American hospitals refuse to adhere to new price transparency law

June 8, 2022 • 11:30 am

UPDATE: To underscore the opacity of the present system, its greed, and the way patients are overcharged, read this NYT article from May, “She was told that surgery would cost about $1,300. Then the bill came: $229,000.” Lisa Melody was charged the “chargemaster” price, even though she didn’t agree to that and her insurance company told her otherwise. When she wouldn’t pay that outrageous price for spinal fusion surgery, the hospital in Colorado sued her. A jury found for Melody, and her final bill was only $767. (h/t Enrico)

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In 2020, when I had hernia surgery, I posted the bill that my insurance company received from the University of Chicago Hospitals. It was nearly $64,000!  Europeans and Canadians were properly shocked at these prices, which indicated a big profit for the hospital. Now I didn’t pay nearly that much, as I have a good insurance plan, but the insurance company had to pay it (sometimes employers themselves foot part of the bill); but Americans without insurance would have be billed at that full price.

Shockingly, until last year, there was no way to find out these prices in advance so you could do comparison shopping. As I said in the earlier posts, almost no hospitals publicize the costs of their services or the medications they give you, so you don’t know what the bill is until after you’ve been treated. As I wrote at the time:

Now, can you know these prices in advance so you can comparison shop among hospitals? The answer is NO. While hospitals differ drastically in their costs, it would be nearly impossible to get a figure for the entire operation in advance. Some hospitals, like the Surgery Center of Oklahoma, will quote you a flat price (and for them, my redo surgery [the hernia operation had to be redone] would have been free), and that price, for hernia surgery similar to mine is, I’m told, about $4,500: only 7% of what the bill was above. Nor are these cheaper hospitals worse at what they do: there seems to be little correlation (or even a negative correlation) between the price of a procedure and the quality of the facility and the doctor. (My doctor at the U of C, by the way, was excellent and has a superb record, but more on doctor-shopping later.)

What about the costs above? Are those the sticker costs that then get discounted when billed to the insurance companies (i.e. are they they the so-called “Chargemaster list prices” for each item), or are they the already-discounted costs given to my insurance company?  I have no idea.  It’s as if you went to the grocery store and there were no prices on the food items, and then after a month you get a bill saying, “This is what you have to pay for groceries.

At the post above, Dr. Lickerman answered many readers’ queries (just search for “Lickerman”), which explained more about how dire health care prices were. Of course, other countries have single-payer insurance, but in many cases that results in a parallel series of private insurance because patients don’t want the long wait associated with many national single-payer systems. When I snapped a tendon in my finger in New Zealand, for instance, I could get treated for free, but it would be at least a five-hour wait in the hospital, or I could pay out of my pocket and get reimbursed in the U.S. I chose the latter, and fortunately my insurance company reimburses for medical treatment overseas.

The lack of transparency in pricing did two things: it prevented consumers from comparison shopping to find the cheapest price (especially important if you are paying out of your pocket or have a high deductible), and it generated huge profits for hospitals, which can adjust its “MSRP” prices as well as the discounts from those prices that are given to insurance companies.

This was supposed to be rectified when in 2020 Congress passed The Health Care PRICE Transparency Act, requiring hospitals to disclose the prices of 300 “shoppable” procedures as well as the billing costs for many drugs. It was supposed to take effect on January 1, 2021, and there were fines for violations.

As of today, almost no hospitals are complying, there is almost no transparency, and fines aren’t even being imposed. I heard about this on the NBC Evening News last night, and decided to see what’s going on. What’s going on is that hospitals, greedy for $$, are ignoring the law. And the Biden Administration isn’t doing anything about it. For laws can be enforced by the executive branch of the government.

Hospitals have four tiers of pricing, and all of these prices should be disclosed for each drug and service.  I quote my doctor, Alex Lickerman, here about these tiers:

Charge master price = this is like sticker price on the car. No insurance company expects to pay this. Hospitals create this because they know different insurance companies will be willing to pay different percentages of their charge master price. When insurance companies advertise that they have the biggest “discounts,” what they mean is reductions down off a hospital’s charge master price (which hospitals historically haven’t disclosed). So BCBS might get a 50% discount. Medicaid might get a 95% discount off the charge master price. Medicare might get an 80-85% discount. (I’m making these discounts up).

This is what the uninsured patient pays, and if they don’t pay (they must be treated), they will be dunned and their credit ruined.

The minimum negotiated price = this is the greatest discount, and therefore the lowest price, a hospital gives a third-party insurance payer.

The maximum negotiated price = this is the lowest discount, and therefore highest price, a hospital gives a third-party insurance payer.

Cash price = the price a patient would pay without insurance. Ironically—and horribly—this is often the full charge master price; that is, the price for the service WITHOUT a discount, which is then charged to people to have the least ability to pay it, i.e., the uninsured.

All these prices were suppose to be disclosed by hospitals on the Internet at the beginning of last year, but very few hospitals have obeyed. These sites (here, here, here, here, and here) give the story:

1). There’s a tremendous variation in prices among hospitals that do list them. The New York Times article from last summer is the best source of information:

The data show that the charge for a joint replacement can range from a low of $5,300 at a hospital in Ada, Okla., to a high of $223,000 at a facility in Monterey Park, Calif. Or within the same area, charges range from $21,000 to $46,000 to treat heart failure in hospitals in Denver, Colo.

Here are some disparate prices from that NYT article, and you can see more examples from the paper. Note that the vertical lines show four times what Medicare pays the hospital (for a colonoscopy) and TEN times what the government pays (for an MRI scan). Almost no insurance company pays anything near as low as what the government pays:

It holds for drugs too, which are often particularly inflated in price. This is for a rabies drug (text from the NYT):

Prices were still secret when Brian Daugherty went to an emergency room near Orlando, Fla., for a rabies shot after a cat bite last summer.

I tried to get some pricing information, but they made it seem like such a rare thing they couldn’t figure out for me,” he said.

He went to AdventHealth Orlando because it was close to his house. That was an expensive decision: It has the highest price for rabies shots among 24 hospitals that included the service in their newly released data sets.

The price there for an adult dose of the drug that prevents rabies varies from $16,953 to $37,214 — not including the emergency-room fee that typically goes with it.

Mr. Daugherty’s total bill was $18,357. After his insurer’s contribution, he owed $6,351.

2.) Few hospitals are complying with the law. 

“One year after this law making hospitals show prices came into effect, unfortunately, we found that only 14.3% of our country’s. . . hospitals are complying with this law,” PRA founder and CEO Cynthia Fisher said.

The NBC News last night reported only 15% compliance.

Yet hospitals are violating the law left and right, and are not being penalized, even though the penalties are trivial compared to the profits that hospitals rake in. Here’s the law:

The law required hospitals to post prices for all services, including gross charges and discounted cash prices.

In addition, the rule requires the information to be available in two formats, a machine-readable file that contains pricing data for third parties to compare between hospitals and a shoppable service list that displays specific services offered at the facility.

And the fines:

Under the final rule, for hospitals with thirty or fewer beds, the minimum civil monetary penalty will increase to $300 per day. For hospitals with more than thirty beds, the minimum civil monetary penalty will be $10 per bed per day, capped at $5,500 per day. This means the minimum amount for noncompliance with the rule would be $109,500 annually while the maximum amount is $2,007,500 annually. CMS is also requiring that the machine-readable files with pricing information be accessible to automated searches and direct downloads.

