The drugs don't work: a modern medical scandal | Ben Goldacre | Business | The Guardian: "The doctors prescribing the drugs don't know they don't do what they're meant to. Nor do their patients. The manufacturers know full well, but they're not telling."
'via Blog this'
These observations further emphasize our ignorance of the mechanisms responsible for primary hyperhidrosis and of the effect of sympathetic ablation
"These observations further emphasize our ignorance of the mechanisms responsible for primary hyperhidrosis and of the effect of sympathetic ablation on the function of the remaining sympathetic system."
"Only investigators who deviate from accepted standards innovate and thus advance science. Obviously, such deviations may also result in disasters;"
Statement made by the former President of the International Society of Sympathetic Surgery, and ETS surgeon, Moshe Hashmonai (Invited Commentary) Endoscopic Lumbar Sympathectomy Following Thoracic Sympathectomy in Patients with Palmoplantar Hyperhidrosis
World J Surg (2011) 35:54–55 DOI 10.1007/s00268-010-0809-5
Ben Goldacre: 'It's appalling … like phone hacking or MPs' expenses' | Business | The Observer
Ben Goldacre: 'It's appalling … like phone hacking or MPs' expenses' | Business | The Observer: "The point of my book is that it's possible for good people in badly designed systems to perpetrate acts of great evil completely unthinkingly. I don't think any of the people I write about would punch an old lady in the face, but they would inflict the same level of harm when they are abstracted away from the outcomes of their actions.
This is made easier, I think, because in general, most drugs do work better than nothing: it's just that we may be misled into using, for example, an expensive new drug where an older, cheaper one is more effective.
Overall, the problem is we don't have a competent regulatory framework that prevents things from going horribly wrong. If companies are allowed to hide the results of clinical trials then they will, and that will distort clinical practice."
'via Blog this'
This is made easier, I think, because in general, most drugs do work better than nothing: it's just that we may be misled into using, for example, an expensive new drug where an older, cheaper one is more effective.
Overall, the problem is we don't have a competent regulatory framework that prevents things from going horribly wrong. If companies are allowed to hide the results of clinical trials then they will, and that will distort clinical practice."
'via Blog this'
Parents can't sue vaccine manufacturers - SFGate
Parents can't sue vaccine manufacturers - SFGate: "Parents whose children are harmed or killed by allegedly defective vaccines can't sue the manufacturers for damages in state court and must instead accept no-fault compensation from a national tribunal for vaccination injuries, a federal appeals court ruled Tuesday.
The Ninth U.S. Circuit Court of Appeals upheld dismissal of a suit by a Las Vegas couple whose baby son suffered seizures and died after an immunization shot, saying such suits were precluded by a 1986 federal law.
The law established a "vaccine court" where those who claimed injuries from vaccination must file their claims. If a hearing officer determined that the harm was consistent with the vaccine's known side effects, the victim would be awarded compensation without having to prove that the manufacturer caused the harm or acted negligently."
'via Blog this'
The Ninth U.S. Circuit Court of Appeals upheld dismissal of a suit by a Las Vegas couple whose baby son suffered seizures and died after an immunization shot, saying such suits were precluded by a 1986 federal law.
The law established a "vaccine court" where those who claimed injuries from vaccination must file their claims. If a hearing officer determined that the harm was consistent with the vaccine's known side effects, the victim would be awarded compensation without having to prove that the manufacturer caused the harm or acted negligently."
'via Blog this'
Arthroscopy to treat osteoarthritis of the knee? | Medical Journal of Australia
Arthroscopy to treat osteoarthritis of the knee? | Medical Journal of Australia: "Changing clinician beliefs and behaviour in response to credible evidence of lack of treatment efficacy remains highly challenging"
'via Blog this'
'via Blog this'
The antidepressant reboxetine: A “headdesk” moment in science
The antidepressant reboxetine: A “headdesk” moment in science | Guest Blog, Scientific American Blog Network: "For psychiatry and behavioral pharmacology, one of those moments came a few weeks ago with the findings of a meta-analysis published in the British Medical Journal (Eyding et al., 2010). The meta-analysis showed that an antidepressant, reboxetine (marketed by Pfizer in Europe, but not in the U.S., under the names Edronax, Norebox, Prolift, Solvex, Davedax or Vestra) doesn’t work. Not only does it not work, it really doesn’t work, and it turns out that Pfizer hadn’t published data on the putative antidepressant from 74% of their patients. "
'via Blog this'
'via Blog this'
New symptoms for ADHD diagnosis
New symptoms for ADHD diagnosis: "In a published ''pros and cons'' list about the additional symptoms, the committee said they were "not empirically derived" and had potential to decrease the accuracy of the criteria.
