F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics

Dr. Mark Berman, of the Cell Surgical Network, in 2014 at his practice in Beverly Hills, Calif. Dr. Berman is a founder of the California Stem Cell Treatment Centers, where patients received an unapproved stem cell treatment made with the help of a smallpox vaccine and other ingredients.

WASHINGTON — The Food and Drug Administration announced a crackdown on dangerous stem cell clinics on Monday, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.

The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down “unscrupulous actors” in regenerative medicine, a broad umbrella that includes stem cell and gene therapies and immunotherapies.

“The F.D.A. will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said Dr. Scott Gottlieb, the F.D.A. commissioner.

Stem cells, which can be extracted from bone marrow, blood or fat, can develop into many different types of cells, and are thought to have the potential to repair or replace tissue damaged by disease, injury or aging. But so far, the F.D.A. has approved only a few stem-cell products.

The companies that the F.D.A. cited have been performing liposuction to remove belly fat from patients, extracting stem cells and then injecting those cells back into the patients to treat various ailments.

On Friday, the agency said, federal marshals seized 500 doses of live Vaccinia virus vaccine for smallpox belonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies for cancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.

The F.D.A. said patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif., received the treatment made with the smallpox vaccine. It also said it had serious concerns about how StemImmune obtained the vaccine for use in an unapproved and potentially dangerous treatment.

StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, according to Thomas Skinner, a C.D.C. spokesman. In its request, the company said it was conducting cancer research involving the vaccinia virus, and needed to vaccinate researchers — a seemingly legitimate reason. The company did not tell the C.D.C. that it was going to inject the vaccine into patients, he said.

A statement from StemImmune said the company said the company had lawfully obtained the drug.

The F.D.A. also issued a warning letter to U.S. Stem Cell, a private clinic in Sunrise, Fla. The company was the subject of a March report in The New England Journal of Medicine, describing how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.

The warning letter accused the company of impairing the F.D.A.’s ability to conduct its inspection by refusing to allow inspectors in, and denying them access to employees. It also said that U.S. Stem Cell had failed to establish proper quality control and sanitary standards.

In a statement Monday afternoon, U.S. Stem Cell denied ever restricting access to F.D.A. inspectors, or having sterility problems. “The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration,” it said.

Noting that the F.D.A. has asked patients with concerns to come forward, the company said it had asked patients who have had positive experiences with their stem cell treatments to notify the agency.

But in the warning letter, the F.D.A. noted that U.S. Stem Cell had claimed its work was not subject to agency regulation. The F.D.A. disagreed, saying that the cells extracted by the company met the definition of both a drug and a biological product, both of which come under the agency’s jurisdiction. In its statement, U.S. Stem Cell said it would abide by the new rules the agency is developing for the field.

Dr. Gottlieb said it was imperative to shut down fraudulent and unsafe players in the field in order to take advantage of the promise of stem cell therapies and to increase innovation in the regenerative medicine field, a program authorized by Congress in the 21st Century Cures Act.

The Sawgrass Medical Center in Sunrise, Fla., where the U.S. Stem Cell clinic operates. The F.D.A. issued a warning letter to U.S. Stem Cell, after a report described how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.

Those enterprises “put the entire field at risk,” Dr. Gottlieb said. “Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.”

The California Stem Cell Treatment Centers were founded in 2010 by Dr. Mark Berman, a plastic surgeon, and Dr. Elliot Lander, a urologist. Dr. Berman defended the company, and said that the F.D.A. had not accurately interpreted its cancer pilot study with StemImmune. Dr. Berman, who is also a director of StemImmune, also said that none of the patients had experienced serious adverse effects or died as a result of the treatment involving the vaccine, which he noted, was free.

Dr. Berman and Dr. Lander also train other physicians to perform liposuction, extract stem cells from the fat and inject the cells to treat many ailments, including heart disease, back and knee pain, asthma and neurological disorders.

After training, the physicians can become affiliates of the Cell Surgical Network, which has more than 60 members around the country. Patients are charged $8,900 per procedure, Dr. Berman said in a previous interview. He said affiliates purchase a centrifuge and incubator from the network for about $29,000, and pay the network $1,000 for the disposable liposuction equipment needed for each procedure.

A Florida woman, Doris Tyler, 77, lost her sight after being treated last September at an affiliate of the Cell Surgical Network, the Ageless Wellness Center in Peachtree City, Ga. Cells from her fat were injected into both eyes.

Before the treatment, Mrs. Tyler’s sight had deteriorated because of age-related macular degeneration. But she said she could still see well enough to get around, cook and read.

