Stem cells grown under low oxygen. These stem cells from Stemedica are licensed to CardioCell.

Dr. David Gorski, a prominent skeptic of therapies offered outside the scientifically controlled clinical trial system, has published an extensive and critical look at the stem cell therapy Gordie Howe received in early December to help him recover from a serious stroke.

I had email exchanges with Gorski while writing my article last week on the treatment, using stem cells provided by San Diego-based Stemedica. Gorski, whose previous blog post at Science Based Medicine on Howe's treatment caught my attention, follows through with an analysis of the clinical trial setup used by Novastem, a Mexican stem cell company licensed by Stemedica to use its cells.

"As sympathetic as I am to the Howe family, Im sorry. I reluctantly have to say that Murray Howe really should know better," Gorski wrote. "If Gordie Howe was treated as part of a clinical trial, then Novastem should have treated him for free! Thats because if it is running a clinical trial, it should treat everyone on the trial for free. Thats the way its done ethically."

I asked Novastem president Rafael Carrillo, about that issue. Carrillo said Novastem doesn't have deep pockets like a big pharmaceutical company, so it needs to charge for the treatment to pay its expenses. Without that money, it can't afford the trial. Patients wouldn't get the opportunity to get care that could help them. Moreover, this arrangement is legal under Mexican law.

Gorksi views this as unethical, even if legal. He objects to the free treatment given to Gordie Howe, because it amounts to publicity for Novastem that will attract paying customers. And even if Howe is doing better, as appears to be the case, it's not possible to tell whether stem cells helped.

The U.S. system has its own flaws, Gorski says, because patient expenses not related to the clinical trial, such as health insurance, are not paid for.

"Patients who dont have health insurance will often have a huge difficulty paying for their care not related to the clinical trial and thus will have difficulties accessing cutting-edge clinical trials because they cant pay for their own regular care," Gorski wrote. "Yay, USA!"

Stemedica is offering its own U.S. trial of the therapy, but people must have had the stroke at least six months ago. That's because people make the most improvement within six months after a stroke. So delaying treatment until after that point will make it easier to detect improvement caused by the stem cell treatment.

Understandably, this requirement to help make the trial scientifically valid frustrates a number of patients who want to be treated as soon as possible. The general rule with stroke is the sooner therapy is provided, the better. So presumably, if the stem cell therapy is effective at all, earlier administration would be even more effective. That's the calculation many people will make, and it's at odds with the American clinical trial protocol.

See the original post here:
More about Gordie Howe's therapy

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