Coronavirus news & views

Vaccine Disinformation Moves To Congress

 “War is peace.
Freedom is slavery.
Ignorance is strength.”
―George Orwell, in 1984

“Anecdote is science.”

That silly notion can now be added to the Orwellian Newspeak Catechism thanks to those who prefer confirmation bias over empirical data to determine their “alternative facts.” This seems to include several  members of Congress.

The war on objective science recently spilled over to Congress where a group of anti-vaccine Congressmen and women and one Senator held an impromptu meeting to confirm their disinformation about so-called injuries caused by the COVID mRNA vaccines (note: the technology just won the Nobel Prize for Medicine). This was not a meeting called by a regular committee but an ad hoc gathering of some committed anti-vaccine rogues. It was held in a tiny back room in the Capitol and was poorly attended, poorly staffed, poorly equipped, and, thankfully, poorly publicized. It was described as a meeting of the “shadow Congress;” accurately named as it dabbled in the penumbra of truth.

Leading this November 13 meeting was Congresswoman Marjorie Taylor Greene (R, Georgia). Greene, no stranger to fantasy, has previously claimed that Jewish space lasers caused recent wildfires in California, that the shootings in Parkland, Sandy Hook and Las Vegas were staged, and that 9/11 was an inside job. Because of these and other extremist reflections, the House sensibly stripped Greene of several committee assignments.

Others on the “committee” included Congressmen Clay Higgins (R, Louisiana), Thomas Massie (R, Kentucky), Warren Davidson (R, Ohio), and Andy Biggs (R, Arizona). Also attending was Senator Ron Johnson (R) from my own State of Wisconsin who has been a vaccine dissembler for a while, claiming, for instance, that the vaccines have killed many people. I recently contacted the Senator’s office and asked why he believed that. They quickly responded and sent me to a web site that was very professional looking and had very many graphs and tables claiming to show that the vaccines caused hundreds of thousands of deaths. The problem is that the data they used to put said graphs and tables together were bogus. The statistics were fraudulent (for example to test the site, an MD submitted a claim saying that the vax turned him into the Incredible Hulk. His claim was accepted!). Anti-vaccine crusaders with radio and blog platforms have urged their audiences to post false information on the site, and the website itself had been debunked numerous times by the investigative press and in science journals for incorrectly reporting the data. I pointed this out to Sen. Johnson’s office and never heard back, in contrast to their earlier quick response. Go figure.

Back to the Shadow Congress Committee meeting: Three people testified: A lawyer, an obstetrician-gynecologist, and a scientist. A summary of the testimony of each, with my comments follows.  

The lawyer. Forty-six-year-old Thomas Renz, went first. He passed the Ohio bar exam in 2019 after five tries and since has made a name for himself, along with the MyPillow guy, Mike Lindell and others, as a COVID conspiracy buff. Renz made three unsupported claims enumerated below: 

1. First, Renz declared without any evidence, that it is vaccinated people who are dying. However, a study published in the Journal of the American Medical Association showed that in 2021, unvaccinated adults were 12 times more likely to be hospitalized and in 2022, that they were 6 times more likely to die after infection. Science shows that COVID vaccines have been estimated to have saved the lives of more than 3 million Americans. Renz’s says otherwise. Who are you going to believe, science or the lawyer, Renz?
2. The lawyer also claimed, again without proof (a lawyer without evidence?), that “COVID is not as bad as SARS or MERS but about as dangerous as a bad flu season.” Well. The first human coronavirus outbreak, SARS-1, was identified in Asia in February 2003. It infected a tad more than 8,000 people, killing ~800. By July 2003, the outbreak was contained without a vaccine. The second coronavirus outbreak, called MERS (Middle East Respiratory Syndrome), appeared in June 2012, in Saudi Arabia. That virus infected >2,500 people, killed about 900 and also was contained in a short while without a vaccine. Compare those numbers to SARS-CoV-2, which so far has killed almost 2 million people in the United States and 7 million people in the world. And four years later it continues; it is not contained even though we have several vaccines. Except for the 1918 flu pandemic, which killed more than 50 million people worldwide (that was before flu vaccines) COVID is worse than any other flu in history and much worse than SARS or MERS. Renz’s lawyerly opinion is bunk. Why is he even testifying on a medical matter?
3. Renz saved the best for last. With the help of an “unnamed whistleblower,” Renz claimed, without proof, of course, that "something suspicious" happened in November 2014 at Fort Riley, Kansas, when the Department of Defense (DOD) and the CIA, in collaboration with the Wuhan Institute of Virology, created SARS-CoV-2 virus. Not in the Wuhan lab mind you, but in Kansas in 2014! To support his claim, Renz offered nothing! It was just his opinion. Renz also asserted that Tony Fauci, the CDC, FDA, and the DOD played a part in a massive cover-up of all this (so how in the world does HE know?). He unbelievably stated that Hunter Biden was also involved (why not?). Funny how the FBI hasn’t picked up on any of that. Renz knows because he says he does. Trust him, he’s a lawyer without evidence. But that is good enough for the Shadow Congress.
   

