Tag Archives: coronavirus

CRS: Congress Can Rein In FDA’s Flexible COVID-19 Vaccine Trial Policies

Beth Wang, Inside Health Policy: June 03, 2020


The Congressional Research Service says Congress could rein in FDA’s broad discretionary authority over vaccine clinical trial policies by legislating how the agency and Institutional Review Boards approach clinical trial designs and reviews for the current COVID-19 pandemic, as well as for future emergencies. In a Tuesday (June 2) report, CRS suggests Congress could provide more specific direction to FDA and IRBs on how to approach clinical trials in emergency situations, and also could appoint a neutral scientific body to consider ethical and scientific issues as well as general guidelines for trials. Congress also could fund global collaboration among regulators, and provide additional funding and resources to facilitate clinical trials, the report suggests, echoing recent calls from lawmakers who have said the United States should get involved with global efforts to fund and develop COVID-19 vaccines and treatments.

Diana Zuckerman, president of the National Center for Health Research, applauded CRS for explaining the vaccine approval process to Congress and for telling lawmakers what their options are so Congress can, in Zuckerman’s words, “ensure a better outcome than we’ve seen with the disastrous coronavirus testing situation (in terms of accuracy, transparency, and availability).” The document, she told Inside Health Policy, does a good job of explaining that FDA has authority to lower approval standards for any drug or vaccine unless Congress steps in. “[B]ased on FDA’s actions of the last 3 months, it seems likely that they will do so in ways that could create the free-for-all that currently exists for coronavirus testing,” Zuckerman wrote in an email. “So the CRS is telling Congress that legislation is the option they have if they want to ensure a better outcome.”

Existing law, CRS says, requires FDA and IRBs to weigh considerations about safety and effectiveness against the desire to bring products to market quickly when evaluating proposed clinical trial designs for vaccines.

[…]

Congress previously told FDA what to do in the drug trial and approval space through passage of the 21st Century Cures Act, but FDA was given leeway in how to interpret the law, Zuckerman explained. “It pushed FDA in a particular direction but still gave the FDA the authority to rely on the agency’s subjective judgment,” she said. If Congress were to step in and tell FDA what it should do, it would be a radical departure, Zuckerman added. “[But it’s] probably necessary given FDA’s response to the pandemic so far, and the Administration’s track record of ignoring Congress when it suits them,” she said.

Read the entire 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 or Compromised Immune Systems Need to Know about Coronavirus (COVID-19)

National Center for Health Research: April 1, 2020


The coronavirus can infect anyone, young or old, healthy or frail. People with cancer and other serious health conditions, and their loved ones, need to be especially careful. Here’s what you need to know.

Some 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. 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 surgery, screening, or other procedures that were considered not urgent or not immediately life-threatening, those might have been 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.  If you are battling cancer or doing follow-up after successful treatment, you don’t want to be exposed to the coronavirus when you go in for surgery or testing procedures.  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.

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.

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 droplets when a person coughs or sneezes – or even when they breathe normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

It is most contagious when the person has 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.  However, most of the time the virus is spreading through close contact with people who have it.

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 most common symptoms are:

  • Fever (this can come and go)
  • dry cough
  • tiredness

Other symptoms include:

  • shortness of breath
  • aches and pains
  • sore throat
  • trouble breathing
  • chest pain or pressure
  • pink eye (conjunctivitis)
  • loss of sense of smell (and sense of taste)

These symptoms are less common but can be signs of COVID-19:

  • runny nose
  • diarrhea
  • nausea or vomiting
  • abdominal discomfort

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, 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, 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 it. There are no proven medications or vaccines, so don’t be fooled by false claims (especially those made by telemarketers).

“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 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
  • avoid public spaces
  • avoid public transportation and unnecessary travel
  • avoid social gatherings
  • work from home
  • stay at least 6 feet away from people when out in public
  • 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?  Experts say that you only need to wear a face mask if you have the virus, to avoid infecting other people you must come in contact with.  It is not clear that it protects you unless you are in close contact with someone with the virus.  If you want to be extra cautious, since the masks that doctors and nurses use are in short supply, you can use homemade masks or scarves to cover your face when you are out in public.  But you should NOT be out in public except when absolutely essential.

If you are undergoing cancer treatment that can weaken your immune system or cause lung 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 a fever, cough, or shortness of breath, call your doctor. If you are currently receiving chemo, a fever is a medical emergency.  Other severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, means 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 week has 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@center4research.org and we’ll get back to you as soon as possible.