DOMINIC COYLE
Blockbuster drugs coming off patent will knock a major hole in our export figures and tax revenues
PHARMACEUTICALS HAVE been a driving force for Ireland’s export success in recent years. Even through the darkest days of our financial collapse and recession, the sector, dominated by the large multinational players, continued to deliver export growth and a glimmer of hope of economic recovery.
However, the most recent trade figures point to a looming problem for the Government. Reporting a 9 per cent fall in exports in December, the Central Statistics Office was unusually frank and detailed in stating that “a substantial part of the decline in the value of exports was due to a high value product in the chemicals and related products sector coming off patent”.
The drug is Lipitor, Pfizer’s blockbuster cholesterol lowering therapy and the world’s best-selling drug in recent years, accounting for revenues of $10.7 billion in 2010. Pfizer’s Cork plant produces 100 per cent of the company’s global requirements for the active pharmaceutical ingredient in the drug and a significant portion of the finished tablets.
Coming off patent will knock a major hole in the future revenues Pfizer can expect to get from the drug as generic competition kicks in. As a rule, loss of patent protection can hit the value of sales by anything between 40 and 70 per cent over time – and not much time at that.
For Ireland, the concern in the December figures was that, for now, generic competition to Lipitor is limited. If that was enough to skew the export figures so dramatically, the worry is what damage future, more intense competition will do to our trade balance.
And Lipitor is just one of a number of key drugs in which Ireland has a commercial interest and which are coming off patent. Chris van Egeraat, a lecturer in economic geography at NUI Maynooth, says seven of the 10 largest-selling drugs worldwide which are losing patent protection are currently produced in Ireland. They include the best-selling drug worldwide in 2010 after Lipitor; Sanofi/Bristol Myers Squibb’s blood clotting treatment Plavix, with sales of $9.43 billion. It comes off patent in May.
Globally, it is estimated that as much as $100 billion in sales will be lost to drug companies between 2009 and 2014 as a result of drugs coming off patent. Expected pipeline delivery in terms of market revenue over the same time amounts to about $30 billion, Dr van Egeraat says.
While he doesn’t expect the loss of patents to lead to huge imminent job losses, it does highlight the ambition of the Government’s new Action Plan for Jobs, which has targeted the health and life sciences sector for significant growth in the coming years to help reach the Government’s 100,000 job target.
However, loss of market sales will clearly impact on trade figures and tax revenues. The Irish Pharmaceutical Healthcare Association (IPHA notes that the pharmaceuticals sector accounts for roughly half of all exports and is the largest contributor to corporation tax, accounting for roughly 50 per cent of the ˆ3.5 billion collected last year.
In employment terms, IPHA president and Pfizer country manager David Gallagher says that about 25,000 people are employed directly in the industry, with a roughly similar number working in related sectors. He notes that pharmaceuticals has been more resilient than other sectors of the economy during recent “economically challenging times”.
The message is pointed, especially at a time when the sector is locked in a dispute with the Government over access to market for its new drugs and the contribution it can make to savings in the health budget sought by the State.
David Gallagher noted recently that an increasing number of innovative medicines are currently not being reimbursed by the Department of Health, despite being approved by regulators and meeting health technology assessments.
He recently accused the department of acting in bad faith by refusing to approve drugs for reimbursement as provided for under the industry’s current pricing agreement with the Department, even though the industry had delivered savings of about ˆ540 million over the past five years, a figure he says equates to a 20 per cent cut.
Even before the latest row, the IPHA said the delay between approval and market access had jumped by over 50 per cent to 157 days in recent years, and only 64 per cent of drugs that received market authorisation in the EU between 2007 and 2009 were made available to patients here.
Matt Moran, director of Ibec group PharmaChem Ireland, said Government policy “needs to urgently recognise the very serious challenges facing the industry”.
“A number of blockbuster drugs are coming off patent and healthcare spending in Ireland has been cut by ˆ600 million in the last five years,” he said. “The future success of the sector must not be taken for granted.”
In a speech last year, Gallagher said further price concessions were “simply untenable”, citing preliminary 2011 figures pointing to a 5.2 per cent decline in the value of the Irish market. “There is a limit to the amount which can be taken out of a market without its effective operation and employment being jeopardised,” he said.
Ireland is not alone. The commercial prospects for big pharma were also thrown into sharp focus with a report on the UK’s pharmaceuticals price regulation scheme, which reported collective industry losses of ?142 million in 2009 despite rising sales.
For its part, the Department of Health needs to find cuts in its budget. In a recent report on pharma pricing, the Economic and Social Research Institute (ESRI said that drug costs account for about 17.5 per cent of public health expenditure in Ireland, up from 14 per cent in 2000.
In 2009, the ESRI says, spending per head of population in Ireland on pharmaceuticals was “amongst the highest in the OECD”.
It is understood the Department of Health is targeting a saving of about ˆ112 million from the drugs bill – either in terms of pricing and access for new medicines or pricing of generics.
The ESRI report recommended a number of approaches. These included pricing drugs on the basis of the lowest cost in a basket of European markets rather than the average, and more regular price updates to capture the impact of falling prices earlier.
The industry says that, despite the small physical size of the Irish market, such a move would be negative in two ways. First, Ireland is itself a component of pricing baskets in eight other larger EU markets. A “match the lowest” price here will inevitably further eat into prices in other more important markets.
