Tag Archives: COVID19

Hahn Defends Using Less ‘Robust’ Data During COVID, But Critics Contend It Has Gone Too Far

Sarah Karlin-Smith, Informa Pharma Intelligence: June 04, 2020


[…]

Anecdotes Are Not Data Sets

The regulatory flexibility touted by Hahn was embraced to some degree by even some of the agency’s most notable critics, who agreed that the nature of the COVID-19 pandemic should allow for a different pace of decision making than under normal circumstances. However, they said they were concerned that FDA is misusing such flexibility, particularly when it came to the emergency use authorization (EUA) for hydroxychloroquine and chloroquine.

“I agree with Dr. Hahn that in emergency situations it makes sense to move quickly and change course quickly if the evidence is different from what was hoped for. But the only justification for making [hydroxychloroquine] immediately widely available was that President Trump had ‘a good feeling about it,” said Diana Zuckerman, president of the National Center for Health Research.

The EUA was granted based on laboratory data and anecdotal clinical reports. (Also see “FDA’s Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments” – Pink Sheet, 30 Mar, 2020.)

Zuckerman described this not as datasets but as anecdotal evidence. “Scientists don’t call anecdotal evidence datasets. As any scientist can tell you, the plural of anecdote is ‘anecdotes’ not ‘data,”” Zuckerman said.

In an emergency situation “making decisions on the fly and using the best data that you have is inevitable,” but the agency should follow certain principles when it does this, said Aaron Kesselheim, the director of the Program on Regulation, Therapeutics and Law at Harvard Medical School and Brigham and Women’s Hospital.

Kesselheim’s third principle was that the FDA should revisit or revise these decisions just as quickly as they made them when new information emerges. He said the FDA has done a good job in some circumstances of adhering to these principles and done less well in others.

As Hahn mentioned in his speech, the agency has reversed some of its early EUAs for COVID-19 tests. (Also see “FDA Yanks Potentially Faulty COVID-19 Antibody Tests – And More May Be On The Chopping Block” – Medtech Insight, 22 May, 2020.)

[…]

Read the full article here.

How MLB is navigating the coronavirus pandemic to play ball

ESPN staff, ESPN: May 19, 2020


MAJOR LEAGUE BASEBALL’S plan to start the season by July 4 relies on a dizzying array of moving parts, including the cooperation of 27 U.S. cities and a foreign country, the availability of more than 200,000 reliable coronavirus tests and a promise not to interfere with the nationwide fight to contain the pandemic.

ESPN examined the challenges facing MLB as it struggles to get back on the field. What emerges is like nothing that has been attempted in the history of American sport, less a baseball season than a military-style operation in which any number of variables could derail the plan, or, worse, contribute to the spread of the deadly disease.

[…]

WHEN MLB ABANDONED the idea to play the season under a bubble-like quarantine, it eased the restrictions that players would face but also created a riskier and more complicated scenario, according to health experts.

Even if teams are limited to regions — reducing travel, as the plan anticipates — players and other personnel will still travel between cities where people are living under different health orders and the virus may be spreading at different rates. Some states have reopened more than others and are projected to see a spike in cases, while others remain all but closed. Georgia, for example, partially ended its stay-at-home order on April 24, lifting restrictions on gyms, bowling alleys, hair salons and other businesses. In Cobb County, where the Braves play, new cases have been averaging about 50 a day. Some models and experts predict Georgia will soon see an increase in deaths because of the reopening.

“I wouldn’t want to put players in Atlanta’s ballpark,” said Beth Blauer, the executive director of the Johns Hopkins Center for Civic Impact, which specializes in the use of data to advise governments and nonprofits on best practices. “You have to determine where to play based on that modeling. You can’t bring players into hot spots. … You’ll know between mid-May and June how devastating the decisions are and where the new hot spots are, potentially.”

Alex Fairly, CEO of Fairly Group, an Amarillo, Texas-based risk management firm whose clients include MLB and the NFL, served as chairman of Lt. Gov. Dan Patrick’s Back to Work Task Force on Sports and Entertainment, which included representatives of the Astros and Houston Texans. The challenge of figuring how sports will be staged safely “fried my brain,” said Fairly, adding that the process caused him to lose sleep. “There are 8,000 issues. No one knows exactly what to do because this has never happened. It’s a true black swan moment.”

