Rimonabant (Acomplia) by Sanofi-Aventis, was licensed for use in the UK since June 2006 for the treatment of obesity.
However, adverts have claimed the drug can cut levels of potentially harmful cholesterol, fats and sugars in the blood to a greater extent than would be expected by weight loss alone. In theory, this should help to reduce the risk of developing type 2 diabetes and heart disease.
A report published in The Drug and Therapeutics Bulletin (DTB) on 30 May 2007 said there was no proof that the drug had any beneficial effects outside those expected by weight loss. The drug had not been effectively compared with other less expensive drug treatment for obesity.
The DTB authors said Orlistat (Xenical), costs less and approved for use in the NHS is the drug for obesity with the most evidence for efficacy and safety to date, and they have previously concluded that it is a reasonable option for obese patients where diet and exercise and/or behavioural measures alone have failed.
Thursday, May 31, 2007
Wednesday, May 30, 2007
Calmer approach to Avandia : The Lancet
Since the NEJM paper ( see posting on 25 May 2007) was published on May 21, frightened diabetes patients flooded their doctors with calls, many patients have stopped taking Avandia or switched to a rival drug Actos although some experts caution there is no urgent need for diabetes patients to stop taking Avandia.
The Lancet published an editorial online on May 23, 2007 to point out that there are important weaknesses in Nisson's meta analysis and call for "a calmer and more considered approach to the safety of Rosiglitazone" in response to the alarm raised by Dr Steven Nisson in NEJM.
According to The Lancet, the 2 most reliable studies to inform decision-making are ADOPT (published by NEJM) and DREAM (published by The Lancet). Although the results of these studies "indicate the need for more reliable information about rosiglitazone's safety", patients should calm down and wait for the results of the RECORD trial, a multi-centre study designed to monitor cardiac risk.
The Lancet published an editorial online on May 23, 2007 to point out that there are important weaknesses in Nisson's meta analysis and call for "a calmer and more considered approach to the safety of Rosiglitazone" in response to the alarm raised by Dr Steven Nisson in NEJM.
According to The Lancet, the 2 most reliable studies to inform decision-making are ADOPT (published by NEJM) and DREAM (published by The Lancet). Although the results of these studies "indicate the need for more reliable information about rosiglitazone's safety", patients should calm down and wait for the results of the RECORD trial, a multi-centre study designed to monitor cardiac risk.
Friday, May 25, 2007
Avandia and myocardial infarction
A leading cardiologist, Steven Nissen, found that Avandia (generic name: rosiglitazone), a diabetes drug, "was associated with significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance."
The study concluded that despite the study's limitation, " patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."
His findings were based on an analysis of 42 RCTs and published online on May 21 by NEJM. "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". The article will appear in the June 14 issue of the Journal.
Avandia is a top-selling diabetes drug manufacturered by GlaxoSmithKline, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes mellitus. Nissen’s analysis on Avandia has caused the Glaxo stock down more than 6% in midday trading.
Dr. Nissen is a strong critic on drug safety, he and colleague, Eric Topol, a well-known cardiologist, raised concerns about the safety of Vioxx in JAMA in 2001 that led to the withdrawal of the drug from the market in 2004. Dr Topol lost his job after testimony against the drug manufacturer Merck in federal trial.
The study concluded that despite the study's limitation, " patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes."
His findings were based on an analysis of 42 RCTs and published online on May 21 by NEJM. "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes". The article will appear in the June 14 issue of the Journal.
Avandia is a top-selling diabetes drug manufacturered by GlaxoSmithKline, introduced in 1999 and is widely used to lower blood glucose levels in patients with type 2 diabetes mellitus. Nissen’s analysis on Avandia has caused the Glaxo stock down more than 6% in midday trading.
Dr. Nissen is a strong critic on drug safety, he and colleague, Eric Topol, a well-known cardiologist, raised concerns about the safety of Vioxx in JAMA in 2001 that led to the withdrawal of the drug from the market in 2004. Dr Topol lost his job after testimony against the drug manufacturer Merck in federal trial.
