The Awful Poo Lady

November 21st, 2006 by Ben Goldacre in bad science, channel 4, gillian mckeith, nutritionists | 48 Comments »

Hahahahahahahaa this just off the wires from the MHRA at 00:01am. Busted! Just remember, yer old uncle Ben was here speaking the truth when Channel 4 and the rest were loving her. Surprisingly vicious for an MHRA press release, I have to say. I guess they want to be taken seriously as policing this kind of nonsense, given recent events (on which more soon, heh)… Anyway, here’s what the MHRA sent out on the wires:

MHRA order removal of Gillian McKeith’s illegal products

Dr Gillian McKeith’s organisation has had to detox its own products after MHRA officers discovered it was advertising and selling goods without legal authorisation whilst making medicinal claims about their efficacy. Dr McKeith’s products, ‘Fast Formula Wild Pink’ for women and ‘Fast Formula Horny’ for men promised to deliver wonders for all in the bedroom.

The MHRA determined that both products were medicines because of the presence of some well-known medicinal herbs and because of the claims being made by Dr McKeith’s organisation. Only licensed medicines may be advertised to the public.

David Carter, Manager of the Medicines Borderline Section said “Companies who place products on the market have a clear duty to ensure that those products comply with all relevant legislation. As Dr McKeith’s organisation had already been made aware of the requirements of medicines legislation in previous years there was no reason for all the products not to be compliant with the law. The MHRA has a comprehensive website with information on the legislation it administers, including the law on herbal products. Furthermore, free advice on the likely status of products is available from staff in the Medicines Borderline Section. It would have been a very simple matter for them to have sought our opinion.”

Date: 21st November 2006
Time: 00.01 HOURS 21/11/06
Subject: Gillian Mc Keith products removed

Contact: Press Office 020 7084 #### #####@mhra.gsi.gov.uk
Out of hours 07770 ### ###

EDIT McKeith Fights Back:

After the MHRA press release, the following appeared on McKeith’s website.

“About Wild Pink Yam and Horny Goat Weed Supplements

Due to the new EU licensing laws regarding herbal products, and after extensive consultation with the MHRA, McKeith Research Ltd has withdrawn two supplement products – Wild Pink Yam and Horny Goat Weed Capsules. The new EU ruling affects a wide range of herbal products currently on sale in the UK, and McKeith Research Ltd is willing to comply with all new regulations as they work closely with the MHRA to ensure that products comply with the new licensing specifications.

She made the same odd statements about EU regulations to the Herald newspaper, and mixed it up with what reads to me like a healthy dose of retro 1990s Sun-style “EU calls chocolate vegelate/straight banana regulations/yoghurt banning” tabloid euroscepticism.

www.theherald.co.uk/news/74984.html

“It’s obvious that the EU bureaucrats are clearly concerned that people in the UK are having too much good sex.”

So needless to say I contacted the MHRA to find out if this EU stuff was true.

The press office were very helpful and told me: “This has nothing to do with new EU regulations.” And just to be absolutely clear: “They were never legal for sale in the UK.” They also point out that there’s no excuse for not knowing about the regulations, and that, rather helpfully ( in case any of you are thinking of setting up in business) the MHRA’s Medicines Borderline Section offers free advice on the phone.

I asked them to put this in an email as well, just to be belt and braces.

So, the MHRA say: “The information on the McKeith website is incorrect. The Wild Pink Yam and Horny Goat Weed products marketed by McKeith Research Ltd were never legal for sale in the UK. The Medicines Act 1968 contains an exemption from licensing for herbal remedies but only in certain, closely defined circumstances. The McKeith products did not meet the terms of the exemption as they both had written recommendations.”

Interestingly the Health Freedom Movement, campaigning against EU vitamin pill labelling regulations, recruited eurosceptic right-wingers like John Redwood MP to speak at their rallies.


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48 Responses



  1. Lave said,

    November 21, 2006 at 4:44 am

    Pulling an all-nighter (stupid PhD deadlines), has never brought such joy before. Splendid.

  2. Lave said,

    November 21, 2006 at 4:48 am

    Also: “Horny Goat Weed” and a picture of the “Dr’s” curmudgeonly face is such a repulsive and hilarious image that it almost takes on some kind of profound meaning,

    (It’s a crass comment – but you were all thinking it.)

  3. Lave said,

    November 21, 2006 at 4:53 am

    Sorry for the multiple posts. But for the “Wild Pink Yam Complex” we see that “In a controlled study, female patients reported significantly maintained sexual desire, orgasmic function and lubrication…”

    Maintained? As in they didn’t get worse? That’s as beautifully worded as the effect of prayer of patients study which results “approached statistical significance.”

  4. prescience said,

    November 21, 2006 at 7:40 am

    Hahahahahahahaa indeed.

