Doctor Skeptic: Fixing a hole

Doctor Skeptic: Fixing a hole: Migraine is common, affecting millions of people worldwide. A patent foramen ovale (PFO – a ‘hole in the heart’ that lets blood cross from...

This study of hype in press releases will change journalism | Science News

This study of hype in press releases will change journalism | Science News: "The most important thing to remember is that there are people, and sometimes patients, waiting on the end of the news cycle. “I wouldn’t be doing [healthnewsreviews.org] if I didn’t think that these kinds of messages and misleading conclusions and observations and statements made in many news releases have the potential — and indeed I think that potential is realized — of hurting people at the end of the food chain,” Schwitzer says. Everyone in the news cycle bears responsibility, in the end, for getting it right."



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Exaggeration in health science news releases - exaggerations communicated by reporters are frequently already present in press releases put out by academic institutions

Exaggeration in health science news releases & what we're going to do about it: "“For me, the takeaway from this study is that there are multiple messengers to blame when it comes to exaggeration in health care news stories. As we’ve shown at HealthNewsReview.org, journalists often need to do a better job of vetting scientific research in their stories. But according to these results, the exaggerations communicated by reporters are frequently already present in press releases put out by academic institutions. This suggests that press officers who write the releases, and the researchers who collaborate on them, are also key players when it comes to the promotion of misinformation.

The study authors make a great point, which is that if academic institutions are the ones initiating the introduction of misleading claims, then there’s a tremendous opportunity for them to improve the quality of health care news if they can change their ways. I think our new effort to review news releases will help with that transition, because it provides a level of accountability that’s been missing until now. I’m really excited to see that our instincts about the need for this service are being emphatically confirmed by these results.”"



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Evidence based medicine is broken | The BMJ

"How many people care that the research pond is polluted,5 with fraud, sham diagnosis, short term data, poor regulation, surrogate ends, questionnaires that can’t be validated, and statistically significant but clinically irrelevant outcomes? Medical experts who should be providing oversight are on the take. Even the National Institute for Health and Care Excellence and the Cochrane Collaboration do not exclude authors with conflicts of interest, who therefore have predetermined agendas.6 7 The current incarnation of EBM is corrupted, let down by academics and regulators alike.8"



http://www.bmj.com/content/348/bmj.g22

"the standards for the evidence are often low and tainted by commercial or personal interests"

In the eyes of doctors and the public, evidence-based medicine is the gold standard of clinic practice. If it’s based on evidence from trials and laboratories, it must be right.

However, evidence-based medicine has its critics, as a bilious outbreak of comment and letters in the BMJ demonstrated recently. Early last month a Glasgow GP, Des Spence, said that the system of EBM had been corrupted. “If we don’t tackle the flaws of EBM there will be a disaster, but I fear it will take a disaster before anyone will listen,” he wrote. 

How could anyone fault the notion of treatment based on scientifically validated evidence? No one. But the critics of EBM argue heatedly that the standards for the evidence are often low and tainted by commercial or personal interests. Dr Spence accuses drug companies of
manipulating the gold standard to their own benefit. “Today EBM is a loaded gun at clinicians’ heads. ‘You better do as the evidence says,’ it hisses, leaving no room for discretion or judgment. EBM is now the problem, fueling overdiagnosis and overtreatment.”
A number of letters pointed out that, while EBM had its flaws, doctors still need to exercise their clinical judgement. They write the prescriptions, not the drug companies.
Dr Spence was supported by Dr Miran Epstein, a medical ethicist at The London School of Medicine. He writes that “EBM “does not regard polluted information, whether it involves misconduct or not, as a sufficient condition for rendering disclosure inadequate. Thus, it lets informed consent degenerate into a legal fiction and the principle of autonomy into a cynical farce. Worst of all, it is perfectly ethical: being the codified expression of the collective conscience of our medicine, it naturally purports to be moral.” 

