Tag Archives: risk

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A weight loss drug complication

People are ordering versions related to semaglutide (ozempic) and dulaglutide (trulicity) from compounding pharmacies for various reasons. Their insurance may not cover the prescription or they may actually not qualify by their weight and complications. Here are the guidelines from the American Gastroenterological Association: https://www.aafp.org/pubs/afp/issues/2023/1000/practice-guidelines-medications-weight-loss.html. Those criteria: a body mass index (BMI) greater than 30 kg per m2 or BMI of 27 kg per m2 or greater with associated complications (e.g., hypertension, diabetes mellitus, and hyperlipidemia).

I have already had requests in clinic for a prescription sent to compounding pharmacy. I am refusing to send prescriptions out of state or to compounding pharmacies, because of the FDA warning. Here: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss. There are a bunch of issues: some compounding pharmacies are not using the FDA approved medicines, they are using something similar, but not the same. Also, the medicine does not come in the pen that injects a controlled amount. People have to draw the drug up and inject it. Some have injected ten times the amount that they should and have been hospitalized. It’s also worrisome that the compounding pharmacies, unlike state-licensed pharmacies, do not have to report complications.

A recent patient has deteriorating kidney function, with his creatinine jumping from 1.10 to 1.58. Creatinine is produced as a waste product by our cells and the kidneys need to clear it. His 1.10 was normal but the 1.58 is high, indicating the his kidneys aren’t clearing well, and that was only a six month interval. He is taking compounded semaglutide and compounded testosterone, with some online approval. That is, he did not get a prescription from our clinic. He started the semaglutide five months ago. The testosterone has been for years. “Stop the semaglutide and we will recheck your kidney function in a month.” His creatinine drops back to 1.10. Acute renal failure is listed as an uncommon side effect of the FDA approved semaglutide, but we don’t know if that is what he’s getting. I tell him the good news about his kidney function and say, “I think you should stay off the compounded drug.” I have not seen the same thing with the FDA approved semaglutide.

It’s complicated, isn’t it? We picked up the problem because he is on other medications and I do yearly labs on people who are on prescription medicines, to check whether their kidney or liver function is deteriorating. Almost all drugs, prescription or over the counter or supplements, are metabolized by either the liver or the kidneys. I only know of two that are not absorbed and not metabolized.

For the Ragtag Daily Prompt: pristine. I would like a pristine pill free body for as long as possible. Ok, I took one tylenol last week and I’d be dead three times over it wasn’t for penicillin.

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Wait

I came close but no cigar
I want a mind that I can love
hand holding mine in the car
I send a quiet prayer above
Love of nature, kind to friends
not afraid of their own dark
Lust to learn until their end
willing to risk to build an ark
Curious but not controlling
Not addicted to booze or drugs
Intense at times and others strolling
Opinions, laughter and lots of hugs
My heart open yet I don’t faint
I think I am waiting for a saint

_____________________________

I wrote the poem yesterday, but I have used up my memory in wordpress and now I need to go through and delete things. Any advice, Martha? I know you did it. It seems that I have to delete the post and the photograph, or is that not true? Advice welcomed.

I search my photographs for gloves and it comes up with two: foxgloves! Well, strictly speaking, that is a form of glove, right?

For the Ragtag Daily Prompt: glove.

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On line weight loss drugs

Don’t buy it. Apparently a company call Him is selling a compounded GLP-1 like drug, have worked around the DEA for the moment, but people are getting really sick and there have been some deaths. Article here.

The workaround is that the DEA will let compounding pharmacies make a drug if there is a shortage. Unfortunately, online companies are doing 734,000 prescriptions a month. People can get them on line without a doctor visit or labs, though there may be a doctor signing off. Remember that they are selling an untested GLP-1, and the side effects of the tested ones can include gall bladder disease, pancreatitis and gastroparesis, where the food sits in the stomach and doesn’t leave. And yes, there have been deaths. This may be the salt of the drug, so that it doesn’t have the slow absorption when injected, and hits all at once. Is weight loss that important?

The guidelines for weight loss drugs are here: https://www.aafp.org/pubs/afp/issues/2023/1000/practice-guidelines-medications-weight-loss.html. This article is from October 2023, so doesn’t have the latest offering. I recently saw a person who did not fall into those guidelines. I refused to prescribe. The person responded, “I’ll go to Mexico and get it.” I reply, “Be sure that they do laboratory work and talk to you about the potential side effects.” I am also reading that now there are faked weight loss injector pens circulating. I don’t know what is in them. Fentanyl? Floor sweepings? Who knows.

