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Sunday, January 16, 2022

Reassurance For Those Afraid of Vaccines Based on Fears About Big Pharma ...

 

(*Edited - content added)


Now, first you need to know, if your fears about vaccines are based on Big Pharma, I get it - I don't automatically trust Big Pharma either.  I also don't automatically trust national-payer insurance companies.  Nor do I automatically trust politicians or government.

In fact, Mark and I waited and observed for a few months, when they first came out, to see what happened in the real world, just because what happens in clinical trials doesn't always happen in real life.


But it does appear to be working to curb the severity of the disease and transmission in areas where people are vaccinated - and here's what I do trust - the consensus of expert opinions, based on thoroughly reviewing the clinical trials.

I trust the majority opinion of expert clinicians in their fields, especially on independent advisory panels for new drugs - as a committee and consensus, mind you - NOT as individuals (who can be greedy, too, and may have their own motivations, such as shares in certain companies).


Plus I have just a tiny bit of extra insight into how our pharmaceutical system works ;)

I've mentioned what I do before, but for those who missed it, I transcribe interviews for an independent pharmaceutical marketing firm, between payers and clinicians, before new drugs launch, from various (and competing) Big Pharma manufacturers.

Not just for the U.S. - I transcribe international interviews as well, meaning government payers in Europe.


The interviews are "double-blind," meaning the person being interviewed is not identified to the pharmaceutical company, and the product and its manufacturer are not identified by name to the person being interviewed (although I will say, often they figure out what the drug is, and who the manufacturer is, because experts already know what's in the pipeline and have already read the clinical trials).



Let me tell you something - those clinician experts in their field - and the payers, who are clinicians and pharmacists themselves - know their sh*t.

They're very practiced at critically reviewing clinical trials - and if there's even the slightest weakness in trial design, efficacy, or safety, they're going to find it.

(That happened with Aduhelm for Alzheimer's disease - though the FDA approved it, virtually no one will pay for it or prescribe it.)

And think about this - especially the medical director or pharmacy director for insurance companies are going to ferret out and pounce on even the slightest flaw so they can leverage when it comes to price negotiation and rebates, believe me.



Though that doesn't apply to vaccines yet in America because the government is still paying for vaccines, though we have mostly private payers/insurance, remember healthcare in Europe is government funded in general  - and especially France and Germany would hop on even the smallest weakness to negotiate price - but they haven't.

Man, France and Germany don't play -  even laughing at manufacturers for trying to get things reimbursed based on BS.  

Because even though the EMA for the EU might even approve the drug, no country is required to adopt it and reimburse/pay for it - and those two countries in particular have exercised that right many times ;)


FYI, France and Germany especially don't like short trials and against placebo trials, especially if something is already on the market.  

They also don't like when a drug is a "me-too" drug that shows no additional benefit, trying to charge a premium price to the drug already on the market, instead of cheaper to lower the prices, as a free market is supposed to work, but nevertheless flies in America especially, due to varying contract rebates.

Also, one thing France and Germany will do that we don't is renegotiate the price after a year or two based on efficacy and safety and market uptake, regardless of when the actual contract ends - this is part of their agreement with the manufacturer - they can renegotiate the access and price at any time.

During these renegotiations, broader access may be granted - and though it's possible for a premium price to be given to a drug later for proven better efficacy and safety, that never happens, the price will go only down - because if a drug becomes a market leader, then they manufacturer is already benefiting from controlling the market share/more of their product is being prescribed/bought than before ;)

Commercial payers in the U.S. can do this only when their contract ends, in at least two years, sometimes as long as five years - based primarily on market share alone - and Medicare/Medicaid typically tends to renegotiate price more when a new product in the same class launches, or generics and biosimilars enter the market, rather than contract renewal time.


Regardless, I really wish we would do healthcare more like either France or Germany, but that ain't gonna happen anytime soon because of people's irrational fears about national healthcare being "socialism" (which is what the corporate fat-cats push so that they can continue to overcharge you for healthcare without sanction) :/


Anyway, though I did not transcribe any interviews for the vaccines (because they were government purchased), I have for some of the pending treatments - and let me tell you, if there's even the smallest weakness in any trial, they will hop on it - payers will tell them straight up that even if it's approved by the FDA, you're going to have to jump through 9 hoops to get it and the experts will tell you they won't prescribe it.