Extra posts for junior doctors
The Health Secretary promised extra posts for junior doctors to ease the crisis over MTAS.
She told MPs there would be 200 additional "run-through programmes" for doctors who are already in training for their chosen specialities. These 200 extra training posts will be at the ST3 entry level and made available in the second round of the application process. Further additional temporary posts - fixed-term specialist training appointments - also will be made available, but it is unclear how many.
The BMA estimates that 12,000 doctors will not get a post as a result of the system.
She told MPs there would be 200 additional "run-through programmes" for doctors who are already in training for their chosen specialities. These 200 extra training posts will be at the ST3 entry level and made available in the second round of the application process. Further additional temporary posts - fixed-term specialist training appointments - also will be made available, but it is unclear how many.
The BMA estimates that 12,000 doctors will not get a post as a result of the system.
Thursday, May 24, 2007
MTAS in The Lancet Comment
A Comment, published in The Lancet this week, 19 -25 May 2007, p.1673 - 75, expressed doctors' concerns and disillusionment about MTAS.
Various polls were published online with the Comment.
3/4 of the respondents rejected the proposal of the single interview.
80% wanted the August changeover date postponed.
85% called for consultants to withdraw from the interview process.
The Comment says both MMC and MTAS are unnecessary and disastrous and calls on the MMC chairman, MTAS and PMETB to "stop this madness".
Various polls were published online with the Comment.
3/4 of the respondents rejected the proposal of the single interview.
80% wanted the August changeover date postponed.
85% called for consultants to withdraw from the interview process.
The Comment says both MMC and MTAS are unnecessary and disastrous and calls on the MMC chairman, MTAS and PMETB to "stop this madness".
Junior doctors lost high court battle over MTAS
Junior doctors have lost their High Court battle to invalidate MTAS interviews.
Remedy UK had argued for the system to be scrapped and all the interviews carried out again because the whole process was unfair and unlawful ( see previous postings). The judge ruled against invalidating the interviews already done but said the doctors' grievance was entirely justified. He said it was a flawed system with disastrous consequences, individual junior doctors could still have good grounds to appeal regarding the jobs allocated to them - or to take their cases before a tribunal.
Remedy UK said that "This is a sad day for doctors and the NHS", but the group would not be appealing the decision.
Last week, ministers were forced to abandon MTAS. The Health Secretary said that after the first round of recruitment, MTAS would not be used again this year. The recruitment process will be handled at a local level by medical deaneries. Junior doctors will be asked to apply directly to hospitals for jobs.
Some leading consultants said the recruitment process is deeply flawed and the continuous crisis could put patients at risk. An online survey of doctors organised by some specialists drew 3,500 responses. 85% of consultants who took part backed a boycott of recruitment interviews, 90% expressed no confidence in the health secretary and chief medical officer.
Chennel 4 News uncovered that every candidate in England was offered a one-off rescue interview, but these interviews need up to 9 consultants to sit on the panel. Patient operations are being cancelled and rescheduled as some consultants struggle to fit their work around interviews.
A group of leading consultants claimed in their letter to The Times that the MTAS has "so far failed at every task" and questioned a decision taken to allow experienced doctors just one interview to determine their future career.
Remedy UK had argued for the system to be scrapped and all the interviews carried out again because the whole process was unfair and unlawful ( see previous postings). The judge ruled against invalidating the interviews already done but said the doctors' grievance was entirely justified. He said it was a flawed system with disastrous consequences, individual junior doctors could still have good grounds to appeal regarding the jobs allocated to them - or to take their cases before a tribunal.
Remedy UK said that "This is a sad day for doctors and the NHS", but the group would not be appealing the decision.
Last week, ministers were forced to abandon MTAS. The Health Secretary said that after the first round of recruitment, MTAS would not be used again this year. The recruitment process will be handled at a local level by medical deaneries. Junior doctors will be asked to apply directly to hospitals for jobs.
