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Sunday, January 5, 2020

How Anxiety Traps Us, and How We Can Break Free

Zulfi, a coaching client of mine, is the envy of many of his peers. As the general manager of a large, successful business, his work is one of the CEO’s core priorities. He does good work and is well-loved by his team.
But Zulfi has a secret. He suffers from anxiety. It keeps him up at night, impacts his health, and takes a lot of time and energy to manage. When people praise Zulfi’s poise during a major customer presentation, they’re unaware that he survived the meeting by taking anti-anxiety medication. Zulfi handles two jobs each day: the one outlined in his job description and the other managing his anxiety.
It’s normal to occasionally experience anxiety, such as when we’re faced with a high-stakes meeting, a stressed-out boss, or a conflict with a colleague. But according to the National Institute of Mental Health, in any given year, 19% of U.S. adults are suffering from an anxiety disorder, and 31% will deal with a disorder at least once in their lifetime.
Mental health experts postulate that, when anxious, we tend to get trapped in false or limited ways of thinking. These thought patterns create a debilitating negative spiral that can take over our lives by convincing us of impending doom and further exacerbating our sense of helplessness. Anxiety Canada, a website devoted to supporting people who suffer from anxiety, lists a number of these traps and thought patterns. Here are the ones my clients, usually senior executives, most commonly experience and the kinds of things they say when in the grip of a specific trap:
  • Catastrophizing: Imagining the worst possible outcome. “I will get fired if the presentation has any glitches.”
  • Mind reading: Imagining what others are thinking. “I know he doesn’t like working with me because he thinks I’m dumb.”
  • Fortune telling: Imagining what the future holds, but without data. “They will all hate me in the new group because I’m the only one who isn’t a physicist.”
  • Black-and-white thinking: Considering only two possible outcomes. “I’ll either hit a home run or get fired.”
  • Overgeneralizing: Painting all situations with a generalized outcome. “I presented to the CEO last year, and it didn’t go well. I never get things right or always fail when it comes to executive audiences.”
If one or more of these thinking traps has a hold on you, try these strategies I’ve used with my coaching clients to overcome them. While I’m not a psychologist or a medical professional, I do have experience helping my clients adjust their behaviors, change the way they think, and increase their effectiveness at work. These suggestions do not replace the need to consult mental health professionals for possible diagnosis and treatment for anxiety, but they can help you break your negative thought patterns, gain control over your anxiety, and allow you to listen to the chatter that really matters in your daily work.
Pause the pattern. Anxiety is often preceded by physical symptoms. Learn to recognize your physical cues of an impending attack: a churning stomach, sweaty palms, or flaring nostrils. These reactions are part of an amygdala hijack, causing your body to react with a fight-or-flight response instead of operating from your thinking brain. When you notice these reactions, consciously change your activities. Engage the thinking part of your brain, for instance, by doing math. But not something as simple as 2+2; try something that will challenge you enough to divert your brain away from your stressor.
Name the trap. Give your pattern a name, whether it is one of the traps listed above or something you come up with yourself. Naming converts the vague threat to something concrete. You regain power by realizing you’ve encountered it before — and survived. You can fine-tune your mitigation strategy based on the specific trap that’s ensnared you. Zulfi, for instance, had a better sense of the steps to take once he’d named his patterns and could distinguish between catastrophizing, mind reading, and fortune telling.
Separate FUD from fact. Create a two-column list. On one side list all your fears, uncertainties, and doubts, or FUD. The second column is for verified facts. Being able to compare the two can quell your fears and bring you back to reality.
For example, when Zulfi indulged in a mix of fortune telling and catastrophizing, he told himself, “Our key strategy is going to fail, and we’ll soon be out of business because our competitor moves faster, and our subsidiaries are located in places of political turmoil.” Entries in his FUD column included: Our competitor will out-innovate us and be faster to market; geopolitical events will spin out of control; we’ll have a great recession; and our best employees will burn out. Entries in his facts column included: We’ve beat the competition to market the last three times; only one of our 16 subsidiaries is in a politically unstable situation; economic indices are stable; and employee attrition is at an all-time low. Seeing the facts next to his fears helped Zulfi tone down his concerns. If you find your FUD column to be much longer than the facts, get others involved. Reach out to someone you trust, and ask them for their point of view. They may also be able to point to some realistic facts to offset your anxieties.
Tell more stories. We make assumptions, jump to conclusions, and tell ourselves stories all the time. Storytelling helps us get through life more efficiently, but it can also be limiting. When we’re anxious, we tend not only to believe our own stories, we believe the most extreme and negative forms of them.
Instead of curbing this reflexive habit, indulge it. Compose three separate stories and ensure they’re very different from each other. For example, when a client’s manager asked him to increase his technical depth, the initial assumption he made — in other words, the story he made up and told himself — was that his manager was dissatisfied with his performance. When I pushed him further, he developed two companion stories: “My manager wants me to showcase my technical depth further to have an even bigger impact in the group,” and “My manager wants my skills to be more easily transferrable, so as I become more senior, I have more places in the company where I can move for my next role.” Expanding the stories you tell yourself about a specific situation shows you there are multiple possibilities, many of them more positive than your initial hypothesis.
Walk your talk. Ask yourself what you’d advise others to do. When my clients are anxious, I ask them what counsel they would give a friend or team member in a similar situation. People who felt clueless a moment before are immediately able to provide sound guidance. If you find yourself saying, “I feel stuck,” “I don’t know what to do,” or “There’s no way out,” ask yourself, “If a colleague came to me with my predicament, what would I tell them?” This pause allows you to become more objective and loosen the thinking trap that has you in its hold.
While all of these strategies can help in the moment when you’re panicked, plans are hard to remember, much less execute. Write these tactics down and take them to your high-risk meetings. When you notice that familiar change in your heart rate or dryness in your throat, glance at your note and try one of these strategies to calm yourself.
After 10 months following these strategies, Zulfi started to notice changes. His anxiety attacks were less frequent, his self-talk changed from self-criticism to self-compassion, and he had more energy to focus on his day job.
It’s human to experience fear, self-doubt, and confusion. In the right dose these feelings can be helpful — they keep us vigilant, engaged, and productive. But when anxieties overburden our brains and undermine performance, it’s time to consciously choose the strategies that put us in charge of our internal dialogue and tune in to the chatter that matters.

