A diagnosis of prostate cancer ups the risk of fatal heart attack or suicide

Prostate cancerReceiving a diagnosis of prostate cancer is a very stressful and upsetting event, so much so that some men go on to have a fatal heart attack or kill themselves.

Two pieces of research by the same study group, one conducted in 340,000 men in the US and the other in 170,000 men from Sweden, have found that the risk of dying from a heart attack is raised by 2 to 11 times in men with a diagnosis of prostate cancer.

In addition, the risk of suicide in the first year after diagnosis in American men with prostate cancer was 40% higher than the national average and the risk in the first three months 90% higher. Astoundingly, Swedish guys were twice as likely to kill themselves in the first three months after diagnosis than men who were cancer free.

Interestingly, the US study found that the risk of suicide was only raised between 1979 and 1992, before the widespread use of screening to detect prostate cancer early.  There was no link between prostate cancer and suicide once screening, known as prostate-specific antigen (PSA) testing, was being used across the board.

So does this mean that screening for prostate cancer reduces the risk of suicide after a diagnosis? The authors think so, suggesting that early screening detects less aggressive tumors that are still treatable, thus less stress inducing.

On the other hand, the use of PSA testing has long been controversial. Many men will have small prostate tumours that never do them any harm and the test itself isn’t very reliable, so screening is associated with overdiagnosis and overtreatment.

By extension, some studies reckon that routine testing for prostate cancer causes undue stress and anxiety among patients who do not understand the implications of an abnormal result.  In fact, the Swedish study did not find any difference in suicide risk between the pre-screening era and after screening had been introduced.

This post was chosen as an Editor's Selection for ResearchBlogging.org

The authors aren’t sure about this difference between their two studies, admitting “The reason for this discrepancy is unclear.” However, it could potentially be caused by the large number of nonaggressive prostate cancers diagnosed during the later years in the US study or improved access to emotional support after diagnosis come the late 80s, which might have lessened despair among patients and reduced their suicide risk.

“These results add to the complex debate of pros and cons of extensive prostate-specific antigen testing and the many nonlethal prostate cancers thus detected,” say the authors.

———————————————————————-
Fall K et al. (2009) Immediate Risk for Cardiovascular Events and Suicide Following a Prostate Cancer Diagnosis: Prospective Cohort Study PLoS Medicine 6 (12). DOI: 10.1371/journal.pmed.1000197

Fang F et al. (2010). Immediate Risk of Suicide and Cardiovascular Death After a Prostate Cancer Diagnosis: Cohort Study in the United States JNCI Journal of the National Cancer Institute DOI: 10.1093/jnci/djp537

Continue Reading

Reducing dietary salt by half a teaspoon could save 92,000 lives a year

SaltA Californian population based study has found that if everyone in the US reduced their daily salt intake by 3 grams – half a teaspoon – the annual number of deaths could be slashed by up to 92,000. In addition, the number of new people who get cardiovascular disease each year could drop by up to 120,000 – that’s equivalent to the population of Cambridge!

In fact, cutting dietary salt intake by as little as 1 gram a day could reduce the number of deaths from any cause by 15,000 to 32,000 and the number of new cases of cardiovascular disease by 20,000 to 40,000.

US regulations recommend that people consume less than 5.8 g of salt a day, yet the average American man gets through almost double that – 10.4 g of salt daily. This is bad news – high salt intake is associated with an increased risk of stroke and cardiovascular disease.

In this study, published in the New England Journal of Medicine, the authors used computer modelling to simulate heart disease and stroke in US adults aged 35-84 years.

They found that a population wide reduction in dietary salt of 3 g per day could potentially reduce the annual number of cases of cardiovascular disease by 60,000 to 120,000, stroke by 32,000 to 66,000, and heart attack by 54,000 to 99,000. The annual number of deaths from any cause could be cut by by 44,000 to 92,000.

Even a modest reduction of 1 g of salt per day could cut the yearly rates of cardiovascular disease, stroke, and heart attack by at least 20,000, 18,000, and 11,000, respectively. “It was a surprise to see the magnitude of the impact on the population, given the small reductions in salt that we were modeling,” Kirsten Bibbins-Domingo, lead author of the study, told Science Daily.

