Safety Issues Played a Role in Vioxx's Withdrawal from the US Market

DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 27, 2006--Research and Markets (http://www.researchandmarkets.com/reports/c31670 ) has announced the addition of The Vioxx Withdrawal: Changes and Opportunities for the Industry to their offering.
The safety issues that precipitated the withdrawal of Vioxx from the U.S. market have had a devastating effect on the market potential of the selective COX-2 inhibitor class and raised doubts about the safety of all nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, the Vioxx withdrawal sparked a continuing controversy over the FDAs regulation of drugs in the United States and the pharmaceutical industrys promotion of drugs.
This report contrasts the Vioxx withdrawal with other U.S. drug withdrawals, highlighting the unusual set of circumstances surrounding the event, and examines its ramifications for the industry. We discuss potential changes to drug regulation and promotion in the United States, consider how public opinion shapes the decisions of regulators and legislators, and propose that the pharmaceutical industry become a willing and proactive partner in the reforms triggered by this unique event.
Business Implications
-- The withdrawal of Vioxx from the U.S. market occurred against a backdrop of public relations disasters for the FDA, public criticism of rising drug costs, debate over Medicare reform, and increasing concern about the safety of approved drugs. The withdrawal set in motion a series of events likely to change the face of drug regulation and marketing in the United States.
-- Public opinion of the pharmaceutical industry is at an all-time low. Criticism of the cost and quality of drug marketing has heightened in the wake of the Vioxx withdrawal because heavy promotion to doctors and the public is blamed for the vigorous uptake of this drug. Further, the public in the United States blames the rising cost of pharmaceuticals, in part, on what it considers excessive marketing.
-- Following a long and public drug safety debate in the United States, the FDA must rebuild its reputation. The lengthy time that Vioxx remained on the market while its safety was in question and high mortality estimates have been most damaging. Public confidence in the agency has been shaken, and many commentators charge that the FDA's short approval times undermine safety.
-- The FDA has responded by introducing a series of reforms and initiatives aimed at strengthening drug safety programs and increasing the transparency of its operations. A return to slower drug approval times looks set for the future, together with more stringent postmarketing surveillance and rapid, effective response to safety concerns.
-- Pharmaceutical companies need to embrace the coming changes if they are to be successful in the future. There is no question that the industry will be held more accountable for its activities, and public perception may be the key to its success.
Topics Covered
Overview
The Perfect Storm
The Vioxx Withdrawal in Context: A Brief Chronology
Far-Reaching Effects
Outlook
List of Figures and Tables
Figure 1. Share Price History: Comparison of Merck and Pfizer Stocks with Industry Indexes
Figure 2. Public Survey Results of Consumer Confidence
Figure 3. Mean US pproval Times for NMEs, 1984-2003
Figure 4. FDA Drug Approvals Against Percentage of Drugs Withdrawn, Based on Year Approval
Figure 5. Public Survey Results of Attitudes to Drug Advertising
Table 1 Drugs Withdrawn for Safety Reasons in the United States, 1980-2005, in Order of Time on the Market
Table 2. Ten Best-Selling Therapeutic Classes by U.S. Sales, 2004
Table 3. Top Ten Drugs by DTC Spend, 2000
Companies Mentioned
-- AstraZeneca
-- Aventis
-- GlaxoSmithKline
-- Merck & Co.
-- Pfizer
-- Schering-Plough
-- Wyeth
For more information visit http://www.researchandmarkets.com/reports/c31670

Doctors dropped from Vioxx lawsuit

RIO GRANDE CITY, Texas (AP) _ Two doctors were dropped Thursday from a lawsuit the family of a Rio Grande City man filed claiming that his fatal 2001 heart attack was caused by Merck & Co.'s painkiller Vioxx. The action came on the second day of the nation's fourth Vioxx trial.
The family of Leonel Garza had sued Merck as well as Dr. Michael Evans and Dr. Juan Posada, both of McAllen. They accused the doctors of medical negligence for giving Garza the painkiller, which plaintiffs attorneys said they should have known was dangerous for a man with heart problems. In opening statements Wednesday, attorneys for the defense, the family and the doctors disagreed over whether Vioxx was in Garza's system when he died. Family attorneys say Dr. Evans gave Garza a seven-day supply in late March 2001 and Dr. Posada gave him a month's supply on April 4, 2001. But attorneys for both the doctors and for Merck say there was no evidence that Posada ever gave Vioxx to Garza. Plaintiffs attorneys agreed Thursday afternoon to remove the doctors from the lawsuit. The plaintiffs wanted to focus on Merck, family attorney Mauro Ruiz told The (McAllen) Monitor. "The doctors were very pleased," Ronald Hole, their attorney, told The Associated Press. "But Dr. Posada, of course, never even gave Vioxx and Dr. Evans just gave him the seven-day trial of Vioxx. That was way out of his system before he passed away." Hole said he believed the doctors were brought into the lawsuit to bring it into state court. There was some discussion Thursday afternoon whether the case should be removed to a federal court, but Merck attorneys decided to allow it to remain in state court, Hole said. Merck, based in Whitehouse Station, N.J., is facing hundreds of lawsuits from people who took the once-popular painkiller. The drug was pulled from the market in September 2004, when a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. However, Merck says no such risk has been shown for shorter periods. In previous trials, Merck lost a case in a Texas court and won in a New Jersey court. A federal case ended in a mistrial.

