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Vitamin K: High Doses of MK-4 and MK-7 Show Promising Results
Osteoporosis & Bone Health | Last Active: Jun 6 10:56pm | Replies (107)Comment receiving replies
@kfhoz I've already replied to your comment, but have been thinking about this ever since. New FDA guidelines allow drug companies to market new bone drugs without providing proof that taking them will result in fewer fractures. The drug companies only have to prove that the drugs raise BMD (bone mineral density). It's then assumed that higher BMD will most likely result in fewer fractures.
We already know that the newer bone drugs are so expensive that most health insurance policies won't cover them, as they can cost thousands of dollars a month. Meaning these drugs are very profitable for the drug companies.
Also, studies have shown that at least 50% of individuals over the age of 50 who experience a fracture do not have osteoporosis. This indicates that fractures can occur even in those with normal bone density. https://academic.oup.com/jcem/article/104/8/3514/5427152
We also know that the FDA has been known to approve medications without requiring the drug manufacturers to actually prove that they work -- or that they won't cause undue harm. https://www.msn.com/en-us/health/other/the-fda-is-approving-drugs-without-evidence-they-work/ar-AA1G9znW
This doesn't make me feel very hopeful or have trust in any current or new bone meds.
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@daisy17 I also have some misgivings about the FDA changes, but the goal is to make the medications less expensive to trial and thus maybe more option and less expensive for us. I have been a tiny bit involved in medical research and doubt that the individual drugs as profitable as they seem on the surface. It is amazingly expensive to develop and trial a drug. Most drugs fail to get approved, and the successful ones have to cover the costs of all of the failures.
EXAMPLE: The history of strontium ranelate for osteoporosis is a sad chapter on many fronts. The drug company could not do the expensive trials on better-known strontium citrate SrC because there is no way for them to get their money back. Not-for-profit entities do not have enough funds to do full RCT out to fracture risk. I doubt that the change in the FDA policy will be sufficient for SrC research to be publicly funded, but it is a step in that direction. Note: I do not take strontium because of insufficient research. But it might work and I wish someone could do more research.