"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

Australia has the highest rate of medical error in the world according to the World Health Organisation

http://www.medneg.com.au/truth.html

Police investigate first case of organ trafficking

POLICE are investigating their first case of organ trafficking in Australia as a global shortage of donors fuels the trade in humans for body parts.
The Herald understands that an elderly Sydney woman suffering from a kidney condition is suspected to have trafficked a younger woman from the Philippines with the intention of harvesting an organ.
It is understood the deal was allegedly made without the younger woman's full consent and discovered during screening interviews at a Sydney hospital before the procedure.

Read more: http://www.smh.com.au/national/police-investigate-first-case-of-organ-trafficking-20110727-1i0d7.html#ixzz1eslMH7ST

Patients should be informed about CT scan radiation exposure

“Hospitals should inform patients regarding the radiation exposure they have undergone during CT scans and other such tests rather than keep them in the dark, health experts said. A study conducted by AIIMS has found that doctors, including senior and junior residents, who regularly subject patients to X-rays and CT scans were ignorant of the harmful effects of radiation exposure.”

Pointing out that radioactive elements emitted from radiation transmit highly charged particles that can damage genetic blueprint of the cell, they said such exposure causes major health problems, including cancer.

“At times the cells can no longer function or repair itself and dies but occasionally the cell multiplies uncontrollably, taking the shape of cancer,” chairman of CT and MRI, Sir Ganga Ram Hospital, T.B.S. Buxi said.

http://www.thehindu.com/health/article2336489.ece

total of 481 cases alleged deficiencies in the informed consent process - 57% of these cases were against surgeons

Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008.

 

 

Results:

A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types — procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) — accounted for 46% of all cases.

http://mja.com.au/public/issues/195_06_190911/gog10379_fm.html

Patients could not consider these risks directly and manage their exposure to them on the basis of information about them

It is widely thought that, in order for medical procedures to be ethically justifiable in normal circumstances, patients must give valid consent for them. This is a central mechanism by which patients exercise control over their medical care and, by extension, their bodies and their lives.

Consent in medical contexts is a tricky topic, but the present case is quite clear: since patients were inadvertently exposed to improperly sterilized equipment, they could not consent even in principle. Reflecting on the pros and cons of having medical tests under these conditions and consenting on this basis was literally impossible. The result is that the powerful transforming effects of consent cannot be found here in any way.

Medical processes of getting consent from patients give patients a chance to exercise control over their bodies and treatment. In principle these processes give us the chance to control our lives actively by learning about risks and making decisions about just what to tolerate. Very often, however, we patients exercise control in the moral sense, accepting that there will be risks involved in medicine and absolving medical professionals for responsibility for these risks under certain defined conditions.
In the present case, patient control was undermined by the inadvertent nature of the exposure. Patients could not consider these risks directly and manage their exposure to them on the basis of information about them.
Nor could they absolve the physician and technicians of responsibility for them, as these risks were in principle unknowable to the patients.
By informing patients of their exposure to these risks after the fact, Ottawa Public Health recognizes that the control that patients deserve to have over their lives has been undermined.

Read more: http://www.ottawacitizen.com/health/Clinic+patients+couldn+properly+consent+procedure/5577783/story.html#ixzz1esFeRo3D

The duty to procure informed consent is among the pillars of medical and research ethics

The duty to procure informed consent (IC) from patients before any significant intervention is among the pillars of medical and research ethics. The provision by the doctor of relevant information about treatment and free decision-making by the patient are essential elements of IC. The paper presents cases of IC where the free decision about treatment is not causally related to the information provided, and claims that such cases pose a difficulty parallel to that presented by the Gettier Problem in epistemology. In analogy to the original problem with the concept of knowledge, these Gettier-type cases show an indeterminacy in the concept of IC: we either need to add some explicit additional condition of causal connection between information and consent, or else we should understand the concept in a new way—specifically, since the practice of autonomy necessarily involves some consideration of the relevant information, we must understand free consent in a way that no longer refers to patient autonomy.
http://jme.bmj.com/content/37/11/642.short

a negative study of Paxil in kids and was spun to make it sound like a positive study when it was published

