Missing Americans: Early death in the United States

Investment Analysis Clubs Macro Economic Trends and Risks
22

Honestly I thought all sorts of things were the problem. Hogwash

The problem for me? If I do nothing I am not happy. Doing nothing was a bad idea in my family household. Really out and out wrong. Not eating is doing nothing. I have to accept and even enjoy something I was not raised to do.

Daft? Sort of…putting down a fork was sort of not included in the list of things where you had to do it. But it was also included in just eat it. We do not want to hear otherwise.

My diet is a do a lot less and do nothing diet with commonsense eating and smaller portions.

Contentment comes and goes but give doing nothing chance.

Blasphemy

:rofl: :rofl: :rofl:

Vee

I have zero faith in those drugs. There are going to be major ramifications. The practice is not conservative enough.

My BIL thinks they are a good idea. He is all for them.

My dad has not weighted in, see what I did there? But it goes against how he practiced medicine by taking a drug off label well now on label and not seeing the results in the wards for five years. BIL feels the drugs are safe. He is saying the dosages are much higher than when used for diabetes. This will end badly in all likelihood.

23

Well, per the article, there’s a realisation that the longer long term is an unknown and the rare adverse events are only going to be recognisable when loadsa people are taking the drug so your BIL’s opinion is most likely going to be the valid one. Weighed against the near certainty of severe adverse consequences with uncontrolled obesity, it’s an option I wouldn’t necessarily turn down myself. Easy for me to say, of course since I’ve never been fat. I can’t imagine entertaining so much as a 5-10 lb weight gain let alone the 50-100lb that seems to be tolerable before it’s not … so I’m thinking these drugs are for those who don’t/can’t exercise self control for whatever reasons.

The studies that appear to show benefits in ASCVD even without a diagnosis of diabetes are pretty interesting (assuming they’re accurate) Kinda suggest that the disease process is underway and the departure from healthy homeostasis happens well before that A1c reaches the magic number that eventually makes folk sit up and think.

Mind you, it’s likely to be just another addition to the smokescreen that craptaculous lifestyle choices add to the reality that real, non self inflicted disease exist.

24

Also to me…and my proactive thinking…it looks like that portrayal of CGMs as useless for non diabetics/pre diabetics and the province of the worried well and biohackers might not be totally accurate either.

There’s got to be something going on that’s different from the glucose response of the genuinely metabolically healthy. You don’t suddenly wake up with the qualifying lab numbers after a stretch of perfect glucose control

25

They would not take him.

26

All doctors are completely right. Until the five year mark where most of them it turned out were wrong. There was a reason that my dad was the number one doctor in his specialty by himself for at least 15 years. This was one of the major building blocks of his reputation. Most drugs, almost all, are pulled within five years. The wards are full of people who had very bad problems with the drugs.

You first. LOL

BIL is not nearly as strict as dad.

BIL and sister called dad when in their early 30s to tell him they were going with a pharma company on vacation. Dad yelled into the phone, “good be a who%e”!!! BIL did not go. He woke up.

Doctors are not perfect…hardly…but when all the peers would send their family to one and only one of them…tells you something.

I am not getting poisoned with a new drug dosing against a different problem because BIL “feels”…something or other. It is an unknown that will in all likelihood backfire.

Adding

I have some psoriasis. Using a non commercial or non chemical soap I have reduced my psoriasis by 95%. Dermatologists for years have poisoned me. I rarely go to them except for a cancer screening.

The PA recently trying to deal with a patch of psoriasis put me on Fluticasone topical. Mild steroid take it for 21 days and then off for 5 days and repeat if necessary. The skin wont be thinned. Okay.

Then PA decides to use Zyrtec topical. So I switch. New drug. I have faith in this PA she is a recent grad. She is so competent.

Wrong. I get the worst insomnia of my life.

Get off of Zyrtec. Go back to Fluticasone.

Wrong. I get mild anemia.

BIL runs my PCP through her paces with his suggestions to me. Okay. No ideas on what is wrong. Both stumped.

In both cases I revert to dads, “look it up online using the Mayo Clinic”. That is why I stopped both topical creams.

Both problems resolved.

BIL is a top researcher. He is a very good clinician. PCP is okay.

Dad is very practical. Anyone can read a book they barely understand and sound off like a dictionary. Dad actually got things done with his patients. Kind of a paradox for a shrink. On the theory side dad was extremely good. On the diagnostic side dad was by far the best and possibly the best on the east coast. Certainly regionally.

27

I think I’ll file this tidbit alongside the European doctors’ salaries and Norwegian doctors figures.

28

You are completely wrong.

