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March 2021 Patient Network Digest
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Josh Sharfstein & Janet Woodcock Illustration: Alex Hogan/STAT; Photo: Getty

FDA Commissioner: Who Would You Choose?
 
Today—approximately one year after COVID-19 changed all Americans’ daily lives—the need for strong, ethical FDA leadership that makes decisions based on science—is increasingly in the news. Patient safety advocates have long known the impact FDA leadership has when reviewing and approving drugs and medical devices. But more Americans are starting to understand this powerful agency that oversees COVID-19 treatments and vaccines makes critical decisions that impact us all.
 
President Trump’s FDA commissioner was replaced by an Acting Commissioner (Dr. Janet Woodcock) until the Biden administration decides who will fill that important role. They have been considering two candidates as frontrunners: Dr. Joshua Sharfstein and Dr. Janet Woodcock.

We don’t know who will win, but one thing is sure: the FDA needs a leader who can improve agency standards and regain credibility. Here's some brief background info about these two candidates and related comments from public health experts and nonprofit leaders. 
 
Dr. Sharfstein
Sharfstein was former deputy FDA chief and is currently Vice Dean for Public Health Practice and Community Engagement at Johns Hopkins Bloomberg School of Public Health. He earned degrees from Harvard College and Harvard Medical School and completed his residency in pediatrics. Sharfstein has received numerous awards for his work in public health, including one from the Consumer Product Safety Commission, an independent federal regulatory agency that works “to reduce the risk of injuries and deaths from consumer products.” (1) Governing Magazine recognized Sharfstein as Public Official of the Year in 2008.
 
Dr. Woodcock
Woodcock worked in the FDA’s Center for Drug Evaluation and Research (CDER) for nearly three decades and as led CDER’s since 2008. She is currently involved in “Operation Warp Speed” to develop COVID-19 treatments. She earned degrees from Bucknell University and Northwestern University Medical School and completed her residency in rheumatology. Woodcock has received numerous awards for her work in public health, including one from Friends of Cancer Research, a largely pharma-funded nonprofit whose stated goal is to “unite scientists, pharmaceutical companies, and policy makers with shared trust and guide them toward meaningful cooperation.” (2)

USAPN is planning to send a letter of support for Dr. Sharfstein, because of his clear commitment to public health, scientific evidence, patient safety, and transparency at the FDA. We welcome comments from USAPN members. Below are more quotes and comments about both candidates.
 
A recent New York Times article reports the FDA vacancy has “exposed rifts among Congressional lawmakers, within the public health and medical communities as well as the health and drug industries that depend on the FDA for approval of their products. In particular, some public health officials have used the open position to debate the leadership qualifications needed to restore the agency’s morale and credibility after a year fighting both a pandemic and a president who often belittled the FDA’s process for approving treatments and vaccines.” (3)
 
The Wall Street Journal reports some prominent critics regard Woodcock “as too deferential to industry” and that she “played a controversial role” in some drug reviews. Senior FDA physicians and reviewers said Woodcock decided in favor of some drugs over their objections, and they “contended that the evidence didn’t support the approval.” (4) USAPN’s board member, Kim Witczak, agrees that safety and efficacy standards were lowered under Woodcock’s leadership.
 
Comments about the candidates vary, with most of the support for Dr. Woodcock expressed by individuals or groups with strong ties to Pharma.

“We have known Dr. Sharfstein for many years, some of us for decades, and can attest to his commitment to policies that are based on science and improve the health of all Americans.”
—Letter from 18 prestigious experts from medical schools, hospitals, and public health.
 
