Category: medicine and health

American Academy of Pediatrics pulls back on “affirmative care” while a Seattle hospital pushes it, offering surgery and puberty blockers to adolescents

August 23, 2022 • 11:45 am

Enlightened medical opinion seems to be coming around to the view that for adolescents who want to change gender, i.e. become transsexual, the use of puberty blockers is not necessarily a good way to go. The blockers, which are supposed to stop puberty in its tracks (in a completely reversible way) are given to allow young people a pause to ponder their options. But they are increasingly seen as untested and possibly unsafe. European countries like Sweden, France, and Finland have either limited the use of puberty blockers to “exceptional cases” or clinical trials, or have prohibited their use entirely.

This is all part of a pushback against “affirmative care”: the idea that if a child decides they want to become transsexual, they must be completely supported, with psychotherapy not examining their decision or encouraging throughtful assessment, with parents urged to accept their child’s wishes, and with the medical establishment dispensing whatever hormone therapy or surgery the child wishes.

The problem with this is not that support shouldn’t be given. It’s that children or teenagers who are too young are being pushed by doctors, parents, and peers to make decisions about issues that may involve irreversible medical interventions. European countries vary in the age at which sex reassignment surgery is legal, usually ranging from 15 to 18. For transgender hormone therapy, ages in Europe range from a minimum of 14 up to 18, with most countries having minimums of 16 to 18.

That kind of therapy causes irreversible changes in the body, while genital surgery renders one sterile and often incapable of orgasm. I have no strong views on age limits except that they should be after puberty and not lower than 16. Your mileage may vary.

And I’ve just discovered, through an article in the City Journal, that the American Academy of Pediatrics, which used to be all for “affirmative care”, seems to have suddenly started reevaluating its position. The article notes this:

Moira Szilagyi, president of the AAP, has written that “gender-affirming care . . . doesn’t push medical treatments or surgery; for the vast majority of children, it recommends the opposite.”

This is a welcome development, and marks a reversal of the AAP’s previous policy. That policy was announced in a 2018 Pediatrics article, whose lead author was Jason Rafferty; it argued that “watchful waiting” is akin to “conversion therapy” and should be avoided. “Watchful waiting” refers to an approach that emphasizes psychotherapy as a measure of first (and hopefully last) resort to help minors in distress feel comfortable in their bodies. Its premise, confirmed by 11 studies, is that the vast majority of children with gender dysphoria will desist by adolescence and feel comfortable enough in their bodies not to require medical transition. The Dutch researchers who developed pediatric transition explicitly warned against early transition. Yet transgender activists in the United States have criticized this model, insisting that because transgender identity (i.e., body rejection) is a normal and healthy aspect of human existence, mental health professionals should never steer patients toward a “cisgender” outcome.

If Szilagyi believes that medicalization is the wrong way to go “for the vast majority of children” with gender dysphoria, then this constitutes a de-facto repudiation of the Rafferty statement and the AAP’s previous policy.

Here’s an extract from AAP President Szilagyi’s piece, an an op-ed in the Wall Street Journal called “Academy of Pediatrics Responds on Trans Treatment for Kids: To ‘affirm’ a child or teen means destigmatizing gender variance and promoting the child’s self-worth.”

Regarding Julia Mason and Leor Sapir’s op-ed “The American Academy of Pediatrics’ Dubious Transgender Science” (Aug. 18): In its recommendations for caring for transgender and gender-diverse young people, the AAP advises pediatricians to offer developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience. This care is nonjudgmental, includes families and allows questions and concerns to be raised in a supportive environment. This is what it means to “affirm” a child or teen; it means destigmatizing gender variance and promoting a child’s self-worth. Gender-affirming care can be lifesaving. It doesn’t push medical treatments or surgery; for the vast majority of children, it recommends the opposite.

This isn’t the story that is being told by anti-transgender activists. No European country has categorically banned gender-affirming care when medically appropriate. Contrary to what Dr. Mason and Mr. Sapir claim, the U.K. isn’t moving away from gender-affirming care. It is moving toward a more regional, multidisciplinary approach, similar to what is practiced in the U.S.

