Category Archives: Coronavirus

Pfizer COVID-19 Vaccine: No Deaths Prevented Over Six Months

Alea iacta est

I ran across a pre-print placebo-controlled scientific study looking at results of Pfizer-BionTec vaccination over the course six months. The primary take-home point for me is that the vaccine did not prevent death. Mysteriously, the study authors didn’t discuss the lack of death prevention by the vaccine; I found the data in Figure 1. The vaccine did prevent severe COVID-19 disease.

The scientific name for this particular vaccine is BNT162b2.

Remember that Big Pharma and the CDC have been telling us since November 2020 that the COVID-19 vaccines are highly effective (~90% or better) in preventing severe disease and death.

The study at hand looked at 22,000 folks who got two doses of the vaccine and another 22,000 who got a saline placebo. There were 16 deaths in the vaccine group, 15 in placebo.

Thirty-one participants met the CDC’s definition of severe COVID-19; 30 of these were in the placebo group. So the odds of developing severe COVID-19 over six months if not vaccinated were 0.136%. Or one in 735. (Tell me if my math is wrong.) I fully expect the odds are higher if elderly, lower if young.

Among the vaccinated, 77 developed COVID-19. The placebo group had 850 cases. The report doesn’t state a definition of a “COVID-19 case.” I presume a positive PCR nasal swab and one or more of the usual symptoms. Maddeningly, when the mainstream media mentions a case count, the number may include folks with a positive PCR swab but no symptoms.

Most participants were enrolled between August and October 2020. The U.S. had a major spike in cases in January 2021. The data cut-off date for this study was March 31, 2021, so many of the participants had significant exposure. Median age for both groups was 51. 76% of participants were in the U.S.

The authors note that the risk of developing COVID-19 in the vaccinated tended to rise over time. Vaccine effectiveness declined about 6% every two months. A booster vaccination might be recommended at some point. Pfizer’s CEO revealed this a couple months ago.

For all I know, the linked-to pre-print article above is a hoax. These data are not going to help Pfizer sell more vaccine! If the pre-print is legit, I assume Pfizer was somehow compelled to publish the results.

This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.

Steve Parker, M.D.

h/t The Last Refuge or theconservativetreehouse.com

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My Recent Posts About COVID-19

Artist’s rendition of coronavirus

I write about COVID-19 at one of my other super-secret blogs. If you’re interested:

Steve Parker, M.D.

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Does Melatonin Prevent or Treat COVID-19?

Photo by Anna Shvets on Pexels.com
<p class="has-drop-cap" value="<amp-fit-text layout="fixed-height" min-font-size="6" max-font-size="72" height="80">Melatonin is a commonly-available over-the-counter sleep aid. In 2020, the Cleveland Clinic did epidemiological study that linked melatonin usage with a 30% reduced risk of contracting COVID-19. Clinical psychologist Michael J Breus, Ph D has an <a rel="noreferrer noopener" href="https://www.psychologytoday.com/us/blog/sleep-newzzz/202005/could-melatonin-help-protect-against-covid-19&quot; target="_blank">article at <em>Psychology Today</em> on the use of melatonin as a preventative or treatment for COVID-19</a>.Melatonin is a commonly-available over-the-counter sleep aid. In 2020, the Cleveland Clinic did epidemiological study that linked melatonin usage with a 30% reduced risk of contracting COVID-19. Clinical psychologist Michael J Breus, Ph D has an article at Psychology Today on the use of melatonin as a preventative or treatment for COVID-19.

Melatonin, of course, is best known as a sleep regulator. But melatonin also plays an important role in regulating the immune system. One way it does so is by influencing the production of small proteins known as cytokines, which act as signalers from the immune system to cells around the body. Cytokines can be inflammation producing (pro-inflammatory cytokines) or inflammation restricting (anti-inflammatory cytokines). Melatonin has been shown to reduce the production of pro-inflammatory cytokines. Melatonin also is well known to be an antioxidant, neutralizing free radical cells and limiting oxidative stress and damage, which contribute inflammation.