Secondly, the industry points to Ireland’s importance as a base of operations for most of the main players in the sector. An increasingly adversarial approach with the State will only damage the prospects for future investment, they say, with one industry source saying the recent approach of the department to market access for new drugs was creating a very poor impression in a number of important boardrooms State-side.
The seriousness with which the pharmaceutical sector views the current price negotiations in Ireland – where eight of the top 10 global players have operations – is highlighted by the engagement of some of the industry’s leading figures with the Government.
The chief executive of one major global player has made a point of briefly visiting Ireland next week. The message in his first visit to the State will not be lost on ministers. The following week, leading executives from another top 10 drug manufacturers gather in Dublin for a meeting at which the attitude of the State to the sector is certain to figure.
On the Government’s side, there is concern too at any adverse impact on such a major employer and contributor to the exchequer. Taoiseach Enda Kenny has recently engaged directly in private meetings with top industry figures here to assure them of the Government’s support despite the ongoing budgetary squeeze.
For their part, the drug companies say that current pricing pressures are restricting innovations. Without adequate compensation, they say, companies simply will not be able to invest in new products given the costs involved and the risk of failure.
This isn’t unique to Ireland. Reporting annual results earlier this month, Bayer chief executive Marijn Dekkers expressed concern “about the side-effects” of health service reforms taking place around the world “because the money we earn from today’s medicines pays for the development of tomorrow’s medicines”.
Pointing to the ˆ2 billion research and development cost of Xarelto, a new drug developed with Johnson Johnson to prevent blood clotting, he said: “We need innovative pharmaceuticals more than ever, because so many known diseases still cannot be treated adequately, or at all, with medicines.”
But that’s part of the problem for the major pharmaceutical companies. Many of the easy treatment areas are now well catered for. A good portion of the drugs that do so are shortly coming off patent and are easily accessible to generic competition.
The opportunities of the future lie in increasingly niche conditions or very high risk areas such as oncology and, especially, neurology. Added to this is the move to biologics and the trend towards more personalised medicines.
The challenge is evident in the fact that, last year, the US drug regulator, the Food and Drug Administration, licensed just a handful of new pharmaceutical therapies. Getting this more select group of drugs to as many markets as possible is increasingly critical for big pharma.
The age of the blockbuster is fading, along with the fat profit margins it offered. That presents major issues for the sector. Over time, through consolidation and acquisition, they have grown into massive unwieldy entities with poorly directed research failing to deliver sufficient pipeline.
In recent years, much effort has been devoted to streamlining operations and increasing productivity, especially on the research side. Thousands of jobs have been shed worldwide, and greater emphasis placed on outsourcing much of the early-stage RD work.
A case in point is Elan’s prospective Alzheimer’s treatment bapineuzumab. Originally developed by the company in association with Wyeth, it is now controlled by Pfizer (which acquired Wyeth to fill a perceived weakness in its biopharmaceuticals operations and Johnson Johnson, which bought an 18.4 per cent stake in Elan in 2009 in a deal valued at $1 billion. Its interest was driven largely by the Irish company’s pipeline – particularly bapineuzumab which is seen as one of the more promising candidates to address a disease with limited treatment options at present and which reports critical Phase III trial data later this year.
The second focus is on developing new markets. But that presents its own problems, not least with business practices that have reflected poorly on the industry.
Several of the largest drug companies have been implicated in an ongoing legal action in Serbia in which a group of 10 doctors and drug company officials were charged with taking, or offering, more than ˆ500,000 in bribes to use specific products. While all deny guilt in this case, an examination of US Securities and Exchange Commission (SEC filings by the world’s top 10 drug companies has found that eight of them recently warned of potential costs related to charges of corruption in overseas markets.
Life is unlikely to get any easier for the sector over the coming two or three years. That raises the stakes in the ongoing price negotiations. The new accord was due to come into force yesterday and, as the leaked Commission assessment this week illustrated, pressure on the Government to deliver the necessary savings to ensure their budgetary projections is only likely to intensify.
A modified osteoporosis treatment drug might be able to tackle human malaria infections, according to new US research.
Based at the University of Illinois, a team spearheaded by Professor Eric Oldfield has discovered that this drug, in adapted form, can enter malaria-infected red blood cells and destroy the disease although, so far, only in mice.
Crucially, though, no significant side effects were recorded as far as the mice's health was concerned.
Modified Osteoporosis Drug
The modified osteoporosis drug draws on chemically-altered variants of zoledronate (marketed as Zometa and risedronate (marketed as Actonel . These, in their original forms, can't traverse the membrane that surrounds red blood cells but, with the addition of new features like an extended lipid structure, they're able to get through.
"We found that compounds that were really active had a very long hydrocarbon chain", Oldfield explained, in a statement. "These compounds can cross the cell membrane and work at very low concentrations."
Malaria Drug Treatments
According to the World Health Organization, it's possible that malaria infections claimed the lives of over one million victims in 2008, the majority of them located in Asia and Sub-Saharan Africa. The parasite that causes malaria is ever-changing and that means, in theory, Malaria drug treatment developers are caught in a constant catch-up game.
There's a constant stream of emergent malaria strains that no treatments presently in production can tackle and that's why, according to Oldfield: "it's important to find new drug targets because malaria drugs last only a few years, maybe 10 years, before you start to get resistance. The parasites mutate and then you lose your malaria drug."
