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    March 2, 2009

    In Vitro Fertilization Connected to Birth Defects — Again. Problems With Lack of Regulation and Safety Testing in the Infertility Business

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    med0303baby_A_433.jpgThe other day, the NY Times ran a story called “Picture Emerging on Genetic Risks of IVF. It reported on a new Centers for Disease Control study that found that children conceived through the most common infertility treatments had a slightly increased risk of several birth defects, including cleft palate and septal heart defects.  believe this is one of the largest studies looking into the connection between Assisted Reproductive Technology (ART) and birth defects, but it’s not  the first.  

    Way back in 2003, I wrote a story for Popular Science called “Sally Has Two Mommies + One Daddy: Making Babies — and Birth Defects?” (Detailed abstract here; PDF of the full story here).   That same year, I also wrote an OpEd for the NY Times called “The Other Baby Experiment,” about the lack of regulation and oversight of infertility treatments, which, in many cases, weren’t tested in safety trials before being offered to patients. I spent months researching that story and was astonished by what I found: extreme fertility treatments, like growing human embryos on pieces of cow and monkey uterus in an experimental procedure called co-culture, or fusing eggs from two women using various procedures to create one viable egg that resulted in a child with DNA from three people (the two egg donors, plus the father).  No one knew what impact any of this might have on the children.  At the time, Phillip Noguchi, director of the FDA’s Office of Cellular, Tissue and Gene Therapies told me, “ART has proceeded largely without formal oversight.  Because of this, some practices now really push the edges of what we’d call genetic manipulation.”  

    It’s no news that infertility treatments are an enormous business:  

    Each year, thousands of women expose themselves and their future children to fertility treatments that were rushed from petri dishes to patients without regulation or human trials. About a million children have been born using assisted reproductive technology, or ART.  Remarkably, the science has become so advanced, couples using it are statistically more likely to conceive a child than those relying on the old-fashioned natural approach. Today, the business of creating children is a $2.7 billion industry. 

    The majority of that business revolves around the most basic and common fertility treatments, like in vitro fertilization and intracytoplasmic sperm injection. When I wrote about this stuff in 2003, the FDA had recently spoken out against co-culture, recommending that the many resulting children be monitored for life and forbidden from donating blood or organs because of the possibility that they’d been infected with deadly animal viruses through co-culture. The FDA had also recently stopped treatments involving cell fusion (though some couples still seek them out in other countries).  Those extreme cases were the only examples of this kind of oversight, and they only happened after many children were conceived using the techniques.
    One of the big questions for me while working on this story was, How is it possible that any infertility treatments — from the most extreme to the most common — weren’t subject to extensive safety trials and oversight before being offered to millions of patients?  The answer:

    While the FDA primarily oversees drugs and medical devices, no U.S. agency regulates medical procedures. Many researchers rely on Institutional Review Boards made up of scientists and laypeople to determine whether experimental procedures–such as new cancer treatments–are ethical. But IRBs are only required for research in federally backed institutions, or for research on FDA-regulated products. ART has always been largely privately funded, so it’s rarely subject to federal regulations or mandatory IRB oversight. Consequently, scientists have developed increasingly risky ART with almost no human research or follow-up studies to ensure safety. This problem went unchallenged, mainly because of taboos about reproductive issues. “We’ve been so tied in knots over anything having to do with abortion, fetuses and embryos, it’s resulted in this extraordinary policy vacuum, which is why ART is largely unregulated,” says Ruth Faden, a health policy professor at Johns Hopkins and director of its Berman Bioethics Institute. “It also created a vacuum with respect to research dollars, so most ART research has been funded by private clinics.”

    For more specifics about the regulation and ethics of ART and its future, check out my interview with Kathy Hudson, founder and director of the Genetics and Public Policy Center at Johns Hopkins.  The interview ran as an online supplement to my Pop Sci story — in it we discussed, among other things, this: 

    RS: What needs to be done to understand the risks ART might have?

    KH: There is an enormous and really tragic paucity of data about the outcomes of ART. There needs to be follow up done to see what effects these procedures have, and who’s going to fund this kind of work is a big question. This work is expensive, and for the feds it’s scary and not high on their list of things to support, because it gets dangerously close to research on embryos.

    RS: Yet there’s such a huge debate over cloning, which raises similar issues.

    KH: Right. There’s an irony here that I just keep finding myself stumped over. Over the last several years, any number of groups have spent a lot of time and attention trying to figure out where they are on cloning, then advocating that position. But even in your wildest dreams, how widespread will reproductive cloning ever be? Is it going to be a real reproductive choice for my nine year-old when he decides that he’s ready to build a family? Meanwhile, back at the ranch, we’ve got ARTs that are here and now. While any number of erudite bodies have sat around meeting tables talking about the necessity for broad public discussion about ART, there really has not been any. So that’s one of our primary objectives.

    Today, six years later, there are things I’d do differently with this story as a writer.  But it’s a useful glimpse into where this issue of ART and birth defects was then, and what has (or hasn’t) changed since.  
    From 2003 my NYTimes OpEd:

    In March 2002, a study in the New England Journal of Medicine reported that the occurrence of major birth defects more than doubles, from 4 percent to about 9 percent, with common infertility treatments like in vitro fertilization and intercytoplasmic sperm injection — the procedure for injecting sperm directly into an egg. So far in 2003, three more studies produced similar data: one found an incre
    ased risk of Beckwith-Wiedemann syndrome, which causes enlarged organs and childhood cancer; another found a five- to seven-fold increased risk of retinoblastoma, a malignant eye tumor. So far, the number of reported cases is small, but they warrant thorough investigation.

