Tag: review

FDA’s drug and e-cigarette warnings counterproductive

A major policy shift is underway, and it is bound to have a dangerous unintended consequence. The new team at the FDA has slapped a black box warning on an important class of drugs that treat inflammatory diseases such as rheumatoid arthritis, Crohn’s disease, and colitis.

The cancer risk highlighted by this new bold warning has been known for years — and hasn’t gotten worse. We already knew of the cancer risk in children and adolescents, and responsible doctors were cautious in using them. The new warning signals only a change in perception of risk, not any change in actual risk.

Physicians should still give due consideration to the benefits of the drugs, especially in light of the paucity of other treatments for debilitating and often dangerous inflammatory diseases. Consider the benefit versus risk analysis for inflammatory diseases with secondary risks.

For example, by not using these drugs out of possibly inflated concerns due to the new additional cancer warning, might inflammatory bowel disease patients face a higher risk of colon cancer as a result of years of inflammation? You won’t see that risk in bold print. But it is just as real. And this is precisely the problem with the FDA’s new policy, which is based on the assumption that erring on the side of more warnings is the safest way to go.

Similarly, this summer, the FDA warned about the safety of e-cigarettes, a product many smokers are using to quit smoking real cigarettes. E-cigarettes are devices that supply users with vaporized nicotine and look like cigarettes, many even having an LED light at the tip. These products, which contain no tobacco and are non-combustible, eliminate virtually all the risks of smoking. For the vast majority of smokers unable to quit even with the help of drugs and counseling, e-cigarettes could be a lifesaver.

Yet the FDA found tiny levels of carcinogens in the product and warned smokers to stay away, essentially telling them to go back to deadly cigarettes.

Unfortunately, it is no surprise that the new leadership at the FDA is taking a more aggressive stance with regard to warnings.

These warnings are a harbinger of how the agency will weigh benefits versus risks: with a thumb weighing down the risk side. This distorted approach has numerous downsides:

• Fewer patients will get the treatment they need, out of an “abundance of caution” and physicians’ fear of litigation.

• Black box warnings, originally meant for only the most dangerous drugs, will become more widespread but less meaningful.

• The FDA, newly armed with regulatory power over tobacco, will make it harder for people to quit smoking cigarettes by warning them away from disfavored alternatives.

• Investors and researchers (innovative drug companies) will have less incentive to pursue new medications that may attract scary warnings.

The old adage “better safe than sorry” is too simplistic in today’s world to be the guiding principle at the FDA.

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Prominent Doctors Respond to the FDA

Dr.’s Siegel, Radu, and Nitzkin all respond to the FDA’s report regarding the electronic cigarette.

BOSTON, July 27 — 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.

In a July 22 news release, the FDA cited the detectable presence of carcinogens and “toxic chemicals” in a “small sample” of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco.

Regrettably, the FDA has used biased reporting of this small and inconclusive study, the complete results of which have not been made public, to secure the vocal support of groups such as the American Academy of Pediatrics Tobacco Consortium, the Institute for Global Health, and the American Lung Association in their attack on electronic cigarettes. These researchers argue that it is absurd to consider taking electronic cigarettes off the market when it is the conventional ones which have been shown to be killing people. Further, the electronic cigarette community calls for accurate and fair reporting relative to the findings and statements of prominent medical professionals in favor of this new and important technology and challenges the media to tell the other side of the story.

“The FDA’s laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes,” says Dr. Michael Siegel. “The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: ‘Are electronic cigarettes safe?’ That is not the right question. The right question is: ‘Are electronic cigarettes much safer than traditional ones?’”

Dr. Rodu states, “The FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and the methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years. These are not the actions of an agency that is science-based and consumer-focused. These pseudo-scientific actions are clearly intended to form the justification for banning a category of products that are probably 99.9% safer than cigarettes.”

Dr. Joel Nitzkin speaking as individual states, “The newly adopted FDA/Tobacco legislation will give full FDA approval to currently marketed conventional cigarettes. The new law encourages cigarette companies to produce new “reduced exposure” cigarettes to be marketed as reduced exposure products, with no scientific evidence that such reductions in exposure will reduce risk of future tobacco related illness and death. In the context of these provisions of the newly adopted FDA/Tobacco bill — FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

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FDA smoke screen on e-cigarettes

Cigarette substitute produces no deadly smoke

At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.?

The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called “e-cigarette” — claiming it was loaded with harmful “toxins” and “carcinogens.” The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes — better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.

In making its distorted, incomplete and misleading statement, 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.

