What Happened Today: May 19, 2022
Disinformation panel goes fishing; Biden flies in formula; FDA irrationality
The Big Story
The Disinformation Governance Board, a Department of Homeland Security panel created to expand the government’s regulatory power over social media platforms and public speech, has been “paused” following weeks of mockery and criticism, and will now be subject to a 75-day review focused on ways to improve public sentiment about its mission. The board was to be led by the controversial disinformation expert Nina Jankowicz, who had earlier helped perpetuate the false claim that reporting based on Hunter Biden’s laptop was Russian disinformation and had dismissed claims of anti-conservative bias on digital platforms while insisting that “often it’s liberal voices that are being silenced, particularly minority voices.” Prior to the pause announced this week, Jankowicz and the board had faced harsh criticism from both conservatives and civil libertarian groups including the American Civil Liberties Union. Though it was nominally designed to continue DHS’s efforts to combat online misinformation that began before the Biden administration—particularly misinformation used by human smugglers to coerce migrants over the U.S. border—the board’s mandate expanded that effort into something much broader: to coordinate the sprawling agencies under the DHS banner, as well as the Biden administration, in an attempt to mediate the online distribution of information about issues as varied as vaccines, election fraud, and Russian, Chinese, and Iranian disinformation campaigns. The board’s public rollout was a public relations disaster, with DHS Secretary Alejandro Mayorkas, in an appearance before legislators in early May, struggling to answer basic questions about its funding and intent and why the panel wasn’t disclosed to lawmakers before its public launch. Most of the criticism, however, was directed toward the board’s executive director, Jankowicz, whose own statements and appearances seemed to contradict DHS messaging about the extent to which the board sought to police public speech. In one video discussion this month, Jankowicz floated the idea of properly “verified” Twitter users being allowed to “edit” the comments of other users if they deemed their content misinformed. In comments to DHS Secretary Mayorkas, Utah Sen. Mitt Romney said the board was a “terrible idea,” adding that it tells the world the United States will be “spreading propaganda in our country.” Along with the DHS announcement of the suspension of the panel, Jankowicz resigned from her post, saying in a statement that the criticism of the panel was a “distraction from the Department’s vital work, and indeed, along with recent events globally and nationally, embodies why it is necessary.”
In The Back Pages: The FDA’s Illogical Dismissal of Fluvoxamine
The Rest
→ In response to the nationwide baby formula shortage, President Biden invoked the Defense Production Act on Wednesday, which empowers his administration to direct private companies to provide baby formula manufacturers with the ingredients they need to increase production. “The president is requiring suppliers to direct needed resources to infant formula manufacturers before any other customer who may have ordered that good,” the White House said. Biden also announced the start of Operation Fly Formula, which will use military commercial jets to airlift baby formula from overseas, bypassing a commercial supply chain snarled with delays and labor shortages. Some hours after Biden’s announcement, the House of Representatives passed a pair of bills that would provide the Food and Drug Administration with $28 million to ensure safety and adequate staffing at formula production plants; the second bill would expand the variety of formulas currently available to low-income women who receive government assistance. Both bills passed the House in a near party-line split, with almost all Republicans voting in opposition.
→ While the White House might be able to solve the formula puzzle by flying in some crates from Europe, the surging cost of fuel is a more complicated matter. With the national average for a gallon of gas inching over $4.50, President Biden is accelerating plans to meet with the crown prince of Saudi Arabia, Mohammed bin Salman, with a possible gathering happening as soon as June, according to a new report today from Bloomberg. The potential meeting in the Middle East is likely a direct result of Western demand for Saudi Arabia oil after fuel prices skyrocketed because of recent inflationary pressure and the major supply gap caused by a boycott of Russia crude oil exports. During his presidential campaign, Biden called the Saudi Arabian kingdom a “pariah” state and initially swore off diplomatic relations with the kingdom’s crown prince after releasing a report early in his administration that found Mohammed bin Salman was responsible for the murder and dismemberment of Jamal Khashoggi, a Washington Post columnist who was critical of Saudi Arabia, after his visit to Istanbul’s Saudi consulate in 2018. The release of the Khashoggi report was seen by some veteran Middle East observers as part of a deliberate effort to put the Saudis on the defensive as the United States pursued a broad new agreement with Saudi Arabia’s strategic rival, Iran.