In response to a reader’s question after my post about why the bills were so much higher when insurance was involved, Dr. Lickerman said this:

Great question! The answer is, many providers will charge a lower cash pay price because payment is immediate. The bill is higher when insurance is involved because providers create a “chargemaster” which has prices that are like an MSRP when you’re buying a car. It represents a ceiling price–an initial price–in a negotiation that almost no one pays. Providers inflate their chargemaster prices because they know they’ll be forced to negotiate different discounts with insurers. So while private insurers get maybe a 50% discount off chargemaster rates, Medicaid takes maybe a 90% discount (which is why most medical systems consider Medicaid to be “bad” insurance: it reimburses them for a given service at the lowest rate). This is why, paradoxically, if you’re uninsured, you may pay more than even large insurance companies. For reasons that defy logic, medical systems will sometimes quote the uninsured their chargemaster rates–the highest price–rather than a true cash pay rate.

If you’re getting care from a small provider (vs. a large hospital system), you’re much more likely to find a reasonable cash pay rate that ends up being cheaper than going through your insurance (depends on your yearly out-of-pocket max and how far into it you’ve already spent).

Large hospital systems likely raise their chargemaster rates to meet revenue targets. Contrary to what you’d expect, insurers are happy to pay these rates because it enables them to increase premiums, which they want to increase because Obamacare imposed a medical loss ratio of 20% on most insurance plans. That means insurers must spend 80% of their revenues (premiums) on healthcare claims. If you’re limited to only 20% of the pie to make profits, what do you do? Find a way to make the pie bigger so that the absolute dollar amounts you bring in goes up. This is what the insurers have done, and it’s why premiums have gone through the roof since Obamacare was enacted. The unit cost of most medical care has increased mostly with inflation. Healthcare prices set by providers have increased by far more.

Even employers find it hard to determine what they will pay for an insurance plan, as they must hire lawyers and consultants to get around the great wall of secrecy. And sometimes even then it doesn’t work, so they’re buying a plan for their employees whose benefits they don’t know and, since employers must sometimes pay some benefits, they don’t even know how much they would be liable for.

This is greed, pure and simple, and it hurts everyone. Many Americans are impoverished by the cost of healthcare and their inability to do comparison shopping.

There are multiple solutions: Single-payer health, Obamacare for everyone, with government help in paying for private insurance, enforcement of transparency, negotiation of drug prices and so on.

Everyone usually prefers the system they have now, unless they have no insurance. I’m wary of the single-payer system just because it hasn’t worked out well in many places. Here’s what Dr. Lickerman said about it on my earlier post, and at the risk of reader ire in Canada and the UK I’ll present it anyway:

Great question. The idea of having a single payer for all healthcare (the government) definitely has its supporters here in the U.S. But it would likely lead to what we see in Canada (the system outside the U.S. I know best), which is untenable wait times for anything other than emergent care, which is all handled by already-burdened ERs. You won’t go broke getting healthcare in Canada like you can in the U.S., but you won’t have appropriate access to healthcare either. The single payer system there has resulted in a dearth of primary care physicians that’s even worse than in the U.S.

But whatever the solution, it’s not what the U.S. has now, and countries like Canada and the UK do have nearly free single-payer care, which does deal quickly with emergencies.  Here’s what the NYT got when it solicited “explanations” from hospitals in its article last August. Look at these Scrooges!

At the Biggest U.S. Hospitals, Few Prices Are Available

Six months after the new rules took effect, the Times reached out to the highest-revenue hospitals that had posted little or no data about their negotiated rates or cash prices. Here’s what they had to say:

We will not be providing a statement or comment.

N.Y.U. Langone has not published its negotiated rates or cash prices.

Services that do not have a fixed payer-specific rate are shown as variable.

Stanford Health Care has not published its cash prices. Of more than 300,000 possible combinations of insurance and medical treatment in its data file, it includes prices for 479.

We do not post standard cash rates, which typically will not reflect the price of care for uninsured patients.

Cedars-Sinai Medical Center, in Los Angeles, has not published its cash prices. The hospital initially posted a 2.5 GB data file composed almost entirely of more than one million lines that contained no data. After The Times inquired about the large file size, the hospital reduced it to a 1.4 MB file.

We have listed the fixed rates where possible and, where that is not possible, have listed them as ‘variable.’
U.C.S.F. Medical Center has not published its cash prices. Of more than eight million possible combinations of insurance and medical treatment in its data file, U.C.S.F. includes negotiated rates for 346. (U.C. Davis, which is part of the same system and has also not published its cash prices, sent an identical statement.)
Penn Medicine is committed to transparency about potential costs.

The Hospital of the University of Pennsylvania added cash prices to its price transparency file after The Times inquired about why that data was missing.

“The resources we provide ensure that our patients know what kind of assistance is available to them and, ultimately, what a procedure will cost them — not us.

Montefiore Medical Center, in the Bronx, has not published its negotiated rates or cash prices.

“V.U.M.C. offers a toll-free number which consumers can call if they have questions about what they may be charged for services.
Vanderbilt University Medical Center, in Nashville, has not published its negotiated rates or cash prices.
Orlando Health has worked hard over the past several years to deliver helpful pricing information to its patients.

Orlando Health has not published its negotiated rates or cash prices.

We are continuing to work on the machine-readable file that includes payer-negotiated rates. … It involves analyzing a daunting number of data points.

Long Island Jewish Medical Center has not published its negotiated rates or cash prices.

The largest hospitals were chosen based on gross revenue reported to the Centers for Medicare and Medicaid Services in 2018, the most recent year with full data available.

 

If you’re an American, you should be plenty mad about this, be you Democrat or Republican. Everyone needs healthcare, and the fat cats are bilking the government and medical patients, all the while knowingly and insouciantly violating the law.

 

My duck-related injuries

May 24, 2022 • 1:15 pm

There is a lack of news today, so I’ll just add this. I have started developing swimmer’s itch again (“cercarial dermatitis“, caused by flatworm larvae associated with waterforwl). I had it last year, and it was dreadful, with an itchy red rash (and I mean itchy) that lasts several weeks. Scratching is useless; only prescription creams offer temporary relief.

This came, of course, from my double immersion in Botany Pond a week ago to rescue an orphan duckling some peabrain put there. Although I failed to rescue it, a student named Brandon did, and it’s now in rehab. As for me, I thought I’d come off scot-free this time because the water was cold and we don’t have many ducks.

No such luck. The rash, due to an immune reaction from the larvae that drilled into me, is starting, and since I was completely underwater once or twice it’s on my hands, feet, belly, and, well, everywhere. When I called the doc to get some prescription steroid cream, I realized that I may have incurred more duck-related injuries than anyone whose job isn’t to raise ducks.

So far:

1.) Swimmer’s itch, bout 1

2.) Head laceration from running into a tree while chasing drake malefactors

3) Serious ear laceration (11 stitches, some double) from snagging my ear on a tree branch while chasing duck malefactors

4.) Swimmer’s itch, bout 2 (both from attempting to rescue orphan ducklings

5.) Badly banged up knee from falling into the pond several years ago.

Non-medical injury: lost my glasses ($200) while trying to catch a duckling in the main pond. Couldn’t find them in the muddy pond bottom. (BTW, all orphans have been successfully caught and rehabbed.)

I won’t show pictures of the wounds themselves, but I had to tell my doctor that I’m sure he’s never had a patient with so many duck-related complaints. He agreed. But of course I’d do it all over again to save the ducks. I do love me some waterfowl.

Here’s after I was dressed in a turban after my ear injury on May 8, 2020:

And remember, try not to go swimming in ponds where there are ducks. (My swim was of course involuntary.)

Predicting ivermectin and hydroxychloquine use by political affiliation

February 20, 2022 • 1:15 pm

This is a strange paper, though it makes sense . But the rationale for publishing it seems to be to say: “See? The Republicans took the quack drugs.” That happens to be true, but how does documentation help public health? Well, the authors of this JAMA Internal Medicine paper give a reason at the end, but it’s hardly convincing.

The paper—rather, a “letter”—was meant to determine how prescriptions for various drugs, including the bogus Covid remedies hydroxyquinone and ivermectin—were correlated with both time and with the political sentiments of the region where the drug was prescribed. The patterns are interesting, but I suspect the authors (all from Harvard or affiliates) were Democrats and really wanted to show that quackery is higher among Republicans.

