“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 over 14,000 children born between 2000 and 2002, and assessed 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 prematurity 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 ( confounding factors . 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 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. This 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. British Medical Journal 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. British Medical Journal, March 1 2012
ABC News, 42-year-old Dr. Hsiu-Ying "Lisa" Tseng, an osteopathic physician from Rowland Heights, reportedly wrote an average of 25 prescriptions per day over the past three years. Tseng, who the
Associated Press (AP said has been nicknamed "Dr. Feelgood," is being charged with second-degree murder in the deaths of "three otherwise healthy men in their 20s." In addition, she faces 21 other felony counts and could face a total of 45 years to life in prison, said AP reporters Linda Deutsch and Greg Risling. Her first court appearance was last Friday, they said. Her arraignment was postponed for one week, and her bail, which is currently set at $3 million, will also be reviewed at that time. She has been charged with the deaths of 29-year-old Vu Nguyen, 25-year-old Steven Ogle, and 21-year-old Joseph Rovero. Nguyen, a Lake Forest resident, died on March 2, 2009. Ogle, a Palm Desert resident, died on April 9, 2009, while Rovero, an Arizona State University student, died on December 18 of that year. "Tseng wrote more than 27,000 prescriptions over a three-year period starting in January 2007 -- an average of 25 a day, according to a DEA affidavit. DEA agents swept into her office in 2010 and suspended her license to write prescriptions," Deutsch and Risling said. In Rovero's case, an autopsy discovered that he died as a result of acute intoxication of Alprazolam and Oxycodone -- better known by their respective brand names, Xanax and OxyContin. An
AP report published by USA Today on Friday said that Tseng prescribed the medicines to him, as well as Somas, after he had come to her office complaining of anxiety as well as pain in his hand, wrist, and back. Those prescriptions were issued "after performing only a partial physical examination that didn't even note which hands or wrists were in pain," according to Osteopathic Medical Board of California records. They accused her of failing to get a patient history and an explanation of the origins of his pain, failure to get prior treatment records to verify his medical history, failure to identify previous doctors, and failure to acquire a history of drug and/or alcohol abuse. Similar failures were found in the other two cases, the AP said. James Acker, a professor at the University of Albany School of Criminal Justice who is not involved with the ongoing proceedings, told Taylor that it was unusual for a doctor to be charged with murder in a case such as this. He said it was "far more" typical for a physician to face the lesser charge of "criminal homicide" -- or, as was in the case of Michael Jackson's doctor, Conrad Murray, involuntary manslaughter. "Where you are knowingly engaging in risky behavior, and it's likely that an adverse consequence such as a death will result, that's sufficient to consider it homicide," he added. --- On the Net:
“Ice cream 'could be as addictive as cocaine',” reported the Daily Mail. In a bid to scoop its rivals, the newspaper claimed that new research had whipped up “concerns that the dessert could be genuinely addictive”.
It’s not clear who exactly had these chilling “concerns” over the possible addictive qualities of the frozen snack, but the study in question looked at measures of brain activity in 151 teenagers while they drank an ice cream milkshake. During the scans, teenagers who had frequently eaten ice cream over the past two weeks showed less activity in the “reward areas” of the brain that give pleasurable sensations. This reduced reward sensation was reported to be similar to what is seen in drug addiction as users become desensitised to drugs.
It should be noted that the study included only healthy teenagers of normal weight, and its results may not represent overweight or older people. It also only tested one food, so the results may not apply to other foods.
Unsurprisingly, the study did not directly compare brain responses to or cravings for ice cream with those for illegal drugs. Therefore, while some aspects of the brain’s response may be similar, it is not correct to say that this study has found that ice cream is “as addictive” as illegal drugs.
Where did the story come from?
The study was carried out by researchers from the Oregon Research Institute in the US. Sources of funding were not clear. The study was published in the peer-reviewed American Journal of Clinical Nutrition.
