Search This Blog

De Omnibus Dubitandum - Lux Veritas

Showing posts with label Medicine. Show all posts
Showing posts with label Medicine. Show all posts

Tuesday, August 27, 2024

CO2 Has Been Indicted by Consensus, Not Real Science or Critical Thinking

The differences between these are enormous 

By John Droz, Jr. Aug 26, 2024 @ Critically Thinking About Select Societal Issues

When asking those who believe that CO2 is a major climate antagonist to make their strongest argument, their most common response is: “CO2 has been identified as the primary Climate culprit by the majority of experts (e.g., climatologists) and scientific organizations (e.g., the IPCC).” This is clearly a consensus claim.

I’ve repeatedly warned that one of the major fights we are in, is to defend genuine Science, as its enemies are actively trying to replace it with political science. This situation is a dead giveaway, as consensus is the currency of politics, NOT Science!

Put another way, the claim of consensus is deference to authority. They are saying don’t ask any questions! Just be quiet as others know a lot more about this matter than you do. Further, they continue, it’s not possible that all those experts would be lying to us!

Both of these are very reasonable viewpoints. However, whether or not they should end the conversation is the question. Let’s look at a recent very close Science parallel for enlightenment. Here is a layperson’s history of what happened…

There are roughly 8 Billion people on the planet who periodically experience stomach ailments (i.e., gastrointestinal distress). The concern often is: will these common human pains turn into something much more major — like an ulcer?

An ulcer is a perforation of the stomach lining, which is a serious matter, and there are about 4 Million cases of these in the US, every year — so it is relatively common.

For nearly 200 years the medical establishment believed that stomach ulcers (technically peptic ulcers) were caused by stress. The hypothesis was that stress produced excess (gastric) acid in the stomach, which (in turn) eventually ate away some of the stomach’s lining. (The first connection between these was made in 1822.)

In this case when I say “medical establishment” I mean worldwide 100% of relevant PhDs, MDs, RNs, PAs, etc. Also 100% of hospitals (like the Mayo Clinic). Also 100% of universities and medical schools (like Johns Hopkins). Also 100% of medical textbooks. Also 100% of medical journals (like the Lancet, and NE Journal of Medicine). Also 100% of medical organizations (like the AMA). Also 100% of government medical agencies (like the FDA, CDC, DOH). Also 100% of pharma-ceutical companies (like Pfizer, Merck, Johnson & Johnson, Bristol Myers Squibb). This was also the position of the MD’s bible: the Physician’s Desk Reference.

As a point of reference, the combined number of worldwide medical experts here is roughly a hundred times the amount of worldwide anti-CO2 experts.

They were ALL wrong!

The basic reason that these many thousands of highly educated people were wrong, is that none of them actually applied the Scientific Method to the accepted and sensibly sounding hypothesis about the cause of stomach ulcers! Instead of taking the time and effort to perform a genuine Scientific assessment of this common worldwide issue, they relied on intuitionplus the fact that other experts were on board. (This is very similar to what is going on regarding Climate and the faulting of CO2.)

What’s the Truth?

The Truth regarding stomach ulcers was discovered when two Australian scientists (Dr. Robin Warren and Dr. Barry Marshall) decided to apply the Scientific Method (!) to the medical establishment’s ulcer hypothesis. (Note that what we still have regarding CO2 is a scientifically unproven hypothesis as to its full relationship with Climate.)

The short story is that in 1982 Drs Warren and Marshall proved that most stomach ulcers are caused by a bacteria: H. pyloriNOT stress-induced excess acid production! (Read sample stories here, here, and here.) Note that this scientific finding is not even remotely similar to the stress/acid hypothesis that tens of thousands of medical experts had fully bought into, for many decades…

This was a VERY BIG DEAL. This NIH study says about their work: “Advances in drug therapy for peptic ulcer have had a significant impact on quality of life and work potential of many millions of affected persons and have contributed to a remarkable decrease in the prevalence of the disease, frequency, and severity of complications, hospitalizations, and mortality.”

Why this Catastrophic Failure of Experts? 

This failure is particularly hard to understand regarding pharmaceutical companies, which have thousands of qualified experts (e.g., PhD Biologists and Chemists). Why didn’t those scientists figure out the truth through scientific experiments, since they have the experts, labs, and money?

