Science is almost never “settled.” Science is a collection of hypotheses and theories that are challenged repeatedly to determine whether they can withstand re-examination with new tools, techniques, and methodologies.

Over the course of history, hypotheses and theories have been abandoned when the results or conclusions were later found to be based on falsified data, faulty methodology, or were not reproducible by other researchers. Often, this process takes years, particularly when findings quickly congeal into consensus – as was the case with the purported link between vaccines and autism (indeed, vaccine-induced autism is the poster child for debunked theories).

But COVID “science” is being reversed – and reversed again – at a dizzying pace. At the center of these flip flops is none other than Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, member of the White House Coronavirus Task Force and avowed Hydroxychloroquine Hater.

With the notable exception of hydroxychloroquine (HCQ), Fauci has, um… adjusted all of his talking points. He’s been on every side of every important question about containment, mitigation, and treatment of COVID-19 – and he’s not alone.

That Was Then, This Is Now: Face Masks

March 2: U.S. Surgeon General Jerome Adams warned that wearing face masks could increase risk of contracting COVID-19, and advised non-healthcare workers to “stop buying masks.”

April 1: In an article published in The New England Journal of Medicine (NEJM), a group of Harvard public health experts wrote: “Wearing a mask outside health care facilities offers little, if any, protection from infection. Public health authorities define a significant exposure to COVID-19 as face-to-face contact within 6 feet with a patient with symptomatic COVID-19 that is sustained for at least a few minutes (and some say more than 10 minutes or even 30 minutes). The chance of catching COVID-19 from a passing interaction in a public space is therefore minimal. In many cases, the desire for widespread masking is a reflexive reaction to anxiety over the pandemic.”

April 3: Centers for Disease Control and Prevention (CDC) recommended that healthy people – who may be asymptomatic or “pre-symptomatic” – wear cloth face coverings in public settings like groceries and drug stores where maintaining six-feet social distancing is not possible. The purpose of wearing a mask was to protect asymptomatic transmission to vulnerable populations like the elderly, particularly in communities experiencing significant outbreaks.

April 5: Asked by a reporter during the then-daily White House Coronavirus Task Force briefing why he was not wearing a face mask, Fauci offered the opposite explanation as the CDC’s about the value of being masked: “The major reason to wear a face mask, is to protect you from infecting you,” adding that he had tested negative for COVID-19 the day before.

April 6: Surgeon General Adams had changed his mind, and was demonstrating how to make cloth masks.

May 27: Fauci reversed himself, telling CNN’s Jim Sciutto he wears a mask in public “because I believe it is effective. . . . I do it when I am in public for the reason that I want to protect myself and protect others, and also because I want to make it be a symbol for people to see that that’s the kind of thing you should be doing.”

May 28: Since the onset of the pandemic, the World Health Organization (WHO) advised against healthy people wearing face masks, and reiterated its recommendation that people without COVID-19 symptoms need to wear a mask only when caring for someone who has contracted the virus. Those who are coughing or sneezing should also wear a mask.

That Was Then, This Is Now: Stay Home, Save Lives

March 15: A group of 22 public health professionals published an open letter in USA Today recommending steps to mitigate COVID-19 spread to ensure adequate hospital capacity to care for stricken patients, that included the advice to “STAY AT HOME as much as possible. . . . even if you have no symptoms. That means avoiding playdates, sleepovers, bars, restaurants, parties or houses of worship. Avoid all crowds.”

May 19: A group of 600 physicians sent a letter to President Trump calling state lockdowns that have kept businesses closed and kids home from school a “mass casualty incident” with “exponentially growing health consequences” and urging him to reopen the country.

May 20: An Italian study contradicted conventional wisdom that keeping elders socially isolated from their families has a protective effect against contracting and dying from COVID-19.

May 21: The head of trauma at John Muir Medical Center in Walnut Creek implored California Governor Gavin Newsom (D) to end his lockdown orders because “we’ve seen a year’s worth of suicide attempts in the last four weeks.”

May 22: A J.P. Morgan strategist published a report concluding that “flawed scientific papers” panicked governments into imposing “inefficient or late” lockdowns administered with “little consideration that they might not only cause economic devastation but potentially more deaths than COVID-19 itself . . . the fact that re-opening did not change the course of the pandemic is consistent with studies showing that initiation of full lockdowns did not alter the course of the pandemic either.”