→ Hong Kong officials are poised to limit access to Telegram, an encrypted cloud-based messaging system, raising fears that the city is beginning to borrow from the playbook used by mainland China’s ruling Communist Party government by censoring more messaging apps and social media sites. Hong Kong’s Office of the Privacy Commissioner for Personal Data, the authority that is initiating the move, has called such censorship necessary, citing concerns about widespread doxxing—or the publication of personal data—on the platform. Critics, however, claim that many of these messages and posts are not “doxxings” but in fact disclosures about the conflicts of interest and business entanglements of prominent public officials. If Telegram is reined in, this will be the largest such limitation put in place in the city since the 2020 Hong Kong National Security Law was passed by China’s Standing Committee of the National People’s Congress. That law, which China passed in the wake of widespread democratic protests, and without Hong Kong’s approval, allows for the prosecution of both any subversion against the Chinese government and any calls for Hong Kong to secede.
→ Shortly after Sweden and Finland submitted their joint application to join NATO on Wednesday, Turkey’s president, Recep Tayyip Erdogan, vowed to veto the bid, explaining that “NATO is a security alliance and we cannot accept terrorists to be in it.” At issue is the Kurdistan Workers’ Party (PKK) and their war against the Turkish state in ethnically Kurdish enclaves across the country. Turkey—along with the European Union and the United States—have not only labeled the PKK a terrorist organization but also been reticent to do anything about this alleged terrorist threat. Indeed, over the weekend Sweden was the host country for a gathering of the PKK’s senior leadership. Previous promises from NATO officials that these differences between Turkey and the Nordic NATO applicants would soon be resolved now appear to have been wishful thinking.
→ The vacancy rate on Manhattan apartments hovered around 1.5% in April, the second-lowest all-time level, reported Bloomberg, a dearth of available housing that’s affected apartment seekers citywide. Last month, Manhattan saw a little more than 4,700 apartment vacancies, a dramatic drop from the 20,740 apartments available at the same time last year, a supply crunch that has sent the median cost of rent soaring to $3,870. The affordable housing crisis in the city is thanks in no small part to the proliferation of short-term rentals available on Airbnb and VRBO, with at least 13,000 listings between them.
→ The British government will not adopt a key recommendation from the Grenfell Tower Inquiry, a judge-led committee created by Prime Minister Theresa May the day after a fire broke out in the Grenfell Tower in London in 2017 and killed 72 people. The inquiry was charged with investigating the causes of the fire and proposing policies that would prevent such tragedies in the future. One recommendation the inquiry offered was “that the owner and manager of every high-rise residential building be required by law to prepare personal emergency evacuation plans for all residents whose ability to self-evacuate may be compromised, either by age or because of a disability.” The government rejected this recommendation even though 15 of the 72 deaths caused by the Glenfell fire were of people who were physically unable to self-evacuate.
→ Amar’e Stoudemire, the six-time NBA All Star who recently joined the Nets as an assistant coach, has announced that he’ll be stepping down from the position because the work schedule is incompatible with Shabbat observance. “I spoke about me not being able to grow in a coaching space because I don’t work on Shabbat,” Stoudemire said in an interview this week. “And so not working on Friday night and Saturdays is difficult for anyone to grow in a coaching space because coaching is such a grind and requires you to be there full-time.” Stoudemire had played in the NBA for 14 years, during which time he became passionate about Judaism and began observing Shabbat, keeping kosher, and praying daily. After retiring from the league, Stoudemire went to Israel to study in a Yeshiva for two years before formally converting to Judaism. Now that he’s stepping down, he’ll be able to dedicate more time to studying Torah and to finding a nice Jewish girl. In an interview in December, he gave out his email address and said that anyone with a good shidduch, or “match,” should contact him.
→ The Scroll Caption Contest: At a speech yesterday in Dallas, George W. Bush put his foot in his mouth with a gaffe during comments about the Russian invasion of Ukraine. “The decision of one man to launch a wholly unjustified and brutal invasion of Iraq. I mean of Ukraine,” he said.
Check out the video below, and reply by email or in the comments with your best video caption. We’ll include the winner in an edition of next week’s Scroll.
Additional reporting provided by The Scroll’s associate editor, David Sugarman
The FDA’s Illogical Dismissal of Fluvoxamine
On Monday, the FDA denied an application for fluvoxamine, a common antidepressant, to receive an Emergency Use Authorization as a COVID-19 treatment. This designation, which has been given to various monoclonal antibodies and other drugs during the pandemic, would have given family doctors a greater sense of confidence and legitimacy in prescribing the drug. While all licensed physicians can prescribe any FDA-approved drug “off-label” at their discretion, in a litigious society in which COVID-19 treatments have become intensely politicized, having FDA backing can make doctors more comfortable with such a move.
