Are Fat Stem Cells a Drug?

I’ve blogged before on the stem cell wild west, or the concept that there’s more misinformation on stem cells these days for patients and physicians than good information. Many colleagues act surprised when I tell them the FDA considers the stem cells that they are isolating from fat in their office an illegal unapproved drug.…
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The Cholesterol Drug Problems Two Step: Or How the Tail Wags the Dog in Medicine

For years, I’ve been an ardent critic of the Madison avenue message that we all desperately need to lower our serum cholesterol by taking cholesterol drugs (statins). First, we have observed that these drugs tend to hurt adult stem cells. Second, I’ve had to research them for my own use. In that research, I was…
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Tweeting from the DC Circuit

A week from today, if the government is still running, we will be squaring off with the FDA on whether cultured stem cells produced by a physician in his or her office for one unique patient are a drug or the practice of medicine. If you want a detailed account of this effort, I‘ve actually…
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Why I Avoid Drug Reps in My Office Like the Plague

There isn’t a week that goes by that I don’t see them lurking near our medication samples closet, but I walk by at double step and haven’t talked to one in many years. They are drug reps, a fixture of modern medicine. The last one I spoke to was from the maker of Oxycontin and it wasn’t…
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FDA Clamps Down on Metal-on-Metal Hips due to Hip Replacement Side Effects

The hip replacement side effects story is getting more concerning every month. Initially, it was the metal on metal or MOM hips used in resurfacing. Then it was the wear particles released by all hip replacement prostheses. Then hip resurfacing devices began failing at an alarming rate. Now the FDA is proposing that metal on…
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Carticel Cultured Cartilage Cell Surgery vs. Regenexx-C Stem cell Research

I’m kind of on a roll with infographics lately. In this one I compare the amount of research that led to the FDA approval of Genzyme Carticel versus the amount that currently exists for Regenexx-C, so Carticel research vs. Regneexx-C research.  Carticel is an FDA approved product where surgically harvested cartilage samples are taken from…
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Thoughtful Story on the Cells=Drugs Controversy

Orthopedics this Week and Walter Eisner did a great job exploring the pros and cons of the FDA considering our Regenexx-C procedure a drug (which forced us to move that procedure to the Cayman Islands). It’s a balanced read on the cells=drugs controversy, here’s the link to the full story “Stem Cell Therapies: Clinical Practice or a…
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What if the Hi Tech Industry were Regulated like the Medical Industry?

A friend came over the other night and as we sat watching the kids, he told me a story about a company in the tech space he admired called “Square”. The company grew from a tiny start-up making small square add-on devices for the iPhone that processed credit cards. It’s now a 3.25 billion dollar company in 4 years. This got me…
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