Fertility laws can't keep pace with technology
January 14, 2011
www.calgaryherald.com/health/Fertility+laws+keep+pace+with+technology/4112177/story.html
As more Canadians are turning to science to help start a family, the country's fertility laws have fallen behind the times, with few rules governing what's legal or morally acceptable when it comes to artificially making babies - and what's not.
Some fertility doctors are still routinely implanting three or more embryos into women, increasing the risk of twins, triplets or quadruplets, as well as the risk of fatal outcomes or lifelong complications among the babies that survive.
The RCMP is investigating at least two cases of alleged buying and selling of human reproductive material - sperm or eggs cells, or surrogate wombs. And women in India are bearing babies for infertile Canadian couples who are travelling abroad to circumvent the criminal ban against the hiring of surrogates in this country.
An Ottawa doctor and Order of Canada recipient is also facing two civil lawsuits alleging he inseminated two women with the wrong sperm, allegations he denies; the families are seeking a court order requiring the doctor be tested "to conclusively rule out the possibility that he is the donor whose sperm was used."
Fertility doctors are offering women the chance to bank their frozen eggs for "reproductive safekeeping," even though many members of their own profession say egg freezing for fertility preservation is experimental and unproven.
And the list of controversies continues to grow.
A sperm-injecting technique that allows once-infertile men to father a child is increasingly being used despite concerns over its safety. The adult children who were born decades ago to anonymous sperm donors are going to court to find out who their fathers are. And alarms are being raised about the growing and aggressive use of drugs that stimulate a woman's ovaries to churn out more eggs than she could ever produce on her own.
In the 33 years since Louise Brown, the world's first baby conceived in a petri dish was born, advances in artificial procreation have made once-unimaginable conceptions possible. A single sperm can be plucked up in a glass pipette and injected headfirst into an egg, allowing men who produce almost no sperm to father a child. Egg donation is making it possible for women with poor, or zero ovarian function to carry a baby. Babies are being "conceived" using donor eggs, donor sperm and surrogate mothers - meaning with no genetic ties whatsoever to the "recipient" parents.
As pressure mounts on the provinces to follow Quebec's lead to fund assisted reproduction technologies, demand for IVF grows and couples wait longer before trying to have a family, assisted reproduction is poised to move from a niche to a mass market in Canada.
But, three days before Christmas, the country's highest court ruled key sections of the nation's fertility law unconstitutional - throwing efforts to regulate Canada's fertility industry back nearly two decades. The Supreme Court of Canada ruling places much of the industry under provincial jurisdiction and control, effectively killing a scheme to regulate assisted reproduction on a national level. Critics say the absence of federal standards for clinics will lead to a patchwork approach across Canada.
Seventeen years ago, the Royal Commission on New Reproductive Technologies pressed for legislation to govern the business of artificial conception. But there are still virtually no national standards or policies to oversee a field of medicine that critics say, despite its altruistic veneer, is ultimately about the commercialization of the creation of life.
Assisted procreation "is aimed at a take-home baby. That's what everyone is in this for," says Margaret Somerville, founding director of the McGill Centre for Medicine, Ethics and Law. "But ultimately, this is a new human being. And what we have not done in any of this is put that new human being at the centre of our decision making."
Competition among clinics has led to concerns about inflated success claims, doctors transferring too many embryos per treatment cycle and overstimulating women with powerful fertility drugs to produce multiple eggs. Privately, leaders in the field talk about clinics that have such low success rates, what they offer should not be considered "treatments." But, without an oversight body, without regulations, standards and enforcement, they say they've been left in a quagmire.
Meanwhile, the baby-making business thrives. From 2001 to 2008, the births of 28,397 babies from assisted reproduction technologies were reported to the Canadian Assisted Reproductive Technology Registry; 407 babies were stillborn.
In 2009 alone, more than 10,000 cycles of in vitro fertilization were performed in all 28 IVF centres in Canada, more than double the cycles reported in 2001.
In most Canadian provinces, there is virtually no public funding for IVF, although the Quebec government pays for up to three cycles of IVF.
