Under guise of ‘free market’, stem cell start ups take sick patients for risky rides

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The allure of stem cell technologies is pressuring policymakers to loosen regulatory control over therapies as patient advocates and unscrupulous private enterprises both buy into and oversell promises to end disease.

The public at large is easily victimized by these claims because of the strong regulatory processes that safeguard medical therapies in the Western world, argue stem cell scientists Paolo Bianco and Douglas Sipp in Nature’s most recent issue. So, when we hear about a new medical treatment, we often assume that its safe even if it hasn’t been vetted.

But stem cells therapies are currently being marketed to patients to treat everything from bad knees to Parkinsons disease without any proof of efficacy. Of course, there is tremendous, legitimate stem cell research going on in universities and private companies around the globe. But the nature of the business of stem cells by unscrupulous private companies subverts the scientific process. Because all the test subjects are paying for treatment, there are no control groups, no placebos and no randomization of subjects.

And there are thousands of dollars on the line for patients who are often very ill and who will need all of their financial assets to live as comfortably with their condition as they can:

Under the guise of ‘patient-funded clinical trials’, clinics in the United States and Mexico persuade people who are seriously ill to pay tens of thousands of dollars for procedures. Because such patients have been told that a product is experimental, they have little recourse when hoped-for cures fail to materialize. Companies can thus profit from selling hope. With their products already on the market, they have little reason to conduct rigorous, conclusive research.

Bianco and Sipp argue that governmental and economic organizations need help to identify and infuse the creativity of those stem cell therapeutics companies that are doing legitimate science and have the ability to truly help patients. But that is a difficult charge in a world where the public hears about pro-athletes getting stem cell injections for bum knees.

Regulatory agencies face a growing challenge in gauging the merits of stem-cell therapies. Meanwhile, governments need better mechanisms to identify and support radical innovation. Untapped tools include public investment banks and equity shares.

For stem-cell research to achieve its therapeutic potential, science, medicine, economy and policy all must work together. If, as has been widely asserted, stem cells represent the future of medicine, then we need to ensure that that future is one in which patients can reasonably expect treatments to be both safe and effective.

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