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Archive for November 2, 2012

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Vegetable Shepherd’s Pie

Vegetable Shepherd's Pie

Lentils and fresh and dried mushrooms give this vegetarian casserole its meaty character. You can prepare most of it in advance and bake it just before your guests arrive.

Ingredients

Topping

  • 3 pounds russet potatoes, unpeeled
  • 3 pounds Yukon Gold potatoes, unpeeled
  • 1/2 cup (1 stick) unsalted butter, cut into 1/2-inch cubes
  • 1 1/2–2 cups whole milk, warmed
  • Kosher salt

Filling

  • 1 ounce dried porcini mushrooms
  • 3/4 cup brown or French green lentils
  • 6 garlic cloves, divided, plus 2 Tbsp. chopped garlic
  • 1 teaspoon kosher salt plus more
  • 5 tablespoons olive oil, divided
  • 3 cups coarsely chopped onions
  • 2 tablespoons tomato paste
  • 2 bay leaves
  • 2 cups dry white wine
  • 8 cups vegetable broth
  • 2 tablespoons cornstarch
  • 2 tablespoons gluten-free white miso or 2 teaspoons gluten-free tamari soy sauce
  • Freshly ground black pepper
  • 12 cups 1/2-inch pieces peeled fall vegetables (such as squash, turnips, carrots, and parsnips)
  • 1 cup frozen pearl onions, thawed, halved
  • 2 4-inch rosemary sprigs
  • 2 cups bite-size pieces mixed fresh mushrooms
  • 1/4 cup chopped mixed fresh herbs (such as parsley, chives, and sage)

Preparation

Topping

  • Preheat oven to 450°. Bake potatoes on a foil-lined baking sheet until tender, about 45 minutes. Let cool slightly, then peel. Press potatoes through a ricer, food mill, or colander into a large bowl. Add butter; stir until well blended. Stir in milk. Season to taste with salt. DO AHEAD Potatoes can be made 1 day ahead. Let cool, press plastic wrap directly onto potatoes, and chill.

Filling

  • Soak dried porcini in 3 cups hot water; set aside. Combine lentils, 1 garlic clove, 1 tsp. salt, and 4 cups water in a medium saucepan. Bring to a boil; reduce heat and simmer, stirring occasionally, until lentils are tender but not mushy, 15–20 minutes. Drain lentils and discard garlic.
  • Heat 3 Tbsp. oil in a large heavy pot over medium heat. Add onions and cook, stirring occasionally, until soft, about 12 minutes. Add chopped garlic and cook for 1 minute. Stir in tomato paste. Cook, stirring constantly, until tomato paste is caramelized, 2–3 minutes.
  • Add bay leaves and wine; stir, scraping up any browned bits. Stir in porcini, slowly pouring porcini soaking liquid into pan but leaving any sediment behind. Bring to a simmer and cook until liquid is reduced by half, about 10 minutes. Stir in broth and cook, stirring occasionally, until reduced by half, about 45 minutes.
  • Strain mixture into a large saucepan and bring to a boil; discard solids in strainer. Stir cornstarch and 2 Tbsp. water in a small bowl to dissolve. Add cornstarch mixture; simmer until thickened, about 5 minutes. Whisk in miso. Season sauce with salt and pepper. Set aside.
  • Preheat oven to 450°. Toss vegetables and pearl onions with remaining 2 Tbsp. oil, 5 garlic cloves, and rosemary sprigs in a large bowl; season with salt and pepper. Divide between 2 rimmed baking sheets. Roast, stirring once, until tender, 20–25 minutes. Transfer garlic cloves to a small bowl; mash well with a fork and stir into sauce. Discard rosemary. DO AHEAD Lentils, sauce, and vegetables can be made 1 day ahead. Cover separately; chill.
  • Arrange lentils in an even layer in a 3-qt. baking dish; set dish on a foil-lined rimmed baking sheet. Toss roasted vegetables with fresh mushrooms and chopped herbs; layer on top of lentils. Pour sauce over vegetables. Spoon potato mixture evenly over.
  • Bake until browned and bubbly, about 30 minutes. Let stand for 15 minutes before serving.

Bonappetit

Have India’s poor become human guinea pigs?

