financial interests may unduly influence professionals’ judgments

widespread relationships with industry have created significant risks that… financial interests may unduly influence professionals’ judgments.

“conflicts of interest” threaten the integrity of research, the objectivity of education, the quality of patient care, and public trust in medicine.

Conflict of Interest in Medical Research, Education, and Practice

Released:

April 21, 2009

Type:

Consensus Report

Topics:

Biomedical and Health Research, Education

Activity:

Conflict of Interest in Medical Research, Education, and Practice

Board:

Board on Health Sciences Policy

Trials of skin cancer drug DZ13 suspended pending investigation at UNSW

http://www.abc.net.au/news/2013-08-12/trials-of-skin-cancer-drug-dz13-suspended-amid-misconduct-claims/4881622

the Australian and New Zealand Clinical Trials Registry will not be signing up

A GLOBAL campaign to publish all clinical trial results within a year of trial registration has been ramped up, but the Australian and New Zealand Clinical Trials Registry will not be signing up — at least, not yet.

Organisations already signed up include the UK Medical Research Council, the Cochrane Collaboration and the World Association of Medical Editors.
MJA InSight Cate Swannell

Monday, 12 August, 2013

Endoscopic sympathectomy is not minimally invasive - doing the operation through a smaller incision is not necessarily less invasive

The term ‘‘minimally invasive surgery’’ was initially applied to coelioscopic procedures such as laparoscopic cholecystectomy and hernia repair, thoracoscopic sympathectomy, and arthroscopy, but has since been abandoned, because doing the same operation through a smaller incision is not necessarily less invasive. The term ‘‘minimally invasive parathyroidectomy’’ does not fully convey the nature of the techniques, and, as previously debated in the wider field of minimal-access surgery, carries connotations of increased safety that are not necessarily supported by the existing data [12].

Surg Clin N Am 84 (2004) 717–734

F. Fausto Palazzo, MS, FRCS(Gen),
Leigh W. Delbridge, MD, FACS*

Department of Surgery, Royal North Shore Hospital, Sydney 2065, NSW, Australia

Our review supports the conclusion that antidepressants generally do more harm than good by disrupting a number of adaptive processes regulated by serotonin

"Our review supports the conclusion that antidepressants generally do more harm than good by disrupting a number of adaptive processes regulated by serotonin. However, there may be specific conditions for which their use is warranted (e.g., cancer, recover y from stroke). We conclude that altered informed consent practices 
and greater caution in the prescription of antidepressants are warranted. "

www.frontiersin.org

April 2012 | Volume 3 | Article 117 | 1 
Primum non nocere: an evolutionary analysis of whether antidepressants do more harm than good

WHO recommends Tamiflu, but has not vetted the Tamiflu data

The bottom line:

• WHO recommends Tamiflu, but has not vetted the Tamiflu data.
• EMA approved Tamiflu, but did not review the full Tamiflu dataset.
• CDC and ECDC encourage the use and stockpiling of Tamiflu, but did not vet the Tamiflu data.
• The majority of Roche's Phase III treatment trials remain unpublished over a decade after completion.
• In Dec 2009, Roche publicly promised independent scientists access to "full study reports" for selected Tamiflu trials, but to date the company has not made even one full report available.
• http://www.bmj.com/tamiflu

The Naked Doctor: an indepth look at the pitfalls of “cutting edge” medicine | Croakey

The Naked Doctor: an indepth look at the pitfalls of “cutting edge” medicine | Croakey: "People don’t understand tiny chances. I have more chance of being dead next Saturday than being both alive and collecting my winnings.

Studies consistently show that both doctors and patients, just like gamblers and stockbrokers, overestimate gains and underestimate losses."

'via Blog this'

Doctor Skeptic: Evidence for bias

Doctor Skeptic: Evidence for bias: "My thesis is that the effectiveness of medical interventions is overestimated and that the harms are underestimated; that the perception of medicine is rosier than the reality. The reason for this is multifactorial, but an important contributor to this effect is bias in the scientific record: the 'literature'."

Big pharma mobilising patients in battle over drugs trials data | Business | The Guardian

Big pharma mobilising patients in battle over drugs trials data | Business | The Guardian:
"The pharmaceutical industry has "mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.

Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies' claims about the safety and efficacy of drugs.

Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects."

PLOS Medicine: Why Most Published Research Findings Are False

PLOS Medicine: Why Most Published Research Findings Are False: "There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research."

Patient awoke to doctors mistakenly preparing to remove her organs

Patient awoke to doctors mistakenly preparing to remove her organs - Yahoo!7: "A report from the American Association for Justice claims that preventable medical errors are the sixth largest cause of death in the U.S."

Medical mistakes: A silent epidemic in Australian hospitals

ABC Radio “The World Today” 10 June 2013

http://www.abc.net.au/worldtoday/content/2013/s3778256.htm

Medical care is 3rd leading cause of death in U.S.

http://chriskresser.com/medical-care-is-the-3rd-leading-cause-of-death-in-the-us

we stopped performing sympathectomies in 1994, since we were alarmed by the complication and failure rate

Physical  medicine
Russell,  Alan  L.  Patient  Care 13.2  (Feb  2002):  19. 

