Section Nine Your Drug May Be The Problem. Are You Taking A Bad Drug? |
Chapter 34. Fosamax
Induced Bilateral Femur Fractures
I received this letter from a lady who suffered bilateral mid-femur fractures after ten years of taking the anti-osteoporosis drug, Fosamax™ (Alendronate):
Dear Dr. Dach, I am a femur-fracture
survivor...bilateral. The right leg broke in March, the left one in July,
2009. I also suffered a compression fracture at L1 in May. I was given Fosamax™ 10 years ago as a
preventive measure. Now I am worse than I would have been 20 years down the
road. I cannot begin to tell you that there are women breaking a leg
everyday! And they do not know why. It was through the fact, that the
orthopedic doctor who took my emergency case on the first leg, had just
received some information about the bilateral fractures. If you held my x-ray
up against several other women’s, you could not tell us apart! I hope you continue to write and correspond about this important subject. My life has been taken away from me in a way that I never dreamed would happen.
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My Reply to VS – These Are Bad Drugs
Dear VS,
Thanks coming forward to share your story of Fosamax induced Femur Fractures. As you know, this type of fracture is very unusual, and only occurs in abnormal bone. This is called "pathological fracture" and is caused by change in bone quality induced by Fosamax™. These pathological mid femur fractures heal very poorly even with the best of treatment. Fosamax™, Actonel™, Boniva™ and all the bisphosphonates work by killing the osteoclast bone cells. This creates pathologic abnormalities in bone architecture that leads to increased bone density on the DEXA scan. Paradoxically, this dense bone is weaker, brittle and prone to pathological fracture at the mid-shaft level of the femur. A fracture at this mid -femur location is highly characteristic of a Fosamax induced fracture. We have been hoodwinked by the Sally Fields Television ads and deceitful marketing campaigns. These are bad drugs. I predict that as mid-femur pathologic fractures become more common, people will start to wake up, and eventually these drugs will be banned. VS, I am very sorry that this happened, and hopefully your efforts will educate others about this pitfall.
Sincerely, Jeffrey Dach MD |
Reports of Spontaneous Mid Femur Fracture on Fosamax
Clarita Odvina MD reported nine cases of spontaneous femur fracture on Fosamax™ (Alendronate). (2) Dr. Goh, a doctor in Singapore, identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. (3) Joseph M Lane MD reported 15 cases of spontaneous femur fracture in women on Fosamax (Alendronate). His report appeared in the New England Journal March 20, 2008. (4) Dr. Lane found that "ten of the 15 patients were found to share a unique radiographic pattern, defined as a simple transverse or oblique (30°) fracture with beaking of the cortex and diffuse cortical thickening of the proximal femoral shaft." (4)
More Case Reports from Jennifer Schneider MD
These additional case reports were published in 2009 Geriatrics by Jennifer Schneider MD (1):
“A 66-year old, previously healthy woman developed a spontaneous stress fracture of her right foot, which eventually healed. Nine months later she took a step in her bedroom and collapsed to the floor. An x-ray revealed a nontraumatic fracture of her right femur. She underwent surgery with placement of an intramedullary rod. Her physician told her she had most likely had a stress fracture, which became a completed fracture. A bone scan done shortly after her surgery revealed a stress fracture of her left femur. Some months later she underwent prophylactic rodding of the left femur. The patient had been on alendronate for 7 years.
A 65-year woman visiting Europe stepped off the bottom step of a van and collapsed. An x-ray revealed a nontraumatic fracture of her left femur. She had been experiencing a dull ache in her left femur for some months. The patient underwent placement of an intramedullary rod. One year later she developed a dull ache in her right femur. A bone scan showed a stress fracture in the right femur. A bone specialist recommended prophylactic rodding of the right femur, which was done. The patient had been on alendronate for 9 years.
A 59-year-old-woman took a step, her right leg gave out, and she fell to the ground as she heard her leg break. Her femur was fractured. The orthopedic surgeon on call told her, “We don’t usually see this type of fracture without trauma.” For the preceding year she’d experienced pain in her right thigh, which was severe enough to cause limping. An x-ray had been negative, and her primary care physician thought she had fibromyalgia. She had been on alendronate for more than 5 years.”endquote Dr Jennifer Schneider . (1)
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Drug Companies Fight Back Attempting to Exonerate Fosamax
The drug companies are aware of this problem, and are fighting back by paying doctors to deny the link between fosamax and pathological fracture of the femur. An example is this study of the Danish National Bone Registry: (6)
"Something is Rotten in Denmark"
The title is : Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated With Alendronate: A Register-Based National Cohort Study by Bo Abrahamsen in the June 2009 Journal of Bone and Mineral Research. The author says, "Recent reports have found long-term Alendronate use to be common in patients with subtrochanteric or proximal diaphyseal femur fracture, raising concerns that these fractures could be a consequence of excessive suppression of bone turnover." (6)
Fosamax Doubles the Risk of Subtrochanteric Fracture
Even though the Danish Registry data actually showed the Fosamax™ (alendronate) group had an increased incidence of subtrochanteric fractures (2.9 vs. 1.6 per 1000 patient years), nonetheless, Dr. Bo Abrahamsen concluded the cause was osteoporosis and NOT the Drug !! Here is the author’s conclusion: "Subtrochanteric/diaphyseal femur fractures ... are best classified as osteoporotic fractures." In my opinion, this conclusion is not only wrong, it is blatantly wrong. These mid-femur fractures are NOT osteoporotic fractures. This is blatantly obvious. I will explain why below.
