Health experts with pharma links more likely to talk up risk

"A number of scientists on the World Health Organization’s (WHO) flu advisory committee, which monitors pandemics and provides guidance for governments, for example, have disclosed links with the pharmaceutical industry.

But given that the media can influence demand for pharmaceutical products and perceptions of risk, we set out to examine whether health experts commentating on swine flu more generally were also more likely to have links to drug companies.

Analysing UK newspaper coverage of the swine flu pandemic between April and July 2009 – the period in which the UK government was taking decisions on how best to respond to the emerging pandemic, including providing the public with vaccine and antiviral drugs – we looked for how often scientists were quoted in articles on the pandemic from a wide range of publications.

We then looked at these comments in more detail to see if scientists made an assessment of the risk to the public from swine flu, and if so, we compared these against assessments made by official agencies such as the Department of Health."

"We found that half of the health experts that commentated on the use of antiviral drugs or vaccine had competing interests. And scientists promoting the use of antiviral drugs were eight times more likely to have a competing interest than those that didn’t comment on their use. We also found that health experts with competing interests were six times more likely than those without to predict a higher risk to the public compared to official assessments."

https://theconversation.com/health-experts-with-pharma-links-more-likely-to-talk-up-risk-20108

Is sympathectomy safe and effective?

Well, it depends on who you ask.

We already know what the surgeons who offer the surgery have to say about it, as most of us was conned into having the surgery. We also know what these surgeons have to say about non-surgical options (ineffective, tedious, time-consuming, expensive, not permanent, resulting in disabling side-effects, very painful, useless - on one website patients are told that application of BOTOX requires general anaesthesia, just to scare them off that one... : http://archive.is/lSWd0 ). The question is answered very differently when you ask a medical professional who offers these non-surgical treatment options. Their advice and their version of FACTS always depends on the treatment and technique they have on offer. 

A very simple exercise: print out the texts from few of these websites and offer it to someone to read. Then let them guess what they think which treatment the medical professional is siding with, that is: which treatment is being offered and advertised by them. 

Here is a sample. You will most certainly detect that this medical professional is NOT offering ETS, as he selected different FACTS about the procedure and it's results.

http://www.lasertreatmentclinics.co.uk/Hyperhidrosis_Endoscopic_Sympathectomy/

and because you can never be safe enough, here is the archived version:

http://archive.is/ei7ft

from:
http://etsandreversals.yuku.com/topic/5658/Is-sympathectomy-safe-and-effective

Making all clinical data public is vital for better medical care

Making all clinical data public is vital for better medical care: "An article published in the journal of the British Medical Association, BMJ, earlier this week illustrates a devastating problem with the “evidence base” in the academic medical literature.

A large proportion of drug trials, particularly those sponsored by pharmaceutical companies, never get published, skewing our picture of drugs' effectiveness and safety."

'via Blog this'

Any sensible person or scientist knows that the drug laws are not based on the science of drugs

David Nutt: 'I was sacked, I was angry, I was right': "Any sensible person or scientist knows that the drug laws are not based on the science of drugs. And it’s a collusion among scientists, politicians, and to some extent the public, to ignore that. It is anti-establishment, but also not, in that it’s such an obvious thing. It’s like the emperor’s new clothes – someone needed to speak up."

'via Blog this'

Medical Students Examine Unconscious Patients Without Consent | Fox News

Medical Students Examine Unconscious Patients Without Consent | Fox News: "Australian and UK medical students carried out intrusive procedures on unconscious and anesthetized patients without first gaining consent, news.com.au reported Friday.

The unauthorized examinations included genital, rectal and breast exams, according to Australian women's magazine Madison, and raised serious questions about the ethics of future doctors.

The research, to be published in international medical journal Medical Education, describes -- among others -- a student with "no qualms" about performing an anal examination on a female patient because she did not think the woman's consent was relevant.

Another case is of a man who was subjected to rectal examinations from a "queue" of medical students after he was anesthetized for surgery.

The author of the study, Professor Charlotte Rees, voiced concerns about senior medical staff ordering students to perform unauthorized procedures, leaving the students torn between the strong ethics of consent in society and the weak ethics of some medical staff."

