Toronto doctor sentenced for abusing sedated patients

Anaesthesiologist George Doodnaught (Toronto police)

A Canadian doctor who sexually assaulted 21 sedated patients while they helplessly watched has been sentenced to 10 years in prison.

Anaesthesiologist George Doodnaught, 65, abused the women, aged 25 to 75, while they were in his care.

The victims testified that they had been conscious when Doodnaught kissed, fondled and assaulted them, but they were unable to move.

All but one of the attacks occurred at North York General Hospital in Toronto. Continue reading “Toronto doctor sentenced for abusing sedated patients”

Subclinical deficiencies of vitamin C and D have each been linked to psychological abnormalities

Public release date: 23-Sep-2010 HRR: Requested Repost

– Patients administered vitamin C had a rapid and statistically and clinically significant improvement in mood state

“About one in five acute-care patients in our hospital have vitamin C levels so low as to be compatible with scurvy,”

Happy Smiley Face from Urine Samples

Subclinical deficiencies of vitamin C and D have each been linked to psychological abnormalities

Simple treatment may counteract widespread problem of subnormal vitamin levels in acute-care patients Continue reading “Subclinical deficiencies of vitamin C and D have each been linked to psychological abnormalities”

Staying on medication had surprisingly little effect lowering hospital readmission rates

Contact: Sarah Avery 919-660-1306 Duke University Medical Center

Staying on medication may not translate to avoiding readmission

DURHAM, N.C. – A targeted effort to help high-risk heart failure patients stay on their medications did improve adherence to drug regimens, but had surprisingly little effect lowering hospital readmission rates, according to a study at Duke Medicine.

The findings, presented Monday at the American Heart Association’s Scientific Sessions meeting in Dallas, suggest that medication management is just one of many issues facing patients most at risk for their conditions to worsen.

Continue reading “Staying on medication had surprisingly little effect lowering hospital readmission rates”

U.S. hospital ICU admissions up 50 percent since 2002

Published: May 15, 2013 at 10:25 PM
 WASHINGTON, May 15 (UPI) — Admissions to U.S.  hospital intensive care units jumped 50 percent from 2002 to 2009, but  researchers are not sure why.

Lead author Peter Mullins of George Washington University’s School of Public Health and Health Services and colleagues found  ICU admissions rose from 2.79 million in 2002-03 to 4.14 million in 2008-09. For  the same time period, overall emergency department admissions grew by only 5.8  percent.

“These findings suggested emergency physicians were sending more patients on  to the ICU,” Mullins said in a statement. “The increase might be the result of  an older, sicker population that needs more care.”

However, the larger question, which this study couldn’t answer, was whether  there will be enough ICU capacity in the future to accommodate the growing  number of patients, particularly the oldest of the old, the study authors  said.

ICU admissions grew the most among patients age 85 and older — increasing 25  percent every two years.

Utilization of tests and services provided to emergency department patients  on their way to the ICU also spiked during the study period, with the largest  rise occurring in computerized tomography or magnetic resonance imaging tests.  In fact, CT and MRI tests provided while still in the emergency department  increased from 16.8 percent to 37.4 percent, the study found.

The most common reasons for ICU admissions were symptoms such as chest pain  or shortness of breath that can signal life-threatening conditions like heart  attacks.

The researchers used data from the National Hospital Ambulatory Care Survey,  a sample of U.S. hospital-based emergency departments. Their study was published  in the journal Academic Emergency Medicine.

Read more:

Would you be willing to use a living animal as a respirator or dialysis machine?

biomedical ethics - Would you be willing to use a living animal as a respirator or dialysis machine?
Feb 23, 2013  8:00 AM

Designers Revital Cohen and Tuur Van Balen use both real and fictional biotechnology to explore the connection between the natural and the man-made, and invite questions about the impact of biotechnology. One of their projects, Life Support, imagines a world in which dogs and sheep take the role of life-saving medical devices. Their photos compel the viewer to ask: If the technology were available, would you want a greyhound respirator?

Cohen and Van Balen dreamed up Life Support in 2008 as an extreme extrapolation of the idea of assistance animals life guide dogs and therapeutic cats. They selected two animals—greyhounds and sheep—that are already bred for commercial use for their photo series. The “Respiratory Dog” is imagined as a retired racing hound that receives special training and a harness that uses the movements of the dog’s chest to pump a mechanical ventilator connected to a tracheotomy tube in its human companion’s neck.

The project description argues that it’s a win-win. Instead of being euthanized or placed in a shelter (The Humane Society notes that greyhounds are often retired at 3.5-4 years old but can live to be 13), the dogs receive the affection and security of a constant human companion, while the human gets a furry respirator.

