Merck Vioxx News and Press Releases

Drugmaker Merck knew Vioxx drug risk, lawsuit says

REDWOOD CITY MAN FELL ILL WHILE IN MERCK STUDY

By Matthai Chakko Kuruvila

Mercury News - Feb. 17, 2005 - A Redwood City man has filed suit against the maker of Vioxx, a pain reliever pulled off the market because of heart attack risks. The suit claims drug giant Merck knew of the danger while the man was given the drug in a clinical trial and suffered a heart attack. The suit also states that doctors overseeing the clinical trial continued to give the drug to Joe Segura after the heart attack. It was only after Vioxx was pulled off the market in September that Segura, 65, learned he'd been taking the drug during the "double-blind'' trial.

Segura's suit is one of hundreds being filed around the country against New Jersey-based Merck. While declining to comment on the specifics of Segura's case, a Merck spokeswoman said it would "vigorously'' fight each of the lawsuits. "Merck acted responsibly every step of the way,'' spokeswoman Casey Stavropoulos wrote in an e-mail. "Merck based its decisions on the data from well-controlled clinical trials and acted in the best interest of patients.''

The lawsuit states that Segura was unaware of the risks of the drugs he was taking. But his attorney, Niki Okcu, declined to say whether a consent form Segura had signed spelled out those risks. The case could hinge on precisely what was disclosed in the consent form, said David Magnus, director of the Stanford Center for Biomedical Ethics.

"If it's true that there are known risks that the company did not disclose in the informed consent process, that would be a very large problem,'' Magnus said.

Even though millions of people apparently have taken Vioxx, the fact that Segura voluntarily participated in a clinical trial raises the stakes for protecting the patient, Magnus said. "When somebody is willing to expose themselves to risk to help benefit scientific research, we have a very high bar,'' he said.

Segura's lawsuit, filed Monday in San Francisco Superior Court, cited newspaper articles that in turn cited e-mails and other correspondence suggesting Merck knew about the heart attack risk posed by Vioxx as early as 1999.

Segura began the clinical trials at San Francisco General Hospital in May 2001, according to his lawsuit. He suffered the heart attack in May 2003 but continued taking the drug until it was removed from the market five months ago. "They knew for years that this was a dangerous drug,'' said another one of Segura's attorneys, Donald Galine. His firm is representing 50 other Vioxx cases, he said.

The suit states that injuries from the heart attack continue to impact Segura's life and have prevented him from working, though Okcu and Galine would not be more specific.

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Contact Matthai Chakko Kuruvila at mkuruvila@ mercurynews.com or (650) 688-7581.

Study reveals why COX-2 painkillers may cause heart disease

19 Nov 2004 - CBC News - WASHINGTON - A painkiller linked to potentially fatal heart disease may contribute to hardening of the arteries in young women.

Drug dangers

There are at least five other medications on the market that should be reviewed, a scientist at the U.S. Food and Drug Administration told a U.S. congressional committee on Thursday.

Today's FDA "is incapable of protecting America against another Vioxx," said David Graham, who sounded the alarm about the dangers of the arthritis drug.

The other drugs Graham named are:

The pain reliever Bextra.
The acne drug Accutane.
The asthma drug Serevent.
The weight loss medication Meridia.
The anti-cholesterol drug Crestor.

The committee is examining the doctor's statement and looking for answers from the FDA.

On Friday, an FDA official said the agency "categorically rejects" accusations it had failed to protect the public from dangerous drugs.

Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research noted all drugs on the market carry risks.

Merck and Co's arthritis drug Vioxx was pulled from the market in September after a study suggested those who took the drug for 18 months had an increased risk of heart attacks and strokes.

Vioxx is in a class of drugs called COX-2 inhibitors that are designed to block inflammation and pain more safely than older painkillers. Other COX-2 inhibitors include Pfizer's Bextra and Pfizer's Celebrex.

Scientists say the high levels of estrogen in premenopausal women slow atherosclerosis, the build-up of plaque in arteries that restricts blood flow.

Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, found the COX-2 enzyme makes a fatty acid that protects female mice from atherosclerosis.

The researchers removed the ovaries from female mice to study the protective effect of estrogen. Turning off the enzyme may contribute to the hardening of arteries, the team said.

FitzGerald acknowledged it is difficult to extrapolate results from mice to humans. Given the Vioxx recall though, the mice findings raise further questions about the use of COX-2 inhibitors, he said.

The results "raise concerns about the use of COX-2 inhibitors in juvenile arthritis, a disease that predominantly affects females," the researchers concluded in Friday's online issue of the journal Science.

"It may also have implications for the design and interpretation of trials of hormone replacement therapy."

The investigators said long-term treatment with COX-2 inhibitors could undermine the protective effect on the heart before menopause.

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