The effects seemed greater in black people – a population with high rates of hypertension and cardiovascular disease – and women would benefit in particular from a reduction in stroke incidence. The number of events related to cardiovascular disease – such as heart attack – would drop in older adults, whereas young people would benefit from lower overall mortality rates.

The public health benefits of a drop in salt intake of 3 g a day would be equivalent to half of all smokers quitting or a 5% reduction in body fat among obese adults, and would save $10 billion to $24 billion a year in healthcare costs.

“Reducing dietary salt is one of those rare interventions that has a huge health benefit and actually saves large amounts of money,” said senior author Lee Goldman. “At a time when so much public debate has focused on the costs of health care for the sick, here is a simple remedy, already proven to be feasible in other countries.”

————————————————————————————————–
Bibbins-Domingo K et al. (2010) Projected Effect of Dietary Salt Reductions on Future Cardiovascular Disease. New England Journal of Medicine DOI: 10.1056/NEJMoa0907355

Continue Reading

Watching too much TV increases risk of death within the next six years

A study of nearly 9,000 Australian adults has reported that people who watched 4 hours of TV a day or more were 46% more likely to die within the next six and a half years than those who watched less than 2 hours a day.  Each one hour increase in daily television viewing increased the risk of death from any cause by 11% and death by cardiovascular disease by 18%.

Previous studies have suggested that sedentary behaviour is associated with a mortality risk.  Furthermore, surveys in the US and the UK indicate that, aside from sleeping, lounging around watching television takes up the most of our time at home – about 3 hours a day in the UK and up to 8 hours a day in the US, apparently.

This study, published in the journal Circulation, examined 8,800 adults aged 25 years or older who were in the Australian Diabetes, Obesity and Lifestyle Study (AusDiab). All participants were interviewed at the start of the study to find out their lifestyle habits, medical history, and the amount of time they had spent watching television or videos in the previous 7 days.

About six and a half years later, on average, mortality status and cause of death for each participant was established from the Australian National Death Index.

Each one hour increase in television viewing time was associated with an 11% increase in the risk of death from any cause and an 18% increase in the likelihood of death related to cardiovascular disease. However, these relationships were attenuated once other factors like medical history and smoking habits were taken into account, but the association between TV time and death from any cause did remain important. The link between television viewing time and cancer mortality was negligible though.

Strikingly, the risk of mortality was much higher in people who watched at least 4 hours of TV a day than in those who watched less than 2 hours – the risk of death from any cause was 46% higher and the risk of death from cardiovascular disease was a whopping 80% more.

Individuals who watched 4 hours of TV a day or more were more likely to be a current or ex-smoker, have a poor diet, be overweight, or have raised blood pressure than those who watched less than 2 hours daily – that is, they seemed generally less healthy and, in theory, would be more likely to just drop dead. However, none of these factors affected the associations between television viewing and mortality.

The public health implications of this study are pretty serious – get TV addicts to cut their viewing in half and they could considerably reduce their risk of death over the next 6 years or so. As the authors say, “our findings suggest that reducing time spent watching television (and possibly other prolonged sedentary behaviors) may also be of benefit in preventing CVD and premature death.” They recommend that as well as promoting exercise, public health bodies should also “focus on reducing sitting time, particularly prolonged television viewing.”

——————————————————————–
Dunstan D et al. (2010) Television Viewing Time and Mortality: The Australian Diabetes, Obesity and Lifestyle Study (AusDiab). Circulation 121 (3): 384-391. DOI: 10.1161/CIRCULATIONAHA.109.894824

Continue Reading

Tamiflu isn’t much good and Roche tried to stop us showing so, says the BMJ

The BMJ has just published a whole slew of papers about Tamiflu (oseltamivir) – a key drug in the public health response against swine flu (influenza A/H1N1).

The linchpin is a Cochrane review on the efficacy of neuraminidase inhibitors – namely zanamivir (Relenza; Glaxo Wellcome) and oseltamivir (Tamiflu; Roche) – for preventing and treating influenza in healthy adults.  The review found that these two drugs were only partly effective against laboratory confirmed symptomatic influenza (oseltamivir 61% effective; zanamivir 62% effective), and no good at all against asymptomatic flu or flu-like illness.

In addition, Tamiflu did not reduce the risk of influenza-related lower respiratory tract complications – bad news for the Department of Health, which recommends using the drug to prevent secondary complications in healthy adults.  The authors conclude: “Neuraminidase inhibitors might be regarded as optional for reducing the symptoms of seasonal influenza. Paucity of good data has undermined previous findings for oseltamivir’s prevention of complications from influenza.”