Would you be willing to use a living animal as a respirator or dialysis machine?

The imaginary “Dialysis Lamb” deals with a more invasive process as it cleans a patient’s blood with its own kidneys. The idea is to create a transgenic lamb using the patient’s own DNA who then lives with the patient. During the day, the lamb roams around outside, drinking and grazing, and then at night it is hooked up to the patient. While both lamb and human sleep, the lamb cleans with human’s blood with its own kidneys.

Even if technologically feasible, both of these ideas come with plenty of logistical problems. But they do encourage us to consider: What line, if any, is there between a dog who fetches medication and other items for a disabled person and must be constantly vigilant for any difficulties her companion suffers, and a dog hooked up to a respirator harness? What is the line between using a sheep for its milk and wool and using its kidneys on a nightly basis?

What do you think? If these concepts were practical, would you have reservations about using them?

Life Support [Cohen Van Balen via Inhabitat]

Health Research Report 04 JAN 2013

Medications in Food, Cause for illness
Cholesterol Medicine affects energy production in muscle in up to 75% of people.
More Deaths Blamed on Plavix
100 Richest People in the world increased wealth by 241 Billion in 2012

Donor network ‘pressured medics to declare patients dead so organs can be harvested’

‘This kid is dead, you got that?’ Donor network ‘pressured medics to declare  patients dead so organs can be harvested’

  • The New York Organ Donor Network accused of  bullying doctors into declaring patients brain dead when they are still alive so  they can strip them of their organs
  • Whistleblower Patrick McMahon says one in  five patients are showing signs of brain activity when they’re cut  up
  • Donor network earns ‘millions and millions’  from selling everything from hearts to skin and eyes to hospitals and insurance  companies
  • Staff required to meet quotas for organs and  can qualify for Christmas bonuses if they convince enough families to  donate

By Daily Mail Reporter

PUBLISHED:09:05 EST, 26  September 2012| UPDATED:17:55 EST, 26 September 2012

Plaintiff: Patrick McMahon, pictured, is suing the donor network for sacking him because he spoke out 

Plaintiff: Patrick McMahon, pictured, is suing the donor  network for sacking him because he spoke out

New York hospitals are routinely ‘harvesting’  organs from patients before they’re even dead, an explosive lawsuit is  claiming.

The suit accuses transplant non-profit The  New York Organ Donor Network of bullying doctors into declaring patients brain  dead when they are still alive.

Plaintiff, Patrick McMahon, 50, reckons one  in five patients is showing signs of brain activity when surgeons declare them  dead and start hacking out their body parts.

‘They’re playing God,’ said McMahon, a former  transplant coordinator who claims he was fired just four months into the role  for speaking out about the practice.

He said that the donor network makes  ‘millions and millions’ from selling the organs they obtain to hospitals and to  insurance companies for transplants.

‘Hearts, lungs, kidneys, joints, bones, skin  graphs, intestines, valves, eyes — it’s all big money,’ he said.

The Air Force Combat veteran and former nurse added that  financially strained hospitals are easily influenced to declare a patient brain  dead because they’re keen to free up bed space.

The lawsuit, filed in Manhattan Supreme Court  on Tuesday, cites a 19-year-old car crash victim who was still struggling to  breathe and showing signs of brain activity when doctors gave the green light  for his organs to be harvested.

Network officials including director Michael  Goldstein allegedly bullied Nassau University Medical Center staff into  declaring the teen dead, stating during a conference call: ‘This kid is dead,  you got that?’

But McMahon said  he believed the 19-year-old could have recovered.

CEO: The network's CEO and president, Helen Irving, pictured, is mentioned in the lawsuit 

CEO: The network’s CEO and president, Helen Irving,  pictured, is mentioned in the lawsuit

Bully: Network dirctor Michael Goldstein, pictured, is accused of saying 'this kid is dead, you got that?' 

Bully: Network dirctor Michael Goldstein, pictured, is  accused of saying ‘this kid is dead, you got that?’


The lawsuit cites three other examples of  patients who were still clinging  to life when doctors gave a ‘note’ – an  official declaration by a  hospital that a patient is brain dead, which, as well  as consent from  next of kin, is required before a transplant can take  place.

The suit claims that a man was admitted to  Kings County Hospital in Brooklyn, a month later, again showing brain  activity.

It claims McMahon protested but was  blown  off by hospital and donor network staff, and the man was declared  brain dead  and his organs harvested.

In November 2011, a woman admitted to Staten  Island University Hospital  after a drug overdose was declared brain dead and  her organs were about  to be harvested when McMahon noticed that she was being  given ‘a  paralyzing anesthetic’ because her body was still jerking.

