24 September 2015

Do You Know What Drug in Your Medicine Cabinet is Most Likely to Kill You?

If you answered Acetaminophen (Tylenol) you would be right.

An overdose of the drug can destroy your liver, and for some people, toxic effects can be as little as twice the therapeutic dose.

Well, the FDA is looking at tightening up regulations on the drug, and the maker of Tylenol ramped up a lobbying campaign to prevent the FDA protecting the public:
Recently filed court documents show the makers of Tylenol planned to enlist the White House and lawmakers to block the Food and Drug Administration from imposing tough new safety restrictions on acetaminophen, the iconic painkiller’s chief ingredient.

An executive with McNeil Consumer Healthcare – which counts Tylenol as its flagship product – told the board of directors for parent company Johnson and Johnson about a campaign to “influence the FDA” and block recommendations made by an agency advisory panel in 2009.

About 150 Americans a year die by accidentally taking too much acetaminophen, the active ingredient in Tylenol. The toll does not have to be so high. Read the story.

After Dr. Janet Woodcock, the FDA’s top drug regulator, put off meeting with McNeil executives, the company’s president, Peter Luther, sent out an August 2009 email.

“We’re being too nice and too worried about stepping on FDA’s toes. It may be time to let members of Congress to put some pressure on FDA,” Luther wrote to other top executives. ”We have to make this our top priority and pull out all stops.”

Acetaminophen is considered safe when taken as directed. But in higher doses, the drug can cause liver damage and death. Studies show the drug is the leading cause of acute liver failure in the U.S., with fatalities increasing seven-fold in the decade between 1995 and 2005 to more than 200 a year.


The previously unreported lobbying campaign was disclosed as part of a trial scheduled to start today in Atlantic City that promises to draw new scrutiny to McNeil’s efforts to protect its painkiller from additional regulation and disclosures about the full extent of its risks.

The case pits McNeil against Regina Jackson, a New Jersey state employee who claims she was hospitalized with elevated liver enzymes after inadvertently exceeding the daily recommended dose for Extra Strength Tylenol for a couple of days.

The Atlantic City case is being watched closely as it is the first to come to trial of more than two hundred lawsuits currently pending in state and federal courts that allege McNeil knew its drug was potentially dangerous while promoting its safety.

As detailed in a 2013 investigation by ProPublica and This American Life, McNeil has opposed warning labels, dosage restrictions and even public awareness campaigns over concerns of profitability.

At the same time, the investigation found that the FDA has delayed implementing suggestions to improve the safety of acetaminophen, taken by tens of millions of Americans every week. Though hearings began more than 38 years ago, the agency has yet to finalize regulations for the safe use of the drug.


The proposed lobbying campaign arose in response to a June 2009 meeting of more than three dozen scientists, researchers and pharmacists convened by the FDA to review the safety of acetaminophen.

The panel of independent experts endorsed a sweeping set of reforms. They recommended that the FDA reduce the total daily dose of acetaminophen, and make extra-strength pills available only by prescription.

McNeil officials viewed the recommendations as a threat to sales of Extra Strength Tylenol, according to R. Clay Milling, one of the plaintiff’s attorneys. McNeil makes about $400 million in revenue from its extra-strength line, compared with only about $14 million from regular strength Tylenol, Milling told the court, according to a transcript.

Milling, who reviewed internal McNeil documents as part of the lawsuit, told the court that a senior McNeil executive made a presentation to the Johnson and Johnson board about a plan that included contacting the White House, the Office of Management and Budget and lawmakers.


The current recommended daily dose for the drug is four grams per day — the equivalent of eight extra strength pills. But occasional reports in scientific literature have documented liver damage occurring after taking as little as two extra pills per day for several days.

The agency has worried about the prevalence of acetaminophen on the market — McNeil and its generic competitors have developed hundreds of over-the-counter products that contain the drug, increasing the risk that a consumer could inadvertently ingest dangerous levels.

The most recent FDA data show that acetaminophen remains, by far, the leading cause of acute liver failure in the United States, with the number of cases increasing.
(emphasis mine)

Pharma greed is not just some asshole hedge fund puke raising prices.

It's also stuff like this, where companies like Johnson & Johnson call in chips to bought and paid for politicians so that they can keep killing people.

In fact, I think that the guys at J&J are worse.  Unlike Martin Shkreli they knew that they were lobbying for the opportunity to profit off of killing hundreds of people a year.


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