Saturday, April 30, 2011

Legal immunity for experts questioned

THE quality of medical information provided by expert witnesses in legal proceedings is often poor, and may be improved if immunity against prosecution for experts is removed, according to AMA president Dr Andrew Pesce.

Dr Pesce’s comments come in response to a recent United Kingdom Supreme Court judgment that abolished immunity against prosecution for expert witnesses. (1)

Although Australia still provides immunity for expert witnesses, the British case could be used as a precedent if a similar case was brought here.

Dr Pesce said removing immunity might encourage experts to do a better job and therefore protect themselves from litigation. “I don’t think it would be a bad thing. It would make doctors focus on providing reports that were of good quality and that made arguments based on good evidence,” he said.

Although Australian expert witnesses currently have legal immunity, there have been instances where medical boards have taken disciplinary action against doctors who have provided erroneous advice.

Dr Pesce said he had substantial experience reviewing expert witness reports, and had written medical advice for about 12 legal cases.

“Too often in my reviews of some experts’ reports I see things that are not backed up by evidence. Often the information is wrong, and not only is it wrong, but there’s no evidence to support it at all.

“It might be opinion but they’re presenting it as fact,” he said.

- Sophie McNamara

MJA InSight

Thursday, April 7, 2011

A pill to enhance moral behaviour? Orwellian concepts not just fiction...

http://www.smh.com.au/technology/sci-tech/racist-angry-the-answer-may-be-in-a-pill-20110407-1d5c9.html


Researchers have become interested in developing biomedical technologies capable of intervening in the biological processes that affect moral behaviour and moral thinking, says a Wellcome Trust research fellow at Oxford University's Uehiro Centre, Dr Tom Douglas. He is a co-author of Enhancing Human Capacities, published this week. 


"Drugs that affect our moral thinking and behaviour already exist but we tend not to think of them in that way," he says. "[Prozac] lowers aggression and bitterness against environment and so could be said to make people more agreeable. Or oxytocin, the so-called love hormone ... 
increases feelings of social bonding and empathy while reducing anxiety. Scientists will develop more of these drugs and create new ways of taking drugs we already know about." 

Kahane does not advocate putting morality drugs in the water supply but does suggest that if administered widely, they might help humanity tackle global issues. 
"Relating to the plight of people on the other side of the world or of future generations is not in our nature," he says. "This new body of drugs could make possible feelings of global affiliation and of abstract empathy for future generations." 



Saturday, March 26, 2011

pharmaceutical industry officials acknowledged they were using prisoners for testing because they were cheaper than chimpanzees

By the early 1970s, even experiments involving prisoners were considered scandalous. In widely covered congressional hearings in 1973, pharmaceutical industry officials acknowledged they were using prisoners for testing because they were cheaper than chimpanzees.



As the supply of prisoners and mental patients dried up, researchers looked to other countries.
It made sense. Clinical trials could be done more cheaply and with fewer rules. And it was easy to find patients who were taking no medication, a factor that can complicate tests of other drugs.
Still, in the last 15 years, two international studies sparked outrage.
One was likened to Tuskegee. U.S.-funded doctors failed to give the AIDS drug AZT to all the HIV-infected pregnant women in a study in Uganda even though it would have protected their newborns. U.S. health officials argued the study would answer questions about AZT's use in the developing world.
The other study, by Pfizer Inc., gave an antibiotic named Trovan to children with meningitis in Nigeria, although there were doubts about its effectiveness for that disease. Critics blamed the experiment for the deaths of 11 children and the disabling of scores of others. Pfizer settled a lawsuit with Nigerian officials for $75 million but admitted no wrongdoing.
Last year, the U.S. Department of Health and Human Services' inspector general reported that between 40 and 65 percent of clinical studies of federally regulated medical products were done in other countries in 2008, and that proportion probably has grown. The report also noted that U.S. regulators inspected fewer than 1 percent of foreign clinical trial sites.
Monitoring research is complicated, and rules that are too rigid could slow new drug development. But it's often hard to get information on international trials, sometimes because of missing records and a paucity of audits, said Dr. Kevin Schulman, a Duke University professor of medicine who has written on the ethics of international studies.
These issues were still being debated when, last October, the Guatemala study came to light.
http://news.yahoo.com/s/ap/20110227/ap_on_he_me/us_med_experiments_on_humans

ongoing campaigns to have the treatment banned were supported by the lack of scientific evidence that it was neither safe nor effective


A comprehensive review of electroshock therapy (ECT) has concluded that the risk of damage caused by the procedure cannot justify its continued use in medicine.
The review of more than 100 previous studies and reports into ECT was carried out by two psychologists, Dr John Read of the University of Auckland and Professor Richard Bentall of the University of Bangor in Wales. Both are noted critics of electro shock treatment and the medical model used in psychiatry.
The findings, published in the December issue of the international scientific journal Epidemiologia e Psichiatria Sociale, state there is minimal support for the effectiveness of ECT in the treatment of depression or schizophrenia. In addition, it states there is no evidence of any benefits beyond the treatment period.
It concludes: “Given the strong evidence of persistent and, for some, permanent brain dysfunction ... and the evidence of a slight but significant increased risk of death, the cost-benefit analysis for ECT is so poor that its use cannot be scientifically justified.”

