Once again bisphosphonates, the most widely prescribed osteoporosis drugs, are linked to a dangerous condition. This time, it’s cancer of the esophagus, one of the deadliest cancers.
Not long after a recent flurry of reports on atypical femur fractures observed by long-term bisphophonate use, a new study in the UK sheds light on the link of oral bisphosphonates – Fosamax, its generic alendronate, Actonel, Boniva, and Didrocal – to an increased risk for esophageal cancer.
You can read the complete article below:
Osteoporosis drug ‘doubles cancer risk'
A drug taken by more than a million people with osteoporosis could double their risk of developing cancer of the oesophagus, according to a study published today.
By Stephen Adams
Published: 12:01AM BST 03 Sep 2010
Those who have taken oral bisphosphonates for five years or more are twice as likely to develop the cancer than those who have not, the analysis of medical records found.
Every year almost 8,000 people in Britain are diagnosed with cancer of the oesophagus, or gullet cancer, and about 7,500 people die from it.
Survival rates are low compared to other cancers, with only three in 10 surviving more than a year after diagnosis.
Among the general population of people aged 60 to 79, the chance of developing oesophageal cancer is about one in 1,000 over five years.
But researchers found that among those who had taken oral bisphosphonates for five years or more the rate doubled to two in 1,000 over the same period.
Among men it increased from 1.5 to three per 1,000 and among women from 0.5 to to one per 1,000.
Last night the Medicines and Healthcare products Regulatory Agency (MHRA), the Government's medicine's regulator, said there was “no need” for patients to stop taking the medication on the basis of he study alone.
The MHRA collaborated with academics at Oxford University's Cancer Epidemiology Unit to look at data from the UK General Practice Research Database, which has anonymised patient records for around six million people.
Among those aged 40 and over, 2,954 had oesophageal cancer, 2,018 had gastric cancer and 10,641 had bowel cancer, all diagnosed between 1995 and 2005.
The results also showed that the chance of oesophageal cancer was 30 per cent higher in people with one or more previous prescriptions for oral bisphosphonates, compared to people who had never taken the drugs.
The risk was almost double for those who had 10 or more prescriptions compared with those who had had between one and nine, according to the study, published today in the British Medical Journal (BMJ) online.
There were no links between the drugs and stomach or bowel cancer.
Some three million people suffer from osteoporosis, according to the National Osteoporosis Society. The Duchess of Cornwall, whose mother and grandmother both died of the disease, is president of the charity.
More than a million people were prescribed a bisphosphonate in 2009/10, according to the MHRA, which work by preventing bone loss and rebuilding lost bone. More than 6.5 million prescriptions were issued.
They are a group of drug that include alendronate, etidronate and risedronate.
Doctors often prescribe them as a preventative measure for those who might be at a higher risk of osteoporosis, such as post-menopausal women.
However, some doctors are becoming concerned that they are being over-prescribed with scant thought of their side effects, which are known to include difficulty swallowing, chest pain and heartburn.
Dr Des Spence, a Glasgow GP who has also written on the subject in the BMJ, said doctors should focus less on the drugs and more on how to avoid falls, as well as on improving diet and increasing targeted exercise.
Dr Spence described the study as “very telling”.
While he said oral bisphosphonates were commonly used to prevent fractures in people who might be at risk of osteoporosis, he thought that approach “isn't supported by the evidence”.
He was unconvinced the benefits outweighed the risks, he added.
If the cancer link proved correct, he said “this would be an opportunity to reflect and think about the use of this medication, particularly in people who havenot had a history of fracture.”
Dr Jane Green, lead author of the study, said their results were “part of a wider picture” because bisphosphonates were “increasingly prescribed to prevent fractures”.
She said: “what is lacking is reliable information on the benefits and risks of their use in the long-term.”
But she added: “Oesophageal cancer is uncommon. The increased risks we found were in people who used oral bisphosphonates for about five years, and even if our results are confirmed, few people taking bisphosphonates are likely to develop oesophageal cancer as a result of taking these drugs.”
