Metro

Mail order teeth aligners are controversial. Now they have an unlikely promoter at Boston Children’s

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The founders of SmileDirectClub became billionaires on the strength of a compelling pitch to anyone with a less-than-perfect smile: You can straighten your teeth at home, without ever visiting an orthodontist, for a third of the price of braces.

Just go to your neighborhood SmileShop — there are 10 in Massachusetts — for a 3-D scan of your mouth and, voila, the company will ship custom teeth aligners straight to your home.

But there’s precious little research into the safety of mail-order orthodontics and, in recent years, problems have cropped up. Some SmileDirect customers complained of cracked or misaligned teeth from their new orthodontics, as well as chronic jaw pain. BuzzFeed News reported in October 2017 that dentists were “waging a war” against the company, as the American Association of Orthodontists filed complaints in 36 states alleging SmileDirect’s treatment was unsafe.

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Then, just as state regulators across the country looked to clamp down on SmileDirect and similar companies, an influential Boston orthodontist came to the rescue of the controversial industry. Dr. Marc Ackerman, director of orthodontics at Boston Children’s Hospital and an assistant professor with Harvard School of Dental Medicine, launched an organization dedicated to defending “teledentistry” and published research vouching for the safety and effectiveness of SmileDirect’s products.

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“I want to be the father of teledentistry,” Ackerman declared in an interview with the Globe.

Now Ackerman is at the center of a growing controversy. One person who identified himself as a dentist sent a written complaint in September to the president of Harvard and to numerous employees of Children’s and Harvard Dental School alleging Ackerman cut corners and violated ethics standards in his research.

Earlier, in 2018, the Massachusetts Board of Registration in Dentistry investigated allegations that Ackerman and other dentists were violating Massachusetts regulations and providing substandard care by using SmileDirect’s technology. (The board took no disciplinary action.)

And he’s the target of scorn from some colleagues who view this new industry as predatory and reckless. One Texas orthodontist wrote to Ackerman on Facebook: “How you live with yourself I have no idea but in the end I hope there is a final judge up above who will call your utter bull---- out for eternity.”

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Ackerman, a third-generation orthodontist who promotes his reputation as an “enfant terrible” of the field, said the controversy only shows that SmileDirect and other mail order companies are threatening the orthodontists’ turf. His critics, he said, are worried about losing money.

He pointed out that he, on the other hand, receives no pay for his work as founder and leader of the American Teledentistry Association.

As for the reports of bad outcomes, Ackerman said people can be hurt by traditional orthodontics, too. The bigger issue, he said, is that many people of modest means can’t afford traditional orthodontics.

“I do this because I’m passionate about it and it’s making a difference” by expanding access to orthodontics for the “have nots,” he said.

But his critics see something darker: an academic advocating for an unproven medical product sold by a company with which he has numerous ties.

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Ackerman acknowledges that he has received financial benefits from SmileDirect, including payment for expert testimony, fees for treating patients using SmileDirect’s digital platform, and valuable medical equipment. And SmileDirect acknowledges donating $176,000 over the past two years to Ackerman’s nonprofit, which he runs from his home.

Plus, as the only prestigious academic prominently defending SmileDirect, he has become a valuable ally to the company’s wealthy founders and investors.

The author of the complaint to Harvard was particularly incensed at Ackerman’s pro-SmileDirect research. Although Ackerman has a history of publishing research in prestigious academic journals, he submitted this study to a comparatively obscure publication, the Journal of Dental Research and Reports, which promises speedy peer review and publication in exchange for payment from the author. Ackerman’s article was published just two weeks after submission, a fraction of the time for review at mainstream journals.

In the article, which favorably reviewed the results of SmileDirect treatment, Ackerman decries confusion about tele-orthodontics that “has unfortunately negatively influenced orthodontists, state dental boards, and the lay public.”

The complainant was signed by name, but the Globe was not able to verify his identity. He also did not return repeated requests for an interview sent to the e-mail address he included in his complaint. People at Children’s and Harvard confirmed receiving copies of the complaint, which has fueled debate at both institutions.

Ackerman said he published his paper in a journal some academics look down on because he believed his work would not get a “fair shake” in a mainstream publication. He stood by his decision not to disclose financial ties to SmileDirect in the article, as is common practice in academic research, because, he said, he wasn’t paid for this research and he designed the study himself.

“I wasn’t biased,” he said, “because I did it my way.”

All this is stirring up debate and concern among dentists at Harvard and Boston Children’s who have passed around copies of the complaint sent to Harvard president Lawrence Bacow, Children’s chief executive Sandra Fenwick, and other medical leaders.

Dr. Mohamed Masoud, the director of the orthodontics program at Harvard Dental School, sent an e-mail to the complaint’s author thanking him for sending it. Later, Masoud told the Globe, “All of us are concerned. The direct-to-consumer business model is dangerous.”

Process comes under fire

Few countries are more concerned about straight teeth than the United States, where more than 5 million people are wearing braces or teeth aligners right now.

