USACIG, maker of the "Electric Cigarette" announced they have signed an exclusive agreement with Hop-on to submit it's electronic cigarette technology to the FDA for clinical studies for the prevention and treatment of Parkinson's disease.
Recent studies by the Parkinson's Institute and Clinical Center lead by Maryka Quik, Ph D have indicated intermittent nicotine treatment can reduce medication induced dyskinesias by as much as 50%. USACIG is hoping their electronic cigarette might be the perfect way to deliver nicotine to Parkinson's patients.
Peter Michaels, CEO of Hop-on, the company one usually associates with multi media services, the first disposable cell phone and the licencing of technology like CDMA, GSM and WIFI, says they are excited to be the exclusive agent for FDA submission.
In a Washington Post article published Thursday, Dr. Elizabeth M. Whelan, the president of the American Council on Science and Health calls the recent FDA press conference on electronic cigarettes "distorted, incomplete and misleading." She further states the FDA "was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk."
Strong words against the government agency charged with protecting the public from unsafe consumer products from a woman notorious for attacking industries who make unscientific or overstated health claims. One might think she would side with the FDA against e-cigarette manufacturers and retailers claiming they are a smoking cessation product or a "healthier alternative" that contains "no carcinogens" without FDA approved studies to back them up.
BOSTON, July 27 /Standard Newswire/ -- The FDA recently went public with misleading information about the safety of electronic cigarettes and the marketing of the devices, not only using its clout but recruiting other prominent organizations to demonize a product that has great public health benefit potential.
A group of prominent doctors and tobacco researchers, including Dr. Michael Siegel at the Boston University School of Public Health, Dr. Joel Nitzkin of the AAPHP Tobacco Control Task Force, and Dr. Brad Rodu, Endowed Chair, Tobacco Harm Reduction Research University of Louisville, challenge the FDA to provide the full quantitative data of the study upon which the FDA has based its warning against electronic cigarettes. They are concerned that the FDA's disingenuous targeting of electronic cigarettes through a biased presentation of the scientific data has had significant negative impact upon the public perception of electronic cigarettes, when the best available evidence suggests that these have shown that the devices offer great potential to reduce serious health issues among traditional tobacco smokers.
A couple of days ago we reported that USACIG has secured a deal with Hop-on to act as their agent to submit an application to the FDA to allow them to begin clinical studies to see if their Electric Cigarette could be an effective treatment for Parkinson's Disease.
This was a surprise move to many people, me included. So i've been looking into it.
Yes, there is some evidence that nicotine could be a treatment for PD and it's been shown smoking may be a major factor in the reason smokers have a lower instance of PD than non smokers. One study from the College of Medicine at the University of Vermont concluded:
We have begun quantitative studies of both acute and chronic nicotine in PD to assess both cognitive and motor effects. Fifteen (15) nondemented subjects (age 66 +/- 5.3; M/F = 11/4) with early to moderate PD (mean Hoehn-Yahr stage = 1.77; MMSE = 28.6) received a dose-ranging study of intravenous nicotine up to 1.25 microg/kg/min, followed by chronic administration of nicotine by transdermal patch with doses ranging up to 14 mg per day for 2 weeks. Testing occurred both during drug administration and up to 2 months after drug cessation to look for prolonged effects.
Breaking news on the vaccine front!! If I were John Banzhaf I'd be sending out press releases saying "in response to my recent blog posts regarding vaccines, the National Institute of Health announced they are giving a $10 million dollar grant to the developers of NicVAX, the anti smoking vaccine, to fund phase III testing." But I won't.
What is NicVAX? An anti-smoking vaccine?
NicVAX is a new injectable vaccine developed by Nabi biopharmaceuticals of Rockville Md which the FDA has already granted "fast track status" to that researchers claim will help people quit smoking and prevent them from relapsing.
NicVAX has already passed initial regulatory hurdles to show the idea is sound and now move to clinical trials where patients are given six monthly shots. Early results show that smokers using the vaccine had a higher rate of success at abstinence from tobacco than those given the placebo.
My report on an article claiming E Cigarettes May Be More Effective Than Swine Flu Vaccine got me to thinking about how the FDA has responded to the public health threat of the swine flu in comparison to the public health threat of smoking. The differences are astounding.
The H1N1 Swine Flu Pandemic has now been declared a "National Emergency" and as the article pointed out
According to President Obama's Council of Advisers on Science and Technology on H1N1, "A plausible scenario is that the epidemic could cause between 30,000 and 90,000 deaths in the United States."
Many doctors questioned the validity of these numbers and in October CBS News pointed out in a scathing report that the CDC had absolutely no idea how many actual swine flu cases there were because they had simply stopped testing people for the virus months ago.
Ok, so i'm doing a search and what do i see in the News section? "E Cigarettes May Be More Effective Than Swine Flu Vaccine". Now you know I have to read this. What? Talk about outrageous health claims. Holy Swine Flu Batman!
As I expected, this press release published in the Earth Times is referring to the study in 1942 conducted by Dr. Oswald Hope Robertson of the University of Chicago's Billings Hospital. He was studying the effects Propylene Glycol might have as a germicide. It's really a fascinating study which is being pointed at more and more lately by electronic cigarette supporters. While it's old and the FDA probably doesn't consider it valid research and anti smoking activists just roll their eyes, it is interesting to look at. I'll have to do a more in depth analysis of the entire study sometime.
I've been seeing Chantix™ mentioned in a lot of places lately. Electronic Cigarette supporters point to it as an example of how dangerous some FDA approved nicotine replacement therapies and stop smoking programs are, but to be honest, i knew little more then a few hundred people have commited suicide due to their use of this drug. So, tonight I poked around the Chantix website a bit. I was truly amazed, and a bit frightened at what I saw.
The FDA Mandated Chantix™ Warning
All FDA approved drugs now have to put certain warnings on their marketing materials. For years i've joked about the TV commercials that are 15 seconds of "use this, it's great tell your doctor you want it" and 15 seconds of "may cause your liver to explode, your eyes to pop out and in rare cases your heart to stop or your brain to explode". So, what are the side effects of this "safe" drug that managed to get FDA approval?
copyright 2009 all rights reserved
*Electronic Cigarettes have not been proven to help you quit smoking and no such claims are being made here. These are the authors personal thoughts on the debate and are not based on any scientific study. Ecigarettes are not marketed as a smoking cessation device and no legitimate manufacturer makes any such claim. E-cigarettes should not be confused with any FDA approved nicotine replacement therapy, for, like cigarettes, they are not FDA approved nicotine delivery systems.
In a Washington Post article published Thursday, Dr. Elizabeth M. Whelan, the president of the American Council on Science and Health calls the recent FDA press conference on electronic cigarettes "distorted, incomplete and misleading." She further states the FDA "was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk."