Osteoporosis: Disease Management or Disease Mongering?

The FDA has warned osteoporosis patients that the very drugs they take to strengthen their bones... may be making them even weaker.

Emerging reports suggest that these drugs may increase risk of thigh-bone fracture. Especially in women taking these drugs for five years or more.

And the agency is telling major drug makers to put a warning on their labels.

But while the agency is issuing its warning... it's also been keen to stress that patients shouldn't quit their drugs. Not unless they start to feel new thigh pain. And not even then. Not until their doctor tells them to quit the drug.

But the real issue isn't that these drugs may be dangerous... It's that they may not actually do any good at all.

The research that promoted these drugs in the first place was funded by the drug companies that stood to gain the most. The results that prompted the FDA to initially approve the drugs don't stand up to much scrutiny.

Too Little, Too Late

People are thinking twice about using their bone-strengthening drugs. A new report shows they may increase the risk of bone fracture. Most of the major osteoporosis drugs are implicated. The list includes:

• Actonel
• Actonel with Calcium
• Atelvia
• Boniva
• Fosamax
• Fosamax Plus D
• Reclast and Boniva

And the FDA has issued a statement:

"While it is not clear whether [these drugs] are the cause, a rare but serious type of thigh bone fracture, has been predominantly reported in patients taking [them]."

The FDA has told the manufacturers to put a warning label on their drugs. But it's told the public to keep taking them... unless their doctor orders them not to.

All the major newspapers reported the story. But none of them chose to dig any deeper. Instead of simply reporting that these drugs may be dangerous... they should have asked if we ever should have been taking them in the first place.

John Abramson, M.D., has been in mainstream medicine for 30 years. He ran his own practice for 20 years and was voted by his medical peers as one of the best doctors in the state - three times! He's currently on the faculty of Harvard Medical School where he teaches classes.

This celebrated medical veteran thinks these drugs should never have been on the market to begin with. He points to 15 years of medical research that suggests these drugs do almost no good whatsoever. And that osteoporosis has been classified as a disease simply to create a billion dollar industry.

"The mainstream women's health movement has been hijacked by commercial interests," says Dr. Abramson. "It acts more like a wolf in sheep's clothing."

That's a bold statement to make... But if you review the evolution of osteoporosis - and the drugs created to treat the disease - you'll see he's on safe ground.

Evolution of Osteoporosis

In the early 80s, few people had even heard of osteoporosis. And it wasn't until the next decade - 1993 - when the World Health Organization (WHO) created clear definitions of it.

This gave firm criteria for doctors to diagnose brittle bones as a disease.

WHO created this guideline: a woman has osteoporosis when her bone mineral density (BMD) is 2.5 deviations below the standard BMD of average healthy young women. The measurement is made by an x-ray exam.

Seems pretty straightforward. Women with a T score of -1.0 and -2.5 have osteoporosis.

Except the WHO study was financed by three drug companies. These three companies were the Rorer Foundation, Sandoz, and SmithKline Beecham. The study they funded led to not only defining criteria for diagnosing osteoporosis... But also to establishing it firmly as a marketable disease.

"The drug companies stood to benefit greatly if definitions of osteoporosis included large numbers of postmenopausal women," says Dr. Abramson. "Especially if BMI testing was adopted into routine medical care."

There's one important point to make here. Women's bones do become more brittle with age. And hip and thigh fractures are a major cause for concern for women after they hit menopause.

But this drug-financed study established the thinning of bones as a disease. Something to be screened for, and treated with costly and ineffective drugs. As opposed to a natural part of getting older. One that can be combated by natural, free, and safe lifestyle changes.

The following year - in 1994 - the WHO study group recommended screenings and interventions. They determined that the "appropriate time" for these tests was menopause. To make sure no one missed it, their recommendation was published in Osteoporosis International.

Suddenly, BMD became part of routine care for millions of postmenopausal women.

"The drug companies were assured that millions would be seeking billions of dollars' worth of their drugs," says Dr. Abramson. All in an effort to prevent and treat the new disease.

By 1995 Fosamax appeared on the market. The first of the brand new osteoporosis drugs. It was swiftly approved by the FDA.