We've previously on this blog discussed the case of Dr. Martin Keller at Brown University and his study of Paxil (paroxetine) in children:
http://brodyhooked.blogspot.com/2008/06/alison-basss-side-effects-another-hall.html
http://brodyhooked.blogspot.com/2011/02/universities-corporate-influence-and.html

Now, thanks to our esteemed colleague Dr. Roy Poses from Health Care Renewal blog, we're provided with this article from the Brown newspaper in which he's quoted:
http://www.browndailyherald.com/prof-s-study-linked-to-child-suicide-1.2673693#.TsZ44VbfWSo

Seems that our other esteemed colleagues at Healthy Skepticism have been after Brown to get the University's help to withdraw the Study 329 claiming that Paxil was safe and effective in children. They argue that the article continues to be cited and can be implicated in suicides in children prescribed Paxil. Brown basically has gone into hiding and has not responded to these overtures.

Thanks to the exposes noted in previous posts on this blog, we know that Dr. Keller received huge sums of money from Pharma; that Study 329 was originally by scientific standards a negative study of Paxil in kids and was spun to make it sound like a positive study when it was published; and that the published version was essentially ghostwritten by a company hack. At least that's what's now on the public record (Dr. Keller routinely refuses to comment), and if Brown knows a different version, it's about time they let us hear it.
http://brodyhooked.blogspot.com/

A Debate on Antidepressants

Finally, the British Journal of General Practice featured a pro-con debate over prescribing antidepressant drugs. Middleton and Moncrieff start off by noting that authoritative national guidelines suggesting that drugs be restricted to moderate-to-severe depression seem to have had little impact on profligate prescribing. They summarize recent research (as we have previously reviewed in this blog) that most antidepressants are nearly indistinguishable from placebo in their effectiveness, and that the theory that depression is fundamentally a disease of chemical imbalance in the brain has been vastly overblown. They conclude that since most of the good done by antidepressants seems to be a form of placebo effect, which relies on forming a strong therapeutic relationship with the patient and showing that one takes the patient's problem seriously, cognitive-behavioral psychotherapy is an excellent alternative to drug treatment and should be more widely used.

In reply, Anderson and Haddad basically change the subject and accuse Middleton and Moncrieff of saying a number of things that they don't say. From their doubting the serotonin theory of depression, Anderson and Haddad assume their opponents are guilty of mind-body dualism and dismiss entirely the role of neurotransmitters in mood. Responding to the claim that antidepressants show very little difference from placebo, Anderson and Haddad pounce on the fact that they show some difference from placebo and therefore the placebo effect cannot explain all of what they do. Anderson and Haddad then say, "[F]or individual patients who will not or cannot engage in other approaches, shouldn't this evidence allow at least a consideration of a trial of antidepressants?" This makes them appear reasonable and moderate and their opponents dogmatic, though Middleton and Moncrieff are far from ruling out antidepressant use in every case. Anderson and Haddad then add that psychological therapy will be a failure if you go to a lousy therapist--neatly ignoring all the evidence of the serious risks of antidepressants, in order to focus on the purported risks of psychotherapy!

Of these two sets of authors, one acknowledges receiving financial support from manufacturers of antidepressants. I'll let you guess which.

Middleton H, Moncrieff J. "They won't do any harm and might do some good": time to think again on the use of antidepressants? British Journal of General Practice 61:47-49, January 2011.

Anderson IM, Haddad PM. Prescribing antidepressants for depression: time to be dimensional and inclusive. British Journal of General Practice 61:50-52, January 2011.
http://brodyhooked.blogspot.com/

Systematic reviews of the effects of healthcare provide essential, but not sufficient information for making well informed decisions.