Meanwhile I am still working on a little weight loss myself. I don’t know if I’ve lost much but clothes are fitting better. The climbing gym and hiking are having an effect. Muscle burns 9 kcal per gram and fat only 4 kcal per gram, so building muscle slims one even if the weight stays the same. My endurance is rising. That feels so good after being on oxygen for a year and a half. I am still trying to eat 1/2 green/yellow or orange vegetables at each meal and I think that is helping too. All this discipline stuff, eeyuk. Oh well.

Anyhow, be careful out there. I do not recommend getting weight loss drugs off the internet or buying it from “friends of friends”. Bad news.

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Less Long Covid if vaccinated

My cats are pound kitties, rescues that were still half-starved kittens when they arrived. They were supposedly six weeks old when I got them, so born in August 2021. This photo is from February 2022. They are still exploring and fascinated by water and faucets and showers. They are doing cat research. Meanwhile, Long Covid research continues.

https://dgalerts.docguide.com/ncov-home/article/lower-long-covid-prevalence-symptom-severity-in-vaccinated-individuals

This is a report on a study which started in October of 2020. “Participants were actively followed for severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) infection. In the study, Hannah E Maier, PhD, University of Michigan, Ann Arbor, Michigan, and colleagues compared the prevalence of symptoms and symptom severity between vaccinated and unvaccinated individuals.” People were enrolled for a year as they got infected, with demographic and health information recorded as they enrolled. They turned in information every two weeks and had blood draws every two months. After a year they were invited to continue for a second year. 3375 were enrolled, more than 1370 filled out Long Covid forms, and 1007 of the 1370 were vaccinated. Long Covid was defined after 90 days.

“At 30 and 90 days post infection, 38% and 13% of individuals reported persistent symptoms, and 6% and 2% reported ≥5 symptoms, respectively. Fatigue (19%), cough (15%), and cognitive dysfunction (12%) were the most commonly reported symptoms at 30 days, whereas loss of smell/taste (8%), fatigue (6%), and cognitive dysfunction (5%) were the most commonly reported symptoms at 90 days. The mean score of symptom severity was 3.6 and 3.9 at 30 days and 90 days post infection, respectively.

At 90 days post infection, 8% of vaccinated individuals reported persistence of any symptoms compared with 27% of unvaccinated individuals (relative risk [RR] = 0.31; 95% confidence interval [CI], 0.22-0.42). Similarly, vaccinated individuals were less likely to have ≥5 symptoms compared with unvaccinated individuals (RR = 0.34; 95% CI, 0.15-0.79).

Furthermore, vaccinated individuals had significantly lower average symptom severity scores at 90 days post infection compared with unvaccinated individuals (relative severity [RS], -2.70; 95% CI, -1.68 to -3.73).“

There also was more Long Covid in the pre Omicron group than Omicron and beyond.

This study is community based and most of the patients were not hospitalized. Overall it has a lower estimate of how common Long Covid is than studies in hospitalized patients. It is reassuring that Long Covid symptoms and prevalence are lower with vaccination, but some people are still severely affected even with vaccination. Vaccination does not stop Long Covid completely though I certainly wish that it did. Mixed good news, but vaccination still looks like the best bet other than moving to a bunker permanently.

The study is published in Open Forum Infectious Diseases: https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofae039/7585852. The quotations are from the DGAlerts article.

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Covid 19 and the heart

This is from the University of New Mexico Roam Echo PASC (Post Acute Sequelae of Covid-19) talk on 11/9/2023 over Zoom.

Cardiovascular Outcomes in Post-COVID Conditions
Jeffrey Hsu, MD, PhD, FACC, Assistant Professor, Division of Cardiology – University of California, Los Angeles Health and Founder, COVID Cardiology Program – University of California, Los Angeles 

I am going to include the references in the order that Dr. Hsu talked about them. This is a sobering and upsetting lecture with the research showing a post Covid-19 increase in cardiovascular risk factors (cholesterol, hypertension, diabetes), and an increase in cardiovascular events in people with no previous cardiovascular diagnosis including heart attack, stroke, pulmonary embolus, blood clots and sudden death.

I don’t expect the general population to read the studies, but look at a few of them. It is very very impressive, the amount of work being done. Now let’s explore the talk and boil it down to three sentences for primary care to explain in clinic. Right. (You can always skip to the last two paragraphs if you get overwhelmed, and come back later.)

Part 1: The Research.