In a statement, Dr Read said the findings suggest that ongoing campaigns by ECT recipients to have the treatment banned were supported by the lack of scientific evidence that it was either safe or effective.
“If we took an evidence-based approach to the heated controversy about ECT it would be banished to the historical rubbish bin of previous treatments thought to be effective in the past, such as rotating chairs, surprise baths and lobotomies,” he said.
Prof Bentall added that the short-term benefits gained by a small minority could not justify the risks to which patients were exposed.
“The continued use of ECT therefore represents a failure to introduce the ideals of evidence-based medicine into psychiatry. This failure has occurred not only in the design and execution of research, but also in the translation of research findings into clinical practice. It seems there is resistance to the research data in the ECT community, and perhaps in psychiatry in general,” he said.
http://wellbeingfoundation.com/news.html

Monday, March 21, 2011

MEDICINE-related deaths are killing more people than heart attacks or cancer

About half a million Australians experience an adverse effect from their prescription medication every year, says pharmacist Ken Lee, whose study “How Safe is Your Prescription?” was launched at the Australian Pharmacy Professional Conference. His research shows about 190 000 hospital admissions a year are associated with medicines and their harmful side effects.


http://www.theaustralian.com.au/news/nation/medications-kill-more-than-cancer-or-heart-attacks/story-e6frg6nf-1226022801971

Thursday, March 17, 2011

26000 a year die of murder, 100000 of medical malpractice

" On the national front, the American Medical Association made headlines at its 1992 convention when it declared war against mur­der and pledged to launch a national campaign against violence. "Murders will continue to increase until we start treating it like a public health problem," one attendee was quoted as saying. "If this were due to a virus, the American people and its leaders would be shouting for a cure," said former Surgeon General C Everett Koop. They're right. No one can argue with their message.
The cause of this great crusade, this mobilization of resources, is that more than 26,000 people were murdered in this country last year. Twenty-six thousand deaths is certainly a cause for con­cern. But wouldn't the AMA be better served—and better serve the public—if it expressed outrage on behalf of the 100,000 Americans who die each year from medical abuse and neglect? Shouldn't a medical association feel some obligation to police its own ranks before it tries to police the streets? If the AMA views 26,000 murders as an epidemic, what does it call 100,000 victims of medical malpractice?"

" The Burt case shows that the best way—perhaps the only way under present circumstances—of forcing incompetent doctors out into the open is through the courts. The only way of subject­ing these practitioners to public scrutiny, and deterring malprac­tice is through the public attention attendant to lawsuits and trials. The courts have become the sole policing body for the med­ical profession, and malpractice lawyers have taken on the role of public prosecutors. Major lawsuits, with the major judgments that go with them, may not completely keep negligent physicians from practicing, but they are the one way that currently exists to deter these individuals from practicing their inept brand of medicine. "
Over the years, we have
given a lot of thought to why the medical profession adheres to this code of silence. What is it about this profession that causes it to protect its own at the expense of the public?"
Harvey F. Wachsman: Lethal Medicine
Publisher: Henry Holt & Co

We disagree that surgery and botulinum toxin are treatments of choice in severe cases of hyperhidrosis

The truth is exactly the opposite. Surgery is only rarely necessary, and the editorial quite properly warns of numerous surgical pitfalls, which include recurrence of hyperhidrosis, almost certain impotence, compensatory sweating, permanent neurological damage from anoxia, and death (their words). Botulinum toxin, which they recommend for axillary or plantar hyperhidrosis, requires 12 injections per axilla and 24-36 injections per foot. Even this horrendous procedure gives only 11 months' relief, and antibody formation may reduce long term efficiency.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1118569/

Iontophoresis should be tried before other treatments

Iontophoresis is easy to perform, effective in about 90% of patients in two studies with 54 and 30 participants, free of hazardous side effects, and well accepted by almost all patients.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1118569/

Wednesday, March 16, 2011

the Kuntz nerve played no part in the success or failure of ETS surgery

If you research the topic of ETS, you will come across various claims and counter-claims
about the importance or otherwise of the Kuntz nerve. The Kuntz nerve is a small nerve
fibre sometimes seen on the second rib not far from the main sympathetic chain. Its
function is not known in humans. Some web-sites on ETS claim success rates of up to
100% for facial blushing because they search for and destroy the Kuntz nerve(s). These
same people also claim to be able to correct failed ETS operations by reoperating and
destroying the Kuntz nerve.
At the meeting of the International Society for Sympathetic Surgery in Germany, May
2003, attended by a majority of the world’s experts in ETS surgery (including us), all but
one of the surgeons present were of the opinion that the Kuntz nerve played no part in the
success or failure of ETS surgery for facial blushing. We share this majority opinion.
www.lapsurgeryaustralia.com.au