Their study contradicts one published only a few weeks ago, using the same dataset, that showed no link between the drugs and the disease.
However, the latest research followed patients for almost twice as long and had greater statistical power.
A spokesman for the MHRA said: “On the basis of the findings of this study there is no need for patients to stop taking their bisphosphonate medicine.
“However, in order to reduce the risk of oesophageal irritation, which is a recognised risk associated with bisphosphonate use it is important to carefully follow the instructions in the Patient Information Leaflet.
“Patients should also report any signs of oesophageal irritation such as difficulties or pain on swallowing, chest pain, or heartburn to their doctor.”
He added: “The safety of all bisphosphonates will continue to be closely monitored.”
Dr Laura Bell, science information officer at Cancer Research UK, said: “This is an important study that will help doctors understand more about the risks and benefits of oral bisphosphonates but it's important to stress that even if people take oral bisphosphonates for a long time the risk of developing oesophageal cancer is still small.
“Anyone who is taking these drugs and is worried about their risk of cancer should talk to their doctor.”
A spokesman for the National Osteoporosis Society said: “When you consider the fact that there are 230,000 osteoporotic fractures every year in the UK and 1,150 hip-fracture-related deaths every month, the case for treatment is strong.
“In addition, the researchers point out that the risk is small and that few people taking bisphosphonates are likely to develop oesophageal cancer.”
When will the medical establishment remove its blindfold and realize that bisphosphonates are a modern-day Hydra? The mythological multi-headed and venomous serpent confronted by Hercules grew two new heads for each one that Hercules chopped off. But in the end and after an arduous fight, Hydra finally perished.
Old News for the Save Our Bones Community
I won’t dwell in the “I-told-you-so” – I promise you – but this is certainly no news for the Save Our Bones community. Almost two years ago, in December of 2008, I posted an article titled ‘New Year Off to a Bad Start for Osteoporosis Drugs’. In it I quote a mainstream article on concerns about the possible link of bisphosphonates and esophageal cancer.
This might have stunned the medical community, especially in light of recent studies showing exactly the opposite.1 Yet they seem to have recovered fast from the initial shock, at least judging by the comments of the MHRA spokesman, as quoted in the Telegraph article: “On the basis of the findings of this study there is no need for patients to stop taking their bisphosphonate medicine.” Or worse, in an interview published by Medscape, Dr. Gerard Blobe, an expert in esophageal cancer, comments that “Clinicians should not stop prescribing oral bisphosphonates… Noncompliant patients might be the ones who develop problems.”2 In other words, according to Dr. Blobe, problems arising from bisphosphonates are self-inflicted by patients who don’t follow their doctor’s “orders”.
Collectivism and the Medical Establishment
But more importantly – and what is most disturbing – is the collectivist philosophy of medical scientific research that condones statistically low yet terrible drug side effects. Because in their view, individuals are reduced to mere numbers. Where is the moral integrity of accepting that it is OK for a small number of people to suffer for the good of a much larger group? The medical establishment seems to tacitly agree on the rules of Russian roulette.
But you and I know that each person counts; each “statistic” is someone with a life, family, friends, hopes, dreams, desires, and feelings. It is morally contemptible in my opinion, to consider statistics as a viable explanation of potential random “collateral damage”. This is especially relevant in the case of osteoporosis, since we are not dealing with a lethal condition.
The Osteoporosis Reversal Program offers bone health solutions without costly drugs and their dangerous side-effects. At Save Our Bones each individual counts as an important part of our community; as valued human beings that strive to be healthy, so they can lead happy and productive lives.
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Till next time,
1 Chris Cardwell, Christian Abnet et al.. The Journal of the American Medical Association. Exposure to Oral Bisphosphonates and Risk of Esophageal Cancer. Volume 304, Number 6, August 11 2010, 657-663.