They did—at least after mid-2020.

 

 

The authors looked at prescriptions written under insurance for four drugs from January 2019 to Dec 2020. The drugs were, as I said, ivermectin and hydroxychloroquine, as well as as the two drugs specified below, which are in effect “control drugs” not used to treat (or rumored to treat) Covid-19. The sample size was huge: 18,555,844 adults, pretty evenly divided between men and women, with the mean overall age of 49.1

The hypothesis:

We hypothesized that the county-level volume of prescriptions for hydroxychloroquine and ivermectin—but not other, similar medications—would be associated with county-level political voting patterns in the 2020 US presidential election.

What they’re trying to say is, “We hypothesized that Republicans fell for quack remedies more often than Democrats.” (I bet the authors are all Democrats.) And their hypothesis was confirmed, except for one brief span of time (see below).

The methods:

In this cross-sectional study, we used deidentified medical claims for all outpatient visits by adults aged 18 years or older in counties with 50 or more enrollees from January 2019 through December 2020 included in the OptumLabs Data Warehouse, which includes medical claims for commercial and Medicare Advantage enrollees, as well as US Census data and 2020 US presidential election results. The institutional review board at Harvard University deemed the study exempt from review and waived the requirement for informed consent because deidentified data were used. The study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.

We divided the county-level Republican vote share in the 2020 presidential election into quartiles. We assessed county-level rates of new prescriptions for hydroxychloroquine and ivermectin (ie, patients with no fills for the medication in the previous 6 months) per 100 000 enrollees and 2 control medications, methotrexate sodium and albendazole (which have similar clinical applications as hydroxychloroquine or ivermectin, respectively, but are not proposed as COVID-19 treatments).

The four plots below show drug prescriptions throughout the survey region over two years. The first two show both methotrexate and hydroxychloroquine.

Plot A) shows total prescriptions, plot C) new prescriptions. In both graphs methotrexate (in orange) doesn’t change over time, while hydroxychloroquine (in green) spikes around April, 2020, and then goes down almost immediately, except for new prescriptions, which also shoot up around July of 2020, nearing election time (more on that later). The April spike for hydroxychloroquine presumably reflects the FDA’s allowing emergency use of hydroxycholoroquine for Covid-19 on April 3 and then revoking that usage on June 15. (I’d forgotten about that!)

Remember that there was a time when people thought hydroxychloroquine might be useful. The graph below is for ivermectin (green) versus Albendazole (orange). Total prescriptions on top, new prescriptions on the bottom. Prescrptions for Albendazole don’t change over the two years, but Ivermectin shoots up beginning in August, 2020, both in terms of general usage and new prescriptions. As we’ll see below, this reflects a general increase in Americans trying to get prescriptions for ivermectin, but most of the rise is due to Republicans seeking prescriptions.

The next four graphs show only new prescriptions for drugs, and this time there are four plots reflecting four levels of Republican voting by country in which prescriptions were written. Orange shows the highest quartile of counties (most Republican) and then in descending order light blue, gray, and green (most Democratic). During the two months of hydroxychloroquine being allowed (period between numbers 1 and 2 on the first graph), people of all political stripes got more prescriptions, but in fact the more Democratic counties got more prescriptions. This presumably reflects Democrats following health guidelines a bit more assiduously than Republicans, though the difference is tiny.

Towards election time, though, new prescriptions for hydroxychloroquine again rose steeply, though much more steeply for more Republican than for more Democratic counties (remember, these are quartiles for Republicanism, so blue, green, and grey lines don’t necessarily mean “Democratic-voting counties”).

Ivermectin doesn’t show the April-May spike that hydroxychloroquine does, as the government didn’t allow and then disallow ivermectin, but there’s a huge spike in new presciptions towards election time, again much more pronounced in the more Republican counties. Note that in the second graph, the numbers 1-4 correspond to different events that might cause more usage of ivermectin. I’ve put the ivermectin key in bold in the paragraph below:

Here’s what the numbers on the X-axis mean:

Arrows show key dates for hydroxychloroquine: (1) announcement of the US Food and Drug Administration’s emergency use authorization on March 28, 2020; and (2) revocation of the emergency use authorization on June 15, 2020. Key dates for ivermectin include: (1) the initial in vitro study claiming a potential antiviral effect of ivermectin5 on April 3, 2020; (2) the National Institutes of Health recommendation against ivermectin use2 on August 1, 2020; (3) release of a now-retracted manuscript preprint that described a clinical trial claiming 90% efficacy of ivermectin against COVID-196 on November 13, 2020; and (4) a widely publicized hearing of the US Senate Committee on Homeland Security and Governmental Affairs that included testimony by Pierre Kory, MD, of St Luke’s Aurora Medical Center, who promoted using ivermectin to treat COVID-19 on December 8, 2020. . . . . .

Not much going on with the two control drugs:

 

The conclusions. If you’re a Democrat, you’ll want to say that the Democrats were following the science (including the April-May spike in hydroxychloroquine use, since the government said it was okay), but the Republicans followed the rumors against the science, accounting for the higher number of new prescriptions at election time. But, as the authors emphasize, what we have here are correlations, not causations.

Why a spike around election time? The authors don’t really say, but i suppose one could theorize that Trump was whipping up Covid-19 sentiments with his pronouncements, making his people more liable to go for quack remedies. Note that the rise in all four quartiles doesn’t really imply that Democrats were taking more ivermectin around election time; the spike could be caused by prescriptions for Republicans in counties that were more likely to vote Democratic overall. I could dig deeper into that, but I don’t think the paper’s worth it.  Here’s the authors’ brief discussion:

In late 2020, the number of new prescriptions for hydroxychloroquine and ivermectin was higher in counties with higher Republican vote share, whereas in early 2020, before revocation of the Food and Drug Administration’s emergency use authorization, prescribing volume for hydroxychloroquine was higher in counties with a lower Republican (ie, higher Democrat) vote share. These findings were absent before the COVID-19 pandemic and for 2 control drugs.

This study has limitations. In an observational study, we could not address the causality of the association between county-level political voting patterns and prescribing of 2 ineffective COVID-19 treatments. Also, we were unable to assess the specific contribution of patient, physician, or other factors to the prescribing patterns.

These limitations notwithstanding, our findings are consistent with the hypothesis that US prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation. Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system.

Here’s what I think the authors are saying, translated into normal language:

We found what we thought: Democrats follow the science and Republicans follow rumors and conspiracy theories. This raises concern for the American system because it shows that the damn Republicans endanger everybody by mistrusting the government.

Now of course I’m a Democrat and have exaggerated the “translation”. But if you read the paper, don’t you think this is what the authors really want to say?

Once again: Ivermectin doesn’t work

February 20, 2022 • 10:00 am

The paper at issue today reports the most thorough and well controlled study of the effect of ivermectin on Covid-19 around, and it was just published in JAMA Internal Medicine. What it supports, contra the claims of Joe Rogan, Bret and Heather Weinstein, and a whole slew of Republican loons, is that the drug ivermectin—as already asserted by the FDA—neither prevents nor cures covid-19. Or rather, this study shows that once adults over 50 who get the virus and are hospitalized with comorbidities, Ivermectin doesn’t help them get better. (An earlier study published in BMC Infectious Diseases, both randomized and double-blinded, and including a placebo, showed that taking ivermectin had no significant effect on keeping people out of the hospital.)

The upshot is that every well controlled study shows that ivermectin is useless in helping you once you get the virus. Another meta-analysis of reasonably well done studies that included prevention concluded that there was no good evidence that the drug even prevented infection.  The only studies that may show value of ivermectin are those in which many participants have high loads of worms as comorbidities. In such studies (which don’t apply in the US or UK), the drug may, by helping you get rid of worms (see below), make recovery from covid more likely. But even in that case there’s no excuse not to get vaccinated.  And of course you wouldn’t take ivermectin unless there was evidence you had worms.

