Trump administration places severe restrictions on fetal tissue research, impeding medical progress

August 6, 2020 • 9:00 am

Let me make this clear from the outset: fetal tissue used for research is taken from abortions that women elect to undergo. The tissue has shown enormous promise for medical research, including its past use in developing the polio vaccine, as well as making useful advances in AIDS research, birth defects, Down Syndrome, spinal cord injuries, organ transplants, diabetes, and many other conditions. The reason fetal tissue is used rather than, say, adult tissue from cadavers is because fetal tissue retains an ability to transform itself into various types of tissue, and also grows faster than adult tissue. Further, because fetal tissue doesn’t elicit nearly as strong an immune response as does adult tissue (you can imagine why this is the case; think pregnancy), you can create strains of mice that have a weakened immune system and also carry fetal tissue in them, facilitating experimental work. (These are known as “humanized mice” and reader Simon has an explanation below the fold about how they’re made and what they’re good for.)

Over the years, conservatives, especially religious ones, have objected to the use of fetal tissue in research because it’s seen as parts of dead babies (i.e., humans with “souls”), with some hinting darkly that allowing the work could actually promote abortions. But if that tissue can save future adult lives, and comes from dead fetuses whose tissue would be otherwise destroyed, what kind of inhumane calculus would forbid its use? Further, I can’t imagine that a single woman who wanted to have her baby would volunteer to have an abortion instead so that the fetal tissue could be used in research. That idea is insane. There is no rational objection to the use of fetal tissue in research save that its use undergoes the same kind of ethics vetting as other use of human tissue, which it already does.

But now, after more than twenty years when government-funded agencies like the National Institutes of Health (NIH) permitted such research, the Trump administration is putting clamps on it, as reported by the article below in the Washington Post (click screenshot to read it). They add that “officials say the president made the final decision.”

The impediments to research come in the form of requiring all government-funded work on fetal tissue to be approved by a new ethics committee beyond the vetting normally used in such research. The kicker is that the committee hasn’t yet been constituted, and may not be for a long time to come. The result is that nobody is writing government grants to do work on fetal tissue. Further, every grant approved by this perhaps-to-be-constituted-someday committee must also be approved by Health and Human Services Secretary Alex Azar, who has the final say. Finally, the new rules require that any research using fetal tissue document that the tissue come with an assurance from the provider that the donating woman provided informed consent, which brings up questions of privacy, both of the women and of the clinics and tissue banks who provide the material.

The ethics panel, if it actually materializes, will meet only once a year, far less often than the number of NIH deadlines.

Current NIH grants using the tissue can continue till they expire, but no future grants are being written, and research on fetal tissue within the NIH has already been halted, as have training grants that use the tissue. Private companies can continue the work, but the big majority of fetal-tissue work is funded by the government, and even for private companies the cost of using “humanized mice” without government support will be prohibitively expensive.

Some researchers are investigating replacement material, like using “deprogrammed” adult tissue, but nothing so far has proven as useful in research as the fetal tissue.

For a vigorous argument by two researchers on the value of using fetal tissue, and what progress has come from it, click on the screenshot below to read an article in Stem Cell Reports:

Again, there is no rationale—beyond the religious view that somehow fetal tissue is sacred—to support this new decision. Without the research, the fetuses would be disposed of normally, and that doesn’t mean burial. So, under pressure from the religious Right, Trump and his administration have slowed down medical research, possibly sacrificing lives that could be saved, and for no good reason. Even Francis Collins, head of the NIH and an evangelical Christian, favors the use of fetal tissue in research.

Once again we see a conflict between faith and fact, with faith impeding not just the discovery of important facts, but ones that could save lives. What kind of tradeoff are these religious crazies making?

h/t: Bat

Click “read more” if you want to learn how “humanized mice” are made. Continue reading “Trump administration places severe restrictions on fetal tissue research, impeding medical progress” →

My emergency-room bill

June 3, 2020 • 11:45 am

On May 6, as I reported, I ripped my ear open on a jagged tree branch while running between the ponds. I didn’t show the picture of the carnage here as it was extremely bloody. I sent a photo to my GP, as it wouldn’t stop bleeding, and he told me to go to the emergency room in the time of the cornavirus, for I’d need stitches. He added, which was true, that it would be pretty much empty because people were afraid to get the virus, even in the ER. But I had to remove my mask during the stitching, as it was around my ear.