'via Blog this'

Epidemiology of medical error | BMJ

Epidemiology of medical error | BMJ: "The Harvard and Australian studies into medical error remain the only studies that provide population level data on the rates of injuries to patients in hospitals and they identified a substantial amount of medical error

In the United States medical error results in 44 000–98 000 unnecessary deaths each year and 1 000 000 excess injuries"

'via Blog this'

Pharma giant fined billions for fraud

GLOBAL healthcare giant Johnson & Johnson will pay more than $2.3 billion to settle allegations that it fraudulently promoted drugs and used kickbacks to promote sales.

In one of the largest healthcare fraud settlements in US history, J&J's criminal and civil fine covers allegations the company marketed risperidone (Risperdal) and other prescription drugs for uses not approved as safe and effective by the Food and Drug Administration (FDA).

The settlement further covers kickbacks J&J allegedly paid to physicians and pharmacies for prescribing and promoting those drugs, the US Justice Department said yesterday. 

Medical Observer

5tov 2013

MORE than 25% of large randomised clinical trials registered with ClinicalTrials.gov have not published any results

MORE than 25% of large randomised clinical trials registered with ClinicalTrials.gov have not published any results in medical literature or in the registry database, according to research published in the BMJ. The researchers examined 585 registered trials with at least 500 participants and which had been completed by 2009. They found 171 trials with a total of almost 300 000 participants had not been published. Industry-sponsored trials were the most likely to remain unpublished. Of unpublished trials, 78% had no results available in ClinicalTrials.gov. For trials where the recruitment status was listed as “completed”, 26% (132/513) remained unpublished, and 29 trials were described as “active, not recruiting”; with 10 of these unpublished. The BMJ authors said trial investigators and sponsors had an ethical obligation to study participants to publish trial results. “The lack of availability of results from these trials contributes to publication bias and also constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation”, they wrote. “Additional safeguards are needed to ensure timely public dissemination of trial data.”
http://www.bmj.com/content/347/bmj.f6104

Scientists voice fears over ethics of drug trials remaining unpublished

http://www.theguardian.com/science/2013/oct/29/scientists-fears-over-unpublished-drug-trials

"It is amazing how long an operation can ‘linger’ after it has been shown to be ineffective"

The 1959 sham surgery experiment (link) involved surgery on all of the participants, but half of them didn’t actually have the artery ligated, and the patients were ‘blinded’ to the type of treatment they received. Most patients in both groups felt better (in fact all patients in the study had improved exercise tolerance), but they were no more likely to improve if they had the surgery than if they had the sham surgery, showing that the treatment did not have a specific therapeutic effect, only a perceived effect. Basically, the operation didn’t work. The study was small (17 enrolled) which might make you think that it was not a powerful enough study to detect the advantage of surgery, but I can counter that with the observation that the patients in the placebo group actually did better than the (real) surgical group for most outcomes. A larger study may have been more conclusive about a difference between the groups: it might have been able to show us that the surgery was significantly harmful.

The good news is that the operation fell out of favour after publication of this study. Similar results from trials of knee arthroscopy for arthritis (link) have not resulted in a similar decrease in rates of surgery (definitely not in my country, anyway). It is amazing how long an operation can ‘linger’ after it has been shown to be ineffective (see my blog on blood letting here). We need to rely more on what the science tells us than on our gut feelings.

http://doctorskeptic.blogspot.com.au/2012/07/placebo-surgery-1-surgery-for-angina.html

List of predatory publishers:

http://scholarlyoa.com/2012/12/06/bealls-list-of-predatory-publishers-2013/

corruption is the greatest moral challenge facing medicine today

Bioethical debate tends to focus on controversial medical procedures, such as genetic modification, IVF, euthanasia and abortion. The latest issue of the Indian Journal of Medical Ethics questions this, arguing that corruption is the greatest moral challenge facing medicine today.

In the lead article, Dr Subrata Chattopadhyay asserts that, "undermining the moral vision -- and nobility -- of the art of healing, corruption is arguably the most serious ethical crisis in medicine today". Chattopadhyay says that corruption in medicine is common everywhere, though he focuses his home country of India.The corruption of disgraced former WMA president Ketan Desai is, it seems, indicative of endemic misconduct.

