Month: November 2021

Psoriasis is a chronic disease in which skin cells rapidly divide, causing the skin to develop rough, red, scaly patches. Plaque psoriasis is the most common form: affected skin has sharply defined, inflamed patches (plaques) with silvery or white scales, often near an elbow or on the shins and trunk.

The cause of psoriasis isn’t known, but there are a number of treatment options. Possibly you’ve seen a glossy, happy ad for one of these treatments, a drug called Skyrizi. It’s been in heavy rotation and in 2020, hit number four on a top 10 list for ad spending by a drug company.

Splashing in blue water

A woman in a bathing suit sprints down a dock and jumps into the water with several friends. There’s lots of smiling and splashing. A voiceover says "I have moderate to severe plaque psoriasis. Now, there’s Skyrizi. Three out of four people achieved 90% clearer skin at four months after just two doses."

Then, the voiceover moves to warning mode: "Skyrizi may increase your risk of infections and lower your ability to fight them. Before treatment your doctor should check you for infections and tuberculosis. Tell your doctor if you have an infection or symptoms such as fever, sweats, chills, muscle aches, or cough, or if you plan to or recently received a vaccine."

As these warnings are delivered, we’re treated to uplifting pop music — "nothing is everything," a woman sings — while attractive young people flail about in the water.

"Ask your doctor about Skyrizi," a voice instructs. Did I mention a plane is skywriting the drug’s logo? I guess it’s putting the "sky" in Skyrizi.

What is Skyrizi?

Skyrizi (risankizumab) is an injectable medication that counteracts interleukin-23, a chemical messenger closely involved in the development of psoriasis. The standard dosing is two injections to start, followed a month later by two injections once a month, and then two injections once every three months.

Did you catch that "injectable" part? This is not a pill. If you missed that point while watching the commercial, it’s not your fault. The word "injection" appears once, written in faint letters at the very end of the commercial.

By the way, the FDA has only approved this drug for moderate to severe — not mild — plaque psoriasis. The studies earning approval enrolled people with psoriasis on at least 10% of their skin and two separate measures of severity.

What the ad gets right

• The ad states that 75% of people with moderate to severe psoriasis experienced 90% clearance of their rash within four months after only two doses of Skyrizi. This reflects the findings of research studies (such as this one) that led to the drug’s approval.
• The recommendations regarding screening for infections (including tuberculosis) and telling your doctor if you’ve gotten a recent vaccine are appropriate and should be standard practice. By lowering the ability to fight infection, this drug can make current infections worse. It may reduce the benefit of certain vaccines, or increase the risk of infection when a person gets a certain type of vaccine called a live-attenuated vaccine.

And the theme song? People with visible psoriasis often cover up their skin due to embarrassment or stigma. The rash isn’t a contagious infection or a reflection of poor health, but other people may react as if it is. So, an effective treatment could potentially allow some to forego covering up and show more skin: it means "everything" to someone suffering with psoriasis to cover "nothing." Thus, a theme song is born.

What else do you need to know?

A few things about this ad may be confusing or incomplete, including:

• Currently, each dose of Skyrizi is actually two injections. So, a more accurate way to summarize its effectiveness would be to say that improvement occurred within four months after four injections (rather than "just two doses").
• Like most newer injectable medications, this one is quite expensive: a year's supply could cost nearly $70,000. The drug maker offers a patient assistance program for people with low income or limited health insurance, but not everyone qualifies. Health insurance plans generally require justification from your doctor for medications like Skyrizi, and your insurer may decide not to cover it. Even if covered, this prior approval process can delay starting the medication, which may still be expensive due to copays and/or deductibles.
• There is no mention of the many other options to treat psoriasis, some of which are far less costly. These include medications that do not have to be injected (such as oral methotrexate or apremilast), and UV light therapy (phototherapy). And there are other injectable medications. So, ask your doctor about the best options for you.

The bottom line

Some people appreciate the information provided by medication ads. Others favor a ban on such advertising, as is the case in most other countries. And recently, two advocacy groups asked the FDA not to allow drug ads to play music when the risks of drug side effects are presented, arguing that it distracts consumers from focusing on this important information.

Since these ads probably are not going away anytime soon, keep in mind that they may spin information in a positive light and leave out other important information altogether. So, be skeptical and ask questions. Get your medication information from your doctor or another unbiased, authoritative source, not a company selling a product.

Regardless of how you feel about medical advertising, it’s hard to hate the Skyrizi theme song. Feel free to sing along.

