Ben Goldacre, The Guardian, Saturday 13 November 2010
If science has any credibility, it derives from transparency: when you make a claim about how something works, you provide references to experiments, which describe openly and in full what was done, in enough detail for the experiment to be replicated, detailing what was measured, and how. Then people discuss what they think this all means in the real world.
Maria Hatzistefanis is a star of lifestyle pages and the owner of Rodial, the cosmetics company who sell a product called “Boob Job” which they claim will give you a “fuller bust” “increase the bust size” and “plump up the décolleté area” with “an instant lifting and firming effect”, and an increase of half a cup size in 56 days. Or rather an increase of “8.4%”. It’s all very precise.
Now I’m not going to lose a great deal of sleep over anybody who buys a magic cream to make their breasts grow bigger. What worries me is that Maria Hatzistefanis’s company are now threatening a doctor with a libel case, simply for daring to voice doubts over these claims.
This is her crime. Dr Dalia Nield told the Mail it was “highly unlikely” the cream would make your breasts bigger, and questioned the amount of information provided by Rodial. “The manufacturers are not giving us any information on tests they have carried out. They are not telling us the exact ingredients in the product and how they increase the size of the breast.”
That’s fair. I don’t trust claims without evidence, especially not unlikely ones about a magic cream that makes your breasts expand. Maybe it does work – I don’t particularly care either way – but when I asked the company to send me any evidence they had, or any information on ingredients, they flatly refused to send me anything at all.
This is especially odd, since I’ve seen the letter that Rodial’s lawyers sent, and they tell Dr Nield: “Our client on request would have provided all information required on clinical assessment and product ingredients.”
Apparently not.
Dr Nield went on to speculate that the gel could be “potentially dangerous… it may even harm the skin and the breasts – we need a full analysis.” Again, this is perfectly reasonable: anything that has real effects on the body may also have unintended side effects, and that is an entirely uncontroversial statement, especially when important information is being witheld.
But then the story gets stranger. When Sense About Science, who have helped drive the campaign for libel law reform in the UK, put out a press release about Rodial threatening Dr Nield with libel, they themselves were contacted by Hegarty LLP, solicitors acting for Rodial Limited. This time they seemed to be trying to stop people from even daring to talk about the existence of their libel threat.
People often ask if there are short cuts in spotting nonsense. In reality, it’s not easy to do in a checklist, because there are so many elaborate ways to distort evidence, but for me there is one very clear risk factor. The entirety of science is built on transparency, giving your evidence, and engaging with legitimate criticism. If you hear of a company refusing to hand over the evidence they say supports their claims, whether they are a drug company or some dismal cosmetics firm, all you know is that you are being deprived of information, and that vital parts of the picture are missing. If you hear someone is threatening to sue their critics, again, all you know is that people will be intimidated from raising legitimate concerns, and again, you are being deprived of information.
Meanwhile, Dr Nield is now one individual facing a large company. Individual doctors and scientists are commonly asked for their opinion on whether or not medical interventions work, and it’s plainly in our collective interest that they give honest answers without fear that their lives will be taken over for years on end by a major company with money and a distorted sense of reputation, and losing vast sums of money even if they successfully defend the case, as has happened so many times recently.
With the law in its current state, doctors and scientists might be wise to simply stop giving any view about any drug or other health-related product that is marketed for commercial purposes, in any forum, and make it clear that from now on, decisions about efficacy should be made solely by the manufacturers. Good luck with that.
Update 14:00 13/11/10
Yay! Rodial have started playing games. So, initially they refused to give me (or others) any evidence for their grand claims, or even say what the ingredients were. Now they’ve quietly changed the contents of their “Boob Job” page: previously it linked to the Daily Mail story (which was weird, since this was the article that their lawyers claimed was libellous, but on the page they linked to is saying “CHECK OUT THE FABULOUS PRESS FOR BOOB JOB ON THE DAILY MAIL”); now it says “CLICK HERE TO SEE THE BOOB JOB KEY INGREDIENT CLINICALS”.
If you’d like to read the “key ingredient clinicals”, whatever the science geniuses at Rodial think this phrase means, that document is here. Having scanned through this document, I think it’s fair to say their evidence is even more informatively ridiculous than I initially assumed it might be. Joy! More to come.
EnglishAtheist said,
November 12, 2010 at 11:53 pm
You can see all of Rodial’s claims of clinicla proof etc here:
furtherthoughtsfortheday.blogspot.com/2010/11/questions-for-rodial.html
I contacted them for evidence of these claims, and unsurprisingly, was also refused.
