I have interviewed two folks on the very important US vs. Regenerative Sciences legal case: Dr. Chris Centeno and Doug Sipp. More background on the case can be found at the FDA Law Blog.
I thank them both for their time and for sharing their unique perspectives.
I have specific rules for these interviews and how I have posted the answers to ensure fairness. Also I’m not providing any commentary of my own in this article. The opinions expressed here are strictly those of Sipp and Centeno. Bolded questions are from me, Paul Knoepfler, and answers are listed below from each. I have posted the answers verbatim and for fairness neither party saw the other party’s answers in advance. The questions to both Centeno and Sipp were identical except where indicated at the end with a question just for Centeno as a party to the case. I have also alternated between whose answer comes first, starting with Centeno. The only rules I requested of the two was that their answers conform to the rules of this blog (e.g. no personal attacks) and that they try to be brief.
Here we go….
What is your perspective on the US v Regenerative Sciences lawsuit?
Centeno: The FDA derives its authority from congress to regulate human tissue through the Public Health Service Act (PHSA). This case will eventually decide whether FDA had the legal authority under the PHSA to classify autologous human tissue as a drug. Another question is whether FDA can regulate any part of the practice of medicine. Rather than give you my own perspective, let me let others speak from their testimony to FDA during the public hearings on the changes to 1271 that permitted this classification:
- American Red Cross opposed on the grounds that FDA had no authority over tissue as a drug (see link)
- The American Society of Clinical Oncology (30,000 oncologists) opposed because these rules would infringe on medical practice and saw no justification for the initiative (see link)
- Others opposing (hyperlinked): Northwestern Organ Transplant Program, Osiris Therapeutics, Biotechnology Association
Sipp: It appears to me that this is going to be a key legal decision that will impact not only the marketing of autologous “stem cell” products and procedures, but potentially that of human cell and tissue products in general.
Can you see convincing points being made on both sides or are you mainly in support of one side or the other?
Sipp: My main desire is to see stem cells introduced into the clinic only via responsible, rigorous and ethical scientific testing. To ensure that this happens, there is a clear need for strong, clear and independently enforced regulations. This case will in large part determine whether the United States is able to protect the integrity of its the emerging regenerative medicine industry through appropriate regulations ensuring that cell-based interventions are demonstrably safe and effective before they are sold to patients en masse. The uncertainties introduced by the self-serving litigation brought by this company have already had widesspead consequences in that they seem to have emboldened many others by suggesting that highly profitable stem cell applications can be marketed without the need for rigorous testing or appropriate oversight, and without fear of prosecution.
Centeno: I see this case as a key test of how society wants medical innovation to occur and the balance between the two types of regulatory errors.
Practicing physicians generally support the continued need for dual new therapy discovery pathways to protect patients and advance medicine-“FDA/Pharma” and “Physician Innovation”. While all of our advances in drug therapy have occurred through the FDA/Pharma pathway, almost all of our innovations in medical procedures have developed through physicians treating patients and outside of the RCT process. Without both, we would have none of the modern medical miracles we all take for granted.
Type 1 regulatory error occurs when we allow a harmful therapy to be widely used-FDA excels in preventing this type of error. Type 2 regulatory error occurs when a beneficial therapy is disallowed-this is mitigated through the Physician Innovation pathway. For example, FDA’s current process is hampered by a glacially slow adoption of new therapies in exchange for obtaining high quality data supporting safety and efficacy, while the physician pathway for innovation allows much quicker access to therapies but is hampered by lower quality data. The FDA approach uses regulatory assurances to expose patients to mass unconsented risk (i.e. patients don’t sign a consent to take the newest Cholesterol drug; they assume certain safety and efficacy parameters). On the other hand, medical procedures require an individual consented risk (ICR). No matter how you slice it, applying a mass manufacture public health model to an individually consented risk makes little sense. For example, patients are consented for significant medical procedure risks every day where it’s often impossible to fully quantify the risk or verify the likelihood of success-just as in an autologous stem cell procedure. So to answer your question, I see the need for both points of view and believe FDA has just lost focus in this instance. I believe when cells are mass manufactured and distributed they should be regulated as drugs because there is mass unconsented risk and that preventing type 2 error has a societal benefit. The flip side of that coin is that applying mass distribution principles to autologous cells magnifies type 1 error and ignores the ICR concept-which hampers innovation. Has FDA made a good decision when pursuing this case? As former FDA commissioner Dr. von Eschenbach recently said in the Wall Street Journal Op Ed, he believed that this case has “cast a pall over the future of regenerative medicine”.
