Pandemic Inspires and Challenges Medical Innovation

Pandemic Inspires and Challenges Medical Innovation

Pandemic Sparks Promising Future for Clinical Trial Speed and Flexibility

Like wartime medicine, the pandemic inspires and challenges medical innovation.

The silver lining of the pandemic is the reinvigorated sense of urgency breaking down
cumbersome and expensive barriers to the FDA’s phased approval process. While the research- lab-to-patient-arm trials for the highly successful COVID-19 vaccines famously moved the traditional pace to warp speed, other critical and life-altering medicines, devices and therapies also broke through during this period.

To be clear, the current surge of medical innovation through clinical trials in immunology, cardiology, multiple sclerosis, oncology and more, is not the result of a rush-to-market panic. All necessary and appropriate testing protocols to ensure quality are still being achieved, but at a more expedient pace in many cases. This is the good news.

“In times of crisis, we can accelerate the development and review process,” explains Andrew Badley, MD, infectious disease specialist, Mayo Clinic. “Throughout the pandemic, many of these steps were accelerated. No steps were skipped. It was just the amount of effort that went into the development and the review that was increased.”

Of course, there is also some not-so-good news about clinical trials today. During the pandemic, the number of new studies launched dropped by as much as 57 percent, according to Trials Journal, and the overall completion rate of clinical trials decreased between 13 and 23 percent globally. Shifting research priorities (11 percent of studies shifted to pandemic-related trials in 2020) and initial challenges in recruiting and following up with volunteer patients during the global lockdown contributed to this decrease. Often, a clinical trial is tethered to an academic medical center with participants centered in one geographical area, limiting volunteer pools and access.

However, the future speed and flexibility of clinical trial protocols is very promising, reflecting the long-term viability of alterations made to the fabric of patient care and research during the pandemic. Some of the new flexibility that is being assessed and considered for permanent use includes:

  1. Telemedicine. While telemedicine has been available for years, the lockdown most certainly fast-tracked adoption among researchers, regulators, physicians and patients. Clinical trial investigators can now use telemedicine for many patient check-ins, saving time and broadening the geography of volunteer pools. Dr. Ray Dorsey, a neurologist at the University of Rochester, noted in a recent article that his virtual clinical study of
    genetic predisposition to Parkinson’s disease moved forward more quickly amid the pandemic, spurred by a rising number of online enrollments.
  2. Delivery. Like specialty pharmacies and physicians during lockdown, clinical trial investigators are now allowed to deliver trial medicine to volunteers.
  3. Remote Access. Volunteer participants are able to use online platforms for completing consent forms, and they can often visit their local physician for basic assessments. Some
    trials also require less frequent check-ins, which can be important in recruiting volunteer patients. The growing number of smartphone-enabled applications that provide measurement of critical physiologic variables means patients don’t need to continually return to the hospital or clinic for tests during the trial. For instance, an entirely remote study testing vitamin D for treating COVID-19 and preventing transmission is being conducted by Brigham and Women’s Hospital; participants obtain their own blood samples with a finger prick, dot the blood drop onto filter paper supplied to them and mail it back.

The Clinical Trial Explainer

In the United States, the Food and Drug Administration (FDA) directs and approves all prescribed medicines, diets, diagnostics, devices and therapies. Clinical trials are the part of research that determines whether a medical intervention should be moved, or “translated,” from the lab to routine patient care. At each phase along the way, the team must answer different questions about safety, efficacy (whether the intervention works as intended) and whether there might be better options available. The current clinical trial journey to FDA approval, shown below, can take years, a mountain of paperwork and millions of dollars – there is room for improvement.

  • Preclinical phase establishes the pharmacological profile and determines toxicity on at least two animal species.
  • Phase I, a short study of 20 to 80 healthy people to determine safe treatment and dosing.
  • Phase II, a larger-scale study of targeted patients to determine treatment effectiveness and identify side effects; can take months to years to complete.
  • Phase III compares the trial intervention with existing therapies; requires several years of multiple data collection check-ins and comparisons. About 1 in 15 won’t make it past phase III.
  • FDA Review and Approval
  • Phase IV follows patients after therapy approval to ensure the intervention is working and prove the long-term benefits outweigh any risks or side effects.

