November 2009 – Helen Jaques

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

November 12, 2009 1 Comment

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.

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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

Clinical trials, Journals

Arch Intern Med roundup: diets, delays and disclosure

November 10, 2009 No Comments

The 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…

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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”

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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.

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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.”

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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

Clinical trials, Journals

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

November 9, 2009 No Comments

A 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.

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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