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Doctor pioneers new birth control method

by: Ray Weiss, Staff Writer, Daytona Beach News Journal
Jane Sciortino never wanted children.
Over the years, she tried a variety of contraceptives from birth control pills to Norplant implants. But she always worried about the possible health risks associated with hormonal-based products.
Over the years, she tried a variety of contraceptives from birth control pills to Norplant implants. But she always worried about the possible health risks associated with hormonal-based products.

"I have two sisters who are **** cancer survivors," says Sciortino, 45, who lives in New Smyrna Beach. "I didnt want hormones."

So three years ago, she underwent a controversial, nonsurgical sterilization procedure in Dr. Randall Whitneys Daytona Beach family planning clinic. Pellets made from an anti-malaria drug were inserted into her uterus, scarring and sealing the ends of her fallopian tubes.

"Ive had no problems. Im the same person," Sciortino said. "Its better than hormones. This is permanent. I have peace of mind."

Quinacrine was used to treat malaria from the 1920s through the 1940s. In 1977, the solid pellets were introduced, replacing an ineffective and risky quinacrine-based solution for sterilization that was developed years before in Chile.

Whitney, 70, is believed to be the only doctor in the United States doing quinacrine-pellet sterilization, having performed 12 procedures since July 2000. A self-described maverick, he maintains other physicians fear lawsuits "until the FDA comes aboard."

The U.S. Food and Drug Administration has not approved quinacrine pellets for sterilization, although testing is under way. Jason Brodsky, an agency spokesman, said the status of any FDA clinical drug study is confidential.

But he said doctors in their individual practices can use an approved drug such as quinacrine in any "off label" way they consider appropriate.

"We regulate the drug products. We dont regulate physicians," he said. "Thats a state issue."

Whitneys medical record is listed by the Florida Department of Health as "clear and active," with no disciplinary or malpractice-liability actions exceeding $100,000 on his record within the last 10 years the criteria set by the state.

Quinacrine sterilization is nothing new.

More than 130,000 women in about 30 countries that include Chile, India and South Vietnam have undergone the permanent birth-control procedure during the last 25 years.

But the quinacrine sterilization was stopped in the early 1990s by some countries after opponents, which included the World Health Organization, raised concerns about uterine cancer risks.

Proponents such as Whitney say follow-up studies of thousands of women overseas debunk those claims.

"The technique is safe and effective. I have seen no side effects," Whitney said of quinacrine sterilization, which is done in two short office visits a month apart. "There have been no deaths or serious complications with the pellets. Its as malpractice-proof as you can get."

Another objection by opponents is that women in poor nations were not properly informed about the permanence of the procedure.

Whitney said all but two of the women he has sterilized with quinacrine are white, and they requested the $500 procedure, which is not covered by health insurance, after they studied the literature and signed a detailed consent form.

Laurel Havlin, 42, an insurance saleswoman who now lives in Atlanta, said she was looking for an alternative to surgical sterilization. She said she "had a history" as a patient with Whitney and trusted him.

"Anytime somethings new, theres a lot of controversy," said Havlin, a former Ormond Beach resident who has three grown children. "But I was willing to take a chance. To me, theres as much risk getting your tubes tied, as with this. And with birth-control pills, you risk **** cancer."

In November 2001, she underwent the quinacrine procedure.

"Ive had no reactions, other than a little cramping the first day," she said. "And I havent gotten pregnant."

Quinacrine sterilization usually is done with no anesthetic. The seven pellets become liquefied, causing inflammation and then scarring. It usually takes three months to become sterile.

Kirsten Moore is the president and chief executive officer of a Washington D.C.-based organization that promotes safe and effective contraception methods for women.

As leader of the Reproductive Health Technologies Project, she took part in a conference three years ago that brought together 55 experts from around the world who discussed the pros and cons of quinacrine sterilization, which resulted in a report, "The Quinacrine Debate and Beyond."

Moore said the current follow-up studies done on patients overseas are not enough to either support or kill the procedure.

"The data was developed outside traditional clinical pathways," she said. "Since (sterilization) is permanent, there needs to be solid, gold-standard data."

She said only a FDA clinical study could give quinacrine sterilization legitimacy.

Dr. Vanessa Cullins, vice president of medical affairs for the Planned Parenthood Federation of America, agrees research on the safety and effectiveness of quinacrine, or any other form of sterilization, should be "methodologically rigorous, designed for FDA approval. .. This is the view weve had all along." Dr. Amy Pollack, president of EngenderHealth, an international family planning agency, says many people object to any form of birth control, and that risks and benefits exist with any form of birth control.

Stephen Mumford from Chapel Hill, N.C., has been an international advocate of quinacrine sterilization for 25 years.

Mumford, who has a doctorate degree in public health, maintains quinacrine already is a safe and effective option for population control, and a low-cost alternative to tubal ligation, which requires hospitalization. "Its something we desperately need. It can be offered in remote areas around the planet," Mumford said. "Were not going to learn more by following large numbers of women for decades. We already have 25 years of follow-ups in Chile and Vietnam."

But Mumford acknowledged FDA approval is necessary to establish quinacrine sterilization as a legitimate birth-control option, allaying the fears and concerns about the permanent procedure.

"Weve always known that. Our problem is it takes a lot of money," he said.

Meanwhile, Mumford says Whitney is the only doctor in America doing the procedures, other than the Buffalo physician who sterilized 10 married women as part of the FDA study, and a few doctors who sterilized "someone they knew." Whitney says he found himself in a similar position more than a decade ago, when he began using Depo-Provera, a cancer-fighting drug that provides women three months of birth control with a single injection.

He said the FDA approved the synthetic hormone in 1992 as a contraceptive only after physicians nationwide already were giving women the shots.

"I was one of the first doctors in Florida to use it, and I was warned that if a lawsuit came, Id be hung out on a limb. Now its a routine, major method of protection," Whitney said. "I think the same thing will happen with quinacrine, if enough doctors get involved. The whole world is watching the United States."

Did You Know?
Until recently, permanent contraception options for women in the United States were limited to conventional tubal ligation, a surgical procedure performed in an operating room and requiring a small abdominal incision and anesthesia.

The Essure sterilization method involves placing a tiny, flexible insert into each fallopian tube through the uterus using a special catheter.

Essure received Food and Drug Administration approval in 2002. Other nonsurgical methods are in various stages of development. They include the Adiana procedure, a twostep implant technique; microwave tubal occlusion and the intrauterine placement of quinacrine pellets.

SOURCE: Association of Reproductive Health Professionals

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Quinacrine changed my life!
The procedure was essentially painless, affordable, and freeing!
I love my new lifestyle.
Thank you, Dr. Whitney!"
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