New Device Helps Stroke Victims with Hand Function Difficulties

Stroke victims often lose function of a hand. The road back to recovery involves months of physical therapy and work.

Last month the FDA approved the Neurolutions IpsiHand Upper Extremity Rehabilitation System for survivors of stroke trying to regain hand, wrist or arm function.  The system uses EEG electrodes to record your brain activity and then uses these messages to move an electronic hand brace according to the intended muscle movement. It essentially delivers your brain’s intended electrical message to the brace to retrain your limb to work.

This is a sophisticated device which will need to be fitted by stroke rehab professionals and then tailored for individual patient needs so it can be successfully used.

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.

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.

New Oral Testosterone Replacement Treatment is on the Horizon

We see a many men who develop testosterone deficiency. Testosterone is a hormone produced in both men and women which plays a tremendous part in our lean muscle mass, our sexuality and our energy levels. It is secreted into the blood and peaks between 8:00 – 10:00 each morning.

To determine whether you have a testosterone deficiency, your blood must be drawn during those hours for accuracy. If two tests show your level below 280 you may benefit from replacement therapy.

To replace testosterone we currently have had only three options. One option is by placing a gel preparation on your skin and allowing it to be absorbed each day. One preparation comes in a gel in a tube and you measure out a particular dosage and administer it to your skin. Another preparation comes in pre-measured transdermal patches which you apply to your skin.

Both skin applications are easy to use and are less likely to cause the adverse effects testosterone is sometimes associated with such as an increased blood thickness or secondary polycythemia. The drawback to these preparations is they cost anywhere from $500 to $1,000 per month. The only less expensive alternative has been the injectable testosterone cypionate which costs about $80 per month and requires an injection into your muscle every two weeks.

The injectable form, while far more affordable, results in more adverse events than the transdermal form. We usually prescribe the lowest dosage possible and then, seven days after your shot, measure your testosterone level with a blood test at any time of the day. Based on the results, we adjust the future dosage.

Marius Pharmaceutical submitted a new drug application to the Food and Drug Administration for an oral form of testosterone undeanoate taken in a gel capsule twice per day. It will be marketed under the name Kyzatrex.

In their initial studies, looking at six months of data, they were able to achieve average expected testosterone levels in 96% of the men who completed the 90-day treatment study. High blood pressure was the only true adverse effect reported. No mention was made of what a month’s supply will cost if the FDA approves the drug for use in primary and secondary testosterone deficiency.

Will I Be Able to Choose My COVID-19 Vaccine?

There are currently four vaccines to prevent COVID-19 in the pipeline. I have been asked numerous times when am I going to have the vaccine in my office and which vaccine should individuals take? This question was addressed by MedPage Today, an online health care periodical on 11/27/2020. The same question was asked of National Institute of Health “chief” Francis Collins, MD, PhD last week at a press briefing. Dr Collins responded there will not be enough vaccine available in December for the whole country and “people who get offered one should feel quite happy about that.” Leana Wen, MD, of George Washington University responded to the same question saying, “Initially there won’t be nearly enough vaccines for hundreds of millions of Americans. We will probably take whatever we are able to get access to.”

If you are a healthcare worker, or in the more vulnerable groups, you are most likely to be offered one of the nRNA vaccines from Pfizer/BioNtech or Moderna because they are further along in completing the FDA required trials and application process for approval. Younger healthier individuals having less priority may get to choose.

Larry Corey, MD, a viral expert at Fred Hutchinson Cancer Institute in Seattle and a leader of the COVID-19 Prevention Network Vaccine Program broke down the numbers at a November 18, 2020 meeting of the American Public Health Association and National Academy of Medicine:

1. The US Government has contracts for 100 million doses of the Pfizer/BioNTech and Moderna vaccines with production producing the 200 million doses by the spring of 2021. That should cover the highest risk groups including healthcare personnel, nursing home residents, essential workers and the medically vulnerable per the CDC Advisory Committee on Immunization Practices (ACIP) guidelines. The vaccine will be shipped to 50 states, the District of Columbia, 8 territories and five large urban health departments including NYC and Chicago. Who receives it first, and where they receive, it will be decided by the local jurisdictions. This process should take until the end of March 2021 leaving some 200 million Americans waiting for a vaccine. Dr. Corey was clear that “We need other vaccines for the rest of the population.”
2. In addition to the Moderna and Pfizer/BioNTech mRNA vaccines, there are products from Oxford/AstraZeneca, Janssen/Johnson &Johnson, Merck, Sanofli/Glaxo SmithKline and Novavax. Jay Butler, MD, deputy director for infectious disease at the CDC expects there to be mass vaccinations run by public health agencies and possibly some vaccination programs at community pharmacies. No mention was made of supplying physician offices or clinics.
3. If there are no major delays, seven different vaccines should be available by the spring of 2021. Naor Bar-Zeev, PhD, of the International Vaccine Access Center at Johns Hopkins University in Baltimore said it is too soon to compare the products because there are no studies comparing them head-to-head. He reminded us that different vaccines might be better suited for different patient populations with pediatric patients, the elderly, the immunocompromised likely to do better with some and not others.