The Ob/Gyn. Next up was Kimberly Biss, MD, a well credentialed obstetrician and gynecologist practicing in Tampa Bay and St. Petersburg, Florida, which makes her testimony all-the-more-difficult to understand.

She claimed that after receiving COVID vaccines, an unspecified number of women in her practice suffered unsubstantiated menstrual cycle irregularities including severe, persistent bleeding. However, the only way to reliably determine whether COVID vaccines caused these  changes in menstruation is to compare the symptoms in women who got the vaccine to women who did not. She didn’t do this. Anecdotal observations like these offered by Biss usually don’t include both groups, which is why medical science considers anecdotes to be unreliable and instead rely on controlled clinical trials to base medical science opinions.

Furthermore, real scientific comparisons between vaccinated and unvaccinated women have been done but these were not entered into evidence at the Shadow Congress Hearing. A study of more than 1,100 women performed by the Boston School of Public Health found that there was no association between COVID-19 vaccination and cycle irregularity, bleed length, heaviness of bleed, or menstrual pain. So, which is more credible, Biss’s personal uncontrolled anecdote on an unknown number of patients whose medical history is unknown vs a controlled scientific study on over 1000 patients with carefully documented medical histories and compared to a comparable cohort of unvaccinated menstruating women?  

Biss further testified that in her practice miscarriage rates went up in vaccinated women, again without indicating the number of patients she saw and without providing any medical documentation. She again failed to note the miscarriage rates in unvaccinated women (why does she always leave out the data from unvaxed women?). Another scientific study of 40,000 pregnant women showed that vaccination was not at all associated with an increased risk of premature births. And other controlled studies have shown that COVID vaccination during pregnancy does not increase the risk of birth defects. Again, what would you believe, Biss’s anecdotes or several well controlled peer-reviewed and published science studies?

Biss continued her misleading anecdotal testimony by claiming that it was unsafe for vaccinated women to breastfeed because she "heard" it caused myocarditis in babies in Scotland. She failed to provide any substantiation for her wild claim that no one else seems to have heard. Not only has breastfeeding proven to be safe in women who have received COVID vaccines, newborn infants benefit from vaccine-induced antibodies in breast milk. This provides newborns with their initial protection against COVID as they develop their own immune system. That is a normal part of the maternal-fetal immune system that newborns immensely benefit from. That is basic immunology.  

Finally, and most outrageous was Biss’s stance on vaccinating children. She advised against vaccinating kids falsely claiming that only “three in one million children will die from COVID.” One wonders where she gets her facts like this and like those about myocarditis in breast fed babies in Scotland. As of January 2023, COVID was the leading cause of infectious disease deaths in children. Contrary to Biss’s claims, the COVID death rate for children less than one year of age was 43 per million. Hundreds of young children have died from COVID and many, many more have been hospitalized long term with the very serious condition called multisystem inflammatory syndrome, or MIS, which I have written about in these pages. COVID is much more serious than the flu for kids. None of those deaths or serious illnesses in kids are acceptable. Her claims to the contrary are simply irresponsible for a physician to make.

Finally, the scientist. Perhaps the silliest testimony in front of MTG’s “shadow” committee came from a scientist and physician named Robert Malone who recently has gone around claiming he “invented” the mRNA vaccine. He did not. In the late 1980s and early 90s, labs around the world were fixated with the idea of trying to express genes in cells via transferring DNA into cell cultures. The technique was called “transfection.” It promised to be a powerful tool for studying the function of genes in cells, but proved enormously difficult as I wrote about earlier. My own lab considered trying it, but discarded the idea in favor of another approach, viral-based gene transfer, which we often used to study gene function, and which some might call routine gain-of-function research as I also described earlier in these pages.

Meanwhile, Malone was a small part of the “transfection” bandwagon and in the late 80s published two papers showing it was possible to transfect fragile mRNA protected by a lipid micro-bubble into cells (most labs transfected DNA, which was easier to work with than mRNA). Undoubtedly, his research represented a stepping stone on the path to developing the vaccines, but he had no role in vaccine development. He was one of very many scientists who contributed incremental advances that ultimately made the vaccines possible. He is now way overselling his role. The technology that produced the mRNA COVID vaccines recently won a Nobel Prize and Malone was never mentioned in the invention. He is only a giant in his own mind.

