Are osteoporosis drugs overused?
People who are just "at risk" clamor for the pills. Is that healthy?
By LISA GREENE, Times Staff Writer
Published January 19, 2008
As women age, they fear osteoporosis so much that one study found 80 percent of elderly women would rather be dead than confined to a nursing home with a broken hip.
But the medicines used to prevent such a grim future are coming under attack. Called bisphosphonates, they include Fosamax and Boniva, the new drug whose TV ads feature Sally Field.
They're the most popular type of drug used to prevent and treat osteoporosis. Doctors write more than 37-million prescriptions each year, worth more than $4-billion, according to health care information company IMS Health.
Few dispute that the drugs are effective, even lifesaving, for people who have osteoporosis. But is it too risky to take the drug simply to prevent the disease?
"That's what's wrong with this massive overpromotion of this class of drugs," said Dr. Sidney Wolfe, health research director of Public Citizen, a consumer advocacy group. "You're dealing with risk swamping out benefit."
Last week, the FDA issued an alert saying that the drugs may cause severe bone and muscle pain. The agency has more than 100 reports of such pain, which usually subsides after patients stop taking the drugs, but it can be "incapacitating."
The drugs also can have unpleasant side effects, such as nausea and irritation of the esophagus. More rare, but more serious, are reports of deteriorating jawbone and heart rhythm disorders. The FDA is reviewing the heart rhythm issue, while lawsuits have been filed by patients with jawbone problems.
The likelihood of having one of those problems is small.
"The risk of getting osteonecrosis of the jaw is about the same as getting struck by lightning," said Dr. Norman Watts, director of bone health and osteoporosis at the University of Cincinnati College of Medicine.
The larger question, critics say, is whether patients are taking risks without reason and being medicated unnecessarily. They are leery of the new term, osteopenia, used to describe people whose bone mass is abnormal but not low enough to be considered osteoporosis.
"You create new diseases, and then you create a new market for a drug," Wolfe said.
Some worry the drugs might change bone structure. Bones may become denser, but also more brittle after years on the drugs, said Dr. J. Douglas Bremner, director of the Clinical Neuroscience Research Unit at Emory University School of Medicine and author of a recent book, Before You Take That Pill.
"It's not always increasing the density of bone in the parts that are most important," he said.
But Dr. Ethel Sirus, president of the National Osteoporosis Foundation, said that's "a theoretical concern."
"We're really not seeing evidence that the bone is not good bone," she said.
Osteoporosis doctors say patients who really benefit from the drugs shouldn't let a fear of rare side effects get in the way.
"Osteoporosis is as common as breast, uterine and ovarian cancer combined," said Dr. Catherine Lynch, director of the general obstetrics and gynecology division at the University of South Florida College of Medicine. "I think if you know somebody with significant osteoporosis, you would treat someone (else) with osteopenia."
Patients with low bone mass worsen without action, said Tampa rheumatologist Harris McIlwain, co-author of Reversing Osteopenia. He stressed that patients have options.
"The important thing to realize is the medicines are one of the treatments for low bone mass and osteoporosis, but not the only one," he said.
Diverse results
Two Florida women tried the same drug with different results.
Tampa resident Grace Zoffness, 86, was diagnosed with osteoporosis on her 70th birthday. She was one of the first patients to start taking Fosamax.
Last July, she was driving into a mall parking lot when a car hit her. Her chest hit the steering wheel, but she didn't break a single bone.
Without Fosamax, Zoffness and her doctor believe, her injuries would have been far worse.
"Fosamax has been a godsend for me," she said.
It didn't work out that way for Naples resident Linda Secrest. Eight years ago, Secrest was diagnosed with osteopenia.
Secrest, 54, started taking Fosamax to prevent future fractures, said attorney Tim O'Brien of Pensacola.
Five years later, Secrest noticed some of her teeth seemed loose. The diagnosis: osteonecrosis of the jaw. Secrest has lost several teeth and undergone repeated procedures to scrape away dying bone. Ultimately, she may have to get an artificial jawbone.
"The irony is, she really took the drug as a preventive measure," O'Brien said.
Other patients have had less severe problems. Three years ago, Kristen Butler, then living in Tampa, scored a little low on a bone density test. Because her mother had osteoporosis, Butler was worried.
"I wanted to prevent it every way I could," she said.
Days after Butler started Fosamax, her legs began to hurt. The pain went away when she stopped the drug. She turned to exercise and calcium supplements to help her bones.
Who should use them?
Doctors who specialize in treating osteoporosis say the problem isn't just that some patients take bisphosphonates unnecessarily. It's that confusion over when to prescribe sometimes keeps patients from getting drugs they truly need.
Part of the problem, said one leading doctor: the whole concept of osteopenia.
"I'm on a personal crusade to stamp out the term osteopenia," said Watts, who also is chairman of the FDA panel on endocrine and metabolic drugs. "It's confusing. A broad category with a single label doesn't work."
How broad is it? Of Americans over age 50, 55 percent are at risk for osteoporosis. That's 44-million people. But only 10-million actually have it. The other 34-million have osteopenia.
Some people with osteopenia need drugs, while others don't, Watts said.
The category includes everything from women who have slight bone loss and no other risk factors to women with much lower bone mass and several risk factors. Those include family history, race, body size, smoking and taking certain medications.
In the next few months, some confusion is expected to clear. The World Health Organization is working on a formula that would combine bone mass and risk factors to evaluate whether drugs would be a good choice.
"This whole problem of what to do with women with osteopenia is going to go away," Sirus said. "There will be advice about what level of risk is high enough that you should be treated."
Osteoporosis
As people age, bones get thinner. They may break easily and heal poorly. The condition commonly afflicts women but men get it too.
Combatting low bone mass
If you've been diagnosed with thinning bones, your doctor may talk to you about several options:
Calcium. Dairy products, certain green vegetables, fortified foods and supplements can help keep bones strong and healthy.
Vitamin D. It helps your body absorb calcium. Sunlight and supplements are the best sources.
Smoking cessation. Smoking may lead to lower bone density and higher risk of fracture.
Exercise. Weight-bearing exercise can strengthen bones.
Drugs. Bisphosphonates and other drugs may increase bone density and reduce fracture risk.
Source: National Osteoporosis Foundation
Understanding bisphosphonates
Your bones don't stay the same: cells in your body break down old bone, while other cells build new bone. Bisphosphonate drugs work by slowing the breakdown of old bone.
Bisphosphonate drugs include Fosamax, Boniva, Actonel and Reclast.
Source: National Osteoporosis Foundation
On the Web
For more information about osteoporosis and its treatment, see www.nof.org.