Science, meet capitalism.

There was an accident on the freeway this morning, which meant I listened to more NPR than my usual getting-to-work dose. Possibly, my peevishness at the boneheads who snarled the roads by colliding so inconsiderately is spilling over into peevishness at the scientists in the stories I heard. You be the judge.

Want to know the sex of your fetus really fast? You might be tempted to get the Baby Gender Mentor test (although you might not be tempted to say "Baby Gender Mentor test" five times fast). But, according to reporter Nell Boyce, you won't have much data to reassure you that this is money well spent.

Basically, Acu-Gen, the biotech firm offering the test, says that they can make an accurate fetal sex determination from a blood sample by 5 weeks after conception. They point to a bunch of publications that purportedly show that what they are offering is scientifically plausible and not a scam at all. The thing is, one of the scientists whose work is cited as supporting Acu-Gen's method, Farideh Bischoff, said in the NPR interview that she was skeptical that such high accuracy could be obtained so early in a pregnancy. (It's worth noting that Acu-Gen screws up the citation, giving it as "Farideh et al." rather than "Bischoff et al.")

Acu-Gen is the only company selling this test, so naturally, the details of the test are proprietary. But there seems not to be any body of, say, clinical trials that they can point to to reassure people who get the test that it's "99.9% accurate". In an interview on the Today Show, Sherry Bonelli, the CEO of PregnancyStore (the only retailer that sells Baby Gender Mentor test), said "They've actually followed more than 2000 women throughout their pregnancies and they've never been wrong." Of course, the emissary of Acu-Gen who responded to NPR's questions about the accuracy of the test, said, in effect, come back in a year when we've followed a bunch of pregnancies to term and can answer your concerns about accuracy.

Do you know that your test is accurate or don't you? (And by "know" I don't mean "know in your heart of hearts" so much as "know from the results of well-designed and well-conducted scientific studies with sufficiently large sample size that the results are reliable".) Pressed on whether tests of the accuracy had already been performed (as Bonelli claimed) or are currently being performed (as the Acu-Gen email to NPR suggested), the head of Acu-Gen, Chang Ming Wang, was evasive.

Diana Bianchi, a fetal DNA expert and another scientist cited by Acu-Gen in support of their method, said in the NPR interview that she was concerned about the claims of high test accuracy, given anecdotal evidence (from sonograms) that the test had given bad results in at least a handful of cases taken together with the lack of persuasive data to support the claims of high accuracy. Sherry Bonelli, Baby Gender Mentor test retailer (who was apparently much more willing to speak on the record than anyone who works for Acu-Gen), said that these scientists are skeptical because ... (wait for it) ... they're jealous of Acu-Gen! See, even though Acu-Gen hasn't provided any evidence that their claim (99.9% accuracy determining the fetus' sex at 5 weeks gestation from a drop of the mother's blood) is true, their critics haven't provided any evidence that Acu-Gen's claim is false. Given that the precise details of Acu-Gen's test are not available to these skeptical scientists (because they're proprietary), it's not obvious how they're supposed to produce such evidence. But that's not going to stop Bonelli from selling the test!

Of course, fetal sex determination via a drop of blood counts as a non-medical test, so the FDA doesn't regulate it (even though results from this test might well lead to a decision to pursue various obviously medical decisions for the expectant mother). Given that there are none of the clinical trials you'd expect for an FDA-regulated test, we're talking about something that, from the point of view of supporting data, is on par with "dietary supplements" advertised late at night on basic cable. Classy!

I wonder how other scientists in the biotech industry feel about this kind of thing. It seems like they should be concerned about a "science"-based product selling itself as science-based to the consumers but putting up very little science to back the claims that are separating consumers from their money. The more this kind of thing happens, the more opportunity there is for consumers to feel screwed over by shoddy science (and in case Acu-Gen's lawyers are reading this, I'm not claiming Baby Mentor Gender test is a scam -- I'm just pointing out that without any data to support it, there is no earthly reason a scientist or an educated consumer would accept its claims!). And, feeling screwed over by shoddy science would tend to feed into a low opinion of scientists. That would sure make it harder for serious scientists in biotech to connect with consumers. And, it would make things harder for scientists in general, even if they're not trying to sell anything but knowledge. Guilt by association sucks, but it's hard to avoid if you don't stand up and call bullsh*t on a member of your community who may be using the mantle of Science to make a fast buck.

One more quickie: this story of a biomedical firm whose listing on the New York Stock Exchange has been delayed. The apparent reason for this delay (NYSE hasn't given an official explanation)? Animal rights groups may have put pressure on the Exchange, because the firm in question, Life Sciences Research, Inc. does a lot of animal testing.

My regular readers (hi, Julie!) know that, while I like doggies and bunnies and duckies, I'm no animal liberationist. But, I'm not all indignant on behalf of Life Sciences Research, Inc. See, this is an example of market forces working, isn't it? There is certainly a demand for animal testing (which is why Life Sciences Research, Inc. has a thriving business), but there are also folks who are agin' it. In a free market (or whatever kind of market it is that we have), consumer opinions make a difference. Even the NYSE is influenced by public opinion.

Babe, that's just another cost of doing business.


Technorati tags: biotech, unsupported claims, science, capitalism