Blog – Page 8 – Helen Jaques

When NOT to screen for cancer

February 22, 2009 1 Comment

Cancer screening Annual screening for prostate cancer may not be required in many elderly men, whereas routine screening for breast cancer should probably never have been implemented, say two separate studies published this week. These studies raise questions as to whether regular screening for common cancers is really necessary and, if so, in which groups.

In the first study, due for publication in the Journal of Urology, the authors assessed 849 men aged from 40 to 92 who had been followed up for 10 years as part of the Baltimore Longitudinal Study on Aging.

During this time period, the men had undergone an average of four tests to measure prostate specific antigen (PSA) levels. PSA level in the blood is used to screen for prostate cancer: if a man has a blood PSA level of of 4.0 ng/ml or higher, it is likely that he has prostate cancer.

The authors found that in a subgroup of men aged 75 years or older who had a PSA level of below 3.o ng/ml – well within the normal range – none died of cancer and only one developed high-risk prostate cancer.

In the US and the UK, men over the age of 50 are advised to undergo annual prostate cancer screening. The findings of this study imply that routine screening may not be needed those who are over 75 and have a normal PSA level, as such individuals are unlikely to die of or experience aggressive prostate cancer during their remaining life. Even if PSA levels indicate that a man over 75 DOES have prostate cancer, it’s likely that he’ll die of something else rather than the malignancy. In such cases men could forgo risky therapy and avoid the nasty side effects that can seriously affect quality of life.

Speaking to Reuters, Dr H Ballentine Carter of Johns Hopkins University in Baltimore, one of the researchers contributing to the study said, “For the overwhelming majority of men over age 75, discontinuing PSA screening is probably a very safe thing to do”.

As for women, an analysis in the BMJ has highlighted the risks associated with mammography – including a high rate of false positives – and suggests that in many cases the risks inherent in routine screening for breast cancer outweigh the benefits.

The authors of this study argue that the NHS Cancer Screening Programmes leaflet about mammography, Breast screening: the facts, is unbalanced in its portrayal of the positives and negatives of screening and constitutes “one sided propaganda about breast screening”.

They suggest that the leaflet overplays the benefits of breast cancer screening, such as the possibility that screening leads to fewer mastectomies. Various studies indicate that the number of mastectomies actually increases when screening is introduced, they point out. The authors even dispute the statement that screening saves lives, highlighting trials showing that screening does not decrease total cancer mortality.

The authors also opine that the leaflet downplays the risks of breast cancer screening, like the possibility of being overdiagnosed, which with mammography is ten times more likely than being accurately diagnosed. “No mention is made of the major harm of screening – that is, unnecessary treatment of harmless lesions that would not have been identified without screening,” they write.

The analysis concludes that breast cancer screening is associated with less benefit and substantially more harm than previously thought and that mammography screening programmes would probably not have been initiated if the individuals who wrote the policies 20 years ago had had the evidence available today.

So should prostate cancer and breast cancer screening programmes be cut back? Doing so would avoid the consequences of false positives and would save health care providers millions of pounds in diagnostic costs.

What do you think? Would you stick to your yearly screening appointments regardless of the risk of being misdiagnosed and subjected to unneccessary treatment, just in case one day screening does catch a malignant but treatable lesion that would have otherwise been missed? Or would you rather steer clear of the hassle of screening and the stress of a false alarm?

Pharmaceutical industry

Improving communication of medication risks and benefits in direct-to-consumer ads

February 19, 2009 No Comments

A new study published in Annals of Internal Medicine has shown that adding a simple fact box to adverts for prescription drugs considerably improves consumer awareness of the risks and benefits of the medication. In this study, people who examined an advert with a drug fact box were more likely to choose the most efficacious drug than were participants who assessed an advert with an in-depth summary of the drug characteristics.

The FDA requires that direct-to-consumer adverts include a ‘brief summary’ of all the risks listed in the drug’s FDA-approved prescribing information. This summary can amount to more than a page of dense text, however, and although companies are supposed to use easy-to-understand language, the text can seem pretty impenetrable. Writing of the current system, the study authors Schwartz et al. say that “the U.S. public currently lacks accessible and accurate information about prescription drug efficacy and side effects. Instead, people are exposed to billions of dollars in marketing designed to generate enthusiasm for new products, leaving them vulnerable to persuasive marketing techniques and selective presentations of information”.

