A new Alzheimer’s drug tested on patients in Charleston just received fast-track approval from the Food and Drug Administration, raising the hopes of patients and families not only for treatment but potentially for prevention of a devastating disease. But advocates are balking at a list price of more than $26,000 annually and severe restrictions on Medicare coverage for it despite promising results.

The FDA granted Accelerated Approval to lecanemab-irmb, which will be marketed as Leqembi, a little more than a month after the announcement of promising results from a research trial for the drug, which is part of clinical trials at the South Carolina Institute for Brain Health at the Ralph H. Johnson VA Health Care System in Charleston.

“Isn’t that great?” said Mary Hewett of Mount Pleasant, whose husband, Ken, took part in the study.

The drug slowed cognitive decline by 27 percent over an 18-month period compared with placebo but also visibly reduced the amount of amyloid plaque, thought to contribute to the damage, in the brains of patients. That’s what makes this drug different, said Dr. Jacobo Mintzer, who leads the Charleston arm of the drug studies at the brain institute.

“It’s the first study that showed positive results in terms of clinical outcomes and biological outcomes,” he said. “And there was a very strong correlation between the two of them.”

Previous drugs seemed to reduce the amyloid but did not seem to improve function, Mintzer said.

The drug is “the most promising we’ve seen in a long time,” said Beth M. Sulkowski, vice president of communications for the Alzheimer’s Association, South Carolina Chapter, which pushed for fast-track approval. “The data we feel stand for themselves. It is not going to be the silver bullet, but there are demonstrated benefits for people who are living with early and mild Alzheimer’s-type dementia. Those people don’t have a lot of time to wait.”

But the association is decrying a decision by the Centers for Medicare and Medicaid Services to limit coverage for this class of medications to people on Medicare who are enrolled in a clinical trial. The agency came up with that decision last April in response to a similar drug, Aduhelm, which also uses a monoclonal antibody to target amyloid plaques but with less promising clinical results. The association filed a formal request with CMS last month to reconsider its decision, and there are signs the agency is ready to do that. CMS issued a statement once the new drug was approved acknowledging the recent evidence and “may reconsider its current coverage based on this review.”

That, Sulkowski said, is “the right move and we hope that it will result in access sooner rather than later.”

That could be critical for many patients because Eisai, the company that helped develop the drug, said the initial price would be $26,500 annually. The company estimated a market of about 100,000 patients in the U.S. in the first few years. There are 95,000 people in South Carolina living with Alzheimer’s disease, but how many are in the mild or early stage that the drug has been approved for is unclear, Sulkowski said.

Veterans are another important category of Alzheimer’s patients. There are 750,000 or more just within the VA system, although how many are in the early stages is unclear, Mintzer said. The VA has been “very thoughtful” about how it approaches treatment for those patients and will likely have guidelines for how they can receive the new drug, he said.

“I think the VA will make it available under specific conditions,” Mintzer said.

Testing is ongoing and the VA brain institute is also taking part in the AHEAD study, which is testing the drug in those at high risk who already have amyloid in the brain but are not yet experiencing memory loss, in hopes of preventing it.

“That’s what will be the game-changer,” Mintzer said, if it pans out.

Ken Hewett is receiving the drug as part of a longer study on the drug’s effectiveness and safety. He doesn’t know if he received the drug or placebo during the original study but he is definitely getting it now, his wife said. And the good news is he is the same, she said.

“No new problems,” Mary Hewett said. “Everything seems status quo, which is good.”

Berkshire Hathaway HomeServices Carolina Sun Real Estate recently hired two real estate agents to its Mount Pleasant office.

Brenda Bryant is originally from Greenville, N.C. and she has a degree from the University of South Carolina Aiken. Bryant lived in the Aiken area for 10 years, then Columbia for 10 years and now has been living on Mount Pleasant for the past 10 years, as well. Bryant has several interests that include genealogy, and buying and selling home décor collectibles.

Bryant also has a passion for real estate and truly enjoys finding her buyers the perfect property. She also has had tremendous success in successfully marketing and selling homes for her seller clients.

Bryant can be reached at (252) 364-6568 or breniznew@gmail.com.

Courtney Vorachek has lived in Charleston for nearly a decade and has used her local status to become one of the premier real estate agents in the tri-county area. Vorachek’s passion for real estate was ignited

when she first moved to Charleston and started to explore the uniqueness of the Lowcountry. Charleston has many different communities to offer, from the beaches to the peninsula, and Vorachek seamlessly guides prospective buyers to the location that checks all of their boxes. Whether a primary residence or a vacation home, she

thrives on helping clients find their perfect place. Vorachek is known for her first class service, client-centered relationships and unmatched negotiation skills. Vorachek mindset is always centered around business and she works relentlessly to ensure her clients complete satisfaction throughout the entire process.