"Sympathectomy is a technique about which we have limited knowledge, applied to disorders about which we have little understanding."

http://www.pfizer.no/templates/Page____886.aspx

Monday, February 14, 2011

Sympathectomy and fraud - HUGE BILL FRAUD CITED AT CLINICS

Twelve Blue Cross and Blue Shield plans, working with the F.B.I., said Friday that they had broken up an elaborate insurance scheme in which thousands of patients from 47 states were sent to California to undergo unnecessary surgical and diagnostic procedures, for which doctors filed more than $1 billion of fraudulent insurance claims. Insurance executives and law enforcement officials said that surgery clinics in Southern California typically paid recruiters $2,000 to $4,000 for each patient who received a medical procedure. The patients, they said, received rewards in the form of cash or discounts on cosmetic surgery.

to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy

In this paper we argue that the standard focus on problems of informed consent in debates about the ethics of human experimentation is inadequate because it fails to capture a more fundamental way in which such experiments may be wrong. Taking clinical trials as our case in point, we suggest that it is the moral offence of using people as mere means which better characterizes what is wrong with violations of personal autonomy in certain kinds of clinical trials. This account also helps bring out another important way in which the autonomy of the participants in clinical trials my be violated, even in cases where they have given informed consent to their involvement. Where relevant information about the trial is framed in such a way as to induce a patient's participation by appeal to their nonrational preferences, this is also a violation of their autonomy, and one which is distinct from a failure of informed consent. The underlying wrongness of both kinds of violations, we argue, is plausibly captured by the moral offence of using people as mere means.

MEDICAL EXPERIMENTATION, INFORMED CONSENT AND USING PEOPLE
DEAN COCKING 1 JUSTIN OAKLEY 1
1 Centre for Human Bioethics Monash University

Wednesday, February 9, 2011

vigorous entrepreneurial spirit that was undeterred by the ineffectiveness of their treatment methods

"The new-found experts developed therapeutic empires with a vigorous entrepreneurial spirit that was undeterred by the ineffectiveness of their treatment methods." (Bell DS, 1989)
Med J Aust 151 : 280-284

"It is a lie that sympatholysis may specifically cure patients

with unqualified "reflex sympathetic dystrophy". This was already stated by the father of sympathectomy, Rene Leriche, more than half a century ago.
...it is not an error, but a lie. While conceptual errors are not only forgivable, but natural to inexact medical science, lies, particularly when entrepreneurially inspired are condemnable and call for a peer intervention.

J. Neurology (1999) 246: 875-879

Monday, February 7, 2011

"we know that antibiotics are misused and overused"

Professor Cars was emphatic that although there are knowledge gaps in Australia, we must act now. “We can’t wait for the data; we know that antibiotics are misused and overused. We know that infection control could be improved without new information.

He attributed the causes of antimicrobial resistance to three things:
• indiscriminate use of antibiotics
• indiscriminate effects of antibiotics, ie, broad activity
• global spread of resistance facilitated by the rapid dynamics of gene transfer between bacteria as a result of travel, trade and poor sanitation and hygiene.

http://www.mjainsight.com.au

Even a surgeon who was convinced that he was not obtaining good results seldom gave up lobotomy

Medical profession is the noblest of all ! . Doctors are akin to God in many ways ! They have the potential to remove the sufferings of mankind . These are the often made quotes about doctors for many centuries. Today’s medical professionals are , a strained lot to fulfil their role expected of them .They have to maintain the social identity and earn enough to sustain their image in society. The onslaught of commercial and pseudo-scientific concepts have ruined the profession considerably.

Those were the days when the family physician concept was flourishing , where in a doctor was taking care of entire family. This concept has taken a different avatar now .

Now a doctor feels , once the patient is seen by him becomes his/her patient rather a property! This perception has grown in a malignant manner , many doctors do not refer to a specialist even in deserving cases fearing patient poaching .

This possessiveness of doctors about their patients leads to many of the unethical behavior .

My case . . .my patient . . . my fees , . . .this sort of approach though appeared good in the past , is rapidly becoming a liability for the patients .Lack of organised health care by private and Government sector also amplifies the issue .It is pathetic to note , at least Govt hospitals have some accountability , majority of private health systems do not have mortality or morbidity auditing .

http://drsvenkatesan.wordpress.com/2010/12/11/why-many-doctors-consider-patients-as-their-property/

Advertised drugs were supported by evidence that was neither "of reasonable quality, nor independent"

Prof Brown is from the Department of Emergency Medicine at Royal Brisbane and Women's Hospital, and the School of Medicine at the University of Queensland.

They said the ban followed discussions with fellow emergency medicine specialists, who had aired concerns such as:

- Advertised drugs were supported by evidence that was neither "of reasonable quality, nor independent".

