Secret research about Tylenol still hidden after 40 years

Last year, top secret documents about Tylenol almost got released.

They claimed to tell the tale of hushed-up experiments conducted by Tylenol maker McNeil Consumer Healthcare – studies with military-sounding code names like “Project Protect” and “Project PAPA.”

The research, according to court documents, was being driven by what was fast becoming the worst-kept secret in health care. Acetaminophen, the ingredient in Tylenol, can destroy your liver.

McNeil was able to keep memos and documents about its secret research out of the public eye – but with another major court case looming, its luck may be running out. We may be just weeks from knowing when McNeil understood the risks of Tylenol, whether it could have made the product safe, and, most importantly, why it didn’t.

Bottling up the truth

Over the years we’ve been warning you about acetaminophen, a drug contained in hundreds of prescription and OTC meds like Tylenol. It’s the leading cause of liver failure in the U.S. and it lands 78,000 people in the ER every year.

It’s killed thousands – and it’s incredibly easy to take an overdose.

And the people who are most aware of that danger are the executives and scientists at McNeil. The company introduced Tylenol 60 years ago and it has a long, long history with the drug. It was even McNeil’s former chairman, Robert McNeil, Jr., who coined the term “acetaminophen.”

Now, when you spend 60 years making a product that has harmed so many, there will be lawsuits. Sure, some are probably filed by ambulance-chasing attorneys who are only out to make a buck. But many aren’t.

And one of the cases seeking justice involved a young girl by the name of Kiyana Lemon.

Kiyana’s mom had purchased Extra Strength Tylenol for her, and said she took it according to the directions. Soon after, Kiyana suffered something called “drug-induced liver injury.”

Kiyana’s liver was in such bad shape she had to undergo a liver transplant at the age of 14. Four years later, she died.

As you might guess, her mom was heartbroken, and she decided to sue McNeil.

During the course of the pre-trial investigations and discoveries, her attorney apparently unearthed some shocking information. Even though McNeil has practically convinced the public that Tylenol is as safe as mother’s milk, it reportedly had been trying since the 1970s to find ways to make the product less toxic to your liver.

The attorney found that:

• More 40 years ago McNeill started doing “confidential/proprietary research” about ways to “improve Tylenol.” Two of these secret plans went by the undercover names of Project Protect and Project PAPA.
• Expert witnesses (two doctors and one Ph.D.) were going to come forth and testify that that “chemical changes” to Tylenol were being explored by McNeil that would prevent it from harming the liver. One was adding something called methionine to its products, which can protect against the liver damage the drug can cause.
• No changes to Tylenol were ever made, and the studies were kept hidden.

McNeil fought tooth and nail to keep that information suppressed, but the judge said it would be heard. The judge was also considering admitting testimony that Tylenol has a “narrow therapeutic-to-toxic window” – meaning it’s easy to cross a very thin line and take an overdose.

Apparently, that’s when McNeil had heard enough. The company settled the lawsuit on the first day, and all the documents on Project Protect and Project PAPA went back into their file cabinets.

At least for now. Next month a jury will hear the case of Denice Hayes, an Alabama teacher who died – like Kiyana Lemon – after taking Extra Strength Tylenol. And don’t be surprised if Project Protect and Project PAPA are back on the docket.

Either way, here’s a “Project Protect” we can all get behind — don’t take any dose of Tylenol, or any other product containing acetaminophen, either prescription or OTC.

Sources:

Superior Court of New Jersey, Memorandum of decision on motion, Lyles vs. McNeil-PPC Inc., et al.