This month’s Save Our Bones Bulletin contains a remarkable revelation about the relationship between cognitive function and the four seasons.
We also bring you an update on Big Pharma’s latest attempt at a quick-fix drug for osteoporosis. This new drug's dubious ascent through the approval process seems to be marching forward, raising red flags left and right.
To round things off, you’ll learn about a stem-cell-based osteoporosis drug created by a private biotech start-up and its unexpected funding source: tax dollars.
Brain Power Peaks In Autumn
A study published this month in PLoS Medicine has shown that cognitive processing power shifts from season to season. People who live in the Northern Hemisphere experience their highest brain function in late summer and early fall, while signs of cognitive decline are at their worst in winter and spring.
The researchers analyzed data from 3,353 participants enrolled in separate cohort studies in the U.S., Canada, and France. Each participant underwent neuropsychological testing, and for some, information about factors associated with Alzheimer's disease was available.
”The authors found that average cognitive functioning was higher in the summer and fall than the winter and spring, equivalent in cognitive effect to 4.8 years difference in age-related decline. Besides, the odds of meeting the diagnostic criteria for mild cognitive impairment or dementia were higher in the winter and spring (odds ratio 1.31, 95% CI: 1.10-1.57) than summer or fall. The association between season and cognitive function remained significant even when the data were controlled for potential confounders, including depression, sleep, physical activity, and thyroid status.
Finally, an association with seasonality was also seen in levels of Alzheimer's-related proteins and genes in cerebrospinal fluid and the brain.”1
The authors of the study suggest increasing dementia-related clinical resources in the winter and early spring since symptoms are likely to be most severe at those times. Their findings also shed light on how much the environment and behavior impact our brains.2
The study wasn’t meant to identify which elements of seasonal shifts cause changes in mental function, but they could include changes in sun exposure (as with Seasonal Affective Disorder), seasonal illnesses, or seasonal behavioral shifts.
A study found that cognitive decline is most pronounced in the winter and spring and that conversely, brain function is at its peak in summer and fall.
Amgen And UCB Resubmit Rejected Drug For FDA Approval
Pharmaceutical giants Amgen and UCB partnered in 2004 with the goal of creating a new osteoporosis drug. This year, they submitted Evenity (romosozumab) to the FDA for approval– for the second time. Their first attempt failed, and for a good reason.
“The FDA rejected the original BLA (Biologics License Application) in July 2017, requesting more data related to adverse cardiovascular events. Evenity is a monoclonal antibody being developed to treat osteoporosis in postmenopausal women. When the companies announced topline data from the Phase III ARCH trial, which compared Evenity to Merck’s Fosamax (alendronate sodium) in May 2017, there was a higher risk of serious cardiovascular events with Evenity than Fosamax.
Evenity works by inhibiting the activity of sclerostin. This results in increased bone formation and reduced bone resorption.”3
Fosamax is ineffective and dangerous- as evidenced by the years of lawsuits brought against Merck for failing to disclose the drug’s devastating side effects. If the FDA- which regularly fails to protect citizens from harmful or deadly drugs- found Evenity to be worse than Fosamax, then we know it’s a disaster waiting to happen.
In spite of that, these powerful pharmaceutical corporations are working to push the drug through the FDA’s approval system. Given how many osteoporosis drugs the FDA has allowed onto the market, it won’t be surprising if the additional studies that Amgen/UCB submitted for review convince the agency to gloss over the clear and present danger of Evenity.
The Save Institute will be keeping an eye on this story, and as it develops, we’ll make sure to keep you up to date.
Amgen and UCB have resubmitted their newest osteoporosis drug Evenity (romosozumab) to the FDA for approval after it was rejected last year due to its dangerous cardiovascular side effects.
California State Program Funds Osteoporosis Drug Development
A government program in California dedicated to supporting the development of stem-cell-based treatments has awarded more than 1.5 million dollars to a pharmaceutical company so that they can pursue trials of a new osteoporosis drug.
The state program is called The California Institute for Regenerative Medicine (CIRM), and their primary focus is the support of medical research and drug development that involves stem cells. They awarded the grant to a privately owned biotech firm called MAX BioPharma Inc. of Santa Monica.
“The California Institute for Regenerative Medicine announced May 24 that it had awarded the pre-clinical biotech firm a $1,689,855 grant.
The funds will enable the six-year-old firm to test a therapy that targets stem cells in a skeleton, creating new bone forming cells and blocking the destruction of bone cells caused by osteoporosis. The disease is especially prevalent in Latinos.
“We’re very happy with this very important support from CIRM,” said Farhad Parhami, founder and chief executive of MAX BioPharma. “It will allow us to finally take some very important steps forward filing with the FDA to begin testing our osteoporosis drug on humans.”4
CIRM’s website states that part of its mission is to provide support where there is “an unmet medical need.”5 There are many untreatable illnesses and conditions which stem cell research could help cure or manage, but osteoporosis does not fall into the category of unmet medical needs.
As Savers know, there are many drug-free, natural ways to strengthen bones. Eating a pH-balanced diet, supplementingwith bone-essential vitamins and minerals, and engaging in weight-bearing exercise are all scientifically tested and proven ways to increase bone density and reduce fracture risk. Better still, they improve overall health without causing any adverse side effects.
Clearly, the almost 1.7 million dollars would have been better spent educating the public about safe and natural ways to reverse osteoporosis.
A state program in California awarded 1.7 million dollars a biotech firm to support trials of a new stem-cell-based osteoporosis drug.
Osteoporosis Drugs Are Not The Answer
Every osteoporosis drug causes terrible side effects in exchange for (at best) mediocre and temporary results that are greatly surpassed by a holistic and natural approach. And Savers know that we already have the tools we need to reduce fracture risk and take care of our bones.
1 PLOS. “Dementia symptoms peak in winter and spring, study finds.” ScienceDaily. ScienceDaily, 4 September 2018. Web. https://www.sciencedaily.com/releases/2018/09/180904140617.htm
2 Andrew S. P. Lim, et al. “Seasonal plasticity of cognition and related biological measures in adults with and without Alzheimer disease: Analysis of multiple cohorts.” PLOS Medicine, 2018; 15 (9):e1002647. Web. https://www.researchgate.net/publication/327428337_Seasonal_plasticity_of_cognition_and_related_biological_measures_in_adults_with_and_without_Alzheimer_disease_Analysis_of_multiple_cohorts
3 Mark Terry. “Amgen and UCB Take Another Shot at Osteoporosis Drug” BioSpace. July 13, 2018. Web. https://www.biospace.com/article/amgen-and-ucb-take-another-shot-at-osteoporosis-drug/
4 Dana Bartholomew. ?MAX BioPharma Awarded $1.7 Million to Fight Osteoporosis.” LA Business Journal. May 24, 2018. Web. https://labusinessjournal.com/news/2018/may/24/max-biopharma-awarded-17-million-fight-osteoporosi/