カリフォルニア医療評議会では、Ms. Sulemanの場合に実地医療の基準に違反していたかどうかについてMichael Kamrava医師を調査中である。NBCニュースとのインタビューにおいて、Ms. Suleman(33)は、Kamrava博士が6つの胚を移植し、それらの2つが双子の中に分かれ、8人の赤ん坊を結果として生じていたと言う。ビバリーヒルズのウェスト・コーストIVFクリニックで実施したという。
Questions Grow for Fertility Clinics
By STEPHANIE SAUL
Published: February 11, 2009
MONTEBELLO, Calif. ― Pictures of children, his trophies, decorate Dr. Tien Chiu’s office.
Three smiling siblings, he says, were the first Japanese-American triplets conceived in a laboratory, while the robust-looking quadruplets were born after sperm was injected into their mother’s eggs with a needle.
To the couples who turned to Dr. Chiu to have families, the babies were special gifts. To the government and fertility industry, though, such large multiple births have begun to look like breakdowns in the system. The issue has taken on renewed scrutiny since a California woman, Nadya Suleman, who already had six children conceived through in vitro procedures, gave birth to octuplets near here last month.
Nearly a third of in vitro births involve twins or more. The government, along with professional associations, have been pushing fertility doctors to reduce that number, citing the disastrous health consequences that sometimes come with multiple births ― infant mortality, low birth weights, long-term disabilities and thousands of dollars worth of medical care.
The American Society for Reproductive Medicine, the association of fertility doctors, even adopted guidelines in 2008 encouraging the transfer of only one embryo for women under 35, and no more than two, except in extraordinary circumstances. The guidelines allow more for older women, up to a maximum of five.
But unlike some other countries, the United States has no laws to enforce those guidelines. The Centers for Disease Control and Prevention has a surveillance system that collects data on fertility clinics, but reporting is voluntary and there are no government sanctions for not reporting.
As a result, experts say many doctors are still implanting too many embryos to increase the chance of pregnancy. Only 11 percent of in vitro procedures in the United States involve single embryos, according to 2006 data from the C.D.C. But recent professional guidelines say that in many cases, it is healthier to implant only one embryo, even if it means the process has to be repeated, because of the risk of multiple births. In the case of Ms. Suleman, the California Medical Board said it was investigating her doctor, Michael Kamrava, to determine whether accepted standards of medical practice were violated. In an interview with NBC News, Ms. Suleman, 33, said that Dr. Kamrava had implanted six embryos, and that two of them had divided into twins, resulting in eight babies.
“She wanted to have many, many babies,” said Dr. Chiu, who added that he had formerly treated Ms. Suleman but declined to give details.
Attempts to reduce the multiple birth rate are also sources of tension in the industry.
One cycle of in vitro fertilization costs about $12,000. Women who are not successful the first time often try again and again, which can push the cost of having a baby to more than $100,000. Because the technology is often not covered by insurance, doctors say they are constantly urged by patients to implant extra embryos. By doing so, women believe they raise their chances of becoming pregnant, but extra embryos also increase the chances of multiple births.
One woman, a nurse who could afford only one try at in vitro, pressured Dr. Chiu to transfer eight embryos. “I said under one condition,” Dr. Chiu remembered. “I made her sign an agreement that she would do selective reduction.” That agreement, to remove some of the embryos if they lived, was very likely unenforceable. But in the end it worked out. Only one embryo survived, and the woman gave birth to a healthy child, he said.
Dr. Chiu said that a situation in which he would implant eight embryos would be a rarity, adding, “I don’t think any doctor would try to make a multiple pregnancy.”
Ms. Suleman now has 14 children born through in vitro fertilization. In the NBC interview, she identified the clinic where she received her treatment as the West Coast IVF Clinic in Beverly Hills, Calif., which is run by Dr. Kamrava. Dr. Kamrava did not return telephone calls seeking comment.
