Study, which contradicts earlier research, looked at patients for longer time period
Article Source: msnbc.com
from:msnbc.comOsteoporosis drugs may raise esophageal cancer risk
Seeded on Thu Sep 2, 2010 7:13 PM EDT (msnbc.com)
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Finding an absolute increase in incidence of 0.1% in a retrospective, non-randomized analysis is, for all practical purposes, a worthless information. This has no statistical significance whatsoever. In other words, the difference in cancer incidence between the patients who took these medications and those who did not, can be attributed to pure chance alone. This is not my personal opinion. This is how all properly conducted medical (or any other scientific) studies are analyzed. Unless the statiscical analysis shows a significant enough difference between the groups (eg. p value < 0.05), any observed difference may be attributable to random chance. If the investigators were truely out to learn the cause-and-effect relationship between bisphosphonates and esophageal cancers, they should have conducted a double-blinded, randomized trial. I am not making any statement here on whether or not I believe there is such a relationship. What I am stating, however, is that this article reported in the BMJ offers useless information while potentially instilling an unwarranted fear to the public. Many medical journals in Europe frequently publish articles that would be flatly rejected by their American counterparts for poor quality controls or questionable analysis. One well-publicized example is that of Lancet publishing (then retracting years later) the study that claimed a cause-and-effect relationship between MMR vaccine and autism.
I imagine that this might be related to the increased incidence in esophageal erosions that are a complication of this medication. I am surprised that the reviewers of the original article did not require the authors to control for this known risk factor in their analysis.
Your comment about the publication of the study related to the MMR vaccine is completely unfounded. Based on the data that was presented for publication by Wakefield, the study definitely warranted publication. The Lancet had no way of knowing that Wakefield had purposely manipulated and falsified the data presented in his study. The retraction of the publication of the study came about because the evidence surfaced that Wakefield had been working with an attorney when he conducted the study and was basically paid to make sure the study said there was a link between Thimerosal (not the MMR vaccine per se as you stated) and autism. Again, at the time of original publication the Lancet had no way of knowing about this. In the future, please make sure you have your facts straight before you denigrate an outstanding publication like the Lancet. I have not seen any major difference in the peer review process used by medical journals in Europe and those in the US. Medical journals in the US have also been forced to periodically backpedal on previously published research for various reasons. None of these event have been due to shoddy peer review processes, but rather new information coming out about the studies as well as new studies indicating different results.
As far as the publication of this particular study, a doubling of a risk, even one as slight as one in 1,000 going to two in 1,000, warrants publication. I agree that there are problems with going back and doing paper studies based on previously collected data (e.g. accounting for other variables), but the technique is generally accepted in the medical research community in both Europe and the US. The study as well as this article makes it clear that there is still a very small risk involved. It clearly states that this should not be a major factor in deciding whether a patient should be place on this class of drugs or not. What it does seem to point out is that there is still much that is not known about the long term effects of this class of drugs. This is good information for doctors to have when it comes to patients encountering related symptoms following a prolonged period on the drug and could provide some diagnostic guidance. Also, did you actually get the data to calculate the p value for this studies results or are you just throwing out terms to try and make your argument sound better. I did not see enough info in the article to calculate the p value, so you either have a source for the data or are just blowing smoke. Conducting a controlled, double blind experiment to verify the data is of course the ideal path to take. Unfortunately, this would take years to complete since the issue is the long term effects. It is better to get the information out based on the retrospective paper study so that doctors can be aware to watch for the problem than to leave the doctors in the dark about it for more than five years until a study could be completed.
JS in SD, seriously you are defending Wakefield at this point? Maybe he was not a charlatan or a fraud, but his results have not been supported by others.
To be fair, many American medical journals publish articles that would be flatly rejected by their European counterparts due to poor quality controls or questionable analysis. Let's hope that this published news article regarding this is flat out wrong because there are many people on these kind of meds and where I work we have to take special caution as it is with patients who had no idea about certain findings in recent years regarding oral surgery treatment and possible complications while being on these kind of meds.
