Update on patients lawsuit against stem cell clinic, Stemgenex

StemGenexThe website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex.  Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case here.

Not surprisingly, the plaintiffs and defense see this case in opposite ways as reflected in quotes in the Law360 article:

“Plaintiffs make non-specific and conclusory allegations with respect to all named defendants,” StemGenex said. “The second amended complaint is so devoid of any specific facts to support its contentions that it is impossible for defendants to reasonably prepare a defense.”

Brian Findley of Mulligan Banham & Findley, a lawyer for the plaintiffs, told Law360 Wednesday that the allegations are “quite specific” and cite false statistics, made-up online reviews and StemGenex employees. If customers told the company that the treatment hadn’t done anything, they were told it could take months to see an effect, or that they should buy another treatment, he said.”

A key issue in this case is the marketing of stem cell offerings from Stemgenex and the plaintiffs allege this marketing was problematic:

“The three StemGenex customers, Selena Moorer, Stephen Ginsberg and Alexandra Gardner, all say that they paid the company $14,900 for each stem cell treatments for lupus, diabetes and other ailments after being persuaded by the number of satisfied customers on the company’s website, but that the treatments had no effect.”

The Stemgenex website still lists an apparent 100% patient satisfaction marketing claim as of today, January 23, 2017 (see screenshot below).

stemgenex

Screenshot from Stemgenex website

According to the Law360 article, Stemgenex has made various arguments to support their motion for dismissal and they overall called the lawsuit a “fishing expedition.”

If you want to follow the case, here is some info:

“The case is Moorer v. StemGenex Medical Group Inc., et al., case number 3:16-cv-02816, in the U.S. District Court for the Southern District of California.”

It seems likely that more patient suits against stem cell clinics will emerge this year. Some, but not all of the other recent cases of this kind including against US Stem Cell, Inc. and its subsidiary US Stem Cell Clinic have been settled before any judgment was issued. I’m not sure of the status of a different proposed potential class action case against The Lung Institute. If you know of other such lawsuits please contact me or post a comment.

Class Action Lawsuit Filed Against Stem Cell Clinic The Lung Institute

Is it possible that a growing number of lawsuits against stem cell clinics could freeze or reverse the growth of the clinic industry that sells unapproved medical therapies? If so, then it would achieve what so far the FDA hasn’t.

Both in the public domain and through the grape-vine I’m hearing that there are a growing number of attorneys zooming in on stem cell clinics.

The Lung Institute

Screenshot from The Lung Institute website

Here in California a law firm is advertising a potential class action suit against one or more stem cell clinics. Details remain sketchy so far.

Now late last week, The Tampa Bay Times reported the filing of a class action suit by Tammy Rivero against the stem cell clinic The Lung Institute (HT to Alexey Bersenev):

“In 2014, Rivero took out a home equity loan to pay $7,500 and traveled from her western North Carolina home to Florida to undergo stem-cell therapy at the Lung Institute in Tampa. The institute claimed she would see results in a matter of weeks, according to a lawsuit Rivero filed last week.

Instead, according to the suit, she got worse. Now Rivero, 58, is the first of what her attorney says are dozens of former patients seeking class-action status in a legal action against the institute.”

The Lung Institute has gotten attention in the past including for its patient recruitment seminars. CBS Chicago reported last year on an unhappy patient at the clinic.

The Times piece goes on to describe the heart of the case:

“Rivero’s suit says the Lung Institute violated Florida’s Deceptive and Unfair Trade Practices Act by duping clients into believing stem-cell therapy worked despite the absence of credible medical evidence.

“It’s one thing for folks that have an incurable disease to try experimental treatments,” said Rivero’s attorney, Ben Vinson Jr. of Tampa. “But it’s another when the person offering the treatment knows it doesn’t work.”

The Lung Institute was quoted as indicating that they believe the current case has no merit:

“Speaking for the institute, Lynne Flaherty Margnelli, executive vice president of Regenerative Medicine Solutions, said in a statement to the Tampa Bay Times: “Lung Institute prides itself on putting patient care first and always operates with the patients’ best interests in mind. We do not believe the case has any merit and we look forward to resolving this matter.”

Of course, in cases like this the clinics are simply alleged to have done certain things and are innocent unless proven otherwise. The cases do shed interesting light on the stem cell clinic industry though.