If Regenerative Sciences wins the case, what do you believe will be the impact of the case more broadly for stem cell treatments in the U.S. and globally?
Centeno: This case will be appealed by both sides and likely end up in the Supreme Court (or not and be settled at the Appellate court level). Therefore its impact won’t be felt for several years. If FDA loses this case, it could lose in many ways and in many different areas. As one specific example, a federal judge could delete parts of 1271 as “ultra vires” (beyond the powers authorized by congress). In that case, I expect the FDA will issue a Compliance Policy Guide (CPG). The CPG must more clearly define what is the practice of medicine and what is the manufacture of a drug. If this future comes to pass, I suspect you’ll see physicians using autologous stem cells alongside any “stem cell drugs” being produced for mass distribution. In the short run this competition will lower prices for consumers and perhaps expand the number of doctors offering questionable therapies. In the long-term, the systems already in place to regulate physicians will respond and autologous stem cells will be regulated the same as the culture of human embryos for fertility treatments (5 day blastocyst procedure). There will be physician regulations through individual states with professional societies jumping in to provide guidelines and accreditation (like the College of American Pathologist’s IVF Accreditation program) as well as a civil court system to address malpractice claims. The physician side won’t be under regulated, as physicians are already regulated through a bevy of entities including medical boards, public health departments, Medicare, hospitals, specialty boards, and the civil court system.
Sipp: In the best-case scenario, it will be a complete disaster for the field. By eroding the ability of the government to exert control over stem cell marketing, a decision in favor of Regenerative Sciences would result in an accelelration of the race to the bottom mentality that already characterizes the industry. The United States has a well-deserved reputation for being at the forefront of biomedical research and science-based regulation, so what happens here will definitely ripple very quickly into other countries. The worst case scenario, I don’t even want to think about.
Do you have a prediction on the outcome of the case?
Sipp: I am not a lawyer and do not have insight into the current status of the proceedings, so I really couldn’t speculate. The company will no doubt try to turn even a loss into a win by claiming government oppression, if it turns out the court rules in favor of the FDA. Either way, watch for it to be used in marketing materials for years to come
Centeno: I don’t see how FDA can prevail. Congress and the courts have always told the agency that it has no regulatory authority over physicians.
In the United States, we have two very separate systems of medical regulation: federal and local. On the federal level, an example is the FDA, whose job it is to regulate drugs and medical devices that aresold in interstate commerce. On the local level, examples include state medical boards as well as the local departments of health. Your doctor is not regulated by the federal government, but by the state in which he or she practices medicine. These separate regulatory systems have always been kept apart by a “Great Wall” that literally prevents physicians from being regulated by the federal government or FDA. An apt example is a physician’s right to use medications off–label. While the FDA can approve a new drug to treat a certain disease, it cannot tell physicians how to prescribe that drug. Physicians are free to use the drug for any disease and in any dose, even if that dose is not the one that’s approved by the FDA. This separation of regulation acts as a system of checks and balances, much like the separation of the executive, judicial and congressional branches of government serves to keep power in check. Why is that important? The bottom line is that your physician is charged with doing whatever it takes to save your life — whether or not the federal government approves of it. The judge in US v. Evers put it best (United States v. Evers, 453 F. Supp. 1141 (M.D. Ala. 1978))- “A free, progressive society has an enormous stake in recognizing and protecting this right of the physician.”
Does this case in any way connect with the recent Texas Medical Board decision?
Centeno: I’m not sure. I have had no discussions with TMB. However, what happened in Texas in inevitable as the FDA doesn’t have the resources to monitor physicians and so state medical boards will have to jump in.
