Meningitis Study

https://original.newsbreak.com/@fareeha-arshad-1587440/2650086157744-researchers-finally-uncovered-the-deadly-pathway-involved-in-the-spreading-of-fungal-meningitis-in-the-brain

Action Stepping Up In Cadden, Chin MI Cases

By Walter F. Roche Jr.

With all their appeals denied, action is expected to step up in Livingston County Michigan in the criminal trials of two former pharmacists charged with 13 counts of second degree murder.
A status conference before Livingston County Judge Michael P. Hatty has been scheduled for July 15 in the cases of Barry Cadden and Glenn Chin.
At that session it is likely that a rough timetable will be sketched out for further pre-trial sessions and, finally for the cases to be presented to a jury.
Cadden and Chin were charged by the Michigan Attorney General for their roles in the deadly 2012 fungal meningitis outbreak. All 13 victims had been injected with steroids produced at the New England Compounding Center. Cadden was president and part owner of NECC while Chin was a supervisory pharmacist in the cleanroom where the drugs, tainted with deadly fungi, were produced.
Both Cadden and Chin filed a series of appeals arguing that the cases never should have been bound over for a jury trial due to a lack of evidence.
Both the state Court of Appeals and the state Supreme Court denied those appeals.
For victims of the outbreak and their families news that the cases are finally moving forward is very much good news.
"This trial can not get started soon enough as far as I am concerned. It has been delayed way too long and we need to have closure one way or the other," said Donna Borton, whose husband was a victim and is still recovering."
"So happy that the Michigan Supreme Court has ruled the trial can proceed," she added.
The July 15 session is scheduled for 10 a.m.in Hatty's Michigan courtroom.
Contact: wfrochejr999@gmail.com

Carter, Conigliaro Sentencings Set

By Walter F. Roche Jr.

Gregory Conigliaro, a former vice president and part owner of a drug company at the center of a deadly 2012 outbreak, will face an Oct. 18 sentencing hearing before a federal judge following his conviction on a charge that he conspired to defraud the U.S. Food and Drug Administration.
Conigliaro's sentencing session will take place at 10. a.m. in Boston, Mass. before U.S. District Judge Richard G. Stearns, the same judge who presided over Conigliao's trial.
Two days later a co-defendant, Sharon Carter, will face Stearns following her conviction on the same conspiracy charge. Carter and Conigliaro were employed at the New England Compounding Center, the company that produced the fungus laden steroids that ultimately caused more than 100 deaths. Carter was NECC's director of operations.
They were among 14 person connected to NECC who were indicted in December of 2014 following a two-year investigation of the outbreak.
Contact: wfrochejr999@gmail.com

Chin to Stay in Michigan

By Walter F. Roche Jr.

One of the two ex-pharmcists facing multiple second degre murder charges is giving up on his efforts to get transferred to a federal prison to complete his 10.5 year sentence set following his conviction on federal racketeering and related charges.
James Buttrey, the lawyer for Glenn Chin, said his client will remain in the Livingston County Michigan Jail awaiting trial on 11 counts of second degree murder.
Chin had petitioned the Livingston County Circuit Court to be allowed to transfer to a federal prison where care for inmates is generally considered to be more favorable.
"Mr. Chin will remain in the Livingston County Jail for the pendency of his case," Buttrey wrote in an email response to questions. Chin and co-defendant Barry Cadden have been charged with 11 counts of second degree murder for the deaths of 11 Michigan patients who were injected with highly contaminated preservative free methylprednisolone acetate.
The drugs, laden with deadly fungi, were produced at a Massachusetts drug compounding firm where both were employed. Cadden was president and part-owner of the New England Compounding Center while Chin was a supervising pharmacist in the clean room where the deadly drugs were produced.
A federal grand jury had also charged both Cadden and Chin with second degree murder, but two separate juries declined to convict them on those charges.
The federal juries did find Cadden and Chin guilty of racketeering and related charges and Cadden was given a 14.5 year sentence and Chin got a 10.5 year sentence.
While Chin's transfer to a federal prison got conditional approval from Judge Michael Hatty, Chin was apparently unsuccessful in getting the federal Bureau of Prisons to place him in one of their facilities.
Contact: wfrochejr999@gmail.com

No New Trial for Conigliaro, Carter

By Walter F. Roche Jr.

