I received an email this morning on a recent 60 minutes episode concerning how poorly managed Pharmaceutical companies are in introducing and releasing prescription drugs to the public. This is why I always stress doing your OWN HOMEWORK before going on a NEW or replacement prescription. Google ALL the side effects of a particular drug and go onto the forums where the real people live and get a feel for what type of problems are out there before becoming someones guinea pig experiment. I am going to paste the body of the email here for you to look at. This is one of the reasons I recommend you buy a subscription to "Life Extension Magazine".
If you watched CBS News 60 Minutes last night, you witnessed the kind of misleading reporting that enables federal agencies to gain unbridled power.
accurately told the story of an unscrupulous manufacturer of
contaminated drugs that caused 48 deaths and over 700 serious
60 Minutesomitted the fact that the FDAknew about this disaster-waiting-to-happen as far back as 2002, but failed to stop it until Americans started dying in 2012.
FDA officials were given free rein on national TV to blame this tragedy on a lack of regulatory authority. As you'll read here, the fault instead lies with bureaucraticincompetence
at the hands of the FDA and the state pharmacy board that permitted
these lethal deviations in good manufacturing practices to occur.
Particularly appalling is the FDA's inability to recognize that manufacturing as many as 17,000 vials of a drug all at once under filthy conditions was a far cry from compounding one drug at a time in a sterile environment.
The contamination problem, however, is not isolated to one bad drugmaker. It turns out that these kinds of safely violations were routine at drug factories that the FDA had certified as being safe.
Instead of blaming the FDA for ignoring this lethal problem, CBS News let FDA officials blame Congress for not giving the FDA more regulatory power over pharmacies. >>>
pretends to protect the public against contaminated drugs. The sordid
facts reveal an agency incapable of acting in a logical manner, and when
the FDA does something "after the fact," they often create worse
Such is the case of a pharmaceutical manufacturer that made contaminated
injectable drugs that have killed 48 and sickened over 700 Americans.
The FDA identified problems with this manufacturer as early as 2002, but dropped the ball into a state pharmacy board's lap that failed to act. The FDA again identified dangerous problems in 2006, but once more failed to take actions other than send a "warning letter." The FDA now claims it needs more power and money to do its job.
This same unscrupulous drug manufacturer was the focus of a 60 Minutes broadcast on March 10, 2013.
What the FDA does not want the
public to know is that the reason this shady manufacturer was able to
take over such a significant part of the market is that FDA actions
caused other companies to stop making certain injectable drugs.
CBS News ignored House and Senate
investigations that documented the FDA's egregious failings in this
matter. CBS instead allowed the FDA to blame this catastrophe on lack
of regulatory authority over compounding pharmacies.
U.S. drug factories in 'terrible shape'
Here's how the New York Times described conditions inside FDA-registered drug factories:
"Weevils floating in vials of heparin. Morphine cartridges
that contain up to twice the labeled dose. Manufacturing plants with
rusty tools, mold in production areas and — in one memorable case — a
barrel of urine."
The New York Times emphasized that these were not reports about the injectable drug maker that caused dozens to die from fungal meningitis. These quality lapses were found at large drug companies whose names are familiar to many Americans.
When these problems were
discovered, the FDA sent out "warnings" to these companies. Instead of
fixing the problems, many of these drugmakers decided it was cheaper to
simply discontinue making the drug(s). The result was severe shortages
of the drugs cited by the FDA. This opened up the market for
disreputable companies to make these drugs, who did so under the same
kind of abysmal conditions the FDA found at large drug factories.
The FDA would like to take
credit for stopping these problems, but in certain cases, it was people
working at the drug factories that came forward to complain about
unsanitary manufacturing conditions, or people dying from contaminated
drugs that prompted FDA action.
The sad fact is that some drug companies are so greedy they will not
stop their highly profitable assembly lines to perform even the most
rudimentary sterilizing procedures.
Contaminated injectable drugs
Fungal meningitis causes inflammation of the lining of the brain and spinal cord that result in dreadful sickness and sometimes death.
A drug factory made large quantities of a steroid (methylprednisolone) that was injected into the joints and spines of aging humans in chronic pain. It provided immediate but temporary relief.
The problem was this drug was contaminated with a black fungus
that easily infected those who were injected with it. Since injectable
drugs bypass the natural barriers afforded by an intact
digestive/immune system, they have to be manufactured and maintained in a
sterile environment to avoid killing patients.
FDA inspections in 2002 and 2006 revealed
injectable drugs being made under substandard (non-sterile)
conditions. It was not until hundreds fell ill and scores died that the
FDA took meaningful action (in 2012).
How the FDA bungled investigation
The name of the company that made the fungus-laced injectable drug is New England Compounding Center (NECC). It pretended to be a compounding pharmacy, but instead functioned as a large drug factory.