And he was supported by lawyer and ethicist Charles Foster, writing in the Practical Ethics blog. He believes that the editors of journals need the help of a regulator to sift the wheat from the chaff. “Journals can’t do it all. We need a cynical, skeptical, well-funded, well-staffed and ideologically very left-wing regulator. With huge teeth.” 

Evidence-based medicine comes under attack
by Michael Cook | 8 Feb 2014 |
tags: commercialization, evidence-based medicine
http://www.bioedge.org/index.php/bioethics/bioethics_article/10841 

Publication bias distorting evidence base, systematic reviews and clinical guidelines

For decades, the systematic review of published randomised controlled trials has been considered the gold standard in medical research, and this was what the original Cochrane reviewers did.

By combining data from all published trials on a particular subject, researchers are able to see effects in much larger numbers of people than would typically be included in a single trial, in theory making their conclusions more powerful.

In theory. The problem in reality is a small thing called publication bias.

Some trials are simply more likely to be published than others, potentially skewing the results of this kind of meta-analysis.

MJA InSIght, Monday, 14 October, 2013

Jane McCredie: Sharing evidence

"pharma giant used fictitious patient quotes to promote its fluticasone product"

"GLAXOSMITHKLINE is among three companies to be fined for breaches of Medicines Australia’s Code of Conduct after the pharma giant used fictitious patient quotes to promote its fluticasone product, Seretide.

MA said in its July–September quarterly report that the Code of Conduct committee dealt with allegations by Mundipharma that GSK’s promotional material on Seretide was false and misleading.

The committee said that while publishing fictitious patient quotes is itself a breach of the code, GSK had exacerbated its breach by placing the statements in quote marks beside the image of a young woman. 

“GSK had agreed during intercompany dialogue to make clear that the statements were not from real patients,” the committee said."

Medical Observer, 

False claims: Pharma companies fined

Warwick Stanley  3rd Nov 2014

“In no other area than Sympathetic Surgery, disagreement, conflicting opinion, different definitions and misleading interpretations of the data exist"

8th ISSS Symposium New York, 2009: 

“In no other area than Sympathetic Surgery, disagreement, conflicting opinion, different definitions and misleading interpretations of the data exist. Mainly regarding surgical indications, the level and extent of the procedure and results evaluation”.

ATS Expert Consensus for the Surgical Treatment of Hyperhidrosis powerpoint presentation  – October 6, 2012, XVI Congreso Boliviana de Cirugia Cardiaca, Toracica y Vascular, Santa Cruz de la Sierra, Bolivia.

http://cirugiadetorax.org/2012/10/09/vats-sympathectomy-for-hyperhidrosis-dr-jose-ribas-de-milanez-de-campos/

or:

https://archive.today/Q047q

medical procedures are misrepresented in the media

"If your patients rely on the mainstream media for medical advice, they may well think that cancer has been cured many times over, and have other inflated views about the benefits of new treatments and tests.

AND they probably would be shocked to learn about the potential downsides of many medical interventions, let alone costs.

That’s the conclusion of a comprehensive analysis of almost 2000 medical news items published in the US by print, online and television outlets between 2006 and 2013.

It was undertaken by the media watchdog Health News Review, and recently published in JAMA Internal Medicine (5 May, 2014). Most stories were judged unsatisfactory in how they covered the costs, benefits, harms and quality of the evidence supporting the new treatment or test, and how it was compared to alternatives.

“Drugs, medical devices, and other interventions were usually portrayed positively; potential harms were minimised and costs were ignored,” wrote the founder of Health News Review, Gary Schwitzer."

Melissa Sweet, Medical Observer, 24th Jun 2014

Lies, Damned Lies, and Medical Science

  http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/



Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong. So why are doctors—to a striking extent—still drawing upon misinformation in their everyday practice? Dr. John Ioannidis has spent his career challenging his peers by exposing their bad science. By David H. Freedman"



https://archive.today/bSQNG

Pharma marketing impacts on junior doctor prescribing

JAMA Network | JAMA Internal Medicine | Association of Marketing Interactions With Medical Trainees’ Knowledge About Evidence-Based Prescribing:  Results From a National Survey: "A 10-point higher industry relations index was associated with 15% lower odds of selecting an evidence-based prescribing choice (odds ratio [OR], 0.85; 95% CI, 0.79-0.92) (P < .001). There was also a significant association between the industry relations index and greater odds of choosing to prescribe brand-name drugs (OR, 1.08; 95% CI, 1.00-1.16) (P = .04).