As I reported, the ER had a lot of precautions, including taking your temperature, socially distancing you in the chairs (only one other guy was waiting, along with three cops who had a professional interest in being there), and ensuring that everyone wore masks.

I was in there for about 5 hours, most of that time spent waiting. Finally, a nice resident in ENT came down and sewed me up, tossing the bloody gauzes on the floor during the long process, so that the floor looked like a MASH unit when we were done. It took about 11 stitches, and was very painful despite the anesthetic—and I consider myself pain-resistant. At any rate, I’m better now, and the stitches fell out, as they were supposed to.

I just got the bill, along with my portion not covered by insurance, which was larger than usual because it was an ER visit. For those of you who are blessed with single-payer medical care, and pay nothing or very little beyond your taxes, here’s my bill:

Actually, it was about $200 more than this because of some other charge. I paid about $200 total. $6,412 is a lot of dosh, but more or less what I expected.

Hydroxychloroquine and chloroquine are not only useless in treating Covid-19, but very harmful

May 22, 2020 • 10:30 am

UPDATES: The discussion of this paper has gone back and forth, and the cause is that neither Alex nor I read the paper carefully. I just skimmed it, and Alex read it quickly but paid most of his attention to the tables. That led to this first update in which he concluded (and I agreed) that the study wasn’t very useful at all:

UPDATE 1:

In two comments below, my own physician, Dr. Alex Lickerman, who carefully read the study I describe below (see his first comment and his second), noted that the sickest patients were the ones more likely to be given the chloroquine drugs, and were also the patients with the highest comorbidities—factors like heart disease that would tend to make them sicker. In other words, as Alex notes,

So–was it the drugs that were responsible for their increased likelihood of death or the risk factors already known to increase the likelihood of death? We simply can’t tell from this study. This is the problem with the observational study design. We CAN almost certainly say that hydroxychloroquine and its ilk don’t improve survival in COVID-19, but whether or not they increase mortality in COVID-19 we don’t yet know.

This is only part of his analysis; read the whole thing in comment 1. He also notes in his second comment that there is no evidence that using hydroxychloroquine as a preventive has any benefit.

I am guilty of not having detected the flaws in the study, which are, I found, not even clearly pointed out by its authors in the traditional “here-are-some-weaknesses-in-this-study” part of the paper, and I thank Alex for the clarification. But even more culpable are the reviewers of that study, who did not insist on a clear outline of its limitations, as well as the medical/science journalists, who touted the study uncritically (like me!) Alex has helped me learn that many medical studies, even in journals as reputable as The Lancet, are pitifully weak or even fatally flawed.

UPDATE 2: In a very useful comment, reader BillyJoe noted that the paper does indeed say that the paper controlled to some extent for comorbidities, so its conclusions are stronger than we thought: we can have more confidence in its conclusions that hydroxychloroquine and chloroquine are positively dangerous when given to people sick with Covid-19. Alex then said yes, he was wrong about the study not taking into account comorbidities, and has posted this comment in the thread:

Yikes! I’m guilty of the same criticism I made of others: not reading the trial carefully. You are absolutely correct that the authors made good-faith attempts to control for the inequalities/confounding variables between treatment groups. This is still a statistical adjustment, not a direct measurement as would be done in a randomized trial, so must be taken with a grain of salt, but to the authors’ credit, they address that.

The problem does remain that when you do the randomized trials, results are often different because of confounding variables the authors didn’t know about and therefore weren’t able to statistically adjust for—but also because sometimes their multivariate analysis (meant to adjust for known confounding variables)–also wasn’t adequate. So we still need a randomized trial to really know the answer definitively.

Nevertheless, I withdraw my criticism of the authors and the Lancet reviewers. I guess this is a good example of why science and statistics should always be done by more than one person! I’m quite embarrassed to have made this mistake. I apologize to readers and to our host, who must now fall on his sword with me.