The newspapers focused on the suggestion that ice cream is “as addictive” as drugs. However, it is not possible to conclude this from the study.
What kind of research was this?
This experimental study looked at whether regularly eating ice cream reduces the brain’s pleasurable “reward” response. When we do things that support our survival, such as eating and drinking, the brain gives us a pleasurable reward sensation, reinforcing this behaviour and encouraging it in future. A similar process is also believed to occur in drug addiction, where a person’s reward response to the drug decreases with repeated exposure, leading to a need to take more of the drug.
The researchers reported that people who are obese experience less of a response to food in the reward centres of the brain, which may contribute to over-eating. Repeatedly eating foods with high levels of calories (called “energy dense” foods has also been shown to lead to brain changes that reduce reward response in rats. The researchers wanted to see if a similar thing happens in humans, by looking at whether regularly eating ice cream reduces the brain’s pleasurable reward response to an ice cream milkshake.
What did the research involve?
The researchers recruited 151 adolescent volunteers who were not overweight. They asked them how often they ate ice cream, and carried out brain scans while they drank either a tasteless solution or an ice cream milkshake. They then looked at whether the volunteers who ate ice cream frequently showed less brain activity in the reward centres of the brain when drinking the ice cream milkshake.
The study excluded any individuals who were overweight or had reported binge eating in the past three months, as well as any who had used illegal drugs, took certain medications, had a head injury or a mental health diagnosis in the last year. The volunteers completed standard food questionnaires about their eating habits over the past two weeks, including how often they ate ice cream. They also answered questions about food cravings and how much they liked certain foods, including ice cream. The volunteers also had their weight, height and body fat measured.
Volunteers were asked to eat their meals as usual but not to eat anything for five hours before the brain scan. The researchers then gave them either a sip of chocolate ice cream milkshake or a tasteless solution, and monitored the activity in their brain. Each participant received both drinks in a randomised order. The researchers then looked at what happened in the brain during each drink, and whether this varied depending on how much ice cream the volunteer usually ate. They also looked at whether body fat or energy intake from other foods influenced the response.
What were the basic results?
The researchers found that when the volunteers drank the ice cream milkshake, it activated the parts of the brain involved in giving a pleasurable “reward” feeling. Volunteers who ate ice cream frequently showed less activity in these pleasurable reward areas in response to the milkshake. Percentage of body fat, total energy intake, percentage of energy from fat and sugar, and intake of other energy-dense foods were not related to the level of reward response to the milkshake.
How did the researchers interpret the results?
The researchers concluded that their findings show that frequent consumption of ice cream reduces the “reward” response in the brain to eating the food. They reported that a similar process is seen in drug addiction.
The researchers also said that understanding these sorts of processes could help us understand how changes in the brain may contribute to, and help maintain, obesity.
Conclusion
This brain-scanning study suggests that the brain’s pleasurable reward response to ice cream decreases if it is eaten frequently. There are some points to note:
- The study only included healthy adolescents who were not overweight. Its results may not be representative of overweight or older individuals.
- The study only tested one food, so the results may not apply to other foods.
- Volunteers’ eating habits were only assessed for the past two weeks, and these may not be representative of their long-term eating habits.
- The study did not look at any other food with a discernable taste, only a “tasteless liquid”. It would have been interesting to see whether the reward response with tasting other foods, including less energy dense foods, also diminished over time.
- News reports of this research have claimed that this study shows that ice cream is “as addictive” as illegal drugs, but this is not the case. While the reduced brain reward seen with frequent ice cream eating was reportedly similar to that seen in the use of addictive drugs, the study unsurprisingly did not directly compare brain responses to ice cream and illegal drugs, or their addictive potential.
Analysis by Bazian
Links To The Headlines
Ice cream 'could be as addictive as cocaine', as researchers reveal cravings for the two are similar. Daily Mail, March 5 2012
Ice cream as 'addictive as drugs' says new study. The Daily Telegraph, March 5 2012
Links To Science
Burger KS and Stice E. Frequent ice cream consumption is associated with reduced striatal response to receipt of an ice cream–based milkshake. First published February 15 2012
Could it be the "messenger" -- typically federal and state agencies and public health officials?