More to the point, Malone testified that the vaccines are contaminated with fragments of DNA and dangerous. He argued, without evidence and contrary to all other science, that these DNA fragments alter cellular DNA of vaccine recipients, causing cancers, autoimmune diseases, and a variety of other disorders. For pregnant women, Malone further opined, again without a shred of proof and contrary to common science, that these DNA fragments could cross the placenta and cause birth defects. Furthermore, according to Malone, the FDA, the CIA, and other government agencies know about this DNA contamination but are covering it up (is Hunter involved in this too??). Again, he offered no evidence at all for this allegation. But, maybe we can excuse him, because there is no evidence to offer.

The idea that the vaccines are contaminated with DNA detritus is old news. All vaccines contain DNA of different sorts, which has never caused any harm as long as vaccines have been given. In fact it is biologically impossible that miniscule amounts of DNA detritus could mess up our cellular DNA. It is irresponsible, and scientifically ignorant of Malone to simply throw this out without elaborating. He didn’t elaborate because to do so would have ruined his “Frankenscience” innuendo that seemed to duly impress the scientifically naïve Shadow Congressional audience he spoke to.

The mRNA used in the vaccine is produced from a DNA strand. The DNA strand is then digested with an enzyme called DNase which chews up all DNA strands, leaving only the DNA building blocks, or remnants of it behind; DNA detritus. It is like taking a large building and demolishing it into its bricks. The large mRNA molecules are then easily biochemically separated from most of the DNA detritus. Even if there were miniscule traces of DNA detritus left over, it is biologically impossible for it to damage cellular DNA. It simply is recycled and reused by our cells. Our cells do that all the time.

But, maybe larger, intact DNA fragments could mess up our cellular DNA? We are exposed to large fragments of DNA all the time with no adverse effects. Consider the following two points: 1) we eat foreign DNA from plants and animals all the time and that DNA enters our blood stream in intact pieces much larger than the digested detritus we have been talking about. Yet, we are totally unaffected by this. 2) We also get vaccinated with whole DNA virus vaccines and have no concern that they affect our cellular DNA. Studies have shown that there is NO genotoxic effect of any of the vaccines.

Finally, consider the inherent conflict in Malone’s position. On the one hand he goes around promoting himself as the inventor of the vaccine technology. He even laments that he has not been given his due credit for the invention. Then he tries to discredit the same invention as something very dangerous and that should not be given to people because it causes enormous harm.

Which is it? Do we laud Malone as he would like for discovering a lifesaving vaccine, or pillory him for creating the dangerous vaccine he says it is? The man is as confused as his testimony.

This is what some of our Congress people spent their time doing last November. The Congressional Flake Caucus wasting their time and our money on a "hearing" without a single reputable testimony. At least it received the very little attention it deserved.

Last word. In an earlier post in these pages I asked the question if it was criminal to intentionally mislead people about lifesaving vaccines. That question is worth raising again, now.

The Next Pandemic Is Here

Who ya gonna call?  --“Ghostbusters”

We seem to have mostly weathered two-plus years of a pandemic like the world has not seen in our lifetimes. It raced across the globe killing and maiming people, and overwhelming health care capabilities. Sure, we have read the history about the black plague, small pox, and the Spanish flu pandemics, but vicarious experience through books and film is no substitute for first-hand experience. We now have that experience. It was sobering to see the novel SARS-CoV-2 virus ravage country after country while medical experts played a desperate game of catch-up to learn how to retard the spread of a brand new virus and how to treat the brand new COVID-19 disease it spawned. It was sobering seeing and hearing about people we know get very ill and sometimes die, and sobering reading the statistics of millions of deaths that occurred worldwide.

While most of us today have not seen such a pandemic wild-fire before, we have seen other, more smoldering pandemics that do not spread as fast. HIV is a good example. It too is a world-wide disease that, for many years was a death sentence for those who were infected. Now it is a well-managed chronic disease, thanks to medical science.

The world was not as frantic over HIV and AIDS as we were over CoV-2 and COVID. The reasons for this are probably two-fold: First, it was quickly recognized that AIDS was largely limited to homosexual men and IV drug users and, therefore, was not an eminent threat to most of us. It was not necessary to quarantine, mask up, and shut down businesses and schools in order to prevent catching the “gay disease.” Second, despite the world-wide spread of AIDS, it is not easy to catch. You must be in very intimate contact with an infected person to catch it—it is not caught by simply breathing the same air as an infected person like COVID is. Clearly, not all pandemics are created equal. Some smolder like AIDS, others fulminate like COVID. What will our next pandemic be like?