Because, exactly like the IPCC, they started with an unproven assumption. In this case, it was that excess acid was causing most ulcers (and that stress was causing the acid)… A cynic would say that there is a second major reason: they didn’t want to get to the Truth, as that was not in their financial best interest!

In any case, following the unproven ulcer hypothesis, pharmaceutical companies produced two types of “solutions”:  

  1. Drugs to reduce stress (anti-anxiety meds like Xanax and Valium) plus 
  2. Drugs to reduce stomach acid (Nexium, Tums, etc.). But neither of these do anything meaningful to address the primary cause of ulcers!

There is an exact parallel with industrial wind energy and solar proposed (by experts) as “solutions” for the climate issue, as neither of those has genuine scientific proof that they work (i.e., save a consequential amount of CO2).

What happened after this Discovery? 

What followed Drs. Warren’s and Marshall’s published peer-reviewed study is also instructive.

To begin with, there was great skepticism by the medical establishment (aka the “experts” who have been wrong for many years).

In 1996 (14 years after Drs. Warren’s and Marshall’s findings were published and verified) the FDA finally approved the first antibiotic for treatment of ulcer disease.

In a 1997 study (15 years after their findings were published and verified), data show that about 75 percent of ulcer patients were still treated primarily with antacid type medications, and only 5 percent receive antibiotic therapy!

This shows the powerful resistance by “experts” to accept the Truth — especially when it exposes the fact that said experts were totally WRONG, for decades.

Prompted by this study, in 1997 the CDC, with other government agencies, academic institutions, and industry, launched a national education campaign to inform health-care providers and consumers about the link between the H. pylori bacteria and ulcers.

Drs. Warren and Marshall subsequently won the 2005 Nobel Prize in Medicine for following the Science.

What’s the Takeaway?

Please reflect on the original question: can tens of thousands of well-educated experts, universities, medical journals, textbooks, medical organizations, pharmaceutical companies, and government agencies, be dead wrong? Absolutely YES!!!

Is this because they are ignorant? (Not in general, but they certainly were ignorant about how Science works.) Is this due to a conspiracy? (Hard to say.)

Summary: the experts were wrong as they lazily went with intuition, plus the comfort of consensus of their peers Furthermore, they decided it was too much trouble to apply scientific rigor via the Scientific Method to their ulcer hypothesis. Lastly, for some of the medical experts, it was in their financial interest to not reveal the truth.

Today we have an almost identical situation with the hypothesis against CO2.

PS — A strong argument can be made that the same departure from Science (short-cutting) happened with COVID-19. That will be another commentary.


Here are other materials by this scientist that you might find interesting:

Check out the Archives of this Critical Thinking substack.

WiseEnergy.orgdiscusses the Science (or lack thereof) behind our energy options.

C19Science.infocovers the lack of genuine Science behind our COVID-19 policies.

Election-Integrity.infomultiple major reports on the election integrity issue.

Media Balance Newsletter: a free, twice-a-month newsletter that covers what the mainstream media does not do, on issues from COVID to climate, elections to education, renewables to religion, etc. Here are the Newsletter’s 2024 Archives. Please send me an email to get your free copy. When emailing me, please make sure to include your full name and the state where you live. (Of course, you can cancel the Media Balance Newsletter at any time - but why would you?

Leave a comment

Share

Thanks for reading Critically Thinking About Select Societal Issues! Please pass a link to this article on to other associates who might benefit. They can subscribe for FREE to receive new posts (typically about once a week).

Wednesday, June 27, 2018

Government Is The Big Reason EpiPen And Other Generics Are So Expensive

By ACSH Staff — June 23, 2018 @ American Council on Science and Health

The drug, 62 years old at the time, was not covered by a patent and was a key antibiotic used in treating persons with HIV/AIDS. The price hike put patients’ health at risk, leading to a cost of hundreds of thousands of dollars for some. Shrekli, unsurprisingly, was vilified (and, for unrelated reasons, ultimately indicted on fraud).

While this conduct was outrageous, it wasn’t illegal. Any pharmaceutical company is free to set the price for its drug at any level the market will bear that maximizes their profits. Other drugs whose prices have risen include treatments for hepatitis C, cancer and high cholesterol. So, while the price hike was not the best public relations move, it is legal.

What explains such a rapid rise in price for a drug that has been around for several years? As a patent lawyer with particular experience in the pharmaceutical industry, I think it’s important to look at the role of patents and also FDA approvals in drug discovery and sales. Currently, a backlog of about 4,000 generic drugs is awaiting FDA approval. Both factors play a role in how both rare and common drugs, such as EpiPens, can shoot up in price so rapidly.