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The stem cell hard sell: my new paper in Stem Cells Translational Medicine

stem cell hard sellI just published a paper in Stem Cells Translational Medicine on my experience traveling to and attending a stem cell clinic patient recruitment seminar.

It was an intense experience and one where I felt at risk. To some extent it is akin to going into the lion’s den. I didn’t know what reaction I would get if I were recognized by those running the seminar, which in fact did happen. They did not seem happy at all that I was there even though I wasn’t disruptive in the least. I had hoped to ask a few questions from my place in the audience, but the format did not allow it. Still I wondered if I could be kicked out. That didn’t happen.

I call these stem cell clinic seminars “infomercial” seminars because they remind me of hard sell pitches on TV.

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Some patients unhappy with stem cell clinics

stem cell shot clinic

Screen shot from CBS Chicago TV segment of syringe filled with “stem cells”

Over the years I’ve heard from quite a few patients of stem cell clinics who feel very strongly about their experiences. Some have quite positive views on getting stem cell interventions, while others feel very negatively about the stem cell clinics. I’ve heard more of the latter kind of experience.

People often tell me that the stem cells from clinics only worked briefly at best and were too expensive. Another complaint is that the clinic responds to patient disappointment often by suggesting additional, expensive shots of stem cells for the “full benefit”. There is also sometimes a sense that the clinic claims while recruiting patients or on the Internet didn’t match the patient’s own experience.

A new report by Pam Zekman at CBS Chicago reflects the polarized views out there. Some they talked to were positive, but others were unhappy.

For example take the case of Charisma Cardine, who has been blind for 13 years, which the report describes as, “the result of a rare central nervous system disease.” 

“They told us that it was a 90 to 95 percent success rate,” Cardine says. “They said they worked with one other patient besides her before and they gained their sight back within two weeks,” her sister, Christiana James, adds. But Cardine’s $9,000 treatment at the Miami Stem Cell Treatment Center did not restore her sight.”

A stem cell doctor from a different clinic quoted in the article, Dr. Daniel Ritacca of the Chicago Stem Cell Treatment Center, has a positive outlook on their clinic’s treatment of more than 4,000 patients. One of his patients, Bob Leonard who suffers from MS, believes his stem cell treatment helped him. The Chicago clinic is part of the stem cell clinic chain, Cell Surgical Network.

For another stem cell clinic patient, Robert Heller who suffers from lung disease, his experience at yet another stem cell clinic, The Lung Institute (also see A Look Inside a Stem Cell Clinic Informercial by Professor David Brafman), was reported as not so positive in the article:

Heller paid $6,500 for treatments but says his condition only got worse. “”They give you a lot of BS and wishful thinking and selling you on hopes. False hopes,” he says.”

Those are strong words.

The reporter Zekman participated in a Lung Institute webinar, where reportedly claims were made that “71 percent of their patients” had seen increases in lung function.

Many in the research community are trying to get a better sense of the range of patient experiences at stem cell clinics.

Have you had a stem cell treatment at a clinic?

What has your experience been like?

Please share it in the comments. Or you can also email me directly (knoepfler@ucdavis.edu).

David Brafman Guest Post: A Look Inside a Stem Cell Clinic Infomercial Event

David_BrafmanBy David Brafman 

With the vast amount of information about stem cells available to the general public, many misconceptions exist regarding stem cells and their potential applications. Paul and other prominent stem cell scientists have done an excellent job of educating the public about the facts regarding stem cells and their potential applications. Nonetheless, over the past several years there has been a proliferation of so-called stem cell ‘clinics’, which promise patients miraculous therapies often for currently incurable diseases and disorders. This is particularly true in Arizona, where some have seized upon unproven stem cell applications and are selling false hopes to the public, especially the large elderly population.

A quick Google search will reveal the extent to which these clinics have spread throughout the Phoenix area. With names such as the ‘Stem Cell Rejuvenation Center’ and ‘Arizona Stem Cell Center’, the pitch of these ‘clinics’ is all the same—They have some proprietary or cutting-edge method of isolating stem cells from a patient’s body and injecting them back into that same patient to treat or even cure any imaginable disease. It’s just that simple!

Like many, I have been shocked by the existence of these clinics and disgusted by the way they are taking advantage of desperate patients. Recently, I attended an informational seminar (more of an infomercial) of one of these local clinics, the Lung Institute (http://lunginstitute.com/). This experience had a profound effect on me and Paul has been kind enough to allow me to share it here. The goal of this post is not to debunk the claims made by this particular stem cell clinic (which is easy to do) but rather share my thoughts on how as scientists we can get involved to stem (no pun intended) the misinformation and false hope peddled by such practices.