This does seem to be a change of policy. “Affirmation” no longer means “go full steam ahead for the gender change” but, properly, to “promote a child’s self-worth.” Further, affirmative care no longer means “pushing medical treatments or surgery; for the vast majority of children it recommends the opposite.”

I’d say that this is a move towards enlightenment, even if it was promoted by what European countries are doing. It’s not clear, though, that this will become the AAP’s official policy.

Nevertheless, some places, like Seattle Children’s Hospital, continue to offer surgery, puberty blockers, and hormones to children as young as nine. Granted, you need parental permission for this treatment, and you can’t get bottom surgery until you’re over 18, but dispensing blockers, drugs, and cutting off the breasts of females younger than 16 is not something I’m a fan of.

This story comes from KOMO news in Seattle, a station and website affiliated with ABC, and you can check its assertions by going to the Seattle Children’s Hospital website on gender care (link below). Click to read:

This is from KOMO:

The gender clinic at Seattle Children’s Hospital (SCH) provides children as young as 9 years old with “gender-affirming medical care,” like puberty blockers, and children in their “mid-teens” with non-genital transition procedures known as “top” surgeries.

We accept new patients ages 9 to 16,” the SCH gender clinic website states. “Patients ages 17 and older and patients who have not yet started puberty will be directed to community resources.”

The website notes that the clinic “primarily provides gender-affirming medical care (such as puberty blockers  and gender-affirming hormones)” to patients. Children must receive parental consent for any “gender-affirming” treatment.

“Brief mental health support” is also available, according to the site, but the clinic suggests that “if you are looking for gender-affirming mental health services only, or for ongoing mental health support,” there are better resources that focus solely on that.

Patients must be 18 years or older to receive gender transition surgeries involving genitals, such as vaginoplasties and phalloplasties, according to another page on SCH’s gender clinic website.

Sure enough, the website link given above says this:

We accept new patients ages 9 to 16. Patients ages 17 and older and patients who have not yet started puberty will be directed to community resources. Our clinic primarily provides gender-affirming medical care (such as puberty blockers and gender-affirming hormones). Brief mental health support focused on family decision making and mental health documentation prior to initiating gender-affirming care is also available. If you are looking for gender-affirming mental health services only, or for ongoing mental health support, here are some community resources.

Puberty blockers, with their attendant medical unknowns, are offered to children who have started puberty but haven’t completed it, and those in their “mid-teens” can get surgeries like double mastectomies, breast augmentation, thyroid cartilage surgery, and “facial gender-affirming surgery.” I can’t find the age at which hormone therapy is given, but I presume it’s either after puberty has begun or in one’s mid-teens.

But there are some claims that seem dubious, like these given at the Hosptial’s pdf on puberty blockers:

No, puberty blockers are not permanent. If you decide to stop puberty blockers without starting cross sex hormones, your body will start going through the puberty of your sex at birth. You can stop the puberty blockers at any time, but we will work with you on how to do that.

We can safely and legally recommend puberty blockers for you based on our medical experience and judgement and your specific health needs. The Endocrine Society and the World Professional Association for Transgender Health support puberty blockers. The Food and Drug Administration (FDA) approves puberty blockers for children who start puberty at a very young age, but has not approved puberty blockers for transgender children.

But at the same place they say this:

The long-term safety of puberty-blocking medicines is not completely understood. There may be long-term risks that we do not know about yet.

Indeed, this is in line with Britain’s new NHS guidelines to not give hormonal treatment, including puberty blockers, to adolescents under 16. Further, Sweden’s Karolinska institute says this:

  • In light of the above, and based on the precautionary principle, which should always be applied, it is hereby decided that hormonal treatments (i.e., puberty blocking and cross-sex hormones, see above) will not be initiated in gender dysphoric patients under the age of 16.
  • For patients between ages 16 and 18, it is hereby decided that treatment may only occur within the clinical trial settings approved by the EPM (Ethical Review Agency/Swedish Institutional Review Board). The patient must receive comprehensive information about potential risks of the treatment, and a careful assessment of the patient’s maturity level must be conducted to determine if the patient is capable of taking an informed stance on, and consenting to, the treatment.