In an accompanying feature, Deborah Cohen retraces the steps leading to the publication of the Cochrane review and highlights all the difficulties the authors had extracting data from Roche, the makers of Tamiflu.  The review “exposed a complex interplay between politics, public health planning, availability of trial data, publishing, and drug regulation.”

Turns out that Roche’s claims that Tamiflu reduces hospital admissions and secondary complications of influenza were based on a 2003 meta-analysis that only included two proper randomised controlled trials and was authored by several Roche employees.  When the authors of the Cochrane review tried to get their hands on the data in this paper to include them in their own analysis, they came up against all sorts of obstacles thrown up by Roche.

Peter Doshi, an author of the new Cochrane review, writes in the BMJ of his struggle to get hold of the elusive data and offers a damning verdict on the use of the drug in the swine flu epidemic. “Since August 2009, our Cochrane review team has tried to obtain the data needed to verify claims that oseltamivir (Tamiflu) lowers serious complications of influenza such as pneumonia. We failed, but in failing discovered that the public evidence base for this global public health drug is fragmented, inconsistent, and contradictory. We are no longer sure that oseltamivir offers a therapeutic and public health policy advantage over cheap, over the counter drugs such as aspirin.”

In an analysis article, Nick Freemantle and Mel Calvert look over the observational studies of Tamiflu that Roche cited in defense of their claims for the drug and found that they also do not support the use of Tamiflu to treat influenza in healthy adults. In their discussion they write: “oseltamivir may reduce the risk of pneumonia in otherwise healthy people who contract flu. However, the absolute benefit is small, and side effects and safety should also be considered. None of the studies examined the role of oseltamivir in patients with H1N1 influenza, which may be associated with higher rates of pneumonitis than seasonal influenza.”

Finally, in a linked editorial, Fiona Godlee, editor of the BMJ, and Mike Clarke, director of the UK Cochrane Centre in Oxford, rail against the obstructive techniques used by Roche and call for full data from clinical trials to be made available to the scientific community.  “Why should the public have to rely on detective work by academics and journalists to patch together the evidence on such a potentially important drug?” they ask.

All this is bad news for public health planning against swine flu – the Department of Health has already stockpiled more than 30 million doses of potentially useless Tamiflu – and even worse news for Roche.

———————————————————————————————–
Jefferson T, Jones M, Doshi P, & Del Mar C (2009) Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ 339 DOI: 10.1136/bmj.b5106

Continue Reading

Robo-doc: Sci-Fi Surgery at the Royal College of Surgeons

Would you let a completely unmanned robot operate on you?  Or what about one manned by a surgeon thousands of miles away?  Sounds out of the question, the stuff of science fiction. But you’d be wrong, robotic surgery is here and has huge implications for medical efficiency and safety, as the Sci-Fi Surgery: Medical Robots exhibition at the Royal College of Surgeons aptly demonstrates.

A robot is “a machine – usually computer controlled – that is capable of movement and interaction with its environment”.  Robots have been used to do manual or tedious tasks in industry for almost 50 years, and now they’re being used for the same purposes in medicine – to support busy nursing staff, for example.

ProbotIn addition, robots are more accurate and have better dexterity than humans.  The reduction in incisions and trauma that can be achieved using surgical machines means a quicker recovery for patients, faster discharge from hospital and a better quality of life after surgery.  Robots also produce consistent results and produce few mistakes, if any.

The first surgical robot was the industrial machine Puma 560, which was used by surgeons in 1985 to position a needle during a brain biopsy.  Fast forward to 1991 and the PROBOT made its appearance on the scene.  The PROBOT is an autonomous device used to remove an enlarged prostate gland in a procedure called transurethral resection of the prostate.  Unsurprisingly, neither surgeons nor patients are happy using a completely “hands off” device like the PROBOT, so newer robots tend to use a “shared control” approach.

Rob017_largeAnother interesting type of robot that was developed in the 1980s is “master-slave” robots.  These robots are used to do remote surgery – that is, to perform procedures when the surgeon and the patient are in different physical locations.  The first master-slave robot was called da Vinci Surgical System and was developed by the US army for use in the field, but is now commonly used to remove prostates.  Another telemanipulator, Zeus, was first used by a surgeon in New York to remove a gallbladder from a patient in France.

