"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

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

You call it love, I call it payola: untangling pharma's close ties with doctors

You call it love, I call it payola: untangling pharma's close ties with doctors:

'via Blog this'

Vaccines for chickens have created virulent new viruses

Vaccines for chickens have created virulent new viruses:

'via Blog this'

surgeons took part in what the school termed "serious and continuing noncompliance"

2 UC Davis surgeons accused of experimenting on dying brain cancer patients | PressDemocrat.com: "surgeons took part in what the school termed "serious and continuing noncompliance""

'via Blog this'

women were persuaded to have hysterectomies - fake claims under a national insurance scheme

As if exploitation of poor Indian women as surrogate mothers and egg donors were not enough, surgeons may have removed the wombs of 7,000 healthy women in Chhattisgarh - a poor and largely rural state in central India -- to enrich themselves by making fake claims under a national insurance scheme. Officials believe that about 2,000 women were persuaded to have hysterectomies in the last six months alone.

It is alleged that doctors frightened poor women from remote areas into having surgery by telling them that they might get cancer without it. Some women even had hysterectomies for back pain. "Panic and fright left us with no option," a 31-year-old woman, who can no longer bear children, told the Hindustan Times.

"It has become a sensitive and serious problem. We are investigating whether these surgeries were being done just for the money or were genuinely needed. The government will take stern action against those found guilty," says state health minister Amar Agrawal.

The state health department plans to take legal action against 22 clinics which apparently did unnecessary surgery and has recommended that nine doctors in the private sector be deregistered. ~ BBC, July 17

http://www.bbc.co.uk/news/world-asia-india-18873716

the concept of evidence-based medicine was highly contested within Western medicine itself

http://theconversation.edu.au/attack-on-complementary-medicine-undermines-safety-8264

"He was prepared to kill people if it saved his authority from being questioned."

http://www.couriermail.com.au/news/sunday-mail/cmc-told-patient-murders-horrifying/story-e6frep2f-1226353778436

the medical board handled matters in-house, and there was no need to go to the police

Although she is co-operating with the CMC, Ms Barber said she was concerned it was not moving quickly enough.
She said the CMC failed in its oversight of the other agencies when she first sounded the alarm.
She has given the CMC the names of 18 doctors she says maimed and killed patients.
Many of the doctors are recklessly incompetent and still practising, she said.
http://www.news.com.au/national/investigators-told-killer-doctor-switched-off-life-support-on-gold-coast-hospital-patients/story-e6frfkvr-1226354390904

"Caesar judging Caesar" - utterly dysfunctional medical boards

In the end, the state's medical board, two-thirds of which are doctors, allowed the doctor to retain his registration to practise with one condition: he stop working in intensive care.

Ms Barber, who revealed a series of concerns to 7.30 in April about malpractice in Queensland hospitals, says it is a case of "Caesar judging Caesar".
She says the review of such cases should be handled by a panel of people who are "legally minded", with the assistance of medical administrators.
"It's completely and utterly dysfunctional and if you were to look in the last 10 years, those [doctors] that actually had been struck off or completely gotten rid of as a result of their incompetence would be - you could count them on one hand. Maybe five or six," she said.
The allegations have been referred to Queensland's Crime and Misconduct Commission (CMC).
The CMC has appointed a former Supreme Court judge to examine what it calls a series of allegations and has referred material to the homicide squad.
Former MP Rob Messenger, who was instrumental in revealing the deeds of Dr Jayant Patel, says the case needs to go to a commission of inquiry "right now".
"It needs to go from an assessment stage to a full-blown investigation stage, but that investigation won't be effective unless witnesses are given protection," he said.
"And it's only a commission of inquiry that will be able to give potential witnesses the protection and confidence for them to come forward and tell the truth, tell their story."
The medical board declined 7:30's request for interview, but released a statement saying its role is to protect the public but that it must also be fair, lawful and provide natural justice to practitioners.
http://www.abc.net.au/news/2012-07-10/doctor-accused-of-ended-patients-lives-prematurely/4122522

Roche is under investigation over a failure to properly report adverse drug side effects

Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines.
At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.
"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine," the EMA said in the statement on Thursday.
"There is, at present, no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or health care professionals to take any action," added the EMA.
A Roche spokesman said the company acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.
http://www.medicalobserver.com.au/news/eye-on-roche-after-failure-to-report-side-effects

“Doctors tend to confuse what they believe with what they know,”

http://inside.org.au/overtested-overtreated-and-over-here/

Overtested, overtreated and over here | Inside Story

Overtested, overtreated and over here | Inside Story

Informed consent: it’s not a reality for too many patients

http://ehln.org/?p=25222

drug marketing undermines patient safety and public health

Am J Public Health. 2011 Mar;101(3):399-404. Epub 2011 Jan 13.

The inverse benefit law: how drug marketing undermines patient safety and public health.

Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.
http://www.ncbi.nlm.nih.gov/pubmed/21233426?dopt=Abstract

disease-mongering activities companies can use to stimulate drug sales

• Promotion of anxiety about future ill-health in healthy individuals
• Inflated disease prevalence rates
• Promotion of aggressive drug treatment of milder symptoms and diseases
• Introduction of questionable new diagnoses—such as PMDD or social anxiety disorder—that are hard to distinguish from normal life
• Redefinition of diseases in terms of surrogate outcomes (i.e., osteoporosis becomes a disease of low bone density rather than fragility fractures)
• Promotion of drugs as a first-line solution for problems previously not considered medical, such as disruptive classroom behaviour or problematic sexual relationships.

Ray Moynihan and colleagues describe disease mongering as, “widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments” [ 1].

The rationale for regulation of drug promotion is health protection, encouragement of appropriate medicine use, and prevention of deceptive advertising. The European community code on medicinal products for human use states that advertising of medicinal products “must encourage the rational use of the product and may not be misleading” [ 34]. Canada's Food and Drugs Act prohibits advertising of a drug that is “false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, merit or safety” [ 35]. The World Health Organization's Ethical Criteria for Medicinal Drug Promotion states that advertisements, “…should not take undue advantage of people's concern for their health” [ 36].

Disease mongering by definition creates erroneous impressions of the condition a product aims to treat and the merit and safety of treatment, and frequently provokes undue anxiety or exaggerates prevalence rates.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1434509/?tool=pubmed

state watchdog agencies including the CMC failed to protect patients from dangerous doctors

http://m.news.com.au/QLD/pg/0/fi1554357.htm

Can physicians regulate themselves?