A clue to that possibility surfaced in
a recent study, "Motivation for Unpasteurized Milk Consumption in Michigan, 2011," by Paul Bartlett and Angela Renee Katafiasz, of Michigan State University, which appeared in a recent issue of "Food Protection Trends."
In an email to Food Safety News, Bartlett said that what surprised him the most about the results of the survey of raw-milk drinkers was that such a small percentage of them trusted public health officials regarding what food is safe to eat.
Only 4 (or 7.1 percent of the 56 raw-milk consumers who responded to the study's questionnaire agreed with a statement that "in general, they trusted recommendations made by state health officials about what foods are safe to eat." Another 10 (or 17.9 percent indicated they didn't agree with the statement, while another 41 (or 73.2 percent said they weren't sure.
"This lack of trust," says the study, "casts doubt on whether or not consumer education by local or state health departments would be effective in preventing milk-borne disease due to raw-milk consumption."
None of this surprises Mark McAfee, the outspoken co-owner of California-based
Organic Pastures, the nation's largest raw-milk producer. In an email to Food Safety News, McAfee said he has always thought that any area where raw milk is sold should have a huge ultra-red pink sign that says something like: "The FDA says raw milk is dangerous because it has not been processed."
"If that were the case," he said, "sales would skyrocket. No one trusts the Food and Drug Administration or its propaganda."
McAfee said the problem is that "state and federal agencies have cried wolf so many times against raw milk that now any cries that might be an honest attempt to warn of the rare incidence of illness is ignored as hatred against all things FDA."
FDA comes into the picture because the agency doesn't allow raw milk sold for human consumption to be transported across state lines.
That same skepticism about what public health officials and agencies have to say about raw milk kept surfacing in the recent Michigan study. When asked if raw milk should be regulated by the government to ensure quality standards, 27 (or 48.2 percent of the respondents disagreed, while only 9 (or 16.1 percent agreed. Another 17 (or 30.4 percent said they weren't sure.
Along those same lines, some of the raw milk consumers in the study said they generally believe that their producers maintain a higher standard of animal care and cleanliness than does the mainstream dairy industry.
The respondents also took issue with some of the survey's other statements, once again revealing sharp differences of opinion with official government views on the potential health hazards of drinking raw milk. For example, when asked if they agreed or disagreed with the statement that "Drinking raw milk increases your risk of getting a foodborne disease," an average of 44 (or 78.6 percent disagreed. Only 6 respondents agreed with the statement, and another 5 (or 8.9 percent of the respondents said they weren't sure. In Februrary, the Centers for Disease Control and Prevention
released a study showing that the rate of disease outbreaks linked to raw milk was 150 times greater than outbreaks linked to pasteurized milk.
In 2010, Michigan had two
Campylobacter foodborne outbreaks associated with raw milk. And last year, 3 probable cases of
Q-fever were reported in people who participated in raw-milk cow-share arrangements, which according to the report, were presumably caused by drinking raw milk. Back in 1947, Michigan became the first state to require that all milk for sale be pasteurized. As such, the sale of raw milk for human consumption is illegal in that state. However cow- and goat-share agreements in which people buy a share of a herd and are therefore considered owners of the milk from the herd are permitted through an informal agreement on the part of the state.
Profile of a raw-milk drinker
The Michigan study starts off by acknowledging that "it is largely unknown why some consumers prefer raw milk over pasteurized milk."
As such, one of the goals of the peer-reviewed study was to come up with a some sort of profile of raw-milk drinkers in Michigan and from there, to summarize their reasons for preferring raw milk to pasteurized milk.
The profile that emerged was a well-educated adult in his/her late 20s who typically lives in a rural area. Overall, the ages of the raw-milk drinkers, which included family members, ranged from less than one year to 75.
