by Mike Adams
the Health Ranger
May 06, 2010
The other day I wrote a story about the
massive recall by McNeil Consumer Healthcare, a subsidiary of
Johnson & Johnson, of its infants' and children's line of
An FDA inspection report found these
drugs to be contaminated with dangerous bacteria (they did not
disclose the actual type) as well as "foreign materials" that were
visible as "dark or black specks".
But a recent story
published by USA Today has revealed
that McNeil actually knew about the bacterial contamination and kept
shipping the products anyway.
Only the drug industry could get away with this type of careless,
reckless behavior with nothing more than a slap on the wrist from
the FDA. In fact, the FDA did not even require McNeil to issue a
recall after discovering the problem; McNeil did so voluntarily over
"theoretical concerns" that were expressed by Deborah Autor,
an FDA official who was quick to emphasize that the risk to
consumers from the tainted products "is remote".
So let me get this straight.
An FDA report finds that a
pharmaceutical company is knowingly using contaminated raw materials
to make children's and infants' medicines in a factory that is
failing to maintain its equipment, properly train its employees and
correctly measure and weigh drug ingredients, and FDA officials
consider the problem to be "theoretical"?
Can you imagine what would happen if an herbal product manufacturer
were found to engage in the same behavior?
The FDA would pounce on them, seize
their products, issue a public warning and probably fine the company
for its reckless behavior.
Big Pharma pulls the same stunt,
it's just business as usual.
To the FDA,
it's all just "theoretical"
My favorite part about this is the FDA's reliance on the word
"theoretical" to try to imagine that somehow no actual safety
According to my thesaurus, some other
words for theoretical include unsubstantiated and hypothetical. In
other words, the FDA is saying it does not actually believe that a
real risk even exists!
And yet FDA Commissioner Margaret Hamburg, at the same time
as the agency is saying there really is no risk and that the whole
thing is just a hypothetical situation, advises parents to
"discontinue using any of the name-brand products being recalled."
Overdosing on acetaminophen, especially in children, is a serious
issue. The Mayo Clinic website warns parents that
overdosing on the drug, even a
little bit, can lead to "life-threatening liver problems."
The FDA report specifies that McNeil's had not been properly
formulating the drug dosages in its children's and infants'
medicines, which is part of the reason for the recall. Improper
concentrations of active ingredients in these products potentially
puts millions of children at risk. But apparently this is no big
deal to the FDA which sees it as nothing more than a "hypothetical"
Yet, just prior to its expression of "theoretical" concern in the
current recall, FDA officials met with McNeil back in February to
express "serious concerns" about the company's poor manufacturing
processes and failures to follow good manufacturing practices. So
which is it?
This kind of double-speak is typical of the FDA when a case involves
a beloved drug company.
If this had been a supplement that was
"hypothetically" thought to be contaminated (even if conclusive
evidence revealed there was no threat at all), health food stores
everywhere would be ordered to strip it from their shelves.
But when drug company negligence leads
to the contamination of children's medicines with bacteria, unknown
particles and improper drug dosage levels, the FDA leaves it to the
company to "voluntarily" recall their own products.
There will probably be no fine levied
against the company, either.
The FDA may
not even hold McNeil responsible for its gross negligence
a recent Los Angeles Times article,
the FDA has not even decided what corrective action it is going to
According to the story,
"options range from sending a
warning letter to seeking criminal penalties."
So in essence, the options include doing
nothing or actually holding McNeil responsible for putting the lives
of millions of children at risk.
To me, only one of these is a really a
viable option. But based on the FDA's track record in dealing with
McNeil (and all other drug companies, for that matter), the agency
is likely to just sweep the whole thing under the rug.
Never mind that a warning letter had already been sent to a McNeil
plant in Puerto Rico several months ago over wooden shipping pallet
chemicals that had been found in other McNeil drugs, causing 70
people to became ill with digestive problems.
When it comes to regulating drug
companies, the FDA has a very short memory.
children's medicines be trusted?
Johnson & Johnson is one of the world's largest companies,
and is consistently rated by both Harris Interactive's National
Corporate Reputation Survey and Barron's Magazine as
being one of the top, most well respected companies in the world.
If the world's most respected company, a "family company", is
operating a subsidiary that is knowingly manufacturing contaminated
children's medicines in factories that are in violation of numerous
safety protocols, what does that say about the entire drug industry?
If the safety and quality of children's
medicines from one of the world's most respected companies cannot be
trusted, then what over-the-counter medicines can you really trust?
children's medicines are filled with chemical toxins anyway
Bacterial contamination and poor manufacturing procedures are not
the only problems with popular over-the-counter (OTC) children's
Even if McNeil had been operating up to
proper standards, many of its children's formulations are still
filled with questionable chemical ingredients like aspartame,
high-fructose corn syrup, sucralose (Splenda), artificial colors and
preservatives, and even parabens, all of which are approved by the
FDA for use in children's and infants' formulas. (Seriously.)
The shocking truth is that, even in their approved and "safe" forms,
most OTC children's medicines are nothing more than dangerous
chemical cocktails being peddled as medicine. They're filled with so
much harmful garbage that they can hardly be considered beneficial.
Most of them are outright useless. These OTC children's medicines
are the quackery of modern medicine.
Back in 2004, I wrote a story about a U.K. study which found that
children's cough syrup is medically
ineffective. In tests, it proved to be just as effective as corn
syrup at alleviating a cough, so basically it did nothing at all.
Most cough syrup is composed primarily of corn syrup anyway, so it
is no surprise that the stuff causes the same effect on the body --
basically just a sugar overload.
Pharmaceutical drugs are almost never a good choice for children.
Not only do the active ingredients cause serious side effects and
liver problems, but the chemical additives make them even more
harmful. I think if more parents became informed about what's really
in children's medicine, they would never willingly give it to their
All these things really just illustrate the FDA's corruption and
behind-the-scenes protection of drug company interests. Even when a
serious problem arises above and beyond the known risks, the agency
acts as if it is no big deal. The health and well-being of millions
of children is put at risk but it's all just make-believe to the
To them, all risks and side effects of pharmaceuticals are merely
"theoretical." But in their (warped) minds, the dangers of herbs and
vitamins are all "very real!"
It raises a very important question:
How many children need to be harmed
or even killed by the Big Pharma/FDA conspiracy before the
American people will demand real FDA reform?