Pro-inflammatory cytokines serve an important purpose, in marshaling the inflammatory response that fights off viruses, bacteria, and other pathogens. That’s the protective mechanism of inflammation at work. But for the pro-inflammatory cytokine response to be beneficial, it must be proportional to the threat. A too vigorous response of pro-inflammatory cytokines creates a dangerous amount of inflammation—and can actually serve to spread the viral infection, rather than tamping it down. It is this inflammatory overreaction and viral spread that appears to take place in the most serious cases of COVID-19.

I spent 10 minutes on the Internet trying to find the appropriate dose of melatonin for its possible preventative and treatment powers. But no luck. It’s likely in the range of 1 to 10 mg/day, typically taken at night or bedtime. For insomnia in my hospitalized patients, I start at 1.5 mg. Most of my colleagues use a much higher dose. Dr Josh Farkas at emcrit.org suggests that the treatment dose is 5 mg/day.

As always, check with your personal physician first.

Steve Parker, M.D.

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Is Ivermectin the COVID-19 Magic Bullet We’ve Been Waiting For?

<p class="has-drop-cap" value="<amp-fit-text layout="fixed-height" min-font-size="6" max-font-size="72" height="80">

face mask, young woman
Probably at little risk of serious illness if she’s generally healthy

From Diabetes Metab Syndr in Sept 2020:

The clinical efficacy and utility of ivermectin in SARS CoV-2 infected patients are unpredictable at this stage, as we are dealing with a completely novel virus. However, repurposing existing drugs as possible COVID-19 treatment is astute usage of existing resources, and we await results of well-designed large scale randomized controlled clinical trials exploring treatment efficacy of ivermectin to treat SARS-CoV-2.

The authors of this letter mention current clinical trials (~38) with a dose [presumably by mouth] ranging from 200 to 1200 mcg/kg body weight, for a duration of 3–7 days, which is showing promising results both in terms of symptoms as well as viral load reduction. Another article mentioned the usual treatment dose is 0.2mg/kg on day 1 and day 3 followed by Days 6 and 8 if not recovered.

The authors cite the Broward Health hospital system study from South Florida. In this small pilot study, hospitalized patients treated with ivermectin had a better survival rate compared with “standard care,” whatever that was back in Spring 2020. The ivermectin-treated patients received “at least one dose” of the drug at 200 mcg/kg, by mouth. Has this report been peer-reviewed and published yet? If not, why not?

We give our horses ivermectin periodically

Moving on…

One small study (probably 60 each in the treatment and placebo groups) found that 12 mg ivermectin by mouth once a month impressively protected healthcare workers against COVID-19.

Another study: “Two-dose ivermectin prophylaxis at a dose of 300 μg/kg with a gap of 72 hours was associated 73% reduction of COVID-19 infection among [hospital] healthcare workers for the following one-month. Further research is required before its large scale use.”

After hydroxychloroquine, azithromycin, and ivermectin, will nitazoxanide be the next panacea? You heard it first here!

A small study in Barcelona found no benefit from a single standard dose (200 mcg/kg) of ivermectin in patients hospitalized with severe disease. They suggest that a higher dose might be useful.

I’ve spent about 90 minutes on my day off trying to figure out if I should prescribe ivermectin to my hospitalized patients. My conclusion is that we need more and better data before it’s ready for prime time. I agree with Dr Ananda Swaminathan, who probably spent many hours more on the subject:

Evidence for the use of Ivermectin is based on in vitro [lab studies, not living animals], prophylaxis, clinical, safety, and large-scale epidemiologic studies (heterogenous populations in multiple different settings) BUT…

Many of the trials thus far are methodologically flawed without enough information about baseline demographics, multiple primary outcomes, soft/subjective outcomes, convenience samples, and unclear definitions, just to name a few

Additionally, a valid concern in evaluating the literature is that many of the trials have not yet passed the peer review process and are in pre-print format

Although Ivermectin is cheap, readily available, with a fairly safe side effect profile, based on the evaluation of the literature above, at this time, Ivermectin should not be recommended outside of a clinical trial to ensure we get a true answer of effect

Ivermectin is interesting, there is certainly signal to evaluate further, but in our desire to want a treatment option, let’s not continue to do the same thing over and over again, as we saw play out with Hydroxychloroquine

Like they say, “more studies are needed.”

