When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman.
Berman and his clinic partner, urologist Elliot Lander, run an adipose stem cell firm called California Stem Cell Treatment Center. This clinic seems effectively to also be the HQ of a network of about 100 stem cell clinics called Cell Surgical Network. The FDA described the clinic’s and the network’s adipose cell product as a drug and the agency has not approved its use in patients.
A lengthy FDA warning letter to Berman popped up this week on a different front.
The letter pertains to a breast augmentation-related device meant to deal with a side effect called capsule contracture. The FDA says in the letter that Berman is using this device called the Pocket Protector on patients despite a lack of agency approval. The FDA also has a long list of other more specific issues with the device and practices related to it.
In a press release accompanying the warning letter, FDA Commissioner Dr. Scott Gottlieb used some striking words. Here’s just one sample excerpt from the lengthy PR (emphasis mine):
“This is not the first time the FDA has notified Dr. Berman concerning his illegal marketing of unapproved medical products and potentially putting his patients at significant risk. Dr. Berman is well aware that the FDA has never approved any product to prevent or treat capsular contracture. By illegally manufacturing and marketing this device, Dr. Berman is taking advantage of patients and exposing them to a broad range of unknown health risks, including not effectively preventing capsular contracture as the product claims or causing additional harm such as infection or adverse reactions with the breast implant. We’ll continue our efforts to protect patients from those individuals who choose to skirt laws intended to keep patients safe and sell unproven and potentially unsafe medical products.”
I asked Dr. Berman for comment on the warning letter and Gottlieb’s statement. Here was his response:
“The FDA comments (written by Dr. Gottlieb or one of his associates on his behalf) are nothing short of libelous. I’ve never taken advantage of a single one of these breast patients. They’ve found me through friends and other doctors after desperately trying to find a way to obtain normal breasts after multiple failed surgeries for capsule contracture. I was the first surgeon in the world to use e-PTFE (i.e. “Gore-Tex” known as one of the safest synthetic implant materials) for plastic surgery patients. Over the years, I figured out how to prevent the recurrence of capsule contracture by lining the breast pocket with e-PTFE and preventing it from contracting around an implant. Over time, I was able to get a .3mm thick sheet of e-PTFE with 40 micron porosity made so there would be tissue in-growth without concentric scar tissue formation, thus preventing scarring of a typical breast pocket around an implant. Since 2003, I’ve treated many women with recalcitrant capsule contractures – many had over 5 operations and some as many as 12. They always got firm again – something well-known to the surgical community.
With the device I developed I could finally give women a chance to heal with normal soft natural appearing breasts – even in the most difficult cases. It required a total capsulectomy with implantation of the e-PTFE bladder and an implant.
Gottlieb may think he cares about advancing women’s health, but I actually have patients that have real problems and I actually have to take care of them and, thankfully, because of a little creativity and good engineering, I’m able to do just that. I’ve been working with the FDA for years trying to get this approved for simple IDE studies. The regulations keep growing quicker than I can finish an IDE application.
There is nothing about me that ranks as a “bad actor.” I’m here for my patients and frankly, I think doctors have turned into sheep and we rely on government agencies to make decisions that should be our responsibility. We’ve really lost control of our practices to so many other industries within healthcare. I take the Hippocratic oath seriously – “If you can help your patient, it is your duty to try.” I’m not happy that I can’t get this exceptionally successful product to market. I just don’t have the unlimited funding necessary, but I’m getting closer and still trying.”
The new warning comes on top of Berman already being in the situation with the agency over marketing of unapproved “fat stem cells” (a diverse mixture of adipose tissue-derived cells with a subpopulation that are stem cells) for a variety of health conditions. Berman, Lander, their specific clinic, and Cell Surgical Network are named as defendants in an ongoing lawsuit brought by FDA/DOJ. The suit, filed last May, seeks a permanent injunction against the marketing of the unapproved fat stem cells. In parallel the FDA also sued for injunction against a Florida stem cell firm, US Stem Cell Clinic/US Stem Cell (USRM).
Earlier in August 2017 the FDA also reported that it had seized (via US Marshals) an unapproved drug product consisting of a combination of fat stem cells and smallpox vaccine from a firm working with California Stem Cell Treatment Center. The combo was apparently administered at California Stem Cell Treatment Center according to the FDA.
We’ll see what happens next, but the tension here just went up a big notch.