Ivermectin is used in humans to cure parasitic worms and head lice, but can be dangerous if taken in doses high enough to kill viruses in vitro. Nevertheless, in this age of conspiracy theories and general lunacy, even credentialed scientists like the Weinsteins have recommended ivermectin and criticized vaccines, even though it’s beyond doubt that the vaccines prevent severe illness and hospitalization. You’d have to be crazy or paranoid to pass up vaccination in favor of ivermectin But thousands do it, so there you are.

With luck, you should be able to get the new study by clicking on the screenshot below, especially if you have the legal Unpaywall app. There’s also a link to the pdf, and if all else fails, make a judicious inquiry.

First, the background: the authors summarize what’s know about Ivermectin in studies to date. As I and others have mentioned before

Although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses. In 2021, 2 randomized clinical trials from Colombia and Argentina found no significant effect of ivermectin on symptom resolution and hospitalization rates for patients with COVID-19. A Cochrane meta-analysis also found insufficient evidence to support the use of ivermectin for the treatment or prevention of COVID-19. [JAC: The meta-analysis is linked above.]

The new study was done in Malaysia (other studies are ongoing, I believe), and iswasrandomized with respect to patient condition and age, but there was no placebo control. That is, half the infected patients were given “standard of care” (none were vaccinated) and the other half were given “standard of care” plus Ivermectin. The outcomes were followed over time.  The result: not only did Ivermectin not work, but there was a slightly higher, though nonsignificant, risk of the ivermectin treated patients progressing to the phase that required supplemental oxygen. That is exactly the opposite of what you would expect if some patients were taking placebos, for you might expect that if there’s a placebo effect, then placebo-ingesting patients would do better than those not taking placebos (i.e., the patients in this study). But despite the absence of placebos, there was still no effect of ivermectin in this study using any measure of “disease progression”.

I’m not going to summarize the results in detail, because the authors do a good job of that themselves.

There are three summaries of the results. First, the “TL/DR” version:

Note below that the 490 patients observed were all over 50 and had documented comorbidities—factors that make them more susceptible to complications and death.  Here is the protocol (indented, bolding is mine except in headers).

The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients’ symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.

Interventions  Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.

Note again: no placebo pills were given. And here’s how they measured outcome:

Main Outcomes and Measures  The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.

The results are below. Note that slightly more patients in the ivermectin-dosed group (4% more) progressed to severe disease (i.e., requiring supplemental oxygen than those in the group treated the same but without ivermectin. Incorporating still other measures of “progression to severe disease,” there was again no significant difference, although there was slightly more deaths (nonsignificantly more) in the ivermectin versus control group. Finally, the most common side effect, diarrhea, was found more often in the ivermectin versus control group,but I can’t find the statistics for that difference.

Results  Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).

And the upshot:

Conclusions and Relevance  In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.

Here’s the entirety of the discussion (bolding mine); note that the authors, as is proper, point out the limitations of the work.

Discussion

In this randomized clinical trial of early ivermectin treatment for adults with mild to moderate COVID-19 and comorbidities, we found no evidence that ivermectin was efficacious in reducing the risk of severe disease. Our findings are consistent with the results of the IVERCOR-COVID19 trial,17 which found that ivermectin was ineffective in reducing the risk of hospitalization.

Prior randomized clinical trials of ivermectin treatment for patients with COVID-19 and with 400 or more patients enrolled focused on outpatients.16,17 In contrast, the patients in our trial were hospitalized, which permitted the observed administration of ivermectin with a high adherence rate. Furthermore, we used clearly defined criteria for ascertaining progression to severe disease.

The pharmacokinetics of ivermectin for treating COVID-19 has been a contentious issue. The plasma inhibitory concentrations of ivermectin for SARS-CoV-2 are high; thus, establishing an effective ivermectin dose regimen without causing toxic effects in patients is difficult.27,28 The dose regimens that produced favorable results against COVID-19 ranged from a 0.2-mg/kg single dose to 0.6 mg/kg/d for 5 days2932; a concentration-dependent antiviral effect was demonstrated by Krolewiecki et al.29 Pharmacokinetic studies have suggested that a single dose of up to 120 mg of ivermectin can be safe and well tolerated.33 Considering the peak of SARS-CoV-2 viral load during the first week of illness and its prolongation in severe disease,34 our trial used an ivermectin dose of 0.4 mg/kg of body weight daily for 5 days. The notably higher incidence of AEs  [“adverse effects”] in the ivermectin group raises concerns about the use of this drug outside of trial settings and without medical supervision.

Limitations

Our study has limitations. First, the open-label trial design might contribute to the underreporting of adverse events in the control group while overestimating the drug effects of ivermectin. Second, our study was not designed to assess the effects of ivermectin on mortality from COVID-19. Finally, the generalizability of our findings may be limited by the older study population, although younger and healthier individuals with low risk of severe disease are less likely to benefit from specific COVID-19 treatments.

Note as well the “limitatation” that placebos were not given. Another limitation is that this study didn’t assess the chance of getting infected in the first place when you take ivermectin, or of being hospitalized if you get infected, though other work (see above) has suggested no effect of ivermectin on either of these measures.

I was prepared to admit that my criticism of ivermectin was wrong had these properly-designed studies shown an effect, but of course because ivermectin is usually suggested as a substitute for getting vaccinated, the real thing you want to know is whether, compared to getting the jabs, you’re better off swallowing ivermectin.  Given the efficacy of the vaccines, which has now been conclusively demonstrated (and yes, the effects wane over time, so we may need a yearly booster), I was already pretty sure that those who touted ivermectin as a better substitute for vaccination were wrong.  But this study does nothing to convince me that I was wrong.

More studies will come out, and eventually we’ll have a pretty solid conclusion. And I’ll bet any reader $100 that it will show that ivermectin is no substitute for vaccination or the other new drugs that are being used to relieve symptoms and combat the virus.

The question now is whether people like Joe Rogan or, especially, Bret and Heather Weinstein will admit that ivermectin—at least in this study—has no effect. Ideally, scientists will admit when they’re wrong, and, as Richard Dawkins has emphasized, that is an admirable trait. Such admissions move science along faster than waiting for a generation wedded to an idea to die off and be replaced by those who have different ideas. Now I haven’t been wrong about ivermectin yet, but when I see a study showing it’s more efficacious than vaccines in keeping you out of the hospital, or alive, I’d like to think I’d say whose three words. Will the Weinsteins say them?

I predict no. We will see a lot of hemming and hawing frothe Quacksters, and perhaps qualifications like “well, the study showed X but didn’t show the real prediction, which is Y.” In fact, I don’t remember hearing anybody pushing quack remedies admit that they were wrong.

The reason I’m so dogged about this is because people who tout quack remedies when there are good ones can do harm. And it’s far worse if they push the quackery while wearing the mantle of science.

But listen up: STAY AWAY FROM THE DAMN IVERMECTIN!

 

h/t: Alex, Leslie

Vaccinations in school; why shouldn’t they be the parent’s “choice”?

February 12, 2022 • 12:20 pm

I have floated this question before, but want to raise it today to see if I can understand a distinction. And that distinction is between many people’s argument that they cannot be forced to get a Covid vaccination to stay on the job, but at the same time they allow their children to be forcibly vaccinated to attend public school.