Pharma payments to doctors stay behind closed doors ... for now

Pharma payments to doctors stay behind closed doors ... for now: "Patients will remain in the dark about whether their treating doctors receive payments from pharmaceutical companies that could influence prescribing habits, after a bill aimed at increasing transparency ground to a halt on Monday. The payments may be indirect (though conference sponsorship or funds to travel to or attend conferences) or direct (though consultation fees).

The Senate Finance and Public Administration Legislation Committee rejected the bill, agreeing with government, industry and the Australian Medical Association (AMA) that self-regulation is the preferred approach."

why do processes intended to prevent or reduce bias fail? Why we can’t trust clinical guidelines?

“On 13 April 1990, in an unprecedented action, the US National Institutes of Health faxed a letter to every physician in the US on how to correctly prescribe a breakthrough treatment for acute spinal cord injury. Many neurosurgeons were sceptical of the evidence that lay behind the new recommendation to give high dose steroids, yet when two respected organisations released a review and a guideline recommending the treatment, they felt obliged to give it. Now, over two decades later, new guidelines warn against the serious harms of high dose steroids. This case and others like it point to the ethical difficulties that doctors face when biased guidelines are promoted and raise the question: why do processes intended to prevent or reduce bias fail?"

http://www.bmj.com/content/346/bmj.f3830

http://ehln.org/?p=29917#sthash.93DXaLjH.dpbs

Surgery death rate 'twice as high as thought'

Twice as many people die after surgery in NHS hospitals as previously thought, according to a new report that finds serious shortcomings in the way many patients are treated.

http://www.telegraph.co.uk/health/healthnews/9556035/Surgery-death-rate-twice-as-high-as-thought.html

deep-brain stimulation (DBS) treatment compromises a person’s decision-making competence

“In a recent article in this journal, Felicitas Kraemer discusses a case in which deep-brain stimulation (DBS) treatment compromises a person’s decision-making competence but reduces feelings of alienation.1 She proposes that, since the patient may find these two conditions mutually exclusive options, this generates a potential conflict between a patient’s ‘autonomy’—understood as competence—and their ‘authenticity’. Against this I shall argue that ‘competence’ and ‘authenticity’ are conditions necessary to a satisfactory analysis of autonomy; Kraemer’s observation that the two may conflict thus renders problematic interpretations of respect for autonomy that rely solely on the former. Integrating the importance of competence and authenticity conditions into respect requires that we move beyond the simple doctrine of non-interference with a patient’s decisions to the more sensitive approaches advocated by some theorists of relational autonomy."
http://jme.bmj.com/content/early/2013/05/21/medethics-2013-101419.full

21% of seniors on risky meds; more in U.S. South | Brown University News and Events

21% of seniors on risky meds; more in U.S. South | Brown University News and Events: "PROVIDENCE, R.I. [Brown University] — More than one in five seniors with Medicare Advantage plans received a prescription for a potentially harmful “high-risk medication” in 2009, according to an analysis by Brown University public health researchers. The questionable prescriptions were significantly more common in the Southeast United States, as well as among women and people living in relatively poor areas.

The demographic trends in the analysis, based on Medicare data from more than 6 million patients, suggest that differences in the rates of prescription of about 110 medications deemed risky for the elderly cannot be explained merely by the individual circumstances of patients, said lead author Danya Qato, a pharmacist and doctoral candidate in health services research at Brown."

Italian court rules MMR vaccine did trigger autism

Italian court rules MMR vaccine did trigger autism: "In what may be a ground-breaking decision, the Italian Court of Rimini has ruled that causation between an MMR vaccine and the resulting autism in a young child “has been established.”

The unnamed child received the vaccine in March of 2004 and on returning home immediately developed adverse symptoms. During the next year the child regressed, receiving the autism diagnosis one year later and is now 100% disabled by the disease.

The Italian court ruled that the child “has been damaged by irreversible complications due to vaccination (prophylaxis trivalent MMR)” and ordered the Ministry of Health to compensate the child with a 15 year annuity and to reimburse the parents of their court cost."

Consumers lose out as TGA reform turns into a hot potato

Consumers lose out as TGA reform turns into a hot potato: "We do need to fix the TGA and the regulation of health products (drugs, devices and “supplements”). The cost of regulatory incapacity – lack of coherent legislation, capture by stakeholders, lack of expertise, unwillingness to take action – significantly outweighs both the TGA’s and the ACCC’s budgets."

'via Blog this'

Consumers lose out as TGA reform turns into a hot potato

Consumers lose out as TGA reform turns into a hot potato: "Let’s look first at regulatory incapacity, specifically the Therapeutic Goods Administration (TGA) – the national pharmaceuticals and medical devices regulator. It’s an agency that’s too important to abolish; we can’t start again from scratch.

Unfortunately, it’s not performing very well – resulting in both serious harm to thousands of Australians and a burden to the taxpayer many times greater than its budget. When the TGA fails, you pay the price through increased public health costs and lower national productivity. And it’s immune from legal action over that failure.

