[Discussion] Medical Quackery

This is a follow up to the thread "Medical quackery in the US upsets me very, very much". The aim of this current thread is to take up the discussion on medical quackery (widening the scope since the US isn't the only country concerned), discuss news item pertaining to it and the potential responses to address it.
The definition of medical quackery is not up for debate and includes, among others, homeopathy, vaccine skepticism, naturopathy, crystal healing, psychic healing.

Quintin_Stone wrote:
Keldar wrote:
RawkGWJ wrote:

Why do so many folks out there think that they’re smarter than their doctors?

Because it's easy to believe that the doctors are pushing the vaccinations not because they're a good idea but because they're being paid off by Big Pharma.

It's not true, mind you. But it's not so difficult to believe.

It doesn't help that some doctors do push opioids because they're being paid off by Big Pharma.

Yes. Sadly there are some actual conspiracies. But that’s different from a conspiracy theory. Actual conspiracies sometimes get brought to justice.

bighoppa wrote:

Because the culture now is to refute knowledge itself. I have former friends that have bought into anti-vax because their newborn was non-verbal. On top of that, they've now gone flat-earth, moon-landing conspiracy, space is fake, 9/11 truther, etc, etc. I had to step away from that relationship despite knowing the guy and his family for 20 years.

Wait, what?

Agent 86 wrote:

Wait, what?

Yeah, the thinking goes that earth is surrounded by Firmament, not space. It goes hand-in-hand with moon landing being faked, the sun and moon are actually close to the planet, flat-earth nonsense. It's all about denying any knowledge or "science" (because a lot of these flakes call themselves scientists) that you don't understand or didn't "research" yourself (because a lot of these flakes think watching each other's youtube videos is research).

To avoid further derailment of the thread, you can watch SciManDan's channel as he does a pretty good job debunking most of this stuff. Other good channels are Conspiracy Catz or Fight the Flat Earth or Godless Engineer. SciManDan has regular posts on Tuesdays ("Tinfoil Tuesday", addressing general conspiracy theory stuff) and Fridays ("Flat Earth Friday", where he focuses specifically on debunking flat earthers).

Should we have a separate thread for this?

Thanks. I had never heard that one. Just...wow.

'space is fake' is an extension of flat earth and NASA conspiracy. In this one, everything NASA does is a lie that can be fully explained (if you close your eyes, plug your ears and go lalalalala) with camera tricks, wire work, and vomit comets.

Like most science denying movements, they have no idea what they think is really reality, they just know everything they're being told is a lie.

bighoppa wrote:

Because the culture now is to refute knowledge itself. I have former friends that have bought into anti-vax because their newborn was non-verbal. On top of that, they've now gone flat-earth, moon-landing conspiracy, space is fake, 9/11 truther, etc, etc. I had to step away from that relationship despite knowing the guy and his family for 20 years.

Emphasis mine. Please have a care with your wording. Having a child on the spectrum (or indeed being on the spectrum yourself) does not make one buy into conspiracy theories. It does, however (and this is especially true of parents who are typicals), put parents in a state of distress, some would even say grief for the idealized child they'll never have. A state which makes them more vulnerable to grasp at straws.
As always, correlation isn't causality.

Incidentally, if you haven't listened to it already, I recommend listening to the Bleach episode of Sawbones. They do throw a trigger warning at the top, and rightfully so, but you'll get a sense of what lengths those parents will go to. It's infuriating and heartbreaking (not to mention ableist too, but that's another topic).

So their "newborn was non-verbal"? Heh, I'm imagining that they expected their child would start talking in the hospital just after being born.

My wife went down the anti-vax rabbit hole when my son was diagnosed with autism. I was able to convince her to vaccinate our daughter but she would only agree if we did an alternative schedule where they were spread out. We had to negotiate HPV vaccine a bit but as a cancer doctor I insisted on that one.

Fear and grief will definitely cause people to lose rational thought sometimes....

gewy wrote:

So their "newborn was non-verbal"? Heh, I'm imagining that they expected their child would start talking in the hospital just after being born.

Yeah, I thought I'd let that slide, but that definitely stood out for me as well.

