Sunday, May 14, 2023

Wraps and Recaps


Vaccine news, new variants, long COVID, emergencies leave and summings-up arrive, origin stories and Chinese “research,” the 2023 Shkreli Awards, and an assortment of conspiracy theories.

 

Treatment

Patient on oxygen in hospital

Steroids in hospitalized patients: Doctors often prescribe corticosteroids such as dexamethasone to COVID-19 outpatients, under the theory that if steroids decrease mortality in severely ill hospitalized patients (as per the RECOVERY trial) then surely they’ll get patients with mild disease better faster. Nope! There’s even evidence that steroids might make outpatients worse. A new study goes further, finding that even hospitalized patients, unless they’re sick enough to need supplemental oxygen, are more, not less likely to die is they are given steroids. And a new RECOVERY trial analysis shows that higher than standard doses of dexamethasone also increase mortality.

Old drugs: I used to prescribe a cocktail of colchicine, fluvoxamine, and inhaled budesonide to at-risk adults with early COVID-19, but I stopped when fluvoxamine flunked a major trial. Now Brazilian researchers have tested a combination of the latter two medications and say it halves the rate of clinical deterioration. But since in my experience few people tolerate their dose of fluvoxamine, I’d stick with Paxlovid when indicated, or budesonide alone in patients who have respiratory symptoms but are ineligible for Paxlovid.

 

Vaccines etc.


Vaginal bleeding: Menstrual abnormalities have long been described as a side effect of COVID-19 vaccines, but only after reading a Washington Post article did I know how severe the bleeding could be. According to the systematic review that article cites, half of all vaccinated women experienced menstrual problems. But reading the original source I saw that those sky-high rates were largely based on a single large study that found a 42% rate of excess bleeding, and also claimed that two-thirds of menopausal women bled vaginally after being vaccinated. This was highly dubious on the face of it, since only a couple of the many hundreds of vaccinated older women I’ve known have told me they bled. Those results became even more dubious when I saw how vaguely the large study’s researchers described their methodology, as a “convenience sample” taking a web-based survey. That’s basically confessing their results are crap. The only study that has compared post-vaccination months with non-vaccination months, a Swedish analysis of 3 million women, found little association with either menstrual irregularities or post-menopausal bleeding (increases of 12-13%, barely reaching statistical significance).

First bivalents: Enough people had updated boosters early in the fall for some data to arrive on how long protection lasts. Researchers from North Carolina report that prevention of hospitalization or death peaked at 67.4% two weeks after vaccination, fell to 44.3% at 10 weeks, and hit 38.4% at 20 weeks. So bivalent boosters, like other boosters, probably last only 4-5 months. Protection against infection was minimal in this study, contradicting some earlier reports. And some other data exist saying that infection and vaccination each protect against severe disease for at least a year.

Second bivalents: FDA authorization for a second bivalent booster came through faster than predicted, in mid-April instead of May. As expected, you’re eligible you’re over 65 and had your other bivalent 4 months ago, or immunocompromised and had it 2 months ago. Repentant no-vaxxers can get a single dose as their primary vaccine course, though there’s no evidence that a single dose of the bivalent works, and excellent evidence that a single dose of monovalent vaccines doesn’t. Pregnant women will also be eligible, because pregnant women and small babies with COVID-19 are at such high risk for severe disease. The government is hinting they might try for a new bivalent booster aimed at post-BA.5 variants such as XBB, even though the BA.5-targetted bivalent seems to protect fairly well against them.

Sanofi-GSK: A manufacturers’ press releast claims it’s effective against Omicron. But that’s only the original Omicron variant, and perhaps BA.5. No news about the XBB subvariants that are now dominant in the UK, the US, and Europe.

NovavaxTwo doses are useless against Omicron, though a third dose offers some protection. Again, no XBB data.

COVAX: The ambitious initiative to vaccinate the global South has failed abjectly, discarding 200 million expired doses during 2022 and lowering its goals going forward. Only 25% of inhabitants of low-income countries are “fully vaccinated,” partly due to rampant vaccine hesitancy in Africa and Eastern Europe. One bit of good news, though: 76% of all human beings over age 60 (who account for 80% of COVID-19 deaths), have had at least a primary series. 

