(Reuters) When Noah Minskoff’s mother died of lung cancer in 2007, e cigarettes were just entering the U.S. market. Minskoff, who had just started medical school in Utah, wondered whether the devices might have saved his mother’s life by helping her quit smoking. Later, he sent some samples to his boyhood friend Nathan Terry, a mechanical engineer, and asked for his opinion.

Terry, who was working in Germany for the French industrial firm Areva, took apart the products to see how they were made. What he found disturbed him at the heart of the devices were heater wires of unknown quality wrapped around bundles of glass fibers and surrounded by steel wool, silicon, plastic, tape and adhesives.

Wires between the heater, circuit board and batteries were connected with lead solder and also housed in tape and plastic. Everything was close to the heat source, meaning consumers were at risk of inhaling fiber and metal particles as well as toxic fumes from hot plastic and lead.

“There were red flags everywhere,” Terry said.

Still, he liked the concept and decided to design a version of his own, avoiding the use of fiberglass, plastic and solder and sourcing his materials entirely in the United States. In 2009 he reunited with Minskoff in California and formed a company, Thermo Essence Technologies, to sell the product.

At $300 a piece, the e cigarette serves a niche market, albeit one with a loyal following among medical marijuana patients and smokers looking for a high end e cigarette. As many as 30,000 have been sold.

But what began as a quest to develop a better e smoke has broadened into an ambitious effort to design a new medical device an inhaler that delivers measured doses of nicotine to help people quit smoking. The technology could also eventually be used as an abuse resistant delivery device for other drugs, including opioid painkillers.

If successful, the inhaler could become the first new smoking cessation product to emerge from the e cigarette field and would compete with products such as GlaxoSmithKline Plc’s nicotine gum and Pfizer Inc’s antismoking drug, Chantix.


To develop the inhaler, Terry formed a second company, Minusa LLC, which is based in Newtown, Connecticut. Minskoff left Thermo Essence for family reasons and is not involved in Minusa. Terry himself is leaving Thermo Essence, which is currently being sold, to concentrate on Minusa.

The new company obtained initial funding from Michael Breede, a commercial real estate turned biotech investor whose father suffered from drug and alcohol addiction and who is eager to see an abuse resistant painkiller device.

“This is in my wheelhouse,” he said. “I think we can put a serious dent in this problem.”

When Terry developed his e cigarette he assumed the U.S. Food and Drug Administration would begin regulating the industry, as it has recently done, proposing a ban on sales to people under the age of 18 and requiring companies to register. Later it could impose product standard and quality controls.

Terry wanted to create a product that would pass any FDA inspection. He used a pure metal wire wrapped around a rod made from magnesia stabilized zirconia, a highly durable ceramic material. Instead of meshes, tape and plastic he used novel porous ceramics and surgical grade alloys, and instead of soldering parts together he connected them mechanically, fitting components together like Legos to complete the circuits.

He built on that design to create his drug delivery device, known as Envi, a single user, tamper resistant, metered dose inhaler.

Envi is about the size of a short cigar and comes with a spare in a case the size of a deck of playing cards.

The nicotine or other drug will come in a sealed cartridge that the patient will insert into the inhaler. To activate the device, the user will have to enter a code. The inhaler will be programed to deliver a certain amount of drug and then turn off.

When the device is returned to the case, which is required after each dose to activate it for the next dose, data on the patient’s usage will be downloaded and available to be viewed electronically by the prescribing physician.

“It will only let you take your prescription,” Terry said. “It will log your usage and transmit it in real time, and make it easier for the doctor to monitor and interact with the patient.”


Terry, 37, who grew up on an organic farm in Ohio to “hippy commune” parents and studied mechanical engineering at the University of Idaho, faces multiple challenges.

Inhalers are typically more expensive to develop than pills, and ensuring patients get the right dose is more complicated.

“I can see a lot of barriers, but the idea is certainly interesting,” said Dr. Ben Forbes, a Reader in Pharmaceutics, broadly the equivalent of a U.S. professor, at King’s College London who specializes in inhaled medications.

There needs to be a good reason to target a drug to the lungs, Forbes said. Drugs that are inhaled may work faster than pills, so a device that offered quick pain relief in an abuse resistant form would be “brilliant” if it could be produced economically, he added.

“Changes in inhaler technology have been very incremental over the years, so maybe something like this would have a place.”

In the meantime, big tobacco companies are developing alternative nicotine products they hope one day will carry a “modified risk” of harm. Some are dispensed through an inhaler.

Unlike Terry’s smoking cessation device, which he plans to file with the FDA’s drug division, these products would be marketed as less risky alternatives to smoking and be processed through the FDA’s tobacco division.