Andy Oxman writes:
Health professionals, patients, policymakers and the public all want to make healthcare decisions that are informed by the best available research evidence. This requires reliable summaries (systematic reviews) of the evidence of the advantages and disadvantages of our options. It also requires complex judgements.
Systematic reviews of the effects of healthcare provide essential, but not sufficient information for making well informed decisions.
Review authors and people who use reviews draw conclusions about the quality of the evidence (how confident we can be in the estimates of effects), either implicitly or explicitly. Such judgments guide subsequent decisions. For example, clinical actions are likely to differ depending on whether one concludes that the evidence that warfarin reduces the risk of stroke in patients with atrial fibrillation is convincing (high quality) or that it is unconvincing (low quality).
http://blogs.crikey.com.au/croakey/

it had been marketed intensively to surgeons on the basis of ''compelling'' but misleading claims

MICHELE STEGER is one of thousands of Australians whose ordeal with failing and poisonous hip implants was described by a Senate committee this week as ''intolerable and unacceptable''.

Not only had the product failed at rate several times higher than normal, the ill-functioning metal joint had spread toxic levels of chromium and cobalt into the tissue of her hip.
The Senate community affairs references committee said it believed ''insufficient information has been provided to consumers regarding concerns with the device. This is regrettable''.
Regret understates Mrs Steger's reaction when she learned in October 2010 that a previous implant that had caused her so much grief officially had been withdrawn from use 10 months previously.
The first hint she got that her DePuy ASR implant had been recalled in December 2009 came neither from her surgeon nor even health authorities.

Read more: http://www.smh.com.au/nsw/senate-finding-little-consolation-for-years-of-hip-pain-20111125-1nz64.html#ixzz1elw9TPyB

The practice of sympathectomy for treating neuropathic pain is based on very weak evidence. Furthermore, complications of the procedure may be significant.

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

http://summaries.cochrane.org/CD002918/cervico-thoracic-or-lumbar-sympathectomy-for-neuropathic-pain

Questions about safety and effectiveness of risperidone

Although it has been established that risperidone has good efficacy for reducing symptoms of DBD in the short term, its effectiveness over longer periods has not been determined and there are now significant questions in relation to safety.

In light of this, clinicians need to inform their patients (and parents) of the limitations of the evidence and the potential risks of using risperidone in the treatment of children with DBD.

Urgent investment is needed to make non-pharmacological interventions with established efficacy available to Australian families to prevent the onset and to reduce symptoms of disruptive behavioural disorder.
http://www.mjainsight.com.au/view?post=james-scott-michael-duhig-take-drugs-out-of-disorders&post_id=7141&cat=comment

multibillion-dollar cancer drug ineffective, harmful

THE Therapeutic Goods Administration will review the latest information available on a drug for advanced breast cancer but will not take it off the shelves following a ban on its use in the United States.
The US Food and Drug Administration revoked approval for Avastin on the grounds that it did not help patients with metastatic breast cancer to live longer, but exposed them to serious side effects such as high blood pressure and haemorrhaging.
The multibillion-dollar drug will remain on the market in the US as a treatment for other types of cancer.

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Avastin was approved in Australia by the TGA in 2008 for use in eligible women with advanced breast cancer in combination with the drug Paclitaxel.
But it is not subsidised through the Pharmaceutical Benefits Scheme for this use.

Avastin is also approved in Australia to treat a range of other cancers including metastatic colon cancer, renal cancer, small lung cell cancer and grade 4 glioma.
It is an antibody that binds to and blocks the action of a substance that helps tumours spread, called vascular endothelial growth factor.