I was able to register for the clinic online. Thankfully, I registered early (an hour before the start of the seminar) because according to the registration portal ‘Space is limited – Only 30 seats available.’ The seminar was held in a nice, recently built medical facility in a location in the Phoenix area that was near a retirement community. I had only expected a few other people to be in attendance but was surprised when I had arrived that it was standing room only. By my count, there were over 40 people in attendance and most, if not all, the people in attendance were elderly, many of them had supplemental oxygen, and by my guess suffering from some sort of lung disease. It would seem that these patients were subject to direct advertising methods—or worse—were referred to the clinic by their own physicians. Being there with all these patients also brought home for me in a very direct way just how many people are suffering and looking for hope. I am sensitive to their situations and wish them the best.

The seminar began with the head of the clinic, Dr. Burton Feinerman, providing an overview of the treatment process. He did not go into specifics but stated that his clinic offered three treatment plans for suffers of lung disease (see attached informational pamphlet). All three options are similar in that ‘stem cells’ are isolated from the patient’s blood, adipose tissue, or bone marrow and delivered back to the body through the use of an IV and/or nebulizer. I will not go into all of the claims that Dr. Feinerman made but some of the more outrageous statements he made were as follows:

  • In a typical ‘treatment’, 200-500 million stem cells are isolated from the patient. These cells are injected intravenously back into the patient, in which they home with 100% frequency back to the lung. Once these cells arrive at the lung, they differentiate into mature, functional pulmonary tissue.
  • These therapies can be used to treat non-pulmonary disease such as ALS, PD, diabetes, etc. Throughout the presentation Dr. Feinerman was careful not to use the word “cure” but instead used words such as “treat” and “help”.
  • The “majority” of patients see some beneficial effects from treatment. When later asked by an audience member what percentage of patients see improvement, Dr. Feinerman stated that the percentage of patients that see improvement is around “70%”.

As any reader of this blog with some basic knowledge about stem cell biology would know that these claims are quite dubious. For example, making the claim that stem cells injected to the blood would somehow find their way back to damaged lung tissue and then repair damaged tissue would be similar to me claiming that I could fix your broken iPhone by just injecting some metal into it. It’s just that simple!

I encourage the readers to view other articles about similar dubious claims that Dr. Feinerman has made in the past:

After Dr. Feinerman’s presentation, several patient coordinators shared ‘success’ stories with the audience. Each story had a similar narrative in that a patient suffering from a lung disease came to the clinic because they were out of treatment options. After receiving treatments, the patient’s status improved. In a short period of time, they were able to perform activities that they were previously unable to perform. If it works these patients, it will surely work for you!

Finally, Elise Myers, the head patient coordinator (and former Bachelor contestantCelebrity endorsement!), shared the next steps patients needed to take in order to sign up for the treatment. At the end of her presentation, she stated that the next round of treatments were going to begin in May. Unfortunately, they were almost fully booked. However, if patients signed up that day they would receive a $2000 discount (as an aside the treatments offered by the Lung Institute have been reported to be in excess of $10,000). Act now to take advantage of this special opportunity!

After Ms. Myers’ presentation, Dr. Feinerman took questions from the audience. The majority of the audience members’ questions where about their particular condition and if the treatments offered by the clinic would be effective in their particular cases. Dr. Feinerman’s response was always an unequivocal “yes”.

At this point I found myself compelled to speak. My original intention of attending this seminar was to just simply observe one of these sessions in person. I had no intention of speaking up or asking questions. However, after observing the questionable claims in person I felt the need to voice my opinion. So, I stated that I was an Assistant Professor in the Department of Bioengineering at Arizona State University who has been performing stem cell-related research for better part of a decade. I commented that from my standpoint the claims that Dr. Feinerman was making about his therapies were dubious and appeared to have no scientific basis. I shared my concern that Dr. Feinerman was selling these patients false hope. Additionally, I encouraged all the patients to research on the internet what other reporters and scientists had to say about the treatments offered by Dr. Feinerman and his clinic. Finally, I encouraged the audience members to perform a simple Google search for ‘Stem Cell Clinics’ to see what other patient experiences have been with clinics similar to the Lung Institute as well as the warnings that the FDA has provided with regards to such clinics.