Despite the lack of detail to date, Moncef Slaoui, MD, head of the federal Operation Warp Speed, told CNN that he expects 70% of the US population to be vaccinated by May 2021.

Drug Shortages Exacerbated by the COVID-19 Pandemic

Globalization and overseas outsourcing of manufacturing has resulted in periodic drug and medical supply shortages since 2001. This issue has been brought to the attention of US authorities multiple times with no action on the part of several administrations.

On this blog I have written about the defunding of the FDA so that many of the drug producing factories in China and India have not been inspected by FDA inspectors for quality in decades. Within the last five years the only major producer of intravenous fluids for the United States and Canada, located in Puerto Rico, was shut down after hurricane damage and electrical grid damage. The US Military was impacted by this factory shutdown and tried to purchase fluids from overseas producers, but they were at top capacity and could not meet the demand. There have been critical shortages of morphine for pain control.

The pandemic has further exacerbated this issue. CIDRAP, the Center for Infectious Disease Research and Policy at the University of Minnesota reported on its website that there is a shortage of 29 of 40 drugs crucial for treating COVID-19 patients. The shortage includes the short term anesthetic propofol, the bronchodilator albuterol, hydroxychloroquine (used for rheumatoid arthritis and certain lupus patients), fentanyl and morphine. The Food and Drug Administration has its own critical list of shortages and lists 18 of 40 on their drug shortage list. An additional 67 out of 165 critical acute drugs are listed as in short supply. This list includes acetaminophen (Tylenol), lidocaine, diazepam (valium) and phenobarbital among the most noteworthy.

As the election for President concludes, it is far overdue for whomever prevails to dedicate one department to evaluate, plan for and prevent critical drug and supply shortages. It is also long past due that the production and distribution of these key pharmaceuticals and medical supplies return to the United States so we are not subject to the whims of a foreign government or find ourselves trying to outbid our allies for supplies.

Michael Osterholm, MD, the director of CIDRAP, sees the coming increase of COVID-19 cases further challenging the existing supply of medications available to the American public.

A Perfect Storm Brewing: Flu Season Plus A COVID-19 Resurgence

I was asked by a colleague what I thought influenza seasonal infections coupled with a predicted second wave of COVID-19 would look like locally? Influenza A arrives locally around Thanksgiving and peaks the last two weeks in January and first two weeks in February. I suspect it is fueled by seasonal visitors coming to Florida bringing the disease from their home locales. We see a low level of influenza B year- round in our pediatric population.

A full-page ad appeared in all Florida newspapers today sponsored by every major health system in the state including Baptist, Tenet, HCA, Cleveland Clinic, Broward Health, Jackson, U M Health, Memorial Health and others. It stressed wearing masks, social distancing and frequent hand washing.

If you get sick with mild symptoms, they encourage remote telehealth care. If you have moderate symptoms, they suggest going to their urgent care facilities. For severe symptoms call 911 or go to the ER. At no time did they suggest calling one of their employed physician offices or visiting your private doctor which is all consistent with CDC recommendations. Private independent and employed physicians just don’t have the ventilation systems, sanitizing systems, personal protective equipment or trained staff to see potential COVID patients in their offices. If a patient is positive, or a staff member converts, what is their responsibility to the next patient or to the other tenants of their building? Is a 14-day quarantine in order?

Much depends on unknown factors. How effective will this year’s flu shot be? In my area, the chain pharmacies already received their supply of influenza vaccine and have shamelessly been pushing it on customers since July. Scientific research shows that in senior citizens the flu shot immunity begins to subside 90 days after you receive the shot. Given that, if your pharmacy tech gives you the flu shot in September, then how much immunity will you have by the time the flu arrives around Thanksgiving?

Quick, accurate and inexpensive testing availability for flu and COVID 19 is an important factor as well. We have had a quick influenza test for years requiring a nasopharyngeal swab. A similar test for COVID -19 has just been released by Abbott Labs and received Emergency Utilization Authorization from the FDA. That means Abbot Labs researchers say it works and the FDA takes them at their word. This test, called “a game changer” by many, will be available in October.

When $15 per hour medical assistants start performing the test rapidly, in volume, I hope the accuracy results are similar to Abbots claims. Our health and lives depend on that. At the same time a finger stick blood drop test is heading to market to quickly detect flu and COVID -19 on the same test card. Finnish scientists and Israeli researchers have quick breathalyzer tests coming soon as well. I hope they work and get here soon. I will test everyone at the door as will restaurants, theaters, sports arenas and most businesses.

All of this information really skirts the issue. With no treatment and vaccines available yet, I expect this flu COVID-19 season to be a human health disaster. With no national plan in place and no close coordination with state and local elected and public health officials, I see the fall and winter as a time of continued disease surges and deaths while the political influence on disease treatment supersedes scientific research and public health realities. Without a coordinated program of PPE and medication distribution, coordination of testing availability and results with contact tracing and specific shutdowns of hot spots without challenges related to loss of freedoms the outlook is grim.