Melissa Raven, a psychiatric epidemiologist and policy analyst at Flinders University, in Adelaide, said that was an "absolutely damning statement".
"They have identified some problems then proceeded blithely on," she said.
Allen Frances, the chairman of the taskforce that produced the present edition of the DSM, said when they increased the number of symptoms they produced an ''epidemic'' of ADHD. They thought it would increase by 15 per cent, but it actually increased by 200 per cent."
'via Blog this'
Melissa Raven, a psychiatric epidemiologist and policy analyst at Flinders University, in Adelaide, said that was an "absolutely damning statement".
"They have identified some problems then proceeded blithely on," she said.
Allen Frances, the chairman of the taskforce that produced the present edition of the DSM, said when they increased the number of symptoms they produced an ''epidemic'' of ADHD. They thought it would increase by 15 per cent, but it actually increased by 200 per cent."
'via Blog this'
'Miracle' drugs put thousands at risk
'Miracle' drugs put thousands at risk: "THOUSANDS of Australians could be taken off cholesterol-lowering medications because of mounting evidence they increase the risk of diabetes and dementia.
Australian health authorities are reviewing their advice after US regulators announced statins will now carry warnings they could increase the risk of diabetes and cognitive impairment.
Statins are the most commonly prescribed drugs in Australia, with about 2 million people thought to be taking them to reduce their heart disease risk."
'via Blog this'
Australian health authorities are reviewing their advice after US regulators announced statins will now carry warnings they could increase the risk of diabetes and cognitive impairment.
Statins are the most commonly prescribed drugs in Australia, with about 2 million people thought to be taking them to reduce their heart disease risk."
'via Blog this'
Madness is undergoing a redesign
Madness is undergoing a redesign: "You know how sometimes you just go a little bit crazy when you have your period? Well, it turns out PMS is about to become a mental illness.
Madness is currently undergoing a redesign, with the Diagnostic and Statistical Manual of Mental Disorders, often called the ‘Psychiatrist’s Bible’ being updated.
Basically, a big group of grey-haired psychiatrists have been getting together to decide what qualifies someone as being mentally ill.
There are a whole heap of proposed changes that have the potential to change how we think about our bodies and behaviours. Rape is set to become a mental disorder, and wanting to have sex all the time is being considered for inclusion."
'via Blog this'
Madness is currently undergoing a redesign, with the Diagnostic and Statistical Manual of Mental Disorders, often called the ‘Psychiatrist’s Bible’ being updated.
Basically, a big group of grey-haired psychiatrists have been getting together to decide what qualifies someone as being mentally ill.
There are a whole heap of proposed changes that have the potential to change how we think about our bodies and behaviours. Rape is set to become a mental disorder, and wanting to have sex all the time is being considered for inclusion."
'via Blog this'
Does doctor still know best? | Australian cardiologists
Does doctor still know best? | Australian cardiologists: "Are Professor MacMahon and the other cardiovascular researchers and clinicians who have called the article “sensationalist” and “hysterical” saying that it is hysterical or sensationalist to suggest that people at low-risk of heart disease should reconsider their use of statins? I would say that position is mainstream, and a conservative approach.
It’s also worth pointing out that sometimes, as in the case of this Medical Observer article, the criticisms are made without the speakers declaring their links to pharmaceutical companies that produce lipid-lowering medications."
'via Blog this'
It’s also worth pointing out that sometimes, as in the case of this Medical Observer article, the criticisms are made without the speakers declaring their links to pharmaceutical companies that produce lipid-lowering medications."
'via Blog this'
A significant admission from an ETS surgeon, President of the ISSS:
"General represents the ESB (whether as ETS as ETSC or ELS) a substantial interference in regulatory processes of the body represent the decision for this operation requires that previously conservative treatments were made. An ESB is therefore at the end of a treatment history, and never at the beginning."
http://www.dhhz.de/index....;subPage=§ion=32
it is an automatic translation (google) from german, so you have to look at what the 'gist' of what he is saying: ETS, ESB = "a substantial interference in regulatory processes of the body"
The drugs don't work: a modern medical scandal | Ben Goldacre | Business | The Guardian
The drugs don't work: a modern medical scandal | Ben Goldacre | Business | The Guardian: "
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."
'via Blog this'
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."
'via Blog this'
The drugs don't work: a modern medical scandal | Ben Goldacre | Business | The Guardian
The drugs don't work: a modern medical scandal | Ben Goldacre | Business | The Guardian: "Drugs are tested by their manufacturers, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits."
'via Blog this'
'via Blog this'
Ending over-diagnosis: how to help without harming
Ending over-diagnosis: how to help without harming: "Over-diagnosis is a significant problem that’s already common in some areas of medicine, such as screening and some mental health conditions. It is a problem now but a bigger threat for the future: better imaging technologies, more biomarkers, more genetic tests and so on, will gradually expand the amount of over-diagnosis that’s possible."