“In the past, even when the FDA review of the drug was scathing, quite often Janet Woodcock or another high level FDA official would be at the meeting, clearly pushing the advisory committee to recommend approval. But by law, these advisory committees are supposed to make recommendations independent of any FDA pressure.” (5)
—Diana Zuckerman, ex-officio member of USAPN’s board and president of the National Center for Health Research, a think tank and advocacy group

“Serving as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history.”
—Letter from patient advocacy organizations
 
“In my time at FDA I admired Janet Woodcock for her operational acumen and uncommonly good judgment. She was respected on Capitol Hill for effectiveness and candor. She will represent FDA’s prerogatives well in a time of crisis, and advance the interests of consumers and patients.” (6)
—Former Trump FDA Commissioner, Scott Gottlieb
 
“Woodcock’s qualifications at this vital moment are unimpeachable. She has always been straightforward in her belief in science, innovation and the important role the FDA plays in the lives of patients.” (7)
—Op-ed by Phillip Sharp, chairperson of Stand up to Cancer; Ellen Sigal, founder of Friends of Cancer Research, and Sherry Lansingfounder of the Sherry Lansing Foundation
 
REFERENCES
1 https://www.cpsc.gov/Safety-Education/Safety-Guides/General-Information/Who-We-Are---What-We-Do-for-You
 
2 https://friendsofcancerresearch.org/about-friends
 
3 https://www.nytimes.com/2021/02/20/health/Covid-FDA-Biden.html
 
4 https://www.wsj.com/articles/janet-woodcock-to-lead-fda-on-interim-basis-11611085397
 
5 https://www.nytimes.com/2021/02/20/health/Covid-FDA-Biden.html

6 https://twitter.com/ScottGottliebMD/status/1351947404174614528
 
7 https://www.latimes.com/opinion/story/2021-02-04/food-drug-administration-janet-woodcock-biden
FDA LEADERSHIP IS CRITICAL:

PLEASE SPEAK UP NOW
Contact your elected representatives and let them know
which candidate you believe can best lead the FDA to ensure the safety, efficacy and security of drugs and medical devices.

Find your representatives at:

www.house.gov/representatives/find-your-representative.
ADVOCATE SPOTLIGHT
Meet USAPN Board Member Maureen Robbins
 
Tell us a bit about the experiences that prompted your involvement in safe patient issues and USAPN.
 
Due to the tragic and untimely death of my 84-year-old father, Joseph Karbelk, I became passionate about sharing my knowledge and experience with others. My father went to the emergency room for what we believed would be therapeutic care. Instead, he was denied his rights as a patient, inappropriately restrained, and incorrectly chemically sedated. Due to these actions, he never recovered. 
 
After my father’s death, I struggled to understand what happened and why. I could not get any answers from the hospitals or doctors. I pulled all his medical records and worked with medical professionals to thoroughly review them. After months of review, we discovered his death was preventable and was accelerated by the hospital staff’s careless actions. 
 
I didn’t know where to turn or how to move forward to share my family’s experiences. Searching the internet for answers, I soon found Kim Witczak on LinkedIn. Kim and I were not connected on LinkedIn, but after reading her story, I contacted her. She responded the next morning and inspired me to share my family’s story. This was the moment that my life forever changed.
 
I’ve spent the last three years working closely with patient safety organizations and am honored to be on the board of USAPN. I’m looking forward to sharing my knowledge and creating change regarding the use of antipsychotic drugs for dementia and Alzheimer’s.  
 
What do you wish you would have known before your own adverse experiences, and how do you help others be better informed? 
  
I wish I would have better recognized how important it is to choose appropriate family advocates—and ensure that all family members have knowledge and access to current, relevant information. This is particularly imperative in a hospital setting. I now work to increase awareness regarding the FDA’s Black Box warning and the inappropriate use of antipsychotics as chemical restraints, particularly among elderly patients and those with dementia and Alzheimer’s.
 
What resources, legislation, and/or tools can help consumers gain accurate health care info to assist them in decision-making?
 
Knowledge and pro-active communication are the tools that all of us, as family members and advocates, must gain and retain as we navigate the unforeseen dangers of America’s medical facilities. We must be prepared to help safeguard our loved ones’ care at the hospital bedside when they need us most. Don’t be afraid to ask questions. The Patient Safety Movement Foundation has a mobile application called PatientAider. It is a valuable source of medical information regarding hospitalization, and I encourage everyone to download it. 
 
