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.
“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:
- Sensitivity to light
- Peripheral neuropathy
- Ruptured tendons/tendonitis
- 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.
“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.
“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,
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/