'via Blog this'
'via Blog this'
Senate Committees – Parliament of Australia
Senate Committees – Parliament of Australia: "PIR pointed to doctors' fears that patients might `lose confidence in the health care system and the advice of health care professionals' if patients were more aware of the `unknowns and risks' which might be revealed in medical and health records. "
'via Blog this'
'via Blog this'
False positives: fraud and misconduct are threatening scientific research | Science | The Guardian
False positives: fraud and misconduct are threatening scientific research | Science | The Guardian: "Publishing his results in the journal PLoS One, he found that an average of 1.97% of scientists admitted to having "fabricated, falsified or modified data or results at least once – a serious form of misconduct by any standard – and up to 33.7% admitted other questionable research practices. In surveys asking about the behaviour of colleagues, admission rates were 14.12% for falsification, and up to 72% for other questionable research practices.""
'via Blog this'
'via Blog this'
Private doctors criticised on births
Private doctors criticised on births: "TENS of thousands of Australian women with low risk of birth complications are undergoing unnecessary medical interventions in private hospitals in a trend that a leading midwifery expert has described as ''horrifying''.
In a landmark study of nearly 700,000 women in NSW hospitals, those giving birth privately were found to have a 20 per cent lower chance of having their first child through normal vaginal delivery.
''The fact that these procedures which were initially life saving are now so commonplace and do not appear to be associated with improved [baby] death rates demands close review,'' found the study, to be published today in the British Medical Journal's open journal.
''The findings … suggest a two-tier system exists in Australia without any obvious benefit for women and babies and a level of medical overservicing which is difficult to defend.''
The leader of the study, Hannah Dahlen, said the women examined between 2000 and 2008 were aged 20 to 34, were not pre-term or overdue and carried babies of normal weight."
'via Blog this'
In a landmark study of nearly 700,000 women in NSW hospitals, those giving birth privately were found to have a 20 per cent lower chance of having their first child through normal vaginal delivery.
''The fact that these procedures which were initially life saving are now so commonplace and do not appear to be associated with improved [baby] death rates demands close review,'' found the study, to be published today in the British Medical Journal's open journal.
''The findings … suggest a two-tier system exists in Australia without any obvious benefit for women and babies and a level of medical overservicing which is difficult to defend.''
The leader of the study, Hannah Dahlen, said the women examined between 2000 and 2008 were aged 20 to 34, were not pre-term or overdue and carried babies of normal weight."
'via Blog this'
Sympathectomy controversial for the treatment of RSD
What Is Reflex Sympathetic Dystrophy Syndrome (RSD)?
Complex Regional Pain Syndrome
By Carol Eustice, About.com Guide
Updated June 06, 2012
About.com Health's Disease and Condition content is reviewed by the Medical Review Board
http://arthritis.about.com/od/rsd/a/rsd.htm
Surgical treatment for hyperhidrosis causes hyperhidrosis...
Localised hyperhidrosis may also be due to:
▪ Stroke
▪ Spinal nerve damage
▪ Peripheral nerve damage
▪ Surgical sympathectomy
▪ Neuropathy
▪ Brain tumour
▪ Chronic anxiety disorder
http://www.dermnet.org.nz/hair-nails-sweat/hyperhidrosis.html
Sympathectomy to treat the urge to smoke
Lipov, Eugene (Chicago, IL, US) treating addiction with disruption of the sympathetic chain.
The custom of a majority is no guarantee of safety and is seldom a guide to best medical practice.
Cameron`s claim that there has been only one death attributable to synchronous bilateral thoracoscopic sympathectomy is implausible. Surgeons and anaesthetists are reticent in publicizing such events and Civil Law Reports of settled cases are an inadequate measure of the current running total. The custom of a majority is no guarantee of safety and is seldom a guide to best medical practice.
Jack Collin,
Consultant Surgeon
Oxford
http://www.bmj.com/content/320/7244/1221?tab=responses
aggressive marketing techniques and what protection is available when things go wrong
The review couldn’t come at a better time. A recent survey shows that many people consider the cost of surgery far more important than the qualifications of the person wielding the knife. When 1,762 were asked about getting ‘work’ done – not just breast enlargement but anything from a nose job to a facelift, eyelid lift, liposuction or even non-surgical procedures such as Botox – two thirds said they would consider cost as a factor. However, only half of those questioned said they would take the qualifications of their practitioner into consideration, and fewer than half were concerned about the quality of their aftercare.
It also indicated that the problems with PIP implants had put many women off surgery in the first place, with 45 per cent of those who might have considered it before saying they had changed their minds. This compares to 24 per cent of men.
