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In the interest of ‘multiliteracies’ I have decided to use this personal blog space to address issues that speak to alternative kinds of literate abilities that it appears we need to develop nowadays. Although I have many to choose from, (e.g., financial literacies, how to navigate the cable and phone companies when you have a problem etc.) the one I shall begin with is more personally significant and may have very real implications for many readers and their families. It concerns the ‘marketing of osteoporosis’ and ‘how a risk factor became a disease’ (see Napoli, M. 2009, The marketing of osteoporosis,AJN, 109(4), 58-61))
The Personal Story
In 2008, my mother was vacationing in Rio de Janeiro, Brazil, when her femur broke while she was standing on the beach. (Lesson #1 – have travel insurance. She did, thankfully, as they demanded $100,000 on a Sunday before they would touch her). In March 2009, the fracture had not healed, so a ‘revision surgery’ was done here in Canada (the Brazilian rod removed, and a new rod and pins put in). By fall, the fracture was still ‘non-union’. Around the same time, she was due to have some dental work done and her dentist advised her to stop using her osteo meds as studies were indicating that this group of drugs interfered with healing and sometimes led to jaw bone death. She did as she was told, and during the short window she was required to go off the drugs for the dental work, she showed the first slight signs of bone being ‘put down’ in her femoral xrays.
This concerned us and we began to seek further information about this medication. We learned of some emerging concerns surrounding the use of these medications she (and increasing numbers of women) have been prescribed for osteoporosis (under the name Fosomax , Actonel, Boniva or Reclast for example – all bisphosphonates aimed at ‘strengthening the bone’). These drugs were originally prescribed with the hope that hip fractures would be reduced. Approved in the absence of long-term studies, we are now learning that the drug may be causing the fracture and preventing the healing.
My mother’s family physician and specialist told us that the benefits of the drug outweighed the risks. After exhausting ideas about why her leg was not healing, her specialist referred her to a second specialist. Within five minutes, the second specialist was showing us on the Xray and CT what he described as ‘the hallmark signs of an ‘actonel fracture’. He also told us that he has seen a sharp increase in this type of fracture caused by this drug in his practice alone. When I questioned him about how we can get this information both back to the family physicians and the others in orthopedic specialties, he said “It is out there, but the pharma companies are really aggressive in their promotion of these drugs”.
My mother is a very young 72, and has been on this drug for more than four years. Since the fracture, she has had to take time off of work , lost a year of driving (aka independence), was forced to move from the home she lived in for 52 years to move to a single level home. Most important to her, she has been unable to travel to visit her grandchildren overseas. She has now been pulled off these drugs, and was told that in all likelihood she will have a third surgery in six months.
What can we do?
From our conversation with her most recent specialist and our own subsequent reading, it is apparent that this drug is widely prescribed in Canada, (reportedly 7 million women in Canada) as it is in the US – meaning that many of you may have a parent, friend or relative taking this medication. As a family, we are working to get this information communicated in a more comprehensive way so that people are well informed of the potential risks. Physicians are not able to go public with patient stories for obvious privacy reasons. I would like to make this information as public as possible. If you or someone you know has been affected by this drug, and you are willing to share your story with Canadians, please contact me as I am gathering stories in an attempt to get a sense of the extent to which Canadians have been affected.
Is ‘Jaw Bone Death’ the ‘canary in the mine’ for future problems in the femur?
I am also interested in hearing from physicians and health care professionals. If you wish to participate in this conversation I can arrange to gather your information under a promise of anonymity. We are concerned about incentive programs and financial ‘conflict of interest’ issues that form part of the systemic conditions that we now find ourselves in, and we are interested in working to improve these conditions in the interest of patient care.
Who Should We Blame?
I often get asked who is to blame in this situation. I believe that we are all complicit. Our government needs to review our regulatory systems to ensure that emerging issues with medications on the market are reported immediately, so that we are making decisions with all of the information available. It is distressing to learn that patient safety warnings in the UK or the US include more information than we do – simply because they have successfully sued the company. Why would this information not be automatically added to all labeling?
Physicians and surgeons need to do a better job of listening to the patient and looking at the big picture. My mother’s first surgeon in Brazil told her that is was impossible that her leg just fractured – because it was outside of that physician’s current understanding, knowledge and experience of femoral fractures to date. What if my mom’s physician had accepted that, as my mother said, the bone had indeed ‘just broke’? Might she have investigated causes of femoral fractures that occur with little or low impact rather than dismissing her? A simple ‘google’ search of spontaneous femoral fractures could have helped her connect the dots in 2008.
