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Home/Spine/Deadly Steroid Compounder Gets 9 Years in Prison
Spine

Deadly Steroid Compounder Gets 9 Years in Prison

June 29, 2017 2 min read Premium comments

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Deadly Steroid Compounder Gets 9 Years in Prison
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The ex-pharmacist from the New England Compounding Center (NECC) who sold deadly epidural steroid injections used to treat back pain, neck, knee and other types of pains, is going to jail for nine years.

64 Dead

In October 2012, the North American Spine Society issued a Spine Safety Alert after a rare form of fungal meningitis was confirmed in 91 patients by the Centers for Disease Control and Prevention (CDC). The first case was reported after an epidural injection at a Tennessee ambulatory surgery center. Eventually, according to federal officials, at least 64 people died of fungal meningitis in the outbreak and more than 700 were injured.

On June 26, 2017, a Massachusetts federal judge sentenced Barry Cadden to nine years in prison. Prosecutors had asked for 35 years.

According to a Law360 report, on March 22, 2017, a jury found Cadden guilty of racketeering, with mail fraud for shipments of the substandard, sometimes deadly drugs as the driving force for the illegal scheme. Cadden was found not guilty on murder charges, as well as some mail fraud racketeering acts and selling adulterated drugs. The jury also acquitted him of conspiracy to defraud the U.S. Food and Drug Administration (FDA).

Prosecutors claimed that under Cadden’s direction, NECC sold drugs before the clinic’s bare-bones safety test results had come in. NECC allegedly ignored the delicate safety procedures for sterilizing drugs and used expired ingredients.

The U.S. Attorney’s Office said Cadden repeatedly took steps to shield NECC’s operations from regulatory oversight by the FDA by claiming to be a pharmacy dispensing drugs pursuant to valid, patient-specific prescriptions. “In fact, NECC routinely dispensed drugs in bulk without valid prescriptions. NECC even used fictional and celebrity names on fake prescriptions to dispense drugs, such as ‘Michael Jackson’, ‘Freddie Mae’ and ‘Diana Ross’.”

“Give him two shots of his own steroid.”

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The Boston Globe reported that a man who lost his mother said Cadden “got away with murder.” A survivor asked the judge to give Cadden the maximum sentence “or give him two shots of his own steroid.”

This situation raised issue regarding oversight of manufacturers, compounders and distributors of these products. Ray Baker, M.D., president of the International Spine Intervention Society, told us in 2012 that this case may have much to do with the fact that physicians don’t want to use near the spine some of the preservatives normally found in these compounds. He said physicians need help in obtaining appropriate sized vials of product at reasonable prices and prepared in a way that can be safely used around the spine.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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