The U.S. is often touted as having the world’s best medical care. But when it distorts the dangers of hormonal treatment, or rushes children and adolescents onto an escalator towards transsexuality without proper therapy and information, it’s a travesty.

h/t: Williams

The death of the Tavistock clinic, recounted by one of the whistleblowers

August 5, 2022 • 12:00 pm

Sue Evans was a nurse therapist working at the Tavistock Clinic in London, dealing largely with issues of gender dysphoria in young people. In this piece from Bari Weiss’s Substack (again, subscribe if you read regularly), Evans describes how in the early 2000s the clinic became a place of fulminating “affirmative therapy”, changing its normal procedure of talk therapy to the willy-nilly dispensing of puberty blockers and hormones—all without any thoughtful examination of what was happening. If there was any “social contagion”, it was among the sheeplike employees at Tavistock who jumped aboard a woke juggernaut at the expense the patients’ well being.

Click to read. Because this has already been covered widely, I’m mentioning it for those who haven’t yet read what happened at Tavistock. You are probably aware that after an independent report on the clinic, the NHS has now ordered its closure, with its functions farmed out to several geographically distributed sub-clinics, and with a lesser concentration on “affirmative therapy” and less recommending of drugs to facilitate transsexual changes.

It wasn’t that long after Evans had been working at Tavistock—which I didn’t realize was a clinic specializing largely in talk therapy—before the idea of giving puberty blockers and hormones to gender dysphoric patients swept through the clinic, much to Evans’s dismay, since there was hardly any expertise there in using drugs for gender transitioning.

And then social contagion, stemming from advocacy groups, intensified the pressure to use drugs.

Evans:

The external influence of the advocacy groups increased. Instead of being a clinical, research-focused service where we were learning and developing ideas, it felt like it was a fait accompli that we had to go along with what Mermaids [an advocacy group] and patients wanted—even if we, the mental-health-care professionals, had legitimate questions about the appropriateness of the treatments that patients and patient advocates were demanding.

For example, a weird paradox arose at a conference on transgender health care hosted by Tavistock around 2005: the opening speaker declared that we were no longer supposed to think of gender dysphoria as a mental illness. But we were a mental-health team working at a mental-health facility. What were we supposed to be doing if not treating patients with psychological conditions?

Remember, this was all before the internet took hold of an entire generation of teenagers. There were no online groups dedicated to gender affirmation and coaching kids on what to say to their providers to secure cross-sex hormones. We mostly saw younger boys who believed themselves to be girls from an early age and a few teenagers who felt like they were trapped in the wrong bodies. So, although I felt aware of the gathering force of thinking around the area of gender dysphoria and transgender identity, it was hard to foresee the slow-motion avalanche that would hit over the next two decades.

Yet even what I saw in those years worried me deeply and working on the Gender Identity Development Service started to affect my personal well-being. I would come home with a headache on the days that I worked in the unit, and my heart would beat quickly when I went in the next morning. It felt like every time I raised a concern about us rushing prematurely to prescribe drugs that would have permanent effects on our patients, I’d be met with an eye roll and the unstated “Oh, here she goes again,” or “Can’t she just fit in?”

A concerned Evans went to the clinical director of Tavistock and raised these issues, and this led to an investigation of the clinic—in 2006.  Evans didn’t see the results of that investigation until 2019, but it was damning. Sadly, the conclusions were also buried:

It was only in 2019 that I saw the full report when Hannah Barnes, a BBC journalist, obtained it via a Freedom of Information request. It confirmed all the disturbing things I had reported: Our data was poor; it wasn’t being stored properly; and there were not sufficient follow-ups with patients once they left the service—meaning we didn’t know how our patients were faring unless they voluntarily wrote to us.

As we have now learned from more recent whistleblowers, the recommendations in the report were buried, and when any criticism or difficult questions arose in the press, the Tavistock management would repeat the same mantra about how they were “a world-class service.” It’s important to acknowledge that there might have been some staff still struggling to deliver thoughtful, measured care, but the noise around our standards was growing louder.