‘She was having brain function when  they  were cutting into her on the table,’ McMahon told MailOnline. ‘He  had given her  a paralyser and there’s no reason to give someone who is  dead a  paralyser.’

He said he confronted the person who gave it  to her and he was speechless.

Lawsuit: The suit claims a 19-year-old car crash victim was still alive when doctors at Nassau University Medical Center, pictured, declared him brain deadLawsuit: The suit claims a 19-year-old car crash victim  was still alive when doctors at Nassau University Medical Center, pictured,  declared him brain dead

‘Finally he said he was told to do it because  while they were cutting her chest open she was moving her chest around. And a  paralyser only paralyses you, it does nothing for the pain,’ he said.

McMahon added that surgeons ‘took everything’  with regards to body parts.

‘They took her eyes, her joints. She was  right there when I was having the conversation. They were inserting the plastic  bones where the real ones had been.’

According to the lawsuit, when  McMahon probed further on the disturbing  case another network employee told hospital staff he was ‘an untrained  troublemaker with a history of raising frivolous issues and  questions.’

‘I had a reputation for raising a red flag,’  he said.

McMahon has accused the donor network of  having a ‘quota’ system and hiring ‘coaches’ to teach staff how to  be more  persuasive in convincing family members to give consent to organ donation.

He said ‘counselling’ staff are like sales  teams who are pressured to meet targets and threatened with the loss of their  jobs if they fall short.

‘If you don’t meet the quotas then you’ll get  fired – that’s a fact. I saw it happen,’ he said.

‘You’re not there for grief  counselling,  you’re there to get organs. It’s all about sales — and  that’s pretty much a  direct quote from the organisation. Counsellors are required to get a 30 per  cent consent rate from families.’

Lawsuit: The New York Organ Donor Network has been accused of bullying hospitals into declaring patients brain dead when they're still alive so organs can be harvested (stock photo)Lawsuit: The New York Organ Donor Network has been  accused of bullying hospitals into declaring patients brain dead when they’re  still alive so organs can be harvested (stock photo)

McMahon added that staff members who collect  the most organs throughout the year qualify for a Christmas bonus.

‘If counselors do well by getting a lot of  organs they are given a bonus in December,’ he said.

The veteran – who worked at the donor network  between July and November last year – said there are about 30-40 staff who are  out in the field, going to hospitals and trying to get signatures and  donations.

He said other workers concentrate on managing  the candidates or the patients who are brain dead.

McMahon claims that on November 4, he told  the network’s CEO and president, Helen Irving, that ‘one in five patients  declared brain dead show signs of brain activity at the time the Note is  issued.’

But the suit says, she replied: ‘This is how  things are done.’

He told MailOnline the next day he was  sacked.

‘My job was to make sure people were doing  things right and when I spoke up I got punished,’ he said. ‘It was disgusting to  me. There was such complacency and a lack of concern. They say ‘these organs  save people’ but what if that person was alive. I witnessed the fact they were  alive.’

The network could not be reached by  MailOnline for comment but spokesman Julia Rivera told The New York Post that  McMahon’s claims of a quota system were ‘ridiculous. There are no  quotas.

Read more: Follow us: @MailOnline on Twitter | DailyMail on Facebook

Common bronchodilator linked to increased deaths

2008 Post for filing

Contact: Marla Paul 312-503-8928 Northwestern University

CHICAGO — A common bronchodilator drug which has been used for more than a decade by patients with chronic obstructive pulmonary disease (COPD) has been linked to a one-third higher risk of cardiovascular-related deaths.

The drug, ipratropium, is sold under the brand names Atrovent and Combivent, the latter a combination product that contains ipratropium.

A new study from Northwestern University’s Feinberg School of Medicine found that veterans with recently diagnosed COPD using ipratropium were 34 percent more likely to die of a heart attack or of arrhythmia than COPD patients using only albuterol (another bronchodilator) or patients not using any treatment.

The study is published in the Sept. 15 issue of the Annals of Internal Medicine.

“This medication may be having some systemic cardiovascular effect that is increasing the risk of death in COPD patients,” said Todd Lee, lead author and research assistant professor in the Institute for HealthCare Studies at the Feinberg School.

COPD is an umbrella term for respiratory diseases that include chronic bronchitis and emphysema. The primary cause is smoking. An estimated 12 million people in the U.S.  have COPD. The disease is the fourth leading cause of death in the U.S. and is expected to grow to the third leading cause by 2020 due largely to an aging population with a higher historical rate of smoking.