Now there is no law in the U.S. saying that you must be vaccinated, period, though of course there are mandates specifying that you can’t work unless you’re vaccinated. New York City’s mandate for municipal workers went into effect today, after the Supreme Court turned down an emergency request yesterday to stall it. Up to 3,000 people might have lost their jobs this morning.  And yet many people still refuse to get vaccinated even if it means the loss of their livelihood. I see them on the news every night, making loud protests about their “rights” being violated by vaccine mandates. Along with that goes the mantra “this is my body and therefore it’s my choice.” And so they get fired, and some of them die, while others infect their fellow citizens.

This mass protest has culminated in the Great Truckers’ Protest of last week, and I hope it’s over now. (Did Trudeau show some moxie?) It was an act of civil disobedience, and therefore warrants punishment, but I had little sympathy for them.

What I don’t understand is this: these same people who assert their rights and bodily autonomy—and I see no “right” to be able to endanger the public safety by infecting others—make not a peep when they get shots for their kids to go to public school.

Not everyone understands that in the U.S., and presumably other countries, any child wishing to attend public school has to get a series of immunizations,

Here, for instance, are the vaccinations required for a child in to attend public school in Illinois.  I count 14 jabs needed to stave off ten diseases. That’s a lot of shots!

Click charts to enlarge:

 

 

Now why aren’t the parents protesting this forcible vaccination? Isn’t that a violation of either the parents’ or the students’ “rights”? If you’re one of the many who talk about “rights” and “my decision”, and yet still want to walk around in public, yes, it’s certainly hypocritical to not bring up “rights” for your children as well. But, except for a few fringe anti-vaxxers, or believers who want religious exemptions for their kids (I’m not sure these are even allowed for school vaccination), we hear no talk of rights for school immunization.

Is this hypocrisy? Well, I can think of several reasons why you could say “no”:

a.) The school vaccines have been proven safe and effective over years of trial, while, of course COVID vaccines have been around just a bit more than a year. The parents could say, “These vaccines work and don’t have bad side effects, so I won’t speak of “rights” But then you could ask them how much safety must be proven before vaccination becomes mandatory. As I recall, when the polio vaccine came out, it became mandatory within just a few years, and people were begging to get it.

b.) You could say that you have the right to decide for your own body, but not for the bodies of your kids, and therefore they should get vaccinated. But this doesn’t work because parents make decisions about the medical treatment of their kids all the time, especially before the kid is sentient enough to make its own choice, which is at a pretty advanced age. For school vaccinations, the parents have to agree by the time the child is five or six.  (Note as well that parents feel that have the right to decide their children’s religious beliefs before the kids are old enough to choose!)

c.) The parents could say that they have the alternative of no employment if they’re not vaccinated, but there’s no alternative for their kids if they’re not vaccinated. That’s not entirely true: there is homeschooling, which is free, and private (often religious) schools that don’t require vaccination. But The latter are often pricey.

d.)_ They are willing to risk getting Covid, but the children are too young to afford that risk. But this reverts back to a) above: if the vaccine isn’t risky for your children, why is it risky for you? (In fact, it’s more dangerous for adults to get Covid than for kids).

There is more to discuss here, but I won’t get into it. I’m just curious why parents who obediently let their kids be vaccinated (even with COVID shots for college!) turn into enraged don’t-tread-on-me” types when it’s their own jabs at issue.

If there’s a rational answer, I would say that a)—proven safety and effectiveness—would be the one, but of course the Covid data so far shows that the risk is minor compared to the effectiveness. Certainly we know that the chance of illness, hospitalization, and death is greatly reduced for adults if they get the shot (we’re talking about resistance of adults to getting vaccinated). Vaccination for adults is, without doubt, a net good save for those who are medically compromised.

But I suspect that more is at stake here—perhaps ideology.  People have largely lost control of their lives during the pandemic, and refusing shots is a way of getting control, and also of showing the government that they can’t control you. This is likely connected with a conservative or libertarian ideology that opposes government intervention. In the case of the truckers, it seems to me they’re pissed off about a lot of things, including  loss of jobs and rising prices, and protesting against vaccines is the nucleus around which these resentments coalesce.

But maybe I’m not asking a meaningful question. It’s just that when I see a bunch of angry people yelling about “rights” and “bodily autonomy” on television, it makes me wonder whey they go all quiet when the needle goes into the arms of their kids.

A reader’s Claptonesque vaccine rant

January 30, 2022 • 9:30 am

The politically charged topics I get the most pushback about, whether it be in personal emails or comments (not all of which I post) are two: transsexual issues and criticism of bogus remedies for Covid. I can’t tell you the rancor I’ve seen about my view that we should be very wary of letting biological men who have assumed the gender of women compete in women’s sports. For that I have of course been called a “transphobe”, but I brush off that invective for I have no fear or hatred of transsexuals; sports is an issue of fairness towards women, and you can’t ignore the evidence. And yes, there is evidence about the performance, physiology, and morphology of men who transition (with or without medical treatment), and it’s not favorable towards the idea that they should take part in in women’s sports.

And of course when I went after ivermectin, people tried to trounce me, even though there was no evidence that it worked to prevent or cure Covid-19 (and there still isn’t).(I got a long email, for example, from Heather Heying, who very politely tried to convince me of the error of my ways.) But most of the ivermectin-pushers have no sense of the scientific reality: even if ivermectin did work, it wouldn’t work nearly as well as vaccinations, for the latter have been tested thoroughly and if Ivermectin had equally profound effects, we’d know it already. Taking all the side effects into account, you’re way, way better getting the jab than taking ivermectin, a drug used in humans for non-covid purposes like parasitic lice and worms.

I just realized that one of the reasons I write here, and what gets me most fired up, is when people misuse science to promote their ideological ends. Both ivermectin and transsexual issues have involved that kind of misuse, as does the current flap in New Zealand, where a tsunami of Wokeness is getting the government and universities to promote Mātauranga Māori, or Māori “ways of knowing”, as a form of science that should be taught as coequal to science in the classroom. While MM contains kernels of empirical truth, the whole movement is little more than an ideology of valorizing the oppressed being turned into science. (This is also happening in the U.S. with nonsense like “sex in humans is not binary” being promulgated as sacred truths.)

Others can believe such nonsense if they want, but when they try to force it on others, or teach it as “science” or “fact” to others, it becomes something I can’t abide. As Hitchens said, more or less, “you can have your toys if you want, but you can’t make me play with them.” Nor can you make my children play with them—in this case “my children” being those who haven’t been exposed to (or who don’t know how to assess) scientific data.

But I digress. It was just a passing epiphany. At any rate, speaking of Covid-19, I got this rather unhinged comment trying to force its way onto my website this morning. I don’t know why reader “Alex” (this would have been his screen name) is so heated up about vaccinatoon, but he seems to be one of those Claptonesque people who cannot abide the idea of being forced to be vaccinated. These people apparently don’t realize that for children to attend public school in America, they need to get many vaccinations. Otherwise, “no school for you.”

I’ll leave it to readers to respond to the comment below. Say what you will to “Alex”, and I’ll send him a link to the comments here.  As always, try to be polite (granted, it’s hard with a hothead like this), and abide by the Roolz, even though Alex didn’t.

Here’s what I got:


A new comment on the post “Bret Weinstein and Heather Heying go unvaccinated for Covid, take and promote Ivermectin instead” is waiting for your approval

Author: Alex

Comment:It’s January 2022. Do you still want to keep banging the “pandemic of the unvaccinated” drum? Because, despite all of your willingness to smear and deride the unvaccinated, I believe those authoritarians who want to continuously ramp up punitive measures against the unvaccinated in the face of the facts before us are the true, anti-scientific deplorables..It’s appalling to me that people want to coerce others into getting this vaccine through loss of livelihood, stripping of freedoms, and even criminal penalties, especially given that we don’t have legal recourse against these companies. That fact alone to me excuses anyone for turning down the vaccine. It’s fine if you personally want to take that risk (I did myself), but to want punitive measures or even to just endlessly ridicule those who decide not to take those odds is reprehensible to me, given the more dubious efficacy of these vaccines than promised and the other repeated breaches of trust from our institutions through this entire pandemic.And I say this as someone who got two shots of Moderna, so you can’t hurl unoriginal “anti-vaxx” insults my way. Seriously, you all need to realize that the tone and comments expressed on this page are totally unconvincing and alienate those like me from your positions. Do what you will with that information.


