I am always highly motivated to bring you the latest osteoporosis news, research, and insights. But I am especially motivated when the news reveals harmful side effects of drugs, so you can be well ahead of the game and steer clear of these toxic substances.
Today I bring you the latest news on one of these toxic (but frequently prescribed) medications in our first topic, followed by the latest “twist” on Forteo (teriparatide).
And you’ll be shocked by recently revealed statistics on clinical trials for new drug approvals, published in the Journal of the American Medical Association, that shows they are not objective at all. In fact, they are actually funded by the drug companies themselves. This trend is on the rise, aiding Big Pharma in the push toward getting their drugs on the market.
Let’s get started!
1. New Label Warnings For Toxic Antibiotics (Fluoroquinolones)
Doctors prescribe antibiotics for various infections, and sometimes over-prescribe them (more on that later). Frighteningly, the “first line of defense” against infection (particularly acute sinus infections) often includes a type of antibiotic that should be avoided: fluoroquinolones.
After more than two decades of reported adverse effects, some of them devastating, the FDA’s Antimicrobial Drugs Advisory Committee (ADMAC) and the Drug Safety and Risk Management Advisory Committee met to discuss the problem. The consensus: stronger warnings on the drug’s labels.
Relevant Excerpt:
“Fluoroquinolone labels need much stronger warnings about the risks for serious adverse events, including tendinitis and tendon rupture, prolongation of the QT interval, and peripheral neuropathy, according to a joint panel of the US Food and Drug Administration (FDA). …
Fluoroquinolone labeling currently has warnings about the risks for tendonitis, tendon rupture, central nervous system effects, peripheral neuropathy, myasthenia gravis exacerbation, QT prolongation and Torsades de Pointes, phototoxicity, and hypersensitivity. But panel members called for stronger wording, with some suggesting the risks be called out with a black box warning. …
Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and gemifloxacin.”1
As the information above describes in brief, the side effects of fluoroquinolones include:
- Headaches
- Nausea
- Diarrhea
- Sensitivity to light
- Peripheral neuropathy
- Ruptured tendons/tendonitis
- Hallucinations
- Tinnitus (ringing in the ear)
Fluoroquinolones are a very toxic class of drugs that should be used solely as a last resort, not a first response. Sadly, unsuspecting patients have had their lives completely turned upside-down by some of these side effects, and they and their families will never be the same.
Why Are Fluoroquinolones So Dangerous?
As the name suggests, fluoroguinolones are fluoride-based. Savers are aware of the fact that fluoride is a toxic substance that, among other things, it damages bones, but what many fail to realize is that fluoride can cross the blood-brain barrier where it acts as a neurotoxin.
That’s not the only detriment that makes fluoroguinolones dangerous. One of their worst “side effects” is shared by all antibiotics: the development of antibiotic-resistant bacteria. This is not something that may happen in the distant future; it’s happening now.
In fact, as of this writing, news has just come out that the first strain of Colistin-resistant E. coli has been found in the United States.2 Colistin is not a fluoroguinolone, but the point remains: the overuse of antibiotics can have (and is having) widespread, devastating effects.
The more immediate effects suffered by victims of fluoroquinolones came as a complete shock to them; no side effects had been discussed when the drug was prescribed. Had they been informed of possible side effects, they might have chosen not to take the drug.
2. The Race Is On: Pharmaceutical Companies Vie For Approval Of Weekly Injectable Abaloparatide And Teriparatide
Forteo (Teriparatide), the daily injectable osteoporosis drug, was introduced in 2002 as an alternative to oral bisphosphonates. Understandably, patient compliance is really poor for this drug. So two pharmaceutical giants in Finland got together to create a new, more “palatable” injectable drug.