Ms. Suleman said in the interview that she was aware of the risks of multiple births, but that she wanted to use all the embryos available to her.
The treatment involves removing eggs from a woman’s ovaries, combining them with sperm in a laboratory, and implanting the resulting embryos in the woman’s uterus. (In some cases the eggs come from a donor.) The number of embryos implanted is often a judgment call and can make a big difference in a pregnancy’s outcome.
“Every single decision we make about embryo transfers is a tough one, because we don’t have a crystal ball,” said Dr. Jeffrey M. Steinberg, who runs the Fertility Institutes, a group of fertility clinics based in Southern California.
The industry has doubled in size in the decade since the C.D.C. started collecting data in 1996. That year, 64,681 procedures were performed in 330 clinics. At last count, the number of procedures was up to 134,260 and there were more than 483 clinics across the country. More than 50,000 children a year are born as a result of in vitro fertilization in this country. Nationwide, it is a more than $1 billion business.
The percentage of births involving triplets or more declined to 2 percent in 2006, from 7 percent in 1996. The American Society for Reproductive Medicine points to that decline as among its successes.
Dr. Daniel A. Potter, medical director of Huntington Reproductive Center, also in Southern California, said the onus remained on the doctor, regardless of the patient’s wishes.
“If someone came in and wanted to transfer six embryos in a situation like we’re talking about, we have an obligation to protect the patient and not let the patient do things that are unreasonable,” Dr. Potter said.
Dr. David Hill, an embryologist who directs the laboratory at the ART Reproductive Center, an in vitro clinic in Beverly Hills, said that the United States had retained a laissez-faire stance toward in vitro procedures, instead of regulating the process like some other countries do.
But comparing the United States industry with Europe’s, for example, may be unfair because some countries cap costs for in vitro fertilization or require coverage by health programs, removing the financial incentive by women to push for pregnancy on the first try.
“The point is, there was greater pressure for U.S. clinics to deliver, no pun intended, on the first try,” Dr. Hill said, “so they would put back more embryos, and hopefully one of them would take.”
More recently, methods of producing and selecting embryos have improved, removing some of the incentive to implant a high number. Recent statistics suggest that the likelihood of pregnancy may be as good with two embryos as with three.
Even so, when patients hear the pros and cons, they often push to have multiple embryos implanted, Dr. Hill said. “I can’t tell you how many patients will come in, and when we explain the risks of twins, they say, ‘Hey, bring it on.’ They’re desperate to get a family going.”
Part of the reason doctors might acquiesce to a patient’s wish could be the fierce competition in the industry. California has more doctors performing in vitro fertilization than any other state, with many concentrated in the Los Angeles area.
The competition means that sales pitches are not unusual.
The Huntington Reproductive Center offers a refund for some women. No pregnancy? You get 90 percent of your money back.
Want to predict the sex of your baby? That is 99.99 percent guaranteed at the Fertility Institutes.
Dr. Kamrava, Ms. Suleman’s doctor, had previously raised eyebrows in the industry by advocating a procedure called “SEED” ― subendometrial embryo delivery, in which he said he could increase pregnancy rates by using a plastic tube to insert embryos under the lining of the uterus for maturation, rather than in the uterus. The procedure’s value was never scientifically proven, according to Dr. Potter.
Several southern California doctors disclosed embryo transfer rates significantly higher than the national norm, according to the C.D.C. data. A look at Dr. Kamrava’s statistics in 2006, for example, might have raised red flags.
They revealed that Dr. Kamrava’s clinic had one of the nation’s highest rates of embryo transfer in younger women ― 3.5 versus a national average of 2.3. Such high embryo-transfer rates are sometimes an indication that a doctor is being too aggressive in trying to raise the number of pregnancies. In Dr. Kamrava’s case, however, those numbers were among the lowest in the nation. Of 56 procedures performed by his clinic in 2006, only two resulted in women giving birth, one to a single baby and the other to twins.
The twins may have been the set born to Ms. Suleman that year.
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