About that crank

So on the blog birthday we asked our dear readers what they’ve learned over the last year, and as a test we gave them this crank who attacks the bisphosphonate anti-osteoporosis drugs in his article “the delusion of bone drugs”.

I think the reader with the best grade is LanceR or Martin, but SurgPA would have done better if he had shown his work.

But let’s talk about some signs that something you’re reading is unscientific crankery. In this case, we don’t have a particularly sophisticated crank, and he let’s the cat out of the bag in his very profile:

Because of Bill’s increasing concerns about the serious, sobering and perilous times we are living and being manipulated into, his intentions will be mainly devoted (as he has been) to posting articles that will alert, inform, expose, and wake up a sleeping reading public. This involves the issues that are not covered, or not covered truthfully by the “National News Media.” “In the time of universal deceit, telling the truth is a revolutionary act.” – George Orwell. To warn the public of the present and coming danger of permitting the federalizing of local police departments across our nation is of the utmost importance. If allowed to continue, the federalizing of local police departments, will result in the planned replication of the infamous “Nazi storm troopers” reminiscent of Hitler´s Germany in recent past history. “A prudent person foresees the danger ahead and takes precautions; the simpleton goes blindly on and suffers the consequences.” -

The guy mentions Orwell and Hitler in his profile! He’s already way behind in presenting himself as a rational source of information that should be listened too. But let’s give him the benefit of the doubt, it was written in the third person, maybe his profile-writer was the crank. What does he have to say about bisphosphonates?

Women across the country are being duped to consume billions of dollars worth of bone poisons under the false pretense that if they take them long enough they will not develop osteoporosis. Even the FDA is becoming alarmed by the side effects of these bone drugs – a rather stunning event considering the FDA hardly ever acts to cast suspicion on the propaganda put out by a Big Pharma blockbuster class of drugs being slickly marketed for prevention.

Wow. In the very first paragraph we have a conspiracy that involves the FDA, and apparently every single doctor in the country that prescribes these drugs.

A recent flood of negative information about these drugs is finally coming to light, including an alarming FDA pain warning, the risk for atrial fibrillation, the numerous cases of rotting jaw bones, and a new major study that concludes after 15 years of widespread use there is not enough science to show if the medications are safe or effective. Sure bone health is extremely important; however, taking bisphosphonate bone drugs does not produce stronger or healthier bones – quite to the contrary.

Here is the source info for the FDA warning:

From its initial marketing date and up to November 2002, the FDA received Serious Adverse Event (SAE) (defined as death, life-threatening, hospitalization [initial or prolonged], disability, congenital anomaly, required intervention to prevent permanent impairment or damage, or important medical event) reports of severe bone, joint, and/or muscle pain, that developed in 112 women, 4 men, 1 adult of unknown sex, and 1 child after starting therapy with the drug. The age range was 7 to 84 years (n = 109; median = 67 years). The child was a 7-year-old boy who mistakenly received alendronate instead of methylphenidate and developed extreme bone pain in his hips, knees, and ankles after 1 dose.

So after more than a decade on the market and several tends of millions people being prescribed the drug FDA has learned of about 120 people who experienced bone pain. The warning is going out in order for doctors to be more aware of the problem just in case it is more widespread. This is a classic example of a crank using examples of science trying to be self-correcting or cautious as proof of some terrible behavior. Literally millions of people have taken these drugs. They are wondering if bone pain should be on the list of possible adverse events and are basically putting a call out to docs to see if they’ve seen something similar and failed to report it. How does the crank represent this information?

The FDA Warning – Severe Pain from Bone Drugs

On Monday, January 7, 2008, the FDA issued a warning on bisphosphonate drugs saying that there is a possibility of “severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates.” The FDA explained that the pain “may occur within days, months, or years after starting bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.”

Translated to English this means that any woman experiencing any bone, joint, or muscle pain of any kind since starting a bisphosphonate bone drug, even if the pain started several years after first taking the drug, should work with her prescribing physician to immediately discontinue use of the drug to see if the pain stops or gets better. Of course, taking statins to lower cholesterol can also cause severe muscle pain and many women are on both drugs – a double whammy.

Oh, I forgot to mention, he’s against statins too. So now, the report of adverse events in about 120 people, after tens of millions of doses is blown out of all proportion. All because the FDA wants to collect more information about a possible side effect that would never have been observed in the smaller trials used to approve the drug.

Then he asks us a devastating question, how could we possibly prescribe these deadly toxins?

Here is a question for the medical profession. Since it is now clearly understood that excessive inflammation is part of the primary cause of every single disease of aging – what makes you think you are helping the overall health of anyone by giving them a highly inflammatory bisphosphonate drug for a number of years?