However smokers end up using the new products will be the subject of intense research by the FDA.

Terry believes he is creating a product that will survive any market configuration. Minusa has a long way to go, and human trials may be two years off. Eventually he hopes to partner with a big drug company.

“I think we can change how drugs are delivered.”

(Reporting by Toni Clarke in Washington Editing by Michele Gershberg and Prudence Crowther)

What’s so bad about e-cigarettes? – nbc news

Bbc news e-cigarettes and the vape debate

FDA regulation would require the companies to tell the agency, but not necessarily the public, what s in their products. FDA is sensitive to protecting competitive secrets.

The FDA is also asking for research on potential harms from inhaling the heated mixture. It might not be as harmful as burning tobacco leaves, but it might not be completely benign, either, says Dr. John Spangler, who runs a smoking cessation clinic at Wake Forest Baptist Medical Center in North Carolina.

It is true that electronic cigarettes are safer than regular cigarettes. On the other hand there are some effects in the lung of the vapors which mimic the same kind of changes that go along with asthma, Spangler told NBC News.

That happens within 5 minutes of using an electronic cigarette. We don t know how long that will last or whether it will lead to permanent lung damage.

Vaping enthusiasts will argue that using the products allows them to skip regular tobacco cigarettes, whose harms are well documented. If that s the case, many health advocates say they are all for them. But there s not much research to say whether that s true.

Spangler s been studying this and doesn t have final data yet. But in general, e cigarettes appear slightly less effective than nicotine gum or patches or drugs such as Chantix, he says.

I do have about 20 percent of my smoking patients in my clinic who are using electronic cigarettes, he said. Of the patients who use them, about 10 percent of them actually quit smoking using electronic cigarettes.

“Most consumers would be shocked to realize the products they buy have less oversight than a bag of dog food.”

And experts argue that if e cigarette makers wanted their products used as quit smoking aids, they d have submitted them to the FDA as such. Instead, manufacturers fought FDA s attempts to regulate them in that way, and won in federal appeals court.

Either way, people who use them should want them regulated, says pulmonologist Dr. Nathan Cobb of Georgetown University School of Medicine.

Electronic cigarettes may represent the next evolution of nicotine replacement, supplanting the gum, patch and the existing inhaler. However, most consumers would be shocked to realize the products they buy have less oversight than a bag of dog food, and are often manufactured and imported from countries that have histories of tainted pharmaceutical and food products, Cobb added.

The fear is that smokers will use e cigarettes as a bridge that gets them through the day in a society that increasingly restricts cigarettes. And the even bigger fear is that e cigarettes will appeal to children, who will get addicted to nicotine.

Kids should not be initiating even an e cigarette that contains no burning tobacco leaves because of the effect that nicotine can have on the developing brain, Zeller says. Several studies suggest nicotine might slow the growth of the adolescent brain.

The Centers for Disease Control and Prevention and FDA say 10 percent of high school students have tried vaping, with numbers rising steadily. More than 21 percent of adults have tried vaping at least once.

The e cigarette industry itself welcomes the FDA s proposal. We have no problem divulging our ingredients, says Miguel Martin, president of e cigarette maker Logic. Martin and other makers also say they support restricting sales to people 18 or older.

“FDA has worked over three years to meet the regulatory challenges presented by this very new and technology driven industry, while preserving and supporting the enormous potential for harm reduction it offers. We share that goal,” added the Smoke Free Alternatives Trade Association.

You should always be suspicious when the tobacco industry applauds something.”

Public health advocates say even that worries them. You should always be suspicious when the tobacco industry applauds something, says Tom Glynn, senior director of cancer science and trends for the American Cancer Society.

Glynn and others remember that the tobacco industry first told Americans that cigarettes were healthful, and then battled the U.S. government in court for decades when the Surgeon General declared that smoking caused cancer. It took decades to prove that tobacco companies colluded to make cigarettes ever more addictive and to cover up research showing tobacco caused not only cancer, but heart disease, stroke, emphysema and other diseases.

They also point to industry attempts to market light cigarettes as less dangerous research shows they are not and companies have pushed menthol cigarettes despite evidence that menthol worsens the health effects.

Like cigarette companies, e cigarette makers claim they don’t market to kids. But they’re using the same themes and tactics tobacco companies have long used to market regular cigarettes to kids, says Matthew Myers, president of the Campaign for Tobacco Free Kids.

And nicotine itself may not be so harmless. The concentrated nicotine juice used in vaping can poison people, and Spangler says nicotine build up in vaping salons could be dangerous, also.

We don t know what will happen to nicotine that settles into the environment, he said.