Todd noted his study is observational and indicates the need for researchers to take a closer look at this medication, which has been considered safe for many years. The study looked at the cause of death of 145,000 veterans with newly diagnosed COPD from 1999 to 2003.

“The safety of drugs for COPD patients has flown under the radar,” Lee said. “We decided to look into the safety of respiratory medications for COPD patients because of some concerns that had been raised in asthma drugs. We were curious as to whether there were safety problems with these medications in patients with COPD.”

Todd said patients and providers should be aware of the potential risk. “When they make treatment decisions they need to weigh these potential risks against other medications that are available for COPD,” he noted

The drugs don’t work: a modern medical scandal

The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling.

    Ben Goldacre The Guardian,   Friday 21 September 2012 18.00 EDT


    Drugs are tested by their manufacturers,  in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits. Photograph: Photograph: Getty Images. Digital manipulation: Phil Partridge for GNL Imaging

    Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

    But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

    It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

    I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

    Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

    Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

    In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.

    Now, on to the details.

    In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.

    These are frightening results, but they come from individual studies. So let’s consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.

    It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor’s drug.

    In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The “ranges” are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:

    “The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”

    How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.

    Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it’s dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.

    And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug’s effectiveness that’s been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.

    In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we’d expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.

    This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.

    For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.

    When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can’t see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.

    Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.

    Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It’s also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.

    To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn’t mean the drug doesn’t work in breast cancer. There might well be some evidence that it’s great for treating that disease, too, but maybe the company hasn’t gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but “off-label”.

    Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.

    So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.

    When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the “drug label” that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.” In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn’t work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.

    It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn’t tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label”, GSK had no legal obligation to tell anyone about what it had found.

    People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.

    Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.

    This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.

    How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.

    After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.

    That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.

    Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as “intimidation”.

    But we are more concerned with the safety and efficacy data. In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

    During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

    Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.

    The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen’s analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.

    Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.

    Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.

    • This is an edited extract from Bad Pharma, by Ben Goldacre, published next week by Fourth Estate at £13.99. To order a copy for £11.19, including UK mainland p&p, call 0330 333 6846, or go to

    Anemia of chronic disease: an adaptive response?

    Re-Post for file 2008
    Contact: Jennifer Paterson
    613-798-5555 x19691
    Canadian Medical Association Journal

    The anemia of chronic disease may be a beneficial, adaptive response to the underlying disease, rather than a negative effect of the illness, postulates an analysis article in CMAJ,

    The authors argue that anemia may be beneficial to patients with inflammatory disease, and advocate restraint in treating mild to moderate forms of anemia.

    “The general assumption is that anemia is a disorder and that patients would be better off without it,” state the authors.

    However, they suggest that anemia of chronic disease has the characteristics of an adaptive physiologic response, and their review of the literature shows that mortality appears to increase when treatment, given to raise hemoglobin levels, overrides mild to moderate anemia of chronic disease. They call for better characterization of the cause of individual patients’ anemia in future trials of anemia treatment, and careful monitoring of adverse outcomes, including mortality, if patients with anemia of chronic disease are included in such trials

    Whole milk is effective and cost-effective as oral contrast agent

    2008 Re-post for filing

    Contact: Necoya Tyson
    American College of Radiology

    An item commonly found in many homes – whole milk – is just as effective, costs less and is easier on the patient than a diluted (0.1%) barium suspension that is also commonly used as an oral contrast agent in conjunction with CT to examine the gastrointestinal tract, a new study finds.

    The study included 215 patients undergoing abdominal and pelvic CT, said Chi Wan Koo, MD, lead author of the study. All patients were given an IV contrast media; 115 were also given whole milk as an oral contrast agent; 100 received a 0.1% barium suspension. Two radiologists reviewed all the images and scored them based on degree of bowel distension and bowel wall visibility. Adequate bowel distension is necessary to optimize resolution of the bowel wall and contents, said Dr. Koo.

    The study found that the images taken of patients who were given whole milk were just as useful as the images that were taken of patients given the diluted barium, she said.

    In addition, patients were given a questionnaire, asking them how well they tolerated the oral contrast agents, and a cost comparison was done. “We found that milk was less expensive, it had better patient acceptance and fewer adverse symptoms,” Dr. Koo said.

    Whole milk and 0.1% barium suspension are valuable in the diagnosis of small bowel disorders, such as ischemia, neoplasm and Crohn’s disease, said Dr. Koo. They are also useful in evaluating pancreatic and biliary abnormalities.




