A Lexington physiologist who fanned international controversy with claims about working to clone human embryos pleaded guilty Thursday to shipping unapproved home pregnancy-aid kits.
Panayiotis M. Zavos, 70, admitted guilt in federal court in Lexington on one misdemeanor count of introducing misbranded medical devices into interstate commerce.
Zavos' potential sentence under advisory guidelines ranges from no jail time to six months, according to the calculation in his plea agreement. However, U.S. District Judge Karen K. Caldwell does not have to follow that guideline range when she sentences Zavos in January. The maximum penalty is one year in prison and a $100,000 fine.
Zavos' company, Zavos Diagnostic Laboratories, also pleaded guilty. The maximum penalty for the company is a fine of $500,000. Under the plea deal, Zavos' attorneys can argue for a lower fine, but not less than $250,000.
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Zavos, a reproductive physiologist, burst into the international news in January 2001 when a partner, Italian physician Severino Antinori, announced in Lexington that he planned to try to clone a human within a year. Zavos said he would be part of the effort and took a high-profile role in advocating for it.
Doctors and others raised ethical concerns, religious objections and medical risks of trying to clone a human, and many denounced the effort. Zavos was unfazed, saying human cloning was inevitable.
"Do we develop it as serious, dedicated scientists? Or do we let somebody else do it in some clandestine laboratory, and start cloning the wealthy and the famous and forget about people who really need this?" he told the Herald-Leader in 2001.
At the time of the announcement, Zavos had been a faculty member since 1979 at the University of Kentucky, where he taught animal-science classes and researched animal reproduction, but he retired soon after.
Zavos said at the time that UK officials were concerned about his association with such a controversial project — that his life was "too colorful for the university to handle."
In 2004, Zavos said he successfully implanted a cloned human embryo in a woman, but scientists expressed deep skepticism. In 2009, he told a British newspaper he had implanted cloned embryos in four women but said none resulted in a pregnancy.
One of Zavos' attorneys in the federal criminal case, Robert Michael Murphy, said he had no information on what happened with Zavos' cloning work.
Murphy said Zavos had shifted his focus in recent years to assisted reproductive technology. He travels often to the Mideast and other areas as part of his work.
Zavos has operated a business called the Andrology Institute of America for more than a decade in Lexington. Andrology is the study of the male reproductive system, according to the website of the American Society of Andrology.
The institute website, which refers to Zavos as the "Father of Andrology," advertises infertility services such as semen analysis and isolation of high-quality sperm.
The products at issue in the federal criminal case were labeled as being made and distributed by the institute and Zavos Diagnostic Laboratories from a Southland Drive office, according to a court document.
The products were home-conception aids that Zavos and Zavos Diagnostic Laboratories sold through a website. The price of the Zavos Home Conception Pak was $79.95, according to a court document.
The kits included items such as a condom and catheter that customers could use to collect sperm and for intrauterine insemination, according to a court document.
The company promoted the products as being effective in promoting conception and said they were approved by the U.S. Food and Drug Administration, but the federal agency had not given its approval, according to a court document.
The home-conception kits did not have adequate directions for use, were made or processed in an establishment not registered with the FDA, and were distributed across state lines without proper notice to the FDA, according to plea documents.
The period covered in the charges was June 2009 through April 2010. Sales of the kits generated $288,000 from 2008 through 2010, according to a court document.
Prosecutors and Zavos' attorneys have been negotiating a resolution of the case for years. In addition to Murphy and his partner, Jarrod James Beck, former U.S. Rep. Ben Chandler represented Zavos.
Zavos declined comment after his hearing, saying he would hold a news conference after his sentencing.
Murphy said Zavos thought the kits were legitimate devices to help women get pregnant.
"He was just trying to sell a product that didn't cost as much" as other kits on the market, Murphy said.
"It's a regulatory violation on his part," Murphy said of Zavos' infraction.
Zavos agreed as part of the plea deal to close or sell his lab and to never again sell medical devices within, to or from the United States.