Protecting senior facilities without a coordinated program and funding for it will not work for residents or employees. Opening schools and day care without similar precautions, training and funding for materials and tracing will lead to hotspots as well. There are members of the student population such as special needs children who need to return too, in person, learning safely and creatively. Others need to learn remotely or be given a chance to catch up later when safe return to in person learning is possible.

Without a plan to assist renters, homeowners, landlords, small business owners, farmers, restaurateurs, etc.; any shutdown for disease will be met with overwhelming resistance. I see a bleak and dangerous health picture developing in the fall/winter creating a perfect influenza/COVID storm.  I hope I am wrong but, if right, the disease surge will overwhelm ERs and hospitals.

Ranitidine (ZANTAC) Removed from Market By FDA

Ranitidine is an H-2 receptor blocker marketed in the United States as Zantac. It is sold over the counter (OTC) without a prescription at the 20 mg dosage and with a prescription at the 40 mg dosage. It is used for peptic ulcer treatment, gastritis treatment, heartburn, gastroesophageal reflux and other diseases in which gastric acid causes inflammation of the lining of the stomach and discomfort.

It is being recalled because when manufacturing this product, new techniques are apparently inadvertently producing a probable carcinogen known as NDMA (N-Nitrosdimethylamaine). The longer the ranitidine sits around, the more NDMA is found. None of the levels measured are believed to be toxic.

Ranitidine is a relatively inexpensive blocker of histamine-2 receptor sites resulting in less digestive acid secretion in the stomach. The NDMA in the production product is the same chemical that resulted in the blood pressure medicine losartan and similar products being recalled. There are several alternative H-2 receptor blocker drugs on the market to replace ranitidine or Zantac. NDMA has not been found in Pepcid (famotidine), Tagamet (cimetidine), omeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Globalization started during the Clinton administration, and encouraged by subsequent Republican and Democratic administrations, has resulted in pharmaceutical manufacturers moving their plants to Asia and other overseas areas where labor is cheaper, and regulations are less rigid. Ronald Reagan eliminated the Food and Drug Administration’s testing lab which set the gold standard for protecting Americans against tainted drugs. Prior to this action, no pharmaceutical product ever reached the American market and had to be recalled.

Subsequent administrations reduced the funding for the FDA, especially in the inspection department. With production now overseas, and virtually unregulated, we are dependent on the goodwill of foreign governments, and the liability attorneys for big pharma, to protect us from tainted products. Almost all antibiotics, both oral and intravenous, and all IV solutions are produced overseas in addition to most of the oral generics we are forced to take by our insurer every day.

We are currently living in a civilization altering pandemic with Coronavirus COVID-19. When this plague is under control, the country will need to reset our economy. My hope is that the big pharmaceutical firms will be legally forced to bring the pharmaceutical manufacturing back to U.S. soil. At the same time, the FDA inspection division needs to be funded fully to ensure that the products we need and ingest are safe and pure!

Sunscreen Ingredients are Absorbed says FDA

For years public health officials, dermatologists and primary care physicians have been encouraging people to apply sunscreen before going out into the outdoors to reduce the risk of sunburn and skin cancers.  We are taught to apply it in advance of exposure by about 30 minutes and to reapply it every few hours especially if we are sweating and swimming.   Living in South Florida, sun exposure is a constant problem so we tend to wear long sleeve clothing with tight woven fabrics to reduce sun exposure.  My 15-month old grandson, visiting last weekend was smeared with sunscreen by his well-meaning parents before we went out to the children’s playground nearby.

These precautions seemed reasonable and sensible until an article appeared in JAMA Dermatology recently.  An article authored by M. Mata, PhD. evaluated the absorption of the chemical constituents of sunscreen after applying it as directed four times per day.  The article was accompanied by a supporting editorial from Robert M. Cliff M.D., a former commissioner in the FDA and now with Duke University School of Medicine and K. Shanika, M.D., PhD.

The study applied sunscreen four times a day to 24 subjects. Blood levels were drawn to assess absorption of the sunscreen products avobenzene, oxybenzone and octocrylene.  The results of the blood testing showed that the levels of these chemicals far exceeded the recommended dosages by multiples. The problem is that no one has evaluated these chemicals to see if at those doses it is safe or toxic causing illness?

The editorial accompanying the findings encourages the public to keep using sunscreen but cautions that the FDA and researchers must quickly find out if exposure to these levels is safe for us?  We do know that the chemical oxybenzone causes permanent bleaching and damage to coral reefs in the ocean from small amounts deposited by swimmers coated with sunscreen. The state of Hawaii has actually banned sunscreens containing oxybenzone to protect their coral reefs.

The fact that these chemicals have been approved and are strongly absorbed with no idea of the consequences is solely the result of elected officials wanting “small government” and reducing funding to the oversight organizations responsible for making sure what we use is not toxic.  It is a classic example of greed and profit over public safety.  The research on the safety of these chemicals must be funded and addressed soon. The American Academy of Pediatrics and Dermatology need to advise parents of youngsters whose minds and bodies are in the development and growth stages what is best to do for their children – sooner rather than later.