Today I had a great bike ride into DC, around East Potomac Park then on to lunch on Wharf and back to North Bethesda along Capital Crescent Trail. I rode between 35-40 miles. It was sunny and coolish – perfect for cycling.
Bruce has been a great biking partner over the past 4 years. We have ridden in DC, Ocean City and completed a couple of metric Centuries. When I get done with my travels, I will hopefully be able to find compatible cyclists in Nashville. It felt awesome to do familiar rides and feel strong. We rode by the site of one of my early biking misadventures. The stairs below did not have the silver “troughs” to assist in getting your bike up and down 3 years ago when I was riding into DC on the Memorial Bridge only to find the bike path blocked for reconstruction. The previous week it had been open. The only option was to carry the bike down the stairs shown below. About half way down, I stumbled a bit and fell – fortunately it was on one of the wide steps to I didn’t go tumbling down. I was lucky!!
After the ride, I packed up and started driving to Hendersonville NC. I made it as far as Christiansburg, VA – over half way. Thanks to Suzanne for hosting me for the past week and sharing Emmy who is a very sweet dog. I had hoped the Eastern Redbud trees were still going to be in bloom. The further south I got tonight, the fewer I noticed before it got dark. Hopefully I will be surprised tomorrow morning.
This week was a perfect beginning for my adventure to reconnect with friends and family, bike and see what evolves for my Chapter 9.
Today I got good news – the last bit of stress I had that might derail my plans for the next several weeks went poof. I am TRULY unleashed now.
The weather turned towards wintery yesterday so I had happy hour last evening on the patio of a friend with temp in the 40’s with a wind so gusty the fire pit wouldn’t provide heat. I was dressed in 4 layers on top and 3 on the bottom as I did not bring warm enough clothes.
Today was a bit warmer for the visit to the DC Arboretum to see lilacs and azaleas. I was carrying mimosa’s (in the large blue bag) to celebrate the good news. We were not able to find a warm enough place outside to enjoy them so we resorted to the car in between the visits to lilacs and the azaleas. The lilacs provided an opportunity for smell testing. My friends would smell them and then I would. On some of then, I could not smell anything, on some a slight floral scent but there was one that I actually think I smelled lilac. Later I had the opportunity to smell test a dead rat trapped in a ceiling. I got a “hint” but not much – not a bad thing in this case. Recovery is in process.
Tonight I will do taste retraining with some Indian food. Tomorrow I will do a chilly bike ride before taking off in the afternoon to go part way to my next destination, Hendersonville, NC. It is supposed to rain much of Saturday along the route so by starting tomorrow I will have a chance to see the beautiful Eastern Redbud Trees along I-81 again..
I introduced KP yesterday in my blog. I was having drinks with KP late yesterday afternoon when the news of the Derek Chauvin convictions was announced. We quietly acknowledged our shared relief. During my many conversations with KP over the years he shared with me what his experience of growing up black in Prince George’s County had been. He was taught how to act WHEN, not IF he had encounters with law enforcement and what some of his experiences were when he did have encounters for driving while black. While I “had heard” of these occurrences from media and didn’t doubt they existed it was powerful to listen to first person recounts. He knew how to act and apparently executed the act well enough that he is still alive.
These conversations were a part of a several year journey of grappling with and gaining a better understanding of inequality, inequity and privilege. The other key players on this journey were the PLUS Research Consortium investigators (https://plusconsortium.umn.edu/) from Community Health and Social Justice backgrounds.
While I understood that my upbringing was not disadvantaged (middle to lower middle class rural Iowa), prior to many conversations with PLUS investigators, I had not thought of it as privileged. I would have thought that having rich parents, an Ivy League education, and a trust fund as being privileged and remote from anything I knew. Over time, I have come to understand that simply being born with white skin is a privilege; having a warm bed to sleep in every night is a privilege; having nutritious food for every meal is a privilege; being expected to go to school every day because that is your job as a child is a privilege; always having employer based health insurance is a privilege.
