Tamara Unleashed

You may be wondering how happy I am to no longer be working at the NIH. I had intended to work until I was 70. If my position had not gotten so “toxic” for my mental and physical health, I would likely still be there until November of this year when I turn 70 However, if I were still there, I would likely be on target to be purged relatively soon because I was the co-founder of a sex and gender minorities working group (less formal than a committee) in the National Institute of Diabetes, Digestive and Kidney Diseases (NIKKD). This week, all the employees of the Office of Sex and Gender Minorities at the National Intitutes of Health (mothership for the institutes) were fired or placed on administrative leave. With more time, DOGE will dig into institute level data and find those individuals who were on institute level groups.

This NIDDK working group started with a lesbian woman, myself and a hetero man from the institute communications office. I was involved because I had more knowledge than most about sex and gender terminology and challenges based on the Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium that I had founded. The purpose of the group was to discover ways to prevent bladder problems in women and girls. I had to the group of over 50 scientists (majority female) grapple with the question “how are we going to define women?”. There was one person in the research group that was a lesbian and worked at Howard Brown, a health care facility in Chicago that provided care to the LGBTQ community. She educated us and encouraged us to be deliberate in our decision making.

This was the first of many, many questions that almost brought me to my knees over the first 2 years of the consortium. It took me a while to truly understand the sex and gender issues and the importance of them.

Lesson 1 – Sex is biologically determined by external genitalia – males have a penis and females do not for the vast majority of individual. However there are babies born with both male and female reproductive organs and baby boys that do not have a penis due to faulty genetics. For most people this is a black and white issue and it is hard to imagine anyone that does not into this dichotomy.

Lesson 2 – Gender is a cultural construct – how a person feels; how they identify. People born with a penis might be much more comfortable with the behaviors and activities that society has defined as for girls and women and vice versa. Some individuals may be comfortable in roles assigned to men and women independent of their reproductive organs or simply not identify one way or the other. At this time a biological male cannot give birth but he can assume the role of a mother.

Lesson 3 – Sexual Attraction is separate from sex and gender. A person can be attracted to someone like them or someone opposite of them or to a person who does not identify as a man or a woman.

Lesson 4 – A transsexual person does not identify as the gender of the body they were born into. For someone that is comfortable in their own gender this is very hard to fathom and it makes people uncomfortable. For some trans individuals dressing as their preferred gender may fulfill their needs; for others, they need hormonal therapy to suppress or enhance biologic characteristics; some need to have breast implants or breast removal (top surgery) and some need to have their genitals altered to match their gender identity (bottom surgery). There are NO rules. It is about the person living their life as true to themselves as they can be.

Once I had these 4 lessons straight in my mind I was less confused and realized these are deeply personal issues that no one chooses. Aside from causing others discomfort and confusion, how someone identifies and who someone chooses to love should not concern anyone. I do understand the angst about transfemales (biologic males) in competitive women’s sports but it does not need to be the political hot potato it has become. I will do a separate blog about that.

From a scientific perspective, there may be important health considerations beyond sexually transmitted infections in some of these small sex and gender groups that do not fall into the traditional dichotomies of male/female, man/woman. We have no way of knowing this because the Case Report Forms in all of the NIH research only collected data about biologic sex (male or female).

So this was why I was willing to get involved. We needed to start at the very beginning and begin to gather data about not just sex, but gender and sexual attraction as well. The PLUS consortium scientists had many protracted discussions about this – everyone agreed we needed to ask the questions but there was concern as to how the participants would feel about being asked. What we found out is that no one cared. They simply answered the questions and there were no concerns. There were very few individuals that chose not to answer the questions but no more than did not answer other sensitive questions such as income level.

Why is this important? When you have enough data on smaller groups of people (minorities) you can start to find out if there is any difference in the way they respond to a treatment. If there is a difference and it is a positive or negative difference, scientists work to discover why and it could potentially lead to a discovery that could impact the majority in a positive way.

So the NIDDK working group of 3 gradually became a working group of about 30 over about 18 months after we educated or colleagues as to why it is important to ask the questions. The group transitioned to a formal committee about the time I left in 2021 and then disappeared over night after the election in November. Hopefully enough data will have been gathered in the last 2-5 years when these questions were asked to provide a foundation for more directed research in the future once sanity is restored (I am being optimistic here).

How did PLUS handle these issues? We asked the questions (sex, gender and sexual attraction). As one of the proposed barriers to bladder health is bathroom access and cleanliness, we recruited sex and gender minorities into our focus group research to see if there were any issues unique to them. We intended to mail surveys out through the mail to be filled out by the woman in the household. We needed to know if it would make a difference if the person answering the survey was a biologic or transfemale. What we discovered is that while the reasons for lack of bathroom access might be different, the questionnaire worked well in both groups. The good news is that the survey is inclusive for all women. However, the number of trans women is so small that it may be difficult to determine if there are any differences between the groups. BUT at least we asked.

