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 To Pay $58 Million in Vioxx Settlement

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 Merck Extends Another Vioxx Settlement Deadline

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 Merck Vioxx Study Scandal Fans Opposition to Proposed FDA Rule Changes

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 Not the Only Drug Company to Use “Ghostwriters”

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 Merck Deception in Vioxx Studies Detailed

Merck & Co. has agreed to extend an important deadline for its Vioxx settlement. Now, people wishing to receive early partial payment of their settlement have an extra month to file paperwork backing up their Vioxx injury claim.  The deadline for those willing to wait for full payment remains July, but could go  as late as October.

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 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 Key Vioxx Settlement Deadline Extended

The Vioxx  settlement passed yet another milestone.  Enough people have signed on to Merck & Co.’s pending $4.85 billion Vioxx settlement to keep settlement activities moving forward, the drug maker announced. Vioxx, or refecoxib, is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever.  Vioxx was pulled from the market in 2004 after being linked to cardiovascular problems.  After a few years of litigation, a comprehensive settlement was proposed in November.  Under the settlement plan, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected their having suffered a heart attack or stroke.

Over 95 percent registered cases against Merck & Co. by the January 15th deadline, much more than the minimum required to proceed.  Also, parties involved in the lawsuit have agreed on some amendments that resolve one outstanding issue and make payouts more attractive to those plaintiffs who have been holding out for a better deal.  The company said over 44,000 of the 47,000 claimants who registered injuries eligible for compensation have submitted some or all of the documentation required to seek a share of the settlement.   Friday was the deadline for accepting the offer; at least 85% of eligible claimants had to enroll by submitting forms and medical authorizations in order to validate the deal.  It isn’t yet clear how many of those submitting paperwork meet all the criteria.  Those who submitted partially completed enrollment packages have until March 31 to provide the rest of their materials. More Vioxx Settlement Meets Vital Deadline

Just as Vioxx maker Merck gets closer to settling thousands of lawsuits against the defective pain reliever, reports have surfaced that a grand jury is investigating the company over the way it marketed Vioxx. According to the Wall Street Journal, the health-care-fraud unit of the U.S. Attorney’s Office for the District of Massachusetts is investigating whether Merck promoted Vioxx to health-care professionals for uses other than those approved by government regulators, a practice known as off-label marketing.

Vioxx was removed from the market in 2004, after a Food & Drug Administration (FDA) study estimated that the defective drug could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings. More Vioxx Grand Jury Probe Latest Headache for Merck

Vioxx plaintiffs in Florida are petitioning a federal court to expand Merck’s proposed $4.85 billion settlement to include those who did not file suit against the company by Nov. 9, 2007.  But many lawyers involved in the Vioxx settlement oppose the petition, fearing that adding more plaintiffs to the Vioxx settlement would lessen the awards each eligible participant would receive.  However, if the situation is not resolved, Vioxx patients who did not file suit against Merck by the November 9 deadline could still bring their own lawsuits.  But that means Merck’s Vioxx troubles – which the $4.85 billion settlement was supposed to resolve – would be far from over.

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 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 Florida Vioxx Plaintiffs Look to Expand Settlement

The pending Merck Vioxx settlement appears to be on track, as more than 95 percent of possible Vioxx claimants have signed on to Merck’s $4.85 million settlement offer.   In other developments, lawyers opposed to an “all or nothing” provision in the proposed Vioxx settlement, have apparently agreed to wording that makes the settlement more palpable.

Over 57,100 claimants of an estimated 60,100—or more than 95 percent—registered their cases against Merck & Co. by the January 15th deadline.  This amount is much more than the minimum required to proceed against Merck in the Vioxx suit.  Vioxx, or refecoxib, is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) and works by reducing substances that cause inflammation, pain, and fever.  Vioxx, a widely used painkiller, was pulled from the market in 2004 after being linked to cardiovascular problems.  Under the settlement plan announced in November, Merck agreed to compensate plaintiffs who can show, under certain conditions, that taking the drug was connected their having suffered a heart attack or stroke. More Vioxx Settlement Gaining Ground, with 95 Percent of Plaintiffs Signing On