Recent examples of its incapacity are failures regarding breast implants and hip implants. The government has responded with a bill that, in part, is an admission of defeat."

'Deceitful' Big Pharma accused of putting lives at risk

'Deceitful' Big Pharma accused of putting lives at risk: "Patients are being deceived into taking drugs they don't need, that don't work or may put lives at risk, according to a scathing review of the influence big drug companies have on healthcare.

Drug companies ''masterfully influenced'' medicine, a joint review by Australian, British and US researchers has found, describing how the enormous profit involved in making and selling drugs gave the industry power to influence every stage of the health system.

''As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed,'' their research, published in the European Journal of Clinical Investigation, found.

A co-author of the paper, Emmanuel Stamatakis, from the University of Sydney's school of public health, said it was ''entirely illogical'' to rely on the pharmaceutical industry to fund medical research."

Victims of faulty breast implants were let down by the TGA

Victims of faulty breast implants were let down by the TGA: "The announcement this week by plaintiff law firm Tindall Gask Bentley that it was abandoning a class action against the Australian distributors of Poly Implant Prosthese (PIP) breast implants illustrates critical defects in Australia’s regulatory framework for medical devices.

For five of the eight years that Medical Vision Australia Pty Ltd (MVA) was the sole Australian distributor of PIP implants, it apparently had no product liability insurance. The company is now in liquidation. There is no point in pursuing MVA, because there simply won’t be sufficient assets to compensate victims. The French manufacturer is facing criminal prosecution, and is also bankrupt."

Report recommends Qld doctors face criminal probe - ABC News (Australian Broadcasting Corporation)

Report recommends Qld doctors face criminal probe - ABC News (Australian Broadcasting Corporation): "A former medical board investigator says a report recommending criminal charges be considered against six Queensland doctors should go further.

The report is the result of an investigation lead by former Fitzgerald inquiry prosecutor and Brisbane barrister Jeff Hunter.

Mr Hunter was hired by the State Government following whistleblower complaints last year, and asked to determine if charges should be laid against doctors who were disciplined over the deaths or harming of their patients.

The ABC has obtained a copy of the report, which recommends six doctors be referred to police for possible criminal charges involving 23 cases.

But whistleblower and former investigator for the Medical Board of Queensland, Jo Barber, says that figure should be closer to 100.

"I am very surprised that they have only chosen to look at six doctors," she said.

"I worked at the medical board and I am familiar with the files there and there are many, many more than six doctors that should be investigated for criminal offences."

'via Blog this'

Six Queensland doctors face criminal charges over harm or death to their patients | The Australian

Six Queensland doctors face criminal charges over harm or death to their patients | The Australian: "SIX Queensland doctors have been referred to police and risk facing criminal charges over the harm or death of their patients.

Health minister Lawrence Springborg says up to 11 medical bungles had been attributed to one practitioner.

The potential police action was one of four recommendations in a report from top criminal law specialist and former crown prosecutor Jeffrey Hunter SC into allegations of medical malpractice by Queensland doctors.

That report was sparked by former medical board investigator turned whistleblower Jo Barber, who lifted the lid on the issue last year.

Mr Springborg says incidents in the report were from public and private hospitals and private clinics from across the state.

It will prompt law changes to alter the way medical malpractice claims are handled in the future, he says."

'via Blog this'

serious crimes committed by QLD doctors and then covered up by our oversight authorites

Vindicated CMC Messenger and Critic to attend PCMC public inquiry: ""This PCMC enquiry has obviously uncovered a culture of corruption and/or dysfunction within the CMC. It has vindicated Jo Barber’s and my public warning issued last year about corruption and/or dysfunction in the CMC ” said Mr Messenger.

It’s now up to Premier Newman to release the findings of the final CMC reports (Mr Hunter SC)  ordered by former Judge Richard Chesterman and prompted by Ms Barber’s public interest disclosures to the crime watchdog over a year ago. The Hunter report could expose serious crimes committed by QLD doctors and then covered up by our oversight authorites including the CMC, QLD Health and AHPRA.

The release of the Hunter report could further vindicate Ms Barber and my actions, better protect QLD patients and bring criminal doctors to justice. Premier Newman who launched an extraordinary personal attack on me on SKY TV a year ago - http://www.youtube.com/watch?v=3OnjH5afz3U  regarding this matter, must now give a guarantee, that the Hunter SC report’s release is not being delayed for political reasons linked to the upcoming federal election campaign in Hinkler.”"

'via Blog this'

Trouble in the Gap: A Bioethical and Sociological Analysis of Informed Consent for High-Risk Medical Procedures - Springer

Trouble in the Gap: A Bioethical and Sociological Analysis of Informed Consent for High-Risk Medical Procedures - Springer: "we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness."

