Drugs to increase bone strength that have reaped billions of dollars in sales aren't worth the cost and the risk of side effects, researchers argue in a paper published in the British Medical Journal.
Medications for osteoporosis, which makes bones more fragile and susceptible to breaking, do little to prevent hip fractures, the most devastating consequence of the disease, the authors conclude. And they can sidetrack patients who should instead be exercising, eating right, and quitting smoking.
The BMJ analysis of data from 33 previous studies suggests that few people benefit from drugs intended to prevent broken hips. Drug therapy "can achieve at best a marginal reduction in hip fractures at the cost of ... serious medical adverse events, and forgone opportunities to have greater impacts on the health of older people" through lifestyle changes, the authors write.
To prevent a single hip fracture, 175 women need to be treated with medication for three years, the paper says. In other words, a woman with osteoporosis would need to take medicine for three years to have a 1-in-175 chance that it would help them avoid a broken hip.
"We probably need to fine-tune the parameters we currently have" for who should be treated, said Asif Ilyas, a surgeon at the Philadelphia orthopedic care provider Rothman Institute, who was not involved in the research. Medication to prevent fractures "hasn’t really been proven to make a difference in the population" as a whole, Ilyas said.
The BMJ paper goes further, describing a classic campaign of disease-mongering, or aggressively expanding the population eligible for treatment. Before the 1980s, osteoporosis was diagnosed only after a fracture. But drug companies supported the development of diagnostic guidelines and tools to assess the risk of osteoporosis and identify candidates for treatment, the article says. They heavily promoted new technology to measure bone density. Now about three-quarters of white women over 65 are considered candidates for treatment under U.S. guidelines, according to the BMJ analysis.
Three leading bone drugs have generated more than $17 billion in combined revenue since 2007 for Merck, Actavis, and Roche, according to data compiled by Bloomberg. The global market for osteoporosis drugs was $8.4 billion in 2013, market researcher Transparency estimates. The first drug to treat osteoporosis in the U.S. was Merck's Fosamax, approved in 1995. Merck's patent on Fosamax expired in 2008.
Merck, Actavis, Roche, and Novartis, another major seller of osteoporosis drugs, had no comment on the study or didn't respond to e-mails seeking comment.
Osteoporosis is an asymptomatic disease. People naturally lose bone mass as they age. About 9 percent of U.S. adults over 50 are thought to have bone loss that constitutes osteoporosis, according to the Centers for Disease Control and Prevention. It's most common among older women, particularly whites and Asians.
Fragile bones can lead to greater risk of fractures in the hip, spine, wrist, or shoulder. Hip fractures are considered the most serious because they typically leave patients bedridden, which can further degrade their health, Ilyas said. Research suggests one-fifth of people who fracture their hips die in the following year.
The case for reducing hip fractures is clear, and the study doesn't dispute that the drugs can be effective in strengthening bones. What's not clear is whether the current approach of widespread screening for osteoporosis and medication for those with fragile bones works.
The problem is that fractures are typically caused by falls, both in people with osteoporosis and in those with normal bone density. Lots of people who don't have osteoporosis fall and break bones anyway. Lots of people who do have osteoporosis don't fall and never sustain fractures. Predicting who's at risk is difficult, so drugs known as bisphosphonates that strengthen bones are prescribed for many people who will not fall, as well as some who will. Furthermore, though the risk of falling increases as people age, there's little evidence to show that the drugs help prevent hip fractures among the oldest patients who are most susceptible.
"It is such a sporadic, such a highly difficult-to-predict traumatic event," said Teppo Järvinen, an orthopedic surgeon at the University of Helsinki, the lead author of the BMJ paper. He said doctors are ignoring evidence of overtreatment. "Most of the doctors are concerned about undertreatment. They are fine with treating hundreds of people unnecessarily if they can help the one that’s going to be harmed," Järvinen said.
Every medical intervention carries the chance of harm as well as benefit. Osteoporosis drugs can have some relatively mild side effects, such as nausea, vomiting, and heartburn. They can also have more serious consequences, including osteonecrosis of the jaw—the death of jaw bone cells—and increased risk of another type of fracture, called atypical femoral fractures. A group of 10,000 long-term users could expect 11 such fractures a year, the BMJ paper says. A review by the Food and Drug Administration in 2012 raised concerns about the long-term use of the drugs.
Järvinen worries that the focus on drug treatment has eclipsed other approaches patients can take to prevent fractures, such as nutrition and exercise. "This advice works for anyone, regardless of bone fragility, and the benefits encompass the entire human body," the paper says. As for drug treatment, the researchers conclude, "the dominant approach to hip fracture prevention is neither viable as a public health strategy nor cost effective."