Omegaven Part II

It was about a month ago, when I first learned of Omegaven from a blog. I’d researched Short Bowel Syndrom on Google Blog Search and landed on the Short Gut News. A lot can be said of patients who keep an online journal of their recovery. As one blog post describes, patients are becoming the new authority.

Once, during a phone call with Jasmina she mentioned Omegaven, having heard about it in Toronto. “Yes!” my voice nearly squeaked in excitement “I just read about it.” And went on to explain my recent ‘discovery’. “Why didn’t Sébastien get Omegaven?” I asked. Jasmina is always calm when she explains things… The short of her answer was that it wasn’t available in Winnipeg. And it’s very expensive. The cost is from $50 to $100 a day per child. In fact, Omegaven isn’t covered by Health Canada. It isn’t even approved by the FDA in the U.S. Why? Omegaven was created in Germany by the company Fresenius Kabi AG. An article in the Wall Street Journal from November of last year explains the German company’s reluctance to bring the drug to the U.S. market:

Omegaven isn’t what “we see as the best product for this kind of application,” says John R. Ducker, president of the research, development and strategic marketing division of Fresenius Kabi. He says Omegaven, developed 15 years ago, was intended as a supplement, and not to be given alone. The company says it doesn’t contain all the essential fatty acids babies need.

Mr. Ducker says the company’s new product, called SMOFlipid, “presents a better option for pediatric feeding.” The company believes the new product does contain all the essential fatty acids babies need and can be used on its own.

Fresenius Kabi says it doesn’t want to invest the resources required to test both products for approval by the U.S. Food and Drug Administration. It hopes to eventually sell the new product in the U.S., Mr. Ducker says, although no timetable has been set and no trials are under way.

SMOFlipid has been approved for adults in a few European countries. Dr. Puder responds on the continued use of Omegaven versus waiting for the new product:

While Dr. Puder says he isn’t opposed to testing the new drug, “I have a sense of urgency here,” he says. “We have something that works, let’s do Omegaven first. Then once we have something approved so these babies don’t die, we can test something else.” He adds: “We are miles and miles ahead on Omegaven. We have safety data on the patients. We have excellent outcomes on the patients.”

The news, that affects so many children born with Short Bowel Syndrom has sparked some debate, and we are anxious to see how the matter develops. Though Sébastien is no longer affected by Short Bowel Syndrome since receiving a transplant, the research is something that touches Jasmina. She doesn’t hesitate to encourage people who come to the hospital who have similar conditions to what Sébastien had. “I’m so proud of Sébastien,” she once told me. “He is an example for other kids…”