Understanding racism is very complex. We need to be able to acknowledge that we have all been racists – often unintentionally. Rather than “I am not a racist”, perhaps it should be “I have not been intentionally racist”. Knowing and being friends with a black person does not mean you are not a racist. In 1974, I “dated” a black man from South Chicago my freshman year of college. It was random; it was fun; it was not a act of rebellion because my family never knew. It was not destined to be a long-term relationship because I was not going to let anything get in the way of medical school. He was kind, funny and respectful. He was insistent that the black women on campus did not know of the relationship. I didn’t understand why at the time. I don’t know if our several month relationship was truly a secret on a campus of 3,000 students but I did not experience any verbal confrontations which is what he was worried about. The relationship simply ended very early in my sophomore year. I never regretted it. In retrospect, I wish I had learned more about his world. Perhaps he didn’t want to share more. This relationship does not mean I have not engaged in racist acts or had racist thoughts.
I have no idea if any of my ancestors were slave owners but that doesn’t free me from responsibility for systemic racism that is the norm in this country. From my position of privilege, how can I truly be anti-racist and more importantly help others recognize their own privilege and seek to be anti-racist. We need to own up to racism and commit to doing better. Easy first steps are to stop denying denying systemic racism exists and acknowledge that each of us has been unintentionally racist – start with owning it. Energy invested in denial does not move us forward.
On a lighter note, today is a fairly quiet day for me. I wasn’t sure how much fatigue I might feel after the longer bike ride yesterday. I slept later but otherwise not adverse events. Fortunately it is cool and windy so I don’t mind not biking.
I was able to visit Nails by Tammy where I got my nail care for 8 years and get a pedicure. I was going to get my usual dark color on my toenails but decided on clear as I have no idea when I am going to get another pedicure. The partitions everywhere are weird but did not impact the quality of the service.
This machine is an engineering marvel. I had my first cup of coffee before preparing my breakfast. As I was microwaving my food, I loaded the Kcup into the Keurig for a second cup. I added the flavor syrup to the coffee cup and pushed the button to brew the coffee. The microwave finished. I got the food and put it down on the bar next to my coffee cup which was empty. I was confused until I realized I had forgotten to put the cup in the Keurig, I turned expecting to find a mess on the counter. But there wasn’t. The drip chamber holds exactly one cup of coffee. I emptied the coffee into my cup and had my breakfast. In that moment when I found my empty cup, I went from being totally confused to being totally amazed.
It was a glorious day for bike riding today and unfortunately, I forgot to take my phone with me so I don’t have any pictures. I took the camera out of the back pouch in the jersey to put a couple of mandarins in for a snack and then forgot to put the phone back into the pouch. When I do things like this (2 in a row, no less), I wonder if it is too late to blame it on Covid.
I rode 27 miles with my friend Bruce and IT FELT GREAT. My longest ride this season and I was not that fatigued. We rode from North Bethesda into DC through Rock Creek Park; took a break on the Georgetown waterfront and rode back to Bethesda on the Capital Crescent Trail. On a Tuesday morning, the pedestrian traffic on the trails was light which made it a perfect ride.
After the ride I met up with 3 friends over the course of the afternoon. One of my meet ups was with KP, the young man who kept me entertained and training for 3 years. I started training in July 2017. I hoped strengthening muscles would help knee pain, that I could lose weight and I needed a reason to leave the office before 8 PM. From previous experience with a trainer 20 years earlier I knew if I paid ahead I would do it. I started out with 2 sessions per week, increased to 3 and then to 4 sessions per week after I committed to cycling 444 miles over 9 days to celebrate a friends 80th birthday the following fall (2018). KP now had a tangible fitness goal to get me ready for and ready I was.
KP dressed up for 4th of July
While KP says I initially intimidated him, we quickly found a easy rapport that kept me coming back. While I got stronger and fitter and the knee pain improved, I didn’t lose weight. KP kept telling me I would have to change my eating to lose weight. I finally committed to weight loss in December of 2019 with a goal of losing 40#. I lost 20# before Covid and 20# during initial 3 months of Covid isolation. It was great to see KP today to tell him again how much joy and health he brought to my life and get my “atta girl” for keeping the weight off for almost a year.
My day ended with a massage by Heather who has magic in her fingers and elbows. While the day had a shaky start, the rest was awesome.
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.
Tamara Unleashed 