Only Big Pharma could come up with a drug that’s even more frightening than the condition it’s supposed to prevent!

And that’s the case with its latest and greatest med for osteoporosis — one given the strange name of Tymlos.

This new drug is so risky that patients are warned to stop taking it after two years. And it came out of the gate with a black box warning for osteosarcoma — a bone cancer that rats developed after being given the drug.

But even the “most common” side effects are pretty bad — including dizziness, nausea, headache, palpitations, fatigue, belly pain, vertigo and hypercalciuria, which is elevated calcium in the urine that can lead to kidney damage.

So, you would think the FDA would give such a drug an extra-long look, you know, to be doubly sure the benefits are worth the risks.

The FDA, however, was more than happy to clear this med even faster than expected, with the drugmaker already lining up its sales force to make sure as many doctors are sold on it as possible.

But you don’t have to risk bone cancer to protect your bones, or even vertigo and nausea! Because there are some ways to keep them strong that are cheap, extremely effective and easy to find.

A shot in the dark

If you were near the headquarters of Radius Health (the company that makes Tymlos) in Waltham, Mass., the drugmaker’s horn tooting would be deafening.

It’s sending out press releases, holding investor webcasts and giving the numbers on how many women are statistically due for a bone fracture.

But if it’s statistics you want on how many will be able to dodge a broken bone with Tymlos, that’s not as easy to come by as you would think.

For example, Radius Health states in bold print on its press release that the drug can reduce the risk of fractured vertebrae by 86 percent.

Wow, that sounds big! But hold on — because that’s using the statistical magic trick called “relative risk,” which can make almost anything sound either very amazing or very dangerous.

The “absolute” risk reduction, however, is a much less significant number of 3.6 percent.

But any way you slice and dice it, whether it’s with confusing percentages or words like “significantly,” “exciting,” or any other kind of razzle-dazzle, at the end of the day you’re left with a drug that has a whole lot of “unknowns” to it.

And one of the biggest is how many women who were just trying to protect their bones will end up with cancer of the bone.

Typically, when a med is risky enough that the FDA believes it may cause a malignant tumor, the agency puts a “risk mitigation” strategy into effect. The first goal is to make sure both doctors and patients know about the danger.

Then, the drugmaker may be required to try and tally up how many actually get cancer by establishing a registry for patients to join who get sick.

I know, it’s absolutely crazy.

But even that wasn’t required for Tymlos. I guess the agency must have thought that with so many dangerous osteoporosis meds on the market already, one more won’t make that much difference.

And with the dash to get this drug to your doctor’s office, the FDA makes it appear as if Big Pharma’s wares are the only way you can protect your bones. But that’s certainly not the case.

Taking vitamin D regularly is very important, as is a vitamin K supplement that’s made from natto or nattokinase.

Vitamin K works synergistically with D to doubly protect bones. And if you’re taking a calcium supplement, K is especially important.

And while the only way to get Tymlos is by giving yourself a shot in the stomach every single day, vitamins D and K are both affordable and available in easy-to-swallow capsule form. You can also get a good dose of vitamin D by exposing your skin to sunlight for around ten minutes a day.

It doesn’t get much easier than that.

“FDA clears abaloparatide for high-risk osteoporosis patients” Megan Brooks, April 28, 2017, Medscape, medscape.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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