My day started with an outdoor exercise class. The class was held on the porch/patio of an unclaimed historical building in Kensington. It is drop in – brining your own yoga mat and free weights. The temperature was in the mid-40s but it didn’t take long to start shedding layers of clothes. I looked and felt like I had a good work out.
On my walk to lunch with a friend, she pointed out this tree that is very near where I used to live. I have walked by it multiple times but never taken the time to notice that it has grown at a right angle. The second angle up is about a foot and a half off of the ground. Nature is amazing,
The day ended with an outdoor Tex-Mex meal in downtown Bethesda. I think my taste is continuing to recover very gradually. I am eating a wider variety of foods than I was preparing for myself. There is little motivation when you can’t appreciate the flavor of food. So with increasing the variety of foods I can say that I am having pleasure eating even if the taste is not really there yet. Maybe taste needs to be stimulated a bit.
I remain hopeful.
I found this opinion piece on the NPR news feed this morning by a family physician in Camden NJ that I thought was pitch perfect regarding her struggle to decide whether to get a Covid vaccine early in her second trimester last December when the vaccine was first available. Decades ago, doctors simply told patients what to do and assumed their instructions would be followed. Now it is all about patient autonomy in decision making – “here’s the data, you decide”. While anyone can make a decision, how can physicians do a better job of helping people make informed decisions. Presenting data without the time and skill to make sure it is understood is not information. https://apple.news/ABuniGb5_QDKu5VVzT7G0_w I decided I wanted to retweet this which led down the rabbit hole of reacquainting myself with my Twitter account.
I am looking forward to a bike ride from North Bethesda along Beach Drive into DC on Rock Creek Parkway meeting up with Capital Crescent Trail in Georgetown. This is one of my favorite rides and will be my longest of the season. Weather is supposed to be perfect for biking tomorrow.
Today was a beautiful day. I visited with 5 friends in 3 different locations and got a 16 mile bike ride in – the ride I did the most often when I lived here -along Beach Drive into DC and back to North Bethesda. It was a bit chilly at the end of the day so I didn’t mind wearing a face covering for the warmth. It is amazing how many people out exercising – whether walking or biking are in masks – likely safer.
This hollowed out tree trunk has a specific memory for me. 3.5 years ago shortly after I started cycling, I got clipless pedals and shoes. This spot is about 5 miles from where I lived and I had made it this far on my first ride without incident – getting shoes in and out of the pedal a few times at stoplights. As I was riding across the street, a woman she asked me for directions. My intent was to stop and help her but I forgot I was clipped in. As I was rolling forward trying to disengage my shoe, I tipped into this tree. The tree was just in the right position to keep me from falling over as I worked to get my shoe disengaged from the pedal so I could put my foot down. I had this sense of impending doom and then great relief as I did not fall over. I was not able to give the women she wanted and she did not seem appreciative that I scraped my leg on the bark trying to help her. This tree kept me from getting more than scratches on my leg and it was sad to see part of it missing.
The neighborhood riding I am doing in Nashville is so different from the riding I was used to here. I was anxious to see how the ride would go today – as a marker of my Covid recovery. The ride felt great and I felt strong doing the 16 miles – like I could have easily done the route again.
I met a friend in DC today and we went of a walk before brunch. We walked through a green space in the neighborhood that was holding a small event to discuss future development of the space. There were a couple of tables with complimentary bagels and fruit. Bagels were from a local shop and my friend wanted to get one but didn’t have a pocket. I offered to carry it in the pocket of the fleece. During the walk, I got warm and tied the fleece around my waist. We stopped to order brunch at Ethiopian cafe on the way back and sat on the patio waiting for the order. After about 10 minutes, I realized I was not sitting evenly on my chair only to discover I was sitting on the bagel in the pocket of my fleece. It was a soft, dense bagel, that was a bit flattened inside the napkin but totally intact. How it took me so long to realize I was sitting on it is a mystery.
I made friends with Paco – a 18 month old Silken Windhound who seemed quite taken with me. He had the most gentle licks. When I have completed my 3 month travel adventure, I think a rescue dog will be in my future.
Later I met up with a young woman for a walk while her young children were napping. When nap time was over I was entertained by the 2 kids outside on their deck. Beautiful kids with lots of energy.
