Pharmaceutical companies are prohibited from marketing drugs “off-label”

Although doctors are allowed to prescribe drugs for any use that they choose, pharmaceutical companies are strictly prohibited from marketing drugs for off-label uses. The prohibition hasn’t stopped them—in fact, most of the large drug companies have paid enormous fines in recent years for their off-label marketing schemes. The fines, however, are much less than the profit that was made by selling the drug for off label use. For this reason, this practice continues with drug companies, and they view the fines as a mere cost of doing business. And while some off-label uses for drugs have been studied and do make sense, many more have been found to be dangerous to patients as well as ineffective.

What’s the worst that could happen if a drug is marketed for an off-label use?

Well, if you are a large pharmaceutical company – say, Merck & Co. – and you propel a painkiller into worldwide sales to more than 20,000,000 people through your off-label marketing, the “worst thing” might be a landslide of lawsuits, criminal charges, and fraud claims costing you billions of dollars to defend and settle. Shareholders might understandably become a bit upset at the expense.

Of course, if you are a patient who took Vioxx, prescribed by your doctor for an off-label use, the “worst thing” that could happen to you would be death from heart attack, stroke or bloodclot, caused by the mislabeled drug. That’s probably the “worst thing” from the viewpoint of your family, too.

So clearly, the “worst that could happen” is something that depends on your point of view. At AME, our purpose is happy, healthy, informed patients. As such, we are less concerned about the drug companies and only concerned about the patient's well being. So from our point of view, patient suffering and death is easily the worst that can happen with off-label prescriptions. Because of this, we want patients to be in control, putting doctors in the hot seat to ensure their prescribed medications are safe and effective.

Vioxx: a savior drug for Merck?

The Food and Drug Administration approved Vioxx as a painkiller in May of 1999, but according to the Justice Department’s investigation, Merck began marketing it almost immediately as a treatment for rheumatoid arthritis. A warning letter from the FDA that this off-label promotion was illegal and needed to stop did not deter Merck from continuing to promote the drug as a solution for rheumatoid arthritis.¹

Vioxx was heavily promoted by Merck drug reps as an excellent alternative to asprin and other pain relievers that helped RA, but could cause gastrointestinal difficulties.²

According to industry analysts, the heavy Vioxx promotion was the result of a serious need for sales at Merck. With the patents on several popular Merck drugs expiring in 2000 and 2001, opening them to generic competition, Merck badly needed Vioxx to replace those lost sales. Says Michael Krensavage, a drug industry analyst at the investment bank Raymond James & Associates, “Vioxx was Merck’s savior, it’s as simple as that.”³

Unfortunately, that overwhelming need for increased sales at Merck led to more than a bad decision to violate the law by promoting Vioxx for off-label uses. It led to another bad decision that would haunt the company even more in years to come: a decision not to authorize study or investigation of the mounting evidence that Vioxx users were developing serious cardiovascular problems. Indeed, the first warning bell was rung at Merck in March of 2000, when a double-blind study of Vioxx use by 8,1000 RA patients revealed that 5 times as many patients taking Vioxx had heart attacks as those taking the older control medication, naproxen.⁴

Records show that Merck executives met, and, after heated discussion, decided to do nothing. And continued to decide to do nothing, as evidence of dangers from Vioxx mounted, right up until September of 2004, when they voluntarily decided to recall Vioxx.

Vioxx Litigation

The flood of litigation that followed the Vioxx recall prompted Merck’s executives to promise bravely that they would fight each lawsuit and win. The jury verdict in the first case tried — $253 million judgment awarded against Merck to a Texas widow, later reduced to $26 million under Texas law – threw some cold water on this bullish decision. And while Merck did, indeed, win more of the individual cases than it lost, nearly 27,000 individual lawsuits led Merck to agree to a joint settlement for $4.85 billion.⁵

The $4.85 billion does not, of course, include the $321,636,000 that Merck was ordered to pay as a criminal sentence for falsely promoting and marketing Vioxx in the first place, or the civil judgment of $628,364,000 that it agreed to pay state and Federal governments for Vioxx Medicaid fraud.⁶

And the price to Merck for the off-label promotion does not end there. In November of 2012, Merck settled still another class action lawsuit filed on behalf of Missouri consumers of Vioxx for another $220 million.⁷

The Cost to Consumers

It’s difficult to determine just how many people were injured by Vioxx, but both researchers and lawyers have tried to figure it out.

When testifying in the Senate, whistleblower Dr. David Graham estimated that 88,000 to 139,000 Americans experienced heart attacks as a side effect from Vioxx, and that 30 to 40 percent of these died. That would be an estimated 27,000 to 55,000 preventable deaths attributed to Vioxx.

Lawyers representing the Vioxx consumers in the $4.85 billion settlement analyzed almost 60,000 claims, finding that 58,022 were potentially eligible for compensation.

Benefits were paid to families of the 2,878 Vioxx uses who died of heart attacks and the 590 who died of strokes.
In total, 20,591 heart attack claims merited payment, along with 12,447 stroke claims.⁸

So who paid more – Merck & Co? Or the Vioxx consumers?

It depends on your viewpoint.

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Sources:

¹ Information, United States v. Merck Sharp & Dohme Corp., paras. 11-18., http://www.justice.gov/civil/cpb/cases/cases/Merck/Merck_Information.pdf
² Ibid.
³ “Despite Warnings, Drug Giant Took Long Path to Vioxx Recall,” NY Times, Nov. 14, 2004, http://www.nytimes.com/2004/11/14/business/14merck.html?_r=0
⁴ Ibid.
⁵ “Merck settles Vioxx lawsuits for $4.85 billion,” Nature, November 13, 2007, http://www.nature.com/news/2007/071113/full/450324b.html
⁶ “U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx,” http://www.justice.gov/opa/pr/2012/April/12-civ-497.html
⁷ “Drugmaker Merck agrees to settle Missouri classaction Vioxx lawsuit for up to $220M, Washington Post, November 2, 2012 http://www.washingtonpost.com/business/drug-maker-merck-agrees-to-220m-settlement-of-class-action-lawsuit-in-missouri-over-vioxx/2012/11/02/1f9e09d0-2500-11e2-92f8-7f9c4daf276a_story.html
⁸ “Merck Paid 3,468 Death Claims to Resolve Vioxx Suits,” Bloomberg News, July 27, 2010, http://www.bloomberg.com/news/2010-07-27/merck-paid-3-468-death-claims-to-resolve-vioxx-suits.html