The scientists involved in this hormone study claim to have “robust evidence” of benefits for women’s sex lives but then also caution that the sample size is too small to be certain. We wish the story had taken a little more time to help readers decide what to believe and that it had included, in particular, information about costs and conflicts of interest. This is especially important given one of the researcher’s past histories with working closely with pharmaceutical companies to help them promote their products.
Also, pulling quotes from a news release without attribution is not best practice.
Hormone treatments are among the most litigated and most controversial drugs on the market. Readers need to understand the full context around any new development in hormone treatment, and they also need to understand what might be driving the science behind the scenes.
Costs are missing from the story, and, given that these are well established products, cost information could have been explained.
The story does a nice job specifically explaining the benefits or lack thereof. It says, “After 12 months, all the women on hormone replacements had improvements in menopausal symptoms, but those taking vitamin D and calcium did not show any significant improvement. At the start of the trial, all groups had similar sexual activity, but after the year, those taking calcium and vitamin D scored an average of 34.9 on the questionnaire scale, while those taking DHEA had a score of 48.6, showing that those on DHEA had more sexual interest and activity.” By presenting the actual scores, readers are able to see how close the scores were and decide for themselves whether the increased benefit was worth the risk of possible side effects.
The story explains the potential harms involved in taking hormone treatments, saying, “sales of HRT drugs have fallen sharply since a large study in 2002 found higher rates of ovarian cancer, breast cancer and strokes in women who took the pills, and the search has since been on for alternatives.” But the story does not address any potential harms of DHEA, which was the subject of the story.
The story signals up high that the study was limited in scope. It explains the basic study design quickly and competently. “For this trial, a team of researchers led by Andrea Genazzani of the University of Pisa followed a group of 48 post-menopausal women with troubling symptoms,” the story says. “Over a year, 12 women took vitamin D and calcium, 12 took DHEA, 12 took standard HRT and 12 took a synthetic steroid called tibolone which is used to alleviate menopausal symptoms.”
The story does not engage in disease mongering.
The article does not quote any outside sources, which we know can be driven by deadline demands. The bigger problem with the story, and it’s a problem shared by many stories about hormone treatments, is that it does not acknowledge the authors’ conflicts of interest. Dr. Andrea Genazzini, for example, has worked with pharmaceutical companies on multiple articles that were ghostwritten by the companies’ marketing firms. You can find this by looking in the Drug Industry Document Archive. We know that it’s tough to cover all the bases when juggling multiple stories in a day, but we hope that more reporters will take the time to at least do a name check on researchers involved in studies of hormone therapy, antidepressants and other drugs that have been the subject of lawsuits and federal investigations. There is a wealth of information in the archive, and readers deserve to know more about it.
The story mentions several alternative treatments to hormones. It says, “American researchers said in January that the antidepressant Lexapro, made by drugmaker Forest Laboratories, significantly cut the number and severity of hot flushes in menopausal women, and other antidepressants including GlaxoSmithKline’s Paxil and the Pfizer drugs Prozac and Effexor also have been found to be effective.”
But it seems strange that the story refers only to these brand name products and does not mention any of the generic medications such as fluoxetine and citalopram that have also been proven to reduce hot flashes.
This issue, and the lack of cost information, make this story less helpful to consumers than it might have been.
The availability is implied, but the story could have been more explicit about how readers might purchase the specific drugs that were studied or whether they were in specific trial stages for this type of treatment. In fact, tibolone is not available in the U.S. though it is available in Europe. DHEA is sold as a supplement over the counter.
There are no claims of novelty made here.
The quotes in the story come from the press release issued by the journal (posted here by News Medical).
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Comments (2)
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Tom Parkhill
December 27, 2011 at 1:52 pmI’m the press officer who wrote (most of) the press release for this article. I agree with some of you say, but there are a couple of points where I think that you are incorrect (and of course, I would say that).
This was not an article which arrived at the press release stage via the intercession of industry. I looked at the contents list for the December issue of the journal and asked myself “what is interesting and what might be newsworthy?”. This is what press officers do. This is also what journalists do. I then ran it past the editors and we agreed to put out what we thought was a fairly careful news release. In one respect, press releases are like children, you send them out in the world but you never know how they will turn out. This particular one got great coverage, which of course pleased me. At the same time, I accept that it probably got more coverage that it may have been due, for a small study. That is the nature of news.
If you look at the original press release (http://www.imsociety.org/pdf_files/comments_and_press_statements/ims_press_statement_20_12_11.pdf ), you will see that it is loaded with caveats, for example at 3 points in the release we say that this is a pilot study (or a small study which needs to be backed up). I even spoke to one of the editors to discuss a comment reinforcing that it was a small preliminary study. This is very firmly indicated in the press release.
You cast some doubt on the sincerity of Professor Genazzani, and the provenance of the news story – it’s your job to question where stories come from and why; I accept that, and I think that you do an excellent job (which is why I subscribe to your newsletter). You can’t always believe what you read in the press! At the same time in both your articles on this story you refer to Professor Genazzani as a woman, when in fact he is a man (Andrea is the Italian equivalent of Andrew). You have picked this up, unquestioningly, from the mistake made by the journalists who reported on the press release. Nobody’s perfect.
However, keep up the good work, I think that what you do is really valuable.
Best wishes
Tom Parkhill
I discuss your specific (negatively rated) points below:
Costs of the intervention – impossible to say if you are dealing internationally. DHEA is OTC in the US, but not in many other countries.
Does the story adequately explain/quantify the harms of the intervention? This could have been written better, and if I was doing it again I would look to indicate the possible known side effects. The press release did say that DHEA should only be used under medical supervision. However, the press release called for more studies, and don’t forget that many of the contraindications of drugs only come with bigger studies (such as the WHI).
Does the story use independent sources and identify conflicts of interest? The press release did address conflicts of interest, it is up to the journalist to back this up with independent comment.
Does the story compare the new approach with existing alternatives? The RCT did compare the approach to two existing treatments and a placebo. We were very specifically NOT trying to say that DHEA was a practical alternative to any treatment, only that the initial work was interesting, but incomplete.
Does the story establish the availability of the treatment/test/product/procedure? Again, in an international press release this is impossible to establish. You have chosen to look at it from a US point of view, which is fine. However, availability should not really have been the issue – we quite specifically said that we could not say that DHEA “was an alternative to HRT”, or anything else – it was a pilot study.
Does the story appear to rely solely or largely on a news release? Again, this is something for the individual journalist to deal with.
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