Don’t Inhale

The year 2020 may set a 100-year record for deaths from lung disease.  Several problems are converging and challenging the lungs of all Americans. Viruses and air pollution are the agents presenting the biggest threats to our lungs at present and in the immediate future. Neither of these problems is avoidable over the short-term, and long-term measures to protect the more than 300 million Americans at risk remain mired in finger-pointing and tribal bickering.

Covid-19 is still killing thousands of Americans every week.  In addition to death by suffocation, this virus also affects organs ranging from the heart to the kidneys and leads to lost arms and legs. The permanent disability caused by this virus is not getting any attention in the media and is scrupulously unmentioned in government reports. We have adopted a Vietnam era approach to the horror: we only count dead bodies and ignore those bodies and lives that have been shattered.

That “only” 207,000 Americans have been killed by this virus out of the millions who have been infected is often cited as proof that the virus is relatively benign. This is false in the extreme. The cost and consequences of this disease have been terrible. Those who survive symptomatic infections are often left with permanent lung, heart and neurologic injuries. Those who have no symptoms associated with their infections are still at risk for problems in the future.

As we enter autumn, influenza is on the horizon. The flu virus damages the lungs and usually kills several tens of thousands annually, but at least it is only seasonal and we have a vaccine against some strains of the flu. That the vaccine being developed for this year’s flu epidemic will provide some protection is still unknown. Each year a different flu vaccine must be developed based upon which strain of the virus appears most likely to spread across the U.S. Even when the vaccine is on target, it provides only partial protection at best.

The third element attacking our lungs in 2020 is smoke from fires along the west coast. You can see this if you look out the window, even if you live in eastern (or Easton) Connecticut. Fortunately, the smoke is being carried primarily by the west to east jetstream, which means it is several thousand feet up in the atmosphere above the east coast. Major cities along the west coast have a much more intimate experience with this smoke. 

The air in cities in Washington, Oregon, and California is simply unbreathable and will continue to be so until these massive fires run out of fuel or are extinguished by rain. Unfortunately, there is plenty of fuel still available, and there is no sign of any substantial rain for several weeks.

Most of the country will need to continue wearing face masks well into 2021, even if an effective vaccine is developed. The head of the Centers for Disease Control and Prevention (CDC) advised Congress that if a vaccine against Covid-19 is developed before the end of 2020, which is highly unlikely, the manufacturing and distribution of any such vaccine would not make it generally available until June 2021 or later.

He also noted that the Covid-19 epidemic in the U.S. could probably be snuffed out in a few weeks if everyone wore masks, observed social distancing, avoided group activities, and frequently washed with soap and water. Why these simple measures are still resisted by large segments of the population will probably be explained by whatever psychiatrists survive our current pandemic.

The vaccines under development are being generously funded by the U.S. government with the expectation that this largesse will speed along the development of a safe and effective Covid-19 vaccine.  Astra Zeneca Pharmaceutical, just one of many drug companies being funded for this vaccine development, has been granted $1.2 billion.

As previously noted, this vaccine trial has been temporarily halted twice because of neurologic problems developing in two of the volunteers in the group receiving the vaccine. The first volunteer getting into trouble was diagnosed with previously undiagnosed multiple sclerosis, a disease primarily affecting nerve fiber insulation.  The second volunteer with a serious disease had transverse myelitis, an inflammation of the spinal cord.

With $ 1.2 billion dollars at stake, AstraZeneca was understandably less than forthright in discussing these two events. Both events were referred to a safety committee, a presumably independent body of physicians and other health professionals which makes the ultimate decision regarding continuing the study. I say “presumably independent” because they are being paid by the vaccine developer and their identities are a matter of public record. 

If they end the study, they not only stop the payments they get for being on a safety committee but they will also find invitations to participate in other safety committees unlikely. In fact, if they even recommend changes that will slow the vaccine development, they almost certainly will not be invited back by other companies looking to develop drugs or vaccines..

By the time the second event surfaced, about 18,000 volunteers had been enrolled in the AstraZeneca trial. According to the study design that has been published, about 12,000 healthy people should have received the vaccine by now out of a planned 20,000. About 6,000 should have received a dummy (saline) injection out of a planned 10,000.

One of 12,000 healthy people developing transverse myelitis may not seem worrisome, but the risk of developing this disorder is about one to six out of a million. That one presumably healthy person got through screening and became symptomatic for multiple sclerosis during the trial is less worrisome since the incidence of this disease in women in England where the volunteer came from is about one in 10,000.

The resumption of the trial after one person was diagnosed with multiple sclerosis, a disease which can and frequently does cause signs and symptoms of transverse myelitis, was not surprising. That the study was only briefly halted after a second volunteer developed a central nervous system complication is more disturbing. 

Typically this development would have prompted amendments to the study or additional investigations of volunteers already enrolled, but these changes would have slowed the study substantially. AstraZeneca has not indicated any such measures were recommended by the safety committee or adopted by the drug company.

If the FDA approves or even allows distribution of a Covid-19 vaccine under what is called an Emergency Use Authorization (EUA) before the end of 2020, caveat emptor (buyer beware). It may be safe and effective, dangerous but effective, or dangerous and ineffective. The population establishing which label applies to this vaccine or vaccines will be hundreds of millions of people in the U.S. alone.

I hope the Covid-19 vaccine works. I hope this year’s flu epidemic is mild. I hope the fires destroying air quality in the west stop soon. I hope our lungs and hearts and kidneys and spinal cords survive 2020 with minimal damage. Despite the risks involved, we all need to keep breathing.    

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