A Vioxx study that was supposedly meant to find out if the recalled painkiller was less likely to cause stomach problems than another drug was really nothing more than a marketing ploy, a new report says.   According to Merck & Co. memos and reports obtained during Vioxx lawsuits, the Advantage study was crafted by Merck’s marketing department to get physicians to prescribe Vioxx.  What’s worse, when the study was published, it omitted information about patients who had suffered cardiovascular problems while enrolled in the trial.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits. (more…)

Another study has confirmed that Vioxx and Bextra increase the risk of having a stroke.  Both Bextra and Vioxx were removed from the market because of their association with heart attacks and stroke.

This latest study, which looked at the stroke risk of COX2 inhibitors like Vioxx and Bextra, as well as the risk of other NSAIDs like ibuprofen, was conducted by researchers at Vanderbilt University in Tennessee.  The study focused on the seven most common NSAIDs, including Celebrex, Vioxx, Bextra, ibuprofen, naproxen, indomethacin, and diclofenac. (more…)

New Jersey-based Merck & Company will begin funding $4.85 billion to resolve state and federal claims over its painkiller Vioxx.  The first payment of $500 million is scheduled for August 6; additional payments will follow.  Merck said it met its threshold to make these payouts and waived its right to walk away from last November’s agreement to settle roughly 50,000 lawsuits.

After years of litigation, a comprehensive settlement was proposed in November under which Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking Vioxx is connected to their having suffered a heart attack or stroke.  More than 48,500 of about 50,000 people—about 97 percent of all eligible claimants—registered, exceeding the 85 percent required threshold.  In addition, Merck extended the enrollment deadline to October 30, 2008 for eligible plaintiffs.  According to the Associated Press, “payouts are expected at a minimum of $5,000 up to a few million dollars” to “former Vioxx users, or their survivors.”  To be eligible, “They must have had pending lawsuits or tolling agreements, which suspend the statute of limitations, as of November 9, 2007, the date the settlement was reached.” (more…)

Merck & Co. was on the winning end of another Vioxx court decision this week, the third favorable ruling involving the deadly painkiller in the past month.  This time, the New Jersey Supreme Court voted 5-1 that Vioxx users who had not shown signs of  an injury are not entitled to medical monitoring paid for by Merck.  The ruling effectively dismisses a class action lawsuit filed by former Vioxx users seeking to have Merck cover diagnostic testing that might uncover undetected Vioxx injuries.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion.  But in 2004, the Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.  The Vioxx recall led to thousands of lawsuits against Merck. (more…)

Vioxx maker Merck & Co. won two court victories this week, in Texas and New Jersey, as appeals courts reversed rulings in Vioxx lawsuits.  However, the Merck victories won’t affect the $4.85 billion settlement the company struck with thousands of Vioxx victims last November.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. (more…)

Drug maker Merck & Co. Inc., will pay $58 million to Massachusetts, 28 other states, and the District of Columbia, to settle lawsuits that claim Merck allegedly used deceptive marketing to promote its popular painkiller Vioxx.  Merck employs over 150 people at a research facility in Boston’s Longwood area.

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever.  A three-year study aimed at showing that Vioxx—at a 25 milligram dose—prevents recurrence of polyps in the colon and rectum was ceased when Merck discovered a higher heart risk compared to patients taking placebos.  Prior to the Vioxx withdrawal, the Food and Drug Administration (FDA) announced that patients taking Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death and patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.  Merck pulled Vioxx from the market on September 30, 2004 after acknowledging that Vioxx could significantly increase the risk of heart attacks. (more…)

Merck just extended the deadline for registered participants to submit paperwork to June 30 on the Vioxx program. Merck states that the proposed $4.85 billion settlement for illness associated with Vioxx—also known as refecoxib—continues on schedule.  The original deadline for claimants to provide documents proving they took Vioxx and then had a heart attack or stroke was May 1; the registration deadline was January 15.

“The resolution program is going forward in a satisfactory way.  We expect to meet and exceed the threshold for funding of the program,” said Merck & Co. spokesman Kent Jarrell.  Lawyers on the plaintiffs’ steering committee said the extension raised no concerns, adding it was anticipated because the claims administrator continues to verify submitted documents.  “The enrollment has been overwhelming and the documents have been coming in at a great pace,” said one of those lawyers. (more…)

Last week’s revelation that Merck Inc. manipulated two Vioxx studies in order to downplay death rates has prompted more criticism of a Food & Drug Administration (FDA) plan to loosen off-label marketing rules that drug makers must adhere to. If approved, the proposed FDA rule change would allow drug and medical device makers to provide doctors with copies of medical journal articles that discuss off-label uses of their products.

Off-label use is the use of a drug or medical device for a purpose not approved by the FDA.  For example, gadolinium contrast dyes are often used off-label in MRA (Magnetic Resonance Angiography) procedures, even though such agents are only approved for use in MRI procedures.  Once a drug or medical device has been approved by the FDA, doctors are free to prescribe it as they see fit.  In fact, a 2006 study estimated that more than 20 percent of all prescriptions written by doctors were for unapproved uses. However, drug and medical device companies are prohibited from advertising off-label uses.  In 1997, Congress created a temporary exception to the off-label marketing rule by allowing drug makers and medical device companies to distribute reprints of peer-reviewed research from reputable medical journals that discussed off-label uses to physicians.  Drug makers and medical device manufacturers were able to do so long as they submitted the articles to the FDA for advance review and had formally asked the FDA to approve the new use described in the journal article.  That exception expired in 2006. (more…)

Earlier this week, it was learned Merck & Company conducted research on Vioxx, and the concealed it role in the studies by paying prominent scientists to lend their names to them. Unfortunatel, this is not an uncommon practice.

“We’ve got to stop this,” said Dr. Catherine D. DeAngelis, editor of the Journal of the American Medical Association (JAMA).  “People are being hurt.  We’ve given away our profession.”  This week, articles in JAMA say Merck not only conducted its own studies on the pain pill Vioxx, it alsohired a company to ghostwrite reports for medical journals which were stated as being written by scientists who did very little of the research.  According to the articles, Merck did not disclose the use of ghostwriters.  The only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices. (more…)

Merck Inc. concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. These revelations – detailed in two reports published in the “Journal of the American Medical Association” (JAMA) – show the extent to which drug companies are able to manipulate clinical trial data. Such practices are used throughout the drug industry, though they are hard to document, the authors of the JAMA reports said. In fact, the only reason the manipulations surrounding the Vioxx studies are coming to light is because lawsuits filed on behalf of people injured by the defective drug forced Merck to release documents detailing the practices

This is not the first time drug makers have been accused of withholding vital safety information about their medications. Recent litigation involving the Ortho Evra birth control patch has revealed documents that indicate Johnson & Johnson hid information on Ortho Evra’s blood clot risk from the Food & Drug Administration (FDA). And the recent scandal surrounding tainted heparin has proven that the FDA is ill-equipped to police the safety of even the most routine medicines. (more…)