Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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How Endo Pharmaceuticals Got Caught Promoting an Orphan Drug "Off Label"

How Endo Pharmaceuticals Got Caught Promoting an Orphan Drug "Off Label" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Truth In Media Project has released the last segment of of its newest series Truth In Media: Big Pharma, The FDA & Health Propaganda. Part 4, titled How Big Pharma Uses Off-Label Drugs, illustrates how pharmaceutical companies have made massive profits in spite of being ordered to pay enormous settlements related to harmful side effects of certain drugs.

Truth In Media’s Ben Swann first discussed the case of Peggy Ryan, a pharmaceutical sales representative for Endo Pharmaceuticals, who spent a decade undercover gathering information and ultimately blowing the whistle on corruption within the company.

Ryan, described as a “rising star” at Endo, said that she had been pressured and directed to push a product called Lidoderm, which was initially created to treat a specific condition called post-herpetic neuralgia. Since Lidoderm was approved to be prescribed only for this condition, the drug was classified as an “orphan drug,” which qualifies a drug to be subsidized by taxpayer dollars in its approval and production to offset low profits related to producing a product that is prescribed to a limited number of patients.

Swann pointed out that the FDA does not monitor orphan drugs for side effects once approved.

Ryan said she was instructed to sell the drug “off-label,” meaning to sell the drug to be used conditions outside of its intended use. Lidoderm ended up being prescribed for a plethora of unapproved health issues including back pain and carpal tunnel syndrome. Many of these prescriptions were covered by Medicare and Medicaid.

“She had access to a lot of information, and she provided that to the government. But then they asked her to wear a wire and obtain audiotapes of the people that she reported to telling her and other employees to essentially to break the law,” Judy Hoyer, a whistleblower attorney whose firm represented Ryan, told Swann.

Endo was ordered to pay $193 million in penalties in a settlement; $21 million was allocated to settle criminal charges, and $172 million was paid out under the False Claims Act. While $193 million is certainly a large sum of money to be paid, Endo made at least $1 billion selling the drug off-label; the penalty paled in comparison to the profits made.

In a separate case that also involved massive drug sale profits in light of little government oversight, highly-cited researcher, doctor and Emory University Professor Doug Bremner discussed the acne drug Accutane with Swann. Bremner, who has spent a great deal of time researching PTSD and depression and the brain, served as an expert witness in litigation proceedings associating depression and suicide with Accutane.

Pharma Guy's insight:

Also read: “How Big Pharma Courts Physicians & Makes Them Look Like They Have a Lot of Money!”; http://sco.lt/6w3HWL

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A New TV DTC Disease Awareness Ad Suggests That Donald Trump May Be "Bent Out of Shape"

A New TV DTC Disease Awareness Ad Suggests That Donald Trump May Be "Bent Out of Shape" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

With all the GOP presidential candidate focus on the size of Donald Trump's penis, I thought a peyronie’s disease [bent, small penis] DTC ad paid for by Endo Pharmaceuticals was applicable to the Donald.

It's a reasonable assumption, because the company claims that one in ten men worldwide may have the condition.

I came across the ad in a MedCity post, which I modified below. You can find the original here: "Endo Pharmaceuticals’ ads bring awareness to penile curvature"; http://sco.lt/6t2GbB)

I also modified the DTC ad graphic image somewhat (see above).

 

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