J&J Vaccine Update: CDC and FDA Recommend Use of J&J’s Janssen COVID-19 Vaccine Resume

On April 23rd, the pause on using J&J’s COVID-19 vaccine in the U.S. was lifted. Click here to see the CDC/FDA official statement. For more information, click here to view or download a PDF of the CDC recommendations.

Please continue to check the CDC website for the latest vaccine information.

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New Year’s Resolutions Are So 2020!

What are your 2021 Anti-Resolutions?

Year after year, the pattern rarely varies. Resolutions made, promptly followed by resolutions broken. The odds of sticking to New Year’s resolutions are, in fact, completely stacked against us, as research shows a paltry success rate of between 10 and 20%. But since the challenges of 2020 have reconfigured every aspect of daily living, 2021 may be the ideal time to reset this ritual as well. Perhaps it’s time we consider this upcoming new year, the year of the anti-resolution for dieting, exercising, eating healthier and managing stress.

We’ve asked therapists steeped in mindful eating, body positivity and resilient thinking to help reframe this perennial wish list. There are no checklists to mark off or milestones to meet, just inspiration to view yourself and the world around you through a new lens.

Instead of Dieting in 2021… Consider being more mindful about what you eat.

Replace the resolve to lose weight on a diet with a shift to mindful eating. “Keep in mind that while all diets work in the short run, there’s not a single plan that has long-term results for the majority of participants, and that’s why people make the same resolution every year,” says Judith Matz, nationally recognized speaker, therapist and co-author of The Diet Survivor’s Handbook and Beyond a Shadow of a Diet. “The deprivation that comes from dieting often leads to overeating or bingeing, setting into motion an endless cycle of frustration.”

Instead, learn to eat when you’re hungry and stop when you’re full, and choose from a wide variety of foods, including healthful ones.

Matz describes the essence of the process. “First, learn to recognize when you are just beginning to feel hungry. If you have a headache, are crabby, irritable, fatigued and low on energy, you’ve waited too long and are much more likely to overeat as a result.”

Next, think about what food would make you feel satisfied. “Sometimes a fresh apple or a raw carrot is exactly what you want, and at other times you might want ice cream or a bowl of pasta. Depriving yourself of foods you love can be counterproductive – there’s room for all types of food,” she says.
For patients with specific medical issues, such as high cholesterol, Matz notes that adjustments can easily be made while still respecting the process: a craving for ice cream can be met with a sorbet instead.

Finally, trust your body to let you know when to stop eating. While that may sound simple, Matz counsels patience, especially for chronic dieters. “It can take time to tune in to your natural cues for both hunger and satiety.”

The key is to stop having rules around food and to really listen to your body. “Ultimately it’s about having a healthy relationship with food rather than focusing solely on eating so-called healthful foods,” she says.

Moving from body image to body appreciation.

An equally important shift is changing the desire for a new body size to a genuine appreciation of the body you have. Matz defines this as “body positivity, relating to your body with acceptance and respect rather than self-criticism and shame.” It means rejecting ingrained cultural messages related to body embarrassment and weight stigma and replacing them with ones that reflect inclusiveness and self-compassion. It encourages taking pleasure in natural body changes throughout your life cycle and not putting off anything you might enjoy doing because you’re not the “perfect” size or shape.

Body positivity also empowers you to view exercise positively rather than as punishment for having the wrong body. “Unhook exercise from weight, and focus on choosing exercise for endurance, strength, flexibility, stress reduction, health, social connection or just the simple pleasure of moving your body,” advises Matz.

Finally, refrain from focusing on weight loss praise, which reinforces the mistaken belief that you can’t be happy, healthy and successful unless you’re a certain body size, says Matz.
“Consider that body positivity is a gift we can give to support family, friends and, most notably, the next generation.”

Find joy in what you do and who you surround yourself with to reduce stress.

Resolving to manage stress effectively is an oft-expressed but infrequently realized New Year’s wish. But it can be triggered by one pivotal question, says influential family therapist Debbie Gross, who asks it at every session with a new client: “What brings you joy?”