Idaho: In my last post I said some Idaho legislators were trying to make using mRNA vaccines “in an individual or any other mammal in this state” a misdemeanor. They’ve now softened the bill – but only by removing the reference to other mammals! It’s unlikely to become law.

BCG (bacille Calmette–GuĂ©rin): Countries that use the BCG tuberculosis vaccination once seemed to have lower rates of COVID-19. Nope. Two randomized trials testing BCG for COVID-19 prevention were already negative, and in a third, among front-line healthcare workers, not only was BCG not protective but a trend toward increased risk approached statistical significance. 

K-9’s: I thought COVID-19-sniffing dogs had gone the way of most cute ideas, i.e. down the drain. But now they’re trying them in California schools and finding decent accuracy despite distracting noises and scampering young kids, though few infections were detected given the low current prevalence. A proposal that could actually be useful: have dogs work the crowds in airports.

 

Variant watch


The “Kraken” Omicron subvariant, XBB.1.5 is now causing most new cases in the United States, the UK, Italy and the rest of Europe. XBB.1.16, “Arcturus,” (“Arturo” in Italy), spread so rapidly in India that some states reinstituted mask mandates, and already causes 12.5% of new cases in the US, though only now arriving in Europe. One typical Arcturus symptom is a nasty conjunctivitis (pinkeye). Then there’s “Acrux,” XBB.2.3, which similarly began in India but is spreading in Europe, and its younger siblings XBB.2.3.2 and XBB.1.9.1.  These variants are more and more transmissible, but people usually get less sick, both because Omicron strains are intrinsically milder and because most of us are protected from severe illness by vaccination and/or previous infections.

XBB.1.16 cannot be considered entirely benign, though, if 5 of the first 105 documented cases in the UK were fatal, hinting that Arcturus might be a particularly virulent type of Omicron.

 

Long COVID

The "magic mushrooms" that contain psilocybin


The “magic mushrooms” that contain psilocybin

TrippingTime magazine featured an article touting hallucinogenic drugs to cure long COVID. Mainly, it’s two case reports, one of a woman who microdoses on LSD and another woman who says a single trip on psilocybin worked miracles. Beyond that, there’s just a pilot study underway at Columbia University and a bill in Arizona that would allocate a million dollars to study psilocybin for conditions that include long COVID. Don’t expect magic.

Gut bugs: There’s always probiotics. A promising placebo-controlled trial in Hong Kong found that long COVID patients who took SIM01, a cocktail of 3 bifidobacteria, for 6 months, had fewer digestive symptoms, cognitive issues, and “general unwellness” than those on placebo. However: there’s no proper manuscript yes, and SIM01 is a proprietary mix not commercially available.

Causes: Malfunctioning monocytes (a kind of white blood cell) may be related to breathlessness, and immune abnormalities in the central nervous system to brain fog. Previous infections with other coronaviruses and sleep apneaare the latest risk factors reported.

Research: The National Institutes of Health have allocated and spent a billion dollars on the long COVID RECOVER initiative. Shockingly, STAT News says all they’ve done so far is watch how patients are doing over time and plan some clinical trials, without as of April 20th having administered treatments to a single patient. To boot, RECOVER is running out of money. This shocked and disgusted me, as it did Eric Topol and other prominent researchers. A headline in Scientific American reads, rightly, “We Need an Operation Warp Speed for Long COVID.”

Reinfection: Among 596 long COVID patients who experienced a repeat bout of COVID-19, 80% said it made their symptoms worse....

Masks: … making it even more shocking that Stanford University researchers enrolling long COVID patients in a Paxlovid study are not themselves wearing facemasks. Some patients have walked out in mid-session, saying this “calls into question the legitimacy of the entire study.”