[E]very doctor will allow a colleague to decimate a whole countryside sooner than violate the bond of professional etiquet [sic] by giving him away. — Bernard Shaw, Preface on Doctors, The Doctor's Dilemma, 1911

Patients want and need to have confidence in their physicians. Yet confidence in physicians is waning. In part this reflects the more generalized public distrust of experts and authority figures that has become characteristic of our age. But the public is increasingly aware that the quality and oversight of medical care are uneven. They are aware of an unexpectedly high frequency of adverse events,1 of reports of hospital and professional mismanagment, such as the pediatric cardiac surgery deaths in Winnipeg,2 and of professional malfeasance, whose most spectacular modern example is the murder of 250 patients over a 27-year period by Dr. Howard Shipman, a British family physician. 

http://www.cmaj.ca/content/172/6/717

"It is plainly not possible for a trust to be, and to be seen to be, 'independent' in investigating a death which may have been caused or contributed to by failures of its own staff or systems."

http://www.guardian.co.uk/society/2012/may/26/campaign-deaths-mental-health-patients

a rare move by a US panel editing the universal diagnostic manual to drop two unpopular proposals for new diagnoses

The decision to back away from a proposed diagnosis of “attenuated psychosis syndrome" – for people at risk of developing psychosis, and from “mixed anxiety depressive disorder” – for people with a mixed state of both illnesses, was a welcome respite from the relentless push to expand the boundaries of pathology, experts said.
The American Psychiatric Association panel in charge of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) also modified the definition of depression to ensure that people experiencing normal grief over the death of a family member or a job loss would not be included.

Professor Gordon Parker, Scentia Professor in the School of Psychiatry at the University of New South Wales, said there had been “great concern in the community over the past 10 years in particular about what you could call ‘psychiatric imperialism’ – where the boundaries of categorising psychiatric disorders has moved from the clearly pathological down into the more normal. There’s that background concern that does need to be respected.”
http://theconversation.edu.au/backdown-on-new-psychiatric-diagnoses-a-welcome-respite-7092

major trial of epoetin misled the medical community about the anemia drug’s risks and benefits-and helped make Amgen rich

http://the-scientist.com/2012/05/14/opinion-misleading-drug-trials/

Qld doctor accused of killing patients

Police in Queensland will this week be asked to launch a murder investigation into claims a doctor killed patients.
Former independent Queensland MP Rob Messenger gave taped interviews of a former colleague of the doctor to media and the Crime and Misconduct Commission (CMC).
On the tape, the whistleblower doctor accuses his former colleague of at least two killings.
One of the incidents involved oxygen being turned down on a patient on life support, which prematurely killed the woman against her wishes.
On another occasion, a surgeon had to restrain the doctor for 15 minutes to stop him from hurting a patient.
"He was prepared to kill people if it saved his authority from being questioned," the doctor said in the recording.
Health Minister Lawrence Springborg said that the doctor was still employed by Queensland Health but had been separated from patients.
http://www.nzherald.co.nz/health/news/article.cfm?c_id=204&objectid=10805741

Retractions (fraud) on the rise in scienific journals

Get Science News From The New York Times »

Source: Journal of Medical Ethics

The highest “retraction index” in the study went to one of the world’s leading medical journals, The New England Journal of Medicine. In a statement for this article, it questioned the study’s methodology, noting that it considered only papers with abstracts, which are included in a small fraction of studies published in each issue. “Because our denominator was low, the index was high,” the statement said.  

In October 2011, for example, the journal Nature reported that published retractions had increased tenfold over the past decade, while the number of published papers had increased by just 44 percent. In 2010 The Journal of Medical Ethics published a study finding the new raft of recent retractions was a mix of misconduct and honest scientific mistakes.

http://www.nytimes.com/2012/04/17/science/rise-in-scientific-journal-retractions-prompts-calls-for-reform.html?_r=2&src=dayp&pagewanted=all

too many bioethicists are being funded by Big Pharma

Gadfly: a person who annoys or criticizes others in order to provoke them into action (Oxford English Dictionary). There is no better word to describe Carl Elliott, a University of Minnesota bioethicist who is probably the profession’s most savage critic. In his column in the Chronicle of Higher Education this week, he returned to a favourite theme: the dangers of cosying up to the pharmaceutical industry. He complains that too many bioethicists are being funded by Big Pharma, which Dr Elliott tends to describe as a Mafia network.
He writes:

“If there is anything surprising about the upsurge in pharma-funded bioethics, it is that it has been accompanied by a dramatic rise in criminal behavior by the pharmaceutical industry: fraud, illegal marketing, ghostwriting, tax evasion, kickbacks, and bribery…

“Apparently, many bioethicists see nothing unseemly about sharing in profits generated by criminal activity. In fact, the bioethicists working with industry are often among the most prominent in the field. If anything, an association with the pharmaceutical industry has become a mark of professional success. What does this say about the future of bioethics?”

http://www.bioedge.org/index.php/bioethics/bioethics_article/10056

behavioral therapy, psychiatry, shock therapy

A controversy has erupted in Massachusetts over the use of skin shock therapy for troubled teenagers. The Judge Rotenberg Educational Center in the suburb of Canton is a facility for people with severe emotional, behavioural and psychiatric problems, including autism. It is the only institution in the US which uses shock therapy – a 2-second application to the skin which feels like a pinch, or, its critics say, a bee sting. About half of its 250 students are treated this way.
This week, a graphic video from 2002 showing a restrained teenager screaming in pain while staff administered 31 shocks galvanised opponents into obtaining more than 200,000 signatures on a on-line petition to state legislators – although it included only 9,000 Massachusetts residents.

The JRC founder, Matthew L. Israel, a behavioural psychologist who trained with Harvard’s B.F. Skinner, was forced to step down last year over an incident in which staff gave two teenagers dozens of shocks after receiving orders from a prank phone call.