Some leading consultants said the recruitment process is deeply flawed and the continuous crisis could put patients at risk. An online survey of doctors organised by some specialists drew 3,500 responses. 85% of consultants who took part backed a boycott of recruitment interviews, 90% expressed no confidence in the health secretary and chief medical officer.
Chennel 4 News uncovered that every candidate in England was offered a one-off rescue interview, but these interviews need up to 9 consultants to sit on the panel. Patient operations are being cancelled and rescheduled as some consultants struggle to fit their work around interviews.
A group of leading consultants claimed in their letter to The Times that the MTAS has "so far failed at every task" and questioned a decision taken to allow experienced doctors just one interview to determine their future career.
Monday, May 21, 2007
"How doctors think"
Dr Jerome Groopman, chief of experimental medicine at Beth Israel Deaconess Medical Center in Boston and teaches at Harvard Medical School, felt disturbed one day while he was on rounds with a group of interns, residents and medical students. He was concerned the trainees failed to question cogently or listen carefully or observe keenly and wanted to explore what goes on in a doctors's mind as he/she treats a patient.
"How doctors think" is Dr Groopman's findings of the thought processes of doctors and the errors in thinking to which they are prone drawing on a wealth of research, extensive interviews with doctors and his own experiences as a doctor and as a patient. He says that most of the mistakes doctors make are cognitive errors, many use strategies of pattern recognition to make quick decisions and are unaware of their cognitive vulnerabilities that influence their medical judgement.
He tells the story of a young woman who had been assessed and treated by numerous specialists including psychologists and psychiatrists over 15 years, but her health continued to deteriorate. The turning point came when she was referred to a gastroenterologists who was recommended to treat her irritable bowel syndrome with diet and tranquilizers. The gastroenterologist acted differently - he reconsidered her case from scratch, questioning, listening, observing and thinking differently about her illness. He diagnosed celiac disease and saved her life - " for 15 years a key aspect of her illnesses had been missed."
Dr Groopman suggests that if doctors can become more aware of their emotions, prejudices and cognitive processes in reaching a diagnosis, and in particular the role that their first impression plays in that process, they can eliminate many of these errors and can be a better caregiver.
Dr Groopman suggests that patient's story is essential in the diagnostic process because doctors need patients and their families to help provide vital information about their illnesses. Patients need to know how doctors think and ask questions to help doctors refocus their thought in making the right diagnosis.
Wednesday, May 16, 2007
If you think life is unfair .....
A study of 8,000 Government senior civil servants working in London, "Unfairness and health: evidence from the Whitehall II Study", published in the Journal of Epidemiology and Community Health, 2007; 61:513-518, found that thoughts of unfair treatment can directly lead to a greater risk of coronary problems. ( f/t via Athens password).
The results showed that those who thought they had experienced the worst injustice were 55% more likely to experience a coronary event than people who thought life was fair. Those who reported low levels of unfair treatment had 28% higher chance of suffering heart disease than those who had no complaints. People who reported moderate unfairness saw their risk rise by 36%.
The results showed that unfair treatment in other aspects of life was linked to increased risk of heart disease. The researcher said "the key message is that we must try to promote fairness in society".
The results showed that those who thought they had experienced the worst injustice were 55% more likely to experience a coronary event than people who thought life was fair. Those who reported low levels of unfair treatment had 28% higher chance of suffering heart disease than those who had no complaints. People who reported moderate unfairness saw their risk rise by 36%.
The results showed that unfair treatment in other aspects of life was linked to increased risk of heart disease. The researcher said "the key message is that we must try to promote fairness in society".
Tuesday, May 15, 2007
Ethnicity & gender on MRCP exams pass rates
A research, undertaken by MRCP in collaboration with UCL, was published in the journal of BMC Medicine, looking at the "effects of ethnicity and gender of UK medical graduates on MRCP exam pass rates during 2003-04".
The researchers found :
In all three parts of the MRCP examination, white candidates performed better than other ethnic groups.
In Part 1 and Part 2 Written Examinations, gender did not make a significant difference.
In the Part 2 Clinical Examination, women performed better than men did. White candidates had a much higher pass rate than non-white candidates and non-white males were least successful, the poor performance was most marked in the communications and ethics assessments.
