The U.S. Food and Drug Administration (FDA) issued a warning letter to Faro Owiesy, a researcher and physician at the California-based Corona Doctors Medical Clinics, for violating a clinical hold. In addition, the agency warned Owiesy for giving an investigational drug to patients before an investigational new drug (IND) application was approved.
The U.S. Food and Drug Administration (FDA) issued a warning letter to Faro Owiesy, a researcher and physician at the California-based Corona Doctors Medical Clinics, for violating a clinical hold. In addition, the agency warned Owiesy for giving an investigational drug to patients before an investigational new drug (IND) application was approved.
The letter was dated November 16 and cites an FDA inspection at Owiesy’s site between June 22 and June 27, 2018 by Denise L. Burosh of the FDA. The review was of Owiesy’s “conduct as the clinical investigator and authorized representative of the sponsor of a clinical investigation.”
The clinical hold was placed on the study during a teleconference held August 10, 2017 “for insufficient information to assess risks to human subjects of the proposed study.”
The agency then followed up, sending a Full Clinical Hold letter dated September 7, 2017.
In short, Owiesy was conducting a clinical trial on patients, which was not approved by the FDA. After a discussion with the agency, where they told him to stop, even after repeated follow-ups by phone and letter, he continued treating patients. An inspection by an FDA official in June of this year found that Owiesy had continued treating patients repeated warnings.
The agency has redacted details about the sponsor of the clinical trials or what drugs or biologics were being used.
Although not confirmed that this is the same trial, Owiesy is listed with ClinicalTrials.gov as principal investigator of a clinical trial for chronic migraine without aura. In that trial, a combination of dexamethasone, lidocaine and thiamine are used to treat migraine headaches.
The web pages states, “The objective of this study is to assess the safety and efficacy of concomitant administration of dexamethasone, lidocaine, and thiamine compounds into the trigeminal nerve branches, the greater and lesser occipital nerve for the treatment of chronic migraine, and craniofacial neuralgia.”
The FDA is giving Owiesy 15 working days from receiving the warning letter to notify the agency in writing of his plan to “prevent similar violations in the future. Failure to adequately and promptly explain the violations noted above may result in regulatory action without further notice.”
In a related story, the U.S. Department of Justice in August filed a civil complaint against two Southern California doctors and their companies for “allegedly offering unproven stem cell treatments at clinics in Rancho Mirage and Beverly Hills without government approval.”
The L.A. federal prosecutors want a permanent injection against California Stem Cell Treatment Center, Cell Surgical Network Corp. and doctors Elliot B. Lander and Mark Berman from marketing stem cell products to patients without FDA approval.
Berman and Lander oversee the operations of about 100 for-profit affiliate clinics, including the two listed in the civil filing.
The filing alleges that the companies make “stromal vascular fraction” products from patients’ body fat. The companies market these as stem cell-based therapies for a variety of diseases, including cancer, pulmonary disease, arthritis, stroke, ALS and multiple sclerosis.
Berman, according to The Press-Enterprise, argues that because the treatments come from the patients themselves, they are not drugs. “They’re your own property. We’re not manufacturing a drug.”
The Department of Justice filed the complaint at the request of the FDA. A similar complaint was filed against U.S. Stem Cell Clinic in Sunrise, Florida.