As a new USAPN board member, what is your focus for the coming year?
 
My focus is on the use of antipsychotic drugs for dementia/Alzheimer’s. The number of older Americans will double by 2060. The number of Americans with Alzheimer’s disease, the most common form of dementia, is expected to increase from 5 million today to 15 million in 2050. The medical profession and long-term care services need to respect this growing population and better meet their needs. Together we can create awareness of the risks of Black Box drugs such as antipsychotics. My goal is to help protect Americans affected by this disease, most of whom can no longer advocate for themselves.

Pictured below: Maureen Robbins and her father, Joseph Karbelk
USAPN LEGISLATIVE ACTION

USAPN represented the patient's voice at several FDA hearings this year to ensure consumer safety is prioritized:

  • USAPN president, Dru West, and board members, Marie Garlock and Kim Witczak, testified on behalf of USA Patient Network at the FDA's Advisory Committee on Vaccines and Related Biological Products."
         December 10 Hearing on Pfizer Vaccine 
         Listen to Kim Witczak's testimony: https://youtu.be/-fj5k-  RgNKw
         Listen to Dru West's testimony: https://youtu.be/SsKyzuTUMMk
 
         Dec 17 Hearing on Moderna Vaccine 
         Listen to Marie Garlock's testimony: https://youtu.be/BunVNPtA3x4
  • USAPN president, Dru West, submitted public comments to the FDA on behalf of USAPN regarding the "Reauthorization of the Prescription Drug User Fee Act."
  • USAPN board member, Linda Radach, testified at the FDA's, "Reauthorization of the Medical Device User Fee Amendements" (MDUFA) hearing.
  • USAPN board member, Marie Garlock, submitted public comment on behalf of USAPN regarding the FDA's "Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI."
  • USAPN board members, Jonathon Furman, Kristina Kaiser, and Kim Witczak, testified at the FDA's "Reauthorization of the Prescription Drug User Fee Act" hearing.
. RESOURCE LINKS to websites and FaceBook groups
on the USA Patient Network 
website

 
We're adding a list of websites and Facebook groups to our resources tab for people who want information, support, or to connect to an advocacy group.  

If you know a group that you want to include, please send us an email with the group's name and website or Facebook information.  
 
REPORT YOUR COVID VACCINE RESPONSES!
ENCOURAGE OTHERS TO REPORT THEIR RESPONSES ALSO.
How to Report Adverse Events to VAERS
Do your part for Vaccine Safety - Report to VAERS Vaccine Adverse Event Reporting System at www.vaers.hhs.gov

There are 2 ways to submit a report to VAERS:

Option 1: Submit a VAERS Report online (Preferred)
The online VAERS Report must be completed and submitted in the same session; it cannot be saved and edited at a later time. Note: sessions time out after 20 minutes of inactivity; no information is saved.

Option 2: Download a Writable PDF Form and upload when ready
The Writable PDF Form can be downloaded and completed electronically on your own time. When ready, return to the VAERS Writable PDF web page (use link above) and follow Step 2 instructions to upload the form.

More information on reporting an adverse event to VAERSexternal icon. If you need further assistance, please email info@VAERS.org or call 1-800-822-7967.

COVID RESPONSES ACROSS THE GLOBE

“By three methods we may learn wisdom:
First, by reflection, which is noblest;
Second, by imitation, which is easiest;
and third by experience, which is the bitterest.”
Confucius


Regardless of where you live, the COVID-19 pandemic drives home the importance of obtaining accurate health and safety information free from industry bias and political influence. Keeping ourselves and loved ones safe is challenging and made more difficult when public health policies and government recommendations in response varied widely depending upon your geographic location.