    The study appears in the May issue of the American Journal of Roentgenology, published by the American Roentgen Ray Society

    How having an operation can send you delirious: Terrifying post-surgery hallucinations strike up to half of the over-65s: “can also leave people in a permanent state of confusion and suffering from dementia”

    By Roger Dobson

    PUBLISHED:18:46 EST, 10  September 2012| UPDATED:18:46 EST, 10 September 2012

    When Gordon Sturmey came around after  surgery, he was convinced people were trying to kill him.

    He believed a nurse was trying to poison him,  and he soon started to think his relatives were also involved.

    Gordon, 65, of Thatcham, Berkshire, had been  admitted to the Royal Berkshire Hospital in Reading, where he underwent surgery  for a perforation in his large intestine triggered by a severe bout of food  poisoning.

    Older patients can suffer from hallucinations, which can be benign, such as flying pigs and alien spaceships, but some report more sinister experiencesOlder patients can suffer from hallucinations, which can  be benign, such as flying pigs and alien spaceships, but some report more  sinister experiences

    ‘Afterwards, I was convinced the nurses and  my family were trying to kill me — and it was very, very real,’ he  recalls.

    ‘When my family came to see me, I asked for  them to be taken away from my bedside.

    ‘I remember one nurse spending 30 minutes  trying to explain what was happening to me, but I didn’t believe  her.’

    Gordon, a retired accountant, had suffered  post-surgery delirium — a side-effect that leaves patients confused,  disorientated, aggressive and prone to hallucinations.

    The condition is alarmingly common,  especially in older age groups.

    Up to half of men and women aged over 65  experience post-surgery delirium.

    Experts say a number of factors place this  age group at risk.

    One reason they are particularly vulnerable  is because they are more likely to have underlying health conditions (such as  diabetes or high blood pressure) or be taking multiple medications — both of  which raise the risk.

    Recently, however, scientists have suggested  another key factor may be that older brains are more susceptible to  inflammation.

    Experts believe that inflammatory molecules  are released when we undergo surgery and can leak into brain tissue, triggering  confusion.

    In younger people the protective barrier  around our brains prevents this from happening, but the barrier becomes less  effective as we age.

    As a result, patients can suffer from  hallucinations.

    These can be benign, such as flying pigs and  alien spaceships, but some patients report more sinister experiences — as Gordon  did.

    Worryingly, experts warn that not only does  delirium slow recovery, it can also leave people in a permanent state of  confusion and suffering from dementia.

    With record numbers of older people  undergoing surgery, there is growing concern that this condition could be  contributing significantly to the numbers of people with  dementia.

    Professor John Young, a researcher at the  Academic Unit of Elderly Care and Rehabilitation at Bradford Royal Infirmary,  explains: ‘We have only recently recognised that delirium can persist long after  the time of surgery.

    ‘In 25 per cent of cases it is permanent, and  can become dementia. It usually appears within the first three days of surgery.

    ‘In some it can be fleeting, lasting just  hours. But in others it can last for days or weeks, or even become  permanent.

    ‘It can double the risk of premature death,  although the death is usually linked to an underlying health  problem.’

    Wards tend to be very bright, busy and noisy, and are disorientating environments for people who are ill and vulnerableWards tend to be very bright, busy and noisy, and are  disorientating environments for people who are ill and vulnerable

    Even when patients recover, many have partial  or full recollection of their terrifying visions, which can continue to haunt  patients for years.

    This was certainly true for Gordon.

    ‘The hallucinations only lasted for about  half a day,’ he says.

    ‘But the experiences are as real to me now as  they were then. I recently attended a meeting and met the nurse who I thought  was trying to  poison me, and I still felt  very  uncomfortable.’

    But why are so many  patients falling  prey to this terrifying condition?

    ‘Many things are going on in the onset of  delirium,’ says Professor Young.

    ‘Surgery is the trigger, but people at high  risk of delirium will have a background of fragile health.

    ‘They are likely to have a chronic illness or  be taking a combination of drugs.

    ‘We don’t fully understand the processes, but  some brain chemicals are implicated, particularly choline and dopamine.

    ‘Many medications can have deleterious  effects on these chemicals, including some anti-histamines, steroids and  pain-relieving opioids.

    ‘It was at first linked with heart surgery,  but it can occur with any procedure.’

    Yet Professor Young says  the condition  is very simple  to prevent.

    ‘We need a cultural change that regards  delirium as a potentially preventable complication,’ he explains.

    ‘The reduction in delirium can be done with a  relatively simple strategy that identifies the risk factors and does something  about those that can be modified.’

    Along with colleagues in Leeds, he is about  to start a major clinical trial at hospitals in Britain, testing a new strategy  for preventing the condition on 500 patients.