In the heat of claim and counter-claim, it is hard to know whether the therapy is mild and helpful or severe and abusive.
The JRC claims that its intensive behavioural therapies have successfully “treated the most difficult behaviours in the nation, often children and young adults who had been confined to psychiatric hospitals because their behaviour disorders could not be effectively treated”. It argues that the shocks are only given after a court and a child’s parents have approved. The alternative, it says, is drugging children and warehousing them in a mental hospital – which is a kind of torture.
Its critics say that electric shock therapy is the kind of torture would not be allowed in a prison. They have even managed to get the Manfred Nowak, the UN's Special Rapporteur on Torture, to ask the US government to investigate the institution. "Of course here they might say, but this is for a good purpose because it is for medical treatment,” Nowak told ABC in 2010. “But even for a good purpose -- because the same is to get from a terrorist information about a future attack, is a good purpose. To get from a criminal a confession is a good purpose.
A health writer in Time magazine, Maia Szalavitz, has written a book on the troubled-teen industry. She is a bitter critic of the JRC and says that it has never published a single peer-reviewed paper which demonstrates that the technique is successful. She dismisses glowing reports from parents as mere anecdotes. 
http://www.bioedge.org/index.php/bioethics/bioethics_article/10060

"Alarming cracks” in the edifice of science

The New York Times highlights the belief of the editor of the journal Infection and Immunity, Ferric C. Fang, that a ten-fold increase in the number of retractions over the past ten years is a symptom of "a dysfunctional scientific climate". And in an opinion piece in Nature, the co-director of the Consortium for Science, Policy and Outcomes at Arizona State University, Daniel Sarewitz, speaks darkly of "alarming cracks" in the scientific edifice which are eroding public trust.

Dr Fang recently issued a call for root-and-branch reform in an eloquent editorial in his journal.
"The present system," he writes, "provides ... potent incentives for behaviors that are detrimental to science and scientists." "You can't afford to fail, to have your hypothesis disproven," Dr. Fang told the Times. "It's a small minority of scientists who engage in frank misconduct. It's a much more insidious thing that you feel compelled to put the best face on everything."
Dr Sarewitz also calls for change to eliminate bias. "Science's internal controls on bias [are] failing, and bias and error [are] trending in the same direction -- towards the pervasive over-selection and over-reporting of false positive results." Significantly for bioethics, he says that "the cracks in the edifice are showing up first in the biomedical realm, because research results are constantly put to the practical test of improving human health".
 http://www.bioedge.org/index.php/bioethics/bioethics_article/10059

Sting Operation Exposes Gaps in Oversight of Human Experiments

Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.
The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.
Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.
As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.
http://online.wsj.com/article/SB123811179572353181.html

How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really

http://www.propublica.org/article/how-does-the-fda-monitor-your-medical-implants

it is now Dr. Wakefield's turn to be exonerated

Mr. Justice Mitting's scathing indictment of GMC's unprofessional and dishonest handling of the Dr. Wakefield case is telling, as it once again calls into question the legitimacy of any of the claims made against Dr. Wakefield and his colleagues concerning their observational, peer-reviewed study. It only further reinforces what has already come to light about the blatant fraud that is the continued witch hunt against Dr. Wakefield for his independent work.

"The welcome decision to exonerate Prof. Walker-Smith is a clear indication that the GMC's case against the Royal Free doctors was manufactured to discredit any association between bowel disease, autism conditions and some of the parents' reported link to the MMR vaccine," writes Age of Autism. "The allegations leveled at Prof. Walker-Smith and the Royal Free team now have to be viewed with total skepticism as nothing more than a witch hunt by vested interests at the highest levels in government, media and the pharmaceutical industry."

This ruling will clearly bolster the efforts of Dr. Wakefield to vindicate his own reputation and career, including his recent lawsuit against Brian Deer, BMJ, and BMJ editor Fiona Godlee, all of which have repeatedly spread lies and slander about Dr. Wakefield and his paper (http://www.naturalnews.com/034974_Andrew_Wakefield_BMJ_lawsuit.html).

Learn more: http://www.naturalnews.com/035256_Professor_Walker-Smith_MMR_vaccines_High_Court.html#ixzz1uFbANzgz

The participation of physicians in torture and murder both before and after World War II is a disturbing legacy

More than 7% of all German physicians became members of the Nazi SS during World War II, compared with less than 1% of the general population. In so doing, these doctors willingly participated in genocide, something that should have been antithetical to the values of their chosen profession. The participation of physicians in torture and murder both before and after World War II is a disturbing legacy seldom discussed in medical school, and underrecognised in contemporary medicine. Is there something inherent in being a physician that promotes a transition from healer to murderer? With this historical background in mind, the author, a medical student, defines and reflects upon moral vulnerabilities still endemic to contemporary medical culture.
http://jme.bmj.com/content/early/2012/05/02/medethics-2011-100372.abstract

Alessandra Colaianni, of Johns Hopkins Medical School, asks the unsettling question: "Is there something inherent in being a physician that promotes a transition from healer to murderer?" Some recent situations in the United States suggest that this is possible: allegations of euthanasia in the wake of Hurricane Katrina, torture of Guantanamo detainees, and the participation of doctors in capital punishment. Colaianni suggests that there are illuminating parallels between medical training and the work of doctors in Auschwitz.
Socialisation and hierarchy: doctors are pressured to conform to group norms, often with techniques like "Sleep deprivation, heightened stress levels and fear of failure". Ambition: just as Nazi doctors participated in the T4 euthanasia program to advance their careers, today's doctors are pressured to succeed even at the risk of losing their integrity. Doctors have a "licence to sin" which can easily be perverted: some "actions are allowed when they are performed by physicians, but are the stuff of horror films and criminal cases when non-licensed personnel attempt them."
Detachment was also a characteristic of Nazi doctors. They could select prisoners by day and dine with their colleagues by night: "the medical profession requires unflappability in the face of things that others would consider disgusting, horrific, or otherwise overwhelming".
Colaianni concludes that medical students need to realise how vulnerable they are to being seduced by the special privileges of their profession. "It is for this reason that a solid grounding in principles of ethics, individualism and human rights is so crucial for physicians and others in positions of power or trust."
http://www.bioedge.org/index.php/bioethics/bioethics_article/10042

doctors misusing mandatory reporting requirements to undermine the competition

“If doctors make a complaint maliciously, with no real basis, for instance if they’re in competition with another doctor, then that could still leave them open to these sorts of actions”, he said.

MJA InSight has previously reported on doctors misusing mandatory reporting requirements for personal agendas. (4)

http://www.mjainsight.com.au/view?post=defamation-risk-in-reporting-colleagues&post_id=8987&cat=news-and-research


SOME doctors are misusing the new mandatory reporting requirements for their own personal agendas, according to a medical defence organisation and other anecdotal reports.


In a comment article in this week’s MJA InSight, the chief executive officer of Avant, David Nathan, says that a quarter of members’ requests for support on mandatory reporting come from doctors who have been reported to AHPRA. (1)

“Unfortunately, several of these cases involve an undertone of market competition or a personal agenda driving the making of such reports”, Mr Nathan wrote.

