Santa Barbara Doctors ExtraCare – November 2021 Newsletter
November 2021 ExtraCare
With Thanksgiving just around the corner we would like to wish you all a safe, enjoyable holiday celebration.
This month we dispel some commonly encountered myths about the COVID vaccine and report on a red yeast rice product recently cited by the FDA.
By: Dr. Sawyer Haig
- There is no clear author
- The author has no obvious credentials related to vaccine expertise
- No research studies are mentioned
The following sources will have accurate vaccine information as well as the latest vaccine news:
- Centers for Disease Control and Prevention (CDC)
- World Health Organization (WHO)
- Immunization Action Coalition (IAC)
- Academic institutions
- Professional medical groups (American College of Physicians, Infectious Diseases Society of America, American College of Allergy, Asthma and immunology, etc.)
Here are some myths I have encountered:
- Studies have found that the vaccines are not only effective but safe.
- mRNA vaccine technology has been in development for decades.It was not invented for COVID-19 vaccine development.
- China was able to isolate and share genetic information about COVID-19 very early in the development process, which allowed for quick identification of vaccine targets.
- No steps were skipped in efficacy and safety testing.The vaccines were developed using an overlapping scheduled to gather data faster.
- COVID-19 was very widespread during vaccine development, so did not take long to see if the vaccine worked for study volunteers who were vaccinated.
- There was an unprecedented amount of funding and resources available for COVID-19 vaccine development. Many governments invested in research and/or paid for vaccines in advance.
- The Pfizer COVID-19 vaccine is now FDA approved, and we expect full approval of Moderna and J& J in the future.
- There is a growing body of evidence that COVID-19 vaccines currently authorized for use in the United States help protect adults and children 5 years and older against COVID-19, including severe illness.The data is actually very impressive.
- In people age 16 and older, the Pfizer-BioNTech COVID-19 vaccine is 91% effective in preventing the COVID-19 virus with symptoms. In children ages 12-15, the vaccine is 100% effective in preventing COVID-19. In children ages 5-11, the vaccine is 91% effective in preventing COVID-19
- In people 18 and older, the Moderna COVID-19 vaccine is 94% effective in prevent in the COVID-19 virus with symptoms.
- In clinical trials the Johnson and Johnson vaccine was 66% effective in preventing the COVID-19 virus with symptoms as of 14 days after vaccination. It was also found to be 85% effective at preventing severe disease with the COVID-19 virus.
The overall risk of hospitalization and death due to COVID-19 is much lower in vaccinated individuals in comparison to unvaccinated individuals.
- More than 363,000,000 doses of COVID-19 vaccines were administered in the U.S. from 12/14/2020 to 8/23/21.Healthcare providers are required to report any death that occurs after COVID-19 vaccination, even if it is unclear whether the vaccine was the cause of death. Death was reported in 0.0019% of vaccine recipients. The assumption is that a percentage of these deaths were not related to the vaccine.
- The most serious possible side effect of the COVID-19 vaccine is anaphylaxis.This only occurs once in approximately 100,000 shots, which is less common than bee stings, fire ant stings, nuts and certain antibiotics. Vaccine clinics are prepared to treat anaphylaxis if it occurs.
- Myocarditis occurring after COVID-19 vaccination has been in the news. The occurrences of myocarditis have been rare. Most of the events occurred in teens to young adults, and the majority of cases were mild and cleared up without treatment.
- It is common to have mild side effects from the vaccines including pain at the injection site, fatigue and chills. Symptoms get better without medical care, typically within 24-48 hours. Second doses of the vaccines should still be given, even if you had one of these reactions after the 1st dose. The side effects DO NOT mean that you have COVID-19 infection; it is simply an indicator that your immune system is responding to the vaccine.
- This is not possible. The vaccine components do not enter the nucleus of the cell, which is where your DNA is located.
- mRNA vaccines work by instructing cells in the body how to make a protein that triggers in immune response. Human cells breakdown and get rid of the mRNA soon after they have finished using the instructions.
- The COVID-19 vaccines will not affect fertility.
