Month: December 2020

Lately it seems like everywhere I look, someone is vaping as they walk by, stand outside a store, or roll up in the car next to me at a stoplight. It’s not surprising: e-cigarette use, or vaping, has become remarkably popular in recent years. About 6% of adults in the US now report vaping. That’s about 15 million people, double the number from just three years ago. Of course, regular cigarettes are known to cause cancer and a host of other health problems.

While considered less harmful than smoking tobacco, vaping isn’t risk-free. We know some, but not all, of its risks. We also know vaping is increasingly popular among teens and young adults, and this makes the recent FDA announcement authorizing sales of three additional vaping products surprising.

A surprise announcement from the FDA

In its announcement, the FDA authorized the R. J. Reynolds Vapor Company to market and sell its Vuse Solo device with tobacco-flavored vaping liquid to adults.

The FDA denied marketing authorization for 10 flavored products made by the same company. It also reports having denied more than a million flavored vaping products from other companies.

By the way, the agency emphasizes it is not actually approving these vaping products, or declaring them safe. The announcement states that marketing authorization will be reversed if

• the company directs advertising to younger audiences
• there is evidence of “significant” new use by teens or by people who did not previously smoke cigarettes
• R. J. Reynolds does not comply with extensive monitoring requirements.

Why did the FDA take this action?

The decision was reportedly based on data from the company — unfortunately not provided in the press release — demonstrating these products would benefit individuals and public health. How? By helping smokers quit.

Some studies have suggested that e-cigarette use can be modestly helpful for smokers trying to quit. For example, an analysis of 61 studies found that e-cigarette use was more effective than other approaches to quitting smoking. The study authors estimated that out of every 100 people who tried to quit smoking by vaping, nine to 14 might be successful. When only using other methods, such as nicotine patches or behavioral counselling, only four to seven smokers out of 100 might quit. A separate study suggests vaping may help smokers who aren’t able to quit reduce the number of cigarettes smoked per day — at least for six months, the duration of the study.

Does vaping harm health less than smoking cigarettes?

Despite claims that vaping is less harmful than smoking cigarettes and that it might help smokers quit, concern about its risks is well deserved.

• Nicotine addiction. Whether in cigarettes or vapes, nicotine is highly addictive. And the amount of nicotine in many vaping products is much higher than in regular cigarettes. Side effects include reduced appetite, increased heart rate and blood pressure, nausea, and diarrhea.
• Harm to lungs and heart. Vapors from e-cigarettes may contain cancer-causing toxins, metals, and lung irritants. Vaping raises risk for lung diseases, such as emphysema, asthma, chronic bronchitis, and chronic obstructive pulmonary disease. It’s also linked to an increased risk of heart attacks. Even secondhand exposure to e-cigarette vapors may trigger asthma.
• Severe, potentially fatal lung injury. In 2019, doctors began seeing people who had recently vaped and developed shortness of breath, cough, fever, and extensive lung damage. Dubbed EVALI (e-cigarette or vaping product use-associated lung injury), more than 2,800 cases and 68 deaths were reported. The condition has been linked to vapors containing THC and a form of vitamin E (called vitamin E acetate) used as a thickening agent when vaping THC. Cases have fallen markedly since 2020. Possibly because of falling case numbers, the FDA announcement of new vaping products didn’t even mention EVALI, which seems odd. If you do vape, see these recommendations to reduce the risk of EVALI.
• Health risks during pregnancy. Nicotine can damage a baby’s developing brain and lungs; some flavorings may be harmful as well. As a result, experts recommend that people who are pregnant not vape.

For teens and children, vaping has additional risks

An alarming number of middle-school and high-school age kids report vaping, despite the nationwide prohibition against selling e-cigarette products to anyone under age 18 (21 in some states). Its popularity is partly related to the marketing of flavors known to appeal to minors, such as bubblegum and berry-flavored products. According to one national survey, approximately 85% of teen vaping involved non-tobacco flavored products.