Read more: http://www.smh.com.au/national/health/patients-continue-to-get-access-to-cancer-drug-banned-in-us-20111120-1npdf.html#ixzz1eHnpWWDE

Peer review and the corruption of science

Peer review is the process that decides whether your work gets published in an academic journal. It doesn't work very well any more, mainly as a result of the enormous number of papers that are being published (an estimated 1.3 million papers in 23,750 journals in 2006). There simply aren't enough competent people to do the job. The overwhelming effect of the huge (and unpaid) effort that is put into reviewing papers is to maintain a status hierarchy of journals. Any paper, however bad, can now get published in a journal that claims to be peer-reviewed.
The blame for this sad situation lies with the people who have imposed a publish-or-perish culture, namely research funders and senior people in universities. To have "written" 800 papers is regarded as something to boast about rather than being rather shameful. University PR departments encourage exaggerated claims, and hard-pressed authors go along with them.
Not long ago, Imperial College's medicine department were told that their "productivity" target for publications was to "publish three papers per annum including one in a prestigious journal with an impact factor of at least five.″ The effect of instructions like that is to reduce the quality of science and to demoralise the victims of this sort of mismanagement.
The only people who benefit from the intense pressure to publish are those in the publishing industry. Hardly a day passes without a new journal starting. My email inbox is full of invitations to publish in a weird variety of journals. They'll take just about anything. The US National Library of Medicine indexes 39 journals that deal with alternative medicine. They are all "peer-reviewed", but rarely publish anything worth reading. The peer review for a journal on homeopathy is, presumably, done largely by other believers in magic. If that were not the case, these journals would soon vanish.
But it isn't only quack journals that have failures in peer review. In June, the British Journal of General Practice published a paper, "Acupuncture for 'frequent attenders' with medically unexplained symptoms: a randomised controlled trial (CACTUS study)". It has lots of numbers, but the result is very easy to see. All you have to do is look at their Figure.
http://www.guardian.co.uk...rish-peer-review-science

patients might lose confidence if become aware of the `unknowns and risks' which might be revealed in medical and health records

The final report of the Professional Indemnity Review (PIR) also noted that doctors feared litigation. 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. [43]

http://www.aph.gov.au/senate/committee/clac_ctte/completed_inquiries/1996-99/medical/report/c02.htm

ONE in 15 medical practitioners registered to work in NSW has a criminal past

ONE in 15 medical practitioners registered to work in NSW has a criminal past, new figures reveal.
The first look into the criminal histories of 13,000 doctors, dentists, psychologists, nurses and pharmacists - many of whom were graduates and foreign medical professionals registering for the first time - has led to calls for further background checks.
There are 156,000 people working in NSW who have not been checked by police under the new system, which does not take into account driving infringements.

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The Minister for Health, Jillian Skinner, and the Australian Medical Association insist the industry is ''weeding out'' unsuitable people.
But eyebrows have been raised by the findings of the Australian Health Practitioner Regulation Agency, the national body established last year to replace a patchwork of more than 80 medical boards around Australia.
Of the 13,421 medicos checked by NSW police at the request of the agency, 936 - or 7 per cent - were found to have ''disclosable court outcomes'' such as convictions for theft, fraud and sexual offences. The figure was slightly higher than the national average of 6 per cent.

Read more: http://www.smh.com.au/national/health/doctors-with-a-dark-side-20111105-1n11m.html#ixzz1cs4xQ6KA

Breast cancer screening review set up amid fears risks outweigh benefits

http://www.guardian.co.uk/society/2011/oct/26/breast-cancer-screening-review-launched

lack of efficacy and safety data for paediatric flu vaccines in general

However, other experts believe the 2006 data should have been acted on, particularly as the rates of fever in children were almost double what had been seen in 2005 data from the same study.

“How a government agency can say it didn’t matter that the side-effect profile was twice what we saw before I find astounding”, said Professor Peter Collignon, professor of infectious diseases at the Australian National University.

Professor Collignon said the argument that the high rates of adverse events seen in 2010 were a one-off event linked only to the 2010 seasonal flu vaccine was becoming questionable.

“There’s enough evidence to show that at least fevers were occurring at higher rates at other times”, he said.

He said increases in fever rates, regardless of convulsion rates, were significant in their own right.

“You don’t have a febrile seizure unless you have a fever”, he said.