Why the TGA should make it harder for people to get Xanax

Why the TGA should make it harder for people to get Xanax: "This class of drug poses significant risks of misuse and dependence, paradoxical reactions, disinhibition, amnesia and intoxication"

parabens, ''endocrine disruptors'' in 'personal care' products linked to cancers

But while most of the concern about parabens has focused on their possible effects on breasts, emerging research suggests they might affect sperm, too. A 2010 study of men attending a US fertility clinic found a link between levels of parabens and DNA damage - although it's early days and more studies need to be done. Still, some companies have withdrawn parabens from their products and ''paraben-free'' is now appearing on many packages.

In 2011, Denmark prohibited their use in personal care products for children under three, says Dr Mariann Lloyd-Smith, senior adviser to the community environmental organisation the National Toxics Network.

But, as she points out, parabens are just one of many chemicals in our environment that come under the heading of ''endocrine disruptors'', meaning they're capable of affecting our hormones.

''Most of these chemicals have never been assessed,'' Lloyd-Smith says. ''You have governments still struggling to understand the effects of single chemicals - so how can we know what the effect of a mixture of these chemicals might be on human health?

''Even if the oestrogenic effect of parabens is mild, you'd think that would be enough to say, 'Why take this risk when you can make cosmetics without them?'''

Lloyd-Smith isn't a lone voice. In February, the World Health Organisation released a report, State of the Science of Endocrine Disrupting Chemicals, which didn't mince words on the subject of potential harm from endocrine disruptors.

Rates of hormone-related cancers, including breast, ovarian, testicular, endometrial and prostate cancer, have risen worldwide over the past 50 years, yet of the almost 800 chemicals known to be capable of interfering with human hormones, or suspected of doing so, only a small fraction has been investigated, the report says.
Parabens, 'endocrine disruptors' in personal care products linked to cancers

Ethiopian women in Israel 'given contraceptive without consent'

Ethiopian women in Israel 'given contraceptive without consent' | World news | guardian.co.uk: "Israel's health ministry is investigating claims that Ethiopian women are being injected with a controversial contraceptive without their knowledge or consent.

Thousands of Ethiopian women are said to be receiving shots of Depo-Provera every three months in Israeli clinics. The contraceptive stops menstruation and has been linked to fertility problems and osteoporosis.

Yaakov Litzman, Israel's deputy minister of health, who has previously denied the practice, will lead the inquiry, a spokesperson announced on Wednesday.

The phenomenon was uncovered when social workers noticed the birth rate among Ethiopian immigrants halving in a decade. An Israeli documentary investigating the scandal was aired in December and prompted a popular outcry."

'via Blog this'

“Questioning the status quo in medicine is not easy,” Dr Harlan Krumholz, of Yale School of Medicine

BioEdge: Doctors slow to blow whistle: "A lawsuit against the medical products giant Johnson & Johnson has raised questions about doctors’ willingness to warn colleagues and patients about bad drugs or devices. According to the New York Times, memos brought as evidence in the first of 10,000 lawsuits over a faulty hip replacement show that doctors were very reluctant to be whistleblowers.

“Questioning the status quo in medicine is not easy,” Dr Harlan Krumholz, of Yale School of Medicine, told the NYT. Doctors also shy away from the work of reporting errors and failures. “The Food and Drug Administration relies on physicians to help monitor product safety by alerting the agency to adverse patient reactions, doctors usually do not make such filings, saying they are too busy for the paperwork,” says the NYT.

Financial ties also influence doctors.  “If someone has been paying you or employing you, it is very difficult to blow the whistle,” said Professor George Loewenstein, of Carnegie-Mellon University. “It offends our sense of loyalty.”"

Researchers call for Voltaren, other diclofenac drugs to be pulled from world markets

Researchers call for Voltaren, other diclofenac drugs to be pulled from world markets: "The painkiller diclofenac, sold as Voltaren, should be pulled from the market, argue researchers from the UK and Canada, after finding it remains popular despite known cardiovascular risks.

Scientists have known for over a decade that some non-steroidal anti-inflammatory drugs such as diclofenac were associated with heart attacks and strokes in vulnerable patients.

In a study published today in the journal PLOS Medicine, researchers found that diclofenac, on average, was the most commonly used NSAID in 15 countries studied, despite being associated with more cardiovascular complications than other NSAIDs, including naproxen.

Diclofenac is the third most popular NSAID in Australia."

Artificial sweeteners linked to higher diabetes risk in women

NEW evidence links artificial sweeteners to a higher risk of type 2 diabetes in women.

“Contrary to conventional thinking, the risk of diabetes is higher with 'light' beverages compared with ‘regular’ sweetened drinks," the French National Institute of Health and Medical Research (INSERM) said after publication of the research in the American Journal of Clinical Nutrition.

The evidence comes from a wide-scale, long-term study, INSERM said in a press release.

More than 66,000 French women were quizzed about their dietary habits and their health was then monitored over 14 years. The women were middle-aged or older when they joined the study.

Sugar-sweetened soft drinks have previously been linked with an increased risk of diabetes, but less is known about their artificially-sweetened counterparts.