So no, I don't trust Big Pharma either, and I get it - but what I do trust is majority opinion of clinicians, pharmacists, and the Medical Directors/Pharmacy Directors for our insurance companies as a whole. 

Now ...

Of course, there are always a few outliers and stragglers who like to do things their own way, there are even a few quacks - or they have their own motivations for things (including being shareholders in certain pharmaceutical companies or they put their money/political motivations above their patients).  

Of course there's doctors who want the latest, shiniest new product.  

Of course there are payers - and especially the PBMs they use - who want big kickback rebates.

But the thing is, these three things together tend to balance each other out.


The insurance companies can get all the kickbacks they want, but if the doctors aren't prescribing it, well, too bad for them.

-AND - 

The doctors can want the latest, newest, shiniest thing, regardless of cost - but if it's in the same class and wants to charge a premium to the last one, too bad for them, too - they're not going to get it easily if it's the same efficacy and safety as the other ones, but too expensive.


So you see, I trust the checks-and-balances system  we have a whole to root out any problems with the drugs -  if not before launch, then typically within a year after.

*NOT when it comes to price, you understand -  just efficacy safety of a drug* ;)



Now, is the reviewing system perfect?

No - and I would add that I would trust France and Germany's pharmaceutical reviewers before ours lol.

But then again, no reviewing system is perfect and mistakes are made.


But if there was a problem, we'd hear about it by now, in the form of a large-scale, international, majority-consensus public outcry from our clinicians themselves, like we did with Aduhelm, only even bigger news - and yet we don't.


And the fact is, the majority opinion hasn't changed - in fact, there's greater respect for the vaccines, they have proven themselves even more efficacious than we thought in clinical trials - keeping in mind they never claimed to prevent infection, just lessen the severity and  spread of disease. 




Yes, there were a few more adverse events than in the clinical trials, but that always happens with new drugs in the real world - but frankly, not many more adverse events than expected based on the clinical trials - in fact,  adverse events have been pretty close to the same percentage found in the clinical trial, just in a larger population than in the clinical trial.

Yes, we also don't know the long-term effects, that's true - but that could happen with any drug we take - no drug is perfectly effective and/or perfectly safe.


Also, as I mentioned previously, there was some debate about Pfizer's booster's small Israel study at first, but when Moderna's study came out proving efficacy waned in all three vaccines and their larger study proved booster efficacy, that sealed the deal.


So what I'm saying is, you're right not to trust Big Pharma.  You're right not to trust insurance companies.  You're right not to trust politicians and government.  You're even right not to trust individual doctors who just want something fast and the latest, shiniest thing, despite it being no more efficacious/safe than the last thing, or they may hold shares in pharmaceutical companies ...

-- BUT -- 

 ... as a whole, these three groups together will balance each other out, in the end  as a majority consensus opinion.

And there would especially be a huge public outcry from clinicians themselves if there was huge a problem, regardless of the kickbacks to insurance companies - just like they did with Aduhelm - not just a few quack outliers.



Does that help? :)


Now -  if you're instead worried about the vaccines due to fear of nanochips or government monitoring or controlling your mind, then I can't help you - perhaps a psychiatrist can lol

Because you're giving medical science and technology too much credit - science simply isn't that advanced yet.


We don't even have actual cures for any virus (except hep C) based on genetic/mRNA technology yet -  not even the common cold.

We can't even make implanted insulin pumps that coordinate with implanted continuous blood-glucose monitors to accurately record blood sugar readings even close to 100% of the time for diabetics yet.

Heck, we can't even make wristband watches that monitor your heart rate and blood pressure as accurately as large, compressive upper armbands yet.

And yet you think anyone has the technology to alter your DNA to that degree, especially via a vaccine, or control and/or monitor what you think and do with a tiny nanochip?  lol.


Alrighty, good luck with that.  You have the right to believe that, but beliefs like that are  probably a lot more detrimental to your health than any vaccine ;)










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