As the global population grows, as the climate changes, as humans push into spaces occupied by wild animals, and as we continue enjoying our ever increasing global connectedness, future pandemics become more likely. We are not guaranteed the luxury of facing just one a century, or even one at a time. As greatly encouraging, even exciting as it was to watch the post-molecular BioX science, as I have called it, roar into life to produce several effective and novel anti-CoV-2 vaccines in record time, there is no guarantee BioX can save us next time.

Well, the “next pandemic” already is upon us and BioX is struggling to deal with it. This pandemic is not as volatile as COVID or the Spanish flu. In fact, compared to COVID, it is a “slow mo’” pandemic, more like AIDS. But, it promises to be more difficult than COVID, even for BioX, to mitigate. It currently kills about 700,000 people annually around the world, but threatens to kill 10 million people a year by 2050 (in contrast, COVID killed ~6 million around the world in 2.5 years).

The problem

 In March 1942, Anne Miller of New Haven, Connecticut, was near death. A bacterial infection had made its way into her bloodstream, which was a death sentence at that time. Desperate to save her, doctors administered an experimental drug called penicillin, which Alexander Fleming accidentally discovered 14 years earlier. In just hours, she recovered, becoming the first person to ever be saved by an antibiotic. Rather than dying in her thirties, Mrs. Miller lived to be 90 years old and Fleming went on to win the Nobel Prize for his inadvertent discovery.

Today, decades later, germs like the one that infected Mrs. Miller, but easily eradicated with antibiotics, are increasingly becoming resistant to penicillin and the many other antibiotics that have since been developed. There is a very good chance that right now, you have such a “superbug” in or on your body—a resistant germ that, given the opportunity could enthusiastically sicken you leaving medical people at a loss on how to treat you. You would be at the mercy of the bug just as all patients with a microbial infection were before Mrs. Miller.

We are not talking about a new, exotic germ like CoV-2 suddenly appearing and ravishing the world. The antimicrobial resistance crisis stems from the simple fact that new antibiotic development cannot keep pace with the rate that common microbes become resistant to antibiotics. This very slowly growing pandemic we are now in involves run-of-the-mill pathogens, bacteria and fungi that have caused disease since humans first dragged their knuckles on the earth. These are bugs which we had well controlled with antibacterial and antifungal drugs, but there is a very definite trend toward these germs becoming resistant to ALL known antimicrobial medicines we have. Infection with multidrug resistant pathogens is the slow moving pandemic that already is among us but that is growing at a logarithmic rate.

Since multi-drug-resistant infections do not respond to our antibiotics, treatment increasingly involves surgically removing an infected organ. For example, in the case of drug-resistant Clostridioides difficile (aka, “C-diff”) colitis, an emergency colectomy is performed when patients no longer respond to antibiotic therapy. CDC data show C-diff infections occur in half a million patients each year, and at least 29,000 die within one month of initial diagnosis. Up to 30% of patients with severe C-diff colitis develop sepsis require emergency surgery, and still their mortality remains high.

As of 2019, about 18 drug resistant pathogens affected >3 million people in the US, causing 48,000 deaths. These bugs cause pneumonia, septic shock, various GI problems, STDs, urinary tract infections, typhoid fever, TB, and infection with the so-called “flesh eating bacteria.” Compared to COVID, this has received relatively little attention in the popular press, but has been a frequent topic in medical lectures and conferences for the last 20 or more years. These infectious disease lectures tend to scare the bejeebers out my colleagues and me. This smoldering pandemic is that serious.

And it is not just antibiotic-resistant bacteria we have to worry about. Certain fungi, especially of the Candida genus, cause various serious ailments in people. Recently, for the first time, the CDC reported five unrelated cases (two in DC and three in Texas) of people infected with fungi that showed “de novo” resistance to all drugs. Usually, drug resistant fungi only appear after infected patients have been treated with antifungals. But, the patients in these five de novo cases had no prior exposure to antifungal drugs. The fungi were already drug-resistant when they infected the patients; they were picked up from the environment already resistant to our medicines.

Antibiotic resistance is now one of the biggest threats to global health. It occurs naturally in naturally occurring pathogens, but is accelerated by overuse of antibiotics in humans and animals, especially farm animals. What happens is that upon treatment with an antibiotic, a single infectious bug out of a population of millions or billions fortuitously mutates and becomes resistant to the antibiotic. The antibiotic then kills off all the non-resistant population, including beneficial bacteria, opening the door for the drug-resistant pathogen to take over. This resistance can occur via many different mechanisms. The bacteria or fungal cell can stop taking up the drug, it can spit out the drug if it is taken up, it can neutralize the drug once it takes it up, or it can change its internal machinery so that it no longer responds to the drug. This problem can be further exacerbated since bacteria and fungi can pass along their mutations by sharing mobile genetic material with their progeny and even with other bugs in their immediate environment that have never been exposed to the antibiotic. They can even pass along this DNA to microbes of different species. Bacteria can also pick up DNA remnants left over from dead germs. Thus, DNA that confers resistance to anti-microbial drugs can spread to the environment even in treated human and animal waste contaminating lakes and streams and ground water.

