Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 1

After L’Affaire Economist, (parts 1, 2, 3) HolfordWatch really wanted to be able to commend Jerome Burne for something. We have noticed that although his last few articles in the Daily Mail haven’t actually carried links to the research upon which he relies, he has provided enough detail to allow the careful reader to identify the papers. It would, of course, be good if we did not have to resort to a treasure hunt to identify the primary sources but that is probably a confluence of out-moded thinking by both journalists and newspaper.

Today, Burne gave generous amounts of detail as to one of the major sources for his claims in his article: Should middle-aged women be taking natural HRT?. HolfordWatch was poised to congratulate Burne for semi-identifying this work up until we actually read the paper that he describes as a “major review”: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?. Leaving aside the lack of appropriate rigour in the paper, we noticed that, despite his usual exquisite sensitivity in such matters, Burne seems to be overlooking the “review” author’s failure to declare what might appear, to others, as a substantial conflict of interest.

Dr Kent Holtorf is the author of this “major review”. He is part of the Holtorf Medical Group: Center for Hormone Imbalance, Hypothyroidism and Fatigue that specialises in…hormones and longevity, including HRT and bio-identical hormone replacement. Forgive me for quoting this at length but, according to the section on bio-identical hormones:

Dr. Holtorf and the doctors at the Holtorf Medical Group, Inc have been using and preaching the superiority and safety of natural hormones verses [sic] synthetic for many years (long before the Women’s Health Initiative Study). There are many doctors that now claim to specialize in natural hormones but our expert knowledge and experience can make the difference between feeling great and so so.

Get Off Premarin, Provera, Prempro and other Synthetic Hormones

And get on to the safe and natural pharmaceutical hormones.

The doctors at the Holtorf Medical Group, Inc can help you actually obtain the health benefits you have been striving for without compromising your health with the side effects of the synthetic hormones you have heard about on the news. [Emphasis added.]

This is relevant because, at the end of this “major review”, we read:

Conflict of Interest Statement
Kent Holtorf, MD discloses no conflicts of interest.

Holtorf offers seminars on bio-identical hormone therapy and physician training. We’re just highlighting this because Burne is sensitive to conflicts of interest (see Economist links above) and it seems a little unusual for him not to have brought Holtorf’s financial interest in bio-identical hormones to his readers’ attention.

Before we go any further, we should state that nobody at HolfordWatch has a position on hormone replacement therapy (HRT), nor do we have a direct or indirect financial or other association with it. We object to the medicalisation of women’s health and are also concerned by what Chris McDonald characterises as the “alternativization of women’s health”:

“Alternativization” is the tendency to understand normal events (for example, menstruation, pregnancy, childbirth, menopause) as pathological states requiring intervention by practitioners of alternative therapies. Alternativization gives practitioners of various art-forms — sometimes poorly understood art-forms — control over women’s health, and authority to “solve” therapeutically what might otherwise have been seen as political, personal, or social issues. Not all alternative therapies will be equally subject to this worry.

Big Herba is not necessarily a lesser perceived evil than Big Pharma just because in this example, its hormones are derived from friendly-natural-sounding, yams and soy rather than horse urine. As Scott of Science-Based Pharmacy puts it in his discussion of bio-identical hormones:

Bioidentical is often used synonymously with the term “natural”, inferring that bioidentical, compounded hormones are natural, effective, and therefore good, while pharmaceutical-company manufactured hormones (bioidentical or not) are unnatural, ineffective and dangerous.

“Natural” is a meaningless term with respect to BHT. All bioidentical hormones are manufactured using wild yams or soy as the starting ingredient, and all undergo chemical conversion in a laboratory to be synthesized to the final ingredient. [1] [3] There are no bioidentical hormones that do no undergo some sort of laboratory manipulation. Consequently there are no truly “natural” bioidentical hormones.

We shall continue a discussion of Burne’s article in Part 2 when we assess the technical aspects and quality of Holtorf’s review.

Related Reading

Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 3.

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20 Comments

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20 responses to “Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 1

  1. Pingback: Twitted by badscienceblogs

  2. Kat

    What’s un-natural about horse urine? There might be a bit of a “eeuww” factor, but it’s a pretty natural product.