Prevention: Last time I debunked the diabetes drug metformin as a long COVID preventive. The latest supposed magic wand is the antiviral molnupiravir. I remain skeptical. In a VA study, people who took molnupiravir early on, a small group because it is recommended only as a last resort, were 14% less likely to develop long COVID, not very impressive. A 38% reduction in deaths after the acute phase of illness is, on the contrary, extremely impressive. But I was confused to see that there were only 14% fewer post-acute hospitalizations, suggesting that most of those deaths happened at home, not in the hospital, where 60% of all US deaths occur.

 

The 2023 Shkreli Awards

Scott Charmoli at work


The Lown Institute has presented its 6th annual Shkreli Awards, the top ten worst examples of profiteering and dysfunction in healthcare, named for the infamous price-gouger and security fraudster Martin ShkreliHere’s this year’s countdown, which I think you’ll like seeing even though it’s COVID-free:

10)  Dentist bags a bundle by breaking patients’ teeth: How did Wisconsin dentist Scott Charmoli go from making 434 crowns a year to more than 1,000? By purposely breaking patients’ teeth, according to federal prosecutors. 

9)    “Dangerous” doctor deemed a star by leadership despite disgraceful malpractice record. Leaders of Catholic Medical Center in Manchester, NH knew cardiac surgeon Dr. Yvon Baribeau had one of the worst malpractice records in the country. Yet they continued to let Baribeau keep operating, and even featured him in hospital advertisements.

8)    Medical labs bilk Medicare for $300 million in elaborate bribery scheme: Three laboratories in North Texas allegedly bribed physicians to order unnecessary drug tests and blood work, so as to score extra Medicare reimbursements.

7)    Patients qualified for financial assistance; hospital sends them to debt collection instead: Nonprofit hospitals are required to provide financial assistance to low-income patients. Instead, Providence health system hounded them to pay and sent debt collectors after them when they didn’t.

6)    When smokers get sick, this tobacco company has the treatment: Philip Morris has spent 175 years selling products that cause heart and lung disease. Now it is poised to make more money treating the very conditions it helped create, by acquiring companies that develop inhaled therapeutics.

5)    Pharma giant exploits bankruptcy loophole to avoid legal responsibility for cancer-causing product: Johnson & Johnson had known for decades that asbestos, a deadly carcinogen, could be contaminating their talc baby powder products, but continued selling them anyway. Now J&J has faced lawsuits from 60,000 cancer patients, largely Black women, the preferred targets of their baby powder marketing. To avoid the lawsuits, J&J created a subsidiary company with all of the baby powder-related liabilities and then declared this shell company bankrupt. After that slick maneuver was thrown out of court, J&J tried a second time, but now it seems an $8.9 billion settlement has been reached.

4)    Hospice CEO allegedly tells employees to hasten patient death to avoid caps on government reimbursements: CEO Bradley Harris and other employees of Novus Hospice in Frisco, Texas, have been sentenced to a combined 84 years in prison for healthcare fraud. Staff received pre-signed prescription pads and were told to dispense opiates without physician oversight. Harris allegedly told employees to deliberately overdose patients so as to hasten death, in order to reduce average patient stays and avoid caps on government reimbursement. One employee was allegedly sent a text message saying, “You need to make this patient go bye-bye.”

3)    System keeps community hospital on life support to cash in on drug discount program meant to serve the poor: The 340B drug program gives safety net hospitals deep discounts on medications to ensure access to care for low-income patients. Richmond Community Hospital in Virginia, owned by Bon Secours Health System, has profited heavily off of this program, yet they don’t have an intensive care unit, a maternity ward, or a functional MRI machine, because Bon Secours diverts the profits to its other hospitals in wealthier, whiter neighborhoods.

2)    Private equity-backed firm runs rural hospitals into ground, leaves patients in unsafe conditions and employees without health insurance: When Noble Health bought two rural hospitals in Missouri, residents hoped this might offer a lifeline to the struggling institutions. Instead, employees faced shortages in supplies and medications, and Noble stopped paying for employees’ health insurance despite deducting “premium” money from their paychecks. Some staff members faced hundreds of thousands in medical bills because they didn’t know they were uninsured.