A federal judge has denied motions for a new trial by the last two defendants in the criminal case stemming from the deadly 2012 fungal meningitis outbreak.
In a brief order issued today U.S. District Judge Richard G. Stearns rejected new trial requests for Gregory Conigliaro and Sharon P. Carter, both formerly affiliated with the now defunct New England Compounding Center, the company blamed for the fungal meningitis outbreak, which ultimately took the lives of more than 100 patients.
Conigliaro was vice president and part owner of NECC. Carter was an NECC supervisor.
The two were found guilty of conspiring to defraud the U.S. Food and Drug Administration. NECC shipped thousands of vials of methylprednisolone acetate contaminated with deadly fungi to hundrerds of health care providers across the country.
Stearns had originally cleared the two of the charges, but they were reinstated by the 1st Circuit Court of appeals.
Carter and Conigliaro were among 14 people affiliated with NECC who were indicted in late 2014 after a two-year federal investigation of the outbreak. Only one of the 14 was cleared of the charges.
In the order issued today Stearns also asked the court clerk to set a date for the sentencing of Carter and Conigliaro.
Contact: wfrochejr999@gmail.com

VT Compounder Hit With FDA Enforcement

District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with Federal Food, Drug and Cosmetic Act
Department of Justice press release, June 13, 2022
- A federal court permanently enjoined a Colchester, Vermont, compounding pharmacy from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced.
In a complaint filed May 20, the United States alleged that Edge Pharm Inc., and its owners and operators Marc Chatoff and Kurt Radke, violated the FDCA by manufacturing and distributing adulterated and misbranded drugs, by causing drugs to become adulterated and misbranded while held for sale, and by introducing new unapproved drugs into interstate commerce.
According to the complaint, the defendants manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility. The complaint further alleged that U.S. Food and Drug Administration (FDA) inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“Edge Pharma LLC has put patients’ lives at risk by repeatedly producing drugs under insanitary conditions and failing to follow good manufacturing practice requirements,” said Director Donald Ashley of the Center for Drug Evaluation and Research (CDER) Office of Compliance.
“While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do. This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”

Last Lewis Post

Terri's last post Chemo2 today. It's been a very long day beginning with a port that had a blockage that we finally got cleared. I had an adverse, unexpected reaction to the chemo. We worked through it, learned what to do for next time. I have very low sodium, a bladder infection, and am generally wiped out by the intensity of all of the events of this day. But we got the tumor genetics back and now know exactly what we're dealing with to target for immune therapies. Pharmacogenetics and prescriptions macrobid and more salt ya'll. My thanks to the awesome oncology team at SLC cancer center in Butte. Throughout it all, they were on top of things and didn't miss a beat.

Cadden's Michigan Appeal Denied

The Michigan Supreme Court has denied an appeal by a former pharmacist who will now face a jury on charges of 11 counts of second degree murder.
In a brief order issued today the state's highest court upheld a prior order issued by the state Court of Appeals which found that Barry J. Cadden should go before a Livingston County jury to face the charges brought by the state Attorney General.
Both Cadden and co-defendant Glenn A. Chin were charged for their roles in the 2012 fungal meningitis outbreak which ultimately took the lives of more than 100 patients.
Cadden was president and part owner of the New England Compounding Center, the company that shipped thousands of contaminated vials of a steroid which was injected into unsuspecting patients. Chin was the supervising pharmacist in the clean room where the tainted drugs were produced.
The two already have been convicted on related federal charges, but two separate juries declined to convict them on second degree murder charges. The Michigan Attorney General subsequently filed murder charges on the deaths of 23 Livingston County patients.
The Supreme Court already has denied a parallel appeal filed by Chin. Both Cadden and Chin will now go before Livingston County Judge Michael Hatty to face trial. They had argued that the Attorney General had failed to provide sufficient evidence for the charges to be presented to a jury.
Contact :wfrochejr999@gmail.com