Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.
Sexual Arousal Study Lawsuit
An Iowa health official signed off on plans to perform sexual experiments at a state facility that cared for people with intellectual disabilities, .
Documents from the Iowa Department of Human Services (DHS) showed that Rick Shults, director of mental health and disability services, approved the purchase of computer software for the experiments at Glenwood Resource Center.
Those experiments were pitched by Jerry Rea, the former superintendent of the center who was fired in December. Shults retired last month.
The documents were released after two doctors and four other former Glenwood employees filed a against the Iowa DHS and top officials earlier this month, claiming their complaints about the sexual arousal research, which would be conducted on fragile and dependent patients, were silenced.
Rea's pitch described the research as using a penile device for measuring arousal, and that it would have "implications for treatment of sexual preoccupation issues." According to the lawsuit, Rea and his team also bought stock photos that included pornographic images, as well as a dedicated computer for the research.
The Department of Justice (DOJ) is also investigating allegations of human experimentation.
More Carcinogen-Tainted Drugs
Online pharmacy Valisure has found high levels of the carcinogen N-Nitrosodimethylamine (NDMA) in some batches of metformin and is asking for regulators to recall certain products, .
In screening 38 batches of metformin from 22 companies, Valisure detected 16 failures from 11 companies. Several batches contained more than 10 times the daily intake limit, the company outlined in a it filed with the FDA.
Valisure said it used the same testing methodology outlined by the FDA, albeit "slightly altered" to achieve a lower limit of detection and a wider reportable range than shown by FDA. It also had its results verified by an FDA-certified current good manufacturing practices (cGMP) laboratory.
Last month, the FDA said it saw in metformin in its own testing, and none were above the acceptable daily intake limit of 96 ng/day. Yet health officials in and have already launched recalls of the drug due to the presence of the carcinogen.
NDMA contamination has been a problem for other drugs, including valsartan and ranitidine (Zantac), prompting recalls.
David Light, Founder and CEO of Valisure, said given how scattered the contamination is, it "may be more difficult to diagnose where, exactly, the metformin contamination is coming from, especially with practically no transparency into the sourcing of materials or the process in how they are synthesized."
"I fear the difference between a clean batch and a contaminated batch may go farther back than API [active pharmaceutical ingredients] -- all the way to the fine chemicals that make the API," Light told 51˶.
He added that the quality control issues may become even worse "as coronavirus continues to derail Chinese drug manufacturing, where the majority of U.S. drugs originate."
"Many of these existing safety and quality issues, like the ones we identified in metformin, likely stem from overseas manufacturers cutting corners," he said. "It is certainly possible that many more corners may be cut in the scramble to ramp up production and fill back-orders."
$195 Million Price-Fixing Settlement
As part of an ongoing federal investigation into the generic drug industry, Sandoz will pay $195 million to settle criminal charges that it conspired to fix prices and rig bids, the largest fine in a U.S. antitrust case, the .
The company, the generics subsidiary of Novartis, was charged with participating in four criminal antitrust conspiracies with competing generic drugmakers from 2013 to 2015: one with a New York generics company regarding clobetasol, desonide ointment, and nystatin-triamcinolone cream; one with Kavod Pharmaceuticals (formerly Rising Pharmaceuticals) to fix the price of benazepril; another with a Michigan generics company regarding desonide ointment; and a fourth with a Pennsylvania company around tobramycin.
Sandoz is the third company to be charged in DOJ's ongoing investigation into anticompetitive practices in the generics industry. Three executives have pled guilty -- including former Sandoz executive Hector Armando Kellum -- and a fourth, Ara Aprahamian, was indicted last month and is awaiting trial.
Sandoz and DOJ agreed on a deferred prosecution agreement, so Sandoz can cooperate with the ongoing investigation.
Child Abuse Doc Under Fire
Another child abuse pediatrician is facing scrutiny for suspecting abuse when there was none, according to .
Barbara Knox, MD, formerly of the University of Wisconsin, charged that Brenna and Joel Siebold abused their son Leo, who was born with heterotaxy syndrome, which required frequent trips to the hospital. Knox listed surgical scars as bruises, and included false information in the child's medical record (including a false claim that the family was in the state insurance program for low-income residents), according to the news outlet.
She also allegedly misrepresented herself as a "blood doctor" to try to convince the family to submit to extra testing, Wisconsin Watch reported.
The family has been cleared, and Knox herself is now under scrutiny. She had been placed on paid leave, and then voluntarily left her job in Wisconsin after officials there raised concerns about her workplace behavior, including "retaliation against and/or intimidation" of colleagues. One complained that he was pressured to report injuries he didn't see.
Knox is now the medical director of Alaska CARES, the child abuse response and evaluation program at Children's Hospital Providence in Anchorage.