FDA Advisory Panel Says Painkillers Can Stay on Market
February 19, 2005 07:52

http://www.npr.org/templates/story/story.php?storyId=4505761

After three days of hearings, an FDA advisory panel says that painkillers such as Celebrex and Vioxx need not be removed from the market despite an increased risk of heart attack and stroke. The panel does recommend some restrictions, including lower doses and more customer warnings.

In a recent entry we talked about some overdue changes that needed to occur over at the FDA specifically regarding a wave a dangerous drugs including Celebrex, Viox, and some information linking Prozac use to Violence and Suicidal tendencies. That article can be found here

The FDA has recently released information that they plan to establish a "Drug Safety Oversight Board" that will be designed to monitor the performance of prescription drugs after they are already on the market to provide insight into possible dangers, or benefits.

The WSJ noted that, Plans for the board were announced on the eve of a congressional hearing on the safety of prescription pain killers like Vioxx and Celebrex that blossomed into a $5 billion-a-year business before risks from potential side effects came to light.

All I can say is that I hope that this new board proves to be successful at detecting risks in medication, rather then leaving that to the profit driven corporations that produce them. http://www.crankyconsumer.org/archives/000199fda_plans_a_drug_safety_board_response_to_celebrex_viox.html Posted by David Michael at February 15, 2005 04:24 PM

Before DTCA (direct-to-consumer advertising), pharmaceutical advertisements appeared in professional publications, promotional materials, and samples intended for physicians, pharmacists, and hospital administrators. Patients were never intended as the primary target for any form of prescription drug advertising. Thus, the commercial success (or failure) of a drug depended on its effectiveness and safety record not on slick marketing campaigns.

While, in a perfect world, the benefits of DTCA touted by some experts would be understandable and even warranted, serious problems plague the system thereby making any such praise undeserved.

(http://www.newstarget.com/z003204.html)

FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients... (Read Article)

A key part of President Bush's agenda for his second term is "legal reform." You can expect to hear him go on about it during his State of the Union address this Wednesday. Unfortunately, like WMD in Iraq and the latest "crisis" in Social Security, the Administration's case for making drastic changes to the legal system is another sham based on misinformation and deception, and serves as a front for the corporate agenda so dear to Mr. Bush.

As part of this drive the Senate will vote the week of February 7 on the so-called "Class Action Fairness Act" (S. 5). There is nothing fair about this proposed law. It is simply a way for corporations to restrict the legal rights of ordinary citizens to fight unscrupulous companies that sell unsafe products, rip off consumers, pollute the environment and employ unfair labor practices.

Please contact your Senators NOW - tell them that you demand fairness in our legal system, and that the only way to do that is to either stop or amend the class action bill. To send them a quick letter, please go to http://action.citizen.org/pc/mail/oneclick_compose/?alertid=6902931

Thanks for forwarding this email to your friends!

BACKGROUND

Class action lawsuits are an effective legal remedy for average citizens to confront large companies. Rather than pursuing an impossibly expensive and difficult individual legal battle against a large corporation, class action lawsuits allow a large number of similarly injured or otherwise impacted citizens (a "class") to join together in a common lawsuit. Class actions have been one of the single most effective methods of enforcing corporate accountability and improving business practices when unscrupulous companies sell unsafe products, rip off consumers, pollute the environment or employ unfair labor practices. Class actions have been used in recent years to stop insurance companies from illegally raising customer premiums, to stop auto giants like Ford from knowingly installing faulty engine parts that caused multiple injuries and deaths, and to stop mega-employers like Wal-Mart from making employees work overtime without pay.

Naturally, therefore, the Bush Administration wants to destroy the class action system. Parroting inaccurate information and downright fabricated stories about "frivolous lawsuits," "judicial hellholes" and the supposed cost of our legal system to business, the Republican leadership of the U.S. Senate is poised to pass the terribly misnamed "Class Action Fairness Act."

The bill is designed to allow defendant companies to move class actions filed in state courts, where they have traditionally been tried, to federal courts. Once in federal court, which is much friendlier to business interests than state courts, cases are far less likely to even get certified - thereby blocking a trial over the merits of the case. What's more, the federal judiciary is so overburdened already that throwing class actions on top of its workload virtually guarantees that any justice from a class action suit will be delayed by years - and as we all know, justice delayed is often justice denied.

Of course industry knows all this, and that is why business interests have had a small army of lobbyists pushing this bill, which is supported by every major industry group and opposed by a large coalition of consumer, civil rights, labor and environmental groups. That should tell you everything you need to know.

The bill should be soundly defeated for the sham "reform" that it is. But while it could be challenging to stop in the Republican-dominated Senate, we have a good chance to amend the bill and fix its most dangerous aspects. Specifically, we urge you to demand that your Senator vote for two amendments to the bill:

* Sen. Bingaman's consumer amendment, which will give federal
judges the tools to certify state law class actions on a nationwide basis so that consumers across the country can hold companies accountable for wrongdoing.

* Sen. Kennedy's civil rights and worker protection amendment,
which carves out state law civil rights and wage-and-hour cases from the scope of the bill, is needed to ensure that ordinary working men and women will continue to have access to their own state courts for cases brought under their own state law.

Class actions are one of the most important parts of the legal system for ordinary folks like you and me.

Please contact your Senators TODAY to let them know that you want the class action system to remain intact - and fair. Go to
http://action.citizen.org/pc/mail/oneclick_compose/?alertid=6902931

For more information on Public Citizen, go to www.citizen.org

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Dear Friend,

President Bush and the insurance industry want you to believe that the nation?s health care crisis is the result of so-called frivolous lawsuits. It?s just not true. Here?s the truth, in the words of USAction?s president William McNary: The real malpractice crisis is not a lawsuit crisis; the real crisis is the children, women and men who have suffered from malpractice. They are not just numbers on an actuary table, they are not just underwriting statistics, and they are not just entries on an insurance profit and loss statement. These are real people who have suffered real pain.

Too often the voices that get drowned out are the voices of the people who have survived medical malpractice and of those who have lost loved ones because of medical error.

This includes people like Dylan and Christine Malone of Washington. The Malones? son, Ian, was born with severe physical and mental disabilities when Christine?s doctor gave her a drug to induce labor -- despite the fact that the drug?s manufacturer warned against the possibility of serious brain damage if used by pregnant women. Ian didn?t even live to see his fifth birthday.

You can view the TV network don?t want you to see. The ad features the Malone Family on USAction?s Website. USAction tried to place the ad on ABC, CBS, NBC, & Fox but all four networks refused to air the ad.

Take Action Now!

After you view the ad, tell your Senators to protect -- not to punish -- families like the Malones who through no fault of their own were victims of medial malpractice. Urge them to address the real crisis by ensuring quality staffing at hospitals and nursing homes, improving care to reduce errors, making a greater effort to discipline incompetent doctors, and making insurance companies open their books to justify their need for rate increases.

In Solidarity,

USAction