Babies with “short bowel syndrome” are fed intravenously to keep them alive. Unfortunately prolonged IV feeding often leads to liver failure. Doctors at Children’s Hospital in Boston haven’t been satisfied with that trade-off and have experimented with a variety of ways to avert liver problems. A particularly promising remedy is to use Omegaven, a fish-oil based formula that’s on the market in Europe (for adults) but not the US.
Omegaven’s maker, Fresenius AG doesn’t want to market Omegaven here. Basically, they’ve decided it’s not in their commercial interest. Instead Fresenius has a new product in development that they’d prefer to bring to market. Meanwhile Fresenius is happy to sell its existing product, Intralipid. That’s tough luck for babies who need treatment now. Fresenius has actively resisted efforts to allow testing of Omegaven, and the FDA hadn’t been too helpful either. The Wall Street Journal wrote an article on the topic (A Doctor’s Push For Drug Pits Him Against Its Maker) a month ago.
Now, according to another Wall Street Journal article (Trial to Test Drug for Sick Babies) the trial is going ahead. The FDA relented and The March of Dimes stepped in with funding. The trial will pit Omegaven against Intralipid. Babies who start on Intralipid will be able to switch to Omegaven if they develop liver damage. Likewise babies starting on Omegaven will be able to switch to Intralipid if they have problems.
Meanwhile Fresenius is getting a free lesson in how not to build a corporate reputation in the US.
Based on what I read in the Journal, I’m going to make a donation to the March of Dimes, and I suggest you consider doing the same. (MedImmune is matching donations dollar for dollar during December, up to $50,000.)December 20, 2006