There was no evidence of the gender of the examiners that made significant difference, however, there was improved performance in communications and ethics of non-white candidates examined by 2 non-white examines.
The researchers found :
In all three parts of the MRCP examination, white candidates performed better than other ethnic groups.
In Part 1 and Part 2 Written Examinations, gender did not make a significant difference.
In the Part 2 Clinical Examination, women performed better than men did. White candidates had a much higher pass rate than non-white candidates and non-white males were least successful, the poor performance was most marked in the communications and ethics assessments.
There was no evidence of the gender of the examiners that made significant difference, however, there was improved performance in communications and ethics of non-white candidates examined by 2 non-white examines.
Friday, May 04, 2007
There is no free lunch
A survey was published in NEJM, 26 April 2007, "A national survey of physician - industry relationships" prompted by the concerns of conflicts of interet.
About 3000 physicians were surveyed between 2003 and 2004, more than half responded. The survey found that 94% of physicians in the US have some form of relationships with the industry reps and the relationships vary depending on the specialty, practice type and professional activities :
83% have received gifts especially food in the workplace;
78% free drug samples;
35% reimbursements for expenses;
28% payments for consulting, speaking, enrolling patients in clinical trials;
7% tickets to entertainments
Cardiologists were more than twice likely to receive fees than family practitioners and other physicians
Physicians in solo or group practices were much more likely to have these relationships than those working in hospitals and clinics.
Family practitioners met "far more often" with industry sales reps and the most likely to receive gifts than other doctors
All specialties except anesthesiology have more frequent meetings with industry today as compared to 2000.
A new code of conduct governing physician–industry relationships was established in 2002 to limit the value of gifts to physicians from industry, but the survey found that some of the physicians failed to observe the guidelines. The findings suggest that the drug industry form tighter relationships with opinion leaders for marketing as they are likely to influence the prescribing practices of other doctors. This has raised the question of "to what extent do these relationships benefit patients?"
In the same week, the journal PLoS Medicne published an article, "Following the script: how drug reps make friends and influence doctors", revealing the strategies deployed relentlessly by reps to influence physicians prescribing. This includes forming false "friendships" with physicians, supplying carefuly selected gifts, drug samples, services and flattery to physicians depending on the information the reps have collected about the physicians' personality types.
Most physicians deny that gifts and freebies could influence their behaviour, but several studies have shown that industry reps are extremely effective in changing prescribing behaviour. Evidence also suggests the information provided to physicians may be largely incorrect. The researcher concluded that "physicians must rely on information on drugs from unconflicted sources and seek friends among those who are not paid to be friends."
About 3000 physicians were surveyed between 2003 and 2004, more than half responded. The survey found that 94% of physicians in the US have some form of relationships with the industry reps and the relationships vary depending on the specialty, practice type and professional activities :
83% have received gifts especially food in the workplace;
78% free drug samples;
35% reimbursements for expenses;
28% payments for consulting, speaking, enrolling patients in clinical trials;
7% tickets to entertainments
Cardiologists were more than twice likely to receive fees than family practitioners and other physicians
Physicians in solo or group practices were much more likely to have these relationships than those working in hospitals and clinics.
Family practitioners met "far more often" with industry sales reps and the most likely to receive gifts than other doctors
All specialties except anesthesiology have more frequent meetings with industry today as compared to 2000.
A new code of conduct governing physician–industry relationships was established in 2002 to limit the value of gifts to physicians from industry, but the survey found that some of the physicians failed to observe the guidelines. The findings suggest that the drug industry form tighter relationships with opinion leaders for marketing as they are likely to influence the prescribing practices of other doctors. This has raised the question of "to what extent do these relationships benefit patients?"
In the same week, the journal PLoS Medicne published an article, "Following the script: how drug reps make friends and influence doctors", revealing the strategies deployed relentlessly by reps to influence physicians prescribing. This includes forming false "friendships" with physicians, supplying carefuly selected gifts, drug samples, services and flattery to physicians depending on the information the reps have collected about the physicians' personality types.