Currently, the major problem with drug resistant infections occurs in in-patient clinical settings—perhaps you have seen the heightened infection control efforts (gowns, gloves, masks, and isolation) in hospitals designed to prevent the spread of untreatable pathogens. People receiving health care, especially those with weakened immune systems, are at higher risk for getting an infection. Routine procedures, such as bladder catheterization or kidney dialysis are common ways to introduce drug resistant germs into clinical patients. But, infection can happen in any surgical or invasive procedure. Treatment of diabetes, cancer, and organ transplantation can weaken a person’s immune system making them even more susceptible for infections that either are, or that can become drug resistant.

But, antibiotic infections can also occur in the community outside of clinical settings. There is the case of Mike who needed a month long hospital stay for kidney failure after bringing home a new puppy from which he caught a multidrug-resistant Campylobacter infection. He was one of 113 people across 17 states who was part of an outbreak linked to pet store puppies. He recovered after surgery to remove a dead section of his stomach.

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The NIH Hospital Experience. About 10 years ago, the NIH Clinical Center in Bethesda was hit with an epidemic of drug resistant infections that killed a number of patients in just a few months. It was such an intractable problem that NIH finally had to gas rooms with a disinfectant, rip out plumbing, and build a wall to isolate infected patients. Still, over a period of six months it reached 17 patients, 11 of whom died. In this case, the bug was Klebsiella pneumoniae, which arrived in June 2011 with a 43-year-old female lung transplant patient who had just transferred from New York City. NIH nurses noted something startling in her chart: She was carrying an antibiotic-resistant infection.

Desperately trying to contain the superbug before it could spread, the NIH staff quickly isolated the woman in the ICU. Staff members donned disposable gowns and gloves before entering her room and her nurses cared for no other patients. After a month, the patient was discharged and the staff believed that their containment measures had worked. There were no signs that the bacteria had spread. But a few weeks later, they were shocked when a second patient tested positive for resistant Klebsiella. A third and fourth soon followed and all these patients died.

This pattern was baffling since, if the bug had not been cleared, it should have reappeared sooner. Even though it was the same type of bacteria, K. pneumoniae, perhaps it had spontaneously arisen anew in the other three patients. But by reading the genomes of the bacteria isolated from each patient, including the NYC transfer, scientists at NIH’s National Human Genome Research Institute saw that the bacteria in the subsequent patients came from the New York patient.

That meant two unsettling things: The bacteria lingered for weeks unnoticed in the hospital environment; and the hospital’s infection control measures for the New York patient failed. A further search for the bacteria found it on a ventilator that had been bleached twice. They also found it in a sink drain in a patient’s room, so they tore out all the plumbing. Yet, it began popping up it in more patients, at a rate of about one per week.

As hospital staff desperately raced to stanch the outbreak, they also struggled to treat the infected patients. Out of desperation, doctors battling the deadly, drug-resistant superbug turned to colistin, an antibiotic of last resort. It is not a new drug, having been discovered in 1949 in a beaker of fermenting bacteria in Japan. It had quickly fallen out of favor then since it causes significant kidney damage. The fact that the doctors resorted to such an old, dangerous drug highlights the lack of new antibiotics coming out of the pharmaceutical pipeline even in the face of a global epidemic of hospital-acquired bugs that quickly grow resistant to our toughest drugs.

While colistin defeated the superbug in a few patients, in at least four, the bacteria evolved so rapidly it outran colistin, too. Those four died. This was when the wall was built and all new Klebsiella-positive patients were moved into a new isolation unit behind the wall. Blood pressure cuffs and other normally reusable gear were tossed after one use. Clinical monitors were hired to follow doctors and nurses around to ensure that they were donning gowns, gloves and masks, and scrubbing their hands after seeing each patient.

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Among the most concerning mutating bacteria are carbapenem-resistant Enterobacteriaceae (CRE). Enterobacteriaceae are a large family of more than 70 bacteria that includes the common E. coli, that normally live in the digestive system and help digest food. But, if conditions allow the bacteria to leave the digestive system, they can cause serious disease that needs to be treated with antibiotics. They too can quickly develop resistance to front-line drugs and become a serious problem.  Carbapenem is an antibiotic "drug of last resort" used to treat disease caused by bacteria resistant to other front line antibiotics. Therefore, CRE are resistant to all or nearly all antibiotics and kill up to half the >13,000 patients who get bloodstream infections from them. The CDC first detected this type of antibiotic-resistant bacteria in 2000. Since then, it has been reported in 41 states. In the 10 years between 2001 and 2011, the percentage of Enterobacteriaceae resistant to antibiotics increased almost fourfold according to the CDC. Recently, the CDC tracked one type of CRE from a single health-care facility to facilities in at least 42 states.