Patents encourage innovation

From www.shutterstock.com
Thomas Edison knew the value of patents.
He held more than 1,000 in his name
High prices for medications are nothing new. They are often expected, given the role of the patent system in fostering innovation in the pharmaceutical industry.

Patents create incentives for persons to innovate by giving them a limited period of exclusivity, currently from the date the patent issues until 20 years after its application date. During the patent’s term, the owner can stop others from making, using or selling the patented invention.

Without this period of exclusivity, companies would have little incentive to engage in research and development. Pharmaceutical research and regulatory approval is a costly endeavor. The average cost to bring a drug to market is $2.6 billion, according to the Tufts Center for the Study of Drug Development.

Imagine the world of pharmaceuticals without patents. The National Institutes of Health predicts drug development would greatly diminish. Once a company put a drug on the market, others could purchase it and likely figure out how to synthesize a competing version, without incurring all of the research and development costs to identify that particular chemical entity.

When competitors enters the market, they would be able to undersell the original innovator, whose price must reflect those sunk costs of research and development. Likely, it would not be profitable to have ever engaged in the drug innovation to begin with.

Patents help stimulate innovation by temporarily avoiding this dynamic.

Playing monopoly

During the patent term, particularly for pharmaceuticals, the patent holder may effectively have a monopoly, allowing the company to charge prices higher than a competitive market would allow. As a society, we largely have accepted this elevated price because we believe it helps pharmaceutical companies to recoup their sunk research and development costs and to perform later research for the next generation of drugs.

Once the patent expires, however, others can enter the market, creating competition and lowering the price for the drug.

There are opponents to the power of these patents. Critics argue that these patents deny patients access to those drugs to patients in need.

There’s more at play here: The FDA

Interestingly, though, the patent system is not to blame for many of these price hikes we hear about in the news. Instead, these drugs, such as the EpiPen, are off-patent, suggesting that generic competition should help keep prices lower.

So, if it isn’t the patent system, then what is at play? It is conceivable the cost of producing some of these drugs has gone up. Similarly, there could be surging demand that drives up prices as well. Neither, though, explain the abrupt, dramatic hikes of some of these medicines.


At the simplest level, there is simply a lack of competition for these drugs, even absent patent protection. Some of this dynamic could be the well-recognized consolidation in the pharmaceutical industry, which may have reduced competition. The low profit margins on some of these drugs may have led some companies to leave the market altogether, leaving only one company.

But even absent consolidation, there is another barrier that appears to be in play: regulations by the FDA, and the huge backlog. Even generic drugs need regulatory approval to be sold, which makes sense. We don’t want fly-by-night companies selling impure or otherwise harmful drugs.

But obtaining approvals does add costs and time to competitors attempting to enter the market. One potential EpiPen competitor, Teva Pharmaceuticals, failed to obtain regulatory approval, delaying their entry into the market. Another competitor, Sanofi, recalled its competing epinephrine delivery device because it may be delivering in incorrect dosage. That leaves Mylan alone in the market, with the power to raise prices, which is what it did.

Congress and the FDA are well aware of the backlog, even though the FDA says it is picking up the pace, thanks to fees charged to the drug companies seeking approval.

In theory, some of these are just short-run problems. Eventually exorbitant prices will draw other competitors to the market and prices will come down, or so goes the thinking of basic supply and demand. But, FDA regulations – if unduly onerous – could continue to create long delays, resulting in higher prices and loss of access to some of these medications.

It may be time for the FDA to reconsider some of its regulations governing these well-known, generic drugs to reduce the cost of approval and to facilitate competition. For example, the FDA may need to consider some sort of accelerated approval for importing drugs already sold in countries with regulatory systems comparable to our own. In that way, competition for these unpatented drugs could return more quickly.

As famed economist John Maynard Keynes noted, in the long run, we’re all dead. But, even if these price hikes are only in the short run, some of these patients may be dead in the short run, too.

At present, companies will charge prices that the market can bear for these drugs. There are few levers the government has to impact these prices. The FDA is in a unique position to act. It should revisit its role in this regulatory structure to ensure it is striking the appropriate balance between protecting patients from flawed drugs and ensuring drugs get to market to reduce prices.


By Timothy Holbrook, Professor of Law, Emory University. This article was originally published on The Conversation. Read the original article.