I am very glad I am not experiencing the current chaos at the NIH.

Prior to starting the Wegovy I committed to truly starting behaviors in a consistent way that would help me keep the weight off once I get to my goal. I have been eating smaller portions, trying not to snack and really exercising every day. Today will be day 14 of consistent exercise – weight training, cycling or elliptical.

What I experienced during my first week of Wegovy was perhaps a small sense of early satiety if I really thought about it, a couple of times where I felt slightly nauseous after eating and maybe a inkling that my intestines are responding in a positive way. That said, I could have imagined it all because nothing is really the same day to day anyway. I was not expecting to have lost much weight the week just based on how I felt, but I was hoping for a bit more the .8 pounds, not even 1 whole pound. BUT I will not be discouraged.

However if after my 4th injection, if I am still losing at this VERY slow rate, I will talk to my doctor about increasing the dose the second month rather than the 3rd or switching to Monjaro which is a GLP and GLP-1 receptor agonist while Wegovy is only a GLP-1 agonist.

PATIENCE

Clinical trials for drugs have two basic goals – to determine whether the drug works for a specific indication and what adverse effects it has. I can’t think of any drug that has only one effect in the body. The goal is that advantage of the desired effect far outweighs any adverse (unwanted) effects that it may have.

The information is collected on case report forms. Our knowledge (facts) is determined by the information that is systematically collected in the forms. There are often important and interesting questions that could be answered in the trial but there is significant tension between the amount of data collected and the participant burden of participating in a trial. The more burden (time it takes to complete the data gathering) the less likely it is that the participant will stay in the trial. Drop outs from the study are BAD and expensive so studies strive to gather only the necessary information so everyone completes the study.

Studies will always gather basic information like weight, blood pressure, pulse, oxygenation and tests for the target of the drug if different from weight, blood pressure, pulse, oxygenation – for example a drug for psoriasis, additional information will be gathered such as examination of the skin. This determines the benefit of the treatment.

Adverse events or side-effects can be determined in one of two ways – spontaneous report or prompted. Spontaneous report occurs in response to a general question – “have you noticed other unwanted symptoms or changes in your health since you started the treatment” or asking about specific symptoms – “have you experienced nausea”. Most studies use spontaneous reporting not prompted. In the past, a spontaneously reported positive unexpected outcome would not have been systematically gathered on the case report forms so it can take a while to learn that a drug has additional positive benefits.

Sildenafil (Viagra) was initially in clinical trials for treating angina. When men were done with the study, they did not want to return their unused medication because they found that it improved their erections. It wasn’t an adverse event for them so they did not report it spontaneously because it was not unwanted or negative. So the clinical program for development of drug treatment for impotence started with patient observation rather than an animal study that is the normal drug discovery process.

This is what is happening with the GLP receptor agonists now. Enough people have noted unexpected positive benefits that more research is being done. In the meantime, doctors can prescribe an approved medication for reasons other than what it is FDA approved for. However, insurance often may not pay for drugs outside of their approved indication. Those who can afford to pay the full cost of the drug will be the front line of observing the full range of benefits of the drug (such as Hollywood stars).

This is what it looks like when you drop an open can of ebony stain and it lands on the bottom – it turns into a fountain. Interestingly, it didn’t stick to my glasses or my Baggallini front pack that I had not taken time to remove after dashing to Walgrens to get wound closure materials for another Tools volunteer that had tripped and gotten a superficial cut at his hairline. I was the only one in the shop when I dropped the can so there was no one to hear my expletives or laugh with me. It was all over my hands and arms and shirt as well. I only had a bit o staining left to do so I dried my hands and arms which just spread it around more. I left my face alone until I got back to the condo which turned out to be good plan.

Once I finished I called Craig to see what kind of solvent would work best to remove the stain. He said lacquer thinner. I found a nearly empty can and went to the condo. The dried stain on my face came right off. Some was very near my eye so I used a Qtip there. What was smeared around on my hands and arms did not come off in the same way but I got enough off that I could do my grocery shopping. Later I discovered that Dawn dishwashing liguid really worked well on what on my hands.

I read an article today about how “Hollywood” is microdosing GLP receptor agonists for things other than weight loss. There is early evidence to suggest that macrodosing can improve Improved mood, lower anxiety, promote clearer thinking, increase focus and attention, decrease substance abuse and increase sense of well-being as well as improve cardiovascular disease and improve cognitive ability in Alzheimer’s.