But orthodontics are expensive —in some cases $5,000 to $7,000 — and often not covered by insurance.

Today, there’s a whole industry devoted to discount aligners led by SmileDirect.

Founded in 2014 by two twentysomething entrepreneurs with no background in dentistry, SmileDirect cut out the middle man — the orthodontist — to dramatically reduce costs. The result: SmileDirect treatment costs $1,895.

The concept was a hit with many consumers. Some Facebook groups contain hundreds of photos of newly straightened teeth. “Y’all!!!!!!,” wrote one customer, whose SmileDirect aligners closed a gap between her front teeth. “I’m AMAZED!!!!”

But Ackerman’s disputed paper is virtually the only research vouching for direct-to-consumer orthodontics. And social media is awash in stories of SmileDirect customers who feel taken advantage of.

Take Lauren Squitieri, for example. She visited the SmileShop near her home in Boca Raton, Fla., where a “SmileGuide” — often a former dental assistant — went over her options, discussed payment, and then used a wand to make a digital scan of her mouth. Soon, the 15-year-old received a box of custom aligners and downloaded an app that told her how long to wear each one.

Within a month, though, she began suffering from blinding headaches, her mother, Beth Kaufman, said. Then, in March, her upper second premolars, on the left and right sides, cracked.

A local dentist, Dr. Alan Slootsky, extracted the cracked teeth, drilled implants in their place, and discovered five additional teeth with cavities.

Slootsky told the Globe that Squitieri’s teeth, which were weakened by substantial decay, cracked due to a lack of proper screening and monitoring.

“Decay should always be taken care of before orthodontics,” he said. But SmileDirect does not perform an in-person dental examination to ensure all is clear.

Instead the company requires customers sign a document saying they have recently undergone a comprehensive dental exam elsewhere. Squitieri had not, but Kaufman signed the document anyway because, she said, she didn’t read it closely.

All told, the dental bill came to $12,435, which Kaufman paid out of pocket. “I feel duped,” she said.

In Massachusetts, SmileDirect has faced numerous formal complaints, including a dozen filed by consumers and dental organizations with Attorney General Maura Healey. In one August letter to Healey, the Massachusetts Dental Society detailed seven bad outcomes — ranging from botched diagnoses to misaligned bites — allegedly caused by direct-to-consumer aligners.

A spokesperson for Healey said her office is reviewing the complaints.

And those cases may be only a fraction of the total, since Massachusetts practitioners report a steady stream of patients turning up in their offices with SmileDirect-related complaints.

Orthodontist Maarten Broess grew alarmed after seeing three patients at his Boston and Brookline practices who were undergoing SmileDirect treatment without having X-rays first, a basic component of an orthodontic workup, Broess said. One patient had severe periodontal disease, which meant he could lose teeth if he continued the treatment.

Dr. Bill Bebrin, a North Shore orthodontist, saw a patient whose SmileDirect aligners had distorted her bite, requiring almost $7,000 of additional dental work.

It’s unclear how many SmileDirect customers have experienced similar complications due, in part, to SmileDirect’s aggressive legal tactics. The company has a history of suing critics and it requires customers to sign nondisclosure agreements — with a $10,000 penalty for speaking out — to secure a refund when things go wrong.

The company has also taken an aggressive stance with the state dental society, sending a letter in December demanding it “cease and desist from making further defamatory statements.”

Jeffrey Sulitzer, SmileDirect’s chief clinical officer, told the Globe that teledentistry exams, such as those conducted over SmileDirect’s platform, “are as efficacious if not even more efficient and safe than an in-person exam,” and cited the teledentistry research of Dr. Paul Glassman of the University of the Pacific School of Dentistry to bolster his statement.

But when he was reached by the Globe, Glassman pointed out major differences between the rigorous teledentistry screening process he tested — which included X-rays and an in-person examination for every patient — and SmileDirect’s online screening protocol.

“The more you deviate from that system [we tested],” Glassman said, “the less you could claim that you’re following the standard of care.”

Sulitzer said that SmileDirect meets the standard of care by having “state-licensed doctors managing, prescribing, and directing the care from the very beginning to the very end.” Indeed, licensed dentists do review photos and scans of SmileDirect customers’ mouths and can edit treatment plans before approving them. Sulitzer also said that dentists can request X-rays when necessary and that they check on patients’ progress every three months.

But Kaufman, the mother in Boca Raton, said she never had any contact with the dentist assigned to her daughter’s case, even after she alerted the company to Squitieri’s problems.

Although he could not produce any studies, besides Ackerman’s, about SmileDirect’s treatment, Sulitzer insisted the company is delivering a substantial benefit to consumers.

“We’re providing access to care and convenience at a significantly lower cost,” he said. “In the end, it’s all about treating 750,000 people who are smiling a lot brighter today than they did before they started with SmileDirectClub.”

Company faces complaints

Long before the advent of direct-to-consumer orthodontics, Ackerman was a widely published academic with a taste for challenging his industry’s received wisdom. In peer-reviewed articles and a notable book, he argued that orthodontists have overstated the health benefits of orthodontic treatment and should focus on what their patients really wanted: a better-looking smile.