Now, what about bisphosphonates? How do they work? He is correct that the drugs work by inhibiting osteoclasts that are the wrecking balls of the bone and causing them to undergo apoptosis. The theory is that by inhibiting osteoclast action things like vertebral compression factors – a major problem of osteoporosis – will be inhibited. The strongest evidence suggests these drugs are in fact effective at preventing vertebral compression fractures, although their efficacy in preventing long bone fractures is not as strong. This is because bone-breaks in older folks isn’t just a factor of bone strength. It also is because of decreased muscle mass, poorer reflexes, decreased proprioception (the impulses that tell your brain your position in space) due to neuropathy, etc. It isn’t just the weak bones, it’s all the things that prevent young people from falling, and mechanisms to catch ourselves or protect ourselves when we fall which develop dysfunction with age. Therefore I think the reason this evidence is weaker is that the only study that would show such an improvement would probably require throwing old ladies down stairs in controlled conditions, but I suspect that ultimately these drugs have utility in preventing hip and wrist fractures as well.

It’s largely the same with his blaming of bisphosphonates for Afib and his hysterical attack on coumadin – a dangerous drug true but also one of medicine’s great lifesavers.

But it’s not until he gets to systematic reviews of efficacy that he shows his real cherry-picking colors.

In fact, the FDA let millions of American women take this drug to prevent osteoporosis when the drug never even went through a normal approval process for its common uses in today´s world (it was only approved for serious bone disease). This is rather shocking to say the least – but true.

The research was reported in a January 2008 issue of the Annals of Internal Medicine (full article here). The conclusion of the study states “Although good evidence suggests that many agents are effective in preventing osteoporotic fractures, data are insufficient to determine the relative efficacy or safety of these agents.” This conclusion, worded to be as politically correct as could be contrived in a drug-related journal, is a shocking indictment of the ineptitude of the FDA. How could a drug be in use for 15 years, with billions of dollars of sales per year, and the FDA has never demanded proof that the drug was safe or effective???

Oy vey. Here is the article, and here is the cherry-pick:

Data Synthesis: Good evidence suggests that alendronate, etidronate, ibandronate, risedronate, zoledronic acid, estrogen, parathyroid hormone (1-34), and raloxifene prevent vertebral fractures more than placebo; the evidence for calcitonin was fair. Good evidence suggests that alendronate, risedronate, and estrogen prevent hip fractures more than placebo; the evidence for zoledronic acid was fair. The effects of vitamin D varied with dose, analogue, and study population for both vertebral and hip fractures. Raloxifene, estrogen, and estrogen-progestin increased the risk for thromboembolic events, and etidronate increased the risk for esophageal ulcerations and gastrointestinal perforations, ulcerations, and bleeding.

Limitation: Few direct comparisons have been conducted between different agents or classes of agents used to treat osteoporosis.

Conclusion: Although good evidence suggests that many agents are effective in preventing osteoporotic fractures, data are insufficient to determine the relative efficacy or safety of these agents.

Relative efficacy! It’s important if you’re a writer to read at greater than the 6th grade level. The paper said that no data demonstrates which of these drugs is the most effective, although they show a clear benefit in preventing fractures. Similarly with his claims that they in low risk populations that they may increase risk – this comes from the authors mentioning that the confidence intervals were to wide to conclude the decrease in fracture risk observed was real in that population – the CI overlapped with 1 and went over. Technically this means yes, these drugs could cause more bone fractures, but in the studies to date they have not, and instead show a non-significant reduction in risk in low risk populations.

So, what do we have here! A mega-crank fake expert. Conspiracy mongering galore. A whopper of a cherry-pick. And some nice logical fallacies to boot (all inflammation is bad, conflating causes and effects etc.)

Maybe next time we’ll try out a more difficult crank to spot.

Comments

  1. #1 jane
    May 12, 2008

    Okay, let me see if I have the facts straight. Bisphosphonates do increase apparent bone density, but there is a dispute over whether they do it in a way that really adds much to bone strength. They do significantly reduce the risk of vertebral fractures, which are mostly asymptomatic. But they reduce the risk of significant long bone fractures much less. In low-risk “patients,” they offer no significant reduction of risk for those fractures. Bone density is only one of many factors that affect risk of hip fractures; others are physical fitness and balance, diet, and weight-bearing exercise. In a few patients, bisphosphonates will cause long-lasting pain, eat holes in the esophagus, or even cause the jawbone to die and rot away. Balance training and exercise will not cause ulcers or loss of the lower jaw in any patients.

    Given all that, personally, I plan to rely on exercise and calcium supplements rather than having myself prophylactically “treated” with drugs like these. No doubt you think that makes me a quack and a crank. I’ll just count up the money that saves me over the next several decades – has anyone calculated the utility of these drugs in terms of total direct and indirect expenditures per hip fracture prevented? – and SMILE.