It’s important to know that

• nicotine negatively affects the developing brain
• the high exposure to nicotine and other toxic chemicals through vaping may be particularly harmful to kids because of their smaller body size
• the addictive potential of nicotine may mean that kids who vape are more likely to become cigarette smokers.

The bottom line

For nonsmokers and teens, there is no controversy: don’t start smoking and don’t vape.

If you’re an adult smoker trying to quit, be aware that the balance of risks and benefits and the long-term health consequences of vaping are uncertain. We need more solid research to help people make decisions. Meanwhile, the FDA has come down on the side of a limited authorization to help adult smokers quit. We’ll know only in retrospect if that was the right move.

If a screening test for prostate cancer produces an abnormal result, the next step is typically a biopsy. In the United States, this is almost always done by threading a biopsy needle into the prostate through the rectum. By watching on an ultrasound machine, doctors can see where the needle is going. Called a transrectal ultrasound (TRUS) biopsy, this procedure comes with a small but growing risk of infections that are in turn increasingly resistant to current antibiotics.

To minimize infection risk, doctors can also thread the biopsy needle through a patch of skin between the anus and scrotum called the perineum, thus bypassing rectal bacteria. These so-called transperineal (TP) biopsies offer a further advantage in that they provide better access to the tip (or apex) of the prostate, which is where 30% of cancers occur. However, they are also more painful for the patient. Until recently, they were done only in hospital operating rooms under general anesthesia.

Today, technical advances are making it possible for doctors to perform TP biopsies under local anesthesia in their own offices. And with this development, pressure to limit infections by adopting this approach is growing.

During a recent study, Harvard scientists looked at how the two methods compare in terms of cancer detection and complication rates. In all, 260 men were included in the study, each closely matched in terms of age, race, prostate-specific antigen levels, and other diagnostic findings. Half the men got TRUS biopsies and the other half got TP biopsies, and all the procedures were performed at a single medical practice between 2014 and 2020. Per standard clinical protocols, all the men in the TRUS group took prophylactic antibiotics to prepare. By contrast, just 43% of men in the TP group took antibiotics, in accordance with physician preferences.

Results showed minimal differences in the cancer detection rate, which was 62% in the TP group and 74% among men who got TRUS biopsies. But importantly, 15% of men with cancer in the TP group had apex tumors that the TRUS biopsies "may have missed," the study authors wrote.

More complications with the TP approach

As far as complications go, one man in the TRUS group developed an infection that was treated with multiple rounds of oral antibiotics. None of the TP-biopsied men got an infection, but eight of them had other complications: one had urinary blood clots that were treated in the hospital, two were catheterized for acute urinary retention, three were medically evaluated for dizziness, and two had temporary swelling of the scrotum.

Why were the TP noninfectious complication rates higher? That's not entirely clear. For various reasons, doctors wound up taking more prostate samples (called cores) on average from men in the TP group than they did from men in the TRUS group. The authors suggest if an equivalent number of cores had been taken from men in either group, then the complication rates might have been more similar. (In fact, larger comparative studies performed in hospital-based settings show no difference in complication rates when equal numbers of cores are obtained). But doctors in the current study also had more experience with TRUS biopsies, and that might also explain the discrepancy, the authors suggest. And as doctors in general become experienced with the TP method, complication rates might fall.

In an editorial comment, Dr. Marc Garnick, the Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, editor of the Harvard Health Publishing Annual Report on Prostate Diseases, and editor in chief of HarvardProstateKnowledge.org, acknowledged positive findings from the study, particularly a reduced need for antibiotics with the TP method, and the discovery of apex tumors TRUS biopsies could have missed. Garnick also highlighted a "steep learning curve" with TP biopsies, and how some of the noninfectious complications required hospital-based care. "The ability to perform TP biopsies in an office setting should enable future comparisons with TRUS to help answer whether this new TP technology has enduring value," he wrote.