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”.
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 HitlerÂ´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 todayÂ´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.