An Oral Medication To Stop Coronavirus?

Researchers have produced a pill that, taken twice a day at the 800 mg dosage for five consecutive days, seems to stop SARS-CoV-2 virus from multiplying and causing clinical symptoms. The work is quite early and needs to proceed through stage 2 and 3 clinical trial phases before it can be presented to the FDA for emergency utilization authorization.

The drug is called molnupirvir. It could be taken in the first few days of infection to prevent advancement to severe disease much like Tamiflu is used with influenza. In initial human trials, the virus was eliminated from the nasopharynx of 49 infected individuals.

Wendy Painter, MD, of Ridgeback Biotherapeutics presented the data at the Conference on Retroviruses and Opportunistic Infections. The drug works by interfering with the virus’s mode of reproducing and mutating – overloading the virus with replication and mutation until the virus burns itself out and can no longer make effective viral copies.

Their method of testing the drug was to administer it, or a placebo, to humans who were infected and in the early stages of symptomatic disease. They used three different dosages and swabbed the participants’ nose and cultured for the virus at different times during the experiment.

At day 5, after the onset of symptoms, there was no detectable infectious virus in the nasopharynx of participants who were treated with molnupiravir. Dr. Painter reminded everyone that the next test will be given to patients who are actually sick with COVID-19 and see if it works. This preliminary data should encourage us that when scientists are given the time and resources, they solve problems. Imagine in the near future a vaccinated society that has at its disposal accurate and reliable quick tests for COVID-19 and the availability of a pill taken twice a day, for five days, to prevent the disease from becoming severe and requiring hospitalization.

Obstructive Sleep Apnea Surgery vs. CPAP? Daytime Anti-Snoring Device?

Obstructive sleep apnea is now epidemic in a population where it runs hand-in-hand with obesity, which is also an epidemic. The consequences of untreated sleep apnea include daytime somnolence, cardiovascular, neurological and endocrine complications.   One of the hallmark signs of obstructive sleep apnea (OSA) is snoring. 

The US Food and Drug Administration (FDA) recently approved an oral device to be worn during the daytime to reduce and/or eliminate snoring. The device is called eXciteOSA made by Signifier Medical Technologies.  The device is a prescription item which will be used by sleep specialists, dentists and ENT physicians.  It has four electrodes that deliver a series of electrical stimuli to the tongue with rest periods in between. The stimulation over time improves tongue function preventing the tongue from collapsing backward into the airway and obstructing it during sleep.  The device is used for 20-minutes once a day, while awake, for six weeks and then once a week thereafter. It is designed to be used in adults 18 years of age or older with snoring and mild OSA. Think of it as physical therapy for the tongue.

The device was tested on 115 patients, 48 of whom had mild obstructive sleep apnea plus snoring. The others were all snorers. The snoring was reduced in volume by more than 20% in 87 of the 115 patients. In the group of patients with the diagnosis of OSA and snoring, the apnea-hypopnea index score was reduced by 48%

It is recommended that a thorough dental exam be performed prior to trying this device. The major side effects noted from its use were excessive saliva production, tongue discomfort or tingling, metallic taste, jaw tightening, tooth filling sensitivity.  No mention of the cost was included in the printed review.

The online journal Practice Update reviewed a JAMA Otolaryngology publication on the use of surgery to treat Obstructive Sleep Apnea versus using a CPAP machine. There are many patients who just can not wear the CPAP mask which is the first-line “gold standard” for treating OSA.  Most patients who spend 90-days adjusting to the mask sleep far better and look forward to using the device to obtain a restful night’s sleep. The study looked at patients who were at high risk for not being able to adhere to a CPAP use regimen. Soft tissue surgery to the uvula was found to reduce the rates of cardiovascular, neurological and endocrine systemic complications compared with prescriptions for CPAP in patients less likely to adhere to or use the CPAP mask. 

The takeaway message is clear. When a patient is unlikely to adhere to CPAP mask use offering soft tissue oral surgery should be offered early while treating the disease.

Tea Can Help Lower Your Blood Pressure

Researchers at the University of California, Irvine, led by George Abbott PhD and Kaitlyn Redford, published their findings in Cellular Physiology and Biochemistry explaining why and how tea lowers your blood pressure. They found that two flavonoid type compounds found in green and black tea activate a specific type of ion channel protein named KCNQ5 which allows potassium ions to diffuse out of cells to reduce cellular excitability. The two catechin type flavonoids acting on KCNQ5 in the smooth muscle of blood vessels relax these blood vessels.

