The deadliest drug in history

I’ve told you how the Institute of Medicine (IOM) is calling for better post-market surveillance for approved drugs. If the FDA actually heeds the IOM’s advice, it may save countless lives. And help us avoid massive pharmaceutical tragedies like the ones caused by Vioxx a decade ago.

Vioxx, as you’ll recall, was a wildly popular arthritis medication manufactured by the pharmaceutical giant Merck. Millions of people took it (25 million, to be precise). And it generated a staggering $2 billion in revenue for Merck every year. Then, in September 2004, just five years after Vioxx hit the market, Merck voluntarily recalled it. The decision seemed to come out of nowhere. But the reason became crystal clear shortly thereafter…

In February 2005, the journal Lancet published the results of a huge study. The study concluded that Vioxx significantly increased the risk of heart attack and stroke. And it was likely responsible for at least 55,000 deaths. 

Within weeks, journalists discovered that Merck had already found its own evidence of these fatal side-effects. Even before they introduced it to the public in 1999.  But Merck ignored these findings. Avoided additional testing. And suppressed concerns voiced by their own scientists.

They threw caution to the wind—and innocent arthritis patients to the wolves. And when the scandal finally broke, Merck did what it could to save face. By issuing the voluntary recall of its lethal pain medication. (As opposed to being forced to recall it by the FDA).

Eventually, after the lawsuits were settled, news of the scandal died down. But, as it turns out, that wasn’t the end of the Vioxx story…

The year after Merck pulled Vioxx from the market, all the major media outlets reported on another health story. The death rate in the U.S. had taken a sharp downturn. Despite an increase in both the size and age of the population, there were 50,000 fewer deaths. USA Today heralded it the “Largest Drop in Annual Deaths in at Least 60 Years.”

All-too-typically, our government health “experts” had no idea what could be behind this strange anomaly.

Had these “experts” taken even a quick scan of their most recent 15 years’ worth of national mortality data, they would have found some intriguing clues. (And if they didn’t look at their own data, who was supposed to?)

The largest rise in American mortality rates occurred in 1999—the year Vioxx was introduced. And the largest drop occurred in 2004—the year it was withdrawn. Vioxx was almost entirely marketed to older Americans. And these dramatic “unexplained” changes in the national death rate were completely concentrated within the 65-and-older population. The FDA’s own studies showed that Vioxx led to deaths from heart attacks and strokes. And, according to the Centers for Disease Control, these were exactly the events that had plummeted, causing the significant dip in mortality rates.

Of course, it’s almost impossible to prove a direct connection. But if there’s any truth at all to this (entirely-plausible) theory, Vioxx may have been directly responsible for 500,000 or more premature deaths. A whole lot more than the 3,468 deaths Merck actually acknowledged during the lawsuits that followed the recall. And nearly 10 times more than the 55,000 originally estimated in the Lancet article that set off the entire controversy.

And yet, almost no one among our political or media elite, or our full-time government health “experts,” seems to know—or care. In fact, a recent Wall Street Journal column even called for relaxing FDA restrictions aimed at avoiding “rare adverse events.” Restrictions that had been imposed after the discovery of “ unanticipated side effects of high-profile drugs like Vioxx.”

Unfortunately, the public’s collective attention span is just that short.

The entire Vioxx scandal generated several days of newspaper headlines. And it periodically returned to the front pages as the resulting lawsuits gradually moved through the courts. But coverage still seems scanty compared to the number of estimated fatalities (which match America’s total losses in the Vietnam War, by the way). In fact, the media coverage was considerably less than what we saw four years ago with the Chinese baby formula scandal. (Which caused just a handful of deaths on the other side of the world.)

Of course, there are some vast differences between these two scandals—one in the U.S. and one in China. Including how they were handled. And not just by the media. But by the governments charged with protecting the public from these sorts of insidious threats. Indeed, there’s much more to say about that!

“Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study.” Lancet 2005; 365(9,458): 475-481