EpiPen Maker’s Troubles and More

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This Past Week’s Investigations in Healthcare

by Greg Portz MedPage Today

It’s time for this week’s edition of Investigative Roundup, gathering some of the best investigative reporting on healthcare from around the country.

Purdue’s Sackler Family Under Fire

 

According to ProPublica, the lawsuit says Purdue and the Sacklers made payments to execs for loyalty, hired a consultant to boost sales, and concealed damaging information about OxyContin. Moreover, they talked about acquiring rights to addiction-treatment drugs including naloxone and the buprenorphine/naloxone combination, Suboxone.

In a statement last week, Purdue said it didn’t act on those discussions. But the lawsuit says defendant Richard Sackler obtained a patent for a drug (unspecified by ProPublica) to treat addiction.

EpiPen Maker’s Allegedly Unchecked Errors

While the price of the EpiPen gradually increased, complaints about the drug to the product’s manufacturer, Meridian Medical Technologies, did too. And the company, a subsidiary of Pfizer, did little to correct its course for three years, according to Business Insider.

Patients complained that some EpiPens were “hard to activate or activated before they could use them, arrived leaking, or came with bent needles or discolored solution.”


At the start of 2014, the FDA admonished Meridian for not looking into such complaints seriously enough. Through reporting based on documents obtained via a public-records request, BI found a lax attitude toward investigating the complaints, and Meridian’s correspondence with regulators showed the firm downplayed the problems. After inspection, the FDA would later call one of Meridian’s internal investigations “deficient.”

The FDA chastised the company in 2017: “[Y]our own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.”

In that same year — three years after the FDA’s initial warning — Meridian recalled the product and began to expand its own investigation.

Since then, “the Meridian manufacturing site has been diligently implementing all commitments made to the FDA,” the company said.

Fighting Opioid Crisis with Unregulated Patient Data

Large companies are mining patient data from health records without patient consentto create “risk scores” for addiction and overdose, ostensibly to help their doctors determine whether or not to prescribe opioids, Politico reports.

Data firms are attempting — and in some cases succeeding — to sell this service to prescribers and insurers by painting it as an uncomplicated way to avoid overprescribing.

But there’s little regulation or transparency on the information that could be used to create the scores. And critics argue that a robotic black-or-white judgment could keep essential pain relief from patients who need it. One bioethicist told Politico that the algorithms come with no guarantee of accuracy and patients have “really no protection.”

Coca-Cola Cozy with CDC?

CNN reports on private emails between employees at Coca-Cola and the CDC, published last week by The Milbank Quarterly. The emails suggest a friendlier connection between the beverage giant and the public healthy agency than was previously suspected. Some imply the Coca-Cola staff were trying to convince the CDC to “frame the debate” about sugar-sweetened drinks and the obesity epidemic.

Although the 295 pages of correspondence from 2011-2017 don’t show that the CDC acted on Coke’s wishes, they do suggest that agency officials were at least receptive to the conversation. There’s at least one instance of an arranged visit to company headquarters by CDC staff.

One researcher who worked on a previous study of Big Soda’s lobbying efforts told CNN, “Frankly, it’s a little bit scary to see the degree to which there is collaboration and partnerships between the CDC and this corporation.”


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Biography
Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master's of Nursing Science Degree as an Educator.

She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen - two daughters-in-law; Suzy and Katie - two granddaughters; Isabella Marianna and Zoe Olivia - and one grandson, Alexander Paul. She also shares her life with husband Gordon Duff, many cats, two rescue pups, and two guinea pigs.

Carol's Archives 2009-2013