___________________

Well, it’s official (I mean, of course, “provisional”): a new and large study published in the medical journal The Lancet (second link below; click screenshots to go to both articles) confirms that hydroxychloroquine and chloroquine not only don’t help patients seriously ill with Covid -19, but increases their mortality (in other words, kills them). Below is the CNN report, with a more layperson-y summary (my emphasis):

Researchers analyzed data from more than 96,000 patients with confirmed Covid-19 from 671 hospitals. All were hospitalized from late December to mid-April, and had died or been discharged by April 21.

Just below 15,000 patients were treated with the antimalarial drugs hydroxychloroquine or chloroquine, or one of those drugs combined with an antibiotic.

All four of those treatments were linked with a higher risk of dying in the hospital. About 1 in 11 patients in the control group died in the hospital. About 1 in 6 patients treated with chloroquine or hydroxychloroquine alone died in the hospital. About 1 in 5 treated with chloroquine and an antibiotic died and almost 1 in 4 treated with hydroxychloroquine and an antibiotic died.

Researchers also found that serious cardiac arrhythmias were more common among patients receiving any of the four treatments. The largest increase was among the group treated with hydroxychloroquine and an antibiotic; 8% of those patients developed a heart arrhythmia, compared with 0.3% of patients in the control group.

Note that the mortality in the control group was about 9%, rising to about 16% with chloroquine or hydroxychloroquine alone, and 20-25% when either of the chloroquine drugs was supplemented with an antibiotic (remember, antibiotics kill bacteria, not viruses like Covid-19. Clearly, refraining from using these drugs is the wisest course of action.

Here’s The Lancet study that went online today, and the findings and summary, while more comprehensive, are the same (“macrolides”, as is meant here, refers to a class of antibiotics that includes erythromycin). If you can’t access the paper, a judicious inquiry will yield it.

Findings:

96 032 patients (mean age 53·8 years, 46·3% women) with COVID-19 were hospitalised during the study period and met the inclusion criteria. Of these, 14 888 patients were in the treatment groups (1868 received chloroquine, 3783 received chloroquine with a macrolide, 3016 received hydroxychloroquine, and 6221 received hydroxychloroquine with a macrolide) and 81 144 patients were in the control group. 10 698 (11·1%) patients died in hospital. After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223–1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368–1·531), chloroquine (16·4%; 1·365, 1·218–1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273–1·469) were each independently associated with an increased risk of in-hospital mortality. Compared with the control group (0·3%), hydroxychloroquine (6·1%; 2·369, 1·935–2·900), hydroxychloroquine with a macrolide (8·1%; 5·106, 4·106–5·983), chloroquine (4·3%; 3·561, 2·760–4·596), and chloroquine with a macrolide (6·5%; 4·011, 3·344–4·812) were independently associated with an increased risk of de-novo ventricular arrhythmia during hospitalisation.

Interpretation:

We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.

You know the upshot: DO NOT TAKE HYDROXYCHLOROQUINE as a Covid-19 drug, as it causes heart problems and, overall, is much worse than standard treatment, doubling your chance of dying. This also means that since there’s yet no evidence that the drug staves off the virus, the side effects on those taking it as a preventive (like Trump) will also include heart issues. That’s been known from earlier but smaller studies.

What Trump is doing is not only injurious to himself (I suspect his heart is a ticking time bomb given his weight and penchant for McDonald’s food), but sets a terrible example to the public. It’s a President flaunting quackery, and of course his supporters are more likely to dose themselves or ask for the drug if they get the virus. The saving grace is that no decent doctor will give an infected patient hydroxychloroquine.

But remember, Trump’s osteopath official physician, Sean Conley, in consultation with Trump, decided that the potential benefits outweighed the risks when prescribing Trump the drug as a preventive. That’s doubly shameful: a faux President being treated by a quack physician with a useless drug, and the President bragging about it and lying about the drug’s “benefits.” No wonder other countries look upon the U.S. with pity!

Trump’s doctor, an osteopath, approved his patient’s use of hydroxychloroquine. That’s quackery, regardless of the doctor’s credentials.

May 20, 2020 • 11:00 am

As you know, last week Donald Trump asserted that he was taking hydroxychloroquine as a preventive for coronavirus, said that thousands of front-line medical workers were also taking it for the same reason, and argued that the drug had proved efficacious against the virus. Yesterday I thought that all three claims might be lies (the first two certainly are), but now the president’s physician, Sean Conley, has weighed in saying that the Prez is indeed dosing himself with the nostrum, and on Conley’s advice.

