The Pandemic’s Wrongest Man – In a crowded field of wrongness, one person stands out: Alex Berenson

It does not reflect well on Fox News that they have had this clown on their channel so often.

I followed Berenson on Twitter for about nine months because I saw him on Tucker Carlson’s show repeatedly and I thought he might be an important contrary voice, but when he started going off on the covid vaccines earlier this year, I unfollowed him because he was obviously wrong and irresponsible.

Derek Thompson writes for The Atlantic:

On February 11, Berenson warned his followers that early data from Israel proved that vaccine advocates “need to start ratcheting down expectations.” This was a strange claim to make at the time: An Israeli health-care provider had reported no deaths and four severe cases among its first 523,000 fully vaccinated people. But the claim seems even more ridiculous now, in light of Israel’s incredible success since then. New positive cases in Israel are down roughly 95 percent since January. Deaths have plunged, even though the economy is almost fully open.


When I asked Berenson to explain his beef with Israel’s vaccine record, he sent a link to a news story in Hebrew that, he said, reported “several hundred deaths and hospitalizations and thousands of infections in people who have received both doses.” I can’t read Hebrew, so I reached out to someone who can, Eran Segal, a computational biologist at the Weizmann Institute of Science, in Rehovot, Israel. He replied by email: “This link actually shows that the vast majority of those who died were NOT vaccinated.” By Segal’s calculations, the vaccines have reduced the risk of death by more than 90 percent in the Israeli population. Segal also said that “numbers of infections only went down, and even more so among the age groups who were first to vaccinate.”

Berenson is wrong about all sorts of little things when it comes to Israel, but I want to emphasize how straightforward and obvious the big picture is here. Israel is a world leader in vaccinations. Its COVID-19 cases have plunged, and its economy is roaring back to life.

Berenson’s claim: Healthy people under 70 shouldn’t get a vaccine.

The reality: Outside of extremely rare cases, every adult should get a vaccine—and if it’s authorized for children, children should get it too.

I wanted to know where Berenson stood on the most important question: Who does he think should get a vaccine, and who does he think shouldn’t? This was the core of his answer:

For most healthy people under 50—and certainly under 35—the side effects from the shots are likely to be worse than a case of Covid. Over 70, sure. The grey zone is somewhere in the middle and probably depends on personal risk factors.

This response has two huge problems. First, although the disease clearly gets more severe with age, drawing a line at 70 is nonsensical. Those in their 50s and early 60s are three times more likely to die from this disease than a 40-something, and 400 times more likely to die than a teenager, according to the CDC.

Second, the suggestion that the vaccine’s side effects are worse than having COVID-19 is ludicrous. The vaccine can cause chills, fever, and other symptoms in the first few days. That’s just the immune system doing its job; severe illness from the vaccines is vanishingly rare. But severe illness in a pandemic is not rare. More than 40,000 people under age 50 have gone to the hospital with COVID-19, according to COVID-NET, a surveillance network that captures hospitalization data. Several studies have indicated that at least one-third of hospitalized people suffer from long-term symptoms of COVID-19. (Guess what seems to alleviate the symptoms of some of these patients? Getting vaccinated.)

The idea that the vaccine is worse than the disease for the under-70 crowd falls apart utterly when we consider the “side effect” of death. Roughly 100,000 people under 65 have died of COVID-19. Meanwhile, out of more than 145 million vaccines administered in the U.S., a CDC review of clinical information found no evidence that they had caused any deaths. The current score in the competition between non-senior pandemic deaths and conclusive vaccine deaths is 100,000–0.

One hundred thousand to zero. That might be the most important statistic in this whole mess. Berenson doesn’t tweet blatantly falsifiable statements about the vaccines every day. For the most part, he peddles doubt, laced with confusing and expert-sounding jargon, which may seem compelling at first but can’t survive contact with expert opinion.

To be honest, I initially had serious doubts about publishing this piece. The trap of exposing conspiracy theories is obvious: To demonstrate why a theory is wrong, you have to explain it and, in doing so, incur the risk that some people will be convinced by the very theory you’re trying to debunk. But that horse has left the barn. More than half of Republicans under the age of 50 say they simply won’t get a vaccine. Their hesitancy is being fanned by right-wing hacks, Fox News showboats, and vaccine skeptics like Alex Berenson. The case for the vaccines is built upon a firm foundation of scientific discovery, clinical-trial data, and real-world evidence. The case against the vaccines wobbles because it is built upon a steaming pile of bullshit.