Sorry, Elemia and those here with kids on the spectrum. Very fair criticism of my post. I let my frustration with my friend get to me and was very dismissive of other real issues. I sincerely apologize and I will try to do better.

Docjoe wrote:

My wife went down the anti-vax rabbit hole when my son was diagnosed with autism. I was able to convince her to vaccinate our daughter but she would only agree if we did an alternative schedule where they were spread out. We had to negotiate HPV vaccine a bit but as a cancer doctor I insisted on that one.

Fear and grief will definitely cause people to lose rational thought sometimes....

Re: the HPV vaccine, the early cervical cancer rates from the UK after the vaccine was introduced are just plain astounding. Despite the anti-vax opposition i think that vaccine in particular will go down in history as a real life saver.

NPR Throughline podcast had an episode recently about the anti-vaxx movement and its history, very much worth listening to. It goes, among other things, into forced vaccinations for Chinese minorities as they were deemed filthier and thus more prone to illness by the (very white) powers that be/were.

Distrust in authorities, rational or irrational, doesn't appear out of thin air...

thrawn82 wrote:
Docjoe wrote:

My wife went down the anti-vax rabbit hole when my son was diagnosed with autism. I was able to convince her to vaccinate our daughter but she would only agree if we did an alternative schedule where they were spread out. We had to negotiate HPV vaccine a bit but as a cancer doctor I insisted on that one.

Fear and grief will definitely cause people to lose rational thought sometimes....

Re: the HPV vaccine, the early cervical cancer rates from the UK after the vaccine was introduced are just plain astounding. Despite the anti-vax opposition i think that vaccine in particular will go down in history as a real life saver.

It’s even more impressive in Australia which is a few laps ahead of the rest of us.

IMAGE(https://scontent-lga3-1.xx.fbcdn.net/v/t1.0-9/60645312_2264036563710556_5072649572518461440_n.jpg?_nc_cat=1&_nc_eui2=AeHQGYY8Rg84HNXJu64-xveWVZwBisuQTnAnet4NoyS34ni3x3_WKhyEN3e6Akk-rdb4Ngl3F0qpQI6dch5wR7gQ-iDjBgbsjqBYLg6oB-s62g&_nc_ht=scontent-lga3-1.xx&oh=eb05d9d68645716b558d20a9a2fc7cd9&oe=5D6AF18D)

Saw that on facebook. It’s brilliant.

IMAGE(https://i.imgur.com/M1BMve5.png)

Just the beginning of the article, because it doesn't like adblockers. But this caught my attention due to recent conversations/posts. I hope more states jump in, but I wonder who will now pay the remainder.

By ANNA STAVER | [email protected] | The Denver Post
PUBLISHED: May 23, 2019 at 11:36 am | UPDATED: May 23, 2019 at 10:05 pm

https://www.denverpost.com/2019/05/2...

Diabetics in Colorado who use insulin to control their blood sugar levels won’t pay more than $100 per month for the drug starting in January thanks to a bill signed into law by Gov. Jared Polis on Wednesday.

“Today, we will declare that the days of insulin price gouging are over in Colorado,” Polis said in his office as he signed the bill, according to CBS Denver.

Insulin has been around for nearly a century, but the price that patients with Type 1 and Type 2 diabetes pay for the drug has doubled since 2012, according to the Healthcare Cost Institute. The cost of insulin can creep up toward $1,000 for those whose health care coverage requires significant cost-sharing.

farley3k wrote:

Diabetics in Colorado who use insulin to control their blood sugar levels won’t pay more than $100 per month for the drug starting in January thanks to a bill signed into law by Gov. Jared Polis on Wednesday.

“Today, we will declare that the days of insulin price gouging are over in Colorado,” Polis said in his office as he signed the bill, according to CBS Denver.

My concern now is whether insulin will still be widely available in Colorado, or whether certain companies will just stop selling it there because it's no longer as profitable.

Well, the high price of insulin doesn't stem from the manufacturing cost, so any company that makes that choice needs to be pilloried.

I’m confused. How is that quackery? That should be a good thing.
Or has this thread kinda drifted into “wow, look at how sucky the US healthcare system is” territory?