Conclusions and Relevance  Among physician trainees, our survey showed an association between positive attitudes toward industry-physician interactions and less knowledge about evidence-based prescribing and greater inclination to recommend brand-name drugs. Policies intended to insulate trainees from pharmaceutical marketing may promote better educational outcomes."

most of the existing literature is geared towards assessing only the effectiveness of the surgical sympathectomy

"Given the fact that most of the existing literature is geared towards a) assessing only the effectiveness of the surgical sympathectomy procedures, and b) publishing only studies with positive results, adverse effects and complications are not systematically reported but rather as a secondary outcome. It seems, therefore, highly likely that the complications as reported here, are truly underestimated.



The study indicates that surgical sympathectomy, irrespective of operative approach and indication, may be associated with many and potentially serious complications."



Are We Paying a High Price for Surgical Sympathectomy? A Systematic Literature Review of Late Complications

http://www.jpain.org/article/S1526-5900%2800%2944124-6/abstract

Antiviral drug stockpile a waste of money, says study | smh.com.au

Antiviral drug stockpile a waste of money, says study | smh.com.au: "Governments around the globe may have wasted billions of dollars stockpiling antiviral drugs to use against an influenza pandemic, according to a damning review drawing on previously suppressed data.
Australia was one of several countries to stockpile the drugs known as Tamiflu and Relenza, believing they would reduce hospital admissions and complications of influenza, such as pneumonia, in the event of an outbreak of swine or bird flu.
But a review of data from trials involving more than 24,000 people, published on Thursday by the Cochrane Collaboration and the British Medical Journal, concluded the drugs were of only marginal benefit, shortening the duration of influenza symptoms by just half a day.
The review found no good evidence that the drugs prevented the spread of the virus between people, or any of its serious consequences, such as infections. It found Tamiflu increased the risk of psychiatric disturbances, renal problems, nausea, vomiting and headaches."



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US scientists were “accomplices after the fact” in Japanese doctors’ war crimes

BioEdge: US scientists were “accomplices after the fact” in Japanese doctors’ war crimes: "A fascinating answer appears in the Cambridge Quarterly of Healthcare Ethics. The broad outline of the story has been well documented, even if it is not widely known. To cut a long story short, the Americans struck a deal with the doctors. They traded immunity from prosecution for access to scientific information from the ghastly Japanese experiments – many of which are too grim to detail here. (If you have the stomach for it, a remorseful doctor describes, at the age of 90, some of his vivisection experiments in an article in the Japan Times.)

A report from US scientists who interviewed the staff of Unit 731 and the surviving records concluded that “Such information could not be obtained in our own laboratories because of scruples [sic] attached to human experimentation"



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BioEdge: The scandal of wasted research dollars

BioEdge: The scandal of wasted research dollars: "Twenty years ago, a British statistician complained in the BMJ that much medical research was “seriously flawed through the use of inappropriate designs, unrepresentative samples, small samples, incorrect methods of analysis, and faulty interpretation.” 

Today, says the BMJ’s former editor, the influential writer Richard Smith, the only word to be changed in that diagnosis is probably “much”. It should now be “most”. And he complains that the leaders of the medical profession are not interested in changing the situation."