- There were cases of "dubious and unethical" research practices by the industry, including "ghost authorship" where scientific papers do not disclose all of their authors.

- Academics could also face industry pressure to withhold negative research, and together this could "inflate views of the efficacy" of heavily promoted drugs.

The professors also said drug ads were counter to a medical journal's mission to provide objective data that enabled doctors to make judgments based on the best available evidence.

"Meanwhile doctors - and indeed journal editors - generally deny they are influenced (by the ads), yet clearly they are," they said.

http://news.smh.com.au/breaking-news-national/medical-journal-bans-drug-company-ads-20110203-1aev8.html

How doctors think...

Review RD09 (2010)

WELFARE OF ANAESTHETISTS

SPECIAL INTEREST GROUP

Australian and New Zealand College of Anaesthetists

Australian Society of Anaesthetists

New Zealand Society of Anaesthetists

WHY DON’T YOU HAVE YOUR OWN GP?

HOW MANY EXCUSES CAN YOU FIND?

HERE ARE 21 !

after Dr Peter Arnold

Australian Medicine November 1997

  1. Taking a health problem to another doctor lays me open to professional ridicule for not recognising, myself, that the problem is a) trivial or b) serious.
  2. I don’t believe that my symptoms really amount to much; they’re probably just something simple. If I wait awhile they will go away.
  3. If I take my symptoms to another doctor, my own diagnosis might be proved wrong!
  4. It would place me in a position where I would have to take the “submissive” role of patient and “counselee”, rather than my usually assertive role as doctor and counsellor.
  5. I wouldn’t know how to be a patient, being accustomed to being the doctor.
  6. Going to another doctor would make me dependent on someone else, when I am used to people being dependent on me.
  7. I would have to accept the other doctor’s opinion, whereas I would know more than he/she does on the subject. In particular I would know this patient better than he/she ever could.
  8. I can manage my own minor problems - if I’m seriously ill I refer myself to a specialist; why do I need a GP?
  9. I’m embarrassed at possibly having to discuss my anxieties about my health - I could be labelled a hypochondriac.
  10. I wouldn’t like my life insurance company to know about any illnesses I might have - they might load my policy. If I don’t consult another doctor, they’ll never know.
  11. I’m fearful of possibly being forced to disclose aspects of my personality or sexuality which I would rather remained secret
  12. Revealing my inner self to a colleague would place him or her at an unfair advantage in our competitive commercial world
  13. I know how I would manage a patient presenting with my problems. How can I accept a different way of going about it?
  14. Can I place my trust in another doctor, whose training and experience may not be as good as my own? I can accept that a specialist would know more about his/her field of practice than I would (unless he/she is in the same speciality) but how can I accept that a GP might know more than I do?
  15. How much do I discuss management, suggest investigations or referral to a specialist? After all, this is the age of patient-doctor partnership. Shouldn’t I have a say in my own management?
  16. Any GP would be intimidated by having to attend to me (especially if I am a specialist); he/she would not be able to treat me objectively.
  17. How well will the GP respect my confidentiality? Will he or she mention me to a spouse? Indeed the spouse might well be the receptionist! How would that affect our relationship, especially in our close-knit neighbourhood?
  18. It isn’t convenient to find the time to see a GP; I’ve got too much work to do looking after my own patients.
  19. How do I make an appointment without being embarrassed about having to front up to the receptionist? Do I sit in the waiting room with the other patients, some of whom may have been MY patients too ?
  20. How confidential will my records be? Will the receptionist read them?
  21. How do I pay the bill? Do I ask to be bulk-billed, or do I pay, and if so at what rate? Do I give a present in appreciation? If so, do I keep giving presents?

http://www.anzca.edu.au/fellows/sig/welfare/review-rd09-why-don2019t-you-have-your-own-gp.html

Medical schools act on pharma influence

Professor James Angus, president of the Medical Deans Australia and New Zealand (the peak body representing medical education in the two countries), said he would address the issue at the next executive meeting of deans later this month.

He was commenting on the results of a survey of 20 Australian medical schools, which assessed their policies regarding disclosure and management of conflict of interest with the pharmaceutical industry, published in the latest MJA.(1)

Coauthor of the study Professor Martin Tattersall, professor of medicine at the University of Sydney, said he suspected there would be some reform and further attention to policies as a result of publication of the study.

However, the current generation of doctors employed in universities, hospitals, public health departments and elsewhere also needed to be much more transparent to their employers and patients about their conflicts of interest, Professor Tattersall said.

“I think the current environment is probably doing medicine and the medical profession a fair amount of harm,” he said.

1. MJA 2011; 194: 121-125.

High doses of common painkillers increase stroke risk

British Medical Journal study links ibuprofen to highest risk of stroke over long term.

The fears relate to non-steroidal anti-inflammatory drugs as well as newer anti-inflammatory drugs known as Cox-2 inhibitors.

