Merck Vioxx News and Press Releases - News Menu

By Robert Steyer
TheStreet.com Staff Reporter

12/20/2004 - Pfizer (PFE:NYSE - news - research) didn't have much time to take advantage of Merck's (MRK:NYSE - news - research) misery after withdrawing its painkiller Vioxx from the market. Two of Pfizer's arthritis drugs, which belong to the same class as Vioxx, are now under regulatory and investor scrutiny. Here's a list of key events and dates.

Sept. 30: Merck pulls Vioxx from the market because a test showed that the drug caused a significant increase in cardiovascular risk among people who took the drug for more than 18 months.

Oct. 1: Pfizer says three large long-term Celebrex studies involving more than 6,000 patients "have not shown any significant safety issues and are expected to continue to completion." Pfizer adds that "the data we've accumulated over time demonstrate that Celebrex does not increase the risk of serious cardiovascular events in patients with arthritis and pain, even at higher-than-recommended doses." Celebrex reached the U.S. market in 1998, a year before Vioxx was available.

Oct. 7: An editorial published in an online version of The New England Journal of Medicine raises questions about COX-2 inhibitors in general. Dr. Garret A. FitzGerald, a medical researcher at the University of Pennsylvania, says the FDA should examine all COX-2 drugs. "We must remember that the absence of evidence is not the evidence of absence," FitzGerald says. He doesn't advocate banning all COX-2 drugs for all patients. These drugs "remain a rational choice for patients at a low cardiovascular risk who have had serious gastrointestinal events, especially while taking traditional" pain relievers. He says it would "seem prudent" to avoid prescribing COX-2 drugs for patients "who have cardiovascular disease or who are at risk for it."

Oct. 15: Pfizer says it is working with regulatory agencies "around the world" to update the label of its COX-2 drug Bextra. Pfizer would later reveal that this update is a black box warning -- the toughest warning required by the FDA -- for a rare but potentially fatal skin rash called Stevens-Johnson syndrome. A warning about this side effect had been on the Bextra label since 2002, a year after Bextra reached the U.S. market. This side effect exists with other medications, including other COX-2 drugs, but it occurs more often with Bextra.

However, Pfizer also reviewed results of two studies involving patients who received Bextra after undergoing heart bypass surgery. In one study, patients who received Bextra plus another COX-2 drug unavailable in the U.S. showed a statistically significant high cardiovascular risk. In the other study, patients receiving Bextra alone had a higher risk; but Pfizer later says these results are not statistically significant. Pfizer says a third study of patients undergoing general surgery found no significant risk of cardiovascular problems among those receiving Bextra and the other COX-2 drug. Bextra is not approved in the U.S for any postsurgical care.

Oct. 15: Pfizer says it will conduct additional studies "to confirm the long-term cardiovascular safety profile" of Bextra in patients who require chronic treatment for arthritis.

Oct. 18: Pfizer says it will conduct a new test of Celebrex to assess its effect on osteoarthritis patients at high risk for heart disease. The study is part of a larger cardiovascular testing program with Celebrex that started in 2002. The new trial is expected to start early in 2005. The test will take two years. Pfizer says some previous small tests "suggest that Celebrex's anti-inflammatory properties, as well as additional unique Celebrex-specific characteristics, may improve vascular function in patients with established coronary artery disease."

Nov. 10:: A report in The New York Times quotes Dr. Garrett FitzGerald as saying people taking Bextra have more than twice the risk of heart attacks and strokes compared with people who took placebos. He bases his comments on pooling data from 5,930 patients participating in 12 clinical trials. FitzGerald says Bextra "is a time bomb waiting to go off." Pfizer says the article "draws unsubstantiated conclusions about the cardiovascular safety" of Bextra and "has not been ... subject to independent scientific review."

Nov. 30: Pfizer says it will submit to the FDA by year-end an application for Dynastat. This is the intravenous COX-2 drug tested with Bextra during the heart bypass surgery and general surgery clinical trials. Although not available in the U.S., Dynastat is sold in 45 countries.