I put it here because it seemed like the thread dealing with medial stuff not for the quackery. We used to have a thread about medical issues but I didn't see it.

I just had an employee of mine come into my office and ask me if CBD oil could cause a drug screen to return a positive. Said they wanted to know before they tried it because they thought it might help them sleep at night. I'm getting the impression that CBD oil is the newest hit cure-all.

I dunno, pot makes me sleepy...

Kehama wrote:

I'm getting the impression that CBD oil is the newest hit cure-all.

It is. I haven't read deeply on the subject yet, but preliminary findings suggest some benefits. However, in classic fashion, the health/fitness media and the general public have decided that it can cure everything from headaches to cancer.

Based on the stuff I see gullible friends on FB posting, it is.

thrawn82 wrote:

Well, the high price of insulin doesn't stem from the manufacturing cost, so any company that makes that choice needs to be pilloried.

It's (mostly) not the manufacturing cost. It's the cost of approval by the FDA (which runs into the billions) and approval by the Patent Office, which grants monopoly rights to the resulting product with all of the attendant problems. We've dealt with this here before, but the insulin people buy today is not the same as what people bought twenty or thirty years ago. Old, regular injectable insulin is extremely cheap, but people don't use it much any more because the newer varieties are better.

An article from Vox does a great job of skewering their own initial claims:

The doctors and researchers who study insulin say it is yet another example — along with EpiPens and decades-old generic drugs — of companies raising the cost of their products because of the lax regulatory environment around drug pricing. “They are doing it because they can,” Jing Luo, a researcher at Brigham and Women’s Hospital, told Vox in 2017, “and it’s scary because it happens in all kinds of different drugs and drug classes.”
The US doesn’t do that. Instead, America has long taken a free market approach to pharmaceuticals.

Then both claims are completely blown away in the rest of the article:

This is in part because companies have made those incremental improvements to insulin products, which has allowed them to keep their formulations under patent, and because older insulin formulations have fallen out of fashion.

But not all insulins are patent-protected. (For example, none of Eli Lilly’s insulins are, according to the drugmaker.) In those cases, Luo said, potential manufacturers may be deterred by secondary patents on non-active ingredients in insulins or on associated devices (such as insulin delivery pens).

There’s also “extreme regulatory complexity” around bringing follow-on generic insulins to market, Luo added. And that’s something regulators, such as the Food and Drug Administration, have been working to streamline. History has shown that their efforts are worthwhile: When cheaper generic options are introduced to the market, overall drug prices come down. A century after insulin was discovered, it’s about time we had one. (Emphasis is mine.)

That billion dollar number for FDA approval gets chucked around a lot, but it doesn't appear to be true, let alone multiple billions.

The median cost of the clinical trials for FDA approval is $19M. (Low of $2M, high of $345M)

https://www.jhsph.edu/news/news-rele...

Insulin is likely to require larger studies as you can get by on a smaller study that a product works better than a placebo, but need a larger one to prove a product works better than the existing solutions.

Yeah, the actual clinical trials are only a tiny percentage of what the development of a new drug costs, and they are only a tiny percentage of what the FDA [ji]requires[/i] for approval.

New drugs take, on average, 12 years to gain FDA approval. The hoops pharmaceutical companies have to jump through to meet FDA requirements are absolutely insane - and, as proven by recent scandals, those hoops are largely ineffective.

Aetius wrote:
thrawn82 wrote:

Well, the high price of insulin doesn't stem from the manufacturing cost, so any company that makes that choice needs to be pilloried.

It's (mostly) not the manufacturing cost. It's the cost of approval by the FDA (which runs into the billions) and approval by the Patent Office, which grants monopoly rights to the resulting product with all of the attendant problems. We've dealt with this here before, but the insulin people buy today is not the same as what people bought twenty or thirty years ago. Old, regular injectable insulin is extremely cheap, but people don't use it much any more because the newer varieties are better.