In my view the agency is almost certain to prevail in court. The permanent injunctions could be in place before the end of this year even with appeals or more likely sometime in the first half of 2020. More broadly, recently the FDA also sent out 20 or so of what I’ve called “mini-warning” letters to other stem cell clinic firms (we don’t know which), advising them that they appear to be out of compliance with the law. Time is running short on these clinic firms as well.
It’s possible we’ll see a wave of clinic firms moving outside the U.S., possibly to the Caribbean or the Middle East, or moving away from marketing fat stem cell injections and perhaps toward cheap, sketchy birth-related “stem cell” products that have flooded the U.S. in the past few years.
Dr. Mark Berman was my doctor for years and he changed my life. He also saved my best friend who was scheduled to have extensive and dangerous back surgery (after getting many opinions from good doctors). Berman gave her one fat cell injection treatment with the help of Dr. Grogan and she no longer needs back surgery. Even more, over the last couple of years her back continued to improve as the implanted fat stem cells worked their magic. The FDA hounded a good man until he died.
I had Laser Spine surgery in 2007 in Tampa, Florida. It stopped 50 years of suicidal thinking. After 10 years or so, my pain, my immobility my cauda equina is returning. I have prayed for stem cell therapy in my spine for recovery. The FDA is encouraged, please, to promote, even as experimental procedures, stem cell therapy. I would be thrilled to volunteer.
“It [the FDA] is squelching innovation.”
You obviously have no background in how innovation works, and in particular in the drug industry. Marketing approval as regulated by the FDA in the US and by other agencies around the world is structured to ensure patient safety on one hand and to raise the standard of care (SoC) on the other – without these two aspects no drug will be granted marketing approval.
Improvement over SoC is what drives innovation, so the FDA maintains the height of the bar to keep less safe or less efficacious treatments from the market where they would only reduce quality of life for patients.
It is like saying patents squelch innovation because they stop people using a particular drug structure – but the truth is they stimulate innovation by driving the search for new and better structures. Without these drivers and the regulations supporting them, we would be at the mercy of salesmen and they have no quality control to prevent them marketing snake oil as innovation. This is what we are seeing with unregulated stem cell therapies.
JULIUS, I hear you. but I am in a chair all day long, on Opioida an Gabapentin, because my insurance does not recognize that removal of
L5S1 scar tissue would be cheaper for the insurance than what is set up now. My quality of life would improve if someone believed me.
@Tilly Dunn, I am glad you found relief. Interesting discussion has developed, thanks for the comments. My last word, just to clear up a few things…
People who want to obediently hand their minds and lives over to the FDA, will still be free to do so. No one will stop them.
The issue is this: Many people (patients and doctors) disagree with those pronouncements, have their own judgements about what the appropriate treatment is in their particular case, and desperately want to try other therapies and drugs. It’s a false alternative to say either the FDA provides vetting or there is none. Companies will do as much as they can as they want to see effective treatments and minimize the side effects.
I think the idea that the FDA is neutral and is actually protecting people is absurd. It is squelching innovation. We don’t see the many life-saving or life-enhancing treatments that are never developed due to this massive bureaucracy and the $1 billion barrier to entry. Patients have far fewer options, and they are not even safe. The few drugs and devices that do (eventually) get through the FDA’s labyrinth are delayed, expensive, and still cause harmful side effects. (One report estimates the number of deaths caused by FDA-approved medicines since 2005 at 73 million.) Only now people have a false sense of security and take these drugs without a second thought because it’s “government approved.”
The FDA has no moral right to prohibit someone exercising their liberty to support their lives how they see fit and to pursue their own happiness. Nor does the FDA have a moral right to prevent entrepreneurs and companies from experiementing, developing and providing drugs and treatments to willing patients. That’s what it means to take the Constitution and the rights therein seriously. The individual is sovereign, the government is properly the protector of those rights. As it stands, the FDA makes patients and the entire medical establishment its serfs.
Of course people who make poor choices will pay the price (and they’ll know that in advance). Any doctors or companies that deliberately mislead patients, or withhold information, should be prosecuted for fraud and worse.
The alternative here is between freedom and force, between the abundant choices of a free market and the limited, overpriced, one-size-fits-all dictates of the paternalistic FDA. Ultimately for the patients battling serious illnesses, it’s between life and death.