The truthful part of the FDA statement was that e-cigarettes have not been through formal efficacy and safety tests at the FDA, and they have only been around a few years. But in the press conference, here is what the FDA did not tell you but should have:

Traditional cigarettes are lethal not because of the trace level presence of specific “carcinogens” and “toxins,” but because by using them, smokers inhale enormous amounts of smoke — otherwise known as “products of combustion.” It is the inhaled smoke that kills in so many ways — from cancers, cardiovascular and lung disease, and more.

The cigarette was a relatively obscure product in our society until the invention of a cigarette rolling machine, and sales rose quickly prior to World War I.

Before that, tobacco was used relatively safely — in chew, pipes, cigars — because little if any smoke was inhaled. Cigarettes changed all of that.

The e-cigarette — a cigarette-mimicking device made up of a battery, an atomizer and a cartridge — allows smokers to inhale, getting a dose of the nicotine they crave, and then sending steam out the other end (with little or no odor) to mimic the ritual and feel of smoking normal cigarettes.

The FDA complained that the e-cigarette was a “nicotine-delivery system.” Well, it got that much right. But again, it’s the smoke that kills, not the nicotine. Yes, nicotine is highly addictive, and it is what keeps the smoker hooked. But getting the nicotine without the smoke is an enormous health advantage for cigarette smokers (the nicotine inserts come in various strengths and the users can adjust them downward as they wish).

The FDA has approved other nicotine-delivery systems in the form of gums and patches — and they have been abysmal failures. The smoking cessation rates using these devices is less than 15 percent after one year, condemning millions of addicted smokers to a lingering death. We desperately need other alternatives. But the FDA has now joined a long list of so-called public-health organizations — including the Campaign for Tobacco Free Kids and the American Lung Association — whose collective motto seems to be “quit or die.” Not only do they reject e-cigarettes, but they also condemn other smokeless products like snus, which have a mere fraction of the health risks associated with smoking cigarettes.

More than 1 million smokers are now using the e-cigarette — a product that offers some, if not all, of the “social amenities” of the real thing — holding the cigarette, taking a drag, seeing a plume of “smoke.” The FDA, lacking data that e-cigarettes pose a health hazard, was so desperate, it called on consumers to phone in adverse side effects of e-cigarettes so they could begin to build a case against them and proceed with their intended ban. They neglected, however, to request smokers who successfully quit using the e-cigarette to also call in.

Cigarette smoking remains the leading cause of preventable disease and death in the United States today. Any alternative acceptable to addicted smokers should be taken seriously. Instead of condemning the e-cigarette, the FDA should be sponsoring studies to evaluate its safety and efficacy — leaving it on the market in the interim.


A Good Review of Green Smoke Compared To Other Companies

This guy reviews the greensmoke electric cigarette and compares it to some other eCigarettes that he has tried. He explains that some other vendors did not fill the cartridges up correctly while greensmoke always had good cartridges.

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Electronic cigarette interview with Dr Adrian Payne

Dr. Adrian Payne

Dr. Adrian Payne

Dr Adrian Payne is the Managing Director of Tobacco Horizons,a Tobacco Harm Reduction Consulting Agency. During a post-doctoral career spanning more than thirty years, he has worked for both tobacco and pharmecutical companies, often in the field of Tobacco Harm Reduction.

ECD: How harmful is the electronic cigarette when compared to a regular cigarette?

Adrian: Based on the safety profiling data on E-cigarettes that has been published so far, I think it’s reasonable to say that they are probably at least two, if not three, orders of magnitude less harmful than regular cigarettes. The key reason for this huge difference is that E-cigarettes don’t generate harmful tobacco smoke. But it’s important to understand that ‘no smoke’ doesn’t necessarily translate into ‘no harm’; it’s possible that some risks might emerge from studies into their long-term use.

However, it’s hard to imagine that any such risks would even begin to approach those of smoking cigarettes. Indeed, probably the issue of main concern with E-cigarettes is that children might ingest the E-cigarette cartridges. So along with the necessary internal quality control checks, it would seem sensible for the various manufacturers to use childproof packaging as a design feature.

ECD: Do we have any idea of the effect of heating up nicotine prior to inhaling it? How is the heating of nicotine by the electronic cigarette different to setting fire to tobacco and inhaling the resultant smoke?

