Swedish "researchers" are at it again.
Last week, they targeted potato chips and french fries for a health scare. This week, it’s Claritin — the most widely used allergy medicine in the U.S. and one of the most widely used in the world.
The nature and timing of the Claritin scare seem somewhat suspicious.
The researchers claim records in the Swedish birth registry show 15 cases of hypospadia — a malformation of the penis that may be repaired through surgery — among about 1,400 infant boys whose mothers allegedly used the drug in early pregnancy.
Claritin has been sold in the U.S. since 1993 and in Western Europe and Canada since 1988. Its world-wide use amounts to about 14 billion patient days per year. Few drugs are more widely used.
The Swedish report is not a controlled scientific study. No comparison was made of hypospadia rates between Claritin users and non-users.
The report is a novelty. Despite Claritin’s widespread use, no previous report has linked the drug with hypospadia. A very reasonable, if not probable explanation is that the reported hypospadia rate isn’t so extraordinary.
Hypospadia rates in the U.S., for example, may reach as high as eight cases in 1,000 births. The reported Swedish rate works out to 10.7 per 1,000 births — not much different than what might normally be expected.
Adding doubt to the purported link between Claritin and hypospadia is the uncertainty over whether the women even used the product during pregnancy or during a period of the pregnancy when hypospadia might result. The data collected in the Swedish registry are from self-reported questionnaires that are not verified and may include incomplete and incorrect health history.
No effort was made to consider other factors that may have caused the reported hypospadias.
Extensive animal tests by Claritin’s manufacturer Schering-Plough, conducted at the request and with the assistance of the Swedish Medical Products Agency, indicate that Claritin does not disrupt normal hormonal processes, the only non-genetic mechanism through which hypospadia is hypothesized to result.
As pointed out in a recent study in the March, 2002, Journal of Urology, hypospadia has a strong genetic component and seems to occur more often among those with low birthweight.
There doesn’t seem to be a reason to panic, yet that is just what someone seems to be fomenting.
At Sweden's request, the European Medicines Evaluation Agency agreed to review the safety of Claritin. Health Canada has launched a probe. The U.S. Food and Drug Administration just announced that it, too, will investigate.
Though the FDA acknowledged it was not aware of any similar reports in the U.S., "we are concerned about this and we are looking at it," said an FDA spokesperson.
But something smells rotten in Denmark … er Sweden, I mean.
Claritin is set to go off patent later this year, opening up quite a competition among pharmaceutical companies.
Schering-Plough’s competitors hope to be able to sell cheaper, generic versions of Claritin. Schering-Plough hopes to be able to sell Claritin over-the-counter before the end of the year and has begun marketing what it says is an improved version of Claritin, called Clarinex, to be available by prescription.
Competition among pharmaceutical manufacturers is far from friendly. It can, in fact, be a downright cutthroat business.
Rival manufacturers of blood pressure medication are believed to have engineered a well-publicized, mid-1990s heart attack scare against Pfizer’s calcium channel blocker drugs. Premarin, a widely-used hormone replacement therapy, and the laxative Ex-Lax have been targets of cancer scares manufactured by industry rivals.
The Swedish report reeks of a set-up. Given what is known about hypospadia, it’s not clear why anyone would focus on Claritin in the first place.
Finally, Sweden is the place I’d go to launch a health scare. It’s been a bottomless source of bogus health scares.
In addition to last week’s alarm that naturally-formed acrylamide in fried and baked foods may cause cancer, Swedish researchers are notorious for frightening us about chemicals in the environment disrupting hormonal processes, power lines causing brain cancer and radon in the home causing lung cancer.
Fifteen hypospadias dubiously linked by Swedish researchers to a popular pharmaceutical product about to go off patent? I may buy a Volvo or a Saab from the Swedes, but not this nonsense.
Steven Milloy is the publisher of JunkScience.com , an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).