Within a month of the injections, Mrs. Tyler had a retinal detachment and lost the sight in her left eye. A few weeks later, the same thing happened to her right eye.

She consulted Dr. Thomas Albini, an eye surgeon at the Bascom-Palmer Eye Institute at the University of Miami, who had also examined the three women who went blind after similar treatment at the U.S. Stem Cell Clinic.

In an interview, Dr. Albini said Mrs. Tyler’s case resembled the others. The stem cells apparently formed a membrane that pulled the retina off the back of the eye, causing blindness. Attempts to reattach the retinas surgically could not restore Mrs. Tyler’s sight. She was permanently blinded.

Calls to the clinic in Peachtree City were not returned.

Dr. Berman said that because of her case, affiliates of the Cell Surgical Network were being advised to avoid giving injections directly into the eyes.

“We made a bad decision to have this done,” Mrs. Tyler’s husband said.

Dr. Gottlieb said the F.D.A. would soon publish documents detailing which new treatments and products are subject to agency regulation, and which are not, and giving details on a new, expedited path for companies with legitimate products, seeking premarket approval.

Some industry representatives applauded the move.

“The F.D.A.’s proposal is clear evidence of the fact that the regenerative medicine sector has matured and has moved from just a research sector to a development of market ready products,” said Michael Werner, a partner in the law firm of Holland & Knight and the executive director of the Alliance for Regenerative Medicine. “He’s clearly distinguishing unscrupulous actors who are playing upon hype and taking advantage of patients and product developers who are actually going to treat diseases.”

‘He is trying to balance patient safety and a regulatory pathway that is as least burdensome as possible,” Mr. Werner said.

Public health advocates praised the F.D.A. for moving against the companies, but said it should have happened sooner, given the widespread knowledge of public harm.

“We certainly welcome this type of action, although it comes belatedly,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The agency has known about these unscrupulous actors for years.”

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PTC path, farmer’s market top priorities

The Newnan Times-Herald

A cart path connecting Senoia to Peachtree City and the return of an outdoor market were the things Senoia residents put the most importance on at at town hall meeting held Thursday.

At the meeting, attendees first talked about the things they like about their town, and then made suggestions for things they would like to see in the future or needed changes. The suggestions were written down individually on large sheets of paper and hung on the walls of the Senoia Senior Citizen Center, where the meeting was held.

Each attendee was given several red sticker dots, and asked to place the dots on the items they felt most strongly about. Several people were seen putting multiple stickers on the cart path poster. Then, the stickers for each item were added up.

The town hall meetings are held every other year by the Senoia Downtown Development Authority. This year’s meeting was facilitated by Candace Boothby of the Newnan-Coweta Chamber of Commerce.

Golf cart connectivity to Peachtree City was the clear winner with 103 votes.

The return of a downtown farmer’s market and outdoor market, which was suggested by Senoia Outdoor Marketplace founder Suzanne Pengelly, received 71 votes. It was written down as “farmer’s market.”

Other items receiving a significant number of votes were consistent code enforcement with 47, wider lanes and shoulders on Rockaway Road with 39 votes, better trash pickup on busy days downtown with 41 votes, better safety and coordination with downtown walking tours with 29 votes, an upscale community center with activities with 50 votes, more off-street parking with 44 votes, another grocery store with 56 votes, and more arts with 50 votes.

“A lot of good information came out tonight,” said Senoia City Manager Harold Simmons.

“A lot of the things we’re already working on,” he said after the meeting. The city recently added 45 parking spaces along Seavy Street, and a concern that was voiced about spray painting of arrows on roadways for runs and bicycle rides has already been taken care of.

A cart path connecting Senoia and Peachtree City is something that has been discussed since at least 2011 but has been put on the back burner. Part of the path would run through unincorporated Coweta County, and the county has no interested in chipping in funding.

In 2014, it was discussed that the county’s lack of funding was an obstacle, as was the failure of the Special Purpose Local Option Sales Tax in Fayette County.

But there has been activity in the background. Simmons said he recently met with Peachtree City officials to discuss the future of a cart path.

In the past, Simmons said, there were rumors that Peachtree City was opposed to such a path. That is not the case, he said. “Peachtree City would love to connect to Senoia, and Senoia would love to connect to Peachtree City.”

But right now, the project is not a high priority for either side.

Peachtree City spends about a million dollars a year to maintain existing trails, Simmons said. And the city manager told him there are still portions of the city that haven’t been connected. Connections in the city and maintenance of existing trails are a higher priority.

On the Senoia side, the city is in the midst of a trail project that will connect the Cumberland subdivision to the Cumberland Village shopping area. The city is also busy with stormwater projects, a future sewer upgrade and the long-awaited intersection improvement at Pylant Street and Hwy. 16, as well as plans for a trail to connect Seavy Street and Ivy Ridge.