Posted in Corona Virus | Comments Off on The Pandemic’s Wrongest Man – In a crowded field of wrongness, one person stands out: Alex Berenson

GG: Journalists Attack the Powerless, Then Self-Victimize to Bar Criticisms of Themselves (3-31-21)

00:00 My UCLA memories and why I love LA
20:00 The Truth About Dentistry, https://www.theatlantic.com/magazine/archive/2019/05/the-trouble-with-dentistry/586039/
40:00 Journalists Attack the Powerless, Then Self-Victimize to Bar Criticisms of Themselves, https://greenwald.substack.com/p/journalists-attack-the-powerless
58:00 Inaugural advice segment
1:00:00 Relational Perspectives on the Body, https://lukeford.net/blog/?p=138094
1:06:30 Big Think Interview With David Schnarch, https://www.youtube.com/watch?v=OgAIY0or-hA
1:10:00 The Lukeosphere
1:11:00 Effective Communication Skills, https://www.audible.com/pd/Effective-Communication-Skills-Audiobook/B00D94332Q
1:26:00 Substack’s success shows readers have had enough of polarised media, https://www.ft.com/content/3e565df2-0cb2-4126-a879-eb2710eef03a
1:45:00 Trial of police officer accused of killing George Floyd
1:57:00 Journalists Are “Centering” Their “Trauma” Because It Enables Them To Acquire Power, https://mtracey.substack.com/p/journalists-are-centering-their-trauma
2:21:00 Anti-Dentite
2:33:00 Mike Enoch analyzed, https://youtu.be/nQUltWs-PXg?t=1005
2:37:00 Ethan Ralph shows up angry, drunk at his GF’s ex-BF and gets in a fight, https://www.youtube.com/watch?v=6RYeOmf1UIE
2:52:00 Anglo vs Dutch vs German media
2:53:20 Keith Woods and the Weak Men who Created Hard Times, https://www.youtube.com/watch?v=Uho0D98quw0&t=1170s
3:00:00 NWG ON THE FLAWS OF ED. DUTTON’S [APPARENT POSITION REGARDING HIS] ‘SPITEFUL MUTANTS’ THEORY, https://www.bitchute.com/video/7q2R1lujYeoc/
3:03:40 Sidney Powell’s Motion to Dismiss EXPLAINED – Viva & Barnes HIGHLIGHT, https://www.youtube.com/watch?v=qnRwy7NMgG
3:15:00 Al Goldstein — Great Adult Entertainment innovator
3:22:30 Owen Benjamin Compliments Redbar, https://www.youtube.com/watch?v=_jUUfvTRw7k&t=376s
3:40:00 Mersh on latest Ethan Ralph drama, https://www.youtube.com/watch?v=6qmG3I4K0dk&t=4177

Posted in America | Comments Off on GG: Journalists Attack the Powerless, Then Self-Victimize to Bar Criticisms of Themselves (3-31-21)

The “only 6%” gambit: The latest viral COVID-19 disinformation

Surgeon David Gorski writes:

It’s always weird to try to get blogging again after an absence due to a health issue with a member of the family and other pressing issues that were more important than my little side hobby and thus crowded it out. True, the absence was only a week and a half, but it’s weird nonetheless. Sometimes, it’s hard to pick a subject. Fortunately (or unfortunately), over the weekend I started seeing memes and content on various social media that went something like this about “only 6%,” as shown by this collection of memes from @BadCOVID19Takes:

Many of them reference this blog post by one of the most idiotic right wing pundits out there, The Gateway Pundit:

The CDC silently updated their numbers this week to show that only 6% of all coronavirus deaths were completely due to the coronavirus alone. The rest of the deaths pinned to the China coronavirus are attributed to individuals who had other serious issues going on.

Jim Hoft, a.k.a. The Gateway Pundit, then went on to quote a Tweet by someone going by the handle Mel Q (@littllemel):

Mel Q's "only 6%" Tweet
Mel Q’s “only 6%” Tweet

Unsurprisingly, Mel Q was overjoyed to have had her Tweet retweeted by President Trump:

It was very disturbing indeed that President Trump chose to amplify this disinformation that “only 6%” of deaths attributed to COVID-19 had actually died of COVID-19 “alone” and that “only 9,210” had died from COVID-19. (Of course, these figures are a bit old, from when “only 153,504” died of COVID-19. The toll today is widely thought to be north of 180,000, which, according to the brain dead “logic” of people like Mel Q, would mean that “only” close to 11,000 people died of “only” COVID-19.)