The cause

The antimicrobial resistance crisis stems from the simple fact that new antibiotic development cannot keep pace with the rate that bacteria become resistant to antibiotics. Between 1945 and 1968, drug companies invented 13 new categories of antibiotics. Between 1968 and today, just two new categories of antibiotics have arrived. In 1980, the FDA approved 4-5 new antibiotics a year, but now only about 1-2 new drugs are submitted annually for approval. Hence, the solution appears quite simple: Develop more novel antibiotics. However, this is quite complicated since BioX science, which led to the rapid development of the novel mRNA anti-COVID vaccines, has not quite caught up to novel antibiotic development. There are two general reasons for this. First, finding a drug that disrupts the metabolism of bacteria or fungi, but that does not interfere with mammalian biochemical pathways is a difficult and narrow path. Second, so far, the market for novel antibiotics has been comparatively small, meaning that the profit incentive for pharma companies has not been large compared to that for so-called lifestyle medications. While a new antibiotic may bring in a billion dollars over its lifetime, a drug for heart disease may net $10 billion. Drugs to treat depression and erectile dysfunction are typically taken for years making them much more profitable than antibiotics that are used short-term.

Even if we could develop new antibiotics faster, their overuse is the primary driver of antibiotic resistance. According to the CDC, in 2018 seven antibiotic prescriptions were written for every 10 Americans. Of these, one-third were unnecessary, and very often were prescribed for viral illnesses that do not respond to antibiotics. Clinicians writing these prescriptions argue that the antibiotic can help prevent the primary viral infection from leading to a secondary bacterial infection. In other words, many antibiotics are prescribed for prophylaxis rather than treatment.

The number of new antibiotics that the FDA approves annually has slowed to a trickle, while the rate of bacterial mutation has grown exponentially. It used to take 21 years on average for bacteria to become resistant when antibiotics were first used. Now it takes just 1 year for bacteria to develop drug resistance because antibiotics are so readily prescribed and used. Today, the CDC lists 18 different types of antibiotic-resistant bacteria, five of which are classified as urgent threats to human health.

Physician-prescribed antibiotics, however, are not the only, or even main, source of our antibiotic resistance crisis. In the U.S., 70%-80% of all antibiotics are given to animals, especially farm animals destined for human consumption.  Drug-resistant pathogens from farm animals can spread to the environment providing a gateway through which drug resistant germs can quickly spread across our communities, food supply, and even our soil and water around the world.

Surprisingly, antibiotic use is even rampant in salmon and other fish farms, which is especially concerning, considering that 90% of fresh salmon eaten in the U.S. comes from such farms. Antibiotic-resistant infections also affect petting zoo animals, which can then transfer the germs to people.

The solution

Antibiotics clearly have been miracle medicines, saving countless lives; however, anytime they are used, they drive the development of antibiotic resistant pathogens that ultimately defeat their purpose.  Developing new antimicrobial drugs to counter the growing resistance to current drugs is not working; it is not keeping pace with the appearance of new antibiotic resistant germs. Without drastic changes in the science and economics behind antibiotic development and business, this will only be a partial solution to the growing pandemic. However, what we can do now is resort to low-tech, less expensive, and more innovative mitigation measures. These include alternative prevention steps such as more judicious use of antibiotics and increased use of isolation and sanitation measures (where have we heard this before?). Isolation and sanitation defenses against infectious diseases have been part of our disease fighting repertoire since the earliest awareness that contagions can spread through communities. It is an ancient remedy, but still the most effective way to protect ourselves against contagious diseases worldwide. Between 2013-2019, these mitigation measures led to an 18% reduction in US deaths from drug resistant infections. It always is better to prevent than treat.

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Alternative medical treatment and prevention options.  Besides the obvious masks, gloves, sanitation, and quarantine measures, there are other alternative medical (i.e., non-antibiotic) options that can be used to prevent and control drug resistant infection. In fact, these methods are often preferable to using antibiotics, which also deplete the microbiome of “good bacteria” that are critical for good health. These options include vaccines, therapeutic antibodies, and bacteriophages.

From 2000 to 2016, members of the WHO increased the use of the pneumococcal vaccine around the world, thereby decreasing antibiotic use which slowed the development of antibiotic resistant S. pneumoniae saving ~250,000 children from death. Pneumonia caused by secondary infection with other bacteria is a leading cause of complications and death in patients who get the flu. Therefore, the influenza vaccines also are effective tools to decrease the risk of drug-resistant bacterial pneumonias by preventing viral influenza. Since patients with COVID can also develop secondary complications from bacterial pneumonia, COVID vaccination now is another important weapon in the arsenal to prevent the development of antibiotic resistant bacterial lung infection.  

