Bill Faloon, Editor and
founder of the Life Extension Foundation has accurate and astute perceptions on
government bureaucracies and failure to protect the citizenry from unscrupulous
manufacturers endangering lives and in many cases ending the lives of
CBS News enables FDA
to Deceive Public, by William Faloon
watched CBS News 60 Minutes this week, 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 illnesses.
60 Minutes omitted
the fact that the FDA knew 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 bureaucratic incompetence at the hands of the FDA and the
state pharmacy board that permitted these lethal deviations in good
manufacturing practices to occur.
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.
contamination problem, however, is not isolated to one bad drug maker. It turns
out that these kinds of safely violations were routine at drug factories that
the FDA had certified as being safe.
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 problems.
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.
unscrupulous drug manufacturer was the focus of a 60 Minutes broadcast on March
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.
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.
factories in 'terrible shape'
the New York Times described conditions inside FDA-registered drug factories:
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.
problems were discovered, the FDA sent out "warnings" to these
companies. Instead of fixing the problems, many of these drug makers 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.
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
meningitis causes inflammation of the lining of the brain and spinal cord that
result in dreadful sickness and sometimes death.
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.
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.
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
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.
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
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.
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 manufacturing guidelines.
NECC did not test the manufacturing equipment used to sterilize injectable
drugs on a timely basis.
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.
hundreds had fallen ill from fungal meningitis, the FDA conducted a thorough
inspection of NECC's drug factory.
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.
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.
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 fungal growth.
troubling in the FDA report was documentation that NECC had found microbial
contamination, but did not enact cleanliness procedures to neutralize this
"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.
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.
cites FDA failure
and Senate held oversight hearings on the NECC tragedy that sickened over 700
and killed 48 people.
wanted to know why the FDA didn't do more to prevent the production and sale of
the tainted steroids.
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 House committee:
fail to act, this type of incident will happen again. It is a matter of when,
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.
to Dr. Hamburg claiming the FDA needed more "authority," one
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 documented numerous violations of existing rules the FDA found in 2006,
yet the FDA failed to take action until citizens started dying.
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.
was lambasted by House Committee members who stated:
is a complete and utter failure on the part of your agency."
is one of the worst public health disasters ever caused by a contaminated drug
in this country."
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'."
can take a regulator to a problem but you can't make him regulate."
an absolute tragedy without any question that 32 people have died."
members came to Dr. Hamburg's defense, arguing that a solution needed to be
found instead of seeking to "prosecute the Food and Drug
harshly critical of FDA
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."
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
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
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
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
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
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."
some senators still believe that giving the FDA more tax dollars will solve
these issues of bureaucratic incompetence and mismanagement.
Senate hearing, FDA Commissioner Margaret A. Hamburg conceded:
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."
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 was not
discussed in congressional hearings was the FDA's history of abusing and
misusing whatever authority that Congress gave it.
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.
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
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 safety.
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.
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
how many times the FDA fails to protect consumers against contaminated drugs,
there are no calls for meaningful reform.
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.
public doesn't yet understand is that contaminated drugs are the result of
draconian regulations that limit free 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.
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.