My favourite part in looking at Rodial’s products is that the first one I looked at was called Snake Serum. Srsly!
le canard noir said,
November 13, 2010 at 9:41 am
If, for some reason, you have not signed the petition to support the campaign to change libel laws you can do so here.
www.libelreform.org/
jdc said,
November 13, 2010 at 2:49 pm
So Rodial have decided to follow in the footsteps of the British Chiropractic Association, Matthias Rath, Gillian McKeith, the New Zealand Chiropractors’ Association, and the Society of Homeopaths. Let’s see how that works out for them.
MJ said,
November 13, 2010 at 2:59 pm
Speaking of transparency, you left out one very pertinent fact about Dr Dalia Nield that was included in the Mail article – Dr Nield is a consultant plastic surgeon at the London Clinic.
www.thelondonclinic.co.uk/consultants/nield,_mrs_dalia_v.aspx
One of her specialties? Breast surgery
That puts the doctor’s statements in a whole new light as Dr Nield effectively sells a competing product. So while the company’s actions are certainly questionable, they are more understandable when you consider that they might view Dr Nield as a competitor who publicly called their product dangerous.
Ben Goldacre said,
November 13, 2010 at 3:24 pm
youre right, i left out a lot as i was short of space: i also wanted to link to all the people who’ve blogged on this, and begun making complaints to the ASA, TSA, MHRA etc, give a description of recent medical/science libel cases, explain how the decks are stacked against defendants even when they are likely to win, go into the background of Rodial’s other activities and products, and much more. there’s now even more to say since Rodial have posted their “evidence”. in light of all that i’m pleased to say i’m going to have to write at much greater length on Rodial.
Skeptico said,
November 13, 2010 at 3:29 pm
From the “key ingredient clinicals” link:
Since the phrase “up to” includes the figure zero, I guess the statement is technically correct.
Rhys Morgan said,
November 13, 2010 at 3:32 pm
Hah, the ‘evidence’ is still laughable.
Tiny sample size, no placebo control and the most glaring oversight?
Not published in a peer reviewed journal. Instead, a self published, couple of pages, full of meaningless impressive looking graphs PDF.
Very telling.
stephenemoss said,
November 13, 2010 at 4:28 pm
As Rhys Morgan points out, there are no peer-reviewed data to support the claims, in fact I could find nothing published on the effects of Sarsasapogenin on adipocytes. Amused that they refer to a *201%* increase in pre-adipocyte differentiation – i.e., a doubling.
If it does work, then it does so by making your fat cells fill up with fat – just what every woman wants.
Bob O'H said,
November 13, 2010 at 4:51 pm
Having scanned through this document, I think it’s fair to say their evidence is even more informatively ridiculous than I initially assumed it might be.
Hey, but it has p-values and everything.
I’ve contacted Sederma (the company who make this stuff) for more information about the in vivo tests. I suggested they put them on the web, to save them hassle later.
CoralBloom said,
November 13, 2010 at 5:04 pm
Another nightmare that can be easily avoided.
Lesson one.
Ladies, learn to love your boobs you’ve got.
Leave ’em alone! Stop worrying, fretting and fussing.
If they aren’t causing you pain or back problems then all you’ve got to do is check them every month and make sure your bra fits properly – a properly fitting bra is better investment, don’t you think?
Yogzotot said,
November 13, 2010 at 5:27 pm
Well, p-values, yes… What p-values are usually considered significant in clinical studies? In psychology it’s usually 0.05 or 0.01. The p-values cited here were 0.3 and 0.1. Hardly convincing.
stephenemoss said,
November 13, 2010 at 5:39 pm
To Yogzotot (some name!). Same in biology. Significance usually means a p-value of less than 0.05. Their p-values are way off being significant.
Blattafrax said,
November 13, 2010 at 9:17 pm
p-values of 0.1 and 0.3. It didn’t make any difference. 0.05 would be considered the point at which we should start taking note.
A quick root around shows the drug is cytotoxic to certain cell types (laboratory hepatoma cell lines) and is investigated as an anti-depressive and Alzheimer’s treatment. It’s an untested pharmaceutical. But reading the PDF is scary enough. It has a proliferative and differentiation effect (cancer) on adipocytes (and any other cells?) – acting through PPARgamma (Rosiglitazone anyone?)
4tytwo said,
November 13, 2010 at 9:37 pm
i initially read ronseal. I knew they were into body tanning but boobs? Anyhow the stuff seems to be used for rehydrating skin normally used everywhere in cosmetics. What I have to disagree with is the comment of CoralBloom to leave your boobs alone. You have to learn to love them and to let them be handled with gentle care by your lover, as according to the volufiline study they can shrink if not treated.