Adrian: The end result of tobacco combustion and nicotine vaporisation is basically the same, i.e. generation of a nicotine-containing aerosol that can then be inhaled by the user. Both processes involve heat, but they are otherwise very different in that the aerosol generated by the E-cigarette does not contain within it the thousands of other chemicals, many of which are thought to be extremely harmful, that result from the combustion of tobacco. It’s true that concerns have been expressed about possible harmful effects of some of the chemical components other than nicotine in the E-cigarette aerosol, for example propylene-glycol. But based on current knowledge, these concerns seem vastly overplayed when compared to the risks of cigarette smoking.

ECD. One criticism that has been leveled at the e-cigarette is that it could encourage youngsters and other non-smokers to take up smoking. Are young people more likely to take up smoking with an electronic cigarette than with a regular cigarette?

I’m not aware of any evidence of adult non-smokers using either E-cigarettes …in any number as a gateway to smoking – if there were I’m sure we would have heard of it by now. Bad news travels fast!

Adrian: As a parent myself, I understand concerns that young people might be attracted to E-cigarettes and then move on to conventional cigarettes. But I’m not aware of any evidence that this is, or is even likely to be, the case. In the first place, E-cigarettes are not ‘pocket-money’ devices. Secondly, I don’t think anyone has raised the same concerns about pharmaceutical nicotine inhalators which, in the UK at least, are available over the counter. Similarly I’m not aware of any evidence of adult non-smokers using either E-cigarettes or pharmaceutical nicotine inhalators in any number as a gateway to smoking – if there were I’m sure we would have heard of it by now. Bad news travels fast!

ECD: You have worked with both the tobacco industries and the pharmaceutical industries. Do you think there is any justification in e-smokers’ beliefs that Philip Morris is interested in snuffing out alternatives to cigarettes via the Tobacco Bill it supports in the US? And are large pharmaceutical companies encouraging public health groups in America to campaign against the devices?

Adrian: To my knowledge, Philip Morris was involved in discussions on the Tobacco Bill it supports in the US long before the advent of E-smoking so I don’t think that these beliefs are justified in the case of E-cigarettes. But what I think are justified are the widely-held beliefs that if this Tobacco Bill is signed into law as currently drafted, E-cigarettes along with other innovative products would face an almost impossible task to get regulatory approval and would therefore be banned.

“E-cigarettes are at risk of being caught in a regulatory trap, with consumers being denied the choice of a far safer product than regular cigarettes…”

This would in effect freeze the market and divide it between regular cigarettes (for those who either want to smoke or partake in the quasi-smoking experience which E-cigarettes provide), smokeless tobacco products (less harmful than cigarettes, but a completely different consumer experience) and pharmaceutical nicotine products (for those want to quit smoking entirely or at minimum cut-down their consumption). So E-cigarettes are at risk of being caught in a regulatory trap, with consumers being denied the choice of a far safer product than regular cigarettes that might meet their smoking abstinence needs better than either smokeless tobacco or pharmaceutical nicotine products.

It would make a lot more sense if a separate regulatory category were to be carved out for cross-over products like E-cigarettes and I’d like to see the manufacturers of these products being more pro-active in this regard. I’m certain such a move would find support from those members of the public health community who see E-cigarettes as potential life-savers rather than as regulatory upstarts. Development and application of an appropriate regulatory package wouldn’t have to be done all at once; it could be incremental, thereby allowing the products to stay on the market in the meantime.

Certainly large pharmaceutical companies with interests in stop-smoking medicines provide very substantial financial support to some of the public health groups that are calling for E-cigarettes to be banned. Incidentally these are the very same public health groups that support the Tobacco Bill backed by Philip Morris. But I’m not aware of any evidence of specific encouragement from these pharmaceutical companies for those groups to take such an antagonistic position. Nor have I seen any position statements on E-cigarettes from the companies themselves. That doesn’t mean to say of course that they are not keeping a close eye on what is happening on the E-cigarette front – I’m sure they are!

ECD: The reaction in the UK seems to be that these devices might help, but that more research is needed. Should more research be done into electronic cigarettes before we allow them to be used by smokers?

“…current smoking prevalence rates are proving surprisingly stubborn to conventional public health interventions.”

Adrian: Well, it’s certainly good that some commentators think that E-cigarettes might help; current smoking prevalence rates are proving surprisingly stubborn to conventional public health interventions. Apart from the reduced harm aspect, E-cigarettes do offer that touchy-feely behavioural aspect of cigarettes that for the most part other alternative products don’t. When it comes to the need for more research, I agree with this, but it should not be at the expense of taking the products of the market in the meantime. If this were to be the case, it really would be a cruel irony if smokers who had switched to E-cigarettes were, as a result, forced to revert to smoking regular cigarettes.