I was particularly interested in the flash new capsule endoscopes on display at the exhibition.  Capsule endoscopes are pill sized cameras that are used to record images of the gastrointestinal tract in patients suspected of having diseases like colon cancer.  The patient swallows the endoscope and the doctor can view on a screen the whole of their digestive tract.  This approach is considerably more comfortable for patients than normal endoscopy, where a camera on the end of a tube is inserted either in the anus or mouth.

ARESOne problem with capsule endoscopy at the moment is that the endoscope flies down the patient’s digestive tract and the doctor has no control over its speed or where its pointing.  A doctor could spot a dodgy looking region of the gut but won’t be able to go back and get a good look at it because the endoscope is still heading down and out.

New prototype endoscopes on display at the Sci-Fi Surgery exhibition hope to solve this issue.  The Scuola Superiore Sant’ Anna in Pisa, Italy, has developed a remote control endoscope that has “legs” it can use to propel itself through a patient’s gastrointestinal tract.  The design of this particular robot is based on the motion of worms and insects.  Dr Arianna Menciassi, Associate Professor of Biomedical Robotics at Scuola Superiore Sant’Anna, Italy, explains: “We turned to biological inspiration because worms have locomotion systems suited to unstructured, slippery environments and are ideally suited for use in the human body.”

The Scuola Superiore Sant’ Anna has also developed a reconfigurable robot that researchers hope can be swallowed in separate segments that will assemble themselves in the gut into a larger device capable of carrying out surgical procedures.

Bloodbot

By far the most disconcerting robot as far as I was concerned was the Bloodbot.  Developed by researchers at Imperial College London, the Bloodbot is designed to help doctors find a vein when taking blood samples.  A probe presses down on the patient’s arm to sense a vein, then inserts a needle under force control.  I don’t know about you, but I’m not keen on having an inanimate object sticking needles in my arm!

With processes in all industries becoming more automated, it was only a matter of time before surgery followed suit.  This little exhibition provides a great primer on the use of machines in medicine.

  • Sci-Fi Surgery: Medical Robots is running at the Qvist gallery in the Hunterian Museum of the Royal College of Surgeons until Wednesday 23rd December 2009. The museum is free and is open Tuesday – Saturday 10.00am – 5.00pm.
Continue Reading

Drug company funded events for health professionals: the state of play in Australia

Cardiologist Jeffrey F Caren, who has a monument of over 1,200 pens gifted to him by drug companies
Cardiologist Jeffrey F Caren, who has a monument of over 1,200 pens gifted to him by drug companies

The links between the pharmaceutical industry and doctors are many and tangled. Drug companies are keen to schmooze doctors and, directly or not, persuade clinicians to prescribe their drug instead of a similar one by a competitor. One way that drug companies try to influence doctors is by sponsoring events, such as conferences or lectures.

Despite legislation, the exact extent to which the pharmaceutical industry sways doctors via this approach is not really known. To try to unravel exactly how much is being spent on sponsoring events for doctors, Robertson and colleagues investigated pharmaceutical industry funding of events in Australia, which has laws stating that details of every sponsored “do”, including the costs of any hospitality, are posted on the Medicines Australia website.

The authors found that during a six month period, the drug industry spent AUD$1 million (about £555,000 or US$900,000) a week in Australia on sponsored “educational events” for health professionals. This equates to about 600 sponsored events a week and an average annual spending of around AUD$1,000 (£555 or US$930) on each doctor.

More than a third (35%) of events were held in plush spots like restaurants, hotels or function centres, which increased the spend on the event by five-fold compared with if the event was held in a hospital (AUD$71.35 vs AUD$12.11).

Bristol-Myers Squibb was the most generous company, with an average spend per head of AUD$95.26 (£53 or US$88), although Astra Zeneca held the most events (1,310 0ver six months).

Professionals specialising in psychology or oncology were the most likely to attend sponsored events, although the biggest spend was on endocrinologists, oncologists and cardiologists.  Tellingly, specialists in these particular disciplines tend to prescribe the highest cost drugs.

Companies had some control over what was discussed at the event in 91% of cases. Where provided, topic descriptions often matched the products made by the sponsor, although there were few mentions of specific drug names.