This claim was rapidly amplified by COVID-19 denialists (those who deny that COVID-19 is deadly and that we need to take the pandemic seriously, instituting social distancing, masking, and in some cases lockdowns to control it), for example:

We’ve met Nick Gillespie before, when he spewed nonsense about the right-to-try and drug approval by the FDA. I’m not surprised that he swallowed disinformation about COVID-19 whole and then regurgitated it unthinkingly.

Amplification of the “only 6%” gambit also included Tweets by various conservative actors and celebrities, like Kevin Sorbo:

Unfortunately, even after Twitter deleted Mel Q’s Tweet, the “only 6%” hashtag is still going strong on Twitter.

I’m sure we’d all agree that this would be awesome if it were true! If “only 6%” of those who died with COVID-19 have actually died because of the coronavirus instead of dying of something else “with” the coronavirus at the same time, then it really would be true that the disease is much less dangerous than previously thought. Sadly, this claim is a huge truckload of fetid dingos’ kidneys piled on with a thick layer of bovine excrement. It’s a misrepresentation of the figures in this chart. Whether it’s unintentional or intentional can be debated. (Actually, to me it can’t. I know we’re not supposed to attribute to malice what can be explained by stupidity, but in the case of COVID-19 deniers I’ve learned that malice and stupidity are usually both involved.)

Overall, the message was similar to previous messages by COVID-19 deniers:

  • That COVID-19 death tolls are being intentionally exaggerated by the media and government for nefarious purposes, in this case the “true” toll is “only 6%” of the toll usually cited.
  • That “only” the sick and the old are at risk.
  • That you don’t have to worry about COVID-19 if you don’t have one or more of the comorbid conditions listed.
  • That, because “only 6%” died of “only COVID-19,” lockdowns, social distancing, masks, etc., are unnecessary.

I sensed an astroturf campaign, much like the one that tried to promote hydroxychloroquine based on hilariously awful “science” not too long ago. But what’s behind it? Much in the manner that the campaign to promote hydroxychloroquine based on risibly bad epidemiology two weeks ago, this astroturf campaign to downplay the risk of COVID-19 (“only 6%” of what you thought it was!) is based on a laughably incompetent and awful interpretation of CDC statistics, with a dash of conspiracy theory thrown in (the CDC “quietly updated the COVID number,” as though the CDC was trying to hide something), because there’s always a conspiracy theory. Adding to the conspiracy theory was Twitter’s deletion of the original Tweet by Mel Q that had been retweeted by President Trump.

Also, note the “Q” in Mel Q’s Twitter handle. That’s not just any “Q.” It’s clearly a reference to QAnon, an utterly bonkers far right conspiracy theory that claims (among many other things) that a network of Satan-worshiping pedophiles—and cannibals who apparently eat the children after abusing them!—are running a global child sex-trafficking ring and are (not coincidentally) trying to take down U.S. President Trump, who, unsurprisingly, has refused to denounce QAnon as the dangerous nonsense that it is.

Worse, the idea has spread from the wingnutosphere into mainstream news. I’ve lost count of the number of stories in mainstream news sources that basically parrot (or at least don’t push back very much against) the idea that the CDC has somehow admitted that “only 6%” of those dying with COVID-19 died of COVID-19, although, fortunately, that changed as the weekend wore on, Trump retweeted the claim, and Twitter took down Mel Q’s Tweet. Unfortunately, that didn’t stop “only 6%” from going viral and trending on Twitter:

I also saw it all over Facebook, even in a Star Trek group that I joined a long time ago.

So what’s behind this “only 6%” gambit? Basically, on August 26, the CDC updated its breakdown of COVID-19 deaths in the US, and one of the tables has deaths categorized by what are described as “comorbidities.” Where did the “only 6%” figure come from? If you peruse the table first, as I did, you’ll have a hard time figuring it out, but then I looked at how the table (Table 3) is described on the CDC website:

Table 3 shows the types of health conditions and contributing causes mentioned in conjunction with deaths involving coronavirus disease 2019 (COVID-19). For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.6 additional conditions or causes per death. The number of deaths with each condition or cause is shown for all deaths and by age groups. For data on comorbidities, click here to download.