It turns out that Sean Conley is an osteopath, as outlined in this Guardian article (click to read the screenshot). Here are his credentials:

Conley received his Doctor of Osteopathic Medicine degree from the Philadelphia College of Osteopathic Medicine in 2006. He is a 2013 graduate of the Emergency Medicine Residency Program of Naval Medical Center Portsmouth in Portsmouth, Virginia. He received the Honor Graduate Award, Nurses’ Choice Award for Outstanding Senior Resident Award, and the Resident Research Award.

Here’s the letter testifying to Trump’s use of the drug on the advice of Conley:

Now I’m not going to say that Conley is a quack just because he’s a DO rather than an MD, though it is odd. Many osteopaths have training nearly identical to that of MDs, and some, I’ve heard, are fine physicians. But this one isn’t.

For Conley is violating the first part of the Hippocratic Oath (well, the revised version of that oath): “First do no harm.” And that’s the problem with hydroxychloroquine: it’s not only not efficacious against coronavirus, but it can be dangerous, causing heart problems, hallucinations, paranoia, and other “neuropsychiatric symptoms” (see article below), which gives one pause.

And Trump isn’t exactly the picture of health. According to the Guardian, he weighs around 239 pounds, just at the threshold of being “obese” (not “morbidly obese”, though, as Nancy Pelosi stated), sleeps 4-5 hours per night, eats a lot of junk food (especially from McDonald’s), and gets no exercise save golf (he probably uses a cart).

Only a fool, I think, would prescribe a useless drug that could be dangerous for someone in Trump’s condition—indeed, for someone in any condition. Conley is not practicing evidence-based medicine, and in behaving this way is endangering his only patient. But give Trump some “credit”, too, for he knows the stuff doesn’t work and is still taking it—perhaps to reassure Americans that there can be a preventive. As Trump argued, “What do you have to lose?” My answer, “Your life, fool!” Conley’s claim in the letter that “the potential benefit from treatment outweighed the relative risks” is pure cant—in fact, the statement cannot possibly be true based on the data we have.

The FDA itself has declared that hydroxychloroquine “has not been shown to be safe and effective”. What on earth is Trump’s doctor doing?

At any rate, the article below from Just Security (click on screenshot), ends with 9 questions for “Dr.” Conley.

Yes, it would be good if Conley answered those questions, but he won’t. Here are four of them:

4. What is the complete medical record of Donald Trump that might put him at risk of dangerous side effects in taking the drug? More specifically, does Trump have any history of heart trouble or disease, or any other medical condition that would make it dangerous for him to take this drug?

5. Conley’s memo states: “After numerous discussions…we concluded the potential benefit from the treatment outweighed the relative risks.” The use of “we” in this sentence is notable. Is Dr. Conley saying that he would not have recommended use of the drug? In other words, is Dr. Conley hiding that Trump’s views outweighed the physician’s sound medical advice of the risks? Why did it take numerous discussions?

6. If it is true that Trump is taking this drug, why has Dr. Conley knowingly prescribed a drug that the FDA and other authorities have determined is potentially fatal, and, moreover, whose beneficial effects on treating COVID-19 are unproven? Why has Dr. Conley prescribed a drug possibly risking the life of the president and in violation of FDA guidelines, medical standards, ethics, and professionalism?

9. Medical researchers have concluded that hydroxychloroquine may cause neuropsychiatric symptoms, “including agitation, insomnia, confusion, mania, hallucinations, paranoia, depression, catatonia, psychosis, and suicidal ideation.” Has Dr. Conley properly assessed his patient, President Trump, for his susceptibility to these symptoms? Since Trump has been taking the drug has Dr. Conley observed that it has produced or exacerbated any of these symptoms in President Trump?

I know that some people will be wishing for Trump’s demise from this drug (you can see it among the usual-suspect bloggers). I don’t wish for anyone’s demise, though I want Trump to be defeated in November. But by putting his imprimatur on the use of hydroxychloroquine to prevent Covid-19 infection, Conley is setting a terrible example not just for those worried about the virus, but for anyone who has confidence in modern medicine.

h/t: David

Dr. Lickerman on coronavirus: is a vaccine in the offing, what’s your risk of infection from casual contact, and what rules should businesses follow if they’re allowed to reopen?