Narayan Survaiya and family
Narayan Survaiya’s mother Tizuja Bai died several weeks after being given new drugs
By Sue Lloyd-Roberts BBC Newsnight

Drug companies are facing mounting pressure to investigate reports that new medicines are being tested on some of the poorest people in India without their knowledge.

“We were surprised,” Nitu Sodey recalls about taking her mother-in-law Chandrakala Bai to Maharaja Yeshwantrao Hospital in Indore in May 2009.

“We are low-caste people and normally when we go to the hospital we are given a five-rupee voucher, but the doctor said he would give us a foreign drug costing 125,000 rupees (£1,400).”

The pair had gone to the hospital, located in the biggest city in Madhya Pradesh, an impoverished province in central India, because Mrs Bai was experiencing chest pains.

Their status as Dalits – the bottom of the Hindu caste system, once known as untouchables – meant that they were both accustomed to going to the back of the queue when they arrived and waiting many hours before seeing a doctor.

Nitu Sodey

This was really expensive treatment for the likes of us”

Nitu Sodey

But this time it was different and they were seen immediately.

“The doctor took the five-rupee voucher given to BLPs [Below the Poverty Line] like us and said the rest would be paid for by a special government fund for poor people,” Mrs Sodey explains. “This was really expensive treatment for the likes of us.”

What Mrs Sodey says she did not know was that her mother-in-law was being enrolled in a drugs trial for the drug Tonapofylline, which was being tested by Biogen Idec. Neither could read and Mrs Sodey says she does not remember signing a consent form.

Mrs Bai suffered heart abnormalities after being given the trial drug. She was taken off it and discharged after a few days. Less than a month later, she suffered a cardiac arrest and died at the age of 45.

The trial, which was registered in the UK by Biogen Idec, was later halted due, say the company, to the number of seizures recorded. The company also says Mrs Bai’s death was not reported to them.

Her case is not an isolated incident.

In a different trial with a different company, Narayan Survaiya says neither he nor his late mother Tizuja Bai were asked if she wanted to participate, or even told that she was taking part in one, when she sought treatment for problems with her legs. And, like Mrs Sodey, he claims the family were told that a charity was footing the bill for the care.

A few weeks after taking the drug, Mr Survaiya says his mother’s health deteriorated and she was left unable to walk.

“I told the doctor, but he said don’t stop the doses. It is a temporary paralysis and the drug will make it better.”

Please don’t do these trials on poor people – rich people can overcome these problems but if I can’t work the whole family suffers”

Ramadhar Shrivastav

His mother died a few weeks later.

In all, 53 people were test subjects in that trial, which was sponsored by British and German drug companies, and eight died. There is no hard evidence that the drug was the cause of death, but nor were there any autopsies to enable a full investigation.

Over the past seven years, some 73 clinical trials on 3,300 patients – 1,833 of whom were children – have taken place at Indore’s Maharaja Yeshwantrao Hospital. Dozens of patients have died during the trials, however no compensation has been paid to the families left behind.

Internal hospital documents seen by Newsnight reveal that since 2005, 80 cases of severe adverse events in trials have been recorded in Indore. One patient listed on the severe adverse events document is Naresh Jatav, who is now four.

His father, Ashish Jatav, says that his son was a healthy three-day-old baby when doctors said he needed a polio vaccine.

Naresh Jatav and family
Naresh Jatav – in the white shirt – with his family

The family says that they had no idea that the drug Naresh was given was a trial one, and that the hospital forms which they signed had been written in English “so we couldn’t understand anything”.

According to an investigation by the hospital, the healthy baby boy had a seizure shortly after receiving the drug and suffered an attack of bronchitis.

Drug trials in India

  • Almost 2,000 trials in past seven years
  • Tests include drugs made by well-known companies such as Biogen Idec, Astra Zeneca and Glaxo Smith Kline
  • 288 deaths in 2008
  • 637 deaths in 2009
  • 668 deaths in 2010
  • 438 deaths in 2011

He now has breathing and eating problems, although the family have been assured that this is nothing to do with the trial vaccine. They say they no longer know what to believe.

