Is the FDA Now Going After Arthritic Patients and Their Doctors?

Vague FDA regulations could spell the end for platelet treatments that use centrifuges, most likely to protect Big Pharma profits. Action Alert!
You may have heard of platelet-rich-plasma (PRP) injections, which are used by orthopedic doctors to treat bone and joint pain. Essentially, PRP treatment begins by drawing blood from a patient, separating platelets from other components of the blood using a centrifuge, then injecting the platelet-rich blood into arthritic joints. PRP is also used in sports medicine to treat tendon, ligament, and muscle injuries.
PRP treatment offers a number of benefits. When compared with surgery, which is often another treatment option, PRP is safer, less costly, and has a more rapid recovery time. It is also a great example of natural medicine, using the body’s own healing powers to treat injuries, as opposed to synthetic drugs or invasive surgeries. In the words of Dr. Steven Sampson, a clinical instructor at UCLA’s medical school, “What’s more natural than your own blood? All we’re doing is amplifying the body’s own healing mechanism. And we’re doing this in the most minimal way possible. There’s no adverse reaction, no immune response, because it’s your blood. Only better.”
As far as clinical evidence of PRP’s effectiveness, there are promising results. One study of patients with chronic elbow tendinitis (“tennis elbow”) found significant improvement in patients treated with PRP in comparison to a control group. Another controlled study compared patients treated with PRP versus patients treated with hyaluronic acid, a lubricant that is often used to treat joint pain; those who received PRP experienced statistically better results. Two other studies also concluded that PRP decreased pain and improved function better than placebo and hyaluronic acid.
So we have a safer, cheaper, and more natural alternative to surgery and pharmaceutical drugs for a whole spectrum of bone, muscle, tendon, and ligament injuries. The only ones who might not be pleased with this treatment are surgeons and drug manufacturers. Unfortunately, they’re the only ones the FDA seems to be listening to.
As is often the case with FDA regulations, it gets a bit complicated, but bear with us as we untangle the threads.
According to FDA rules, human cells, tissues and cellular or tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion or transfer into a human recipient are regulated to “prevent the introduction, transmission, and spread of communicable diseases.”
There are, however, a number of exemptions to this rule. For instance, if you remove HCT/Ps from an individual and implant them back into the same individual during the same surgical procedure, you are exempted from the FDA’s regulations. What constitutes the “same surgical procedure”?
FDA’s view is that autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, or sizing, or certain manufacturing steps, raise no additional risks of contamination and communicable disease transmission beyond that typically associated with surgery [emphasis added].
You will note that spinning blood in a centrifuge for PRP treatment is not mentioned. It’s unclear whether this is a conscious move by the FDA to make it more difficult and costly to perform PRP treatments, or an error of omission.
If this phrasing is intentional, it would force doctors to go to approved centers for the type of cells they could far more easily extract from a patient’s blood in their own in-office centrifuges. This would almost certainly result in increased costs, fewer docs willing to go through the hassle, and worst of all, patients not being able to use their own blood and therefore incurring a much greater risk of infection. But even if the omission was unintentional, the uncertainty created by the FDA concerning PRP will likely cause many doctors not to offer the treatment to their patients to avoid having the book thrown at them.
The FDA has been bold in extending its reach over these kinds of treatments. In 2012, we reported on a court case in Colorado in which the court agreed with the FDA that stem cell treatments similar to the PRP treatment described above are now considered to be “drugs” under the FDA’s jurisdiction. In that case, the medical clinic offering the treatment argued, quite logically, that stem cell treatments using the patient’s own cells for the benefit of that same patient should be regulated at the state level as the practice of medicine.
At one point, the FDA even argued that the patient’s own feces, if used therapeutically, would become a “drug” and would therefore be subject to FDA approval, although it later backed off this ridiculous claim. It seems likely to us that these FDA power-grabs are a ploy to protect the market for FDA-approved drugs. Something similar could be at work in the case of PRP. After all, Big Pharma’s arthritis drugs bring in an annual $35 billion in profits worldwide.
Action Alert! Write to the FDA today and urge them to clearly indicate that PRP treatments using in-office centrifuges are exempt from their regulations. Please take action immediately.