Vioxx — FUBAR

Beyond All Recognition

Remember phone booths? Back in the 1940s, phone booth repairmen began using two acronyms: SNAFU and FUBAR.

SNAFU stands for “Situation normal, all fouled up.” And FUBAR: “Fouled up beyond all recognition.” (When these acronyms became part of military jargon they were given a profane twist, which you might be familiar with.)

For giant drug company Merck and the New England Journal of Medicine, the Vioxx fiasco has now made the full journey from SNAFU to FUBAR. Along the way, we’ve been given a glimpse of the astounding greed and deception that goes on when a drug company puts a priority on marketing at the expense of consumer safety.

How low can you go?

For those who may be new to the Vioxx mess, here’s a quick recap:

• We first warned HSI members about the risks of Vioxx in a 2002 e-Alert
• In 2004, Merck took Vioxx off the market after a study revealed cardiovascular risks associated with the drug
• According to a Senate investigation, FDA officials tried to suppress a report prepared by the agency that concluded “27,000 heart attacks and sudden cardiac deaths” could have been avoided if patients had been using Celebrex instead of Vioxx

The first of possibly thousands of lawsuits filed against Merck began in 2005. So far, Merck has won three and lost three. But now those three losses are in serious jeopardy of being overturned.

One of the few strong points in the Merck defense has been a statement that appeared in NEJM supporting data suggesting the drug’s risks became a problem only after 18 months of use.

But many experts disputed that claim. In the e-Alert “What Would Judy Say?” (12/19/05), I told you about trial testimony by Eric Topol, M.D., chairman of the cardiovascular medicine department at the Cleveland Clinic. The trial concerned a man who had a fatal heart attack after only one month of Vioxx use. Dr. Topol cited research that revealed Vioxx might prompt heart attacks at any time after use begins.

From concern to correction

The worm began to turn in December 2005 when NEJM editors issued an “expression of concern” stating that damaging clinical evidence had been suppressed.

Last week, NEJM editors issued a correction that will appear in the July 13 issue.

NEJM executive editor Dr. Gregory D. Curfman told the Boston Globe that the correction is intended to make clear that any suggestion that heart attack risk only occurs after 18 months of Vioxx use is “a misinterpretation of the data.”

Oh stop being so polite! Just come out and say it! Merck deliberately concealed important data that makes the 18-month claim a lie! Dr. Curfman was more on point last December when he gave this statement to HealthDay: “We have very solid evidence that important data on cardiac events was deleted or withheld, which rendered the study of suboptimal quality.”

Suboptimal? How about “worthless”?

In response, to the NEJM correction, Merck representatives stated that the company “stands behind the original results” that appeared in the journal.

And to cap off this disaster – beyond all recognition – the Globe reports that Merck has sent an analysis to the FDA that indicates Vioxx heart risks may persist for one full year after a patient discontinues use.

This would all have a comical aspect if not for the deaths and devastated families Vioxx has left in its wake.

A new era

Here’s what’s really sad: If Vioxx were taken off the market today, all of the thousands of current pending lawsuits against Merck might never make it to court.

A new ruling by the FDA went into effect last week, making it much more difficult for consumers to submit liability claims. I’ll be taking a closer look at this in an e-Alert next week. But for now, suffice it to say this is a belated Valentine’s Day gift from the FDA to drug companies. And all I got them was a box of chocolate.

Sources:
“Cardiovascular Events Associated with Rofecoxib in a Colorectal Adenoma Chemoprevention Trial” New England Journal of Medicine, Posted online before publication, 6/26/06, content.nejm.org
“Only a Few Months of Vioxx Could Harm Heart, Journal Says” Diedtra Henderson, The Boston Globe, 6/27/06, boston.com
“New England Journal Charges Merck Deleted Vioxx Study Data” Amanda Gardner, HealthDay, 12/8/05, yahoo.com