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The world's biggest health study will shortly wind up recruiting, having today passed the 500,000 subject mark – persuading one in fifty Britons aged 40-69 to let researchers follow their health for the next 30 years.
The £66 million , backed by all the major institutions of British medical research, will "generate new knowledge about relationships between health, disease, genes and environment for many years to come", according to Sir Mark Walport, Director of the Wellcome Trust.
The study aims to be as deep as it is wide, with patients followed in considerable detail. Each has provided samples of blood, urine and saliva, and answered questionnaires on diet, exercise, family and personal history. Each has undergone a battery of tests including lung function, arterial stiffness, bone mineral density, grip strength, brain function, intraocular pressure, sight and hearing.
Much of the analysis won't be happening for at least a decade. But after that, organizers expect a steady stream of revelations in everything from cancer to heart disease to diabetes and arthritis. Needless to say, with their similar genetic heritage, many Canadians can expect Biobank will generate findings relevant to their lives. The study's ethical code dictates sharing anonymized data with all credible foreign researchers.
A key function of Biobank is to act as a gene database. As the NHS's reporting system picks up subjects' health woes, their samples will be analyzed to look for genetic correlations. But participants have been told they won't be getting any genetic analysis back. In fact, they don't stand to gain personally in any way. One striking feature of the study is that even if it detects evidence of illness in participants, whether through blood or urine samples, or because they have genes that turn out to be high-risk, Biobank won't inform the affected patients or their physicians.
One reason for this, the organizers say, is to stop insurance companies from penalising study volunteers. Insurance contracts often legally require purchasers to disclose test results they know, but not those they don't.
But a major ultimate goal of the Biobank is to find the links between DNA and diseases, and disseminate that knowledge as widely as possible. One suspects that at some point, the insurance companies are going to get involved in that process.
This morning, as they celebrated the recruiting of the half-millionth Biobank recruit, the great and the good of British medical research were effusive in their praise of these “local heroes” who will give so much of their time over the next 30 years for no obvious personal benefit. But hang on a minute – if they're all altruistic heroes, then how can they be a representative sample of the British population?
Posted by David Elkins and others at 3:54 PM
The results are compiled in the 2010 edition of their ongoing report ionally. The highly-regarded Dutch system came in first place, closely followed by Britain and Australia. Germany and New Zealand lagged behind, with Canada bringing up the rearguard of public health systems. The US, predictably, limped in a distant last.
The US scored badly not just on access, efficiency and equity, but even on quality of care, a category in which it came sixth, with only Canada doing worse.
Canada's great weaknesses will come as no surprise to anyone who lives here: primary care, primary care and primary care. The report reflects the growing belief among Canadians that if you haven't got a GP now, you may never get one.
A corollary of this is overreliance on emergency services and lack of adequate preventive care. Wait times are an issue for patients, who also complain of lack of out-of-hours care. And Canada gets very poor marks for our patchwork adoption of electronic medical records.
Canada was actually the biggest per capita spender of the "socialised medicine" countries, at US$3,895 a head. New Zealand occupied the bargain basement at a paltry $2,454. Needless to say, the USA truly was Number One on this metric, blowing away all opposition with its awesome $7,290 per capita health spending.
The Canadian Medical Association's president, Dr Anne Doig, told CanWest News that she accepted the findings, which matched those of other organisations. “These [Commonwealth Fund] reports are held to be reasonably accurate and methodologically sound,” she said.
Dr Doig agreed that primary care needs work and that electronic records should be adopted faster, but contended the problems go deeper than that. Canada needs a patient-centred system of care, she said. “One could argue the system serves itself rather than the patient.”
Canadians did well on the metric of "Long, Healthy, Productive Lives", coming second behind Australia. But Dr Doig said: “Arguably, that is deteriorating. And if things don’t change, we might find we don’t do as well in another 20 years. We are essentially enjoying the benefits of reforms that happened in the ‘60s and ‘70s.” Transforming the health system is the CMA's biggest single project these days, she noted.
Of course, the countries that get the most bang for their patient-centred buck, like Holland and France, also spend less on doctors' salaries than Canada does. We'll let you know when the CMA starts pushing for that reform.
Posted by David Elkins and others at 3:06 PM
Health Canada waits to see which way FDA will jump
The diabetes drug rosiglitazone (Avandia) may shortly become the latest high-profile pill to meet an early demise after serious side effects emerged in real-world use.
The U.S. Food and Drug Administration will be meeting next week to consider the fate of the insulin sensitizer, whose cardiac safety has been called into question. Elevated risk of heart attack and other cardiac events has been documented by several studies.
