Feature

New York Attorney General Sues Stem Cell Clinic for False, Misleading Claims

Letitia James

The New York attorney general, Letitia James, has filed a lawsuit against a Manhattan stem cell clinic and the physician running it for allegedly selling unproven treatments for lupus and other autoimmune conditions, among others.

The suit was filed last week on behalf of the people of the state of New York against Park Avenue Stem Cell (PASC) in New York City, and Joel Singer, MD. The clinic used a number of web-based and social media platforms to offer services to treat autoimmune disease, erectile dysfunction, cardiac and pulmonary disease, along with orthopedic and neurological diseases. In addition, links on the site directed users to view scientific literature supporting the use of stem cell therapies to treat these conditions. However, existing literature fails to demonstrate consensus backing the use of stem cells for these patient populations.

Rates for stem cell procedures offered at PASC began at around $4,000.

While the website does offer disclaimers, James alleges that they are insufficient to offset the misleading claims about the efficacy and safety of stem cell treatments in the overall presentation of the clinic’s online presence.

“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful and immoral,” James said in a statement.

Perhaps more troubling, patients were led by the website to believe that by undergoing procedures, they were part of an “FDA-approved,” patient-funded clinical trial with IRB numbers ICSS-2016-001 through ICSS-2016-21, according to the suit. However, many patients are unaware that the FDA does not approve the types of preliminary trials touted by the site, and that most clinical trials do not receive funding from patients.

One other misleading component of the PASC website involved testimonials from National Football League player Darrel Reid and radio show host Curtis Sliwa. Available scientific evidence failed to back the claims made by Reid and Sliwa, and the site failed to disclose that both men received free treatment from the clinic in exchange for their testimonials.

A key concern in the New York attorney general’s case is that while the FDA does allow a handful of stem cell procedures using cord blood, PASC performed procedures with adipose tissue, the use of which is currently not approved by the Administration.

Scott Gottlieb
Scott Gottlieb

Although Scott Gottlieb, MD, is departing as FDA Commissioner, James may have the backing of the FDA in light of two similar complaints that were filed against stem cell clinics last year. In fact, PASC was affiliated with one of the companies that was sued by the FDA in 2018: the California-based Cell Surgical Network.

“We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products,” Gottlieb said in a statement. “But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”

Looking at autoimmune-disease specific grievances, at various times between 2016 and 2018, the PASC website has made false or dubious claims such as, “There is a great deal of excitement about using stem cells to treat Autoimmune Disease,” and, “The use of autologous SVF in the mitigation of Autoimmune Diseases such as Lupus, MS, Scleroderma are also being studied,” according to the lawsuit.

In one other section dealing with autoimmune diseases, the website offers that an available stem cell procedure entails, “wiping out a patient’s immune system using cancer drugs and then rebooting it with stem cell transplant,” according to the lawsuit. This claim is linked to clinical trial results, however, the conclusions drawn in the clinical trial fail to show consensus that the treatment is as effective as advertised and, more importantly, PASC does not even offer that procedure as part of its menu of services.

The lawsuit also highlights dubious claims regarding joint diseases and other associated inflammatory conditions. These include statements such as, “Our center focuses on utilizing your own stem cells and targeting them for orthopedic purposes, so that your body can repair itself, without any invasive treatments,” and, “We have an [sic] intensive clinical experience in the investigation of the use of SVF to mitigate inflammation and damage in the joint,” according to the lawsuit. Again, the claims are unsupported by either FDA approval or clinical evidence.

There are more than 600 clinics advertising various stem cell interventions in the United States alone. While hope runs high among patients with rheumatic and autoimmune conditions, and their doctors, that these treatments may one day be an alternative to invasive surgeries, current evidence does not support most stem cell treatments for these patient populations. – by Rob Volansky

Letitia James

The New York attorney general, Letitia James, has filed a lawsuit against a Manhattan stem cell clinic and the physician running it for allegedly selling unproven treatments for lupus and other autoimmune conditions, among others.

The suit was filed last week on behalf of the people of the state of New York against Park Avenue Stem Cell (PASC) in New York City, and Joel Singer, MD. The clinic used a number of web-based and social media platforms to offer services to treat autoimmune disease, erectile dysfunction, cardiac and pulmonary disease, along with orthopedic and neurological diseases. In addition, links on the site directed users to view scientific literature supporting the use of stem cell therapies to treat these conditions. However, existing literature fails to demonstrate consensus backing the use of stem cells for these patient populations.

Rates for stem cell procedures offered at PASC began at around $4,000.

While the website does offer disclaimers, James alleges that they are insufficient to offset the misleading claims about the efficacy and safety of stem cell treatments in the overall presentation of the clinic’s online presence.

“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful and immoral,” James said in a statement.

Perhaps more troubling, patients were led by the website to believe that by undergoing procedures, they were part of an “FDA-approved,” patient-funded clinical trial with IRB numbers ICSS-2016-001 through ICSS-2016-21, according to the suit. However, many patients are unaware that the FDA does not approve the types of preliminary trials touted by the site, and that most clinical trials do not receive funding from patients.

One other misleading component of the PASC website involved testimonials from National Football League player Darrel Reid and radio show host Curtis Sliwa. Available scientific evidence failed to back the claims made by Reid and Sliwa, and the site failed to disclose that both men received free treatment from the clinic in exchange for their testimonials.

A key concern in the New York attorney general’s case is that while the FDA does allow a handful of stem cell procedures using cord blood, PASC performed procedures with adipose tissue, the use of which is currently not approved by the Administration.

Scott Gottlieb
Scott Gottlieb

Although Scott Gottlieb, MD, is departing as FDA Commissioner, James may have the backing of the FDA in light of two similar complaints that were filed against stem cell clinics last year. In fact, PASC was affiliated with one of the companies that was sued by the FDA in 2018: the California-based Cell Surgical Network.

“We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products,” Gottlieb said in a statement. “But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”

Looking at autoimmune-disease specific grievances, at various times between 2016 and 2018, the PASC website has made false or dubious claims such as, “There is a great deal of excitement about using stem cells to treat Autoimmune Disease,” and, “The use of autologous SVF in the mitigation of Autoimmune Diseases such as Lupus, MS, Scleroderma are also being studied,” according to the lawsuit.

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In one other section dealing with autoimmune diseases, the website offers that an available stem cell procedure entails, “wiping out a patient’s immune system using cancer drugs and then rebooting it with stem cell transplant,” according to the lawsuit. This claim is linked to clinical trial results, however, the conclusions drawn in the clinical trial fail to show consensus that the treatment is as effective as advertised and, more importantly, PASC does not even offer that procedure as part of its menu of services.

The lawsuit also highlights dubious claims regarding joint diseases and other associated inflammatory conditions. These include statements such as, “Our center focuses on utilizing your own stem cells and targeting them for orthopedic purposes, so that your body can repair itself, without any invasive treatments,” and, “We have an [sic] intensive clinical experience in the investigation of the use of SVF to mitigate inflammation and damage in the joint,” according to the lawsuit. Again, the claims are unsupported by either FDA approval or clinical evidence.

There are more than 600 clinics advertising various stem cell interventions in the United States alone. While hope runs high among patients with rheumatic and autoimmune conditions, and their doctors, that these treatments may one day be an alternative to invasive surgeries, current evidence does not support most stem cell treatments for these patient populations. – by Rob Volansky