Five months ago, I wrote about an old drug that showed great promise as treatment for Covid-19 (Fluvoxamine – Maybe the Perfect Covid Drug?) Today, it looks like fluvoxamine is just another drug embattled by the politics of the Biden Administration.

It seems that the Food and Drug Administration (FDA) does things differently when evaluating old drugs than they do for new ones. Allysia Finley, writing in The Wall Street Journal, says that applications for new uses of generic drugs are reviewed under different standards that those for novel treatments. For that reason, the FDA rejected a Covid emergency use authorization (EUA) application by doctors for use of the antidepressant fluvoxamine.

This has happened before. Hydroxychloroquine and ivermectin are two anti-parasitic drugs that appeared to be beneficial in the treatment of Covid early in the pandemic. David Boulware, an infectious disease specialist at the University of Minnesota, helped lead four of the trials of these drugs.

In December, Dr. Boulware and several colleagues submitted an EUA application for fluvoxamine to treat non-hospitalized adult Covid patients. Three trials have shown the drug, typically prescribed for obsessive-compulsive and mood disorders, could prevent patients from becoming sicker, potentially because of its anti-inflammatory properties. One large randomized controlled trial (the best type of research) in Brazil found that fluvoxamine reduced the risk of hospitalization or emergency care by 32 percent. Those who stuck to the treatment regimen were 66% less likely to be hospitalized and 91% less likely to die. These findings were first published in the British medical journal Lancet in October.

There’s more good news. A smaller trial in fall 2020 found that none of the 80 patients given fluvoxamine got worse compared with six of the 72 who received a placebo – and four of those were hospitalized. Moreover, it was found that at the Golden Gate Fields horse-racing track in Berkeley, California, none of the 65 workers who took the drug were hospitalized or had symptoms 14 days later. However, six of the 48 who didn’t were hospitalized, and more than half had lingering symptoms.

In my earlier post, I described the perfect Covid treatment would have the following characteristics:

• Effective in reducing hospitalizations and death
• Oral treatment available at home
• Proven safety record over many years
• Readily available
• Low cost

Fluvoxamine checks all of these boxes.

 

The FDA has issued many EUAs for new Covid treatments based on less evidence. The Merck-Ridgeback Biotherapeutics’ antiviral molnupiravir was authorized after a single trial found it reduced hospitalization among high-risk patients by 31% and death by 89%. The FDA authorized Eli Lilly’s monoclonal antibody bebtelovimabafter a small study found it reduced viral load in a greater share of patients on the seventh day of treatment. Yet the drug wasn’t found to reduce hospitalizations or death compared to placebo.

What accounts for this disparity of approvals?

Dr. Boulware assailed the agency’s “inconsistent logic” and its use of “different definitions for ‘hospitalization’ for big pharma vs. low-cost generic drugs.” He also criticized the FDA’s lack of clear guidance and expectations when dealing with medical researchers, which contrasts with its constructive working relationship with drugmakers.

Ms. Finley says some conservatives accuse regulators of trying to protect drugmaker profits by limiting access to repurposed generics, but there’s no evidence of that. The FDA in recent years has approved record numbers of generics, mostly while under the leadership of Dr. Scott Gottlieb, FDA commissioner during the Trump Administration. But there is new leadership in the White House and in the FDA.  It’s hard not to believe there might be some influence of Big Pharma in the approval process of inexpensive, repurposed generic drugs.

Ms. Finley does say this: “But by applying inconsistent regulatory standards and rejecting fluvoxamine despite its demonstrated benefits, the FDA may engender more political cynicism that undermines support for pharmaceutical innovations such as Covid vaccines.”

What distinguishes our country from authoritarian governments in China, Russia, Iran, Cuba and North Korea? There are several answers to this question including free speech, due process under the law, freedom of assembly, and others. But perhaps the most important is freedom of the press.

However, freedom of the press comes with an implied responsibility – to report the truth without bias. Only then can our democracy function properly. Sadly, the media is letting us down, and our democracy and our freedom are at stake.

By now, nearly everyone acknowledges the fact that our media has become bias toward the left. This undeniable fact was perhaps first acknowledged by long-time CBS News correspondent Bernard Goldberg in his 2001 book, Bias – A CBS Insider Exposes How the Media Distort the News. Goldberg explained that this bias was often unintentional, but nevertheless real. Many journalists on the left are so surrounded by others like them that they cannot recognize their bias.

But this bias that may have begun unintentionally, has now progressed to undeniable reporting of misinformation, or the stifling of the truth, in the pursuit of a political agenda. Perhaps the most recent and undeniable demonstration of this change was in the months leading up to the 2020 presidential election. Many of the media on the left determined it was their job to do everything possible to rid the country of President Donald Trump – even if it meant disseminating harmful, often dangerous misinformation about the Covid-19 pandemic.