In addition to loving her career in real estate, Vorachek has a passion for fitness and owns The Barre Code in Mount Pleasant. She loves all that Charleston has to offer and in her free time she enjoys exploring the many wonderful restaurants, beautiful beaches,

amazing golf courses and any country concert she can find locally. Also, she loves dogs, especially golden retrievers.

Reach Vorachek at (843) 817-3148 or courtney@bhhssun.com and visit her website at courtney.myhomecharleston.com

It’s no secret that business is booming in Mount Pleasant, with ribbon-cutting and groundbreaking ceremonies happening left and right. The Town of Mount Pleasant recently hired Matt Brady as the new economic development manager at the start of November. It will be his responsibility to support business growth and development in the town.

Brady is the first and only person in the municipality focused solely on economic development, a role that was previously the job of several town staff members, with no one dedicated to the job full-time. Before this role, he worked as the economic development director for the City of Goose Creek for five years and was the first person to serve the city in that role, too.

“With Matt and his talent working this strategy every day, we hope that it’s going to make Mount Pleasant an even more dynamic place to live and do business,” said Mount Pleasant Town Administrator Eric DeMoura. “The business community is of extreme importance to us and we want to do everything we can to support it.”

Brady will be responsible for implementing the key needs of the town as identified by the economic development strategy, developed by third-party consulting firm SB Friedman earlier this year.

At the top of the list was attainable housing, and attracting and attaining good, high-paying jobs. According to the economic development strategy, only 26% of town residents work within Mount Pleasant.

“One of the simplest definitions of economic development is wealth creation distributed equitably. That’s what we want to do. It’s a cliché, but a ‘rising tide lifts all boats,’” Brady said. “We want people who have to leave town to work their job to be able to slash the commute and work at a wonderful, good-paying, good benefits firm right here in town.”

The undeveloped Faison Road property, purchased by the Town for roughly $6.5 million in 2021, has been at the center of the attainable housing question. A handful of firms submitted plans for the property in September, a majority of them including plans for attainable housing units. Brady will be the town’s “chief representative” in selecting a group or firm to develop the property, DeMoura said.

The project has not yet been awarded to a firm, though three firms presented their proposals to the council in a special town council meeting on Nov. 1. Brady, who serves on a technical committee for the Charleston Metro Chamber of Commerce’s attainable housing coalition, said that attainable housing isn’t an issue exclusive to Mount Pleasant.

“Attainable housing is a question that is kind of swirling around the entire region,” Brady said. “Being able to support your workforce in that way is an important component of economic development and it will continue to be a very important part of economic development.”

A major part of Brady’s job will be attracting high-paying jobs to Mount Pleasant, as well as being a resource for already-established businesses in the town. The economic development strategy targets jobs in the informational technology (IT) and life sciences sector as desirable industries to bring to Mount Pleasant. Brady said he also wants to focus on entrepreneurship and innovation.

“I think it’s important to recognize that we have a lot of great businesses that are in town already. We truly appreciate them, and the Town is here as a resource for them as well. That goes for small businesses up to large firms that have hundreds of employees. We want to do everything we can to help them grow and expand their presence in Mount Pleasant,” Brady said.

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The Dec. 30 Post and Courier article on the massive Cainhoy Plantation development is journalism at its best. Reporter Clare Fieseler clearly explained what the developer is proposing and the extensive negative impacts it would have on wildlife and the environment.

The article also provides helpful background on the origins and rationale of the federal regulatory programs enacted in the 1970s to protect wetlands and endangered species such as those with which this property is richly endowed. As the article indicates, the extent of destruction approved on Cainhoy is virtually unprecedented during the half-century that these laws have been in place.

The 9,000-acre development, now rebranded “Point Hope,” was annexed into the city of Charleston in 1996 by Mayor Joe Riley (who defended the project in an October op-ed). The owners have subsequently benefited from tens of millions of dollars in public funding — for new and widened highways, emergency medical service facilities, public schools, fire stations, sewer and water lines and other value-enhancing amenities.

Taxes flowing from Charleston and from Berkeley County citizens, from South Carolina taxpayers and from the federal government have all converged to make what was formerly a rural timber and sporting tract now worth hundreds of millions of dollars. The destruction proposed by the developers would be unacceptable under any circumstances, but the scale and extent of public financial support underpinning the Cainhoy project make the developers’ callous disregard for the environment especially offensive.