Steve Parker, M.D.

PS: Something you can do to help prevent and survive COVID-19 is to get and stay as healthy as possible. Let me help:

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How Do You Get Compensation If Hurt By a COVID-19 Vaccine?

The vaccination needle probably won’t be this large

I know it’s a little early to be asking that question. Within a year, an unknown number of you will be asking. Where do you go for satisfaction? The CICP: Countermeasures Injury Compensation Program. Forget about suing the vaccine manufacturer, distributor, or medical practitioner who jabbed you. They got the federal government to absolve them of liability in most cases. If injured, you need to file your claim within a year of vaccination.

As far as I know, this program only applies to U.S. residents. Perhaps only U.S. citizens.

Here’s an excerpt from a related fedgov program, the NVICP web page:

Vaccines save lives by preventing disease.

Most people who get vaccines have no serious problems. Vaccines, like any medicines, can cause side effects, but most are very rare and very mild. Some health problems that follow vaccinations are not caused by vaccines.

In very rare cases, a vaccine can cause a serious problem, such as a severe allergic reaction.  

In these instances, the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement. 

Many physicians in my community are excited and lined up to take the COVID-19 vaccine. But not me. I even have risk factors for more serious COVID-19 disease: age 66 and hypertension. After reviewing what little data are available from the Warp Speed vaccine trials, I’m not convinced the vaccines are safe enough for me. I’ll take my chances with the virus rather than the vaccine. I’m not afraid of dying from COVID-19; if that happens I’ll be in heaven with Jesus. I’ve lived a full and lucky life, blessed by a wonderful wife, fantastic children, good health, missed Viet Nam by a few years, no major economic upheaval. My biggest concern about catching the virus is the burden it would lay on my co-workers if I’m off-duty for 1 to 3 weeks.

That said, if I were older and had other co-morbidities, I might take the vaccine now. When we have more long-term data on vaccine safety, I might take the vaccine. It could take up to a couple years before we have that data.

I am not anti-vaccine, in general. As a child I got the vaccines for polio, measles, mumps, rubella, tetanus, and probably diphtheria, maybe others. I took the hepatitis B vaccine as an adult because I’m exposed to blood from my patients. I’m due for another tetanus booster and will take it without reservation.

Steve Parker, M.D.

PS: I’m doing everything I can to optimize my health and immune system, including weight management and regular exercise.

PPS: Pharmacist Scott Gavura at Science Based Medicine provides a table comparing vaccination vs catching the virus vs hydroxychloroquine treatment. He implies my odds of death from COVID-19 infection are two out of a hundred (2%). I don’t think it’s nearly that high.

PPPS: Click for an interesting article on CICP at the Centre for Research on Globalization. I have no idea of its accuracy.

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Covid-19 Vaccine May Not Live Up to the Hype

professor, equations
The governments “top men” are working on it

Peter Doshi, an associate editor at British Medical Journal, is not favorably impressed with the recent vaccine trial announcements. “90% effective.” “95% effective!”

Coronavirus guru Anthony Fauci assures us that a coronavirus vaccine will only be FDA-approved if it’s “safe and effective.”

From Doshi:

But what will it mean exactly when a vaccine is declared “effective”? To the public this seems fairly obvious. “The primary goal of a covid-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said bluntly.

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”

Yet the current phase III trials are not actually set up to prove either. None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

Will COVID-19 vaccines save lives? Current trials aren’t designed to tell us.
elderly man, face mask
Do you ever wonder why we didn’t see widespread use face masks during a typical flu season in the past?

Switching gears to the flu vaccine for a minute. The flu vaccine’s been a godsend in preventing influenza death among the frail elderly, right? Not so fast there, pardner. Doshi again:

But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.

Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths.

Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality.

The Moderna and Pfizer trials enrolled 30,000 and 44,000 participants, respectively. That sounds like a lot of people to be vaccinated. But they only vaccinate half the folks. The other have serve as a control group. Next, the investigators track the occurrence of coronavirus events over time, then compare the two groups. An “event” may be anything from a cough plus positive COVID-19 PCR test, to hospitalization or death. Of course, they also look at potential adverse effect of vaccination, comparing the two groups.

The trials aren’t going to give us good information on COVID-19 hospitalizations and death rates because those outcomes are so infrequent. Most people with symptomatic COVID-19 experience only mild symptoms; there are relatively few cases of serious disease in a general population of 30,000.

Who needs a safe and effective vaccine the most?

  • Those over 60-65
  • Anybody seriously immunocompromised (i.e., a poor immune system too weak to fight infection).

Immunocompromised people are excluded from the seven ongoing trials. So these trials focus on those over 60, right? Wrong. The Moderna trial eligibility started at age 18. Pfizer’s accepted 12-year-olds.

Surely the vaccine trials will have some participants over 60-years-old. There just may not be enough to generate clinically meaningful data on serious disease outcomes and adverse effects in the elderly.

Steven Novella says Moderna developed their vaccine with a grant from the U.S. government, and Pfizer funded themselves. Each vaccine has cost over two billion dollars to develop. They will be the first ever mRNA vaccines approved by the FDA. Our other vaccines are based on different technology. Both vaccines require two shots, 28 days apart.

Steve Parker, M.D.

PS: I am not generally anti-vaccination.

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Four in Ten U.S. #COVID19 #Coronavirus Deaths Had Diabetes

elderly, face mask, surgical mask, corona, epidemic, pandemic, couple

Still unclear whether masks prevent infection. I wear an N95 when admitting COVID-19 patients. 

In July, the CDC published data on the characteristics of 50,000 U.S. residents who died of COVID-19 between mid-Feb and mid-May, 2020.

Some points:

  • 55% were male
  • 80% were aged ≥65 years
  • 14% were Hispanic/Latino (Hispanic)
  • 21% were black
  • 40% were white
  • 4% were Asian
  • 0.3% were American Indian/Alaska Native (AI/AN),
  • 3% were multiracial or other race
  • race/ethnicity was unknown for 18.0%
  • median decedent age was 78 years (median means half who died were over 78, half were under 78)

CDC didn’t have much clinical data on all 50,000 decedents. But they were able to collect supplementary data on close to 11,000 of them;

  • 61% were male
  • 75% were aged ≥65 years
  • 24% were Hispanic
  • 25% were black
  • 35% were white
  • 6% were Asian
  • 3% were multiracial or other race
  • race/ethnicity was unknown for 6%
  • decedent age varied by race and ethnicity; median age was 71 years among Hispanic decedents, 72 years among all nonwhite, non-Hispanic decedents, and 81 years among white decedents. The percentages of Hispanic (35%) and nonwhite (30%) decedents who were aged <65 years were more than twice those of white decedents (13%)

What about underlying conditions among these 11,000 decedents for whom supplementary data was available?

At least one underlying medical condition was reported for 8,134 (76%) of decedents for whom sup­plementary data were collected, including 83% of decedents aged <65 years. Overall, the most common underlying medical conditions were:

  • cardiovascular disease (61%)
  • diabetes mellitus (40%)
  • chronic kidney disease (21%)
  • chronic lung disease (19%)
  • among decedents aged <65 years, 83% had one or more underlying medical conditions
  • among decedents aged ≥85 years, 70% had one or more underlying medical conditions
  • diabetes was more common among decedents aged <65 years (50%) than among those aged ≥85 years (26%).