Baseball’s plan designates about 100 essential employees per team — players and other on-field personnel and “a limited number of essential staff who come in close proximity to the players.” These “Tier 1” and “Tier 2” individuals will be tested multiple times per week, though the plan doesn’t specify how many times that would be. The plan says nothing about regular testing for 150 “Tier 3” individuals who are involved in “essential event services” but will be separated from the others. If those people come into contact with someone who has the virus, they will be tested.

Beyond their families, teammates, managers and other baseball personnel, players still will be exposed to a broad range of people — from hotel staff to security personnel; from bus drivers to flight attendants. All will be traveling in their own circles when not working; MLB’s plan does not say anything about testing those workers. That creates added potential for an outbreak, experts said.

“One of the things I try to explain to people is that whatever other people are doing who live anywhere near you, is gonna affect you,” said Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., a nonprofit independent think tank. “Just because you’re not going to get a tattoo when you’re in Georgia when your team is playing the Braves, if the person serving you at the restaurant is married to a person who got a tattoo or married to the person who is the tattoo artist, then you as a customer at that restaurant or even picking up carryout has the potential for being contaminated by those people who are doing those things.”

Keeping stadiums and other areas sterile will be a perpetual ordeal. It will involve perimeter security to keep fans away, both at the ballpark and hotels, where autograph seekers often congregate.

[…]

IN INTERVIEWS WITH dozens of health care experts — doctors, epidemiologists, immunologists, policy specialists, government authorities — there was consensus that the main component to keeping baseball safe will be diagnostic testing. That’s the same issue that has bedeviled the national effort to combat the coronavirus.

The goal of testing is to weed out and isolate those who test positive and prevent outbreaks. The risks of insufficient testing are incalculable. Clusters of the coronavirus have erupted in group and travel environments. In early March, more than 100 people became infected at a Boston leadership conference of Biogen, turning the drug company into an unwitting spreader of the disease to other states.

With that nightmare scenario for baseball in mind, and players and staff traveling in and out of their communities, it’s imperative for MLB to ferret out positive cases before they spread, the experts said. MLB’s plan calls for testing players and personnel “multiple times” per week, but not daily, as some experts suggest.

“If you were doing daily testing, you’d have the ability to pick up very low numbers on the virus, pick it up as soon as somebody has the ability to transmit,” said Dr. Melissa Nolan, an infectious disease expert at the University of South Carolina.

Nolan described MLB’s testing plan as a B-minus — compared to an A-plus if you were testing daily — but said she believed it could be effective, particularly if players are diligent about social distancing and limit their exposure away from the ballpark.

Trout told ESPN: “I don’t see us playing without testing every day.”

Dr. Howard Forman, a Yale professor of health policy who has offered guidance to some sports leagues and teams, said he believes baseball’s plan should work. He noted that data suggest the prevalence of the virus among top-level athletes is likely to be extremely low, plus it will be easier to limit exposure without fans and other workers at the ballparks. Forman wouldn’t say which leagues he had spoken with.

Under MLB’s plan, only the person who tests positive will be quarantined. That policy conflicts with current Centers for Disease Control and Prevention guidelines, which call for anyone who has had close contact with a confirmed case to quarantine for 14 days. “Our experts are advising us that we don’t need a 14-day quarantine [in such cases],” Manfred told CNN. The plan says baseball is following rules established by “health care institutions and governmental entities” but does not specify which entities.

Baseball is in a difficult position: Quarantining players who come in contact with infected individuals could force MLB to shut down entire teams.

Most health experts interviewed by ESPN said they believe MLB would be increasing the risk of an outbreak by not quarantining more extensively, if only for a few days.

“CDC guidelines are pretty clear that anybody who makes substantial contact with somebody who has the virus needs to be quarantined,” Dr. Ashish Jha, director of the Harvard Health Institute, told ESPN. “I think baseball has to ask themselves on what basis are they going against the CDC guidelines. How confident are they gonna be that another player on another team didn’t have substantial contact with that player? It just strikes me as risky. My feeling is it just depends on how lucky you feel.”

Zuckerman, who runs the nonprofit think tank in D.C., said, “I could understand not quarantining for 14 days, because potentially you’d end up never being able to play. But not quarantining at all seems dangerous.” But Humble, the former Arizona health director, said MLB developed “a reasonable plan. The idea of the CDC guidance is to minimize risk, so if you find another way, that’s OK. Guidance shouldn’t be one-size-fits-all. This may even be better, because of the frequency of testing, which is robust.”