Doctors regularly prescribe such drugs to treat painful conditions, including osteoarthritis.

They are given at much higher doses than those found in over-the-counter remedies, which are used for occasional headaches, aches and pains.

The study, in the British Medical Journal, found that compared with a dummy drug lumiracoxib increased the risk of heart attacks, while ibuprofen was linked to the highest risk of stroke (more than treble the risk).

Diclofenac almost tripled the risk, while etoricoxib and diclofenac were associated with around a fourfold increased risk of suffering death from cardiovascular causes.

The authors, from the University of Bern in Switzerland, said: "Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms."

http://www.guardian.co.uk/science/2011/jan/12/high-doses-painkillers-stroke-risk

Fraud Case Rocks Anesthesiology Community

In what experts are calling one of the largest known cases of academic misconduct, a leading anesthesiology researcher has been accused of falsifying data and other fraud in potentially dozens of published studies.

Scott S. Reuben, MD, of Baystate Medical Center in Springfield, Mass., a pioneer in the area of multimodal analgesia, is said to have fabricated his results in at least 21, and perhaps many more, articles dating back to 1996.


A recent PubMed search for Dr. Reuben’s name turned up 72 citations, the most recent an article in the December issue of the Journal of Cardiothoracic and Vascular Anesthesia on preventing the development of chronic pain after thoracic surgery.

What’s particularly surprising given the dimensions of the case, Ms. Johnston said, is that Dr. Reuben’s research managed to raise no alarms among peer reviewers. However, she added, “the peer review system can only do so much. Trust is a major component of the academic world. It’s backed up by the implication that your reputation will be destroyed if you violate that trust.”
http://www.anesthesiology...;a_id=12634&ses=ogs



Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances.
http://www.masslive.com/n...uben_former_chief_o.html

the scope of the Reuben fraud “massive.”

The retractions came after an internal investigation by Baystate turned up evidence of widespread fraud in Dr. Reuben’s research. Jane Albert, a spokeswoman for Baystate, said the inquiry was undertaken after an internal reviewer at the medical center had raised questions last year. Ms. Albert said the hospital’s investigation raised “no allegations concerning any patient care. This was focused on academic integrity.”

A recent PubMed search for Dr. Reuben’s name turned up 72 citations, the most recent an article in the December issue of the Journal of Cardiothoracic and Vascular Anesthesia on preventing the development of chronic pain after thoracic surgery.

Josephine Johnston, an attorney specializing in research integrity at the Hastings Center, in Garrison, N.Y., called the scope of the Reuben fraud “massive.”
http://www.anesthesiologynews.com/ViewArticle.aspx?d_id=3&a_id=12634&ses=ogst

6% admitted failing to present data if it contradicted their previous research

Firstly, if you're planning a career in scientific fraud, then medicine is an excellent place to start.

Findings in complex biological systems - like "people" - are often contradictory and difficult to replicate, so you could easily advance your career and never get caught.

And fraud is not so unusual, depending on where you draw the line. In 2005 the journal Nature published an anonymous survey of 3,247 scientists: 0.3% admitted they had falsified research data at some point in their careers, in acts of outright fraud; but more interestingly, 6% admitted failing to present data if it contradicted their previous research.

Reuben (Scott S Reuben) was at the other end of the scale. He simply never conducted various clinical trials he wrote about for 10 years.

In some cases he didn't even pretend to get approval to conduct studies on patients, but just charged ahead and invented the results all the same.

The details haven't come out yet - investigators have asked various academic journals to formally withdraw at least 21 studies - but fabrication is often easier to spot than selective editing, and some people have argued for various fraud detection tools to be used more commonly by academic journals.

...

And in medicine, data isn't an arbitrary or abstract thing: Reuben's work examined the best way to manage pain after operations, and he provided evidence that non-opiate medications are equally effective.

Now that field is in turmoil. And pain really matters.

http://www.guardian.co.uk/commentisfree/2009/mar/14/bad-science-medicine-fraud

Sunday, February 6, 2011

fraud and bias in medical research - BMJ 12 Feb 2009

Because of the massive quantity of material published each month in medical journals, readers of those journals are likely to focus on reading the prestigious ones. Readers are likely to assume that these prestigious journals would be less likely to have an industry bias in their selection of articles for publication. That assumption is questionable, at least in the UK, according to a new study published in the British Medical Journal (12 Feb 2009).

Dr. Ben Goldacre writes:

The British Medical Journal this week publishes a complex study that is quietly one of the most subversive pieces of research ever printed. It analyses every study ever done on the influenza vaccine - although it's reasonable to assume that its results might hold for other subject areas - looking at whether funding source affected the quality of a study, the accuracy of its summary, and the eminence of the journal in which it was published....

We already know that industry-funded studies are more likely to give a positive result for the sponsors' drug, and in this case too, government-funded studies were less likely to have conclusions favouring the vaccines. We already know that poorer quality studies are more likely to produce positive results - for drugs, for homeopathy, for anything - and 70% of the studies they reviewed were of poor quality. And it has also been shown that industry-funded studies are more likely to overstate their results in their conclusions.