Engrams emerging as the basic unit of memory

Engrams emerging as the basic unit of memory
Above: Memory engram cells labeled green and red in the prefrontal cortex of a mouse. Image credit: Takashi Kitamura Credit: Takashi Kitamura/MIT Picower Institute
Though scientist Richard Semon introduced the concept of the “engram” 115 years ago to posit a neural basis for memory, direct evidence for engrams has only begun to accumulate recently as sophisticated technologies and methods have become available. In a new review in Science, Professors Susumu Tonegawa of The Picower Institute for Learning and Memory at MIT and Sheena Josselyn of the Hospital for Sick Children (SickKids) and the University of Toronto describe the rapid progress they and colleagues have been making over the last dozen years in identifying, characterizing and even manipulating engrams, as well as the major outstanding questions of the field.
Experiments in rodents have revealed that engrams exist as multiscale networks of neurons. An experience becomes stored as a potentially retrievable  in the brain when excited neurons in a brain region such as the hippocampus or amygdala become recruited into a local ensemble. These ensembles combine with others in other regions, such as the cortex, into an “engram complex.” Crucial to this process of linking engram cells is the ability of neurons to forge new circuit connections, via processes known as “” and “dendritic spine formation.” Importantly, experiments show that the memory initially stored across an engram complex can be retrieved by its reactivation but may also persist “silently” even when memories cannot be naturally recalled, for instance in mouse models used to study memory disorders such as early stage Alzheimer’s disease.
“More than 100 years ago Semon put forth a law of engraphy,” wrote Josselyn, Senior Scientist at SickKids, Professor of Psychology and Physiology at the University of Toronto and Senior Fellow in the Brain, Mind & Consciousness Program at the Canadian Institute for Advanced Research, (CIFAR) and Tonegawa, Picower Professor of Biology and Neuroscience at the RIKEN-MIT Laboratory for Neural Circuit Genetics at MIT and Investigator of the Howard Hughes Medical Institute. “Combining these theoretical ideas with the new tools that allow researchers to image and manipulate engrams at the level of cell ensembles facilitated many important insights into memory function.”
“For instance, evidence indicates that both increased intrinsic excitability and synaptic plasticity work hand in hand to form engrams and that these processes may also be important in memory linking, memory retrieval, and memory consolidation.”
For as much as the field has learned, Josselyn and Tonegawa wrote, there are still important unanswered questions and untapped potential applications: How do engrams change over time? How can engrams and memories be studied more directly in humans? And can applying knowledge about biological engrams inspire advances in , which in turn could feedback new insights into the workings of engrams?

