Volunteering for the COVID-19 Vaccine Trials

My civic-minded daughter in California asked me what I thought about her volunteering for one of the drug trials or vaccine trials involving COVID-19. She asked me if I knew how they found volunteers for these research studies. I told her I had no idea, but I would investigate it.

The Center for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) websites directed me to a volunteer network formed to find volunteers to test treatments for HIV disease. I was directed to a website being run by the Fred Hutchinson Cancer Institute in the Midwest.

Mr. Hutchinson was a former major league baseball player and the manager of the great Cincinnati Reds baseball team that lost to my beloved New York Yankees in a World Series in the 1960’s. Fred had contracted cancer and been involved in philanthropic works in cancer research. After his death, the center took on his name. It is a first-class extraordinary cancer research and care facility. They are supervising the COVID-19 Trials Prevention Network.

If you access the site at http://www.coronaviruspreventionnetwork.org you have an opportunity to volunteer for prevention and treatment studies. There is a short questionnaire to fill out asking you about your health, height, weight, exposure to COVID-19 and contact information. If you are selected for a trial, you will be contacted and at that point have a chance to review what is being studied and what the risks and benefits are for your participation.

Filling out the form does not obligate you to participate but does put you in the pool of individuals willing to consider participating in a prevention or treatment trial.

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 11th and Dade and Broward County on May 18th, 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.”

Tdap Booster Vaccinations

Several years ago an epidemic of whooping cough (pertussis) was ongoing in affluent areas of California and Arizona. Epidemiologists from the Center for Disease Control (CDC) and National Institute of Health (NIH) descended on those areas to determine the cause of the life threatening illness to very young children.

Much to their surprise, grandparents were inadvertently transmitting it to their new and not completely vaccinated grandchildren. As youngsters, these grandparents took the suggested DPT series of shots believing they were resistant to diphtheria, pertussis and tetanus for life.

Like most things, as we get older, the immune system just doesn’t work as well. The immunity to pertussis waned and adults were catching the adult version of whooping cough in the form of an upper respiratory tract infection with bronchitis. The adult version resembled a run of the mill viral upper respiratory tract infection with a prolonged barking cough. This was just the type of infection which infectious disease experts were suggesting we do not treat with antibiotics and instead let our immune systems fight off independently. Unknown to us was the fact that even after we stopped coughing, if this was in fact adult whooping cough, we could transmit the pertussis bacteria for well over a year after we stopped coughing.

The solution to the problem was to give these adults a booster shot against pertussis when they received their tetanus shot booster. It is recommended that we get a tetanus booster every seven to ten years.

Tdap, produced by Sanofli Pasteur, was the solution and an international campaign of vaccination was begun. The campaign was successful but what do you do seven to ten years later when the next tetanus shot is due? In a study sponsored by the manufacturer, adults 18- 64, were given a second dosage 8-10 years after the first Tdap shot and tolerated it very well. Blood levels for immunogenicity taken 28 days later showed the benefit of the second shot.

The data has been submitted to the CDC and its vaccination Prevention Advisory Panel for consideration for a change in the recommendations on vaccinating adults.

Lack of Vaccination Coverage in the Medical Office

This week a patient, going on a foreign trip, was required to fill out a vaccination and immunization record to obtain a visa. To his dismay he discovered his records were not available. On further questioning he realized his vaccinations were done at retail clinics and pharmacies up and down the Eastern seaboard. Yes, he had requested a record of the vaccination be sent to the office but it never arrived.

I am a firm believer in the recommendation of the CDC, American College of Physicians and Advisory Council on Immunization Practices. Their literature is displayed in my office and available as a resource to my patients. I find it abhorrent that CMS, through its Medicare Part D program, will pay for the shingles shots (Zostavax and Shingrix) and the pneumonia series (Prevnar 13 and Pneumovax 23) at the pharmacy but not at a doctor’s office. The pharmacies use these vaccinations as loss leaders to get individuals into the store hoping that they will buy additional items while there.

As a general internist and practitioner of adult medicine, I too use these vaccinations as a “loss leader.” When patients call for a vaccination and have not been seen in a long while we encourage an appointment. We check on prevention items recommended by the ACP. the AAFP and the USPTF and make sure the patients are current on mammograms, HPV or Pap testing, colonoscopies, eye exams, hearing evaluations, skin and body checkups and other essential health items. We make little or no money on vaccinations or immunizations but like the idea that once a patient is here we can provide a gentle reminder about those health tasks we all need to follow up on with some regularity.

I like the idea of making vaccinations and immunizations more convenient for patients. I just believe the same payment should be made if the patient is in your office or in the pharmacy. In addition, the law should require the pharmacy to send a record of the vaccination to the patient’s physician so we can have immunization records readily available.