The first paper is about veterans without cardiovascular disease, followed for one year after Covid-19, matched with a cohort who did not have Covid-19. This is before immunization was available. They were studying the heart and cardiovascular risk. The veterans who had had Covid-19 infection were twice as likely to be diagnosed with cardiovascular risk then the veterans who had not had Covid-19. The risk was higher in the veterans with more severe Covid-19, the risk was present in all subgroups: old, young, male, female, with or without other risk factors. At two years out, the people who had been hospitalized for Covid-19 still had a persistent increased risk of death and cardiovascular incidents (heart attack, stroke, sudden death, blood clots).

To be clear, this is NOT Long Covid patients. This is just a cohort of veterans who had Covid-19. This would indicate that everyone who had Covid-19 has an increased cardiovascular risk.

Here is the first paper: 1. https://www.nature.com/articles/s41591-022-01689-3

Two more papers looked at more general populations who got Covid-19 before the vaccine was available and found the same thing. The veterans tended to be older and more male patients, but the general population studies found the same pattern in women and younger patients. Papers:

2. https://www.scientificamerican.com/article/the-risk-of-heart-disease-after-covid/, “Health modeller Sarah Wulf Hanson at the University of Washington’s Institute for Health Metrics and Evaluation in Seattle used Al-Aly’s data to estimate how many heart attacks and strokes COVID-19 has been associated with. Her unpublished work suggests that, in 2020, complications after COVID-19 caused 12,000 extra strokes and 44,000 extra heart attacks in the United States, numbers that jumped up to 18,000 strokes and 66,000 heart attacks in 2021. This means that COVID-19 could have increased the rates of heart attack by about 8% and of stroke by about 2%. “It is sobering,” Wulf Hanson says.

3.https://www.nature.com/articles/s41591-023-02521-2

Non hospitalized patients had decreased risk for some cardiovascular problems but not all and still had significantly higher risk than people who had not had Covid-19. I am busily thinking UH-OH, this is really bad, in this lecture.

He stated that the data is not in yet about vaccination, whether it lowers the cardiovascular damage compared to unvaccinated.

The initial study was on veterans, mostly male and mostly white, but then was replicated in other similar studies that were not on veterans, but on a general population.

From the second and third study, 700,000 patients with a mean age 40 and more than half female, were studied for new cardiovascular disease in the year following Covid-19 and found an increased risk of death within one year, 0.34% vs 0.28% HR 1.6. That was in 2020, a nonvaccinated population. Another study showed similar results, 13,000 patients with Covid-19 and 26,000 without, average age 51. There was a similar risk increase in cardiovascular disease and an increased risk of death within one year.

4. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00349-2/fulltext

5. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2802095

So do other infections do the same thing? Studies of acute risk of myocardial infarction risk after influenza, done before the pandemic, indicate an increased risk of myocardial infarction within one week after infection, but not beyond that week. So Covid-19 is really really nasty to our cardiovascular system.

6. https://www.nejm.org/doi/10.1056/NEJMoa1702090

7. https://www.nejm.org/doi/10.1056/NEJMra1808137

Pneumonia and sepsis can increase risk of cardiovascular disease, but there have not been the extensive studies as in Covid-19. More and better studies.

One to two years after diagnosis, there is increased cardiovascular and cerebrovascular risk, both:

  1. Cardiovascular risk factors, worsening after covid
  2. Thrombosis risk

8. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00044-4/fulltext

The risk of is up diabetes 40% in the post Covid-19 patients. That does not mean that 40% are diagnosed with diabetes, but that the risk is higher after Covid-19. For example, if in the non-Covid cohort 100 of 1000 40 year olds develop type 2 diabetes, then it’s 140 of 1000 in the post Covid-19 group.

The risk of dyslipidemia in 50,000 patients went up 24%. Dyslipidemia means increased LDL cholesterol or increased triglycerides and lower HDL or all of them.

9. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00355-2/fulltext

10. https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.21174

Hypertension is up too and weight gain.

11. https://www.nature.com/articles/s41577-022-00762-9

New onset hypertension is up 22% in hospitalized patients post Covid-19 and 11% in unhospitalized post Covid patients.

Myocardial infarction (heart attack) and ischemic stroke both go up. Ischemic stroke is the more common kind of stroke and is the clotting version. Bleeding strokes are less common.

Why does Covid-19 do this? What is the mechanism? The studies are pointing towards thromboembolism as the mechanism in both increased cardiovascular risk factors (dyslipidemia, hypertension, stroke, heart attack, clots). Thrombosis means clots. Remember the talk about micro-clots? (My write up here: https://drkottaway.com/2023/04/14/xeno-or-infection-phobic/). Micro-clots can lead to bigger clots. A clot in a heart artery causes a heart attack; in the brain an ischemic stroke; a clot in the leg can break into pieces and block the lung arteries. Irritation in the heart and the arteries can increase blood pressure. I’m not sure how it can increase diabetes, but it does.