  2. #2 MarkH
    May 12, 2008

    You’re not a crank, you’re just cautious and you’ve taken his arguments at face value.

    How about if I add the following facts.
    1. The risk of osteonecrosis of the jaw is about 1:100,000 patients and occurs usually after invasive jaw surgery or dental work. It is also treatable.
    2. The risk of bone pain is far less, based on the numbers we have so far, possibly one in a million, and the majority of the time ceased with use of the drug.
    3. No study of calcium or vitamin D supplementation or both has been shown to be effective in preventing bone fractures in osteoporotic patients.
    4. Vertebral fractures are not asymptomatic. Sometimes they are painless, often they are not, and further they make you shrink. You’ve seen little old ladies that have curled up into little question marks. Osteoporosis is not a benign condition, vertebral fractures are terrible.

    Exercise and weight loss are excellent ideas. They will not prevent osteoporotic changes, but they may provide some benefit. They are also difficult to implement, and as an intervention will not be used by the overwhelming majority of patients.

    Now what do you think about the intervention?

  3. #3 Martin
    May 12, 2008

    Woo! I won! I won!

    What’s my prize? Cash? A place on your Blog Roll? Some Vitamin D pills?

  4. #4 jane
    May 12, 2008

    I still think no way. I have difficulty swallowing large pills (took Lariam for six weeks once and quit because it just about killed me) and would bet that my absolute risk of suffering GI damage would be higher than the reduction (if any) in my absolute risk of getting a hip fracture.

    I don’t want a dowager’s hump either, but the vast majority of older women don’t suffer from extreme spinal deformities. We are all beaten over the head with the message that MOST adult women are at risk and face that fate if they don’t get medicated, but most old women today, who got to that age without medication, aren’t in such a condition. And again, there’s more to that problem than bone structure. There’s also posture and physical fitness. Unused chest muscles contract and cause people to become round-shouldered, stoop, and have to crane their heads upward to see straight forward, even if their vertebrae are not so bad.

    You dismiss exercise because it is “difficult” and “will not be used by the overwhelming majority of patients.” Okay, I am no triathlete (this is one of those things I plan to work on Real Soon Now), but I do manage to get some load-bearing exercise into my fairly busy life. Maybe more people would do that if their doctors actively encouraged them to do so, instead of just encouraging them to take prophylactic medications. Maybe the medical profession should confront societal factors that make healthy lifestyles more difficult. People don’t have time to walk to work or cook real food, so they go to the doctor and get drugs to counter the effects of extreme sedentism and crappy Western diet. But those doctor visits, pills, and further visits for treatment of side effects can cost enough to absorb the earnings from many hours of work. People might prefer just not to work those hours, thereby having time to get more exercise and eat better food, but workers usually have no say in how long they work, as employers will extract as many hours as they legally can. Should that be treated as a medical issue?

  5. #5 Oldfart
    May 12, 2008

    I would be almost willing to bet that the side effects of load-bearing excercise are far worse (occur more often) than the consumption of bone pills. Yet no one would suggest that you stop exercising. Why, then, would you stop taking bone pills if your doctor thought it was important for your health? Why, also, would you blame your doctor for the evil capitalists that employ you and force you to work (gasp!) and the owners of McDonalds that force you to endure the excesses of the poor Western diet.

    Sounds like you need to go find a deserted island somewhere and commune with nature for awhile. A few days of starvation and pointless wandering should refresh your memory about why you work and why you eat. The starvation might also allow you to get back “in touch with your body” and allow you to eat the healthy foods that are available everywhere in the USA thanks to those evil capitalists.

  6. #6 LanceR
    May 12, 2008

    W00T! I passed! <grin> I didn’t even know there was going to *be* a test!

    Seriously, as a layperson, I cannot be expected to know everything about each scientific field I will run across. That is why this blog has been very helpful when something trips my bullsh*t alarm. I now can put a finger on exactly what is causing me to wonder about what I’m hearing.

    Thanks MarkH, ChrisH and PalMD! And a big “thank you” to all the cranks who’ve dropped by and let us sharpen our wits dealing with their “arguments”!

  7. #7 Nimravid
    May 12, 2008

    1. The risk of osteonecrosis of the jaw is about 1:100,000 patients and occurs usually after invasive jaw surgery or dental work. It is also treatable.

    Additionally from my reading jaw osteonecrosis is most common (and still rare) when bisphosphonates are used as an accessory drug in the treatment of bone cancer. The doses for this are much higher than the doses used for osteoporosis. I’m not sure that there have been any cases of jaw osteonecrosis associated with bisphosphonates for osteoporosis.

  8. #8 pec
    May 12, 2008

    You think you can disrupt complex natural processes without adverse consequences, but you’re wrong.

