Good News on Treatment & Prevention of COVID-19

A study in the New England Journal of Medicine (NEJM) examined the effects of a new vaccine which uses mRNA injections to stimulate an immune antibody response against the coronavirus. The published study looked at two potential dosages while looking at younger patients and those over 65 years old.

Both doses of the injection vaccine produced an antibody response in the younger patients and senior adults. Side effects were minimal – mostly injection site irritation and soreness. Some patients ran low grade fevers and had myalgias. The vaccine is now in a larger Phase 3 trial.

This vaccine and another mRNA product in testing and production both have the drawback of requiring storage at -40 to -80 centigrade which most pharmacies and physician facilities do not routinely provide. It is hoped this vaccine will be available by the end of year 2020. There have been no challenge tests with this vaccine, meaning vaccinated individuals who develop antibodies have not been directly exposed to the coronavirus to see if those levels of immunity are protective.

On the same day of the publication of the NEJM study on the mRNA vaccine, the pharmaceutical company Regeneron released a shareholder report on its Phase1 and 2 IV anti COVID-19 monoclonal antibody. They took antibodies from recovered COVID-19 patients, identified the most important ones and then synthetically created duplicates of two of the more important antibodies in a form that is infused by IV administration. This product blocks the P spike on the coronavirus from working, preventing the coronavirus from attaching to and entering human cells.

They enrolled COVID-19 infected patients with symptoms but not severe enough to require hospitalization. They found that those with a low viral load of the disease developed an immune response with IgG antibodies to COVID-19. Those who had few or no antibodies were overwhelmed by the virus and had high viral loads measured. They found that the Regeneron product worked best in those with a high viral load and few or absent antibodies to COVID-19 virus and more symptoms. These patients cleared the virus quicker with the monoclonal antibody product than non-medicated patients receiving standard care. They had alleviation of symptoms quicker and tolerated the infusion and product well.

In addition to this trial on non-hospitalized patients there is currently an ongoing trial in hospitalized patients in Phase 2 and 3.There is additionally a trial in family members of COVID-19 positive patients to see if the Regeneron monoclonal antibodies can prevent them from acquiring the virus in close household contact.

There is light at the end of the tunnel. We just need to continue to social distance, wear masks in public settings, hand wash frequently and remain patient because these products are very close to release.

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.”

Heartburn, Indigestion & Protein Pump Inhibitors

I have seen multiple adult patients with intractable heartburn, reflux, indigestion and chest pressure all related to food and digestive enzymes kicking back up the esophagus from the stomach through a lax group of muscles known as the lower esophageal sphincter.  All these patients receive a fiber optic upper endoscopy (EGD) at some point and are observed and biopsied to eliminate the possibility of ulcers, cancer, gastric polyps, esophageal cancer, potential esophageal cancer and Helicobacter Pylori bacteria as the cause.

They are all treated with weight control suggestions, avoiding a host of foods, most of which are quite healthy from a cardiovascular standpoint plus limits on alcohol, elimination of tobacco and other indulgences of adults. We ask these patients to wear loose clothing at the waistline, avoid reclining for three hours after eating and take a host of medicines including proton pump inhibitors (PPI) such as Nexium, Protonix, Prilosec.  Drugs like Tagamet, Zantac (H2 Receptor Blockers), Tums, Rolaids are far less effective.

In recent years, numerous articles have appeared in medical journals stating that protein pump inhibitors, when taken regularly, can predispose to increased and early death, pneumonia and dementia.  A large review article from a prominent GI group in Boston, and published in the New England Journal of Medicine, tried to eloquently refute these claims but the doubt about long term safety lingers buoyed by numerous lay periodicals and online internet sites sensationalizing the down sides of these medicines.

To allay the patients fears, doctors and patients work together to try and stop the PPIs and substitute the older standbys like Tagamet and Zantac but they just don’t provide the symptom relief that the PPI’s do. Patient’s face the dilemma of taking the medicine that works best and incurring the potential risks or suffering.

In a recent edition of the journal Gastroenterology, Paul Moayyedi, MB ChB, PhD from McMaster University in Canada followed 17,000 patients for three years with half the group taking PPI’s. Those taking a PPI (Protonix) for three years had no more illness or adverse effects than those taking a placebo.  L. Cohen, MD, a reviewer at Mount Sinai School of Medicine in NY, concluded that the study provided strong evidence of the safety of PPIs for patients taking the drug for three consecutive years.

The controversy will continue. I am sure next week someone will produce data revealing some additional horrible consequences of taking these medications to relieve heartburn. It will ultimately come down to individual decisions about quality of life versus potential risks because the lifestyle changes necessary to control this problem are difficult for human beings to sustain over a long period of time.

Drinking Coffee, Lower Mortality

Over the years, the consumption of coffee and its relationship to your health has been controversial.  In my medical school, internship, and training years in the late 1970‘s, it was thought that consuming more than five caffeinated beverages per day was associated with an increased risk of pancreatic cancer. That relationship has since been disproved.

The May 17th issue of the New England Journal of Medicine published a study on coffee drinking that will certainly make coffee drinkers more comfortable with a consuming a “cup of Joe.” They looked at a National Institute of Health – AARP study that began 1995 and includes almost 230,000 men and 173,000 women. They found that coffee drinking was associated with many negative behaviors including cigarette smoking, less exercise, eating more red meat, and eating less fresh fruits and vegetables.  Upon initially looking at the data, coffee drinking was associated with an increased mortality. However, when researches removed the negative behaviors from the data, and looked at the people who drank coffee but didn’t smoke and exercised; they found a significant drop in the mortality of coffee drinkers. Over 13 years, men who drank 4-5 cups of coffee per day had a risk reduction of 12% while women had a risk reduction of 16%.

The risk reduction was considered “modest” by Neal Freedman, PhD of the National Cancer Institute.  Lona Sandon, RD (registered dietitian) of the UT Southwestern Medical Center in Dallas said, “Based on this study alone I would not tell people to start drinking more coffee to lower their risk of death.”   She felt individuals should “stop smoking, be more physically active, and eat fruits, veggies, whole grains and healthy fats…. A little coffee doesn’t appear to hurt.”  Cheryl Williams, RD, of Emory Heart and Vascular Center in Atlanta commented that “if you are not a coffee drinker, this study is not a good enough reason to start.”

The study seemed to show that with consumption of 4-5 cups of coffee per day your risk of death due to cardiovascular disease, respiratory disease, injuries and accidents, diabetes and infections decreased. Coffee consumption did not appear to protect against cancer-related deaths. The design of the study does not allow us the luxury of saying drinking coffee is the “cause” of an “effect” of lowered overall mortality, but does certainly hint at it.

What is clear is that coffee drinking does not appear to have an adverse effect on already healthy lifestyles, but will not protect an individual from the detrimental effects of smoking, poor dietary choices and inactivity.