Jemaeux said,
November 13, 2010 at 10:14 pm
Sarsasapogenin is also used for increasing the size of pectorals, apparently.
www.phitoussicom.com/wp-content/uploads/2008/05/dp-super-pec.pdf
Also used to treat ALS. Gotta love a multi-action drug.
www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2009/10/WC500005789.pdf
decium said,
November 13, 2010 at 11:18 pm
So you see an improvement of up to 8.4% do you? Would this be even noticible? An 8.4% increase in volume represents a roughly 3% increase in length along one dimension, so if the boobs stuck out 10cm (for arguments sake) then afterwards they’d stick out 10.3cm. Now who can spot 3mm longer breasts?
asuffield said,
November 13, 2010 at 11:27 pm
It occurs to me that you can easily create a modest improvement in breast volume by application of anything that causes swelling. Pick your favourite irritant.
Blattafrax said,
November 14, 2010 at 11:44 am
@Decium
It’s not as much as that. The gain in volume was 330 mm3 for the best responders. That’s ~0.5mm over an area the size of a Post-it note.
here is the patent behind the product. It has the advantage (?) of not having a pair of plump breasts as the first thing you see when we are talking about mm-scale changes in A-cup sizes.
Lots of problems here:
An 8.4% increase in the 1st quartile, combined with an overall 2.2% increase means that 3/4 of the subjects had no change. (Although the p-values already tell us there was no change.)
What is the probability the post-hoc analysis of the best responders was made with a simple T-test?
Why was the ‘clinical test’ single-blind and not double-blind? There is no reason for the experimenter to know which breast is treated.
Why was a technique used for assessment of wrinkle-treatments used for breast-volume calculation. What are the details of the experiment? What is the reproducibility of the measurements?
But the patent gives the crucial comments by the inventors of the product: The increase is described as “moderate” and “not very significant”.
Moderate and not very significant. To which we could “in a small sample size”; “with an undefined statistical analysis”; “incompletly blinded experiment” and “lacking an experimental description”. All in a PPARgamma-inducing pharmaceutical package.
B0YC0TT said,
November 14, 2010 at 11:48 am
On the subject of scientific transparency, have you read the Hockey Stick Illusion, which sets out in gory detail just how far certain scientists will go to avoid publication of the data that is supposed to support their conclusions?
martin_g said,
November 14, 2010 at 9:00 pm
Honestly, there seem to be an awful lot of knockers out there? I notice that one of the ingredients is Sodium Hydroxide (or, as I prefer to call it, Caustic Soda)which is a highly effective chemical. At least it works wonders on my sceptic tank.
martin_g said,
November 14, 2010 at 9:01 pm
Oops . . . I meant ‘septic’.
lorcancoyle said,
November 15, 2010 at 6:12 am
After reading the rest of the Sederma site a selected sample size of one was observed as having a 93% increase in lethargic biomechanical reactions, including involuntary yawning and subsequent ROFL. Maybe I can sell them my magic pixie dust formula which combats these effects?
Also, in a very minor way you could defend Rodial by saying they believed the marketing blurb from Sederma, may be stretching it though. Interesting that a subsidiary of Croda, a major speciality chemicals business, is coming out with this stuff – if they write this stuff for cosmetics what do they write for important products?
SirTainleyBarking said,
November 15, 2010 at 9:24 am
*Sigh*
Sederma is actually a quite well known in the industry as a decent quality extract supplier.
Rule one for formulators using materials like this, DO NOT USE THE SELL SHEET AS YOUR CLAIMS SUBSTANTIATION.
The sell sheet gives an idea of what the material MAY do in your product IF you use it at recommended levels. All cosmetic bases vary in the texture and the materials they contain. This could easily make a difference, so for 10% extra tit size, to be claimed in any arena where you may get called on it, DO YOUR OWN DAMN TESTING!
Thats what I have to do to get claims for the action of magic pixie dust through people like the ASA, Clearcast and the like
Thanks Rodial, You’ve now made my day to day job harder again. Drum this into your thick heads. If I’m called on the effectiveness of my products, Evidence to refute or STFU.
Sending the land sharks in makes you look foolish!
Declaration of Interest: Cosmetic formulator.
Guy said,
November 15, 2010 at 11:01 am
Their write up is really funny. It’s not science but a parody of it that we are more used to seeing in cosemetic and hair care commercials. Strange that not using their cream seems to shrink the other breast!
On a more serious note, this product contains plant steroids (possible precursors to sex steroids)and might actually have an active ingredient. If it is genuinely a drug, then it should be assessed for benefit and harm and regulated.
jackbanner1 said,
November 15, 2010 at 9:34 pm
Spread the word that the ingredients cause cancer and then refuse to show the “evidence”. See how they like it.
flybywire said,
November 15, 2010 at 10:03 pm
this is off topic, but is anyone else enjoying watching ‘Dr Gillian Mckeith PHD’ on I’m a celebrity get me out of here as much as I am? I realise most people on here don’t watch it, but it really is worth it!