    Osteoporosis, like most of our “degenerative” diseases, is a lifestyle disease, and probably would seldom or never occur in women who get adequate physical exercise.

    You don’t think about the system, or sub-system as a whole. You notice that introducing this toxic chemical increases bone density and jump to the conclusion that your goal has been met. Well maybe there is more involved in bone health than density.

    After the bone drug craze has gone on for a while you will find, once again, that millions of women have been damaged.

  9. #9 pec
    May 12, 2008

    “Why, then, would you stop taking bone pills if your doctor thought it was important for your health?”

    So … we’re supposed to let doctors do our thinking for us? We’re supposed to turn off our minds, relax and float downstream? Stop questioning, because it’s annoying and bad for sales?

    I don’t think capitalists are generally evil; I believe in capitalism. But most people who grow up in a capitalist society learn to be skeptical of TV ads. For some reason, this has not been the case with the drug ads — people seem to have complete faith in them. I guess they think it would be illegal to advertise a drug that is not perfectly safe.

    Well I wish everyone would start being as skeptical of the drug ads as they are of ads for other products. The drug companies want your money; they don’t care about your bones, or your long-term health. Stop taking bone drugs and start improving your lifestyle.

  10. #10 PalMD
    May 12, 2008
  11. #11 LanceR
    May 12, 2008

    Save a goat!

  12. #12 Martin
    May 13, 2008

    @PalMD: If you really want to see trolls, come look at LayScience lately. I made the mistaking of posting on 9/11 yesterday, and it’s not pretty…. :S

  13. #13 MarkH
    May 13, 2008

    pec, unlike PAL I have zero tolerance for your HIV/AIDS denialist anti-medicine bullshit. Get lost.

    Jane, I’m not dismissing exercise but medicine is the realm of the possible. Encouraging people to eat right and exercise is a part of every doctor’s visit. Patient noncompliance is an equally important part of the ritual.

    Knowing that about 95% of people won’t take proactive steps to keep their bones healthy with weight-bearing exercise and keeping off the pounds, which intervention is now better?

  14. #14 pec
    May 13, 2008

    “Knowing that about 95% of people won’t take proactive steps to keep their bones healthy with weight-bearing exercise and keeping off the pounds, which intervention is now better?”

    You think that’s a good enough reason for giving them poison drugs? “Well you should try a little exercise but if you don’t feel like it, here’s a wonderful drug. Sally Field says she takes it and it works — you could look just like her.”

    If a patient is physically capable of exercise and won’t do it, that is NO EXCUSE for drugging them. Tell them the truth — there is no other save and effective way to prevent many of the “degenerative” diseases.

    If you provide easier alternatives, they will take the easier alternative. Because they trust you, and they assume that if exercise was MUCH MUCH BETTER AND SAFER than your drugs, that you would not offer the drugs.

  15. #15 Martin
    May 13, 2008

    Pec ranted: “You think that’s a good enough reason for giving them poison drugs? Tell them the truth — there is no other save and effective way to prevent many of the “degenerative” diseases.”

    Lol, Pec, the more use you hysterical (not to mention unfounded) language like “poison drugs”, the less people will listen to you. Maybe you should consider trying reason supported by referenced data? Otherwise, people will just keep ignoring you and you’ll get even more frustrated and bitter than you evidently already are.

  16. #16 LanceR
    May 13, 2008

    Let’s see… overgeneralizing all drugs as “poison”, scare quotes around words that he disagrees with, ALL CAPS rants, and he’s referenced a “medical conspiracy” in the past…

    Probably a crank. He just needs to claim the mantle of Gallileo and we’ll have him pegged!

  17. #17 jane
    May 13, 2008

    Sorry, exercise is still the better intervention. Human beings are meant to be physically active, and people who exercise have not just healthier bones, but less heart disease, less cancer, and less senile dementia, as well as better balance, fitness, etc. Bisphosphonates won’t do anything for any of those other conditions. If you want to live past 80 and still be functional, you better keep walking and use your muscles once in a while. Any doctor who does not make that clear to his patients is not doing his job.

    It seems like certain non-MDs are emotionally invested in the idea that the way we live in the US is perfect, so anyone who suggests that we change in any way must be a commie. The only alternative to living the pure Amurrican workaholic lifestyle is to go to a “deserted island” and experience “starvation and pointless wandering”? Oh please, give me a break.

  18. #18 Jamie
    May 13, 2008

    “Sorry, exercise is still the better intervention.”
    Because of course it would be impossible to do both.

  19. #19 Melissa G
    May 13, 2008

    The crank said:

    “Since it is now clearly understood that excessive inflammation is part of the primary cause of every single disease of aging”

    OMG OMG OMG, on top of everything else, he buys into inflammation woo! Blaming inflammation for all disease and aging is a very common quackery/crankery. Do a search on quackwatch.com for “inflammation” for some entertaining yet profoundly sad reading.