May 14, 2020 • 10:45 am

I’m calling attention to a new post by my physician, Dr. Alex Lickerman—part of his continuing series on the pandemic and the virus. In this one, he lays out guidelines about how a business should operate to be opened safely if it’s allowed to and wants to; but he emphasizes at the outset that he is not recommending that businesses reopen:

If we consider the public health perspective only, maintaining the stay-at-home order still makes the most sense. We still don’t have a vaccine or effective treatment that lowers the mortality rate of COVID-19. Whenever large enough groups of people gather, there will be increases in the number of cases. Flattening the curve by maintaining the stay-at-home order spreads those increases out over time so that the healthcare system isn’t overwhelmed and everyone who needs a ventilator gets one.

and adds this:

So our purpose with this post isn’t to tell you whether or not reopen your business—that’s a judgment each of you have to make on your own—but rather to provide recommendations that will minimize the risk to your business and your employees if you do decide to reopen. We recognize that people are afraid both of contracting COVID-19 and of worsening economic disaster. Both fears are legitimate. But we think all decisions should be made based on science and statistics, not emotion. Our intent, then, is to provide you with the most accurate, up-to-date evidence-based statistics possible.

In fact, most of the post is devoted to discussing whether a useful vaccine is in the offing and what your chances are of contracting the virus from others, including those who are asymptomatic. The guidelines for opening a relatively safe business is at the end of the piece, and I’ll let you read that for yourself.

Click on the screenshot to read. Alex will be reading the thread from time to time, so feel free to ask him questions.

The stuff that interested me are two issues?

1.) What’s the story with a vaccine? And it’s worse than I thought. Not only will it take time to develop any vaccine, but it may not be possible to produce an efficacious vaccine at all:

Some have been thinking that we can’t fully reopen the economy until we have a vaccine. But how soon might that happen? We don’t know. We might never. We still don’t have one for hepatitis C or HIV. But even if we do develop one (and many are currently in the works), proving it both to be safe and effective will take time. To deliberately infect volunteers who’ve been vaccinated against SARS-CoV-2 to see if they’re immune would be unethical given the fact that the disease is fatal in some cases (you can do this with animals, but animals aren’t humans). Instead, once we have a viable vaccine candidate that’s passed Phase 1 and 2 trials, we immunize a large group of people and follow them through time, comparing their rates of COVID-19 infection to a matched group that hasn’t been immunized, all while observing for complications that didn’t show up in the Phase 1 or 2 trials.

Unfortunately, sometimes the treatment is worse than the disease. Studies show that when given immunizations to some diseases—dengue, respiratory syncytial virus, and SARS, for example—a paradoxical phenomenon occurs: subjects develop more severe disease. There are thought to be two mechanisms that cause this: 1) antibody-dependent enhancement, where a virus leverages the antibodies that we generate in response to vaccination to aid infection, and 2) cell-based enhancement, where immunization leads to severe allergic inflammation that can cause worse disease outcomes.

Unfortunately, vaccines used to induce mice to produce antibodies to the virus that causes SARS—a coronavirus similar to the virus that causes COVID-19—were shown to place the mice at high risk for life-threatening cell-based enhancement. Fortunately, when researchers altered their vaccine strategy and aimed to create a vaccine against only a portion of the spike protein of the SARS virus, cell-based enhancement was blocked. Sadly, funding dried up just as researchers were about to proceed to clinical trials in humans. Now, with the COVID-19 pandemic, that research is restarting.

Not only that, but even if you recover from the coronavirus, you may not have sufficient antibodies to mount a response to re-infection, much less show up on a test as having recovered from an infection. Alex’s bottom line is this:

We still don’t have a vaccine or know when or even if we will have one. We also don’t know if infection produces immunity, for how long that immunity might last, or if infection predisposes to a more severe course from re-infection.