Osteoporosis screenings, treatment, and drugs became part of the American lifestyle. Almost overnight.

But there has never been any proof to show that any of these steps actually help women whatsoever.

"There has never been a controlled study to determine whether there is a benefit to screening women with BMD tests," says Dr. Abramson. "There is no evidence showing that all those tests and all those drugs is leading to better health."

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Development of Drugs

The first released drug sounds pretty good... In theory. It binds to the surface of bones to strengthen them.

And a study published in The Journal of the American Medical Association showed that it could reduce hip fracture risk by 56 percent. But if you actually follow how they got to that 56 percent... things aren't nearly so impressive.

Without the drugs, the study showed women had a 99.5 percent of avoiding hip fracture. With drugs, their risk improved to 99.8 percent. It's a tiny decrease in risk. In fact taking risk down from 0.5 percent to 0.2 percent. But it certainly sounds better when you tinker with the math so it gets reported as 56 percent.

Here's another way of putting it. A total of 81 women would have to take the drug for over four years to prevent a single fracture among them. That dismal improvement equals $300,000 in profit for the drug makers.

One other result was hidden away... Fosamax increased the risk of hip fracture by 84 percent for women with osteopenia. And the risk of wrist fractures increased by 50 percent.

Another study published in The New England Journal of Medicine in 2001 revealed that Actonel was no better. The study reviewed 3,880 women. A total of 80 percent were diagnosed with osteoporosis. The researchers concluded that it had "no effect on the incidence of hip fracture."

So these drugs can't prevent hip fracture... But can they prevent osteoporosis?

The FDA approved these drugs because they increased BMD.

"But bone density is only a surrogate end point," says Dr. Abramson. "The real reason for taking these drugs is to reduce fractures."

And somehow... while these drugs increased BMD... they didn't reduce fracture risk.

There are two different types of bone. Most of our bones have a hard, dense outer layer called cortical bone. But the weakest points - like the wrists and hips - have an internal structure of trabecular bone. This bone is what protects you from fractures.

When women age, they lose trabecular bone faster than cortical bone. Osteoporosis drugs only bind to the cortical bones. Which is why they don't protect against fracture and injury although they do increase overall BMD.

How to Protect Yourself

Recent developments show that osteoporosis drugs may pose increased risk of fracture. Studies from the very genesis of these drugs show they don't do much good to protect you from fracture.

You're paying plenty of money to take a drug that may only offer dangerous side effects.

So what can women do to strengthen their bones naturally?

"There are no magic pills," says Dr. Abramson. "But there are ways to significantly strengthen bones and reduce the risk of fracture at any age."

Exercise and diet are the two keys to keeping bones strong.

"There is good evidence that exercise builds up trabecular bone," says Dr. Abramson. "Which then provides internal support to vulnerable areas of the skeleton."

The Study of Osteoporotic Fractures - sponsored by NIH - tested this out on 10,000 women over seven years. It looked at the progress of women who were over 65. The reduction of risk fractures in women who exercised the most was startling. Only six in every thousand suffered fracture.

A study in Sweden enrolled women who were over 83 years old in a fall-protection program. The program used exercise and balance-increasing techniques. Over eight months, they found that just one percent of women suffered fracture during the program.

There's a clear path to protection. Exercise increases bone strength. The kind of bones which combat fractures. Balance-improvement prevents falls and accidents - the major causes of life-changing fractures.

"Tai chi improves balance," says Dr. Abramson. "It cuts the risk of falls in half for people over 70."

Researchers did a study on how tai chi can increase balance in older people. They found that seniors who practiced tai chi every day increased their balance. The group who practiced regular tai chi had 70 percent fewer falls than the group who didn't do any tai chi.

Tai chi is not the only way to improve balance. You can also improve balance and strengthen muscle and bones through yoga and Pilates.

Several studies show that calcium and vitamin D supplements strengthen those essential trabecular bones.

Dr. Abramson recommends 1,200 - 1,500 mg of calcium each day. He says you should also take 400 - 800 IU of vitamin D.

To your health,

Ian Robinson,
Managing Editor,
NHD "Health Watch"