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Evidence based medicine is broken - BMJ

Des Spence cites “poor regulation” as one of the phenomena that compound the profit-driven pollution of Evidence-Based Medicine (EBM).[1] He is not alone. This conception seems to be gaining in popularity.[2,3]

Indeed, the current regulation is handmaiden to the polluters, as this partial list of examples indicates:

• The regulation does not demand that the research agenda be driven strictly by patient needs, not corporate interests.
• It is silent about the adequacy of selection criteria, outcome measures, and statistical significance, three variables that are often used by the polluters to manipulate evidence.
• It says nothing about what should count as scientific and unscientific research. This lacuna allows the latter to take place too, provided, of course, that it labels itself as "scientific".
• The regulation introduces exceptions to the head-to-head rule, exceptions that allow the polluters to test every new drug against placebo or no treatment thereby showing us exactly what they want: efficacy, but not necessarily over the current treatment.[4]
• It does not ban regulators, health care institutions and medical professionals from having financial conflicts of interest. Worse than that, "transparency", the only thing it insists on and quite feebly so, gives both the doctor and the patient nothing but the misleading impression that they can make a truly informed choice.
• The regulation does not ban subject recruitment through financial incentives, a practice capable of introducing outcome bias.
• It does not ban seeding trials, i.e., marketing exercises concealed as scientific research.
• It does not ban manipulative advertising to both doctor and patient inside or outside "scientific" journals.
• It does not ban medicalisation and “me too” drugs.
• It does not regard polluted information, whether it involves misconduct or not, as a sufficient condition for rendering disclosure inadequate. Thus, it lets informed consent degenerate into a legal fiction and the principle of autonomy into a cynical farce.[5]
• Worst of all, it is perfectly ethical: being the codified expression of the collective conscience of our medicine, it naturally purports to be moral.

In light of these examples we should ask ourselves: If the polluters of medical knowledge can tick the ethical box, then what does that say about our ethic?

Having said that, the notion of poor ethic-regulation can be both misleading and self-defeating if it is taken to entail that an ethical-regulatory change could help purify EBM. This is not only false. It actually plays to the hands of the polluters.

The belief that there must be some truly humanistic ethic-regulation out there that could help purify EBM is totally absurd. As long as our medicine depends financially on and must buy its tools from the polluters — in short, as long as it remains under their thumb — it will reject such an ethic-regulation wholesale or, more dangerously, co-opt it to suit their interests. There can be no other option. If we wish to have a truly humanistic ethic, we should get ourselves a truly humanistic medicine first.

1 Spence D. Evidence based medicine is broken. BMJ 2014;348:g22.

2 Goldacre B. Bad Pharma. London:Fourth Estate, 2012.

3 Gøtzsche PC. Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare. London:Redcliffe, 2013.

4 WMA Declaration of Helsinki 2013; pt. 33.

5 Epstein M. Legal and institutional fictions in medical ethics: a common, and yet largely overlooked, phenomenon. J Med Ethics 2007;33(6):362-364.

http://www.bmj.com/content/348/bmj.g22/rr/680463

BioEdge: Evidence-based medicine comes under attack

BioEdge: Evidence-based medicine comes under attack: "evidence-based medicine has its critics, as a bilious outbreak of comment and letters in the BMJ demonstrated recently. Early last month a Glasgow GP, Des Spence, said that the system of EBM had been corrupted. “If we don’t tackle the flaws of EBM there will be a disaster, but I fear it will take a disaster before anyone will listen,” he wrote.

How could anyone fault the notion of treatment based on scientifically validated evidence? No one. But the critics of EBM argue heatedly that the standards for the evidence are often low and tainted by commercial or personal interests."

http://www.bioedge.org/index.php/bioethics/bioethics_article/10841

Does removing breast cancer affect survival?

Allow me to make an assertion: breast cancer survival is not influenced by surgical excision of the primary tumour. This goes against the prevailing wisdom that cancer is cured by removing it, but that kind of thinking is simplistic and at odds with much of the evidence. Lets walk through that evidence.

There is a theory that breast cancer is a systemic, rather than a local disease, and that local control (by surgery) does not influence the course of the disease regarding its ability to cause death. The common thinking about breast cancer is that it starts in the breast and spreads such that if you remove it early, and completely, you can be cured. This is the basis of breast cancer screening, but as I have discussed before, there is debate about whether screening reduces one’s risk of dying.

more:

http://doctorskeptic.blogspot.com.au/2014/01/does-removing-breast-cancer-affect.html

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."

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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."

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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."

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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."