The FDA claims that it lacks adequate regulatory authority over
compounding pharmacies, but the FDA's inspection of NECC in year 2002 revealed
problems with record keeping, sterility, and other issues. That same
year the FDA informed the Massachusetts State Board of Pharmacy of an
adverse reaction to methylprednisolone, which is the same drug that in 2012 caused the fungal-meningitis outbreak.
Had the FDA done their job back in 2002,
they would have forced NECC to register as a drug manufacturer and
subjected NECC to stricter regulatory oversight, which may not have prevented the problems since FDA-registered drug makers were later found to have similar unsanitary facilities.
The FDA and Massachusetts State Pharmacy Board's most blatant
failure in this matter was to uncover horrific conditions inside NECC …
and take no practical steps to enforce safety compliance before tragedy struck.
Good Manufacturing Practices overlooked
According to Massachusetts state
regulators, the NECC drug factory failed to sterilize injectable
drugs, something that is mandatory for a substance that is going to be
injected into the body.
NECC did not keep manufacturing
equipment clean, operated a leaky boiler near the "clean room" where
injectable drugs were packaged, and shipped products before receiving
test results showing the products were sterile, which violates good
In addition, NECC did not test the manufacturing equipment used to sterilize injectable drugs on a timely basis.
The result of a multitude of quality lapses was injectable vials
that contained black matter inside, which turned out to be the fungus
that caused 48 deaths.
FDA inspects after catastrophe
After hundreds had fallen ill from fungal meningitis, the FDA conducted a thorough inspection of NECC's drug factory.
The FDA's report cited greenish-yellowish discoloration on
sterilization equipment and non-sterile raw ingredients. The FDA found
that 25% of supposedly sterile vials were contaminated with
greenish-black foreign matter and that 100% of these vials sent for
analysis contained fungus.
The FDA noted that NECC was unable to provide documentation that its
steam autoclave devices were capable of achieving product sterility, a
critical factor when making injectable drugs. In fact, FDA inspectors
found greenish-yellow discoloration inside the one cleaning autoclave
and a tarnished discoloration inside another.
NECC turned off its air conditioning in "clean rooms" from 8 p.m. to
5:30 a.m., which is improper because failing to keep clean rooms at
low temperature and low humidity provides a fertile environment for
Particularly troubling in the
FDA report was documentation that NECC had found microbial
contamination, but did not enact cleanliness procedures to neutralize
this lethal threat.
Furthermore, "clean rooms" used
to make injectable drugs had been identified by NECC's own staff as
detecting bacteria and molds in January 2012, but the FDA could find no evidence that the company acted to fix these lethal problems.
The FDA's belated inspection of NECC did nothing to prevent the
suffering and death of hundreds of victims who contracted fungal
infections from contaminated vials of methylprednisolone injected into their spines and joints.
Congress cites FDA failure
The House and Senate held oversight hearings on the NECC tragedy that sickened over 700 and killed 48 people.
Congress wanted to know why the FDA didn't do more to prevent the production and sale of the tainted steroids.
As anticipated, the FDA claimed that it didn't have enough authority
to regulate pharmacies that compound drugs. FDA Commissioner (Margaret
Hamburg, M.D.) warned that if Congress doesn't strengthen legislation,
another similar tragedy is inevitable. Dr. Hamburg stated before the
"If we fail to act, this type of incident will happen again. It is a matter of when, not if."
What Dr. Hamburg may not have
expected was irrefutable documentation that the FDA and the
Massachusetts State Board of Pharmacy both repeatedly visited NECC and
found problems, but the strongest action the FDA took was the issuance
of a warning letter in 2006.
In response to Dr. Hamburg claiming the FDA needed more "authority," one representative responded:
"We're just not buying it, doctor "… "You lack the authority to do anything, yet you send a letter like this? " (In reference to the FDA 2006 Warning Letter).
This warning letter documented numerous violations of existing rules the FDA found in 2006, yet the FDA failed to take action until citizens started dying.
House members repeatedly berated regulators who failed to prevent the fungal meningitis outbreak, stating the FDA and Massachusetts state regulators both knew as far back as 2002 that there were problems at NECC, which distributed tens of thousands of doses of contaminated steroids.
Dr. Hamburg was lambasted by House Committee members who stated:
"This is a complete and utter failure on the part of your agency."
"This is one of the worst public health disasters ever caused by a contaminated drug in this country."
"After a tragedy like this the first question we all ask
is 'Could this have been prevented?' After an examination of documents
produced by the Massachusetts Board of Pharmacy and the U.S. Food and
Drug Administration, the answer here appears to be, 'Yes'."
"You can take a regulator to a problem but you can't make him regulate."
"It's an absolute tragedy without any question that 32 people have died."
