Friday, May 7, 2010

Children's Tylenol Update

It is all over the news, the FDA has come forward to "slam" the factory
conditions that produces the cold medicine for children.

If you remember, the official recall statement pertained to the concern
of quality issues and it was voluntary and not a mandatory recall, keep
this in mind when reading the article from naturalnews.com

----------------start of article--------------------------------
www.naturalnews.com

(NaturalNews) 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 Tylenol products. 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 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. But when 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 problem existed. 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" problem.

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
According to a recent Los Angeles Times article , the FDA has not even
decided what corrective action it is going to take. 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.


Can any 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?

Most 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 medicines.
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 children.

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 FDA.

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?

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