Are osteoporosis drugs overused?
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.
Combating low bone mass
If you have 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.
c.2008 St. Petersburg Times