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Why did the medical establishment allow Pharma's 12-year bone scam?

ASK THIS | January 31, 2012

Creating a phony need, getting treatment of it Medicare-reimbursable – and greatly increasing the danger of esophageal cancer and other serious health problems.

By Martha Rosenberg

Women are in such danger of osteoporosis they need regular bone scans. That was conventional medical "wisdom" after the first lucrative bone drug surfaced over a decade ago. But an article in last month's New England Journal of Medicine reveals that the warnings don't apply to 90 percent of women who have been getting the scans and subsequent bone drugs for no valid reason. How did this happen?

In 1994, a year before 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 faux "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, said the Associated Press, when there had been only 750 before the bone drugs hit the market. The diagnosis of osteopenia increased seven fold.

The Bone Measurement Institute and other Merck-funded groups 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 cities. The publicly-funded bone scans were so lucrative to drug companies that when their  Medicare-reimbursement became threatened, an article in the Cleveland Clinic Journal of Medicine article exhorted readers to "Lobby your legislators;" scientific objectivity be damned.

The article, "Managing Osteoporosis: Challenges and Strategies," (PDF) says 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 will 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, MD, 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 as fallacious, wrote 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, 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 heart beats and intractable pain, according to medical journals and FDA warnings.

Nor do the bone drugs even 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, ossified and fractures. 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." Oops. Medical journals and patients on the web site askapatient 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'd seen patients with bisphosphonate- compromised bone personally, when asked, reported the Los Angeles Times.

Still, Jeremy Allen, who put the routine bone scan on the map for Merck, stands by his work. "Fosamax became a successful drug," he told National Public Radio. The bisphosphonates "have been successful, and there are a lot less women dying of hip fracures or stooped over than there were a generation ago." 

“I get a great sense of satisfaction that I was able to rejigger the marketplace so that women could be treated for osteoporosis before it got them," Allen says. "That was a good episode of my life."

 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. Look 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?'" she told USA Today. "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."

And it should be even more embarrassing that the con only surfaced when the biggest bone drug patents have expired so the drug companies don't even care, because the big bucks are behind them.

An earlier version of this story ran on the AlterNet website.

Scans can be Great for Prevention
Posted by Darlene Varaleau
02/01/2012, 12:20 AM

The scans my doctor ordered in spite of my good health and low risk have helped me to prevent osteoporosis. As I was entering menopause, scans two years apart indicated that I was losing bone density at a rate of 8% a year. I subsequently researched the optimal use of calcium, vitamin D, vitamin K2 and strontium and have almost halted the bone loss. (I am due for another scan to measure the effectiveness of my program.) Osteoporosis is rampant in my family and I expect to be one of the few members who do not get it. The bone scans and osteoporosis vitamins (rather than medication) helped me to achieve this.

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