Oral Surgery Assistant Extraordinaire,
Pamela
These drugs do cause osteonecrosis of the jaw..and complications in providing routine dental treatment....mainly iv injections for breast cancer are the culprit.......however long term use of the pills is still being figured out and the public....ie women are the long term guinea pigs......perhaps the benefits of the drugs out weigh the risks ............dentists hate them........pulling a tooth could turn in to a permanent nonhealing hole for a patient and now dentists have to tell women patients this every time they need work and the patients are always shocked to find out because their doctors never discuss this with them. nearly every women over 60 is taking them.
this complication does not commonly occur in patients taking bisphosphonates for osteoporosis. it is much more common in those taking bisphosphonates for the treatment of hypercalcemia of multiple myeloma and other malignancies. a 2006 german study found 97% of 300 cases of onj to occur in cancer patients, and 3 cases of onj in 780,000 patients taking bisphosphonates for osteoporosis prophylaxis and/or treatment (.00038%).
I took Actonel for 18 months. I, physically nor genetically, am not a normal candidate for osteoporosis but I followed my doctor's advice. The side effects were horrible. What I didn't know were the side effects that included debilitating UTI symptoms (tests showed no infections) and extreme bone pain. After multiple expensive tests and doctor visits that found nothing seriously wrong, and with the bone density test in question, I voluntarily quit taking the Actonel. My doctor was not happy. For the most part the symptoms disappeared. The pain in my hip remains and after repeated xrays and cat scans, there appears to be nothing that could be causing the pain.
These drugs were not meant to be taken long term. Prescribing them for a woman in her 70's or 80's makes sense, but not in her 50's. We just don't know the long term effects.
What it comes down to is did I want a good quality of life for the next 20 years and take a chance of breaking a bone when I'm 80, or to suffer for the next 20 years with the side effects. I chose to live my life pain and symptom free.
I refused to take Actonel despite osteopenia. I walk 2 miles a day and now go to the gym every day and walk another 2 miles and lift weights. I will not take drugs unless absolutely necessary after taking Prem pro for years . It was the perfect pill my doctor said. Turns out he was wrong.
Susan: Why do you say that taking Prempro for years was a problem? I took Prempro for over 15 years, and I never had any problems with it at all. I recently went off Prempro because I had been taking it so long, and the only problem I had was a mini-menopause period of hot flashes and night sweats, but that disappeared after a month or so. I don't consider my doctor to be wrong in prescribing it -- everyone's body is different. Some people can take medications and have NO problems; others have problems. It's pretty much the luck of the draw in my book, but I prefer to know about these things ahead of time so I can make a valued judgment with my doctor as to whether or not I want to take the medication. My doctor and I have a good relationship, and he and I make decisions together based on my own personal condition and health.
Although the average risk for cancer of the esophagus is low, there are women, such as those who have had a long history of acid reflux, who are already at higher risk and they need to know how much this will increase their risk. And a lot of presently young women will be at risk when they reach that age because they had GERD as kids or teens due to asthma meds.
Drug companies and doctors over-medicate us. People are on medicines to treat side effects of medicines. And watch out if you are being treated for something that has been treated safely for generations, like thyroid. Rather than increase something safe even when blood tests show you need a higher dose your suppliment (which drug companies can't get rich off of because they are not new and under patents) your doctor will start trying to add meds to treat symptoms.
I personally feel my health is being compromised because of the refusal to properly and safely treat a known medical problem, while trying to treat symptoms of that problem instead with the latest and greatest drugs full of dangerous side effects.
Obviously you don't have a thyroid problem, or if you do, not a very bad one. I'm not a pill popper, but would fight to the death if someone tried to take my thyroid medication away. If your thyroid problem is caused by an auto-immune disorder (like mine) there isn't an acceptable non-medical option and I certainly am not going to deal with all the problems I had prior to being put on medication.
Same for me with Crohns Disease. Not taking meds to control it can assure me of horrible pain and another resection, or worse. I also have been on Fosamax for years, as I am very small boned and am pre osteoporosis, or whatever the term is they use. Damed if you do take meds, damned if your don't. I guess I can expect to self-destruct at any moment.
