A Florida oncologist faces 70 months in federal prison for using unapproved drugs to treat her patients.
As previously reported by Medscape Medical News, Diana Anda Norbergs, MD, 61, the former owner and operator of East Lake Oncology, a cancer treatment clinic located in Palm Harbor, Florida, was convicted in November 2016 of smuggling unapproved and misbranded drugs into the United States and then administering them to her patients.
More precisely, she was convicted of receipt and delivery of misbranded drugs, smuggling goods into the United States, healthcare fraud, and mail fraud. She would purchase discounted drugs from an overseas distributer and then bill Medicare and other insurers for the more expensive US versions.
Dr Norbergs was sentenced on Friday, August 4. According to the Tampa Bay Times, she cried as US District Judge James Moody read a long and detailed statement.
She also apologized to her patients, of whom 66 were said to have been treated with the unapproved drugs.
“I am so sorry for the stress I may have caused you and your family members,” Dr Norbergs was quoted as saying. “My patients were the most important thing in my life. I would never intentionally harm anybody.”
In addition to receiving a prison sentence, she will also have to pay $848,671 in restitution, most of it going to Medicare.
Beginning in 2009, Dr Norbergs ordered and directed her staff to order drugs from foreign distributors, including pharmaceuticals from Quality Specialty Products. None of these drugs were registered with or approved by the US Food and Drug Administration (FDA).
At her trial in November, the 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).
Knew Exactly What She Was Doing
Dr Norbergs had administered at least $700,000 worth of the foreign drugs but continued to bill payers at the higher price of the more costly FDA-approved versions. Her defense attorney noted repeatedly throughout her trial that none of her patients suffered any harm from this treatment.
Her patients may feel differently. As reported by the Tampa Bay Times, the daughter of a woman who was treated by Dr Norbergs and died in 2011 wondered whether her mother had died prematurely.
“I’ll spend the rest of my life wondering if my mother would have lived longer if she’d gotten the treatment she deserved,” she said.
Judge Moody was not sympathetic toward Dr Norbergs. “Were I a patient and I received nonapproved drugs, I would be angry,” he said during sentencing.
In her statement to the court, Dr Norbergs claimed that she believed that the drugs she was using were essentially the same as the government-approved US versions. The prosecution pointed out that she knew exactly what she was doing.
Among other evidence that was produced, they cited a visit from an FDA agent in 2011, who had subpoenaed her for her business records and had instructed her to stop buying foreign, unapproved drugs.
The following year, she was warned by the FDA after she had purchased drugs from a foreign distributor, Richard Pharma, which was known to have sold Altuzan, a counterfeit version of the chemotherapy drug bevacizumab (Avastin, Genentech).
“Even if the version had not been counterfeit,” an FDA official wrote at the time, “Altuzan itself is not approved by FDA.”
Intellectually Inferior?
Perhaps the final blow came from psychologist Mitchell Kroungold, PhD, who had examined Dr Norbergs prior to her sentencing. He testified that her intelligence was below that of most other practicing physicians.
He also noted that she has a “mild neurocognitive disorder,” which could be related to a medically induced coma Dr Norbergs underwent after back surgery in 2006.
Dr Kroungold also pointed out that she has a “compulsive and dependent personality style.”
Dr Norbergs will remain free on bond pending an appeal of her conviction. She is no longer able to practice medicine and voluntarily surrendered her medical license in May 2017.
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