A Perfect Storm Setting the Stage for a COVID-19 Catastrophe

The last week in June always means the recent medical school graduates have just begun their first days as real physicians working in the halls of our nation’s hospitals. With youth comes energy, altruism, enthusiasm and inexperience.

The first year was once called an internship and is now called Post Graduate Year 1. Directors of training programs and their teaching colleagues work overtime to orient, teach and supervise closely so that inexperience does not interfere with excellent patient care. Excellent programs have layer after layer of patient care review to prevent the development of judgement and experience from adversely affecting outcomes in care.

We are in the middle of a health care crisis of previously unseen proportion by old timers like me and newly minted physicians. As the coronavirus surged in the state of NY, state officials accelerated the graduation of fourth year medical students and sent them into the fray to care for COVID-19 patients on the front lines. A general call for extra help went out to the medical community nationally to bring back retired physicians but to also reassign specialty doctors to COVID-19 care even though they had little recent experience in infectious disease and respiratory care.

Some news stories talked of dentists and podiatrists being drafted to provide medical care for ailing New Yorkers. The death toll in the NY hospitals was exceptionally high and some critics believe the use of inexperienced clinicians, with minimal supervision, contributed to these extremely high death and complication rates. I believe that while that may be a factor, the real issues were lack of familiarity with a new pathogen, lack of effective medication, lack of personal protective equipment as well as a lack of sleep and rest and mental health counseling all contributing to the inexperience but valiant efforts made by NY health care personnel.

With new medical school graduates on the wards here in Florida, we now face many of the same issues our colleagues in the NY Metropolitan area faced several months ago. What they did not face months ago was a population unwilling to follow the safety measures outlined by Public Health officials, infectious disease specialists and scientists.

The financial hub of the USA, perhaps the world, closed quickly to save lives and slow the spread of disease. Our south Florida hospitals have prepared extensively for the arrival of the new medical graduates. Our best faculty members are out teaching and supervising. Despite this, they are at a disadvantage because there is no governmental leadership by example at the county, state or Federal level.

The number of Florida residents who continue to treat wearing a mask as a civil liberties issue, rather than a deadly public health issue, is astounding. The number of Floridians who do not believe that keeping a safe social distance apart prevents disease spread and fail to observe the recommended guidelines as a protest about loss of freedom is mind boggling.

 Instead of Floridians demanding a comprehensive and organized program to stop COVID-19 while meeting the financial. food, educational, safety, housing, childcare and supply needs of the populace, we have politicians telling us that the increased rate of infectivity is safe in young people. Young people give it to middle aged and old people, and they have a greater chance of getting sicker, ending up hospitalized and dying.

The daily local hospital case load is increasing. The available beds are decreasing. We have not even factored in that we are now in hurricane season which might call for evacuations and mass movements of Floridians for storm related safety.

This is the perfect storm scenario. If you are happy with it then carry on. If you are not then please call, write, text and email your elected officials at all levels of government and tell them in no uncertain terms what your needs are.

Distancing, N95 Masks and Eye Covering Protect Against Respiratory Illness

To wear a facial covering or mask, or not, has been turned into a political affiliation and machismo issue in the United States instead of a scientific, medical and public health issue. A publication in the British medical journal Lancet clearly brought the issue into a medical public health category.  The “cliff notes” summary of the study is that for each meter (2.2 meters = one foot) you distance from a contagious individual, the less likelihood you have of becoming infected with that illness.  Facial coverings diminish your risk of catching the disease by about 15% and N95 or KN95 respirator masks work better than surgical masks, bandanas or cloth masks.

The study was a systemic review and meta-analysis of 172 observational studies involving SARS, MERS and COVID-19 spanning six continents with almost 26,000 participants.  Daniel Chu, MD, PhD made it clear, “The risk for infection is highly dependent on the distance to the individual infected and the type of face mask and eye protections worn. Six feet or more away is the optimal distance to maintain. While N95 masks scored best in terms of protection for health care workers, facial coverings of any type reduced the chance of infections from 17.4% to 3.1%. Eye protection reduced the risk of infection from 16% to 5.5%.”

