Month: June 2023

In June, the FDA approved a new treatment for the most advanced type of prostate cancer. Patients who have this condition, which is called metastatic castration-resistant prostate cancer (mCRPC), have few therapeutic options, so the approval helps to fill an urgent need.

mCRPC sets in when the front-line hormonal therapies that doctors use first for treating metastatic prostate cancer stop working. These drugs limit the body’s production of testosterone, a hormone that fuels prostate cancer growth. If they are no longer effective, then doctors switch to a different class of drugs known as anti-androgens that further inhibit testosterone by blocking its cell receptor. One of those drugs is called enzalutamide.

The newly approved treatment combines enzalutamide with a second drug, talazoparib, that was already on the market for female cancer patients who test positive for BRCA mutations. These inherited gene defects boost risks for breast and ovarian cancer, but they can also elevate risks for prostate cancer in men. Indeed, an estimated 10% of men with metastatic prostate cancer are BRCA-positive.

Talazoparib inhibits a DNA-repair system called PARP that the tumor cells need to keep their own genes in working order. When PARP is blocked by treatment, the cancer cells will eventually die. Other PARP inhibitors, including olaparib and rucaparib, are already approved for advanced prostate cancer in BRCA-positive men.

During research leading to this latest approval, 399 men with mCRPC were randomly divided into two groups. One group received talazoparib plus enzalutamide; the other group was treated with enzalutamide plus placebo. The men averaged 70 years in age, and most of them had already been treated with chemotherapy and/or a different anti-androgen called abiraterone. All the men were positive for either BRCA mutations or defects affecting other DNA-repair genes.

What the study showed

Results from the still-unpublished study were presented at the 2023 American Society of Oncology Annual Meeting in June. After a median follow-up of roughly 17 months, the enzalutamide/talazoparib combination reduced the risk of death or visible signs of tumor progression by 55%.

Among the specific subgroup of BRCA-positive patients, “there was an 80% reduction in risk progression or death, which is enormous for these men and obviously very welcome,” said lead researcher Dr. Karim Fizazi, a professor at the University of Paris-Saclay in France.

Scientists had hoped that combining PARP inhibitors with anti-androgens would similarly benefit prostate cancer patients with no DNA-repair defects, but evidence from a different study by Dr. Fizazi and his colleagues shows they do not.

For that reason, the FDA approved the new combination only for mCRPC patients who test positive for mutations affecting DNA-repair genes. Dr. Fizazi and his colleagues are continuing to monitor the enrolled patients for improvements in other areas, such as overall survival, quality of life, and subsequent need for chemotherapy.

Dr. David Einstein, an assistant professor of medicine at Harvard Medical School and a medical oncologist at Beth Israel Deaconess Medical Center in Boston, says the evidence helps to confirm that PARP inhibitors have a role to play in genetically-selected men with mCRPC. Additional research is needed to assess if the observed benefits are “specific to the combination or just because access to PARP inhibition was provided at some point in the disease course,” he says.

“Genetic testing for BRCA, which originally targeted females, is now becoming mainstream for men with a family history of breast and ovarian cancers, as well as men with mCRPC regardless of family history,” says Dr. Marc B. Garnick, the Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center. “This is important, as it has implications for other family members and treatment choices alike. Also important to note is that where this study enrolled men who had already been treated with chemotherapy and/or abiraterone, future research will likely move the enzalutamide/talazoparib combination — or components of it — to earlier disease stages.”

About the Author

Charlie Schmidt, Editor, Harvard Medical School Annual Report on Prostate Diseases

Charlie Schmidt is an award-winning freelance science writer based in Portland, Maine. In addition to writing for Harvard Health Publishing, Charlie has written for Science magazine, the Journal of the National Cancer Institute, Environmental Health Perspectives, … See Full Bio View all posts by Charlie Schmidt

About the Reviewer

Marc B. Garnick, MD, Editor in Chief, Harvard Medical School Annual Report on Prostate Diseases; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Marc B. Garnick is an internationally renowned expert in medical oncology and urologic cancer. A clinical professor of medicine at Harvard Medical School, he also maintains an active clinical practice at Beth Israel Deaconess Medical … See Full Bio View all posts by Marc B. Garnick, MD

I admit it: I’m not a fan of drug ads. I think the information provided is often confusing and rarely well-balanced. Plus, there are just so many ads. They show up on TV and streaming programs, on social media, on billboards and the sides of busses, on tote bags, and in public bathrooms. Yes, there’s no refuge — even there — from the billions spent on direct-to-consumer ads in the US.