Prove otherwise. I have seen you make this claim that drugs are kept on the market often after five years.

It is the exact opposite. Put up finally some evidence.

I think you have zero expertise in this even after your training. Or at worst you were not even paying any attention. Obviously.

But it is complete misdirection of people here for you to be saying drugs are not often pulled. They are almost all pulled for the side effects.

Just beyond belief how little you know. Worse when you wont admit you do not know things. Arrogant. Stop hiding behind your training. You get things so wrong it is mind blowing.

29

While drugs are in the pipeline for ten years before the wider market…the drugs are used in phase three widely in the market. Where the five years begins is not central to my dad’s claim.

1 for all of you reading this can save your life not experimenting when you do not have to with new drugs.
*** Special note if you listen to the arrogant and ignore this, there are much worse things that can happen to you because of some of these drugs than your actual death.
2 for any of you investing in the latest “story drug” you are playing with fire. Do not listen to a dentist who has not seen, heard nor thought about this without a single clue.

Why 90% of clinical drug development fails and how to improve it? - PMC.

Drug discovery and development is a long, costly, and high-risk process that takes over 10–15 years with an average cost of over $1–2 billion for each new drug to be approved for clinical use1. For any pharmaceutical company or academic institution, it is a big achievement to advance a drug candidate to phase I clinical trial after drug candidates are rigorously optimized at preclinical stage. However, nine out of ten drug candidates after they have entered clinical studies would fail during phase I, II, III clinical trials and drug approval2,3. It is also worth noting that the 90% failure rate is for the drug candidates that are already advanced to phase I clinical trial, which does not include the drug candidates in the preclinical stages. If drug candidates in the preclinical stage are also counted, the failure rate of drug discovery/development is even higher than 90%.

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30

I’m sure most folk are aware that drugs in phase III trials are not yet approved or used “widely in the market” …but you never know.
And since it’s a whack-a-mole sorta day…

31

Bolded * down below…that starts to get into the hundreds of thousands of patients depending on the drug and illness.

VeeEnn you do not know. You seem totally new to the topic. Don’t risk anyone else’s life or limb just because you have training in something entirely different. If you do not know something get over it. Stop the character assassination garbage.

Phase III clinical trials: Is it better than what’s already available?

Treatments that have been shown to work in phase II clinical trials must succeed in one more phase before they’re approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.

Because doctors do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the standard treatment or the new treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study. Randomization and blinding are discussed in more detail later.

Key points of phase III clinical trials

* Most phase III clinical trials include a large number of patients, at least several hundred. * These studies are often done in many places across the country (or even around the world) at the same time. * Phase III clinical trials are more likely to be offered in local community hospitals and doctor's offices. * These studies tend to last longer than phase I and II studies. * Placebos may be used in some phase III studies, but they’re never used alone if there’s a treatment available that works. Sometimes, a patient who is randomly assigned to the placebo for part of the study will at some point be offered the standard treatment as well.

As with other trials, patients in phase III clinical trials are watched closely for side effects, and treatment is stopped if they’re too hard to manage.

32

Correct …a very different situation from “used widely in the market”.

33

You are doing that nitpicking stuff again when you do not know anything.

The Phase III trials are the market. The only difference is the studies are set up differently than later on. People demand drugs because of the “stories” about how great the new drug will be. They demand doctors put them on new drugs in Phase III. We can be talking millions of people depending on the disease. Phase III is the market until later when a drug is approved or denied.

BTW beyond the 90% or more of drugs rejected by the end of Phase III there is another “crazy stat” which pans out strangely but not fully knowable about 3.5% roughly of the rest of them being pulled from the market.

The problem with the later stat it is not 3.5% of 10%. It is 3.5% of 100%. And the stat varies depending on the source and study.

That leaves something like 6% of drugs making it to market and staying on the market longer than 5 years. Rough percentage.

That is higher than I expected. The reason my dad was ultra cautious because the 90 whatever percentage did a lot of harm very often. He did not bet on the 6% with the 90% mixed in.

By the time we get to 3.5 or 4.5% v what is left 5.5 or 6.5% believe it or not you are still not playing with safer drugs much of the time. The drugs to be pulled later can do serious harm about 40% of the time. VeeEnn that may be all sorts of Tiddlywinks to you but if you play guinea pig you will probably regret it.

Like I did mention some of the side effects can be worse than death.

34

Suing is never going to make it up to any of us.

But guess what? Good luck getting a dime out of them.

Google result

You do not have grounds for a lawsuit unless your attorney can show evidence establishing three things: You sustained an injury. The drug was defective due to improper design, manufacturing or a failure to warn. Your injury was a side effect of the defective medication.

