Merck Vioxx News and Press Releases

By Paul Swiech
pswiech@pantagraph.com

BLOOMINGTON - January 27, 2005 - There is life after Vioxx for the hundreds of Central Illinois residents. The anti-inflammatory drug was pulled last fall because it increased patients' risk of heart attack and stroke. Now, patients have several options. Some are doing fine on their new therapy. Others are in pain. "We don't want people to just stop taking everything (all medicines)," said Karen Ferguson, director of the McLean County Branch of the Arthritis Foundation. "They need to talk with their doctor."

"The majority of my patients who were on Vioxx are now taking Celebrex or Bextra and are maintaining," said Dr. Joseph Newcomer, an orthopedic surgeon with Orthopedic & Sports Medicine Center in Normal and Pontiac. "Given in recommended doses, those medicines are safe," he said.

Dr. Stephen Belgrave, a family practice physician at Carle Clinic in Bloomington, said many of his patients who had been prescribed Vioxx now are taking Celebrex or another anti-inflammatory medicine and most are doing fine.

Vioxx, Celebrex and Bextra are in a class of anti-inflammatory drugs called cox-2 inhibitors that relieve joint pain without causing stomach or gastrointestinal problems. Vioxx was the most popular and was prescribed for people with chronic osteoarthritis and rheumatoid arthritis as well as those with severe muscular strain or ligament sprain.

In a typical orthopedic practice, 50 percent to 70 percent of patients are on an anti-inflammatory drug, Newcomer said.

Many patients take traditional anti-inflammatory medicines, such as ibuprofen, which includes Advil and Motrin. But those who couldn't because of increased risk of stomach ulcers were prescribed Vioxx, Celebrex or Bextra, Newcomer said.

The Vioxx announcement surprised Newcomer and Belgrave even though most of their patients weren't on Vioxx at the time. Neither doctor was aware of any patients having heart complications from Vioxx. Only 5 percent to 10 percent of Newcomer's patients were on Vioxx.

"I was already making the move from Vioxx to Bextra because Bextra seemed to work better for my patients," he said. "But there were those patients who absolutely loved Vioxx."

Only about 5 percent of Belgrave's patients were on Vioxx and other cox-2 inhibitors. They were arthritis and severe muscular strain patients who were at high risk of a gastrointestinal bleed and who didn't get relief from Tylenol.

Since Vioxx was removed, Belgrave patients at high risk of a gastrointestinal bleed were prescribed Celebrex. Most of Newcomer's Vioxx patients have switched to Celebrex or Bextra. Federal scientists announced a month ago that Celebrex raises the risk of heart attack when taken at high doses and ordered a review of all studies of cox-2 drugs. But the drug wasn't pulled and Newcomer asserted that Celebrex is "very safe when given in recommended doses."

Belgrave makes sure patients understand that there may be an increased cardiac risk with Celebrex, although it hasn't yet been proven. Patients at risk of coronary artery disease may be prescribed a standard anti-inflammatory, such as Relafen or Clinoril, which must be taken with a heartburn medicine, such as Prilosec or Prevacid, Belgrave said.

Another recent announcement contended Bextra causes skin lesions. "I have several hundred people on Bextra and have never seen that," Newcomer responded.

Patients who have chosen not to take Celebrex or Bextra and who can't take ibuprofen are dealing with their pain with Tylenol Arthritis or Extra Strength Tylenol in conjunction with heat or ice, and water- or land-based exercise programs, such as those offered by the Arthritis Foundation.

Belgrave also recommends exercise and other therapy that takes the focus off the drugs.

Painkiller Bextra might lead to heart attack risk when combined with aspirin

- Staff writers
February 21, 2005 - New studies say that the popular painkiller Bextra, when taken with aspirin, seems to significantly increase a patient's risk of heart attack. Bextra is among several new painkillers that are undergoing intense scrutiny from regulators because the drugs have been implicated in some heart attack cases. Vioxx has been taken off the market, and the license for Celebrex is currently under review. To learn more on this topic, be sure to also read the related article, Arthritis drug Bextra found to promote heart attacks and strokes.

Combining aspirin (search) with the painkiller Bextra (search) may magnify the heart-related risks associated with Bextra and similar drugs.
They suggest that combining Bextra with aspirin may increase the risk of blood clots that could trigger a heart attack or stroke.
Last month, the FDA added anew warning to Bextra, which states that Bextra should not be used in patients undergoing heart bypass surgery after a clinical trial showed an increase in heart problems in bypass patients using Bextra.

A similar drug, Vioxx (search), was removed from the market in September 2004 because of an increase in heart attacks and stroke in patients taking the drug for at least 18 months.

A third, similar drug, Celebrex, was linked to heart attacks last month as well. Like the other Cox-2 inhibitors, Vioxx and Celebrex (search), it was designed to treat arthritis and other painful conditions. Older drugs like ibuprofen (search) and naproxen (search) treat pain and inflammation by blocking two enzymes, Cox-1 and Cox-2.

