Brett Kelman and Anna Werner, CBS News
Mon, 13 May 2024 11:30:00 +0000

The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.

According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn't require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.

The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult's jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.

Two former FDA officials said the AGGA was likely able to stay on the market — and off the FDA's radar — for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

“That's a red flag for me. If I don't see a single report to the FDA, I typically think there is something going on,” Kinard said. “When they don't report, what you have is devices that stay on the market much longer than they should. And patients get harmed.”

Johns Dental Laboratories declined to comment when reached by phone and its lawyers did not respond to requests for an interview. The family-owned company, which has operated since 1939 in the western Indiana city of Terre Haute, sells dozens of products to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.

Twelve of Johns Dental's products are registered with the FDA as Class II medical devices, meaning they carry at least a moderate risk, and some have been featured on the company website for at least two decades, according to screen captures preserved by the Internet Archive.

The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental's other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella's exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental's total sales revenue.

In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella's company a “royalty” of $50 to $65 for every sale.

“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella's specifications,” she said, according to a deposition transcript.

The FDA's lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time, it was not required to inspect Johns Dental until 2018 when the company registered as a “contract manufacturer” of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a “dental laboratory,” which normally do not manufacture their own products and only modify devices made by other companies to fit dentists' specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.

Kinard said that based on her experience at the FDA she believes the agency prioritizes medical devices over dental devices, which may have contributed to the lack of inspections at Johns Dental.

“There hasn't been much attention to dental devices in the past,” Kinard said. “Hopefully that's going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.”

The AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application. Last year, the KFF Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone — and some said they'd lost teeth. Multiple dental specialists said in interviews that they had examined AGGA patients whose teeth had been shoved out of position by the device, sometimes causing tens of thousands of dollars in damage.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who published research on AGGA patients that appeared on a National Institutes of Health website. “It doesn't grow the jaw. It doesn't widen the jaw. It just pushes the teeth out of their original position.

Johns Dental and Galella have negotiated out-of-court settlements with the original 20 AGGA plaintiffs without publicly admitting fault. At least 13 more AGGA patients have filed similar lawsuits since the KFF Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.

Galella declined to be interviewed in 2023 and neither he nor his attorneys responded to recent requests for comment. One of his attorneys, Alan Fumuso, said in a 2023 statement that the AGGA “is safe and can achieve beneficial results” when used properly.

In the wake of the KFF Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.

Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA's website shows that Johns Dental was issued seven citations, but the substance of the agency's findings was not known until the inspection report was obtained this year.

FDA investigator David Gasparovich wrote in that report that he arrived unannounced at Johns Dental last July and was met by five attorneys who instructed employees not to answer any questions about the AGGA or the company's complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.

“He asked if he could photograph my credentials,” Gasparovich wrote in his report. “This was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.”

The FDA requires device companies to investigate product complaints and submit a “medical device report” to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich's inspection report states that Johns Dental had “not adequately investigated customer complaints,” and its complaint policies were “not adequately established,” allowing employees to not investigate if the product was not first returned to the company.

Johns Dental received four complaints about the AGGA after the KFF Health News-CBS News report, including one that came after the FDA announced “safety concerns” about the device, according to the inspection report.

“Zero (0) out of the four (4) complaints were investigated,” Gasparovich wrote in the report. “Each complaint was closed on the same day it was received.”

In the months after Gasparovich's inspection, Johns Dental sent letters to the FDA saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address other FDA concerns, according to the documents obtained through FOIA.

Former FDA analyst M. Jason Brooke, now an attorney who advises medical device companies, said the FDA uses an internal risk-based algorithm to determine when to inspect manufacturers and he advises his clients to expect inspections every three to five years.

Brooke said the AGGA is an example of how the FDA's oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don't report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.

When a company “doesn't follow the law,” Brooke said, “the FDA is in the dark.”

“If there aren't complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there's just a dearth of information for the FDA to consume to trigger an inspection,” Brooke said.

CBS News producer Nicole Keller contributed to this article.