The ACP, AMA, American College of Physicians and American Academy of Family Practitioners should be using their influence to encourage the Center for Medicare Services (CMS) to pay for these vaccines in doctors’ offices as well as in pharmacies and retail clinics. If encouragement doesn’t work then legal action is appropriate.

Does Tdap Protect You From Whooping Cough?

Within the past few years an epidemic of whooping cough swept through and injured youngsters in California and Arizona. There were tragic childhood mortalities in the frail not yet vaccinated pediatric population. The researchers from the Center for Disease Control and National Institute of Health swooped in and concluded that adults, primarily grandparents, were transmitting the disease to their newly arrived and not yet immunized grandchildren. They reasoned that the adults’ immunity from their childhood vaccinations with DPT had worn off and they were unknowingly transmitting it to the youngsters after a mild adult upper respiratory tract infection with bronchitis.  We were told that in adults, Bordetella pertussis produced bronchitis indistinguishable from a viral bronchitis. This was just the type of illness health care leaders were telling physicians not to prescribe an antibiotic for in their international campaign for the prevention of antibiotic resistance developing.  Little did they know at first that in adults, the bronchitis is a mild illness but in children it is aggressive and is often lethal.  They were not originally aware that long after our adult mild bronchitis resolved we could still transmit the bordetella pertussis to our grandchildren.

Their solution was to re-immunize adults with a pertussis booster in combination with your next tetanus shot. The combination was called Tdap.  A national information campaign was undertaken to get primary care physicians to spread the word to their adult patients.  The question is does it really work? In a recently published study led by Dr. Nicola P. Klein of the Kaiser Permanente Vaccine Study Center in Northern California which appeared in the Journal Pediatrics, it seems that the vaccine is only effective for a short time in the very healthy and robust 11 and 12 year children.  Their study showed that Tdap protected young adolescents 69% of the time in the first year, 57% in the second year, 25% in the third year and only 9% in the fourth year.  The vaccine was given during an epidemic in California in whooping cough in the hopes of averting a greater infection rate.

 

The failure of the vaccine to provide long term benefits in adolescents and teenagers will lead to different immunization strategies. Tdap is already a milder form of a former vaccine, scaled down to prevent some of the rare side effects seen when it was administered.  A possible return to that previous vaccine or whole cell preparation may be needed. Another proposal calls for vaccinating pregnant women hoping that their maternal antibodies will pass to the fetus and provide long term protection.

The real question with no answer is what about the millions of adults who received Tdap with immune systems far less robust and protective than adolescents?  Are they immune and for how long?  No one knows because the research has not been done or published yet.  Still the CDC and the NIH and the American College of Physicians call for adult immunization with Tdap.  The Kaiser Permanente Study will surely establish the need for an adult efficacy investigation. Until then we will give the Tdap while we wait for answers. It does raise the question of whether our approach to adult bronchitis should include an antibiotic that treats Bordetella pertussis until a quick test is developed to distinguish it from run of the mill viral pneumonias.

Zika Fever and Virus

The Brazilian Government has asked young women to avoid becoming pregnant until they can determine how to stop the spread of Zika fever.  Pregnant women, especially those who are infected in the early stages of pregnancy are at high risk for their offspring developing microcephaly. This small brain in an even smaller skull leads to death or severe permanent neurological deficits. There are now over 3,800 children born with microcephaly in Brazil due to their mother’s infection with Zika Virus.

Zika Virus is in the family of Dengue Fever. It is transmitted by the bite of the Aedes mosquito which also transmits Chikengunya Fever. The incubation period is only 2 – 14 days producing symptoms in only one of five people who have been infected. Symptoms are generally very mild with a very low grade fever, a rash, joint and muscle pains, headache, conjunctivitis and vomiting in some. Treatment is supportive with the disease resolving in about one week.

In adults infected in Brazil there has been an upsurge of post infection Guillan – Barre syndrome which is believed to be due to the disease.  While the mode of transmission has been by mosquito in most instances there are two cases in the United States believed to be due to blood to blood transmission and or sexual fluid transmission. Both of these individuals became infected in Brazil.

The Center for Disease Control and Prevention (CDC) has noted the presence of Zika fever in South America, Central America, the Caribbean   and now Mexico.  Avoiding mosquito bites is the best way to avoid the disease. For women who are infected there is no commercial test to confirm the diagnosis.  A polymerase chain reaction RNA test available through the Florida Department of Health and research centers can be obtained one week after the onset of symptoms.

 

In the United States a protocol has been developed with obstetricians to screen pregnant women who have been infected with frequent ultrasound evaluations of the developing child to determine if the virus has affected the development of the fetus.

 

The emergence of this virus, which is devastating to developing fetuses, is leading to calls for the development of a vaccine which is “at best” years off. For now the best we can do is avoid endemic areas and be diligent in mosquito control.