1)    Insurers systematically overbill Medicare Advantage, siphoning billions of taxpayer money: Most of the large MA insurers have been accused of fraud or overbilling by the US government, costing taxpayers as much as $25 billion in 2020.

 

Bye-bye Goodbye



Even before the Public Health Emergency evaporated, experts started warning that a new COVID-19 surge rivaling the Omicron tsunami could hit during the next two years, estimating 20%-40% probability. And while over 1000 Americans still die every week and multiple other metrics suggest prudence, the great Massachusetts General Hospital has stopped requiring facemasks, prompting street demonstrations and sarcastic comments such as, “It is excellent strategy by MGH. Creating thousands of additional cases of Long COVID guarantees sustained demand for medical services.”

The threat that uninsured individuals will have to either pay for COVID-19 vaccines out of pocket or depend on Byzantine “patient assistance programs” from Moderna and Pfizer may be lifting, as the Biden administration arranges directly with pharmacies to keep vaccines free of charge. Unfortunately it’s not clear which chains will sign on. The same “bridge access program” is supposed to guarantee free access to COVID-19 testing and treatment through September 2024.

Many Americans are partying like it’s 2019. Not so fast! In April a national track-and-field event caused at least 76 infections. And at the CDC’s own annual conference, at least 35 of the 2000 attendees came down with COVID-19. No masking, no distancing, apparently no enhanced ventilation.

Speaking of the CDC, director Rochelle Walensky is unexpectedly stepping down. Though Joe Biden claims, “Walensky leaves CDC a stronger institution,” the public disagrees. The percentage of Americans who say they trust it fell from 69% to 44% over the first 20 months of the pandemic, and ever since Walensky was hired in January 2021 I’ve been saying she wasn’t up to the task. Nice, well-meaning, but in over her head. Maybe now the agency will get the overhaul that distinguished scientists including the People’s CDC think it so urgently needs. 

Omicron is mild compared to previous strains, and by 2022 most Americans were vaccinated, but COVID-19 was nonetheless the fourth leading cause of death in the United States last year. Only cancer, heart disease, and unintentional injuries killed more people. That’s half the COVID-19 deaths in 2021, but still. The official death toll was 250,000, and 100,000 more are predicted to die this year – 35,000 have already. But we may never get those figures straight, since the CDC has stopped tracking COVID-19 cases, transmission rates, and deaths, now that the PHE is gone and states and laboratories are no longer obliged to collaborate, as emphasized in a Times op-ed by creators of the late great Johns Hopkins Coronavirus Research Center. Deaths will be followed using the National Vital Statistics System, with substantial delays. Hospitalizations and wastewater levels will still be tracked, through data sources are spotty to incomplete. I find the CDC’s own explanatory document confusing. 

Italy too has ended its state of emergency, with all COVID-19-related restrictions gone as of May 1st except mask mandates in nursing homes and on hospital wards that house fragile or elderly patients (most do, of course). But I still hear of so many infections that I will continue to wear masks in shared indoor spaces and will renew the supply I keep to give my patients. 

The World Health Organization too has declared an end to the COVID-19 global health emergency, while adding that the pandemic is not yet over and warning countries not to dismantle response systems, a warning likely to go unheeded in the US. One month after Covid Czar Jeff Zients was replaced by Ashish Jha, they’re again struggling to find a new one, with hints that they’re getting down near the bottom of the barrel.

 

The never-ending origin story

The University of Wuhan

We have had many hints the Chinese government suppressed information about the origins and the early days of COVID-19, but until reading a recent New York Times article I had no idea of the lengths they had gone to and the degree to which they had succeeded – and are still succeeding – in quashing scientific research. Highly recommended, and chilling.

I mistakenly wrote last time that the manuscript linking Huanan Market raccoon dogs to SARS-CoV-2 had already been published. But now it has, in Science, and got toned down considerably following peer review. There is now more emphasis on the previously-reported case clustering and much less on the genetic findings that were touted as proof of a market origin. Harvard scientist Alina Chan, New York Times columnist David Wallace-Wells, and several online commentators now discount its conclusions altogether. I too no longer believe the genetic findings to be a smoking gun.