Professor Collignon said the bigger issue was the lack of efficacy and safety data for paediatric flu vaccines in general, based on long-term prospective studies involving thousands of children.

“Those studies haven’t been done and they need to be done.”

- Sophie McNamara
MJA InSight, 

1. Parliament of Australia: Community Affairs Legislative Committee, 19 October 2011

2. The Australian: Child’s fit escalates CSL flu jab row, 21 October 2011

3. MJA InSight: Fluvax PI omitted fever data, 17 October 2011

Posted 24 October 2011

if more than one child in 1000 has a febrile seizure, the vaccine is doing more harm than good

PUBLISHED research linking CSL’s influenza vaccine to high rates of fever in children was omitted from the product information for its 2010 Fluvax product, which caused serious adverse reactions in children.
The product information (PI) included data from the 2005 flu season showing that after receiving Fluvax, fever was experienced by 22.5% of children aged from 6 months to less than 3 years and 15.6% of children aged from 3 years to less than 9 years.

However, the PI omitted data from the 2006 season which showed that the rate of fever had increased considerably — to 39.5% in the younger age group and 27% in the older group. Of the 272 children who received the 2006 vaccine, one child in the older group experienced a febrile convulsion.

However, Professor Collignon said it was important to weigh the risks of the vaccine with the risks of influenza itself.

“By my calculations, if more than one child in 1000 has a febrile seizure, the vaccine is doing more harm than good”.

In 2010, Fluvax was found to be causally linked to a significantly increased rate of fevers and febrile convulsions among Australian children. One published estimate put the rate of paediatric febrile convulsions at 3.3 per 1000 doses, or more than 200 times the rate in the only other published population-based estimate. (3)
MJA InSight, 17 October 2011

CLINICAL practice guidelines are vulnerable to bias

CLINICAL practice guidelines are vulnerable to bias, with only 15% of NHMRC guidelines from Australia’s most prolific guideline developers including a declaration of conflicts of interest, new research has found.

Although a conflict of interest (COI) statement has long been required from authors of research papers, it is often lacking for developers of clinical practice guidelines, despite the influence of guidelines on clinical care.

The research, in the latest issue of the MJA, looked at more than 200 clinical guidelines that were listed on the NHMRC website. Its authors concluded that the NHMRC needed to “urgently promote a more ethically sound development process for guidelines”.

“Our review of the country’s most prolific guideline developers shows that only 15% of guidelines have COI statements”, they said.

“This raises questions about whether medical bodies are affected by unrecognised, and thus unaddressed, extraneous interests, and may erode the trust the community has in the profession to speak authoritatively about health problems.”
MJA InSight, 17 October 2011

Deceit and fraud in medical research

Deceit and fraud in medical research is a serious problem for the credibility of published literature. Although estimating its prevalence is difficult, reported incidences are alarming. The spectrum of the problem ranges from what may seem as rather innocuous gift authorship to wholesale fabrication of data. Potential factors which may have promoted fraud and deceit include financial gain, personal fame, the competitive scientific environment and scientific hubris. Fraud and deceit are difficult to detect and are generally brought to the fore by whistleblowers.
International Journal of Surgery
Volume 4, Issue 2, 2006, Pages 122-126
Usman Jaffer, and Alan E.P. Cameron

many claims in Australia do not result in payments to plaintiffs

However, as with the US research, many claims in Australia do not result in payments to plaintiffs. This fact often comes as a surprise to medical practitioners as it is not well publicised.

It is not a simple matter for a plaintiff to succeed in a claim for compensation based in medical negligence. And it certainly is an expensive exercise especially when there can be no guarantee of success.

For doctors involved in a claim that is successfully defended there is usually no direct financial cost.
Ms Cheryl McDonald is claims department manager with MIGA (Medical Insurance Group Australia).
 