After 2 walks I didn’t feel too guilty when I decided not to ride my bike because it was cooler than I was prepared for.
While I hadn’t seen either of these women in person in over a year, it didn’t seem like tha at all. We had regular meetings via Zoom. Perhaps because via Zoom people are more themselves and less of their work persona. Many of us got comfortable being “seen au natural” from the neck up. We saw inside each other’s homes with opportunities to see kids, pets and other family members.
It will be very interesting to see how “the workplace” evolves post pandemic.
I planned to leave Nashville for the 9.5 hours of driving time to get to DC at 10 AM. I was late by 30 minutes but I will return to a clean condo on May 3rd so I think it will be worth it.
I dropped some perishables off at my son’s so he took the photo. It was a beautiful day and I arrived in DC at 930 PM ET – 10 hours after I left. I love car trips and with a hybrid, 5 hour energy and healthy food I can eat as I drive I can took 3 10 minute breaks. Driving along I-81 along through the Shenandoah Valley today was magnificent with the Eastern Rosebud trees budding along the way.
I listened to The Prophets by Robert Jones Jr. While I was immediately drawn into the novel, the narration would benefit by longer pauses and better deliniation between chapters/characters. I got a bit confused more than once. It may be a novel that is better to read than listen to. The portrayal of a community of slaves on a Mississippi cotton plantation from multiple perspectives is intriguing. I may listen to it again later in my journey to make sure I learn as much as I can.
There was a lot more traffic on the beltway than 6 months ago – seemed pretty typical for 9 PM on a Friday pre-pandemic. When I got on city streets, I immediately noted two people walking alone on the sidewalk with masks on. People in the DC Metro area (including Maryland and Virginia) took precautions much more seriously than TN last summer and this seems still to be the case. In Nashville people are still masking indoors but it would be a rare occurrence for someone to be walking alone outdoors with a mask on.
Fingers crossed that Vaccinations BEST Variants and our gradual return to “normalcy” continues. I would like our new normal to include voluntary use of masks as a norm during cold and flu season. Masks no longer look odd.
Tomorrow is my day 1 of my adventure – a 10 hour drive to DC. I am looking forward to seeing friends and going on some of my favorite bike rides. I ordered up a week of beautiful spring days without rain and thus far the 10 day forecast looks excellent. Fingers crossed.
Drug safety is a challenging topic that I have been thinking about since my years in Pharma and after yesterday’s blog I decided I wanted to try to tackle it. Prior to my years in Pharma I had the misconception that FDA approval meant that a drug was safe in most people in most circumstances and while that is a simple, reasonable way of thinking about it, the reality is complex. Yet most practicing clinicians do not understand their important role in ultimately determining the safety profile of a drug.
In fact no-one can ever say a drug is safe – this implies that a drug can be used in any person under any circumstance without any chance of anything bad happening. Until a drug has been given every individual who has their own special set of conditions, it cannot be determined to be safe. This is NOT possible. Therefore that best than can be said is that any drug, biologic or device tested has a favorable safety profile.
As I mentioned yesterday, when a company has a new product they want to seek FDA approval for, the company and the FDA meet early in the process to determine how many people the product needs to be tested in and how long the people need to be followed to allow for determination that the product in fact does what it is intended to do (efficacy – it works) and has a satisfactory safety profile to allow it to be sold in the United States. Every country has its own rules and process for this.
The bigger the number of people in the clinical trials and the longer they are followed, the better it is for determining risk/benefit from the FDA perspective. But if these numbers are too high, the expense to the company developing the product may be too high to take the risk. This would mean fewer new products being developed. So there is an inherent tension between companies, the FDA and the public which wants better treatments. Every case is slightly different and for some conditions, particularly rare conditions, the clinical trials may require far fewer participants than common conditions such as diabetes or high blood pressure.
When a product receives FDA approval, a group of government and external scientists have reviewed the data submitted by the company. The external scientists (advisory panel) provide recommendations to the FDA and the FDA makes the decision if the benefit of using this product outweighs the risks. If during the clinical studies, a safety signal emerges in a subset of participants, the product might be approved with warnings that it should not be used in certain individuals or under certain circumstances. This information is communicated to prescribing clinicians through the product label, educational seminars before and after the product is launched, through various persons employed by the company, and a variety of other means.