In the face of an unchanged work milieu, Evans quit her work on gender-dysphoric patients. That’s when an explosion of referrals hit the clinic—mostly biological female adolescents who wanted to transition to the male gender. Later, when one of them—who had been rushed through puberty at 16, went on testosterone at 17, and had a double mastectomy—participated in a lawsuit against the clinic, Evans signed on as a co-claimant. They won, with the ruling that minors under 16 could not give informed consent for puberty blockers (these nearly always lead to hormone injections and full transition). But they lost the appeal.

Then, in September 2021, the government commissioned another report on Tavistock, and this one disbanded the facility, farming out its mission to other clinics and deemphasizing the default use of drugs to transition as well as urging more emphasis on objective but empathic talk therapy as a first line of treatment. This result we all know.

Evans had a rough time of it, but ends on a high note:

I didn’t seek any of this. It has been a pretty stressful few years. When I get a letter from patients or parents from around the world, and they tell me, “Well done, thank you for speaking up, you didn’t give up,” I sometimes get a lump in my throat. It’s been hard to be suspected of being prejudiced when all I wanted was safer clinical practice, more scrutiny and evidence collecting, and improved data storage.

Because what I am is a nurse. And my job as a nurse is to treat all my patients with respect and an open mind. I try to think about who they are as people, and to relate to their experience and empathize with them. I also believe we need to keep an open and curious clinical mind when something is occurring in society that seems novel or not yet fully understood. It should never be that doctors and nurses are unable to question diagnoses and prescriptions.

If my actions all those years ago have made a contribution, then I am proud. I made the right decision to raise my hand to ask another unwanted question.

There will come a time, I think, when this rush to transition, with its attendant use of “affirmative therapy”, puberty blockers, and hormone treatment, will be seen as a crazy era in medicine and therapy. Of course there are people for whom this kind of transitioning is the right thing to do, but what we often see now is madness, with affirmative therapy being pushed not because we have evidence that it’s the best thing to do for gender dysphoria—we don’t  have that evidence—but because it’s ideologically “proper.” If someone suggests that they feel as if they might belong in a marginalized group, the philosophy now seems to be to get them in that group as soon as possible, ignoring other outcomes of dysphoria, like homosexuality.

Recent pushback on “affirmative care” and hormone blockers

July 31, 2022 • 9:15 am

I’m guessing that some day historians will look back at the mishigass surrounding “affirmative care” and wonder what the deuce was going on in America in the 2020s.

Now let me say at the outset that I have no objection to people with “gender dysphoria” changing their gender using drugs and surgery. But I also think that transitioning should not be allowed until after puberty, and for two reasons. First, we don’t know eough about the safety of “puberty blockers” used to stop the process while adolescents figure out their sexual identity, and second, because children who are too young to make mature judgments should not be allowed to make irreversible decisions about their bodies. Eighteen seems to me to be an appropriate age to begin a medical process of transitioning.

My objection to “affirmative care” is not that we shouldn’t treat young people repectfully when they have with a sincere desire to transition, or fail to support them. But in the U.S., and previously in the UK, the default option was “affirmative care”, with no real psychological probing to dissect the roots of gender dysphoria and see if it was a form of distress that might resolve into a child becoming gay. “Affirmative care”, in its most extreme form, pronounces children who question their sexuality as transsexuals, deems them ready to change sex, and encourages them to go on puberty blockers and then hormone therapy. (There are few adolescents who, once on blockers, decide to stop them and “de-transition.”)

I’m cautious because the huge rise in the number of adolescents who declare themselves transsexual (particularly biological women who want to change gender) could have a number of causes: a relaxation of the stigma against transsexuality, an increase in the genetic propensity to change gender (that’s impossible given the rate of the rise), or—as Abigail Shrier argues in her book Irreversible Damage, a sort of social contagion—a sense among young people that it’s far more cool to be trans than to be gay, and because such people get a lot of props and attention. (Shrier doesn’t claim that transition is always prompted by social contagion.)