    • Rita

      Guess what I’m going to say? – Yup, it’s bad for the unfortunate mares who are impregnated – and what happens to the foals?, you may well ask – and “milked” of their urine………….humans behaving badly again, I’m afraid – is there no end to it?
      I’m menopausal, it’s damned uncomfortable, but not as uncomfortable as being a Premarin mare – and if it was, get over it, dammit!

  3. the superiority and safety of natural hormones verses synthetic

    I’d certainly agree with Holtorf Medical Group that poetry and music can be healing, but I’m not sure that they need to be synthetic :)

  4. That’s really quite something. I’ve been trying, but I really can’t understand how anyone could consider that someone who has been “using and preaching the superiority and safety of” bioidenticals would not have a conflict of interest to declare when writing about the subject.

    “It would, of course, be good if we did not have to resort to a treasure hunt to identify the primary sources but that is probably a confluence of out-moded thinking by both journalists and newspaper.”
    Absolutely. I once contacted several newspapers (and a broadcaster) to ask them about their policy of not providing direct links to the research they discuss but, sadly, did not receive a single reply to my email.

  5. Pingback: Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 2 « Holford Watch: Patrick Holford, nutritionism and bad science

  6. Pingback: Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 3 « Holford Watch: Patrick Holford, nutritionism and bad science

  7. Big Herba – heh. Or maybe Big Leaf? Big Plant?

  8. J. Anderson

    ““Alternativization” is the tendency to understand normal events (for example, menstruation, pregnancy, childbirth, menopause) as pathological states requiring intervention by practitioners of alternative therapies.” This article makes me furious.I know several women who have their lives utterly changed for the better by using natural hormones. We lead incredibly busy and stressful lives, some people sail through the menopause, other women do not and as a result of imbalances, suffer loss of self, depression and confusion. Why don’t you actually ask women themselves what the results of this are? Too busy sneering to care and probably think women who go to alternative practioners are a load of idiotic gibbering wrecks who are unable to think rationally.

    • It’s a shame that you can be so enraged by reading something that it seems that you do not manage to read the remainder because it seems as if you didn’t read the part that stated that this was about the scholarship of the article, not the issue of BHT. Nor the part that explained what ‘natural’ means in such a context.

      The MacDonald article that you quote as the source of your irritation is a very intriguing one. If medicalisation of women’s health is a problem, then it seems logical that similar approaches to alerernativisation would also be inappropriate.

  9. Jerome Burne

    It is always nice to have someone read your articles closely although as usual your critique favours trees over wood and, to continue with the clichés, taking hammers to nuts. It does seem worth beginning by making the very obvious point that I am writing for the Daily Mail. This means that the audience has a strong female bias and that most of them – and I am simply quoting editorial wisdom – are primarily interested in “what this development means to me”. Not in the depth of the scientific research supporting it. While I am all in favour of references and evidence and the rest of the scientific edifice, complaining that it is not there in the Daily Mail is rather like critiquing a Nature paper on the grounds it was lacking in individual case histories and full of confusing statistics and jargon.

    So, to specific points.

    *You object to having to “resort to a treasure hunt to identify the primary sources”. See above.

    *”Burne gave generous amounts of detail as to one of the major sources” – Not sure what your definition of “generous” is but in an article of 2000 words I actually devoted fewer than 150.

    Your essential point here is that the author Holtorf has been a supporter of bio-identical hormones for years and uses them in his centre and that he did not declare this interest. He probably should have done and there are doubtless criticisms that can be made of his review but the point is that an article in a daily paper health feature is not the place to look for such detailed discussions.

    As usual with your concentration on minutiae you miss the broader point which is that the reiteration by official bodies such as the AMA and others in the UK that there is no evidence for bioidentical hormones is just not true. There is not conclusive evidence and there is disputed evidence but to claim that there is none is simply wrong. The effect of this has been to deny many women who want HRT for various reasons – mostly help with distressing symptoms – an alternative. This wilful ignorance seems to me a far more serious failure than your point about the author of one piece having an undeclared interest.