Let me live: Apparently you did not understand. I am fighting to stay on and even increase my thyroid suppliment to proper levels, but because it is a medicine that has been around forever, the drug companies and doctors keep wanting to use new meds (NOT THYROID) to treat individual symptoms. The doctors want to keep the dose really low (while TSH levels keep RISING) and treat me separately for cholestrerol and each of the other symptoms of low thyroid. (The cholesterol medicine tried to shut my kidneys down and cause extreme muscle pain and I have read up on and found I would probably have the same side effects with all of them.) They are afraid of making me hyper, when my levels are just barely within "normal" (TSH 4) by their lab's standards, but considered hypothyroid by a number of other labs which consider anything over TSH 3 to be hypo. I'm pretty sure pushing meds for osteoporosis will be next, when again they could lower my risk by simply properly treating the thyroid.
Thyroid suppliments are now usually synthetic rather than natural, but still proven safe when used in doses that suppliment what is lacking since the early 1900s. My mother was on thyroid from either the late 40s or early 50s. Problem is, doctors want to rely on what a lab says, instead of whether their patients are healthy on the dose.
I also found out the doctor used scare tactics to get me to take the cholesterol meds, by claiming I had really high dangerous cholesterol numbers. I found out after I had such a bad reaction, and demanded the lab tests (they did not want to give them to me) that my thyroid was lower (TSH higher) and cholesterol was just barely above normal.
Now I have to go do something about my itchy dry eyes (doctor says allergies), draw my almost nonexistant eyebrows on (menopause indeed!) and eat about half a lunch (I know I won't lose the weight the doctor says I should until the Synthroid is increased but I'm trying to at least gain weight slower.)
When I said my mother was on thyroid suppliments from the 40s or 50s I meant 1940s or early 1950s. Agewise, she was in her 20s and she did very well on them with almost no hypothyroid symptoms recurring until she was in her late 40s when her doctor dramatically cut the dosage due to new and "better" tests. For the rest of her life, she tired more easily, fought weight, and had various other hypothyroid problems that doctors blaimed on menopause because that was at about the same time they cut her thyroid dosages. She lived to her 80s and did not have the "benefit" of all these new drugs. But they did try to treat symptoms for her, too, with estrogen, as that is what they put everyone on then. She didn't like how estrogen made her feel and quit against doctor's orders. We now know that would have increased her cancer risks, perhaps even caused her to have lost that fight with cancer she had in her 60s.
I don't worry about thyroid suppliments as my mother lived into her 80s. I do worry about all these other new drugs and their side effects.
Sorry EAE, I did misunderstand your first post. I fortunately have a great PA treating my thyroid problem; she said we need to get my thyroid completely under control before treating my sky-high LDL level. I thought my inability to lose weight, missing eyebrows, etc. was due to menopause, I'm glad she tested my thyroid. My optometrist convinced me to try Restasis for my dry eyes, it works great, I now only have to use saline drops occasionally (instead of every two hours every day).
My mom's 87 and when the doctor wanted to put her on cholesterol medication she laughed at him; but at least she takes her blood pressure med.
long before people say study too small, should be reason to think, talk to your dr- it is your body- there are some side effects to everything, and maybe being more physically able, longer is the more natural choice
As a cancer survivor- this article gave me room for thought.Everyone has to make their own decisions, and good for this study
i was on fosamax one month and was hospitalized with extreme chest pain.it caused performation to my esophagus.it took me months to get over it.i couldnt eat or drink for 3 weeks and still have bouts of esophagitis 3 years later.do no take this,no one told me the dangers. i lost weight,eat healthier and get my calcium the old fashioned way thru diet.if u are prescribed this drug ask questions and research it yourself,i wish i had...
I took Fosamax and Actonal and had side effects from both. There were days I could hardly get out of bed because my bones and muscles hurt so bad. Complaints to Dr. fell on deaf ears because I was osteopenic and "needed" to prevent osteoporosis. Dr. did begin to "treat" the side effects (muscle relaxants and acid reflux medications)and that was it for me. I stopped taking it and began feeling better. When I told the Dr., they had a fit and continued to try and convince me of the need, giving me more scripts which I did not fill. Dr's do not listen to their patients anymore. They listen to the Pharm companies.
