36 We are dedicated to improving the health and safety of adults and Is a COVID-19 Vaccine a Good Idea for You? Will Your Life children by using research Go Back to Normal? to develop more effective treatments and policies. If you are at high risk of COVID-19 because you are The Cancer Prevention older, have cancer or other serious diseases, or even if you’re at average risk, you’re probably wondering and Treatment Fund is our if you should get a vaccine as soon as possible. As major program. we write this, there is not yet a COVID-19 vaccine that is widely available. But, we have preliminary data about some of the vaccines. The goal of this article is to give you the information you need to help you make an informed decision. We will also try to answer this key question: Will the vaccines be good enough so that life goes back to normal? On October 22, the FDA held a public Advisory gotten the vaccine. That sounds very impressive. Committee meeting to discuss the scientific However, these studies must continue and it could standards needed for a COVID-19 vaccine to be be many months before the studies can conclude Our Cancer Prevention considered good enough to be sold. Food and Drug whether the vaccines prevent hospitalizations or and Treatment Fund helps Administration (FDA) approval standards are deaths of the people most at risk. And it could be higher than the standards for FDA’s “Emergency much longer before we know if people taking either adults and children reduce Use Authorization” (EUA). That’s why we would of these vaccines are immune from later COVID have more confidence in a vaccine that was infections. their risk of getting cancer approved by FDA, rather than authorized through and helps everyone get the an EUA. Meanwhile, we remain concerned about the major flaws that we described in our testimony: best possible treatment. At the meeting, we were impressed by how U.S. government agencies are working to prepare for a The FDA asked companies to measure COVID-19 vaccine to be evaluated and effectiveness in terms of reducing “symptomatic Cancer Helpline: disseminated. However, in her testimony before the COVID-19.” They defined symptomatic COVID- [email protected] Advisory Committee, NCHR president Dr. Diana 19 as a patient who tested positive and has at Zuckerman expressed her concerns that the vaccine least 1 symptom. However, the symptom could Websites: trials that FDA has required have serious design be very mild, such as a mild cough. www.center4research.org flaws. The standards set by the FDA and described in the companies’ studies make it likely that at least www.stopcancerfund.org some COVID vaccines won’t achieve what the public The FDA requires the companies to study at expects. Instead, it is likely that some vaccines will least half of the participants for at least 2 Twitter: only be proven to reduce the risk of mild infections, months after they were vaccinated or given the @NC4HR but won’t be proven to reduce the risk of placebo. That is too short to study how well a @stopcancerfund hospitalization, ICU use, or death. vaccine works. Some patients won’t even be @Implants101 exposed to the virus within 2 months. For those In November, Pfizer and Moderna each announced that are exposed, we need a longer follow-up to Instagram that their preliminary research indicated that their know how long an effective vaccine remains @safe.to.play COVID vaccine was approximately 95% effective. We can’t rely on later studies for long- @breastimplantinfo effective. However, only 100-200 of the 30,000- term effectiveness information, because once a 40,000 participants in each trial had tested positive vaccine becomes widely available, most people for the virus and had at least one mild symptom. don’t want to participate in a study where they Each company announced that 95% of those COVID might get the placebo instead of the vaccine. patients were in the placebo group and only 5% had Continued on Page 6 Board of Directors Brandel France de Bravo, MPH Consultant Sarah Deutsch, JD Daniel Fox, PhD President Emeritus, Milbank Memorial Fund International Consortium of Investigative Journalists, Ben Gitterman, MD July 2, 2020 Associate Clinical Professor Pediatrics and Public Health George Washington University Nancy Hardt, MD Cosmopolitan, August 18, 2020 Professor Emerita of Pathology and OB/GYN at University of Florida College of Medicine Judith L. Harris, JD President, Matthew Harris Ornstein Memorial Foundation Alan Mendelson, LLD Axion Venture Partners Omega Logan Silva, MD Former President, American Medical Women’s Association Duchy Trachtenberg Former Councilmember Montgomery County, MD Susanne Wilke, PhD, MBA Venture Capitalist At an FDA Advisory Panel Meeting on COVID-19 Many people are turning to telemedicine as a Susan F. Wood, PhD vaccine safety in October, NCHR president Dr. way to see their doctors during the pandemic. Research Professor Diana Zuckerman said that current vaccine trials NCHR’s