Other articles in the issue include a summary of corruption cases in several of the major pharmaceutical companies of Europe and the US and the declining ethical standards of the Indian Medical Council.

http://www.bioedge.org/index.php/bioethics/bioethics_article/10704

THE risk of fever in children after one dose of trivalent influenza vaccine could be more than three times higher than published data suggests

"THE risk of fever in children after one dose of trivalent influenza vaccine (TIV) could be more than three times higher than published data suggests, according to new research."

"Australian researchers sought to assess the baseline prevalence of fever following the 2010 ban on CSL’s Fluvax in children under five but the information was not available in English language journals."

"The review found that following one dose of TIV, the median average weekly risk of any fever (≥37.5 degrees Celsius) was 26% in unpublished trials compared to 8.2% in published papers."

Medical Observer,

Neil Bramwell, 30th Sept 2013

Unravelling madness

By Chris Barton

4:00 AM Saturday Apr 4, 2009

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Richard Bentall believes that patients should be given the choice to have drug treatment, rather than be coerced into it. Photo / Simon Baker

In 1993 Richard Bentall went a bit mad.

He voluntarily took an antipsychotic drug and at first thought he'd get through unscathed.

"For the first hour I didn't feel too bad. I thought maybe this is okay. I can get away with this. I felt a bit light-headed."

Then somebody asked him to fill in a form. "I looked at this test and I couldn't have filled it in to save my life. It would have been easier to climb Mt Everest."

That was the least of his troubles. Bentall, an expert on psychosis from the University of Bangor in Wales who is in New Zealand under the University of Auckland Hood Fellowship programme, developed akathisia - unpleasant sensations of inner restlessness and an inability to sit still.

"It was accompanied by a feeling that I couldn't do anything, which is really distressing. I felt profoundly depressed. They tried to persuade me to do these cognitive tests on the computer and I just started crying."

Volunteers were given either 5mg of the antipsychotic droperidol, 1mg of lorazepam, a type of tranquillizer, or a placebo.

"The experiment completely failed," says Bentall. "Because first, it's absolutely mind-bogglingly obvious to anybody after an hour whether or not they are taking an antipsychotic or a placebo - the side effects are so marked. There is no such thing as a placebo antipsychotic in that sense."

But it was the fact that most of the healthy volunteers who took the antipsychotic became so unwell, let alone do the cognitive tests, that meant the study couldn't continue. One psychiatrist became suicidal and had to be put under observation.

In his controversial book Let Them Eat Prozac Healy wrote about what the volunteers experienced. "It was not like anything that had happened to them before... Highly personal memories of previous unhappy times - broken relationships or loneliness - seemed to be flooding back. And if they previously held themselves responsible for these unhappy times, they seemed to hold themselves responsible for feeling the way they did now as well."

http://www.nzherald.co.nz/nz/news/article.cfmc_id=1&objectid=10565099&pnum=0

Story of antipsychotics is one of myth and misrepresentation

The way antipsychotics have been misrepresented, their benefits inflated, their dangers minimised, illustrates how what is presented as neutral and objective “science” may in fact conceal a whole array of political and commercial interests. The psychiatric profession wanted to present a new image to society and politicians wished to replace costly mental institutions with cheaper community care.

All of this has helped transform antipsychotic drugs from dreaded chemical straight-jackets to modern-day soothers, lining the coffers of the pharmaceutical industry along the way. It’s time we woke up.

"Serious effects have been obscured because the frank descriptions provided by early clinicians were replaced by a vision of the drugs as a cleverly targeted, sophisticated and essentially benign treatment. And despite no convincing evidence to support the theory, the view emerged that they work by reversing an underlying “chemical imbalance” or other such abnormality rather than by inducing an abnormal or altered state."

http://theconversation.com/story-of-antipsychotics-is-one-of-myth-and-misrepresentation-18306

Neuralgia due to sympathectomy common

Depending on the skill of the surgeon and difficulty encountered performing various intraoperative maneuvers, the incidence of complications following sympathectomy should be the same as that following any other extraperitoneal or extrapleural operation. However, a frequent complication following sympathectomy, and one which is apparently unrelated to operative technique, is that of postsympathectomy neuralgia.

This neuralgia is characterized by aching thigh pain after lumbar sympathectomy or aching shoulder and arm pain after cervical sympathectomy. The pain is intense in severity, sudden in onset and disappearance, and not related to any major neurologic manifestations.

Recently we have reviewed the files of the Vascular Surgical Service at the West Roxbury Veteran's Hospital and the literature on this condition. This report is a presentation of our findings.

