Healthy Skepticism Library item: 11113

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Publication type: news

Todd S.
Despite risks, some clamoring for Vioxx
The Star-Ledger (Newark, N.J.) 2007 Aug 7
http://www.sunjournal.com/story/223951-3/Business/Despite_risks_some_clamoring_for_Vioxx/

Full text:

Nearly three years after Merck pulled Vioxx off the market because of alarming safety data, patients continue to write letters and send e-mails urging the drugmaker’s executives to reconsider their decision.

Dozens of people who once used the prescription drug have written to the New Jersey-based company describing their pain, praising Vioxx and complaining that nothing else on the market works.

When Merck withdrew its top-selling pain-relief medicine in 2004, the health risks associated with the drug intensified growing outrage over the Food and Drug Administration’s inability to monitor the safety of widely used prescription drugs. Deep concerns about drug safety have not let up since.

In the past five months, Novartis suspended Zelnorm, a medicine for irritable bowel syndrome, and Eli Lilly withdrew Pergolide, its drug for Parkinson’s disease, after it was linked to heart problems. Then, in May, the FDA issued safety warnings about the diabetes drug Avandia.

Vioxx remains the poster child for the drug-safety issue. More than 20 million Americans used Vioxx, which at its height generated $2.5 billion in annual revenue for Merck. Today, the company faces nearly 27,000 lawsuits filed by plaintiffs who blame heart attacks, strokes and deaths on the drug.

That hasn’t deterred James Pileggi, who took Vioxx for four years to relieve pain caused by severe degeneration of the facet joints of his spine.

“Vioxx knocked out the pain,” Pileggi, a retired furniture maker, said during a telephone interview from his home in Maryland. “I’m not prone to any of the cardiovascular issues. I’m not at risk. To me, it was a godsend.”

Pileggi and others like him are the flip side of the drug-safety controversy – patients left without a medicine they counted on, now desperately searching for alternatives. These patients argue that they – not regulators or lawyers – should decide whether a drug’s benefits outweigh its risks, or even whether a drug poses any risks to them at all.

Marvin Lipman, chief medical adviser for the nonprofit Consumers Union, which has advocated for drug-safety reforms, said such responses, while not unusual, are misguided.

“People do get used to the idea that one drug can help them,” Lipman said. “A person’s conviction that something is helping them or that only one thing will help them is often erroneous. The impact may be exaggerated.”

The conditions that Vioxx and Zelnorm treat are not life-threatening, Lipman said, and the patients who use both medicines have safer alternatives.

Try telling that to some former Vioxx patients.

Ben Malcom, a retired U.S. Army colonel and avid racquetball player from Georgia, used Vioxx for roughly three years to relieve arthritis pain in his knees. He was 75 when the drug was withdrawn.

“I always kept in good shape,” he said. “My knees have slowed me down, but when I was taking Vioxx, I could play a good game of racquetball and be competitive.”

When Merck stopped selling Vioxx, Malcom kept his remaining pills and took them without concern over the next year when he needed relief. “If it came back on the market tomorrow, I would get a prescription and start taking it tomorrow,” he said. “That’s how strongly I feel about it.”

Vioxx allowed Pileggi to operate a woodworking business, where he routinely carried large pieces of wood and moved furniture.

Now 61, Pileggi said he has been unable to find an effective alternative to Vioxx. Celebrex, which works in the same way as Vioxx, seemed like a placebo to him. A generic non-steroidal anti-inflammatory he started using provided far less relief than Vioxx.

In early 2005, nearly a year after Vioxx was pulled from the market, Pileggi sold his business.

“On a scale of one to 10, I was experiencing a constant eight,” he said of his pain. “Even with a back support harness on – and I wore one of those all the time – it was like having a knife stuck in your back.”

When Novartis suspended sales of Zelnorm, the company received a wave of telephone calls from patients who used the drug to treat chronic constipation related to irritable bowel syndrome.

“We had a number of calls; so has the Food and Drug Administration,” Novartis spokeswoman Karen Sutherland said. “These are patients saying this (drug) had a great impact on my life.”

Last week, federal regulators agreed to make Zelnorm available through a restricted-use program. The patients must meet strict criteria: They should not have pre-existing heart problems and they must be in critical need of the drug, according to FDA officials.

Michael Smith, a 34-year-old New York attorney, was pressing Novartis and the FDA for a supply of Zelnorm before the restricted-use program went into effect. He said he did not feel conflicted about taking the drug despite warnings it carried a higher-than-expected risk of heart attack and stroke.

“Historically, there’s been a bias against these drugs,” Smith said. “For some reason, they’ve gone out of their way to emphasize the risk factors. They look at them as treating lifestyle types of conditions.

“This is, unfortunately, not what I would consider a lifestyle condition. It’s purely about being able to function.”

Merck, meanwhile, had hoped to replace Vioxx with a successor painkiller. But earlier this year, the company was unsuccessful in getting regulatory approval to market the new drug, called Arcoxi. It was another disappointment for people hoping Vioxx – or something like it – might be available again.

Evelyn Plemons, 59, of Shell Beach, Calif., took 12.5 milligrams of Vioxx daily to relieve the pain of osteoarthritis in her spine. The drug also allowed her to maintain her daily three-to-four-mile walking routine.

“I don’t like taking drugs,” said Plemons, who works as office administrator for her husband, a self-employed accident reconstructionist. “You really have to look at the risks and benefits. It has to be a decision made between the doctor and the patient.”

As an alternative to Vioxx, she is taking Celebrex. The pain-relief medicine, which is made by Pfizer, is in the same class of drugs as Vioxx. Pfizer is carrying out a 20,000-patient study to determine if Celebrex poses similar dangers to patients.

Plemons said she has to take a larger dose of Celebrex – 200 milligrams twice a day.

“That’s what is required to get relief,” she said. “Don’t think I’m not concerned about that.”