Only the first and second hypotheses are supportable, and I think both are at play, but to deny that social contagion hypothesis plays any role in the temporal changes shown below is to deny reality. There are simply too many cases of seeing “detransitioners” (“desisters”) discuss the social pressure they were under, and of others seeing it at play in real life.

Below is an article by writer Lisa Davis you should read (click the screenshot). It’s on Bari Weiss’s site (and I don’t want to hear that Weiss is “alt-right” so that you can ignore it), and explains how several European countries, including the UK, Sweden, France, and Finland, are changing course on affirmative care, replacing it not with a refusal to let people transition, but with a more compassionate and psychologically-oriented inquiry into the roots of gender dysphoria.

The change in Europe comes from a realization of the weakness of the evidence supporting two assertions of trans activists: that puberty blockers are completely harmless and can be completely reversed if someone changes their mind, and that allowing medical transitioning reduces the rate of mental illness and suicide among those with gender dysphoria. We now know that the evidence for the first claim is wrong, and for the second is plagued by methodological weaknesses. We simply need a lot more data, and the Europeans are being cautious while Americans ignore the counterevidence. That’s unwise given the drastic and irreversible nature of many transitions.

Here’s a graph from the article above showing the increase in referrals to the gender-affirming Tavistock clinic, and this is just between 2009 and 2017 (original source here). Both the proportion of and the increase in biological females (compared to males) referred to the clinic for affirmation have increased substantially. If your hypothesis is that the rise reflects purely the de-stigmatizing of transsexuality, this discrepancy between the sexes must be explained. Of course, it also has to be explained if you hold a “social contagion” hypothesis.


 

I completely agree with Andrew Sullivan in his Friday column section called “Yes, the trans madness is real” when he says this:

I recall a few years ago having a heated conversation with some well-meaning trans activists who appeared completely aghast when I voiced some worries about the treatment of kids with gender dysphoria. What if the kid is gay, I asked? How do we know for sure if a pre-pubescent child really is trans and not just experimenting with gender the way many gay kids do? And are these nine-year-old children really mature enough to make life-long decisions that could make them permanently sterile, keep them on drugs for the rest of their lives, or permanently remove their capacity to have an orgasm? How could pre-pubescent kids even know what an orgasm was?

My activist friends were shocked. It seemed to me as if they had never previously been asked these questions. They were all very-well intentioned, and not entirely wrong — in a few extreme cases, there might be a reason to permanently change a child’s sex. But they assured me that no such errors were ever made, that the process was entirely ethical, and that all medical authorities backed it. They insisted that puberty blockers were harmless and fully reversible. The bubble is real.

I think it’s better to give kids with gender dysphoria extensive psychological counseling—NOT affirmative from the outset, i.e., not “affirming” that children who say they’re of another gender must be right—before giving them irreversible medical treatment, treatment that we now know can render people sterile, unable to enjoy sex, and, in the case of puberty blockers, cause other medical damage. Sullivan, who experienced dysphoria himself, says that many adolescents go through a period of confused sexuality, and perhaps would become gay were it not more fashionable to change gender.

Both articles detail some big changes in Europe about how to treat gender dysphoria. I’ll summarize what most of us know already (the first article above gives links):

  • Sweden has revised its guidelines for treating gender dysphoria in adolescents, arguing that gender-affirming treatment may be more harmful than good, and claiming that affirmative treatment “should be offered only in exceptional cases.”
  • Finland, using an evidence-based approach showing that many young people seeking transitioning had severe psychiatric problems, that there were risks to using puberty blockers (see below), both physically in in terms of sexuality, changed its protocol for treating gender dysphoria:

(From Davis’s piece): In Finland, for patients who fit the profile of participants in the Dutch study, after a prolonged period of evaluation, and with a multidisciplinary team including a psychiatrist, psychologist, social worker and nurse, puberty blockers may be started near the onset of puberty, and cross-sex hormones may be possible starting at age 16. Assessments take place at two gender identity clinics; gender surgeries are offered only at one center. Both Finland and Sweden now stress gathering data and extensive follow-up.