Each cycle costs, on average, $12,000. Couples have re-mortgaged their homes to pay for treatment.
Despite the money changing hands, many in the field deny that they're engaged in commercial transactions.
"In the reproductive business - which is a business - you have this very strange denial of the commercial aspect of what people are doing," says Debora Spar, author of The Baby Business: How Money, Science and Politics Drive the Commerce of Conception.
"I get it, I understand it. I think because reproductive technologies are so new people still have this knee-jerk reaction against them - they get very scared when the words 'baby' or 'reproduction' occur in the same sentence as money," says Spar, president of Barnard College in New York City. "The truth of the matter is that there is commerce going on - and it's pretty expensive and high-priced commerce going on."
In the U.S., "you can buy sperm, you can buy eggs - that's really the market that has exploded - you can rent wombs and you can increasingly put together these complicated package deals, where you buy the sperm from one source, the egg from another and the surrogate mother."
Canada's Supreme Court left in place prohibitions against paying for sperm or egg donors or surrogacy services - activities that carry fines of up to $500,000 or 10 years in prison. But many Canadians are buying and importing donor sperm and eggs from the U.S. - often with the help of Canadian fertility clinics - or travelling abroad for surrogates.
But the most pressing issue is the number of pregnancies still being conceived at a given time. According to preliminary results reported for 2009, the pregnancy rate in Canada was 37 per cent per cycle of IVF started. Twenty-nine per cent of those pregnancies were twins. Two per cent were triplets or quadruplets.
Mothers pregnant with twins are five times more likely to experience complications, such as high blood pressure and gestational diabetes, than women carrying only one baby. Multiples are almost always born prematurely and underweight. They're more likely than singletons to die in their first year of life and are at greater risk of severe, lifelong health problems, such as cerebral palsy.
Doctors say that when parents are paying, the pressure is to transfer more embryos in each cycle of IVF to increase the odds that at least one embryo will implant and a baby will result. Critics say it's ultimately doctors who are driving multiple pregnancy rates, because they're the ones putting the embryos back in.
Quebec began funding up to three IVF treatment cycles for infertile couples last August, with the proviso that just one embryo be transferred at a time in most cases.
In the first three months of the new policy, only 3.8 per cent of IVF cycles resulted in multiples - a fraction of the old rate of 27 per cent.
IVF - where doctors have control over the number of embryos transferred to the uterus - is only part of the problem. More infertile Canadians are resorting to a fertility treatment that doesn't have nearly the success of IVF, but costs thousands of dollars less: ovarian stimulation with artificial insemination. Women inject themselves with the same drugs used in IVF to stimulate their ovaries to produce more than one egg. But, unlike with IVF, there's less control over the number of mature eggs that develop and end up fertilized once the woman is inseminated.
"I'll tell you right now, you don't want more than three mature follicles in there," says Dr. Carl Laskin, president of the Canadian Fertility and Andrology Society. Without proper monitoring, some women can ovulate six or more eggs.
Whether through IVF or ovarian stimulation alone, if a couple ends up with a "high-order multiple," some will choose fetal reduction - a relatively simple procedure that carries huge emotional and psychological ramifications. During the procedure, one or more of the fetuses can be terminated using a solution of potassium chloride that is injected via an ultrasound-guided needle into the fetal heart. There is always the risk of losing the other fetuses.
Professional guidelines developed in 2006 called for more "elective" single-embryo transfers; the goal is to increase the number of single-embryo transfers to more than 50 per cent of cycles for good prognosis patients by 2012.
Of the more than 10,000 cycles of IVF reported in Canada last year, fewer than six per cent involved single embryo transfers.
Laskin's group says the fastest way to lower the multiple birth rate is to tie provincial funding to single-embryo transfers. When patients aren't paying, single embryo transfers are easier to sell, he says.
But those watching say the need for oversight and regulation has never been greater. "The technology is only going to get more complicated, the options are only going to get greater and once you open the door, you can't ever pull back."