Schwartz et al. assessed whether using a ‘drug facts box’ – a 1-page round-up of a drug’s benefits and side effects, with key information on the chance of various outcomes provided in a table – improved knowledge of the risks and benefits associated with a medication and helped patients make informed treatment choices.

This study was split into two randomised trials that assessed two types of fact box: one box on how a drug treats current symptoms and one on how a drug prevents the onset of symptoms.

In the symptom drug box trial, the authors tested adverts for a fake proton-pump inhibitor (PPI) – Maxtor – and an imaginary histamine-2 (H2) blocker – Amcid. These two types of drug are used to treat symptoms of heartburn and have similar adverse effects, but clinical data show that PPIs clearly outperform H2 blockers. All 231 participants received the same ‘ad image page’ (the colorful front page) and then also received either the symptom fact box (drug box group) or a brief summary (control group).

In the prevention drug box trial, the authors used adverts for a statin – Concor – and clopidogrel – Pridclo – for prevention of future cardiovascular events. Such events are relatively rare, so the drugs have small absolute effects and are, therefore, not appropriate for many individuals. The 219 study participants were randomly assigned to receive either adverts with a brief summary or adverts with a drug box.

In the symptom drug box trial, more participants in the drug box group than in the control group were able to accurately recount the risks of the two heartburn drugs. In addition, the perceptions of individuals in the drug box group more accurately reflected the actual efficacy of the drugs. When asked which drug they would prefer to take, 68% of the drug box group chose the PPI – objectively the more effective drug – compared with 31% of the control group.

Participants in the prevention drug box trial who received the drug box adverts were more likely to understand the side effects of the two drugs. Also, most of the patients in the drug box group were able to accurately quantify the small reduction in the risk of cardiovascular events provided by the two drugs, whereas more than half of the participants in the control group overestimated the benefits of the drugs by a factor of 10 or more. Individuals in the drug box group were, therefore, more likely to conclude than the side effects associated with the drugs outweighed the small benefits provided.

The authors write: “Some may wonder whether we simply proved the obvious: one group was provided with the ‘right answers’, whereas the other was not. However, that is precisely the goal of the drug box—it provides the data needed to make informed decisions. Without these data, people can only guess, and their guesses are most likely based on the information that appears in the ads.”
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Schwartz LM et al. (2009) Communicating Drug Benefits and Harms With a Drug Facts Box: Two Randomized Trials. Ann Intern Med Early-release article: 17 February 2009

Cancer

Researchers identify new prostate cancer marker detectable in urine

February 12, 2009 1 Comment

Researchers in the US have found a new marker of the aggressiveness of prostate cancer that is detectable in the urine of men with the malignancy. Sreekumar et al. discovered that levels of sarcosine, a common amino acid found in many biological tissues, are higher in invasive prostate cancers than in benign cancers and are detectable in the urine of affected men.

Currently, prostate cancer is detected by measuring blood levels of a marker called prostate specific antigen (PSA). The diagnosis is then confirmed by taking a tissue sample (biopsy) from the prostate using a fine needle – an uncomfortable and undignified process – and examining it under a microscope.

If further trials confirm that sarcosine levels in the urine do reflect how advanced a prostate cancer is, measurement of this marker could be used as a noninvasive way to predict the aggressiveness of a cancer and thus a patient’s prognosis.

In this study, the authors recorded all the metabolites (low molecular weight molecules produced by cells) found in samples from patients with various stages of prostate cancer, ranging from benign cancer to advanced metastatic cancer. In total, 1,126 metabolites in 262 clinical samples related to prostate cancer were profiled. The authors then compared the metabolites found in the various types of tumor tissues in order to unearth ‘molecular signatures’ that distinguished the different stages of prostate cancer.

In total, 87 metabolites that distinguished prostate cancer from benign prostate tissue were found, and the levels of six of these metabolites were even higher in metastatic cancer than in any other stage of disease. Sarcosine, an N-methyl derivative of the amino acid glycine, was highly increased in metastatic samples and, importantly, was undetectable in the benign samples.