Evidence suggests that attending a drug company sponsored event can indeed change the prescribing practices of a doctor, making the figures in this report quite disturbing.  For example, judging by the numbers in this study, as many as 13,000 Australian doctors could be under the thumb of the pharmaceutical industry.  As the authors point out, “from a company perspective, it is cheap and easy to sponsor meetings in hospitals and health centres, and the return on this ‘investment’ is likely to be high.”

In the UK, the Association of the British Pharmaceutical Industry code of conduct states that pharmaceutical companies sponsoring meetings and seminars can only provide “subsistence” for events and can only offer economy air travel to delegates sponsored to attend meetings. The code also states that lavish venues must not be used and that the costs covered “must not exceed the level which the recipients would normally adopt when paying for themselves”.

In the US, several states have mandatory disclosure laws for physician payments so that it is a bit clearer to everybody who is cosying up with drug companies and who isn’t, but these data aren’t foolproof.  For example, laws on physician reporting of industry gifts in Vermont and Minnesota exempt payments of less than US$100.

It’s worth mentioning that the system in Australia is actually more transparent than that in either the UK or the US, given that since mid-2007, there has been mandatory reporting of details of every industry-sponsored event in Oz.  On that note, the situation is probably worse in the northern hemisphere, as noted by an article last year in British newspaper The Guardian.

And although there is legislation in place these days, as the authors point out, “lavish gifts and generous travel support … have been progressively discouraged by industry and professional guidelines. It is likely that the frequent, more modest, sponsored educational events will become increasingly important and influential, and the principal form of contact between industry and health professionals.”

This research clearly outlines how endemic industry courting of doctors really is.

—————————————————————————————————-

Robertson J, Moynihan R, Walkom E, Bero L, & Henry D. (2009) Mandatory Disclosure of Pharmaceutical Industry-Funded Events for Health Professionals. PLoS Medicine 6 (11). DOI: 10.1371/journal.pmed.1000128

Continue Reading

Arch Intern Med roundup: diets, delays and disclosure

Arch intern MedThe journal Archives of Internal Medicine has a several cracking research papers this week.

Low carb dieters are grumpier than those on low fat diets

First up is Brinkworth et al.‘s research on the long-term psychological effects of low carbohydrate diets compared with low fat diets.

In this study, 106 overweight and obese individuals were randomly assigned to receive a low carbohydrate, high fat diet or a high carbohydrate, low fat plan. After one year, those participants on the low carbohydrate diet were more likely to be anxious, depressed, angry or confused than were those on the low fat diet. Both diets had the same number of calories and produced a similar amount of weight loss (13.7kg).

The authors suggest that the social difficulty of adhering to a low carbohydrate plan, which is counter to the typical Western diet full of pasta and bread, may be in part responsible for the mood deterioration in the low carb group. Alternatively, protein and fat intake may differently affect brain levels of serotonin, the so-called “happy hormone” (NB: its a neurotransmitter, not a hormone).

The Daily Telegraph points out that the infamous meat-heavy Atkins diet is essentially a low carb, high fat plan – bad news for all the celebrity fans.  Suddenly the term “hangry” makes more sense…

——————-
Brinkworth GD, Buckley JD, Noakes M, Clifton PM, & Wilson CJ (2009) Long-term Effects of a Very Low-Carbohydrate Diet and a Low-Fat Diet on Mood and Cognitive Function. Arch Intern Med 169 (20): 1873-1880. URL: Here

Fewer than ever emergency department patients are being seen on time

Next is Horwitz and Bradley’s paper on wait times to see a doctor in US emergency departments. The authors assessed more than 150,000 visits and found that only one in four patients were seen within the target triage time in 2006, compared with one in five in 2007.  By 2006, the odds of being seen on time were 30% lower than in 1997.

Interestingly, the proportion of patients seen on time did not differ on the basis of insurance status or race/ethnicity.  As the LA Times put it, “The conventional wisdom that throngs of low-income, uninsured people who use the ER as a substitute for primary care visits are to blame is wrong.”

Instead, the change in wait times was driven by delays in attending to emergency cases, who were 87% less likely to be seen within the target time than nonurgent cases.