Dear JD in SD
Before you launch any more personal attacks (blowing smoke, etc), let me reiterate my take on this. I am not ruling out the possibility that there may indeed be a cause-effect relationship between the use of bisphosphonates and the esophageal cancer. There was another article published on 8/11/10 in JAMA that analyzed the same patient databease from UK and concluded that there was no correlation between the two. The difference between that study and this one is, in addition to the length of the follow up (mean 4.5 yrs vs 7.5 yrs), the investigators used quite different set of criteria to assign the patients into case/control cohorts. As you are probably well aware, this is a problem we always encounter with these retrospective analysis. If 10 different groups of investigators set out to prove the same endpoint, using the same database, we will likely end up with multiple conflicting conclusions depending on how each group assigned their cohorts. By the way, did you happen to notice that there were greater percentages of former and current smokers in the study arm than in the control arm in the BMJ study? 25% of the study arm were current smokers vs 16% of the control arm. Now THAT is a very significant confounding variable to ignore.
The best way to prevent osteoporosis is to use your body. Go take a hike and quit relying on pills to prolong your life. Treat your body well, and it will take care of itself.
The women in this study who did get cancer... what might have been different about them? Did they take the medication properly? Did they experience severe side-effects? Did they have a family history of cancer? A personal history of reflux or other such problems? What was their diet, exercise, life-style like? These are the questions that come to mind when I read such an article, but of course they are never answered.
Doctors are no longer taught natural remedies (and such) in medical school like they were years ago. One doctor told me it changed with the pharmacy companies got involved. My husband was on two medications for cholesterol and one for Restless Leg Syndrome and one other one. I kept telling him to eat better and exercise. He kept saying the doctors said he would always be on them. He also had a "virus" in which they told him he would always have to use a suppository. Finally, he is eating right, exercising and lost weight. he is off the RLS medicine, the suppositories and one of his cholesterol medicines. And the cholesterol medicine caused aches in his joints which are also gone. One more to get rid of!
I was POST menopausal at 31!! Done. They insisted I take hormones. I listened. After several years I was feeling nauseous and I could barely get the pills down. I stopped taking them. After many more years they insisited I get back on them. I did and had to stop again. Then I started taking hormone shots. I gained 50 pounds! Nothing felt right. I finally stopped it all, continued to change my eating habits and exercise regularly. I feel much better and no more headaches. I am just about 59 now, lost the weight, look years youngers and the doctors say I am perfectly healthy.
You need to listen to your body and do what you think is best, not what they think. Research, decide for yourself. Doctors don't know everything.
P.S. I don't take flu shots either. I got sick every time. Finally one doctor said that the conventional wisdom is that flu shots don't make you sick, but too many of his patients have said they had problems, so there must be something to it. Finally a doctor who listens. But he moved. Bummer.
Natural is better. I went thru menopause without hormones, all it takes is a good attitude and dark chocolate for night sweats. Doctors and drugs are killing more people than Mother Nature.
Many comments here that do not take all things into consideration. Some people have to take bisphophonates for other purposes as well. No amount of exercise or change in diet will have the same impact for me as taking a bisphosphonate. I take 1600 mg of Clodronate daily in a clinical trial for preventing a reoccurance of breast cancer. When I was diagnosed my life changed to this simple statement "the benefits outweigh the risks". I was very informed about necrosis as well as the gerd that is a side effect. I also needed the go ahead from my dentist. Yes, I have to take a PPI (prevacid) but again the benefits outweigh the risks. The clodronate is not FDA approved but has been very successful in Europe in the prevention of breast cancer reoccurance. Life is a crap shoot. My doctor told me if you read all the possible side effects of an aspirin you would never take another. In my opinion we should listen to our bodies, question our doctors from all sides & stay informed. I am glad that this information is out there for those who don't "talk" to their doctors. We are our body's keeper, fight for it. Every day is a gift.
I don't think any of us would argue there is a need for many of these medicines. Our argument is that they push them inappropriately and some of us end up with side effects worse than what we were given them for.
If you absolutely need a medicine, and there are terrible side effects, you take it. Most extreme example I can think of is chemotherapy and cancer. But if the medicine is worse than what you are being treated for, it is best to seek another answer. And too many doctors don't seem to want their patients making informed decisions anymore!
I began taking alendronates about 5 years ago. My early side effects included mucous colitis and esophageal and stomach irritation. After about a year, the colitis and stomach issues improved greatly. But the esophageal irritation has continued. My singing and talking voice has changed, and I have daily bouts of continuous throat clearing, which also irritate everyone around me! I have had questions about the effect of this medication on mucous and epithelial cells throughuot the body. At the very least, I intend to ask my doctor if it's possible to monitor for pre-cancerous conditions in the throat.