The authors then tested out what happened when they eliminated the enzyme glycine-N-methyl transferase, which is crucial for the production of sarcosine from its precursor glycine. The invasive properties of prostate cancer cells in culture were attenuated when this enzyme, and thus sarcosine, was absent. Addition of sarcosine to benign prostate epithelial cells or knockdown of the enzyme that is responsible for sarcosine degradation caused noncancerous cells to become invasive. Taken together, these findings suggest that not only is sarcosine a marker of cancer aggressiveness, it also has a role in endowing a cancer with malignant properties. Components of the sarcosine pathway may thus serve as new targets in the development of drugs that combat prostate cancer metastasis.

Lastly, the authors measured levels of sarcosine in urine specimens from individuals who had been definitively diagnosed with prostate cancer on the basis of PSA levels and prostate biopsy and compared these results with those from individuals who were biopsy negative. Levels of sarcosine were significantly higher in the urine of men with prostate cancer than in those without, confirming that measurement of sarcosine in the urine may act as an indicator of prostate cancer.

Senior study author Dr Arul Chinnaiyan told The Independent: “One of the biggest challenges we face in prostate cancer is determining if the cancer is aggressive. We end up over treating our patients because physicians don’t know which tumours will be slow-growing. With this research, we have identified a potential marker for the aggressive tumours.”

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Sreekumar A et al. (2009) Metabolomic profiles delineate potential role for sarcosine in prostate cancer progression Nature 457 (7231): 910-914 DOI: 10.1038/nature07762

Diet and nutrition, Nephrology

Make it a DIET coke break, for the sake of your kidneys

February 11, 2009 8 Comments

Diet coke break New research published in PLoS One has shown that drinking two or more fizzy drinks a day can double a woman’s chance of developing signs of kidney disease – but only if she drinks full-sugar sodas.

David A Shoham and colleagues studied data from more than 9,000 individuals in the population-based National Health and Nutrition Examination Survey (1999–2004). They found that women who drank two or more cans of soda per day were nearly twice as likely to develop early signs of kidney disease compared with women who consumed fewer sugary soft drinks. Women who drank diet soda were not at increased risk of kidney disease, nor were men.

The rise in diabetes, obesity and kidney disease in the US has paralleled an increase in the use of high fructose corn syrup in American food. High fructose corn syrup is used in particular as a cheap way to sweeten fizzy drinks; thus, the authors investigated whether consumption of soft drinks is associated with albuminuria, a sensitive marker of early kidney damage.

In total, 11% of the sample population were found to have albumnuria, and 17% of the study group drank two or more sugary soft drinks per day. Individuals who drank more than two fizzy drinks a day were 40% more likely to have albuminuria than were participants with a more moderate intake of soda. Consumption of diet soda, however, was not associated with albuminura.

When the authors broke down their results by gender, they found that women who reported drinking two or more sodas in the previous 24 hours were 1.86 times more likely to have albuminuria than were women who drank less soda. Drinking fizzy drinks had no significant effect on the risk of albuminuria in men.

An analysis of type of soda showed that consumption of sugary non-colas was most strongly linked with albuminuria, whereas sugary cola and diet cola and non-cola drinks showed no such association.

The authors conclude that the correlation between drinking sugary sodas and albuminuria indicates that high fructose corn syrup is in part responsible for the increase in kidney disease in the US. According to the National Kidney Foundation, about 26 million American adults have chronic kidney disease.

Dr Shoham, however, has said. “I don’t think there is anything demonic about high fructose corn syrup per se … People are consuming too much sugar. The problem with high fructose corn syrup is that it contributes to over consumption. It’s cheap, it has a long shelf life and it allows you to buy a case of soda for less than $10.”
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Shoham DA et al. (2008) Sugary Soda Consumption and Albuminuria: Results from the National Health and Nutrition Examination Survey, 1999–2004 PLoS ONE 3 (10) DOI: 10.1371/journal.pone.0003431

Journals

Nature Clinical Practice journals relaunch as Nature Reviews

February 2, 2009 No Comments

The eight specialty-based Nature Clinical Practice journals, which form part of the medical publishing arm of Nature Publishing Group, are to relaunch in April 2009 as Nature Reviews.

As well as joining the hugely successful Nature Reviews portfolio, which will increase in size from seven to fifteen titles in one fell swoop, the Nature Clinical Practice journals will be given a ‘facelift’ in print and online. The previously rather austere journals are soon going to be printed in full colour, and the layout of the content has been shaken up to make the journals more eye catching and easier to navigate.