What I did with this information is given Alex an entire post to rant about the vaccination. That’s better than just ditching his comment as medically uninformed and potentially dangerous, which was my first inclination.

How “indigenous medicine” differs from “medicine”

January 25, 2022 • 11:15 am

I seem to be spending a lot of time reading about Mātauranga Māori (the indigenous “way of knowing” of the Māori of New Zealand, henceforth called MM), for there’s a battle over whether it’s to be considered “coequal to science” in New Zealand science classes, and whether MM should be taught with as much intensity, truth value, and classroom time as “modern science”— which is simply what we call “science”.  Yesterday I did a two-hour video podcast with a New Zealander on the subject, and it should be posted soon.

In the meantime, I’m looking for specific claims about MM and how it can tell us stuff that modern science can’t, or can somehow supplement modern science.

If you try to run down the claims of the “science” in MM, it invariably comes down to one of three examples.

First, Polynesians learned to navigate by the stars and other signs (this is a form of cultural selection, as those who couldn’t do it didn’t survive), which is indeed a form of knowledge, but doesn’t deserve as much classroom time as, say, the theory and mechanisms of biological evolution.

Second, the Māori teach us proper stewardship of the land. This claim is at best dubious given their historical destruction of the land and its fauna), as well as the value of scientific conservationists, who are using modern methods, for example, to save the kakapo: the world’s only flightless parrot.

Third, we have the recurrent claim that the Māori idea of a water demon in a river taught people that when the demon twitched its tail, the river would overflow, supposedly prompting road builders to circumvent the stream. I can’t tell you how many times I’ve heard the water-demon claim adumbrated as exemplifying the true value of MM. But hydrodynamics, which is what the builders really relied on, tells you much more than mythological tales or metaphors about where to put your roads. If MM is so valuable, why do its advocate always go back to the “water demon example”?

The same goes for medicine. Many Māori practice traditional medicine, often involving medicinal plants but also prayer and the numinous. Does it work? It could in practice, because, after all, we’ve gotten clues to modern medicines from observing indigenous practices. The ingestion of cinchona bark, which contains quinine, was a folk remedy for malaria, and 25% of modern pharmceuticals are said to have been derived from plants. But finding out what about the bark was the active substance, and how well it worked, required more than indigenous knowledge.

These examples can constitute knowledge gained from experience, but the gold standard for testing drugs these days is not a trial-and-error process, but the vastly more efficient method of double-blind testing.  Below is a paper from Frontiers in Immunology that’s been represented to me as an example of how MM can help science find new drugs. Sadly, the paper doesn’t even come close to doing that. Click on the screenshot to read; you can download a pdf there, too.

I’m not going to go through it. It simply describes how the Māori suffer excessively from type 2 diabetes (this is largely blamed on colonialism, which apparently gave them no healthy sources of food), and that there are traditional plants that they ingest to relieve the symptoms and damage of the condition. They then list all the possible plants, describe the chemicals in them, and say which ones might improve diabetes because rat studies have shown them to effect the insulin/glucose storage pathways. (Many of the plants lack even that minimal evidence.)

What is lacking in the study is this:

a.) Any evidence that these remedies actually work (there are, of course, no double blind studies). The whole paper is full of statements like, “Traditional reports describe compound X as having good effect for diabetes” and “Māori practitioners are known to use the leaves of Y to help alleviate symptoms.” This is assertion based on tradition, not evidence, though it could be evidence were the plants or their extracts tested under proper clinical conditions.

b.) Any evidence that the chemicals in the long list of plants help alleviate diabetes in humans.

c.) Any evidence that the plant “medicines” are better than the drugs currently used to treat type 2 diabetes.

In other words, the studies show a lot of “this is possible” and “that is possible” but give no substantive evidence for the efficacy of the Māori treatment for diabetes. This lack of evidence for efficacy is of course not unique to Māori medicine, but is characteristic of much “alternative” medicine throughout the world, as well as other traditional cures like reiki, faith-healing, and so on. In fact, faith is an integral part of Māori medicine, as the authors note (my emphasis)

Given the uniqueness and diversity of New Zealand indigenous flora, it is likely that new anti-diabetic treatments will be discovered from these sources. [JAC: I am not sure this is at all true. There may be more efficacious plants elsewhere in the world!] The plant vegetation foods, seeds, roots, nuts, and fruits that formed the basis of traditional Māori diet and rongoā would seem worthwhile targets in a systematic search for anti-diabetic agents. It is also important to understand that Māori believe the beneficial effects of rākau rongoā are not due to the plant alone, but are more importantly due to other traditional influences such as faith in Te Atua God, personal mauri (connection) with Papatūānuku (mother earth), a good sense of oneself as Māori, and a good sense of whakapapa (family history). In Māori communities, natural health and traditional medicinal practices are increasingly widely supported (Williams, 2001).

This means that Māori culture plays some ineffable role in the cures. And the need for “faith” to make the medicine works is a blatant way of insulating the potential treatments from falsification.

One such statement:

There has been growing recognition that “health” is more than an individualistic, biomedical concept; health is also determined by social circumstances and contexts (Lines et al., 2019). These social determinants of health involve the conditions under which people live and work, and include diverse factors such as language, culture, and identity. Indigenous culture is a dynamic and adaptive system of meaning that is learned, shared, and transmitted from one generation to the next and is reflected in the values, norms, practices, symbols, ways of life, and other social interactions of a given culture (Kreuter and McClure, 2004). Relationships, interconnectivity, and community are fundamental to these dynamics (Lines et al., 2019).

Language and identity? But wait; there’s more:

For Māori, the indigenous peoples of New Zealand, there is an intrinsic connection between the health of the people and the health of their land (McGowan, 2017). Māori developed mātauranga of their whenua over centuries, which was passed down from their ancestors who originated from Hawaiiki (Smith, 1898). As such, mātauranga Māori is about connection to Papatūānuku or whenua land (McGowan, 2017). Once those connections are broken, mātauranga Māori becomes less of a living knowledge. A disconnection of mātauranga Māori commonly occurs when it is taken out of context in which it originated.

That makes no sense at all to me.

So we see how MM can be rendered immune to falsification, which is a way to say that it’s “not science”.  Anything that can’t be falsified shouldn’t be taught in science class.

Futher, you can say, as advocates of paranormal stuff like ESP often do, that “it won’t work if taken out of context”.  An example (don’t ask me to translate). Emphasis is mine:

Many Māori support the use of animal testing to understand the effects of rongoā at the physiological and molecular level, if that knowledge is unknown. Many Māori support animal testing of rākau rongoā if the research is conducted under the guidance and protection of a Māori kaumatua (elder), kairongoā (rongoā Māori practitioner), and Māori kairangahau (researcher). As mentioned earlier, Māori have strong interests in kaitiakitanga and rangatiratanga, and support animal testing of rākau rongoā if it is preserved and governed under their guidance.

Māori view the intake of rongoā by animals as a very natural process, which can help guide laboratory research if conducted in a culturally humane and safe environment for the animal and rākau rongoā under investigation. Furthermore, it is important that a karakia (prayer) is given by a Māori kaumatua before the research commences and ends, including when the animal is euthanized humanely.

The requirement that you must have specific Māori elders around to do the research properly, and to recite a specific prayer, is another way of immunizing this kind of MM against falsification.