The same day, Fauci changed his mind about the lockdowns in an interview with CNBC’s Meg Tirrell: “We can’t stay locked down for such a considerable period of time that you might do irreparable damage and have unintended consequences, including consequences for health.”

May 26: A month after reopening gyms, hair and nail salons, and parks, Georgia hasn’t seen the spike in new COVID-19 cases public health experts warned about. The same is true in Florida after the state began easing lockdown restrictions on May 4 – as well as in Arizona, Colorado, and other states.

May 30: Dr. John Carlo, former medical director of Dallas County’s health department, told The Dallas Morning News that looters, rioters, and arsonists laying waste to entire neighborhoods nationwide are less at risk of contracting or passing on COVID-19 than people attending an indoor gathering (like a church service, maybe?).

That Was Then, This Is Now: Surface Contamination

March 17: A study published in NEJM suggested that COVID-19 can remain infectious on surfaces for hours to days under consistent laboratory conditions (room temperature, 65 percent humidity). For instance, coronavirus was viable on cardboard for up to 24 hours, and on plastic and stainless steel for up to 72 hours.

March 26: CDC notes, “Current evidence suggests that [COVID-19] may remain viable for hours to days on surfaces made from a variety of materials. Cleaning of visibly dirty surfaces followed by disinfection is a best practice measure for prevention of COVID-19 and other viral respiratory illnesses in households and community settings.”

May 22: CDC updates its guidance: “It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes. This is not thought to be the main way the virus spreads, but we are still learning more about how this virus spreads.”

That Was Then, This Is Now: HCQ

March 28: Food and Drug Administration (FDA) issued an emergency use authorization (EUA) allowing HCQ and chloroquine (CQ) to be used to treat certain patients hospitalized with COVID-19.

April 24: FDA warned that HCQ and CQ, alone or combined with azithromycin, are associated with heart rhythm problems and issued a warning that they should be “limited to clinical trial settings or for treating certain hospitalized [COVID-19] patients under the EUA.

April 27: The Arizona chapter of the Association of American Physicians and Surgeons sent a letter to Governor Doug Ducey asking him to rescind his executive order forbidding prophylactic use of CQ or HCQ based on “clear and convincing evidence of benefit both pre-exposure and post-exposure.” A press release announcing the letter states that studies show the drugs can “decrease the number of days when a patient is contagious, reduce the need for ventilators, and shorten the time to clinical recovery.”

May 19: After President Trump divulged that he had begun taking HCQ prophylactically after his butler tested positive for coronavirus, FDA Commissioner Stephen Hahn said, “The decision to take any drug is ultimately a decision between a patient and their doctor.” By the way, on May 26, El Salvador President Nayib Bukele said he also uses HCQ prophylactically, and that “most” world leaders do as well.

May 22: The Lancet published a retrospective observational study that found no therapeutic benefit associated with HCQ or CQ, and increased risks of ventricular arrhythmias and in-hospital death with COVID-19.” As a result, WHO suspended its clinical trial of HCQ on May 27.

May 30: More than 160 clinicians, medical researchers, statisticians, and ethicists worldwide signed an open letter addressed to The Lancet pointing to serious problems with the study design and data sets underlying the findings. “In the interests of transparency” they requested the pre-publication peer review comments on the manuscript be made public.

That Was Then, This Is Now: Second Wave

April 29: During a White House Coronavirus Task Force presser, Fauci said a second wave of coronavirus in the United States is “inevitable,” and that if states ease lockdown restrictions too soon new infection rates could skyrocket and deaths could outpace projections.

May 27: Fauci said, “I want people to really appreciate that [a second wave] could happen, but it is not inevitable. If we do the kinds of things that we’re putting in place now, to have the workforce, the system, and the will to do the kinds of things that are the clear and effective identification, isolation and contact tracing, we can prevent this second wave that we’re talking about.”

That Was Then, This Is Now: COVID Antibodies

April 14: David Walt, professor of pathology at Harvard Medical School, told Bloomberg News, “There is no proof at this point that the development of an antibody response will be protective. There is no evidence yet that people can’t be re-infected with the virus.”

