Doc Sues Over Vax Mandate; False Child Abuse Claims? FDA's Decongestant Delay

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

Iowa Doc Sues Hospital Over COVID-19 Vaccine Mandate

An Iowa-based physician who has been critical of COVID-19 mandates has sued a Missouri-based health system over discrimination related to its vaccine requirements for staff members, according to the Missouri Independent.

Mollie James, DO, MPH, who is based in Chariton, Iowa, has reportedly filed a civil lawsuit against Mercy ACO Clinical Services, Mercy Health, and Mercy Health East Communities in the circuit court of St. Louis County, the report said.

Mercy St. Louis, the facility where James was employed at the time, did allow for medical or religious exceptions, according to the report. Despite the exception, James' lawsuit alleges that she lost her job for refusing to get the vaccine.

James reportedly applied for religious exemption, writing on the application that "healing power is from God alone" and that she "takes direction and guidance treatments from Him and Him alone."

However, James' application was reportedly denied in August 2021. She later resigned from her position at Mercy St. Louis, according to the report.

James' lawsuit reportedly aims to seek unspecified damages for religious discrimination and retaliation, the report stated. As of press time, the health system had not responded to James' lawsuit.

Prior to filing the lawsuit, James sought a right-to-sue letter from the Missouri Commission on Human Rights, a common precursor to a civil lawsuit for discrimination, but her request was denied, according to the report.

In addition to filing the lawsuit against Mercy Health, she is also appealing the commission's decision.

Pediatrician Pushes Back Against Medical Child Abuse

A Washington-based pediatrician has been pushing back against reportedly inaccurate claims of child abuse by other physicians in the state, which can have traumatic effects on families, according to a Seattle Times article.

Niran Al-Agba, MD, pediatrician and owner of Silverdale Pediatrics in Silverdale, Washington, has become an expert witness defending parents accused of child abuse.

Overall, Al-Agba has found alternative medical explanations for a child's condition in 47 of the 61 cases (77%) she has reviewed. Her winning approach comes from her ability to provide credible medical explanations for alleged signs of abuse in children, according to the report.

While she tends to review highly questionable cases, her record highlights concerns from parents and their defense attorneys who have said the state moves forward with abuse allegations based on insufficiently vetted suspicions of physicians, according to the report.

Al-Agba has developed a high profile in reviewing cases where other medical providers have reported or diagnosed abuse during evaluations for the Washington state's Department of Children, Youth and Families (DCYF), according to the report. In several recent cases, where children were separated from their parents, Al-Agba provided alternative medical opinions and diagnoses that led to the reversal of the state's efforts to remove a child from their family.

In one such case, Al-Agba diagnosed an infant with Mongolian spots. The infant had been placed in the custody of a grandparent after another physician had reportedly contacted DCYF over concerns that the marks were bruises.

Not everyone in the state is satisfied with Al-Agba's record though. Some expert witnesses and medical examiners in the state claim that Al-Agba has no training in abuse, so she should not be relied for most cases, the article said. One physician, Kenneth Feldman, MD, of Seattle Children's Hospital, said she has also become a professional witness, who is making "quite a bit of money," according to the article.

On the other hand, Al-Agba told the Seattle Times she sees things differently. "We always seem to believe they're bad parents. And sometimes that's true. Sometimes, someone has hurt the child. But actually, my experience is that more often than not, they haven't," she said.

Decades-Long Campaign Against Decongestant

The process to convince the FDA to reconsider the approved use of oral phenylephrine, a common ingredient in cold and flu medicines, spanned roughly six decades, according to a New York Times article.

An FDA advisory panel's conclusion earlier this month that phenylephrine is ineffective is the culmination of an effort launched during President John F. Kennedy's administration, when a new law was passed requiring FDA to evaluate a drug's effectiveness in addition to its safety, according to the report.

However, the agency didn't begin reviewing over-the-counter cold medicines as a drug class until the mid-1970s. By the early 2000s, the rise of illegal methamphetamine labs led to frequent misuse of pseudoephedrine, one of the most common decongestants on the market at that time. In an effort to curb the meth crisis, lawmakers began passing laws to limit access to that drug, which left phenylephrine as the last choice decongestant for pharmaceutical companies.

By then, a team of clinical researchers at the University of Florida, led by Leslie Hendeles, PharmD, professor emeritus in the College of Pharmacy, had already started putting pressure on the FDA to reconsider the drug's efficacy. Hendeles published his first critique of the drug in 1993, and over the next 30 years, he and his team wrote papers highlighting the lack of evidence and even sought the help of a Congressman, Rep. Henry Waxman (D-Calif.), to convince the agency to reconsider the drug.

When the FDA advisory panel voted unanimously that the drug was ineffective, Hendeles was present and gave remarks during the open comment portion of the hearing, according to the article. "Nothing was as exciting and exhilarating as the vote," Hendeles told the Times.

The recommendation does not mean FDA will make an immediate change, and pharmaceutical companies could still fight any action to remove their products from the market.

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