Due to a shortage of personal protective equipment (PPE), the CDC downgraded its requirements for health care workers treating sick infected individuals  to surgical masks, cloth masks or bandanas.  Professor Raina MacIntyre, MBBS, PhD at the Kirby Institute University of New South Wales in Sydney went on to say that recommending anything less than an N95 mask for health care workers is like sending troops into battle “ unarmed or with bows and arrows against a fully armed enemy.”

Many wonder what the difference is between an N95 respirator mask and a KN95 respirator mask. They both are supposed to prevent 95% of the particles of a certain size from penetrating. If the masks are reviewed and approved and certified by USA agencies such as OSHA or the CDC, they are labeled N95.  If they are reviewed by similar agencies in China, they are labeled KN95. In most cases the product is made outside the USA even if the company is an American firm.

Key points to remember are:

• Distancing works with over six feet best for preventing person to person transmission of respiratory illnesses like Covid-19.
• Facial coverings reduce the risk of infection.
• N95 and KN95 are the gold standard for health care workers.
• Eye covering reduces infections even further. 

This is not a macho or political issue. It’s an infectious disease public health issue.  Be smart and considerate of others. Cover your mouth, cover your eyes and keep six feet or more apart.

There is Still a Pandemic in Florida Folks!

I opened the local newspaper to headlines that the Palm Beach County Commission has opened county facilities but is not requiring visitors to wear masks, facial coverings or observe social distancing rules.  A county commissioner was quoted as believing that it was not within their authority to require facial coverings.  Strange opinion when they have closed businesses , facilities and services due to COVID-19 and then reopened them independent of Public Health, CDC or even White House guiding rules and regulations and published the conditions under which these facilities will open and operate.  I imagine, or hope, the County civil servants have union representation that will address the issue of their employees being called back to work with their health and safety being taken for granted.

Recently, I spoke to a patient who believes COVID-19 is overblown. They are closer to 80 years old than 70, continues to smoke tobacco regularly despite having documented coronary artery disease and is incensed that the free flow of patients has not restarted in our medical practice.

I keep coming back to the same question.  Despite our Governor opening the state up again, what has changed medically or scientifically?

1. We still do not have an onsite quick accurate test to determine if a patient has COVID-19 and is a contagious asymptomatic carrier. Yes, testing sites have increased but most test results come from a lab with a 48-hour wait delay.  Our local medical center, Boca Raton Regional Hospital Baptist Health system has on the physician website a request to only perform quick in-house COVID-19 testing one time on admitted patients only because they do not have enough supplies on hand.  Patient’s presenting to the Emergency Department still receive a nasal swab which is sent to an outside reference lab and results take 48 hours.
2. We don’t have enough personal protective equipment for hospital staff to change masks, capes, face shields and gloves according to their own guidelines for treating an infectious patient and preventing transmission of the pathogen to others, including you! In view of the shortage of equipment, the CDC and hospital infectious disease departments have relaxed their own guidelines several times to ensure their guidelines agree with the way equipment is being used.
3. We still do not have a treatment other than supportive care. Yes, there is some evidence that remdesevir early in the course helps and that a triple drug regimen in more severe cases helps.
4. We are still months away from having a vaccine.

In Palm Beach County, civic leaders admit they bowed to the pressure of struggling businesses, distressed parents out of work, and home with school age children, and political pressure from Washington and Tallahassee in deciding to open the economy back up.  With Palm Beach County opening May 11^th and Dade and Broward County on May 18^th, we should begin to see an increased infection rate over the next two weeks based on the incubation period of COVID-19 and its complication rate developing around Day 8 or 9.  

I sincerely hope I am wrong about this, but my infectious disease colleagues, critical care colleagues and Emergency Department colleagues have shared this professional opinion with me.  This disease infects and kills youngsters, young adults, teenagers as well as senior citizens.  Asymptomatic carriers of the COVID-19 bug infect 5.7 individuals before they discover they are sick. 

Despite this, we ask county employees and restaurant servers to spend time up close with no requirement to wear a facial covering.  Tell me, what has changed other than the level of patience of our elected officials and their overwhelming desire to gain public favor and get re-elected regardless of the health care costs and carnage from COVID-19?