    Results from pilot studies suggest that  targeting ten risk factors can lead to vast improvement: disorientation,  dehydration, constipation, an existing mental impairment, sleep problems,  infection, immobility, breathing difficulties, pain and multiple drug  use.

    ‘We decided to do this work because it has  been neglected in research,’ he says.

    ‘I was astounded by the sheer number of cases  and the distress it caused.’

    A small pilot study showed a 50 per cent  reduction in the incidence of dementia.

    ‘The modern hospital is in many ways the  opposite of a traditional caring environment,’ says Professor Young.

    Wards tend to be very bright, busy and noisy,  and are disorientating environments for people who are ill and  vulnerable.

    ‘We also now realise it is crucial that  patients are adequately hydrated around the clock, and that they are able to  sleep, as both dehydration and lack of sleep contribute to  delirium.

    ‘It is also important to orientate and  reassure the patient with clocks, a calendar, and frequent staff contact, and to  ensure they have their glasses and hearing aid if they need them.

    ‘This preventive approach is extremely cost  effective. If a patient develops delirium, they tend to stay longer in  hospital.

    ‘And at £300 a day per patient, that soon  mounts up.

    ‘Unfortunately, health services have been  slow to recognise that the modern general hospital should increasingly be  regarded as an older person’s facility.

    ‘We have largely designed a system to cater  for people who have only one thing wrong with them at once — but this has  changed, and it’s now mainly used by elderly people who have many things  wrong.’

    Gordon now assists in running a support group  for patients who have suffered from the condition and believes greater awareness  is vital.

    ‘Although people have different  hallucinations, they never forget their experience,’ he says.

    To  contact the support group, email icusupportnetworkreading

    Read more:

    Stroke patients get helping hand from ‘telepathic’ robot arm which can respond to your thoughts

    By Eddie Wrenn

    PUBLISHED:06:24 EST, 3  September 2012| UPDATED:06:24 EST, 3 September 2012


    Stroke patients who have lose the use of  their arms could find a helping hand in the form of a robotic arm that can  ‘telepathically’ respond to your thoughts.

    The research, led by Rice University and the  University of Houston, has led to an exo-skeleton which covers the arm from  fingertips to elbow and can help perform simple tasks, as well gently assisting – and sometimes resisting – movement to build strength and  accuracy.

    The new neurotechnology will interpret brain  waves using an EEG neural interface, which can read thought patterns and assign  them to movements.

    A University of Houston (UH) graduate student tests MAHI-EXO II, the robotic rehabilitation device which aims to help spinal-cord-injury patients recoverA University of Houston (UH) graduate student tests  MAHI-EXO II, the robotic rehabilitation device which aims to help  spinal-cord-injury patients recover

    Repetitive motion has proven effective at  retraining motor nerve pathways damaged by a stroke, but patients must be  motivated to do the work, said principal investigator Marcia O’Malley, an  associate professor at Rice and director of Rice’s Mechatronics and Haptic  Interfaces Lab.

    She said: ‘With a lot of robotics, if you  want to engage the patient, the robot has to know what the patient is  doing.

    ‘If the patient tries to move, the robot has  to anticipate that and help.

    ‘But without sophisticated sensing, the  patient has to physically move – or initiate some movement.’

    Mechanical marvel: The arm will eventually cover the entire arm - from elbow to fingertip - to help aid movementMechanical marvel: The arm will eventually cover the  entire arm – from elbow to fingertip – to help aid movement

    The team led by José Luis Contreras-Vidal,  director of UH’s Laboratory for Noninvasive Brain-Machine Interface Systems and  a professor of electrical and computer engineering, was the first to  successfully reconstruct 3D hand and walking movements from brain signals  recorded in a noninvasive way using an EEG brain cap.

    The technology allows users to control, with  their thoughts, robotic legs and below-elbow amputees to control neuroprosthetic  limbs. The new project will be one of the first to design a BMI system for  stroke survivors.

    Initially, EEG devices will translate brain  waves from healthy subjects into control outputs to operate the MAHI-EXO II  robot, and then from stroke survivors who have some ability to initiate  movements, to prompt the robot into action.

    That will allow the team to refine the  EEG-robot interface before moving to a clinical population of stroke patients  with no residual upper-limb function.

    When set into motion, the intelligent  exoskeleton will use thoughts to trigger repetitive motions and retrain the  brain’s motor networks.

    An earlier version of the MAHI-EXO II  developed by O’Malley, already in validation trials to rehabilitate  spinal-cord-injury patients at the UTHealth Motor Recovery Lab at TIRR Memorial  Hermann, incorporates sophisticated feedback that allows the patient to work as  hard as possible while gently assisting – and sometimes resisting – movement to  build strength and accuracy.

