WEEKLY HEALTH BULLETIN July 25, 2009
DRUGS FOR YOUR BONES.
Follow the rules or pay the price
Drugs like Fosamax and Atonal are multi-billion dollar drugs used to treat osteoporosis. These are two commonly prescribed members of a class of drugs known as oral bisphosphonates. Bone is constantly being built and broken down. Bisphosphonates harden bone by slowing down the normal breakdown process.
Bisphosphonates therefore build mass by accumulating old bone, a fact that raises a lot of concern about the longer term impact of these drugs on bone health. It also helps explain why the data actually shows these drugs don’t work very well in the first place, in spite of what you hear from some doctors and TV commercials.
HARD-TO-FOLLOW DOSING PROTOCOL
People who take these questionable drugs need to follow the dosing instructions closely or they risk putting themselves in harm’s way. No other drug demands such a difficult-to-follow, elaborate ritual. You take them first thing in the morning with a glass of water. Then you have to remain upright for 30 minutes before eating or lying down. Failure to do so risks injury to your esophagus, which runs from your mouth to your stomach.
ESOPHAGEAL INJURY POSSIBLE
Crystalline material similar to ground Fosamax tablets have been found in patients with erosive esophagitis. Damage to the mucosa lining the esophagus has been observed in some of these patients, which suggest cancer causing potential. Indeed, recent reports have linked the use of bisphosphonates with esophageal cancer (New England Journal of Medicine, 2009, 360).
It’s hard to know how common these serious gastrointestinal problems really are. In the original trials conducted by Merck, there was little difference in the frequency of gastrointestinal side effects between those people who received Fosamax and those who received placebo. In the real world, however, these side effects may be a much more serious problem than these studies let on.
REAL WORLD VS. CONTROLLED STUDIES
The vast majority of these gastrointestinal problems can be prevented by closely following the dosing instructions. These make sure you get the pill out of your mouth, through your esophagus and in an out of your stomach as quickly as possible with minimal contact with the delicate mucosal ling of these organs.
Any deviations from the strict dosing procedure can result in serious tissue injury and reduced absorption.
For example, in the elderly who are taking many pills at different times of the day it may be easy to get confused about what’s what, a recipe for disaster with this caustic, injurious drug. I regularly encounter patients who report difficulty in adhering to this strict dosing requirements.
CANCER A POSSIBILITY
In clinical trials, we can be sure that the companies who run them go out of their way to make sure patients take these drugs correctly. In the real world of rushed 12 minute appointments, this does not always happen. Related gastrointestinal problems can be quite serious. The FDA has received over 40 reports of esophageal cancer related to Fosamax use; 14 resulted in a patient’s death.
The median time from starting the drug to cancer diagnosis was 2.1 years in this country and just 1.3 years in Europe and Japan.
Not surprisingly, there have been subsequent analyses by doctors working for Merck and other drug companies denying the connection between these drugs and cancer.
WHY TAKE THE CHANCE?
You will continue to hear from doctors and the mainstream media that there is no definitive proof of harm. This is irresponsible. There are enough troubling red flags in this picture for us to demand proof of no harm. Of course the idea of pulling a $3.6 billion drug off the market is a pipe dream, at best. This shouldn’t stop you from deciding to stop taking the drug yourself, especially since taking it is highly unlikely to be of any benefit whatsoever, based on the available research.
DO THESE DRUGS WORK?
That’s right, like so many other drugs we rely upon in our drug loving health care system, the data shows that bisphosphonates don’t make in any difference in the vast majority of people who take them. For example, one the first studies for Fosamax showed it reduced the absolute chance of getting a hip fracture in women who already have osteopororis by a mere 0.3% — from 0.5% a year to 0.2% a year. This means 81 women with osteoporosis have to take Fosamax for a 4.2 years (a cost of over $300,000) to prevent one of them getting a hip fracture. Boy, that drug doesn’t work very well! Yet doctors continue to blithely dole out these expensive, dangerous drugs oblivious to the true risks they pose to their patients. (JAMA 1998; 280).
You’ll be able to find out more in an upcoming issue on preventing and treatment of osteoporosis – whether you’re a man or a woman – without resorting to the usual drugs, which aren’t much good anyway.
Alan Inglis MD
American Country Doctor