    I could have used various other papers instead of Holtorf’s which made the same general point. For instance: “Could transdermal estradiol + Progesterone be a safer postmenopausal HRT? A review by Marc L’Hermite et all in Maturitas – July/August 2008. The conclusion was that it “might offer significant benefits and added safety.”

    Or how about a case control study from France involving 271 consecutive cases with “a first documented episode of idiopathic VTE (venous thromboembolism). Conclusion: “oral but not transdermal estrogen is associated with increased VTE risk. In addition our data suggest that norpregnane derivates may be thrombogenic whereas the micronized progesterone and pregnane derivatives appear to be safe with respect to thrombotic risk.” Circulation Feb 20 2007

    Your nitpicking critique misses not only the general point that there is sensible evidence supporting bioidenticals but also the even stronger one that there are now a number of senior British gynaecologists – quoted in the article – who also believe, with the usual caveat about more research, that bioidentical hormones may well offer a superior option to many women. Now that seems to me to be a point well worth making. They also constitute and argument from authority – they are experts, they will be familiar with a range of evidence of which Holtorf is just one example – and as such can be taken as supporting his general conclusion.

    *It is a pity that in your efforts to discredit the article that you fell into the hoary old trap of confusing natural with bioidentical.

    You state: “There are no bioidentical hormones that do no undergo some sort of laboratory manipulation. Consequently there are no truly “natural” bioidentical hormones.”

    This is one of the canards regularly wheeled out against bioidentical hormones. The implication is that all those woolly people rooting for bioidenticals don’t know their science. Not only is it utterly wrong but I specifically dealt with it in the article.

    I wrote: “Many women believe that bio-identical hormones are safer because they are made from plant sources. In fact nearly all replacement hormones both bio-identical and the ones in regular HRT come originally from plant sources (although Premarin comes from horse urine). It’s not the source that is the key but how the chemicals are tweaked in the lab.”

    This is why attempting to score points by suggesting Premarin is “natural” is irrelevant too. The issue with Premarin, as with progestins, is that the hormones it supplies are different to those your body makes.

    *Finally I am always amazed at the narrowness of your focus. Is the aim of your site and considerable time you must put into it simply to try to point out, fairly ineffectually, errors in my articles or in publications by Patrick Holford? If you are concerned about the perversion of science for commercial ends why do you persist in nagging away at the kids with the catapults and ignore the passing tanks?

    You must know that a cavalier attitude to evidence has been a hallmark of drug company marketing, frequently with fatal results. In light of the repeated (and incorrect) assertions that there is no proper clinical trial evidence for bioidenticals it is worth remembering that until the WHI study there was none for HRT either – lots of observational stuff but no long term trial and the pills were prescribed in their millions.

    But the fiddling was far more specific. Recently a particularly striking example fudging figures on HRT came to light as a result of investigations by Senator Grassley of the American Congress into “ghost-writing”. A report in the New York Times showed how Wyeth Pharmaceuticals and a medical writing firm produced ghost-written journal articles–all signed by prominent gynaecologists—that were designed to deceive doctors about the safety of Prempro. (THE NEW YORK TIMES December 12, 2008 “Drug Maker Said to Pay Ghostwriters for Journal Articles”)

    One of these was published in The American Journal of Obstetrics and Gynecology in May 2003 – a year after the WHI study had found the increased the risk of breast cancer – saying that there was “no definitive evidence” that progestins cause breast cancer, adding that hormone users had a better chance of surviving cancer. An article that was distributed to large numbers of doctors. Why not do something useful and chase up dangerous distortions like that?

    Finally although the anti bioidentical camp keep on playing down the HRT risks there is growing evidence that a falling incidence of breast cancer among postmenopausal women in the United Kingdom may be linked to lesser use of hormone replacement therapy (HRT). (See BMJ 2009;338:b791)

    • The post, yet again, was about the scholarship not about the BHT. It is a shame that several commenters don’t seem to have read far enough to notice that in any one of the relevant pieces.

      From your comments, it rather seems as if you accept that the review on which you ground your work was less than optimal. In which case, why cite it? It does not empower women to tell them what someone thinks that they want to hear rather than give an accurate precis of the state of the evidence. If you had better grounded evidence then it might have served your readership better to use it.