Explore further

More information: Sheena A. Josselyn et al, Memory engrams: Recalling the past and imagining the future, Science (2020). DOI: 10.1126/science.aaw4325

NextMind over matter at CES

NextMind announces $399 Dev Kit for first real-time ‘brain-sensing’ BCI wearable, wins two CES Innovation Awards
NextMind, a fast-growing neurotechnology startup specializing in noninvasive neural interfaces, today announced it is offering a $399 Dev Kit for its unique wearable that allows users to control anything in their digital world by using just their thoughts. The NextMind device, which is the world’s first noninvasive, hands-free brain-computer interface for real-time interaction, also won two CES Innovation Awards today —Best of Innovation in Augmented and Virtual Reality and Honoree in Wearable Technologies. NextMind is providing demonstrations in Booth No. 534 at CES Unveiled Las Vegas tonight from 5 p.m. to 8:30 p.m. at the Mandalay Bay and also at CES this week at LVCC, South Hall 1, Booth No. 21839.
NextMind is at CES 2020 this week debuting the first real-time ‘brain-sensing’ BCI wearable that let's you control your digital world with just your thoughts. (Photo: Business Wire)
NextMind is at CES 2020 this week debuting the first real-time ‘brain-sensing’ BCI wearable that let’s you control your digital world with just your thoughts. (Photo: Business Wire)
“We are honored to receive such recognition from the Consumer Technology Association for NextMind, and eager to get our Dev Kit out to developers and partners so that they can explore the many amazing ways this powerful real-time brain-computer interface will create new user experiences with the digital world,” said Sid Kouider, founder and CEO of NextMind. “We look forward to giving CES attendees a demo that will blow their minds when they fully realize the power and deep immersive experience that NextMind can provide in gaming, computer control and their personal interaction with the internet of things just by focusing their thoughts. And this is just the beginning for us, as we look forward to the future and further evolving this technology.”
NextMind’s lightweight wearable captures electrical brain signals from the user’s visual cortex, and by using machine learning algorithms, translates that output into direct digital commands for devices in real time, all while hands-free. The small, round device fits into the back of a cap or headband and rests gently on the user’s head, or it can be used via AR/VR headset.
Kouider first unveiled the NextMind BCI wearable onstage at the prestigious technology forum Slush 2019 in November.
NextMind is shipping Early Access Evaluation Kits to selected partners and developers this month. The company will begin shipping the first batch of $399 Dev Kits during the second quarter of 2020. Developers interested in being one of the first to receive a NextMind Dev Kit can sign up for the Pre-Order Waitlist at https://www.next-mind.com/waitlist/.
NextMind is a fast-growing technology startup specializing in groundbreaking, noninvasive neural interfaces. By combining innovative, noninvasive brain-sensing technology with machine learning algorithms, NextMind’s technology translates brain signals into digital commands in real time, making it easier for end users to interact and control computers and VR/AR headsets.

One Medical Files For $100M IPO

Healthcare startup One Medical filed its S-1 registration document with the U.S. Securities and Exchange Commission on Friday, one of a handful of companies to kick off the year’s initial public offering cycle.

The company, which has a membership model for patients to access care virtually or at One Medical Clinics, is aiming to raise $100 million through its IPO, according to the filing. One Medical applied to list its stock on the Nasdaq under the ticker “ONEM,” and J.P. Morgan and Morgan Stanley are acting as the lead underwriters for the IPO.

Company Stats

As a private company, One Medical raised $532.1 million in total funding, according to Crunchbase. The company, which was founded in 2007, last raised money in August 2018, when it raised $220 million in a private equity round led by the Carlyle Group. One Medical’s other investors also include GV and Benchmark.
One Medical had 397,000 members in nine markets in the U.S. as of September 30, 2019, according to the filing. It also had about 6,000 enterprise clients.
While the company, which is legally named 1Life Healthcare, is based in San Francisco, it has a physical presence in Boston, New York, Chicago, Los Angeles, Phoenix, San Diego, Seattle, Washington, D.C. and the greater Bay Area. One Medical has 77 offices, including employer on-site clinics.

The Money

The company reported net revenue of nearly $198.9 million for the first nine months of 2019. That represents a 29 percent increase from the same period last year, when net revenue was $154.6 million.
One Medical attributed the bump to a 23 percent increase in members between the first nine months of 2018 and the first nine months of 2019 (membership increased by 74,000 people from 323,000 people to 397,000 people). The company also doubled its spending on sales and marketing during the first three quarters of the year, going from $14.4 million in 2018 to $28.8 million in 2019.
Between the first three quarters of 2018 and 2019, the company’s net losses increased from about $26.9 million in 2018 to $34.2 million in 2019. Its net losses for the entirety of 2018 was $45.5 million, up nearly 44 percent from $31.7 million in 2017.