As the authors says, “The percentage of patients in the emergency department who are seen by a physician within the time recommended … is at its lowest point in at least 10 years”

——————-
Horwitz LI & Bradley EH (2009) Percentage of US Emergency Department Patients Seen Within the Recommended Triage Time: 1997 to 2006. Arch Intern Med 169 (20): 1857-1865. URL: Here

GP visits are getting longer and better

Timings are also increasing in primary care, but rather than waiting times the time patients spend with their doctor is growing, according to Chen and colleagues.

Visits by adults to primary care physicians in the US between 1997 and 2005 increased by 10%, from 273 million to 338 million annually.  During this period, the mean duration of visit increased from 18.0 minutes to 20.8 minutes. Visit duration increased the most for people with any form of arthritis – by 5.9 minutes.

The increase in time spent with physicians seemed to be down to doctors spending longer counselling their patients. Visits for counselling or screening generally took 2.6-4.2 minutes longer than visits in which patients did not receive these services, whereas there was no change in the duration of visits in which doctors simply provided medication.

“Although it is possible that physicians have become less efficient over time, it is far more likely that visit duration has increased because it takes more resources or time to care for an older and sicker population,” the authors conclude. These findings thus contradict the belief that doctors are shaving time off consultations to meet efficiency goals, says the Wall Street Journal.

————–
Chen LM, Farwell WR, & Jha AK (2009) Primary Care Visit Duration and Quality: Does Good Care Take Longer? Arch Intern Med 169 (20): 1866-1872. URL: Here

Patients rate care better if doctors disclose mistakes

Finally, López et al. looked at how health professional disclosure of adverse events – an injury caused by some aspect of medical care and not by the underlying medical condition – affects patient perceptions of care.  They found that in patients who experienced an adverse event in hospital, those whose doctor told them about the event were likely to rate their care more highly than patients whose caregivers did not address the problem.

A total of 845 adverse events were reported in this sample of almost 2,600 acute care adult patients, but only 40% of these were disclosed. However, disclosure of preventable and nonpreventable events was associated with high ratings of quality of care. In addition, patients who felt that they were able to protect themselves from adverse events were likely to rate their care favourably.

On the other hand, patients who experienced medical accidents that were preventable, caused increased discomfort, or continued to negatively affect the patient for some time after the event tended to rate their care poorly.

“Although rates of disclosure remain disappointingly low, our findings should encourage more disclosure and allay fears of malpractice lawsuits,” say the authors. “Patients want to be told the truth, and they perceive disclosure as integral to high-quality medical care.”

———————-
López L, Weissman JS, Schneider EC, Weingart SN, Cohen AP, & Epstein AM (2009) Disclosure of Hospital Adverse Events and Its Association With Patients’ Ratings of the Quality of Care. Arch Intern Med 169 (20): 1888-1894. URL: Here

Continue Reading

Nearly a third of clinical trials don’t adequately report adverse events

Medical libraryA study published in Archives of Internal Medicine has found that almost a third of clinical trials reported in top medical journals don’t adequately report the side effects of the intervention being tested.

Pitrou et al. assessed the reporting of safety data in 133 randomised controlled trials published between January 2006 and January 2007 in five high impact factor medical journals: New England Journal of Medicine, Lancet, Journal of the American Medical Association, British Medical Journal and Annals of Internal Medicine. PLoS Medicine was included in the search for relevant papers, but no trials from this journal were assessed.

Although 88.7% of published trials mentioned at some point the adverse effects of the study intervention – that is, the drug or non-pharmacological treatment being investigated – 32.6% of all trials didn’t properly report the adverse events data. For example, 17 articles only provided a description of the most common adverse events, whereas 16 reported just severe adverse events.

Thirty-six articles (27.1%) did not give any information the severity of the adverse events reported.  In addition, 63 reports (47.4%) did not give any data on the number of patients who withdrew from the trial owing to adverse events.

So why is this research important?  As the authors say, “the reporting of harm is as important as the reporting of efficacy in publications of clinical trials.”  Insufficient reporting of side effects affects the interpretation of the trial results and distorts the picture of the drug for both clinicians and patients – the drug seems effective but without full adverse effect data no-one can properly assess the risks and benefits of using it.

Writing in an Editorial in the same issue of Arch Intern Med, John PA Ioannidis discusses this issue further. “Accurate information on harms of medical interventions is essential for evidence-based practice”, he says. “Most newly introduced treatments usually have small, incremental benefits, if any, against already available interventions, and differences in the profile of harms should play a key role on treatment choice.”

