Fringe Cloning Venture Raises Troubling Issues

A reproduction specialist once accused of unethical behavior is helping to spearhead a team of foreign scientists on a crash research program to replicate humans.

By AARON ZITNER, STEPHANIE SIMON, Los Angeles Times © 4/22/01 Times Staff Writers

LEXINGTON, Ky. -- When Central Baptist Hospital fired Panayiotis Zavos seven years ago, officials issued a terse explanation: The male reproduction specialist had engaged in "unethical and illegal behavior," an administrator wrote to colleagues. "If Dr. Zavos appears in the lab, please inform me and security immediately. Do not leave him alone in the lab for any reason."

Hospital officials believed that Zavos, a part-time contractor, had used their staff and their premises to help run his private fertility business. They suspected him of violating state law by helping patients have children through surrogate mothers and said he kept patient fees that should have gone to the hospital.

What happened years ago in Lexington would mean little to the rest of the world except that Panayiotis Zavos has suddenly become a leading advocate of something far more controversial--and potentially far more dangerous--than surrogate motherhood. In January, he touched off an international media frenzy by claiming that he, along with a team of foreign scientists, would begin a crash research program to help infertile couples have children through the first-ever human cloning.

Zavos boasts that his 25 years of research on reproduction make him the right person to develop a technology that most cloning experts say is too dangerous to try with humans. In animals, cloning produces dozens of stillborn or unhealthy offspring--some of them grotesquely deformed--for every healthy animal.

To widespread skepticism among scientists, Zavos has told Congress, foreign leaders and countless journalists that he can overcome such problems. He says his team offers a competent contrast to the rogue researchers who may already be trying to clone people in secret--"irresponsible individuals, Saddam Hussein," he said recently. "Obviously, there are a lot of Saddam Husseins in the world."

"Producing developmentally abnormal human children is clearly not ethically acceptable by us," he testified before Congress last month.

But here in Lexington, Zavos' dismissal from Central Baptist Hospital colors his claim that he can draw the line between what is ethical and what is not.

In fact, the dismissal touched off a long and improbable chain of events that led to a rebuke from a judge for misusing the legal system and a citation from the University of Kentucky, where he was a professor of animal sciences, for violating federal rules designed to protect people in medical research.

A jury ordered him to pay a former employee nearly $500,000 in a lawsuit. His own lawyer was subsequently disbarred, in part because of an effort to hide Zavos' assets from the ex-employee.

Zavos denies the allegations made by Central Baptist and the University of Kentucky, and he said that he legally "shielded" his assets from his former employee, which he considered a shrewd move. Yet his record troubles some former colleagues.

"Past behavior seems to indicate to those of us who have had to work with Zavos that his values, ethics and integrity may be in question," said William G. Sisson, president of Central Baptist Hospital.

"If he's not willing to follow those protocol requirements [at the hospital and university], what is he going to be doing when he gets into the larger issue of cloning?" asked Linda Hewitt, a lab technician who raised some of the earliest concerns about Zavos at Central Baptist.

Zavos has plenty of fans, who consider him vibrant, smart and above all, extraordinarily devoted to helping infertile couples have children. "Dr. Zavos was instrumental in us being able to have a family after I can't tell you how many people told us to forget it," said Emily Dyre, a Louisville patient who now has two children. "I think the world of the man."

Health of Child Still the Standard

With his cloning venture, Zavos is drawing criticism far beyond Lexington. The technology has matured to where someone might indeed be able to clone a person. But nearly every cloning expert says it has not developed enough to ensure that the child would be healthy.

Cloning humans today "would be extremely irresponsible," said Ian Wilmut, the Scottish scientist responsible for Dolly, the cloned sheep. "Likely outcomes would include late abortions, the birth of dead children and, worst of all, abnormal children that lived."

Zavos claims to have raised millions of dollars from private donors and started cloning research in a clandestine lab overseas, which cannot be verified. Still, his team has already been criticized by Democratic and Republican lawmakers for proceeding before society has worked out the moral implications of human cloning. His plans have prompted lawmakers to file legislation to bar human cloning, angering medical researchers who fear this might also shut down cloning work aimed at producing cures for disease, rather than children.

Said Arthur Caplan, a University of Pennsylvania bioethicist who also testified before Congress: "I think he is the most dangerous of the current fringe proponents of cloning, because he knows more, stretches the facts and seems to be wallowing in a mix of publicity and fund-raising that rests on a foundation of hype."

People Desperate for Own Children, He Says

A self-described "cowboy," Zavos, 57, seems at peace with himself even while so many others complain about his behavior.

"I'm willing to go to hell to get something done, if I believe it's the right thing to do," Zavos said earlier this month. Wiry, intense and wearing his customary white lab coat, he was interviewed in his combined medical supply and semen analysis office in Lexington. He said he was committed to helping people who have "no other option" to exercise their "right to reproduce."