      Entertained that you are focusing on “cavalier attitude to evidence” – note the claim about the NNT for statins in the book you co-authored with Patrick Holford.

      The claims about AZT and vitamin C in re: effective interventions for HIV are not minor or trivial claims. It is not good enough that there is a minor note correcting this in the latest version rather than an update to the text.

      Holford talks about himself in terms of ‘De Vinci’, I don’t know how thrilled he might be that you compare his millionaire status and standing as CEO of various charities and position with Biocare to that of a ‘kid with a catapult’.

    • You may not be aware that there was more than one version of your article and that the earlier one (from which we were working) did not contain all of the ‘expert comment’ or extra detail that appears in the later version. However, we didn’t mention that as we assumed that it had more to do with the sub-editors rather than you.

      It’s a shame that you didn’t realise that the comment about natural v. synthetic hormones was with reference to the issue of medicalisation and “alternativization” of women’s health rather than your article. Had we intended to comment on your article at that point, we would have mentioned it.

      Not really impressed by arguments from authority. We emphasise access to primary sources and scrutiny of them.

    • It is a pity that in your efforts to discredit the article that you fell into the hoary old trap of confusing natural with bioidentical.

      Given that the headline of the article is “Should middle-aged women be taking natural HRT”, it did seem to invite this type of interpretation. I appreciate that this may have been down to the sub-editors – but, if so, have you raised this with the Mail?

      By the way, I’d welcome details of the research backing up the claims made in your article on SPECT scans.

  10. jerome burne

    You say: “The post, yet again, was about the scholarship not about the BHT. ….”
    While I welcome a critical scrutiny I have to say that looking for “scholarship” in the Daily Mail is a quixotic venture.

    As it happens I do go to considerable lengths to look at the evidence and talk to experts but there is no pretence that such an article is a work of scholarship. The point about Holtof’s is that it was an example of a fairly detailed article published in a respectable and peer reviewed journal that was favourable.

    I could also have referred to another equally detailed article by Holtorf and Schwartz – (Prim Care Clin Office Pract 35 (2008) 669–705) as well as the two others mentioned in my previous post. But as far as “serving my readership better” goes they would have added nothing

    That is because the the purpose of the article was not to conduct a review of the scientific literature. It was firstly to alert people to the existence of bioidentical hormones – the fact that an equal number of Americans take them as do regular HRT means that they are an issue that deserves far more discussion and coverage in the UK than they have so far.

    The second was to very briefly skim over some of the high points of the evidence, not to painstakingly build a scientific case. The third and this feeds directly into the second point – to alert people to the fact that a variety of bioidentical hormones are already available on the NHS. A fact on its own which indicates that they have a sensible evidence base.

    That point is further reinforced by the support given to them by the gynaecologists. You say you are “not really impressed by arguments from authority. We emphasise access to primary sources and scrutiny of them.”

    All very well and good but – and I’m sorry to keep repeating this – not in a daily newspaper. You are looking at a fish and keep pointing out that it does not ride a bicycle very well. The point of authoritative experts in newspapers is that they act as a kind of short hand, this person whose job it is to know about this, supports it. As far as serving readers goes, that is one way of doing the job.

    I don’t understand your point about the comment about natural v. synthetic hormones being with reference to the issue of medicalisation and “alternativization”. It may well have been but that doesn’t affect the fact that it is wrong and misleading.

    • You might consider this recent classy remark from Carl Zimmer when he was highlighting that the Telegraph had removed a piece that was criticised by Ben Goldacre and failed to put up a notice about that removal:

      You should check my links, too. Eternal vigilance is the price of online journalism.

      On the natural v. synthetic point, you comment:

      I wrote: “Many women believe that bio-identical hormones are safer because they are made from plant sources. In fact nearly all replacement hormones both bio-identical and the ones in regular HRT come originally from plant sources (although Premarin comes from horse urine). It’s not the source that is the key but how the chemicals are tweaked in the lab.”

      This is why attempting to score points by suggesting Premarin is “natural” is irrelevant too. The issue with Premarin, as with progestins, is that the hormones it supplies are different to those your body makes.

