It’s long been a problem that aerosolized medicine is not as precise as we would like. Many doctors say that it as equal parts art and science of medicine.
The moment a compound is turned into a vapor and inhaled, a lot of variables pop up. Among these variables are how much pressure is left in the delivery device, how much force the individual puts of the spray mechanism and for how long, whether the drug separates or stales over time, overall health of the individual using the device, and even whether the individual actually knows how to use the device properly (they can be rather complex). There are also concerns about abuse with many aerosol medications.
Aerosol medication is a valuable treatment option for a lot of patients. It allows for more granular exposure to an active agent, often reduces side effects, cuts down how long it takes to have an effect, and can even cut some side effects out completely. This is beneficial whether the active component is nicotine, medical marijuana, antibiotics, or bronchodilators (mostly for asthma).
Some leading e-cig opponents argue that there is no why to know how much nicotine an individual is getting from electronic cigarettes. It actually turns out that e-cigs take many of the variables out of the equation. Funny how that happens when you use science and technology to solve a problem. By heating and vaporizing a refillable liquid, electronic cigarettes provide a lot more constants to the delivery of whatever is inside.
Add on that many aerosol medications are wildly expensive (especially in the U.S.) and it appears that there should be a better way.
It appears that the advent of electronic cigarettes has inspired one company (and probably a few more) to develop a serious piece of hardware for serious e-cig users. It’s not much more than a $200 to $500 high quality mod unit, but as it turns out, that mod unit can be used for a lot more than nicotine. That it might help cut down on the $250 per month cost of inhalers for some individuals here in the U.S. (closer to $7 in some other places), is only a boost to the product.
But this is something many electronic cigarette advocates actually fear. After the FDA was told by courts that it couldn’t control and ban electronic cigarettes as unregulated drug delivery devices, many fear that slapping drugs other than nicotine into them may change that decision. While the FDA is attempting to group e-cigs into tobacco products to regulate them (which is plenty problematic too), it may quickly realize that going back to its original argument is the better option — one that will grant it a lot more power over the devices.
In June of last year, I reached out to e-cig advocate Michael Siegel on this very topic. ”I’m afraid that if electronic cigarettes started to be used for other drugs, the whole market might collapse because then the federal regulators would certainly toughen up on the product and many state regulators might also take the product off the market,” said Siegel. ”I think electronic cigarettes are uniquely suited as a substitute for smoking because they resemble cigarettes.”
That the FDA is attempting to regulate something that is primarily a technology may turn out to be the most significant problem. The state of e-cigs one year ago isn’t the same as it is today. The state of e-cigs one year from now can only be guessed at. It seems likely that the FDA will always be fighting an industry that evolves far, far quicker than regulation does.
Their answer to that already seems clear. The FDA’s new proposal for electronic cigarette regulation creates a bottleneck wherein any product developed or improved since 2007 much be approved by the FDA through a lengthy and expensive application process.
Red tape will keep the industry from moving faster than the FDA, and the FDA hardly moves.