23andMe can open a Pandora’s Box of a family’s medical secrets

Unwrapping the holiday gift of a genetic testing kit could mean revealing a previously unknown world of health concerns — and complicated family questions.
By spitting in a test tube and sending it to companies like 23andMe or Ancestry.com, consumers might learn of potential genetic predispositions to Type 2 Diabetes, breast cancer, carrier status for cystic fibrosis and certain blood conditions.
‘I wanted to sound confident. I wanted to get across the most important thing.’
—Dorothy Pomerantz, a 49-year-old Los Angeles-area mother
It’s still not an easy conversation, something Dorothy Pomerantz knows all too well. The 49-year-old Los Angeles-area mother lost sleep and thought long about how she would inform her children, then ages 11 and 14, about a genetic mutation putting her at an elevated risk of breast and ovarian cancer.
“I wanted to sound confident. I wanted to get across the most important thing, which was I was going to be OK,” she told MarketWatch.
Pomerantz first learned of her BRCA1 mutation from a 23andMe test. She confirmed it with a genetic counselor. She had preventative surgery, including a mastectomy with implant reconstruction.
Pomerantz needed around three to four months before she could calmly relay the test results to her kids and speak about her surgery plans. She tried framing the presentation as, “I’m here to answer questions, but not giving more information than they need,” she said.
After the talk, her kids “both just sort of paused and went, ‘Okay, that sounds great. What’s for dinner?’” said Pomerantz, who is the managing editor of FitchInk, an editorial consulting and content company.
She also told her cousins, some of whom had daughters. Pomerantz didn’t want to browbeat anyone into getting tests, but wanted to tell them, because, “As hard as it is knowing, not knowing is much worse.”
But she respects someone who may choose not to share the news as it’s “a personal decision.”
The cousins were appreciative and Pomerantz remembers one, a doctor herself, telling her, “I can’t believe you got tested. I would never want to know. This does make me rethink wanting to get tested.”
As far as Pomerantz knows, none of her cousins has pursued further testing.

Such results, as Pomerantz discovered, can unleash all sorts of difficult medical questions about further verification, treatment and possible surgery. Those same results can also force personal dilemmas: With whom should users share surprising or unwelcome medical results? And how do they break such news?
‘It’s all in the realm of ethics, and not in the realm of law.’
—Ellen Wright Clayton, Vanderbilt Law School professor
These are emotionally-charged questions with few clear-cut answers, experts say.
“It’s all in the realm of ethics, and not in the realm of law,” said Ellen Wright Clayton, a professor who focuses on the law, medicine and genetics at Vanderbilt Law School.