Medical Observer, 8th Feb 2013

BioEdge: German cleric apologises over rape victim mistreatment

BioEdge: German cleric apologises over rape victim mistreatment: "The incident, which occurred in December last year, involved a young woman suspected of being date-raped. An Emergency Centre doctor contacted Cologne’s St. Vincent’s Catholic Hospital and Holy Spirit Hospital to arrange a gynaecological examination for the woman, only to be told that these hospitals had a policy of not conducting examinations after sexual attacks. The hospitals were concerned that such examinations would force them to provide advice on unwanted pregnancies.

Cardinal Joachim Meisner said that there had been a grave “misunderstanding” in the hospitals. He stated that the hospitals should have provided the woman with medical help, though they would have drawn the line at treatment that would have prevented a pregnancy."

BioEdge: Israel halts underhanded contraceptive injections for Ethiopian migrants

BioEdge: Israel halts underhanded contraceptive injections for Ethiopian migrants: "Years of rumours that Ethiopian women were pressured into having contraceptive injections by Israeli officials have finally been confirmed. The Health Ministry has ordered immigration officials in Ethiopia and health workers in Israel to stop coercing or coaxing women into accepting the long-lasting injectable contraceptive Depo-Provera.

The directive instructed doctors “not to renew prescriptions of Depo Provera to women of Ethiopian origin or any other women who, for whatever reason, may not understand the treatment’s implications.” They should also ask patients why they want to take the shot, using a translator if necessary. The Ministry did not confirm or acknowledge any wrongdoing.

Ethiopians who claim to be Jews are welcome to migrate to Israel under the Law of Return, but they face discrimination and have not always integrated well into Israeli society. Births among Ethiopian women have dropped by 50% in the last decade, according to a report by the “Vacuum” investigative news program on Israeli Educational Television. “This story reeks of racism, paternalism and arrogance. It’s a story to be ashamed of,” journalist Gal Gabai concluded. "

Discharge summaries get diagnosis wrong

Discharge summaries get diagnosis wrong: "SCORES of patients are leaving hospital with the wrong diagnosis in their medical records, causing massive discrepancies in hospital funding amounting to hundreds of thousands of dollars.

An audit of 150 patients' discharge summaries at Maroondah Hospital in Melbourne between November 2011 and January last year found half were missing significant clinical information and one in 10 had the wrong diagnosis.

The findings suggest hospitals are putting patients at risk, giving GPs the wrong information to continue caring for patients after a hospital stay and incorrectly coding their work for government funding."

Families face battle with GSK over dangerous diabetes drug | Business | The Guardian

Families face battle with GSK over dangerous diabetes drug | Business | The Guardian: "GlaxoSmithKline has agreed to payouts in US lawsuits alleging Avandia pills could cause heart attacks. Photograph: Bloomberg/Getty Images
Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug's harmful effects. But, despite this, GSK is not prepared to settle claims in the UK without a court fight."

Families face battle with GSK over dangerous diabetes drug | Business | The Guardian

Families face battle with GSK over dangerous diabetes drug | Business | The Guardian: "GlaxoSmithKline has agreed to payouts in US lawsuits alleging Avandia pills could cause heart attacks. Photograph: Bloomberg/Getty Images
Thousands of families in the UK could be deprived of compensation for the death or harm of a relative caused by the diabetes drug Avandia, even though the British maker has agreed to pay billions of dollars to settle similar claims in the US.

The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.

A scientist with the and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.

The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug's harmful effects. But, despite this, GSK is not prepared to settle claims in the UK without a court fight."

Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?

Antidepressants, in particular newer agents, are among the most widely prescribed medications worldwide with annual sales of billions of dollars. The introduction of these agents in the market has passed through seemingly strict regulatory control. Over a thousand randomized trials have been conducted with antidepressants. Statistically significant benefits have been repeatedly demonstrated and the medical literature is flooded with several hundreds of "positive" trials (both pre-approval and post-approval). However, two recent meta-analyses question this picture. The first meta-analysis used data that were submitted to FDA for the approval of 12 antidepressant drugs. While only half of these trials had formally significant effectiveness, published reports almost ubiquitously claimed significant results. "Negative" trials were either left unpublished or were distorted to present "positive" results. The average benefit of these drugs based on the FDA data was of small magnitude, while the published literature suggested larger benefits. A second meta-analysis using also FDA-submitted data examined the relationship between treatment effect and baseline severity of depression. Drug-placebo differences increased with increasing baseline severity and the difference became large enough to be clinically important only in the very small minority of patient populations with severe major depression. In severe major depression, antidepressants did not become more effective, simply placebo lost effectiveness. These data suggest that antidepressants may be less effective than their wide marketing suggests. Short-term benefits are small and long-term balance of benefits and harms is understudied. I discuss how the use of many small randomized trials with clinically non-relevant outcomes, improper interpretation of statistical significance, manipulated study design, biased selection of study populations, short follow-up, and selective and distorted reporting of results has built and nourished a seemingly evidence-based myth on antidepressant effectiveness and how higher evidence standards, with very large long-term trials and careful prospective meta-analyses of individual-level data may reach closer to the truth and clinically useful evidence.
http://www.peh-med.com/content/3/1/14

Pfizer to Pay Record 23 Billion Fine

Pfizer to Pay Record 23 Billion Fine: "In the largest health care fraud settlement in history, pharmaceutical giant Pfizer must pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra. The other drugs were the antipsychotic Geodon, the antibiotic Zyvox, and the anti-epileptic Lyrica.
Once the Food and Drug Administration approves drugs, doctors can prescribe them off-label for any use, but makers can't market them for anything other than approved uses. Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a felony violation for promoting off-label uses of Bextra. At the FDA's request, Pfizer pulled Bextra off the market in April 2005 because of its risks."