  20. #20 daedalus2u
    May 13, 2008

    Bone strength is mediated through nitric oxide. Bone strain causes deformation of bone, which causes fluid flow in the bone pores. The shear from this fluid flow causes the production of NO (via essentially the same mechanism shear causes NO production in the vasculature). NO stimulates the osteoblasts and inhibits the osteoclasts, causing deposition of bone mineral where NO levels are highest (by stimulating osteoblasts) and causing the resorption of bone where NO levels are lowest (by not inhibiting osteoclasts)

    The strain mediated production of NO is the “fundamental” mechanism of bone strength regulation. It has to be because bone strength is “well controlled”, that is there is feedback regulation of bone strength depending on the mechanical loads the bones experience. If there were not feedback control, then either bones would become like rubber, or would take over the entire leg cross section. That doesn’t happen, so there is feedback control of bone strength depending on bone loading.

    The precise “operating point” of the NO mediated strain vs. bone deposition is what the other pathways affecting bone strength regulate. Inflammation lowers NO levels and shifts bone density lower. Estrogen activates nitric oxide synthase shifting bone density higher. Androgens act directly on bone cells to shift the operating point to higher density. Bisphosphonates inhibit the dissolution of bone mineral. This causes an increase in bone density, but if the density is not at the “exact right spot” (where bone strain is highest), that increased density doesn’t contribute (as much) to bone strength as if that bone mineral was in the “exact right spot.”

    Administration of organic nitrates does have as much effect on bone density as does estrogen.

    http://www.ncbi.nlm.nih.gov/pubmed/11092405

    Nitroglycerine is not good NO donor. Raising NO levels by other mechanisms would be better and with fewer adverse side effects.

    It is the NO generated during load bearing exercise that increases bone strength. The basal NO level affects the efficiency by which that NO increases bone density. More basal NO, less exercise is needed to get to the same bone-strain/bone-NO generation operating point.

  21. #21 jane
    May 13, 2008

    Of course it’s possible both to exercise and pop pills. The question is where you should stop popping. Osteoporosis is hardly the only risk consumers are threatened with. There are any number of diseases you might get in the future. If you are prophylactically medicated for one of them, odds are decent that you’ll suffer no serious harm – although if drugs are being heavily promoted, like bisphosphonates, it means that they are still in patent, and by definition we do not know what the repercussions of 30 years of use might be. But if you spent half a lifetime taking pills to try to prevent each possible future disease, you’d have a pretty good chance of suffering side effects. Your cancer preventive might cause heart disease, your heart drug might cause cancer, and polypharmacy often leads to mental dysfunction – for which you would most likely be treated, not with an end to medication, but with yet more pills. How do you decide which risks are so scary that everyone should feel obliged to spend money and risk side effects to avoid them?

  22. #22 Pat Curley
    May 13, 2008

    One of my favorite bits about the 9-11 “Truthers” is the same disconnect. “The mainstream media doesn’t cover this news, and look, here’s an article on the BBC’s webpage that proves my point!”

  23. #23 PalMD
    May 13, 2008

    Jane, the data from randomized controlled trials are actually quite clear. The effect of bisphosphanates is significantly better in increasing bone density and decreasing significant fractures than non-medical interventions. That doesn’t mean exercise etc isn’t important—it is, but it is only one tool, and unfortunately not the most powerful one.

  24. #24 daedalus2u
    May 13, 2008

    One of the final common pathways by which inflammation skews physiology is by interfering with NO signaling. It isn’t really “interference”, it is the normal way to modify NO signaling. It is only “normal” when you have the “normal” basal level of NO. If that level is off, then so is every pathway mediated through NO.

  25. #25 Anonymous
    May 13, 2008

    Exercise, of course, has most direct effects on bone density if done over a lifetime. However, studies in older people have shown that exercise reduces fracture risk by 20-40%. Balance training also can cut the risk of falling in the first place nearly in half, and getting off mind-altering meds helps too. Hips don’t just snap as you’re walking down the street. No fall, no fracture.

    To try to find out how those risk reductions compare to those for bisphosphonates, I followed the link Dr. Hoofnagle provided. Most bisphosphonate studies mentioned in this review showed reduction in nonvertebral fractures for people at high risk, but the best was 33%, and most studies showed less. For people not at high risk, risk reduction was less and less well supported. The review authors make special note of one study with a 21% risk reduction. So it seems like the right kind of exercise could be just as good. BTW, the review also reports that women with hemiplegia from stroke who took vitamin D had a 59% reduction in falls, and thereby had fewer hip fractures.

