Κυριακή, 27 Νοεμβρίου 2016

AN ONCOLOGIST HEADING TO JAIL

A Florida oncologist faces more than 500 years in prison for unethical prescribing practices and fraud, according to local media reports.
Diana Anda Norbergs, MD, 61, former owner and operator of East Lake Oncology, a cancer treatment clinic located in Palm Harbor, Florida, has been convicted of smuggling unapproved and misbranded drugs into the United States and then administering them to her patients.
She would then also bill Medicare and other insurers for the more expensive US versions.
2-week trial that ended on November 16 heard evidence that Dr. Norbergs ordered and directed others working at the practice to order drugs from foreign distributors, beginning in 2009. This included drugs from Quality Specialty Products (QSP) that were not registered with or approved by the US Food and Drug Administration (FDA)
According to the Tampa Bay Times, a federal jury deliberated for about 2 hours before finding her guilty of all 45 criminal charges that were levied against her, including receipt and delivery of misbranded drugs (17 counts), smuggling goods into the United States (12 counts), healthcare fraud (11 counts), and mail fraud (5 counts).
Upon hearing the verdict, Dr Norbergs "hung her head and wept," the newspaper reports.
Her attorney, George Tragos, stated that they were "very disappointed" and that they would probably appeal.
Dr Norbergs now faces a maximum penalty of 20 years in federal prison for each count of mail fraud and smuggling, 10 years of imprisonment for each count of healthcare fraud, and 3 years for each count of receipt and delivery of misbranded drugs.
The sentencing hearing is scheduled for February 16, 2017.
Unlicensed and Counterfeit Medicines 
During the 2-week trial, Dr Norbergs testified that she had no idea her clinic was using unapproved drugs from unlicensed foreign distributors and that she believed that the drugs she was receiving had been FDA approved and could be legally sold in the United States.
Testimony and evidence presented at the trial revealed that the drugs sold to her clinic by QSP and other foreign, unlicensed distributors were in fact not FDA approved and QSP had reportedly sold counterfeit versions of a chemotherapy drug that did not contain a key ingredient.
But even after learning this, Dr Norbergs continued to purchase drugs from QSP and administer them to her patients. When QSP shut down, she switched to purchasing drugs from other foreign, unlicensed distributors.
Many of these items were drugs shipped directly to her from overseas, and the packaging and documents shipped with the drugs revealed that they were manufactured and packaged for distribution in foreign countries, and not in the United States.
In 2012, the FDA had warned Dr Norbergs that she had purchased drugs from a foreign distributor, Richard Pharma, which was known to have sold a counterfeit version of the chemotherapy drug Altuzan(counterfeit bevacizumab).
"Even if the version had not been counterfeit," an FDA official wrote at the time, "Altuzan itself is not approved by FDA."
The previous year, in 2011, she had received a visit from an FDA agent who issued a subpoena for business records. At that time, the FDA agent had warned her to "cease and desist," but she continued to buy foreign, unapproved drugs.
At her trial, the prosecutors said that her motive was greed.
"There was plenty of information that told her to change her ways," Assistant US Attorney Adam Saltzman said in closing arguments. "But she didn't change her ways. She didn't care."
Apparently Dr Norbergs was having financial problems. In 2009, her bookkeeper, Sherri Lynn Ventresca, was convicted of grand theft and fraud charges for siphoning more than $2 million from the practice and is currently serving a prison sentence.
A 2009 article also reported that her practice was unable to pay for chemotherapy drugs and was having to refer patients to hospitals for treatment. A few years earlier, she had filed for bankruptcy protection.
A 2006 list of creditors included an $800,000 claim from Florida Infusion Services in Palm Harbor and a $750,000 claim from Oncology Therapeutics Network in California.

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