“The recent problems with PIP breast implants have shone a light on the cosmetic surgery industry,” says Professor Sir Bruce Keogh, the NHS medical director leading the review.
“Many questions have been raised – particularly around the regulation of clinics, whether all practitioners are adequately qualified, how well people are advised when money is changing hands, aggressive marketing techniques and what protection is available when things go wrong.
“I am concerned that too many people do not realise how serious cosmetic surgery is and do not consider the life-long implications – and potential complications – it can have.”
He has called on all those who have had a cosmetic procedure, particularly those who have had a bad experience, to get in touch. His recommendations are expected to be presented to the government by March next year.
http://www.scotsman.com/lifestyle/health/a-forthcoming-review-of-cosmetic-practices-aims-to-make-treatment-safer-and-improve-aftercare-1-2490666
AMA will resist calls for the public naming of individual doctors and how much they receive from drug companies
Industry group Medicines Australia is under pressure from its members to name doctors who receive payments and publicly disclose the amounts and will today unveil a new Transparency Working Group to advise on the best way to do this.
The Australian Medical Association will resist calls for the public naming of individual doctors and how much they receive from drug companies.
AMA president Steve Hambleton said: "The risks are public reporting may misinform the public and if it is attributed to the wrong practitioner, it could be damaging."Instead, the AMA wants doctors to tell patients in the privacy of the consulting room about their relationship with medicine companies.
In the same way that doctors are required to disclose to patients their interest in a hospital to which they refer them, they should tell them of their links with medicine companies, he said.
http://www.theaustralian.com.au/news/nation/doctors-on-the-spot-to-reveal-pharma-junkets/story-e6frg6nf-1226449605658
a person can be prosecuted for gross negligence for recommending surgery that should not have been recommended
Although perhaps strained, the upshot of the decision is that it is now clear beyond doubt that a person can be prosecuted for gross negligence for recommending surgery that should not have been recommended, even if the surgery was itself carried out competently.
http://theconversation.edu.au/high-court-orders-a-retrial-after-upholding-jayant-patels-appeal-8971
Another case of disabled thermoregulation and heatstroke following sympathectomy
We describe an extreme case of compensatory truncal hyper- hidrosis and anhidrosis over the head and neck region which led to a heatstroke.
Six months after the initial operation, he had an episode of heatstroke while perform- ing outdoor duties which required running for around 5 km. The temperature on the day was between 30–32°C, and the relative humidity was between 75 and 85%. At that time, he complained of light-headedness, ‘feeling’ that heat could not dissipate from his head and neck region and muscle cramp in his legs. He was transferred to a hospital and was found to have a body tem- perature of 40°C and shock. His presentation was similar to a previous report by Sihoe et al. [1] on a patient with post- sympathectomy heatstroke. He was subsequently successfully treated with fluid and electrolyte resuscitation and supportive care.
Interactive CardioVascular and Thoracic Surgery 14 (2012) 350–352
69% of patients continued to have relief after ETS, patient satisfaction rate was 56%
There were no operative mortalities, minor complications occurred in 22%. Initial success rate was 88%. Median follow up was 93 (24-168) months, response rate to the questionnaire was 85%. Sixty-nine per cent of patients continued to have relief of initial symptoms, whereas patient satisfaction rate was 56%. CS was present in 42 patients (68%). Long-term satisfaction rates per initial indication group were 42% for facial blushing and 65% for hyperhidrosis (n.s.), and CS was present in 79% vs 61%, respectively.
CONCLUSION:
ETS appears a safe treatment for upper limb hyperhydrosis with acceptable long-term results. For excessive blushing, however, long-term satifaction rates of ETS are severely hampered by a high incidence of disturbing compensatory sweating. ETS should only be indicated in patients with unbearable symptoms refractory to non-surgical treatment. The patient information must include the long-term substantial risk for sever CS and regret of the procedure.
Doctor-Patient Disagreements Over Informed Consent Can Lead To Litigation
http://www.medicalnewstoday.com/releases/248775.php
surgeon guilty of maliciously inflicting grievous bodily harm
http://www.smh.com.au/nsw/genital-mutilation-sentence-manifestly-inadequate-court-told-20120813-24439.html
"sympathectomy highlighted the disparity between what is known in practice and what appears in the literature"
The March 2004 edition was quite outstanding, with an excellent editorial reminding the reader that only good results are published. The review on thoracoscopic sympathectomy highlighted the disparity between what is known in practice and what appears in the literature.
‘Know Your Results’, the topic of the ASGBI Annual Scientific Meeting, is of outstanding importance; what is more, the surgeon has to go on knowing his/her results to ensure standards of practice do not slip.
The Journal appreciates comments and criticism and the correspondence column remains a crucial part of the BJS in its interaction between editors and reader. It is also part of the scientific process.