In recent years, healthcare providers also have been increasingly using therapeutic antibodies to treat viral and bacterial infection. For example, antibody therapy is often used to treat recurrent C-diff GI infections, and antibodies to prevent and treat bacterial associated pneumonia also are being developed. So far, we have not seen bacteria develop resistance to antibodies.

Finally, a different and very novel approach to dealing with untreatable bacterial infection has recently taken advantage of bacteriophages, which are viruses that can specifically infect and kill bacteria. There are a few cases in which phage therapy has been used to cure people dying of multidrug-resistant bacterial infections.  According to Pew Charitable Trusts, as of June 2019, 29 non-antibiotic products like therapeutic antibodies and phages were in clinical development and seven were in Phase 3 clinical trials. 

Perhaps BioX is indeed coming to rescue us from the growing pandemic of drug-resistant pathogens.

Notes: 1) By way of disclaimer, your correspondent has consulted for a biotech company that engages in “big genome” research to search for novel antibiotic molecules produced by everyday bacteria and fungi that grow in the soil under your feet. Something like this could be part of the future of novel antibiotic development. 2) In order to have blog updates delivered to your email, see the simple Subscription Instructions here. Remember, you can easily unsubscribe when you want. But, you can’t beat the price.

Son Of Omicron

“A rose is a rose is a rose.” –Gertrude Stein

Omicron is Omicron is Omicron (except when it becomes something different).

Two-plus years into the pandemic, many Americans are ready to declare the COVID crisis over. But, we have been at this juncture before—at the end of the very first surge (remember “flattening the curve?”), and again as Delta faded. Each time, a new virus variant came roaring back. Why should it be different now?

There are reports of two new sons of Omicron circulating in the world. The original Omicron, or BA.1 has spawned BA.2 and BA.3. While little is known about BA.3 at this time, very early indications are that BA.2 represents an even more infectious variant of Omicron, and it is spreading around the world and the US. This variant of a variant seems to be about 30% more infectious than Omicron BA.1. It quickly overtook BA.1 in South Africa and other countries and has caused a second Omicron surge in Denmark. BA.2 has been detected in 74 countries, and has become dominant in at least 10 of them: Bangladesh, Brunei, China, Denmark, Guam, India, Montenegro, Nepal, Pakistan and the Philippines, according to the World Health Organization's weekly epidemiological report.

In the US, BA.2 has been reported in 47 states and accounts for ~4% of all new infections according to the CDC, and it appears to be doubling fast. Samuel Scarpino, director of pathogen surveillance at the Rockefeller Foundation says that if infections double again to 8%, we will be in another exponential growth phase, or the fifth wave of the pandemic. In other words, BA.2 seems to be quickly backfilling the vacuum left as BA.1 peters out.

While BA.2 clearly arose from BA.1, it carries dozens of additional gene changes, making BA.2 as distinct from BA.1 as the Alpha, Beta, Gamma and Delta variants were from each other. This suggests that BA.2 might soon be given its own unique Greek letter designation.

What does BA.2 augur? While vaccination and prior infection still appear to protect fairly well against BA.2, this variant still seems more adept at skirting the immune system then the original Omicron. An early report also shows that vaccine induced antibodies often fail to neutralize BA.2 in tissue culture, and that the virus better replicates than BA.1 in nasal epithelial cell cultures. Nevertheless, those who have been vaccinated and boosted are 74% less likely to become ill from BA.2.

Hopefully, this reduced immunity will still be enough to provide an immunological redoubt against extensive spread of BA.2. The best thing that could happen is that as we become increasingly immunized by vaccine and infection, it might be enough to continue the drop in BA.1 Omicron infections, and check any surge from the new BA.2 variant. This is speculation at this point, and one thing we have learned over the last 2+ years is that the virus does not often respond as expected.

Then there is this: Very preliminary laboratory data hint that BA.2 might cause more severe disease than BA.1, and it appears capable of foiling some of the key weapons we have against COVID-19. In initial lab studies, a Japanese team reported that BA.2 has structural features that might make it as virulent as Delta was. This prediction of increased virulence was supported by hamster infection experiments, but this has yet to be confirmed or refuted in real-life epidemiological studies. Rest assured, those studies are underway, so we will see.

BA.2 also is almost completely resistant to some COVID treatments, such as sotrovimab, a monoclonal antibody therapy that is currently used against Omicron.