Meanwhile, both Zeynep Tufekci and a Washington Post Editorial have showcased poor biosafety practices in virology labs, and not only or even mostly in China. 

 

Drawing conclusions


The end of the emergency has brought an epidemic of summings-up. A New York Times editorialist nicely proposes pandemic lessons. Jeremy Faust offers his take. Education professors describe education gaps. And members of Biden’s COVID-19 team lay down 13 other lessons, though I confess to having issues with numbers 1, 6, 7, and 10.

An authoritative report has described the response to the pandemic as a massive global failure, saying notably that:

-       There were “widespread failures of prevention, transparency, rationality, basic public health practice, and operational cooperation and international solidarity that resulted in an estimated 17.7 million deaths.”

-       Governments were “unprepared and too slow in their response, paid too little attention to the most vulnerable groups in their societies, and were hampered by a lack of international cooperation and an epidemic of misinformation.” 

-       The disastrous global response “reversed progress made towards the UN Sustainable Development Goals (SDGs) in many countries”

The American response was particularly shameful, bringing greater per-capita excess mortality than almost any other developed economy, not all of it directly from COVID infections. This revealed “a collective national incompetence in government,” according to in-depth analyses published by a set of experts in the book Lessons From the COVID War: An Investigative Report. As described in the Washington Post, its overall message is that the United States started out with more capabilities than any other country in the world, but its leaders “could not apply their country’s vast assets effectively enough in practice,” with Trump’s only commendable action Operation Warp Speed. 

Anthony Fauci did his own summing-up in a long interview with David Wallace-Wells: 

- He attributes the dreadful United States outcomes mostly to a low vaccination rate that he blames on Republicans know-nothings, but also to the “fractured” American healthcare system with its enormous racial and ethnic health disparities. (Americans of color have been more likely to die prematurely during the pandemic, and lost many more years of life.) 

- He estimates that without Operation Warp Speed it would have taken 3 years to develop a vaccine instead of 11 months, and that 5 million Americans would have died instead of one.

- He defends standard practices like masking, distancing, and contact tracing.

- He defends himself against accusations that amount to not having had a functional crystal ball in January-February 2020. 

- He explains why herd immunity can never be reached against COVID-19, emphasizing asymptomatic spread, viral mutation, and short-lived immunity. 

- He nicely summarizes the debate over the pandemic’s origin, focusing on the improbability of a lab leak, the irrelevance of NIH funding of the Wuhan Institute of Virology, and the confusion over “gain-of-function” research.

 

 

Lies and damned lies



Switzerland Bans the COVID Vaccines” reads the headline in The Geller Report, the mouthpiece of Pamela Geller, whose books (banned from Amazon) include such titles as The Post-American Presidency: The Obama Administration’s War On America, and Stop the Islamization of America: A Practical Guide to the Resistance. Nope, Switzerland hasn’t banned COVID-19 vaccines. It simply isn't recommending mass boosters during the spring and summer of 2023, preferring to wait until fall, allowing exceptions for particularly high-risk individuals.

The Unvaccinated Won't Be Unvaccinated for Long With mRNA in the Food Supply” is a tweet that’s been viewed 1.9 million times. The most inventive novax tale ever?

A spinoff: “Produce from AeroFarms contains COVID-19 vaccine.” The video (no longer viewable) apparently has text that asks, “Are Whole Foods customers being (injected) with the C19 mRNA shot via food products without their customer's knowledge or consent?” and adds, “This is attempted murder.” Factcheck by USA Today.

“3 entire years of Covid vaccine propaganda, FDA now says unsafe & ineffective.” Oh yeah?

“Practically everyone is immunocompromised to at least some extent post-Covid infection,” says Hannah Carter on Facebook. See this and this for why this statement is bullshit.

“Face masks may raise risk of stillbirths, testicular dysfunction and cognitive decline due to build-up of carbon dioxide.” This Daily Mail headline is based on a German study that’s complete nonsense. Which figures, since the article appears in a pay-to-publish journal so corrupt that it has to bribe its peer reviewers!