What Do The Latest Vioxx Study Results Mean, And What Will Merck Do?

The assertions, claims, and interpretations about what the new data from the so-called "Approve" study means regarding any increased risk of a heart attack or stroke during the first year after a person stopped taking Vioxx, and how it will influence the developing Vioxx litigation, are all over the place — as you were starting to think after reading different articles.

The Wall Street Journal (WSJ) on May 12, 2006, under the headline "Merck Study Finds A Vioxx Risk After Use Ended", said that data for the fourth-year patients who were followed in the Approve study "suggests patients remained at risk of a heart attack or stroke during the first year after they stopped taking [Vioxx]."  The WSJ article pointed out:

In a follow-up analysis of the 2,587-patient study called Approve that led the company to pull the drug from the market in September 2004, Merck officials said patients who took the drug during a three-year trial were 1.64 times as likely to have a heart attack or stroke during a subsequent year when they weren’t taking it, compared with those who had been on a placebo.

But this May 11, 2006 Associated Press (AP) article came at the new Approve data from a different angle, under this banner: "Study: Vioxx Users Not at Increased Risk — Study Finds Vioxx Users Not at Higher Risk of Heart Attack, Stroke in Year After Stopping Drug".  This AP article showed the other side of the recent Approve data:

Merck said data from a "preliminary safety analysis" of an additional year of patient follow-up, part of the study’s original plan, did not show a statistically significant difference in the rate of heart attacks and strokes among patients who had been on Vioxx and those who had taken a dummy pill. That means the differences over that year could have been due to chance.

Merck’s general counsel Kenneth Frazier asserts that the new Approve results should help Merck defend itself against those legal cases — among the more than 11,000 Vioxx lawsuits filed against Merck to date — where a person blamed Vioxx for their heart attack or stroke event at some time in the year after they had already stopped using Vioxx.  As reported in the May 11 AP Vioxx article, Mr. Frazier told analysts and reporters on a conference call: "We [at Merck] believe that the data don’t provide for a claim for a patient who had an event after they stopped taking [Vioxx]."

Perhaps Matthew Herper had the best handle on the situation when he used the headline "Vioxx: More Murk For Merck" for his May 11, 2006 online Forbes piece.

Merck says the data show that the heart risk from Vioxx does not persist, because the difference in outcomes between patients who stopped taking the drug and patients who stopped taking a placebo is not statistically significant. But responses from scientists and a Wall Street analyst were all over the map. . . .

The results do show that there is no statistically significant increase in heart attacks among patients who have stopped taking Vioxx compared to those who have stopped taking placebo. However, the data provide no certainty. The door is left open to arguments that Vioxx may increase the risk of heart attacks and strokes. Whether that is true could be crucial as Merck defends itself against more than 11,000 Vioxx-related lawsuits.

Meanwhile, just one week before this latest development in the Vioxx litigation, from "Vioxx Heart Risk Found to Be Early and Persistent", an online piece posted May 3, 2006 on MedPage Today, we learned that perhaps even very short-term Vioxx use — as little as a week or two weeks of daily use — could increase a Vioxx user’s risk of heart attack or stroke. Moreover, in direct contradiction to some of the recent takes on the latest Approve data (see above), this MedPage article indicated that the increased risk on having a cardiovascular event ended on day seven after one stopped taking Vioxx.

The possible increased risk of having a heart attack or stroke after only short-term use was emphasized in this May 2, 2006 Bloomberg article, "Vioxx-Linked Heart Attacks May Occur Within 2 Weeks, Study Says", which starts:

Merck & Co.’s Vioxx painkiller may raise the risk of a heart attack within two weeks after patients start taking the drug, earlier than previous studies have shown, according to Canadian researchers.

More than a fourth of 239 elderly patients who had heart attacks while on Vioxx did so within six to 13 days after they first started taking the drug, according to a study published online today by the Canadian Medical Association Journal.

Of course, all of this is under consideration by the various interested parties as the two-year anniversary of the Vioxx recall, and the lawsuit filing deadline for many Vioxx plaintiffs, rolls around in September 2006.

(Posted by: Tom Lamb)