As an example, there are almost 1 MM US physicians. There is one FDA which is overburdened and underfunded. There are 50 state medical boards charged with overseeing physicians while FDA is strictly prohibited from having authority over physicians. Even if congress decided tomorrow to grant FDA regulatory authority over physicians, it would have to dramatically increase the size of the agency just to keep up. For example, FDA performs about 1,000 annual drug manufacture factory inspections and finds cGMP violations in 54% of these plants. To police physicians, it would need to increase that number 10x just to have a very poor surveillance program (inspecting about 1% of physicians per anum). In addition, the efficiency of these inspections would drop off a cliff. Right now FDA can safeguard the health of millions of patient drug doses by inspecting one large drug factory. If they were inspecting physician offices for autologous stem cell “manufacture”, that efficiency would drop to at best tens to hundreds of “doses” per year per inspection. So the numbers above would need to increase by at least 1,000X to monitor 1 million US physicians using stem cells at a similar level of surveillance as exists now. That overall 10,000X increase in FDA size would take it from about 12,000 employees to somewhere north of ten million, making it by far largest federal agency and much larger than the rest of the federal government. Therefore, the only place physicians using stem cells could be regulated is by the states which are already funded to police physicians.
Sipp: I don’t know of any direct connection between the main actors, other than various associations with a group calling itself the International Cellular Medicine Society, which was founded by Regenerative Sciences’ owner. Both cases do seem to represent sinister challenges to the authority of the FDA, while offering no alternative of equivalent legal, scientific and moral authority to replace it.
What is your view of where stem cell-based treatments are heading more globally? Are there countries of particular concern to you? How does the U.S. fit into that spectrum?
Sipp: Stem cell pseudomedicine has failed to show its safety and efficacy in any rigorous scientific tests of which I am aware, but it has clearly shown itself to be immensely profitable, which is why it continues to grow despite warnings by government, medical and scientific groups from around the world. The country I worry most about, hands down, is the US, because it will set the tone for the rest of the world, and also because it is seeing the most rapid expansion of the industry in recent years – growth that is fueled in large part by the efforts of profiteers to undermine the already under-funded system that is all that stands in the way of their ability to exploit even more patients for financial gain.
Centeno: I’m concerned by the proliferation of clinics who operate in a vacuum and offer treatments for every known disease. In fact, I support clinics who work through an IRB for novel or potentially risky therapies, track all patients in a formalized registry, and publish their data in the peer reviewed literature.
Over the past few years we’ve seen a few ex-US clinics move towards these standards and I’m confident that this will have a domino effect so that more clinics follow these guidelines. This doesn’t mean that the clinics offering silly therapies are going to go completely away, just like alternative health clinics offering dubious alternative therapies to cancer patients aren’t going to cease. However, as more high quality physician directed care is offered, the sites offering cells for every known condition will reduce in number.
Any country that allows the use of stem cells outside of the “IRB/ registry/publication” framework I discussed is a concern. I don’t approve of clinics offering therapies with little prima facie evidence of efficacy.
Over the past year or so, the US has arguably become the world’s biggest purveyor of stem cell treatments. If one includes the use of stem cells isolated from bone marrow to promote spinal fusion, there are literally thousands of applications of stem cells every day that have no level 1 evidence of efficacy. These 510k cleared bedside “stem cell concentrator” systems are being used with at best level 2-3 evidence or anecdotal experience that stem cells may help reduce the likelihood of a bony non-union. On the more concerning side, the US has seen a recent explosion of clinics offering mostly IV adipose Stromal Vascular Fraction based therapies for every known disease (from Alzheimer’s to ALS to anti-aging/cosmetic use). The FDA’s efforts (they have now classified SVF as a biologic drug) have had little impact on this phenomenon, as there are simply too many physicians.
I don’t support this explosion of clinics that operate outside of the framework I’ve described. I think we’ll eventually see more Texas type interventions from state medical boards to curb these clinics and apply standards.
(Question just for Centeno) As a party directly involved can you give us a concise history of how the case developed?
Centeno: In 2005 we ported an established equine model of cultured MSC use to orthopedic patients. At that time, we received a consensus of three legal opinions that culturing cells for our own patient’s use was the practice of medicine. We received IRB approval and treated a small number of patients initially (knee, hip, low back OA) using imaging guided joint injections and research grade MRI. We also followed these patients in a registry and no patient paid for care. Our goal wasn’t to perform an RCT, but to get a sense as clinicians what worked and didn’t work. By the end of 2007, we began treating our usual patients with cells. All of this data has been published or is still in submission for publication.
In early 2008 we received an “Untitled Letter” from FDA questioning whether we were producing a biologic drug. We responded to the letter, but the agency refused to meet to discuss why they took this position. In 2009 they arrived at our clinic and issued 482/483 forms (notices of a drug factory inspection). Since FDA maintained that we were a drug factory, deficient in many ways as any physician office, hospital, or O.R. would be, and this made no common sense to us, we sued in Denver District court. The court eventually ruled that since an “Untitled Letter” wasn’t final agency action, the court couldn’t review our case.