A more robust and incisive criticism of articles known to be flawed would prevent the retractions that have recently been published in the Lancet.
Christopher Russell, Chairman, BJS Society
Association of Surgeons of Great Britain and Ireland, ANNUAL REPORT 2004
what should be done to better regulate a controversial private industry that is often accused of exploiting vulnerable people
The government has launched a review into cosmetic surgery following the breast implant scandal, which could lead to tighter controls over advertising and the way private clinics operate.
Sir Bruce Keogh, medical director of the NHS, is leading the review at the request of Health Secretary Andrew Lansley. Professor Keogh is calling for the public to share their own experiences and give their opinions on what should be done to better regulate a controversial private industry that is often accused of exploiting vulnerable people.
"Many questions have been raised, particularly around the regulation of clinics, whether all practitioners are adequately qualified, how well people are advised when money is changing hands, aggressive marketing techniques, and what protection is available when things go wrong.
"I am concerned that too many people do not realise how serious cosmetic surgery is and do not consider the life-long implications – and potential complications – it can have."
"My fear is that there is a political resistance to introducing any form of statutory regulation," said Walsh whose organisation has since helped patients who have suffered harm as a result of those procedures. "It has become somewhat politically incorrect to introduce regulation. That ideology in our opinion seems to have trumped patient safety in a number of cases."
Publications authored by prolific ETS surgeons should be carefully examined and compared
Ann Thorac Surg. 2004 Sep;78(3):10525.
Selective division of T3 rami communicantes (T3 ramicotomy) in the treatment of palmar hyperhidrosis.
Lee DY, Kim DH, Paik HC.
Respiratory Center, Department of Thoracic and Cardiovascular Surgery, Yongdong Severance Hospital, Yonsei
Respiratory Center, Department of Thoracic and Cardiovascular Surgery, Yongdong Severance Hospital, Yonsei
University College of Medicine, Seoul, People's Republic of China. dylee@yumc.yonsei.ac.kr
Abstract
BACKGROUND: Compensatory sweating (CS) is the main cause of a patient's dissatisfaction after sympathetic surgery for palmar hyperhidrosis.Preservation of the sympathetic nerve trunk and limitations on the range of dissection are necessary to reduce CS.
METHODS: We compared 64 patients (31 male, 33 female) (group 1) who underwent a T2 sympathicotomy between July 1998 and February 1999 and 83 patients (58 male, 25 female) (group 2) who underwent a T3 ramicotomy between August 2000 and December 2002.
RESULTS: In group 1, 60 patients (93.8%) exhibited a decreased sweating on both hands, but 4 patients (6.2%) exhibited a persistent sweating on both hands. For group 2, 58 patients (69.9%) experienced a decreased sweating on both hands, 15 patients (18.1%) experienced a persistent sweating on both hands, and 10 patients (12.0%) experienced a persistent sweating on one hand. The grade of CS in group 2 was significantly lower than in group 1 (p < 0.001) and, notably, the rate of embarrassing and disabling CS in group 2 (15.5% [9 out of 58]) was significantly lower than in group 1 (43.3% [26 out of 60], p value < 0.001). The rate of satisfaction was 78.1% (50 out of 64) for group 1 and 68.6% (57 out of 83) for group 2 with no significant statistical difference indicated (p = 0.202).
CONCLUSIONS: The incidence of sweating postoperatively was relatively high in the T3 ramicotomy group, although the T3 surgery did result in a lower incidence of CS when compared with a T2 sympathicotomy.
PMID: 15337046 [PubMed indexed for MEDLINE]
Publication Types, MeSH Terms LinkOut more resources
II.
Surg Today. 2012 Jul 15. [Epub ahead of print]
A comparison between two types of limited sympathetic surgery for palmar hyperhidrosis.
Hwang JJ, Kim DH, Hong YJ, Lee DY.
Department of Thoracic and Cardiovascular Surgery, Eulji University Hospital, Daejeon, Korea.
Department of Thoracic and Cardiovascular Surgery, Eulji University Hospital, Daejeon, Korea.
Abstract
PURPOSE: Endoscopic thoracic sympathetic surgery is effective for treating palmar hyperhidrosis, although compensatory sweating (CS) is a significant and annoying side effect. The purpose of this study was to compare the results of limited resection at two different locations.
METHODS: From May 2004 to June 2009, T3 sympathicotomy (group I) was performed in 46 patients and T3,4 ramicotomy (group II) was performed in 43 patients during the same period. T3 sympathicotomy (group I) and T3,4 ramicotomy (group II) were performed during the same period. Using questionnaires, completed by the patients, the satisfaction rates and grades of CS were analyzed.