April 24: WHO issued a statement warning that “There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”

April 25: WHO walked back its April 24 statement: “We expect that most people who are infected with #COVID-19 will develop an antibody response that will provide some level of protection.”

April 29: A study published in Nature Medicine found that people who recovered from COVID-19 developed antibodies against re-infection within two to three weeks of the onset of symptoms.

May 12: Asked by Senator Rand Paul (R-Ky.) during a Senate hearing whether recovering from coronavirus confers immunity to re-infection, Fauci said, “[W]hen you have antibodies present it very likely indicates a degree of protection . . . but natural history studies over a period of months to years will then definitively tell you if that’s the case.”

That Was Then, This Is Now: When a Vaccine Will be Available

March 3: Fauci pooh-poohed the idea of speeding up development of a vaccine against COVID-19: “The whole process is going to take a year, a year and a half, at least.”

May 18: Biotechnology firm Moderna released preliminary phase-one clinical trial data showing its COVID-19 vaccine was safe and produced protective antibodies in eight healthy volunteers ages 18 to 55 years old.

May 22: Fauci told NPR, “I think it is conceivable . . . that we could have a vaccine that we could be beginning to deploy at the end of this calendar year, December 2020, or into January 2021.”

May 27: Fauci predicted on CNN that “We have a good chance—if all the things fall in the right place—that we might have a vaccine that would be deployable by the end of the year, by November-December.”

May 29: Moderna’s vaccine enters phase-two clinical trials. Roughly 600 participants in eight states were recruited, half of them between 18 and 55 years old and half older than 55. They will be tracked for 12 months after receiving either a placebo or two doses of the vaccine 28 days apart.

Scientists are still trying to figure out this never-before-seen virus, so we should cut them some slack. Unfortunately, public health officials seize on each study finding to refute or validate policy and guidelines that they seem to be making up as they go along.

Not to be outdone, politicians are spewing contradictory and seemingly capricious edicts issued in the name of “science.” For instance, Mayor Eric Garcetti told Los Angeles beachgoers that it’s “safe” to be on wet sand but not on dry sand, whereas New York City Mayor Bill De Blasio said the opposite and threatened to have police forcibly remove people from the water.

Americans are understandably starting to question the judgment of public health officials and elected officials, and losing patience with nonsensical prohibitions on planting a garden, getting a mammogram, and joining their congregation in worship.

Thousands of people around the country are taking to the streets to demand that their states reopen schools, small businesses, and workplaces. Some intrepid business owners whose communities are not coronavirus hot spots are also defying lockdown orders – even at the risk of license suspension or being jailed.

The science is “evolving,” and the demands of Americans to resume their lives are as science-based – if not more so – as the prohibitions, they are seeking to have rescinded.

This article has been republished with permission from American Greatness.

[Image Credit: Flickr-NIAID, CC BY 2.0]

Russia, the US and the Covid-19 vaccine free-for-all

Opinion by Dr. Kent Sepkowitz - CNN — Mon, 20 Jul 2020 06:53:37 +0000

Editor’s Note: Kent Sepkowitz is a CNN medical analyst and a physician and infection control expert at Memorial Sloan Kettering Cancer Center in New York. The views expressed in this commentary are his own. View more opinion at CNN.

(CNN) Last Thursday, security officials from three countries told us that Russian hackers were targeting organizations involved in Covid-19 vaccine research in the United States, Canada, and the United Kingdom.

At first glance, this seems like an old school Cold War story with everyone other than James Bond involved. All of the familiar elements are present: a shady group of Russians called APT29, which also goes by the name “Cozy Bear” — the same group accused of hacking the Democratic National Committee in the run-up to the 2016 presidential election — and a stout denial of wrongdoing from Kirill Dmitriev, who leads the Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund, which has invested in at least one company developing a vaccine. “Accusations … regarding hacking attacks against western pharmaceutical companies are an attempt to tarnish the Russian coronavirus vaccine,” he said.

Dmitriev, who was educated at Stanford and Harvard Business School, further pressed Russia’s innocence by announcing Friday that AstraZeneca, the UK-based pharmaceutical company that is working on “the Oxford vaccine,” has agreed to allow production in Russia by a company supported by the RDIF. Despite the deal, Dmitriev said he believed the Russian vaccine was superior, so much so that he and his septuagenarian parents have already received a dose.