If you peruse the table itself, you’ll soon see that it doesn’t show that “only 6%” of COVID-19 deaths were due primarily to COVID-19 and that, among those with comorbid conditions who died, there were 2.6 additional conditions or causes. The only way one might make such an misinterpretation is either through a profound misunderstanding of how this table was compiled or through willfully lying about the significance of the figures in this table. For one thing, looking at the table you’ll see things like “cardiac arrest,” “septic shock,” “multiorgan failure,” and “respiratory failure.” These can all be sequelae of severe COVID-19 infection that ultimately lead to death; so it would be shocking if they weren’t on the table:

To understand how the CDC table was tabulated, let’s elaborate on the Tweet above. You have to understand that it was compiled from standardized death certificates. It’s been a long time since I’ve had to fill out a death certificate—thankfully!—but I still remember how they work. On the death certificate form, there is a space for the immediate cause of death and then several lines for underlying causes. In brief, death certificates are filled out by the medical certifier (who can be the physician who had treated the patient before death), who provides his best medical opinion regarding the cause of death. Part I of the death certificate includes the proximal cause of death, or what directly caused the death, and Part II lists conditions that contributed to the death:

For example, if a patient dies of respiratory failure due to acute respiratory distress syndrome (ARDS), which was the result of pneumonia, which was the result of COVID-19, the proximal cause of death was the respiratory failure, but contributing causes were ARDS and COVID-19, with the one farthest up the chain being the underlying cause of death under Part I. If the patient had hypertension or asthma, that would go under Part II. As I like to say, if you suffer a cardiac arrest due to blood loss after being shot, the cardiac arrest might have been the proximal cause of death, but you still died of a gunshot wound. Still, that didn’t stop the Twitter brain trust from asking idiotic questions like:

https://twitter.com/mypersonalia/status/1300013312957087745?s=20

The answer is no. Anyone who has even the most rudimentary understanding of how death certificates are filled out would laugh at just how ignorant the person asking this question must be.

Sometimes these underlying causes contribute to the death. For example, if you have hemophilia and suffer a stab wound that leads you to bleed out and die when someone with normal blood clotting probably would have survived, then you still died of a stab wound, but the hemophilia was a contributing cause of death.

It’s really not that difficult to understand. Former fellow ScienceBlogs blogger Mark Hoofnagle Tweeted this:

And another, simpler, explanation:

And a couple of examples Tweeted three weeks before the “only 6%” disinformation campaign began:

It is true that sometimes determining the most important underlying cause isn’t always straightforward, but in the vast majority of COVID-19 cases it is. If someone with hypertension, obesity, and type 2 diabetes catches COVID-19, then develops pneumonia, then develops failure of multiple organ systems, and finally dies of respiratory failure, the proximate cause of death is respiratory failure, but the underlying cause of death is COVID-19, without which the respiratory failure never would have happened. Yes, it is well-known that certain conditions greatly increase your risk of dying if you contract COVID-19. These include, among several others:

  • Age (the chance of dying of COVID-19 begins to increase dramatically after age 50 and becomes truly frightening by age 80)
  • Obesity (BMI > 30)
  • Being male
  • Cancer
  • Chronic kidney disease
  • COPD (chronic obstructive pulmonary disease)
  • Immunocompromised state (weakened immune system) from solid organ transplant
  • Obesity (body mass index [BMI] of 30 or higher)
  • Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
  • Sickle cell disease
  • Type 2 diabetes mellitus

These are contributory factors, but if you have one or more of these conditions when you contract COVID-19 and later die, it’ll very likely be the COVID-19, not your underlying health condition, that killed you. The underlying health condition(s) might have played a role in making you sicker, but it’ll be the virus that does you in.

Of course, the “only 6%” gambit is even more dishonest than it seems. Why? Because we have actual data published the same day as Table 3 telling us that. More importantly, the actual interpretation of the underlying data for the table shows:

In other words, COVID-19 is the underlying cause of around 92.3% of the deaths in the dataset, not 6%.

Also, the US isn’t the only country in the world with COVID-19. There are data from many other nations. As “Health Nerd” notes:

One important thing to note is that a lot of this is specific to the U.S. There are, oddly enough, quite a few other countries around the world, and they all have their own way of recording deaths. In some places, for example India, there has been a lot of criticism that the death reporting is shockingly bad and thus the country may be missing some or even the majority of their COVID-19 deaths. In other places, like Belgium, the death reporting is so good that it may explain the high COVID-19 death rates — they are simply picking up coronavirus deaths that other places have missed.