    Well done, Ben. Like Lave I’m pulling an all-nighter (here in Vancouver), and enormously fortified by reading this splendid news.

    All we need now is an open space, a pole, an appreciative crowd and a bunch of dry sticks to make our joy complete.

    Who’s next?

  5. Tristan said,

    November 21, 2006 at 8:00 am

    In. Your. Face. McKeith!

  6. Mojo said,

    November 21, 2006 at 8:21 am

    Hmm. Can’t she just register them under the new traditional herbal registration scheme (assuming that she can demonstrate “evidence of traditional usege”) and just carry on as before?

  7. Teek said,

    November 21, 2006 at 8:24 am

    oh sweet victory Ben – well done to you and all others involved in bringing TAPL to book – but rest not as yet hardy warriors, for there are many more products on the market with outrageous claims for efficacy, sold by quaks and charlatans… let this be the beginning of the War on Terrible Science…

  8. Nebbish said,

    November 21, 2006 at 8:31 am

    And just what is ‘McKeith Rapid Micron Technology RMT’? No relation to Buggins Sluggardly Inch Technology, no doubt…

  9. lexmith said,

    November 21, 2006 at 9:19 am

    Sluggardly Half Inch Technology (SHIT) you mean?

  10. pronetomadness said,

    November 21, 2006 at 9:23 am

    Where can I get non chemical solvents?

  11. katem said,

    November 21, 2006 at 10:04 am

    Hurray!

  12. TimW said,

    November 21, 2006 at 10:30 am

    Lave, “approached statistical significance” is a bold assertion. In the past I have heard “almost approached statistical significance.”

  13. Frank said,

    November 21, 2006 at 10:59 am

    Am I the only one relishing the irony of a McKeith product censured because it actually worked?

  14. Mojo said,

    November 21, 2006 at 11:56 am

    Frank said: “Am I the only one relishing the irony of a McKeith product censured because it actually worked?”

    Has it been established that either of them actually works?

    In any case, she might be able to get them back on the market without providing any evidence of efficacy: it is quite possible that she will be able to register them under the MHRA’s “Traditional Herbal Medicines Registration Scheme”, which doesn’t require proof of efficacy: “the normal requirement for medicines to demonstrate efficacy will be replaced by a requirement to demonstrate traditional use”.

    www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=95

    According to today’s press release, the MHRA decided that the products were medicines “because of the presence of some well-known medicinal herbs” as well as the claims made. All McKeith needs to do is to estblish that these herbs have been “traditionally” used to try to produce the effects she claims.

    According to the MHRA press release of 8th November announcing the first registration of a product under this scheme, “minor claims are permitted on the basis of evidence of traditional usage”. As these products are not claiming to treat life-threatening diseases, the claims could well come within the MHRA’s definition of “minor”.

  15. Delster said,

    November 21, 2006 at 12:08 pm

    Unfortunatly we can’t get homeopathy under “presence of medicinal herbs” as there’s nothing in them but it’s a start :-)

  16. cath having fun said,

    November 21, 2006 at 12:38 pm

    so all the Mckeith organisation needs to do is to empty the capsules, wash them out, refill with water and market them as ‘homeopathic’ – then they’ll get the support of MHRA?

  17. jj_hankinson said,

    November 21, 2006 at 1:02 pm

    Given that she apparently has a “team of research scientists” it must be likely that one or two of them have seen Ben’s articles and perhaps even this posting…

    Come on “research scientists” – give us an insider’s view of the inner workings of McKeith… (actually come to think of it I’ll give that a miss… ;-)

  18. jdc325 said,

    November 21, 2006 at 1:27 pm

    To relaunch these medicinal products, I’m sure she would need a manufacturer’s license (to be issued by the MHRA).

  19. TimW said,

    November 21, 2006 at 2:44 pm

    According to BBC news:
    [A spokesman for the firm said they were happy to comply with the ruling after EU laws had changed.

    He added: “Laws are changing all the time. This is what happened in this case and, therefore, we took the products off sale.”]

    Any truth in that, or just bullshite?

  20. mrstrellis said,

    November 21, 2006 at 2:51 pm

    I’ve never seen anything so off-putting in my life. Perhaps she could re-sell these as contraceptives.

  21. barkotron said,

    November 21, 2006 at 3:08 pm

    “In. Your. Face. McKeith!”

    In this context, I really, really wish you’d said something else. Brain rubbers please!

  22. Frank said,

    November 21, 2006 at 3:40 pm

    Mojo said: “Has it been established that either of them actually works?”

    too bad for me that I i sacrifice clarity for brevity. I was referring to the remedies having an “well known medicinal ingedient” and therefore being classed as a medicine (as opposed to homeopathic crap), rather than explicitly claiming they worked.

    That just tickles me.

