Given the option of living with pain or an increased heart attack risk, some Baby Boomers are assuming the risk and going back to a drug still considered potentially dangerous by the government.
Two years after Vioxx and other powerful arthritis pain fighters were linked to cardiovascular trouble, there is a big comeback under way for those types of drugs known as Cox-2 inhibitors.
One of them, Pfizer Inc.’s Celebrex, saw its sales jump 18 percent last year, even though it must now be sold with a “black box” label warning of the risk to the heart.
Now Merck & Co., which pulled Vioxx from the market in 2004 and is fighting billions of dollars in court damage claims, is trying again with another Cox-2 drug. It is seeking U.S. approval to introduce Arcoxia, while the Swiss drug giant Novartis AG is doing a large clinical safety trial of its own Cox-2, Prexige. Later this year, Novartis will ask U.S. regulators for permission to market it.
“People are coming back to prescription pain medications in a big way because there is an epidemic of arthritis and pain out there,” said Dr. Calvin Brown, an associate professor of rheumatology at Rush University Medical Center in Chicago who prescribes Celebrex to certain patients. “Baby Boomers are now in their arthritis years. There is a huge need for painkillers to help people with arthritis.”
The pain-relief business has always been big, but with a record number of middle-age Americans trying to manage their aches and keep active, a potential multibillion-dollar U.S. market is luring pharmaceutical companies back to what seemed to be a taboo category.
They are making their moves because despite the bad rap, many experts believe the risks connected to Cox-2s can be managed through smarter prescription methods by doctors. Patients agree, but they also are desperate for relief.
Merck and Pfizer say they have gotten “thousands” of requests from patients who want Vioxx or another drug, Bextra.
More than 45 million Americans have arthritis, according to the Arthritis Foundation, which advocates for patient choice of prescriptions. “If they don’t have heart disease, they are going to take it,” said the foundation’s chief public health officer, Dr. Patience White, a rheumatologist. “People in our society are risk averse, but in reality, when it comes down to you and what benefit you would see from the medicine … it comes down on the side of whatever taking the risk is.”
Take Randy Highley, a 55-year-old from suburban Hinsdale. Before he competes in triathlons, he takes several Vioxx for knee pain, dipping into a three-month supply he got before the drug was pulled.
“We can drink and there are risks associated with drinking, and I think this is a far more dramatic case for letting us assume [a known] risk,” Highley said. “If there was some danger and they did not tell you, that would be a problem for me. But knowing, just from media accounts, I think this is a risk that I could certainly take and feel comfortable with it.”
Highley, a chief financial officer with FH Prince & Co. in Chicago, said there are numerous prescription safety risks, citing recent FDA-requested revisions to labels on Ambien, Lunesta and other popular sleep aids to warn that the pills may result in driving or eating while sleeping.
Doctors say they are closely monitoring their arthritis patients in the wake of the Vioxx controversy while weighing risk factors such as obesity, diabetes and high blood pressure.
“We all play it safe,” Brown said of prescribing Celebrex and other prescription pain pills still on the market. “If there is any potential for heart problems, we don’t give it anymore. There are some people who really need this kind of pain relief. It’s this or nothing.”
Worldwide sales of Celebrex, made by Pfizer Inc. and developed by the now-shuttered G.D. Searle in Skokie, jumped 18 percent last year, eclipsing $2 billion. Its growth trend is in sharp contrast to the huge loss in sales that the pain-relief prescription experienced in 2005. Celebrex sales plummeted 48 percent that year to $1.73 billion from $3.3 billion in 2004.
At their peak in 2004, Cox-2 drugs accounted for more than $5 billion in U.S. sales.
Celebrex and Vioxx were hailed when they were launched in 1999 as “super aspirin” because they did not harm the lining of the stomach or cause ulcers the way aspirin and other traditional treatments could. Some patients who took up to 16 pills of aspirin per day found they could get the same relief from one dose of a Cox-2 inhibitor.
But Celebrex took a major hit after it was linked to increased risk of heart attacks and strokes, as did Vioxx and Bextra, sold by Pfizer. In February 2005, some doctors on a Food and Drug Administration advisory panel said all three drugs increased heart risks as part of a “class effect” for Cox-2 drugs. Panelists’ statements came in the wake of Merck & Co.’s fall 2004 decision to pull Vioxx from the market, citing a study showing increased risks of heart attacks and strokes.
Although the 2005 FDA panel voiced greater safety concerns over Vioxx and Bextra than Celebrex, Pfizer eventually pulled Bextra in spring 2005 at the request of the FDA after research showed a potentially deadly skin condition among other potentially harmful side effects.
The FDA has never formally ruled on whether Vioxx should stay off the market. The agency did, however, order sweeping warnings that Cox-2 drugs, as well as painkillers known as non-steroidal anti-inflammatories, can harm hearts. They now carry “black box” warning labels. At the time, panel members said the warnings on all three Cox-2s amounted to a “skull and crossbones.”
Vioxx continues to fight claims in court. Merck has won nine Vioxx product-liability cases in federal and state courts, lost five cases and has vowed to take on each of the thousands of cases brought against it over the drug’s risks.
Allegations that Merck tried to cover up cardiovascular risks several years before pulling Vioxx have surfaced during the trials and put a spotlight on the FDA and its oversight of drug safety. Merck has defended its research and said it promptly and appropriately disclosed results to federal regulators.
Pfizer has an ongoing clinical trial monitored by the FDA to evaluate Celebrex safety. An advisory panel of the FDA meets April 12 and is expected to provide consumers and doctors with an indication about whether Arcoxia will be recommended to the agency for U.S. approval.
A consumer group believes Arcoxia is dangerous and has the same “class effect” that causes an increased risk to the heart as other Cox-2 drugs.
“They all have increased cardiovascular risk,” said Dr. Sidney Wolfe, head of Public Citizen’s health research group. “There is no evidence that [Cox-2 drugs] are more effective than any of the older NSAIDs.”
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bjapsen@tribune.com
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Impact of arthritis
Arthritis is a term used to describe more than 100 different conditions that affect joints and other parts of the body.
– About 46 million Americans (1 in 5 adults) have been diagnosed with some form of arthritis, rheumatoid arthritis, gout, lupus or fibromyalgia.
– That number is expected to increase to 64.9 million in 2030.
– Arthritis is the leading cause of disability in the U.S.
– Arthritis costs the U.S. economy $86.2 billion, according to 2004 CDC data, the most recent available.
– Arthritis annually results in 39 million physician visits, 744,000 hospitalizations, 3 million visits to outpatient departments and 2.2 million visits to emergency departments.
Source: Arthritis Foundation (www.arthritis.org).