Finally, the authors disparage modern medicine simply because it’s “colonial”. I found the statement below amusing—but also infuriating (remember, this is a peer-reviewed paper in an immunology journal):

Mainstream health systems are constantly charging Māori to validate the efficacy of their rongoā Māori practice based on mainstream health systems, without recognizing that Māori have their own body of knowledge and practice systems based on mātauranga Māori and tikanga Māori (traditional kaupapa Māori protocol) (Koia, 2016). This is viewed as institutional racism and Crown inaction on health equity in New Zealand (Came et al., 2019). Furthermore, this also supports historical practices of colonization and forced assimilation enacted by the Crown as profoundly racist (Smith, 2012). Furthermore, colonial policies informed by superior Pākehā people, institutions, and systems, have allowed entitlement of Pākehā to resources and power, including those related to traditional rongoā Māori practices. As such, the New Zealand Crown are thought to be in breach of Treaty of Waitangi obligations in terms of inequity between mainstream health systems and traditional rongoā Māori healing practices.

In other words, “We don’t need no stinking tests because that’s just racist colonialism.”

As I said, there may be value in investigating “traditional” plants used in indigenous treatment of diabetes. But you can’t just assert that or say “traditionally, plant X has been used and seen to be helpful.” Further, new remedies have to be at least as useful (taking into account side effects) as the ones already in use. There may be no plant as effective as insulin in some severe cases of type 2 diabetes. I find it ironic that the authors note this at the end of their paper:

Based on traditional reports and knowledge, karamu, kūmarahou, and kawakawa each display anti-diabetic potential. Remarkably, no molecular or biomedical research has been conducted to confirm the anti-diabetic efficacy of these rākau rongoā and to understand the mechanisms by which these effects are achieved. Although early phytochemical studies confirm known constituents, research is yet to be performed to validate anti-diabetic agents of the given rākau rongoā. 2D cell culture and animal model systems provide ways to study the effectiveness of anti-diabetic agents sourced from rākau rongoā.

Translation: those plants have chemicals in them, but we’re not sure whether they work.

That’s an admission that they have no idea whether any of the plants they suggest are of even potential value (the “potential” here is defined very thinly). Finally, the efficacy of the plants is said to defend on the need for a specific Māori harvesting protocol that comes close to religious practice (my emphasis):

The preparation of rongoā from these should be performed following certain principles and Figure 2 illustrates a kaupapa Māori molecular research scheme to undertake pre-clinical and clinical studies to test efficacy of karamu, kūmarahou, and kawakawa rākau rongoā in T2DM “mate huka.” Harvesting and aqueous extraction of rākau rongoā ought to be performed under the direction of a kairongoā or Māori kaumātua. In line with traditional Māori protocol, karakia is essential to acknowledge and thank the gift of Tane Mahuta prior to harvesting any rākau rongoā plant material. Harvesting rākau rongoā involves considering the needs of others, ensuring sustainability in the forest, being gentle with footprints in the forest, harvesting the eastside of the plant by hand, never harvest in the rain and to harvest leaves during growing season (Kerridge, 2014

The east side of the plant?  Harvesting during the growing season alone? I can think of reasons why one might do the opposite—and at least you should try a variety of protocols, like harvesting on the west side of the plant!

I found little of value in this paper, but was astounded to see how infused the medicine is with prayer, proper Māori elders, and unjustified harvesting practices, as well as having some unspecified but necessary connection to the land.  There are ways to do double-blind tests on the plants even without a clinical study, but none of that has been done in this case.

I will continue to read defenses of MM as being scientific or supplementing science, but I tell you, it’s a mental beating. And imagine what’s in store for New Zealand medical schools if MM is required to be taught, as it may well be, as an alternative and equally valuable way of treating disease or injury!

Bari Weiss: anti-vaxer?

January 22, 2022 • 11:30 am

In this segment of Bill Maher’s show last night, Democratic Congressman Ritchie Torres from New York, Bari Weiss, and Maher discuss Covid-19, with the topic being “whether it’s time to move past Covid restrictions and get back to normal.” Weiss and Maher seem to say “yes,” while Torres urges caution. 

Bari Weiss declares that she’s “had it” with Covid, that masks don’t work, that you can be vaccinated and still get infected with omicron, that lockdowns cause suicide, that few children have died from Covid and that “it’s time to end it”, apparently meaning we no longer need to take precautions against Covid, including getting rid of masks, lockdowns, and vaccinations. She’s arguing, as Torres characterizes her view, that “the response to the disease has been worse than the disease itself.” But have 800,000 Americans committed suicide from Covid-induced depression? No: look at the data from StatNews:

Those of us who posited that suicide rates may actually decline during the pandemic were either dismissed or criticized. But we were right: Provisional data released by the U.S. Centers for Disease Control and Prevention suggests that for the entire year of 2020 — when most lockdown procedures were put in place, many communities saw their highest rates of Covid-related deaths, and economic uncertainty was at its peak — suicide rates dropped by 3%.

For verification of this, see here and here (the latter is the Suicide Prevention Resource Center, which says that more data should be analyzed when it comes in later).

As for the efficacy of masks, the data summarizing their value can be seen at the CDC website, which actually gives data and doesn’t just say “wear masks”.

The gist of what she says here is that we shouldn’t have done anything about the pandemic. Maybe we would have had 2 millions deaths, but that’s just collateral damage.

Torres makes the point that nearly 100% the people in the hospital with Covid now are unvaccinated. They’re still dying, so how can you claim that vaccines don’t work? (The original clinical trials, of course, confirmed the efficacy of the vaccine.). As reader Paul wrote,

At least on COVID, Bari Weiss seems to have joined the other side. She and Bill seem to believe that the vaccine only protects the recipient against hospitalization and death and doesn’t help them avoid catching and passing on the disease. In general, Weiss seems to be positioning herself as a “media personality” rather than a writer, at least that’s my take.

Not only that, but she’s not even hewing to the data.  She’s come perilously close to being an anti-vaxer, if she isn’t one already.

In Weiss’s case, she hasn’t stayed in her ideological position while the left moved further left. No, she appears to be shifting to the right. I wouldn’t be surprised if eventually she become a never-Trumper Republican. I hope not, but what she had to say in this short segment greatly disheartened me.  And so did Maher’s response.

Weiss, at least, owes America a clarification of what she means when she says, “it’s time to end it.” End WHAT?

 

You can order your free Covid test kits now

January 18, 2022 • 11:30 am

Although American households were supposed to order their 4 free Covid test kits beginning tomorrow, reader Paul, quick to the mark, found out that you can order them NOW.

Just go to this site (or click on the screenshot below), and enter your name and address after pressing the blue button. Check out (no charge), and you’ll immediately get a confirmation email from the USPS.

The details (remember, rapid antigen tests aren’t usually accepted for international travel):

  • Limit of one order per residential address
  • One order includes 4 individual rapid antigen COVID-19 tests
  • Orders will ship free starting in late January

DO IT NOW!  Thanks, Paul.