Still, Dmitriev insists this is a story of countries needing to “pick sides” regarding which vaccine to buy and distribute to its citizens. In his view, this is a superpower race to the top that features the US, China, the UK, and, of course, Russia, as the contestants.

This approach to market dominance echoes President Donald Trump’s reported March offer of “large sums of money” to a German company to get first and only dibs on their candidate vaccine. Or his more recent swoop and run of almost all available remdesivir – keeping the only drug that has an emergency use authorization from the US Food and Drug Administration to treat Covid-19 largely in America’s hands.

But Dmitriev’s bullying “pick sides” directive and Trump’s “buy it up” approach arise from the wrong set of assumptions. As strangely comforting, or at least familiar, as the superpowers-seeking-world-dominance story might be, it does not fit with the reality about medical discovery. Medical advances have saved countless lives, earned billions of dollars of profit, and made dozens of scientists world famous. But unlike the arms race or the race to space, where there were just two belligerents with deep pockets and an urge for world control, in the medical domain countless other companies, countries, and international consortia are in every race. And they all can and will beg, borrow, and steal from each other.

There were no competing commercial companies looking for a piece of the action when the atomic bomb was built or when Mercury One was launched into space. But in the medical world, there are. Lots of them.

Consider a drug like the antidepressant Prozac (fluoxetine), introduced in the 1980s and one of the first billion-dollar medications. It was the only available drug in its class for a few years but then the market caught up to it and spawned similar compounds. Then the generics started grabbing a piece of the pie. Same story for the statins. And antibiotics. And sleeping pills. And heartburn medicine. Yes, the first one to the approval gets the first billion but soon after that everyone else gets into the action.

Of course, the extreme urgency to get a vaccine up and into millions of people as soon as possible changes the story somewhat. But as of July 15, we have 23 vaccine products that are being tested in humans and another 140 in various stages of pre-clinical development, according to the World Health Organization.

Given the public health crisis at hand, the need to make political hay, and our chronically imbalanced perception of risk and benefit, many of these products are likely to be approved or at least given FDA Emergency Use Authorization. Plus Russia and some other countries have a less strict system for regulatory approval. According to Dmitriev, the Russian vaccine will move from a Phase 1-like study (small and focused on safety) to delivery to the general population in just a few months — an unheard-of pace in the West. This beat ’em to the punch approach overlooks the long history with other medications used in desperate situations, especially cancer, when borders become quite porous and what is approved in one country quickly finds its way to the next.

These unique conditions likely will lead to multiple vaccine products becoming available one way or another. Determining efficacy will be difficult and subject to squabbles among experts but — if we are lucky — the first generation of COVID-19 vaccines will be 50% to 60% effective, similar to the influenza shots on a good-match year. And the side effect profile hopefully will be favorable, though in the recent Moderna product, which is entering a large definitive Phase 3 shortly, 21% of patients at the most potent dose had one or more “severe adverse events,” including severe fatigue, headache, and chills.

That does not even consider the questions about second vaccination and sorting out whether it is safe or advisable to vaccinate with one product now (maybe the Oxford?) then another later (hmm, I would like to try the Moderna, thank you) in hopes of bigger and better immunity.

I suspect we are about to enter a vaccine free-for-all with preferences based on extremely sparse information. Indeed, the recent “debate” over the efficacy of hydroxychloroquine in the treatment of COVID-19 will pale in comparison to the data-lite, opinion-heavy give-me-that-one-now “national discussion” we are about to enter into.

It’s unclear what, if any, information was collected from the putative Russian hack. Given the inevitable confusion ahead, getting to the head of the line just does not make sense as an explanation, at least from a financial windfall perspective or a saving lives perspective. But the need to dominate voiced both by Trump and the leader of Russian vaccine efforts, Dmitriev, makes the likely reason for any sneak attack all too clear. It’s less about saving the world with a vaccine than about beating the other guy and taking home the first-place medal.

Source: https://www.cnn.com/2020/07/19/opinions/vaccine-covid-19-russia-hack-us-sepkowitz/index.html

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Fauci’s Flip Flops