But Tom Jefferson and colleagues looked, for the first time, at where studies are published. Academics measure the eminence of a journal by its "impact factor": an indicator of how commonly, on average, research papers in that journal go on to be referred to by other research papers. The average journal impact factor for the 92 government-funded studies was 3.74; for the 52 studies wholly or partly funded by industry, the average impact factor was 8.78. Studies funded by the pharmaceutical industry are massively more likely to get into the bigger, more respected journals.

http://www.guardian.co.uk/commentisfree/2009/feb/14/bad-science-medical-research

reporting bias is a widespread phenomenon in the medical literature

Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors.

Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions: depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma. Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication. The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions.In conclusion, reporting bias is a widespread phenomenon in the medical literature. Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale. This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.

http://www.ncbi.nlm.nih.gov/pubmed/20388211

Superior results in the leucotomized groups - Medical bias and conflicts of interest

Abstract

During the past two decades intracranial surgery for intractable mental disease has evolved in the direction of greater precision in and the making of smaller lesions. The most experience has been with bilateral stereotactically produced lesions of a few milliliters' volume in the white matter related to the limbic system. These have been placed just above the anterior half of the corpus callosum in the fibers deep to the gyrus cinguli or in the fibers below the anterior horns of the lateral ventricles or in both areas. Such operations have nearly eliminated the sequelae of the earlier much more extensive lobotomies. Critical and thorough evaluations in Great Britain of relatively small numbers of patients operated on compared with retrospectively matched controls not operated on have revealed superior results in the leucotomized groups. The mental disorders most clearly responding to this surgery appear to be those characterized by stereotypy of an excessive and futile emotional response — i.e., phobias, anxieties, obsessions, depressions and the affective component (when present) of schizophrenia. (N Engl J Med 289:1117–1125, 1973)

William H. Sweet, M.D., D.Sc.

N Engl J Med 1973; 289:1117-1125November 22, 1973

Friday, February 4, 2011

Lack of disclosure to ETS patients is unethical and would be criminal in a just society

It is the doctor's moral and ethical duty to provide you with full and honest disclosure of the facts prior to surgery. The whole doctrine of informed consent is to prevent patients from having to realize they made a mistake in hindsight. You shouldn't have had to find out from a former patient's wife that the surgery would cause drenching sweating on your back. It was Garza's job to do that. He completely lied to you regarding the supposed reversibility. Anyone who goes through medical school knows that can't crush a nerve with a metal clamp, remove it later and have the nerve return to normal functioning.

Although it is not possible to predict exactly what will occur in each individual case, there is nearly 100 years of published scientific and medical research available on the effects of sympathectomy. That research paints a very different picture of the effects of this surgery than the one presented to patients considering this surgery. That's the issue. Generally, they lie and tell patients that CS is inconsequential in all but a tiny fraction of cases and simply fail to disclose a huge number of verified adverse effects of the surgery. They take advantage of the patient's ignorance on medical matter. It's unethical and would be criminal in a just society.

In short, you do have a way of knowing what will likely occur as a result of the surgery before you have it done. All the information necessary to make an informed decision exists. It's just not getting to patients.

http://etsandreversals.yuku.com/reply/22927/Would-you-do-it-again#reply-22927

Surgical sympathectomy listed as neurologic disorder

Other neurologic disorders
- Idiopathic orthostatic hypotension
- Multiple sclerosis
- Parkinsonism
- Posterior fossa tumor
- Shy-Drager syndrome
- Spinal cord injury with paraplegia
- Surgical sympathectomy (the elective life-style procedure to treat blushing and hand sweating)
- Syringomyelia
- Syringobulbia
- Tabes dorsales (syphillis)
- Wernicke's encephalopathy
Dizziness: Classification and Pathophysiology
The Journal of Manual and Manipulative Therapy, Vol. 12, No 4 (2004)

Monday, January 31, 2011

Medical students are performing intrusive exams on unconscious patients

No consent: patients probed by medical students

AUSTRALIAN medical students are performing intimate examinations on unconscious and anaesthetised patients without their consent.

The shocking discovery, revealed in new research to be published in an international medical journal, raises serious questions about the ethical standards of our next generation of doctors.

It is expected to provoke a furious reaction from patient groups.

Unauthorised intimate procedures carried out by students included genital, rectal and breast exams. Almost half of patients were under the influence of medication or unconscious, while the remainder were conscious.

Among cases described in the research was that of a man who had been anaesthetised in preparation for surgery but was then unknowingly subjected to rectal examinations from a “queue” of students.

He hadn’t given consent beforehand.
http://madisonmag.com.au/news/no-consent-patients-probed-by-medical-students.htm

Saturday, January 22, 2011

DRUG company-sponsored trials published in medical journals should be regarded as marketing

DRUG company-sponsored trials published in medical journals should be regarded as marketing, unless proved otherwise, a researcher with the independent Cochrane Collaboration says.