Next he shows a slide about thrombosis and how complex it is. Sars covid-19 seems to promote perfect storm of events that leads to environment for thrombosis in multiple ways.

Covid-19 infects epithelial cells, causes a hyperactive immune response, orchestrates subsequent response, causes platelet hyperactivation and then hyperactive innate immune response, causes damage to glycocalyx that protects and vascular endothelial injury, decreases antithrombogenic and increases prothrombogenic activity which promotes thrombosis in the vasculature, platelet activation and coagulopathy. Got that? No? Me either, my last immune system class was in 1988 when I was working at the National Institutes of Health. It’s bad, meaning it can kill us or cause damage that is disabling.

12. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30937-5/fulltext

My notes are a bit disjointed here: The endothelial cells (which line arteries) express H2 receptors that Covid-19 virus needs to enter the cells. The H2 receptors are also in glomerular capillary loops (kidneys), and immune cells and cause apoptosis of lung endothelial cells. Apoptosis is a form of programmed cell death that occurs in multicellular organisms and some eukaryotic microorganisms. So you don’t want your lung cells doing that. Lung, small bowel, and pulmonary microvasculature can all be affected.

13. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(22)00355-2/fulltext

Plaque in human coronary vessels, in the immune cells, spike and Sars cov 2 identified in coronary artherosclerotic plaque.

Direct on coronary and cerebrovascular cells. (Ok, I don’t know what I meant by this note.)

Part II: Now what? What is our approach to healing this?

There is still limited data! (The clinical trials are roaring along but they take time.) Here are a bunch of studies, all using blood thinners. Blood thinners include aspirin, plavix, heparin, enoxaparin or apixaban. Do NOT start aspirin at home at this point, because when you add a blood thinner, there is a risk of bleeding, including bleeding stroke and intestinal bleeding. So far, the studies are discouraging.

Aspirin 150Mg Recovery trial: no difference in mortality: major bleeding 1.6% vs 1/0 % Lancet 2022. This is a double baby aspirin dose, 30 days in study, no benefit in acute setting.

14. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30937-5/fulltext

Non critically ill hosp patients ACTIV 4A trial P2Y12 inhibitor – heparin alone or clopidigril (plavix) plus heparin, no benefit, major bleeding 2.0% vs 0.7% so worse in the both group.

15. https://www.nejm.org/doi/10.1056/NEJMoa2103417

16. https://doi.org/10.1001/jama.2021.17272

Harmed patients with severe disease.

ACTIV-4B aspirin or apixiban in outpatient, stopped early, event rate low, higher rates of minor bleeding in the 5mg apixiban group.

Feedom covid 19 trial: Non ICU Hospitalized, compared prophylactic heparin to enoxaparin or apixaban. Signal to provide benefit, lower rates of death and intubation, similar bleeding rates

17. https://www.sciencedirect.com/science/article/pii/S0735109723045278?via%3Dihub

So what does our Post Covid Cardiologist recommend to physicians and patients:

First year post covid: look for cardiovascular symptoms.

Screen for risk factors, hypertension, diabetes, hyperlipidemia, obeisity.

Optimization of risk factors, smoking cessation (and I would add that alcohol also causes damage to the heart and arteries, though tobacco is worse.

Assess candidacy for statin therapy for primary prevention.

18. https://cardiab.biomedcentral.com/articles/10.1186/s12933-021-01359-7

There is a study of triple therapy (meaning THREE blood thinners) that showed improvement but that was in older patients who already have heart disease before Covid-19. So it doesn’t apply.

He says there aren’t any good studies of blood thinners in Long Covid-19 yet and it is not clear that the Long Covid people are worse as far as the cardiovascular risk than everyone else. And remember, these studies are on unvaccinated people, so for the year following the first year of Covid-19. We don’t have the results for vaccinated people. He says that if someone is high risk or has cardiac symptoms chest pain etc put on 81 mg aspirin and a statin (and work it up, of course. Do the testing.

For now use anticoagulation (blood thinners) only if there is clear evidence of thrombus: deep venous thrombosis or pulmonary embolus. Freedom covid-19 study showed major bleed risk 0.1-0.4%.