president told Drugwatch that to George Washington University “have serious design flaws” because they don’t make sure patients get the most out of their require that the vaccines save lives or prevent visits, they should prepare all of their questions Diana Zuckerman, PhD hospitalizations. She told The Wall Street President and concerns in writing in advance. Nat’l Center for Health Research Journal and Bloomberg News that the two- month follow-up the FDA asked for is too short to We can’t be show how long the vaccines will work and bought. whether they will prevent the most serious Allergan announced it had been unable to find and infections. Or will it only prevent mild symptoms notify 52,000 women whose textured breast for people at lower risk? implants had been recalled due to cancer risks. Our Center doesn’t NCHR’s president told Fortune that accept funding from Allergan needed a major ad campaign to notify drug companies or women, instead of expecting patient groups to do device As Major League Baseball and the National all the work. And when FDA sent a warning letter manufacturers, so Hockey League tried to figure out how to to Allergan because they didn’t complete required we rely on the continue professional sports during a studies, Dr. Zuckerman told the International pandemic, Dr. Zuckerman was interviewed for Consortium of Investigative generosity of several articles in the Washington Journalists that breast implant companies rarely individual donors. Post sports pages about the lax standards for comply with FDA requirements because FDA never You can donate baseball and the more credible safeguards for penalizes them for not complying. online at the NHL. stopcancerfund.org Page 2 Does Online Therapy Work? Thank you to our By Meg Seymour, PhD, NCHR Senior Fellow people not receiving therapy, to determine if online wonderful therapy makes a difference. It did. In addition, the It’s been an unusually stressful year for many one study that directly compared the effectiveness of President’s Americans. Financial problems and job insecurity, the online CBT to in-person CBT found that the two taking care of children while working from home, and methods of therapy were equally effective at reducing Circle Donors: worrying about contracting the coronavirus have depression. The people who stayed in therapy the made it a tough year. Many people feel socially longest had the greatest benefit in reducing their isolated and lonely due to social distancing depression. Dianne and Rick Ammons requirements and precautions. Adding to that, many Holly Bilden-Stehling were concerned about the election and policy issues A 2020 study looked at another type of therapy called that affect their lives every day. Solution-Focused Brief Therapy, which Diana Conway focuses on setting goals and finding solutions to one’s Sarah Deutsch There is research to back up what might seem problems. The researchers randomly assigned college obvious: In a July 2020 survey by the Kaiser Family students with mild to moderate levels of anxiety to Bill Gittler Foundation, more than half of American adults receive either online therapy or in-person therapy. Judith Harris reported that worry and stress over the pandemic had Both methods of therapy were equally effective at negatively affected their mental health. Rates of reducing anxiety. Janet Holt anxiety were more than 3 times as high as they were a Eldon Horst year earlier, and rates of depression were close to 4 Some research has studied the effectiveness of online times as high. According to a June 2020 report therapy for treating PTSD. A review of more than 40 Judy and Peter Kovler published by the Centers for Disease Control and studies found that both online and in-person therapy Lisa Lopez Prevention (CDC), adults were twice as likely to report reduced PTSD symptoms. The therapies included CBT seriously considering suicide in the past 30 days as well as a type of trauma therapy called Cognitive Alan Mendelson compared to the percentage of adults who reported Processing Therapy. Not only did online seriously considering suicide in a 2018 survey. therapy reduce PTSD symptoms, but patients were Claudia Miller equally likely to stick with either method of therapy. Patricia Mitchell But at the same time that stress is up, options for And, those who had online therapy were just as treatment have changed. To make therapy safer, most satisfied with their experience as the in-person Patricia and Jerry Olson now takes place over online video chat programs, therapy patients. Renee Ridgeley rather than a traditional in-person session. Is online therapy, also called teletherapy, as effective as What is Still Unknown? Susanne Wilke meeting in-person? Jennifer Yttri CBT is considered an effective form of relatively short-term therapy, but it would be helpful to also Pam and Barry Zuckerman study teletherapy using other types of therapy, and for issues other than anxiety, depression, and PTSD.