Nature Clinical Practice is a series of monthly review journals targeted at doctors and physicians. The peer-reviewed publications aim to deliver timely interpretations of key research developments, thus facilitating the translation of the latest findings into clinical practice. Doctors often don’t have time to keep abreast of developments in their field, so Nature Clinical Practice does the reading for the clinician, filtering original research published in primary journals and highlighting the most important and relevant findings.

ncp-new-names

Launched in 2004 and 2005, the Nature Clinical Practice journals cover the fields of cardiology, clinical oncology, endocrinology, gastroenterology & hepatology, nephrology, neurology, rheumatology and urology. Articles are written by experts in the field and include editorial and opinion pieces, short highlights of research from the current literature, commentaries on the application of recent research to practical patient care, comprehensive reviews, and in-depth case studies.

“Including the eight clinical journals as part of the Nature Reviews series will enable us to bring to the clinical sciences the qualities that have made the life science Nature Reviews journals so successful,” says Dr James Butcher, Publisher of the clinical Nature Reviews titles. “No other publishing company is able to offer high quality monthly review journals covering advances in medical research from bench to bedside.”

“The clinical Nature Reviews journals will retain the high quality content that practicing clinicians rely on from the Nature Clinical Practice titles,” continues Dr Butcher. “We hope that the journals will now also become indispensable resources for clinical academics working in research settings who are familiar with the look and feel of the life science Nature Reviews titles.”

I actually used to work for Nature Clinical Practice and had the chance to check out samples of the relaunch journals before I left the company. I thought the new full-colour Nature Reviews journals looked infinitely better than their somewhat dry and serious predessors, the vivid new layout really enhancing the high quality and rigorously edited content. I’m really looking forward to browsing the real thing once the first clinical Nature Reviews journals are published in April.

Internet

Am I on the Wall Street Journal website?!

January 31, 2009 1 Comment

I was looking through my blog stats today and spotted that I had a few referals from http://onespot.wsj.com/health/2009/01/29/270945597-health-bloggers-bite-back-as. Check it:

Yup, it looks like The Wall Street Journal website has aggregated the blog post I wrote this week about the Wellsphere kerfuffle.

A quick bit of research and I have discovered that OneSpot.com is a blog aggregator and filter that WSJ.com uses to beef out their website with third-party content. Here’s the blurb:

WSJ.com uses OneSpot to find and deliver these headlines and links. To get the list, OneSpot identifies the active members of the health content community by analyzing a set of sources provided by the WSJ editorial staff. OneSpot matches them to thousands of other related sources from around the Web. By continuously monitoring these sites and outbound links, OneSpot generates a list of popular health stories.

I can’t find a complete list of which other blogs WSJ is aggregating, but a quick look at http://onespot.wsj.com/health/ shows that the content of blogging contemporaries of mine such as Medgadget and The Happy Hospitalist is being rated as worthy of inclusion as that of big-name news sites like BBC Health and New York Times Health.

I feel like my blog is really starting to take off recently and this kind of encouraging coverage makes me want to post as often as I can. Big self-congratulatory pat on the back for me. Well, not too big – I’m feeling pretty pukey this evening. I believe an Australian has poisoned me with chicken nuggets. Not as some kind of post-colonial revenge, but due to poor oven operating skills. I’m going to go to bed. Or throw up. Or throw up then go to bed. Emphatically not go to bed then throw up.

Less self-absorbed posting will continue on Monday. Have a good weekend folks!

P.S. Of course, the difference between this kind of blog aggregation and what Wellsphere is doing is that WSJ.com readers get directed to my website to read the full post. I get exposure on a well-known website AND the website traffic? This is the kind of deal Wellsphere should have cut.

Internet

Health bloggers bite back as Wellsphere sells on posts provided for free

January 29, 2009 13 Comments

Wellsphere, a health community website that brings together information from more than 1,500 medical experts and bloggers, has been sold to HealthCentral Network, a collection medical information websites and condition-specific portals.

Dr Geoffrey Rutledge, Chief Medical Information Officer of Wellsphere, generated content for his site by sending flattering emails to thousands of medicine and health bloggers (sample text “I want to tell you I think your writing is great”, “we are building a network of the web’s leading health bloggers – and I think you would be a great addition”). Bloggers gave Wellsphere permission to publish the entire RSS feed of their site, i.e. posts they had already written, in return for exposure for their blog and more traffic.