Further details of this new malaria treatment research have been published by the Proceedings of the National Academy of Sciences.
Image copyright US Centers for Disease Control and Prevention
Cardiac Science recalls a suite of automated external defibrillators over defective circuit boards and Flight Medical pulls ventilator cables that may cause electrical shortages.
Cardiac Science's voluntary field correction for a suite of automated external defibrillators got Class I recall status from the FDA over concerns that a failed component may keep the device from providing life-saving therapy during a heart attack.
The company's PowerHeart G3 AEDs are mobile devices, often found in hospitals, schools or physicians' offices, intended to be used by trained personnel to deliver defibrillation therapy to someone suffering sudden cardiac arrest.
Submitted by Brandon Smith from
Alt-Market
Americans Will Need “Black Markets” To Survive
As Americans, we live in two worlds; the world of mainstream fantasy, and the world of day-to-day reality right outside our front doors. One disappears the moment we shut off our television. The other, does not…
When dealing with the economy, it is the foundation blocks that remain when the proverbial house of cards flutters away in the wind, and these basic roots are what we should be most concerned about. While much of what we see in terms of economic news is awash in a sticky gray cloud of disinformation and uneducated opinion, there are still certain constants that we can always rely on to give us a sense of our general financial environment. Two of these constants are supply and demand. Central banks like the private Federal Reserve may have the ability to flood markets with fiat liquidity to skew indexes and stocks, and our government certainly has the ability to interpret employment numbers in such a way as to paint the rosiest picture possible, but ultimately, these entities cannot artificially manipulate the public into a state of demand when they are, for all intents and purposes, dead broke.
In contrast, the establishment does have the ability to make specific demands or necessities illegal to possess, and can even attempt to restrict their supply. Though, in most cases this leads not to the control they seek, but a sudden and sharp loss of regulation through the growth of covert trade. The people need what the people need, and no government, no matter how titanic, can stop them from getting these commodities when demand is strong enough.
This process of removing necessary or desirable items from a trade environment leads inevitably to counter-prohibition often in the form of strict cash transactions, barter markets, or “black markets” as they are normally derided by those in power. The problem for economic totalitarians is that the harder they squeeze the masses, the more intricate the rebellion becomes, especially when all they want is to participate in free markets the way our forefathers intended.
The so called “drug war” is proof positive of the impossibility of locking down a product, especially one that has no moral bearing on the people who are involved in its use. Only when a considerable majority of a populace can be convinced of the inherent immoral nature of an illicit item can its trade finally be squelched. During any attempt to outlaw a form of commerce, a steady stream of informants convinced of their service to the “greater good” is required for success. Dishonorable governments, therefore, do not usually engage in direct confrontation with black markets. Instead, they seek to encourage the public to view trade outside mainstream legal standards as “taboo”. They must condition us to react with guilt or misplaced righteousness in the face of black market activity, and associate its conduct as dangerous and destructive to the community, turning citizens into an appendage of the bureaucratic eye.
But, what happens when black markets, due to calamity, become a pillar of survival for a society? What happens when the mainstream economy no longer meets the available demand? What happens when this condition has been deliberately engineered by the power structure to hasten cultural desperation and dependence?
In this event, black markets not only sustain a nation through times of weakness, but they also become a form of revolution; a method for fighting back against the centralization of oppressive oligarchies and diminishing their ability to bottleneck important resources. Black markets are a means of fighting back, and are as important as any weapon in the battle for liberty. Here are just a few reasons why such organizational actions may be required in the near future…
The Mainstream Economy Is Slowly Killing Us
There are, unfortunately, some Americans out there who have not caught on yet to the grave circumstances in which we live. Obviously, the stock market seems to have nearly recovered from its epic collapse in 2008 and 2009, and employment, according to the Labor Department, is on the mend. The numbers say it all, right? Wrong! The numbers say very little, especially when they are a product of “creative mathematics”.
Despite the extreme spike in the Dow Jones since 2010, and all the talk of recovery, what the mainstream rarely mentions are the details surrounding this miraculous return from the dead for stocks.
One of the most important factors to consider when gauging the health of the markets is “volume”; the amount of shares being traded and the amount of investors active on any given business day. Since the very beginning of the Dow’s meteoric rise, the markets have been stricken with undeniably low volume interspersed with all too brief moments of activity. In fact, this past January recorded the lowest NYSE volume since 1999:
http://www.bloomberg.com/news/2012-01-23/stock-trading-is-lowest-in-u-s-since-2008.html
Market volume has tumbled over 20% since last year, and is down over 50% from 2008 when the debt implosion began:
http://blogs.wsj.com/marketbeat/2012/02/24/trading-volume-anemic-this-year/
So then, if trade is sinking, why has the Dow jumped to nearly 13,000? Low volume is the key. In a low volume market, less individual investors are present to counteract the buying and selling of larger players, like international banks. When this happens, the big boys are able to trigger market spikes, or market drops, literally at will. Add to this the high probability that much of the stimulus that the Federal Reserve has regurgitated into the ether probably ended up in the coffers of corporate banks which then used the funny money to snap up equities, and presto! Instant market rally! But, a rally that is illusory and unstable.
