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Macular Degeneration UPDATE SUMMER 2019
A newsletter devoted to the most current medical, social and psychological aspects of all visual diseases
FDA Wins Groundbreaking Case
Against For-Profit Stem Cell Company
By William Wan and Laurie McGinley
June 4 at 11:50 AM
In a decision expected to send a chill through the booming stem cell industry,
a federal judge ruled in favor of the Food and Drug Administration on Monday in a
lawsuit against a Florida-based stem cell company whose treatments have blinded at
least four patients.
Judge Ursula Ungaro agreed that the FDA has the authority to regulate a procedure that has become widespread in the burgeoning industry — using patients’ fat to create a stem cell treatment. The judge ruled that the FDA is entitled to an injunction ordering U.S. Stem Cell to halt the procedure.
The judgment represents a major victory for the government, which has increasingly tried to constrain the industry even as it has rapidly expanded in recent years. “This case is an important victory in the FDA’s work to protect the public health,” the agency said in a statement. “We’ve been taking action, like this case, against clinics that abuse the trust of patients and endanger their health.
We will continue to promote the sound and scientific development of regenerative medicine products, but we will not tolerate those in this field who try to skirt the law and put patients in harm’s way.” Scientists, medical associations and health officials have criticized stem cell clinics for selling treatments unproven by science and unapproved by the government for a wide spectrum of unrelated ailments, such as Parkinson’s disease, multiple sclerosis, joint pain and erectile dysfunction.
“This decision says the FDA has the authority to define a certain kind of stem cell product as a drug product” that requires FDA approval and compliance with other agency rules, said Paul Knoepfler, a stem cell biologist at the University of California at Davis. “There are potentially hundreds of clinics using the same model, and this ruling basically says the FDA can assuming
this is not overturned on appeal — say you are using an unapproved drug, and that’s a
Beginning in 2015, at least four patients were blinded after U.S. Stem Cell and clinics
associated with the company injected stem cell treatments into their eyes. The FDA’s slow initial response to patient injuries permitted U.S. Stem Cell to continue operating four years after those first reports of blindness. Although the company stopped injecting its fat-derived treatments into eyes after the patients sued, it continues to sell the therapy to people with spinal injuries, Parkinson’s disease, multiple sclerosis and other serious chronic conditions.
Last year, just three weeks after the government filed suit, an additional patient had a catastrophic reaction after visiting a clinic in South Miami, Fl., that is affiliated with
U.S. Stem Cell.
A 59-year-old woman felt faint and started vomiting two hours after receiving injections
for arthritis pain. Her case was described in an “adverse event” report filed with the FDA and obtained by The Washington Post through the Freedom of Information Act.
In her judgment Monday, Ungaro said that unless the company is ordered to stop, “there is a reasonable likelihood that defendants will continue to violate”
regulations by offering the unapproved treatments.
In a written statement, U.S. Stem Cell said, “While we believe there is substantial
evidence to prove the efficacy of this protocol, we must immediately comply with the
court as we review the decision.” A spokeswoman said the company plans to continue offering stem cell treatments derived from bone marrow and other tissue.
Making $6.7 million in revenue last year, U.S. Stem Cell operates three clinics and has trained doctors at 150 others, making it one of the most influential stem cell companies
in the nation. Over the past year, it has hired a top law firm to defend against the lawsuit and cultivated formidable allies with close ties to President Trump, including
GOP operative Roger Stone and Newsmax chief executive Christopher Ruddy.
In the lawsuit, the government accused the company of “openly violating the law and endangering patients by manufacturing an unapproved, experimental drug.”
Responding in court, the company called the FDA’s new rules “a power grab” and argued its treatment is a medical procedure that can’t be regulated as a drug.
Ungaro noted in her summary judgment that the clinic makes “numerous claims” about the benefits provided by the treatment derived from fat cells for an array of
illnesses, including Parkinson’s disease, lung disease and diabetes. She added that the
clinic has boasted its therapy is superior to conventional medicine in treating these serious diseases.
She also said the FDA inspected the clinic seven times between October 2015 and May 2017. The ruling does not automatically prevent other companies from offering the same treatment, said Sam Halabi, a law professor at the University of Missouri. “But it sends a very strong signal to the market, and other judges will look at this decision quite seriously and use it as a crucial road map for similar lawsuits that appear before them,” he said.
Leigh Turner, a bioethicist at the University of Minnesota and a longtime critic of the stem cell clinics, welcomed the decision but questioned whether it would
prompt other companies to get out of the business. “Are some of them just going to say there are so many businesses out there that the FDA won’t knock on our door so we will just keep going?” he asked.