However, the small print of Wellsphere’s terms and conditions states that by giving Wellsphere permission to reproduce their posts, bloggers automatically grant the company “a royalty-free, paid-up, non-exclusive, worldwide, irrevocable, perpetual license to use, make, sell, offer to sell, have made, and further sublicense any such User Materials[.]” (Thanks to Symtym for checking this out )

Bloggers who allowed Wellsphere to replicate their posts have suddenly realised that content they happily provided free is no longer theirs and has been sold off to HealthCentral for a profit, and boy are they mad.

Exactly how much HealthCentral paid for Wellsphere has not been disclosed, but neither company is short of cash. Techcrunch reports that Wellsphere has raised $3 million in funding from venture capitalists, whereas HealthCentral has $50 million in capital. Bloggers are fuming that such well endowed companies haven’t given them a share of the pie, or even consulted them about the consolidation deal.

On the other hand, HealthCentral’s CEO Christopher Schroeder told the Wall Street Journal Health Blog that most bloggers “are happy and we hope with all our resources and quality-content background we will really strengthen these engagements”. Fat chance, says the blogosphere. Interestingly, his colleague Jeremy Shane told Medical Marketing & Media that “Wellsphere’s bloggers may be monetized through the placement of banners and other advertising”. Hmm…

For the benefit of other Europeans like me who were happily sleeping while the Wellsphere debacle kicked off in the US, here’s a roundup of the reaction across the blogosphere.

Writing on on Getting Better, Dr Val Jones asks “Is this the biggest scam ever pulled on health bloggers?”, whereas over on Science-based Medicine she goes a step further and calls for “the medical/science/health blogosphere to rise up ‘Motrin moms-style’.” (Last year Motrin, a company that sells analgesic medicines, tried to sell product to Mums who carry their child in a sling or a wrap by pointing out that this practice could cause back pain, and also for good measure said that ‘baby carrying’ was a fad that made Mums look “tired and crazy”. Unsurprisingly, Mums didn’t take kindly to this and headed to the internet in droves to voice their outrage, eventually forcing Motrin to take down the offensive advert and apologize to each Mother who had complained). Dr Val discusses the issue at more length in yesterday’s Doctor Anonymous show.

Jenni Prokopy, Editor of ChronicBabe.com, is sympathetic to bloggers who feel short changed by Wellsphere’s actions. She does point out, however, that blogging constitutes proper publishing and as such writers should be thinking about getting paid and about their rights regarding copyright and intellectual property.

On Musings of a Distractible Mind, Dr Rob details his lucky escape from Wellsphere after 4 months of syndication provided him with zero extra traffic.

Theresa Chan, author of Rural Doctoring, is nervous about possible sinister outcomes of Wellsphere’s approach to content. “What if they decided to compile and publish a book for sale on their site, entitled 1001 Health Tips From Real Doctors, and proceeded to include one of my posts verbatim, along with posts by a proponent of chelation therapy for operable coronary artery disease and an anti-vaccination followers of Jenny McCarthy?”, she asks. “Their Terms of Service would give them the right to use my post in their book, and I would have no control over the implications of association with other content I strongly oppose.” Kevin, M.D. likewise is suspicious of Wellsphere’s motives, and asks “Is WellSphere a scam, and is its leadership laughing all the way to the bank after the HealthCentral acquisition?”.

Ana, a Brazilian who writes about mental health, tried to get out of Wellsphere mere days before the storm kicked off – I wonder how she’s getting on, as diabetes patient Kerri Morrone Sparling of SixUntilMe had to resort to shock tactics to get her Wellsphere account deleted.

My Strong Medicine, Beyond Meds and The Butter Compartment have all also given their two penneth on the Wellsphere scandal.

Over on Twitter there is reams of discussion on the subject of Wellsphere. Dr. Vijay Sadasivam, who blogs at Scan Man’s Notes, points out a 2007 expose of office life at Wellsphere, and TrishaTorrey notes that Wellsphere are on Twitter themselves (@wellsphere) and should be copied in on any complaints.