Relevant Excerpt:
“Paras Biopharmaceuticals has teamed up with Novozymes to generate a ‘once-a-week’ biobetter of Teriparatide…
Paras Biopharmaceuticals has developed a highly efficient production technology platform for the biosimilar of Recombinant Teriparatide (Forteo Biosimilar). Extending the release of the base molecule (to once-a-week) by incorporating Novozymes’ VELTIS technology will offer new solutions. Already well-established in the fields of diabetes, hemophilia and neutropenia, the VELTIS platform is able to provide once-weekly, once bi-weekly or once-monthly peptide or protein dosing. As a result, VELTIS offers the potential for enhanced patient adherence and improved therapeutic impact.”3
The pharmaceutical companies hope to increase “patient adherence”, a documented issue with Forteo according to a 2012 study. Researchers found that within one year of initiating Forteo treatment, only 21% of the patients were “highly-adherent,” leading to the blunt conclusion that “Adherence to teriparatide therapy was suboptimal.”4
Meanwhile, in the United States, biotech company Radius Health Inc. is preparing to release this admittedly “experimental” drug, abalaoparatide, within the next year. They are also hoping to out-compete Forteo.
“The company’s experimental drug — a bone-building hormone with the scientific name abaloparatide — could become a mass-market ‘blockbuster,’ topping $1 billion in annual sales, executives believe. Radius, which has applied for its approval in Europe, will request a US brand name when it files its application with the FDA, the first Massachusetts biotech company to seek approval this year.”5
So what do we know about this new delivery technology? The Finnish companies use a technology called VELTIS, and the words belonging to the acronym are not revealed. In equally vague language, we’re told that “VELTIS is a clinically-proven technology based on engineered albumins delivered to allow the drug developer to optimize dose size and frequency to achieve stricter patient adherence (compliance).”3
There is no information on how the U.S.-based Radius Health Inc. plans to create a teriparatide shot that can be given far less frequently than before. And there is no notation whatsoever of possible side effects, the same problem faced by the victims of fluoroquinolones, which were discussed above.
The sad reality is that this will be marketed as the “latest” osteoporosis drug, and the public will be more likely to submit to the injections if they believe this is a newer, safer drug (and if the injections are infrequent). This is where the Save Our Bones philosophy applies more than ever: there is no such thing as a 100% safe osteoporosis drug.
3. Conflict Of Interest: More Clinical Trials Than Ever Funded By Big Pharma
A disturbing “self-regulating” cycle on the part of the drug companies has recently been elucidated, pointing to a clear conflict of interest. This information was published in the Journal of the American Medical Association.
Relevant Excerpt:
“New research shows a 43% increase in clinical trials funded by drug companies during 2006-2014. Can you say ‘conflict of interest?’
The U.S. Food and Drug Administration (FDA) mandates clinical trials of safety and efficacy for all drugs intended for sale to Americans. Current regulations require that trials start with testing on laboratory animals and culminate with tests on human subjects.
The problem is that – with millions and sometimes billions of dollars at stake – there’s no requirement for these tests to be done by a third party. The drug industry is basically ‘policing itself.’ …
One scientist responsible for this new research, Stephan Ehrhardt, noted:
‘. . . given that the industry has a vested interest in the outcome of those trials, we don’t get good data to inform the health of the public.’
Ehrhardt also explained that NIH [National Institutes of Health]-funded trials look at wider health impacts than pharma-funded trials do. NIH’s budget doesn’t depend on FDA’s approval of a drug. In contrast, the pharmaceutical corporations stand to profit immensely, so they have a narrower focus. They just want the data that will get them the FDA’s approval.”5 (emphasis mine)
The FDA approval process is long and drawn-out, and Big Pharma is more than willing to cut corners and facilitate the process, even if it means producing biased study results. Sadly, unsuspecting patients who take their doctor’s word at face value can end up with life-changing side effects.
At the Save Institute we not only examine the information as shown by the available data, we go beyond, dig deeper, and connect the dots. The Osteoporosis Reversal Program is backed by such analysis, with over one hundred scientific references.
Stop Worrying About Your Bone Loss
Join thousands of Savers from around the world who have reversed or prevented their bone loss naturally and scientifically with the Osteoporosis Reversal Program.
The Program is based on solid research, and non-biased interpretation of the scientific data, and is designed to reverse and prevent bone loss and to support overall health and well-being.