'via Blog this'

Flu Vaccine Increases Risk of Serious Pandemic Flu Illness

Flu Vaccine Increases Risk of Serious Pandemic Flu Illness: "The Canadian press recently broke the story that new research confirms initial findings that the flu vaccine appeared to actually increase people's risk of getting sick with H1N1, and cause more serious bouts of illness to boot.

According to the Vancouver Sun:1

"Researchers, led by Vancouver's Dr. Danuta Skowronski, an influenza expert at the B.C. Centre for Disease Control, noticed in the early weeks of the [2009 H1N1] pandemic that people who got a flu shot for the 2008-09 winter seemed to be more likely to get infected with the pandemic virus than people who hadn't received a flu shot. Five studies done in several provinces showed the same unsettling results."

New Study Confirms: Flu Vaccine Really Does Increase Your Risk of Serious Pandemic Flu Illness"
http://www.abc.net.au/news/2011-03-04/vaccines-may-have-increased-swine-flu-risk/1967508

German doctors shaken by corruption allegations

BioEdge: German doctors shaken by corruption allegations: "The German Medical Association has investigated nearly 1,000 cases of corrupt doctors over the past few years, according to its president, Frank Ulrich Montgomery.

Dr Montgomery told Der Spiegel that more than half of the case involved alleged bribes from an Israeli pharmaceutical company, Ratiopharm. The doctors were paid for prescribing its drugs to their patients. This was “clearly prohibited”, says Dr Montgomery.

“The Medical Association punished 163 Ratiopharm doctors after state prosecutors made the files available to us,” said Montgomery. He wants the government to pass legislation which would permit the Medical Association itself to conduct searches and confiscate files.

However, this is opposed by health insurance companies. “Corruption is not a minor offence which doctors can regulate amongst themselves,” said an industry spokesman."

'via Blog this'

Register all trials, report all results – it's long overdue

Register all trials, report all results – it's long overdue: "If researchers go to the effort of getting funds, recruiting patients, and following them up, you would think that they would be keen to publish the results. So it’s surprising that our best estimates show around half of all completed clinical trials have never been published in academic journals. And the half we have is biased towards trials with positive results."

'via Blog this'

The hidden world of medical racism in the United States

The hidden world of medical racism in the United States: "The idea that discredited, repugnant ideas about racial differences might play a role in medical diagnoses and treatment today is one that doctors ought to find profoundly disturbing. The racially biased treatment of patients is a grievous violation of medical ethics and a direct threat to the dignity of the profession.

But over the past two decades, American medical literature has published hundreds of peer-reviewed studies that point to racially-motivated decisions by physicians that may do serious medical harm. The principal result of these studies has simply been more studies of the same kind."

'via Blog this'

The hidden world of medical racism in the United States

The hidden world of medical racism in the United States: "The idea that discredited, repugnant ideas about racial differences might play a role in medical diagnoses and treatment today is one that doctors ought to find profoundly disturbing. The racially biased treatment of patients is a grievous violation of medical ethics and a direct threat to the dignity of the profession.

But over the past two decades, American medical literature has published hundreds of peer-reviewed studies that point to racially-motivated decisions by physicians that may do serious medical harm. The principal result of these studies has simply been more studies of the same kind."

'via Blog this'

Well-known antibiotic amoxycillin found to be ineffective cough treatment

Well-known antibiotic amoxycillin found to be ineffective cough treatment: "An antibiotic commonly prescribed for infections including coughs and bronchitis is ineffective at relieving symptoms, and may actually be harmful if overused, according to a new European study.

The study of 2,061 adults, published in The Lancet Infectious Diseases, found patients prescribed amoxycillin did not recover more quickly or have significantly fewer symptoms than those who received no medication.

“Using amoxycillin to treat respiratory infections in patients not suspected of having pneumonia is not likely to help and could be harmful,” said Professor Paul Little from the University of Southampton in the UK who led the research."

'via Blog this'

Remove industry bias from clinical trials before it's too late

Remove industry bias from clinical trials before it's too late: "A study published today shows that clinical trials with industry sponsorship report greater benefits and fewer harmful side effects. In the discussion, the authors note that most reviews and guidelines don’t report the funding sources for the included trials."

'via Blog this'

BioEdge: Leveson Inquiry recommends reform of science reporting

BioEdge: Leveson Inquiry recommends reform of science reporting: "Remember patients: don't call something a "cure" that is not a cure."