In an article published in the British Medical Journal this week, researcher Tom Jefferson said that robust, independent assessments of drugs could not be carried out while companies were allowed to keep trial data secret on the basis that it is privately owned.

Mr Jefferson said it was vital that data be made freely available because trials and meta analyses of drugs in respected publications were ''heavily influenced by drug companies' marketing decisions on what is and isn't published''.


http://www.theage.com.au/national/sponsored-drug-trials-under-fire-20110121-1a02a.html

Sunday, January 16, 2011

medical sects and cults that propagate the Absurd

“...when irrational beliefs are shared with a surrounding community of sympathetic thinkers, errors become institutionalized. Thus are generated medical sects and cults that propagate the Absurd....
The guardians that usually keep the institution of medicine from reeling off into irrationality are social contracts built into medical science and ethical behavior. The academic community guards the contractual borders of science, while laws and regulations encode our ethical system. For the Absurd to have advanced, there must have been some breakdown of these social guardians.”
Propagation of the Absurd: demarcation of the Absurd revisited
Wallace Sampson, MD Editor and Clinical Professor of Medicine, Stanford University
Kimball Atwood IV, MD, Anaesthesiologist; and Assistant Clinical Professor, Tufts University School of Medicine Medical Journal of Australia Dec. 2005

France pledges reform after diabetes drug scandal

French Health Minister Xavier Bertrand has promised a complete revamp of the country's medical regulatory system.

He was speaking after an official report said a diabetes drug which caused up to 2,000 deaths should have been banned 10 years earlier.

The drug - known as Mediator - should have been banned as early as 1999, when it began to emerge that it could cause heart disease, the report said.

Several other European countries and the US then withdrew it.

'Political connections'

But Mediator remained on sale in France for another 10 years.

Between 500 and 2,000 people in France are believed to have died because of its side effects.

It was developed to treat diabetics but millions of people took it simply to lose weight.

The report by a government agency, the Social Affairs Inspectorate, said it was incomprehensible that the authorities had failed to act sooner.

Mr Bertrand said it was now his duty to rebuild the regulatory system to protect the public.

His statement is being seen as an admission that one of the biggest medical scandals in France in recent years may not be an isolated case.

http://www.bbc.co.uk/news/world-europe-12200506

Wednesday, January 5, 2011

Why many doctors* consider patients as their property ?

Medical profession is the noblest of all ! . Doctors are akin to God in many ways ! They have the potential to remove the sufferings of mankind . These are the often made quotes about doctors for many centuries. Today’s medical professionals are , a strained lot to fulfil their role expected of them .They have to maintain the social identity and earn enough to sustain their image in society. The onslaught of commercial and pseudo-scientific concepts have ruined the profession considerably.

http://drsvenkatesan.wordpress.com/2010/12/11/why-many-doctors-consider-patients-as-their-property/

Monday, December 20, 2010

Deadly Medicine: FDA Fails to Regulate Rapidly Growing Industry of Overseas Drug Testing

Pharmaceutical companies are increasingly conducting clinical trials for new drugs outside the U.S., usually in countries where regulations are less stringent and trials are much cheaper, often leading to deadly results. Twenty years ago, only 271 trials of drugs intended for use by Americans were conducted overseas. By 2008, the number had risen to nearly 6,500—many taking places in areas with poor and illiterate test subjects. Journalist Jim Steele joins to talk about his special investigation just published in Vanity Fair.
http://www.democracynow.org/2010/12/17/deadly_medicine_fda_fails_to_regulate

Sunday, December 19, 2010

Call for ban on shock therapy

Jill Stark
December 19, 2010

    ELECTRIC shock therapy may cause permanent brain damage and long-term memory loss and should no longer be used as a treatment for mental illness, researchers say.

    Psychologists who analysed more than 100 studies of the controversial treatment say the risks of shock therapy outweigh the benefits and it should be consigned to the ''historical rubbish bin'' alongside lobotomies.

    Electroconvulsive therapy, or ECT, induces seizures by delivering an electric current to the brain. It has divided the medical profession, with some arguing the practice is archaic and others maintaining it is highly effective and can be life-saving for severely depressed patients.

    Earlier this year, The Sunday Age revealed there had been a 10 per cent increase from 2008 to 2009 in the number of Victorians receiving ECT. A third underwent the procedure against their will.

    The review's lead author, John Read, of the University of Auckland, looked at placebo-controlled studies and concluded shock therapy had minimal effects for people with depression and schizophrenia.

    ''The dwindling numbers of psychiatrists who still use this procedure, which sends 150 volts through brain cells equipped to deal with tiny fractions of one volt, are no doubt well-intentioned, but the research just does not support them,'' Associate Professor Read said.