Till next time,
References:
1 https://www.medscape.com/viewarticle/854067
2 Christensen, Jen and Goldschmidt, Debra. “A dreaded superbug found for the first time in a U.S. woman.” CNN Health. May 27, 2016. Web. May 28, 2016. https://www.cnn.com/2016/05/26/health/first-superbug-cre-case-in-us/
3 Parkinson, Dave. “Paras Biopharmaceuticals forms partnership with Novozymes to embrace VeltisR technology for once-a-week Teriparatide Biobetter for Osteoporosis.” Breaking Finance News. November 23, 2015. Web. M ay 28, 2016. https://breakingfinancenews.com/investing/paras-biopharmaceuticals-forms-partnership-with-novozymes-to-embrace-veltis-technology-for-once-a-week-teriparatide-biobetter-for-osteoporosis/5141/
4 Hazel-Fernandez, Leslie, et al. “Association of teriparatide adherence and persistence with clinical and economic outcomes in Medicare Part D recipients: a retrospective cohort study.” BMC Musculoskeletal Disorders. Doi: 10.1186/1471-2474-14-4. January 3, 2013. Web. May 28, 2016. https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-14-4
5 Sarich, Christina. Unsettling Truth: Most Clinical Trials Are Funded By Big Pharma: Concerns arise over drug safety and conflicts of interest.” Natural Society. March 23, 2016. Web. May 2016. https://naturalsociety.com/big-pharma-funds-most-clinical-trials-6111/
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Hi Katherine,
Please check your inbox for a message from customer support, where these issues are typically handled. 🙂
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I ate veggies and fruits and exercise daily and have no problem with my osteoporosis.
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I an moving to Pa. My email address is the same. My kids wants to take care of me.
I an old. God bless -
I am a Seventy-three year old woman pensioner. I have osteoporosis in spine and hips. I was taking alendronic Acid but had bad side effects i stopped taking them. Now I eat healthy take some vitamins and follow save our bones, program. I’m so glad for information that is giving daily with exercises to help our bones. I feel so much better without pharmaceutical drugs. Thank you save our bones
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If fluoride damages bones and is a neuro toxin that crosses the blood brain barrier, can we all unite in trying to stop the fluoridation of our water? It doesn’t make sense because fluoride is added to toothpaste and mouthwash if people want to use it. The rest of us shouldn’t be exposed to it if we don’t want the damaging health affects.
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Hi Vivian,
Have you come across information on Ostinol? i read a small article on it. It says it signals your bones to make new healthy tissue without the bad side effects of most bone prescriptions. It’s been used by orthopedic surgeons after surgery for years. It also said there is a 10% increase in bone density in 8 months and a 51% increase in 34 months. It’s found in health food stores.
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Be aware that veterinary docs also use these dangerous drugs. My dog was given a drug called Baytril. I didn’t realize until researching it later that it is a fluroquinolone and he did have some side effects from it. You can’t always tell by the name of the drug.
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I haven’t heard any comment from you on the effect of natural progesterone hormone on osteoporosis. Apparently, this hormone has a proven effect on promoting new bone formation of 15% over 3 years, and it’s effect is greater the higher degree of osteoporosis you have. Please let’s have your comments on this. Note, the synthetic hormone progestin also has a minor 5% improvement, but is not recommended because it’s not the biological exact progesterone, and it causes side effects.
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Novartis the reclast maker will tell you if you have a absorbtion deficiency then reclast is not for you ….I had a gastric bypass with a rue n y so I can’t absorbe ….so Dr Sanson knew this and still insisted I have it ……my whole body went toxic because the acid had no way out and damaged every organ and my eyes ….hurt all over
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I was normal and active but had thyroid issues the Doctor insisted I take reclast back in 2016 because she said I had low bone density …Please don’t let them give you that poison I almost died and I have not been the same and Doctors stick together in a small town ..west monroe la
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Hang in there, Lori – your body was made for health, not disease, and it is possible to recover from drug side effects as the drug leaves your system.
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thank you for alerting the world about antibiotics that destroy our bones and collagen i should also contribute that the diet sometimes fails our body to acquire enough calcium due the presence of heavy metals in the body and poor bowel flora
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When my back gave way with spinal compression fractures I finally saw an osteoporosis specialist who said I am a prime candidate for more fractures. He said I have to do something and mentioned Forteo which I know is hugely expensive and told him could not be afforded so he recommended prolia. Did I have a choice??? So I took my first shot recently and it will be every six months. I know what it does to seemingly make the bones stronger, which is scary too. But what am I to do? I say this with tears in my eyes, as I still have some back pain and take meds for that. I also have some head/brain issues that distress me. Will be making an appt with my Dr. today.