Dr Mukesh Haikerwal, chair of the World Medical Association and former president of the AMA, said he was also aware of cases where reports had been made “not in good faith”.
http://www.mjainsight.com.au/view?post=mandatory-reporting-%25e2%2580%259cmisused%25e2%2580%259d&post_id=6941&cat=issue-41-31-october-2011

huge percentages of people who give their informed consent to treatment do not really understand what they have chosen

Informed consent is one of the foundations of bioethical discourse. Bureaucrats have forced doctors and researchers to fill out endless forms in the belief that informed consent will enhance patients’ autonomy.
However, questions are being asked about whether this business of informed consent is really working. In an early online article in the Journal of Medical Ethics, Neil Levy, the Australian editor of another journal, Neuroethics, argues that bioethicists need to rethink informed consent.
Why? Because the lesson of all of modern psychology and of post-modern philosophy is that our rationality is terribly flawed. We are blind to the future consequences of our actions; we are not objective in assessing claims that touch us personally;  we overestimate the effects of setbacks on our well-being; we are unreliable in estimating how bad or how good events made us feel. In short, human reasoning is subject to many fallibilities. it seems utterly naïve to think that Yes always means Yes and No always means No. So Levy declares that doctors need to return to paternalism, to some extent:

“patient autonomy is best promoted by constraining the informed consent procedure. By limiting the degree of freedom patients have to choose, the good that informed consent is supposed to protect can be promoted…

Somewhat surprisingly, Arthur Caplan, of the University of Pennsylvania, probably the best-known bioethicist in the US, agrees with Levy. In a companion article, he says:

“autonomy is fundamentally inadequate in healthcare settings and requires supplementation by experience-based paternalism on the part of doctors and healthcare providers…

“A large number of studies have shown that huge percentages of people who give their informed consent to treatment or to their involvement in research do not really understand what they have chosen. Autonomy lives with hope and hope, in the form of the therapeutic misconception, often trumps autonomy.”

Questioning informed consent shakes a pillar of modern bioethics and the call for more benevolent paternalism is sure to face stiff opposition.
http://www.bioedge.org/index.php/bioethics/bioethics_article/9979#comments

medics in the UK offering to carry out the illegal procedure on girls

As many as 100,000 women in Britain have undergone female genital mutilations (FGM) with medics in the UK offering to carry out the illegal procedure on girls as young as 10, it has been reported.
Investigators from the Sunday Times said they had secretly filmed a doctor, dentist and alternative medicine practitioner who were allegedly willing to perform FGM or arrange for the operation to be carried out. The doctor and dentist deny any wrongdoing.
The practice, which involves the surgical removal of external genitalia and in some cases the stitching of the vaginal opening, is illegal in Britain and carries up to a 14-year prison sentence. It is also against the law to arrange FGM.
http://www.guardian.co.uk/uk/2012/apr/22/female-genital-mutilation-uk-medics

“autonomy is fundamentally inadequate in healthcare settings"

“A large number of studies have shown that huge percentages of people who give their informed consent to treatment or to their involvement in research do not really understand what they have chosen. Autonomy lives with hope and hope, in the form of the therapeutic misconception, often trumps autonomy.”
http://www.bioedge.org/index.php/bioethics/bioethics_article/9979#comments

Mandatory influenza vaccination in healthcare professionals? Strong arguments are missing and important risks are taken

http://www.bmj.com/content/344/bmj.e2217/rr/580256

trainees could be accused of “battery” for performing pelvic examinations under anaesthesia, say legal analysts

http://www.bmj.com/content/344/bmj.e2426

The reasons why doctors traditionally take so long to question dogma are complex

“I cannot help but wonder how such a situation came to develop… If I had been told by a physician, no matter how senior, that infants don’t feel pain, I would never have believed it. What constitutes the difference between my reaction and that of the thousands of physicians who did believe it?” Jill Lawson, 1988

JILL Lawson was one of the leaders of the parents’ campaign of the mid 1980s to shield infants from surgical pain.

In a letter published in the New England Journal of Medicine she questioned why doctors did not react as individuals to such an incomprehensible assertion.

The reasons why doctors traditionally take so long to question dogma are complex but we are known to be a rather conservative group of people. As late as 1974, experiments were still being conducted to ascertain whether infants felt pain.
http://www.mjainsight.com.au/view?post=charlie-teo-let%E2%80%99s-extend-our-compassion&post_id=8674&cat=comment

Drug trial results must be made public

A team of public health experts has called for the release of all clinical drug trial results for independent analysis following a “frustrating” three-year battle for access to data on controversial flu drug Tamiflu.
The team, which includes Bond University Professor of Public Health Chris Del Mar, says that in the case of Tamiflu – stockpiled by many countries at enormous cost to taxpayers – drug companies, drug regulators, and public health bodies such as the World Health Organisation have all made discrepant claims about its clinical effects.
Despite a recent review that raised questions about the efficacy of Tamiflu, the drug remains on the World Health Organisation’s List of Essential Medicines.


On several occasions in recent years, health bodies in Japan have raised concerns about the side-effects of Tamiflu after children who were taking the drug apparently committed suicide or harmed themselves.
“We are worried about the side-effects of [Tamiflu], which have been inconsistently reported,” Professor Del Mar said.
http://theconversation.edu.au/drug-trial-results-must-be-made-public-6358

most surgeons do not have a clear understanding of their short-term outcomes for the majority of procedures they perform

The public would probably be surprised to know that most surgeons do not have a clear understanding of their short-term outcomes for the majority of procedures they perform.

Of even greater concern is the lack of data on long-term outcomes associated with surgical interventions.

Many surgeons argue that they are too busy and do not have the time and resources to conduct this sort of follow-up. This is not entirely without foundation, but it does seem difficult to defend a stance that says “I will continue to work feverishly at the operations I do but not assess how successful my results are”.

Guy Maddern (ASERNIP-s): No excuse for poor surgical outcomes

MJA INSIGHT, 8 August 2011

serious misrepresentation of both the effectiveness and safety of the drug

The results were published in 2001 by Keller et al. in the journal article, “Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial”, in the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP). The article concluded that “paroxetine is generally well tolerated and effective for major depression in adolescents”.
This was a serious misrepresentation of both the effectiveness and safety of the drug. In fact, when SKB set out their methodology for their proposed study protocol, they had specified two primary and six secondary outcome measures. All eight proved negative, that is, on none of those measures did children on paroxetine do better than those on placebo.

The published article misrepresented one of the primary outcomes so that it appeared positive, and deleted all six pre-specified secondary outcomes, replacing them with more favourable measures.
SKB papers also revealed that at least eight adolescents in the paroxetine group had self-harmed or reported emergent suicidal ideas compared to only one in the placebo group. But these adverse events were not properly reported in the published paper. Instead, some were described as “emotional liability” while others were left out altogether.
http://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071

Aniello Iannuzzi: Conflict of power

The third, mostly unspoken, category of conflict is power, and the most obvious example is committees.

