Patients meet regulators

by Alexey Bersenev on March 26, 2013 · 0 comments

in regulation

The regulation of cell therapies, particularly stem cells, is a tough issue. On the one hand, the use of cells is very new, complex and unique kind of therapy and, therefore, it’s a big challenge for regulators. On the other hand, there are many players and stakeholders, whose interests should be taken in account. The regulators claim to provide a public safety, but how frequent do they actually listen and get feedback from the patients? Not frequent at all! As a consequence, most of the patients think that over-regulation of cell therapies by the FDA forces them to look for alternatives outside the country and does more harm than good. This week, clash between patients and regulators took an extreme way in a form of “street protest” in Italy. Some professionals think, that exclusion patients from regulatory decision making is unethical. To me, the obvious solution is to meet, talk and educate each other!

Magically, this remarkable event finally has happened! A month ago, the FDA run the first-ever public hearing for ALS patients community. I collected some useful links and tweets about event in this story. You can also watch a webcast.

One of the prominent voices of ALS community, patient from NeuralStem trialTed Harada gave a speech, which perfectly reflects (in my opinion) a public opinion and frustration about current (“paternalistic”) regulatory approach of FDA. Some quotes:

Patients diagnosed with fatal diseases should be given the opportunity to take elevated risks with informed and educated consent in regards to their treatment options.

I’d suggest that FDA has an obligation to encourage and reward innovation. And not just sit on a sidelines. We can’t afford it.

I’d suggest that your paternalistic approach put patients in more harm ways than it does protect them.

Lack of incentive for ALS investment as well as expanded access encourages ALS patients take risks in unregulated and potentially unscrupulous treatments.

It was a call for action and for collaboration. It’s not clear what was a catalyst for this event, but possibly, a recent big failure of new biotech drug for ALS. In any case, this was a very important event. It demonstrated that a dialogue is possible!

I believe that patients have a power to influence and educate regulators via advocacy groups. I think, that the open dialogue and transparency is the only way to find a balance between patients safety/ protection and rapid development of new medical innovations, such as cell therapy.


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