And me? I was also approached by Wellsphere last year but turned down their offer mainly on the basis of their shonky web design. I thought their homepage was completely unhelpful, giving away nothing about what the site was for, and their WellPages portals, although packed with pretty good content, weren’t exactly easy to find or navigate. I also read a post from August 2008 on the Neurocritic blog and took heed of their gossip on Wellsphere’s employees and business approach, and read on The Assertive Cancer Patient about how ill advised it is to sign away your blog – your own intellectual property – to a company like Wellsphere.

Like the Assertive Cancer Patient, I am also a freelance writer. Although I happily blog for free – for pleasure and as an online CV – I know that if I chose to I could sell the same quality writing, or even the exact same post, to a newspaper or magazine; thus, giving it away is just silly.

So where does this leave bloggers? If you’re happy with the exposure Wellsphere is giving your blog then you don’t necessarily need to do anything, but most bloggers are severely irked by how they have been treated by the company and are doing their best to delete their account.

If anything, this whole kerfuffle has been a lesson to the whole blogosphere on the importance of protecting your intellectual property online (check CreativeCommons.org for more info on this subject) and on how crucial it is to read the small print.

Sexual health

So you won’t go blind, but you might get prostate cancer

January 26, 2009 10 Comments

This one's a myth. You should be worried about your prostate gland instead.

Although the schoolyard rumours that masturbation causes blindness or hairy palms aren’t true, a new study published in BJU International has found that too much playing solo in your twenties and thirties can increase the risk of prostate cancer.

The study of more than 800 men found that a high level of sexual activity or masturbation before the onset of middle age was associated with subsequent development of prostate cancer.

The authors suggest that the elevated levels of sex hormones some men experience in their twenties and thirties could be responsible for both a high sex drive and a high risk of prostate cancer later in life.

This British study retrospectively studied the sexual habits of 431 men who had been diagnosed with prostate cancer before the age of 60 and compared their reported behaviour with that of 409 healthy controls.

The authors found that men with prostate cancer were more likely to be very sexually active in their twenties and thirties – that is, had intercourse or masturbated 20 times a month or more – than were controls. In fact, 40% of the men who had prostate cancer were categorized as being very sexually active in their twenties compared with 32% of men in the control group. This pattern pretty much persisted throughout the men’s thirties and forties, and the differences in sexual activity evened out in their fifties.

Men with prostate cancer were also more apt to masturbate frequently than were men in the control group, with the greatest difference observed when the men were in their twenties (34% versus 24%) and thirties (41% versus 31%).

“Overall we found a significant association between prostate cancer and sexual activity in a man’s twenties and between masturbation and prostate cancer in the twenties and thirties. However there was no significant association between sexual activity and prostate cancer in a man’s forties”, said lead author Dr Polyxeni Dimitropoulou.

“A possible explanation for the protective effect that men in their fifties appear to receive from overall sexual activity, and particularly masturbation, is that the release of accumulated toxins during sexual activity reduces the risk of developing cancer in the prostate area. This theory has, however, not been firmly established and further research is necessary.”

Prostate cancer is the most common cancer in men in the UK, accounting for nearly a quarter of all new male cancer diagnoses. Cancer Research UK estimates that one man is diagnosed with prostate cancer every 15 minutes in the UK.

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Dimitropoulou P et al. (2009) Sexual activity and prostate cancer risk in men diagnosed at a younger age. BJU International 103 (2): 178-185 DOI: 10.1111/j.1464-410X.2008.08030.x

Pregnancy and babies

Spousal abuse increases the risk of miscarriage by 50%

January 25, 2009 No Comments

Domestic violence against women, more specifically violence perpetrated by a partner or spouse, is an important problem worldwide. A 2005 study by the World Health Organization that assessed 24,000 women in 10 countries found that between 15% and 71% of women had experienced physical or sexual violence, or both, at the hands of their partner. Women in rural areas in Bangladesh, Ethiopia, Peru, and the United Republic of Tanzania were most likely to suffer abuse; alarmingly, as many as 71% of women in Ethiopia reported having experienced sexual and/or physical violence by an intimate partner.

Physical violence can also occur during pregnancy, with such abuse often involving blows or kicks to the abdomen. Of all women in the WHO study who who reported spousal abuse, between 11% and 44% also experienced violence during pregnancy. Not surprisingly, abuse during pregnancy is associated with adverse birth outcomes.

