The use of celebrities in drug advertisements raises all sorts of questions. It is important to know that they are hired to endorse a drug. (Mike Theiler/National Osteoporosis Foundation via Getty Images)
Women are in such danger of osteoporosis they need regular bone scans. That was conventional medical wisdom since the first lucrative bone drug surfaced over a decade ago.
But an article in the Jan. 19 issue of New England Journal of Medicine concluded: “Osteoporosis would develop in less than 10 percent of older, postmenopausal women during rescreening intervals of approximately 15 years for women with normal bone density or mild osteopenia. …”
In 1994, a year before the introduction of Fosamax, Merck’s blockbuster bone drug, was approved, Merck began marketing the dangers of osteoporosis “far beyond ailing old ladies.”
It hired researcher Jeremy Allen to whip up osteopenia fears to sell bone drugs by planting bone-scan machines in medical offices across the country, says National Public Radio. Allen created the Bone Measurement Institute to establish osteopenia, the “risk of osteoporosis,” as a health epidemic.
The scheme worked. By 1999, there were 10,000 bone-scan machines in medical offices, according to the Associated Press, when there had been only 750 before the bone drugs hit the market. The diagnosis of osteopenia increased seven-fold.
Allen’s company also pushed through the Bone Mass Measurement Act, which made bone scans Medicare-reimbursable. The legislation was written by Rep. Constance A. Morella (R-Md.), who appeared with HHS Secretary Donna Shalala in 1998 at a rally kicking off free bone-density screenings to be offered in 100 U.S. cities.
The publicly funded bone scans were so lucrative to drug companies that when their Medicare reimbursement became threatened, an article appeared in the Cleveland Clinic Journal of Medicine exhorting readers to “lobby your legislators.”
The above article, “Managing Osteoporosis: Challenges and Strategies,” says that without Medicare reimbursement, patients are “likely to be harmed by limited access to DXA testing [bone scans] because of fewer instruments in operation and greater distances to travel to reach them,” and outpatient facilities would incur “financial losses.”
While osteoporosis is a real disease, osteopenia was never meant to be “a disease in itself to be treated,” says Dartmouth Medical School professor Anna Tosteson, M.D., who attended the 1992 World Health Organization meeting in Rome where the term was first invented. The scientists in the room were simply tired and agreed on a definition of the term because they wanted to adjourn for the night, she told NPR.
The bone density units, called T scores, used to define osteopenia are equally fallacious, wrote reporter Susan Kelleher in the Seattle Times: They had “boundaries so broad they include more than half of all women over 50.”
If bone drugs like Fosamax, Boniva, and Actonel (called bisphosphonates) weren’t harmful, the bone-scan con would simply be a case of overmedicating women, ripping off patients and taxpayers, and raising insurance costs.
But bisphosphonates have been reported to greatly increase the risk of esophageal cancer and osteonecrosis of the jaw—jawbone death. Some dentists will not work on women who take them. Bisphosphonates are also linked to irregular heartbeats and intractable pain, according to medical journals and FDA warnings.
Bone drugs do not prevent fractures—their intended purpose! By suppressing bone remodeling, they are supposed to stop bone loss. But since the bone is not being renewed, it becomes brittle and ossified and fractures easily.
The thigh bones of patients on bisphosphonates have “simply snapped while they were walking or standing,” after “weeks or months of unexplained aching,” reported the New York Times in an article called “Drugs to Build Bones May Weaken Them.” Medical journals and patients on the website askapatient.com have been reporting the fractures for years.
At the 2010 American Academy of Orthopaedic Surgeons annual meeting in New Orleans, doctors were actually shown the qualitative differences in bisphosphonate-treated bone and could see how the bone had degraded over four years of treatment. Half the doctors at one presentation said they had seen patients with bisphosphonate-compromised bone, reported the Los Angeles Times.
It should be embarrassing to the medical establishment and Medicare administrators that the drug industry and its paid celebrities drove the mania for the bone scans, osteopenia, and bone drugs.
Here’s how “Today” host Meredith Vieira helped: “When I became menopausal, my doctor recommended I get a bone-mineral-density test. I had never even heard of it, to be quite honest. I thought, I’m in great health, great shape. I have no symptoms. Why do I need this?
“To illustrate how ignorant I was when I had the test done, I asked where I could change, and the nurse told me I didn’t need to take off my clothes. They did a test on my heel, hip, and spine, which only took a matter of five minutes. And it was totally painless. It’s so simple to do,” she told USA Today.
It should be even more embarrassing that the con only surfaced when the biggest bone-drug patents expired, so the drug companies don’t even care—because the big bucks are behind them.
This is the last of a three-part series.
Martha Rosenberg is a health reporter and author who lives in Chicago.