It will be interesting to see what holds up over time and which of these self-reported benefits are studied for approved indications. As the early expensive testing is already done for the initial approval, it is way less expensive to do the testing to get a new indication which could increase demand. It will be interesting to see at what point if any, the cost of these products starts to decrease. 

During my first week, I have not noted much of anything yet. I am trying to eat smaller amounts to avoid the nausea which may be working except that I feel hungrier. I am curious if I will have lost any weight when I weigh on Saturday. I continually remind myself that this is a journey. I have a 11 day streak now of either aerobic exercise (cycling or elliptical) or weight training. I want to minimize muscle loss and have good habits established to keep the weight off. 

GLP-1 receptor agonists were initially studied and approved for the treatment of diabetes. As often happens with treatments, once they are used in humans, people start to experience adverse events and benefits that were not previously known about. Pharma companies do extensive research on new drugs before (Phases 1, 2 and 3) and AFTER (Phase 4) they are approved. However, no matter how much is known about a particular drug, there is only one person in the world that has the exact anatomy and physiology and health conditions that I have and that is ME. So my experience will likely be within all that is known about the medication, but I could experience something unique or unexpected that is not in the FDA approved label. Should this happen, I would report it to the FDA and and the Pharma company. This is the process that leads to drugs being withdrawn from the market years after they are approved.

Adverse events that are very rare do not show up until the drug is used by a magnitude more of people than is studied in the initial clinical trials. Prior to approval, drugs are studied in usually less than 5,000 patients. After approved drugs can be prescribed to hundreds of thousands of patients so new outcomes show up – good and bad. These outcomes need to be reported and aggregated in order to determine if an action is necessary. Unfortunately the reporting process is time consuming for patient and physician so often reports are incomplete which can delay important actions.

Most clinical trials compare groups of subjects on different treatments but there is a type of research know as “N of 1” studies where the subject is his/her own control. I am conduction a N of 1 trial on myself.

I lost 40 pounds nearly 5 years ago and have kept much of it off. I always intended to lose another 20-30 pounds using the same Weight Watcher diet but a couple of health issues got in the way: persistent loss of taste from Covid and onset of a variation of irritable bowel syndrome which makes eating the same foods I used for weight loss more difficult. I didn’t really gain back weight until I started cooking and baking for Craig.

I had my routine colonoscopy a month ago with a hope that colon biopsies might reveal a treatable cause for the IBS. The good news is that I had NO polyps for the first time ever. The bad news – no colitis. The cause of my IBS remains unclear and I will continue to manage it.

So after months of making attempts to eat less, the plantar fasciitis set in which curtailed activity for several months and I gained 8 pounds over the winter.

I have a couple of friends who had used GLP-1 receptor agonists with good results. They both talked about the significant constipation as an undesirable side-effect. For me that would be a benefit and not a bad thing. So at may annual Medicare Wellness visit a couple of weeks ago, I asked my doctor what she thought me using the GLP-1 receptor agonist for weight loss. She said the following – obesity is a chronic condition and if I am successful with getting off the 30-40 pounds I would like, I would have to work very hard to keep it off and may need the injections chronically to maintain it. In addition to losing fat, I would lose muscle mass and the potential for nausea, diarrhea or more likely constipation. She said she had avoided giving me a diagnosis of obesity so she was not sure if insurance would cover it. She suggested Wegovy, (ozempic specifically approved for weight loss) and I waited to see if insurance would cover it. I still wasn’t sure if I was going to ahead or not.

My main rationale for doing it is that this is my 70th year and while I hope to have a couple of more “healthy” decades, I am most concerned about the wear and tear on my joints as the major impediment to maintaining good health over time. The weight loss will be very beneficial for my joints and for my enjoyment of physical activities which are crucial for my mental and physical health and keeping the weight off. Also I am hoping for constipation and the potential of a “reset” to my dysfunctional intestines.

Insurance is covering 50% of the cost so I decided to “go for maximum health” in my 70th year. This is smart for my insurance company because if successful, I should be able to avoid a knee replacement.

Wegovy has weekly injections and I didn’t feel the needle at all. I wouldn’t have minded daily injections because if there are significant side-effects, they won’t last as long. Wegovy starts at half dose for 2 months and then dose is increased. So far I have not really noted anything – except perhaps a slight nausea after eating. I have decreased portion sizes as suggested and am doing some form of exercise every day to help minimize the muscle loss.

I am only going to weigh weekly.

The journey has begun.

I have not blogged since October and every time I approach doing some writing, I cannot figure out what to say. All I wanted for my birthday on November 6th was the election or likely election of Kamala Harris. It then became of weeks long exercise in sorting through the stages of grief and the many shades of depression.

