[Yahoo] Bush Law to protect big company from litigation; The Return of Vioxx Breaking News: FDA Panel: Celebrex Should Stay on Market Vioxx may return to the market Vioxx may return to market At FDA hearing, expert questions safety of Mobic By Bruce Japsen Tribune staff reporter Published February 18, 2005 WASHINGTON -- Merck & Co., which pulled its popular arthritis drug Vioxx last year because of heart risks, said Thursday that it may return it to the U.S. market if a Food and Drug Administration advisory panel finds that the drug's heart risks are similar to those of rivals still on the market. But an outspoken FDA researcher said he believed that the suddenly popular arthritis pill Mobic--which many people turned to after Vioxx was pulled--also may cause increased risk of heart attacks. Mobic, sold in the U.S. by North Chicago-based Abbott Laboratories, has been the primary benefactor from problems with the so-called Cox-2 class of painkillers. Merck's dramatic announcement and new testimony questioning the health risks of prescription painkillers puts pressure on advisers to the FDA to make the call on whether Vioxx and its rivals Celebrex and Bextra, used by millions of people, should remain on the market in some form or be pulled altogether. "If the advisory committee and FDA conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers," Peter Kim, president of Merck's research laboratories, said during testimony at an FDA hearing looking into health risks of Cox-2 drugs. Although Merck pulled Vioxx from the market, Pfizer Inc., which owns both Celebrex and Bextra, only issued warnings and continues to sell the drugs. Critics contend that the FDA didn't move quickly enough to respond to the health problems associated with the drugs, prompting calls from Congress to overhaul the governmental agency. On Thursday, Kim said that Merck's decision to withdraw the drug last fall "was the responsible course to take given the availability of alternative therapies." `A class effect' But after two days of testimony and data this week, he said that the health risks are no longer unique to Vioxx. "Merck believes that the data suggests a class effect." The company's surprising about-face followed the testimony earlier in the day of one outspoken FDA official who said that "the relative risk" of a heart problem from using Vioxx at higher doses was "more significant than smoking, diabetes or hypertension." Dr. David Graham, a safety researcher for the FDA who stunned the industry when he went before Congress last fall and blew the whistle on the safety of several other drugs, also said he believed high dosages of Vioxx, Celebrex and Bextra were a threat to patient safety. He also warned that the arthritis pill Mobic, which benefited from the Vioxx scandal because it falls outside the Cox-2 class, also may cause increased risk of heart attacks. Mobic is on pace to reap more than $1 billion in U.S. sales--a measure Wall Street deems a blockbuster. The drug has also risen in price, with its maker, Boehringer Ingelheim of Germany, raising the price to where its most common dose is now as expensive as Celebrex. Boehringer defended the drug, criticizing Graham's study as lacking credibility because it was neither peer-reviewed nor published like most others typically presented and debated at scientific and regulatory meetings. Abbott, which co-promotes Mobic, had no comment and referred calls to Boehringer. "David Graham's study is preliminary and unpublished data," said Boehringer spokesman John Yonsky. "It's impossible for us to respond to a study when we have not seen it." With millions of people looking for safe pain relief, Merck's announcement Thursday puts even more pressure on the embattled FDA. "This announcement by Merck alters the dynamics," said Dr. Gurkirpal Singh, a Stanford University researcher critical of the Cox-2 drugs. "This catches me totally by surprise, and now the [FDA] advisory panel must decide how much less safe Vioxx is than the other Cox-2 inhibitors." California patients studied Graham's study observed a database of more than 600,000 patients insured by California's Medicaid program for the poor. Typically, he said, one in 50 people each year between the ages of 65 and 74 have a heart attack. The same database was used to form his hypothesis that the relative risk of a heart attack was greater for a patient taking Vioxx than if they smoked, had diabetes or had high blood pressure. But Graham said that the typical rate of heart attack increases by 37 percent for those taking Mobic, by 32 percent for those taking Vioxx and by 9 percent for those taking Celebrex, according to data from the study he described as preliminary. Mobic is part of an older class of drugs known as non-steroidal anti-inflammatories. Critics like Graham say it is unnecessary for patients to take more expensive drugs when there are more than 20 generic and over-the-counter non-steroidal drugs on the market. Graham added to the mounting data about whether Cox-2 drugs should ever have been prescribed to most Americans when they came on the market in the 1990s. "You actually know very little about the actual population benefit of any of these products," Graham told the panel, which will decide Friday on whether Celebrex and Bextra will remain on the market. Despite Graham's rising-star status on Capitol Hill, his analysis has been criticized by drugmakers and researchers alike. His extrapolation of Vioxx dangers to thousands of patients has been labeled irresponsible by some. "Any estimate of harm from Vioxx is speculation," Merck said in a statement that followed Graham's appearance before the committee. What Merck may be banking on is the FDA panel clearing lower dosages of Cox-2 drugs as safe. Many researchers, for example, have testified this week that lower dosages of Cox-2s may have minimal risks. One member of the panel said he knows of a "few" of the more than two dozen FDA advisory panelists were considering voting to ban Celebrex and Bextra. The late news on Vioxx left many researchers scratching their heads. FDA Panel: Celebrex Should Stay on Market By RANDOLPH E. SCHMID, Associated Press Writer WASHINGTON - Advisers to the Food and Drug Administration (news - web sites) concluded Friday that the popular painkiller Celebrex poses an increased risk for heart problems but should be allowed to remain on the market. The FDA (news - web sites)'s arthritis and drug safety advisory committees, concluding three days of meetings to assess the risks of three popular painkillers called Cox-2 inhibitors, were to address Vioxx and Bextra later in the day. The advisers also were set to frame recommendations to the FDA about whether further testing is needed for the drugs and any special warnings or limits that should be placed on them. The committees were asked to assess the drugs after Vioxx was pulled from the market last fall because of heart problems in users. Since then questions have been raised about the Bextra and Celebrex as well. Committee members noted that Celebrex seems to have the least heart side effect of the three drugs, though some complained about the lack of needed data. Meeting chairman Alistair J.J. Wood of Vanderbilt University Medical School said the safety problems reported in connection with Cox-2 inhibitors exceed those of products that have been withdrawn from the market. However, since the side effect involving heart attacks, irregular heartbeat and stroke is a relatively common problem, that makes it harder to pin it to the drugs than if it were a rare side effect.