Committees are the fastest growing things in health care — teamwork, collaboration, consultation, liaison, planning, strategy, development, review are just some of the buzzwords used to justify downing tools and having a yak.

We can’t just blame government for this — have a look at how many committees the AMA has created.

Many committees are very influential. A number have remuneration and benefits attached, not to mention the time off work. They can also offer the natural companion of power — prestige.

The appointments to these committees are often driven by politics, connections and geography rather than by merit.
http://www.mjainsight.com.au/view?post=aniello-iannuzzi-conflict-of-power&post_id=8543&cat=comment

the quest for international recognition may overcome the natural caution or circumspection required of clinical judgement

The discussion has focused almost exclusively on pecuniary, or financial, interests. But these may play a relatively minor role in medicine. Most doctors or researchers don’t do what they do primarily to increase their material wealth. If making money was their primary goal, they could choose more effective ways of doing so.
The motivations that underlie most decisions in medicine are not financial. Rather they range from an interest in patient care or research or public welfare, to a commitment to certain ideas, principles or values and the desire for personal advancement in career, reputation or status.
These factors are powerful drivers of decisions and actions and are no less capable of generating conflicts than the prospect of monetary rewards. Division of loyalties between the roles of clinician, researcher, administrator or public health practitioner may create serious concerns or anxieties; personal religious or political commitments may undermine the operation of an ethics or policy committee; and the quest for international recognition may overcome the natural caution or circumspection required of clinical judgement.
http://theconversation.edu.au/dont-show-me-the-money-the-dangers-of-non-financial-conflicts-5013

lack of adequate management of conflicts of interest among experts generating clinical guidelines in Australia

http://theconversation.edu.au/show-and-tell-conflicts-of-interest-undeclared-for-clinical-guidelines-3890

between 44,000 and 98,000 people die in US hospitals each year as a result of preventable medical errors

http://www.iom.edu/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx

the medical profession is so trusted that its activities are rarely questioned

By Paul Komesaroff, Monash University; Ian Kerridge, University of Sydney, and Wendy Lipworth, University of New South Waleshttps://theconversation.edu.au/big-debts-in-small-packages-the-dangers-of-pens-and-post-it-notes-4949

Adverse events in surgical patients in Australia

The AE (adverse events) rate for surgical admissions was 21.9%. Disability that was resolved within 12 months occurred in 83%, 13% had permanent disability, and 4% resulted in death. Reviewers found that 48% of AEs were highly preventable. The risk of an AE depended on the procedure and increased with age and length of stay.
http://www.ncbi.nlm.nih.gov/pubmed/12201185

The Quality in Australian Health Care Study

Med J Aust. 1995 Nov 6;163(9):458-71.

Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD.

Source

Royal North Shore Hospital, North Sydney, NSW.

Abstract

A review of the medical records of over 14,000 admissions to 28 hospitals in New South Wales and South Australia revealed that 16.6% of these admissions were associated with an "adverse event", which resulted in disability or a longer hospital stay for the patient and was caused by health care management; 51% of the adverse events were considered preventable. In 77.1% the disability had resolved within 12 months, but in 13.7% the disability was permanent and in 4.9% the patient died.
http://www.ncbi.nlm.nih.gov/pubmed/7476634?dopt=Abstract

Comment in

• Med J Aust. 2001 Apr 2;174(7):369.

while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality

While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality.
http://www.springerlink.com/content/b674622731k4850q/?p=780854c9fdb64f988dd69a0651085be7&pi=10

It is only because there is no paper or money trail that the conflicts of interest based on power go unmentioned and uncorrected

Committees are the fastest growing things in health care — teamwork, collaboration, consultation, liaison, planning, strategy, development, review are just some of the buzzwords used to justify downing tools and having a yak.

We can’t just blame government for this — have a look at how many committees the AMA has created.

Many committees are very influential. A number have remuneration and benefits attached, not to mention the time off work. They can also offer the natural companion of power — prestige.

The appointments to these committees are often driven by politics, connections and geography rather than by merit.

Some are even implementing gag clauses on doctors and even medical students. If someone is subject to a gag clause it should be declared as a conflict of interest.

As a profession we need to be asking about who decides appointments, how they are decided and whether members of committees are nominees or representatives. The latter have to tow a line, the former can be independent.

Power can manifest as workforce manipulation, even without monetary gain. Examples of this are the colleges, universities, regional training providers (RTPs) and hospital networks.

How many times have we seen the students or the registrars of the professor given the best jobs? How often do the supervisors on the boards of colleges and RTPs get the best registrars while others have to make do with the lower achieving ones or none at all?

Can doing a PhD under a certain boss somehow lead to a prime hospital appointment regardless of the academic merits of the thesis? Splashing the name of the boss on a few publications — with his/her minimal input — is a way to seal the deal.

There is certainly a culture of “doing one’s time” or “being seen” that prevails within our profession. When such candidates are given jobs over those with more merit, you cannot but help conclude that major conflicts of interest are at play.
http://www.mjainsight.com.au/view?post=aniello-iannuzzi-conflict-of-power&post_id=8543&cat=comment

Publication bias concerns grow

CONCERN that published research does not provide doctors with the full evidence base about medications is increasing, with an analysis of antipsychotic trials finding several examples of publication bias.

The research, published in PLoS Medicine, analysed 24 trials registered with the US Food and Drug Administration of eight second-generation antipsychotics. (1)

The study found that four of the trials were never published. Of these, three failed to show that the study drug was significantly better than placebo, and one showed the drug was statistically inferior to the active comparator.

It is the latest example of researchers using data from published and unpublished research in their analysis — and finding discrepancies between the two sources.

An analysis of antidepressant trials by the same researchers in 2008 found that publication bias nearly doubled the apparent proportion of positive trials and increased the apparent effect size of antidepressants by one third. (2)

A recent reanalysis of neuraminidase inhibitors for influenza using primary trial data was conducted after researchers found that 60% of patient data from oseltamivir trials had never been published. The reanalysis found that oseltamivir did not seem to reduce hospitalisations, contrary to the findings of published reports. (3)

One of the authors of the oseltamivir review was Professor Chris Del Mar, professor of public health at Queensland’s Bond University. Professor Del Mar told MJA InSight that the latest research on antipsychotics showed that if doctors only read published research, they would get a biased view of these medications.