The profile, which, co-author Bartlett readily says is limited due to the small number of raw-milk drinkers surveyed, contrasts starkly with a profile of raw-milk drinkers in California that emerged in an earlier report, "
Profile of Raw Milk Consumers."
Authored primarily by scientists then at FDA's Center for Food Safety and Applied Nutrition, the report analyzed responses to questions in the 1994 California Behavioral Risk Factor Surveillance System Survey that asked respondents about whether they drank raw milk, the amount consumed, the reason for drinking raw milk, and where raw milk was most often obtained.
The researchers found that among the 3,999 survey respondents, 128 (about 3.2 percent reported drinking raw milk the previous year. These raw-milk consumers were more likely that those who didn't drink raw milk to be younger than 40, male, Hispanic and to have less than a high school education.
However, these survey results included any responder who had drunk raw milk in the previous year no matter how much or how little.
One of the conclusions of the California report was that additional research is needed to further refine the profile of raw milk drinkers and determine their risk of adverse effects from drinking raw milk.
The report also said that "Although the role of raw milk as a vehicle in disease transmission has been well-documented, information regarding the prevalence of raw-milk consumption in sparse."
Estimates of the percentage of milk drinkers who drink raw milk range from 1 to 3 percent of the U.S. population, although no one knows for sure since it's too difficult to track the information.
Organic Pastures McAfee was happy to share some information about his raw-milk customers, based on informal studies and polls conducted by the dairy. What surfaces is that 50 percent of the dairy's raw-milk customers are well-educated moms between 20 and 45 years old. The rest of the dairy's raw-milk customers are what McAfee describes as "being all over the place" and can be anyone: young, old, fat, skinny, gay, straight, religious, agnostic, healthy, sick, abandoned by doctors, not wanting to go to doctors, Eastern Bloc immigrants, left wingers, right wingers, no wingers, Tea Party members, and homeschoolers.
"It is everyone," he said.
Why raw milk?
Supporting local farms topped the list of the reasons the Michigan raw-milk survey respondents gave for preferring raw milk, with 48 (or 85.7 of them citing that as a reason. Next came taste, with 47 (or 83.9 percent giving that as a reason. "Holistic health benefits" were cited by 43 (or 76.8 percent of the respondents. Thirty-two respondents (or 57.1 percent said they don't feel processed milk is safe. A majority of the study's raw-milk drinkers shared their beliefs that raw milk was beneficial for relieving digestive problems, intestinal diseases and allergies. Some said they believe raw milk is beneficial for heart disease, neurologic disease, acne, and cancer. Others shared anecdotal claims that when they drink pasteurized milk, they experience symptoms of lactose intolerance, which they said doesn't happen when they drink unpasteurized milk. People with lactose intolerance have a hard time digesting lactose, which is a type of natural sugar found in milk and dairy products. The intolerance occurs when the small intestine doesn't make enough of the enzyme, lactase, which is needed to break down or digest lactose. Symptoms include gas, belly pain, and bloating.
However, a
study out of Stanford Medical School (financed by raw milk advocates not only raised questions about how widespread lactose intolerance really is, but found that raw milk did not confer any benefit over pasteurized milk in relieving symptoms of lactose intolerance. Health authorities say that no matter what benefits might be associated anecdotally with raw milk, the risk of contracting a foodborne disease such as E. coli, Salmonella, Campylobacter or Listeria infection outweighs any of the unproven benefits. They point out that if harmful microorganisms from cow excrement contaminates the raw milk, those drinking it can come down with serious digestive problems, kidney failure, or even death.
In California, labels on raw-milk containers must say: "Raw (unpasteurized milk and raw milk dairy products may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics or antacids; and those having chronic illnesses or other conditions that weaken their immunity." The Michigan study also revealed that the average number of years the respondents have been drinking raw milk is 6.1 and that 92 percent of the milk the respondents' families drink is raw milk.