    From last week’s New York Times story by Gina Kolata:
      

    the real question — what is the chance that an IVF baby will have a birth defect? — has not been definitively answered. That would require a large, rigorous study that followed these babies. The C.D.C. study provides comparative risks but not absolute risks.  Yet even though the risks appear to be small, researchers who are studying the molecular biology of embryos grown in petri dishes say they would like a better understanding of what happens, so they can improve the procedure and allow couples to make more informed decisions.

    “There is a growing consensus in the clinical community that there are risks,” said Richard M. Schultz, associate dean for the natural sciences at the University of Pennsylvania. “It is now incumbent on us to figure out what are the risks and whether we can do things to minimize the risks.”

    (photo credit here)

    9 Responses to “In Vitro Fertilization Connected to Birth Defects — Again. Problems With Lack of Regulation and Safety Testing in the Infertility Business”

    1. Brittany says:

      This is the first I’ve heard of IVF associated with birth defects. I always thought IVF was a safe alternative for women trying to have a baby. I think most women who choose to use IVF are so desperate to have a chid, they continue the procedures fully knowing the risks involved. Sad…

    2. Linda says:

      “There’s also the question of whether there are underlying issues that cause infertility that would produce higher risks of birth defects on their own. How would you tease out that particular variable in these studies?”
      And how would you count underlying issues that don’t cause infertility but might make it harder for a fertile woman to find a sex partner? Like if she’s perfectly fertile, she has a cleft palate or something, and she lives in a society that labels her ugly for it so it’s harder for her to find a man to give her sperm more directly than through a sperm bank and IVF?
      For that matter, what about women who never tried to conceive naturally before trying IVF? Like if she’s lesbian and never wanted sex with a man, she’s bi and by the time she wants to get pregnant she’s too faithful to her wife to have sex with a man again, she’s hetero but can’t attract a man for whatever non-physical reason, etc.? How do they get tests for infertility?
      “Good point MLO, about maternal age being a greater predictor of birth defects than IVF. We certainly wouldn’t think of regulating away the right of 40 year old women to have babies if they had sperm readily available. Not sure why it seems more acceptable to others to regulate minor risks in treatment.”
      Good point. That also reminds me of this:
      http://news.bbc.co.uk/2/hi/health/1916462.stm
      “A lesbian couple in the US have provoked strong criticism by deliberately choosing to have a deaf baby.
      “Sharon Duchesneau and Candy McCullough, who have both been deaf since birth, were turned down by a series of sperm banks they approached looking for a donor suffering from congenital deafness.
      “The couple, who have been together for eight years, then approached a family friend who was totally deaf, and had five generations of deafness in his family.
      “He donated sperm which was used to impregnate Sharon Duchesneau.
      “Baby Gauvin McCullough is now four-months-old, and has a slight amount of hearing in one ear.
      “The couple have said they will let him decide when he is older if he wants to wear a hearing aid.
      “The man has already donated sperm for the couple’s five-year-old daughter Johanne, who is profoundly deaf and can only communicate through sign language…”
      I wonder how many people would blame the IVF in this case but say nothing if the couple achieved the same results via Duchesneau having unprotected sex with this man instead?

    3. neurolover says:

      Good point MLO, about maternal age being a greater predictor of birth defects than IVF. We certainly wouldn’t think of regulating away the right of 40 year old women to have babies if they had sperm readily available. Not sure why it seems more acceptable to others to regulate minor risks in treatment.

    4. MLO says:

      Instead of reading really bad science reporting, read the actual studies. They don’t agree with what reporters report.

    5. OmegaMom says:

      There’s also the question of whether there are underlying issues that cause infertility that would produce higher risks of birth defects on their own. How would you tease out that particular variable in these studies?

    6. MLO says:

      A 1% increase in likelihood of birth defects is barely statistically significant. The worry-trolling around reproductive science is mind-boggling.
      The real reason there is no research in the USA? Insurance companies refuse to cover infertility – and much infertility would be preventable if women’s health issues were taken seriously.
      Most of the issues would be non-issues if there was a real push for research and women’s health issues such as endometriosis and PCOS were taken seriously. Neither are taken seriously by the inherently misogynistic medical culture.
      Maternal age is a much higher predictor of birth defects than IVF vs. non-IVF birth.
      I have to wonder why people focus on this issue rather than the issues that lead to infertility? Perhaps it is because it shines a light on how dismissive physicians are to women’s gynecological diseases? I think that might be it.

    7. Fascinating post, Rebecca!

    8. Well said. IVF is one of gynecology’s most profitable surgeries (and yes, it is a surgery with the same general risks as other surgeries). For all of its hype and advertising, IVF is painful, invasive, expensive, and it has a 2/3 failure rate with serious risks, as mentioned above. Some reputable studies put the percentage of birth defects even higher. It can result in increased risk of ovarian cancer, ovarian hyperstimulation syndrome, multiple embryos, congenital health problems, birth defects in about 10% of IVF infants (including a three times greater risk of cerebral palsy), and death of the mother. For more on IVF, read Gena Corea’s book The Mother Machine. We’re rarely told that side of the story, so thanks for this Rebecca.

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