The FDA inspected our clinic as a drug factory again in 2010. At this time, we filed for simultaneous TRO’s in Denver and DC Federal courts-the goal being to force the agency to take an action. The DC docket moved faster and we presented oral arguments to Judge Collier. Before the judge could rule, the FDA filed for an injunction to prevent us from culturing cells. As part of a stipulation between the parties, we rolled all suits and countersuits into one case, stopped culturing MSCs at our Colorado facility until the case was resolved, and continued our same day isolation procedures which were 21 CFR 1271.15(b) compliant.
Both sides hired experts. FDA’s experts stated we were producing a drug while our experts disagreed and confirmed that the standards we were following for autologous cell culture exceeded those used for medical grade IVF cell culture (expert 1 andexpert 2). An interesting exchange that explains some of the basic issues in the case is illustrated in Dr. Freeman’s response to one FDA’s expert’s criticisms of our research.
In August of 2011, the judge issued a “Show Cause” order. In her order, she brought forth new issues. The judge asked the FDA to show how congress authorized the agency to classify a cell as a drug and how a cell had “chemical action”. Both parties have responded and the judge has yet to rule on her order. In the meantime, many legal watchers have chimed in with their opinions/predictions:
I think most Americans are growing tired of this nanny state nonsense!
Amy,
I am not sure about your background. You sound like someone who is a doctor. I am not a doctor, however, I’ve been researching stem cells for several years, and when I raise the subject with most doctors, I find myself more knowledgeable about the topic then they are. Here are the facts on clinical trials:
Under-enrollment of patients in trials slows research progress and deters potential funders from investing in research. With this reality, most researchers end up paying a higher price in terms of more costs and longer time horizons to therapeutic breakthroughs. Did you know that 80 percent of clinical trials finish late due to difficulties enrolling participants? Also did you know that one-third of trials do not finish or ever begin? FDA clinical trials are not the answer for curable innovations and medical break-through, especially with autologous stem cell treatments.
Listen Amy, let me put to you in simple terms – they are my cells and not yours. Please stop trying to impose your ideals on my cells and other people’s. You are dealing in demagoguery when you say that the general public needs to be protected from “predatory doctors” or “quack clinics.” If you wish to have your stem cells from your own body manipulated or extracted by clinics with FDA stamps of approval then do so. I find it patronizing that someone in your position thinks the general public is too ignorant or misinformed about making the right decision on which stem cell treatment is right for them.
There are grants available for research which other institutions have applied for and used for trials. Last look there were 600+ trials at clinicaltrials.gov without even counting private investors, WHO databases etc.
The public does not have the information or training to make the choices you suggest. It is certainly not a matter of intelligence in reality many trained scientists and ethicists choose not to make judgements in areas they are unfamiliar with or untrained in for fear of bringing harm.
Another layer of complexity is in the area of vulnerability of patients. Of course they are desperate for anything that hints of working whether it is safe or not. When MDs endorse treatments that are unregulated this makes it even more troubling because we are taught to trust MDs as authority figures and experts on our health. They take an oath to do no harm and it is inconceivable that they would take advantage of vulnerable patients and yet some do.
Medical research did not work fine before the FDA there were thousand of unneeded adverse events, deaths and other tragedies. Ethics came about because people were not capable of self regulating in order to protect
others.
The cost of a clinical trial has been highly overstated and equated with all the costs of bringing a new drug to market. Even with all the present FDA classifications the trial costs are minute in comparison to drug development.
Trials are doable, they choose not to do trials thinking their way is better, patients suffer and no progress is made for science.
No Mary, it is not 1968. It is 2012. A major crossroad in how medicine may be practiced differently in the near future or in the far future and whichever stance we take today can affect millions in the future. I would prefer taking the position like millions of others of not choosing to quitclaim their bodies or cells to the government.
Right Albert, they can just quitclaim their money to you. How convenient, given your profound understanding of sheep.