ECD: Should health groups help to fund this expense, as they should also be un-biased.  Also, should the e cigarette be taxed by the government to compensate for potential loss in revenue?

“I’d hope that governments would use tax policy to steer smokers towards safer products rather than drive them away from them.”

Adrian: At a time of economic crisis when many health groups are under financial pressure, the funding may have to come from elsewhere. But it would be entirely appropriate, if not essential, for health groups to be involved in the design of protocols and the undertaking and review of research to evaluate more fully the long-term potential of E-cigarettes as less harmful alternatives to cigarettes. Yes there might be a revenue loss from fewer cigarettes being smoked if E-cigarettes took off in a big way. But I’d hope that governments would use tax policy to steer smokers towards safer products rather than drive them away from them.

ECD: The current advice for smokers from bodies like ASH UK is that nicotine replacement aids should be used by smokers instead of electronic cigarettes. How effective are these aids in helping smokers give up over the long term?

Adrian: Nicotine replacement aids clearly work for some people, but overall these aids are much less effective than one might anticipate, especially over the long–term. For example, in a recent study they were found to be effective in only 1.6% of users, although this admittedly this was better than the 0.4% achieved with placebo treatment.

It’s of course feasible that the development of newer nicotine replacement aids that more closely reproduce the pharmacokinetic profile of the intake of nicotine from cigarettes might improve on this, and currently there is a lot of interest in testing this concept. But at the end of the day it seems the most important thing that helps smokers to give up is having the willpower to do so. If E-cigarettes prove over time to be an effective transition tool in enabling smokers thinking about quitting to develop and build on the willpower to help them do so, then it would be an obvious benefit. I’d hope that if this is the case, bodies like ASH UK would recognise it as such and respond positively by revising their advice accordingly.

ECD: Of course, e-cigarettes are not the only alternative to smoking. Snus is regarded as one of the safest alternatives and some experts we have interviewed believe it contains no measurable risk at all.   In your opinion, has the banning of Snus caused the death of smokers in the UK?

“…the reasoning for maintaining the ban [on snus] seems more political than scientific…Quite bizarre really!”

Adrian: Times have changed since the EU ban on snus was originally imposed and even hard-line tobacco control advocates now acknowledge that snus is much safer than cigarettes. So the reasoning for maintaining the ban seems more political than scientific, especially given that some smokeless products that are potentially much more harmful than snus are legally on sale. Quite bizarre really!

Perhaps the best answer would be to replace the specific EU ban on snus with a comprehensive overhaul of EU tobacco and nicotine regulation. I’d hope that this would put all nicotine-containing products under the same regulatory umbrella, classify them according to risk, and ensure that consumers are informed accordingly so that they can self-regulate their risk.

To get back to your question, according to one study over 200,000 premature deaths might be avoided annually in just fifteen EU countries if smoking rates were as low as in Sweden, which is attributed in large part by many observers to the Swedish preference for snus instead of cigarettes. So intuitively, it’s very tempting to say ‘yes’. However, without snus having been on sale legally in the UK it’s not really possible to give a definite answer. This is because we don’t know what the UK consumer reaction might have been to snus being made available as an alternative to cigarettes.

“…public health backing, rather than criticism, of the launch of such products can play a vital role in getting the message across to the consumer, even if these products originate from the tobacco industry.”

It’s not sufficient to just put a less harmful product like snus on the shelves in the hope that consumers will buy it; it has to have consumer relevance and sufficient utility to stimulate trial and repeat purchase. The same is of course true for E-cigarettes and any other less harmful cigarette-alternative. This is where public health backing, rather than criticism, of the launch of such products can play a vital role in getting the message across to the consumer, even if these products originate from the tobacco industry.

ECD: Do you see parallels between Snus and E-Cigarettes?

Adrian: Absolutely, there are definite parallels here. Both products offer smokers nicotine-providing alternatives to cigarettes at a vastly reduced relative risk, primarily because of users not having to inhale tobacco smoke. Both products also offer the consumer some elements of the ritualistic aspects of smoking that medicines don’t. And Sweden offers a good example of how preferences have changed when consumers are given the choice. That doesn’t mean to say that either type of product would necessarily have a universal attraction for smokers. But even if only a small minority of smokers switched, the public health benefits could still be considerable.

“Prohibition didn’t work for alcohol in the US and I see no reason why it should work for tobacco either.”

