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Compliance In Focus
Posted by John Lehmann on Thu, Jan 12, 2012

Stem Cell Fraud

CBS recently revisited an important consumer health topic – the misrepresentation of stem cell treatments on the internet. In the 60 Minutes investigation, Dr. Joanne Kurtzberg of Duke University comments that there are ‘huge dangers’ of injecting unregulated stem cell treatments into a patient’s blood or spinal fluid because “little fragments and debris would get trapped somewhere in the blood stream and could cause a stroke, or in the brain [they] could cause an inflammatory reaction.” You can read the transcript here, and find the videos from the previous installments of the story from 2010 here and here.

The FDA has also released warnings about fraudulent stem cell claims and reminds consumers that no stem cell treatments have been approved in the United States, with limited exceptions for cord blood products. Undoubtedly, stem cell research is an important piece of the puzzle in the future of medicine and holds great promise for healing. However, the FDA also cautions that stem cells can develop into inappropriate cell types, cause excessive cell growth, or cause the development of tumors. The state of stem cell research is still in its infancy, with many years of research ahead required to demonstrate that stem cell treatments can be carefully controlled and are safe and effective.

In this FDA consumer update, the case of three men charged with “15 counts of criminal activity related to manufacturing, selling, and using stem cells without FDA sanction or approval” is reviewed. The FDA’s Office of Criminal Investigations (OCI) has committed to pursuing criminals who prey on patients and families and expose the public to dangerous medical products with unproven safety and efficacy profiles. For treatments advertised outside of the United States, the FDA cannot comment on their safety and effectiveness, and consumers should be aware that other countries may not be subject to the same level of regulatory oversight as products marketed in the US.

The issue of fraudulent claims brings the importance of Good Clinical Practice into focus. Consumers should be extremely wary of medical products without the FDA’s approval, which represents careful consideration of a product’s safety and efficacy, including clinical study data. These unverified stem cell treatments have not been tested in controlled clinical trials, and as Dr. Kurtzberg and the FDA warned, they may pose serious health risks.

As monitors, we are troubled when vulnerable populations are taken advantage of with false hopes, and we are even more troubled that patients could be put in serious danger from these unverified stem cell treatments. Our hope is that promising future treatments are brought to patients through well-controlled studies and subsequent FDA approval.

Did you see this episode of 60 Minutes? What was your reaction to the story?

Topics: john lehmann, Monitors, Clinical Research

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