Pregnant Women Beware

“Don’t worry, be happy” slogan could harm your baby

DRUG BUST by Alan Cassels

The people’s briefing note on prescription drugs

Portrait of columnist Alan Cassels• It’s springtime in Canada and with nature in full bloom, it’s timely to reflect on reproduction in all its forms.

If you’re in the drug manufacturing business, your organization exists to produce profits. While we might criticize pharmaceutical companies for putting profits before public health, my sense is you can’t fault a company for seeking profits any more than you can fault a cat for chasing mice; it’s what they do.

But if you place the business of selling drugs beside the business of human reproduction – i.e. having babies – you witness some strange things. You discover, for example, that some drug companies and the spokespeople they fund don’t seem all that worried about women taking drugs while pregnant.

Midwives, obstetricians and doctors are typically very cautious when it comes to counselling their pregnant patients around prescription drugs. Yet they can’t avoid the savvy drug manufacturers that clearly don’t want to cut themselves off from the lucrative market represented by millions of pregnant or lactating women. Manufacturers serve shareholders; in fact, that’s the only constituency they must report to so they can’t ignore any segment of the market. However, exploiting the pregnancy market has many potential challenges.

For starters, it’s not as easy as it looks to convince pregnant women to take drugs; you have to overcome one of the strongest forces on the planet – a woman’s intuition, which seems finely tuned towards precaution and safety. Things that don’t ‘feel right’ – such as the suggestion to ingest powerful chemicals when you’ve got a baby inside you –are hard to suppress. Regardless of the assurances of some experts, many medical treatments, including prescription drugs, vitamins and alternative therapies, have never been properly tested in pregnant women. When faced with this dilemma, I think women trust their intuition, often guided by outside sources of information that seems credible.

Drug companies and their paid surrogates have to work awfully hard to seem credible to women. What makes it difficult is the lingering taint of past drug disasters – the ones that were catastrophic for many women and their babies. Drugs such as thalidomide or DES (diethylstilbestrol) were given to pregnant women with disastrous consequences and so downplaying those examples by claiming that we do things differently today seems a key strategy. Many suggest the world is much safer now and that modern drug regulatory systems are ensuring those disasters could never happen again.

I interrupt this column to bring you a public service message: “Anyone want to buy a bridge?” Now, where was I?

The most infamous example is the thalidomide disaster of the sixties, which stemmed from a drug given to pregnant women to treat morning sickness. Thalidomide resulted in thousands of children being born with deformed limbs and digits. One would expect that images of “flipper babies” would be seared into our public consciousness, putting a halt to treating pregnant women with pharmaceuticals. Yet that disaster, however stark in its imagery, had a sister: DES was a synthetic estrogen prescribed to millions of pregnant women for nearly 30 years, causing cancers of the vagina and cervix in the daughters of women who took DES during pregnancy (among other things).

If you are pregnant and concerned about prescription drugs, where can you find good information? According to a recent article in Glow, a slick Canadian fashion magazine, the major source of information for Canadian mothers-to-be is the Motherisk program in Toronto – www.motherisk.org – which was created to “give women and health professionals accurate and reliable information.”

According to the Motherisk website, the group actively “reviews data from around the world and conducts studies to determine the risks of drugs during pregnancy.” They conclude “it is now clear that there are many drugs that are safe for use in pregnancy.” I seriously wondered about that – my intuition was telling me something different – so I decided to look closely at what Motherisk said about one major drug class used in pregnancy: antidepressants.

Their information says that some research “described a poor neonatal adaptation syndrome in newborns whose mothers had been taking tricyclic, SSRI or SNRI antidepressants near term,” adding that “the most common adverse effects associated with this syndrome are transient, mostly self-limiting, jitteriness; grasping muscle weakness; and respiratory difficulties that sometimes require use of a ventilator.” The suggestion is that these difficulties pale in comparison to the risk of the mother and fetus if the mother’s depression isn’t treated.

What is odd is that the Motherisk program fails to mention other major dangers found by independent research groups that have done fairly exhaustive research on the issue. The Therapeutics Initiative at UBC – which takes no drug company money – reports an extensive analysis of six studies of antidepressants in pregnancy and found “SSRI use was associated with more spontaneous abortions.” (See their newsletter at http://www.ti.ubc.ca/letter76)

Lejla Halilovic is a women’s health activist in Toronto and she has a number of problems with Motherisk’s information. Her biggest concern, besides feeling the information they provide women is outdated, is that Motherisk fails to point out specific drug safety advisories issued by regulators. She says “it’s outrageous that one of Canada’s biggest resources for pregnant women lacks Health Canada warnings,” such as the one warning of (Paxil) paroxetine’s risk posted in December 2005.

The UBC folks conclude that, based on a meta-analysis of 14 observational studies, paroxetine may cause as many as one in 200 women to have a baby with heart problems. Does Motherisk mention “cardiac malformations?” It’s not there. Well, what about other SSRIs, like Prozac (fluoxetine) or Zoloft (sertraline)? Do they have the same kind of risk? UBC research found an eight-year follow-up study of all births in Denmark, where women had filled at least two prescriptions for SSRIs while pregnant. Those women had a one in 246 chance of having a child with a heart defect.

Motherisk also fails to mention SSRIs can cause persistent pulmonary hypertension of the newborn (PPHN), in about one per 1,000 live births and can be potentially fatal.

So let me recap: a major agency in Canada that alleges to inform women of the safety of drugs in pregnancy doesn’t mention major Health Canada safety warnings and fails to note that miscarriages, cardiac effects and other rare, but potentially fatal, dangers are associated with taking antidepressants while pregnant. I’m scratching my head; why would they leave such important stuff out?

Please don’t say they are pharma flacks.

Lejla Halilovic reminds me that Motherisk is staffed by very good and committed people but, alas, with any drug source you need to know who is paying the bills. A quick tour of the Motherisk site explains the website service is sponsored by a drug company (Duchesnay), a drug store (Shopper’s Drug Mart) and a foundation (Sick Kids Foundation), which itself takes money from most major drug companies.

Of all the information on the Motherisk website, the disclaimer is probably the most honest. It notes, “We do not guarantee or warrant the quality, accuracy, completeness, timeliness, appropriateness or suitability of the information provided,” adding, “you assume full responsibility for the use of the information.”

Amen to that.

Pregnant and told to take pharmaceuticals? Perhaps you can start by avoiding sources that are obviously drug-tainted. Remind yourself that thalidomide and DES were huge disasters, partly due to the biased information given to women.

Again and again, we need to be reminded that information, which is clearly being funded by an industry that lives to chase down and capture new customers, as the cat chases mice, cannot be acting in the best interests of patients.

This is especially worth remembering next time someone is trying to override your intuition with a “don’t worry, be happy” message around drugs in pregnancy.

Alan Cassels is a drug policy researcher at the University of Victoria and the author of the just-launched Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. Read more of what he’s writing about at www.alancassels.com

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