Her second specialist focused solely on the technical fracture; he was unaware of her status as a cancer survivor or her history at all until we pointed out critical information that we assumed he had reviewed to prior to making health-care decisions or recommendations. We believe that this is one of the outcomes of an unmanageable caseload, as it was clear that he was seeing hundreds of patients per day. While we acknowledge these challenges, the systemic conditions that have led doctors to practice in this way are not without very grave implications to patient care.
Patients (and their families) must become more actively involved in the decision-making process and learn how to ask the important questions that need to be asked, and take the time to learn as much as you can about the care you are receiving; what is known about the medication you are being prescribed, the population, dosage and time for studies that approval decisions were made on etc. Bring a critical eye to the information you read. Who is producing it? Who is funding the author(s) of the study?
As a family, we have also personally benefited from the advances of science and the new medications that have emerged in the form of managing chronic illnesses and battling cancer. We realize that ‘big pharma’ has contributed a great deal to this part of our lives as well. However, the business goals of maximizing profit often run afoul of the health care goals that focus on improved patient care. Would my mother have taken this drug if we were aware that there was a possibility of a femoral fracture? Well, it is possible. To be honest, when I review the list of ‘possible side effects’ that come with most medications, they often seem worse than the presenting symptoms. However, had we known that bisphosphonates carried a risk of femoral fracture -no matter how small the current literature claims – we would not have wasted the past two years, and two surgeries searching for answers and still taking the very medication that has been causing the problem. That is what is particularly disheartening. Had the risk been noted on the packaging, it would have alerted the first physician in 2008 to take her off the medication, and her healing could have started then.
The scientific literature currently reports that there is minimal ‘proof’ of a connection. What they don’t report is the context for this claim; a context that makes visible the lack of data they have to make any kinds of claims. They don’t have sufficient numbers to make any broad generalizations – but in the absence of those numbers, they should not side be so confident that it is not going to do harm. How many others are in the same situation that we have been for the past two years? How can an accurate picture emerge when so many surgeons and physicians appear to be unaware that there is potential for this drug to be doing so much harm??
Please pass this information along to others that will benefit from knowing about it. Let’s work together to improve public education about this very serious drug complication.
UPDATE: Sept. 14th, 2010
CTV National’s Health Reporter Avis Favaro created a ‘feature report’ on this story, the same day that a Report of a Task Force of the American Society for Bone and Mineral Research calling for a National Registry of women with fractures. Although currently considered ‘rare’ the growing concern expressed (and we share) is that we are quite possibly unaware of the extent to which women may have suffered fractures that have been treated and never connected back to their medication. Better labelling on the packages and raising awareness with both patients and medical care-givers is critical to establish a more accurate picture of the disturbing picture that is emerging.
UPDATE: October, 2010
After years of careful responses that suggested that there was no evidence that Bisphosphonates were connected to increased risks of femoral fracture, the FDA has now issued a warning of femoral fracture risk with bisphosphonates and notified the public that the warning will be added to patient drug labeling. The lack of evidence led to the lack of an earlier warning. Customarily, Canada followed suit: Osteoporosis Canada published Information for Patients, and new Clinical Practice Guidelines that represent a “paradigm shift in the prevention and treatment of osteoporotic fractures, moving the focus from treating low bone mineral density (BMD) to better identifying fractures caused by weakened bones (fragility fractures). All still believe the incidents to be quite rare. I hope they are, but am pleased to see that we are going to participating in an international database so that the actual number of fractures can be better measured. If doctors are unaware of the connection and therefore don’t attribute the fracture to a possible association to bisphosphonates, then it is difficult to say just how rare these fractures may be.
UPDATE: February 2011
Since I have received so many email from people asking, I thought I would add our latest update. My mom walked into her appointment with her specialist recently, without the aid of crutches and in the absence of any significant pain. The xrays revealed that indeed, three of four sides of the fracture have shown significant healing. She was given the ‘green light’ to travel, and so, two and a half years after the initial fracture, she is in the UK, visiting her grandchildren. She will continue physiotherapy to ensure that her walk is as mechanically correct as it can be.
Remarkably, in our conversation with her specialist, we learned that since the story was aired on CTV less than six months ago, the number of patients that he saw with a related injury went from 15 to 320! This is in ONE doctor’s practice, in one Canadian city. How might we better facilitate ways to communicate so that we might all be better informed?
Contact: Kathy Hibbert firstname.lastname@example.org