More on “Your Body is a Drug”… For some reason, this past week, the internet was been abuzz with news of our landmark case against FDA’s position that “your body=drug factory”. While some of the attention is bringing to the forefront FDA’s nonsensical assertions (your cells=drugs), regrettably most of the reporting on both sides of the fence has been incorrect-some innocent and some malicious. One set of incorrect reports was that our court documents showed the FDA had issues with the Regenexx-SD procedure. This was flat out wrong (the FDA specifically said it had no issues with any of the same day procedures we were performing (-SD, -AD, -PL, and -SCP)). Another source report blindly copy and pasted last week was malicious in that it claimed journalistic independence, but produced a one sided muckraker of an article. In this case, a small California organization had a young reporter contact one of the attorneys. From this woman’s questions it was clear she had no idea of which end was up and she was under a deadline while I was in clinic, so I told our counsel to speak with her. You know you’ve botched the reporting when you misquote even the attorney! All of this attention on the landmark struggle and the subsequent errors in reporting require that someone put it all out there. Below are some of the summaries of important documents so this sort of thing doesn’t happen again.
Our focus is re-inventing orthopedic care using the same day procedures the FDA says it permits in the US and continuing our cultured work in an environment more conducive to medical innovation (the Caymans). This goal is no less than the invention of a new medical specialty-Interventional Orthopedics. In the meantime, we happen to be fighting a landmark civil rights case over whether the U.S. government can regulate your body and your physician the same as it regulates a drug factory.
Case Document Summaries: The beginnings of the cells=drugs policy began more than a decade ago. First, it’s worth saying that prior to my interactions with the agency on this issue, like most physicians, I was agnostic about the FDA. If they approved a drug that might help my patients, I was excited to see if it really worked and if they flubbed a drug approval I was concerned. However, the term FDA wasn’t in my daily lexicon or consciousness. That all changed in 2008.
Mid to Late 1990’s-The FDA announces that it wants to regulate cells the same as drugs and gets an earful from industry. The opposition comes on a number of fronts: the FDA has no congressional authority to make this move, it will infringe on the practice of medicine, and there is no justification for this unprecedented power grab.
- American Red Cross opposition-The proposed regulations infringe on the practice of medicine, have no authority from congress, and autologous cells are tissue and not drugs. The Red cross brings up an important point that seems lost on the agency and the medical research industry, the patient’s own cells are only as good as the patient’s other tissues. Therefore, trying to create drug-like concepts of purity and potency for autologous cells is at best fitting a square peg into a round hole.
- Northwestern University Transplant Program opposition-no need to add additional regulations
- Osiris Therapeutics states that culturing MSCs shouldn’t be regulated as a drug
- Reprogenesis and Hyman Phellps-The group states that the small University start-up’s treatment for the dreaded childhood disease of VUR (culturing cartilage cells and injecting them to prevent urine from backing up into the child’s kidneys) shouldn’t be regulated as a drug. Note that this company went out of business as it was unable to raise funds for the new cells=drugs regulation and this innovative treatment for childhood VUR was thus relegated to the dustbin of history.
- American Society of Clinical Oncology-Representing 30,000 oncologists, this organization wrote a barn burner of a letter, calling the agency out for regulations that would hurt doctors and patients. They note that the most striking aspect of the new proposed rules is the complete lack of any justification for the new initiative.
- There are more letters in opposition, but these are some of the most colorful
2005-2006-The Regenexx procedures are born as part of IRB approved and supervised clinical studies using both same day and cultured stem cells for orthopedic injuries. These are not Pharma trials, but an example of how physicians innovate to help patients. For more on the difference between FDA/Pharma innovation and physician innovation, click here. Multiple legal opinions are obtained which all state that the Regenexx-C procedure is the practice medicine and specifically not the production of a new drug.
2006-FDA makes a “midnight” change to the 21 CFR 1271 regulations without the public commentary period which is required by law. By changing a single word, they grant themselves sweeping new powers to regulate your body as a drug factory. See Boston College Legal Scholar Mary Ann Chirba’s discussion of the issue and her comment in opposition to these changes that she submitted to FDA.
Late 2007-After two years of treating patients in the IRB and supervised study, we feel we have enough positive results to begin treating patients, first on a limited basis. The results of these studies are still being published, here’s an incomplete list of these publications indexed in the US Library of Medicine.
2008-2010-The FDA writes an “Untitled Letter” regarding Regenexx-C and thus begins the landmark case. We formally respond that we have multiple legal opinions that what we are doing isn’t producing a drug, they refuse to meet to discuss the issue. The high points are that we sue the agency in 2008 and then again in 2010 trying to get them to tell anybody their reasoning why cells=drugs and on what authority they are making this decision. In addition, the agency takes no definite action for 2 years, preventing us from formally questioning their postion. We finally poke the tiger enough by 2010 that they sue us back, thus starting the phase when we can legally question their cells=drugs policy. As part of an agreement between the parties, we state that we will only use same day procedures in the U.S. and not culture cells until a judge decides who is right in this dispute. There’s a good summary of the case by KL Gates.