A new study published this week in British journal The Lancet has found that spousal violence during pregnancy can also affect unborn babies, increasing the risk of miscarriage or stillbirth by 50% in women in sub-Saharan Africa. Given that such a large proportion of risk for fetal mortality can be pinned onto spousal violence, such fetal deaths are potentially preventable; indeed, this study showed that interventions that reduce domestic violence could prevent more than a third of fetal deaths.

The authors of this study interviewed 2,562 women of childbearing age who lived in Cameroon, a large and relatively stable country on the west coast of Africa. Participants were asked about their experiences of emotional, physical, and sexual violence from their spouse and whether they had ever had a spontaneous abortion (miscarriage) or a stillbirth.

In total, more than half of the women interviewed reported having experienced at least one type of violence from their husband, most typically physical violence (39%), followed by emotional (31%) and sexual (15%) abuse.

Compared with women who had not experienced any form of domestic violence, women who had experienced abuse were 50% more likely to have had a miscarriage or stillbirth. Women who were exposed to at least two types of violence (for example both physical and emotional abuse) had a higher frequency of fetal death than did victims of only one type of violence.

Strikingly, emotional violence was almost as strongly associated with fetal death as were physical abuse and sexual violence; however, the strongest link between spousal violence and fetal death was seen in women who suffered sexual abuse. On the other hand, women who experienced emotional abuse were most likely to have repeated instances of miscarriage or stillbirth.

This study also threw up some rather surprising results. Women married to men with some education were more likely to have experienced domestic violence than were women married to uneducated men, and women in the richer categories were also more likely to experience abuse than their poorer counterparts. These results are at odds with findings elsewhere: as the authors point out, “in the USA, abused women tend to be younger, less educated, and more economically disadvantaged”.

Estimates in this study suggest that interventions to prevent spousal abuse could also prevent a considerable proportion of miscarriages and stillbirths. An intervention that is 100% effective at reducing domestic violence, or even one that is only 75% effective, could prevent up to a third of fetal deaths.

Writing in a comment article that accompanies this research, Claudia Garcia-Moreno, a member of the WHO Department of Reproductive Health and Research in Geneva, discusses the significance of these findings.

This study is an important contribution to the field, because it is one of the first to document this association [between spousal abuse and fetal death] and one of the first in Africa, where the rate of fetal loss is high. [The authors] highlight the important contribution that addressing intimate-partner violence can make in prevention, particularly recurrent fetal loss, and in the improvement of maternal and neonatal health.

It is important that public-health initiatives to prevent spousal abuse are implemented, not only in sub-Saharan Africa but worldwide, in order to prevent unnecessary fetal deaths and to protect the health and wellbeing of pregnant women. Given that during pregnancy is one of the only times that healthy women have frequent scheduled contact with the health system, it is important, both for mother and baby, that antenatal care is improved so that women suffering at the hands of their partners can be identified and offered support.

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Alio A et al. (2009) Spousal violence and potentially preventable single and recurrent spontaneous fetal loss in an African setting: cross-sectional study The Lancet 373 (9660): 318-324 DOI: 10.1016/S0140-6736(09)60096-9

Journals, Pharmaceutical industry

Pharmaceutical industry promotion of off-label prescribing – responsible or reckless?

January 24, 2009 2 Comments

Last week the US Food and Drug Administration ruled that the pharmaceutical industry could promote drugs for uses that haven’t been cleared by the regulatory body. The new FDA guidelines permit the “dissemination of medical journal articles and medical or scientific reference publications on unapproved uses of drugs and medical devices.”

In order to be prescribed to treat a certain disease, a drug needs to be formally assessed and approved for this use by the FDA. The practice of ‘off-label prescribing’ entails doctors using a drug to treat a particular disease regardless of whether the FDA has confirmed that the drug is a safe and effective treatment for the disease in question. As the FDA puts it, “Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product’s approved labeling”.

Off-label prescribing is reasonably common, even though you may not have heard it described this way. An article published in Archives of Internal Medicine in 2006 reported that more than 20% of prescriptions in the US during 2001 were for off-label uses of a drug. One example of off-label prescribing is the use of the drug Avastin – approved by the FDA for the treatment of metastatic colorectal cancer and breast cancer – to treat the condition wet macular degeneration, an age-related eye disease that can lead to vision loss.