She explains, “It’s transformational in terms of moving out of the survival mode many experienced last year, and into thriving mode. When people are in crisis, they become overwhelmed by the thought that no one will meet their needs. Their only goal is to focus on how to get through this moment; their attitude is ‘If I don’t take care of me, who will?’”

To stop the “anxiety spiral” in the brain, Gross recommends the “5, 4, 3” grounding exercise for staying in the present: “Focus on five things you can see, four things you can hear and three things you can feel, either physically or emotionally.”

And while it’s all too easy to devolve into perpetual doom and gloom against a backdrop of unceasing anxiety, Gross says we have a choice – Eeyore or Tigger?
“We can wake up each day just waiting for the next problem to come our way, or we can look at the world with more of a ‘beginner mind’ that recognizes small, everyday miracles,” she says. “It takes real work for some to switch the channel in their brain to that mindset, but the difference it makes is astounding.”

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Start 2021 off Right by Sticking to your Winter Exercise Plan

A Winter Workout Routine Will Prepare You For Life After COVID 

Exercise will reduce pain, improve function and mobility, lower blood pressure and blood sugar,  decrease risk of chronic illness and death from heart disease and many forms of cancer,  enhance mood and focus, and may even help reduce your risk of contracting COVID-19.

Despite those compelling benefits, only 5% of us stick to an exercise regimen. With months of  staying close to home base ahead, we asked national exercise expert Dr. Josh D’Angelo, PT, of MovementX to help us beat the odds and emerge from our winter cocoons fitter, stronger and  more limber than before.

“Recent research has shown that even a little bit of exercise and movement is beneficial in  improving your movement, health and life,” says Dr. D’Angelo. “We start with a focus on  functional strength training exercises because it provides the best protection against future  injury and helps with everything from mobility to balance. To maximize your gains, we  encourage supplementing with 15-20 minutes of aerobic exercise, such as walking briskly,  riding a stationary bike, dancing … or anything that gets you moving and you enjoy! And  remember, every little bit of movement helps.”

Following are some ways to get started, from MovementX’s “AgeProof Your Body” program:

Work toward repeating three complete sets of these fundamental exercises: squats, pushups  and abdominal strengthening for your core. Start with 5-8 repetitions each, and build weekly.  Rest, repeat.

  • Squats. Focusing on lower body and core strength, this is one of the most functional  activities and will also get your heart rate going. Proper mechanics are important.
    • Stand up straight, feet shoulder width apart.
    • Slowly bend knees and drop your hips backward to sit in chair. Rise and repeat.
    • Pro Tip: Push energy down in your heels and into the midfoot – you should be  able to wiggle your toes, and you should not feel discomfort in your knees or  back.
    • Advanced: Add load (dumbbells or household objects) or vary your speed as your  strength and endurance improve. Adding repetitions can also increase the  challenge
  • Pushups. These are challenging, but start with this beginner position and perform 5-8 repetitions until you can advance to a lower position and more reps.
    • Start by standing 18-24 inches away from a wall. Extend your arms and place  your hands on the wall, shoulder width apart. Lean toward the wall, keeping  your arms straight
    • Bend your elbows, allowing your body to come closer to the wall – let your chest  lead, and keep your body straight.
    • Push away. You should feel this in your chest, shoulders and core.
    • Advanced: How low can you go? As you progress with the wall pushup, start  with your feet farther away from the wall. Even lower? Position your hands on a  sturdy chair for a lower incline. Lower? Go to the floor on your mat, starting with  your knees set on the floor. The lowest is going for the full pushup position with  only your hands and toes touching the floor.
  • Abdominals Series. Core strength is key to developing functional fitness that helps  prevent injuries, reduce back pain and make your daily activities easier to accomplish.
    • Setup: Lie on your back with knees bent, feet on floor, and arms by your sides.  Your lower back should not be arched at all during this exercise; push it down  into the floor to tighten abs.
    • Slowly bring knees up toward your chest as you bend your elbows to let your  hands meet your knees (at the edge of the thigh).
    • Push your hands into your thigh just where it meets your knee, pressing your  hands up and toward the ceiling. Continue to do this for 20 seconds. Make sure  to breathe! Work your way up to holding for 30 seconds.

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Can We Co-Exist with COVID-19?