After a positive test, clubs are required to work with local health officials to trace those who came in contact with the infected individual. Those people will receive an expedited test and, if negative, will be allowed to remain active — raising the possibility that people exposed to the virus could return to baseball within minutes. Baseball’s plan calls for additional testing of those individuals every day for one week, with results returned within 24 hours. “That’s time someone could be infecting other players, staff, their families,” one union source said.

Experts told ESPN that it can take several days for someone to test positive after contracting the virus.

[…]

Read the full article here

You Can’t Travel, but You Can Vacation at Home

Hilary Nangle, AARP, May 12, 2020


In a pre-Covid-19 world, the freedom to be at home without obligations would have seemed like a vacation. But isolating for the coronavirus has changed that perspective. The American belief in productivity may make some feel guilty for taking a vacation day at home, but experts say that it’s no less important to do so now than it was before the pandemic.

“It’s important because it seems like something that we shouldn’t do, because with no place to go, it feels like a waste of time,” says Andrea Bonior, a clinical psychologist in Bethesda, Maryland, and author of Detox Your Thoughts. “We have this big blurring between working and home, and taking a day off is a way to reclaim that boundary.”

Home should be a place for pausing, resting and healing, Bonior says, and she recommends doing something creative, social or nourishing with an “off” day at home — even watching TV without guilt. It may seem silly, because you may be working at home anyway, but it’s important to reclaim some space emotionally, and time off — without commitment or obligation — is key to helping lower overall stress levels.

Over the past few years, it has become “harder to distinguish vacation days from other ones,” says Diana Zuckerman, a psychologist and epidemiologist and president of the National Center for Health Research in Washington, D.C. But, “it’s important to have at least a day or two when you don’t work.”

How to plan a ‘home-cation’

But how does one vacation, literally, in the home? Bonior recommends starting by thinking about where, if you could travel, you would go. “That’s a clue to your values right now. If you would choose to spend time with other people, maybe spend time connecting digitally with others.” You might play a game, host a watch party for a movie, or start a book group online.

If you’re thinking about nature, you’re probably craving fresh air and sunshine. Depending upon your circumstances, maybe find a safe place to take a long walk. Or, if you have a backyard, sit outside and read or enjoy a garden. “Don’t dismiss the importance of sunshine, even through a window,” Bonior says. Pair that with watching nature documentaries or travel shows or simply looking at pictures of trees. “There’s research literature on how even looking at pictures of trees makes people feel better,” Zuckerman says. “For a lot of people, nature really does make a difference. Looking at the natural world can be uplifting.”

Some “home-cation” ideas require a bit of advance planning, others can be as easy as allowing yourself to make popcorn and watch movies. Speaking of movies, why not create a daylong film festival? Pick a genre, location or actor and queue up related movies. Or, create a music or dance festival.

Whether you’re pining for France, coastal Maine, a spa escape, or a camping getaway, you can recreate a semblance of your dream trip by using your senses to help evoke the experience. Think about typical food and drink, not only the flavors but also the aromas and textures; think about what you’d see and hear; and think about what you would do. Now set about recreating that at home. Here, a few examples to get you started.

Vacation in France without leaving home

If France is calling to you, spend a day there. Let technology aid your imagination and help you travel faster than the old Concorde. First, listen to Edith Piaf or other typical French music to set the mood. Then get ready for some virtual tours. Go up into the Parisian signature Eiffel Tower, built for the 1889 World’s Fair; descend into the Lascaux Caves in southwestern France to see the prehistoric cave paintings; discover the Mona Lisa without a hint of crowds at the Louvre or browse the paintings in Museé d’Orsay.

You may not be able to stroll the incredible Champs d’Elysses, but you might tantalize your taste buds with the flavors of France you would find along that avenue; perhaps a green salad with bread and a cheese and charcuterie plate. Or maybe make a delicious croque monsieur (a fancy-pants broiled ham and cheese).

Read the full article here

Tests for COVID-19: Has the FDA said yes too many times?

By Robert M. Kaplan and Diana Zuckerman, The Hill Opinion Contributors, May 6, 2020


There are many controversies about the coronavirus, but there is one point of consensus: We need testing, testing, and then more testing. But yesterday, in response to criticisms from chairs of two House health subcommittees, the FDA tightened their standards for antibody tests intended to identify people who were previously exposed to the coronavirus. Why?

Typically, the FDA approves tests based on evidence of accuracy. But, under the urgency of the pandemic, the FDA temporarily lifted the requirement that tests be validated before they are marketed. Until the new policy was announced, it was not clear when or if the FDA would review the accuracy of each test.