Absence of Leadership Is Why COVID-19 Is Destroying The USA

Two articles arrived at my desk discussing the ongoing tragedy of COVID-19. One is written in the New England Journal of Medicine by Dr. Eric Schneider. Dr Schneider sees the ability to test someone quickly and reliably as the only way out of the pandemic and back to some degree of normal life without there being mass casualties and deaths. He is appalled that foreign nations with far less developed scientific communities have developed testing and contact tracing so that they can limit the spread of the disease while safely opening those societies again. 

He cites the failure of the Trump administration to heed warnings, prepare for the arrival of the virus and more importantly to produce, distribute and test the public while collecting and organizing the data as the only reason we are now left with “non pharmacological interventions (NPIs)”   Shutting down society and staying at home is our only successful  NPI option to date.  He goes on to criticize the administration for looking for that magic cure with a medication or a quick vaccine which the scientists working on them insist will take longer than the President claims it will.  While Dr. Schneider believes that NPI’s have been successful, they carry their own price of economic ruin, social isolation and a restless population now demonstrating loudly to resume commerce and normal activities even though the infection rate and death rate will be so much higher. 

An editorial in the revered British Journal The Lancet today discusses the need to revive the CDC. The editorial highlights the history of the Center for Disease Control and its role as a world leader in public health and safety.  It then goes on to illustrate how the Ronald Reagan and George W. Bush administrations, and now the Trump administration, have destroyed its funding and marginalized its role.

The Lancet editorial board first criticizes those administrations for reducing funding when the CDC was leading the fight against HIV disease worldwide. The current administration has eliminated funding and support even further.

The CDC always kept pandemic surveillance personnel in China since Asia has always been a birthplace of new serious viral illnesses such as SARS, Bird Flu and MERS. Funding elimination resulted in the last CDC surveillance officer leaving China in July of 2019.

When the current CDC Director Nancy Meissonier, MD warned the world about the COVID-19 pandemic on February 25, 2020; she was removed from White House briefings and public appearances because of her prophetic statement. “The CDC needs a director who can provide leadership without the threat of being silenced and who has the technical capacity to lead today’s complicated effor. Americans must put a president in the White House come January 2021, who will understand that public health should not be guided by partisan politics.”

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!

PLCO Data Support Protective Effect of Aspirin in Preventing Deaths

In recent months, the US Preventive Task Force has recommended adults without diabetes or documented coronary artery disease avoid taking baby aspirin to prevent heart attacks and strokes. They believe the risk of bleeding outweighs the benefit derived. They still recommend aspirin prevention in men with known cardiovascular, cerebrovascular disease and diabetes.

The Prostate, Lung, Colorectal and Ovarian Cancer Trial (PLCO) just made the decision-making much more complex. In their study, reported in this month’s JAMA Network Open, they found that taking aspirin as infrequently as 1 to 3 times per month reduced the risk of all-cause and cancer related mortality compared to no aspirin in their study with 146,152 patient participants.

Weekly use of aspirin significantly reduced the risk of mortality from both GI and colorectal cancer and all mortality endpoints irrespective of how heavy you were. When the study looked at 12.5 years of aspirin use 1 to 3 times a month, compared to none, the all-cause mortality was reduced by 16%. The results were even more encouraging when aspirin was taken three or more times per week.

The PLCO Cancer Screening Trial involved participants aged 55-74 who were randomized to a cancer screening group or a control group at 10 United States Medical Centers. This review looked at men and women 65 years or older at baseline. While this study showed a beneficial effect of aspirin in the elderly, other recent studies have been less favorable. The ASPREE study, Aspirin in Reducing Events in the Elderly, found that individuals taking 100 mg of aspirin daily were at increased risk for all-cause mortality compared to those taking a placebo.

The decision to take low dose aspirin, or not, is something you should discuss with your physician so that you can tailor the situation and risks to your personalized needs.

Medicare Advantage – Great Insurance If You Are Healthy

It is open enrollment period through December 7, 2019 for those of us 65 years of age and older who are supposed to sign on to www.medicare.gov to choose our 2020 prescription drug plan Part D. This is also the open enrollment period for insurance owned and operated by private managed care Medicare Advantage programs. These plans preceded ObamaCare, or the Affordable Care Act, and are private managed care plans. They were designed to save the government money but, in fact, year after year are more costly per patient than traditional Medicare.