Similar conflicting information also applies to some drugs and medical devices. For example, suppose you live in England and fill a prescription for SSRIs (drugs often marketed to treat depression). In that case, your patient information leaflet will communicate the risk that withdrawal symptoms can last for months. If you live in the US and fill the same SSRI prescription, this risk information will not be provided. 
 
Mixed messages and conflicting recommendations can cause confusion and anxiety during already stressful times. According to the Center for Crisis and Risk Communication, “research shows that public concerns typically are based 95 percent on perceptions and only five percent on facts. People’s behavior usually is predicated on perceptions – often misperceptions – that differ substantially from reality (facts).”
 
Here’s a snapshot of one global family and the COVID-19 responses in their respective locations.
 
Sibling #1 in Sweden
Sweden’s initial response to COVID-19 has sometimes been reported as “laissez-faire” compared to its European neighbors. The country eschewed major lockdowns, most businesses and schools remained open, and some health authorities advised against mask-wearing. Sibling #1 was hospitalized for several weeks for an internal infection shortly after the pandemic started. She shared a room with several patients and noted many patients and healthcare providers did not wear masks. Given that the antibiotic she was prescribed suppressed her immune system, these inconsistent behaviors increased her concern that she might contract COVID-19 while in the hospital.
 
Sibling #2 in Panama
According to data from the University of Oxford, Panama’s response to COVID-19 was one of the strictest and swiftest responses of any country. After 14 COVID cases were reported, workplaces and schools were closed on March 12th, and only essential businesses remained open. A national quarantine soon followed. Based on her government ID number, sibling #2 was assigned a specific 2-hour time to shop for groceries and medical supplies. Residents were allowed out three times per week, and men and women were given opposite days. For nearly six months, the only businesses authorized to open were banks, pharmacies, grocery stores, and medical centers. When restaurants later reopened, service was restricted to carry out and delivery. A nationwide total quarantine was in place every weekend. 
 
Today, Panama requires that masks be worn everywhere but home. Before entering any business, patrons must step on a floor mat filled with disinfectant, have their temperature taken, and hands sanitized. If the electronic thermometer records a fever, entry is denied.
 
Sibling #3 and #4 in America
In the United States, few government actions were initially taken at the federal and state level to contain the spread of COVID-19, notes a Brooking Institute study. The initial reluctance to encourage behavior changes and disrupt everyday daily life was followed weeks later by conflicting recommendations to use hand sanitizer and wear masks. 
 
Sibling #3, a Florida resident, said at the time, “Life here is mostly unchanged; it makes us wonder if maybe pandemic concerns have been overblown.” CNN reported the Florida governor “consistently downplayed the severity of the pandemic, and local governments were blocked “from enforcing their own measures to protect residents from coronavirus.” 
 
In Ohio, where sibling #4 lives, Republican governor DeWine’s COVID response was hailed as a “national guide.” On March 3rd, before the state had any reported COVID cases, the governor banned spectators at a large sporting event. Within weeks, schools, restaurants, and sporting events were closed statewide. 
 
Similar to the 9/11 Commission Report, policy experts anticipate Congress will officially review the US pandemic response to learn from past mistakes and develop better pandemic protocols for the future.

REFERENCES
1 http://centerforriskcommunication.org/environmental-risk-communications/

2 https://www.washingtonpost.com/nation/2020/11/16/coronavirus-covid-live-updates-us/
 
3 https://www.americasquarterly.org/article/preparation-is-key-lessons-from-panamas-pandemic-response/
 
4 https://www.brookings.edu/research/the-federal-governments-coronavirus-actions-and-failures-timeline-and-themes/ 
 
5 https://edition.cnn.com/2020/12/17/us/desantis-covid-florida-invs/index.htmlIn 
 
6 https://www.washingtonpost.com/national/coronavirus-ohio-dewine-outbreak/2020/03/16/9bde6b1e-67b2-11ea-9923-57073adce27c_story.html 
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