Dr. Scott W. Atlas, Stanford University Medical School Professor and Hoover Institute fellow recalls the vicious media treatment he received during his brief tenure as a presidential advisor to President Trump on the pandemic response in the months leading up to the election of 2020 in his new book, A Plague on Our House – My Fight at the Trump White House to Stop Covid from Destroying America. In my last post, I discussed six myths that were widely promoted by the media during the early days of the pandemic, despite scientific evidence to the contrary. (see Covid Pandemic Myths) Today, I want to further address this issue of media bias and how their promotion of misinformation contributed to prolonging the pandemic and causing needless harm and deaths.

Dr. Atlas begins, “I arrived in Washington in the middle of a crisis, in a heavily polarized nation burdened by fear, encountering a hostile media inflamed during an election year. I learned quickly, abruptly, what was meant by a “Washington Welcome.” Once I was unveiled as an advisor to President Trump, my eyes were opened by the realization that even in this once-in-a -lifetime crisis, the dissemination of truth is not the priority of American media.”

This bias is not confined to the legacy media – newspapers and television – but also pervades social media platforms and even publishers, which are controlled by Big Tech. Dr. Atlas says, “But it was not just the content of the media; it was the way it was delivered that influenced the public.  Nowadays, misleading stories are easier to invent and quicker to amplify on both platforms.” He says the American media proved to be a uniquely unreliable purveyor of information. American media stood out in editorializing the pandemic, worse than all other English-language news sources.

To prove his point, Dr. Atlas says more than nine million articles had been published from January 31 through July 31, 2020. Here are some frightening statistics about the media’s performance during that time:

• America’s reporting was alone in virtually always being negative – nine of ten stories by all of America’s major media outlets were negative in tone. Fox News articles were as negative as those from CNN. But outside the U.S., the major news stories were negative only half the time.
• On the vaccine – the most important hope of almost everyone – America’s major media were particularly negative. Vaccine stories in the U.S. major media were 45 percentage points more likely to be negative than vaccine stories in the non-U.S. media.
• American media intentionally omitted or delayed reporting positive news.
  • Even when new Covid cases were declining in the U.S., articles describing increasing cases outnumbered stories of decreasing cases by a factor of more than five to one.
  • Work on a vaccine was reported on February 18, 2020, by the UK’s news, but Fox News, CNN, the New York Times, and the Washington Post did not begin any coverage of Professor Gilbert’s Covid-19 vaccine until late April.
  • The earliest available report about a vaccine development in the U.S. major media, dated April 23, began with England’s chief medical officer, Chris Whitty, saying that the probability of having a vaccine “anytime in the next calendar year” is “incredibly small.” (The vaccine was announced just six months later and was being given to Americans in December, 2020.)
• America’s media created a frightening, false narrative about schools with biased news. While the world’s data was overwhelmingly positive about schools reopening, 90 percent of school reopening articles from U.S. mainstream media were negative; only half (56%) were negative in other countries. (Europe’s schools were widely opened for fall 2020, whereas only 18 percent of U.S. schools were in-person and 60 percent were virtual-only.)

 

What accounts for these differences? Did the coming presidential election impact the results? There can be little doubt it did as the media sought to do everything in their power to rid the country of President Trump. That meant demonizing Dr. Atlas once he was associated with President Trump, regardless of the scientific basis for his policy conclusions. This attack upon him was not limited to the legacy media, but was strongly supported by Big Tech, including Twitter, YouTube, and Facebook.

In August, Facebook told the Washington Post they had taken down seven million posts “for spreading coronavirus misinformation.” Atlas gives three other examples of Big Tech censorship:

• On September 11, YouTube pulled down an interview recorded three months before on June 23 in which he discussed the safety of school reopening and the extremely low risk for children from Covid-19, including the low risk of transmission from children to adults.
• On October 18, Twitter blocked his account. He had posted a multipart tweet the day before questioning the efficacy of masks, listing cities and states where cases surged despite masking and quoting authoritative data, including CDC, WHO, and Oxford.
• On March 18, 2021, Florida Governor DeSantis assembled an expert panel to discuss the pandemic. The panel included Atlas, Martin Kulldorff of Harvard, Jay Bhattacharya of Stanford, and Sunetra Gupta of Oxford. Despite the world-renowned expertise of these four doctors and scientists, YouTube took down the interview when their views contradicted the views of the White House Corona Virus Task Force. They cited this as “medical misinformation.”

 

I have personally experienced censorship by Facebook and Amazon. In September, 2020, when my own book, Changing Healthcare, contained material about the Covid pandemic, it was rejected by the publishers at Amazon until that material was removed. When Facebook considered some of my blog posts as too controversial, they were taken down.

