NIH Leaders Evade FOIA? Discovery of Counterfeit Ozempic; Device Battery Scam?

Welcome to the latest edition of Investigative Roundup, highlighting some of the best investigative reporting on healthcare each week.

NIH Leadership Evaded FOIA?

Leadership of the NIH and National Institute of Allergy and Infectious Diseases (NIAID) are under fire for potentially suppressing information requests from journalists, according to The Nation.

The House Select Subcommittee on the Coronavirus Pandemic, which is looking into the origins of the pandemic, has alleged that the NIH and NIAID have dodged Freedom of Information Act (FOIA) requests about COVID, with strategies like intentionally misspelling words to avoid keyword searches.

Last summer, it was revealed that David Morens, MD, a longtime advisor to Fauci, had evaded FOIA by using personal email. But after this misconduct became known, Morens’ personal emails were obtained and revealed more instances of him doing the same.

For example, in one email, he wrote that, “The best way to avoid FOIA hassles is to delete all emails when you learn a subject is getting sensitive.”

Morens was grilled at a hearing by the committee, where he apologized for some behavior, defended some of his conduct, but also made a lot of excuses, per The Nation.

But was Anthony Fauci, MD in on it? Fauci addressed this in his testimony earlier this week, noting that to his knowledge, he has never conducted official business on his personal account.

How FDA Discovered Counterfeit Ozempic

As GLP-1s like semaglutide (Ozempic) skyrocket in popularity, so too have counterfeits, which can be dangerous to patients and trick even a keen eye, according to a report in Vanity Fair.

Last December, the FDA sent an alert that it found counterfeit Ozempic in the U.S. — but finding out where the fakes originated is a complicated puzzle. As these drugs rise in popularity, more people want in on the cash cow, according to the article. But counterfeits can be dangerous to patients. Some have even contained insulin, which is dangerous for non-diabetics to inject.

The article detailed how James Pinckney II, MD, thought he found a more affordable supplier of GLP-1s from a reputable business: F.M. Howell & Company. He went to their warehouse, bought some, and had an independent company, Hudson Scientific, test it. The product had a real lot number, but all boxes had the same serial number, which was a red flag.

Tests revealed that the discounted “Ozempic” had the correct ingredients but at higher than the specified dose. Plus, the needles looked slightly different and the labels were askew. It was indeed counterfeit.

While regulators still don’t know where this counterfeit originated from, Dennis Moore, of Hudson Scientific, put it this way: “The system failed. That’s the key piece.”

Medical Device Battery Scam?

Medical device maker Zynex Medical is under scrutiny for reportedly oversupplying their patients and then billing their insurance — which doesn’t always pay up, according to reporting in STAT.

One patient, Michelle Bean, received heaps of batteries she didn’t need for a medical device she only used occasionally. The company would send her a new supply each month, allowing it to bill insurers for thousands of dollars. Zynex Medical told Bean that her insurance covered it. But eventually, Zynex Medical told her that her insurance never paid and she was on the hook for nearly $1,000.

Zynex Medical’s first FDA clearance in 1998 was for an electric stimulator device for muscle pain, which wasn’t a new concept. Instead of following the path that many medtech giants do — innovating new devices — Zynex Medical figured out a new business strategy: automatically shipping and billing supplies each month and only stopping if a patient or insurance company contacted them, STAT reported.

Former Zynex Medical employees told STAT that this model put pressure on reps to sell more at any cost.

One rep told STAT, “I feel like during my time there, I had a leading role in making people’s lives worse.”

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