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Deadly FDA Neglect

July 2010

By William Faloon

William Faloon 
William Faloon

You might be surprised to know that the leading cause of acute liver failure in the United States is not alcohol abuse, nor viral hepatitis.

The number one reason Americans suffer acute liver failure is a drug the FDA has allowed to be sold for decades after its lethal toxicities were known.1

This drug is available over-the-counter and in prescription combinations. In many cases, those ingesting this toxic drug (under various brand names) don’t even know they are taking it.

The FDA has bent over backwards to protect billions of dollars of profits earned annually by pharmaceutical companies who sell this deadly drug.

As the body count mounted in 2009, the FDA was forced to mandate a lower dosage and remove it from prescription combinations that were particularly lethal.2

The FDA’s feeble actions to appease critics are too little and far too late. The reduced dose will spare some lives, but this toxic drug will still inflict a considerable death toll. The fact that this carnage has gone on for decades confirms the FDA’s blatant failure to protect the public.

What Called My Attention to This Drug-Induced Bloodbath?

Back in the early 1980s, I was having one of my all-night brain-storming sessions with scientists who routinely think “outside the box” when it comes to medical issues. One of these scientists enlightened me to the mechanism by which the pain reliever acetaminophen causes liver damage.

When acetaminophen is ingested, a rapid depletion of glutathione in the liver occurs.3,4 The result of glutathione depletion is free radical destruction of liver cells.5-9 The scientists I spoke with suggested that Life Extension® make a combination product of acetaminophen and N-acetyl cysteine (a glutathione-enhancing amino acid). According to these scientists, this would probably eliminate virtually all acetaminophen-related acute deaths.10-14

Since acetaminophen and N-acetyl cysteine are both sold over-the-counter, you might think that making a “safer” acetaminophen formula would not be difficult.

There is one problem. The FDA prohibits combining existing drugs and dietary supplements unless a New Drug Application is filed, tens of millions of dollars of clinical studies are performed, and the FDA agrees to allow the combination to be sold. The whole process can cost upwards of $100 million and take a decade to complete.

So by bureaucratic edict, a safer form of acetaminophen never made it to market.

FDA Throws Us in Jail!

Deadly FDA Neglect

In the late 1980s, the FDA began raiding our facilities for the purposes of gathering evidence to put me and others in jail. According to the FDA, our products were not approved by the agency and were therefore inherently unsafe.

We fought back by showing that not only were the products we recommended safe and effective, but that many of the drugs the FDA claimed to be safe were really poisons!

We were indicted in the early 1990s under the charges that our product recommendations violated the FDA’s coveted regulatory structure, which included having approved labeling so consumers and their doctors could safely use these products.

My Weekly Radio Show

In response to those who believed the FDA’s fabricated attacks against us, I set up my own radio show on one of the largest stations in South Florida.

Almost every week I would identify a drug the FDA approved as “safe” and reveal just how dangerous it really was. I would then discuss ways to make these drugs safer, such as taking coenzyme Q10 if a statin cholesterol-lowering drug were needed. It was known way back then that statin drugs interfere with CoQ10 synthesis in the body.15 By taking supplemental CoQ10, one could replenish their body with this life-sustaining nutrient that is depleted by statin drugs and aging.

FDA Throws Us in Jail!

In recalling my conversations with forward-thinking scientists in the early 1980s, I researched acetaminophen and was astounded by the multiple toxic effects this drug inflicts on the liver,16-20 kidney,21-26 and other organs.27-29

When I went to the pharmacy to check out the labeling, there were no warnings required by the FDA to indicate this drug’s lethal side effects.

So here I was facing decades in prison for recommending products that did not have FDA-approved labeling, yet the FDA did not require labeling for one of the most dangerous drugs on the market to warn consumers about its lethal effects.

These egregious disparities were not lost on prosecutors, who eventually dismissed the FDA’s flawed indictments against us.

Just How Dangerous Is Acetaminophen?

Each year, acetaminophen poisoning results in 100,000 calls to poison control centers, 56,000 emergency room visits, 26,000 hospitalizations, and more than 450 deaths from liver failure.30

Acetaminophen’s deadly effects extend beyond the liver. Regular users of acetaminophen may double their risk of kidney cancer, a disease that kills 12,000 Americans each year. 25,26,31-33 The incidence of kidney cancer in the US has risen 126% since the 1950s,34 a jump that may be tied to the growing use of drugs containing acetaminophen and its metabolites.

Because acetaminophen generates damaging free radicals throughout the body, it may very well increase the risk of many age-related diseases. In fact, scientists can consistently induce cataracts in the eyes of laboratory animals by giving them acetaminophen.35 They consider acetaminophen a “cataratogenic agent.” Interestingly, if antioxidants are provided to the animals, the cataract-inducing effects36-40 of acetaminophen are often completely neutralized.41,42

Just imagine how the FDA would respond if a dietary supplement caused even a few of these adverse reactions. The FDA would immediately shut down the company and probably pursue criminal charges against the owners. Not so with acetaminophen. Since it is “approved” by the FDA, little has been done up till now to restrict consumer access to it.

FDA Scientific Advisory Panel Recognizes Risks

In 2009, an outside advisory panel recommended that the FDA ban narcotics containing acetaminophen.43 The panel also recommended that the amount of acetaminophen contained in OTC products be reduced.

The FDA’s response to its own Scientific Advisory Panel was to implement some changes to protect Americans against the liver damage inflicted by over-the-counter and prescription acetaminophen drugs.44,45 No mention was made about combining N-acetyl cysteine to protect against glutathione depletion and subsequent free radical-induced liver damage. There was also no mention about the other health problems (like kidney failure and kidney cancer) potentially caused by acetaminophen.

Acetaminophen and the FDA: A Sordid History

The most popular acetaminophen-containing drug is Tylenol®, and its makers wasted no time in running full page ads proclaiming that Tylenol® remains the “safest” pain relieving drug on the market. There appears to be no limit to how low pharmaceutical companies will sink to protect their immoral profits. To imply that acetaminophen is “safe” is a scientific contradiction.

Acetaminophen and the FDA: A Sordid History

The 2009 announcement about acetaminophen’s deadly effects is not the first time an independent group of doctors recommended the FDA do something about this drug.

In 2002, another independent advisory committee commissioned by the FDA urged that warnings be put on the labels of acetaminophen drugs.46,47 The FDA said no to its own scientific advisors. Instead, the FDA budgeted a mere twenty thousand dollars29,30 to develop material that it hoped would be run in magazines and distributed by pharmacy chains for free!48 This is the bureaucratic equivalent of doing nothing.

By 2004, the FDA capitulated to scientific pressure and mandated a minimal warning be placed on acetaminophen labels, which did nothing to stop the slaughter caused by this deadly drug.49