This is not a good medicine, but some of us are in a lose-lose situation. Exercise isn't the whole answer. Living stress free would be even better! Thanks to Dr. Susan Brown, I am making some dietary changes and hoping for the best.
I can't remember which drug it was, but I was prescribed one for osteopenia, it seems like it had phosporus in it. The thing is I took one tablet and an hour later bent down to pick something up. The reflux from the pill was rediculous. Having GERD, there is no way that I was going to subject myself to this torture once a week. I get my dairy anyway and I walk. And the funny thing is, they got new equipment at the university and low and behold all of a sudden I did not have anything wrong with me. I wonder just how many people were incorrectly diagnosed and are taking that crap for no good reason. Osteoporosis is no laughing matter, but the treatment for it sucks. So I have a trade off, broken bones later or higher cholesterol from the dairy fats. I'll take the dairy, and the walk and forgo the crap they gave me. It's been about 14 years and I still have not had any breaks. The constant irritation from the medication would, long term either cause excessive scarring, perforation and ulceration or the big CA. Besides, I love dairy.
Folks...legally with anything from aspirin on....if even 1 person has a problem (regardless of their personal health background), it has to be reported. It's called "CYA." God forbid it happened to someone else, there would be a lawsuit because it was not mentioned. It's about personal choice and should be discussed with your doctor(s).
You must not have taken this drug.
I don't take these drugs, even though my doctor recommended them, but I have a friend that did. She got such pain in her esophagus that she had to stop taking them and it took months for her to feel better. I guess we'll just walk a lot.
My Mother took Fosamax for several years to treat Osteoporosis. I can't help but wonder if this drug may have been the cause of her cancer. She did not smoke. She did not drink. She was not overweight. Other than rheumatoid arthritis and osteporosis, she was extremely healthy. She died of cancer in 2001.
I take Fortical nasal spray because I had serious pain with the oral drugs. Since doing this I have lost my sense of taste and smell. Has anyone had this experience?
The older I get (62) the more I believe in the natural way of fighting these "diseases." I took biophosphates (fosamax etc) for 10 years and have just been told I have osteoporsis. These drugs are worthless. Eat right and EXERCISE.
I landed in the hospital after I began taking fosamax. The pain in my chest was the worst pain I have ever felt. Every breath was excrutiating. After many many tests, it was concluded that I was suffering from esophageal pain caused by. . .fosamax.
I stopped taking it and have not had another round of esophageal pain since. I am not at all surprised that it raises the risk of esophageal cancer. I had already read reports that it can cause necrosis of the jaw.
Altho I have osteopenia and a family history of osteoporosis, it is just not worth the risk. It's a bad drug.
I also went from osteopenia to osteoporosis even though I was taking Calcium tablets for years. I was enlightened about the trouble we have digesting these tablets due to a number of reasons. (try dissolving a pill in a glass of vinegar and water. If it's still in pill form in 30 minutes you are wasting your money). I began drinking a Calcium/Magnesium fizz powder with Vit D. It comes in many flavors. After 3 years I reversed my condition and no longer have osteoporosis. I am hopeful that my next bone scan will show no osteopenia (the first step in thinning of the bones). Good info, ladies
I also went from osteopenia to osteoporosis even though I was taking Calcium tablets for years. I was enlightened about the trouble we have digesting these tablets due to a number of reasons. (try dissolving a pill in a glass of vinegar and water. If it's still in pill form in 30 minutes you are wasting your money). I began drinking a Calcium/Magnesium fizz powder with Vit D. It comes in many flavors. After 3 years I reversed my condition and no longer have osteoporosis. I am hopeful that my next bone scan will show no osteopenia (the first step in thinning of the bones). Good info, ladies
I took Fosamax for about one year. Due to being a chronic pain patient, I've had to take opiates for pain ~ and they do a number on your teeth. My dentist wouldn't even CLEAN my teeth until I'd been off the Fosamax for at least a year. And now they think it might cause cancer of the esophagus? No thanks ~ I've already had cancer and it's no fun. There's NO WAY I'd take any more of this "stuff" until they know exactly what it does. I'd rather break a hip.