Improving employment numbers are yet another financial hologram. As most of us in the Liberty Movement are well aware, the Labor Department does not calculate true unemployment in the U.S. Instead, it merely calculates those people who currently receive unemployment benefits. Once a person hits the extension limit (99 weeks in many states on his benefits, he is removed from the rolls, and is no longer counted in the “official” unemployment percentage. While Barack Obama and MSM pundits are quick to point out the drop in jobless to 8.3%, what they conveniently fail to mention is that MILLIONS of Americans have been unemployed for so long that they have been removed from the statistics entirely, and this condition is what has caused the primary fall in jobless percentages, not burgeoning business growth.
Roughly 11 million Americans who are jobless have nonetheless been excluded from the statistical government tally because of a loss of benefits:
According to the Congressional Budget Office, over 40% of the currently unemployed have been so for over 6 months. It also points out that America is suffering the worst case of long term unemployment since the Great Depression:
http://www.cbo.gov/sites/default/files/cbofiles/attachments/02-16-Unemployment.pdf
More than 10.5 million people in the U.S. also receive disability payments, which automatically removes them from the unemployment count, making it seem as though jobs are being created, rather than lost:
http://www.foxnews.com/politics/2012/02/19/report-millions-jobless-file-for-disability-when-unemployment-benefits-run-out/
Around 8.2 million Americans only work part time, meaning they work less hours than are generally considered to be necessary for self-support. These people are still counted as “employed” even if they work a few hours a week.
True unemployment, according to John Williams of Shadowstats, is hovering near 23%:
http://www.shadowstats.com/alternate_data/unemployment-charts
Combine these circumstances with the ever weakening dollar, price inflation in foods and other commodities, and rocketing energy costs, and you have an economy that is strangling the life out of the middle-class and the poor in this country. It is only a matter of time before the populace begins searching for alternative means of subsistence, even if that entails “illegal” activities.
Government Cracking Down On Freedom Of Trade
I was recently walking through the parking lot of a grocery store and ran into a group of women huddled intently around the back of a mini-van. One of the women was reaching into a cooler and handing out glass containers filled with milk. I approached to ask if she was selling raw milk, and if so, how much was she charging. Of course, they turned startled and wide eyed as if I had just stumbled upon their secret opium ring. Somehow it had slipped my mind how ferocious the FDA has become when tracking down raw milk producers. The fact that these women were absolutely terrified of being caught with something as innocuous as MILK was disturbing to me. How could we as a society allow this insanity on the part of our government to continue?
That moment reminded me of the utter irrelevance of petty law, as well as the determination of human beings to defy such law.
The Orwellian hammer has been thrust in the face of those who trade in raw milk, organic produce, and herbal supplements, while small businesses are annihilated by government dues and red tape. In the meantime, law enforcement officials have been sent strapped to shut down children’s lemonade stands (no, seriously :
http://www.cbsnews.com/2100-500164_162-20079838.html
Government legislation which would give the FDA jurisdiction over personal gardens has been fielded. Retail gold and silver purchases of over $600 are now tracked and taxed. The IRS even believes it has the right to tax barter exchanges, even though they do not explain how bartered goods could be legally qualified as “income”, or how they can conceive of ever being able to trace such private trade:
http://www.irs.gov/newsroom/article/0,,id=205581,00.html
Want to choose what kind of currency you would like to use to protect your buying power? Not if the Department Of Justice’s Anne Tompkins has anything to say about it. After the railroading of Liberty Dollar founder Bernard von NotHaus, she stated:
“Attempts to undermine the legitimate currency of this country are simply a unique form of domestic terrorism…”
“While these forms of anti-government activities do not involve violence, they are every bit as insidious and represent a clear and present danger to the economic stability of this country,” she added. “We are determined to meet these threats through infiltration, disruption, and dismantling of organizations which seek to challenge the legitimacy of our democratic form of government.”
http://www.fbi.gov/charlotte/press-releases/2011/defendant-convicted-of-minting-his-own-currency
As our economic situation grows increasingly precarious in this country, more and more people will turn towards localized non-corporate, non-mainstream business methods and products. And, the government will no doubt attempt to greatly restrict or tax these alternatives. This mentality is driven in part by their insatiable appetite for money, but mostly, it’s about domination. They do what they do because they fear decentralized markets, and the ability of the citizenry to conceive of choices outside the system. Slaves are not supposed to choose the economy they will participate in…
A “black market” is only a trade dynamic that the government disapproves of, and the government disapproves of most things these days. Frankly, its time to stop worrying about what Washington D.C. consents to. They have unfailingly demonstrated through rhetoric and action that they are not interested in the fiscal or social health of this nation, and so, we must take matters into our own hands.
Black Market Advantages
If the events in EU nations such as Greece, Spain, and Italy are any indication, the U.S., with its massive debt to GDP ratio (real debt includes entitlement programs , is looking at one of two possible scenarios: default, austerity measures, and high taxes, or, hyperinflation, and then default, austerity measures, and high taxes. In the past we have mentioned barter networking and alternative market programs springing up in countries like Greece and Spain allowing the people to cope with the faltering economy. Much of this trade is done away from the watchful eyes of government, simply because they cannot afford the gnashing buffalo-sized bites that bureaucrats would take from their savings in the process. When a government goes rogue, and causes the people harm, the people are in no way obligated to continue supporting that government.
