ISSCR Policy Advocacy in Action

  • 7 October, 2019

Polices created by legislators and regulators can have a profound impact on stem cell and biomedical research and the development of new treatments. While individual researchers may feel vulnerable to new policies and powerless to change them alone, the ISSCR represents a collective and influential voice of over 4,000 stem cell scientists, clinicians, and professionals that is having an impact.

The ISSCR has been working on several fronts to advocate for responsible stem cell research and its application. ISSCR experts were consulted as Google drafted new policies to prevent the marketing of unproven stem cell therapies globally.  The ISSCR also led a fly-in to Washington D.C. to meet with U.S. congressional representatives, senators, and U.S. Department of Health and Human Services (HHS) officials to advocate for stem cell research. These initiatives reflect the ISSCR’s expanding policy influence.

Google’s New Marketing Restrictions
After consulting with ISSCR experts and others, Google announced a new global policy banning advertising for unproven stem cell treatments and other speculative medical interventions. Google’s new policy is a much-needed and welcome step to curb the unscrupulous marketing of unproven stem cell therapies. While stem cells have the potential to help us understand and treat a wide range of diseases, most stem cell interventions remain experimental and should only be offered to patients through well-regulated clinical trials. The premature marketing and commercialization of unproven stem cell products threatens public health, their confidence in biomedical research, and undermines the development of legitimate new therapies.

The new policy sends a strong message to nefarious clinics preying on vulnerable patients and is an important step in an ongoing process of reducing the visibility of clinics offering unproven stem cell products around the world.

Advocacy on Capitol Hill IMG_0532crop
On 18 September, 2019, the ISSCR led teams of scientists and experts to meet with policymakers that included HHS senior officials, members of congress, and U.S. senators to voice concerns regarding 1) the U.S. administration’s new policy on research using fetal tissue, 2) the spread of clinics selling unproven and unapproved stem cell “treatments,” and 3) to voice our support for increasing biomedical research funding.

Image from left to right: Melissa Carpenter, Sally Temple, Sean Morrison, Arnold Kriegstein, Deepak Srivastava, Eric Anthony, and Charles Murry

Fetal Tissue Research Restrictions
On 5 June, 2019, the HHS department announced a new policy that banned the use of fetal tissue for National Institutes of Health (NIH) intramural research, and created new barriers for extramurally-funded research, including an extraneous ethics review. I fear these new policies will have a chilling effect on crucial research using fetal tissue and dissuade scientists from including fetal tissue research in future grant proposals. We expressed these concerns and urged federal representatives and department officials to limit the negative impacts of the new policy and convey their support of fetal tissue research and the life-changing discoveries that emerge from it.

Unproven Stem Cell Products
The global number of clinics selling unproven products continues to grow, with recent estimates placing the number at over 1,000 in the U.S. alone. In parallel, some employer-based health plans have begun offering coverage for unproven treatments, which are additionally beginning to creep into the space of academic medical centers and hospitals. 

While the U.S. Food and Drug Administration (FDA) and Federal Trade Commission Golden_2crop (FTC) are stepping up their enforcement of clinics offering unapproved therapies or false marketing claims, there is much more to be done. The ISSCR conveyed our support for the important work of the FDA and FTC to protect patients and encouraged policymakers to provide the resources needed for these enforcement activities.

Image from left to right: Zubin Master, Martin Pera, Rep. Jared Golden (D-ME), Tenneille Ludwig, and Chris Barry.

Biomedical Funding
Sustained annual increases in federal funding of biomedical research, including stem cell research, are essential to drive science and accelerate the development of new therapies that will bring hope to millions of patients. The ISSCR emphasized the importance of federal support for research by increasing NIH funding and asked members of congress to work together to do so.

The ISSCR has been increasing its efforts to make its unified voice heard and champion policies that will enable and encourage responsible stem cell research. If stem cell science is to have a truly transformative impact on human health worldwide, we must fight for policies that will allow the potential of stem cells to be realized.

Deepak Srivastava
ISSCR President, 2019-2020