Time after time in Indore, I heard a depressingly familiar tale of poor, often uneducated people saying how flattered and privileged they were made to feel as they were suddenly offered the chance to receive medicines usually out of their reach. All of them claim that, contrary to Indian laws governing drugs trials, there was no informed consent.

I also repeatedly heard patients’ relatives say that the treatment they received at Maharaja Yeshwantrao Hospital was overseen by Dr Anil Bharani.

Dr Bharani has since been charged by the state government for receiving illegal payments and foreign trips from drug companies, and for carrying out drugs trials without patients’ consent.

He refused to speak to Newsnight, even when I approached him in person in his office at the hospital. He called security and I was marched out of the hospital by an armed guard. But two days later, Dr Bharani was himself transferred from the hospital after more than 30 years’ service.

Dr Bharani is just one of a number of doctors at the hospital who have been already been fined for irregularities during drugs trials. None of the problems might have ever come to light if it had not been for another doctor, Dr Anand Rai, who had an office on the same floor of the hospital.

Dr Arnand Rai with Sue Lloyd Roberts
Dr Rai says he was fired for raising concerns

Dr Rai says he became concerned when he saw poor people being ushered in to the best consulting rooms. He says he was sacked from his job because of his questioning, but that he has been researching the hospital trials ever since.

“They choose only poor people,” he says, even though drug trial protocols demand that they should be carried out on all sections of society. “They chose poor, illiterate people who do not understand the meaning of clinical drug trials.”

Dr KD Bhargava, head of the ethics committee at Maharaja Yeshwantrao Hospital, admits that the hospital’s oversight of the trials has been flawed. “Suddenly lots of money got involved and there was too much going on. And, yes, maybe we may have lost control,” he says.

But the issue goes well beyond one hospital.

Since India relaxed its laws governing drugs trials in 2005, foreign drug companies have been keen to take advantage of the country’s pool of educated, English-speaking doctors and the huge population from which to choose trial subjects.

The Bhopal disaster

A rally in memory of the Bhopal victims
  • Considered the world’s worst industrial disaster
  • On night of 2 December 1984, Union Carbide’s pesticide plant leaked tonnes of lethal chemicals over Bhopal
  • At least 3,000 people died in first 24 hours
  • And thousands more from after-affects

In the past seven years, nearly 2,000 trials have taken place in the country and the number of deaths increased from 288 in 2008 to 637 in 2009 to 668 in 2010, before falling to 438 deaths in 2011, the latest figures available.

The provincial capital of Madhya Pradesh is Bhopal – a city whose name will for ever be linked with the world’s worst industrial accident. An explosion at the Union Carbide plant caused a gas leak that killed an estimated 25,000 people, campaigners say.

The only good thing to come out of the disaster was the Bhopal Memorial Hospital, built as part of a compensation agreement with Union Carbide to help care for some half a million locals affected by the disaster.

Little did they know that when they came for treatment, some would be used for clinical drug trials.

Ramadhar Shrivastav was one such person. As he makes his way uncertainly to the door of his house to greet me, he says he was lucky, having got off comparatively lightly in the 1984 disaster – only his sight was affected.

Five years ago, he suffered a heart attack and went to the Bhopal Memorial Hospital. He does not read English, and it was a journalist who last year noted that his discharge paper showed that he was part of a trial by the British company Astra Zeneca on a drug being tested for patients with ACS (acute coronary syndrome).

Mr Shrivastav claims the drug has affected him badly and he now cannot work.

Ramadhar Shrivastav and family
Ramadhar Shrivastav had previously been caught up in the Bhopal leak

When he learned we were from Britain, he asked us to pass on a message to Astra Zeneca.

“Please don’t do these trials on poor people. Rich people can overcome these problems but if I can’t work, the whole family suffers. Why did they choose us? They should have tested it on themselves.”

Astra Zeneca admit there were problems with consent with a few patients on the trial identified through there routine monitoring during the trial and the issues were quickly rectified. They say that Mr Shrivastav was not one of those affected.

From a medical point of view, doctors agree that the long-term effects of exposure to the Bhopal gas, methyl isocyanate, are still not known so why use the victims for drug trials? I put this question a doctor involved in setting up the Bhopal Memorial Hospital and who once served on the ethics committee there, Professor NP Mishra.