- This myth was mainly fueled by false reports on social media that claim that the spike protein on the coronavirus is identical to Syncitin-1, a spike protein involved in the growth an attachment of the placenta during pregnancy. In fact these two spike proteins are completely different and distinct. The COVID-19 vaccines do not trigger an immune reaction to syncitin-1.
- A study has shown that risk of reinfection is more than 2 times higher in people who had COVID-19 and did not get vaccinated in comparison to those who were infected and got vaccinated.
- Evidence continues to indicate that getting the COVID-19 vaccine is the best protection against getting COVID-19 illness, regardless of whether you have had COVID-19 previously or not.
- The mRNA vaccines contain mRNA, fats (to protect the mRNA), salts and sugar.
- The COVID-19 vaccines were not developed using fetal tissue. They do not contain any material such as implants, microchips or tracking devices.
In particular, I have found the brand Cholestene, manufactured by Healthy Origins HPF, to be extremely effective in reducing cholesterol levels in my patients. Imagine my surprise when a patient notified me earlier this month that the FDA has recommended that this product be recalled given the presence of the active drug, lovastatin, found in its composition.
This news spurred me to look into red yeast rice supplements further.
Red yeast rice is the product of a yeast (Monascus purpureus) grown on white rice. The powdered yeast-rice mixture is a dietary staple in Asia and has been used in traditional Chinese medicine. Red yeast rice is also sold as a supplement to reduce cholesterol.
Some red yeast rice products contain substances called monacolins, which are produced by the yeast. Monacolin K is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin, which is one of the drugs in the category known as statins. These drugs lower blood cholesterol levels by reducing the production of cholesterol by the liver.
The composition of red yeast rice products varies depending on the yeast strains and culture conditions used to manufacture them. The strains and conditions used to produce culinary red yeast rice differ from those used to produce products that are intended to lower cholesterol. Tests performed by the FDA indicate that the red yeast rice sold as a food product contains only traces of monacolin K or none at all.
In clinical trials of red yeast rice products that contained substantial amounts of monacolin K, the products lowered blood levels of total cholesterol and low-density lipoprotein (LDL) cholesterol. There appeared to be an inverse relationship between the amount of monacolin K
in the product and the degree of cholesterol lowering.
In 1998, the FDA determined that a red yeast rice product that contained a substantial amount of monacolin K was an unapproved new drug, not a dietary supplement. On several occasions since then, the FDA has taken action against companies selling red yeast rice products that contain more than trace amounts of monacolin K, warning them that it is against the law to market these products as dietary supplements.
That’s where Cholestene fits in. On July 9, 2021 the FDA released a public notification that cholestene contains a hidden drug ingredient, lovastatin, and advised the public not to purchase it.
So what’s so bad about taking red yeast rice?
The potential side effects of taking a statin include myopathy (muscle symptoms such as pain and weakness), rhabdomyolysis (a condition in which muscle fibers break down, releasing substances into the bloodstream that can harm the kidneys), and liver toxicity. Each of these three side effects has been reported in people who were taking red yeast rice.
Lovastatin can also interact with a variety of drugs to increase the risk of muscle and liver toxicity and red yeast rice containing monacolin K could interact with drugs in the same way.
In addition, if the process of culturing red yeast rice is not carefully controlled, a substance called citrinin can form. Citrinin has been shown to cause kidney failure in experimental animals and genetic damage in human cells. In a 2011 analysis of red yeast rice products sold as dietary supplements, 4 out of 11 products were found to contain this contaminant.
The biggest problem with taking red yeast rice supplement is that consumers have no way of knowing how much monacolin K is present in the product. The labels on these products usually state only the amount of red yeast rice that they contain, not the amount of monacolin K.
So, as you can see, the answer to the question “should you be taking a red yeast rice supplement” is not an easy one. My advice, if you decide to take the supplement, is to monitor for symptoms of toxicity and to make sure that you include this supplement on all medication lists to avoid the possibility of drug interactions. In addition, patients on red yeast rice supplement need to be monitored as we monitor patients on statins with periodic blood testing.
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