——————————
By: Brett Kelman and Anna Werner, CBS News
Title: FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device
Sourced From: kffhealthnews.org/news/article/fda-inspection-johns-dental-agga-device/
Published Date: Mon, 13 May 2024 11:30:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/san-francisco-tries-tough-love-by-tying-welfare-to-drug-rehab/

Ronnie Cohen
Mon, 13 May 2024 09:00:00 +0000

Raymond Llano carries a plastic bag with everything he owns in one hand, a cup of coffee in the other, and the flattened cardboard box he uses as a bed under his arm as he waits in line for lunch at Glide Memorial Church in San Francisco. At 55, he hasn't had a home for 15 years, since he lost a job at Target.

Llano once tried to get on public assistance but couldn't — something, he said, looking perplexed, about owing the state money — and he'd like to apply again.

But beginning next year, if he does, he'll face a new city requirement that single adults with no dependents who receive cash benefits be screened for illegal drug use and, if deemed necessary, enter treatment. San Francisco's voters approved the new mandate in March.

Llano has no objection to being screened. He said he uses cannabis, which is legal in California, though not federally, but does not use other drugs. Nonetheless, he said, “I suppose I would try recovery.”

Another man in the free-lunch line, Francis Farrell, 56, was far less agreeable. “You can screen me,” he said, raising his voice, “but I don't think you should force me into your idea of treatment.”

No one will be forced to undergo substance abuse treatment, nor will anyone be subject to drug testing, San Francisco officials insist. Rather, starting in January 2025, San Francisco's public assistance recipients who screen positive for addiction on a 10-question drug abuse test will be referred to treatment. Those who refuse or fail to show up for treatment will forfeit the $109 a month that the city grants to homeless adults who qualify for city shelters or supportive housing, or the $712 a month it grants to adults with home addresses.

The city famous for its tolerance is resorting to tough love.

Trent Rhorer, executive director of the San Francisco Human Services Agency, cited three reasons for the new measure, which was fashioned after similar policies in Los Angeles and New York: to incentivize people with a substance use disorder to enter treatment, to prevent taxpayer money from being used to buy illegal drugs, and to dissuade drug seekers from moving to San Francisco.

“We're giving them the opportunity to engage in something, without requiring sobriety, to hopefully get on a path to recovery,” Rhorer told KFF Health News.

When Mayor London Breed introduced the ballot initiative known as Measure F in a news conference last year, she called it an incentive to encourage drug-addicted recipients of public assistance to enter “into a program that will help save their life.” Accidental overdoses killed more than 800 people in San Francisco last year.

But in the eyes of many health care providers, researchers, and harm reduction advocates, the measure is neither an incentive nor an opportunity.

The policy was designed to have “a coercive, punitive effect” and could do more harm than good, said Vitka Eisen, president and chief executive of HealthRIGHT 360, San Francisco's largest drug treatment provider.

“It would have been an interesting project, much more in the spirit of San Francisco as a hub of innovation, to figure out if we can identify people with substance use disorder. And if they go into treatment and stay for a period of time, they'll get an increased benefit,” Eisen said.

About 5,800 people in the city currently receive benefits from the County Adult Assistance Programs, or CAAP. Under Measure F, those who acknowledge drug abuse on the screening test but refuse treatment and live in city-provided shelter will lose their cash benefits but can maintain their shelter, Rhorer said. However, CAAP recipients who refuse treatment and depend on public assistance to pay their rent in private housing could lose their homes.

The city will give recipients three chances to show up for treatment and will pay rent directly to a landlord for one month, Rhorer said. Measure F came in response to the grim conditions on some San Francisco streets, where men and women lie on sidewalks, often blocking passersby with their arms and legs splayed, or stand bent over, frozen like statues. Many use fentanyl, a synthetic opioid that has turned a long-standing homelessness problem into a public health emergency.

About 12% of people who fatally overdosed in San Francisco last year were CAAP recipients, Rhorer said.

Compassion fatigue seems to have settled over this city known for its kindheartedness. Measure F proponents raised $667,000 — more than 17 times as much as opponents — largely from business executives and tech investors, according to the San Francisco Ethics Commission. Then in March, 58% of voters approved the measure.

