bias towards the tobacco or pharmaceutical industries - they actually are experts and researchers on tobacco control and the anti-smoking movement. You can look any of them up. Feel free to contact them for more information.

 

[DC2]

Kristen, you might consider also directing her to the information you have posted here in the past regarding the "manual" that many of these anti-smoking organizations follow, and the tactics they are instructed to use.

 

[Vicks Vap-oh-Yeah]

You could also have her look into the Illinois bill we squashed this spring...Cathy Drea was there, and she opposed altering the bill to restrict sales to minors only, instead opting to pursue the all or nothing approach to PV control. She deliberately dropped the initials of the ACA, I believe, and she's a paid lobbyist for the ALA.

I know JustJulie posted a transcript of the proceedings, as well as an audio file of the hearing a while back.

 

[DC2]

Here is something else she might be interested in...
http://news.prnewswire.com/DisplayR...&STORY=/www/story/03-24-2009/0004993931&EDATE

Statement of the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids

WASHINGTON, March 24 /PRNewswire-USNewswire/ -- The American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Campaign for Tobacco-Free Kids applaud Senator Frank Lautenberg of New Jersey's call for the Food and Drug Administration to exert its authority and immediately remove e-cigarettes from the market.

FDA officials have been quoted numerous times in many publications during the past few weeks saying that e-cigarettes are "new drugs," which require prior approval from the FDA before they are allowed to be sold. Without this approval, e-cigarettes are illegal to market or sell. Despite these statements, no action has been taken to remove e-cigarettes from the market.

Currently, e-cigarettes are being sold in 62 kiosks at malls across the United States, with plans to expand to another 55. E-cigarettes are also being marketed towards young people, who can purchase them in fruit flavors and online, without having to verify their ages.

Makers and retailers of these products have been making unproven health claims about their products, claiming that they are safer than normal cigarettes and asserting that they can help people to quit smoking. Absent scientific evidence, these claims are in blatant violation of FDA rules.

In fact, no studies have been done on e-cigarettes to date regarding their health effects or their effectiveness as cessation aids. Like the "light" and "low tar" cigarettes that tobacco companies claimed were healthier for consumers, there is no evidence to back up the claims made by e-cigarette makers. In September of 2008, the World Health Organization stated that they have "no evidence to confirm the product's safety or efficacy."

Our organizations thank Senator Lautenberg for his leadership in urging the FDA to remove these products from the market and echo his call that the FDA move quickly to remove these products from the marketplace.

While the FDA currently does not have jurisdiction over tobacco products, it does have jurisdiction over other products that contain nicotine including e-cigarettes, which have been marketed as delivering nicotine without tobacco.

SOURCE American Lung Association

 

[DC2]

Here is an article that shows the extent of ties between the FDA and Big Pharma...
FDA Denies Philip Morris Request on Tobacco Panel - WSJ.com

By DAVID KESMODEL

The U.S. Food and Drug Administration rejected a request by cigarette giant Philip Morris USA to remove four members of a key tobacco-products advisory panel that the company said had extensive conflicts of interest.

Altria Group Inc. disclosed in a quarterly financial report with regulators Wednesday that its Philip Morris USA unit asked the FDA last month to withdraw four nominees because they had financial and other conflicts, including having served as paid expert witnesses for plaintiffs in litigation against tobacco companies. The Tobacco Products Scientific Advisory Committee was formed in the wake of the landmark law enacted last year that gave the agency broad powers to oversee the industry.

The FDA denied the request in a letter to the tobacco purveyor on March 25. According to an agency spokeswoman, the letter said the "FDA followed existing law and procedure to recruit the best scientific experts and to ensure that [the panel] has a balanced composition of expertise to handle the many complex tobacco-related issues it will face."

Philip Morris USA, the largest U.S. cigarette maker by sales, and U.S. Smokeless Tobacco Co., another unit of Richmond, Va.-based Altria, requested that the agency remove as panelists Neal Benowitz, Gregory Connolly, Jack Henningfield and Jonathan Samet.

In a March 22 letter to the agency, the companies said the panelists have financial conflicts and "irreconcilable biases" that would undermine the credibility of the committee, which is charged with reviewing a wide range of tobacco products and making recommendations to the agency.
The four "appointees have pronounced and disqualifying conflicts and biases arising from their active and zealous participation as paid expert witnesses for plaintiffs in lawsuits" that attempt to cripple or destroy the industry, the letter said.

The four men are among nine voting members of the 12-member committee. Dr. Samet, a professor of medicine at the University of Southern California, is chairman. Dr. Samet has provided expert deposition or trial testimony for plaintiffs in at least seven cases brought against tobacco companies, Altria said, and has charged fees of $300 per hour. He also has received grants from at least one pharmaceutical company that makes and markets products that help people quit smoking.

Dr. Samet said Thursday that he did not want to comment on Altria's request other than to say the FDA "has fully reviewed my professional career," including any perceived or real conflicts. He said that he did not personally keep any of the money paid for his expert testimony in tobacco-industry litigation. All of it, he said, went to Johns Hopkins University, where he previously worked.

The Wall Street Journal previously reported that Messrs. Henningfield and Benowitz have ties to pharmaceutical companies that market stop-smoking medicine.

Altria said in its quarterly financial report to the Securities and Exchange Commission on Wednesday that the FDA said it had satisfied itself, after an inquiry, that the panelists "did not have disqualifying conflicts of interest."

Altria was a key backer of the legislation signed into law by President Barack Obama last year to make the FDA the industry's regulator. It said in its letter that "we recognize and support the important role" of the advisory panel.

The FDA has said federal law permits it to grant waivers to allow some experts with conflicts of interest to serve on advisory committees, and it has done so on certain drug-advisory panels. FDA Commissioner Margaret A. Hamburg said in an April 21 letter to staff members that it is "clearly better for the agency" when "advisors have no conflicts of interest." However, she said, "I recognize the fact that many of the top authorities in specific areas may have conflicts of interest."

Altria noted in its SEC filing that the FDA told the tobacco company that it would continue to screen all members of the advisory panel for potential conflicts of interest on matters taken up at panel meetings. This could lead some panel members not to participate in the discussion of certain topics.