Board of Pharmacy suspended licenses for them to distribute them

The drugs are in the same class as Ozempic and Wegovy, and as demand for them has soared, so have shortages and concerns that the people most in need can’t get them. There are also worries that improperly formulated drugs might be used and that the unscrupulous might be cashing in. 

The drugs carry an average annual list price of $12,000, according to the Peterson KFF Health Tracker.

The medicines, “glucagon-like peptide-1 receptor agonists,” or “GLP-1s,” mimic naturally occurring hormones to suppress appetite. They were developed for diabetics, but after the U.S. Food and Drug Administration approved several to treat diabetes, demand shot up and regulators have struggled to keep up.

“The GLP-1 marketplace is an absolute free-for-all right now,” Antonio Ciaccia, an Ohio-based drug-pricing expert, said last week.

Making the free-for-all worrisome is that the drugs can have serious side effects, including dizziness, vomiting, infection, and, in rare cases, pancreatitis, thyroid cancer and kidney injury, the Cleveland Clinic reported. 

Earlier this month, the Ohio Board of Pharmacy acted against two doctor-run clinics for allegedly dispensing GLP-1 drugs in ways that were outside properly regulated channels.

Ae2 Aesthetic Essentials in Willoughby Hills offers weight loss and cosmetic procedures. On Jan. 17, it surrendered its license to distribute dangerous drugs after Dr. Diethra Cox, the person responsible for prescription drugs, told Board of Pharmacy inspectors how the clinic had obtained them.

“Dr. Cox and her staff at the clinic, who were acting under her supervision and direction, were administering and personally furnishing tirzepatide labeled ‘For Research Use Only’ and semaglutide labeled ‘For Research Purpose Only,'” an addendum to the surrender agreement said. “Note: Research Use Only drugs are not approved by the Food and Drug Administration. They are drugs specifically designed and labeled for use in scientific research and not for clinical or diagnostic purposes.”

Staff at the clinic told inspectors that the drugs didn’t come with instructions on how to reconstitute them, and said they didn’t know when the drugs would expire.

Cox told inspectors that “she gets the drugs from a co-op group of physicians,” the report said. “She communicates via text message to obtain the drug that is sold by Dr. Nanda.”

She added that “she was provided a copy of a ‘purity test’ as the physicians’ reason the drugs were OK to use for patients,” the report said.

Cox didn’t immediately respond to a message left at the clinic. But she and the clinic agreed to never again apply for a license to distribute dangerous drugs, and further discipline remains pending.

The board also suspended the license of Jiva Med Spa, which has locations in Columbus, Dayton and Cincinnati. Ae2 had provided inspectors with records of 14 transactions in which the Willoughby Hills clinic bought $38,000 worth of weight-loss drugs from Jiva Med Spa.

The responsible person there, Dr. Rakesh A. Nanda, said he “purchased the research-use-only drugs from an out-of-state unlicensed seller,” the summary suspension order said.

A phone message left at Jiva Med Spa wasn’t immediately returned Monday.

As described in the suspension order, what Nanda told Board of Pharmacy inspectors seems contradictory.

He told inspectors he didn’t distribute any research-use-only drugs to other clinics, but he said he made presentations about them at professional conferences.

Nanda said, “He does help other clinics obtain the drugs from the unlicensed seller by either providing the seller’s information, or by making the purchase himself on the buying clinic’s behalf. He explained he has collected payment from other clinics and in turn paid the unlicensed seller. Dr. Nanda stated he is awarded a reduced purchasing price from the unlicensed seller for aiding their business.”

The order said Nanda claimed it was OK for him to use the research-only drugs because he was actually doing his own research, and he got patients to sign consent forms. 

The Board of Pharmacy order didn’t say whether Nanda’s work was overseen by an institutional review board as the FDA requires for research that could harm human subjects. It also didn’t say whether Nanda provided inspectors with documentation of the methodology for his research or any data gathered.

It’s unclear what the state regulator that oversees medical licensing might be doing in the cases of Nanda and Cox.

“We are aware of the actions taken by the Board of Pharmacy against Dr. Cox and Dr. Nanda,” Jerica Stewart, chief of communications for the State Medical Board of Ohio, said in an email. “Under Ohio law, the board is prohibited from disclosing information about complaints and investigative materials due to confidentiality.”

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This story is provided by Ohio Capital Journal, a part of States Newsroom, a national 501 (c)(3) nonprofit. See the original story here.