Black markets give the citizenry a means to protest the taxation of a government that no longer represents them. In a country stricken with austerity, these networks allow the public to thrive without having to pay for the mistakes or misdeeds of political officials and corporate swindlers. In a hyperinflationary environment, black markets (or barter markets that have been deemed unlawful , can be used to supplant the imploding fiat currency altogether, and energize community markets that would otherwise be unable to function. Ultimately, black markets feed and clothe the grassroots movement towards economic responsibility, and every man and woman with any sense of independence should rally around this resource with the intention to fight should it ever be threatened.
“Legality” is arbitrary in the face of inherent conscience, or what some call “natural law”. Without arbitrary legality, and unjust and unwarranted regulation, many federal alphabet agencies would not exist, including the FDA, the IRS, the EPA, the BLM, etc. These institutions do not matter. What they say has no meaning. What matters is what is honorable, what is factual, and what is right. Our loyalty, as Americans, is to our principles and our heritage. Beyond that, we don’t owe anyone anything. A black market in one place and time is a legitimate market in another. For now, private localized trade is able to flow with only minor interference, but there will come a day when even the most practical and harmless personal transactions will be visited with administrative reproach and vitriol. Alternative market champions will be accused of “extremism”, and undermining the mainstream economy. We will be vilified as separatists, isolationists, terrorists, and traitors. I believe it will be far more surreal than what we can possibly imagine now.
They are welcome to call us whatever they like. Honestly……who cares? Let the paper pushers do their angry little dance. The goal is freedom; in life, in politics, and in trade. If we do not change how this country does business ourselves, the results will be far more frightening than any government agent at our doorstep, and the costs will be absolute…
“Babies born just a few weeks early have a higher risk of poor health,” The Guardian reported today. According to the newspaper, new research has found that being born just a few weeks early can raise their risk of conditions such as asthma.
It is already known that babies born prematurely (before 37 weeks of pregnancy may have a higher risk of immediate or longer-term health problems, and the earlier a baby is born, the higher the risk. To examine the issue researchers followed the health of over 14,000 children born between 2000 and 2002, and examined their health at the ages of three and five years old. Outcomes including growth, hospital admissions, use of medication, asthma and long-standing illnesses were looked at particularly in relation to whether the children were moderately premature (32-36 weeks of pregnancy or born at what the researchers called “early” full term (37-38 weeks . Babies born moderately prematurely or at early term were more likely to have been re-admitted to hospital in the first few months of life than babies born at 39-41 weeks. Babies born moderately prematurely also had a higher risk of asthma symptoms than full-term babies.
These findings are broadly in line with what is already known about the effects of prematurity, and do not change the UK’s current definition of full-term pregnancy as 37 weeks and over. However, the study does show how different degrees of prematurely may affect health. Further study of the issue would be valuable, to explore longer-term health outcomes that may be caused by prematurity and the factors that may influence the likelihood of these poor health outcomes.
Where did the story come from?
The study was carried out by researchers from the University of Leicester and other UK institutions. It was funded by the Bupa Foundation and published in the peer-reviewed British Medical Journal.
The media generally covered this research in a balanced way.
What kind of research was this?
In the UK, the normal length of a pregnancy is classed as 37 weeks or above. It is already known that babies born prematurely (before 37 weeks may be at increased risk of immediate and longer-term health problems, and that the risks are higher the earlier a baby is born. However, the authors say that there has been minimal research into the longer-term health outcomes of infants specifically born moderately preterm (which this study defines as 32-36 weeks and at what the researchers termed as ‘early full term’ (37-38 weeks .
To investigate this, the researchers used a cohort study. This is a good way to follow up and compare health outcomes in groups of people that have been exposed to different factors. In this case, the exposure was the number of weeks of pregnancy at which the babies were born. However, a cohort study that looks at a group’s health relies on the accuracy of reported health outcomes and diagnoses. For example, one condition this study looked at was asthma, and the researchers asked parents about whether their child had wheezing symptom or asthma. However, this does not necessarily equate to a medical diagnosis of asthma.
This type of study also needs to take into account potential factors that could be related to both risk of prematurity and risk of the health outcome. For example, parental smoking is linked to an increase risk of prematurity, and also to an increased risk of asthma in the child.
What did the research involve?
This study involved participants of the Millennium Cohort Study (MCS , a piece of research in which the subjects were gathered by random sampling of child benefit registers. It featured 18,818 infants born in the UK between 2000 and 2002. The number of weeks of pregnancy at birth was calculated from the mother’s report of her expected due date. Births were grouped into:
- very preterm (defined by the authors as 23-31 weeks
- moderate preterm (32-33 weeks
- late preterm (34-36 weeks
- early term (37-38 weeks
- full term (39-41 weeks
These are not the standard accepted definitions. For example, the charity BLISS, for “babies born too soon”, defines full-term pregnancy as 37 weeks or more, moderately premature as 35-37 weeks, very premature as 29-34 weeks, and extremely premature as birth before 29 weeks.
Child health outcomes were monitored over five years of follow-up. Outcomes assessed included:
- child height, weight and body mass index at three and five years
- parental reports of the number of hospital admissions (not related to accidents since birth or the previous interview, collected at nine months and at three and five years.