Bush's new law will protect big pharmaceutical companies like Merck, Pfizer, Wyeth from hefty litigation costs. CNN news: Bush signs class-action bill into law Legislation will limit 'lawsuit abuse,' backers say Friday, February 18, 2005 Posted: 11:59 AM EST (1659 GMT) President Bush signs a bill to curtailing class-action lawsuits Friday. WASHINGTON (AP) -- President Bush wasted no time in signing a bill that he says will curtail multimillion-dollar class-action lawsuits against companies. The first legislative triumph of Bush's second term is a historic step toward "breaking one of the main shackles holding back our economy and America's work force -- lawsuit abuse," said House Speaker Dennis Hastert, R-Illinois. The House approved the bill by a 279-149 vote Thursday as businesses finally saw success after a decade of efforts to reduce their legal liability from cases where a single person or a small group can represent the interests in court of many thousands of people. While businesses failed to get the measure to apply to suits already in the courts, Bush offered immediate help by signing the bill Friday. The president has described class-action suits as often frivolous. Businesses complain that state judges and juries have been too generous to plaintiffs. The bill "will help protect people who are wrongfully harmed while reducing the frivolous lawsuits that clog our courts, hurt the economy, cost jobs, and burden American businesses," Bush said. Under the legislation, class-action suits seeking $5 million or more would be heard in state court only if the primary defendant and more than one-third of the plaintiffs are from the same state. But if fewer than one-third of the plaintiffs are from the same state as the primary defendant, and more than $5 million is at stake, the case would go to federal court. Consumer groups and trial lawyers fought against the bill, but lost their struggle when Republicans gained seats in last fall's elections and Democrats defected on the issue. "The House of Representatives joined the Senate in sending a clear message to the nation: the rights of large corporations that take advantage of seniors, low-wage workers and local communities are more important than the rights of average American citizens," said Helen Gonzales of USAction, a liberal, pro-consumer activist group. Changing the legal system -- including class-action, medical malpractice and asbestos injury lawsuits -- has been a priority of Bush, the GOP and businesses. They have criticized what they see as a litigation crisis that enables lawyers to reap huge profits while businesses and consumers are stuck with the bill. Bush and other Republicans say greedy lawyers have taken advantage of the state class-action suit system by filing frivolous cases in places where they know they can win big dollar verdicts. Meanwhile, those lawyers' clients get only small sums or coupons giving them discounts for products of the company they just sued, GOP lawmakers contend. House Majority Whip Roy Blunt, R-Missouri, said that moving those cases to federal court will ensure that state judges will no longer "routinely approve settlements in which the lawyers receive large fees and the class members receive virtually nothing." But Democrats say Republicans just want to protect corporations from taking responsibility for their wrongdoing by keeping them clear of state courts that might issue multimillion-dollar verdicts against them. Federal courts are expected to allow fewer large class-action suits to go forward, which Democrats say means more businesses will get away with wrongdoing and fewer ordinary people will be protected. "It's the final payback to the tobacco industry, to the asbestos industry, to the oil industry, to the chemical industry at the expense of ordinary families who need to be able go to court to protect their loved ones when their health has been compromised," said Rep. Ed Markey, D-Massachusetts. "And these people are saying that your state isn't smart enough, your jurors aren't smart enough" to hear those cases. The bill also would limit lawyers' fees in settlements where plaintiffs get discounts on products instead of financial settlements. The measure links the fees to the coupon's redemption rate or the actual hours spent working on a case.