Yes, like a sheep herder trying to snap the public awake from the kind of nanny state you promote, because you’re so smart and the public is too stupid to make decisions on their own. Medical research has worked pretty fine until the FDA started meddle in and say the cells in your own body are chemical producing drugs. I guess if I am an independent researcher like Dr. Burzynski that has viable proposed research, I would need those 10’s of millions of dollars for a FDA clinical drug trial, because autologous stem cells are not considered a medical procedure by the FDA. Do you have those millions to give me, so I can get started a new clinical trial??? Hmm, my guess is no, so I guess I can’t research, so I guess there is no chance for medical breakthrough that can revolutionize medicine.
It is funny how the same old argument reverts to unscrupulous clinics proliferating from unproven treatments. Please go back in time and tell that to James Blundell who decided to perform the first blood transfusion, or the first doctor in 1968 who decided to performed the first successful allogeneic transplant of bone marrow – all done as medical procedures and not a costly “DRUG” clinical trial. They probably would have said, ‘forget about it’ if that was the case back then.
It has become the narrative for many that oppose stem cell treatments without the FDA’s control, because no one has really said that there is no risk with any new medical procedure. In their minds, we are destined to mirror the same quack clinics we find overseas. We can agree that regulation is all good, however not to the point that chokes future progress.
Now the FDA has overstepped their regulatory grounds to say that any auspicious relationship between a doctor and patient or any future medical procedure can potentially be selected by the FDA as a drug or under the same risk of having millions of chemically produced drugs distributed to millions. I guess the FDA has expanded their objectives to protect millions from harmful prescription drugs to becoming a power hungry federal agency even if it means stifling future medical cures. At this point, I would say that any doctor that sides with the FDA is basically shooting themselves in the foot, and the FDA’s draconian regulations have become totally counter-productive. I am so glad Texas and Centeno has said enough is enough FDA!!!
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News flash Albert, It’s no longer 1968. http://ohsr.od.nih.gov/guidelines/belmont.html
Mary,
No you are right, so if we had it your way, lets quitclaim our bodies and our rights to the government – you know like sheep.
Looking at complaints investigated by ICMS (a 501c3 organisation), what benefits of this investigation came back to patients? Further to this patients pay their 350 and are lulled into a false sense of security and so would be unlikely to go also to their medical boards or the FDA or regulatory agency in the country of origin so that information is conveniently sealed within ICMS.
The ICMS uses questionnaires which will provide less information to authorities than the patients already recorded medical records and for this patients are footing the bill. When individuals go for a traditional surgery the patient doesn’t pay extra to have the follow up recorded. It appears the patient is being asked to take financial responsibility for the safety of the treatment.
How much credibility would an ICMS report have in a court of law should a patient or their families have need to address the courts for compensation in the face of a procedure gone wrong?
ICMS offers malpractice insurance to the cell business practitioners but don’t see any insurance for patients at all?
It is possible that the patients regular health insurance may deny all responsibility for treatment if complications ensue because by engaging in an unregulated treatment, sort of like void the warranty by adding unapproved parts.
A full blown systemic infection of the blood/bone etc is not cheap or easy to treat.
Art,
Some of these questions would be better for David Audley, the ICMS administrator. However, I will answer the ones I can:
-The RNL investigation was undertaken because RNL had begun to participate on a limited basis in the registry. RNL then ceased operations, so there was no patient benefit/lack of benefit possible
-You may have a mistaken understanding of what a registry is and is not and how traditional medicine operates. After patients have surgery for example, they are not provided 3 mo, 6 mo, and annual complex symptom and functional questionnaires-which is what the ICMS registry does. They may receive a phone call. This information is also not routinely ever found in any patient chart.
-Any ICMS member who treats patients can be sued just like any physician can be sued
-I have never seen any insurance deny coverage for complications due to an investigational procedure or use of medications. If they did, then every time your doctor prescribed a medication off-label or had one compounded and complications ensued, you’d be on the hook.
One area that is confusing with Regenerative/Regenexx arrangement is they were all over the internet about only the cultured cells really being potent enough to do the job. When they were faced with the permanent injunctions by FDA still in the courts they offer this other treatment instead and claim that works while setting up in the Caymans.
Peter, do you have any links or other info to back that up that emphasis has changed? If so, that’d be helpful for people in assessing that. Thanks.
