It’s Alive!

My Adventures in the Skin Trade

Question: What’s made from medical waste and costs $21,000 a square inch?

Answer: the MLG-COMPLETE Wound Care Graft from Samaritan Biologics. The MLG-COMPLETE consists of paper-thin patches of dried “perinatal tissue” (placenta, umbilical cord, and amniotic sac), harvested from women after childbirth, and rich in the “natural birth components” the company claims can promote healing of severe wounds.

MLG-COMPLETE is only the most expensive of over 100 costly “skin substitutes” with names like Restorigin, Xcellerate, and Impax—essentially, high-end bandages produced from discarded human flesh (mostly placentas), that are costing Medicare billions of dollars a year. According to a New York Times investigation in April, spending on skin substitutes has increased fortyfold in the past five years to over $10 billion in 2024, more than Medicare spent on ambulances or anesthesia—without clear proof that the products work.

While skin substitutes are being used to treat the millions of diabetic skin ulcers and venous leg ulcers that plague an aging population, manufacturers don’t have to prove the coverings work any better than ordinary, cheaper dressings because the government categorizes them like donated organs as HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-based Products). All that’s required of manufacturers is proof of processing safety and sterility.

According to the Times report, another regulatory loophole has allowed Samaritan Biologics, ExtremityCare, Surgenex and other substitute skin producers to effectively set their own prices, which Medicare has routinely covered despite the questionable efficacy of their products.

And yet, even though skin substitutes have become one of the most grievous examples of Medicare waste in history, the Trump administration has been slow to act. In fact, during his campaign, Trump denounced a Biden-era plan to radically cut payments for skin substitutes. A $2 million donation by the skin substitute company ExtremityCare to a super PAC supporting Trump may have had something to do with his unfavorable response. But in the wake of the Times report, the Centers for Medicare and Medicaid Services announced that its payment for skin substitutes would be slashed to $806 per square inch—then promptly kicked the can down the road by delaying implementation of the rule change until next year.

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Many years ago, when I was just starting in pharma advertising, I was assigned to work on a product called Apligraf that was being comarketed by its parent company Organogenesis and Novartis. Apligraf is still available as a skin substitute, but one which bears little resemblance to the fancy bandages that are currently bleeding billions from Medicare.

The critical difference between Apligraf and the newer skin substitutes is that Apligraf isn’t dried, dead tissue, but instead is composed of living skin cells—harvested from foreskins not placenta and cultured on a collagen matrix. (Foreskin tissue is preferred as a source of fibroblasts, the specialized cells that repair damaged tissue in the body.)

"It’s Alive!” was the headline we used in our ads—a bizarre but not inappropriate echo of Dr. Frankenstein’s exclamation when the eyes of his monster fluttered open. An image of the delicate lab-made membrane circled by a glowing gold aura as it’s lifted from its container by a surgically gloved hand occupied the hero space of the ad.

Another crucial difference between Apligraf and its upstart successors is that it doesn’t rely on a bureaucratic loophole to sidestep proof of efficacy, but has been fully approved as a medical device by the FDA, based on rigorous clinical studies demonstrating that it works. Nearly twice as many patients with diabetic foot ulcers and venous leg ulcers saw their wounds heal completely with Apligraf compared to standard dressings.

And Apligraf was and remains relatively cheap compared to competitors. The price today for a 7 square-inch circular disk is $1,900 per dose—more economical by a factor of thousands than the marvelous MLG-COMPLETE.

Apligraf wasn’t enough of a money-maker for Novartis and the marketing rights reverted to its originator Organogenesis, but if you’re ever in need of a skin substitute, there’s still no substitute for Apligraf.

The Apligraf account was a cool gig while it lasted, and I learned a thing or two. For example, whenever I accidentally gouge or gash myself, I’m still fascinated by the physiological fact that wounds heal from the outside in; you can watch the skin repairing itself from the edges to the middle. The other thing I learned was that, when marketing anything to doctors, be it pill or poultice, the more abstract, creative, and out-of-the-box your idea, the less likely they are to get it. This was driven home to me when we tested ideas to “refresh” the tried and true “It’s Alive!” campaign. The ad I’d come up with showed a close-up of a foot with a nearly healed diabetic foot ulcer secured by a padlock, along with the headline “Closed!” The doctors were confused; they wanted to know how to unlock it.