RESULTS: No significant differences in age distribution or sex ratios were observed between the two groups. The satisfaction rate was 91.3 % in group I and 79.1 % in group II. The operation time was 19.8 (±6.6) min (sic!) in group I, and 51.6 (±18.8) min in group II, showing a statistically significant difference (p < 0.002). The incidence of persistent hand sweating in group II (16.3 %) was higher than that observed in group I (2.2 %). The incidence of compensatory sweating on the lower extremities was higher in group II (37.2 %) than in group I (10.9 %).
CONCLUSIONS: Although ramicotomy is considered to be an effective method for treating hyperhidrosis and has a theoretical advantage of allowing greater anatomical resection, it requires longer operation time and induces more severe compensatory sweating in the lower limbs resulting in reduced satisfaction rates.
PMID: 22798011 [PubMed as supplied by publisher]
major defects in the current complaint handling system
“Products cannot be marketed as'BRAND headache', ‘BRAND backache’, ‘BRAND joint pain’ if they include the same active ingredients in the same quantity.”
Accordingly, I have now submitted a complaint to the CRP, TGA and ACCC alleging that the current promotion of Nurofen by Reckitt Benckiser (Australia) Pty Ltd is in breach of the Competition and Consumer Act 2010 (misleading and deceptive conduct) and also a number of sections of the Therapeutic Goods Advertising Code (2007).
Finally, I believe this case shows up major defects in the current complaint handling system. Sponsors can disagree with the independent CRP determination and continue to promote while the problem is referred to the TGA. TGA regulation 9 determinations are slow (and in this case legalistic and missing the wood by focusing on a tree); meanwhile promotion continues. The sponsor can advise they have complied (using a strict legalistic interpretation of words) but in fact, questionable promotion continues.
It is my view that promotion should cease once a CRP determination has been made and until such time as any review has exonerated the claims made. The current system is heavily weighted in favour of the sponsor and provides consumers with little protection.
http://theconversation.edu.au/tga-failure-gives-nurofen-consumers-a-headache-8762
"this wasn’t just error, but it was intent” by the doctors
Hospital Chain Inquiry Cited Unnecessary Cardiac Work
But the nurse’s complaint was far from the only evidence that unnecessary — even dangerous — procedures were taking place at some HCA hospitals, driving up costs and increasing profits.
HCA, the largest for-profit hospital chain in the United States with 163 facilities, had uncovered evidence as far back as 2002 and as recently as late 2010 showing that some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing. Those hospitals included the Cedars Medical Center in Miami, which the company no longer owns, and the Regional Medical Center Bayonet Point. In some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary, according to internal reports.
http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html?_r=2
Demand for sanctions on alternative therapists
PUBLIC health leaders have called for tougher and more consistent regulation of unregistered alternative therapy providers but appeared split on whether more pre-emptive policing is needed to protect sometimes desperate and vulnerable consumers.
Former University of NSW head of medicine and founder of Friends of Science in Medicine, Emeritus Professor John Dwyer, called for state-based regulators and the national registration body AHPRA to actively seek out unregistered practitioners who may be promising results without scientific support.
“All of [the regulators] work on an ‘after the event’ protocol,” Professor Dwyer said.
“They’re not out there looking to see what rubbish is on the net and moving in to say, ‘Hey, you’re making this claim, you can’t’,” he said.
“[Australia needs] consumer protection that says if you are charging money for a health service and you have no credibility and no credentials, that’s illegal… and there should be very heavy penalties for it.”
http://www.medicalobserver.com.au/news/demand-for-sanctions-on-alternative-therapists
The statistics about errors in medical reasoning are sobering
The statistics about errors in medical reasoning are sobering. The correct diagnosis is missed or delayed in up to 14% of acute admissions (J Gen Intern Med 2005; 20: 334-339). If the diagnosis is correct, up to 43% of patients do not receive recommended care (doi: 10.5694/mja12.10510), and about $800 billion — nearly one-third of all health care spending — is wasted on unnecessary diagnostic tests, procedures and extra days in hospital (http://www.reuters.com/article/2012/02/16/us-overtreatment-idUSTRE81F0UF20120216). Wilson and colleague’s landmark analysis of the cause of adverse events in the Australian health care system reported that almost half of reported adverse events involved errors of reasoning (MJA 1999; 170: 411-415).
Med J Aust 2012; 197 (3): 129.
Med J Aust 2012; 197 (3): 129.
Bitter pills - The Australian May 17, 2008
Suspecting the drugs she was taking were the cause, Kohout resolved to get off them and discovered two things she had not anticipated. One was that she couldn’t function without them. The second was that her doctors refused to help her.
Scaling down is a tortuously slow process, made more difficult by the fact that her psychiatrist earlier this year abandoned her, insisting she needed to spend the rest of her life medicated.