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Hi Betty,
I firmly believe that you do have a choice about whether or not you take osteoporosis drugs (or any drug). It’s your health and your body, and no one can force you to take any particular drug if you do not feel comfortable.
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Good morning! I wish I had had this article in January of this year which I developed a stubborn bronchitis that I wasn’t able to recover from on my own. I waited a month then went to an Urgent Care where I was given doxycycline and when that didn’t help, I went to my regular Internist a few weeks later who prescribed levofloxacin along with Prednesone, saying “This will knock out anything”. Two days on this and I tore my Achilles Tendon by simply walking my dog. Unfortunately I had not read the enclosed info with the RX or I would have seen the warning. I kept taking the meds and just thought I had a bad ankle sprain although it was not like a normal sprain at all. Hobbling along another month I happened to find the RX warning on my desk… A month of PT saved the day, but I will always in the future ask my doctor about any possible side effects, before she writes the script. It was awful!
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I am so sorry to hear about your torn tendon, Carol! Thankfully, you had access to a good physical therapy program.
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you discussed this perils of a higher dosage weekly injections of Forteo but I am wondering about your opinion of Forteo in daily injections. of course it has side effects, but I have painful compression fractures and have been told to expect more. do you believe that Forteo can help prevent more fractures if I am willing to take the risk of a dangerous drug? thank you for all your help. you make this journey sacred.
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Hi Carla,
You can read my take on Forteo by clicking on the link in the article, which I have copied and pasted it below for your convenience:
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thank you vivian. It is so wonderful to have all this info at my finger tips while I make such a difficult decision.
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My problem is that I am allergic to most antibiotics and Cipro is one of the few that I can tolerate. The only thing I can think to do is to eat a plant based whole food diet, and get regular exercise and sleep, try to manage stress, This all helps me stay well but sometimes I still will need Cipro.
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Hi Sharon,
Your situation is a good example of an emergency where fluoroquinolones might be appropriate. Remember, too, that you can ask your doctor or attending physician for an alternative to fluoroquinolones. Just as you inform them of your allergies to certain antibiotics, you can also inform them of your desire to avoid fluoroquinolones if at all possible.
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I recently suffered from a Urinary Tract Infection and my doctor prescribed Ciprofloxacin. I took a five day regimen. If this was damaging my bones, what was the alternative I have? I couldn’t just ignore the UTI, what should I have done?
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Hi Danna,
I am glad you came through your infection without any complications! Hopefully, you will not have any more infections to deal with, but if you do, you can ask your doctor for a safer alternative to Ciprofloxacin if he or she wants to prescribe it again. You can also explore natural antibiotics like bee propolis, which you can read about at this link:
https://saveourbones.com/propolis-a-natural-antibiotic-thats-good-for-your-bones/
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I am a very healthy woman, 77 years old, but have been diagnosed with osteoporosis.
I rejected availing myself of the medications traditionally used when diagnosed about
8 years ago. I have a small frame and weigh about 108 pounds and I am very active in
terms of both mental and physical challenges but I feel I should be doing something
more to deal with the osteo diagnosis. I am not on medication and my blood tests
show strong levels of calcium and vitamin D—-two of the many vitamins I take daily.
Do you have any advice on what I can do to deal with the osteo and yet not compromise my health in doing so??? Thank you.-
Hi Marcy,
Welcome! You’ve come to the right place. The “Saver” approach to osteoporosis directly addresses your concern – it’s all about managing osteoporosis without compromising your health. In fact, a bone-healthy the nutritional and lifestyle plan boosts your overall health as well as your bones.
Feel free to peruse the copious free information on this site, and you’ll see that you do not have to give up good health to build bone. It’s quite the opposite, in fact!
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I am in a similar situation and would like to know the answer to Marcy’s question. Thank you
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My mother ordered your book and never received it. When she contacted customer support, she was told that the hard copies are out of stock and it isn’t known when there will be new ones. How can you remedy this issue for her?