My own view is that giving puberty blockers “near the onset of puberty”, or at age 16, is too young.

  • The National Academy of Medicine in France has urged caution in proceeding with drugs and surgery in cases of gender dysphoria since some of it may be due to social contagion. It recommends more extensive psychological counseling of those with gender dysphoria.
  • The Tavistock clinic in London (a notorious place for affirmative therapy) is to be closed, replaced by a number of regional clinics practicing a different brand of care. This is the result of a critical review headed by Dr. Hillary Cass, commissioned to review Tavistock and its practices. Their recommendations, which the government accepted, was to de-centralize the clinics, adopt more “holistic care”, and ratchet back on the use of puberty blockers, which now appear to have possibly severe medical consequences.
  • The medical consequences of puberty-blocking drugs like Lupron, which according to Sullivan have been known for a while, include brain swelling and loss of vision, possible bone damage, and other irreversible effects. In fact, these blockers are used for other conditions, and I understand are always prescribed by doctors treating gender dysphoria “off label”, i.e., they’re not specifically recommended by the FDA for stalling puberty while a child ponders its gender.

This month the FDA added brain swelling to the warning labels of puberty blockers. The sample size is small, and these problems appear only in biological females (the most common sex experiencing gender dysphoria), but an FDA warning is nothing to take lightly. Here’s a tweet about the dichotomy between the American use of blockers willy-nilly in American “affirmative care”, and the warnings on drug labels. Clearly, more research needs to be done (that’s what Sweden and Finland concluded) before blockers are used so readily. But, in contrast to the caution about other new remedies, like Covid-19 vaccines, the standards for usage are very lax in the U.S., and were in the UK as well:

Nevertheless, as both Sullivan and Davis point out, the U.S., urged on by the Biden Administration, is going full steam ahead with affirmative care.

Sullivan:

In the US, however, as many states move in the European direction, the left is pushing harder. California has a bill offering sanctuary for any child seeking a sex change. The Biden administration still insists that “every major medical association agrees: gender-affirming care is life-saving, medically necessary, age-appropriate and a critical tool for health care providers.” The absolute certainty, compared with the second thoughts in Europe, is striking.

Davis, referring to Finland and Sweden’s revised guidelines in comparison to America’s (my emphasis):

Both guidelines starkly contrast with those proffered by the Illinois-based World Professional Association of Transgender Health, an advocacy group made up of activists, academics, lawyers, and healthcare providers, which has set the standard when it comes to transgender care in the United States. WPATH will soon issue new standards that lower recommended ages for blockers, hormones and surgeries. (WPATH did not respond to a request for comment.)

WPATH’s position is in keeping with an array of U.S. medical associations and activist groups across the country that insist gender-affirming care is “life-saving.” Assistant Secretary of Health Rachel Levine, who is herself a transgender woman, recently asserted that there is a medical consensus as to its benefits. Some activists and gender clinicians in the U.S. feel that WPATH doesn’t go far enough, asserting that any child who wants puberty blockers should get them, for instance, or claiming that a teenager who later regrets having her breasts removed can just get new ones.

In Sweden and Finland, this issue has been primarily a question of health and medicine. Here in the U.S. it is a political football.

Why the ignoring of evidence and lack of caution in the U.S. as opposed to Europe? Why are we not following the examples of countries that take an evidence-based approach to medical policy about gender dysphoria? Surely one of the reasons is “wokeness”: the idea that changing gender is to be admired as an act of courage, and that transgender people, or those who wish to become so, should be valorized as members of stigmatized minorities. And, sadly, the Biden administration has bought into the pronouncements of the extreme Left, which include unquestioning approbation for “affirmative care.”

Yes, there’s some stigma about transgender people, and yes, we should help those who, after intensive medical and psychological examination, are deemed to be serious about their gender misindentification rather than confused about their sexuality. And yes, we should treat transgender people in nearly all respects as equals to members of the biological sex they assume.  But what we should not do is, in the interests of seeming virtuous, rush children and adolescents into very serious and irreversible medical procedures without proper vetting.

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)

_________________________________

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 days29–32; 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