Related Topics: HRT, Opinion, Research, World Menopause Month

HRT – Don’t Believe What You Read

The shocking truth about how pharmaceutical companies hired ghostwriters to distort results.

AnnA Rushton
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Personally, I find it a good rule to approach all written material with a very open mind and to take nothing you’ve read on trust — particularly when it comes to the launch of a new product or drug.  I have previously covered the subject of medical ghostwriting and how it has been used to virtually rewrite scientific trials if the outcome is not to the drug companies satisfaction, but I have just become aware of a new twist.   While I knew this practice had extended to many new drugs being brought on to the market, it has just come to light in relation to Prempro HRT just how far that misinformation has gone.

We know this because of the very first academic analysis of 1500 documents unsealed in a lawsuit against pharmaceutical giant Wyeth (now part of Pfizer). The litigation was filed in July 2009 against menopausal hormone manufacturers by 14,000 women whose claims related to the development of breast cancer while taking the hormone therapy Prempro (conjugated equine estrogens – horse urine to you and me).  The case itself has been well documented, and the facts that were revealed during it came as quite a shock and it is that disquiet which is behind the US federal court decision to release the documents to the public.

An investigation of these documents by Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC was just published in PLoS Medicine. She analyzed dozens of ghostwritten reviews and commentaries about Prempro which were published in medical journals and journal supplements. Her conclusion?

“facts were manipulated within the articles to promote unproven benefits and to downplay the harms of Prempro. What’s more, the articles were deliberately written in a way to place any competing therapies in a negative light.”

No prizes for guessing what those competing therapies were — the pharmaceutical companies have never been keen on alternatives to HRT such as bio-identical natural hormones like progesterone.  These articles were widely circulated to physicians directly and also to the drug salesmen who represent the products of pharmaceutical companies like Wyeth.  They were used to convince doctors that Prempro was a good product and to inform them about how and why it should be given to menopausal women.  It was certainly effective as a campaign because it was enthusiastically prescribed by doctors and resulted in millions of packs of Prempro being sold.
Just why did doctors fall for this?  The simple answer is that the information was presented to them in a form that they trusted — that is as respectable research and scientific reports.  The problem is that any original research was ‘spun’ so that they received a misleading account of both the benefits and drawbacks to the drug.  This was done by hiring DesignWrite, a medical education and communication company to produce ghostwritten articles that took the basic research and in many cases turned it on its head.

Well what is wrong with a bit of creative writing?  As a writer and creative coach myself I could say nothing at all, but there is a great deal that is seriously wrong when it comes to distorting the facts that potentially have fatal effects on women’s health.  How did they do this?

Firstly, the ghostwriters were told to mitigate the perceived risks of breast cancer associated with it and also to defend and promote alleged cardiovascular benefits of HRT.   Alleged is certainly right as the supposed facts presented were unsupported by scientific evidence and in fact the reverse was certainly already known; that there are risks associated with HRT and cardiovascular disease.

Secondly, Wyeth also used ghostwriters to promote a range of other conditions for which HRT might be beneficial and for which there is absolutely no proof whatsoever such as the prevention of dementia, Parkinson’s disease, vision problems, and even wrinkles.  This aspect of their work is certainly well known to me, as at one time I seriously considered writing a small pamphlet entitled “101 uses of HRT you never knew about” because every time there was any negative press about HRT a positive report for a previously unknown use would hit the media the following week.
So why would they go to all this trouble?  The answer of course, as ever, is profit because these misleading reports enabled them to sell a great deal more of their product.  It was certainly a profitable business for the ghostwriters as just for Prempro alone they were paid between $20-$25,000 an article and in total produced 20 articles which reflected the positive spin that Wyeth wanted to have put on their product.

Last Word
I will leave it to Dr. Adriane Fugh-Berman to have the last word, and this is what she concluded in her study:

“Given the growing evidence that ghostwriting has been used to promote HRT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted,”

I couldn’t have put it better myself.

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Please feel free to discuss this article in the comments section below, but note that the author cannot respond to queries made there.
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Comments 8
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JR | 4:35 pm, October 6th, 2010

It’ll be interesting to see what further analyses of Jerilynn Prior’s recent progesterone-only trial reveal. She, rightly so, has claimed there has been an estrogen therapy conspiracy for decades, which stifled her attempts to get her P-only trials results published in scientific journals.

It was actually surprising to read how progesterone was as good as estrogen at quelling hot flashes and that progesterone alone also got rid of night sweats and improved deep sleep. Hopefully her trial’s findings regarding breast tissue changes, blood clotting, etc. will be positive and provide women with an alternative. I doubt it’ll be a health tonic, but hopefully it’ll be safe…

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AnnA Rushton | 4:59 pm, October 6th, 2010

I agree, and will be keeping a close eye out for any further revelations!

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JR | 5:53 pm, October 6th, 2010

Dr Prior’s work has been quite revealing. Both her own discoveries and how they fit into the marketing game of HRT.

As she’s pointed out, it has been so hard to tease out the good, the bad, and the ugly of estrogen and progresterone, alone or together. For one thing, she has proved that hot flashes aren’t caused by “low” estrogen at all, but rather fluctuations of high estrogen levels with low progesterone. She’s also shown that the “good” effects of progesterone occur in the 2nd half of the menstrual cycle when estrogen levels are low, such as breast maturation and the clearing of the uterine lining. In accordance with her reasoning, I think P-only trials are LONG overdue.

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Myron | 8:08 am, October 20th, 2012
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Yasmin Khan | 4:39 pm, January 24th, 2013

thank you so much for creating this site. I have just started to experience the sign of menopause. I was very upset and had some sleepless nights but I took things into control and increase my level of expercise and i am now eating a lot of green vegatables such as spinich. I am taking fruit and juice plus suppliments. I have purchased the serenity cream which I use once a day. My sleep has improved and the hot flushes have subsided. I will not take HRT since reading your article. Many of my friends are doctors and they laugh at me when I tell them my solutions for menopausal symptoms.

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Mary Joslyn | 4:50 pm, September 20th, 2013

I am living proof that what is said here is TRUE. I took HRT and developed breast cancer! So far I am lucky to be a 9 year survivor! Have been using progesterone cream for a few years with mixed results. I am still having hot flashes at 70+ years. Any advice would be helpful. Thanks for your work for all women!

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AnnA Rushton | 10:56 am, September 24th, 2013

Unfortunately Mary flashes post menopause seem to be increasingly common. A recent study has shown that a much higher proportion of ‘older’ women (average age 59 in this study) than was expected still suffer from hot flashes and night sweats, well after menopause is assumed to be over. Other factors such as stress can also play a part at this stage so you may find this article helpful:
http://www.bio-hormone-health.com/2013/02/01/don’t-underestimate-the-effect-of-stress-on-your-hormonal-symptoms/

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