I’ve often wondered how highly-promoted, expensive new drugs stack up against other available treatments. Now a new study in JAMA Network Open considers exactly that.

Many advertised drugs are no better than older drugs

The study assessed 73 of the most heavily advertised drugs in the US between 2015 and 2021. Each drug had been rated by at least one independent health agency. Researchers tallied how many of these drugs received a high therapeutic value rating, indicating that a drug had at least a moderate advantage compared with previously available treatments.

The results? Only about one in four of these heavily advertised drugs had high therapeutic value. During the six years of the study, pharmaceutical companies spent an estimated $15.9 billion promoting drugs on TV that showed no major advantage over less costly drugs!

Why drug ads are not popular

Only the US and New Zealand allow direct-to-consumer medication marketing. The American Medical Association recommended a ban in 2015. While I’ve often written about reasons to be skeptical, let’s focus here on three potential harms to your wallet and your health.

Drug ads may

• raise already astronomical health care costs by increasing requests for unnecessary treatment and promoting much costlier medicines than older or generic drugs.
• create diseases to be treated. Everyday experiences, such as fatigue or occasional dryness in the eyes, may be framed in drug ads as medical conditions warranting immediate treatment. Yet often, such symptoms are minor, temporary experiences. Another example is “low T” (referring to low blood testosterone). While it’s not a recognized illness on its own, ads for it have likely contributed to increased prescriptions for testosterone-containing medicines.
• promote new drugs before enough is known about long-term safety. The pain reliever rofecoxib (Vioxx) is one example. This anti-inflammatory medicine was supposed to be safer than older medicines. It was withdrawn from the market when evidence emerged that it might increase the risk of heart attack and stroke.

Four questions to ask your doctor if you’re curious about a drug ad

Wondering whether you should be taking an advertised drug? Ask your doctor:

• Do I have a condition for which this drug is recommended?
• Is there any reason to expect this drug will be more helpful than what I’m already taking?
• Is this drug more expensive than my current treatment?
• Do my health conditions or the medications I already take make the drug in the ad a poor choice for me?

The bottom line

The AMA recommended banning drug ads nearly a decade ago. But a drug ad ban seems unlikely, given strong lobbying by the pharmaceutical companies and concerns about violating their freedom of speech.

Still, cigarette commercials were banned in 1971, so it’s not an impossible dream. Meanwhile, my advice is to be skeptical about information in drug ads, and rely on more reliable sources of medical information, including your doctor. Consider contacting the Federal Communications Commission if you have complaints about these ads — a step few Americans seem to take. And try this: mute the TV, fast-forward your podcast, and close pop-ups as soon as drug ads appear.

About the Author

Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Robert H. Shmerling is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center (BIDMC), and is a current member of the corresponding faculty in medicine at Harvard Medical School. … See Full Bio View all posts by Robert H. Shmerling, MD

Editor’s note: in honor of Pride Month, we’re re-publishing a 2019 post by Dr. Cecil Webster.

Generally speaking, discussing what happens in our bedrooms outside of the bedroom can be anxiety-provoking. Let’s try to make your doctor’s office an exception. Why is this important? People in the LGBTQ+ community contend not only with a full range of health needs, but also with environments that may lead to unique mental and physical health challenges. Whether or not you have come out in general, doing so with your doctor may prove critical in managing your health. Sexual experiences, with their impact on identity, varied emotional significance, and disease risk, are a keystone for helping your doctor understand how to personalize your healthcare.