- parental reports of any longstanding illness or disability of more than three months’ duration and diagnosed by a health professional, collected at three and five years (a limiting longstanding illness was defined as one which limited activities that are normal for the child’s age group
- parental reports of wheezing within the previous 12 months, and parental reports of asthma collected at three and five years
- parental reports of the use of prescribed drugs, collected at five years
- parents’ ratings of child health, defined as excellent, very good, good, fair or poor, collected at five years
The researchers used statistical methods to look at the outcomes in groups groups born at different stages of pregnancy and compared them to (their definition of full-term babies. Analyses were adjusted to account for various potential confounding factors, principally numerous social and demographic factors. The researchers also estimated “population attributable fractions” (PAFs associated with preterm and early term birth, which is an estimate of the contribution that a particular risk factor has to a health outcome. PAF represents the reduction in the proportion of people in the population with a particular health problem that could be expected if the exposure to a risk factor were reduced to the ideal exposure. In this case, it would represent the proportion of children that would no longer have a particular health problem if all babies were born at full term rather than preterm.
What were the basic results?
After the researchers excluded participants in the MCS study with incomplete data on time in the womb at birth, they interviewed the parents of 14,273 children at 3 years of age and 14,056 at 5 years. They found certain sociodemographic factors, such as lower maternal educational status and maternal smoking, to be associated with prematurity, as is already known.
The researchers generally found a “dose response” effect of prematurity, meaning that the more premature a baby was, the higher the likelihood of general health problems, hospital admissions and longstanding illnesses. They calculated the odds of each outcome compared to children born at 39-41 weeks. The full details of these outcomes are as follows:
The odds for three or more hospital admissions by five years of age were:
- 6.0 times higher for children born at 23-31 weeks
- 3.0 times higher for children born at 32-33 weeks
- 1.9 times higher for children born at 34-36 weeks
- 1.4 times higher for children born at 37-38 weeks
The odds for any longstanding illness at five years of age were:
- 2.4 times higher for children born at 23-31 weeks
- 2.0 times higher for children born at 32-33 weeks
- 1.5 times higher for children born at 34-36 weeks
- 1.1 times higher for children born at 37-38 weeks
The odds for the child’s health being rated as only fair or poor by parents at five years of age were:
- 2.3 times higher for children born at 23-31 weeks
- 2.8 times higher for children born at 32-33 weeks
- 1.5 times higher for children born at 34-36 weeks
- 1.3 times higher for children born at 37-38 weeks
The odds for asthma and wheezing at five years of age were:
- 2.9 times higher for children born at 23-31 weeks
- 1.7 times higher for children born at 32-33 weeks
- 1.5 times higher for children born at 34-36 weeks
- 1.2 times higher for children born at 37-38 weeks
The greatest contribution to the burden of disease at three and five years was among children born at late/moderate preterm or early term. The calculated PAFs for being admitted to hospital at least three times between the ages of 9 months and 5 years were:
- 5.7% for children born at 32-36 weeks (i.e. you would expect a 5.7% reduction in the number of young children admitted three or more times if babies were born at full term rather than moderate preterm
- 7.2% for children born at 37-38 weeks (you would expect a 7.2% reduction in the number of young children being admitted if babies were born at full term rather than early term
- 3.8% for children born before 37 weeks (you would expect a 3.8% reduction in the number of young children being admitted if babies were born at full term rather than very preterm
Similarly, PAFs for longstanding illnesses were:
- 5.4% for early term births
- 5.4% for moderate or late preterm births
- 2.7% for very preterm births
How did the researchers interpret the results?
The researchers concluded that “the health outcomes of moderate/late preterm and early term babies are worse than those of full term babies.” They say that it would be useful for further research to look into how much of the effect is due to prematurity itself, and how much is due to other factors such as maternal or foetal complications.
Conclusion
This valuable research examined childhood health outcomes in a large group of children born at different stages of pregnancy.
Important points to consider when interpreting this research include:
- The authors generally found that the likelihood of poorer health outcomes was higher with increasing prematurity (a dose response effect . This is in line with what is already known about the generally poor immediate and longer-term health outcomes among babies born increasingly prematurely.
- The greatest contribution to overall burden of disease at ages three and five years was calculated to be among children born at 32-36 weeks or at 37-38 weeks. Though a gestation of less than 32 weeks might be expected to have a greater influence on the burden of disease, it must be remembered that many more babies are born above 32 weeks of gestation than below it. Therefore, in the population as a whole, the greater number of babies born within the 32-38 week range would have a greater effect than the small number of babies born extremely early.
- The definitions that the authors used for the purposes of this study are not standard definitions. For example, the standard definition of full-term pregnancy is birth at 37 weeks or more, and it is not split into “early term” at 37-38 weeks and “full term” only at 39-41 weeks. Similarly, definitions of prematurity differ from those used by other UK health organisations.
- There is a possibility of inaccuracy as both age at birth and health outcomes were reported by parents, rather than assessed through medical records. For example, a parental report of wheezing or asthma does not necessarily constitute a confirmed medical diagnosis of asthma.
Overall, the study found that the more premature a baby is, the greater the likelihood of health problems in childhood, and that some effect of prematurity may even be seen in pregnancies approaching full term. Further study in this area would be valuable, both to explore the wider range of longer-term health outcomes that may be caused by prematurity, and to look into associated factors (medical or sociodemographic, for example that may influence the likelihood of these outcomes.