An article from Vox does a great job of skewering their own initial claims:

The doctors and researchers who study insulin say it is yet another example — along with EpiPens and decades-old generic drugs — of companies raising the cost of their products because of the lax regulatory environment around drug pricing. “They are doing it because they can,” Jing Luo, a researcher at Brigham and Women’s Hospital, told Vox in 2017, “and it’s scary because it happens in all kinds of different drugs and drug classes.”
The US doesn’t do that. Instead, America has long taken a free market approach to pharmaceuticals.

Then both claims are completely blown away in the rest of the article:

This is in part because companies have made those incremental improvements to insulin products, which has allowed them to keep their formulations under patent, and because older insulin formulations have fallen out of fashion.

But not all insulins are patent-protected. (For example, none of Eli Lilly’s insulins are, according to the drugmaker.) In those cases, Luo said, potential manufacturers may be deterred by secondary patents on non-active ingredients in insulins or on associated devices (such as insulin delivery pens).

There’s also “extreme regulatory complexity” around bringing follow-on generic insulins to market, Luo added. And that’s something regulators, such as the Food and Drug Administration, have been working to streamline. History has shown that their efforts are worthwhile: When cheaper generic options are introduced to the market, overall drug prices come down. A century after insulin was discovered, it’s about time we had one. (Emphasis is mine.)

Huh it's like we're not even reading the same article. Vox's initial claim is on the laxity around regulation of drug pricing, not drug approval. And they mention the drug approval process "extreme regulatory complexity" at the tail end, almost as an afterthought, which could be bias except that that is very similar to the conclusion drawn in the very same study you cite as proof of dramatically escalating costs:

Finally, it is difficult to assess whether and how regulatory burdens may have impacted changes in industry R&D costs over time. However, occasionally, an exogenous shift in the types and amount of information perceived as necessary for regulatory approval for particular classes of drugs can be instructive. For example, during our study period the FDA issued guidance (Food and Drug Administration, 2008) for the development of drugs to treat diabetes in late 2008 that highlighted a need to better assess and characterize cardiovascular risks for this class of compounds, after a number of cardiovascular concerns emerged regarding a previously approved drug (Avandia®). A number of development metrics positively related toR&D costs canbe examined pre- and post-guidance.

DiMasi (2015), for example, found that average U.S. clinical development times increased from 4.7 to 6.7 years for diabetes drugs approved in the United States from 2000–2008 to 2009–2014, respectively. In addition, Viereck and Boudes (2011) found that the number of randomized patients and patient-years in NDAs for diabetes drugs approved from 2005 to 2010 increased more than 2.5 and 4.0 times, respectively, before and after the guidelines were issued. Our sample data show that diabetes drugs were among the most costly (particularly for phase III [92% higher than the overall average]).

Our analysis of cost drivers indicates that the rate of increase observed in the current study was driven mainly by increases in the real out-of-pocket costs of development for individual drugs and by much higher failure rates for drugs that are tested in human subjects, but not particularly by changes in development times or the cost-of-capital. Continued analysis of the productivity of biopharmaceutical R&D should remain an important research objective.

Aetius wrote:

Yeah, the actual clinical trials are only a tiny percentage of what the development of a new drug costs, and they are only a tiny percentage of what the FDA [ji]requires[/i] for approval.

New drugs take, on average, 12 years to gain FDA approval. The hoops pharmaceutical companies have to jump through to meet FDA requirements are absolutely insane - and, as proven by recent scandals, those hoops are largely ineffective.

Sounds like we need better hoops then, not less hoops.

Aetius wrote:

Yeah, the actual clinical trials are only a tiny percentage of what the development of a new drug costs, and they are only a tiny percentage of what the FDA [ji]requires[/i] for approval.

New drugs take, on average, 12 years to gain FDA approval. The hoops pharmaceutical companies have to jump through to meet FDA requirements are absolutely insane - and, as proven by recent scandals, those hoops are largely ineffective.

Neither of which have anything to do with insulin, a drug that's been around for nearly a century and that's been approved by the FDA for decades and decades. And those two facts certainly don't explain why the price of insulin *doubled* from 2012 to 2016 and has had double digit price increases every year since then.

Even the argument that it costs too much to get FDA approval is dubious because it comes from an industry that's spent more on marketing drugs than on researching and developing said drugs for years.