Thursday, September 29, 2005

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.

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At 8:47 PM, Blogger JM said...


At 8:41 AM, Blogger Maureen said...

About Baby Gender Mentor: When you say, "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!" you're leaving out a piece of the puzzle.

In late June, there was a media blitz for this product, starting with a feature on the Today Show. NBC, CNN, ABC, and many other media outlets covered this product, and NOT ONE SINGLE report questioned this test's accuracy. They all just repeated that the test was 99.9% accurate, then went on to interview bioethicists to make it sound like every parent who wants to know gender has a sinister motive. Check NPR's June coverage of this topic, they ROUND UP and say it's "virtually 100% accurate".

So why did consumers buy into this test? Because Katie Couric told them it worked.

At 5:56 PM, Blogger Doctor Free-Ride, Ph.D. said...

Maureen, you're absolutely right that consumers have been led by "news coverage" to assume that this product *has* to be reliable. Silly info-tainment. But I'm at a loss to know how to get it through people's heads that Katie Couric is not, in this instance, being a journalist (e.g., asking critical questions about evidence).

Since the consumer is hypnotized by the media blitz, it feels to me like scientists have a stake in educating the consumers. Because, if this turns out to be a scam, other biotech firms have to deal with guilt by association.

BTW, I see from your site that you were out there months ahead of NPR on this story. Well done!

At 4:31 PM, Blogger john lichtenstein said...

I loved Sherry Bonelli on NPR. I get the same "You skeptics are jealous", "You have no proof our product doesn't work", and "Our tests are proprietary" excuses from the folks who sell investment opportunities in perpetual motion machines.

At 12:38 PM, Blogger molly said...

Here's some proof for you all that the Gender mentor Test is not 99.9% correct. I received my results 4 days ago, it stated that I would be expecting a baby girl. I was thrilled, called my family and friends to let them know. Then to my amazement 2 days ago I got and e-mail from Acu-Gen asking me to please go back and check my results again because they had to be ran a second time. To my shock the test said that I was having a baby girl and a baby boy. I didn't believe this and I immediatly contacted my OB who not 2 hours ago performed a level 2 ultrasound. I am as I already knew from 2 previous ultrasounds having ONE baby. I called the lab and they are sending me another test to try it again. I will not believe these results either, but I figured I have already paid the $275 for the test I may as well see what it comes out the third time. Either way, they are wrong about the twins, and because they said I was having a boy and a girl I am still in the same position I was before I took the test. I have no idea which gender my baby is. I would be more upset, but I am happy with a boy or a girl so I'll just have to wait.

At 7:03 PM, Blogger Wonderwoman said...

The 99.9% accuracy rate lured me to try it. I already have 2 boys and I was so impatient to know if I was finally going to have a baby girl. So, I spent the $275.00 to find out. I actually live less than 5 miles from where the labs address was and I was excited at being able to drop off my test right after I sealed the envelope containing my blood. I rushed to drop if off hoping my results would come sooner. I knew the street where the lab was on; however, the lab was very very shady. Unmarked and locked. Dark and no one around in the back of a building. At first I couldn't even find the number for the address. I circled over and over....finally I spotted the number after counting doors. I walked to the door, but it was locked. I stood there for a min. observing my package and then suddenly from the dark office an Asian man opened the door only enough to speak with me. He didn't offer to have me step in but I was hesitant anywhere whereas he was the only one in the office....I gave him my sealed pckage and he took it and said thank you and shut the door before I could say anything else. I didn't get an email with my results until I emailed him first. Finally I got my result- they said I was carrying female...I was soooooo excited. Last week I had my ultrasound and my "female" had an obvious male part. I feel scammed big time. The shady place probably won't give me my money back. They say with a birth certificate but now I read other places that you need to send them your baby's blood, a birth certificate with the same address of where you were when you bought the kit...No way am I sending them my baby's blood....I wish I hadn't have been so nieve..... Its a shame... Hormonal women that are really excited and unable to wait taken advantage of. Someone clearly should look into this "shady lab"...

At 2:24 AM, Blogger Hazel said...

Wonderwoman, what were you thinking? Well of course you weren't. I suppose I would have been the same, just hoping against hope... but of course that shady lab doesn't even have a proper money-back guarantee does it? Shew! More snake-oil salesmen than ever before, hiding behind the boggle of science and stupid journalists.

At 10:35 AM, Blogger AncientTruth said...

It could be you are under the false impression that scientists are more moral then other people.

The truth is: They aren't

At 6:27 AM, Blogger Anna said...

Unfortunately capitalism often resists science.. Winstrol


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