Electric Cigarette to seek FDA approval as Parkinson's Treatment?

 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.

Preliminary analysis shows improvements after acute nicotine in several areas of cognitive performance, particularly measures such as reaction time, central processing speed, and decreased tracking error.

Improvements in attention and semantic retrieval were not seen. After chronic nicotine, improvements were seen in several motor measures suggesting improved extrapyramidal functioning. This appeared to be sustained for up to 1 month after drug. The treatment was well tolerated. Nicotinic stimulation may have promise for improving both cognitive and motor aspects of Parkinson's disease.

But are USACIG and Hop-on really serious and properly prepared to seek FDA approval as a PD treatment?

First up, Hop-on is a technology company. They deal with licencing things like CDMA, GSM, WIFI and are perhaps most famous for their development of the world's first disposable cell phone. They are currently one of only a handful of US manufacturers of cell phone technology. This is not the type of company one might expect to be submitting electronic cigarettes to the FDA for clinical trials.

Second, USACIG is not a major player and says it is "seeking funding" for clinical trials. While they claim to have some doctors on their board of directors to handle any "medical opportunities" that might arise, do they really have the millions it's going to take for clinical trials?

And Third, is there really that much money in Parkinson's Disease? You'd think if anyone is going to go through clinical trials and seek FDA approval as a medical treatment, it would be as a nicotine replacement therapy rather than a treatment for PD. I'd think there would be more opportunity in the NRT arena than in PD treatment and the electric cigarette might not be the best device when put up against the current treatment methods of the patch. Smokers miss the action of smoking making the electronic version attractive to them as a cessation device, but wouldn't it be easier for a Parkinson's patient to wear a patch rather than puff on an electric cigarette?

I guess time will tell if they can get the money to even start clinical trials. It is a novel idea, but something just doesn't seem right here.

Could this be a well planned publicity stunt? Or are these two companies really serious? We shall see.