“He told me that if I tried to stop, he couldn’t continue to be my doctor,” she recalls. “His last words to me were: ‘In my opinion, you’re on a path to self-destruction.’”
Katrina Stott, a nurse whose job it is to review the medications taken by these patients, says 60 per cent of patients aged over 70 arrive at the hospital because of a drug issue. “If you look at these patients, quite often they will take one tablet for a medical condition and another tablet to counteract the first tablet’s side-effects,” says Stott.
At Fairfield Hospital, Stott once encountered an 82-year-old woman who took 34 medications daily and another 15 over-the-counter drugs as needed. “She came in with nausea and vomiting,” recalls the nurse. “She wasn’t eating, which is hardly surprising.” The blood-thinning drug Warfarin, Stott notes, has prolonged the lives of thousands of old people, but it’s also a rat poison that reacts so unpredictably with common drugs and foods that bruising and even haemorrhaging can result.
Dr Jay Ramanathan, a GP who works with Stott, says simply: “It’s a perverse thought, but at times you wonder how people survive despite their treatment.”
The severe side-effects and withdrawal symptoms associated with long-term benzodiazepine use are chronicled in standard medical texts, on websites and in books such as Benzo Junkie, by Australian writer Beatrice Faust. Antidepressants at high doses, meanwhile, can cause a serotonin imbalance, which triggers fever, agitation and muscle rigidity. Kohout does not recall ever being told about these issues by the psychiatrist, and her husband was shocked to find out about them when he came across the benzo.org.uk website in early 2006.
“We saw so many doctors who knew amazingly little about these substances,” says Johnson. “And these are people who prescribe them, for God’s sake. She’d been assured by the psychiatrist it was safe for her to take these drugs in the way he’d prescribed, and she was meticulous about following his advice.”
Recovering in hospital, Kohout for the first time received encouragement when a nurse and a consultant psychiatrist quietly advised her to continue reducing her drug load, albeit more slowly. But the hospital psychiatrist could not take her on as a private patient and Kohout found herself in a medical twilight zone: she needed a doctor to continue prescribing the drugs, but her GP refused to manage her withdrawal and referred her to a new psychiatrist, who refused to countenance the idea of her stopping the drugs.
“He argued with me all the way. He kept saying it was unknown for someone who has been on these kinds of drugs for as long as I had to come off them. He said I had a chemical imbalance in the brain and he went through the whole story I’d heard a thousand times before about how it was evident from my family history that it was genetic.” Having already consulted at least a dozen doctors of one kind or another, Kohout felt her only option was to endure the psychiatrist’s criticisms and continue withdrawing with the help of a naturopath and whatever advice she could glean from the internet.
Over the course of 2007 her white blood cell count dropped and she developed kidney stones, dehydration and gastric ulcers; she suffered constant abdominal upsets and required surgery to remove a lesion on her cornea – a listed side-effect of fluoxetine. In January her psychiatrist told Kohout he no longer wanted her as a patient because without drugs she was headed for “self-destruction”. By then, however, she was already beginning to regain a measure of her old clarity and strength. After consulting Reconnexion, a self-help group specialising in benzodiazepine dependence, she was referred to a GP, Dr John Walters, who agreed to help with her withdrawal.
Asked if the drugs she was prescribed might have had a toxic effect, Dr Walters replies: “They would probably be toxic to anyone. If someone gave you one daily dose of what Jana was on – even now, but certainly at the peak of her drug-taking – you would probably be laid out for a few days.”
“There is something terribly wrong with the culture of doctors and our medical services,” he says. “Jana has found relief with naturopathy and Chinese medicine, where the practitioner is prepared to spend time talking to the person and genuinely trying to find relief for them. It took her nearly nine years to find a GP willing to do this. She’s stronger now than she was six months ago; she looks better and she’s herself again. Whereas for years she was just going backwards. This illness has been a terrible test of her – and it was all because she was such a good patient.”
Staff writer Richard Guilliatt’s previous story was “Why kids hate Australian history” (February 23-24).
http://www.theaustralian.com.au/news/features/bitter-pills/story-e6frg8h6-1111116357589
Scaling down is a tortuously slow process, made more difficult by the fact that her psychiatrist earlier this year abandoned her, insisting she needed to spend the rest of her life medicated.
“He told me that if I tried to stop, he couldn’t continue to be my doctor,” she recalls. “His last words to me were: ‘In my opinion, you’re on a path to self-destruction.’”
Katrina Stott, a nurse whose job it is to review the medications taken by these patients, says 60 per cent of patients aged over 70 arrive at the hospital because of a drug issue. “If you look at these patients, quite often they will take one tablet for a medical condition and another tablet to counteract the first tablet’s side-effects,” says Stott.