2.) What kind of exposure to the infected or to asymptomatic carriers do you need to get the virus yourself? Here the news is a bit better: it appears that you need pretty sustained exposure to someone who’s infected or to an asymptomatic carrier to get a high risk of getting the disease. In other words, you need “close contact”. Now that can be someone sneezing in your face or coughing at you, but simply being in the presence of others for a short while without those things happening (especially if you wear an effective mask, and cloth masks, while better than nothing, are not nearly as effective as surgical masks), doesn’t put you in extreme danger. A few excerpts:

Thus, it seems even when people ignore current social distancing guidelines, the risk of transmission is, in fact, low, and—given the much higher rate among household contacts—largely determined by amount of contact time a person has with an infected patient. This is likely because with more contact time, higher risk scenarios are more likely to occur, i.e., coughing without a mask on, touching shared surfaces and then one’s face, and so on. It seems it’s not quite as easy as many think to encounter an infectious dose of the SARS-CoV-2 virus.

. . . . What does all this mean? First, transmission rates from contact tracing studies seem to cluster under 1 percent or around 10-20 percent. The difference may be due to behavior differences in study subjects, to differences in average contact time of close contacts with index cases, or to methodological differences in the studies. Whatever the reason for the differences in attack rates, all the studies suggest that when you have close contact with an infected person, the risk of becoming infected is, in fact, relatively low. Consider also that what defined “close contact” behavior in the studies above is behavior that most of us are now doing our best to avoid (e.g., being closer than six feet to others for a prolonged period of time or having unprotected direct contact with infected secretions).

. . . .What this means, among other things, is that everyone must become strict about self-quarantining once they show any infectious symptoms whatsoever (including: sinus congestion, runny nose, sore throat, ear pain, cough, vomiting, diarrhea, fever, chills, body aches, loss of smell or taste, discolored toes). In America, we’ve endured a culture of going to work while sick that must now end.

As for asymptomatic carriers, the chance of getting it, even when you work in an office with someone (and who is doing that now), is also low:

How likely would you be to catch COVID-19 from an asymptomatic person working in the same office as you? Research suggests that if you do have the kind of sustained close contact with asymptomatic cases that occurs in households (a reasonable surrogate for a workplace), the risk of catching COVID-19 is only 0.33 percent (compared to a risk of 3.3 percent for sustained close contact with mildly symptomatic cases, a risk of 6.2 percent for sustained close contact with severely symptomatic cases, and a risk of 13.6 percent for sustained close contact with someone who’s coughing and expectorating, meaning bringing up phlegm).

So we have some bad news (vaccine) and some good news (you’re not in as much danger of being infected as you thought).

Here are Alex’s previous posts on the coronavirus:

Two anniversaries today, both marking the end of wars, one against people, the other against a virus

May 8, 2020 • 9:45 am

I missed this because I left out today’s anniversaries in the Hili dialogue. There are two big ones today, both pointed out by Fiona Fox, director of the Science Media Centre in Britain. Dr. Fox quotes remembrances from two of her experts (h/t Steve Jones):

From Professor Geoffrey L Smith FRS, Head, Department of Pathology, University of Cambridge

Today is VE-Day. [JAC: the 75th anniversary.] It is also the 40^th anniversary of the WHO declaration of the eradication of smallpox, which in the 20^th century alone killed an estimated 400 million people, many more people than in both world wars. Whilst in the midst of another viral pandemic, we should remember the magnificent role that WHO played in ridding the world of smallpox and the power of vaccination. WHO should be encouraged, supported and funded in its efforts to control and eliminate COVID-19.

Quoting Macaulay, History of England 5, 2468-70, (1914)

“Smallpox, the most terrible of all the ministers of death: The smallpox was always present, filling the churchyard with corpses, tormenting with constant fears all whom it had not yet stricken, leaving on those whose lives it spared the hideous traces of its power, turning the babe into a changeling at which the mother shuddered, and making the eyes and cheeks of the betrothed maidens objects of horror to the lover”

Edward Jenner predicted the global eradication of smallpox in 1801 when he said

“it now becomes too manifest to admit of controversy that the annihilation of the smallpox, the most dreadful scourge of the human species, must be the final result of this practice”

Now let us do this to COVID-19.

JAC: Here’s what smallpox does even when it spares a life. This child will be irreparably scarred:

From Wikipedia: A child with smallpox in Bangladesh in 1973. The bumps filled with thick fluid and a depression or dimple in the center are characteristic.