The FDA website shows that, to date, the FDA has temporarily approved coronavirus testing for 84 different labs and companies. There were 14 new approvals in the last week alone and more than 400 more applications are waiting for FDA’s review. Unfortunately, none of the tests currently available – not the 84 and not the other 400 — have a record of proven accuracy that can be independently verified.

[….]

What happens when hundreds of unvalidated tests flood the market? Monitoring a pandemic requires accurate, consistent information. With so many tests, we can’t know when cases are peaking, stabilizing, or decreasing in different communities — and therefore, when it is possible to loosen restrictions on social distancing.

Read the article here https://thehill.com/opinion/healthcare/496403-tests-for-covid-19-has-the-fda-said-yes-too-many-times

 

What People With Cancer Need to Know about Coronavirus (COVID-19)

Cancer Prevention and Treatment Fund: May 18, 2020

The coronavirus can infect anyone, young or old, healthy or frail.  Here’s what you need to know.

People who are over 60 or who have cancer and other serious health conditions, and their loved ones, need to be especially careful.  Anyone with high blood pressure, heart disease, or cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.  For other types of cancer, treatments such as chemotherapy, targeted therapies, immunotherapy, and radiation, can weaken the immune system and possibly cause lung problems. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus.

Blood cancers such as leukemia, lymphoma,  and myeloma also attack the immune system and therefore reduce the patients’ natural defenses and making them susceptible to infections. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus. Anyone with cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.

If you had scheduled medical appointments, surgery, screening, or other procedures that were considered not urgent or not immediately life-threatening, those were probably postponed. This is for everyone’s protection.  Many hospital staff,  including doctors, nurses, receptionists, and cleaning staff, have been exposed to the virus and don’t know whether they can infect others.  You don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures for other medical conditions.  And, you don’t want your medical center to be less able to fight the coronavirus at a time when it is spreading throughout your community.  However, if non-urgent medical appointments are being rescheduled again in your community, you and your doctor should decide whether or not to try to get an appointment soon, or whether to delay those medical visits or procedures for a few more weeks.

The coronavirus is spreading in all 50 states, in urban, suburban, and rural areas, so it is important to listen to health experts (and governors or mayors) who tell you to stay home, limit contact with others, and keep a distance of 6 feet away when you or your family members or caregivers go grocery shopping or other essential activities.  Unfortunately, some governors, mayors, and state legislators are reopening businesses for economic and political reasons, despite the health risks to patients.  Even if you are staying at home as much as possible, the fact that others in your community are going to restaurants, stores, and hair salons will put you at greater risk when you make essential visits to the supermarket or to the doctor, because you may come into contact with people who are infected because aren’t being as careful as you are.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.  Since it is new, nobody has immunity from it.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through invisible or very tiny droplets when a person coughs or sneezes – or even when they breathe or talk normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

The virus is thought to be most contagious just before or after a person develops symptoms, but it is possible to catch the virus from infected people who have no symptoms at all.

In addition, these droplets (as well as fecal matter containing the virus) can end up on surfaces where it can survive for hours or even days. When you touch these surfaces and then touch your face, you can be exposed to the virus. That’s why it’s important to wash your hands regularly.  If you don’t have antiseptic wipes, you can wipe down surfaces in your bathroom, kitchen, and other rooms with bleach of rubbing alcohol to help prevent exposure.

What about food or food packaging?  The risk of catching the virus from packaging is very low, but since the virus can survive for up to 24 hours on cardboard and up to 3 days on plastic and stainless steel, it’s a good idea to wash your hands for at least 20 seconds after handling mail, takeout containers, and packaging from groceries. You can also disinfect food packages using a cleaning product that kills viruses, but don’t use disinfectants on food.

What are the symptoms of COVID-19?

Symptoms tend to start between 2 and 14 days after coming into contact with the virus.  Although some people have compared the symptoms to a cold or flu, there are some differences. The CDC says that people with these symptoms or combinations of symptoms may have COVID-19:

  • Cough
  • Shortness of breath or difficulty breathing

Or at least two of these symptoms:

  • Fever
  • Chills
  • Repeated shaking with chills
  • Muscle pain
  • Headache
  • Sore throat
  • New loss of taste or smell

Those are the most common symptoms.  However, children or adults can have other symptoms as well, including heart problems and “covid toes” that look like a minor case of frostbite. Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe.  These are the ones that require immediate medical attention:

  • difficulty breathing or shortness of breath
  • persistent chest pain or pressure
  • confusion or inability to awaken
  • blueish color in the lips or face

People who are older than 60, people with high blood pressure, and people who have existing serious health conditions, such as heart disease, lung disease, and diabetes, are more likely to develop severe illness and complications from COVID-19. This includes people who are receiving cancer treatments that can weaken the immune system.  The most serious complications include pneumonia, stroke, blood clots, organ failure, and death.