As I was talking, Ms. Myers’ rushed over and grabbed the microphone from Dr. Feinerman. She told me that “I didn’t know what it was like not to be able to breath”. In addition, unlike FDA-approved clinical trials in which certain patients receive a placebo, that all of their patients receive the “real thing”. I replied that I was not trying to cause a scene or debate them directly but I was simply encouraging all patients in attendance to do their research. Ms. Myer’s replied that the patients have done their research and that many were working with their doctors in coordination with the Lung Institute (that’s a concerning thought—doctors are referring patients to these clinics!). Finally, as I was being escorted out of the presentation, she said “Don’t act like you are the first person to question what we are doing”. Thank goodness!

Obviously, I was not surprised by the reaction I received from the employees of the Lung Institute. However, I was surprised by the reaction of the patients in the audience as the majority echoed Ms. Myers displeasure and were applauding as I was leaving. I certainly was not expecting the audience to give me a standing ovation but this response left me quite disheartened and feeling somewhat hopeless. So, what can we do as scientists or other concerned stakeholders to effectively combat these clinics and ensure that patients are well-informed?

Here are my suggestions:

  • Attend an informational seminar offer by a local stem cell ‘clinic’. Most major metropolitan areas have a handful of similar stem cell clinics offering similar therapies as the Lung Institute. As such, many have public informational seminars or webinars. I encourage you to attend one of these seminars or watch one of their webinars. In my experience, attending one of these seminars firsthand is a completely different experience than simply reading about their existence. It will likely not only spark feelings of anger but also give you an experience to share with others. As an aside, I would not necessarily encourage you to speak out because as a former mentor of mine told me “debating members of these clinics is like debating creationists”. However, if you feel compelled to speak, know that if you convince just one person who is considering these therapies to question their legitimacy then speaking out is worth it.
  • Educate your colleagues. Amazingly, when I shared my experience with my colleagues (many of whom are stem cell researchers), they were shocked to learn that these clinics exist. In fact, one colleague of mine asked me about a stem cell therapy for baldness that he thought was FDA approved. Misinformation also exists among those with advanced degrees.
  • Communicate with patient advocacy groups. One thing I learned from my experience is that many patients considering these therapies have tried all other alternatives and are desperate for any potential therapy. It is understandable that they are looking for hope. So, educating patients about the dangers of these clinics needs to be done in a sensitive manner ideally by individuals that the patients trust. A good way to do this is through patient advocacy groups. For example, a graduate student in my lab who also attended the Lung Institute seminar recently shared his experience with the local chapter of the Cystic Fibrosis Foundation. Surprisingly, there were a few patients that had heard about the Lung Institute and were considering their treatments. Overall, they were grateful that he shared his experience and that he had provided them with information about the dangers of these clinics. Keep in mind that some patients such as some of those at the clinic seminar that I attended may on the other hand get upset with your questioning of the clinics. This may be uncomfortable, but it is important to be respectful of patients and diverse perspectives.
  • Share your knowledge and experience with non-scientist friends. You may not know someone who is considering one of these therapies but you will be shocked by how many of your non-scientist friends do.
  • Contact your local, state, and federal representatives. I have done this myself and have been frustrated by the lack of response. Nonetheless, it is easy to send your representatives a short, email sharing your concern about these clinics. I have made it a point to send the same email every month. The more people who start doing this, the more likely there is to be a response.
  • Contact the FDA. Several of these local clinics have been profiled and questioned by Paul and the national media, yet they continue to exist. Why does the FDA and other regulatory agencies allow these clinics to continue to operate? The issue is complex and Paul has done an excellent job of breaking down the various components. I also agree with Paul that the FDA has dropped the ball with regards to properly regulating these clinics. However, with the proliferation of these clinics, the FDA may simply not know some exist or exactly what they are claiming. Send an email to the FDA at ConsumerInfo@fda.hhs.gov expressing your concerns and share your experiences. Again, the more people voicing their concern, the greater the chance that the FDA will respond.

As scientists or other concerned members of the stem cell community, we have a responsibility beyond research. In the end, I believe eliminating these questionable stem cell clinics will require the involvement of as many scientists as possible as well as other members of the stem cell community. Get involved!

If readers want to discuss my experience or any other related issues, I can be contacted at David.Brafman@asu.edu or readers can leave comments here on this blog post.