He says trials are carried out for the long-term benefit of patients. “It’s not being tried out to harm them.”

Professor NP Mishra

It’s not being tried out to harm them”

Professor NP Mishra

But haven’t these people suffered enough? Is it right to put them at further risk in a clinical drug trial? “The way you talk, medicines would never be developed.”

I ask again, why choose gas victims? “That I cannot comment on,” he says. “It was not my job to find out.”

The problem, I found while working on this subject, is finding anyone who is prepared to be held responsible.

I found Tarjun Prajapati supervising a construction site in a new suburb of Bhopal. He is joint owner of a building company. His father was a gas victim who, four years ago, suffered a heart attack. He was given drug called Fondaparinux at the Memorial Hospital. When he ran out of the medication, his son found it easier to nip out to the shops rather than cross town to pick up more from the hospital for his father.

“I went to the market to buy them but couldn’t,” he remembers. “I was told they were only available from the hospital and only then did I realise he was on a trial drug. I feel very bad that my dad died because of those medicines.”

This claim is impossible to verify because, once again, there was no autopsy.

On the trial documents, it says that the British company Glaxo Smith Kline (GSK) are the sponsors of the drug, are responsible for the trial and are the investigators of the drug.

But GSK says they bought the rights to the drug while the trial was being carried out by the French company Sanofi, which is named as a collaborator on the document. When we contacted Sanofi, they told us the trial was in fact “conducted through an Indian research organisation called Quintiles”.

Lawyer Satnam  Singh Bains
Satnam Singh Bains, a British barrister in Indore, is looking into the complaints

There is no doubt that the drugs trial set-up can be complicated. A couple of drug companies might team up and then delegate the actual work of the trial to what in India are called Clinical Research Outsourcing Organisations. In the past, when there have charges of malpractice, drug companies have tended to blame these local companies.

Which leaves those who believe they have a just grievance against the drug companies somewhat bewildered.

Lawyers are now looking at whether there is a case to answer in the UK. Satnam Singh Bains, a British barrister in Indore, is looking into a couple of cases.

He shows me a recently published report by the Indian Parliamentary Committee on Health and Family Welfare that looks into what is happening around the country. The report is damning.

It confirms that the set-up for regulating trials in India is, in Mr Singh Bains’ words, “not fit for purpose”. There are too few inspectors at the regulatory agency, coping with too many demands, including having to supply data on 700 parliamentary questions and 150 court cases in one year.

“Still worse,” the report says, “there is adequate documentary evidence to come to the conclusion that many opinions [during the drug trials] were actually written by the invisible hand of drug manufacturers and experts [the doctors] merely obliged by putting their signatures.”

Mr Singh Bains says there are real concerns. “About, at the very least, collusion between experts and the drug manufacturers or, at worse, there is a suggestion that there is a fraud taking place – that these reports are being signed off without any independent, clinical scrutiny of their findings in the way that conclusions are expressed.”

He adds that this could have global implications about “whether the findings of these clinical trials can be safely relied upon”.

Watch Sue Lloyd-Roberts Newsnight report in full

BBC

Faulty implants: Europe ‘too slow’

Hip replacement
New regulations are needed to make medical implants safer, a new report suggests

The European Commission is not acting quickly enough to protect patients from potential harm from medical implants, a parliamentary committee warns.

Current Europe-wide regulation on medical implants, such as hip replacement joints, is too slow to change, they say.

The EC is revising the regulation, but changes are not expected to take effect until at least 2015.

The report comes after recent concerns about the safety of hip implants.

“I think in the interests of patients we would get a better system in place if the commission speeded up the process to revise current regulations,” said Andrew Miller, chairman of the Science and Technology Select Committee.

 

There is an urgent need for more transparency in the regulatory system..”

Andrew Miller Science and Technology Select Committee

Under the present system new devices must gain the Europe-wide mark of approval – the CE mark – from one of 70 regulatory organisations, known as notified bodies.

The committee raised concerns that notified bodies might vary in quality and that manufacturers might be shopping around for regulators based in the country with the least stringent regulations.