Vaccination against the virus that causes COVID-19 is the most important lifesaving tool we have in this pandemic. Fortunately, the vaccines authorized in the US have proven remarkably safe and effective. And we’ve known from the start that the strong protection they provide would likely wane over time.

But has protection declined enough to warrant booster shots? Studies published in the last few months by researchers in the UK, Israel, and the US (reviewed here and here) raised this possibility, and Israel and the UK have already started ambitious booster programs.

First things first: Vaccinate everyone

In the US, the CDC and FDA have reviewed the necessity, safety, and effectiveness of boosters for the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines. I’ll discuss these recommendations in a moment.

But first, it’s important not to overlook this fact: vaccinating the unvaccinated should be a much bigger priority than giving booster shots to those who’ve received vaccines. That goes for people in the US who have been unable or unwilling to get the vaccine, and people in places throughout the world with limited access to vaccines.

Broadening the pool of people with initial vaccinations would not only save more lives than promoting boosters, but would also reduce COVID-related healthcare disparities between richer and poorer countries. That’s why the World Health Organization (WHO) called for a moratorium on booster doses. Meanwhile, the Biden administration has announced a promise to donate another half billion vaccines to countries with low vaccination rates, bringing the total US commitment to donate 1.1 billion doses. The administration emphasizes that starting a booster program in the US and helping other countries get their citizens vaccinated are not mutually exclusive.

Is there a difference between a booster dose and a third shot?

It’s not trick wording: not all extra vaccine doses are boosters. In August 2021, the FDA approved a third dose of the Pfizer or Moderna vaccine for people who are immunocompromised. This includes people who have HIV and those receiving treatment for cancer that suppresses the immune system. For them, the extra dose is not a booster; it’s considered part of their initial immunization series.

Getting the timing and dose right on vaccine boosters

Ideally, vaccine boosters are given no sooner than necessary, but well before widespread protective immunity declines. The risks of waiting too long are obvious: as immunity wanes, the rates of infection, serious illness, and death may begin to rise.

But there are downsides to providing boosters too early:

• Side effects might be more common. While studies published to date suggest that boosters are safe, we don’t yet have long-term data.
• The benefit may be small. It may be better to wait on boosters if most people are still well-protected by their initial vaccinations.
• Current boosters may not cover future variants. If new variants of concern emerge in the coming months, boosters may be modified to cover them.
• Waiting longer before a booster might lead to a stronger immune response. As noted by Dr. Anthony Fauci recently: “If you allow the immune response to mature over a period of a few months, you get much more of a bang out of the shot.”

The recommended dose for the Pfizer/BioNTech booster and Johnson & Johnson booster is the same as the initial dose. For the Moderna booster it’s a half-dose, which may reduce the risk of side effects and increase the number of doses available to others.

Recommendations for vaccine boosters

In the US, adults 18 or older who have had a COVID vaccine are eligible for a booster shot.

• If you had the Pfizer/BioNTech or Moderna vaccine The FDA and CDC have authorized Pfizer/BioNTech and Moderna boosters for all adults 18 or older at least 6 months after the initial series. According to the CDC, people 50 or older, or adults 18 or older who live in long-term care facilities should get boosters. Other adults 18 or older may decide whether to have a booster.   
• If you had the Johnson & Johnson vaccine A booster dose of the Johnson & Johnson vaccine has also been authorized for all adults 18 or older two or more months after the first dose.

Mixing or matching booster shots

The FDA and the CDC have concluded that mixing or matching vaccines when getting a booster dose is safe and effective. Regardless of the initial vaccine you received, any of the three available vaccines may be given as a booster.

Plenty of unknowns

The release of these new recommendations for vaccine boosters raises a number of questions:

• How convincing is the safety data? Reports to date suggest boosters are safe, but we need more research and real-world data.
• Will the boosters be modified to protect against emerging variants of concern?
• Will additional boosters be needed in the future? If so, how often?

There are important gaps in our knowledge of how well vaccine boosters work. We need larger and longer-term studies involving a broad range of participants representing all races and ethnicities and people with compromised immune systems. Look for further information in coming months.

What’s next?

You can expect the FDA and CDC to continue to expand recommendations for boosters based on review and analysis of ongoing research. Guidelines for teens and kids under age 18 will be particularly important. In the meantime, we should redouble our efforts to vaccinate people who haven’t yet received vaccines. Boosters can play an important role in protecting individuals. But, as CDC director Dr. Rochelle Wallensky notes, “we will not boost our way out of this pandemic.”

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.