2010-As part of FDA’s suit to assert cells=drugs, there are a bevy of experts back and forth on both sides of this issue. The best summary (and easiest read) of what these experts say and our response is by Michael Freeman, Ph.D., M.P.H. from OHSU. Basically, according to Dr. Freeman, the FDA creates a “Straw Man” argument to support cells=drugs. FDA boldly asserts that since Regenexx-C creates a new drug (a concept in dispute since the late 1990’s), then Regenexx-C must have drug style clinical trials before it can be used. Dr. Freeman points out that half of all of the medical innovations we all take for granted didn’t follow this FDA/Pharma development path, but instead were developed by physicians, the same way Regenexx-C was born. Dr. Freeman points out that one of FDA’s experts (George Muschler, M.D.) illustrates the differences between pharma innovation (new drug) and physician innovation (Regenexx-C) very nicely. He discovers that Dr. Muschler has a competitive device to Regenexx-C that more than minimally manipulates cells (crossing the line the FDA has arbitrarily set for a drug). While Dr. Muschler uses the straw man to hold Regenexx-C to drug trial standards, his own device which produces what the FDA would now classify as a drug was first used in humans and received FDA approval with nothing more than a study performed in dogs. Dr. Freeman points out that the data amassed in support of Dr. Muschler’s device is an apt example of how physicians innovate, often producing new procedures based on observations on how best to help patients. In addition, Carticel (yet another FDA “approved” cell process now deemed a drug) was approved by the agency in 9 months with far less research data than Regenexx-C has at this point. In the end, Dr. Freeman states that the arguments of all of FDA’s experts all hang by the same tenuous thread, if cells aren’t drugs (the main issue in dispute), than all of FDA’s criticisms of Regenexx are moot as demonstrated by their own expert Dr. Muschler. More good information can be obtained by reviewing the statement of our fertility experts. In the fertility world, human cells are cultured using processes more invasive than those used as part of the Regenexx-C procedure, but this cell culture isn’t FDA regulated. In fact, when an Cambridge educated physician expert and a Ph.D. embryologist were hired to review the safety standards used to culture cells in the Regenexx-C procedure, the safety standards used exceeded those common in similar fertility cultures (in-vitro fertilization). Fertility expert 1 opinion, fertility expert 2 opinion.
Late 2011-The judge in our case files an “Order to Show Cause” against the FDA and denies all of FDA’s motions. The FDA responds with the argument: congress told us chemicals=drugs, cells excrete chemicals, hence cells=drugs.
2011/early 2012-FDA continues to expand it’s definition of “cells=drugs” by making several moves. It issues letters to several companies who had been previously told their cellular transplant tissues were to be regulated as transplant tissues instead of a new drug. However, these companies learn that now they are producing drugs (AlloSource Letter, ParCell Labs Letter). It also issues letters to answer medical practitioners who has asked whether FDA sought to regulate processing fat stem cells at the bedside. Even though a variation of this fat transfer procedure has been performed for more than a century by surgeons and the planned stem cell procedures would be performed in the doctor’s office as part of the same procedure, FDA states that the doctor is creating a new drug. This further extends the reach of the “cells=drugs” policy (fat stem cells=drugs for orthopedics letter, fat stem cells=drugs for cosmetic surgery letter). Most concerning is that FDA’s new fat opinions seem to suggest that simply breaking down the fat to liberate cells crosses the cells=drugs line. Since this automatically occurs in the hundreds of thousands of annual liposuction procedures performed across the U.S. everyday (the back and forth motion of the liposuction tool breaks down the structure of the fat), does this mean all of these surgeons are unwillingly creating new drugs?
Early 2012-Dr. Freeman, an expert from OHSU in public health policy in traumatic injuries, has an editorial accepted for publication in a medical journal entitled, “Does the FDA have Regulatory Authority over Adult Autologous Stem Cell Therapies? 21 CFR 1271 and the Emperor’s New Clothes”. In this article, he states that there is no scientific public health rationale for regulating your body the same as a drug factory, yet like the Emperor in the Hans Christian Andersen tale, everybody is afraid to tell the agency that none of it’s regulatory assertions make common sense.
Is your body a drug factory? Does FDA have authority to support it’s power grab? Did congress ever authorize FDA to turn cells into drugs? All of these issues will eventually be answered by a federal judge in what has become a lightning rod case that will define how physicians use your cells in the 21st century. In the meantime, nothing about this landmark struggle impacts our ability to provide high quality cellular care for orthopedic injuries.