In addition, this research raises the issue of reported research focusing on the benefits of the intervention being investigated and playing down the negative aspects – the dreaded publication bias.

Guidelines like the Consolidated Standards of Reporting Trials (CONSORT) statement have been put together to try to make sure that researchers report their trials in a complete and transparent way. The CONSORT Statement is a set of 22 recommendations for reporting randomised controlled trials that provides a standard way for authors to prepare reports of trial findings, thus aiding critical appraisal and interpretation of the results.

Granted, the CONSORT statement was only published in 2001 and thus it’s not entirely suprising that trial reporting wasn’t completely up to scratch in the 2006 papers analysed by Pitrou et al.

However, several journals, including BMJ, currently insist that authors fill in the CONSORT checklist and provide a flow chart before the paper can be accepted.  Let’s hope that researchers and publishers are now taking seriously the issue of thoroughly reporting adverse effects.

————————————————————————————
Pitrou I, Boutron I, Ahmad N & Ravaud P (2009) Reporting of safety results in published reports of randomized controlled trials. Archives of Internal Medicine 169 (19): 1756-61. PMID: 19858432

Continue Reading

Metal causes cancer, but iron prevents it. Courtesy of the Daily Mail.

dailymailHere’s a Friday funny for you: my friend put me onto a hilarious website called “Kill or cure“, which classifies inanimate objects on the basis of whether British newspaper the Daily Mail says they cause cancer or cure it.

Metal, according to the Daily Mail, causes cancer, but nobody panic, iron and zinc prevent it.

Nuts prevent cancer, but peanuts cause it.  Cod liver oil can give you cancer, but fish oils will protect you.  Are you still with me?!

Absolutely hilarious.

See also: the Daily Mail Oncological Ontology Project

Continue Reading

So what happened to the AIDs vaccine?

HIVYou might remember all the hullabaloo last month about the HIV vaccine developed by the US military and tested on 16,000 people in Thailand.  Hailed as an “HIV breakthrough” and a “historic milestone“, the initial press release of the study certainly had the media convinced that a prevention for AIDs was just around the corner.

Now the research has been presented in full at the AIDS Vaccine 2009 Conference in Paris and in the New England Journal of Medicine, and reactions are far more circumspect.

Granted, the vaccine in question is the first ever to provide any kind of protection against HIV, but it only prevented HIV-1 infection in 31.2% of participants. 74 of the 8198 volunteer who received the placebo vaccine became infected with HIV-1, but 51 of the 8197 people who were given the vaccine still managed to get infected – a difference of only 23 people.

I’m not really sure what happened with this story.  Did it get press released before publication and before anyone had a good look at all the data?  To be fair the initial news stories were pretty good in their reporting of the research, but why is the story doing the rounds again?

New Scientist is on the ball with this.  In September they published an article “What to make of the HIV vaccine ‘triumph’“, in which they point out that “the victory was won by the slenderest of numerical margins.”

In addition, New Scientist provides some sort of answer to my previous question.  Says the article: “The result was disclosed at the earliest available opportunity at the request of the Thai collaborators, says Merlin Robb, deputy director for clinical research at the MHRP.  “The Thai Ministry of Public Health was very anxious to let the volunteers in Thailand know the result as soon as possible, instead of waiting for a scientific conference,” says Robb. “This reflects our commitment to the volunteers and transparency in all aspects of this trial,” he said.”

So what’s with this jumping of the gun and presenting research before it’s been published in a peer review journal?  But researchers live in a “publish or perish” environment and are in constant fear of being “pipped to the post”.

The BMJ says “We do not want material that is published in the BMJ appearing beforehand, in detail, in the mass media” and “The BMJ does not want to publish material that has already appeared in full elsewhere“. And the New England Journal of Medicine cites their “Ingelfinger rule“, which “requires that author-researchers not release the details of their findings to the mass media before their work undergoes peer review and is published.”

I don’t think this research would have subsequently been published in the NEJM if the authors had in fact broken the embargo, so there must have ben some intense behind the scenes bargaining to get the paper released early – but only a month early.

I’m not really sure what point I’m trying to make here, but I think it’s certainly interesting that this paper made a bug splash a month before the full data was published then did the rounds again.

Continue Reading