Let me repeat that, according to government auditors, MEDICARE ADVANTAGE PLANS COST MORE PER PATIENT PER YEAR THAN TRADITIONAL MEDICARE! If you sign up for one you will need to abide by the managed care company’s contracted panel of doctors and facilities. You do not get to choose the best doctor or hospital for your problem – just the best on your contracted panel. These insurers tell you it’s the same as Medicare but it is not. They will provide you with an insurance ID card colored and lettered to mimic Medicare but it is not Medicare.

It is great for healthy patients until they get sick. There are few, if any, monthly costs to enrollees. Generic drugs, inexpensive vision care, inexpensive hearing and dental care are often included. If you develop a complicated health problem and want to see the best it is usually OUT OF NETWORK. If you get sick out of your home area you may well be OUT OF NETWORK. These plans are immensely profitable to insurers.

They are so profitable that seniors are bombarded with mail advertising, full page newspaper advertising and constant prime time TV advertising using celebrity spokespersons. The ads encourage seniors to travel and fund their grandchildren with the savings they will reap from joining their plan.

They don’t explain what happens when mom has a new lymphoma and cannot go to MD Anderson or Memorial Hospital or Dana Farber for diagnosis and cutting-edge care. They don’t tell you about the experience of your contracted panel doctor to treat Grandpa’s throbbing headache caused by a brain vascular malformation because the regional neuro vascular interventionalist of choice is not on grandpa’s panel.

I have an idea. How about putting the cost of all the expensive enrollment advertising done by these private Medicare Advantage plans in to better benefits for their clients?  We all know the answer to that.

Changes in Florida’s Prescribing Medication Laws

In their ultimate wisdom, the Florida Legislature has decided that all medication prescribing shall be done electronically by computer beginning in January 2020.  As of November 1^st, the Florida Medical Association has not informed its members of this but it was discussed briefly at a hospital staff meeting.

We were told that most pharmacies will no longer honor paper written prescriptions.  My office electronic health record system, which slows down seeing patients remarkably, has had electronic prescribing software which we have used for several years now.  The big change is that we will now be required to order controlled substances online electronically when in the past it was not permitted.

Since the opioid crisis struck Florida, physicians have been required to create an account with the State’s narcotics hotline named E-Forsce and check out the recipient prior to prescribing controlled substances for pain.  We then issued a written prescription.

It never made sense to me why if one is trying to track narcotic prescribing it wasn’t being done on computers from the beginning?  Nonetheless, this is a change which will require prescribers to download additional software and use two methods of identification as the legitimate prescriber before you can actually prescribe for your patients.

It will give you the freedom to prescribe from your phone or tablet when out of your office which is a convenience not available in the last few years. It will however mean more time in front of the computer screen, more user names and passwords to remember and less time actually listening, talking and communicating with patients.

Influenza Vaccination in Adults

It is time once again to be thinking about taking your flu shot.   A recently published study by the National Foundation for Infectious Diseases (NFID) estimated that only 52% of US adults plan to take the flu shot.  Reasons for not being vaccinated include:

• I do not believe it works (51%)
• Concern it would cause an adverse effect (34%)
• Concern that the vaccine would give them the flu (22%)

Health and Human Services Secretary Alex M. Azar II said, “Each season, flu vaccination prevents several million illnesses, tens of thousands of hospitalizations and thousands of deaths.  Over recent years, on average, flu vaccination has reduced the average adult’s chance of going to the doctor by between 30 – 60%.

A recent study performed by the northern California Kaiser Permanente Group, using seven years of flu season data, shows the immunity from the shot is near perfect for the first six weeks and then begins to wane. They estimate your post-vaccination chance of getting the flu, even if immunized, increases by 16% every 28 days after the shot but is near perfect for the first 42 days.

It is believed the Center for Disease Control (CDC) will recommend in future years that adults receive two flu shots each season. One will be administered at the beginning of the season and one six weeks later.  For the moment, the CDC acknowledges the flu season begins at different times in different regions of the country and suggests you receive your vaccination about two weeks before it arrives.

In South Florida, we typically see the arrival of the Influenza A virus after Thanksgiving. It peaks the last two weeks in January and first two weeks in February. For this reason, we suggest taking the shot later in the fall.

Vaccines are inactivated meaning they are not live and cannot give anyone the flu!

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.