Jeesh42 said,
November 15, 2010 at 10:03 pm
As Charlie Brooker said, people who work in fashion are idiots.
AC said,
November 16, 2010 at 1:33 pm
They presumably have to decide how this thing is working. If they are saying that the chemicals within this have a physiological effect, my understanding is that it is a medicine, and must therefore be regulated by the MHRA, who require proper evidence.
If they go the usual cosmetics route (surveys ‘appears’ bigger) then the ASA require them to have evidence ready in advance (e.g. 12.1 of CAP) and not to claim that they can cure “dysfunctions or malformation” (12.6) – your call if you think breast size falls in this category.
The article and comments suggest that they haven’t acheived on either front.
whippet75 said,
November 16, 2010 at 1:39 pm
So according to their own information this stuff is a PPARy agonist, and by the looks of the in vitro effects a pretty potent one. Hmmm… wasn’t another PPARy agonist recently pulled from clinical use due to it increasing the risk of heart attack and stroke ??
locka99 said,
November 16, 2010 at 5:02 pm
Perhaps this amazing cream is whipped cream. Just scarf down as much as you can and in no time your breasts, belly and bum will enjoy a 8.4% increase in volume. Or more! Extra efficacy if cream is used in conjunction with a pork pie treatment.
richardelguru said,
November 16, 2010 at 6:33 pm
It’s sad that so many peoples attitude towards breasts mistakes quantity for quality.
TheDixieFlatline said,
November 16, 2010 at 9:51 pm
Comment seen on the Mail story:
£125 to end up with fat hands? nah ill pass.
I *hope* they intended to point out an obvious absurdity. Intended or not though, good point.
jmt_dh1 said,
November 20, 2010 at 11:11 am
I’m not big on statistics, but nobody seems to have commented on their use of “1st quartile”. As far as I can see, they appear to take this to mean the “quartile of biggest increase” on the treated size and the “quartile of biggest shrinkage” on the non-treated side. That’s pretty appalling… not that that’s exactly the only problem with the “brochure”!
mrstrellis said,
November 20, 2010 at 11:03 pm
I managed to get my breasts to increase by over 50% over a period of 10 months or so.
All you have to do is get knocked up. The bug boobies last as long as you breastfeed. Yay!
mikewhit said,
November 21, 2010 at 11:22 pm
“Dr Nield effectively sells a competing product.” or alternatively, knows what she is talking about.
Otherwise you could never have specialist A talking about specialist B’s work in the same field if you asserted competitive conflict of interest.
judgefloyd said,
November 26, 2010 at 11:23 am
I don’t know what Goldacre is carping about here – their pdf looks very sciency. More to the point, who is this FOITS who checks out the breast plumping on the (no doubt statistically significant) 30 women?
yours, almost called FOITS,
Floyd
Mike S said,
December 3, 2010 at 11:39 am
I thought this might be a joke to start with – but Rodial actually sell snake oil … www.rodial.co.uk/product/skincare/glamoxy-snake-serum/256
descartes11 said,
December 6, 2010 at 10:37 am
Interesting article. There is a fine line between the rights to free speech and libelous comments, but I believe the lawyers are on the wrong side today.
If anyone’s interested in a hardness tester to analyse this, I’d suggest they visit the website: www.metallography.co.uk/
Gregory Goldmacher said,
December 10, 2010 at 1:45 pm
Just looked up FOITS, and it’s a technique for evaluating the microstructure of skin – smoothness or roughness, basically.
Not sure if it would be the appropriate test here.
However, if the company needs to evaluate women’s breasts, I am sure there are many highly trained scientists who would volunteer their services.
Gregory Goldmacher said,
December 10, 2010 at 1:45 pm
Quick ref on FOITS:
www.ncbi.nlm.nih.gov/pubmed/11155533
baratron said,
January 9, 2011 at 11:17 pm
I especially love that they measured the breast size “after 28 days” and “after 56 days”. Most women experience a change in their breast size over their menstrual cycle. Many women do not have a 28-day menstrual cycle. An increase in breast size could simply be due to being premenstrual!
sagemfl said,
July 13, 2011 at 7:11 pm
But the cream did seem to increase the amount of fat cells – even if this doesn’t improve the size much, if one were to gain weight, the breast would probably absorb more than usual in relative to the rest of the body, right? (which is just what women want)
Kyudoka said,
January 16, 2013 at 1:58 pm
money.aol.co.uk/2013/01/16/misleading-beauty-cream-banned/?ncid=wsc-uk-money-headline
Follow this link for details of ASA ban on Rodial AD