MJA InSight, Issue 38 - 10 Oct, 2011

The dangers of DOGMA in medicine

'Physicians are quite as intolerant as theologians. They never had the power of burning at the stake for medical opinions, but they certainly have shown the will.'
Harriet Beecher Stowe, Little foxes (1865)

The cognitive "illusion of knowledge" also plays a role. We have to believe that we know the answer and that there is only one answer, the one we have. To accept that we do not know the answer, or that other people might know the answer while we do not, is emotionally challenging and calls into question our very professional essence. Best to believe that what we think we know is actually true.

Finally, in a world full of "experts", controversy and opinion, holding on to a dogma is reassuring and may well have  life-saving functions. Yet, dogma has a dark side and its dangers may be as great as its benefits. Doctors would do well to maintain a degree of cautious skepticism for both bold new fashions and received wisdom, whether generated by he world or by the self. They would do even better to question what they do, and see such questioning as an asset. It is everyone's responsibility to find out how to ask questions systematically, find answers from searching the literature, critically appraise the literature and apply the results to practice. 
www.mja.com.au/public/issues/195_07_031011/bel10866_fm.pdf
MJA195 (7) · 3 October 2011 

ECT Pamphlet Withdrawn in Australia

Written by Wayne Smith West Australia Desk    Dec 29, 2000 A +  A -  RESET

Distribution of a pamphlet on electroconvulsive therapy (shock treatment) published by the Mental Health Division of the Health Department of West Australia, has been discontinued, following a complaint. The pamphlet which was supplied to the public from six State operated shock facilities, the Guardianship and Administration Board, the Office of the Public Advocate and elsewhere, contained false and misleading information which served to recklessly misguide the most vulnerable members of the community, No Iframes and their family and friends. The pamphlet which carried the government seal, described ECT as a "small electric current," even though the strength of current in ECT, induced a grand-mal seizure and the Australian Safety Standards gives no such value as "small" to electric current. The pamphlet also claimed that "There is no medical evidence that the brain is damaged," even though the medical literature is littered with such instances from both the historic use and the modern method of ECT. In fact, there is a small added risk of brain damage in the modern method, from the anesthetic alone. The pamphlet and its content which "helps answer questions" was being used by psychiatrists in the process of obtaining 'informed consent' while avoiding the obligation of a truthful disclosure. As of October 2001, the pamphlet "Electroconvulsive therapy" catalogue No: HP6824 - has been given the official status, "OBSOLETE" For what it is worth, we are assured by the Health department today by phone, that they will not be publishing any information in the future on the topic of ECT. http://www.healthyplace.com/depression/shocked-ect/ect-pamphlet-withdrawn-in-australia/menu-id-1362/

Child shock therapy

CHILDREN younger than four who are considered mentally disturbed are being treated with controversial electric shock treatment.
Medicare figures show the use of Electroconvulsive Therapy has tripled in Victoria in the private health sector alone in six years.
A VicHealth report confirms more than 18,000 treatments were conducted in Victoria in 2007-2008.
Federal Government statistics show the use of ECT - an electric shock delivered straight to the brain - in the state's private health system increased from 1944 treatments in 2001-2002 to 6009 in 2007-2008.
About 12,000 treatments were performed in the public health system last financial year.
Medicare statistics record 203 ECT treatments on children younger than 14 - including 55 aged four and younger.
Two of the under-4s were in Victoria.

Last financial year, 6197 ECT treatments were given to Victorians against their will.
This news comes as the Western Australian Government moves to ban ECT procedures for children under 12.
The Victorian Government would not say if it would follow.
The figures have shocked some experts.
Prof Pat McGorry, chair of the National Youth Mental Health Foundation, said ECT treatment for children whose brains were still forming was worrying.
"That is of great concern, a very worrying trend and we need to know why," he said.
"Why has its use increased at that rate? I am shocked and amazed that children that young are being treated this way."
Though doctors are still mystified as to how it works, ECT is used to treat mental disorders such as manic depression and psychosis.
The figures show nearly three times as many women had shock treatment compared with men.
Side effects include memory loss, seizures and headaches.
Modern treatment involves anaesthetic before each ECT treatment, which occur at intervals during a few weeks.
http://www.heraldsun.com.au/news/victoria/child-shock-therapy/story-e6frf7kx-1111118657718

