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Kristi Rosa, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Kelly Davio,  This Week in Managed Care from the Managed Markets News Network

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments...SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine...in 2016 and 2013 without safety oversight that is routinely performed by the FDA or an institutional review board...The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments…Rational Vaccines has said it considers the 2016 trial a success—though it is unclear what data it used to support that claim...SIU has...acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university.

Former pharmaceutical executive Martin Shkreli wept and apologized before being sentenced to seven years in prison...for securities fraud. A U.S. District Court judge in Brooklyn handed down the sentence after a jury in August found him guilty of defrauding investors in his hedge funds...Judge Kiyo Matsumoto said she believed Shkreli to be genuinely remorseful for his crimes, but she expressed concern that a minimal sentence might not deter him in future...The judge...also imposed a $75,000 fine apart from the $7.4 million forfeiture that she...ruled Shkreli must pay.

The dividing line between Senate Democrats and Republicans on the 340B drug pricing program was set on Thursday, with Democrats siding with the hospitals, saying the savings from the program is desperately needed for the poorest populations, while Republicans took the side of drugmakers, saying the program is being abused and needs to be reformed...But the hearing also put the spotlight on the lack of transparency from both the pharmaceutical and hospital industries, as neither side could agree to some basic statistics, such as what percent of the total drug spend in the US goes into the 340B program...reform and more oversight may still come...A study published in Health Affairs in 2014 found that 340B hospitals are expanding their base into communities that tend to be affluent and well-insured, which runs counter to the objectives of the program. The Alliance for Integrity and Reform of 340B, backed by the biopharma industry and other groups, also released a report that found in 2015, 61% of participants spent less on charity care compared to both 2014 and 2013 despite additional revenue received...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Insurance is designed, theoretically, to protect against the catastrophic: tornadoes, floods, hurricanes — or, where our health is concerned, cancer or another devastating disease...To make that financial protection affordable, many pay into the system: the healthy are supposed to subsidize the sick...But at a conference...organized by the health insurance industry, FDA Commissioner Scott Gottlieb delivered a startling message: You're doing it wrong..."Sick people aren't supposed to be subsidizing the healthy," Gottlieb told an audience at the National Health Policy Conference of AHIP, the health insurer industry group. "That's exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance."...Gottlieb's remarks were focused on the health of the market for biosimilars — copycats of complex, biologic medicines — and his concerns that industry consolidation and what he called rigged payment schemes may be stifling their development.

Elizabeth Holmes was an even smoother scamster than anyone thought -- and she's apparently getting to keep her job...The SEC just charged the 34-year-old onetime billionaire with fraud related to claims she made about her blood-testing company, Theranos. To settle the charges, Holmes is giving up 18.9 million Theranos shares, losing voting control of the company, paying a $500,000 fine and will be barred from running a public company for ten years. She will, however, continue as the chief executive of Theranos, which under the fraudulent scheme described by the SEC raised $700 million...What emerges from the SEC's complaint is this: ...that Theranos’ sales were much lower than the company had led outsiders to believe. But the SEC puts a fine point on it: At a time when Theranos claimed it had annual sales of $100 million, sales were just $100,000...SEC says Holmes showed...(Walgreens) executives written evidence that Theranos would be able to run just about any blood test on its machines by the end of that year, using drops of blood taken from finger pricks instead of using needles. The next year, the pharmacy executives raised concerns with Holmes that this device might need to be approved by the FDA. But they missed the scale of her deception...Theranos miniLab was supposed to have been rolled out...the machine wasn't ready at all. That's when, (Sunny Balwani) Balwani and Holmes told their engineers to start using other companies' machines in unapproved ways to analyze finger-prick samples, the complaint says. Theranos allegedly never told the pharmacy executives...

Nevada Attorney General Adam Paul Laxalt has announced the formation of a Statewide Partnership on the Opioid Crisis. The Working Group’s first meeting will take place Thursday, and will include members from local and federal law enforcement, prosecutors, experts in the medical field, elected officials, and judicial and educational representatives...The primary function of the statewide partnership is to make recommendations to the Attorney General’s Office and Nevada’s Statewide Opioid Coordinator on best practices for data sharing to combat the opioid crisis. The AG says this remains a critical gap in Nevada’s response to the crisis...

A Rhode Island doctor was sentenced...to more than four years in prison after admitting he took kickbacks from Insys Therapeutics Inc to prescribe its fentanyl-based cancer pain drug to people who did not suffer from the condition...Jerrold Rosenberg...was sentenced by U.S. District Judge John McConnell...who said the doctor effectively sold his medical license to a pharmaceutical company seeking to boost its profits...McConnell said patients were put at risk by Rosenberg, who has admitted the $188,000 Insys paid him in the form of speaker fees were a factor in his decision to write prescriptions for the medication, Subsys...Federal prosecutors...have accused seven former executives and managers at Insys, including billionaire founder John Kapoor, of participating in a scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it...