For years, conservation groups have attempted to work with the owners to achieve a positive resolution that respects the environment and also meets their financial goals. The Coastal Conservation League commissioned Dover Kohl & Partners, an award-winning designer of I’On in Mount Pleasant, to produce a plan that envisions the developer building the same number of houses but dramatically reducing the damage to wetlands and wildlife habitat. However, as Chris DeScherer with the Southern Environmental Law Center explained, the developers rebuffed that proposal, along with every other effort to work collaboratively toward a positive outcome. They continue to allege that the project, as planned, with the destruction of almost 200 acres of wetlands, represents “smart growth.”

In addition to the ecological destruction of one of the most beautiful parts of the Lowcountry, this project would add tens of thousands of vehicles to roads that are already terribly congested. If the development proceeds as proposed, current residents who travel to North Charleston and Mount Pleasant, and employees who commute to the Cainhoy peninsula for work, will find their trips dramatically worsened.

The project also is one more threat to the survival of the historic Jack Primus community, whose leader (and former Conservation League board member) Fred Lincoln helped guide the effort against the Global Gateway port proposal in the late 1990s. The community is already flanked on the south and southeast with a wall of shipping container yards, warehouses, gas stations and fast-food restaurants, a shameful testament to the lack of concern for this historic neighborhood.

As we move into the New Year, marking the 50th anniversary of the Endangered Species Act and the 51st anniversary of the Clean Water Act, it is discouraging to think that a project such as Cainhoy/Point Hope could have progressed as far as it has. How federal agencies responsible for protecting the environment could approve a permit that condones such unprecedented damage to the natural and cultural heritage of this area is inexplicable.

However, thanks to the persistence of four nonprofit conservation groups — the Coastal Conservation League, the Southern Environmental Law Center, the Charleston Waterkeeper and the S.C. Wildlife Federation (organizations that are collectively supported by tens of thousands of individuals and private foundations) — there remains an opportunity to overturn this egregious approval and move the project back to the drawing board. Perhaps then we’ll see a new design that will better meet the needs of people and nature at Cainhoy.

Dana Beach is a conservationist and Charleston resident.

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MOUNT PLEASANT, S.C. (WCBD)- Neighbors from Belle Hall, Grassy Creek and Tidal Walk are in opposition to all six of the possible plans to redesign the Long Point Road and Interstate 526 interchange.

Concerns were voiced on Tuesday at Mount Pleasant Town Hall with Mayor Will Haynie and councilmembers present.

“One of the major concerns with all the alternatives is that it closes off Belle Hall Parkway as an entrance to over 1,200 homes,” said Daniel Senden, a Grassy Creek Neighbor. “Closing (Belle Hall Parkway) off would exacerbate that problem by creating more traffic in other avenues that would cause a sincere safety concern for every resident.”

Neighbors don’t want some of the options to be approved because the construction of a flyover bridge will harm their communities. A handful of homes would have to be demolished if the flyover is built.

“Alternatives 2 and 6 also have a flyover bridge, a new interchange on I-526 in Mount Pleasant,” said Senden. “Putting that interchange directly in front of our neighborhood will be a major safety concern for us.”

The South Carolina Department of Transportation (SCDOT) is collecting and listening to feedback from neighbors about the plan. SCDOT says that they will draw up new plans if needed.

“We probably wouldn’t add new alternatives unless something comes to light that we haven’t looked at before. But, we would refine them at this point to make them better and address the communities concerns,” said Joy Riley, the Project Director for SCDOT.

The State Ports Authority (SPA) uses the interchange for trucks to drive into the Wando Welch Terminal every day and is in favor of helping the traffic congestion.

“Having a dedicated road between I-526 and Wando Welch Terminal would provide direct access for container trucks carrying cargo. This would enhance safety and traffic fluidity for both the port and the community by having a large majority of truck traffic separated from residential traffic,” said Kelsi Brewer, an SPA spokesperson.

Neighbors like Angie Anderson are in favor of options like those being considered before redesigning the whole interchange.

“There’s stages that I think need to be looked at instead of pushing all these alternatives and all this money spent right off the bat without knowing if they’re effective,” said Anderson.

Councilmember Gary Santos thinks that the SPA could help the issue by using more barges instead of trucks to transport cargo from one terminal to another.

“When you have cargo that’s going to a certain port that doesn’t have to leave out of Charleston you’d put them on barges and send them over to North Charleston where they can load them out of ships there and go out of there. If you have ships calling at the Wando terminal then they can put that cargo on barges in North Charleston and send those over,” said Santos.

Neighbors along Long Point Road are staying positive while the SCDOT continues to sift through public comments.

“We want to continue to meet with the SCDOT. We want to continue to meet with the town and really work on a solution that benefits everybody,” said Senden.

The hope of Riley and her team is to have a public hearing in a year to decide what the plan is for construction.