Since fentanyl began replacing heroin around 2019, Rhorer said, “drug tourists” have flocked to San Francisco, where the opioid has been cheap and plentiful. Lenient law enforcement and relatively generous cash public assistance grants also have drawn people with addiction, he said, although police activity has increased since last spring.

A recent city report found that only 53% of the 718 people whom police cited for substance use over a 10-month period that ended in February said they lived in the city.

“People who live in San Francisco, who really need the most help, don't get the help they need due to the influx of people coming from somewhere else,” said Cedric Akbar, who runs recovery programs and co-founded Positive Directions Equals Changes. “And should our tax dollars go to the ones in San Francisco, or are we going to take care of the whole country?”

Akbar began using heroin when he moved to San Francisco from Houston in the 1980s and has been in recovery for 31 years. He said he would have preferred even stricter requirements for eligibility for public assistance than those in Measure F but hopes the new mandate will at least help give people access to treatment.

The city's capacity for treatment is also a concern. Eisen and others describe a dire shortage of behavioral health workers to staff treatment facilities and residential step-down units, which are crucial for housing those in recovery from drug addiction.

New programs funded by the recently approved Proposition 1 in California, which authorizes the state to spend $6.38 billion to build mental health treatment facilities and provide housing for homeless people, are meant to address the shortages.

Leslie Suen, an addiction medicine physician and an assistant professor at the University of California-San Francisco, fears that pushing CAAP recipients into treatment could turn them off. When people “were stigmatized, or coerced, or told they would face consequences if they didn't do a certain thing,” she said, “that pushed them away from the health system even further.”

Though evidence suggests compulsory treatment can provide short-term benefits, it also can lead to long-term harm, the National Institute on Drug Abuse said in an email.

“To achieve the best outcomes,” the email said, treatment should be “delivered without stigma or penalty.”

Almost everyone with a substance use disorder enters treatment under some kind of pressure, whether from a parent, a spouse, an employer, or the criminal justice system, said Keith Humphreys, a Stanford University psychiatry professor.

Nonetheless, he questioned the morality of requiring welfare recipients, as opposed to criminals, to get drug treatment.

“I would never start with people who are poor but not committing crimes,” he said. “I would start with people who are harming others.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

——————————
By: Ronnie Cohen
Title: San Francisco Tries Tough Love by Tying Welfare to Drug Rehab
Sourced From: kffhealthnews.org/news/article/san-francisco-welfare-drug-rehab/
Published Date: Mon, 13 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/democrats-seek-to-make-gop-pay-for-threats-to-reproductive-rights/

Samantha Liss
Fri, 10 May 2024 09:00:00 +0000

ST. CHARLES, Mo. — Democrat Lucas Kunce is trying to pin reproductive care restrictions on Sen. Josh Hawley (R-Mo.), betting it will boost his chances of unseating the incumbent in November.

In a recent ad campaign, Kunce accuses Hawley of jeopardizing reproductive care, including in vitro fertilization. Staring straight into the camera, with tears in her eyes, a Missouri mom identified only as Jessica recounts how she struggled for years to conceive.

“Now there are efforts to ban IVF, and Josh Hawley got them started,” Jessica says. “I want Josh Hawley to look me in the eye and tell me that I can't have the child that I deserve.”

Never mind that IVF is legal in Missouri, or that Hawley has said he supports limited access to abortion as a “pro-life” Republican. In key races across the country, Democrats are branding their Republican rivals as threats to women's health after a broad erosion of reproductive rights since the Supreme Court struck down Roe v. Wade, including near-total state abortion bans, efforts to restrict medication abortion, and a court ruling that limited IVF in Alabama.

On top of the messaging campaigns, Democrats hope ballot measures to guarantee abortion rights in as many as 13 states — including Missouri, Arizona, and Florida — will help boost turnout in their favor.

The issue puts the GOP on the defensive, said J. Miles Coleman, an election analyst at the University of Virginia.