My comment a medication with bad side effects wont be considered defective generally.

Unlike J&J’s talc

37

VeeEnn this is simple stop belittling me.

38

I hardly need to…you’re doing a bang up job yourself.

Enough of that. 'twas not I who flagged your post BTW and I’m going to have a bit of a struggle on my hands to point out the errors in your diatribe. Readers other than yourself might be aware of this but just in case…

The image you’re portraying is that phase III data is being collected by multi regional centers worldwide and in numbers vastly in excess of a)what’s necessary b) commonsensical. The FDA is the licensing body for drug marketing in the US as well as globally. Data from US centers historically tend to carry more weight because of the ease of oversight for centers that’re conducting studies and that those centers…oftentimes large academic institutions with a strong research track record…simply have the infrastructure designed to provide meaningful data. And population specificity.

Other countries with a well established pharmaceutical industry…UK, France, Sweden etc…are also accepted as equivalent. Mind you, folk in the pharmaceutical industries in those countries might say different. My BIL was a biochemist for Astra and he had a thing or 17 to say about the FDA requirements. But the image of millions of folk turning up to their doctor’s office demanding to be included in drug trials is an illusion. Inclusion criteria are very strict (the cynics would say the better to game the results)

There used to be folk working in pharma on various boards in the Olde Days who could be called upon to do better explanations than I.

39

Sometimes even too strict! I’ve heard of people (and known one) that desperately want access to new drugs that haven’t completed their trials yet. I have a friend with pancreatic cancer who actually traveled to Europe for a treatment that wasn’t yet approved by the FDA. He’s still here 7 years later, and 7 years is a LOT for pancreatic cancer.

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40

For sure. I think the memory of dodging the Thalidomide bullet is still there. When we have our get togethers with cronies in England and the cost of drugs here (US) vs there comes up. I’ll oftentimes say…and not 100% joking … that sure their drugs are cheaper/better negotiated rates etc because the multinationals can soak the US consumer
The reply is…and quite right. Approval over here is usually quicker so we get to act as guinea pigs for your approval process.

41

oy please

There are 399 trials in the world with greater >500,000 participants. See fig. H.
There are 791 trials with 100,001 to 500,000 participants.

While the 399 trials does not break out how many are over 1 million we are getting there. The trials run from very limited in phase three to over one million participants.

42

Caveat Emptor

And 20

The bottom line folks you can be careful and not have side effects that are horrible where death could have been better.

Or you can listen to people who would risk your life and limb for a silly argument.

Mark, the FDA does all sorts of crazy things and denials. That does not mean it Phase III trials are hard to get into. People demand in all the time. The stories are quite lovely on how the drugs will work. The results? Not so good.

43

I am no expert on this topic, but I have some real knowledge.

Let me start by making my main point.

Do not forget that being in a drug trial is not only an opportunity to fight for life, or for a less impaired life, but also a chance to make one possibly last life contribution, being willing to be a guinea pig who will probably NOT win the big lottery but who will help crucial knowledge advance, helping those who come after. Being on a mission to help others even when desperately ill or dying is of great value.

Waaaay back in the 80’s into the early 90’s the devastating, no treatments exist, almost always fatal HIV epidemic caused an earthquake in human drug testing, and I was part of that.

I was a co-owner of the powerhouse international gay bi-weekly The Advocate,

a founding organizer of gay political powerhouses such as HRC,

and amongst the very earliest (1979) persons in the USA infected with HIV.

This gave me a prime view of the immense transformation in USA policies on drug testing.

At that time I focused on countering the bigots and entrepreneurial pseudo-Christian fanatic “leaders” who (despite their disgusting mealymouth prayers for our being saved from spiritual and physical death) basically wanted all of us uppity militant “immoral” homos to die. I confronted and combatted them publicly and privately and politically (Reagan’s administration was loaded with them ). But I also pushed my infected (like I was and am) readers and associates to do everything they could to be useful guinea pigs for legitimate and well designed drug trials. AND, I was part of the fierce movement (starring ACT UP and many others)

pushing the FDA and CDC and NIAID and funding committees in Congress to work as hard and as fast and as high volume as they could reasonably imagine, which was a lot harder and faster than they were accustomed. Profoundly conservative, Christian Surgeon General C.E Koop

was our shockingly exceptional, excellent, and insightful ally, whom I thank eternally.

For good and for ill that era set us up for the era we are now in. Our push for more open and accelerated drug trials did some good and no doubt some bad. Balancing that out and making corrections is very important, but remains a very hot potato. I am glad to have left the complex battlefield.

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