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Tuesday, May 27, 2014

E-cigarettes and the FDA: Where should we stand?

People have smoked tobacco for centuries, possibly thousands of years, and cigarettes were first machine made in France in the 1880s. In the U.S., smoking peaked in the year 1965 when 50% of men and 33% of women smoked, with a per capita consumption of more than 4,000 cigarettes per year. When health effects of smoking began to be widely publicized, particularly its association with lung cancer, cigarette smoking began to decline.

Nicotine, the psychoactive ingredient in cigarettes, is addictive, producing a withdrawal syndrome that is at least partially relieved by nicotine replacement. Cigarette smoking, though, also has cultural meaning, which has contributed to its popularity. For decades therapeutic nicotine replacement has been available to people who want to quit smoking, first only by prescription, but now over the counter since the 1990s. The first product, a nicotine chewing gum, was released in the late 1970’s, followed by a patch, a nasal spray and finally an inhaler. The inhaler delivered an aerosol of a nicotine solution from a cartridge attached to a small plastic mouthpiece which is absorbed primarily through the mucus membranes of the mouth. My patients told me that it tasted nasty and it made them look like they were sucking on a tampon. It was a great idea, but not very well executed.

It always seemed to me that what was really needed was a device that looked like a cigarette and delivered nicotine to smokers without the toxic chemicals that were associated with burning tobacco. Nicotine itself, other than being addictive, is not particularly toxic and certainly doesn’t cause lung disease, atherosclerosis, or cancer. In 2003 a Chinese pharmacist Hon Lik (per Wikipedia) invented the first electronic cigarette, which vaporized a solution of propylene glycol and nicotine for inhalation. Within a year a similar device was marketed in China for helping people quit smoking.

Other technology has subsequently been introduced, mainly based on the aerosolization of a nicotine solution by a battery powered heated coil inside a vaguely cigarette shaped device. Flavors are often added, and some e-cigarettes have only flavor and no nicotine. European tobacco companies have been enthusiastic about inventing and developing their versions of e-cigarettes, and Phillip Morris, a U.S. tobacco company, has bought the rights to a nicotine delivery device based on the aerosolization of nicotine by pyruvate, which would not require a battery or produce smoke.

Looking online, I see that I can buy an e-cigarette starter kit for about $25, and the e-juice (nicotine solution) to fill it for about $1/mL, and it looks like 1 mL yields about 120 puffs. I can also buy a pack of FDA-approved Nicorette inhalers, 20 in a pack, for about $30, and according to the package, a smoker would use 3-6 cartridges a day. Sounds like about $7.50 a day. The forums on e-cigarette use are all over the place, but it sounds like a heavy user might inhale 4 mL a day or so, a more moderate one 1 mL, so $1 to $4. Disposable ones can cost more. Cigarettes, depending on where you live, cost upwards of $5 a pack, as much as $14.50 in New York.

E-cigarettes have developed quite the following, and have their enthusiastic and stylish supporters. Using an e-cigarette, or cartomizer, is called “vaping” and some people are excited not just about the nicotine, but also about the devices and flavors and overall coolness of the technology. Poisoning has been reported, primarily due to young children drinking the replacement solution. There is no significant evidence of toxicity related to using the devices as recommended. The Food and Drug Administration (FDA) does not presently regulate e-cigarettes, but recently announced a plan to categorize them as a tobacco product, requiring producers to register and to share with the FDA details about how they are made and what they contain. They also would not allow free samples or purchase by anyone under the age of 18. Manufacturers would not be able to say, without proof, that e-cigarettes are safer than cigarettes and would have to say that nicotine is addictive. These proposals are still being discussed it is not clear when or if they will be adopted.

Which brings up a very important point. We don’t actually know if e-cigarettes are safe or if they help people quit smoking. It seems likely that if there is a cheaper alternative to cigarettes that gives a person the same nicotine high, tastes like pomegranate (or strawberry or whatever) rather than burning leaves, can be used in public places and costs a fraction of what cigarettes do, people will tend to prefer it. But we don’t know this. It seems likely that a product that contains nicotine rather than burning leaves with associated carbon monoxide and carcinogens will cause less health problems, but we also don’t know this.