At Fairfield Hospital, Stott once encountered an 82-year-old woman who took 34 medications daily and another 15 over-the-counter drugs as needed. “She came in with nausea and vomiting,” recalls the nurse. “She wasn’t eating, which is hardly surprising.” The blood-thinning drug Warfarin, Stott notes, has prolonged the lives of thousands of old people, but it’s also a rat poison that reacts so unpredictably with common drugs and foods that bruising and even haemorrhaging can result.
Dr Jay Ramanathan, a GP who works with Stott, says simply: “It’s a perverse thought, but at times you wonder how people survive despite their treatment.”
The severe side-effects and withdrawal symptoms associated with long-term benzodiazepine use are chronicled in standard medical texts, on websites and in books such as Benzo Junkie, by Australian writer Beatrice Faust. Antidepressants at high doses, meanwhile, can cause a serotonin imbalance, which triggers fever, agitation and muscle rigidity. Kohout does not recall ever being told about these issues by the psychiatrist, and her husband was shocked to find out about them when he came across the benzo.org.uk website in early 2006.
“We saw so many doctors who knew amazingly little about these substances,” says Johnson. “And these are people who prescribe them, for God’s sake. She’d been assured by the psychiatrist it was safe for her to take these drugs in the way he’d prescribed, and she was meticulous about following his advice.”
Recovering in hospital, Kohout for the first time received encouragement when a nurse and a consultant psychiatrist quietly advised her to continue reducing her drug load, albeit more slowly. But the hospital psychiatrist could not take her on as a private patient and Kohout found herself in a medical twilight zone: she needed a doctor to continue prescribing the drugs, but her GP refused to manage her withdrawal and referred her to a new psychiatrist, who refused to countenance the idea of her stopping the drugs.
“He argued with me all the way. He kept saying it was unknown for someone who has been on these kinds of drugs for as long as I had to come off them. He said I had a chemical imbalance in the brain and he went through the whole story I’d heard a thousand times before about how it was evident from my family history that it was genetic.” Having already consulted at least a dozen doctors of one kind or another, Kohout felt her only option was to endure the psychiatrist’s criticisms and continue withdrawing with the help of a naturopath and whatever advice she could glean from the internet.
Over the course of 2007 her white blood cell count dropped and she developed kidney stones, dehydration and gastric ulcers; she suffered constant abdominal upsets and required surgery to remove a lesion on her cornea – a listed side-effect of fluoxetine. In January her psychiatrist told Kohout he no longer wanted her as a patient because without drugs she was headed for “self-destruction”. By then, however, she was already beginning to regain a measure of her old clarity and strength. After consulting Reconnexion, a self-help group specialising in benzodiazepine dependence, she was referred to a GP, Dr John Walters, who agreed to help with her withdrawal.
Asked if the drugs she was prescribed might have had a toxic effect, Dr Walters replies: “They would probably be toxic to anyone. If someone gave you one daily dose of what Jana was on – even now, but certainly at the peak of her drug-taking – you would probably be laid out for a few days.”
“There is something terribly wrong with the culture of doctors and our medical services,” he says. “Jana has found relief with naturopathy and Chinese medicine, where the practitioner is prepared to spend time talking to the person and genuinely trying to find relief for them. It took her nearly nine years to find a GP willing to do this. She’s stronger now than she was six months ago; she looks better and she’s herself again. Whereas for years she was just going backwards. This illness has been a terrible test of her – and it was all because she was such a good patient.”
Staff writer Richard Guilliatt’s previous story was “Why kids hate Australian history” (February 23-24).
http://www.theaustralian.com.au/news/features/bitter-pills/story-e6frg8h6-1111116357589
deaths after surgery account for up to one in five people who die in hospital each year
http://www.smh.com.au/national/health/shame-private-hospitals-over-deaths-say-surgeons-20120728-232vq.html
Anthem medical policy for ETS surgery
- Presence of medical complications or skin maceration with secondary infection; or
- Significant functional impairment, as documented in the medical record.
Botulinum toxin is considered medically necessary in the treatment of secondary hyperhidrosis when the condition is related to surgical complications and both of the following criteria are met:
- Presence of medical complications or skin maceration with secondary infection; and
- Significant functional impairment, as documented in the medical record.
Treatment of primary axillary or palmar hyperhidrosis with endoscopic thoracic sympathectomy is consideredmedically necessary in the small subset of individuals with hyperhidrosis where both of the following criteria (1 and 2) have been met:
- It has been adequately documented that all efforts at nonsurgical therapy have failed; and
- Either of the following:
- Presence of medical complications or skin maceration with secondary infection; or
- Significant functional impairment, as documented in the medical records;
http://www.anthem.com/medicalpolicies/policies/mp_pw_a050005.htm
Subscribe to:
Posts (Atom)