“I don't really think Republicans have found a great way to respond to it yet,” he said.

Abortion is such a salient issue in Arizona, for example, that election analysts say a U.S. House seat occupied by Republican Juan Ciscomani is now a toss-up.

Hawley appears in less peril, for now. He holds a wide lead in polls, though Kunce outraised him in the most recent quarter, raking in $2.25 million in donations compared with the incumbent's $846,000, according to campaign finance reports. Still, Hawley's war chest is more than twice the size of Kunce's.

Kunce, a Marine veteran and antitrust advocate, said he likes his odds.

“I just don't think we're gonna lose,” he told KFF Health News. “Missourians want freedom and the ability to control their own lives.”

Hawley's campaign declined to comment. He has backed a federal ban on abortion after 15 weeks and has said he supports exceptions for rape and incest and to protect the lives of pregnant women. Missouri's state ban is near total, with no exceptions for rape or incest.

“This is Josh Hawley's life's mission. It's his family's business,” Kunce said, a nod to Erin Morrow Hawley, the senator's wife, a lawyer who argued before the Supreme Court in March on behalf of activists who sought to limit access to the abortion pill mifepristone.

State abortion rights have won out everywhere they've been on the ballot since the end of Roe in 2022, including in Republican-led Kentucky and Ohio.

An abortion rights ballot initiative is also expected in Montana, where a Republican challenge to Democrat Jon Tester could decide control of the Senate.

On a late-April Saturday along historic Main Street in St. Charles, Missouri, people holding makeshift clipboards fashioned from yard signs from past elections invited locals strolling brick sidewalks to sign a petition to get the initiative on Missouri ballots. Nearby, diners enjoyed lunch on a patio tucked under a canopy of trees in this affluent St. Louis suburb.

Missouri was the first state to ban abortion after Roe fell; it is outlawed except in “cases of medical emergency.” The measure would add the right to abortion to the state constitution.

Larry Bax, 65, of St. Charles County, said he votes Republican most of the time but signed the ballot measure petition along with his wife, Debbie Bax, 66.

“We were never single-issue voters. Never in our life,” he said. “This has made us single-issue because this is so wrong.”

They won't vote for Hawley this fall, they said, but are unsure if they'll support the Democratic nominee.

Jim Seidel, 64, who lives in Wright City, 50 miles west of St. Louis, also signed the petition. He said he believes Missourians deserve the opportunity to vote on the issue.

“I've been a Republican all my life until just recently,” Seidel said. “It's just gone really wacky.”

He plans to vote for Kunce in November if he wins the Democratic primary in August, as seems likely. Seidel previously voted for a few Democrats, including Bill Clinton and Claire McCaskill, whom Hawley unseated as senator six years ago.

“Most of the time,” he added, Hawley is “strongly in the wrong camp.”

Over about two hours in conservative St. Charles, KFF Health News observed only one person actively declining to sign the petition. The woman told the volunteers she and her family opposed abortion rights and quickly walked away. The Catholic Church has discouraged voters from signing. At St. Joseph Parish in a nearby suburb, for example, a sign flashed: “Decline to Sign Reproductive Health Petition!”

The ballot measure organizers turned in more than twice the required number of signatures May 3, though, and now await certification from the secretary of state's office.

Larry Bax's concern goes beyond abortion and the ballot measure in Missouri. He worries about more governmental limits on reproductive care, such as on IVF or birth control. “How much further can that reach extend?” he said. Kunce is banking on enough voters feeling like Bax and Seidel to get an upset similar to the one that occurred in 2012 for the same seat — also over abortion. McCaskill defeated Republican Todd Akin that year, largely because of his infamous response when asked about abortion: “If it's a legitimate rape, the female body has ways to try to shut that whole thing down.”

——————————
By: Samantha Liss
Title: Democrats Seek To Make GOP Pay for Threats to Reproductive Rights
Sourced From: kffhealthnews.org/news/article/democrats-campaign-reproductive-rights-abortion/
Published Date: Fri, 10 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/their-first-baby-came-with-medical-debt-these-illinois-parents-wont-have-another/