According to an article in the New York Times, Merck, the manufacturer of Vioxx has admitted a huge error in their primary testing. As it turns out, Merck’s testing does NOT prove that heart damage occurs only after using Vioxx for 18 months or more. Here are selected excerpts from the article:
In an admission that could undermine one of its core defenses in Vioxx-related lawsuits, Merck said yesterday that it had erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use.
But Dr. Peter S. Kim, Merck’s chief scientist, said the company stood by the overall findings it reported in 2005 — including the conclusion that the drug’s heart risks were not apparent if patients took it less than 18 months.
But outside scientists said yesterday that Merck’s admission, when considered along with other clinical trials of the drug and studies tracking real-world Vioxx use, supports critics’ longstanding claims that Vioxx caused heart problems quickly.
The 18-month issue is crucial both for the 20 million Americans who took Vioxx, an arthritis drug and painkiller, and for Merck’s future. Merck faces at least 11,500 lawsuits, covering 23,000 people, from patients who say that Vioxx caused their heart attacks and strokes. Merck cited the 18-month theory when it withdrew Vioxx, a painkiller, from the market in September 2004, based on preliminary findings from a clinical trial called Approve.
In defending the lawsuits, Merck has consistently taken the position that Vioxx can cause heart problems only if it is used continuously for more than 18 months. But in the five Vioxx court cases in which juries have reached decisions so far, Merck has lost three times — twice in cases in which the heart attack victim had taken the drug for fewer than 18 months.
In reality, the test that the company said it had used to check the results shows that there is a 7 percent chance that Vioxx has an equally high risk of causing heart attacks both before and after the 18-month benchmark is reached.
That 7 percent figure may seem like a relatively small chance of error, but scientists say it is high enough to mean that Merck has not proved its theory.
Some outside scientists said that the new data indicated that Vioxx’s dangers became evident after only about four months of use. Merck disputed that interpretation and said yesterday that its newly discovered mistake was unrelated to that new data.
But Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, and a frequent critic of Merck, said the mistake the company disclosed yesterday was yet another example of Merck’s mishandling data to make Vioxx seem safer.