Zavos has received hundreds of e-mails from people desperate to produce their own children since he made the cloning project public. One U.S. naval officer stationed in Japan wrote that he and his wife had adopted three children, "but it's just not the same as a child from our blood." A man from New Zealand, unable to produce sperm, begged Zavos to help: "I would do anything to have my own child!"

Zavos says he would not be doing the lab work on cloning. That job falls to a team of 10 or so scientists from around the world who, he says, have already started research on animals. They include the prominent Italian fertility doctor Severino Antinori, who has already pushed the boundaries of fertility treatment by helping women become pregnant well after menopause, including a 62-year-old woman.

Zavos calls himself "the referee," in charge of reviewing the group's research data and recommending when it is safe to move from animal to human cloning, though other team members will have input. He says he is reviewing medical records of prospective patients to cull 10 couples from more than 1,000 volunteers who are willing to be cloned.

Zavos has also become the team's international spokesman, a role he clearly relishes. "I just got off the phone with Barbara Walters!" he said on a recent morning, looking delighted.

He showed off his computer in-box, clogged with e-mails from news reporters. A Japanese magazine writer was due the next day. So many TV crews have followed Zavos around--NBC's "Dateline" alone spent four days filming him in February--that the Federal Express delivery man was surprised to see no cameras in the office.

"You're looking better now that you don't have all that press on you," he told Zavos.

Zavos said he will debate Dolly creator Wilmut at Oxford University in June, and he has recently signed on with the speaker's bureau that represents Mikhail S. Gorbachev and Larry King. Already, he said, the bureau has found him three speaking engagements at $10,000 to $15,000 apiece, including one in June before health care executives at the Los Angeles Convention Center.

"I have come a long way, I must say," Zavos said with a smile.

Mother Became Pregnant 26 Times

Born in Cyprus to a poor family, Zavos (pronounced: za-VOSE) remembers selling oranges on the roadside at age 5. His mother, who never learned to read or write, became pregnant 26 times, Zavos said. Eight siblings survived into adulthood. Zavos is the only one to have a college degree. In fact, as he likes to point out, he has four.

Zavos arrived in the United States in 1966, at age 22, and enrolled at Emporia State University in Kansas. To earn cash, he worked nights in a milk-processing plant. To learn English, he watched television. He especially loved the commercials. The slogan from an old restaurant ad is now his motto for his cloning group: "We'll do it right, or we won't do it."

Drawn to reproductive physiology, he eventually moved to the University of Minnesota, where he earned a doctorate. His research focused on ways to freeze turkey sperm.

By the early 1990s, Zavos had won an academic post in the animal sciences department at the University of Kentucky. He published prolifically and won several U.S. patents. Eager to make his mark in the world of human reproduction, he started a private business that sold supplies to fertility clinics.

Zavos also opened a second business, which offered sperm analysis and related services. In addition, he worked at Central Baptist, performing lab work for 10 hours a week in the hospital's reproductive clinic at an annual salary of $55,000. While not a physician, Zavos is trained as an andrologist, or male reproduction specialist.

Then, in 1994, the many parts of his complex work life began colliding uncomfortably. That is when Zavos' lab technician at Central Baptist, Linda Hewitt, told her supervisors that she suspected Zavos was helping surrogate mothers become pregnant and breaking hospital billing rules.

As a Christian institution, Central Baptist helps only married couples conceive children, and it bars any activities related to surrogate motherhood. Kentucky law also bars arrangements in which a surrogate mother is paid a fee.

Hewitt "came to me with the names of people that she thought Dr. Zavos was doing surrogacy with," Michael W. Vernon, former director of the hospital's reproductive labs, testified in a 1996 deposition. "And also she was uncomfortable with the fact that it seemed like he was seeing his patients at Central Baptist, and she knew that when he saw patients at Central Baptist they were supposed to be registered and billed for Central Baptist, and they weren't."

After running a computer check, the hospital found several people who had registered as patients but who had never been billed, Vernon testified in a 1997 civil suit that Zavos brought against another person. Vernon said the hospital contacted two of the patients, who claimed that they had actually paid their bills.

One patient faxed a copy of a canceled check to show proof of payment, Vernon said, "for a procedure that was done by Linda Hewitt in Central Baptist, using Central Baptist equipment. The money should have gone to Central Baptist. It was for two sperm preparations, which are $63 apiece. . . . But the check came in for $1,540, and it was made out directly to Dr. Zavos for the procedure performed by Linda Hewitt. And on that day he was terminated."

Zavos, in an interview, said that some of his private patients might have been inadvertently registered as hospital patients because he asked them to meet him at the hospital rather than his private lab to produce specimens. But he insisted that he never used hospital equipment or personnel to prepare specimens for his private business. "No, no, no, of course not," he said. "Absolutely not."

Zavos also said he is confident his work with surrogacy patients, which he still performs, is legal, because all he does is prepare semen for insemination. He said he plays no role in arranging contracts between surrogates and clients, which, in his reading, is the action barred by state law.