And here’s the resolution: short, sweet, and succinct:

From Michael A. Skinner, PhD FRSB, Reader in Virology, Imperial College London

With attention focused on the 75th anniversary of VE Day, and distracted by the COVID-19 pandemic, an important anniversary may pass us by, with some relevance to our present situation.

On 8 May 1980, the 33rd Assembly of the World Health Organisation officially endorsed the successful eradication of smallpox in October 1979.

Several points are noteworthy:

Smallpox (with a mortality rate of about 30%) killed 300 million people in the 20th century alone (three times the death toll of both World Wars), and 500 million in its final hundred years).

– Smallpox is believed (informed by virus genome sequence data) to have “jumped” from an animal source millennia ago (there is good evidence it was present in ancient Egypt)

– No one can therefore seriously suggest that the variola virus that causes it arose from anything other than a natural source.

– Infections were controlled and reduced by vaccination; the disease was finally eradicated by a massive global campaign spearheaded by WHO.

– That campaign relied on rigorous and extensive field epidemiology, using a “track, trace and [ring] vaccinate” approach (with no rapid molecular diagnostics available at the time, diagnosis relied on recognition of the distinctive lesions and other symptoms)

– The final battlegrounds for the eradication were Bangladesh, Ethiopia, Kenya and Somalia, where the last natural case was identified.

Refs.

WHO commemoration of the 40th anniversary of smallpox.

Message below about celebratory press conference (including link) described on this page

And here’s a quiz for you. Another deadly viral disease, but in animals, has also been completely eliminated by a combination of monitoring and vaccination. This one was declared eliminated in 2011. Do you know the disease? Look here for the answer.

Faith-soaked physician to conduct study of prayer in curing Covid-19

May 2, 2020 • 10:30 am

Does prayer work to cure diseases? Anecdotal evidence from Lourdes, where amputees and the eyeless aren’t cured, suggest not. And we all know the results of the Templeton-funded study of the effects of intercessory prayer on recovery of cardiac patients, the most thorough study of intercessory prayer yet, involving over 1800 patients (Benson et al. 2006). Those results: no effect of prayer; or, as the study notes:

Our study had 2 main findings. First, intercessory prayer itself had no effect on whether complications occurred after CABG. Second, patients who were certain that intercessors would pray for them had a higher rate of complications than patients who were uncertain but did receive intercessory prayer.

In other words, the only effect even close to being statistically significant was that patients who knew they were being prayed for had more complications than patients not prayed for. Prayer worked in the wrong direction! That must have disappointed Templeton!

Further, a 2006 meta-analysis of 14 studies of medical effects of intercessory prayer showed no significant effects overall. The results and conclusions are in a red box below; note that the authors advise “that further resources not be allocated to this line of research.” (Click on screenshot to go to the study.)

But someone disagrees about there being no more need for research: Dr. Dhanunjaya Lakkireddy, a cardiologist at the Kansas City Heart Rhythm Institute. Lakireddy is doing a double-blind study of the effect of intercessory prayer on the mortality rates (and other indices of “being cured”) from Covid-19. NPR, which always has a weakness for the numinous, highlights it in the article below (click on screenshot):

There’s no audio yet, but the site says there will be. UPDATE: The online version is here, and it’s short (2 minutes) and not the same as the transcript. But there’s little difference between them.

Lakkireddy plans a study of 1000 patients in intensive care with Covid-19. Lakireddy is a true believer, and it shows in his comments to NPR (below). The emphases are mine.

“We all believe in science, and we also believe in faith,” Lakkireddy says. “If there is a supernatural power, which a lot of us believe, would that power of prayer and divine intervention change the outcomes in a concerted fashion? That was our question.”

We believe in faith? What does that mean? Faith is belief—belief without strong or convincing evidence! Perhaps Lakkkireddy means he believes that faith can cure, which is what he’s testing. But saying that we “believe” in science is a bête noire of mine, and bothered me enough that I wrote an article in Slate arguing that “faith” in science really means “confidence in the reliability of the methods and its outcomes”, not “blind adherence to unevidenced claims,” which is what religious faith is.

But wait! There’s more! Lakkireddy, who has dipped his toes into several faiths, and clearly has a weakness for the numinous, goes on:

The investigators will assess how long the patients remain on ventilators, how many suffer from organ failure, how quickly they are released from intensive care and how many die.

