Merck Vioxx News and Press Releases

Arthritis sufferers find acupuncture helps them function, relieves pain

BY CAROLYN POIROT

Knight Ridder Newspapers

FORT WORTH, Texas - (KRT) - Dec. 24, 2004 - The largest, longest, most rigorous scientific trial of acupuncture conducted has found the ancient Chinese medical treatment safe and effective in helping to relieve pain and restore function in patients with osteoarthritis of the knee, researchers announced this week. The randomized, controlled study involved 570 patients who received acupuncture in addition to whatever drugs they were already using.

With acupuncture, patients showed a significant increase in function by week eight, and by week 14 a significant decrease in pain, said Dr. Brian Berman, principal investigator and director of the Center for Integrative Medicine at the University of Maryland School of Medicine.

The report is practically the only good news that people with arthritis have received lately. Researchers have reported an increased risk of heart disease and strokes associated with popular prescription arthritis drugs Vioxx and Celebrex, both COX-2 inhibitors. Vioxx was taken off the market in late September, and Friday the U.S. Food and Drug Administration advised doctors to consider prescribing alternatives to Celebrex, when indicated.

On Monday, scientists stopped a study testing whether naproxen and Celebrex would reduce the risk of Alzheimer's disease. They noted an increase in heart attack and stroke among participants who were taking naproxen, an over-the-counter anti-inflammatory pain reliever on the market for nearly 30 years. Many people with arthritis do not get acceptable pain relief with any drugs, researchers said Monday.

Patients receiving traditional Chinese acupuncture reported a 40 to 45 percent improvement in both calculated pain and calculated impairment. A second group receiving "sham acupuncture" reported a 30 percent improvement compared with a group receiving only education and counseling in addition to whatever they were taking for their disease. The "sham acupuncture" mimicked true acupuncture except that the needles used did not puncture the skin at points around the knees and ankles.

The pain relievers the test subjects were taking included 11 percent on high-dose acetaminophen, 30 percent on various NSAIDs (such as aspirin naproxen), 28 percent on COX-2 inhibitors and 6 percent on narcotic analgesics. Physicians involved in the study, funded by the National Institutes of Health and conducted by the University of Maryland School of Medicine, announced the results in a telephone news briefing Monday.

More than 20 million Americans suffer from osteoarthritis, also known as degenerative or "wear and tear," arthritis. It is the major cause of functional limitations in people 65 and older living in community settings, said Dr. Marc Hochberg, head of the Division of rheumatology at the University of Maryland and co-investigator for the study.

Heart risks doubled in Vioxx cancer study

Source: (cancerfacts.com)
HOUSTON – Feb. 16, 2005 – The largest clinical trial ever to test the cancer prevention properties of the anti-inflammatory drug, Vioxx, has resulted in double the risk of heart attacks and strokes compared to patients who took the placebo, according to researchers.

The risk of heart attacks and stroke associated with Vioxx was first discovered and reported last September by the study's safety monitoring board, which shutdown the trial aimed at reducing colon cancer. Merck, the drug's maker had pulled the drug from the U.S. market, following earlier research that first exposed a link to cardiovascular problems for the drug originally developed to ease arthritis pain.

Led by Dr. Robert S. Bresalier, of The University of Texas M. D. Anderson Cancer Center, the reserachers found that 46 of the 1,287 patients taking Vioxx daily had confirmed cardiovascular events over a three year period - mostly heart attacks or strokes. In the 1,299 patients given a placebo drug, there were 26 such events. Each group, however, had the same number of deaths and not all were related to heart attacks or strokes. The study results published early in the Feb. 15 on-line issue of The New England Journal of Medicine, will appear later in print.

"The overall number of cardiovascular events is small, but, nevertheless, the difference between the groups is significant," Bresalier, said in a news release. "Because patient benefit is the most important criteria for any study, it was appropriate to stop the trial," Bresalier says. "We don't know why Vioxx increased this risk, but we now have an opportunity to study whether subpopulations of patients are more susceptible than others."

The trial, known as APPROVe (Adenomatous Polyp Prevention on Vioxx), was the longest test yet of Vioxx as a cancer-prevention drug. The study had been designed to determine whether the drug could prevent the re-growth of precancerous colon polyps in people who had already had polyps removed.

The prospective chemoprevention study randomly 2,586 participants from 108 centers in 29 countries to receive either 25 mgs. of Vioxx daily or a placebo drug for three years, 2001-2004. The trial was stopped September 30, 2004 - approximately two months before its planned completion.

The most notable trend, according to Bresalier, was that patients did not begin to experience cardiovascular problems such as heart attacks or strokes until after 18 months of treatment.

"In the first 18 months, the risks for the two treatments were similar," said Bresalier, who is professor and chair of the Department of Gastrointestinal Medicine and Nutrition at M. D. Anderson.

Other cardiac problems, such as hypertension-related events, pulmonary edema and congestive heart failure-related events were much more prevalent in the Vioxx-treated group compared to the placebo group and show up earlier. The data on these cases, however, is less firm, Bresalier notes, because, unlike heart attacks or strokes, these problems were not "adjudicated," or validated by a separate committee. This was not a cardiovascular trial, reminds Bresalier, so while investigators reported all events, only the most serious were fully examined.

"I think it's unfortunate that we've perhaps lost a class of drugs which potentially has very important roles in a variety of diseases - arthritis, cancer prevention, cancer treatment, treatment of Alzheimer's disease, treatment of precancerous lesions, not only in the colon but in the esophagus and many other organs," says Bresalier. "What we don't know is, if the cardiovascular results seen in Vioxx represents a class effect of COX-2 inhibitors or if this is an individual effect to this drug. I don't think we can tell this from this one trial or from the trials that are out there at the moment. That's going to be the real question."

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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