The Epstein-Barr virus appears to be an important cause of multiple sclerosis

January 14, 2022 • 9:15 am

The Epstein-Barr virus has been associated with a variety of diseases; as Wikipedia notes (my emphasis, and I’ve left in the footnotes so you can consult 11-13, which I’ve put in bold):

The Epstein–Barr virus (EBV), formally called Human gammaherpesvirus 4, is one of the nine known human herpesvirus types in the herpes family, and is one of the most common viruses in humans. EBV is a double-stranded DNA virus.[2]

It is best known as the cause of infectious mononucleosis (“mono” or “glandular fever”). It is also associated with various non-malignant, premalignant, and malignant Epstein–Barr virus-associated lymphoproliferative diseases such as Burkitt lymphoma, hemophagocytic lymphohistiocytosis,[3] and Hodgkin’s lymphoma; non-lymphoid malignancies such as gastric cancer and nasopharyngeal carcinoma; and conditions associated with human immunodeficiency virus such as hairy leukoplakia and central nervous system lymphomas.[4][5] The virus is also associated with the childhood disorders of Alice in Wonderland syndrome[6] and acute cerebellar ataxia[7] and, based on some evidence, higher risks of developing certain autoimmune diseases,[8] especially dermatomyositis, systemic lupus erythematosus, rheumatoid arthritis, Sjögren’s syndrome,[9][10] and multiple sclerosis.[11][12][13][14] About 200,000 cancer cases globally per year are thought to be attributable to EBV.[15][16]

Infection with EBV occurs by the oral transfer of saliva[17] and genital secretions. Most people become infected with EBV and gain adaptive immunity. In the United States, about half of all five-year-old children and about 90% of adults have evidence of previous infection.[18] Infants become susceptible to EBV as soon as maternal antibody protection disappears. Many children become infected with EBV, and these infections usually cause no symptoms or are indistinguishable from the other mild, brief illnesses of childhood. In the United States and other developed countries, many people are not infected with EBV in their childhood years.[19] When infection with EBV occurs during adolescence, it causes infectious mononucleosis 35 to 50% of the time.[20] In 2022, it has been shown that EBV infection increase the risk of developing multiple sclerosis by 32-fold.[21]

EBV infects B cells of the immune system and epithelial cells. Once EBV’s initial lytic infection is brought under control, EBV latency persists in the individual’s B cells for the rest of their life.[17][22]

Here are two EBV virl particles with some proteinaceous spheres (not nuclei!) containing the viruses’ genetic material.  I had mono about twenty years ago, so I’m probably carrying the virus, too.

It has spikes, like Covid-19:

Source

At any rate, note that the association with the virus (henceforth “EBV”) with multiple sclerosis (“MS”) has been suggested before (references 11-13, ref. 14 is this paper). I haven’t read the first three papers, but #14 is just out in Science, and I’ll mention it briefly today. It surely is, given the discussions, the strongest evidence to date for an EBV cause of MS.

The paper was called to my attention by the tweet below from Matthew. And, apparently, this is the strongest suggestion yet that EBV actually causes multiple sclerosis.  If this proves to be the case, and the evidence is pretty strong, then this opens the way to preventing MS, most likely via I suspect shots in the young, because once the diease develops, a shot wouldn’t work. In fact, Moderna is at this moment making an mRNA vaccine against the virus. (Although, coronaviruses like Covid-19 have RNA instead of DNA as their genetic material—EBV has DNA—it doesn’t matter what genetic material the virus uses to replicate, for the mRNA in a vaccine is used by the body to make viral protein that then activates the host’s immune system.)

One note: MS is a disease that appears when your immune system attacks the myelin sheath surrounding the nerves, which disrupts nerve impulses. That in turn can lead to multiple effects, including difficulty in breathing, walking, and seeing. All of us have known people with MS, and you’re probably aware that the disease varies widely in its severity, with of the afflicted dying very quickly and others living a life of nearly normal span. On average, MS takes away five to ten years from your life, and a lot of that life is unpleasant.

Here’s the tweet that alerted Matthew, and then me, to the new results:

The paper below with the nearly dispositive data is free; click screenshot for access or get the pdf here. The reference is at the bottom.

(There’s also a News and Views piece on this article, which you can get for free by clicking the screenshot):

Now the best way to see if the virus causes the disease is to inject virus-free humans with EBV, and see if the injected group gets MS more often than does a control (noninjected) group. But since 90% of adults are infected anyway, and this experiment is highly unethical, one has to find other ways.

These researchers did the next best thing: a retrospective analysis of blood serum left over from AIDS tests on more than 10 million U.S. military personnel.  The criterion for “causality” here is the philosophical one: A causes B if you never get B unless you have A beforehand. (This doesn’t mean, of course that A is the sole cause of B.) As the authors say, “causality implies that some individuals who developed MS after EBV infection would not have developed MS if they had not been affected by EBV.” Note that they say “some individuals”, as there may be other causes of MS. But this is more than an association study, as EBV negative individuals could be tested for infection status during their period of activity duty, and then screened for MS to see whether the disease is associated with earlier infection.

The ten million soldiers were screened over a period of 20 years, and the leftover serum, fortunately, had been stored.  All samples were analyzed for EBV infection and then the MS status of the individuals determined during the period of active duty.

5.3% of individuals whose blood were tested were EBV-negative (as I said, most of us are infected) and in a sample of ten million that’s about half a million people.

Among the personnel examined, 955 MS cases were identified, of which 801 cases had several blood samples available taken at differen times. For each one they looked at three serum samples taken BEFORE onset of the symptoms. Each case was matched with at least one non-MS-afflicted control individual of same age, sex, ethnicity, branch of service, and date of blood collection.

The results were pretty compelling. Under the causation scenario, you’d expect MS to develop almost entirely in the group that were initially EBV negative but then got infected, and only then did they develop MS.

And that’s what they found. To quote the paper:

Only one of the 801 MS cases occurred in an individual who was EBV-negative in the last sample, which was collected at a median of 1 year before MS onset [hazard ratio (HR) for MS comparing EBV-positive versus EBV-negative = 26.5; 95% confidence interval (CI): 3.7 to 191.6; P = 0.001, conditional logistic regression]. At baseline, 35 MS cases and 107 controls were EBV-negative. All but one of these 35 EBV-negative MS cases became infected with EBV during the follow-up, and all seroconverted before the onset of MS (fig. S3). The median time from the first EBV-positive sample to MS onset was 5 years (range: 0 to 10 years), and the median time from estimated EBV seroconversion, defined as the midpoint between the last seronegative sample and the first seropositive sample, to MS onset was 7.5 years (range: 2 to 15 years).

Remember, all of the 801 cases were EBV negative at the first sampling. Then all but one of the individuals who developed MS had gone from EBV negative to EBV positive. (The authors discuss the one outlier case, but you can read that for yourself.) To see if it was really EBV that was associated with the onset of MS, they looked at other viruses as well, and also looked at other disease markers that could show whether MS had already begun (but without physical symptoms) when the patients were still EBV-negative. (They didn’t find that.)

They did other tests as well trying (like good scientists) to try to rule out a causal role of EBV in MS. They ruled out “confounding by unknown factors” because of the strong association between EBV infection and later development of MS. No risk factor could account for the huge increase in MS propensity among those who went from EBV negative to EBV positive.

The other factor was “reverse causation”: perhaps EBV doesn’t cause MS, but the early development of MS, not detected clinically, could make a patient more susceptible to EBV infection. This is ruled out because only the EBV virus was associated with the pathology, while one would expect the “reverse causation” syndrome to make MS patients more susceptible to other viruses.  That wasn’t seen.

I won’t go on except to show this graph, which displays significant differences in the level of antibodies against various human viruses between controls and those who got MS (remember, these are all EBV negative people at the start of the trial.) The blue bars represented antibodies against viral proteins that showed higher levels in controls than in those who got MS, while the orange bars represent the level of antibodies  significantly higher in the blood samples of those those who got MS than the controls. As you see, the level of antibodies against EBV is much, much higher in the pre- and post-MS-onset blood samples than in the control (no MS) samples. In other words, no other virus beside EBV was associated with MS either before or after the symptoms appeared.

The last paragraph of the Science paper suggests MS therapy with monoclonal antibodies against the viral proteins might be better than current therapies, and in fact we’re using monoclonal antibodies now to help patients already infected with Covid-19.

But a better tactic would be not to get the disease in the first place, and the tweet below suggests a vaccine that might do this is in development. And if EBV is associated with all those diseases mentioned above, like cancer and inflammatory bowell disease then a jab when young might stave those off, too!

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Reference:

Bjornevek, K. et al. 2022. Longitudinal analysis reveals high prevalence of Epstein-Barr virus associated with multiple sclerosis. Science,10.1126/science.abj8222(2022).