What I didn’t understand is that in the first several months after release of a new product on the market that new safety signals can start to emerge. The product will be prescribed to a wider variety of persons than were in the clinical trials and uncommon or rare events can only show up after the product is given to large numbers of persons. Active reporting of adverse reactions to new products by the prescribers, pharmacists and patients is crucial to this process. Rare adverse reactions cannot show up until the product has been used in very large numbers of people. In some circumstances it can take years for enough persons with the same reaction to be reported to become a safety signal. Thus some products are on the market for many years and been a great benefit to many persons when there FDA approval is withdrawn and the product is removed from the market. These are tough calls. Sometimes a product may be removed from the market in some countries and not in others. There are no hard and fast rules.
The new safety signal for the J&J vaccine, cerebral venous sinus thrombosis, was discovered in a few months because the was given to millions of persons in a very short period of time. This rare event was identified and FDA and CDC called for a pause for a careful assessment of risk-benefit of continuing to use the vaccine. A difficult decision.
No one can tell any individual that any of the vaccines authorized for emergency use in the US is safe for them or any family member. No one can say that any of the over the counter products we buy and take every day is safe. The best that can be said is that they have excellent safety profiles after being used in millions of persons. For the vaccines, they were used in millions of persons in a few short months. Because of the large numbers of persons vaccinated AND the efforts to encourage those vaccinated to proactively report their experience with the vaccine, I have NO hesitation with being injected with any of the vaccinations currently authorized for emergency use in the US.
If I could do it all over again, I would do better at reporting adverse reactions – even if they were not severe and I didn’t think they were a big deal.
“The new efficacy data (is 91.3% effective against symptomatic COVID-19), plus a safety analysis comprising data from more than 12,000 people who were fully immunized for at least six months, allow the companies to file a drug application with the FDA to turn the shot’s emergency use authorization into a full approval, Pfizer CEO Albert Bourla, Ph.D., said in a statement.”
My son and daughter-in-law are exposed to a fair amount of vaccine hesitancy and when they ask me to help them answer the concerns, I have struggled to find answers to not unreasonable questions given the confusing language that is being used in various official documents.
The educational information given to individuals receiving the Pfizer-BioNTech vaccine states that the vaccine is unapproved. Technically, the FDA has issued Pfizer-BioNTech, Moderna and J&J authorization for emergency use. I could find no explanation for what it would take to get full FDA approval. For some people hesitant to get a vaccine, full FDA approval is a VERY important milestone. In the context of the rapid development of all of the vaccines some degree of caution is not unreasonable.
While it is not explicitly stated in the article, the FDA required 6 months of efficacy and safety data on a large number of people to consider full approval. At the beginning of the drug development process the FDA tells the companies what data is needed to seek FDA approval. In the circumstance of this pandemic, it was apparently determined that authorization for emergency use would be granted if vaccines demonstrated that they protected against getting Covid-19 with low adverse reactions 7 days after the second vaccination. Emergency use was authorized when the group that received vaccination had 8 COVID-19 cases and 162 COVID-19 cases in the placebo group for 95% efficacy.
The Pfizer-BioNTech vaccine still has excellent efficacy at 6 months – 91% with no signal of any safety concerns in the clinical trial participants or in the millions of vaccinated people. The requirement for 6 month data makes sense for full FDA approval and I am glad 12 month data was not required. Perhaps this type of information is confidential between companies and FDA, but it would have been helpful to know that full FDA approval was possible in the first half of 2021 when enough study participants had been followed for 6 months.
Today, we have news that the J&J one dose vaccine has been put on pause for extremely unusual complication – cerebral venous sinus thrombosis (CVST), that occurred in 6 women (out of 7 million people vaccinated). This is extremely rare. The risk-benefit of this decision is complicated because this one dose vaccine that does not require extreme cold for storage is the easiest to use underserved communities that are most at risk for Covid-19. It is possible that more than 6 people scheduled to get the J&J vaccine will contract and die of Covid during this pause. Is this really the right decision?
My initial reaction was why not just pause in women under 50 years since all of the CVST occurred in women less than 50. However after reflection, I think taking a short pause to make sure there is not significant under-reporting is reasonable. Reporting adverse reactions can be a very time consuming process and is not always done outside of clinical studies.