    The authors define high-risk as having a lifetime fracture risk of 33% and a ten-year risk from at least 3% at age 50 to 10% at age 70. Low-risk means a <10-21% lifetime risk, and 10-year risk from <1% at 50 to 2% at 70. Intermediate risk – this is what they say – means a 21% lifetime risk and 1% to 4% 10-year risks. Okay, suppose you’re 70, your risk of having a fracture in the next decade is 4%, and bisphosphonate cuts that by 30%. There’s roughly a 1.2% chance over 10 years, or 0.12% chance per year, that you’ll avoid a fracture because you took bisphosphonate. According to this review, pooled data from 3 trials of etidronate showed that the absolute increased risk of esophageal ulcer, perforation, or bleeding was about 0.37%, and one etidronate study had an increased absolute risk of 0.79% (it doesn’t say how long the studies were, but I assume not more than a couple of years). (There were also notable atrial fibrillation risks in two trials, and they link to a review that expresses concern about the dead jaw issue.)

    It therefore looks to me like, even if I had no particular difficulties with large pills, each year I took these drugs I would be more likely to suffer GI damage than to be spared a fracture. (I’m nowhere near 70, BTW.) For someone who has real osteoporosis, who has already had fractures, those odds might change. For me, it is perfectly rational to refuse to spend money on a “treatment” that is more likely to harm me than help me. Also, I can be confident that exercise will improve my heart health; there’s no risk that it might give me atrial fibrillation that would then get me socked on yet more drugs.

  26. #26 jane
    May 13, 2008

    Whoops, it ate part of my message. Don’t know how that happened. Intermediate-risk people – this was what they said – had a lifetime risk of 21%, and a ten-year risk ranging from 1% at 50 to 4% at 70. Low-risk numbers respectively were <10-21%, <1%, and 2%.

  27. #27 jane
    May 13, 2008

    Apologies for the repeated posting! It seems you cannot use the “less than” sign, or everything after is gone. People who were defined as low-risk, and yet were being medicated prophylactically, are said to have a lifetime risk ranging from less than 10% up to 21%; their ten-year risk ranges from less than 1% at 50 to 2% at 70.

  28. #28 jane
    May 13, 2008

    Sorry again. So the point I was trying to make, which I neglected to do in my third message above, was that if you have a 4% ten-year risk and the drug gives you a 30% risk reduction, your absolute chance of avoiding a fracture is about 1.2% over 10 years, or 0.12% per year. But according to the review, in studies of some bisphosphonates, the absolute increase in esophageal ulceration, bleeding, or perforation was from 0.37% to 0.79%.

  29. #29 LanceR
    May 13, 2008

    FYI, to make a < sign, use <

  30. #30 LanceR
    May 13, 2008

    Well, that didn’t work!

    FYI, to make a < sign, use & lt ; (take out the spaces)

  31. #31 jane
    May 13, 2008

    As in, it will take me &lt12 posting attempts to figure this out? If you’re seeing this, it must have worked…

  32. #32 pec
    May 13, 2008

    “Your cancer preventive might cause heart disease, your heart drug might cause cancer, and polypharmacy often leads to mental dysfunction – for which you would most likely be treated, not with an end to medication, but with yet more pills.”

    Very true Jane. I know people who are caught in that vicious cycle.

    “That doesn’t mean exercise etc isn’t important—it is, but it is only one tool, and unfortunately not the most powerful one.”

    Ridiculous. There have been more and more studies showing that exercise is essential for good overall health. There are no adverse side effects. As Jane pointed out, the side effect of one drug is often treated with another drug, which causes other side effects, and so on.

    It is irresponsible, as well as ignorant, for an MD to say drugs are better than exercise for preventing degenerative diseases. That kind of thinking is harmful to your patients, and to the whole society.

    This is actually the first time I have heard anyone, even a mainstream MD, say anything like this
    depp=true
    notiz=[get lost pec, HIV/AIDS denialist cranks aren't welcome in this discussion]

  33. #33 MarkH
    May 14, 2008

    Sorry I can’t seem to get this point across to you Jane. I’m trying but it won’t seem to take.

    Exercise is great and wonderful. If you do it, your MD couldn’t be happier. The recommendation of diet and exercise by MDs occurs with almost every office visit, and very rarely takes. As an intervention one can accomplish in an MD office it is poor. People don’t take their doctor’s advice, sad but true.

    As an intervention which can make a significant difference in a patient’s life, especially one with diminished exercise capacity at risk for these fractures, bisphosphonates are a realistic solution, and an intervention that is likely to be implemented.