An FDA advisory committee has already reviewed the evidence once in 2007. They concluded that rosiglitazone caused more ischemic events than placebo, but not more than metformin or a sulfonylurea.
The , however, seems likely to drive a stake into rosiglitazone's heart [JAMA, June 2010;304(4)]. For one thing, this retrospective review of 227,000 elderly American patients compared rosiglitazone directly against the other drug in the thiazolidinedione class, pioglitazone (Actos), and found increased risk of stroke, heart failure, and all-cause mortality.
Worse for maker GlaxoSmithKline, the study was led by David Graham, the FDA's associate director of drug safety. Reporting a "number needed to harm" of 60 patients, Dr Graham recommends that rosiglitazone be taken off the market.
Dr David Juurlink of Toronto's Sunnybrook Health Sciences Centre, lead author of the largest on the drug's safety (BMJ 2009;339:b2942), echoes Dr Graham's call in a in the same issue of JAMA.
In the past, beleaguered drugs have sometimes survived these FDA reviews after panel members with extensive ties to manufacturers voted to keep them on the market. But today's FDA is a chastened agency, stung by conflict of interest scandals. They need to show their regulatory teeth, especially in the current U.S. political environment where lax regulators are the villain of the moment.
Nobody at the FDA will feel like going to bat for rosiglitazone anyway, since the agency was criticized earlier this year in a by the Senate Finance Committee for letting trials continue even as the extra heart attacks piled up among rosiglitazone patients – the FDA itself has estimated that the drug played a role in 83,000 heart attacks from 1999 to 2007. The Senate also accused the drug's maker of knowing the dangers early but sitting on the information, an accusation that GlaxoSmithKline vehemently denies.
Canadian regulators, meanwhile, say "the benefits are still considered to outweigh the risks" when the drug is used according to Canadian monographs, and within additional limits set by warnings issued in 2007. They will “monitor” the FDA meeting and will continue to review evidence submitted to them by the manufacturer.
that Canada should remove rosiglitazone from the market now, since doing it right after the FDA would be bad “optics”. Health Canada issued a statement on rosiglitazone today, proudly pointing out that their post-market recommendations on the drug's use are actually somewhat tighter than those of the American agency.
But Health Canada's warnings about rosiglitazone were issued in November 2007, right after the FDA reviewed the issue and decided to give it their notorious “black box”.
It's inevitable that, being a government ministry and therefore insufferably pompous, Health Canada will deny to their last breath that they follow the FDA. But if the FDA pulls rosiglitazone, can anyone envisage Health Canada keeping the drug on the market? Now that would be bad optics.
Posted by David Elkins and others at 3:02 PM
Labels: diabetes, Dr David Juurlink, heart disease, rosiglitazone
Maple Leaf Garden’s sex abuse victim Martin Kruze was but one of many to choose the Bloor Street Viaduct to end his life
When someone is determined to end his or her life, choosing to jump off a bridge is a pretty good bet. The impact of falling over 30 metres at about 120-129 kilometres an hour is akin to being hit by a speeding car.
To prevent the temptation by those overcome with despair and hopelessness, a barrier was constructed around Toronto’s Bloor Street Viaduct in 2003 – at a cost of 5½ million dollars. Known as the second most popular “suicide bridge” in the world (San Francisco’s Golden Gate ranks number one), some of the 400 people who’ve taken their lives there had travelled from afar to this particular bridge, since its construction in 1918.
City planners were anxious to know whether such a deterrent – dubbed the Luminous Veil – would work.
The verdict: “It works…,” says chief psychiatrist Anthony Levitt of Sunnybrook Health Sciences Centre, “…at the Bloor Street Viaduct.” Indeed, suicide rates there dropped from an average of 9.3 to zero per year. Depressed individuals – mostly men in their mid-30s -- however, chose alternative bridges to end their lives since the Luminous Veil was constructed, making the annual rate of bridge jumping suicides almost unchanged. Dr. Levitt and resident doctor Mark Sinyor, part of the study team at Sunnybrook and the U of T (BMJ 2010;341:c2884) noted that since the barrier was erected bridge jumpers rose from 8.7 to 14.2 each year at other bridges. The researchers conclude that building physical barriers is only a part of the solution. “You need programs that improve access to psychiatrists and other mental health workers,” says Dr. Sinyor.
It seems abundantly clear that if millions of dollars are available to fight suicide, perhaps they could be better spent for mental health support, leaving artists like Bruce Cockburn to invent an alternate line for “You could have gone off the Bloor Street Viaduct” in his humorous song, “Anything Could Happen.”
Posted by David Elkins and others at 11:57 AM
Labels: bridge jumping, Dr Anthony Levitt, Dr Mark Sinyor, mental health, suicide