Shock therapy forced on patients

THE number of mental health patients forced to undergo electroconvulsive therapy in NSW has doubled in the past decade, and a lack of legal representation is leaving some of the state's most vulnerable patients without a say over their own treatment.
The case of one 84-year-old pensioner who did summon legal help to avoid ECT has highlighted a situation that leaves involuntary patients - and their families - powerless to challenge psychiatrists.
In NSW, involuntary ECT requires the approval of the Mental Health Review Tribunal. All mental health patients are entitled to a lawyer, but only one in 10 patients is represented in the tribunal's hearings.

The tribunal held 315 hearings for involuntary ECT in 1998. In 2007 there were 626 hearings. In that period legal representation in ECT hearings wavered between 4.9 and 8.9 per cent. Ninety-eight per cent of applications for involuntary ECT were approved.
The chief executive of the Public Interest Advocacy Centre, Robin Banks, said the wishes of involuntary patients were given little consideration. She believed the absence of lawyers was "a serious loss of freedom" and a situation that undermined Australia's commitment to human rights.
"A minimum protection within any decision-making process like this … should be that the person can have access to legal representation," she said. "It's a pretty basic right we're talking about: the right to control your own body and what treatment you receive."
The tribunal, too, would welcome more input.
"We can't force Legal Aid to give legal aid to everybody," said the tribunal's president, Greg James, QC. "[But] patients, the public and the tribunal would be much better off if legal aid were available. The whole reason we do this monitoring of ECT is to make sure the public can feel protected. There is a distrust in the community of such psychiatric treatments."

Read more: http://www.smh.com.au/national/shock-therapy-forced-on-patients-20090605-byi6.html#ixzz1Z7SySLdz

The influenza vaccine debate - 57% of 209 children aged 6–59 months who received CSL TIV experienced a febrile reaction, compared with 17% of 110 children who received another TIV

The 2010 trivalent influenza vaccine (TIV) manufactured in Australia by CSL Biotherapies (CSL) caused an excess of febrile reactions, including febrile convulsions, among Australian children.1 A retrospective cohort study conducted in Western Australia found that 57% of 209 children aged 6–59 months who received CSL TIV experienced a febrile reaction, compared with 17% of 110 children who received another TIV (P < 0.0001).1 The Australian Technical Advisory Group on Immunisation concluded that the rate of febrile convulsions among children vaccinated with the 2010 CSL TIV may have been as high as 1 per 100.2 The Therapeutic Goods Administration (TGA) stated that the cause of these reactions had still not been determined as of 8 July 2011.3

In the United States, CSL TIV was initially approved by the Food and Drug Administration (FDA) in 2007 for use in adults, and in 2009 for use in children aged 6 months and older.16 On 15 June 2011, the FDA issued a warning letter to CSL.17 After reviewing the US regulator’s findings, the Australian regulator (the TGA) concluded that, “The two regulators are in agreement over the problems identified at CSL”.3 The FDA highlighted potential issues with the splitting procedure used by CSL.17 According to the FDA, sodium taurodeoxycholate lots that failed identification tests at CSL were nonetheless accepted for use. The FDA also stated that CSL “failed to determine optimal splitting conditions for new virus strains before the strains [were] used in production” and that “the tests used to evaluate the completeness of virus splitting [were] deficient” as the assays used were not “validated for their ability to discriminate between split and whole virus”.17 These concerns, together with the previous Canadian and European experiences, suggest that incompletely split virus, and perhaps other factors related to the use of deoxycholate, provide a plausible explanation of the AEFI associated with the 2010 CSL TIV.
http://www.mja.com.au/public/issues/195_06_190911/kel10941_fm.html