March 17, 2006 11:33:22 pm
When a beaming friend held up her twins born recently through in-vitro fertilisation (IVF), I was reminded that couples are increasingly encouraged to view this technology as just another option in addressing infertility. The truth of the matter is that even though Louise Browne, the world’s first test-tube baby, will celebrate her 28th birthday this year, we still do not have good data on the long-term safety of infertility drugs. Hormone treatment and multiple egg extraction do not receive sufficient attention in the area of stem cell research, and often receive even less in IVF. This must not lead one to assume that it is safe. There are several reasons why many women seem to be comfortable with the idea of hormone treatment: the desperation to have a child, pressure from families, failure of many fertility clinics, and continued glorification of having one’s ‘own’ child as opposed to adopting one.
But why are women treated with hormones in the first place? When a woman goes for IVF, she is typically treated with two sets of hormones: those that will stop ovulation by shutting down her ovaries and later those that will hyperstimulate them so that multiple eggs are produced. Generally, let’s remember, only one egg is produced each month during the menstrual cycle. There can therefore be serious problems with these steps, but women are largely uninformed about them.
Lupron, and related drugs, are used for this purpose. Lupron causes a range of problems that have been identified and also reported to the US FDA. These range from rash and dizziness to liver dysfunction and myasthenia. Although approved for specific medical uses in the US, Lupron has not been approved for this specific use in infertility clinics or for extracting eggs for research purposes. As often happens in the US, a drug that is approved for at least one medical condition may then be used for other unapproved purposes. This off-label use is legal but, in Lupron’s case, the FDA has conducted no formal review and approval. Researchers have expressed concern that more than one-third of women who took Lupron did not “demonstrate either partial reversibility” or a “return” of bone mass in the six months after they stopped taking the drug. Some women lost as much as 7.3 per cent of bone density during treatment, more than twice the amount the warnings list.
The drugs used to hyperstimulate the ovaries can also cause problems. A condition called ovarian hyperstimulation syndrome, involves the development of cysts, enlargement of ovaries and fluid build-up, which can lead to renal failure, and even death. The reported prevalence of this severe condition is up to 8 per cent.
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As there is growing worldwide interest in stem cell research, there will be greater demand for eggs, and women from poorer countries will come under increasing pressure. Even though earlier guidelines for Assisted Reproductive Technology in India ban the sale of gametes and embryos, they are routinely flouted in clinics across the country. Women view this as a way to offset the high cost of IVF.
In India, the Indian Council for Medical Research’s draft guidelines on stem cell research allow the use of embryos left over from IVF. While stem cell research is beginning to grow, its regulation is still evolving in most countries including India. India should take the lead in setting not just national but international standards for egg donation.
The writer is a biologist and president of the Council for Responsible Genetics in Cambridge, Massachusetts
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