Zavos' dismissal by Central Baptist triggered a series of disputes with others, including employees at his medical supply company, Zavos Biotechnology Laboratories Inc.

Potential Biohazard Alleged by Workers

On the day in February 1994 that the hospital ended his contract, Zavos "began running an andrology laboratory on the property of the company and allowing patients to masturbate in the bathrooms so as to produce a sample for analysis, and quite simply: we are concerned for our health," two employees later wrote to Kentucky's workplace safety office. Their concern was that Zavos was not properly handling semen samples, a potential biohazard.

After the first patient had arrived and gone, the staff confronted Zavos about a variety of workplace complaints. And, unhappy with his responses, three of them soon quit. State officials ultimately fined Zavos $125 for failure to mark a container as holding biohazardous waste.

The situation turned uglier. In May, Zavos swore out a criminal complaint charging one of those former employees, Sheila Thompson, with making harassing calls that disrupted his business.

She was arrested at her home on Mother's Day weekend and detained for two hours, she later testified. But at trial, a judge testily threw out the charge.

"I don't think this was brought by Dr. Zavos in good faith," then-District Judge Sheila Isaac said. "I believe it was vindictive."

Still, Zavos pursued the matter, filing a civil suit against Thompson. But that backfired. She countersued, resulting in a trial that aired the details of the scientist's firing from Central Baptist Hospital. The result: Zavos was ordered to pay Thompson $492,500 for malicious prosecution.

She had trouble collecting because Zavos transferred "a significant amount of assets" from his company to his wife's control, the Kentucky Bar Assn. later found. That contributed to the disbarment of Zavos' lawyer, Ronald A. Newcomer, for helping Zavos "dispose of property following an adverse monetary judgment." Zavos and Thompson later came to a financial settlement.

The tension with Thompson had one other unfortunate consequence for Zavos. One of her calls about Zavos was to a medical research review board at the University of Kentucky. That helped prompt a probe of Zavos' role in supplying semen for a research project on ways to kill the AIDS virus. In August 1994, the review board ruled that Zavos had failed to seek needed approvals designed to protect people who participate in research experiments. It said he had violated university policies and federal regulations, and it put him on notice that his research would be subject to "unlimited, unannounced inspections."

"In his years of experience at two institutions in Kentucky, he has developed problems at both. That should tell you something," said Sisson, the hospital chief, who said he was commenting not to attack Zavos personally but to raise awareness of the protections that patients are entitled to under law.

Zavos retired from the university in February and today carries the title professor emeritus. He still operates a medical supply company and a sperm analysis lab. He also has a new focus: a fertility clinic that he operates with his physician wife, Pette Zarmakoupis-Zavos, which offers such sophisticated services as in vitro fertilization, the technique that produces "test-tube babies."

On its Web site and in its literature, Zavos' Kentucky Center for Reproductive Medicine & IVF boasts a "clinical pregnancy rate of 50%" for 1999, which it says "may well be one of the highest success rates in the country."

But, unlike most other clinics, it does not report how many of those pregnancies resulted in live births or give other details that the industry encourages.

Presented this way, the clinic's statistics "leave no way for consumers to evaluate the information in a way that's going to be meaningful for them," said Sean Tipton, spokesman for the American Society for Reproductive Medicine in Birmingham, Ala., a 9,000-member association of fertility clinic professionals. "What consumers want to know is, 'What are the chances of me having a baby?' And if you can't get any information about how many patients they've treated, or what the patients were like, and you're reporting pregnancies but not deliveries, that question remains unanswered for the consumer."

Zavos responded that he and his wife "choose not to report our statistics" for now because they have been doing in vitro procedures for less than two years and want time to build a track record.
     

'Cowboys Are the Guys That Get the Job Done'

With his ambitious work life, Zavos has become prosperous. Two years ago, he bought a 10,000-square-foot house in a gated golf course community. The three-car garage can only hold half the Zavos fleet, which includes a Lexus, a Porsche and a Mercedes.

That success, he said, is what motivates some of his critics. "Anybody that is successful is going to have a lot of enemies," he said. "They resent the fact that Zavos drives a different car every day."

He said he and his research colleagues want to develop cloning out of a sincere desire to help couples produce children when all standard fertility treatments fail.

"We are not regular scientists. We are the irregulars," he said. "This country was built on cowboys. Cowboys are the guys that get the job done."

Basics of Cloning

Traditional reproduction involves both eggs and sperm, producing offspring with genes from both a mother and a father. In cloning, an animal inherits all its genes from a single adult. Most cloned embryos fail to grow or they die in the womb, experts say.

Normal reproduction

An egg and a sperm each have only half a set of DNA. They must fuse and join their DNA to get the whole blueprint for an organism.

Cloning process

An egg's DNA is replaced with a single set of DNA from a different animal. The egg removes locks in fetal-growth genes. The egg divides and grows into an embryo, which can then be implanted.

* * *                     Times staff writer Tony Perry in                   San                   Diego contributed to this                   story