“It’s just not a good time for us to try to fit that in,” Simmons said. The Peachtree City connection is a long-term project, he said. A lack of county funding is no longer seen as a problem.

As for the outdoor market, the city council has opposed the market because it conflicts with the city’s rules on open-air markets. A four-month moratorium on open-air markets that are not held on an improved parking lot was put in place in June.

“The citizens have spoken in favor of the return of the downtown farmers and outdoor market,” Pengelly said in an email Friday. “The ‘grandfathered’ Senoia Outdoor Marketplace looks forward to returning downtown once the moratorium is lifted.”

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Are You Ready to Visit Peachtree City?

Most people really don’t think much about Georgia when it comes to taking a vacation. Yet, the Georgia coast is quite beautiful and the weather is warm enough to help keep you comfortable when the temperatures are colder up north. That being said, most people don’t visit Georgia to stay unless they are visiting relatives.

If you have not really considered Georgia as a travel destination, you must never have researched Peachtree city. It is a vacation destination that you certainly would want to consider. In fact, it was nominated by Money magazine as one of the best small towns to live in but even if you don’t live there, a visit is still going to help you to slow down and enjoy life.

One of the interesting things about Peachtree city is the fact that there are golf carts everywhere. In fact, there are green belts throughout the area and around a number of lakes that span some 90 miles. These are golf cart paths and you can slow down and take a look at all that the area has to offer from one of those motorized carts.

In addition to seeing life at 15 miles an hour, you also be able to visit some of the most beautiful lakes that the United States has the offer. There are two lakes as well as 3 different golf courses that are world-class. Recreational activities are certainly not limited in the area and regardless of whether you enjoy fine dining, a day out shopping or staying at a luxury hotel, you are sure to enjoy what it has to offer.

Peachtree city is located only 26 miles to the south of Atlanta and it is easily accessible. Why not stop by for a visit this year? You won’t regret it!

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Say goodbye to Lake Peachtree again

Lake Kedron to be lowered some also

The Lake Peachtree spillway and dam project is about to get underway. The best way to keep up with the lengthy project is now located on the Peachtree City website.

Located on the homepage at www.peachtree-city.org, City Clerk Betsy Tyler provides a comprehensive look at the project and its various phases.

Above, a view of Lake Peachtree during dredging in 2014. File photo.

As for the current status of the project, bidding is underway and the work to begin lowering the lake for the construction of the spillway will begin on Aug. 28.

City council members at the Aug. 3 meeting were told that seven of the eight pre-qualified bidders attended the conference on the project. An award recommendation for the spillway and dam project is expected at the Aug. 17 council meeting.

The project is expected to see substantial completion, when the lake can begin filling, in May 2018, said City Manager Jon Rorie.

The multi-phase project, estimated to run approximately $4 million, will include a $2 million contribution from Fayette County.

The construction phase of the project comes with seven stages.

Stage 1 begins Aug. 28 with the initial lowering of Lake Peachtree by eight feet.

Stage 2, in September-October, will see the construction of the temporary coffer dam on the lake’s south side.

Stage 3, in November, will have Lake Kedron lowered two feet and Lake Peachtree raised two feet.

Stage 4, during December-February, will include construction of the new spillway foundation.

Stage 5, in February, will possibly raise Lake Peachtree another two feet.

Stage 6, during March-May, will have the new spillway, called a piano key weir, constructed.

Stage 7, during May and June, will return Lake Peachtree and Lake Kedron to full pool.

A section of cart path along Kelly Drive near the spillway will be closed when construction begins. Detour routes with applicable signage will be posted throughout the affected areas.

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VIDEO: Peachtree City Little Leaguer smashes monster grand slam on ESPN

WARNER ROBINS, Ga. – The team from Peachtree City is just two wins away from a trip to Williamsport and the Little League World Series.

But it’s video of one of the players hitting a monster homerun that has the entire baseball world buzzing.

Jayce Blalock, who stars on the Peachtree City National LL team, hit a grand slam during Sunday’s 14-2 victory that cleared the fence by what looked like a mile.

Video of the 13-year-old’s grand slam — estimated by announcers as 375 feet — posted on Little League’s official Facebook page has been viewed more than 1 million times!

If Peachtree City National LL wins Monday and Tuesday, they’re headed to Williamsport. And you can imagine all eyes will be on Blalock and his power bat.

Channel 2’s Berndt Petersen is in Warner Robins for today’s game. WATCH Channel 2 Action News at Noon for a LIVE report.

© 2017 Cox Media Group.

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