Most physicians deny that gifts and freebies could influence their behaviour, but several studies have shown that industry reps are extremely effective in changing prescribing behaviour. Evidence also suggests the information provided to physicians may be largely incorrect. The researcher concluded that "physicians must rely on information on drugs from unconflicted sources and seek friends among those who are not paid to be friends."
Tuesday, May 01, 2007
MTAS update
In the controversy over MTAS ( See posting on 28 March 2007), Channel 4 News reported on 20 April that a leaked document showed that the Government was considering offering voluntary work overseas for unsuccessful doctors. VSO had given information on its placements to the DoH. The document also revealed that about 10,000 doctors may be at risk. Read more...
Channel 4 News also reported on 24 April the security breach, alerted by a doctor, after an error at the MTAS website where highly personal details of thousands of junior doctors could be seen. The DoH was informed by Channel 4 News and the website was temporarily suspended amid concerns of security lapses.
The latest error of MTAS was the rejection of the application of a UK born doctor, Dr Luk who went to Cambridge University, because he did not have the "correct immigration status". Although the London Deanery has apologised for the error, he still has not had any interviews.
Doctors groups reacted with dismay and had little faith left with what they described a "shambolic" system. At the doctors conference in London last Saturday, delegates passed a motion calling for the Health Secretary Hewitt and Health Minister Hunt to resign, for NAO to investigate how much public money had been spent on the computer system and for the system to be scrapped.
The data watchdog, ICO, is to investigate the security breach that led to personal details made available online. Read more ...
Using iPods to teach doctors to recognise heartbeats
Research studies show that the average doctor identifies 40% of heart sounds correctly.
Dr Michael Barrett, associate professor and cardiologist at Temple University studied 149 doctors who listened 400 times to five common heart murmurs for 90 minutes on iPods. After the listening session, they got 80% right.
Dr Barrett believes that the key to learning heart murmurs is repetition but 400 heartbeats were too much to ask of a live patient, so he uses computer-generated simulations of "heart songs" and convert them into MP3 files that can be downloaded to iPods. His medical students listen to the recordings whenever they have the time, this will help improve their stethoscope skills.
Last month at the annual conference of the American College of Cardiology (ACC), Dr Barrett presented the findings of his study and said "cardiology can be taught by iPod …. older physicians can also benefit from adding the MP3s to their music libraries".
Channel 4 News also reported on 24 April the security breach, alerted by a doctor, after an error at the MTAS website where highly personal details of thousands of junior doctors could be seen. The DoH was informed by Channel 4 News and the website was temporarily suspended amid concerns of security lapses.
The latest error of MTAS was the rejection of the application of a UK born doctor, Dr Luk who went to Cambridge University, because he did not have the "correct immigration status". Although the London Deanery has apologised for the error, he still has not had any interviews.
Doctors groups reacted with dismay and had little faith left with what they described a "shambolic" system. At the doctors conference in London last Saturday, delegates passed a motion calling for the Health Secretary Hewitt and Health Minister Hunt to resign, for NAO to investigate how much public money had been spent on the computer system and for the system to be scrapped.
The data watchdog, ICO, is to investigate the security breach that led to personal details made available online. Read more ...
Using iPods to teach doctors to recognise heartbeats
Research studies show that the average doctor identifies 40% of heart sounds correctly.
Dr Michael Barrett, associate professor and cardiologist at Temple University studied 149 doctors who listened 400 times to five common heart murmurs for 90 minutes on iPods. After the listening session, they got 80% right.
Dr Barrett believes that the key to learning heart murmurs is repetition but 400 heartbeats were too much to ask of a live patient, so he uses computer-generated simulations of "heart songs" and convert them into MP3 files that can be downloaded to iPods. His medical students listen to the recordings whenever they have the time, this will help improve their stethoscope skills.
Last month at the annual conference of the American College of Cardiology (ACC), Dr Barrett presented the findings of his study and said "cardiology can be taught by iPod …. older physicians can also benefit from adding the MP3s to their music libraries".
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