The predicament is increasingly common as more people buy direct-to-consumer kits to identify their genetic makeup and heritage for starting prices of approximately $100. An estimated 26 million consumers took direct-to-consumer genetic tests by the start of 2019, according to MIT Technology Review estimates from earlier this year.
Clayton emphasized the direct-to-consumer tests only reveal so much compared to “comprehensive” results from genetic counselors, who are health-care professionals trained to provide risk assessment, counseling and support for individuals with inherited conditions.
‘You’re less likely to regret having communicated than having kept it a secret.’
—Gillian Hooker, president-elect of the National Society of Genetic Counselors
Clayton hopes people would eventually tell family members about results, and says a consensus of doctors share the same view. “We like for people to be able to share this information, so that other individuals can be tested if they choose to be. If they are found at risk, they can do something to try to prevent it,” said Clayton.
“You’re less likely to regret having communicated than having kept it a secret,” said Gillian Hooker, president-elect of the National Society of Genetic Counselors.
“More open conversations are happening,” she added. “I think our expectations of privacy around these things are certainly changing as more and more people get tested, and the public becomes more aware.”
What the results may, and may not, show
Direct-to-consumer testing “only looks for limited sets,” Clayton said. “I’m not telling people not to do it. They just need to know what they are going to get and not going to get.”
The Pentagon recently advised military members not use the direct-to-consumer tests, Yahoo! News reported VZ, -1.06%
‘I’m not telling people not to do it. They just need to know what they are going to get and not going to get.’
Vanderbilt Law School Professor Ellen Wright Clayton
“Until further assessment, it is advised that service members receive this information from a licensed professional rather than a consumer product,” Lt. Col. Uriah Orland, a Department of Defense spokesman, told MarketWatch in an email. There could be the “unintentional discovery of markers that affect readiness” and a service member’s career, Orland said.
“Testing performed by [direct-to-consumer] companies may or may not provide reliable, accurate results,” he said.
Representatives for 23andMe and Ancestry, which offers AncestryHealth, emphasized customer results are reliable and closely protected.
“All of our customers should be assured we take the utmost efforts to protect their privacy, and that the results we provide are highly accurate,” a 23andMe spokeswoman said. “Our FDA-authorized health reports have been tested to be over 99% accurate.” All testing is done in the United States and the company doesn’t share any information without clear consent from customers, she added.
23andMe’s website acknowledges its BRCA1/BRCA2 reports are not comprehensive and ”should not be used to make medical decisions.”
Likewise, an Ancestry spokeswoman said, “protecting our customers’ privacy and being good stewards of their data is Ancestry’s highest priority.” The company “does not share customer DNA data with insurers, employers, or third-party marketers. Ancestry will also not share customer personal information with law enforcement unless compelled to by valid legal process, such as a court order or search warrant.”
Important caveats to keep in mind
“Genetics rarely are a prediction of you will or won’t get a disease. It’s all about probabilities,” said Hooker, who is the vice president of clinical development at Concert Genetics, a health technology company near Nashville, Tenn.
It’s important to know the context surrounding any distressing diagnosis, like family history and lifestyle factors, Hooker said. “Take a breath and make sure you know what it means first,” or find someone who can explain results, she said.
‘Take a breath and make sure you know what it means first.’
—Gillian Hooker, president-elect of the National Society of Genetic Counselors
Anyone who wants to share the news should start with close relatives like siblings and parents, Hooker added. Talking to aunts, uncles and cousins are a different judgment call, she said.
Services like 23andMe and AncestryHealth emphasize that they give added information with results, and both can link customers with genetic counselors.
In addition to customer education, Invitae NVTA, -1.41%, a genetics test requiring a doctor’s order, can provide customers with wording for a letter to send to family members, said Kate Lynch, a genetics counselor at the company.
However people share the news, Lynch said, “a lot of personalities come into play. Some relatives will be happy to hear from you … and other relatives will not be happy to hear from you. And you can’t predict that very well.”
“For some people, information is immediately empowering,” causing them to do their own testing and research. For others, “It could feel stressful, it could feel confusing.”
Red flags, whether coming from a test kit or a genetic counselor, deal with risks of having a condition over the course of a lifetime, Hooker said. That’s an important piece of information to communicate to any relative.
What’s more, Hooker said you are giving your relatives choices about what their next step should be. It’s a dramatically different scenario than a negative prognosis from a doctor. “In most cases, you have time to think.”