A commitment to purchasing raw milk can be seen in the average number of miles a respondent travels out of his or her way to buy raw milk: 24.2 miles. The average number of pickups of raw milk each month was 4.1.
The study
Questionnaires were sent out to raw-milk producers, 20 of whom agreed to participate in the study. The producers, in turn, were sent survey questions, which they forwarded on to their cow- or goat-share members. Of the 160 questionnaires sent out, 56 were returned.
While the study has been criticized for being self-selecting in that it only questioned people who drink raw milk and biased because it started out with the assumption that it's potentially harmful to your health to drink raw milk, co-author Bartlett told Food Safety News that it was done "for the cost of postage" as a project for a 3-credit course. And, yes, he definitely would have liked to have had a higher response rate and a larger study.
He also pointed out that the hypothesized health benefits of raw milk are difficult to study because it would be unethical to randomly assign people to drink raw milk and others to drink pasteurized milk. Besides which, such a study could not be done blindly because the study subjects would certainly know if they were drinking raw or pasteurized milk (although the Stanford study effectively masked the taste differences with an added flavoring.
More information about raw milk can be found
here.
Greece's parliament has passed major new pharmaceutical cost-containment legislation which will require drugmakers to cover, each quarter, any overspending on the strict limits which the bill sets for the national drugs bill.
The new law - which passed on a 213-58 vote, with a number of deputies abstaining - states that overall drugs spending by Greece's social insurance funds must not exceed 2.88 billion euros for this year.
The legislation also mandates that, from April 1, clinicians must prescribe medicines from the 10 most-widely used therapeutic classes by generic name only, and from June 1 this requirement will apply to all products on Greece's positive reimbursement list. The funds will reimburse at the level of the cheapest product in each class, and any cost difference between this and the product supplied will have to be paid for by the patient.
Moreover, "inappropriate" prescribing - ie, of medicines by other than their generic name, and not of the cheapest product available - will now be classed as a criminal offence, according to local reports.
Generics currently account for just 18% of the pharmaceutical market in Greece, one of the lowest levels in the European Union (EU , and the latest measures aim to bring this up to the EU average of 50%. Health Minister Andreas Loverdos - who says he intends to slice a massive one billion euros off the nation's drug spending in a single year - has condemned a "coalition of interests" for allegedly attempting to cast doubts on the quality and safety of generics with the aim of hindering their wider uptake in Greece; however, counterfeit drugs are a significantly greater problem for Greece than for other EU nations.
The new law also seeks to save money by mandating the use of computerised prescriptions, with the imposition of a 1-euro fine on doctors for each hand-written prescription, and deregulation of pharmacy opening hours.
The legislation constitutes a requirement by the EU, the European Central Bank (ECB and the International Monetary Fund (IMF - Greece's "troika" of creditors - for agreeing a second bailout of 130 billion euros for Greece.
It is also reported that Yiannis Tounta, president of Greece's National Organisation of Medicines (EOF has been in talks with the troika concerning moves to delay the introduction into Greece of innovative new medicines until the products have been accepted for reimbursement by 8-10 other EU member states. Cancer drugs would be excluded from the proposals.
Commenting on the new legislation, analysts at IHS Global Inslght say that the requirement for pharmaceutical companies to pay back any spending above the stated limit in each quarter is "very negative." This is especially so given that many multinational and Greek drugmakers are owed considerable amounts, by the public hospitals in particular, and that the multinationals which have been paid in Greek government bonds have seen their value plummet, they note.
• A number of decrees concerning implementation of some of the major measures contained within the cost-containment legislation are expected to be announced shortly.
breast cancer medication instead of chewable fluoride tablets. While the fluoride the children were supposed to receive is used to prevent tooth decay, the pill Tamoxifen blocks the production of estrogen. CVS has alerted all the families and apologized, but no one can figure out exactly how this happened.
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Hackers demonstrate new wireless attacks against insulin pumps, GE and Masimo ink a new OEM deal and Cardiac Science and Flight Medical launch Class I recalls.
