The state of Vermont is pushing a bill that would require physicians who use either PRP or BMAC to post this sign in their waiting room:
This ad would be illegal and could result in a lost medical license:
Respected colleagues and IOF members,
We need your help.
Your use of orthobiologics is under attack. Your ability to advertise legitimate orthobiologics is also under attack. What’s happening in Vermont will soon be on your doorstep.
So what’s the ask? I implore you to take the 10 min out of your day, TODAY. Please use our template to send a message to Vermont legislators, and express our passion for the proper use of this game-changing medicine. Write a personal statement of your interest in the field, and one story of how it has benefited you, your patients, and your community. Then add the bullet points that have been put together by our team. It is critical to meet this attack on our practices head-on. If we allow this to continue, we will all be facing the same issue in our states and could be further limited in our abilities to help our patients.
I write this with grave concern that our freedoms as doctors to properly and thoughtfully treat our patients are in peril. As a specialty regenerative medicine is at even more significant risk, as there are major influences that do not want to see this type of medicine prosper. It transcends many levels, and it has become very clear that the bench scientists, who work to create drugs, are aligned with big pharma and want to label PRP, BMAC, and any autologous therapy as a drug, and limit its use.
Obviously, there are bad actors in the space, and it is clear that many providers that are using “stem cells” or regenerative injections are ignorant at best, and in many cases simply duplicitous. This “bad actor” behavior has created a narrative that the bench scientists, big pharma, and anyone that wants to see regenerative medicine use curtailed, can latch onto. It makes it extremely challenging for those that are doing things the “right way”. We are the group of individuals that are making this happen for the future of the profession, and most importantly for the future our of patients.
Thank you for taking the time to read this message, and please put in a few minutes to help. In addition please forward the message to your community, and anyone that is involved in the field and can help to spread the word, and communicate with the leadership in Vermont.
If you are interested in helping to stop this Vermont bill and protect PRP and BMC nationally, then please send an email to:
- Sen. Virginia “Ginny” Lyons, Chair firstname.lastname@example.org
- Sen. Richard Westman, Vice Chair email@example.com
- Sen. Ann Cummings firstname.lastname@example.org
- Sen. Dick McCormack email@example.com
- Sen. Debbie Ingram DIngram@leg.state.vt.us
To email all, click here.
Here are some talking points (feel free to copy and use on your letterhead):
Enter your personal paragraph and story of what regenerative medicine means to you, your patients and your community.
- Platelet-rich plasma (PRP) is a blood product created by FDA cleared bedside centrifuges and is used by tens of thousands of physicians nationally to help orthopedic injuries heal.
- Bone marrow aspirate concentrate (BMAC) is created by taking autologous bone marrow aspiration and centrifuging it. It has been used since the 1980s in orthopedic injuries such as fracture non-union and spine surgery.
- I oppose S.252 which would cause platelet-rich plasma, a therapy with more than 70 peer-reviewed randomized controlled trials showing safety and efficacy to be placed into the category of “stem cell therapy”. Your bill does the same with BMC.
- PRP is used widely in orthopedics and recently was awarded coverage by the military insurer TRICARE. That was based on the strength of the published data on knee arthritis and tennis elbow.
- BMC is used widely in orthopedics.
- Neither is a “stem cell therapy”, but autologous blood and bone marrow products that are used in orthopedics to enhance healing and reduce healthcare costs.
- The same surgical procedure exemption is NOT a loophole, but a delineation that allows physicians to use autologous tissue in surgery. By supporting this bill as written, you are ensnaring countless surgeons and physicians who use autologous tissue to help patients.
- Your bill creates a bizarre circular loop and is not harmonized with federal law. The FDA has stated that it doesn’t regulate PRP or BMC as a drug and that these are medical procedures regulated by the states under the same surgical procedure exemption found at 21 CFR 1271.15(b). However, your bill requires that FDA approve PRP and BMC, both of which it has stated that it does not regulate.
- Hence your bill turns physicians treating orthopedic injuries with these research-based substances into “scofflaws”. They first must post a sign designed to sow mistrust. That sign doesn’t accurately describe what they do nor the regulatory status of either orthobiologic substance and it misleads patients. They also can’t get either product “FDA approved” as there is no pathway for that FDA approval. If they don’t post the sign they can lose their medical license.
- While I applaud the idea of dealing with bad actors in the “stem cell therapy” space, for these reasons, I oppose S.252 and urge you to start over on this confusing and ill-conceived legislation. This bill will ultimately harm and confuse patients.
– Rahul N. Desai, MD