'via Blog this'

BioEdge: The ultimate hot potato: female genital mutilation is not as bad as it seems

BioEdge: The ultimate hot potato: female genital mutilation is not as bad as it seems: "The authors’ aim is to "move the coverage of the topic from an over-heated, ideologically charged, and one-sided story about 'mutilation,' morbidity, and patriarchal oppression to a real, evidence-based policy debate governed by the standards of critical reason and fact checking."

The claims and counter-claims are too long to list. But the authors – about 15 of them, mostly from Western countries – make the following points about female genital mutilation (or “female genital surgery”, as they call it)"

Provocatively, the authors argue that women and girls who have undergone genital mutilation should not be stigmatized or taught to expect sexual dysfunction. This might cause “psychological mutilation", potentially compromising the development of a normal and healthy psychosexual life.

Bad Science

Bad Science: "This morning at 11:30, Dr Sarah Wollaston MP will ask questions in parliament about the ongoing scandal of missing trial data. This is widely recognised as a problem by academics and doctors, but governments, regulators, and journalists have neglected the problem, while industry simply denies it. Watch the questions live here or watch it later here.
As an example, we spent £500m stockpiling Tamiflu in the UK, but the company Roche are still withholding vitally important information about the trials on whether it works from Cochrane, the international academic collaboration who make gold standard reviews of evidence for doctors, patients, and governments."

'via Blog this'

Irving Kirsch, P.h.D: Antidepressants: The Emperor's New Drugs?

Irving Kirsch, P.h.D: Antidepressants: The Emperor's New Drugs?: "It turned out that 75 percent of the antidepressant effect was also produced by placebos - sugar pills with no active ingredients that are used to control the effects of hope and expectation in clinical trials. In other words, most of the improvement seen in patients given antidepressants was a placebo effect."

'via Blog this'

Peer review: Bad Pharma by Ben Goldacre

Peer review: Bad Pharma by Ben Goldacre: "In Bad Pharma he repeats this trick, but the headline news is infinitely more disturbing: contemporary medicine is acutely sick and in desperate need of therapy. Usually, it’s naturopaths who run this argument, portraying what they see as contemporary medicine’s de-humanising reductionism.

Goldacre’s perspective is very different: medicine’s evidence base has been undermined by an unscrupulous alliance of the pharmaceutical industry and regulators, which leads to the routine suppression of negative studies revealing many drugs to be either ineffective or less effective than those they seek to replace.

This suppression has been wilful and many academics (the industry’s “key opinion leaders”) have acted as willing partners in the enterprise, putting their names to ghostwritten articles reporting positive trials, while failing to publish negative trials.

Since there’s so much missing data, we can’t really say whether the therapies we use work or not. "

'via Blog this'

opioids for nerve pain when the evidence for their usefulness is known to be unconvincing

The Conversation: "Too many GPs and other doctors are forced to prescribe opioids for nerve pain when the evidence for their usefulness is known to be unconvincing. As previously mentioned in this column, long-term opioid therapy for non-cancer pain has limited benefits compared to the potential for reduced quality of life, even if the generally overstated risk of abuse and addiction is discounted. This is especially true for nerve pain, also known as neuropathic pain. The pain is simply generated in a way that opioid drugs don’t really influence."

'via Blog this'

Tamiflu effectiveness questioned as drug company refuses to release data

Tamiflu effectiveness questioned as drug company refuses to release data: "Public health researchers have stepped up their campaign to access clinical trial data about influenza drug Tamiflu, amid concerns about its effectiveness.

Professor Peter Gøtzsche, leader of the Nordic Cochrane Centre in Copenhagen, has called for drug company Roche, which manufacturers Tamiflu, to be sued over its refusal to share data with independent researchers.

Meanwhile, questions are being raised about whether Tamiflu works in the way its manufacturers claim, or acts like paracetamol instead.

Tamiflu, or oseltamivir, is supposed to reduce complications from flu, such as pneumonia, and reduce the rate of hospitalisation and death during outbreaks of the illness.

The drug was stockpiled in Australia, Europe and the US following the swine flu outbreak of 2009. The British Medical Journal claims it has made billions of pounds for Roche."

'via Blog this'

Doctor pleads guilty to abortion clinic infections

Doctor pleads guilty to abortion clinic infections: "He made admissions to the Medical Practitioners Board in 1995 that he had abused fentanyl and pethidine, obtained by forging prescriptions.

He was charged by police with several counts of failing to give notice that a patient was drug-dependent and obtaining a drug of dependence by forging prescriptions.

He was convicted over the charges, received community-based orders and two months’ jail, which was wholly suspended for 18 months.

In July 1996 he was also charged with multiple counts of aiding and abetting another person to forge a prescription for drugs, and for being in possession of a drug of dependence, using a drug of dependence and introducing a drug into the body of another. He was again convicted and released on a community-based order for 18 months.

He was ordered to undergo assessment for a drug addiction, submit to medical, psychological and/or psychiatric treatment and be drug-tested as part of his conditions.

The medical board suspended him in 1996 before he returned to work at Box Hill Hospital the following year.