Scientists have previously found that tea can reduce blood pressure by a small amount. Their discovery of the role of the KCNQ5 protein now gives pharmaceutical developers a target for future medications. Hypertension is present in one third of adults in the world.

Tea has been consumed for over 4,000 years and two billion cups a day are consumed worldwide. Next to water it is the most common liquid consumed on the planet. It all comes from the leaves of the evergreen species Camellia sinensis with a difference in the fermentation process producing either green, oolong or black teas.

In much of the world, tea is consumed with milk mixed in. Dr Abbott’s group found that in the laboratory when milk was added to the teas it negated the effects of the KCNQ5 protein. They additionally found different temperatures of the tea resulted in different effectiveness of the KCNQ5 protein. Professor Abbott noted however that in humans’ digestive tracts our stomach and intestines separate out the milk products from the active KCNQ5 protein allowing it to work. He also noted that with our body temperature being about 37 degrees centigrade, the positive effects of the tea continued to work independent of whether you consumed hot tea or iced tea.

The message from this research is that a cup or two of tea per day will help lower your blood pressure.

Foreign Dependence on the Drug Supply Chain

I have written often about the problems we have as a nation being dependent on foreign nations for the raw materials and manufacturing of common everyday drugs and supplies. The COVID-19 pandemic has only amplified that problem as the U.S. compete for supplies against nation states for needed drugs to treat the infected and prevent transmission. I have addressed how many common drugs are manufactured in China, India and Israel and, due to financial cutbacks for FDA inspections, production plants have not been inspected for years.

I have also addressed how a hurricane that destroyed Puerto Rico left the only intravenous solution producing factory in North or South America unable to function – leaving hospitals and the military short of vital materials for health care. We witnessed the shortage of personal protective materials including masks, face shields, gloves, sanitizers, etc. as the coronavirus spread through the Americas with businesses and states bidding against nations for a limited supply of products, preferentially kept in the nation they were manufactured in.

This past Wednesday, President Biden issued and signed an Executive Order directing Federal agencies to study ways to secure the supply chain for pharmaceutical goods and manufactured goods. The Executive Order will direct 100-day reviews for supply chains for pharmaceutical goods, computer chips, large capacity batteries like those used in electrical cars to prevent dependence on foreign governments. The studies call for “consulting with experts in private industry, academia, workers and communities”.

The hope is we will create manufacturing diversity and redundancy bringing some manufacturing home but insuring that one nation or one site will not be responsible for the total production of any vital product. In my view, this is a long overdue step in the right direction based on what has transpired in the recent past.

Vitamin D & Cardiovascular Health

The online journal Practice Update reviewed a publication in the Journal of the American College of Cardiology which basically says excessive calcium supplementation may harm your healthy heart. It was published at a pertinent time because it came while I was trying to convince my post-menopausal wife that between her Vitamin D pearls, calcium, Vitamin D pills and her multivitamin she was taking too much Vitamin D. Her measured 25-hydroxy Vitamin D level came back at 63.

Vitamin D is a fat-soluble vitamin like vitamins A and K. Extra doses of fat-soluble vitamins are stored in the body’s cells and can reach harmful and toxic levels. The normal level of Vitamin D measured by a standard blood test is considered to be 20 or greater by the World Health Organization. In North America it was originally higher at 28 then raised to 30. The Covid-19 Pandemic has raised issues about low levels of Vitamin D being a risk for catching the disease, and developing complications, but no one has defined what levels are considered unsafe.

The National Academy of Medicine, after reviewing this data, has set these limits and levels:

  1. Deficiency is less than or equal to 12ng/ml
  2. Inadequacy is 12-20 ng/ml
  3. Adequate is 20-50 ng/ml
  4. Risk of Adverse Effects occurs at > 50ng/ml

The data suggest avoiding supplementation unless the 25-hydroxy Vitamin D level is <20 and probably best reserved for <12 ng/ml.

Calcium is best absorbed when accompanied by Vitamin D .  Taking smaller doses like 500 mg plus 1000 of Vitamin D3 works. For osteoporotic patients they suggest 600mg of Calcium plus 1000 IU of Vitamin D3 daily. They want you to eat a diet that supplies another 600 mg of calcium a day plus walk for weight bearing exercise and get 15 or more minutes of sunlight daily. Of interest was the statement that calcium supplements may harm your heart, but any calcium obtained naturally through foods does not.

The article was reviewed and commented on by David Rakel, MD, FAAFP with the take home message being, “Eat a high-fiber, plant-based diet with some fish and go outside and play.”