Analysis by Bazian
Links To The Headlines
Infancy health risk linked to early birth by research. BBC News, March 2 2012
Babies born a few weeks early 'suffer health risks'. The Guardian, March 2 2012
Links To Science
Boyle EM, Poulsen G, Field DJ et al. Effects of gestational age at birth on health outcomes at 3 and 5 years of age: population based cohort study. BMJ 2012; 344
Press release: Population-based cohort study of the effects of gestational age at birth on health outcomes at three and five years of age. BMJ, March 1 2012
Not so long ago, this year's must-see action hero was sleeping in his car. Now, after saving the world in John Carter, he's starring alongside Rihanna
"Oh fuck off!" The words are out of my mouth before I have a chance to think about the ramifications of saying them to a Hollywood actor, especially one whose star is about to turn supernova. As soon as I do, I think I might throw up. And then, after the briefest of pauses, Taylor Kitsch's perfect eyes wrinkle up and his perfect mouth emits a perfect laugh, all manly and throaty and sounding of a thousand cigarettes.
The incident occurs just after Kitsch has finished telling me about the house he's building by a lake in Austin, Texas, and the boat, which he sails upon said lake. It comes after he's said how much he loves England ("I love the dry, wry humour" , and doesn't like LA ("It's too one-sided" ; all punctuated with swearing, jokes and the confidence of a man who can wear cowboy boots, bootcut jeans (well, he does live in Texas and
still
look absurdly attractive.
I don't mean to curse at him, but it is almost too much to take, all of this, and the vision of him building a house just doesn't seem fair to the rest of the population, neither male nor female. If there was a real-life, modern-day Adam, or if Gosling in The Notebook really did exist, it would be in the form of the man sitting in front of me. Which is probably why he's saving the planet in two films this spring. First up is John Carter, a Disney action behemoth based on the 1964 book by Tarzan creator Edgar Rice Burroughs; then comes the guns-blazing Battleship, in which he stars alongside Liam Neeson and
Rihanna. As if that isn't enough, Kitsch will follow with
Oliver Stone's Savages, in which he plays a pot grower taking on a Mexican drug cartel to rescue his girlfriend (Blake Lively .
It might seem a brazen burst on to the scene but Kitsch, 30, has done his time in the waiting room. There was the almost career as a hockey player in his native Canada, until injury got the better of him, then a move to New York and a brief stint as a model. During that time he studied acting on the side and won small roles in forgettable films such as
Snakes On A Plane and John Tucker Must Die. There was a stint in LA, living – literally – out of his $1,100 car, in between auditioning for parts. But it was not until getting cast as Tim Riggins in American football TV drama,
Friday Night Lights – a spin off from the 2004 film – that his career kick-started his career in earnest.
"I played a high school kid at 26, 27; I still never use a razor, maybe to spite him," grins Kitsch, reclining back into his sofa. "But I love that role, man. I was told it was to be supporting at the beginning: you're going to be used incrementally, you could be gone by the first season. But it turned out to be quite the opposite. They gave me the empowerment to be really free. No rehearsals and the most important thing to me was to be able to improv. I love to throw curveballs; all those quotes people come up to me and say about Riggins, I'd say 90% are from the improv. I'd be like, 'Hey, this paragraph here? Literally not going to do it. Just going to do a look right here.' And they'd be like, 'Let's try it!'"
The confidence the role gave him obviously worked. It led to meatier parts, playing war photographer Kevin Carter in 2010's The Bang Bang Club and Gambit in X-Men Origins: Wolverine. And FNL also saw Kitsch forge a friendship with the show's director, Peter Berg, who hand-picked him for the lead role of Alex Hopper in Battleship.
"Pete and I go way back," says Kitsch, grinning, and extolling his pal in language you might expect from a veteran of a US sports drama. "He came to pitch Battleship to me and that alone is incredible; we're friends first and foremost and we've gone through a lot together personally, so it's a big risk to ask a close friend to get in the trenches with you on a different level. Because making movies is fucking tough and you're going to bat heads and you're going to challenge each other. But I think that was why I signed on, to go to battle with Pete."
'For 11 months, I was on a regimen of training and dieting. I was working six-day weeks. I would get my wake-up call at 4.33am'
Before Battleship, however, is John Carter – or "JC" as Kitsch likes to call him – an American civil war veteran transported from Earth to Mars. Not the easiest of premises to sell, but with the help of giant billboards featuring a long-haired Kitsch half-naked save for a loin cloth, one that has the potential to sell itself. It's his first lead role, and the pressure is on.
"I don't think anyone is going to put more on it than me," he says, ruffling that hair underneath his oversized beanie hat. "Of course it's the grandeur of it all, and the effects. I don't have any power over that but the character is something you just dive into. For 11 months, I was on a regimen of training and dieting. I stayed four months at the Metropolitan hotel in Mayfair, right by Hyde Park, but I was working six-day weeks, so I literally went out once. I would get my wake-up call at 4.33am to train. But it's worth it; the aesthetic of John Carter … you can't fuck around with that."
Was there a pie or two at the end of filming, then? "Oh my god, if I even fucking
told
you how hard I partied after that …" he starts, going almost misty eyed. "I rented an over-the-top house on the lake where I live in Austin, that I would never live in, like
ridiculous
; it was a joke. I flew in 11 of my friends, and my brother; friends that I grew up with and a few that I met through work. Eleven guys for five days, on the lake and going into the town. I fucking was a different person."