The FDA highlight the importance of off-label prescribing, stating that “These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care”. Such practices permit innovation and allow physicians to use their own judgment on the basis of their personal experience prescribing a drug.

The new FDA guidelines sound like good news for the pharmaceutical industry. By promoting off-label uses of already approved drugs, companies can squeeze more profit out of ‘old’ drugs and can ease off the lengthy and expensive process of investigating novel drugs. But what’s to stop such companies ruthlessly promoting dubious off-label uses for established drugs and risking the health of patients by encouraging doctors to use drugs when there’s not adequate evidence of their efficacy for a certain disease?

Well, the new FDA guidelines include a lot of restrictions as to exactly how off-label uses can be promoted to doctors. For starters, the guidelines discuss the use of journal articles or medical publications to promote off-label prescribing, meaning that pharmaceutical sales reps will be handing out genuine research that has been conducted by independent groups, not self-penned marketing material.

The guidelines also include lots of important limitations on what type of journal articles, or reprints, can be handed out, including that the articles must:

Be published in a peer-reviewed journal that has experts on the subject on the editorial board
Not be part of a publication or supplement that is funded in whole or in part by the company that wishes to use the article
Be in the form of an unabridged reprint, copy of an article, or reference publication
Not be marked, highlighted, summarized, or characterized by the manufacturer in any way
Be disseminated with a representative publication, when such information exists, that reaches contrary or different conclusions regarding the unapproved use
Be distributed separately from information that is promotional in nature. For example, if a sales representative delivers a reprint to a physician in his office, the reprint should not be physically attached to any promotional material the sales representative uses or delivers during the office visit and should not be the subject of discussion between the sales representative and the physician during the sales visit

So the FDA have done their best to tie up pharmaceutical companies in such a way as to ensure that doctors receive the most accurate and unbiased information possible on off-label drug uses.

Having said that, bias and conflict of interest is an important problem here – of course sales representatives are going to do their best to only hand out journal articles that show the off-label use of their drug in a positive light. You can bet that pharmaceutical companies won’t be providing doctors with the full body of evidence when it comes to use of their drug for a particular disease, as cumulatively such research could be more ambivalent about the benefits of an off-label use.

Also, in many cases even the total body of evidence doesn’t show that an off-label use is effective. Indeed, the aforementioned Archives of Internal Medicine paper showed that three-quarters of off-label uses were not backed up by scientific evidence. There is an argument that the clinical trials process and the publication procedure lags behind real life, and that although there are no trials showing that an off-label use is effective, many doctors will have prescribed a drug this way and seen the beneficial results for themselves. Fair enough, to a degree, but this undermines the whole issue of the pharmaceutical industry giving out published research on off-label uses anyway, so will be of little interest to such companies.

Finally, how on earth is the FDA going to police their restrictions? They can insist that the pharmaceutical industry follows their rules, but there is plenty of evidence that such regulations are regularly flouted. For example, despite the new guidelines, the straightforward marketing of a drug for uses not cleared by the FDA is still illegal. Global pharmaceutical company Eli Lilly used catchy slogans to persuade doctors to prescribe the antipsychotic agent Zyprexa for unauthorized use in elderly patients and has this month been fined $1.5 billion for doing so.

I’m not the only one with misgivings about these well-intentioned but ultimately flawed guidelines. California senator Henry Waxman told Medscape that the new FDA decision “fundamentally undermines the requirement that companies prove to the FDA that each new use is safe and effective” and makes it easier for drugmakers to promote potentially risky medical practices. Over on Nature Network, research scientist Craig Rowell proclaimed that “Alarm bells should be ringing” – despite his support of off-label prescribing, Craig is still deeply skeptical that pharmaceutical companies will stick faithfully to the restrictions.

What’s the bottom line for patients here? Many will benefit from by off-label prescribing, or at least not be harmed, and doctors will be better able to prescribe off label if they are thoroughly informed about such practices. The sticking point is whether the pharmaceutical industry can be relied on to accurately and fairly disseminate information about off-label uses; experience suggests probably not. Whether the FDA has made a shrewd move in getting pharmaceutical companies to do this promotion for them, or a big mistake, remains to be seen.

The Pharma Marketing blog has an interesting post on this issue, which discusses policing of the new guidelines and the efficacy – or not – of off-label prescribing.

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