CDC and ACP: Stop Prescribing Antibiotics for Common Respiratory Infections

The Affordable Health Care Act has created patient satisfaction surveys which can affect a physician’s reimbursement for services rendered plus their actual employment by large insurers and health care systems. This has created a fear of not giving patients something or something they want at visits for colds, sore throats and other viral illnesses. Aaron M Harris, MD, MPH, an internist and epidemiologist with the CDC noted that antibiotics are prescribed at 100 million ambulatory visits annually and 41% of these prescriptions are for respiratory conditions. The unnecessary use of antibiotics has resulted in an increasing number of bacteria developing resistance to common antibiotics and to a surge in Emergency Department visits for adverse effects of these medications plus the development of antibiotic related colitis. To address the issue of overuse of antibiotics, Dr Harris and associates conducted a literature review of evidence based data on the use of antibiotics and its effects and presented guidelines for antibiotic use endorsed by the American College of Physicians and the Center for Disease Control.

  1. Physicians should not prescribe antibiotics for patients with uncomplicated bronchitis unless they suspect pneumonia are present”. Acute bronchitis is among the e most common adult outpatient diagnoses, with about 100 million ambulatory care visits in the US per year, more than 70% of which result in a prescription for antibiotics.” The authors suggested using cough suppressants, expectorants, first generation antihistamines, and decongestants for symptom relief.
  2. Patients who have a sore throat (pharyngitis) should only receive an antibiotic if they have confirmed group A streptococcal pharyngitis. Harris group estimates that antibiotics for adult sore throats are needed less than 2% of the time but are prescribed at most outpatient visits for pharyngitis. Physicians say it is quicker and easier to write a prescription than it is to explain to the patient why they do not need an antibiotic.
  3. Sinusitis and the common cold result in overprescribing and unnecessary use of antibiotics often. Over four million adults are diagnosed with sinusitis annually and more than 80% of their ambulatory visits result in the prescribing of an antibiotic unnecessarily. “ Treatment with antibiotics should be reserved for patients with acute rhinosinusitis who have persistent symptoms for more than ten days, nasal discharge or facial pain that lasts more than 3 consecutive days and signs of high fever with onset of severe symptoms. They also suggest patients who had a simple sinusitis or cold that lasted five days and suddenly gets worse (double sickening) qualified for an antibiotic

Last year two patients in the practice who were treated with antibiotics prescribed elsewhere for situations outside the current guidelines developed severe antibiotic related colitis. They presented with fever, severe abdominal pain and persistent watery bloody diarrhea. Usual treatment with oral vancomycin and cholestyramine did not cure the illness. One patient lost thirty pounds, the other sixty pounds. Fecal transplants were required to quell the disease. At the same time community based urine infections now require a change in antibiotic selection because so many of the organisms are now resistant to the less toxic, less expensive , less complicated antibiotics that traditionally worked.

“My doctor always gives me an antibiotic and I know my body and what it needs,” can no longer be the criteria for antibiotic use.

Influenza Vaccine 2015- 2016 Season

The Center for Disease Control and Prevention (CDC) has recommended that all adult s receive the flu shot vaccination this coming fall. Our supply of flu vaccine is expected to arrive by September 1, 2015 and we will begin administering the vaccine shortly thereafter. This season there will be three types of intramuscular injectable flu vaccines available. All will contain a non-live attenuated version of the flu viruses. The Senior High Dose vaccine is recommended for all adults 65 years of age or older. The Trivalent or Quadrivalent vaccine is suggested for younger adults. The vaccine will contain 3 antigens including: an A/California/7/2009 H1N1 pdm09- like virus, an A/Switzerland/9715293/2013 H3N2 like virus and a B/Phuket/3073/2013 like virus. It is called a trivalent vaccine because it contains three virus types. The Quadrivalent Vaccine will contain a fourth antigen B/Brisbane/60/2008 like virus.

Please call the office to set up an appointment for your vaccination. Once you have received the vaccine it takes about ten to fourteen days for your body to develop antibodies against the flu. Influenza begins to appear in the northern United States in late October. The season can run through February into March. In South Florida we see little flu prior to Thanksgiving with the disease peaking in late January early February. Immunity in younger healthier patients will last throughout the flu season. Older and sicker individuals see their immunity decrease over time lasting as short a period as 3-4 months in some. The shortened immunity in seniors is the reason we usually suggest they receive the vaccine between Halloween and Thanksgiving. If you have any questions please call the office.

Flu Vaccine will be available at most commercial pharmacies as well as our office and at many workplaces. Please let us know if and when you obtain the vaccine elsewhere and tell us which of the vaccines you received.

I am often asked about adverse reactions and side effects of the vaccine. It is a dead virus. It cannot give you influenza. A successful vaccine will produce some redness, warmth and swelling at the injection site. That means that your immune system is working and reacting appropriately to the injected material. If this occurs put some ice on it and take two acetaminophen. Feel free to call us or set up an appointment to be seen that day so we can evaluate the injection site.