By Jack Minor
A pain management clinic in Denver, specializing in an experimental therapy that uses a patient’s own stem cells to treat damaged limbs, has been told it must stop because the federal government considers the treatment to be “manufacturing drugs”.
Since 2005 the Centeno-Schultz clinic has pioneered Regenexx, a treatment where a patient’s stem cells are removed, cultivated for two weeks in a lab then re-injected back into the body. The procedure is used to treat patients with knee injuries, partial rotator cuff tears in the shoulder and lower back disc bulges. According to Dr. Christopher Centeno the treatment is effective at reducing pain and in avoiding surgery for the vast majority of patients.
Centeno said that beginning in 2008 the FDA expressed concern that the injected stem cells could be considered a drug and asked for more information about the procedure. The clinic provided a legal opinion describing why the procedure did not meet the definition of a drug. Among the reasons given were that the stem cells were part of a person’s own body tissue and Congress did not give the FDA authority to regulate a person’s body tissue. Additionally the clinic cited the traditional role of state government in regulating clinics. The clinic does not take any federal insurance payments, grants or any other federal monies.
Centeno said they offered to meet with the FDA face to face regarding the procedure but the government refused. Since the FDA refused to meet with them, the clinic filed a lawsuit in order to be able to continue the procedure. The government then filed motions to have the cases thrown out under the doctrine of “ripeness.” Centeno explained the doctrine by saying that “ripeness” basically says if the government shows up to blow up your house you cannot question its right to do so until after the house is blown up.
On Aug. 6 the FDA stated it would seek an injunction in federal court alleging “violations of current good manufacturing process.” In making the announcement Karen Midthun, acting director for the FDA’s Center for Biologics Evaluation and Research, said “Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.” Midthun went on to say “the FDA recognizes the importance of the development of novel and promising new therapies. However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
“You have the right to go to a doctor and have stem cells taken out and put back in your body that’s between you and me, it’s not the business of the federal government” Centeno said. When asked if there have been any negative side effects with the procedure Centeno said no, and noted the FDA’s issue has never been about the safety of the procedure.
As a result of the FDA’s actions the clinic no longer cultivates the cells to multiply them but simply removes them from one area and re-injects them during a same-day procedure. Centavo said if the government were to succeed with its claim the real losers would be the patients who have been helped by the procedure.
Patients of the Regenexx procedure have been outspoken regarding the FDA’s actions. Barbara Jones of Boulder, CO has had three procedures and was looking forward to having a 4th. Jones expressed “extreme disappointment in the FDA’s closed minded thinking and disregard for a patient’s need to relieve pain.” She has had the procedure on both hands and one knee.
Harold Kaye a resident of Aurora said “Regenexx has changed my life. Before I met Drs Centeno and Schultz, my life was very painful and debilitating. I now have the strength, and ability to live my retirement as I have always wanted. It is sad that others in my situation may not get the chance to get this treatment here in the USA but it doesn’t surprise me that the Federal Government could be so short sighted.”
When asked if the FDA’s recent actions were a direct result of Health Care Reform Centeno said he believes there definitely is a connection. “This is a move by the federal government to regulate medicine which is traditionally been regulated by the states. That move is consistent with Obamacare where patients are treated according to strict guidelines” Centeno noted that Dr. Ezekiel Emanuel, brother of White House Chief of Staff Rahm Emanuel, has said doctors take their Hippocratic oath too seriously and has said care should not be given to those “who are irreversibly prevented from becoming or becoming participating citizens.” Dr. Emanuel is a health policy advisor with the Obama administration.
Centeno said if the government is permitted to declare that all treatment is a drug it could have ramifications in other areas as well. For instance a doctor seeing a patient with high cholesterol may no longer be able to recommend fish oil as that is not an approved drug by the federal government. “The issue is do we want the federal government to be involved in the doctor-patient relationship?”