“This is another indication that, at the moment, our system for providing information to clinicians about the efficacy of commercially sensitive products is broken. More and more, it seems to look as if medical journals are simply becoming the marketing arm of commercial interests such as the pharmaceutical industry”, he said.

While the association between trial outcome and publication status in the latest research did not reach statistical significance — probably due to the low number of relevant trials — Professor Del Mar said the numbers speak for themselves.

He said although the publication bias in the latest analysis was not as strong as found for antidepressants or neuraminidase inhibitors, it was another example of the problem.

“We’re beginning to see a pattern that what goes through the regulators is not what we see in journals”, he said.

Professor Gordon Parker, Scientia professor of psychiatry at the University of NSW, said the latest analysis of antipsychotics showed that “if we are to rely on the evidence base, then we do need to examine the data from unpublished studies as well as published”.

However, he said the bigger issue was the real-world effectiveness of psychopharmacological drugs.

He cited the 2005 Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study, which unexpectedly found that a first-generation antipsychotic, perphenazine, performed generally as well as newer atypical antipsychotics, with fewer side effects. (4)
http://www.mjainsight.com.au/view?post=publication-bias-concerns-grow&post_id=8579&cat=news-and-research

The loss of trust in the medical profession

Although rarely explicitly stated, it’s expected that physicians will act with humanity, integrity and care. And, on an individual level, it seems that most do.
Those training as doctors also make a substantial personal investment of resources, time and intellect. Lengthy years of training coupled with high levels of individual responsibility and professional accountability are the norm.
In return for their efforts, doctors are given considerable professional autonomy, respect, social prestige and financial reward. As a result of their specialised knowledge – and the unique power that comes with it – they are afforded privilege and trust above that of many other professional groups.
This reciprocity is the basis of the social contract in medicine, which emerged in the 19th century. In return for status and financial rewards, physicians would meet the medical needs of society through service and altruism.

Threats to the social contract

The expectation of reciprocity inherent within this social contract still arguably influences how health care is funded and structured in this country. But the fundamental spirit of this contract appears under threat on a number of fronts.

In his recent analysis of Medicare expenditure, former director of the Professional Services Review (PSR), Tony Webber, noted that an estimated two to three billion dollars are inappropriately spent every year. Much of this, he claims, arises from misuse of medical benefits scheme funding by individual physicians and corporate owners of medical businesses. Such observations undermine public trust in doctors and in their social contract.

Regarding medical care purely as a business transaction places the clinical encounter at the intersection of commerce and science – away from its traditional place at the nexus of humanity and science. For the public, this may be seen as a moral shift that signals doctors will place self-interest above the common good.

Finally, high profile failures of the medical profession to effectively self-regulate (another benefit traditionally bestowed them under the social contract) have contributed to recent legislative change. The introduction of national registration now requires mandatory reporting of poorly performing, or impaired colleagues across Australia. Public perception that the profession as a group has failed to act in the public interest and effectively sanction unprofessional colleagues has further eroded public trust.
Sylvia Cruess notes, “The loss of trust in the medical profession (although not necessarily in individual physicians) comes from a better informed citizenry, which is demanding greater levels of accountability, more transparency, and greater assurance of quality. The greatest challenge to medicine’s professional status at the present time comes from the general public.”
If health care is a shared social good funded primarily through public investment, the public deserves a stronger role in determining how these goods are distributed. In the United Kingdom and in the state of Oregon in the United States stronger public participation in key areas of health care has been achieved with some success through citizen’s juries. Such models could be considered in Australia.


http://theconversation.edu.au/power-and-duty-is-the-social-contract-in-medicine-still-relevant-3941

End advertising for cosmetic surgery

This week an unlikely coalition of British feminists and plastic surgeons called upon the British government to end advertising for cosmetic surgery. They say cosmetic surgery adverts serve to ‘‘recklessly trivialise’’ invasive procedures that carry ‘‘inherent health risks’’.

http://www.dailylife.com.au/news-and-views/dl-opinion/normalising-breast-surgery-20120316-1va6v.html

http://www.guardian.co.uk/lifeandstyle/2012/mar/14/cosmetic-surgery-advertising-ban

scientific fraud was often misrepresented as the work of aberrant individuals

Aubrey Blumsohn, a senior lecturer in metabolic bone disease at the University of Sheffield, said scientific fraud was often misrepresented as the work of aberrant individuals.

But, he told the conference, “It is not rare, it is a group activity.” He said it could involve collusion between drug companies, researchers, journal editors, ghost writers, and regulators.

He said the mechanism for fraud was usually more nuanced than direct fabrication of scientific findings and involved techniques and behaviour that could “disturb the scientific record.”

He said the details of fraud often only emerged during litigation but that this “should not be the most important part of the process.”

http://www.bmj.com/content/344/bmj.e1526?etoc=

Healthcare is still plagued by statistical deception and bad science

Healthcare is still plagued by statistical deception and bad science that distort policy and put patients at risk, the Radical Statistics group’s annual conference heard on 24 February.

Senior academics said flawed and fraudulent use of data was having a malign effect and many parties were to blame, including the government, economists, drug companies, regulators, medical publishers, and researchers.

http://www.bmj.com/content/344/bmj.e1526?etoc=

Assaulting alternative medicine: worthwhile or witch hunt?

Fresh from its successes in the United Kingdom, the campaign to close down complementary and alternative medicine courses at universities is moving down under. A new group called the Friends of Science in Medicine wants to stop what it calls “pseudoscience” on campus, and vice chancellors at many of Australia’s universities are in its sights. So is this a reasonable reassertion of scientific principles or a bellicose, tribal attack on the competition?

Any “friend of science” would surely be horrified by much of what happens inside conventional medicine, yet the campaign in Australia is aimed solely at the complementary sector. One of the founders of the Australian campaign, the University of New South Wales emeritus professor John Dwyer, says that it is not a witch hunt and not about attacking practitioners or researchers: it is about ending the teaching of “pseudoscience.”

Alan Bensoussan, a complementary medicine researcher at the University of Western Sydney, says that although the Friends of Science in Medicine sounds innocuous enough, he fears it is an attempt to purge universities of learning about areas such as Chinese medicine, approaches that could produce new ways of dealing with some chronic diseases.
http://www.bmj.com/content/344/bmj.e1075.full?ijkey=zwFDDTnYJvF0ooA&keytype=ref

"I think the surgeons may not be aware of the long term consequences of denervation"

Email response from Dr. Ahmet Hoke of  John Hopkins School of Medicine,  School of Neurology - Specifically I asked him his opinion on three things:

1. What was his opinion of ETS in terms of risks vs benefits
2. His opinion on why Thoracic surgeons would advertise a surgical reversal approach when, as he sees it, it would  have a very low probability of success
3. His opinion on the Davinci Robot Reversal article regarding surgical reattachment of the sympathetic nerves

1. It all depends on the risk benefit analysis, for some patients yes it may make sense as not everyone develops as severe side effects.
2. I think the surgeons may not be aware of the long term consequences of denervation.

