Day 3 of the Till & McCulloch Meetings continued with many interesting talks. The one that I have chosen to write about in more detail Dr. Douglas Sipp’s, titled “The Stem Cell Dark Economy.” I think his talk was really thought provoking, and important to be shared with our readers.
He began with an old ad starring Mel Gibson that was advocating against regulating vitamins and dietary supplements by the government.
This ad is a product of health food companies lobbying against the government to vote down a bill that would give more power to the Food and Drug Administration (FDA) to regulate vitamins and dietary supplements. Indeed, in 1994, the Dietary Supplement Health and Education Act (DSHEA), which defines and regulates these substances, was signed into law by President Bill Clinton.
Under this Act, the FDA has the ability to regulate these supplements as food and only has regulatory authority once they are on the market. This means that the providers of such products do not need to show any evidence of safety or efficacy, but they do need to label and market their products accurately. The DSHEA resulted in an explosive growth of companies manufacturing such products in the U.S. A business report, published this year, estimates that health food companies will sell USD$27.6 billion in 2016.
According to Dr. Sipp, a similar situation is happening in the use of stem cells in clinics across the U.S. The term “stem cell tourism” started to emerge in the early 2000s, and it refers to the cross-border travel of people from rich countries to developing countries to get stem cell treatments. Contradictory to this initial concept, a recent report shows that direct-to-consumer marketing strategies were heavily seeded inside the U.S.
In a second report, Leigh Turner and Paul Knoepfler show that 570 clinics inside the U.S. offer stem cell interventions. The authors gathered their data based on intensive internet-based keyword searches on marketing strategies that such clinics use to promote their stem cell interventions. Interestingly, there seemed to be an increase in claims that involved using autologous adipose-derived stem cells. The authors report that this methodology did not provide any data on the sizes of the operations, the number of patients involved, the outcome of the interventions and any studies on safety and effectiveness of the procedures. Such lack of clarity in the series of specific marketing claims made by these clinics is concerning.
According to Dr. Sipp, the stem cell industry has shifted from what was spread out clinics localized to developing countries to a huge network of clinics with franchises inside the U.S., which now have a lot of legislative support from think tanks. These policy institutes are lobbying for further deregulation of stem cells, similar to the pattern seen for dietary supplements. They argue that stem cell products and procedures should not be regulated the way drugs are.
Through marketing strategies such as “Free-to-Choose” they advocate for a free market for stem cells and the right to choose rhetoric. Patients who can, should be able to pay for the treatment they want and receive it. While it is understandable that patients with debilitating diseases want to have the freedom to choose all possible treatment options, deregulation is not the best answer. Unfortunately, the right to choose rhetoric is misleading patients into not trusting the scientific community. Thus there should be increased efforts to communicate scientific research on stem cells – their potential, possible risks and side effects, results of studies, etc. – to patients.
Furthermore, deregulation of such treatments will let the clinics, and physicians involved, generate revenue from treatments that have not been fully tested. As Dr. Sipp suggests, a bright future for stem cell research and treatments will only be achieved through collaborations among patient advocacy groups, scientists and the medical and legislative communities. This, in turn, will ensure that innovation moves forward and patients receive safe and effective treatments in a timely manner. This is in line with Tina Ceroni’s talk the day before requesting more patient inclusion.
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