An Epidemiologist Separates Fact from Fiction and Offers Hope for the Future

Epidemiologists seek to learn why, how and when some people contract diseases when others don’t. Their findings are used to help monitor public health status, develop new medical treatments and disease prevention efforts, and provide an evidence base to healthcare and policy leaders.

Whether you feel the coronavirus is receding or set to surge, that testing is plentiful or inadequate, or that cases are reported as too high or too low may vary considerably based on where you live and your political leanings.

For an objective, no-spin perspective, we checked in with Jodie Guest, PhD, an epidemiologist at Emory University in Atlanta. Dr. Guest’s life’s work is studying the distribution, causes, prevention and control of diseases in populations.

Her answers to some of today’s most important questions about COVID-19 are below. Please note these reflect the situation mid-September…check our website for further updates.

Q: Are we seeing a slowdown in the number of new COVID-19 cases in the U.S.?

Dr. Guest: The number of new cases has, fortunately, plateaued or slowed down, but in many places the plateaus reflect substantially higher numbers than were reported in April, when everyone was still staying home. My concern is with schools and businesses reopening and less willingness to follow safety guidelines, the numbers may creep back up.

Q: What sites do you trust for accurate reporting on COVID-19?

Dr. Guest: I compare numbers from Johns Hopkins, Centers for Disease Control (CDC) and Worldometer to see if they match.

Q: What is the significance of the latest report from the CDC that just 6% of coronavirus deaths to date have COVID-19 as the only cause of death?

Dr. Guest: It’s not at all surprising for two reasons. One is that more than 60% of Americans have an underlying condition, such as obesity or diabetes. The risk of complications and hospitalization for people with two to three underlying conditions who contracted the virus is up to five times greater than for people with no [underlying] conditions. Second, death certificates list everything that may have contributed to mortality, including comorbid conditions and conditions caused by COVID-19 such as pneumonia. This does NOT mean that any of the more than 200,000 people who had heart disease or diabetes as an underlying condition didn’t actually die of COVID-19.

Q: Why are people of color and Latinos at greater risk of death from COVID-19?

 

Dr. Guest: This is not about a genetic risk of death. It’s driven by multiple factors, including a higher incidence of underlying conditions, less access to proper healthcare, greater risk of infection at the workplace and crowded living conditions that preclude social distancing.

Q: What is your take on the revised CDC guidelines that say testing for people who have been exposed to COVID-19 should be limited to those with symptoms?

Dr. Guest: Many of us in the public health community feel very strongly that we need to be testing asymptomatic people. From a public health perspective, more testing of asymptomatic people, not less, must be done to control the virus. NOTE: As of 9.18.20, CDC guidelines were revised again to state: “if you have been in close contact, such as within 6 feet of a person with documented SARS-CoV-2 infection for at least 15 minutes, and do not have symptoms, you need a test.”

Q: What are the relative risks of activity as we move forward?

Dr. Guest: There’s so much variation based on how carefully an activity is done, but there are four good rules that apply to all: Outside is safer than inside, shorter time is safer than longer, small groups are safer than bigger, and distance is safer than closeness.

Q: How might COVID-19 affect the epidemic of flu we see annually?

Dr. Guest: If we take COVID-19 prevention measures seriously – masking, social distancing, handwashing – we could have a light flu season. If we don’t, COVID-19 will make it worse. The good news is that this has already spurred many people to get their flu shots.

Q: Any other silver linings you’re seeing?

Dr. Guest: For the first time, we are having a national conversation around health disparities and inequalities. We might actually come to a reckoning and take corrective action, and that would be spectacular.

Q: What is most important for people to know about getting back to normal?

Dr. Guest: Eventually we’ll have a vaccine but we’re not going to eliminate COVID-19 completely. However, there needn’t be this level of impact on our society. I can’t emphasize enough that we have control over how this virus spreads. We need strict guidelines and most importantly, a social contract with everyone in your community. This may be the first time many of us are asking “What are we willing to do for each other?” I hope we can all rise to the challenge.


When considering whether it is safe to resume an activity, there is much variation based on how carefully an activity is done. Additional details are provided in the infographic below, courtesy of www.covid19reopen.com

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