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			by Mike Adams 
			the Health Ranger 
			May 06, 2010from 
			NaturalNews Website
 
			  
			  
			  
			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 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.
 
			  
			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?   |