The paper you refer to is not a good model of what happens to the patients because they cut the nerve and immediately repaired it. In such immediate repairs, the ganglia does not loose it's neurons and can regenerate. A better model would be to cut the nerves, wait 6 months and then do the repair; I suspect the recovery would be a lot less.
Ahmet Hoke M.D., Ph.D. FRCPC
Professor of Neurology and Neuroscience
Director, Neuromuscular Division
Johns Hopkins School of Medicine
Department of Neurology
855 N. Wolfe St., Neurology 248
Baltimore, MD, 21205
USA

It is of concern that most mental health initiatives are associated with an increase in suicide rates

Aust N Z J Psychiatry. 2004 Nov-Dec;38(11-12):933-9.
http://www.ncbi.nlm.nih.gov/pubmed/15555028

"Pharma Collaboration", unreported in the Australian media, linked the Mental Health Council of Australia directly to global pharmaceutical giants

IN OCTOBER 2004, the nation's most influential mental illness advocacy group signed a deal that financially tied it to some of the world's biggest pharmaceutical companies.
The so-called "Pharma Collaboration", unreported in the Australian media, linked the Mental Health Council of Australia directly to global pharmaceutical giants Pfizer, Eli Lilly, Glaxo SmithKline, Bristol Myers Squibb, Lundbeck, Wyeth and Astra Zeneca.
It has been a good deal for the non-profit council, which promotes itself as Australia's peak mental health group, providing 8 per cent of its total income. It also seems to have benefited the drug companies, which have a strong financial interest in selling medication to treat mental illness, especially the "new epidemic" of depression.

http://www.theage.com.au/news/national/mental-health-takes-industry-pills/2006/08/07/1154802820416.html

Mental health funding lacks transparency

9% of the population of Australia is taking psychiatric drugs, 5% are on antidepressants. In USA 6% are on antipsychotics making them the most commonly prescribed drugs but information on our percentages is not available in Australia. About 1% of the population suffers from schizophrenia, http://www.schizophrenia.com/szfacts.htm 0.5% to1% from bipolar http://en.wikipedia.org/wiki/Bipolar_disorder (found by the WHO's epidemiological studies over scores of years and across cultures) and biological depression is rare and treatable. 40% of these tiny percentages of persons who do suffer from genuine schizophrenia or bipolar also have genetic mutations: they are hard to treat and require close monitoring with special care. The small number of persons being treated for mental illness diagnosed and confirmed before medication, comprise a tiny minority of those I see. It is the population with side effects that manifest as the huge increase in demand (and costs) since the first of the new generation drugs, Prozac, was introduced in 1990. An adverse response to the first drug or illicit substance should suggest that the patient might have a diminishing metabolism genetic polymorphism. This information can be gained, in retrospect, by taking a good history and a buccal swab. This problem is the outcome of the education of psychiatrists by the pharmaceutical industry, which fund key opinion leaders, guideline writers, beyondblue, Lifeblood, Sphere all organisations that provide psychiatric education that serves their commercial interests and are all funded by the Pharma Collaboration. This is in conflict with the altruism, the need to put patients first, that one associates with the practice of medicine and is in the realms of the unthinkable. http://www.theage.com.au/news/national/mental-health-takes-industry-pills/2006/08/07/1154802820416.html http://www.mhca.org.au/index.php/our-work/mhcapharma-collaboration Drug-company-funded Key Opinion Leaders write tomes on “intractable schizophrenia.” The relationship of drug side effects and genes shows that most persons so diagnosed are suffering from side effects, and only a few from side effects superimposed on pre-existing mental illness. www.trsconsensus.com.au Mental illness should first be diagnosed before treatment that has similar side effects is introduced. This also accounts for deteriorating outcomes in serious (read medicated) mental illness. The evidence from epidemiologists is that the death rate and suicide rate (and violence) have increased hugely for treated serious mental illness and are 20 times as high now as they were before we started medicating willy-nilly with no regard for genetics. I quote again from Akathisia Homicides http://www.dovepress.com/articles.php?article_id=7993. "Deteriorating outcomes in mental illness, deaths, violence, and suicide rates have been documented by epidemiologists and have increased up to 20-fold since 1924. http://bjp.rcpsych.org/content/188/3/223.long http://www.ncbi.nlm.nih.gov/pubmed/21172095 http://www.ncbi.nlm.nih.gov/pubmed?term=Do%20nations’%20mental%20health%20policies%2C%20programs%20and%20legislation%20influence%20their%20suicide%20rates http://www.arafmi.org/resource/tracking-tragedy-report-homicide-serious-injury-and-suicide-2008 http://www.epi.msu.edu/janthony/EpidemiologyReviewsPathopsychology/McGrath2008.pdf Some people taking psychiatric drugs develop akathisia and some people who develop akathisia kill themselves or others. Yet the drugs can be effective in persons suffering serious depression, provided their doses are adjusted according to their ability to metabolise them normally and there is informed monitoring.

http://www.mjainsight.com.au/view?post=mental-health-funding-lacks-transparency&post_id=7889&cat=issue-3-30-january-2012

Harm from mammography outweighs the benefits

Breast cancer screening cannot be justified, says researcher

Book argues harm outweighs small number of lives saved, and accuses mammography supporters of misconduct

Women in the UK are called for breast screening every three years from the age of 50. Photograph: Rui Vieira/PA

Breast cancer screening can no longer be justified, because the harm to many women from needless diagnosis and damaging treatment outweighs the small number of lives saved, according to a book that accuses many in the scientific establishment of misconduct in their efforts to bury the evidence of critics and keep mammography alive.
Peter Gøtzsche, director of the independent Nordic Cochrane Collaboration, has spent more than 10 years investigating and analysing data from the trials of breast screening that were run, mostly in Sweden, before countries such as the UK introduced their national programmes.
Mammography screening: truth, lies and controversy, from Radcliffe Publishing, spells out the findings of the Nordic Cochrane group for laywomen, rather than for scientists.
The data, Gøtzsche has maintained for more than a decade, does not support mass screening as a preventive measure. Screening does not cut breast cancer deaths by 30%, it saves probably one life for every 2,000 women who go for a mammogram. But it harms 10 others.

http://www.guardian.co.uk/science/2012/jan/23/breast-cancer-screening-not-justified

Bias in eye of beholder

There’s no doubt that doctors’ financial relationships with industry could be used — fairly or otherwise — to question their credibility.