He tested positive for hepatitis C — a disease of which the health department must be notified — in 1997."

GMC suspends 'rogue surgeon' accused of unnecessary breast operations | Society | The Guardian

GMC suspends 'rogue surgeon' accused of unnecessary breast operations | Society | The Guardian: "
An alleged "rogue surgeon" has been suspended by the General Medical Council after it emerged he might have performed "unnecessary or inappropriate" breast operations on more than 1,000 women in Britain.

Ian Stuart Paterson, a breast cancer specialist who worked at NHS and private hospitals in the Midlands from 1994 until last month, is suspected of misdiagnosing at least 450 of the women with breast cancer when they were in fact healthy, and then performing unnecessary "lumpectomy" surgery."

We need a different national conversation about ADHD

We need a different national conversation about ADHD: "That’s why Australia needs to start a broader conversation about ADHD. And if we do, we might uncover a deep contradiction in our past response.

While we laud the qualities of activity, alertness and resistance to authority in our grandparents as foundations of the ANZAC tradition, we consider these same qualities in our children as something to be treated with medication.

It leads to the question – if Ginger Meggs were around today, would he be ADHD?"

'via Blog this'

The drugs don't work: a modern medical scandal

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'

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'

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'

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'

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'

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'

'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'

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'

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'

Thousands of children put at risk by asthma medication

Thousands of children put at risk by asthma medication:

'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 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'

Complaints about doctors' professional conduct reach record levels | Society | The Guardian

Complaints about doctors' professional conduct reach record levels | Society | The Guardian: "
Publication of the findings came just a day after a British Social Attitudes survey showed public satisfaction with the NHS had slumped for the first time, last year, from 70% to 58% – although the slide was thought to relate to concern about reforms to the health service rather than individual doctors' performance.

Most of the complaints last year – 5,665 – came from members of the public. The rest were made by other doctors, other healthcare staff, and other people in authority such as police officers, coroners and medical directors.

Only a fraction of complaints eventually result in some form of disciplinary action. "We are probably doing something with around 1,200 doctors," said Dickson. "Of those, around 700 will get advice. The remaining 500 get a range of sanctions."

The most serious action – where a doctor is struck off the medical register and is no longer able to practise – was taken against 65 doctors last year, compared with 73 in 2010. Since the number of hearings went down, this was a rise in the proportion of cases investigated that resulted in doctors being struck off."

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Drapetomania - Wikipedia, the free encyclopedia

Drapetomania - Wikipedia, the free encyclopedia: "Cartwright described the disorder – which, he said, was "unknown to our medical authorities, although its diagnostic symptom, the absconding from service, is well known to our planters and overseers"[4] – in a paper delivered before the Medical Association of Louisiana[2]:291 that was widely reprinted.

He stated that the malady was a consequence of masters who "made themselves too familiar with [slaves], treating them as equals".[5]

If any one or more of them, at any time, are inclined to raise their heads to a level with their master or overseer, humanity and their own good requires that they should be punished until they fall into that submissive state which was intended for them to occupy. They have only to be kept in that state, and treated like children to prevent and cure them from running away." [6]
In Diseases and Peculiarities of the Negro Race, Cartwright writes that the Bible calls for a slave to be submissive to his master, and by doing so, the slave will have no desire to run away.[4]"

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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'

Witnesses back Hicks on chemical torture, drug experiments

Witnesses back Hicks on chemical torture: "Other investigations show that Guantanamo Bay detainees, including David Hicks, were forced to take high dosages of the controversial anti-malaria drug mefloquine despite showing no signs of the disease, an unprecedented practice that has been likened to ''pharmacologic waterboarding'' by a US military doctor.

Questions have been raised about whether the mass administration of the drug to detainees was a secret, illegal experiment after a medical journal article last month by an army doctor, Major Remington Nevin, highlighted the ''inappropriate use'' of the drug, asking if its use had been motivated by its psychotic side effects. The US Centre for Disease Control has issued a warning against the use of mefloquine on anyone suffering psychiatric disturbances or having a history of depression. Dr Nevin has also warned that high doses of the drug can cause brain injuries.

Evidence including previously secret reports and witnesses including a Guantanamo guard, and New York lawyer, Josh Dratel, support Mr Hicks's claims that he was drugged."

'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'

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

"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 iscalling 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."

http://www.guardian.co.uk/world/2012/aug/15/french-breast-implant-scandal-health-and-wellbeing

"this wasn’t just error, but it was intent” by the doctors

Hospital Chain Inquiry Cited Unnecessary Cardiac Work

“The allegations related to unnecessary procedures being performed in the cath lab are substantiated,” according to a confidential memo written by a company ethics officer, Stephen Johnson, and reviewed by The New York Times.

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

Do Physicians Know When Their Diagnoses Are Correct?

Even experienced clinicians may be unaware of the correctness of their diagnoses at the time they make them. Medical decision support systems, and other interventions designed to reduce medical errors, cannot rely exclusively on clinicians' perceptions of their needs for such support.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1490097/

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.

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