Dec. 17: Pfizer says that one of two clinical trials examining Celebrex as a possible treatment for certain colon polyps demonstrated an increased cardiovascular risk over a placebo. However, the other trial revealed no greater cardiovascular risk than a placebo. "The cardiovascular findings in one of the studies are unexpected and are not consistent with the reported findings in the second study," Pfizer says. Most patients in both tests took higher doses than the average amount recommended for people with arthritis and pain.

Pfizer says it is studying the results and communicating with U.S. and foreign regulators as well as physicians and patients. Pfizer says it has no plans to withdraw Celebrex. The FDA says it is reviewing the data. Pfizer later says it will suspend direct-to-consumer advertising for Celebrex until the FDA responds.

Answer the Phone: Your Identity is on the Line

Beverly Hills, CA -- (ArriveNet - May 06, 2005) -- There hasn't been much good news in the battle against identity theft lately, with fraudsters staying one step ahead of the game. But don't panic, our old friend the telephone has come to the rescue.

We're all aware of the problem of identity theft, but did you know that your local pizza chain has had a solution for years? You recognize it as the system that prevents little Johnny from having twenty pizzas delivered to your door at midnight: the pizza chain calls you immediately after the order is placed to verify the validity of the order. Because little Johnny is afraid to be caught, he'll think twice about causing this pizza-related havoc.

TeleSign's patent-pending verification system has transferred this pizza concept to the high-tech world. It works like this: after filling out a form on a website, the user is prompted to enter his phone number. A robotic system then places a call to that number and speaks aloud a unique three digit code. Once that code is entered into the website, the authentication is complete. This system can be implemented at any point on a website: at registration, purchase, a specific time interval, or at the request of a user.

Email verification is the current standard for user authentication, but email may end up filtered, junked, bulked, or trashed. Because of spam, viruses, and phishing, email filtering has become so aggressive that even legitimate emails don't reach the inbox. But a telephone call cannot be stopped, making this the perfect time for the introduction of TeleSign’s solution.

The future of ecommerce is threatened by rampant fraud and lack of trust. TeleSign will force anonymous users to expose their faces by revealing their working phone numbers.

To try an interactive demo, visit (http://www.telesign.com/demo2/demo.asp) and have your phone ready.

For more information about TeleSign’s products and services, visit (http://www.telesign.com/demo2/) or email press2@telesign.com.

About TeleSign Corp.
TeleSign is a leader in innovative internet security solutions and provider of intelligent telephone-based verification solutions for any entity conducting business online where trust is essential and where fraud is a concern. TeleSign’s patent-pending Verification System provides a critical layer of security for the e-commerce world and is a proven deterrent against ill-intentioned web users. The company’s first product, the TeleSign Verification System, blends the latest internet, security and telephony technologies into a powerful new tool to combat fraud and enhance trust in e-business.

TeleSign Corp. seeks to provide simplified solutions for any company conducting business online where trust is essential and where fraud is a concern. TeleSign’s patent-pending Verification System provides a critical layer of security for the e-commerce world and is a proven deterrent against ill-intentioned web users. TeleSign’s Verification System is able to legitimize a web user’s claimed identification at a miniscule cost and with little inconvenience to all parties involved.

TeleSign’s Verification System is based upon the premise that ill-intentioned web users hesitate to disclose their working phone numbers. By placing a computer-generated telephone call coupled with a unique security code, we insist that a web user provide a legitimate telephone number or be rooted out. The company’s first product, the TeleSign Verification System, blends the latest internet, security and telephony technologies into a powerful new tool to combat fraud in e-commerce.

Visit http://www.telesign.com/demo2/ or call 310-276-5900 for more information.

TeleSign Corporation
Contact: Sam Gonen
Telephone: (310) 276-7843
Email: press2@telesign.com

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