However, one thing remains true: most countries go to great lengths to ensure that deaths are correctly classified. Death reporting is incredibly important, and in most places it’s a detailed process that has to be checked carefully. In most cases, we can say with some certainty that deaths attributed to COVID-19 are, at best, a solid count, and at worst probably an underestimate. If anything, it’s likely that we are missing quite a few deaths that have been caused by coronavirus, but for whatever reason not picked up in our reporting systems, and thus the death count is actually higher than the reported figure.

And I say all of this as someone who has spent quite a bit of time studying COVID-19 death rates. I’ve now co-authored two studies looking at the fatality rates of COVID-19, and can say with some certainty that they are pretty good estimates, if probably a little low.

The bottom line is that the “only 6%” gambit is disinformation. It’s likely either astroturf or a product of the deranged minds of QAnon conspiracy theorists (or both). What’s most depressing is that we have a President who amplifies dangerous disinformation like this to a social media ecosystem of willing accomplices, allowing nonsense like this to go viral. As for the inevitable tone police trolls who will likely lament that I’m being way too sarcastic, insulting, and nasty, tough. Anything related to QAnon doesn’t deserve my civility.

Posted in Corona Virus | Comments Off on The “only 6%” gambit: The latest viral COVID-19 disinformation

The Truth About Dentistry

Dentists seem to have the lowest standards of any profession. Horrifying. No wonder so many commit suicide.

From The Atlantic in 2019:

When you’re in the dentist’s chair, the power imbalance between practitioner and patient becomes palpable. A masked figure looms over your recumbent body, wielding power tools and sharp metal instruments, doing things to your mouth you cannot see, asking you questions you cannot properly answer, and judging you all the while. The experience simultaneously invokes physical danger, emotional vulnerability, and mental limpness. A cavity or receding gum line can suddenly feel like a personal failure. When a dentist declares that there is a problem, that something must be done before it’s too late, who has the courage or expertise to disagree? When he points at spectral smudges on an X-ray, how are we to know what’s true? In other medical contexts, such as a visit to a general practitioner or a cardiologist, we are fairly accustomed to seeking a second opinion before agreeing to surgery or an expensive regimen of pills with harsh side effects. But in the dentist’s office—perhaps because we both dread dental procedures and belittle their medical significance—the impulse is to comply without much consideration, to get the whole thing over with as quickly as possible.

The uneasy relationship between dentist and patient is further complicated by an unfortunate reality: Common dental procedures are not always as safe, effective, or durable as we are meant to believe. As a profession, dentistry has not yet applied the same level of self-scrutiny as medicine, or embraced as sweeping an emphasis on scientific evidence. “We are isolated from the larger health-care system. So when evidence-based policies are being made, dentistry is often left out of the equation,” says Jane Gillette, a dentist in Bozeman, Montana, who works closely with the American Dental Association’s Center for Evidence-Based Dentistry, which was established in 2007. “We’re kind of behind the times, but increasingly we are trying to move the needle forward.”

Consider the maxim that everyone should visit the dentist twice a year for cleanings. We hear it so often, and from such a young age, that we’ve internalized it as truth. But this supposed commandment of oral health has no scientific grounding. Scholars have traced its origins to a few potential sources, including a toothpaste advertisement from the 1930s and an illustrated pamphlet from 1849 that follows the travails of a man with a severe toothache. Today, an increasing number of dentists acknowledge that adults with good oral hygiene need to see a dentist only once every 12 to 16 months.

Many standard dental treatments—to say nothing of all the recent innovations and cosmetic extravagances—are likewise not well substantiated by research. Many have never been tested in meticulous clinical trials. And the data that are available are not always reassuring.

The Cochrane organization, a highly respected arbiter of evidence-based medicine, has conducted systematic reviews of oral-health studies since 1999. In these reviews, researchers analyze the scientific literature on a particular dental intervention, focusing on the most rigorous and well-designed studies. In some cases, the findings clearly justify a given procedure. For example, dental sealants—liquid plastics painted onto the pits and grooves of teeth like nail polish—reduce tooth decay in children and have no known risks. (Despite this, they are not widely used, possibly because they are too simple and inexpensive to earn dentists much money.)