We live in the most litigious society in history. On television, every single day, we see advertisements to join class-action lawsuits against the pharmaceutical industry for unforeseen problems, and these problems arose after years of careful, methodical research. Is anyone surprised, then, that the regulations would escalate to protect both the patients as well as the companies who are trying to create therapeutics? So many will point the finger at pharmaceutical companies when adverse reactions or even recalls happen, and, as stated previously, that is with several years of careful, methodical work to ensure that such things DON’T occur….but then many of those same people will give a “pass” on clinics that bypass all of those preventative measures. Big pharma is “bad” when a drug turns out to have unforeseen consequences, but the clinics are “good” when they bypass the oversight that would prevent such occurrences? We cannot carefully screen big pharma and be lax in our assessments of stem cell therapies, new medical procedures, or new medical devices. One cannot have one set of standards for big pharma and a separate set of standards for the clinics that want to do “exploratory” human procedures. It ALL deserves careful scrutiny to prevent problems or potential scams. It is not difficult or unreasonable to expect new therapies to have to be well-vetted before they are released to the consumer public. And when a single individual or group of individuals repeatedly bypass protocol, yes, there have to be consequences. This is neither an attack nor a condemnation of any particular person or group of people, but protocols and procedures HAVE TO BE followed for all groups creating new medical technologies, and no one should be above those protocols and procedures. They ALL have to meet the same sets of standards. This has to be looked at dispassionately and objectively, which is what we, as scientists, are called to do. When products are released to the public and marketed as valid options without any regulatory oversight or supporting, published data, how is that fair to the public? I do not question the compassion or the caring of those clinics which choose to skirt regulations….that is not the issue. Following the regulatory framework IS what is at issue here. The FDA has a tough job, and they take a lot of heat for what they do….but they are providing a public service. This “us or them” mentality that so many seem to want to adopt is neither realistic nor constructive, and it lacks wisdom.
It is also facile to state that the FDA is solely responsible for the long timelines of new drugs or medical devices. In the case of drugs, the majority of drug candidates will fail at some point during clinical trials. The drug development process, by its very nature, takes a lot of time and money, and the FDA cannot and should not be held solely accountable for that. Many times in Science, we are forced to take steps back and go back “to the drawing board”. THAT is the single biggest impediment to therapeutic development.
This article is alarming if it is accurate. The FDA is a deterrent to it’s mandate if the costs for new innovations have to be paid for. Why is the FDA not a paid arm of the Federal Government? Is corruption at the heart of this?
I saw Dr. Berman in a recent documentary on stem cell therapy, and he struck me as honest, articulate and passionate about his work, who has by all accounts made great advances in areas of plastic surgery, and helped many desperate patients.
The same cannot be said for the FDA. The FDA is deadly barrier between patients and their doctors and treatments. It is strangling innovation and progress in healthcare, and a major reason for slow progress and high costs in healthcare.
The average time it takes to get a new drug approved is 12 years and it costs over $1 billion dollars. This massive barrier kills many products and ideas at the outset. Not many entrepreneurs or start ups can afford this extortionate price, nor the delay, which doesn’t even guarantee their product will be approved.
People with serious life-threatening conditions are counting their days, a year is literally a lifetime. And in the end, the bureaucrats at the FDA are human like anyone else, and vastly less knowledgeable than most experts on the cutting edge of the technology like Dr. Berman. No amount of testing and endless delays can guarantee the safety of patients.
The FDA should (at the most) make recommendations, not prohibit potentially revolutionary new treatments to patients. Individuals should be free to confer with doctors of their choice and evaluate all their options and the associated risks involved based on available research, medical board recommendations and other information.
Hi Nigel, Scroll down and see my reply of 26.2.2019 and it will explain why I so fully support what you comment on. When I was prescribed the Constella (Linaclotide), I was thrilled at it’s effect. This is a new drug and has saved me from having my large bowel removed. I wonder if your ‘thumbs down’ are employees of the FDA.
xoxox Love, Tilly Dunn/Ottawa.
Admittedly, I am new to the world of stem cells. Thank you so much for giving me this opportunity to comment. From what I have seen in the past week, Stem Cells: that our in our own body, are the newest, biggest hope for seniors that I have ever seen. Stem Cells are the first and last hope for all those who are born with congenital defects and all those who have illnesses. Please, don’t fight those who are on the front lines of this new discovery of our own cell use. FDA, you are a watchdog, I know. Will you do the right thing and not be influenced by existing organiztions who may bribe you?
the wheels of justice grind very slow but they grind very fine, (more often than not anyway.).
When the first sentence contains the word “libelous”, I stop reading.
I’m losing patience with these arguments against getting approval from the FDA. If the therapy is so good, it should be easy to obtain FDA approval. The FDA wants to help patients; they want to help clinicians. Why not arrange an INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER products) meeting with the FDA? Their feedback is very valuable.