In the studies, which appear in the Jan. 17 issue of Circulation: Journal of the American Heart Association, researchers examined some potential mechanisms behind the increase in heart problems associated with Cox-2 inhibitors.

In the first study, researchers studied the effects of Bextra and aspirin on hardening of the arteries (atherosclerosis) in mice prone to the condition. They found that low-dose aspirin slowed the development of atherosclerosis in the mice, but it seemed ineffective once the disease was established. "We were amazed," says researcher Karine Egan, PhD, of the University of Pennsylvania, in a news release.

By adding a Cox-2 inhibitor, researchers say the beneficial effects of aspirin may be lost by tipping the balance in favor of the Cox-1 enzyme.

Mixing Bextra, Aspirin May Up Blood Clot risk

By Jennifer Warner

January 20, 2005 - Combining aspirin (search) with the painkiller Bextra (search) may magnify the heart-related risks associated with Bextra and similar drugs. Two new studies offer new clues about the role of Bextra in heart disease. They suggest that combining Bextra with aspirin may increase the risk of blood clots that could trigger a heart attack or stroke.

Last month, the FDA added anew warning to Bextra, which states that Bextra should not be used in patients undergoing heart bypass surgery after a clinical trial showed an increase in heart problems in bypass patients using Bextra.

A similar drug, Vioxx (search), was removed from the market in September 2004 because of an increase in heart attacks and stroke in patients taking the drug for at least 18 months. A third, similar drug, Celebrex, was linked to heart attacks last month as well.

Bextra is a member of a class of drugs called Cox-2 inhibitors (search). Like the other Cox-2 inhibitors, Vioxx and Celebrex (search), it was designed to treat arthritis and other painful conditions. Older drugs like ibuprofen (search) and naproxen (search) treat pain and inflammation by blocking two enzymes, Cox-1 and Cox-2. However, blocking the Cox-1 enzyme has been linked with side effects such as stomach ulcers. Bextra and related drugs treat inflammation and pain by blocking only Cox-2, thus decreasing the side effect of stomach ulcers.

Researchers 'Amazed'

In the studies, which appear in the Jan. 17 issue of Circulation: Journal of the American Heart Association, researchers examined some potential mechanisms behind the increase in heart problems associated with Cox-2 inhibitors.

In the first study, researchers studied the effects of Bextra and aspirin on hardening of the arteries (atherosclerosis) in mice prone to the condition. They found that low-dose aspirin slowed the development of atherosclerosis in the mice, but it seemed ineffective once the disease was established.

Adding a Cox-2 inhibitor didn’t enhance the beneficial effects of aspirin. Instead, researchers found the combination of Bextra and aspirin produced potentially dangerous changes in the makeup of the plaque within the arteries.

"We were amazed," says researcher Karine Egan, PhD, of the University of Pennsylvania, in a news release. "Addition of the Cox-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke."

Researchers say aspirin protects against atherosclerosis by blocking Cox-1. By adding a Cox-2 inhibitor, researchers say the beneficial effects of aspirin may be lost by tipping the balance in favor of the Cox-1 enzyme. This could increase the chance of developing dangerous blood clots that could lead to a heart attack or stroke.

More Heart Problems for Bextra

In a related editorial, researchers presented the combined results of two clinical studies of the drug Bextra and Dynastat (search).

Dynastat is an intravenous drug that is converted to the active ingredient in Bextra within minutes by the body. In the first study, about 400 people undergoing heart bypass surgery received 40 mg of Dynastat followed by 40 mg of Bextra for 14 days. In the second, larger study, the Bextra dose was reduced to 20 mg for 10 days.

Despite the reduction of dose and duration of therapy, the results showed that a cluster of heart problems was again apparent.

In combining the results of the two studies, researchers found people who used these drugs were three times more likely to have heart problems than those who received a placebo.

Researchers caution that these results should not be taken out of context, and both of these studies involved people at high risk of heart problems because they were undergoing heart bypass surgery.

However, they say the findings represent a class effect of the Cox-2 inhibitors and suggest that doctors should be alerted to the potential for heart problems associated with the use of Cox-2 inhibitors, especially among those at moderate to high risk for heart disease.

“The circumstances under which Cox-2 inhibitors can safely be administered for extended periods to patients at low risk of cardiovascular disease remain to be defined,” write Curt Furberg, MD, PhD, of Wake Forest University School of Medicine, and colleagues.

By Jennifer Warner, reviewed by Michael W. Smith, MD

SOURCES: Egan, K. Circulation: Journal of the American Heart Association, Jan. 17, 2005; vol 111. News release, American Heart Association. News release, University of Pennsylvania Medical Center. WebMD Medical News: “Heart Warning Added to Bextra Label.”

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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