…Fluoridation of drinking water seems to help reduce tooth decay in children, but there is insufficient evidence that it does the same for adults. Some data suggest that regular flossing, in addition to brushing, mitigates gum disease, but there is only “weak, very unreliable” evidence that it combats plaque. As for common but invasive dental procedures, an increasing number of dentists question the tradition of prophylactic wisdom-teeth removal; often, the safer choice is to monitor unproblematic teeth for any worrying developments. Little medical evidence justifies the substitution of tooth-colored resins for typical metal amalgams to fill cavities. And what limited data we have don’t clearly indicate whether it’s better to repair a root-canaled tooth with a crown or a filling. When Cochrane researchers tried to determine whether faulty metal fillings should be repaired or replaced, they could not find a single study that met their standards.

“The body of evidence for dentistry is disappointing,” says Derek Richards, the director of the Centre for Evidence-Based Dentistry at the University of Dundee, in Scotland. “Dentists tend to want to treat or intervene. They are more akin to surgeons than they are to physicians. We suffer a little from that. Everybody keeps fiddling with stuff, trying out the newest thing, but they don’t test them properly in a good-quality trial.”

* When physicians complete their residency, they typically work for a hospital, university, or large health-care organization with substantial oversight, strict ethical codes, and standardized treatment regimens. By contrast, about 80 percent of the nation’s 200,000 active dentists have individual practices, and although they are bound by a code of ethics, they typically don’t have the same level of oversight.

* Among other problems, dentistry’s struggle to embrace scientific inquiry has left dentists with considerable latitude to advise unnecessary procedures—whether intentionally or not. The standard euphemism for this proclivity is overtreatment. Favored procedures, many of which are elaborate and steeply priced, include root canals, the application of crowns and veneers, teeth whitening and filing, deep cleaning, gum grafts, fillings for “microcavities”—incipient lesions that do not require immediate treatment—and superfluous restorations and replacements, such as swapping old metal fillings for modern resin ones. Whereas medicine has made progress in reckoning with at least some of its own tendencies toward excessive and misguided treatment, dentistry is lagging behind. It remains “largely focused upon surgical procedures to treat the symptoms of disease,” Mary Otto writes. “America’s dental care system continues to reward those surgical procedures far more than it does prevention.”

“Excessive diagnosis and treatment are endemic,” says Jeffrey H. Camm, a dentist of more than 35 years who wryly described his peers’ penchant for “creative diagnosis” in a 2013 commentary published by the American Dental Association. “I don’t want to be damning. I think the majority of dentists are pretty good.” But many have “this attitude of ‘Oh, here’s a spot, I’ve got to do something.’ I’ve been contacted by all kinds of practitioners who are upset because patients come in and they already have three crowns, or 12 fillings, or another dentist told them that their 2-year-old child has several cavities and needs to be sedated for the procedure.”

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The Natural Cures They Don’t Want You To Know About!

Surgeon David Gorski writes:

One of the biggest medical conspiracy theories for a long time has been that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement. who posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA called off, free market innovation would flourish and all these cures, so long suppressed by an overweening regulatory apparatus, the floodgates would open and these cures, long held back by the dam of the FDA, would flow to the people.(Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws.

* I can totally understand the patient impetus for these laws, given that I have had family members with terminal illnesses. Unfortunately, however, forces like the Goldwater Institute are taking advantage of the very human desire not to die and not to be forced to watch one’s loved ones die, all in order to push bad legislation. Indeed, the Goldwater Institute uses terminally ill patients desperate for their lives in much the same way Stanislaw Burzynski uses them: As shields and weapons in their battle against the FDA and state medical boards. That’s why, as I’ve morbidly joked before, being against right-to-try in the eye of the public is not unlike being against Mom, apple pie, the American flag, and puppies, hence the reluctance of even doctors doing clinical trials to publicly voice opposition. The most predictable attack against anyone who dares to publicly oppose these bills has been to portray opponents as not just callous, but as practically twirling their mustaches with delight and cackling evilly while watching terminally ill patients die without hope.

* Not surprisingly, libertarians are declaring this a big “win” for patient’s rights. It’s nothing of the sort. The flavor of the arguments can best be seen in two articles from Reason.com’s Nick Gillespie, who is clearly clueless about clinical trials. Basically, he took to Reason.com to gloat, referencing an article from over two weeks ago that he entitled The Upside of Ebola (Yes, There May Actually Be One). It’s about as blatant a move to take advantage of the Ebola outbreak to promote bad right-to-try legislation as I’ve ever seen. The subtitle exults:

A rising death toll, mass panic, scary mortality rate—what could possibly be good about the out-of-control epidemic? It may accelerate the adoption of laws giving patients more power.