    The technology allows users to control, with their thoughts, robotic legs and below-elbow amputees to control neuroprosthetic limbsThe technology allows users to control, with their  thoughts, robotic legs and below-elbow amputees to control neuroprosthetic  limbs

    ‘The capability to harness a user’s intent  through the EEG neural interface to control robots makes it possible to fully  engage the patient during rehabilitation,’ Contreras-Vidal said.

    ‘Putting the patient directly in the “loop”  is expected to accelerate motor learning and improve motor  performance.

    The EEG technology will also provide valuable  real-time assessments of plasticity in brain networks due to the robot  intervention – critical information for reverse engineering of the  brain.’

    The three institutions bring unique  perspectives to the project, O’Malley said. Rice’s robotic devices and UH’s  neural interfaces will make it possible for TIRR Memorial Hermann, led by Gerard  Francisco, director of the UTHealth Motor Recovery Lab, to facilitate  translational research to fast-track engineering findings into clinical  practice.

    ‘This is truly an outstanding opportunity to  demonstrate how various technological advances can potentially boost traditional  rehabilitation therapies,’ said Francisco, chief medical officer of TIRR  Memorial Hermann and professor and chairman of physical medicine and  rehabilitation at UTHealth.

    ‘What makes this initiative even more  exciting is that the NRI recognized the value of our collaborative effort by  awarding the this grant to multiple principal investigators. This project will  be among the first to investigate the benefits of combined therapeutic  interventions to help stroke survivors.

    Read more:

    Mayo Clinic: Common blood pressure drug linked to severe GI problems: Celiac disease from Olmesartan/Benicar in the US, Olmetec in EU and Canada, WinBP, Golme in India, Erastapex in Egypt

    Contact: Nick Hanson 507-284-5005 Mayo Clinic

    Patients in clinical trial taking Olmesartan had symptoms of celiac disease

    ROCHESTER, Minn. — Mayo Clinic researchers have discovered an association between a commonly prescribed blood pressure drug, Olmesartan, and severe gastrointestinal issues such as nausea, vomiting, diarrhea, weight loss and electrolyte abnormalities — symptoms common among those who have celiac disease. The findings are published online today in the medical journal Mayo Clinic Proceedings.

    From 2008-11, Mayo Clinic physicians treated 22 patients with symptoms similar to celiac disease, including intestinal inflammation and abnormalities. Patients came from 17 states, and some had been diagnosed with celiac disease. They had chronic diarrhea and weight loss; the median weight loss was 39 pounds, and one patient lost 125 pounds. Fourteen of the 22 were hospitalized because of the severity of their symptoms. When given a blood test, however, these patients didn’t come back with results typical of celiac disease. They also didn’t respond to treatments such as gluten-free diets.

    After examining their medications, Mayo Clinic gastroenterologist Joseph Murray, M.D., pulled several of the patients off Olmesartan. Their symptoms dramatically improved. Eventually, all 22 were taken off the drug, and all showed improvement. Eighteen of the 22 patients had intestinal biopsies after stopping the medication and showed improvement.

    “We thought these cases were celiac disease initially because their biopsies showed features very like celiac disease, such as inflammation,” says Dr. Murray, the lead author. “What made them different was they didn’t have the antibodies in their blood that are typical for celiac disease.”

    Olmesartan — prescribed for the treatment of hypertension, or high blood pressure — works by blocking substances that tighten blood vessels, allowing blood to flow more smoothly and the heart to pump more efficiently, according to the U.S. National Library on Medicine.

    “It’s really an awareness issue. We want doctors to be aware of this issue, so if they see a patient who is having this type of syndrome — they think about medications as a possible association,” Dr. Murray says. “We’ve reported an association. What needs to be known next is the science to understand why there is such an association.”


    The investigators were supported in part by the National Institutes of Health, the American College of Gastroenterology Junior Faculty Development Award, the Swedish Society of Medicine, the Swedish Research Council and the Fulbright Commission.

    About Mayo Clinic

    Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visit and

    TELECONFERENCE BRIEFING:  Mayo Clinic gastroenterologist Joseph Murray, M.D., will host a teleconference on his findings at 3:30 p.m. ET today, June 21. Call 877-358-3883. Please RSVP if you plan to call in.

    Video Alert: Visit the Mayo Clinic News Blog for links to downloadable video and audio of Joseph Murray, M.D., discussing the findings

    Hospitals ‘letting patients die to save money’

    Hospitals may be depriving elderly patients of food and drink to hasten their   deaths as part of cost-cutting measures to free up bed space, leading   doctors warn.