Will these help?
http://www.youtube.com/watch?v=rD76QRAVmLQ Growing cells out in numbers
http://repaircells.blogspot.com/2008/11/stem-cell-mania.html number 5
http://repaircells.blogspot.com/2008/04/stem-cell-hype-vs-medicine.html number 4
http://www.centenoschultz.com/services/regenexx-procedures/ All offered
http://www.regenexx.com/2011/05/how-does-regenexx-sd-or-ad-compare-to-regenexx-c/ Comparison charts by patient opinion Likert scale
Interesting discussion on MetaFILTER looking at communication styles, concerns about arms length associations and reasonable vetting of evidence. http://www.metafilter.com/90174/Defying-the-FDA-Doctors-in-Colorado-Offer-Stem-Cell-Therapies-for-Joint-Diseases
Mary,
It’s true that early on we were concerned about cell number for certain orthopedic applications. The good news is that we have been able to achieve good results using a same day procedure with fewer cells (I have just reviewed this data and it should be posted and then submitted for publication soon) in patients with certain orthopedic conditions. Having said that, based on 7 years of clinical experience in this area, we do recommend that some of our patients with more severe issues look at using cultured cells rather than same day.
These are orthopedic patients not patients with a terminal diseases so lets refrain from getting dragged through the rule of rescue. Rule of rescue puts others in a mind set where they are asked to force a choice based on a life or death argument and brings up emotion that often clouds rational thought.
Secondly you can do whatever you want with your cells, it is the manipulation of those cells by outside parties that is regulated. So lets say your cells are a car, a medication or even your airplane travel. Wouldn’t you want these to be regulated for safety and reliability? The FDA employs with your tax dollars those that are qualified and experienced in this oversight so why not work with them rather than a group containing mostly members that have a financial interest in the industry? If you crash in an American Airlines plane would you want them or another airline who all have a vested interest in protecting each other deciding who is at fault?
Jo Ann, this is an important point about these not being terminally ill patients or patients facing life-threatening diseases. Disease context is very important for appropriately evaluating the acceptable level of risk for any given therapy.
Paul and Jo Ann,
Let’s think about this from a broader perspective. There are common diseases that cause great suffering but are not terminal (except in the sense that life itself is terminal). How do you weight suffering relative to life?
I would argue that a treatment with a “fair” degree of safety should not be withheld. And it certainly should not be withheld just because it hasn’t passed the efficacy standards of FDA and Mr Sipp (both very fallible, from what I have read).
OK, you may not like my use of the word “fair” since it is not defined in any precise manner. By then again, the FDA uses words like “minimally” without precise definition. Further FDA has a long history of introducing such fiddle-diddle words into poorly vetted guidance documents and re-defining words in ways which I regard to be capricious and arbitrary. This has caused the FDA to become a very bloated bureaucracy… For example, see:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/medical-food-mumbo-jumbo-confusing-fda-guidance-documents-will-discourage-medical-food-development.html
and:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/09/the-obesity-epidemic-fdas-growing-waistline.html
JoAnn – I don’t believe the FDA works with offshore clinics. The ICMS program does. An independent group would be much desired, however, I don’t believe it is a reality at the moment. My concerns probably do not belong in this discussion as they are not confined to just what is happening here in the U.S.
I also don’t believe a person can do whatever they like with their stem cells. Technically yes, but realistically no. I don’t know many people who could harvest their own stem cells and then administer themselves a treatment.
There are times that objectivity can be lost or clouded with fears from drastic changes to any current paradigm that is threatened like medicine practiced today, and when a revolutionary method prompts drastic changes like stem cell treatments, our trepidations arise with fears of the unknown. Each stakeholder of these eventual cutting edge treatments like those in poor health, the pharmaceutical companies, research facilities, regulatory agencies, and doctors, they all have their selfish persuasions like expeditious change for hope, pessimism, fear, or worse trying to safe-guard their self interests. However, there is one particular stakeholder that has the most to lose and the most to gain, and they are the sick, disabled, and terminally ill. How dare anyone tell someone that the issue of Dr. Centeno’s case against the FDA is being clouded by someone that is terminally ill! The outcome of his case can help this main stakeholder except for the pessimist, the frightened, or the one that is greedy to protect their self interests at any cost. Please if you wish to have your stem cells protected by the FDA, then do so, and make sure that your stem cells are only used or treated by facilities that are screened by FDA clinical trials, but don’t impose your beliefs to those that want own their stem cells from their own body.