In fact, this happened last week when Melbourne endocrinologist Professor Henry Burger and overseas colleagues published a re-evaluation of the results of the of the Million Women Study, disputing claims it showed a causal link between hormone replacement therapy (HRT) and increased breast cancer risk.

Predictably enough, the paper sparked a fiery debate. Some experts welcomed the finding; others disputed it and pointed to the authors’ financial relationships with manufacturers.

Dr Andrew Penman, of the NSW Cancer Council, told ABC radio the authors were “playing the game” of seeding doubt about well established scientific findings, “and you really do have to question their interest, given their association with the industry”.

No doubt, the HRT debate still has some distance to run, but the demand for greater public disclosure means doctors in all fields of medicine are likely to find themselves grappling with more of these kinds of conflict of interest allegations.

We humans are not very good at detecting our own biases, though we can be hyper-vigilant about those of others.

Studies in the past have suggested most doctors do not believe their own decisions are affected by industry gifts or payments — though they tend to be more sceptical about their colleagues’ ability to remain impartial.


http://www.mjainsight.com.au/view?post=jane-mccredie-bias-in-eye-of-beholder&post_id=7768&cat=comment

Confidence in research shattered

A REANALYSIS of evidence supporting the anti-influenza drug oseltamivir has undermined confidence in published research for one of the review authors, who has called for an overhaul of the way systematic reviews are conducted.

Professor Chris Del Mar, professor of public health at Bond University, Queensland, was one of seven Cochrane researchers who reanalysed the evidence for oseltamivir (Tamiflu) using primary trial data, much of which was unpublished. (1)

They found several inconsistencies with published reports, such as that oseltamivir did not reduce hospitalisations. The reanalysis also showed a possible underreporting of adverse events, although the drug was found to reduce duration of influenza symptoms by 21 hours.

Governments globally had spent billions of dollars stockpiling oseltamivir after a previously published analysis, funded by Roche, found that the drug reduced complications and hospital admissions. However, eight out of the 10 trials used in the Roche analysis were unpublished and their data sets were not available from either the authors or Roche. (2)

The researchers postponed an analysis of zanamivir (Relenza) evidence because its manufacturer, GlaxoSmithKline offered to provide individual patient data.

The Cochrane researchers found that 60% of patient data from oseltamivir trials had never been published, a fact Professor Del Mar described as “disgraceful”.

http://www.mjainsight.com.au/view?post=confidence-in-research-shattered&post_id=7790&cat=news-and-research

Bias in Medical Research by A. Indrayan

Bias are possible in many ways in a research activity. Please see some of the bias mentioned by A. Indrayan in the book, Basic Methods of Medical Research by AITBS Publishers, J-5/6, Krishan Nagar, Delhi - 110051.
Varieties of Bias
bias in concept
bias in design
bias in selection of subjects
bias due to concomitant medication or concurrent disease
instruction bias
length bias
bias in detection of cases
lead-time bias
bias due to confounder
contamination in controls
Berkson's bias
bias in ascertainment or assessment
interviewer bias or observer bias
instrument bias
Hawthrone effect
recall bias
response bias
repeat testing bias
mid-course bias
self-improvement effect
digit preference
bias due to non-response
attrition bias
bias in handling outliers
recording bias
bias in analysis
bias due to lack or power
interpretation bias
reporting bias
bias in presentation of results
publication bias

As you ought not to attempt to cure eyes without head, or head without body, so you ought not to treat body without mind.

Socrates, Ca. 400 B.C.

VISITING doctors are charging public hospitals up to $90 million each year for services they haven't performed

VISITING doctors are charging public hospitals up to $90 million each year for services they haven't performed, the state's auditor-general has found.
Visiting medical officers and staff specialists, including surgeons, who make up more than half the 13,000 doctors working in public hospitals, charge more than $500 million each year for their work in the public system.
Public hospitals pay staff specialists, many of whom also run private practices, from $198,212 to $390,528 each year.
Some hospitals, which checked claims from visiting medical officers thoroughly, found errors in between 10 and 18 per cent of claims. The Audit Office of NSW estimates this rate is replicated across all public hospitals, many of which use ''minimal checks'' to support claims for payment.
The errors include multiple claims for the same patient service and for patients who were not in hospital on the day claimed.

Read more: http://www.smh.com.au/national/health/doctors-bill-hospitals-for-work-they-havent-done-20111214-1ouy4.html#ixzz1gbDylQzs

He was finally deregistered in September 2009, after he failed to pay his fees

Dr Hasil has a chequered history in Australia, including being investigated by Tasmanian police in relation to the unsolved 1995 murder of an Italian tourist, Victoria Cafasso.
The NSW Medical Board had ignored warnings from its Tasmanian counterpart that Dr Hasil lied about being jailed in Singapore in 1995 for domestic violence against his second wife, Rose Doyle, and registered him anyway.
Yesterday, the commission also told the tribunal he failed to notify the NSW Medical Board that he was convicted of high-range drink driving in September 2008.
He was finally deregistered in September 2009, after he failed to pay his fees. He was again convicted of high-range drink driving in October 2009 and has a conviction for assault.

He also sustained a major head injury from a fall in October 2009, which had resulted in a physical or mental impairment likely to affect his ability to practise medicine, Ms McNaughton said.
He failed the Royal Australian and New Zealand College of Obstetricians and Gynaecologists' assessments four times.
Connie Scholl said she had not recovered from the ordeal of allegedly being abused by Dr Hasil in 2002 while stitching her vaginal and anal area after birth, calling her ''horse woman'' after she kicked him in the face in pain.
Her written complaint to the commission alleges that, ''As Dr Hasil was getting up off the ground I heard him say to the midwives, 'stirrup the bitch' … it was also at this time that Dr Hasil said to me, 'you Australian women don't know how to have babies'''.
She alleged he forcefully put his hand on her vagina and said, ''Who is the boss now?''
Ms Scholl complained to Lismore hospital in September 2003, but it failed to act.
Ms Scholl said she was angry that none of the victims had received an apology from the hospital management and no one had been made accountable.

Read more: http://www.smh.com.au/nsw/rogue-obstetrician-faces-15-counts-of-abuse-malpractice-20111212-1orkv.html#ixzz1gMTbj5ac