When Dr. Victoria Seewaldt of Duke University School of Medicine reviewed a controversial new book about osteoporosis in the Journal of the American Medical Association* in 2005, she started off as an admitted skeptic. The review was for Gillian Sanson‘s book, The Myth of Osteoporosis: What Every Woman Should Know About Creating Bone Health. The book’s premise challenged almost every truism that most doctors believed – and may still believe – about osteoporosis.

Dr. Seewaldt is not only a physician, but also the daughter of an osteoporosis patient; her mother was diagnosed after fracturing a hip at age 72. She explained:

“Until her hip fracture, my mother was a ferocious shopper. Even in her early 70s, my mother would race down Fifth Avenue in New York City, shopping bags in hand, leaving me out of breath and begging for a rest.

“Then one day, my mother fractured her hip. Suddenly, our lives changed. For this reason, l initially approached Gillian Sanson’s book with significant reservations.”

But by the end of this book, Dr. Seewaldt found that her “reservations had turned to enthusiasm”.  She had actually come to agree with many of Sanson’s points, particularly these three important messages about the diagnosis and treatment of osteoporosis:

  • Bone density is only one component of bone strength. Bone strength is also determined by bone micro-architecture, vitality, and the ability of bone to repair itself.
  • There are no international normal reference standards for dual x-ray absorptiometry bone density diagnostic machines. Manufacturers set their own standards, and, therefore, women’s bone density results will likely vary among machines, regions, and countries.
  • While a severe deficiency in dietary calcium can lead to deficient bone formation, high dietary calcium intake will not always prevent osteoporosis. Serum calcium levels are tightly regulated, and calcium absorption varies greatly between individuals. Therefore, not all dietary calcium will be absorbed, and calcium supplements do not guarantee adequate bone density.

Another controversy that Sanson’s book addressed was the widespread use of both hormone therapy and pharmaceutical drugs called bisphosphonates (like Merck’s blockbuster Fosamax or Procter & Gamble’s Actonel) to treat/prevent osteoporosis. Dr. Seewaldt agreed:

“The Women’s Health Initiative studies have raised substantial concerns about the association of combined estrogen and progesterone post-menopausal hormone therapywith cardiovascular disease and gynecologic cancers, and these medications need to be prescribed with caution.

“As for drugs for osteoporosis, we do not yet understand the health implications oflongterm bisphosphonate use.”

That last line might be a gross understatement, according to Dr. H. Gilbert Welch in his book Over-diagnosed: Making People Sick in the Pursuit of Health. Here are the overall numbers for treatment of decreased bone density with bisphosphonate drugs:

  • Winners (drug treatment saved them from a fracture): 5%
  • Treated for naught (had a fracture anyway, despite treatment): 44%
  • Losers (treated, but never would have had a fracture without treatment): 51%

Even more alarming, Dr. Susan Ott of the University of Washington worries that taking these  osteoporosis medications longterm — over five years or more — might actually make bones brittle.  In a 2004 letter published in the Annals of Internal Medicine, Dr. Ott wrote:

“Many people believe that these drugs are ‘bone builders,’ but the evidence shows they are actually bone hardeners.”

Other researchers also suggested that many years of using bisphonate drugs like Fosamax (or Actonel) could eventually cause more bone fractures.

Georgetown University physician Dr. Adriane Fugh-Berman (well-known for her outspoken criticism of Big Pharma-funded ghostwritten journal articles supporting hormone therapy) shares these serious concerns about osteoporosis pharmaceuticals, lamenting the fact that drug companies have represented osteoporosis to women as “a deadly disease, a silent killer affecting millions of women who go about their daily lives, unaware that their bones are dwindling to kindling.” 

For example, she offers an example of “marketing-based medicine” in a 1995 book for consumers enthusiastically titled Estrogen: The Facts Can Change Your Life! A Complete Guide to Reversing the Effects of Menopause Using Hormone Replacement Therapy. This book states ominously:

If osteoporosis gets bad enough, a woman who has it could suffer a broken arm lifting a casserole out of the oven, or reaching back to zip up her dress. She could break her foot stepping put of bed, or a rib upon sneezing.”