Authors On Drug Company Pay Roll
Here is a list of author's competing interests:
Dr. Abrahamsen receives consultancy fees from Nycomed and Novartis, research grants from Roche, and speaker's fees from Servier, Eli Lilly, and MSD. Dr. Eiken receives speaker fees from Nycomed, Roche, and Servier. Dr. Eastell receives research funding or consultation honoraria from Amgen, AstraZeneca, Aventis, Eli Lilly, GlaxoSmithKline, Hologic, Interleukin Genetics, Kyphon, Lilly, Maxygen, Nastech Pharmaceuticals, Nestle Research Center, New Zealand Milk Limited, Novartis, Novo-Nordisk, Ono Pharma, Organon, Osteologix, Paraxel, Pfizer, Procter & Gamble, Roche Diagnostics, Sanofi-aventis, Servier, Shire, Transpharma Medical Limited, Unilever, and Unipath.
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Sound familiar?
Fosamax™ Induced Fractures have a UNIQUE Radiographic Appearance
Joseph M Lane MD reported a unique radiographic pattern of these Fosamax induced fractures.(4) This means these spontaneous mid-femur fractures are pathological fractures induced by the drug, and virtually NEVER happen unless the patient is on a bisphosphonate drug like Fosamax™.
The Anatomy Dictates that the Femoral Neck Will Fracture First
Osteoporotic fractures present most commonly as compression fractures of the vertebral bodies, or as femoral neck fractures. Even in cases of severe osteoporosis, the femur never spontaneously fractures at the mid femur level simply because the anatomy dictates that the femoral neck will fracture first. I have known this from personal experience as a radiologist for thirty years reading X-Rays of fracture cases. A spontaneous mid-femur fracture is extremely rare and indicates a pathologic fracture caused by a drug or disease process.
Fosamax Same Unique Pattern As Rare Genetic Bone Disease of Toulouse Lautrec
Left Image: Henri de Toulouse-Lautrec, one of the greatest painters of the Post-Impressionist period. 1864- 1901. Note short stature caused by spontaneous bilateral mid-femur fractures as a child from genetic bone disease called pycnodysostosis
Another important observation is the similarity between Fosamax™ induced femur fractures and a rare genetic bone disease, Pycnodysostosis, also called Toulouse Lautrec's Disease.(7-8) This genetic disease causes malfunctioning osteoclasts, the same mode of action of the drug, Fosamax™. The famous French Impressionist artist, Toulouse Lautrec suffered bilateral femur fractures as a child which never healed properly resulting in short stature, as shown in old photographs.(8) Lautrec's femur fractures had the same unique radiographic appearance described by Dr Joseph Lane for Fosamax™ induced femur fracture.(7-8)
Summary: Fosamax™ induced mid-femur fractures have a unique radiographic appearance, and share this unique appearance with a rare genetic bone disease (Toulouse Lautrec's Disease). Therefore, these mid-femur fractures are not typical osteoporotic fractures, they are a distinct form of pathologic fracture induced by the drugs, Fosamax, Actonel and Boniva. These are “Bad Drugs” that should be banned or severely curtailed.
References for Chapter 34. Fosamax™ Induced Femur Fractures
(1) http://www.jenniferschneider.com/articles/Bisphosphonates.pdf Bisphosphonates and low-impact
femoral fractures: Current evidence on alendronate-fracture risk by Jennifer P.
Schneider, MD, PhD. Geriatrics.2009;64(1):18-23.
(2) http://jcem.endojournals.org/cgi/content/full/90/3/1294 The Journal of Clinical
Endocrinology & Metabolism Vol. 90, No. 3 1294-1301 Severely Suppressed
Bone Turnover: A Potential Complication of Alendronate Therapy Clarita V. Odvina, Joseph E. Zerwekh, D.
Sudhaker Rao, Naim Maalouf, Frank A. Gottschalk and Charles Y. C. Pak
(3) http://www.jbjs.org.uk/cgi/content/abstract/89-B/3/349 Journal of Bone and Joint Surgery - British Volume, Vol 89-B, Issue 3, 349-353. Subtrochanteric insufficiency fractures in patients on alendronate therapy A CAUTION, S.-K. Goh et al.
(4) http://content.nejm.org/cgi/content/full/358/12/1304 NEJM Volume 358:1304-1306 March 20, 2008 Number 12. Atypical Fractures of the Femoral Diaphysis in Postmenopausal Women Taking Alendronate Brett A. Lenart, B.S. Dean G. Lorich, M.D. Joseph M. Lane, M.D. Weill Cornell Medical College New York, NY 10021
(5) http://www.medpagetoday.com/MeetingCoverage/ASBMR/10904 Alendronate Exonerated in 'Atypical' Femoral Fractures By Michael Smith, North American Correspondent, MedPage Today. September 15, 2008 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco .
(6) http://onlinelibrary.wiley.com/doi/10.1359/jbmr.081247/pdf J BMR, Volume 24, Number 6, 2009, Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated With Alendronate: A Register-Based National Cohort Study Bo Abrahamsen,1 Pia Eiken,2 and Richard Eastell
(7) http://hormones.gr/preview.php?c_id=38 Pycnodysostosis: Toulouse-Lautrec's and Aesop's disease? By Christos S. Bartsocas. HORMONES 2002, 1(4):260-262
(8) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1811887/?tool=pubmed Proc R Soc Med. 1970 Aug; 63(8):800-5.Toulouse-Lautrec--triumph over infirmity. Cawthorne T.
Author: Dr Dach
Jeffrey Dach MD