Yeah, sure. Thousands of people are dying of a horrible disease in Africa while people in the U.S. are freaking out about the possibility of the virus causing outbreaks right here at home, and Gillespie sees these events, apparently more than anything else, as an opportunity to push his libertarian agenda with respect to medicine:

Ebola’s arrival and seeming spread in America is causing mass panic, tasteless Internet jokes, and incredibly poorly timed magazine covers. Can anything good come out of the disease, which has no known cure and a terrifying mortality rate of 50 percent?

Yes. To the extent it forces a conversation about the regulations surrounding the development of new drugs and the right of terminal patients to experiment with their own bodies, Ebola in the United States may well accelerate adoption of so-called right-to-try laws. These radical laws allow terminally ill patients access to drugs, devices, and treatments that haven’t yet been fully approved by the Federal Drug Administration and other medical authorities. The patients and their estates agree not to bring legal action against caregivers, pharmaceutical companies, and insurers.

You don’t have to be a doctrinaire libertarian—though it helps—to see the value in letting people with nothing left to lose experiment on themselves. They may get a new lease on life. The rest of us get meaningful information that may speed up the development of the next great medical intervention.

Actually, you do rather have to be a doctrinaire libertarian to have a reality distortion field as powerful as Nick Gillespie’s that leads him to write drivel like this. Ebola and right-to-try laws. Hmmmm. How is one thing not like the other (or not related to the other)? First of all, Gillespie’s rationale is a complete non sequitur, clearly designed to take advantage of the Ebola panic to persuade people that right-to-try laws are a good idea, even though such laws would not have had one whit of an effect on the odd patient in the US who might be infected with Ebola. After all, Ebola, as deadly as it is, is not a terminal illness. Second, I can’t help but note that existing FDA mechanisms got ZMapp to American Ebola patients rather rapidly, no need for right-to-try laws necessary. But excuse me. What Gillespie says is that Ebola and ZMapp are “forcing a conversation.” I suppose that’s true, but it’s the wrong conversation, a profoundly deceptive conversation, in which an advocate of right-to-try laws shamelessly takes plays on people’s fears of Ebola to promote these bad laws. Claiming that there is “no good argument against right-to-try” (wrong, wrong, wrong), Gillespie also shamelessly attacks straw men, representing the primary argument against right-to-try as giving patients “false hope.” There are lots of other reasons why these are bad laws.

But Gillespie is just getting warmed up:

But what’s already cruel is the FDA’s drug-testing process. It’s massively expensive and overly long, costing between $800 million and $1 billion to bring a drug to market and taking a decade or more to complete the approval process. There’s every reason to believe that the FDA approval process is killing as many or more people than it saves, especially as the FDA doesn’t allow approvals from Europe and elsewhere to stand in for trials here.

Uh, no. There is not “every reason to believe” anything of the sort. See? Once again, there’s the myth that there are all these fantastic cures out there that the FDA, through its bureaucratic inertia, is keeping from you. I am rather grateful, though, that Gillespie, through his link, makes his intent very clear. The article to which he linkes is entitled Kill The FDA (Before It Kills Again), in which, referencing the movie Dallas Buyers Club—which I finally saw on cable and was surprised to find that, leaving aside its historical inaccuracies about the AIDS epidemic in the 1980s, taken just as a movie it was at best just OK (I was seriously disappointed)—Gillespie proclaims that the FDA “continues to choke down the supply of life-saving and life-enhancing drugs that will everyone agrees will play a massive role not just in reducing future health care costs but in improving the quality of all our lives.” And what is his rationale? Wrap your mind around this:

As my Reason colleague Ronald Bailey has written, this means the FDA’s caution “may be killing more people than it saves.” How’s that? “If it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”

Completely missing from Bailey’s and Gillespie’s equation is the number of drugs that the FDA doesn’t approve because they don’t show efficacy and safety that could allow even more than those 20,000 people a year to die or even actively kill some of them. As conceded by even Bailey, it was the FDA that prevented, for example, approval of Thalidomide in the US and the rash of birth defects seen elsewhere in the world. Bailey’s argument is, at best, tenuous, at worse misleading. Gillespie notes:

A 2006 Government Accountability Office (GAO) study found that the number of new drug applications submitted to the FDA between 1993 and 2004 increased by just 38 percent despite an increase in research and development of 147 percent. The mismatch, said GAO, was the result of many factors, ranging from basic issues with translating discoveries into usable drugs, patent law, and dubious business decisions by drug makers. But the problems also included “uncertainty regarding regulatory standards for determining whether a drug should be approved as safe and effective,” a reality that almost certainly made pharmaceutical companies more likely to tweak old drugs rather than go all in on new medicines.