  23. jdc325 said,

    November 21, 2006 at 4:06 pm

    RE 19: Unlicensed products presented as medicines have been illegal for years. Anything either containing medicinal ingredients or labelled as a medicine has to be licensed. I think this originates from the 1968 Medicines Act. If I’m right then it’s definitely bullshite. Is it worth checking?

  24. jdc325 said,

    November 21, 2006 at 4:10 pm

    And the MHRA said “Dr McKeith’s organisation had already been made aware of the requirements of medicines legislation in previous years there was no reason for all the products not to be compliant with the law”. That doesn;t sound new to me.

  25. MartinC said,

    November 21, 2006 at 4:54 pm

    I think it’s interesting that she is referred to by the BBC as ‘Ms’ McKeith in their story, and her ‘qualification’ isn’t mentioned anywhere

  26. BobP said,

    November 21, 2006 at 6:01 pm

    Could be fun working in the Medicines Borderline deparment. I wonder what they do all day?

  27. TimW said,

    November 21, 2006 at 6:38 pm

    Thanks jdc325. I thought there was a smell about it.

  28. Mojo said,

    November 21, 2006 at 9:23 pm

    There has been a recent change in the law relating to herbal medicines, but the new rules, to quote the MHRA website, have “a seven year transitional period” which “will mean that products do not need to be registered until 30 April 2011″. I don’t see that this new scheme would make a currently legal product illegal in any case; it seems to be intended to relax the rules for herbal medicines.

    Any medicine on the market has had to be licensed (or registered under one of the other “schemes”) since the Medicines Act came into force in 1971. I guess that’s only 35 years…

  29. zooloo said,

    November 21, 2006 at 10:50 pm

    pwnd as I believe people say nowadays.

  30. Mojo said,

    November 22, 2006 at 2:15 pm

    The Times’s coverage has another comment from the MHRA:

    “A spokesman for the MHRA said that “there is no evidence of the products’ efficacy for the medicinal purpose for which they were advertised. The company may reapply for a medicine licence for these products but will have to prove that they conform to standards in safety, quality and efficacy.””

    www.timesonline.co.uk/article/0,,2-2462980,00.html

    Maybe the traditional herbal medicines scheme won’t apply after all.

  31. apothecary said,

    November 22, 2006 at 4:27 pm

    Great, ain’t it.

    On a slightly different tack – post 3 and 12 re “approaching statistical significance”. This has always bothered me. I mean, the idea that P=0.049 (ie a 1 in 20.4 chance the result is a fluke) is statistically significant, but a P=0.051 (ie a 1 in 19.6 it’s a fluke) is not significant – as though significance were an absolute and we could dichotomise results (not sureabout the English there). Certainly Big Pharma has not been too scrupulous about exploiting this idea (and type II error, and the difference between clinical significance and statistical significance, and ….).

    I might be willing to accept a treatment based on P=0.06 or even greater, if there was no alternative treatment, the consequences of no treatment were awful and the cost (financial, risk and severity of harms, etc) was low. But I might not accept treatment at P=0.01 if the benefits were small and the cost was very high.

    Just for interest, in medicine P=0.05 is the conventional limit, but what about other sciences? What sort of P values are conventional as significant in, say, engineering, or chemistry, etc?

    Cheers

  32. Despard said,

    November 22, 2006 at 6:12 pm

    It totally depends. I’m not sure statistics is used in the same way in those disciplines – as far as I recall from my undergraduate degree, it isn’t used at all in physics.

    In psychology, the usual level is 0.05, though obviously a lower alpha level is all to the good.

  33. CDavis said,

    November 22, 2006 at 7:13 pm

    Hmm. Poo Central are making it look as though some piece of EU regulation gorn maaad simply caught them unawares:

    ‘About Wild Pink Yam and Horny Goat Weed Supplements

    Due to the new EU licensing laws regarding herbal products, and after extensive consultation with the MHRA, McKeith Research Ltd has withdrawn two supplement products – Wild Pink Yam and Horny Goat Weed Capsules. The new EU ruling affects a wide range of herbal products currently on sale in the UK, and McKeith Research Ltd is willing to comply with all new regulations as they work closely with the MHRA to ensure that products comply with the new licensing specifications.’

    Love the ‘extensive consultation’. Bastards.

    CD

  34. CDavis said,

    November 22, 2006 at 7:56 pm

    And more. Here’s McPoo herself on this issue:

    “It’s obvious that the EU bureaucrats are clearly concerned that people in the UK are having too much good sex.”

    Snarl. Gnash.

    CD

  35. TimW said,

    November 22, 2006 at 9:07 pm

    In a way, it’s nice to see them straight-out-shameless-lie about it. Helps clarify what sort of an organisation they are.

    Like the website says:
    “Welcome to the new Dr Gillian McKeith Official Website – Empowering people to improve their lives through information, food and lifestyle”

    Information, right. Thanks a lot.