Where Were the Women? Gender Parity in Clinical Trials

In 2017, a total of 19% of all new HIV infections in the United States and nearly half of infections globally were in cisgender (nontransgender) women. Women of childbearing potential shoulder a disproportionate burden, which raises further concerns about perinatal transmission of the virus. Preexposure prophylaxis — pharmacologic prevention of HIV acquisition with coformulated tenofovir disoproxil fumarate and emtricitabine (F/TDF) — has been shown to be effective in women, was approved by the Food and Drug Administration (FDA) in 2012 for women and men, and is a cornerstone of the national strategy for Ending the HIV Epidemic.
Coformulated tenofovir alafenamide and emtricitabine (F/TAF) is a sister prodrug of F/TDF that has the potential to cause less loss of bone mineral density and fewer renal toxic effects than F/TDF. A new drug application for F/TAF for the treatment of HIV infection in men and women was submitted to the FDA in April 2015 and approved in April 2016. The FDA reviewed a substantial amount of safety and efficacy data for F/TAF, as it does for all new medications, and confirmed that the supporting studies met its established criteria for statistical rigor, pharmacologic standards, and inclusion of diverse populations.
Two months after its approval for treatment, F/TAF’s manufacturer, Gilead Sciences, moved forward with an effort to expand the drug’s indications to include prevention of HIV infection. To do so, they collaborated with researchers, community members, and the FDA to develop a new preexposure prophylaxis trial protocol — the DISCOVER trial — and to work toward a supplemental new drug application for F/TAF. Designed as a noninferiority trial, DISCOVER compared F/TDF with F/TAF in more than 5000 men who have sex with men and 74 transgender women who have sex with men to evaluate the efficacy and safety of F/TAF when used for prevention. The trial specifically excluded cisgender women because of perceived challenges in enrollment and concern about reaching a meaningful end point. DISCOVER was registered with and posted to ClinicalTrials.gov (NCT02842086. opens in new tab) in June 2016.
The requirements for a supplemental new drug application are similar to those for a drug’s initial new drug application, and the new application is subjected to the same scientific and ethical standards. These include the FDA Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, which “requires sponsors to include a fair representation of both genders as participants in clinical trials so that clinically significant gender-related differences in response can be detected.”1 The guidance also specifies that trial participants must be representative of the patient population likely to be prescribed the drug once it is approved and that data must be presented for each relevant subgroup.1
In March 2019, the manufacturer reported in abstract form the initial efficacy and safety data from the DISCOVER trial. Despite the few new HIV infections that occurred during the study, F/TAF was found to be noninferior to F/TDF, with a similar adverse-event profile. Serum creatinine levels were significantly different between the two groups, although the difference probably did not carry any clinical significance: F/TAF resulted in a change of 0.01 mg per deciliter and F/TDF a change of 0.02 mg per deciliter.2
On August 7, 2019, the Antimicrobial Drugs Advisory Committee of the FDA discussed the recently reported and unpublished data from DISCOVER. They also reviewed the previously published pharmacokinetic data on F/TAF that demonstrated similar systemic levels of F/TAF in men and women with daily dosing of the medication.2 At the time of consideration, and nearly 3 years after the public notification of the launch of the DISCOVER Trial, no trial was actively examining (or had yet examined) F/TAF for use as preexposure prophylaxis in cisgender women. The committee acknowledged that differences in drug levels between rectal and vaginal mucosa may affect overall efficacy in HIV prevention and voted 16 to 2 for approval of F/TAF in men who have sex with men and transgender women and 8 to 10 against approval in cisgender women.3 Scientists and community advocates on the panel recognized the consequences of this decision, which was dictated by the inadequacy of prevention data for women, and were keenly aware of the impact the disapproval would have on access for cisgender women. The committee chair conveyed this frustration, saying, “We’ve failed women.” Ultimately, on October 3, 2019, the FDA approved F/TAF for HIV prevention in at-risk “adults and adolescents,” but “excluding those who have receptive vaginal sex.”4
This controversial story highlights numerous flaws in the drug-approval process. From the time the trial was first registered with ClinicalTrials.gov in 2016, through the approval of the protocol by human-subjects committees at 94 clinical sites, to the submission of a supplemental new drug application to the FDA with review by the Antimicrobial Drugs Advisory Committee in August 2019 and then final approval by the FDA, it was evident that the submission would never meet the gender-specific standards set forth by the FDA’s own guidance.
Equity and inclusion in clinical trial design are essential to scientific advancement, ensuring that the benefits of innovation and drug discovery safely reach everyone in need. Historically, women — especially those who were pregnant or had childbearing potential — were often considered a vulnerable population and therefore excluded from clinical trials; this practice limited our understanding of women’s health and the potential for diverse pharmacologic responses. The FDA’s Office of Good Clinical Practice first called for representation of all genders in clinical trials in 1993, simultaneously acknowledging that human-subjects committees should include these standards in their evaluation of protocols and surveillance of research.1
There are limited evidence-based reasons for excluding people from trials on the basis of gender. Just this year, the FDA posted draft guidelines on the inclusion of men in studies of new breast-cancer therapeutics, citing prior exclusion as a barrier to effective treatment options. Men account for less than 1% of all breast-cancer cases, but under these guidelines, the “FDA does not intend to consider low expected accrual rates of male patients with breast cancer to be a sufficient scientific rationale for excluding them from a clinical trial.”5 Meanwhile, in the same month these guidelines were published, the FDA advisory committee reviewed data on F/TAF for HIV prevention that intentionally excluded women — a population that accounts for nearly 20% of all new HIV infections in the United States and 46% of all infections globally. The manufacturer justified its decision by citing difficulty in identifying “a relevant female cohort.”2
The responsibility for the exclusion of women in the design of the DISCOVER trial and the gender-specific approval of F/TAF for HIV prevention rests on all of us. Clinical trial design requires diverse voices and intentional inclusion criteria. It is up to human-subjects committees to maintain vigilant oversight of study protocols with these FDA standards in mind, regardless of whether the studies in question are industry-sponsored. And when the FDA is presented with data that exclude half the world’s population, it can use the tools at its disposal to address the violation.
The current approval of F/TAF that excludes “those who have receptive vaginal sex” establishes a two-tier system in which men may be prescribed the medication with insurance approval, whereas women may receive it only off-label, in the absence of data, and without insurance coverage. The path forward should be clear: a well-designed, rapidly enrolled, robust clinical trial of efficacy in cisgender women is urgently needed.
In granting approval for the drug’s expanded indication, the FDA obligated the manufacturer to study the drug in cisgender women. In response, the company plans to undertake a limited study in 1500 women in sub-Saharan Africa focused on safety and noninferiority that is scheduled to begin enrollment by 2020. In short, a study involving women that was deemed infeasible in 2016 is finally being considered. The backlash from the scientific, global, and advocacy communities against the FDA’s limited approval of F/TAF suggests that they expected and deserved better; they are all watching for remediation. The responsibility now lies with the FDA and the scientific community to enforce the rapid completion and reporting of this study in women and, in the process, to work to revise the current regulations and drug-approval process to truly require equity and inclusion.
Disclosure forms provided by the authors are available at NEJM.org.
This article was published on October 30, 2019, at NEJM.org.

