"It may be that Vioxx is causing permanent damage to the cardiovascular system, accelerating atherosclerosis or a sustained increase in blood pressure," said Dr Curt Furberg, a professor of public health at Wake Forest University, and a member of the FDA Safety and Risk Management Advisory Committee, according to a report by Reuter's news on May 18, 2006.
During his examination of the report, Dr Furberg determined that within the one-year follow-up of the APPROVE study, 7 Vioxx users had strokes, and 2 others had mini-strokes, compared with no strokes in patients taking a placebo.
"These data raise some very important questions because for a while we assumed Vioxx caused temporary problems, and here it is more than that," Dr Furberg told Reuters. "It could be causing permanent damage."
"In the past we weren't quite sure of the stroke risk," he added, "so stroke is now back on the agenda in a bigger way."
Also this week the Wall Street Journal reported that heart attack risks for Vioxx users increase long before the 18 month period claimed by Merck. The new report is the 1-year follow-up to the APPROVE trial and includes a graph tracking "confirmed thrombotic cardiovascular events," that shows that at four months of use, the number of CV events among Vioxx users began to outnumber those in patients who were given a placebo.
On May 18, 2006, CNN's Moneyline reported that: "Merck is denying news reports that suggest new data from the drug maker indicates Vioxx increased heart attack risks earlier than previously reported and that the risk for stroke persisted long after the patient stopped taking the drug."
But then when has it ever done anything but deny its wrongdoings?
This appears to be a month of reckoning for Merck because another study published earlier this month in the online edition of the Canadian Medical Journal, Queen's University researcher Linda Lévesque, along with James Brophy and Bin Zhangat at McGill University in Montreal Canada, found that 25% of Vioxx users who suffered a heart attack did so within 14 days of taking the first dose.
What this all means to Merck's legal team is that the stakes are getting higher and the company's SEC filings indicate the drug giant knows it.
Last year, Merck had listed a reserve of $675 million for legal defense expenses related to Vioxx; but in January 2006, the company announced that it had increased the fund by $295 million to cover legal costs through 2007.
According to Merck's SEC filings, in 2005, the company had worldwide sales of $22 billion, compared to $22.9 billion for 2004. Total sales decreased 4% for the year, which Merck says, reflects a decrease of 7% related to the VIOXX withdrawal, offset by revenue growth in all other products of 3%.
Included in marketing and administrative expenses, the company noted reserves solely for future legal defense costs for Vioxx litigation recorded in the 4th quarter of 2005 and 2004, of $295 million and $604 million, respectively, as well as $141 million associated with the withdrawal of Vioxx recorded in 2004.
According to a January 31, 2006 Merck press release, there are "9,650 lawsuits, which include approximately 19,100 plaintiff groups alleging personal injuries resulting from the use of VIOXX."
In addition, another 3800 plaintiffs have signed tolling agreements, meaning they have cut a deal with Merck to forego suing in the short term; but should Merck start losing Vioxx lawsuits in marginal cases, attorneys say, those thousands are likely to multiply.
There are also numerous lawsuits filed against Merck for claims other than personal injuries. For instance, the Attorney General of Texas, Greg Abbott, has filed a lawsuit seeking $250 million, accusing Merck of defrauding Texas citizens by representing Vioxx as safe when applying for the drug's approval to be included on the state's list of drugs approved to be covered for patients on Medicaid.
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Former Vioxx users could be at risk of developing strokes for years, a prominent scientist said this week after evaluating new data from a 107-page report on patients who were followed for a year after they stopped the drug
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