We live in dangerous times when the free exchange of ideas is no longer free. This is especially frightening when those ideas concern our healthcare. Science is never settled – it is crucial there exist an atmosphere of open discussion among scientists and the community to allow for the full expression of points of view that will lead to the most accurate conclusions. Our future health depends on it. When the media interrupts this free exchange of ideas, we are no better off than those who live in the authoritarian countries of this world.

 

 

It has now been nearly two and a half years since the world became aware of a new coronavirus, which was subsequently named SARSCoV-2 or Covid-19. While very little was known about this novel virus in January, 2020, we know a lot about it now.

Along the way, there has been a lot of misinformation disseminated by public health officials and the media, much of it for political gain. Unfortunately, this virus was first discovered in an election year and many of the sources of this misinformation were influenced by their displeasure with the Trump administration. They let their political bias affect their judgment and the country has suffered greatly as a result.

Scott W. Atlas, M.D. is a Stanford University Medical School professor and Hoover Institute fellow who was hired by the Trump Administration in July 2020 to advise the president on the Covid pandemic. This Washington outsider, with no political agenda, was forced to deal with the already entrenched White House Corona Virus Task Force and its bureaucratic physicians, Dr. Deborah Birx, Dr. Anthony Fauci, and Dr. Robert Redfield.

His recently published book, A Plague Upon Our House, describes the frustration he experienced trying to bring scientific analysis to the Task Force. He relates his futile attempts to steer that ship away from the destructive course they had chosen with lockdowns, school and business closures, and testing of low-risk youth while not sufficiently protecting those at high risk in senior living facilities. Though he had the support of President Trump and others, he was unable to sway the locked-in policies of the other medical members of the team, especially Task Force Coordinator, Dr. Birx.\

In his book, Dr. Atlas presents the scientific evidence that answers key questions about the pandemic and refutes several myths about Covid-19 that have been widely disseminated.

Myth #1 – Mathematical models are reliable indicators of future pandemic spread.

Early in the crisis, many researchers around the world used mathematical models to predict how the pandemic would spread. Most egregious were the predictions of the Imperial College of Neil Ferguson and colleagues. For Sweden, they predicted 30,434 deaths if lockdowns were implemented, and 66,393 deaths if left unmitigated. After a full year of ignoring Ferguson’s strategy, as of March, 2021, Sweden had a total of 13,496 deaths.

Oxford University’s Professor Sunetra Gupta, one of the world’s most renowned epidemiologists and modelers, authored a 2001 piece in Nature subtitled “Scientists sometimes use mathematics to give the illusion of certainty.” In this article she warned of the dangers of relying on mathematical models. Her prescient warning, however, was not heeded and many grossly inaccurate predictions came out of these models. Dr. Birx frequently used these models to justify her pandemic policies, often inaccurately believing her policies were working if the actual numbers were lower than the model predictions.

Myth #2 – The risk of death from Covid-19 to children was the same as adults.

This myth was discredited many times early in the pandemic, but the media continued to promote this misinformation. The actual data as early as April 2020 showed the rate of death for people under eighteen was zero per 100,000. In New York City in the 2020 summer, 99.94 percent of deaths occurred in people over eighteen; only one child without underlying conditions died, comprising 0.005 percent of 18,988 deaths. CDC later calculated those under twenty to have a 99.997 percent chance of survival.

Myth #3 – Children often transmitted asymptomatic disease to adults.

This myth was often used as an excuse for closing schools – mostly by the teachers’ unions. They claimed it was not safe for teachers to go back to classrooms for fear of contracting Covid-19 from the children. While children are often transmitters of influenza, the same is not true of Covid-19. An early contract tracing study in Iceland, published in April 2020 in The New England Journal of Medicine, stated, “We have not found a single instance of a child infecting parents.”

A Swiss study found that school was the source of only 0.3 percent of infections. Sweden kept its schools open throughout their pandemic surge, without mask-wearing or social-distancing mandates. They experienced an extremely low incidence of significant Covid-19 and zero deaths in nearly 2 million school children ages one to sixteen. Sweden’s teachers showed no increase in age-adjusted risk of severe Covid-19. The European Centre for Disease Prevention reported a seventeen-country study and concluded that “Open schools were not associated with accelerating community transmission.”

The media widely disseminated the news of a surge in Israel’s cases after reopening of schools. This report was later discredited, but the media never publicized the correction. The same thing happened in South Korea, but again was discredited. The corrected analysis showed no evidence of a child passing the infection to an adult, but this was not widely reported.

Myth #4 – School closures were necessary to protect children.