Incidence  Pain following sympathectomy has been described as "an all too common complaint."⁸ Reports have varied in incidence from 2.1% to "practically every case."

http://archsurg.jamanetwork.com/article.aspx?articleid=560162

"no primary data can be located, and no evidence has been found that the study described in the article was conducted"

THE University of Queensland has been forced to ask a respected academic journal to retract a 2011 study on Parkinson's disease because there is no evidence that the research was ever conducted.

The Australian understands a whistleblower lodged a complaint about the study, whose lead author was former UQ professor Bruce Murdoch, an internationally renowned expert on speech and language disorders.

UQ vice-chancellor Peter Hoj said the university had asked the European Journal of Neurology to retract the paper, and it had agreed, on the grounds "no primary data can be located, and no evidence has been found that the study described in the article was conducted".

Professor Murdoch had run the university's Centre for Neurogenic Communication Disorders Research. He is no longer employed at UQ and could not be contacted last night.

There has been no finding of misconduct against anybody. The investigation is continuing.

Mr Hoj said the retraction meant the global scientific community would be alerted that the study could not be relied on for further research.

The study, Treatment of articulatory dysfunction in Parkinson's disease using repetitive transcranial magnetic stimulation, was published online by the journal in October 2011. Professor Murdoch was lead author, with a researcher from the Speech Science Laboratory at the University of Hong Kong also cited. 

http://www.theaustralian.com.au/higher-education/uq-pulls-study-on-lack-of-evidence/story-e6frgcjx-1226710106648

Doctors Who Profit From Radiation Prescribe It More Often, Study Finds

http://www.nytimes.com/2013/08/19/us/doctors-who-profit-from-radiation-prescribe-it-more-often-study-finds.html?_r=0

financial interests may unduly influence professionals’ judgments

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

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

Conflict of Interest in Medical Research, Education, and Practice

Released:

April 21, 2009

Type:

Consensus Report

Topics:

Biomedical and Health Research, Education

Activity:

Conflict of Interest in Medical Research, Education, and Practice

Board:

Board on Health Sciences Policy

Trials of skin cancer drug DZ13 suspended pending investigation at UNSW

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

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

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

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

Monday, 12 August, 2013

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

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

Surg Clin N Am 84 (2004) 717–734

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

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

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

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

www.frontiersin.org

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

WHO recommends Tamiflu, but has not vetted the Tamiflu data

The bottom line:

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

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

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

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

'via Blog this'

Doctor Skeptic: Evidence for bias

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

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

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

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

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

PLOS Medicine: Why Most Published Research Findings Are False

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

Patient awoke to doctors mistakenly preparing to remove her organs

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

Medical mistakes: A silent epidemic in Australian hospitals

ABC Radio “The World Today” 10 June 2013

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

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

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

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

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

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

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

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

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

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

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

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

Surgery death rate 'twice as high as thought'

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

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

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

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

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

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

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

Italian court rules MMR vaccine did trigger autism

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

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

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

Consumers lose out as TGA reform turns into a hot potato

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

'via Blog this'

Consumers lose out as TGA reform turns into a hot potato

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

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

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

'Deceitful' Big Pharma accused of putting lives at risk

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

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

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

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

Victims of faulty breast implants were let down by the TGA

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

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

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

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

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

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

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

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

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

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

'via Blog this'

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

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

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

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

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

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

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

'via Blog this'

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

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

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

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

'via Blog this'

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

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

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

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

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

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

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

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

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

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

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

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

Ethiopian women in Israel 'given contraceptive without consent'

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

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

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

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

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

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

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

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

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

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

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

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

Diclofenac is the third most popular NSAID in Australia."

Artificial sweeteners linked to higher diabetes risk in women

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

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

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

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

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

Medical Observer, 8th Feb 2013

BioEdge: German cleric apologises over rape victim mistreatment

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

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

BioEdge: Israel halts underhanded contraceptive injections for Ethiopian migrants

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

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

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

Discharge summaries get diagnosis wrong

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Pfizer to Pay Record 23 Billion Fine

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

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Flu Vaccine Increases Risk of Serious Pandemic Flu Illness

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

According to the Vancouver Sun:1

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

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

German doctors shaken by corruption allegations

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

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

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

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

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

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

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