“There is an urgent need for more transparency in the regulatory system so that patients and doctors know where their implant is coming from, and crucially whether the product has previously been turned down by other regulatory bodies,” Mr Miller said.

‘Inadequate’ safety testing

He is calling for there to be a public record every time a manufacturer approaches a notified body for approval, allowing this “forum shopping” to be spotted more easily.

The report also warns some patients may be given medical implants that have had little known safety testing, as currently regulators may rely on safety information gathered from similar, equivalent products.

This means an implant may be used across the European Union without evidence of its own safety and performance, the report says.

The committee recommends that for all medical implants that are currently in use, any existing data must be published immediately.

It also calls for compulsory reporting by doctors of any faulty products they come across.

“The British Association of Aesthetic Plastic Surgeons is pleased that the government has moved to better regulate all CE-marked medical devices, and in particular, we praise the call for all existing evidence on medical devices to be published immediately,” said consultant plastic surgeon and former BAAPS president Nigel Mercer.

“Without these changes the public cannot be sure that they can ever be safe from another PIP-like fiasco.”

Professor Norman Williams, president of the Royal College of Surgeons, agreed there urgently needed to be an “increase of transparency and accountability across the entire regulatory framework for medical implants”.

BBC

Multiple sclerosis: New drug ‘most effective’

Brain scan
MS attacks nerves in the brain and spinal cord

By James Gallagher Health and science reporter, BBC News

A new drug is the “most effective” treatment for relapsing-remitting multiple sclerosis, say UK researchers.

During MS the body’s immune system turns on its own nerves causing debilitating muscle problems.

Researchers at the University of Cambridge say a cancer drug, which wipes out and resets the immune system, has better results than other options.

However, there is concern that a drugs company is about to increase the cost of the drug as a result.

Around 100,000 people in the UK have multiple sclerosis. When the condition is diagnosed most will have a form of the disease know as relapsing-remitting MS, in which the symptoms can almost disappear for a time, before suddenly returning.

Built from scratch

The researchers tested a leukaemia drug, alemtuzumab, which had shown benefits for MS in small studies.

In leukaemia, a blood cancer, it controls the excess production of white blood cells. In MS patients, the dose eliminates the immune cells entirely, forcing a new immune system to be built from scratch which should not attack the nerves.

Two trials, published in the Lancet medical journal, compared the effectiveness of alemtuzumab with a first-choice drug, interferon beta-1a.

One compared the effectiveness in patients given the drug after being diagnosed, the other looked at patients given the drug after other treatments had failed.

Both showed the drug was around 50% more effective at preventing relapses and patients had less disability at the end of the study than when they started.

Dr Alasdair Coles, from the University of Cambridge, said: “Although other MS drugs have emerged over the last year, which is certainly good news for patients, none has shown superior effects on disability when compared to interferon except alemtuzumab.”

He told the BBC: “It is certainly the most effective MS drug, based on these clinical trials, but this is definitely not a cure.”

However, he warned there were side-effects. These include developing other immune disorders.

He said he thought the drug would be most useful for patients for whom standard treatment had failed and in a “minority” of patients as a first-choice drug.

Eventually relapsing-remitting MS can become progressive MS as the good spells become shorter and less frequent. The drug will have no effect on this form of the disease.

Expense fears

The drug has been withdrawn from the market in Europe and the US as the manufacturer, Genzyme, intends to have it licensed as a treatment for MS.

A Lancet editorial warns: “There is concern that with a licence for multiple sclerosis, the cost of alemtuzumab could rise and might become too expensive for many patients and health systems.

“Finding promising treatments such as alemtuzumab is important. But so is keeping alemtuzumab accessible and affordable.”

Dr Doug Brown, head of biomedical research at the MS Society, said: “These results are great news for people with relapsing-remitting multiple sclerosis.

“Alemtuzumab has been found to be an effective treatment for people with MS – but it’s only useful to them if it’s available on the NHS.

“We urge Genzyme to price the treatment responsibly so that if it’s licensed, it’s deemed cost-effective on the NHS.”

The company said it would not come up with a price for the drug “until it is approved by regulatory authorities” and that it would “engage constructively” with the National Institute for Health and Clinical Excellence, which evaluates the cost-effectiveness of drugs for use in the NHS.