Lakkireddy describes himself as “born into Hinduism,” but he says he attended a Catholic school and has spent time in synagogues, Buddhist monasteries, and mosques.

“I believe in the power of all religions,” he says. “I think if we believe in the wonders of God and the universal good of any religion, then we’ve got to combine hands and join the forces of each of these faiths together for the single cause of saving humanity from this pandemic.”

He already knows that religion will help with the pandemic! Is this the right guy to conduct a double-blind study on Covid-19? He has an interest in the outcome, of course, but one can only hope that he’s being supervised by other people to ensure rigorous, double-blind methodology. But wait! There’s still more!

Scientific studies of the power of prayer have been attempted before. Lakkireddy’s description of his study lists six previous clinical trials involving religious intervention. Some showed slight improvement for patients receiving prayer. Other studies have found no significant prayer effect.

Note that the “other studies” links to the meta-analysis above: a summary of ALL studies, and a summary that shows no effect of prayer overall. As far as I can see, previous studies cited by Lakkireddy were already incorporated into that meta-analysis. Shame on NPR for pretending that a meta-analysis of 14 studies is the same thing as a group of studies.

Lakkireddy says he can not explain how people praying remotely for someone they don’t know (or a group of people,) could actually make a difference in their health outcomes, and he acknowledges that some of his medical colleagues have had “a mixed reaction” to his study proposal.

“Even from my wife, who’s a physician herself,” he says. “She was skeptical. She was, like, ‘OK, what is it that you’re looking at?”

Lakkireddy says he has no idea what he will find. “But it’s not like we’re putting anyone at risk,” he says. “A miracle could happen. There’s always hope, right?”

Yes, there’s always hope of a miracle. But given the meta-analysis above, which recommends that “we should stop this nonsense”, there are no data to give us hope. There are data to give us no hope. And hope is really something that should not be entertained by a principal investigator, for that gives rise to confirmation bias. You could, for example, do p-hacking, hoping that at least one outcome will be in your favor, reaching statistical significance.

You can learn more about Lakkireddy’s study at the “clinical trials” section of the National Institutes of Medicine, which registers all proposed and ongoing trials. It also adds the interesting tidbit that Lakkireddy’s prayers will involve those of five different denominations. Is Lakireddy testing which religion is “right”, i.e., prayers to its god are the only ones that work?

I can find no information about funding on the site.

Brief Summary:

This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a “universal” prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.

I’m torn between thinking this is a waste of time, as an overview of previous studies shows no effect of prayer—not surprising in view of the inefficacy of God in “faith based healing” as practiced by various Christian sects, of the failure of prayer to restore missing limbs and eyes, and of no evidence for the presence of any God)—and, on the other hand, wanting it to proceed because, if the study is done properly and with sufficient rigor, it’s not going to support evidence for a prayer-answering God. (I do think that, as a true believer, Lakkireddy should let others run the study and analyze its results).

Now it is possible that the study will “work”: either prayer will have a significant effect, or prayers for one religion will have a significant effect. (If only Jewish prayers work, for example, will Christians, Hindus, and Muslims immediately abandon their faith? I wouldn’t bank on it!).

In Faith Versus Fact I detail what kind of results would make me (tentatively) accept a deity. Consistent effects of one kind of prayer (or all kinds of prayers) on healing would make me sit up and take notice, that’s for sure. But we haven’t had that.

Two more points. First, if the study shows no effect of prayer, I expect NPR to do a followup reporting that result. (They surely would if they find a positive effect!). And I will badger them about this after the study ends in August.

Finally, the mere existence of this study gives the lie to religionists’ claim that “Science cannot study the supernatural, for that realm is off limits to naturalistic analysis.” But, as even Lakkireddy admits, this is a case in which science can indeed study supernatural claims! But we shall see if they’re supported. These studies usually have a one-way effect: if they show an effect, the faithful trumpet it to the skies. But if they show no effect, the faithful quietly shelve the results and speak no more of them.

h/t: Bob

	Weishan on The “Memorandum of Under…
	Steve Lawrence on Despite its uselessness, homeo…
	mike on Despite its uselessness, homeo…
	Bryan on Despite its uselessness, homeo…
	Mark R. on Thursday: Hili dialogue