      It has been explained to you that Scott’s description of natural v. synthetic bio-identical hormones (which you seem to accept as accurate) was made with reference to the issue of medicalisation and “alternativization”, you characterise it as “wrong and misleading”. Likewise, I fail to understand your point here.

      [A] variety of bioidentical hormones are already available on the NHS. A fact on its own which indicates that they have a sensible evidence base.

      Magnetic leg wraps are available on the NHS: the evidence for them is less than compelling. And, again, the point at issue is scholarship, not BHT.

      Raising awareness by providing information that is built on a shaky foundation does not help an evidence-based discussion. How does it help a woman to visit her Menopause Clinic and ask about BHT based on the information in your article, only to have the Clinic look up the Holtorf review and then discuss the flaws with her before providing her with different information?

      I would be very surprised if the Daily Mail were willing to endorse your attitude to their readers and the need to provide correct information to them. As for your implication that newspapers provide mediation between readers and experts, I shall defer to Ben Goldacre:

      Firstly, they can’t get journalists to directly link to their studies. I suspect newspapers like to fantasise that they are mediators between specialist tricky knowledge and the wider public, but I wouldn’t be so flattering. In fact, if you have access to the original journals, you can see just how rubbish things can get.

      Why should the public trust the information in newspapers when journalists who write for them say:

      it was not part of my brief to go investigating the data that some expert has spent years compiling…

      and appear to deprecate the need for accuracy when writing for a newspaper?

      As for adding in detail, I re-iterate, it is the quality of the scholarship that counts, not its volume.

  11. Wulfstan

    Kids with catapults? Correct me if I’m wrong but did I hear a rumour that Patrick Holford was, until recently, a Visiting Professor at the University of Teesside? Didn’t he recently deliver a guest lecture to the London Met. Uni.?

    I also thought, I may be wrong, that Patrick Holford and his merry FFTB-ers were asking for more money to run more projects in schools despite some criticism of the standards of their last report (apparently, the literature review had some errors and the statistics were flawed-to meaningless in spots – apart from that, it was fine).

    Again, this may be just something I heard, but iirc, then the Brain Bio Centre is touting for business from private health insurers and PCTs in matters relating to mental health and nutrition.

    I might be wrong, but isn’t Patrick Holford still lecturing from time to time at the ION? Aren’t IONistas, as per BANT, trying to get some of their people accepted by the NHS for various lifestyle programmes? People from courses on which certain books are regarded as reference texts despite the flaws in them, the standard of their scholarship and the fact that some of the people who originally endorsed them have asked for those endorsements to be removed?

  12. jerome burne

    As far as Spect scans were concerned, I’m afraid this is another case of you asking newsapers to do things that they are not designed to do. the article was an extract from a book. The Mail had brought the rights to the book and asked me to write a summary that highlighted some of the points that would be of interest to readers.

    In such a case it was not part of my brief to go investigating the data that some expert has spent years compiling. That is the job firstly of the editors of the publishing house and secondly of reviewers, in this case most likely in scholarly publications.

    If you have issues with the author’s scholarship I suggest that you take it up with him.

    • As far as Spect scans were concerned, I’m afraid this is another case of you asking newsapers to do things that they are not designed to do. the article was an extract from a book…In such a case it was not part of my brief to go investigating the data that some expert has spent years compiling.

      It wasn’t clear to me that this was just a book extract. The article’s in your name, refers to Amen in the 3rd person, etc.

      As to an expectation that newspapers doing things they’re not designed to do – the article even misdescribes Amen’s role at UCal. This type of fact-checking is not (or should not be) something alien to newspapers – and this type of checking is especially important if you’re relying on a source’s expertise, rather than analysing his data and work independently.

      Beyond that – very basic research (e.g. a simple Google search) shows that there are a number of concerns with certain applications of SPECT and Amen’s work – including the type of applications discussed in your article. I don’t think it would have been unreasonable to expect a newspaper to consider this (or to contact critics such as Harriet Hall for comment).

  13. For those who are interested, the updated (and permanent) URL for my paper on the Alternativization of Women’s Health is:

    http://www.ethicsweb.ca/papers/Alternativization2002.pdf

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