August 2005

 

Dear Friends

Greetings from Auckland where we are basking in a mild and beautiful winter...well so far, and today anyway. I hope this finds you well.

Since last October I have enjoyed the constant support and friendship of Timra Freedman - a wonderful wise woman from Boston. Timra is supremely healthy and energetic and leads a fabulous full life. She exercises every day, has an excellent diet, and has taken supplemental vitamins and minerals for years. Timra was given a diagnosis of osteoporosis last year after a bone mineral density scan. The only fractures she has sustained were the result of a serious high-impact bike accident in 2001 when a car wrongly turned across her path. As she says “I certainly don't think that it had anything to do with the state of my bones at the time. I just hit her car so hard!” She reluctantly took Fosamax for 6 months and then Actonel for one month. Both drugs made her ill.

After reading my book The Myth of Osteoporosis Timra was galvanised to promote the issues around the over-diagnosis and over treatment of osteoporosis and osteopenia in the well. She has tirelessly contacted U.S. doctors, specialists, organisations, media, journalists, and individuals. Her Herculean efforts are bearing fruit. On July 6 my book was very favourably reviewed in the prestigious Journal of the American Medical Association (JAMA) and in May was the impetus for an article by medical journalist Judy Foreman in the Boston Globe, New York Sun, Baltimore Sun and the Los Angeles Times. Timra’s perseverance and dedication prove that one person can make a difference. I am totally indebted to her.

New ‘must read’ books:
There are three excellent new books available on the reclassifying of healthy people as ill and the marketing of potent drugs to prevent conditions that may never happen or were once categorised as normal. Selling Sickness – How Drug Companies Are Turning Us All Into Patients by Ray Moynihan and Alan Cassels, and Overdosed America: The Broken Promise of American Medicine by John Abramson M.D. discuss conditions such as hypertension where the goal posts have been moved to encompass some 50 million Americans; and ‘prehypertension’, a category that turns previously normal blood pressure levels into a treatable condition. Cassells and Moynihan describe the gradual blurring of the boundaries defining normal and abnormal behaviour so that female mood swings can be categorised as ‘premenstrual dysphoric disorder’ (PMDD), a lowering of libido in older women ‘female sexual dysfunction’ (FSD), shyness ‘social phobia’, and being disorganised and distracted ‘adult attention deficit disorder’ – all conditions that have, of course, a pharmaceutical ‘solution’. John Abramson reveals the difficulties physicians face when much of the medical literature they have been trained to believe is accurate and scientific is little more than cleverly manipulated data designed to market drugs.

The Myth of Cholesterol:: Dispelling the Fear and Creating Real Heart Health by Paul Dugliss M.D., and Sandra Fernandez M.S.P.H., challenges the established belief that cholesterol plays a major role in heart disease. Just as osteoporosis has been redefined to include almost half the adult female population, so has the threshold been altered for a diagnosis of ‘dangerous’ cholesterol levels. The official U.S. cholesterol guidelines have been rewritten several times, increasing the number of people taking statin drug treatment from 13 million in the 90’s to 40 million in 2004. What the public aren’t told is that many of the experts who created the new guidelines were linked to the drug companies who stood to benefit. Neither do many people know that studies published in JAMA and the New England Journal of Medicine show that elevated cholesterol does not significantly increase a healthy women's risk of heart disease or overall mortality, and that women who exercise and maintain a healthy diet develop 83 percent less heart disease than those who don't. Remarkably, not one of the six major clinical studies that the new cholesterol guidelines are based on provides significant evidence that statins are beneficial for healthy women.

Bisphosphonate news:
Last month I wrote about a worrying and largely unacknowledged side-effect of bisphosphonates – the chronic, often severe, joint and bone pain, swelling of ankles and feet, muscles cramping and stiffness, and difficulty walking reported by many women using Fosamax and Actonel. Serendipitously, the Food and Drug Administration published correspondence in the Archives of Internal Medicine in February 2005 analysing over 100 reports of similar physical symptoms described by some consumers as ‘severe’ ‘extreme’ ‘disabling’ or ‘incapacitating’. The authors comment that the clinical trials leading to the FDA approval of Fosamax and Actonel did not identify this side-effect, but acknowledge that previously unknown side-effects can sometimes surface once a drug is out there in the market place.

This certainly seems to be the case with bisphosphonates as the list of negative effects grows ever longer. The FDA advised dentists and cancer physicians in May 2005 that the labels or package inserts for the injectable bisphosphonate drugs zoledronic acid (Zometa) and pamidronate (Aredia) had been revised to warn about the possibility of osteonecrosis of the jaw with the use of these drugs. Osteonecrosis literally means “bone death.” There have also been reports in the medical literature of osteonecrosis of the jaw associated with the use of Fosamax and Actonel.

There are concerns that Fosamax might impair bone healing and that the drug-induced increase in bone minerals could make bones more brittle. A report in The Journal of Clinical Endocrinology and Metabolism in March 2005 described nine patients on Fosamax with osteoporosis or osteopenia who had non-traumatic (low impact) fractures. Six patients continuing the drug experienced delayed or no healing of broken bones. In her July 11 New York Times article Postmenopausal Women Face Issues About Bone Loss journalist Jane Brody reports on the case of "a healthy active woman, 59, who after six years on Fosamax for osteopenia in her spine was jolted on a subway and broke her thigh bone. The injury took two years to heal, and the healing occurred only after she had stopped taking Fosamax. A year later, she resumed the drug, only to suffer a non-traumatic fracture in her foot."

The vast majority who take Fosamax will receive no benefit. A just-published review of the data for a range of osteoporosis treatments from eleven randomised clinical trials of at least 3 years duration failed to find any non-vertebral fracture benefit at all from Fosamax raising further questions about its widespread unchecked use.

Our challenge as healthcare consumers is to find genuinely independent information regarding disease prevention, the diagnosis of conditions, and the safest most effective methods of treatment. It can be hard to find, but is increasingly available as more doctors, journalists and individuals question the over-medicalisation of ‘worried well’ adult populations and the aggressive way the pharmaceutical industry is convincing people that drugs are preferable to time-tested simple lifestyle changes such as eating well, exercising and quitting smoking.

Wishing you great good health

Gillian

IMPORTANT:
If you have had adverse or severe reactions to any drug you can report this to the FDA by going to http://www.fda.gov/medwatch/report/consumer/consumer.htm
or by phoning 1(800) FDA-1088.