fda approval

Have a listen here.

Senior Fellow Greg Conko breaks down the fight over Avastin, a drug used to treat several types of cancer. The FDA is poised to rescind Avastin’s approval for treating breast cancer. It will retain its approval for other cancers. This will make life difficult, and possibly shorter, for some breast cancer patients. Conko believes this battle boils down to one question: who decides which treatments patients can use? Will it be the FDA, or doctors and patients?

Oh yeah, I’m going there. Cigarettes are a human achievement. Just like food items (i.e. chocolate) or beverages (i.e. wine) cigarettes are a consumable product that can enhance the enjoyment of the smoker’s life. Sure, it can cause a lot of problems for the smoker and irritate folks around him or her, but those are trade-offs that, as with many other things, one must account for when deciding whether or not to take a certain action. ecigs

All that said, quitting is a really good idea. The achievement this post seeks to praise is the device that shows great promise in helping smokers improve the quality of their lives while allowing them to continue behaviors that they find enjoyable.

Smoking in the modern age is not like it used to be. Gone are the days when you could light up anywhere, buy a pack for pennies, and expect the nonsmokers to “suck it up” so to speak. Almost anyone who has or continues to smoke understands that maintaining the habit is costly, time consuming, and hazardous to one’s health and psychology.

But quitting can sometimes be more difficult than living with the immediate frustrations of smoking. One major barrier to helping smokers quit is that most of them genuinely enjoy the act of smoking. Whether it’s the rush of nicotine or the habitual behaviors surrounding the process of lighting up, even those smokers who intellectually understand the dangers of smoking don’t want to stop.

The electronic cigarette, or e-cigarette might change all of that.

First developed in 2003 by a Beijing company now known as The Golden Dragon Group Ltd. the electronic cigarette is was approved by the FDA for sale in the US in 2008. These battery powered devices, which can look like cigarettes, cigars, or even pens, provide a dose of nicotine through the process of vaporizing a gel solution.

In addition to purported nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no tobacco, smoke, or combustion is actually involved in its operation…They are battery powered, and create their effect by vaporizing nicotine which is dissolved in a solution of water and propylene glycol.

The question for some however, is whether or not these new electronic cigarettes really are safe. As one producer website noted, while the safety of the e-cigarette may not be exactly known, it is assuredly safer than smoking conventional cigarettes. For one, there is a definitive reduction in the risk of accidental fires as the e-cigs are battery powered and have no burning element.

E-smoking is almost identical to cigarette smoking. The major difference is that the e-cigarette is always “lit”. Most of them even have an LED on the end that lights up like a cigarette ember when you draw on it. You can put it down or pick it up at any time without worrying about burning anything. It is only on when you actually draw on it. How much you smoke is related more to how many puffs you desire rather than on the length of the cigarette.

But what about the health consequences of long-term e-smoking? Again, it isn’t exactly known how much safer e-cigarettes are than conventional smoking, but again, it is almost assuredly safer to smoke the vaporized nicotine solution than the tar-laced smoke of tobacco products.

Even if e-cigs are about ten times as harmful as smokeless tobacco, that still makes them about 1/10th as harmful as smoking. Smoking is just that bad.

First of all, there is no burning of any plant matter so all those combustion related carcinogens are no longer present. Of course, in most cases, nicotine is still present but, as we’ve written elsewhere, nicotine is one of the more benign elements in tobacco…All that remains is some uncertainty about the effects of propylene glycol with long term regular use.

Almost anything else that is not acutely toxic (and we know the e-cigs are not) will be safer. Even if e-cigs are about ten times as harmful as smokeless tobacco, that still makes them about 1/10th as harmful as smoking. Smoking is just that bad.

Predictably, the FDA sought to prevent the sale of e-cigarettes in the states, claiming that the effects had not been thoroughly studied. However, in January of this year Federal Judge Richard Leon ruled in favor of plaintiffs Smoking Everywhere and Njoy who filed a jurisdictional lawsuit against the FDA. In his concluding remarks Judge Leon commented:

This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable

According to Matt Salmon, president of the Electronic Cigarette Association (ECA) and former congressman, in the two short years since the product was introduced in the US there’s an estimated 300,000 e-smokers now.

Did you know that the federal government has a Gastrointestinal Drugs Advisory Committee? It’s true. If you don’t believe me, you can attend their upcoming meeting on February 23. The topic of the day will be a new drug application to treat hepatic encephalopathy.

Hopefully some hepatic encephalopathy sufferers will be there. They can ask the Committee why the FDA takes as long as a decade (and as much as $800 million!) to approve medications that could be helping people and saving lives right now.