Turner said some clinics will “play the odds” and continue performing the fat based
procedures, while others may simply shift into questionable types of stem cell
treatment not addressed in the ruling — such as birth-related stem cell products. “I
don’t expect to see the disappearance of the direct-to-consumer industry,” he said.
“These businesses are too dug in, and there’s too much money to be made.”
Former FDA commissioner Scott Gottlieb called the decision a “pivotal ruling”
indicating that the FDA “is on strong footing” in challenging the practices of the clinics offering unapproved stem cell therapies. “This was a must-win case for the FDA,” he said. “It’s highly significant in that it establishes
the agency’s ability to regulate in this space, and it paves the way for the agency to bring more enforcement actions.”
Gottlieb, who stepped up FDA action against the clinics offering unproven treatments, said the decision sends a strong message to the industry and will bolster agency
efforts to take immediate action “against firms putting patients at immediate risk.”
William Wan is a national correspondent covering
health, science and news for The Washington Post. He previously served as the Post’s China correspondent in Beijing, roving U.S. national correspondent, foreign policy
reporter and religion reporter.
Laurie McGinley covers health and medicine for The Washington Post. She focuses on the Food and Drug Administration as well as cancer research and treatment.
She was previously The Post’s health, science and environment editor.
New Medical Director of the
Macular Degeneration Association
Joshua Mali, MD, of The Eye Associates, has been chosen as the new Medical Director of the Macular Degeneration Association. Founded in 2007, The Macular Degeneration Association (MDA) is a nonprofit health organization dedicated to educating and empowering age-related macular degeneration (AMD) patients. To fulfill their mission, the Macular Degeneration Association funds research, publishes scientific findings and provides funding for awareness programs to people with AMD, their families, healthcare professionals, and the public.
The Association is also actively involved in advocating for scientific research and for the rights of people with AMD.
Dr. Mali’s background and education makes him the perfect choice for MDA. Dr.
Joshua Mali graduated Summa Cum Laude in Biology from West Virginia University (WVU) where he received the prestigious WVU Foundation Outstanding Senior Award. He then continued at WVU School of Medicine for his medical degree and internship in which he was awarded the WV Medical Scholarship Award. Upon deciding to specialize in ophthalmology, he went on to Albany Medical College for his residency and was elected Chief Resident by his peers and faculty.
He also did his medical and surgical Vitreo-Retinal fellowship training at Retina Consultants/Albany Medical College while serving as an Assistant Professor of Ophthalmology. During his fellowship, he became one of the first retinal specialists in the United States to use Iluvien, a new steroid implant for diabetic macular edema.
Currently, Dr. Mali is a board -certified ophthalmologist and award-winning retinal specialist for The Eye Associates, a multispecialty ophthalmology private practice in Sarasota, Florida and is an Attending Physician at Manatee Memorial Hospital
(Bradenton, FL) where he performs retinal surgeries. In addition, Dr. Mali is the Founder & CEO of Mali Enterprises which is currently selling his award-winning invention: The Mali Eyeglass Holder (www.malienterprises.org).
This innovative product is used to safely and securely hold the patient’s eyeglasses during the slit lamp microscope examination. In addition, this versatile product can attach to most tables in healthcare examination rooms, procedure rooms, tables/nightstands at home or in the office to hold eyeglasses as needed. This is a must-have accessory for Ophthalmologists, Optometrists, Dentists, and all other
physicians/healthcare professionals that utilize slit lamps and
Dr. Mali utilizes the most advanced surgical techniques and technology in the world to deliver the highest quality retinal surgery for his patients. He has published research in
esteemed medical publications including JAMA Ophthalmology, Ophthalmology Times, Ocular Surgery News, and Retina Today.
Currently, Dr. Mali is a principal investigator for many clinical trials including a new treatment for wet macular degeneration, diabetic retinopathy, and uveitis. He has presented at national and international research meetings and has given lectures across
In addition, his retinal surgical video was included in the American Society of Retinal Specialists (ASRS) Innovative Retina Surgical Video Series. Dr. Mali was
named 2018 America’s Top Ophthalmologist.
He was also recently honored with the 2018 Outstanding Alumnus for the West Virginia
University Department of Biology for being a leader in his field and all his success as an
accomplished retinal surgeon and innovator.