Maybe the FDA made the right decision, or the wrong decision for the right reasons. But, in either case, the agency’s decision concerning a potential treatment for a disease that has killed more than 1 million people in the United States deserves more scrutiny—especially considering that approving fluvoxamine would potentially have taken sales away from other drugs produced by big pharma companies that are already available.
Fluvoxamine has been making headlines as a potential COVID-19 treatment since at least March 2021, but it was clear by late 2020 that the drug had potential. After a promising initial study conducted by researchers at Washington University of St. Louis, the drug displayed miraculous effect in a small case study out of California and then great effect in a randomized controlled trial published last October. Other subsequent studies have been less impressive.
The FDA, in its 27-page review of the evidence, said that the first two of these trials were too small to be convincing and that the third didn’t meet its criteria for approval, even though it showed clear benefit. Dr. David Boulware, the University of Minnesota professor who submitted the Emergency Use Authorization request, explained the issue on his Twitter account. “I’m disappointed that FDA holds generics to different standards as big pharma, in this case using different definition of endpoints of what is #COVID19 related ‘hospitalization,’” he wrote. The FDA also cites two subsequent trials that were halted for lack of efficacy. The question of fluvoxamine’s utility in outpatient treatment of COVID-19 is not settled, then, but a repeated pattern of benefit supports Dr. Boulware’s submission.
The issue might simply be that fluvoxamine is a direct market competitor of big pharma products currently being pushed as early treatment drugs for COVID-19, namely Pfizer’s Paxlovid, Gilead Sciences remdesivir, and Merck’s molnupiravir. Purely antiviral agents, these competitor drugs do not perform the same function as fluvoxamine (anti-inflammatory and anti-platelet) in fighting COVID-19, which means, theoretically, they could be used jointly with fluvoxamine. Moreover, for an antiviral to be effective, it has to be administered in the very early phase of illness, when the virus is replicating. But as an anti-inflammatory—COVID-19 is primarily an inflammatory illness—fluvoxamine continues to be useful as the disease progresses. And, notably ignored in the FDA’s rationale, fluvoxamine has a very specific anti-platelet aggregation effect, which is critical because coagulopathy is one of the most pernicious elements of COVID-19 when patients descend into severe illness.
While the big pharma options may not be able to help you after the first few days of symptoms, they sure are expensive. Paxlovid is about $530 per course of treatment, molnupiravir about $700, and remdesivir more than $3,000. A 10-day supply of fluvoxamine might cost you $40 without insurance.
Even more disturbing, Paxlovid seems to be priming patients for relapsing illness and has a bevy of drug-drug interactions. Molnupiravir is a mutagenic drug with an unknown long-term impact on male reproductive health, and remdesivir is extremely toxic to the kidneys.
While fluvoxamine is not without side effects, it is a decidedly safe drug, included on the WHO’s list of Essential Medicines. A 2006 study in the International Journal of Clinical Practice states that, “It is noteworthy … that fluvoxamine has a comparatively good profile in terms of adverse events. It has a particularly low impact on sexual function (this may therefore reduce patient non-compliance) and an excellent safety profile in the elderly.”
Could it be that conflicts of interest inside the FDA have privileged some drugs over others? Even when those drugs have serious potential downsides and less studies proving their efficacy? And what are the criteria, really, for getting a drug approved?
The mentality around a COVID-19 solution has been largely myopic. We’re always looking for a singular magic pill: hydroxychloroquine, ivermectin, monoclonal antibodies, Paxlovid, convalescent plasma, a vaccine. But the doctors who have been fighting COVID-19 on the front lines will tell you that combatting this illness should be patient specific and include a multipronged approach. Fluvoxamine may not be a magic pill, but with its high degree of safety, its multi-system effect on inflammation, platelets, and serotonin, and its accessible cost, many doctors were hoping the FDA would help them get it in the toolbox.
In 1991, at the height of the AIDS crisis, many sick patients were suffering from a secondary infection called cytomegalovirus, which caused them to go blind. The National Institutes of Health ran a tiny clinical trial of a drug called foscarnet (also toxic to the kidneys) in the hopes it might help prevent blindness in these patients. They only had 24 patients: 13 received treatment, 11 received nothing. But the drug worked. And the FDA, on the basis of that small trial, approved it for the treatment of that condition.
Yet 31 years later, while COVID-19 continues to ravage many of the most vulnerable people in our society, the FDA has taken a potentially helpful tool off the table.
Clayton Fox is a former Tablet fellow who has written for RealClearInvestigations, The American Conservative, Brownstone Institute, and Los Angeles Magazine. Find him on Twitter, @clayfoxwriter.
What Happened Today: May 19, 2022
There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of fluvoxamine for the treatment of COVID-19. https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/fluvoxamine/