Do You Really Want Unknown Filth Injecting Into Your Body?
No,
this is not a story about vaccination and the contaminants they
contain. This is about more every day drugs and unknown filth that often
shows up, when there is no effective quality control.
In a nutshell, pharmaceutical companies are always edging and
trying to get away with murder (yes, murder). Sometimes they get caught.
Most often they do not.
Getting caught isn’t a problem; they just pay the fine and
carry on (at least here in the USA). It’s accounting: the fine = minus X
but our profit is X3 so—no problem. We make money. What’s
missing from the calculations, of course, is the number of dead or
damaged patients. WE DON’T CALCULATE THAT, it’s worthless math!
What got me started?
A story by Kristina Fiore, Director of Enterprise &
Investigative Reporting, in MedPage Today October 15, 2020, about
contaminants in injectable Acetazolamide, a diuretic medication used to
treat glaucoma, epilepsy, altitude sickness, periodic paralysis,
idiopathic intracranial hypertension (raised brain pressure of unclear
cause), and heart failure. It may be used long term for the treatment of
open angle glaucoma and short term for acute angle closure glaucoma
until surgery can be carried out. It is taken by mouth or injection into
a vein.
Not in my veins!
Researchers at the University of Kentucky have called on the
FDA to recall certain formulations of the injectable acetazolamide,
after their own chemical analysis turned up unknown impurities.
The team filed a citizen petition on Sept. 30, citing anomalies
in vials within the same lot for products from both a Dutch company,
Mylan, and a British multi-national Hikma. Near-infrared spectroscopy
revealed extra peaks indicative of contamination—but it wasn’t clear
what those contaminants were, as the researchers couldn't find matches
in pharmacology libraries.
"In 30 years of near-infrared spectroscopy, I haven't seen too
many drugs that look like that," said Philip Almeter, PharmD, chief
pharmacist of the University of Kentucky HealthCare, in Lexington. "We
thought we should pull it right away and figure out why it was looking
so contaminated. We still are not sure what it's contaminated with."1
Last year, Almeter and colleague Robert Lodder, PhD, of the
University of Kentucky College of Pharmacy, also in Lexington, launched
what they called the Drug Quality Study to test pharmaceuticals used in
the university's health system before they're given to patients.
Injectable acetazolamide was the first product they tested.
When they looked at Mylan's drug using near-infrared
spectroscopy, they found 11 of 30 vials from the same lot had
significant variations from USP standards, suggesting "a manufacturing
procedure that is out of process control," they wrote in the FDA
petition.
What’s more, Mylan were cheating! Lab results from a third
party, the Albany Molecular Research Inc (AMRI), confirmed via
high-performance liquid chromatography that the contaminated vials only
contained 80% to 87% of the active pharmaceutical ingredient, versus USP
standard calling for 97%.
That’s seriously short-changing to users and could put a patient’s life at risk.
The researchers also tested an injectable acetazolamide product
from Hikma, finding anomalies in two of 10 vials in the same lot using
near-infrared spectroscopy. Subsequent analysis by AMRI showed the vials
contained only 83.5% to 85.6% API, again well below the USP standard.
So Hikma too are cheats.
But what are the impurities? Nobody knows. They could be
impurities or breakdown products that naturally formed because it wasn't
handled properly, according to Lodder. But whatever the contaminants
were, they were not to be found in any known scientific library of
substance patterns.
Meantime, the health system has since pulled both the Mylan and
Hikma products from its pharmacy shelves. It's using a third product,
made by X-Gen, that apparently passed the Almeter and Lodder
spectrometry scan.
[Continue To Read Online If You Prefer...]
Where Was The FDA In This?
Predictable. Don’t want to disturb their Big Pharma cronies, of
course. They told Almeter and Lodder to file a MedWatch report (so it
could be buried and forgotten). Disappointed by the response, Almeter
and Lodder filed a citizen petition instead!2
Citizen petitions are part of the basic law
governing everything the FDA does - at any time, any “interested person”
can request that the FDA “issue, amend, or revoke a regulation or
order,” or “take or refrain from taking any other form of administrative
action.”
In practice, citizen’s petitions are used mainly by
pharmaceutical companies themselves, to attack and harass each other, by
causing delays.
There's a need for monitoring quality of finished
pharmaceutical products given the global manufacturing market and
challenges in FDA inspections of those facilities, Almeter said. He
means the FDA “inspections” are cursory or non-existent and not really
up to a verifiable standard.
But then we all know, FDA is not looking out for patients interests, but for Pharma profits.
The idea for the university's Drug Quality Study came, Almeter explained, after reading Katherine Eban's book Bottle of Lies, which exposed serious manufacturing deficiencies in the generic drug industry.3
No
doubt the drug industry would like to see more books like this,
destroying the credibility of cheap generics. But also, there is no
doubt, that some Indian manufacturers are big cheats; that’s how
business is done in India! It’s caveat emptor (buyer beware).
The trouble is, there is little money made on generics, so not
much incentive to play the game straight. What does that mean for
patients? Best response is don’t take the medicines. You are at risk
with all meds. Don’t be fooled” Big Pharma meds are made in exactly the
same factories in India and elsewhere!
In fact ninety percent of the prescription drugs consumed in
the United States are generics, and the majority of them are produced
overseas, mostly in India and China.4
Of course the COVID-19 situation is further hindering
inspections, and thus concerns about quality are even greater, Almeter
said. The stakes are especially high for sterile injectables, which need
to be made extremely carefully given that they're often injected
directly into the bloodstream.
David Light, CEO of Valisure, entered the conversation and said
that "from an overall chemical quality perspective there are certainly
additional points of concern with an injectable beyond what we've
already seen as problems with oral solids like tablets and capsules."
"By being in liquid form, the drug is effectively in a
'solvent' which can make degradation and other undesirable reactions
more likely to happen than when the drug is in a more static, solid
form," Light said. "Even getting precise dosage can be more challenging
since the manufacturer will have to account for solubility, dissolution
rates, evaporation and other liquid-related considerations."
So remember that when you are confronted with injectables.
Insulin is one of the most common. But what are you actually getting in
your shot? Chemical contaminants and a very different dose to what you
are TOLD you are getting.
I’d go for a natural cure, if I were you. All you have to do is
eat right, live right and take your supplements. The rest is up to
Mother Nature!
Stay well, please!
Prof. Keith Scott-Mumby
The Official Alternative Doctor
References:
1. https://www.medpagetoday.com/publichealthpolicy/productalert/89135
2. https://en.wikipedia.org/wiki/FDA_citizen_petition
3. https://www.amazon.com/Bottles-Lies-Ranbaxy-Indian-Pharma/dp/9353450446/
4. https://www.wired.com/story/8-ways-overseas-drug-manufacturers-dupe-fda/
No comments:
Post a Comment