Author Affiliations

From the Division of Infectious Diseases, Department of Medicine (R.H.G., R.P.W.), and the Medical Practice Evaluation Center (R.P.W.), Massachusetts General Hospital, and the Harvard University Center for AIDS Research, Harvard Medical School (R.P.W.) — both in Boston.

Responsibility of Physicians to Maintain Competency

Physician education during residency and fellowship has shifted from a model based on how long a physician trains to one that emphasizes assessing and encouraging measurable competence.1 There needs to be a similar shift to ensuring competency for physicians who have completed their training, with an emphasis on maintaining knowledge and clinical skills to ensure patient safety. This leads to several questions. Who must be competent in what? Who decides? Does experience count? How does aging affect competence? In medicine, an expansive range of competencies are considered important, and not every physician maintains every competency. Achieving, assuring, and maintaining competency across medicine requires time and effort and involves perseverance for individual physicians and the health care system. In this Viewpoint, we discuss 2 forces that can lead to diminishing competence over time: deterioration in ability with age and decrease in opportunities for maintenance and self-improvement.
Deliberate practice, as described by Ericsson2 and demonstrated in many fields, including music, chess, and surgery, is the sequential, mindful repetition of a training task with feedback that leads to effective improvement in performance. Early in training, there is a rapid learning trajectory in which large gains in performance occur through intentional learning activities. However, for some individuals, when formal training ceases performance can eventually degrade and can be documented by a forgetting curve,3 in which the rate of decay depends on a number of factors, including the complexity of the skill in question, opportunities for practice, and support from the health system. For example, in many specialties, residents are intensively trained in procedural skills, such as intubation and central line placement; however, these skills decay without continued practice and repeated training.4 It is important to recognize that there is a threshold for competency that must be maintained. This skill decay over time may be compounded by the aging of the physician population, which has made maintenance of competency an important issue in medicine in the United States and around the world.5 The literature on aging and its effects on professional performance is mixed with evidence of cognitive and physical decline of abilities in some individuals. However, there is evidence that competency in medicine can be successfully maintained through intentional deliberate practice and mastery learning with procedural simulation training.2,4,6
Advances in medicine and clinical procedures continue to change practice, and some physicians may not have the opportunity to keep up with new diseases, diagnostics, and therapies or may not be able to achieve sufficient mastery of technical skills required for performance of new procedures.7 While physicians may retain the expertise from years of experience, in some areas (especially in procedurally oriented disciplines), some physicians may be subject to the trajectory of skill decay. Yet, their identity as physicians is an important self-concept and supports their professional credibility. As some physicians mature in their careers, they may choose to decrease their clinical time as they move toward retirement; spending more time with their family; or increasing professional administrative, research, or teaching activities. Even though these physicians have accumulated comprehensive expertise from thousands of patient encounters and a complementary understanding of the health care system, teamwork, and patient-centered care, physicians who decrease their clinical time must maintain a certain equipoise, balancing their nonclinical time against the important need to maintain skills in procedures they may be called on to perform, even if only rarely. For example, emergency physicians might need to refresh their skills in intubation, cricothyrotomy, central line placement, thoracotomy, or focused ultrasonography if they have not performed these procedures recently.
As physicians practice into their sixth, seventh, and eighth decades of life, there is a balance between their increasing depth of expertise gained through experience and the forces such as aging, other causes of cognitive decline, and decreased opportunity for deliberate practice that can lead to skill decay. Can the balance tip in a way that results in risks for the care of the patient? What can be done to mitigate risks and protect patients? The following 5 proposed considerations may be helpful to addressing competency decline.
First is the mandate for lifelong learning and the controversial issue of mechanisms to ensure maintenance of certification.8 Even though some aspects of maintenance of certification are unpopular and perhaps ineffectively implemented, the underlying principle is sound and reflects the importance of maintaining knowledge and competency as a professional responsibility. Physicians must continuously refresh their foundational knowledge and stay up-to-date with new and evolving knowledge as well as procedural competence. This continued learning can occur through formal continuing medical education courses, informal learning activities (such as listening to educational podcasts or reading), Just In Time Medicine clinical references, and interactions with consultants and colleagues. Helping physicians identify what they do not know and make knowledge gaps transparent is essential to this process.