    Take the example of an obese person coming into the office with hyperlipidemia and diabetes. You don’t tell them, go exercise and lose weight, then maybe we’ll treat you. You give them the preventatives that will lower their risk of heart disease, you treat the diabetes which will kill them. Yes, exercise and weight loss would be a superior way to deal with the problem, but the fact is people won’t do it. So you recommend diet and weight loss, and you give them lipitor and metformin because such interventions are proven effective in extending lives.

  34. #34 jane
    May 14, 2008

    It’s not been my experience that exercise is a regular subject of discussion for doctors, even though I am a scrawny enough woman that it ought to be obvious I could use more. :) No doctor or nurse practitioner has ever asked me whether I eat a lot of processed foods, or much of anything else about my diet. It seems like as long as you are thin, they aren’t worried about what you eat. They do ask “if” you drink, with a hint that if you admit to that fondness for Cotes du Rhone, you’ll have an “alcoholic” note put in your chart. Other than that, the only lifestyle questions I have gotten regularly are about smoking and sex. My husband is quite overweight and takes a diuretic for high blood pressure. I have accompanied him to several doctor visits during which his diet and exercise habits were never discussed. Maybe the doctors believe that “the fact is people won’t do it,” so why bother to try?

    MarkH, if I don’t agree with you it doesn’t mean that the point “won’t take.” If the point is that many people won’t walk anywhere, I retort that more might if they were encouraged and enabled to do so. If the point is that a particular drug modestly lowers the risk of a particular condition, okay, I accept that fact. So what? I don’t think it is necessary to pursue every possible means of reducing every possible risk. Above, I noted that numbers from that review suggested that unless you were at very high risk, you might be more likely to be harmed than helped by bisphosphonates. There’s a thing on MSNBC today that said over half of *insured* Americans are now on long-term meds, nearly 60% of adults, and of people over 65, 28% of women and 22% of men were taking over five meds. If you take prophylactic drugs for everything you might be “at risk of,” you will wind up in that group. Personally, I’d rather avoid that if possible. It’s one thing to take the risks of Lipitor and Metformin if you had diabetes, but it would be another thing to take them because you were afraid you might get diabetes.

  35. #35 MarkH
    May 14, 2008

    No one would prescribe you metformin as a preventative. EBM works based on protocols based on scientific study of the efficacy of interventions.

    Exercise and diet recommendations as an intervention have been studied extensively in the primary care setting. The data uniformly suggest that encouraging exercise and good nutrition is only successful in a tiny minority of patients. Doctors can’t make you take good advice. From a strictly EBM standpoint, there is not good evidence for the intervention. Good doctors do it anyway (my mom does it with every patient), even though the evidence doesn’t show any great effect, because there’s always the chance this will be the time people will finally listen to you. Similarly telling people to quit smoking rarely works, but good doctors will try every visit to convince people to behave better.

    As far as side-effects of these drugs, doctors balance the risks against the benefits, and if you are at high risk you should probably be getting these drugs even at risk of ulcers which are treatable, and avoidable with correct administration.

    Also I don’t know what evidence there is processed foods are demonstrably worse for you than organic foods in terms of health outcomes, it would be a very difficult study to do but it might be a wing of the Nurses health study. I might take a look. Until that happens, nutrition is going to be focused around what has been demonstrated in the scientific literature. Mainly that maintaining low body weight, and eating high-fiber diets with lower quantities of animal fats is probably the safest recommendation (eat lots of plants, it’s ok to eat the occasional animal, avoid the bacon cooked in butter). Most other diet information is conflicting or just woo.

    All the same I think we’ve gotten pretty far off topic. There is no global conspiracy between docs, the FDA, and drug companies to push fosamax on people, and the tactics this guy uses to make his point are blatantly dishonest. While the bisphosphonates aren’t a great class of drugs, they’re pretty good at what they do. I’d prescribe them to my grandmother (we did) and as always a good doctor considers risks and benefits of every intervention. They wouldn’t be appropriate for someone who exercises, is in good shape, and has a low risk of osteoporosis. If the patient were a post-menopausal woman with a family history and a sedentary lifestyle (the overwhelming majority of Americans) it would be a beneficial intervention very likely to take.

  36. #36 khan
    May 15, 2008

    While we’re discussing osteoporosis:

    Is there a test for it?
    At what age (and how frequently) should a person get tested?

  37. #37 jane
    May 15, 2008

    You ought to read Overdosed America, by John Abramson. He explains how osteoporosis is defined entirely by how dense your bones are in comparison to an average *young* woman. If you are just one standard deviation below that average, you have “osteopenia.” That means by definition that quite a few 20-year-olds do. If you are 2.5 standard deviations below average, you have “osteoporosis.” Bone density always naturally gets lower as you age, so by the time you are 50, 20% of women have “osteoporosis” and another 40% have “osteopenia.” By the time you are 70, 50% of all women have “osteoporosis” and no doubt most of the rest have “osteopenia.” So when they tell you with alarm that your bone density is “2.5 standard deviations below average!” it could mean that you are perfectly average for your age.

