author and cofounder of the U.S National Women's Health Network

Read the July 6, 2005 JAMA review of The Myth of Osteoporosis

For regular updates & commentary check out my blog www.gilliansanson.wordpress.com

July 30 2008
NEWS: Snapping thigh bones caused by bisphosphonates?

Hard on the heels of the FDA’s January 2008 alert about serious joint bone and muscle pain associated with the bisphosphonates, comes a worrying series of reports of spontaneous fracturing of the femur (thigh bone) in women who have taken Fosamax for several years.

There have long been concerns that the bisphosphonate action of suppressing bone turnover may cause bone to deteriorate in strength and become more brittle over time. It would seem that those fears are being realized and although still small, the number of spontaneous fractures is prompting an FDA investigation of the phenomenon.  Reports from Singapore, Hong Kong and the US all have a similar story to tell: the thighbones of women patients on Fosamax for five years or more have simply snapped while they were walking or standing. Some individuals experienced hip and thigh pain leading up to the event, and others had no warning whatsoever. Biopsies after fracture have shown severely depressed bone formation.

Bisphosphonates are becoming easier to take, with once-a-month Boniva (enthusiastically promoted by actress Sally Field), and once-a-year Reclast now available. These are much higher doses than daily and weekly Fosamax and we don’t have evidence from clinical trials to reassure us that the side-effects with these higher doses are not even greater. In her 2005 editorial on the long term safety of bisphosphonates Dr Susan Ott Associate Professor of Medicine at the University of Washington warned:  ‘The bisphosphonates in doses used today suppress bone formation to a greater extent than the other antiresorbing medications, so it is possible that microdamage accumulation would develop after 15 or 20 yr—just about the time between menopause and the usual onset of osteoporotic fractures. Certainly this is an issue that requires long-term, carefully designed research.’

Maybe the damage is occurring sooner than she expected. In a July 2008 New York Times article Dr Ott admits to having now seen instances of spontaneous fracture: “I have several similar patients myself. …Prior to these recent articles, there were a few cases here and a few cases there, but they are kind of starting to add up.”

The long term effects of bisphosphonates remain unknown. These drugs accumulate in the body, alter the chemical structure of bone, and have an indefinite half life.  This means that the drug’s effect goes on, for better or worse. Stopping the drug doesn’t mean that it leaves the body

Recent evidence for jaw necrosis and other bone necrosis (bone death) associated with bisphosphonate are a further warning that these are drugs with the potential for serious harm.
Vioxx, Celebrex, HRT, Prozac, Aredia… the list of blockbuster drugs once heralded as safe and effective but later found to put consumers at serious risk goes on. Are bisphosphonates, the multi-billion dollar wonder drugs for bones with over 10 million users worldwide going to end up discredited and discarded also? 

Deciphering Drug Adverts

We need to fully understand the benefits, side-effects and risks of a drug before embarking on treatment.  Prescription drug information from advertising or brochures employs the clever use of medical concepts that require interpretation. Advertisers rely on our ignorance of such matters and drugs are often made to seem more effective than they really are. Many of us might choose not to take a particular medication if we understood the very small absolute benefit on offer. 

The most common way of presenting the benefit of a drug is to use the observed percentage risk reduction for people taking it. So it is common to hear statements like ‘Aspirin offers men a 32% reduction in risk of heart attack’, or ‘Fosamax offers a 50% reduction in risk for hip fracture’. But these impressive sounding percentages only provide the relative risk reduction and not the more telling absolute risk reduction.

Fosamax ads are a good example. The majority of people don’t fracture their bones. Even ‘high risk’ women and men are at low absolute risk for fracture. In the large trial that measured the fracture benefit of Fosamax, it was found that in a population of 2,027 postmenopausal women with osteoporosis and previous fracture (a high risk group) over a three year period, there were 22 hip fractures in the 1000 women in the placebo group, and 11 hip fractures in the 1000 women who were taking the drug, (a difference of just 11 fractures). Thus 2.2 percent of the placebo group fractured, and 1.1 percent of the Fosamax group fractured. Because 1.1 percent is 50% of 2.2 percent, Fosamax is claimed to reduce hip fractures by 50%. This is a relative risk reduction. The actual or absolute reduction is only 1 percent!

Another and sometimes better way to look at the effectiveness of a drug is to consider the numbers needed to treat or NNT. Numbers needed to treat tend to give a picture of a drug’s effectiveness in terms of the number of people who need to take it in order for one of them to benefit. Aspirin for example, has an NNT of 3.2 when used for migraine headache. That means, approximately three people with migraine symptoms would need to use it in order for one of them to get relief. This is considered an effective treatment. With Fosamax, 90 high risk women would need to be treated for three years in order to prevent one hip fracture in one of them. The remaining 89 would receive no benefit and be exposed to the risks and side-effects of the drug. It is estimated that hundreds of women aged 50 years with low bone density would need to be treated for more than 3 years to prevent one hip fracture in one of them.  

It is a good idea to ask your doctor what the NNT is for a particular drug and what the absolute risk reduction is.

Dr Aubrey Blumsohn’s scientific misconduct website details on-going ethical scandals confronting pharmaceutical research. The stranger-than-fiction story of his expose of Proctor and Gamble’s VERY dodgy dealings over the osteoporosis drug Actonel make for riveting reading.

The Burdensome BONZ Report

A staggering 84,354 New Zealanders are predicted to break bones this year as a result of osteoporosis; that’s one osteoporosis related fracture every six minutes and a hip fracture every two hours. By 2020 the annual osteoporosis-related fracture rates are expected to exceed 115,000. So cautions the Fonterra funded ‘Burden of Osteoporosis in New Zealand Report’ commissioned by Osteoporosis New Zealand. But a closer look at the report reveals it is essentially a fabrication. More

New Book:
‘Pesticides and Breast Cancer: A Wake Up Call’ by Dr Meriel Watts 
Breast cancer incidence rose 30-40 percent from the 1970s to the 1990s and rates continue to escalate in the Asia Pacific region. New Zealand has one of the highest rates in the world. New Zealand’s Dr Meriel Watts set out to identify what synthetic chemicals may be contributing to breast cancer. Her research took three years.
 It has been estimated that more than 80 percent of breast cancer cases are associated with environmental factors that include exposure to contaminants, lifestyle, and diet. There is considerable international concern that some of the 70,000 synthetic chemicals in our environment today may be directly linked to a large percentage of breast cancer cases, but there are no epidemiological studies to determine this. It has been observed that breast cancer incidence in Western countries has paralleled the proliferation of synthetic chemicals since World War II, and that as developing countries take up industrial agricultural practices their breast cancer rates escalate similarly. More
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Best wishes

Gillian

Previous Posts:

• Strontium as an osteoporosis treatment.
• Bisphosphonates - how safe and effective are they?
• bisphosphonates and osteonecrosis of the jaw (external link)
• Evista – what is it good for again?
• The effects of StatinsThe effects of Statins
  Although cholesterol lowering drugs have been on the market for more than 20 years there is still much that is not known about their effects. Patients taking statins (such as Lipitor, Zocor, Pravacol, Mevacor and Crestor) may experience side-effects such as joint pain or memory loss and not realize they may be linked to the statin. Beatrice Golomb who heads the USCSD study into statins has recently launched a website at www.statineffects.com so that users can report adverse or positive effects. The evidence collected will provide a more accurate picture of the effects of these drugs – something that the FDA’s lack of post-marketing surveillance has not provided. The site also provides helpful information including lists of well known and lesser-known side-effects.

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