There are so many competing e-cigarette producers that none is likely to come up with the money to support research that would be convincing of the safety and effectiveness of the whole class of products, including those made by their competitors. Some small studies are mostly encouraging. Compared to cigarette smoke extracts, the extracts of e-cigarettes are much less toxic to mouse fibroblast cells. Air quality was not significantly affected by e-cigarette use for the compounds tested, including glycols (which would be expected to be found in e-cigarette smoke) along with other standard pollutants found in high levels when cigarette smoking is present. About 400 e-cigarette users were followed for a year, to look at use of both e-cigarettes and tobacco cigarettes. E-cigarette use was about stable over the year, and for former smokers there was a 6% relapse rate to tobacco, whereas about 46% of subjects who smoked tobacco as well as e-cigarettes completely ceased using tobacco at the end of a year. One study of smokers and nonsmokers showed no significant reduction in lung function acutely after using e-cigarettes briefly, but another slightly larger study of smokers only showed a restriction of airflow in smokers after using e-cigarettes for 5 minutes. No studies have addressed long term lung effects of regular use of e-cigarettes, and this information is much more relevant.

So where should we, as physicians, stand on the subject of e-cigarettes? First and foremost, not on the side of ignorance. I hear many physicians speak out for or against e-cigarettes without knowing anything about them. My own hospital banned them, as have many other hospitals, based on not very much real information. Countries around the world ban them or regulate them or ignore them completely, based primarily on opinion. They are legal in Germany. They are regulated as a medicinal product in Denmark. They are illegal with a heavy fine in Hong Kong, but legal in China. In Hungary it is legal to buy them and use them but it is illegal to sell the nicotine solution.

I tend to think that e-cigarettes are a good invention. I suspect that if they came out several decades ago our smoking related morbidity would be much lower. They have the potential to come pretty close to eliminating tobacco smoking, much more effectively than regulation and physician nagging has done. They will not reduce nicotine addiction and have the potential to increase it, but it is not clear that nicotine addiction is a public health problem. Clearly good research is important, and it is likely that convincing evidence of safety will not be available for years, and will have difficulty finding funding. Phillip Morris probably will be first to show their product to be safe, if it is, but it will be in their best interest to make sure that data is not generalizable to other e-cigarettes.

The FDA is right to regulate the e-cigarette industry and to require that the manufacturers be honest about what is in them, since there are quite a number of chemicals that make people sick when they are aerosolized and inhaled. Even if e-cigarettes aren’t exactly food or drug or tobacco product, they are somewhere in between all of these things and their popularity gives them tremendous potential to do harm if nobody is watching. Even so, creating excessive burdens that interfere with their ability to successfully undermine the tobacco industry (about which there is truly nothing good to say) would be an error.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.

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Blog log

Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:

Albert Fuchs, MD
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.

And Thus, It Begins
Amanda Xi, ACP Medical Student Member, is a first-year medical student at the OUWB School of Medicine, charter class of 2015, in Rochester, Mich., from which she which chronicles her journey through medical training from day 1 of medical school.

Auscultation
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.

Controversies in Hospital Infection Prevention
Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).

db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.

Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care.

DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.

Everything Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.

FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.

I'm dok
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.

Informatics Professor
William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.

David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.

KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.

MD Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology, and as a patient who's had breast cancer.

Mired in MedEd
Alexander M. Djuricich, MD, FACP, is the Associate Dean for Continuing Medical Education (CME), and a Program Director in Medicine-Pediatrics at the Indiana University School of Medicine in Indianapolis, where he blogs about medical education.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice internist, returns with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind).

Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a small community hospital in Connecticut. His blog is a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Reflections of a Grady Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being a doctor in a community hospital in Atlanta.

The Blog of Paul Sufka
Paul Sufka, MD, ACP Member, is a board certified rheumatologist in St. Paul, Minn. He was a chief resident in internal medicine with the University of Minnesota and then completed his fellowship training in rheumatology in June 2011 at the University of Minnesota Department of Rheumatology. His interests include the use of technology in medicine.

Technology in (Medical) Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management.

Peter A. Lipson, MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. The blog, which has been around in various forms since 2007, offers musings on the intersection of science, medicine, and culture.

Why is American Health Care So Expensive?
Janice Boughton, MD, FACP, practiced internal medicine for 20 years before adopting a career in hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling.

World's Best Site
Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington.

Other blogs of note:

American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

Clinical Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

PLoS Blog
The Public Library of Science's open access materials include a blog.

White Coat Rants
One of the most popular anonymous blogs written by an emergency room physician.

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