How can I protect myself and others?

The best way for anyone to protect themselves is to avoid being exposed to the virus. There are no proven cures or vaccines, so don’t be fooled by false claims (especially those made by telemarketers).  The one medication that has been proven to help very ill patients by reducing the number of days of hospitalization is remdesivir, which is not widely available and has not been proven to save lives.  Despite the hopes of the White House, hydroxychloroquine with or without azithromycin is not recommended because it has been found to increase heart problems and has not been shown to prevent or treat COVID-19.

“Social distancing” or “physical distancing” refers to staying away from other people because it is impossible to know who has the virus.  The safest people in your life are the ones you are living with who are not exposed to others who might have the virus (in other words, they are not going to work or spending time close to other people). Staying at home and not seeing your friends and loved ones is not fun, but it is essential for your own safety and for everyone else’s.  If everyone does that now, the spread of this virus will be reduced sooner, and some of these restrictions will no longer be necessary in a few weeks.

  • stay at home or go outside in your yard or neighborhood where you can keep at least 6 feet away from others
  • avoid public spaces where there are other people, especially indoors
  • avoid public transportation and unnecessary travel
  • avoid all social gatherings that are indoors or where people are close together
  • work from home
  • stay at least 6 feet away from people when out in public (indoors or outdoors)
  • avoid physical contact in social situations, such as shaking hands, hugging or kissing

AND

  • wash your hands using soap and water for at least 20 seconds, especially after being out in public
  • use alcohol-based hand sanitizer when soap and water aren’t available (or wash your hands as soon as you get home)
  • avoid touching your face when your hands aren’t clean or you are out in public
  • avoid contact with people you don’t know very well
  • clean and disinfect surfaces you touch daily, including things you might not think of like doorknobs, light switches, faucet handles, and phones. Make sure you use a cleaning agent that is effective for killing viruses.

What about a face mask?  Since we don’t know who has the virus and who doesn’t, masks provide some additional protection when you are out in public or with people you don’t live with.  But you should NOT be out in public or with people you don’t live with except when absolutely essential.  Even though some states are encouraging businesses to reopen, that doesn’t mean it is safe for you to go to them.  Especially avoid those that require closeness to others or whose workers are close to many other people, such as a tattoo parlor, hair or nail salon, restaurant, or movie theater.  If you must go to a store, try to go to one that makes appointments with customers or limits the number of customers, and spend less than one hour indoors to reduce exposure to any coronavirus that is in the air.

If you have a weakened immune system or other serious health problems, here are extra steps to protect yourself:

  • Make a plan with your doctor to monitor for symptoms
  • Avoid friends and family except those you live with or depend on for essentials.  Otherwise, rely on your phone to maintain contact.
  • Have a plan with your loved ones or caregiver if you or they get sick
  • Have the medications you rely on and order any you need in advance (to be delivered, if possible)
  • Ask a friend or family member to shop for groceries for you
  • Wash your hands (20 seconds with soap and water) even more often if you are exposed to others

What should I do if I develop symptoms?

If you develop more than one of the symptoms listed above, call your doctor.  If you have severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. But, if you are receiving treatment for cancer, be sure to tell your doctor.  Do not just show up at the doctor’s office with symptoms:  Call them first so you have tell them about your symptoms and they can help decide what to do.  If you do become sick, you can take the following steps to protect others:

  • Stay home, unless you need essential medical care
  • Wear a facemask when you are near others.  (People caring for you should also wear a facemask).
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one or two weeks have passed since you first noticed symptoms or your fever goes away for 3 full days without fever-reducing medicine.  If you have been diagnosed with COVID-19 based on test results, you should follow these steps until you have 2 negative test results taken 24-hours apart, your fever goes away without fever-reducing medicine, and your symptoms improve.

What if my cancer treatment is delayed?

When a person is diagnosed with cancer, they are likely to want treatment as soon as possible.  Treatment or testing may seem more urgent than it really is, especially with cancers that often grow slowly, such as prostate cancer or breast cancer. And, if you don’t have COVID-19, you don’t want to be exposed to it during cancer surgery, testing, or follow-up appointments.  Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@stopcancerfund.org and we’ll get back to you as soon as possible.