Craig and I have arrived at the need to check in on our feelings about our microenvironment (us), environment (family and friends) and the macroenvironment (country and global concerns) separately.

We traveled for Thanksgiving and stayed local for Christmas. We did the best we could. I am between my first and second cataract surgery. All is going fine but the 4 weeks in between is strange with respect to vision. I have remove my corrective lens from the right side of the glasses that was done first. My vision is off in both eyes but in different ways. Hopefully when both eyes are done and my brain has adjusted to the trifocal lenses, I will have great vision without glasses.

I have had significant heel pain for about 8 weeks now. It preceded the election or I would say it was psychosomatic. I have purchased more shoe inserts, shoes, night splints for plantar fasciitis with no help. I have tried to stay off of it and tried to walk through pain. I am taking dicolfenac pills and tried the topical which made it tolerable. I then remembered a dear friend told me about arnica several years back so I got some of that about 10 days ago. If I apply it every few hours, I can periodically forget about the pain. I have an appointment with a podiatrist next week.

If I were to do a validated questionnaire about depression, I would not have depression so I have come up with a term for how I feel – slumpy.

I am alive, well and about midway on the slumpiness scale.

On our first day of sorting and loading wood, this shed had the 3 large lumber racks inside completely covered in wood. One rack was across the back and there was on along each side wall. There were 3 feet of walking space in between filled with random pieces of lumber. The first day we unloaded the wood on the racks and the second day we disassembled the racks. The floor of each of the shelves for the lumber were also pieces of lumbar.

Within an hour or so of getting started, I ran a nail sticking out from a board completely through the sole of my work boot. Fortunately the nail went between my toes. I stopped to examine my foot and make sure there was not blood. In the afternoon, with the ground covered in various piles of wood and steel that was being sorted, Craig lost his balance, fell and scraped his forehead. He broke the skin and it looked like he had a significant cut but it did not really bleed more that just at the edges. He did not even stop to get it cleaned up which I strongly suggested. He was right, he is healing fine with no signs of infection.

We were both incredibly lucky. Fortunately we are both inclined to let our bodies heal our injuries rather than seek medical care quickly so we are tolerant of that behavior in each other even though it might be uncomfortable.

We went from the “high” of Natalie and Craig’s Songwriter Round to 3 days of sorting, lifting and hauling old lumbar from a property that is being sold next week. Craig can not walk away from good lumber. We hauled out 3 pick up trucks and one 16 foot trailer of wood and steel. This haul is not only the lumber, but 3 steel huge lumber racks, steel saw horses. It was a great upper body work out.

It was very dusty work and after the first day we said we should have worn masks which we failed to do on both subsequent days. Not sure if this truck is more Ma and Pa Kettle or Jed and Granny.

Now we need to assemble the lumber racks behind the shop. The spot for the racks was occupied by an old RV that we have decided not to restore. So after spending 2 days loading lumber, we(he) spent Sunday figuring out how to move the RV. He tried Katie the tractor to tow her but she was not quite enough. Fortunately the truck was up to the task.

Here is the RV that was moved from the spot that is not being prepared for the 3 side to side lumbar racks with wood posts and steel horizontal bars to be reconstructed on top of this gravel. Once constructed Craig has a plan for how to make a cover for the racks to keep the wood dry. There is a large lumber rack inside the shop as well. Hopefully the goal is NOT to fill this storage capacity but to use the space to organize what we have so that we can easily find what we may need. We have a lot of lumber down under the trees where they do not get a lot of rain and perhaps we can move the good stuff up to this rack.

Hopefully we will have the opportunity to make use of all of the lumber that we have.

Craig was well prepared for this event. There was a decent size group in the restaurant where the Round is held. Natalie’s parents drove up to see it. It went by in a blink. They both sounded great and their two styles worked well together. It was so fun to hear Natalie sing one of Craig’s songs and to add violin. AMAZING. They each played 3 songs and it timed out at just under 30 minutes which was perfect.

When Craig came off stage he said “I was out of tune so I held back on guitar”. I didn’t notice either. He sounded great. Most important to me is to be able to hear his lyrics and follow the stories he was telling. Neither James or Natalie noticed he was out of tune. After watching the video a few times, Craig finally said “that was not as bad as I thought” and posted it to YouTube. https://www.youtube.com/watch?v=IMKZkPfx4_w

The pause in all of our projects was worth it. He got back on stage with Natalie’s support and the response of the audiences and other songwriters will keep him going. I am so proud of and happy for Craig. As he said on stage – This was like being a 5 year old in Disneyland.

The next post will explain why I am so behind in posting this.