    The review, published this week in the journal Epidemiologia e Psichiatra Sociale, found almost all ECT patients suffered some amnesia. ''For a proportion of those people some of that memory loss is recouped over time,'' Associate Professor Read said. ''However, we are now seeing that for a significant proportion of people that brain dysfunction is permanent. ECT can, for a minority of people, produce some very short-term benefits; it can lift people's mood quite quickly.

    ''The problem is that there's no evidence at all that that benefit lasts beyond the end of the period that you're giving the electric shock treatment for.''

    However, eminent psychiatrist Ian Hickie, executive director of the Brain and Mind Research Institute, said the findings were ''ridiculous'' and that while previously it was presumed that ECT caused memory loss, advances in brain imaging had shown the patient's depression was often to blame.

    ''The relative safety of ECT has actually improved over time and there have been major changes in the way it is delivered to minimise the risks,'' Professor Hickie said.

    ''This review is completely out of step with the last decade of systematic neuroscience and related clinical studies.''

    While shock therapy is not commonly given to young people, statistics from Victoria's Chief Psychiatrist show seven children under 17 were given a total of 46 ECT treatments last year. Associate Professor Read said this was particularly concerning because the brain was still developing.

    The Royal Australian and New Zealand College of Psychiatrists says ECT is one of the least risky medical procedures carried out under general anaesthetic and is beneficial in treating some serious mental illnesses.

    http://www.theage.com.au/victoria/call-for-ban-on-shock-therapy-20101218-191e2.html

    Flu vaccine to be thrown out

    AUSTRALIA'S remaining stock of swine flu vaccine will expire soon and will have to be thrown out, at a cost of $100 million.

    At the height of last year's pandemic, the federal government spent almost $200 million buying 21 million doses of Panvax H1N1.

    Just under half was distributed to doctors, with fewer actually used on patients. That leaves 3.8 million doses to be donated to the World Health Organisation and 7.8 million doses to be destroyed.

    A Health Department spokeswoman said the first batch of vaccine began to expire in October and the entire stock would expire by December 31. Expired vaccine will be disposed of as medical waste.

    Opposition Health spokesman Peter Dutton said the destroyed stocks represented huge waste.

    ''This is yet another rounding issue for this government,'' he said. ''The Gillard government just can't get the detail right. They have overreacted to a number of key issues and their response to this issue is going to cost taxpayers tens of millions.

    ''The government saw political advantage and they put their own spin ahead of patients' own interests.''

    Health Minister Nicola Roxon said at the start of the month Australia's pandemic phase had moved from ''protect'' to ''alert'', signalling the end of the swine flu pandemic here.

    http://www.smh.com.au/lifestyle/lifematters/flu-vaccine-to-be-thrown-out-20101218-191c2.html

    Tuesday, December 14, 2010

    WikiLeaks cables: Pfizer 'used dirty tricks to avoid clinical trial payout'

    Cables say drug giant hired investigators to find evidence of corruption on Nigerian attorney general to persuade him to drop legal action

    The world's biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable.

    Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996.

    Last year, the company came to a tentative settlement with the Kano state government which was to cost it $75m.

    But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government.

    The cable reports a meeting between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It states: "According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media."

    http://www.guardian.co.uk/business/2010/dec/09/wikileaks-cables-pfizer-nigeria?CMP=twt_gu

    Wednesday, November 24, 2010

    only 1% of the articles in medical journals are scientifically sound

    According to the editor of the British Medical Journal, Richard Smith, only about 15% of medical interventions are supported by solid scientific evidence.


    According to Professor David Eddy, of Duke University, only 1% of the articles in medical journals are scientifically sound and many treatments have never been assessed at all.


    The British Medical Journal (BMJ) website Clinical Evidence reports that, of the 2404 treatments they have surveyed, only 15% are rated as beneficial, while 47% are of unknown effectiveness.



    Where is the wisdom…? The Poverty of Medical Evidence

    By RICHARD SMITH, Editor of BMJ


    British Medical Journal 1991 (Oct 5); 303: 798–799


    Safety and Ethics in Healthcare

    "...professionals may adopt unreasonable practices. Practices may develop in professions, particularly as to disclosure, not because they serve the interests of the clients, but because they protect the interests or convenience of members of the profession. The court has an obligation to scrutinize professional practices to ensure that they accord with the standard of reasonableness imposed by the law."

    Incresingly, the question is not whether the defendant's conduct conforms with the practices of the profession, but whether it conforms with standards of reasonableness. (p. 150)

    "The right of patients self-determination is well entrenched both in law and in ethical codes. Respect for patient autonomy now occupies centre stage in medical ethics. In considering patient autonomy one needs to think about truth telling, confidentiality, privacy, disclosure of information and consent. Each is important and all have important implications for healthcare professionals." (p. 167)

    Safety and Ethics in Healthcare: A Guide to Getting it Right, By Bill Runciman, Alan Merry

    Published by Ashgate Publishing, Ltd., 2007