Bottom line: During the Spanish flu, as people wearied of the social restrictions designed to prevent the spread of the virus (there were no vaccines or drugs for flu then), many pushed back against the restrictions, which led to premature relaxation of the mandates. Cities like Denver and Philadelphia, which lifted their mandates early paid a hefty price. Other cities like St. Louis, which took a more cautious approach were relatively unscathed. Let’s hope that we are not relaxing and entering a “control phase” too quickly.

What’s ahead of us is not COVID’s end, but might be the start of a phase in which we continue to invest in measures to continue to shrink the virus’s burden. Success in this is not entirely up to us. The virus will have a say too. Our future will depend both on the virus’s continued and unpredictable evolution and on our responses, both immunological and social. The goal is to get ahead of any new variants with wide spread immunity and a growing formulary of antibody and drug treatments, and, yes, this might also require renewed mandates.

A detailed report  looking at past suspected coronavirus pandemics (e.g., the Russian “flu”of 1889, which was probably a coronavirus) published last August in the journal Microbial Biotechnology, suggested plausible scenarios in which elevated levels of COVID-19 deaths could last another five years or longer. This of course depends on what happens to and after BA.2.

It probably is not quite time to relax all mask mandates or let up on the push to vaccinate.

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Don’t Forget The Drugs: An Update

In these pages last March, I reminded readers to be thankful for the vaccines that prevent COVID-19, but to not forget the antiviral drugs that are being developed that might treat the disease. Both vaccines and antivirals are part of the same quiver of weapons we have to fight the pandemic. In that blog post, I mentioned an experimental drug, molnupiravir that was being developed by Merck and Ridgeback Therapeutics. Well, they just posted an encouraging update. It continues to show success at preventing serious disease when given to high-risk people early after infection. Its only side effects were similar to the placebo, meaning it is very safe. In animal studies, the drug also was effective against different CoV-2 variants, including Delta, and against other coronaviruses including SARS and MERS. Molnupiravir is a “prodrug,” which means that it has no activity on its own; rather it is metabolized after ingestion to an active drug that was developed in the early 2000s to treat hepatitis C.

This is a significant step for being able to easily protect high-risk patients at home. The pill that patients take on their own cuts their risk of hospitalization or death by ~50%. The results were so encouraging that the study was halted after consultation with the FDA. Early termination of studies like this is only done when interim data analyses show such good efficacy of a treatment that it would be unethical to continue enrolling subjects, some of whom would receive placebo, thereby being denied an effective therapy.

The drug slows the spread of the virus in infected people by forcing the enzyme that copies the viral genetic material into making so many mistakes the virus cannot reproduce. That, in turn, reduces the patient’s viral load, shortening the infection and damping the type of over-exuberant immune response (cytokine storm) that causes serious problems in many COVID patients. It was not effective when given to already hospitalized, or advanced, patients. It is on track to be approved by the FDA by the end of the year, and would be the first proven and approved oral antiviral drug for treating COVID-19 (neither ivermectin nor hydroxychloroquine have been proven or approved).

The FDA has already cleared another antiviral drug, remdesivir, for treating COVID-19, but it is only used to treat advanced patients who are already hospitalized (interestingly remdesivir was also originally developed to treat hepatitis C and it is also used to treat Ebola). Several lab-produced monoclonal antibody treatments have also been approved by the FDA for treating mild to moderate COVID-19 and they are more successful than molnupiravir at preventing advanced disease. But both remdesivir and the antibody treatments require an intravenous infusion done in a health care setting, making them more complicated and more expensive than just taking a pill at home, which is a decided advantage of molnupiravir. Finally, one of the more effective approved drugs against COVID-19 is the steroid, dexamethasone, but that is only given to very sick patients since its side effects are significant. Therefore, there is much room in the anti-COVID quiver for effective, simple-to-administer drugs such as molnupiravir. Both Pfizer and Roche also have other antiviral drugs that block viral replication in advanced stages of development. Stay tuned.

As of October 5, 2021, the Milken Institute tracker shows that there are 331 “treatments” for COVID-19 in development worldwide. This effort recently got a $3.2 billion boost from the US Antiviral Program for Pandemics, which is a rejuvenated initiative that was started during the MERS outbreak in 2012, but was tabled after MERS fizzled out. Then there is the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, also sponsored by NIH. These programs focus on developing non-vaccine therapies designed to treat not prevent the disease and they include studies of medicines currently used to treat other diseases (including ivermectin, which has yet to be proven effective) as well as studies of new drugs.

While the news about molnupiravir is encouraging, health experts are concerned that the news also could increase complacency regarding vaccines in the vax-hesitant. It is important to realize that prevention (vaccination) is almost always preferable to treatment (drugs).

Get the vax.

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