This pause also allows time for education of ALL clinicians about the diagnosis and treatment for CVST. Given CVST is rare, many clinicians may not know they require a different treatment approach. For me, this is the most compelling reason for the pause. If more clots occur, let’s make sure clinicians can diagnose them quickly, treat them appropriately and report them to the company or FDA.
Both Pfizer-BioNTech and J&J vaccines have excellent safety profiles. J&J was put on pause because of a signal of a safety concern became apparent after it had been used in 7 million people. It will be fully investigated. This demonstrates why the FDA required longer term follow-up before considering full approval.
We are all learning so much about topics we never thought about before March 2020.
I have been waiting to get my first vaccination. I was fortunate to get the antibody infusion on January 11 when I had Covid. I had to wait 90 days to get vaccinated and got my first dose of the Pfizer vaccination this morning through Vanderbilt. It was a very well organized operation. I have been resting since the vaccination – out of caution. Unsure if I feel “previral” or or not but will take it easy the rest of the day.
Last Friday I had to do a telephone interview for a long-term care insurance. It was 90 minutes of questions under the penalty of insurance fraud. I knew there was going to be a memory portion to the examination so I purposefully scheduled the assessment several weeks after the time change and scheduled it immediately after I worked out when I normally feel great. I didn’t realize that I had pretest anxiety until I had incredible difficulty doing some of the exercises I have been doing for months. It happened several times which did not help my anxiety. The memory part was actually the least stressful. The questions about medical history were the poorly written questions, asked too quickly with different time frames – sometimes past 10 years, sometimes past 5 years and sometimes past 1 year. These questions were not written by anyone with skill in question writing assuming the intent is to get accurate information. The following morning, I woke up thinking about the 10 words I had been asked to memorize. Oak, list, servant, project, brand, cup, list, spring, rank – and now I have 9/10. As is classic for the health related insurance industry, they want to make sure they offer insurance to individuals who are the least likely to need it. I am not sure if I passed the test or not.
Sunday for Siblings Day I posted a picture of the 5Ts in 2018. My sister-in-law was able to find our most classic sibling photo from 1964. I remember that day, the blue spring coat and Easter bonnet. I was very embarrassed by this photo for several decades but now it brings me great joy. This was taken in the lawn outside of the farm house prior to going to the Beulah Methodist Church – out in the middle of the country between the two farms my parents grew up on. My parents were married there and the 5 siblings were all baptized there. The old country church was eventually converted into a home and I always wanted to go inside and see what it looked like.
Two days to get ready for Part 1 of my travel adventure.
Intermittent bladder infections have been a part of my life since grade school – 5th grade I think. I would go to the doctor in my town of 700 residents. The office was one room in his home and he would dispense sulfa tablets in a little envelope from his office. The symptoms would resolve quickly . I got one or two a year for a few years. As my mom also had bladder infections occasionally, no one was concerned.
My worst experience was when I was in my 40s. I had not had an infection in a few years when I got a low cramping sensation just as the airplane door was closed on a flight from Philadelphia to Phoenix. By the time the fasten seat belt light went out for the first time, I bolted for the toilet. The pain was intense when I peed. Before I got back to my seat I felt like I needed to go again. I had no idea how I was going to make it through the next fours. Fortunately I was in the aisle seat and the middle seat was empty. My incessant wiggly in my seat had less impact on others than it might have had. After about 4 trips to the toilet, I asked my aisle mate if she might have any medications that might help. Amazingly she had a few phenazopyridine, also known as Pyridium. I took two and they kept me sane for the rest of the flight. I spent over $100 on inflight calls arranging to get an antibiotic prescribed when I landed in Phoenix and talking with people to keep me distracted. I got the antibiotics on the way to the hotel. The first dose worked well enough that I was able to get through my speech the next morning. Symptoms were completely gone by the time I flew home at the end of the day.
Lesson 1: I started carrying my own water on long flights to stay hydrated. This was before the bottled water industry exploded and I always carried Pyridium and a few antibiotics.