Second is the responsibility to keep training. While some procedures are routine, there are uncommon and complicated procedures or new techniques for procedures that require additional training, especially in procedural specialties, such as surgical fields, emergency medicine, and critical care, all of which include common and rare procedures, such as cricothyrotomy, thoracotomy, and new laparoscopic techniques. These less commonly performed procedures require disproportionate time for maintenance of skill that must be acknowledged in physician work schedules. Simulation is widely available but unevenly used by practicing physicians and usually not considered part of the department’s or simulation center’s budget for simulation or the time physicians spend retraining, relying on the volunteerism of the physician. Retraining opportunities allow physicians to refresh their procedural skills and develop familiarity with new equipment and methods. There are some national-level pressures for maintenance of skills; for example, the Joint Commission requires appropriate credentials for procedural sedation. In addition, some departments have faculty-specific procedural training that is voluntary, or may be mandated, including annual procedural sedation certification. Also, some specialties, such as electrophysiology, have delineated the knowledge and procedural competencies expected.9
However, less clear is where the locus of responsibility should lie for ensuring competency through apportioning of work hours between the time demands of nonclinical work and time for retraining to maintain and enhance clinical skills. How can continued training opportunities be designed that are proactive, judicious, individualized and transparent? To what extent should retraining depend on the physician?
Third, physicians can choose practices that involve less exposure to procedures or content for which they believe are no longer expert, such as in lower acuity areas with parallel coverage of a procedural team, more reliance on colleagues to assist when needed, or both. Maximizing collective competence is in alignment with systems-based approaches, but requires policies that do not feel punitive. The optimal solution is likely to differ between settings. Meanwhile, there is the possibility that even with diminished competency, some physicians with perhaps limited skills for some procedures may still be needed in some areas.
Fourth is the importance of self-assessment and reflection. Honest and objective self-assessment at the individual level can be challenging to achieve, especially given that professional identity is wrapped in the physician persona, and for a physician to be able to admit that he or she is not competent in something is a loss of self. It is critical that physicians intentionally seek assessment data via external metrics, such as number of patient complications, patient morbidity, or peer feedback regarding their practice.
Fifth, beyond the individual physician, the health care system has a critical responsibility for ensuring competency of physicians and surgeons for performing procedures. As medical education becomes more capable of determining competency through work-based assessments, it may be possible to determine which physicians no longer meet a competency threshold. Heath care systems need to have triggers that initiate exploration of physician competence, which might include frequency of safety events and complications, low volume of complicated procedures, patient reported outcome measures, patient and staff complaints, and low referral patterns from colleagues.10 These triggers should launch a more extensive examination of practice, including peer assessments, direct observation, health record analytics, cognitive testing, procedural testing, and other methods of competency assessment.6 It is important to recognize that the competencies that allow a physician the ability to practice are complex and multifactorial and, therefore, difficult to measure. Once an issue becomes apparent, the physician and health care system have a joint responsibility to ensure that the physician can demonstrate the necessary competency for practice skills or procedural expertise, retrain for the necessary skills, or retire that procedure from his or her practice.
Given the reality of forgetting curves, the medical profession has an important responsibility to ensure quality of care and to protect patients from potential harms. This requires physicians to understand how they acquire and maintain expertise, including the time, practice, and self-challenge necessary to achieve and maintain peak performance. Physicians also must understand that when they cease to perform certain clinical activities, such as uncommon procedures, previous experience can only go so far and performance may decline unless deliberate retraining steps are taken. However, it is first essential for physicians to be willing to recognize that safety for patients requires complete transparency about competency in clinical skills and performance.
Article Information
Corresponding Author: Sally A. Santen, MD, PhD, Virginia Commonwealth University School of Medicine, 1201 E Marshall St, MMEC 4-214, PO Box 980565, Richmond, VA 23298 (sally.santen@vcuhealth.org).
Published Online: December 26, 2019. doi:10.1001/jama.2019.21081