Dr. Fugh-Berman also cites a 2002 study** published in the medical journal Lancet that investigated 2,448 patients admitted to hospital with hip fracture.

Researchers found a disturbingly high rate of post-operative complications. And patients with multiple medical problems before hospitalization did far worse; in fact, about 10% died within a month, usually of chest infections or heart failure.

But, warns Dr. Fugh-Berman, this does not mean that osteoporotic hip fractures were the culprits.

In fact, the Lancet report concludes:

“Few of these deaths can be attributed to the hip fracture per se; most are due instead to chronic illnesses that led to both the fracture and to the patient’s ultimate demise.”

Indeed, even if your bones “look like Swiss cheese”, says Dr. Fugh-Berman, avoiding falls is more important than building bone because falls cause more than 90% of hip fractures and 80% of other fractures:

“Preventing falls would prevent most fractures. Just increasing physical activity could cut falls by half. Fall risk factors include being older; having muscle weakness or limited mobility; being challenged by environmental hazards (e.g., throw rugs, slippery shoes); taking four or more medications or taking psychoactive drugs; having dementia, visual difficulties, or Parkinson’s; and experiencing a stroke. Age is probably most important: women over 85 are nearly 8 times more likely to be hospitalized for hip fracture than women aged 65-74.”

According to Dr. Fugh-Berman, osteoporosis is not a killer disease. In fact, it’s not really a disease at all, but a structural abnormality.

She has even less tolerance for the diagnosis of “osteopenia“, as she explains:

“Osteopenia is a term that’s become popular recently as a way to expand market share for bone-building drugs.

“Let’s see: osteopenia is a risk factor for osteoporosis. Which is a risk factor for hip fracture. Which is a risk factor for surgery, immobility and complications. Which are risk factors for death, but primarily in frail elderly nursing home residents (and not just the women!)”

In fact, Dr. Fugh-Berman strongly advocates for a multi-modal fall prevention and mitigation program that could have a real effect on decreasing fall-related disability and death, including:

  • eye exams
  • medication adjustments
  • strength training
  • environmental modifications
  • hip protectors
  • appropriate anti-osteoporosis therapies

She maintains that overall good health is critical for preventing falls, and staying well means more than just taking prescription drugs or hormonal supplements. Regular exercise, maintaining normal weight, and avoiding smoking and alcohol are key to continued good health. Muscle strength, good balance, and good eyesight are all important for preventing falls. Finally, Dr. Berman warns:

Scaring ambulatory, community-dwelling women into taking anti-osteoporosis drugs benefits corporate coffers, not women’s health.”

And Dr. Victoria Seewaldt wondered about this important point, too, in her JAMA review of Gillian Sanson’s book as she reflected on her own mother’s experience.

“Did she fracture her hip because of low bone density, or because she lived in an old house with a narrow twisting staircase that lacked good lighting? I think back to my mother’s description of how she ventured down into the basement one night, forgot to turn on the light, missed the step in the dark, and ended up with a fractured hip.

“l can only speculate as to whether my mother – had she read Sanson’s chapter on preventing falls – would have stopped, turned on the light, and, instead of falling down that flight of stairs, would still be leaving me in her wake, breathless and  sweaty amid the shoppers in New York City.”

 

* Review in JAMA. July 6, 2005; Vol 294, No.1: 113

** Cummings SR, Melton LJ. ‘Epidemiology and outcomes of osteoporotic fractures.’ Lancet 2002; 359:1761-67.

 

Reproduced with permission from The Ethical Nag: marketing Ethics for the Easily Swayed by Carolyn Thomas –   http://ethicalnag.org

Carolyn has over 37 years experience in journalism marketing and public relations.She has a particular interest in medical research and Big Pharma marketing issues.

The original article appears here