He has also been recognized by several honored organizations including Alpha
Epsilon Delta (serving as vice-president for the WVU chapter), a prestigious National Premedical Honor Society, Beta Beta Beta
(WVU Chapter), a National Biological Honor Society, and the National Society of Collegiate Scholars. In addition to these honors, he was also selected for membership in the Golden Key International Society, American Society of Retina Specialists (ASRS), American Society of Cataract and Refractive Surgeons (ASCRS), and the American Academy of Ophthalmology (AAO).
He is the proud member of the Manatee County Medical Society (MCMS), Sarasota
County Medical Society (SCMS), Florida Medical Association (FMA), and Florida Ophthalmological Society (FSO). Dr. Mali has given his time and contributed his medical
expertise to worthy organizations such as Medical Ministry International, Georgia Lions Camp for the Blind, Columbia Lighthouse for the Blind, and Baha’i inspired Health for
He has participated in mission trips all over the world including most recently in Mexico and Nicaragua. Locally, he serves as a volunteer ophthalmologist in Bradenton (FL) with
Remote Area Medical (RAM) which provides free medical services for under-served patient populations in the United States. He was also a mentor/preceptor for a NASA sponsored WVU Robotics Team.
Dr. Mali is married to his lovely and beautiful wife Yasmin, and they have a daughter Julia. Dr. Mali has dedicated his career to serving his patients and providing the highest quality eye care for the community.
Joining with the Macular Degeneration Association is truly an honor and privilege. With the support of MDA, he is thrilled about the opportunity to dedicate his efforts to educating and empowering age-related macular degeneration patients and help continue the great work the association has been focused on for years including improving the lives of those affected by eye diseases and providing unwavering commitment of caring through ophthalmological research, information, advocacy
and fundraising efforts.
He is also excited and proud to be the Distinguished Speaker at all the Macular Degeneration Association Awareness Programs. He truly enjoys educating
patients, caregivers, and family members of patients about their eye diseases and guiding them through their diagnoses. Dr. Mali has a guiding principle that continues to serve his patients so well and offers evidence why the MDA entrusted him to be the
new Medical Director of the Association: “As a retina specialist,
it is an honor for me to provide the highest quality eyecare and
treat all my patients as members of my family.”
PRESERVE & PROTECT YOUR VISION DONATE TODAY
Without ongoing contributions from generous donors
like you, the Macular Degeneration Association would be unable to fund Research and Education for the millions of people living with macular degeneration.
Phone, Mail or Online
Phone: Please call (941)893-4387 today to speak to one of our Donor Services Representatives.
Mail: Send your check or money order today payable to:
MACULAR DEGENERATION ASSOCIATION
5969 Cattleridge Boulevard, Suite 100
Sarasota, FL 34232
Online: Please visit www.macularhope.org today and click on the Donation tab.
Stocks, Securities, Mutual Funds and IRAs
Please give serious consideration to the donation of stock and mutual fund shares as this offers numerous opportunities to make a most gracious gift and receive tax advantages.
Wills, Bequests and Planned Gifts
Please give serious consideration to the designation of MDA in your Will, Charitable Trusts, Life Insurance, Appreciated Securities and Real Estate as this offers preplanned giving opportunities that will serve the macular community for years to come. Please call Lynne Henry (941)893-4389 at the Macular Degeneration Association, today, for personal assistance in initiating this effort.
The following language has been reviewed and is deemed a legally acceptable form for including such a bequest in a will:
“I give and bequeath to the Macular Degeneration Association, 5969 Cattleridge Blvd. Suite # 100 Sarasota, FL 34232 for discretionary use in carrying out its aims and purposes, (the sum of $) or (a sum equal to
% of the value of my gross estate at the time of my death under this will or any codicil hereto).”
The Macular Degeneration Association Federal ID number is 27-3025707
Honor a family member, friend or special event by donating to MDA. Pay tribute to someone you love whose life has been impacted by macular degeneration. In l
MEMORIAL AND HONOR GIVING
Honor a family member, friend or special event by donating to MDA. Pay tribute to someone you love whose life has been impacted by macular degeneration.
In lieu of flowers, please consider designating Macular Degeneration Association as your charity of choice.
Launch a Giving Campaign
Please consider leading a team at work by encouraging your colleagues and staff to join together to help those living with macular degeneration. Launch a workplace giving campaign today.
Ask about Matching Gifts
Many gracious employers double or even triple charitable donations made by individual employees. Some companies will match gifts made by retirees and or their spouses. Contact your employer for matching gift eligibility as this allows you to maximize your personal donation.