Notice how this is another non sequitur applied to right-to-try laws, given that the answer to this problem would be regulatory clarity, not state-by-state right-to-try laws. Think of it this way: What’s more uncertain? The FDA or having different laws in different states regarding “right to try”? Gillespie’s citing his previous article claiming that the FDA is killing you in an article promoting right-to-try is a very good indication what these laws are really about. They are not about helping patients. That’s how they are sold to desperately ill patients, but in reality libertarians like Gillespie and Bailey are using desperately ill patients in the same way that Stanislaw Burzynski is: As a powerful tool to sway public opinion against the FDA and towards their viewpoint.

There’s a reason that certain aspects of these laws are not as widely emphasized in the PR offensive in favor of right to try. It’s because they are pure “health freedom” and libertarian wingnuttery. For example, if you look at the Goldwater Institute template for right to try laws, which, unfortunately, has been the basis of every right to try law passed and under consideration, you’ll notice a number of highly problematic clauses. As I’ve discussed multiple times, there is the requirement that the drug or device has only passed phase 1 trials, which, given how few drugs that have passed phase 1 actually make it through to approval, is a really low bar, especially since most phase 1 trials involve fewer than around 25 patients.

More disturbing are the financial aspects. The Goldwater Institute legislative language template (to which the Michigan legislation is virtually identical) allows drug companies to charge patients, with no provision to help patients pay for exercising right-to-try. Indeed, it specifically states that the bill “does not require any governmental agency to pay costs associated with the use, care, or treatment of a patient with an investigational drug, biological product, or device” and that insurance companies do not have to pay for costs associated with the use of such therapies. You know what this means? Insurance companies could refuse to pay for care related to complications that might occur because of experimental treatments. You use an experimental drug and suffer a complication? Too bad! Your insurance company can cut you off! Now, it’s unlikely that government entities like Medicare or Medicaid would do that, but insurance companies certainly will.

Basically, what this law says is: If you can afford it yourself, no help, you can have it. If not, you’re SOL. As I’ve pointed out, if there’s one thing worse than dying of a terminal illness, it’s suffering unnecessary complications from a drug that is incredibly unlikely to save or significantly prolong your life and bankrupting yourself and family in the process. Right-to-try encourages just that. What’s more compassionate? Attacking the FDA and degrading the approval process that requires drug safety and efficacy while dangling false hope in front of patients or standing up and protecting patients from the harm such a policy could cause. Let’s just put it this way: I predict that Stanislaw Burzynski will soon be sending antineoplastons to patients in right-to-try states if, as he keeps bragging, the FDA has allowed him to reopen his clinical trials. After all, his antineoplastons would qualify just fine under right-to-try laws if they’re back under clinical trial. Indeed, if there’s one thing the decades-long battle between the FDA and Burzynski tells us, it’s that the FDA actually bends over way too far backwards to allow manufacturers of dubious drugs to prove themselves.

Finally, the anti-FDA rhetoric, such as linked to by Gillespie, is a very good indication that the true purpose of right-to-try legislation is to neuter the FDA’s power to control drug approval, thus greatly loosening or even eliminating hurdles to the drug approval process. It is no coincidence that the strongest, richest, and most vocal proponents of these laws are the Goldwater Institute and libertarians like Nick Gillespie and Ronald Bailey, who, not coincidentally, think that the FDA is “killing us.” Those articles are a definite tell. It’s also clearly a strategy to get right-to-try passed in as many states as possible and get referendums passed by wide margins to pressure the federal government to weaken the FDA.

In the end, though, right-to-try laws are what I like to call “placebo” laws in that they make people who pass them and support them feel good but don’t actually address the problem that they are supposedly intended to address. Drug approval regulatory authority lies with the FDA; it could completely ignore state right-to-try laws. The FDA also has a compassionate use program and rarely turns down such requests. Admittedly, the application process is long and probably too onerous, but the answer to that problem is not state right-to-try laws. It’s to address the issue at the federal level. I’ve also said in an interview that, now that my state government has foolishly passed a right-to-try law, one of two things is likely to happen: Either nothing, because federal authority trumps state authority, or disaster for patients, doctors, and, yes, biotech and drug companies. Everybody, myself included, wants to help terminally ill patients. After all, I’ve seen too many of them. Right to try and similar misguided efforts, however, are not the way.

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