He is a confident fellow, Taylor Kitsch. We are used to a more falsely humble Hollywood these days – "Oh I'm so lucky, oh it just happened, oh I'm so blessed" and so forth – but perhaps because he doesn't live there, Kitsch doesn't seem to suffer from that syndrome. He will happily tell you how hard he worked to get a role. He will sing praises of those he has learned from – Willem Defoe,
Dominic West, or Benicio Del Toro – and cast shadows upon those he hasn't, dismissing their methods without naming names. It may sound over-bearing but with Kitsch, such self-belief seems to come from a genuine place of simply wanting to make things happen. You sense he's used to being the best. But it's not every ex-model pretty boy who manages to land two lead roles in a year, convincing studios to take a risk on a relative unknown. How did he manage to pull it off?
"Oh I threatened them quite often," he says, grinning. "I would love to ask them that, too. I had a call from my manager saying the director, Andrew Stanton (Wall-E , wanted to meet me. The screen test was quite heavy; John Carter has quite a burden. I think getting that part of it was a big thing [for Stanton]. But he was so emphatic and his energy was so infectious, that I left the audition thinking, 'If he gives me a good kick at it, I'm going to fight for it, I'm going to throw my hat in the ring for sure.'"
'John Carter tested me quite intensely. I literally suffered from exhaustion, passed out a couple of times. It took everything I had'
For all his fighting talk, Kitsch is the first to admit that it was not an easy ride, and not only for the training that left him physically battered and bruised.
"John Carter tested me quite intensely," he says in a southern drawl that belies the fact he's actually from a tiny Canadian town called Kelowna. "I literally suffered from exhaustion on John Carter, passed out a couple of times from it, so it took everything I had on that level. But also, emotionally. We shot the scene where his family are taken away from him, and that's 14 hours of Carter in mourning; that's intense. If it's Friday Night Lights, you can do it because you need two takes of raw emotion. You do it for literally about 30 minutes, if that, and then you're done. This was rough, but rewarding because when you see it cut in at certain spots, fuck it can hit ya, and I love that."
He may be owning the action hero this year, but Kitsch is determined to be taken seriously as an actor. "I love the story part of acting," he says. "I love bringing people into the emotional part of it. My favourite scenes in John Carter are the emotional ones, especially when you can collaborate with Stanton, who can rip your heart out and make you cry laughing in the same breath."
It's quite rare for an action picture to have a heart, I suggest; mostly it's just brawn and battles. "It is, but if it was one of those movies, I wouldn't have done it." He pauses, then with the confidence dipping a notch, says, "I was scared shitless with Bang Bang Club. Kevin Carter was a South African, drug-addicted, suicidal war photographer, and it was a true story that his family and best friend would see. Doing that justice is way more pressure … Then shooting Savages with Oliver Stone. I think that role will turn some heads in the sense of how unapologetic the character is. ThHe just doesn't give a fuck. But that's fun."
It is an exciting time for Taylor Kitsch and if he plays things right, he could have just what he wants. Is he happy with where he is going? "You work for years on end," he says, "and it's not theatre where you can have that validation right away. You hope people love it, and you're proud of the work. I remember driving around Sunset Boulevard in the car that I was living in. Now you drive down Sunset and there is a huge John Carter billboard. I had probably about 25 people texting me about it, and that is a pretty cool feeling. But what I
really
love is how different these guys are. And that's the beauty of it, hopefully."
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defeated in a 51 to 48 vote that broke largely along party lines. Democrat Senators Ben Nelson of Nebraska, Bob Casey of Pennsylvania and Joe Manchin of West Virginia crossed party lines to vote with the Republicans, while Republican Senator Olympia Snowe voted with the Democrats. Senators Casey and Manchin are up for re-election this year. Democrats said the language of the Blunt amendment, known as the "Respect for Rights of Conscience Act,” was far too broad, and could be used by some employers to deny benefits beyond contraception. "It would allow any employer or insurer to deny coverage for virtually any treatment for virtually any reason," said Senate Majority Leader Harry Reid (D-NV , who called the bill "an extreme, ideological amendment." Although the legislation was never expected to pass, Senator Reid said he had allowed it to come to a vote because Republicans would not let the transportation bill advance without a vote on the Blunt amendment. In a
statement issued after the vote, Senator Blunt vowed that the fight was not over, and said he would continue working with lawmakers on both sides of the aisle. “I am truly disappointed by the partisanship that has been injected into this debate on religious freedoms,” he said. “For the first time in our history, the Obama Administration’s health care mandate is an egregious violation of our First Amendment rights.” “Unfortunately, this is only a glimpse of what Americans can expect as a result of President Obama’s government health care takeover – which is why we need to repeal and replace this bill with common-sense bipartisan solutions,” he said. Senate Democrats, who characterized the legislation as something that would deny women access to contraception, took to the microphones immediately following the vote, calling the bill’s defeat a victory for women. "This was an important step today and an important the message to the women - and to the men - in this country that we and the Democratic caucus will stand up to fight for their rights," Senator Patty Murray (D-WA told reporters. Attorneys general from seven states -- Nebraska, Florida, Michigan, Ohio, Oklahoma, South Carolina and Texas – filed a lawsuit against the Obama administration last week to block the contraceptive mandate. The full text of the bill can be viewed at
http://thomas.loc.gov/cgi-bin/query/z?c112:S.1467:
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