BBC

Liverpool Care Pathway: Minister will listen to concerns

Elderly patient waiting to be seen

It is “completely wrong” for terminally ill patients to be put on a “pathway” to death without relatives being consulted, a health minister has said.

Norman Lamb has called a meeting of doctors and patients to discuss worries about the Liverpool Care Pathway – which can see water and food withdrawn.

A Conservative peer has called for an inquiry amid claims some people treated in this way could have survived.

Mr Lamb also defended the practice of paying hospitals for using the pathway.

He was reacting to reports in the Daily Telegraph that two third of NHS Trusts in England using the Liverpool Care Pathway regime have been paid sums totalling millions of pounds for reaching targets related to their use.

Relieving suffering

Responses to a Freedom of Information request by the paper have suggested that at least £12.4m has been paid out to trusts in the past three years.

The pathway was developed at the Royal Liverpool University Hospital and the city’s Marie Curie hospice to relieve suffering in dying patients, setting out principles for their treatment in their final days and hours.

Payments have been made to encourage and ensure that patients and their loved ones are involved in the critical discussions that take place at the end of life”

Norman Lamb Health minister

Mr Lamb said any payments made in connection with the pathway happened at a local level, without the government’s involvement.

“Payments should only be made to encourage better care for people at the end of life,” he told BBC Radio 4’s World at One.

“Payments have been made to encourage and ensure that patients and their loved ones are involved in the critical discussions that take place at the end of life. If that is the result of the system, then that seems to me to be a good outcome.”

The Lib Dem minister, responsible for social care, said his “sole interest” was making the final days of someone’s life as comfortable and dignified as possible whether they chose to be in hospital, a hospice or at home.

“This (the pathway) is an approach improving the experience at the end of life. This is an approach supported by Macmillan and Marie Curie. Would those organisations really advocate a programme that denied dignity to people at the end of life.”

‘Right to complain’

Mr Lamb said he wanted to hear about cases where patients or their families had not been properly involved in, or informed about, how they were being treated and had convened a “roundtable” of clinicians and patients groups later this month to discuss the issue.

“Families are right to complain when that happens and it is that sort of approach which has to be challenged,” he added. “I am absolutely determined myself to ensure we do challenge that.”

“I want to hear where things have gone wrong. I want to ensure we address that absolutely, but a lot of good things have happened in recent years to improve the experience at the end of life.”

Conservative peer Baroness Knight, who is calling for an inquiry into suggestions the Liverpool Care Pathway had accelerated some people’s deaths, said she had heard of cases where people were deprived of water without their consent.

“One man actually rang the police and asked ‘let me get some water’,” she told BBC Breakfast. “That cannot be right. To die needing water is not a pleasant experience.”

“What I think has happened is that a good idea at the beginning has translated into some very heartbroken people who have seen their relative die when actually they could have saved them.”

But Dr David Nicholl, a consultant neurologist, told the BBC he was not aware of any financial targets connected to the pathway and that he believed hospitals were only concerned with getting more resources for good quality palliative care

“It is quite explicit that patients, where possible, should be fully consulted and their families consulted.

“Where there have been problems, I would say it has not been with the pathway but due to a lack of communication.”

BBC

香港查出護理品含有毒物質‧廖中萊:衛部嚴密監督

(雪蘭莪‧八打靈再也31日訊)衛生部長拿督斯里廖中萊指出,針對香港港九藥房總商會抽查逾300款個人護理產品,發現近半數含防腐劑及塑化劑等11種有毒物質事件,衛生部將與香港相關單位聯繫,瞭解該調查詳情。

他指出,衛生部一直嚴密監督國內市場販售的個人護理產品,而所有產品都必須向該部藥劑組註冊。

“截至目前,未發現有大馬產品含有超出標籤的過量成份,除非是一些沒註冊的非法產品,如有我們 會採取行動對付,而衛生部也不時會如香港般進行市場與抽樣調查,確保產品安全。"他向星洲日報指出,衛生部將持續監督市場上出售的產品,只要其他國家出現 有問題產品的資訊,大馬都會謹慎跟進與處理。

星洲日報

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