Ackerman jumped into the SmileDirect debate right after the BuzzFeed story reported that orthodontists had raised the alarm about the company. To Ackerman, orthodontists were just trying to kneecap a competitor. And, as the leading orthodontist at the nation’s top pediatric hospital and a professor at Harvard, Ackerman knew that his word carried weight.

But Ackerman stumbled almost immediately: Shortly after he formed the teledentistry association, the organization’s address was listed in state filings as being the same as SmileDirect’s headquarters. Ackerman and SmileDirect both claim this was a mix-up — caused by a paralegal’s error. But Ackerman’s advocacy for direct-to-consumer orthodontics, which closely parallels SmileDirect’s own efforts, has raised doubts about his independence.

In New Mexico this year, Ackerman lobbied for a bill to expand the definition of teledentistry. He said the state’s large rural population made it a perfect lab for teledentistry generally, not just for SmileDirect.

But the bill Ackerman promoted was virtually identical to one that SmileDirect’s Sulitzer had unsuccessfully pushed in 2018.

This year, though, with Ackerman as the lead advocate, legislators passed the bill, which would have made it easier for out-of-state dentists to treat New Mexico residents using teledentistry platforms, such as SmileDirect’s. “I think the legislators attached a certain legitimacy to the American Teledentistry Association,” said Tom Schripsema, executive director of the New Mexico Dental Association, which opposed the bill.

New Mexico Governor Michelle Lujan Grisham eventually vetoed it, writing that it “simply does not strike the right balance between access to dental care and patient safety.”

Ackerman has also served as a consultant to SmileDirect in its disputes with the dental boards of Alabama and Georgia, according to SmileDirect’s general counsel Susan Greenspon Rammelt.

At other times, Ackerman has defended the company to the press, written essays promoting the direct-to-consumer business model, and heralded SmileDirect’s legal victories and new business deals on the teledentistry association’s website.

SmileDirect insists its lobbying efforts are not coordinated with Ackerman’s organization. “The ATDA has its own legislative efforts that they have taken up independently,” Greenspon Rammelt told the Globe.

Ackerman echoed SmileDirect, saying he had no idea his lobbying campaign followed SmileDirect’s own push for virtually identical legislation.

“I am not a shill for SmileDirect,” Ackerman said.

Although Ackerman declined to detail the sources of the association’s income, SmileDirect confirmed that it is a substantial donor, giving $176,000 in 2018 and 2019. Only one other company listed as a “partner” of the association, a SmileDirect competitor called Candid Co., acknowledged donating money, in the form of $5,000 annual membership fees.

Some of Ackerman’s peers have come to regard his advocacy for SmileDirect with suspicion, including one, Dr. Larry White, an orthodontist in Texas, whom Ackerman said he respects. White was listed on the website of the journal where Ackerman published his SmileDirect research — a fact that Ackerman suggested boosted his confidence in the journal’s legitimacy.

But when contacted by the Globe, White said he had never heard of the journal and had no idea why his name and photo were on its website. He added that Ackerman was a “nice fella” and “probably a good clinician,” but that his articles and blog posts about SmileDirect were “sketchy.”

Another leading orthodontist and emeritus professor at the University of Manchester in England, Dr. Kevin O’Brien, went further. In a blog post, O’Brien questioned the reputation of the journal where Ackerman published his study. And he argued Ackerman improperly combined the data for two different kinds of measurements — “crowding” and “spacing”— rendering his data “meaningless.” Ackerman conceded that this critique of the way he handled these measurements might have merit.

It is unclear if Harvard or Boston Children’s has responded to the complaint against Ackerman. A Harvard Dental School spokesperson told the Globe, “If there was an investigation into [Ackerman], it would go through Children’s.” A hospital spokesperson said it “does not comment on issues related to staff members.”

As Ackerman has come under fire, so has SmileDirect. This year the American Dental Association filed complaints with the Food and Drug Administration and the Federal Trade Commission alleging that SmileDirect’s business model posed a danger to the public and ran afoul of federal regulations. (SmileDirect dismissed the allegations as “misleading” and “untrue” and the FDA denied the ADA’s request to shut down SmileDirect’s business.)

And, since SmileDirect began trading on the stock market in early September, California has passed restrictive teledentistry legislation, a Nashville law firm representing SmileDirect customers has filed a class action lawsuit, and one Wall Street researcher has published a scathing report about SmileDirect’s alleged shoddy practices. The stock price has plummeted, depriving the company’s founders of their new billionaire status.

But SmileDirect has pressed on. The company is opening hundreds of SmileShops inside Walgreens and CVS stores and it is expanding into international markets, including England and Australia. In a recent call with investors, chief executive David Katzman said SmileDirect had only just begun to realize its “mission to democratize access to a smile each and every person loves.”

Mike Damiano can be reached at mdamiano@
protonmail.com
.