Calls for more widespread safety information on PGD

By Sarah Guy, MedWire Reporter

The informed consent process for prospective parents considering prenatal genetic diagnosis (PGD) may be inadequate due to a lack of disclosure by fertility clinics about the risks involved in the procedure, says a US researcher.

Michelle LaBonte (Wellesley College, Massachusetts), who catalogued material on websites of In vitro fertilization (IVF) centers that offer PGD, found that over three-quarters of sites did not mention safety or risk at all.

Given the important role the internet plays in consumer education, this is the way the majority of parents initially learn about the procedure, she maintains, suggesting that such information can also produce biases that influence decision-making.

After analyzing the websites of 262 US IVF-PDG centers, LaBonte found that 78.2% neither had statements relating to the safety of the PGD procedure, nor to the potential risks it carries.

Of those that did contain risk or safety information, the most frequent statement was that human studies have demonstrated the safety of PGD (10.3% of all centers).

In fact, existing reports about how the embryo biopsy procedure affects any children born are conflicting, remarks LaBonte, with some studies showing no adverse health outcomes, and others indicating subtle neurologic deficiencies as one possible outcome. She found that none of the websites mentioned neurologic risks.

The proportion of centers proclaiming only the safety of PGD, only the risk of it, and those that included statements about risk but also proclaimed its safety, was similar, at 8.4%, 6.1%, and 7.3%, respectively.

"Most interestingly," says LaBonte, is that 94.7% of the centers with mixed safety statements included a mention that "human studies have documented safety" of the procedure, and this kind of proclamation is likely to trump any that raises risk.

The author suggests various reasons why PGD risk may be absent from providers' websites, including that the focus of the procedure itself is on the reduction of risk ‑ risk from disease/abnormalities, that the focus may be on individuals' choice rather than safety in order to protect patient autonomy, that no significant adverse effects have yet been solidly proven in humans, and that providers may be subject to financial incentives to encourage prospective parents to undertake PGD.

"Prospective parents of PGD babies should be made aware of all safety information, including that of human and animal studies, and be informed that long-term, definitive safety studies have not yet been carried out. Anything less should not be considered 'informed' consent," concludes LaBonte in the Journal of Medical Ethics.

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