  36. Despard said,

    November 22, 2006 at 9:50 pm

    Perhaps this is the reason for the recent crackdown.

    news.bbc.co.uk/1/hi/health/6166324.stm

  37. Filias Cupio said,

    November 22, 2006 at 9:53 pm

    In my not-too-extensive experience, in physics significance is 3 sigma or P=0.005. Uncertainties are usually given as standard error (1 sigma) or as 95% confidence limits. Personally, I would regard a P=0.05 result as suggestive rather than significant.

  38. Martin said,

    November 23, 2006 at 8:13 am

    In engineering, well my branch of engineering which is continuous processing of highly flammable, pressurised hydrocarbons, we don’t use statistical significance.

    We design all our equipment very carefully, and then add 10%.

  39. three tigers said,

    November 23, 2006 at 9:26 am

    I’d love to see the patent (since the products are patent-pending) and find out how they got the evidence of efficacy.

    Also since to get a patent, the subject of the patent must be “new “or a new use, evidence of traditional usage would count as prior art and would not be patentable.

    Anyone know if there is a legal definition of patent pending, and if your product or idea is found not to be patentable, you can no longer cite Patent Pending on the blurb?

  40. Delster said,

    November 24, 2006 at 10:29 am

    Martin,

    This is the difference between engineering and medicine… we don;t have to rely on patients subjective opinions of how much better they feel etc… with us it either works or it doesn’t or in your case explodes or doesn’t…. might i recommend 20%? :-)

  41. Martin said,

    November 24, 2006 at 1:04 pm

    Actually, adding a design margin (the percentage varies, but is rarely less than 10%) has several advantages. For instance, if you make a small mistake in sizing the equipment, it can be covered by the design margin. (It doesn’t cover a Nasa-sized mistake, eg, feet = metres, though.)

    Also, when the operators get their hands on the equipment and manage to produce over the design capacity, they get to feel smug – because they can use the equipment better than it was designed for. They often don’t understand that they’re pushing the safety margin, but will give you more work in the future.

    We often get more work on sites which have gone bang (Buncefield, Texas City, etc.)

    Just found this on the BBC site: news.bbc.co.uk/1/hi/england/london/6179374.stm

    One quote from the CAM apologist is that Professor Waxman’s opinion is interesting, but is a personal one. Pulling together other Bad Science articles; I wonder if a Court of Law would consider Professor Waxman’s opinion as ‘personal’ or ‘expert’?

  42. boro_dave said,

    November 24, 2006 at 1:16 pm

    Patent pending means you have a live patent application on file somewhere in the world. Use of it when you haven’t got an application is illegal.

    I searched for patents registered to mckeith, but the only ones are related to stud walls by a Mr Stuart McKeith.

    Happy to search for other relevant company names if you can suggest them

  43. apgaylard said,

    November 25, 2006 at 1:48 pm

    Re: Stats and Significance
    In my branch of engineering (automotive) the current fashion is to have an appropriate separation between the mean value of any vital system metric and its “failure” value (failure mode avoidance). This separation can vary from three “standard deviations” to six and higher (I have come across values as high as eleven for really important processes).

    It does seem counter-intuitive that medical practitioners and researchers are prepared to accept a 1 in 20 chance of their result being a “fluke” and thus their process not actually working when deployed, when dealing with matters of health and wellbeing; whilst my industry sees the need to achieve no more than 3.4 defects per million opportunities (the mis-named “Six Sigma” creed) when designing relatively mundane (non-safety critical) aspects of a common consumer product.

    One answer may be that failures are obvious in engineering (my car won’t start, the AC doesn’t work …) whilst the complexities of the human organism and psyche can obscure that treatments aren’t actually doing what they were intended to do.

  44. Delster said,

    November 27, 2006 at 12:07 pm

    I’m in Telecommunications myself and on sites like Heathrow airport we have to build in quadruple redundancy. So if the primary systems go out any one of the other back up’s can pick up the entire load.

    This includes having 4 seperate physical routes for the cables. Setting up the software and hardware so even if a mix of hardware units & other cable routes go out it’ll find a way to route the calls & traffic. Can you imagine the chaos if the south east england air traffic control goes down?

  45. butterfish said,

    November 27, 2006 at 1:05 pm

    RMT is supposed to be ‘the most natural way to maintain the efficacy of the plants’. More natural than just eating the plants?

  46. jobbys said,

    December 1, 2006 at 6:51 am

    Low libido fans of Ms McKeith needn’t worry, her other Love products are still freely available (supported by excellent clinical evidence).

    www.naturesmax.co.uk/catalog/Living-Food-Love-Bites-200g-tub-p-16661.html

    Just remember though, sex makes kittens cry and that just isn’t nice.

    www.b3tards.com/u/50ea193c5fcac48cfdc2/stampoutsecs2.jpg

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