Mary – With all due respect, patients who agree to treatment when a clinic is in the ICMS program are fully informed of the cost of the clinical registry. There is no censoring or discouragement during the evaluations for patients to not report adverse effects. ICMS is a non profit organization subject to strict laws as are all non profits. Stacking the deck against patients are those that would choose to have us wait years to be able to use our own stem cells for treatments that may improve the quality of our lives. $350.00 is little to pay for a post treatment follow up program that can help not only the participant but other patients in the future. I paid more than that a couple of months ago to have an ear exam that lasted less than 15 minutes.
Would anyone like to address the fact that Chris sits on the board of ICMS that stacks the deck against patients reporting adverse effects to the tune of $350.00 per treatment to submit it to ICMS? While they only charge $50.00 to a clinic to advertise with impunity. The inmates are running the asylum.
http://cellmedicinesociety.org/attachments/184_ICMS%20Open%20Treatment%20Registry%20-%20Overview.pdf
Mary,
I’m no longer a part of the administration of ICMS and haven’t been for some time. While it’s true I was one of it’s founders and am still a proponent of what they are trying to accomplish, just like Doug and ISSCR my time has come and gone and it’s been handed off to others to try and fulfill it’s mission, using their own expertise.
As a patient advocate and also someone who suffers from a terminal disease, I support Dr. Centeno’s position. Patients are interested in safe treatments and therefore the Texas model is attractive to us. There is no way to stop patients, many of then who are desperately ill, from getting treatments wherever they can. I do not know of any patients who feel that their own stem cells should be regulated as drugs by an already over burdened regulatory agency. Unless there is self interest or motivation to deny patients treatments that could possibly improve their lives, then the best solution is allowing autologous stem cell treatments as a practice of medicine to be done under the guidance of an IRB. Since we are all unique individuals, it is not clear to me how a clinical trial is practical for each person receiving his or her own stem cells. Instead, focus on the safety of the procedure. Patients can’t be controlled, so why not do the very best to insure that the procedure is safe? If someone is very ill, in pain or dying, then no one should feel that they can make a decision as to what that person should or should not do as far as trying an experimental treatment.
It’s not time to play God, it’s time for a sensible solution.
Thanks for posting Paul. The deregulatory arguments continue to rely almost entirely on evidently willful misunderstanding of three issues:
First, the idea that regulating the research process somehow prevents patient access to efficacious therapies. The point of research is to find the answer to that question (as well, of course, to establish safety) – unregulated commercialization of untested products is by design incapable of providing answers to such questions, and indeed this business model relies on the answers not being found.
Second, the idea that the FDA simply treats a patient’s own cells as drugs is fallacious. The law is clear in stating that only cells that are more than minimally manipulated, or that are are expected to have non-homologous, systemic, or metabolic effects on transplantation are regulated as biologics. What the FDA is really regulating is the ability of third parties to harvest a person’s cells, process them outside the body and transplant them without first establishing a scientific basis.Many private physicians have decided to violate it because of the inconvenience it causes to their business model. Others have offshored their practices to countries with weaker regulatory systems. Meanwhile, real scientists recognize the need for adequate controls and oversight and continue to chip away at the actual scientific problems, rather than chase profits through patient exploitation. Such doctors are eager to argue about legalistic hairsplitting, but even a cursory look at their “research” reveals an absence of basic controls, blinding, randomization, etc. – because these are essentially impossible when you make patients pay to be subjects in an endless pseudo-experiment.
Third, many of these businesspeople act as if the FDA v Regenerative Sciences case is a fait accompli, or that by being sued by the government for violating established laws they have engaged in some kind of heroics. The realtiy is that they are following a well-trodden course by others engaging in pseudomedical moneymaking. First break a law, then whinge about how the government is oppressing you for breaking it. If Chris et al. were sincere in wanting to challenge the law, it would seem the ethical order in which to do so would be to pursue the matter in the courts or legislature first, then build a business on the new legal footing only after succeeding in the challenge.
Finally, I have rejected Chris’ “challenge” previously and do so again here. I hope that he will spend more time and effort on finding ways to adequately and ethically test his rapidly growing inventory of products for safety and efficacy prior to injecting them into patients wholesale, rather than wasting his time and mine on frivolous and fruitless arguments.
Thanks, Doug, for the comment and participating in this dual interview.