A regrettable parallel is that the opposition of some to cigarette alternatives such as snus and E-cigarettes seems to be born out of an absolutist view that the use of tobacco products (or anything resembling them) should be eradicated from modern-day society. Prohibition didn’t work for alcohol in the US and I see no reason why it should work for tobacco either. Some detractors claim that making cigarette alternatives like snus and E-cigarettes available encourages dual-use in combination with cigarettes and thus delays quitting smoking. But the same criticism could equally well be directed towards medicinal nicotine products marketed to relieve cravings during temporary abstinence from smoking.

“…the current controversy about both snus and E-cigarettes is indicative of the fact that current models of tobacco and nicotine regulation have outlived their usefulness.”

Finally, I’d say that the current controversy about both snus and E-cigarettes is indicative of the fact that current models of tobacco and nicotine regulation have outlived their usefulness. Urgent revision is required to help, rather than hinder, consumers being able to make healthier choices if they either don’t want to, or can’t, quit their nicotine dependence entirely. E-cigarettes and the voices of the many E-cigarette users world-wide could prove to be a powerful catalyst for change in this regard; as someone who has long had a passionate interest in tobacco harm reduction, I certainly hope so!


A Basic Overview of the eCigarette.

An electronic cigarette (or e-cig) is an alternative to the cigarette, providing small amounts of the chemical nicotine with each inhalation.

The device takes the form of a tiny rod which is slightly longer than a normal cigarette. The mouthpiece of the device contains a replaceable cartridge filled with nicotine suspended in food grade propylene glycol, and usually contains artificial flavors. When the user inhales through the device, the air flow is detected by a sensor. A microswitch then activates an atomizer, which injects tiny droplets of the liquid into the flowing air and vaporizes the nicotine. This produces a vapor mist which is inhaled by the user. The addition of propylene glycol to the liquid makes the mist better resemble normal cigarette smoke. The microprocessor also activates a colored LED at the tip to simulate real smoking.

E-cigarettes generally use a rechargeable battery as a power source. Battery life varies between devices, with some lasting a day between charges, and others lasting a week.

Cartridges for e-cigarettes are usually offered in a variety of formulations, with different flavors, some of which resemble traditional cigarette flavors (e.g. Marlboro reds, Marlboro lights, Menthol) and some of which are flavored with mint, fruit, coffee, etc. They also come in various nicotine concentrations. At the upper range of nicotine concentrations, e-cigarette smoking is equivalent in nicotine delivery to average tobacco cigarettes. There are also a range of milder options, including completely nicotine-free cartridges. Depending on the device, the solution cartridges are good for between 100 to 600 drags. An empty cartridge can be replaced with a new cartridge or it can be refilled with solution. This solution is sometimes called e-liquid and is often sold in bottles of 15ml, 30ml, and 50ml sizes.

When starting off your first time as a Ecig user you will need to purchase a Kit. Kits include 1-2 Electronic cigarettes, 5 Cartridges and a Charger unit. This will help you for the first few days to test out and understand how an Ecig works. Cartridges in a Kit come prefilled with standard tobacco flavor and vary in strength of nicotine, from high 18MG to zero nicotine. When your cartridge runs low or empty on liquid you will need to either replace the cartridge with a fresh one, or refill the cartridge with liquid if you have pruchased E-Liquid to do so. Below is a simple definition of each part of an eletronic Cigarette

electronic_cigarette_diagram

CARTRIDGES

These are the holders for the liquid nicotine. On smaller models they are usually the mouthpiece as well, which is nice because it can be replaced easily. These can also be bought without liquid in them and refilled manually and re-used. You can also clean these by pulling out the poly fiber material, rinsing, and then drying.

BATTERIES

Pretty self explanatory. Battery life differs depending on cigarette model. The usually last for about 3 hours use and the larger the e-cigarette usually the longer the battery. These batteries do degrade over time so you will eventually have to replace them, some say they can be charged about 300 times before they are dead.

ATOMIZERS

This is the heart of the e-cigarette. This part heats up and converts the liquid into vaporizes nicotine. These can be cleaned and/or replaced. They have a tendency to degrade and die over time. So they will eventually have to be cleaned. Some side effects of a dirty atomizer or one that needs replacement is a burnt smell/taste when smoked with, less vapor being created, or not producing enough heat to make any vapor.

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Quick Review of the GreenSmoke eCigarette

This lovely lady gives us an overview of the GreenSmoke eCigarette. She explains basically how it works and shows us the amazing amount of vapor that the GreenSmoke puts out. Buy a GreenSmoke for 10% off! Click Here.

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Video Review 01 of GreenSmoke

This is the first video review of the GreenSmoke Electric Cigarette

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