Internal Document: Merck Reportedly Considered Changing Vioxx Drug Formulation in 2000
On June 23, 2005 Theresa Agovino and The Associated Press (AP) reported that in 2000 Merck & Co.'s researchers considered reformulating Vioxx in an attempt to reduce the cardiovascular side effects which ultimately led to the September 2004 Vioxx recall. The internal company discussions at Merck about changing the Vioxx formula came during the time when the drug company was engaged in a public relations campaign aimed at discounting a March 2000 study that pointed out Vioxx's potential heart attack risk.
The March 2000 Vioxx Gastrointestinal Outcomes Research, or VIGOR, study revealed that patients taking Vioxx were five times more likely to have heart attacks than individuals using the generic medicine naproxen. Following the release of the VIGOR study, Merck contended repeatedly that the study's finding about increased rate of heart attacks was a result of naproxen's cardioprotective properties and was not the result of Vioxx use.
Now, it appears, at the same time as making its "naproxen-not-Vioxx" contentions, Merck had its researchers considering how Vioxx could be reformulated such that the active chemical in Vioxx, rofecoxib, would be combined with a thromboxane inhibitor. The apparent purpose of adding another agent to Vioxx was an attempt to reduce the risk of heart attacks and strokes in patients using Vioxx, such as the participants in the VIGOR study.
This June 2005 AP article is based on an internal Merck document that was inadvertently produced to plaintiffs' lawyers in the discovery process in one of the hundreds of filed Vioxx lawsuits. In the AP article, itself, it was reported that a copy of this internal Merck document was provided to The Associated Press on the condition that its source not be identified. Theresa Agovino, the AP reporter, summarized parts of this so-called "smoking-gun" Merck document in her article:
According to the document, Edward Scolnick, the former head of Merck's research labs, was the first to suggest combining Vioxx with an agent that would block blood platelets from clotting. Such clots can lead to heart attacks and strokes. There are three dates on the document; the first is March 30, 2000.
The document's authors said Vioxx might reduce the production of a substance called prostacyclin, which prevents platelet aggregation. That reduction may alter the ratio of prostacyclin to thromboxane, a substance which can constrict blood vessels and cause clotting. The change may cause increased risk of cardiac and cerebral adverse events, the document said.
The internal Merck document recently became an issue in a New Jersey Vioxx lawsuit when Merck objected to the document's use as evidence in any Vioxx case. The basis for the legal objection by Merck's lawyers is that the subject document was an attorney-client communication between Merck's researcher and the drug company's in-house patent counsel. On May 27, 2005 New Jersey Superior Court Judge Carol E. Higbee ruled in favor of Merck as regards this objection, holding that the Merck internal document was privileged and could not be used at trial.
Thousand of wrongful death claims and personal injury lawsuits have been filed against Merck based on the legal theory that the drug company hid Vioxx's serious side effect risks. Currently, the first Vioxx trial is scheduled to start July 11, 2005 in a Brazoria County, Texas state court. The second Vioxx case set for trial is one that will be heard in an Atlantic County, New Jersey state court; the scheduled trial date for the New Jersey Vioxx case is August 1, 2005.
Read more about events leading up to the Vioxx recall:
(Posted by: Tom Lamb)