Judge: Attorneys in Vioxx Trial are not to talk to reporters

NEW ORLEANS -- The judge overseeing the federal Vioxx trial asked attorneys Friday not to talk to reporters. Attorneys for manufacturer Merck & Co. and for Evelyn Plunkett, whose husband died of a heart attack after taking Vioxx for a month, met with U.S. District Judge Eldon Fallon for two hours Friday afternoon.
Fallon also imposed an informal gag before the first federal trial, which ended with the verdict hung 8-1 in Merck's favor. It will be retried starting Feb. 6 in New Orleans. A state jury in Texas awarded $253 million in damages, though state law will cut that to no more than $26.1 million. A New Jersey state court absolved Merck. During the federal court deliberations, the New England Journal of Medicine published an editorial saying that a study which has been a major focus of both federal and state trials had downplayed the drug's possible dangers. Plunkett's attorneys have said the editorial bolsters their claims that Whitehouse Station, N.J.-based Merck hid the drug's dangers. The company pulled the drug in 2004, after another study found that taking it for at least 18 months doubles the risk of heart attacks.

Vioxx trial turning city of 12,000 into media ground zero

Business suits, BlackBerries and laptops seem to have taken over this town.
As the nation’s fourth Vioxx lawsuit began this week in Rio Grande City, dozens of lawyers, reporters, analysts and expert witnesses descended on this city of about 12,000.
They came for an up-close view of a high-profile, high-stakes lawsuit in which the family of a local man who died while taking the arthritis drug is suing pharmaceutical giant Merck — for $1 billion in punitive damages.
The lawsuit has attracted national attention for a host of reasons, among them the Rio Grande Valley’s reputation for generous civil awards and predictions that the case could prove pivotal for future Vioxx suits. Merck so far has lost one suit, won one, and one was declared a mistrial.
But locals have mixed feelings about having the spotlight on Rio Grande City, and about the outsiders who are shining that spotlight.
"It’s good for the economy, but it’s a short-term economic impact. Whether it brings notoriety to Rio Grande City, well, we’ll see," said Mauro Villarreal, head of the city’s economic development corporation.
Villarreal worried a big award to the plaintiffs could contribute to perceptions of the area as overly friendly toward plaintiffs. In December, the American Tort Reform Association, a national group that advocates curbing awards in civil suits,named the Valley and the Texas Gulf Coast the country’s top "judicial hellhole" for 2005.
Local businesspeople said they welcomed the extra clientele. Still, they dodged questions about potential downsides to the influx of outsiders, many of whom operate at a faster pace than the middle-age and elderly tourists who usually populate the city’s hotels and restaurants at this time of year.
"They’re not Winter Texans. I can tell they’re here on business," said Elizabeth Garza, a front desk clerk at the city’s Best Western Garden Inn.
Twenty people associated with the lawsuit have booked rooms at the inn, Garza said with a little smile, but to protect their privacy, she would not reveal identities. The inn is much fuller than usual for this time of year, she said.
La Borde House, a turn-of-the-century mansion and hotel that is one of the city’s most popular tourist attractions, also is booked. Plaintiffs’ lawyers and support staffers have rented out the downtown hotel for the week, according to Historical Commission employees who oversee the hotel’s operations.
"For us it’s just business," said administrative assistant Nadia Elizondo. "I don’t see any downsides. People are coming here."
On Tuesday morning, the plaintiffs’ legal team had set up shop in the hotel’s normally empty parlor, pushing antique furniture against the walls to make room for a long folding conference table covered with boxes of files. Security evidently was tight: A woman typing on a laptop referred visitors to the Historical Commission, explaining, "Nobody’s allowed in here." A sign on the hotel door said, "Dear visitors, we are currently at full occupancy and cannot allow viewing of the hotel."
At the Starr County Courthouse, the visitor parking lot, mostly empty on an average day, was full. Cars lined both sides of the street leading to the building.
Lawyers on cell phones paced around the building and a woman working on a laptop sat on the front steps of the courthouse. Television camera operators camped out, waiting for the court to recess.
A few feet away, the courthouse’s groundskeeper, 71-year-old Ramiro Diaz, surveyed the scene.
A former migrant laborer who most days can be seen in his standard jeans, western hat and boots, he seemed unperturbed, merely assuming his usual posture and waving to passing acquaintances.