Lesson 2: Up to that point, I was selectively allowing women with recurrent bladder infections to self-treat with antibiotics. Moving forward, for women that commonly traveled I made emergency UTI travel packs (Pyridium and a 3 days of antibiotics) available if they wanted. Over the past decade, with the availability of urgent care centers and concerns about antibiotic resistant bacteria and over use of antibiotics, travel packs may be less appropriate and necessary than twenty years ago – although I still carry mine.
Lesson 3: I gained a deeper empathy for my patients with IC (interstitial cystitis/bladder pain syndrome). The intensity of the discomfort/pain/urgency in my bladder was overwhelming – particularly when the fasten seat belt sign was on and I was not free to use the toilet. Prior to the taking the Pyridium on the flight, there was nothing that could distract me from my bladder. I was fortunate that I knew what was causing these symptoms and was confident that one or two antibiotics would get rid of the symptoms. But what if they didn’t? Many women that end up with a diagnosis of IC describe having UTI symptoms that just don’t go away. I now understood why women told me they sometimes fell asleep on the toilet or chose to sleep in the bathtub when symptoms were at their worst. While our understanding of the complexity of this often debilitating condition has improved over the past 30 years, treatment is still pretty much trial and error through a series of treatments that can work well in some women. We still have much to learn about this pain syndrome.
The flight to Phoenix may have been my first awakening to the prospect of prevention of bladder problems. Waiting for women to show up for care with often inadequate treatments was not good enough. I already understood the power of knowledge and behavior change to treat conditions, why not reposition these strategies for prevention? It took over 15 years for the awakening to evolve into action.
Last night I had the opportunity to go backstage at Grand Ol Opry and observe my fabulous daughter in law, Natalie, in the preparation for her hosting roles on Grand Ol Opry Live AND perform as a member of Runaway June. It was the first time since the pandemic started that artists were allowed to invite family backstage. The Opryland staff take Covid precautions seriously. I had such a good time and was in awe of the skill it took for Natalie to juggle all of the roles she had last night. I hope there is a daughter-in-law day soon. I have much more to say about Natalie.
Today is Siblings Day. There are 5 of us – Terry, Tamara, Timothy, Troyt and Traci (or the 5 Ts). I am the only one that left Iowa. We have all become parents and had very different paths through adulthood. While our views of the world are very different, we have always agreed on the importance of family. I will visit them in June towards the end of my travels. I hope we can all be together to update this 2018 photo.
I have had persistent loss of taste and persistent loss of taste and smell since Covid. I have grown pretty accustomed to it. I think the loss of taste decreases the desire for any second helpings which is a good thing. I can tell one flavored coffee syrup is different from another, but not what each flavor is. This past week I had my first glimpse that my sense of smell might be coming back. I thought I might have smelled the fresh salmon as I removed it from the packaging. Later than evening, I had a brief feeling that my environment had gone from black and white to color related to smell. It was odd, brief and not related to any pharmaceutical enhancement. The following evening, I feel pretty sure that I actually smelled the basil in pesto. I have hope.
My first Covid vaccination in Tuesday. I begin my travels on Friday April 16th. I am getting very excited.
Thursday I took my government issued equipment (one mobile, one iPad, one Dell tablet and one PC laptop) to FedEx to have shipped back to DC. It feels good to have one computer, one reading device and one mobile phone. I am working hard to readjust to the Mac OS as I have spent most of my time on a PC for 19 years.
I will greatly miss the great IT support staff that we had. I always had problems others did not seem to seem to have. I kept them challenged. They showed endless patience and were generally able to find a solution or “work around”. One of the things government employees are excellent at is finding the “work around” to the rules that need to b followed, but if followed too carefully are counter to getting the job done. The obvious solution to just changing the rules that don’t make sense or work is problematic because to change the rules, you have to go through Congress. Even a functional Congress would not have time to address all of the individual needs of the government offices, agencies, departments, institutes etc. So each government group must find ways to operate within the rules as best they can.
Sending my equipment off was a specific sense of finality. Leaving is not all positive and I am sure over the next several weeks, I will find I am not able to do things I was accustomed to doing with access to the VPN of the federal government.
During my first week of semi-retirement, I have been gradually integrating and updating contacts and files – trying to get organized for moving forward. I have starting putting entries on Medium (tamarabavendam@medium.com) I am loving writing more than I thought I would. I am not really sure what I am doing but I will continue to figure it out.
Tamara Unleashed 