US doc gets six years for in unapproved cancer drug case

A Florida doctor has been sentenced to nearly six years in prison for smuggling misbranded and unapproved cancer drugs into America, some of which were likely counterfeit, and administering them to patients.

Diana Anda Norbergs, MD, (61) was initially convicted last November by a jury for receipt and delivery of misbranded drugs, smuggling goods into the US, healthcare fraud and mail fraud.

The court heard that the owner of East Lake Oncology, in Palm Harbor, Florida, had been ordering cheap drugs – such as MabThera, Ribomustin and Zometa – from unlicensed overseas distributors, including from the UK and Canada, since 2009.

The drugs were packaged for distribution in a variety of countries, including Turkey and Germany, but not the US.

According to the US Attorney's Office for the Middle District of Florida, some of these distributors sold counterfeit chemotherapy drugs, with some containing no active ingredient.

Norbergs treated 66 patients with the dodgy drugs and then submitted fraudulent claims for reimbursement to Medicare, purporting that the drugs were the more expensive US Food and Drug Administration-approved versions.

The US Attorney argued that Dr Norbergs aimed to profit from the scam by pocketing the windfall from the Medicare reimbursements.

Norbergs' defence attorney George Tragos said the oncologist had genuinely believed the drugs she sourced were legitimate FDA-approved versions that could be sold in the US, while emphasising that none of the patients treated with the dodgy drugs appeared to have suffered any physical harm or untoward side effects.

Although, one woman, whose mother died in 2011, said: "I'll spend the rest of my life wondering if my mother would have lived longer if she'd gotten the treatment she deserved," the Tampa Bay Times reported.

Norbergs claimed in her defence that had she known the drugs were not legitimate she would have stopped buying and administering them. However, the prosecution claimed Dr Norbergs knew what she was doing, presenting evidence during the trial that noted she had received a visit from an FDA agent in 2011 who had warned her to stop buying foreign, unapproved drugs, yet this advice was not heeded.

During her sentencing hearing, Norbergs apologised for her actions. "I am so sorry for the stress I may have caused you and your family members. My patients were the most important thing in my life. I would never intentionally harm anybody," said the Tampa Bay Times.

However, US District Judge James Moody said Norbergs' actions had betrayed the trust patients had put in her, adding: "Were I a patient, and I received nonapproved drugs, I would be angry."

She was sentenced to 70 months in prison and has been ordered to pay more than $800,000 in fines, mostly to Medicare. An appeal is pending.

The Norbergs case follows a similar case in February when a New Jersey oncologist was accused of importing cancer drugs illegally and making fraudulent Medicare claims. He agreed to pay $1.7m to resolve the case.

At the time, Paul Fishman, US Attorney for New Jersey, said: "Illegally imported drugs avoid the FDA's rigorous oversight and manufacturing standards. Healthcare providers who import those drugs are exposing their patients to serious risks or harm from contaminated or counterfeit products."

The US is currently debating changing legislation to allow cheaper drug imports into America from Canada and possibly Europe in a bid to address the ballooning cost of prescription drugs in the US. However, the pharmaceutical industry, pharmacy groups and former FDA commissioners have opposed the proposals, claiming the new rules would compromise the integrity and security of the US drug supply chain and increase the risk of unapproved and counterfeit drugs reaching patients.

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