    Despite all that supposed osteoporosis in middle-aged to early-elderly women, two-thirds of hip fractures are in women over 80. Also, bone density score only predicts one-sixth of fracture risk. The rest relates to things like balance, eyesight, and what mind-altering meds you have been put on. Abramson argues that what they have done is redefine normal aging as a disease, since most women who live a normal lifespan will be “osteoporotic” and most of the rest will be labeled as at risk. He says that it doesn’t make any more sense to call the natural bone loss all women experience a disease than it would to call natural age-related loss of muscle mass a disease. We could do that too, since loss of muscle mass has a lot to do with disability in older people, but I bet we won’t so long as the only things that build up muscle are dietary supplements and not drugs. And Abramson’s kicker is: The panel that defined osteoporosis in this very narrow, single-score way, that was guaranteed to mean MOST American women would end up diagnosed and treated…was funded by three drug companies that made drugs to treat osteoporosis. Hmmm.

  38. #38 PalMD
    May 15, 2008

    While we’re discussing osteoporosis:

    Is there a test for it?
    At what age (and how frequently) should a person get tested?

    Yes, khan, despite what Jane says, we have effective tests for osteoporosis. There are clinical implications to the diagnosis, which apparently is an idea jane thinks we haven’t thought of. For example, in a DEXA scan, T scores of greater than 2.5 SDs below the mean are associated with a significantly higher risk of fracture than normal numbers.

    Screening recommendations mostly cover postmenopausal women, but based on literature, the recommendations are evolving.

  39. #39 jane
    May 16, 2008

    I have been reading your blog for a while, but haven’t posted before because of the hostility and contempt you show for uppity “patients”, and I probably won’t post again for the same reason. If osteoporosis is defined, by a drug company-funded panel, only as your score on a test, then by definition there is a test for osteoporosis. Whether it is an “effective” test or not maybe depends upon whether testing people and treating them based on the tests leaves them better or worse off in the long run. Abramson says there’s never been a randomized trial to show whether routine bone density testing and associated treatment is really beneficial. True?

    You don’t know what I think, not least because you don’t respect skeptics enough to read their comments and take them at face value. I said in so many words that there is a study showing that bone density predicts one sixth of fracture risk. That’s “clinical implications” for you. The question I ask is why we don’t put five times as much effort and expense into changing the factors that predict five-sixths of fracture risk, but that you can’t treat with a lifetime of pills from a drug company. Well, some of us are smart enough to get books out of the library and make our own decisions, instead of just trusting and obeying a doctor who may be getting all his continuing education from the Merck representative. I won’t argue with you any more, since I’ve said enough to send anyone who is feeling skeptical to the library, so have a nice day.

  40. #40 khan
    May 16, 2008

    Screening recommendations mostly cover postmenopausal women, but based on literature, the recommendations are evolving.

    Thanks.

    I’m 57, female, with no family history of OP.

  41. #41 PalMD
    May 16, 2008

    I have been reading your blog for a while, but haven’t posted before because of the hostility and contempt you show for uppity “patients”, and I probably won’t post again for the same reason.

    Thank you, but I’ve heard that one before.

    If osteoporosis is defined, by a drug company-funded panel, only as your score on a test, then by definition there is a test for osteoporosis.

    What an odd set of unfounded assertions.

    Whether it is an “effective” test or not maybe depends upon whether testing people and treating them based on the tests leaves them better or worse off in the long run. Abramson says there’s never been a randomized trial to show whether routine bone density testing and associated treatment is really beneficial. True?

    False. The tests for osteoporosis are correlated with fracture risk, and fracture risk is decreased significantly by the use of bisphosphonates. The clinical recommendations are based on whether patients’ fracture risk is reduced, as measured by bone densiometry.

    You don’t know what I think, not least because you don’t respect skeptics enough to read their comments and take them at face value. I said in so many words that there is a study showing that bone density predicts one sixth of fracture risk. That’s “clinical implications” for you. The question I ask is why we don’t put five times as much effort and expense into changing the factors that predict five-sixths of fracture risk, but that you can’t treat with a lifetime of pills from a drug company.

    If you can find some way to make that into a meaningful statement, it would be easier to fisk parse.

    Well, some of us are smart enough to get books out of the library and make our own decisions, instead of just trusting and obeying a doctor who may be getting all his continuing education from the Merck representative. I won’t argue with you any more, since I’ve said enough to send anyone who is feeling skeptical to the library, so have a nice day.

    Being skeptical and informed is good. Thinking yourself an expert when you are not is somewhat risky. Making assumptions about how doctors are educated when you apparently don’t know much about it is offensive.