From the CDC report

Regional and state level efforts to examine the roles of these factors in SARS-CoV-2 transmission and COVID-19-associated deaths could lead to targeted, community-level, mortality prevention initiatives. Examples include health communication campaigns targeted towards Hispanics and nonwhite persons aged <65 years. These campaigns could encourage social distancing and the need for wearing cloth face coverings in public settings. In addition, health care providers should be encouraged to consider the possibility of disease progression, particularly in Hispanic and nonwhite persons aged <65 years and persons of any race/ethnicity, regardless of age, with underlying medical conditions, especially diabetes.

Steve Parker, M.D.

PS: Are poorly controlled diabetics more likely to die from COVID-19? We don’t have any hard data on that yet. Almost 40 years of clinical practice tell me the answer is quiet likely “yes.” Let me help you control your diabetes.

low-carb mediterranean diet

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Obesity Is a Risk Factor for Greater #COVID19 Severity #Coronavirus

BMI over 30

From Diabetes Care:

Health care professionals caring for COVID-19 patients should be cognizant of the increased likelihood of severe COVID-19 in obese patients. In particular, the presence of obesity increases the risk of severe illness approximately threefold with a consequent longer hospital stay.

Source: Obesity Is a Risk Factor for Greater COVID-19 Severity | Diabetes Care

Not sure if you’re obese? Check your BMI.

Steve Parker, M.D.

Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords. com

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Characteristics and Risk Factors for Death in #COVID19 Patients With Diabetes in Wuhan, China

elderly, face mask, surgical mask, corona, epidemic, pandemic, couple

Still unclear whether masks prevent infection

From Diabetes Care:

In summary, the findings of our study suggested that COVID-19 patients with diabetes had worse outcomes compared with the sex- and age-matched patients without diabetes. Diabetes was not independently associated with in-hospital death, while hypertension, cardiovascular disease, and chronic pulmonary disease played more important roles in contributing to the mortality of COVID-19 patients. In-hospital death among COVID-19 patients with diabetes was associated with hypertension and advanced age, whereas only older age was independently associated with death among matched patients without diabetes. The need for early monitoring and supportive care should be addressed in these patients at high risks.

Source: Clinical Characteristics and Risk Factors for Mortality of COVID-19 Patients With Diabetes in Wuhan, China: A Two-Center, Retrospective Study | Diabetes Care

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Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords.com.

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Derek Lowe on ACEI and ARB Hypertension Drugs and #COVID19 #Coronavirus

Artist’s rendition of coronavirus

Recall that the coronavirus itself uses the ACE2 protein as an entry point into cells. One worry has been that the use of antihypertensive drugs [specifically angiotensin converting enzyme inhibitors or angiotensin receptor blockers] might well cause ACE2 expression to increase, which seems as if it could be a bad idea, providing more targets for the virus to latch on to. But this survey of the literature found little evidence that these expression changes even happen. The animal data that show these effects, they report, tend to be via acute injury models or doses that are much higher than human patients encounter, and there seems to be no good evidence that it happens in humans. So that’s one thing to think about: a big part of the worry about antihypertension drugs may not be even be founded on a real problem.

We also have some clinical data: this preprint from a multicenter team in Wuhan retrospectively evaluates 43 patients with hypertension who were taking drugs in these two classes versus 83 hypertension patients who were not taking ACE inhibitors or ARBs, versus. 125 age- and gender-matched controls without hypertension at all. They also compared hospital admission statistics in general to patients’ medical histories. They first confirmed what others have found, that hypertension itself is a risk factor: the patients admitted for treatment had higher levels of hypertension than the general population, and once admitted those patients had higher death rates and longer hospital stays. But when they looked at the hypertension patients who were taking either ACE inhibitors or ARBs, their numbers were better. They had comparable blood pressure numbers to those taking other drugs, but they were a lower percent of critical patients (9.3% versus 22.9%, near miss on statistical significance) and had a lower death rate (4.7% versus 13.3%). The ACE/ARB cohort also had lower inflammation markers (c-reactive protein and calcitonin). So while the data are noisy, there may be a trend towards protection in those taking angiotensin-targeting drugs. All the more reason to heed the advice not to change therapies for people with hypertension.

Source: Angiotensin and Coronavirus Infection: The Latest as of April 7 | In the Pipeline

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