The cardiologist speaker has not started triple therapy on any patents given unknown benefit at this time, with known significant major bleeding risk. He recommends shared decision making, meaning the patient should be presented with the risks and choices. Um, ok, boil this talk down into three sentences. Good luck. EEEEEEE!

Part III: Summary.

Whether you had Covid-19 before being vaccinated or after, or aren’t sure if you ever had it, it is worth seeing your provider to check your blood pressure, do diabetes screening, stop smoking (anything, and I include vaping in that), reduce or eliminate alcohol, keep your weight reasonable, check your cholesterol and go to your provider if there is any weirdness post Covid-19. And if you have not been vaccinated, oh, my gosh. Unless you have an immunology problem where your immunologist says “NO!”, get vaccinated.

Lastly, I’ve heard many claims that death rates were “over reported” for Covid-19. No. In a death certificate, the acute injury or infection is reported FIRST and then other related causes. Such as: Covid-19, ischemic stroke, hypertension, tobacco overuse syndrome. There were MORE strokes and heart attacks and sudden death, with Covid-19 as the final straw in many people who already had cardiovascular disease. They died sooner than they would have if not infected. That is not over reporting.

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A friend, Brent Butler, took the photograph, used with permission. I think it shows how I felt after this talk. Yet I still have hope, because you can’t deal with something unless you know about it.

If you want a link for the talks, message me. Anyone can tune in.

Covid-19 continues to fandangle us. There. I verbed the Ragtag Daily Prompt: fandangle.

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Vaccination talk

My cousin asks me once, why do doctors say, “This will only hurt a little?’ when they give a shot.

I thought about it. “It’s a matter of scale. Picture this: in room one, I have a woman who thinks her lung cancer is back and it is. In room two I have a mother and daughter crying because the daughter is pregnant and frightened. In room three, I have a well adult who needs a vaccination. Scale their levels of pain.”

Room one is very high, room two is very high, room three barely registers on my pain scale.

Poll: 1 in 7 parents have not talked about vaccines with their child’s doctor

I would give out a health department vaccination information booklet by 24 weeks to my pregnant patients, especially the first pregnancy. I previously had given it later, but then I had a woman who refused the child’s vaccines at visit after visit after visit, saying that they were still doing research. The child still had no vaccinations at 9 months.

Remember the woman who refused vaccinations for her children? She had more than four children. They all got whooping cough, pertussis. They whooped for months and were on quarantine. They were not allowed out of the household, any of them, until they were no longer infectious. The mother said she now was for vaccines and got them vaccinated.

I have seen adults with pertussis. Adults do not whoop but they cough. They can cough until they throw up or until they break a rib. For months. It is not fun at all. The adult Tdap stands for tetnus, diptheria, and acellular pertussis. I have never seen a case of diptheria and I don’t want to. It sounds horrible and can kill.

Have I seen a complication of a vaccination? One in 30 years of practice. And I know a person who had a complication, but they were not my patient.

The illnesses cause way more damage and disability than the vaccine. In residency I care for a young man in a group home. He can’t talk and has an odd skull shape. His mother got measles during the pregnancy. Measles is one of the infections that can cause severe birth defects. Get vaccinated before getting pregnant, though half the pregnancies in the US are “unintended”. That usually means “unbirthcontrolled”. I do not really understand that, since the risk of pregnancy in a fertile woman is one in four every time. Twenty five percent seems a pretty high risk to me.

I’ve written about my response to my last Covid-19 vaccination. It’s not a complication. It is an antibody response and it means that my immune system is WORKING, though admittedly it is weird and annoying. I don’t like the muscle dysfunction, but I will get the vaccinations anyhow.

I have a very alternative young woman in for prenatal care once. I give her the vaccination booklet. “Oh, my child is getting every vaccine there is,” she says.

“May I ask why? I was not expecting you to say that.”

“I was in the Peace Corps in Africa. I have seen kids die from every single one of the diseases we vaccinate for. My kid will get ALL the vaccinations.”

I said, “Please would you talk to my other moms?”

She smiled at that. “Maybe.”

I hope she did and does.

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beach tower

Sections of the dunes collapse. I stopped climbing them when I was sitting above my children and I was hit from behind by a collapse and pushed 5 feet forward. There was no warning, just sound and hit. I was not buried, but I realized how I could have been. I took my kids down off the dune.

There are sections of stairs left where the bottom sections have been washed away. Some days as it warms up, you hear sand sliding down, tiny trickles. I have a friend who saw a huge section collapse, all the way out to the water, with trees. He and another walker missed being buried by five minutes.

We walk the beach anyhow. This will collapse eventually but was standing on Saturday.