As we have already discussed, children were at extremely low risk for serious infection with Covid, much less than seasonal influenza. Yet the harms of closing schools are still being calculated.  They include poor learning, dropouts, social isolation, suicidal ideation, mental health illness and drug abuse, and parental child abuse.  Since schools are the primary source of discovering child abuse, the number of missed cases of abuse skyrocketed with the closure of schools. In just two months of school closures in March and April of 2020, a Florida study estimated that approximately 15,000 child abuse cases went unreported, or 27 percent fewer than expected. The authors admitted their numbers were “likely underestimated.”

School closures were especially harmful to children in lower-income and less-educated households. Researchers associated with the Centre for Economic Policy Research summarized last fall that “school and childcare closures have significant negative long-term consequences on the human capital and welfare of the affected children, especially those from disadvantaged socio-economic backgrounds.”

Dr. Atlas says, “The policy of reopening in-person schools has been supported by the data, time after time, for more than a full year. And the United States stands out, in abject shame even among our peer nations since the fall of 2020, uniquely willing to sacrifice its children out of fear for adults.”

Myth #5 – Wearing masks is an effective deterrent to the spread of Covid-19.

A quick look back at the public-health officials’ advice about masks should be revealing. Masks were first deemed ineffective and unnecessary by Dr. Fauci, and also Surgeon General Jerome Adams. Then shortly later they became indispensable. You don’t have to be a doctor to realize that’s counterintuitive. Doctors wear masks in surgery largely to prevent their own aerosols from contaminating the patient. They do not wear them to protect themselves from the patient, except in cases of HIV when blood spatter could harm the surgeon.

Covid-19 is spread by aerosols. Even Dr. Fauci was discovered to say to a colleague, “The typical mask you buy in the drug store is not really effective in keeping out a virus, which is small enough to pass through the material. It might, however, provide some slight benefit in keeping out gross droplets if someone coughs or sneezes on you.” The Covid-19 virus is about 0.12 microns in size, similar to influenza and far smaller than the pore size in surgical masks. Dr. Atlas says, “It should not be necessary to explain how absurd it was to even consider that a scarf or bandana would stop the virus.” Perhaps the most absurd statement ever to come out of the Task Force was from Dr. Redfield who testified to Congress that, “If every one of us wore a mask, this pandemic would be over in eight to twelve weeks.”

Myth #6 – Lockdowns are effective to slow the spread of the virus.

An initial period of “fifteen days to slow the spread” seemed justified to prevent hospitals from being overwhelmed. But this quickly became a policy of long-term lockdowns, largely under the recommendations of Task Force Coordinator, Dr. Birx. This misguided policy decision has had numerous harmful consequences:

• Half of the 650,000 cancer patients skipped chemotherapy during the first months of the lockdowns.
• Forty percent of stroke patients and half of heart attack patients were so afraid they did not call an ambulance; in March-April 2020, New York City alone had a 400 percent increase in deaths from non-Covid heart disease.
• Organ transplants from living donors were down 85 percent from the same period the last year.
• Two thirds to over 80 percent of cancer screenings were skipped in the first three months, including 70 percent of colonoscopies and 67 percent of mammograms. Over nine months, 750,000 to over 1,000,000 new U.S. cancer cases went undetected.
• Over the next fifteen years, the unemployment “shock” alone, according to a NBER study, will generate an increased death rate and reduced life expectancy disproportionately affecting African-Americans and women. That computes into a staggering 890,000 extra American deaths – from the lockdowns, not the virus.

 

These staggering numbers might almost seem justified if the lockdowns were effective. But the overwhelming evidence is to the contrary. Perhaps the best comparison is between the states of California and Florida. California was quick to institute lockdowns and among the slowest to remove them. Florida, in contrast, was among the first to remove lockdowns and open businesses and schools. Despite the fact that Florida’s population is much older, and therefore more vulnerable to Covid, Florida outshined California in nearly every measurable demographic.

• Florida did better than California in protecting its citizens from dying.
  • The overall age-adjusted per-capita Covid mortality rate in Florida is 118/100,000 while California’s is 168/100,000.
• Florida did better at protecting its minorities
  • Hispanics and blacks died at higher rates than whites in California; both at lower rates in Florida than whites
• Florida did better at protecting jobs for lower-income people.
  • Employment for low-wage earners in California was down 38.3 percent, but up by 0.4 percent in Florida.
• Florida outperformed the overall U.S. for Covid deaths per capita.
• Florida outperformed 25 individual lockdown states in Covid deaths per capita
• Florida outperformed – by 40 percent – the overall U.S. age-adjusted Covid mortality
• Florida ranks number one of the ten largest states in lowest excess mortality

Dr. Atlas summarizes: “Lockdowns did not stop the virus or save lives. Massive lives were lost because of the lockdowns. Focused protection was the safer and more ethical strategy.”