I found these 2 links to fall in line with Doug’s key points.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm221656.htm
http://www.scribd.com/doc/80024212/Stem-Muschler
Mary,
Your links were addressed by our expert Dr. Freeman of OHSU. See his rebuttal (in detail) here: https://www.box.com/s/vzlh0sqt3v987m33vnfj
Really Mr. Sipp, you really have not listened to anything Dr. Centeno has said. His preferred method of treating his patients is here in the U.S., and under current medical regulations and numerous overseeing bodies. However, making the argument that his treatments should be on hold, until the FDA proves its efficacy is absurd and paradox to Dr. Centeno’s contention.
Let me get this straight, you want him and his patients to hold off on treatments, because you think the FDA and you hold a superior position in what is best for the general public? Really, well let’s herd up the sheep for slaughter. I guess your misguided virtues would be acceptable as long as you or your love are healthy. Hypothetically, when the day comes that a medical stem cell treatment proven by medical procedure and not from the FDA can cure you or your love ones in the future, I hope you have the courage to thank Dr. Centeno and anyone else that is fighting for the use of their own stem cells. Please relish on that thought for while, because it is very plausible outcome.
First, I appreciate Paul for posting what I wrote and for entertaining that there are always two sides to every story. Second, Doug has again taken a complex issue and boiled it down to simple and scary messages that fit a bias-the use of stem cells as the practice of medicine=horrible and the only way to innovate in medicine is the Pharma pathway. I think where Doug and I can agree is that clinics who don’t follow any translation process designed to protect patients, who don’t extensively track patients for outcomes and complications, and who don’t publish their data are not helping advance the goal of getting cell therapies to patients that work and are safe. As I have always said on Linked In, if you don’t like that the physician pathway for innovation has produced about half of all of the modern care we all take for granted and followed a reverse pathway to the Pharma model (case reports, case series, comparison trials, and RCTs instead of beginning with RCTs), then don’t avail yourself of in-vitro fertilization, fracture stabilization surgery, back surgery, cardiac stents, bariatric surgery, or open heart surgery. Bottom line, we need two viable pathways for innovation for society to benefit-the Pharma RCT approach and the physician innovation approach. As for us, we’ll be starting our first RCT this summer after publishing our data using the physician innovation approach and refining our protocols-using a time honored and viable medical tradition that benefits society.
On another note, I have challenged to Doug to move this debate to a peer reviewed journal and have already had a journal provisionally accept the format. The goal is to have a debate on the academic concepts with as little opinion as possible and as much logical thought as feasible. I again challenge Doug to this type of peer reviewed debate.
Thanks again for doing the interview, Chris, and for your comment.
Chris seems to have more Legal concerns than Scientific ones when he hands the patient this to sign off on after their non-refundable deposit. No wonder he talks in circles and threatens to sue any one.
“…the Patient exclusively assigns all Intellectual Property rights, including copyright to Physician for any written, pictorial, and/or electronic commentary….enforceable for a period of five years from Physician’s last date of service…Should a breach of this Agreement result in litigation, the prevailing party shall be entitled to reasonable costs, expenses and attorney fees associated with the litigation….” (Mutual Agreement, 01.14.11) applicable to any such material composed for publication about his or her Regenexx experience, is far more dangerous to public health, should it be generally emulated in the medical community.
Chris, it seems to me for the most part there is a reasonable consensus in the field that we need both innovation and safety, but a challenge in my mind is that these two things–innovation and safety–often are at odds with each other. If you overregulate to ensure safety, you hurt innovation and slow down the field. If you underregulate to spur innovation and speed up new treatments, you increase risk. What’s just the right amount of regulation? How do you find the right balance of say being a physician innovator but also maintaining safety? How do IRBs address such a challenge as well? Thanks. Paul
Paul,
Yes, that’s the essence of regulatory type 1 and 2 errors-both have to be balanced. Physicians are already hyper-regulated by any number of bodies and factors-state medical boards, board and sub specialty certifications, the public health department, the civil tort system, hospital privledges, etc… My personal bias is that we need regulations that treat individually consented risks (ICRs) like any surgery and mass production risks like any drug. Right now, the risk of any given autologous stem cell therapy is equivalent (from a public health standpoint) to the risk of any given surgical procedure (both ICRs). As I have discussed, there are countless surgical procedures undertaken where quantifying risk and benefit is very difficult.
Chris Centeno, M.D.