    By , Medical Correspondent

    Tens of thousands of patients with terminal illnesses are placed on a “death   pathway” to help end their lives every year. However, in   a letter to The Daily Telegraph, six doctors warn that hospitals may   be using the controversial scheme to reduce strain on hospital resources.

    Supporters of the Liverpool Care Pathway, which allows medical staff to   withhold fluid and drugs in a patient’s final days, claim it is the kindest   way of letting them slip away. But the experts say in their letter that   natural deaths are often freer of pain and distress.

    Informed consent is not always being sought by doctors, who fail to ask   patients about their wishes while they are still in control of their   faculties, warn the six. This has led to an increase in patients carrying   cards informing doctors that they do not wish to be put on the pathway in   the last few days of their lives.

    The six doctors are experts in elderly care and wrote the letter in   conjunction with the Medical Ethics Alliance, a Christian medical   organisation. They say that many members of the public have contacted them   with examples of inappropriate use of the pathway, which is implemented in   up to 29 per cent of hospital deaths.

    They warn that there is no “scientific way of diagnosing imminent death.” They   write: “It is essentially a prediction, and it is possible that other   considerations may come into reaching such a decision, not excluding the   availability of resources.”

    Dr Gillian Craig, a retired geriatrician and former vice-chairman of the   Medical Ethics Alliance, is one of the six signatories to The Daily   Telegraph letter.

    “If you are cynical about it, as I am, you can see it as a cost-cutting   measure, if you don’t want your beds to be filled with old people,” she   said. She advised that those who did not want to be put on the pathway   should carry cards made by Dr Rosalind Bearcroft, a consultant psychiatrist   from Kent, and another signatory.

    Last year The Daily Telegraph reported that the numbers being put on the   pathway had doubled in just two years, with tens of thousands of patients   now involved. But up to half of families are not being informed of   clinicians’ decision to put a relative on the pathway, the report by the   Royal College of Physicians found. Advocates point out that the Liverpool   Care Pathway has been approved by the National Institute for Health and   Clinical Excellence (Nice) and is backed by the Department of Health.

    A Department of Health spokesperson said: “People coming to the end of their   lives should have a right to high quality, compassionate and dignified care.

    “The Liverpool Care Pathway (LCP) is not about saving money. It is an   established and respected tool that is recommended by NICE and has   overwhelming support from clinicians at home and abroad.

    “The decision to use the pathway should involve patients and family members,   and a patient’s condition should be closely monitored. If, as sometimes   happens, a patient improves, they are taken off the LCP and given whatever   treatments best suit their new needs. To ensure the LCP is used properly, it   is important that staff receive the appropriate training and support.”

    Cod liver oil outperforms standard drugs for tuberculosis

    Could cod liver oil help combat tuberculosis?

    Repost from Dec 2011

    A review of a historical study from 1848 reveals that cod liver oil was an effective treatment for tuberculosis, says Professor Sir Malcolm Green in the Christmas issue published on today.

    In the study, carried out by physicians at the Hospital for Consumption, Chelsea (now the Royal Brompton Hospital), 542 patients with consumption (tuberculosis) received standard treatment with cod liver oil. These patients were compared with 535 ‘control’ patients who received standard treatment alone (without cod liver oil).

    While improvement rates were similar in the two groups, the disease was stabilised in 18% of the patients given cod liver oil, compared with only 6% of those in the control group. Deterioration or death occurred in 33% of patients given standard treatment alone, but in only 19% of those given cod liver oil, a reduction of 14%.

    Professor Green says that some children are still given cod liver oil today and perhaps this relates back to the late 19th and early 20th centuries when cod liver oil was widely used to treat and prevent tuberculosis.

    He adds that the steady fall in tuberculosis deaths in the late 19th and early 20th centuries is often attributed to better living conditions. While a reduction in overcrowded living might have reduced transmission, Green believes improved nutrition was probably as important. “It could well be that the widespread use of cod liver oil encouraged by doctors played a significant part,” he writes.

    Cod liver oil is a rich source of Vitamin D, which we now know is important in fighting infections, as well as preventing conditions such as rickets, says the author.

    He says: “A role for vitamin D in combating tuberculosis gives a rational basis for sunshine therapy, which was widely practised for patients in sanatoriums before chemotherapy became available, as vitamin D is synthesised in the skin when exposed to the sun. Patients were put out on their beds to lie in the sun in summer and winter, and many were sent to Switzerland and other sunny countries for treatment.”  He adds that today many patients who develop TB in the UK are found to be Vitamin D deficient.

    Green concludes that since tuberculosis is still a common infection, accounting for  millions of deaths annually across the world, there may yet be a role for vitamin D supplements in combating this terrible killer.