Admittedly, talking about your intimate sexual experiences or your gender identity may feel uncomfortable. Many LGBTQ+ patients worry that their clinicians may not be knowledgeable about their needs, or that they’ll to have to educate them. Finding a LGBTQ+ adept doctor, preparing ahead of time for your next appointment, and courageously asking tough questions can give you and your health the best shot.

Finding a skilled clinician who is LGBTQ+ adept

Many large cities have healthcare institutions whose mission centers on care for LGBTQ+ peoples. However, these organizations may prove inaccessible to many for a variety of reasons. Regardless of your location, asking friends, family, or others to recommend a clinician may be a game changer. If your trans friend had a relatively painless experience visiting an area gynecologist, perhaps your Pap smear may go smoothly there as well. If your coworker has a psychiatrist who regularly asks him about his Grindr use, perhaps it may be easier to navigate your gay relationship questions with her.

Word of mouth is often an undervalued method of finding someone skilled and attentive to the needs of LGBTQ+ individuals. Online, many clinicians offer a short bio with their areas of expertise, and there are provider directories featuring trusted clinicians. Further, some doctors regularly write articles and give talks that may offer clues about desired knowledge. A simple Google search of your provider may yield a bounty.

Next, give your doctor or healthcare organization a call. Don’t be shy about requesting someone whose practice matches your specific needs. Your health information is protected, and generally, physicians hold your clinical privacy dear. Keep in mind that not all clinics will know or share whether or not your doctor is, for example, also a lesbian, but they may pair you with someone well suited to your request or point you in the right direction.

Preparing for your appointment

Let’s say you are nervous about coming out to your doctor. A little preparation may ease this burden. Here are some quick tips:

• Let them know you’re nervous at the start of the conversation.
• Be as bold as you can tolerate.
• Write down what you are excited about, nervous about, and/or curious about.
• Go in with a few goals and start with what’s most important.
• Maximize your comfort. If your partner is calming, bring them. If Beyoncé soothes what ails you, bring her along too.
• Lightly correct or update your clinician if they get something wrong.

Ask tough questions, give clear answers

As a psychiatrist who works with kids and adults, I often hear questions like, “I don’t know really how to say this, but I started experimenting with other guys. Does this mean I’m gay?” I may start by asking if you’ve enjoyed it. My colleagues in health care might begin with the same question.

Pleasurable experiences come in all sorts of constellations, and healthy exploration is part of being human. Additionally, clinicians need to assess and address your safety. Many LGBTQ+ people are at higher risk of intimate partner violence. We may ask about your use of condoms, how many partners you’ve had recently, your use of substances during sex, and how these experiences may shift how you see yourself. Give clear answers if possible, but don’t fret if you’re uncertain. Your doctor will not likely provide a label or pry unnecessarily. They may offer constructive information on the use of condoms, reasons to consider using PrEP (which can effectively prevent HIV), and places you can go for more guidance. Physicians enjoy giving personalized information so that you may make informed healthcare decisions.

There is no end to what is on people’s minds. Be bold. Will tucking reduce my sperm count? Maybe. Does binding my breasts come with risk? Likely. Was Shangela robbed of her RuPaul’s Drag Race: All Stars 3 crown? Utterly, but let’s get back to your cholesterol, shall we?

Remember that it is often impossible to squeeze everything into one appointment. Afterward, take time to catch your breath, reflect on what you’ve learned, and come up with more questions for next time. We’re here for that.

About the Author

Cecil R. Webster, Jr., MD, Contributor

Dr. Cecil R. Webster, Jr. is a child, adolescent, and adult psychiatrist in Boston. He is a lecturer in psychiatry at McLean Hospital and Harvard Medical School, and consultant for diversity health outreach programs at the … See Full Bio View all posts by Cecil R. Webster, Jr., MD

Summer is an ideal time to take a hike, especially if you have the opportunity to explore one of our country’s many state and national parks. But if you venture far from home, it’s essential to make sure you’re prepared for the local climate and other conditions you may encounter on the trail, especially if you’re not an experienced hiker. Higher temperatures than you’re accustomed to or other extreme weather can be deadly.