Other House members came to Dr. Hamburg's defense, arguing that a solution needed to be found instead of seeking to "prosecute the Food and Drug Administration."
Senate more harshly critical of FDA
The day after the House hearing where the FDA asked for more
authority, a bipartisan staff of the Senate Health, Education, Labor
and Pensions Committee issued a report detailing how federal and state
regulators knew nearly a decade ago of serious safety concerns with the
NECC tied to hundreds of meningitis cases, but failed to act decisively. The report concluded that "bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health."
While acknowledging the lack of clarity in what the FDA's role should be in regulating compounding pharmacies, the Senate cited plenty of evidence that the FDA should have taken action against NECC, which clearly was functioning as a drug factory.
The Senate investigators wrote, "Both federal and state regulators were well aware that NECC and its owners posed a risk to the public health" and "repeatedly failed to demonstrate that the company could safely compound sterile products."
One senator told of an elderly patient from her state whose mouth had become infiltrated with mold that "she had to be swabbed free of black fungal matter before she died."
The Senate report uncovered an internal FDA memo in 2003 that concluded there was "potential
for serious public health consequences if NECC's compounding
practices, in particular those relating to specific sterile products,
are not improved."
The Senate confirmed that NECC-produced methylprednisolone "had previously been a suspected cause of at least two cases with bacterial meningitis-like symptoms" in 2002, leading to an FDA inspection … with no meaningful action taken.
Most senators expressed skepticism that the FDA could effectively use widened authority under any new law, one stating "the FDA has failed to use its existing authority," with another stating, "This has been going on since 2002 … It took all this time, and nobody did anything."
Regrettably, some senators still believe that giving the FDA more tax dollars will solve these issues of bureaucratic incompetence and mismanagement.
At the Senate hearing, FDA Commissioner Margaret A. Hamburg conceded:
"Perhaps we should have been more aggressive," referring to the FDA's failure to inspect NECC and follow up on the 2006 warning letter. "There was a lot of debate within the agency about whether to proceed."
Senators repeatedly questioned the FDA's sending NECC a warning letter in 2006 and a letter in 2008 saying that it planned to inspect, but not following through until after the fungal meningitis outbreak occurred in late 2012.
What Congress overlooked
What was not discussed in congressional hearings was the FDA's history of abusing and misusing whatever authority that Congress gave it.
For example, when the FDA first discovered problems at NECC (in 2002), it chose to direct its limited resources to prosecuting a man named Jay Kimball who sold a drug (liquid deprenyl) that harmed no one.
In 2006, while FDA did not think it needed to stop
NECC's lethal manufacturing practices, it somehow found the time to
censor claims by cherry growers that cited scientific studies on their website showing cherries conferred health benefits.
What few understand is how the FDA has abused its authority in a discriminatory
manner. The new "authority" the FDA is seeking would enable the agency
to pick out small, well-run compounding pharmacies and regulate them
out of business using minor technical arguments that have no bearing on
How much more FDA failure will Americans tolerate?
In 1906, a book called "The Jungle"
was published that described appalling conditions inside America's
meat packing industry. The revelations in this book resulted in the
establishment of federal laws that mandated standards of strength,
purity and quality of foods and drugs.
Conditions inside some of America's drug factories are eerily
similar to those described in "The Jungle," yet the FDA has been around
for more than 100 years! How much longer is the public expected to wait
before the FDA effectively spends its $4 billion
annual budget on real consumer protection, as opposed to threatening
walnut and cherry growers for claiming health benefits for their foods?
No matter how many times the FDA fails to protect consumers against contaminated drugs, there are no calls for meaningful reform.
Instead of recognizing FDA
ineptitude, cries ring out to give the FDA more money and power … as
Americans perish from contaminated drugs the FDA should have stopped.
No free market!
What the public doesn't yet understand is that contaminated drugs are the result of draconian regulations that limitfree market competition. By restricting drug factories to only those overseen by incompetent bureaucrats, the inevitable result will be shortages, poor quality and high prices.
One of the challenges in dealing
with the NECC catastrophe is that there may be new shortages of
injectable drugs because there are not enough drug factories in the
U.S. to meet patient demand. Shortages create opportunities for
unsavory companies to dump even greater amounts of overpriced and
contaminated drugs into the bodies of unsuspecting victims.
This kind of problem would not continue in a free market, but ever-increasing regulations are exacerbating the problems of drug shortages, deadly manufacturing practices, and obscenely high prices.
We will re-publish this response to the FDA's deceptive tactics aired last night on 60 Minutes in greater detail later this year in Life Extension Magazine®.
I thought it critical to alert
members immediately about this misleading propaganda as it may
influence policy makers into giving the FDA more authority. The facts
clearly show that the FDA failed to use the power it already has to stop contaminated drugs from poisoning the American public.
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