“If you’re taking a hike in mid-July in the Arizona desert, there’s a very different list of considerations than if you’re in the mountains of Montana or the forests of North Carolina,” says Dr. N. Stuart Harris, chief of the Division of Wilderness Medicine at Harvard-affiliated Massachusetts General Hospital. Here’s a run-down of what to consider before you hit the trail.

Traveling companions, safety notifications, and orientation

First, it’s safer to travel in pairs or a group of people. But always tell someone not on your hike where you’re going, your anticipated route, and when you expect to return. National parks often require reservations or permits for overnight stays or treks to certain locales, and keep a record of day-hikers, so sign up as requested. If you end up getting injured or lost, the information can make a huge difference in locating you more quickly.

Remember to bring a map and know how to orient yourself. In many wilderness areas, cell service may be spotty or nonexistent, so don’t count on using your phone’s GPS.

In the desert, you may be able to see for 50 miles in the distance. But if you’re in a steep, wooded area, you might not be able to see 100 yards ahead and it’s much easier to become disoriented, says Dr. Harris.

Be ready for heat, humidity, and other weather hazards

Check forecasts first. Always check the forecast so you can be prepared for weather changes. Temperatures may drop and wind may increase as you climb higher. If you’re in an area prone to thunderstorms, lightning injury should definitely be on your radar, says Dr. Harris. Learn these lightning safety tips from the Centers for Disease Control and Prevention. Because these storms usually strike in the afternoon, you can minimize your risk by hiking in the earlier part of the day.

Hydrate well. During any type of exercise — especially hiking, which often demands a fair bit of exertion — be sure to drink extra water to replace the fluid you lose from sweating. On a warm day, you might not notice you’re sweating if it’s breezy. Pay attention to any signs or alerts advising hikers on how much water is best to carry.

Consider humidity. Temperature isn’t the only consideration, however. “If you’re in Arizona and the temperature is over 100° F, your body may be better able to release heat by sweating than if you’re in a very humid area,” says Dr. Harris. In the Great Smoky Mountains, for example, the temperature in July may be only in the high 80s. But humidity levels usually hover around 75% or higher. That means your sweat will evaporate more slowly, so your body’s natural cooling mechanism doesn’t work as efficiently. Be sure to rest and hydrate if you start feeling overheated.

What to wear and bring

Many park websites offer detailed safety tips specific to the terrain and weather you may encounter on a hike, so check before you go. Five basics to consider are as follows:

• If your hike involves rocky or uneven terrain, hiking boots will offer more support than tennis shoes.
• You’ll be more comfortable in lightweight, moisture-wicking clothing, but bring extra layers and rain gear, if the weather forecast suggests this is appropriate. Temperature drops can be surprising in some places when the sun wanes, so be prepared to layer up as needed if you’re out longer than expected.
• Wear a wide-brimmed hat and sunglasses to shield you from the sun’s glare — and don’t forget to apply sunscreen to all exposed skin before you set off.
• Along with plenty of fluids, bring high-energy snacks. If you get off course or encounter a problem, you’ll be glad you did.

Additionally, depending on where you’re hiking, you may need to dodge rash-inducing plants, including stinging nettles, poison oak, or poison ivy. Bring insect repellent to fend off biting insects and follow prevention strategies for ticks, which may harbor bacteria responsible for Lyme disease and other illnesses. Finally, carry a first aid kit with bandages for cuts and scrapes and moleskin for blisters.

About the Author

Julie Corliss, Executive Editor, Harvard Heart Letter

Julie Corliss is the executive editor of the Harvard Heart Letter. Before working at Harvard, she was a medical writer and editor at HealthNews, a consumer newsletter affiliated with The New England Journal of Medicine. She … See Full Bio View all posts by Julie Corliss

About the Reviewer

Howard E. LeWine, MD, Chief Medical Editor, Harvard Health Publishing

Dr. Howard LeWine is a practicing internist at Brigham and Women’s Hospital in Boston, Chief Medical Editor at Harvard Health Publishing, and editor in chief of Harvard Men’s Health Watch. See Full Bio View all posts by Howard E. LeWine, MD