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Our understanding of misery has changed less than we think
In the middle of the 12th century
Hildegard of Bingen explained the aetiology of melancholia. The clue was in the name. Black bile, too much of it: "It causes the veins in the heart to overflow; it causes depression and doubt in every consolation so that the person can find no joy in heavenly life and no consolation in his earthly existence." It was the result of an imbalance of
the four humours that circulate in the body. A physician as well as a nun and composer, she is very specific about the biology and anatomy of the humours: "Each of the dominating humours is covered with a quarter of the one coming after and a half of the third. The weaker humour regulates the two parts and the remaining part of the third, to make sure it doesn't exceed its limits."
Today, we believe we know better. Depression is largely considered to be an imbalance of the neurochemistry in the brain, and is treated accordingly. Clark Lawlor explains the contemporary view: "An early model was
norepinephrine, one of the amine family …too little meant depression, too much meant elation. Serotonin deficiency is possibly the most well-known of the contenders for causing depression." Selective serotonin reuptake inhibitors (SSRIs such as Prozac increase the amount of serotonin in the brain, and are now the most widely prescribed response to a modern diagnosis of depression and even the newer, milder condition of
dysthymia – chronic low mood and sadness, perhaps equally well described as "melancholia".
People on SSRIs often feel better. Which is odd, because the number of people whose mood is improved is only very slightly above that of control groups taking placebos, and some drugs that actually reduce serotonin levels are statistically as effective as antidepressants which increase those levels.
The fact is that, as a non-neurologist and non-biochemist, I have no more real understanding about the functioning of genes, the resulting brain chemistry and the effect on mood than Hildegard of Bingen had about the proportion and action of the humours on the veins in the heart. It seems, too, that psychiatrists aren't entirely sure about the chemical mechanisms of depression. Even so, I pop a prophylactic Prozac every morning, because if I don't think too hard about what I don't know, like the early moderns, the notion of chemical imbalance makes some sense to me (in conjunction with other causes of my life-long tendency to sink into debilitating depression.
Lawlor's history of the journey from Aristotle and Galen on melancholia, to
Aaron Beck's and
Martin Seligman's cognitive behavioural approach to depression is notably not a story of progress and increased understanding, but of changes in culture, language and technology about a particular common human condition. It is most valuable as a history of thought about the varying degrees of sadness and despair that have been consistently experienced from antiquity to the present day. Timothie Bright's 1613 description of the effect of excessive black bile – "which shut up the hart as it were in a dungeon of obscurity, causeth manie fearfull fancies … whereby we are in heaviness, sit comfortless, feare distrust, doubt dispaire, and lament, when no cause requireth it" – is as good a picture of depression as I know it as any I've heard or read.
It's surprising, then, when Lawlor says that the early moderns' understanding of what seemed to them like an epidemic of melancholia as a result of the imbalance of bodily humours is "alien to our contemporary world view, even if we can discern similarities with modern symptoms". He uses the phrase "profound strangeness" about their treatment of melancholia with both religious and physical cures. Call the religious spiritual or psychological, and the physical purgings an attempt to rebalance the system, and neither their descriptions nor their fundamental ignorance seem all that different from our own flailing attempts to deal with what again looks like an epidemic of depression.
The Elizabethan picture is confusing, with melancholia being recognised as a fashionable pose, a disorder of the mind, a sign of genius and a precursor of psychosis, but it was hardly more diversely understood than it has been since modernity offered us psychoanalytical, physicalist and cognitive versions of the experience of what is now officially called "major depressive disorder". MRI scans and biochemistry are our new tools, but they are as subject to interpretation as the possibility of the spleen overheating and tipping the system into a hot, dry, burnt condition of melancholia.
Galen's assumption was that the perfect balance is rare, and that most people were in flux, tipping more or less away from balance according to their own behaviours, the environment and their humoral predispositions. This is hardly alien to our understanding of how the body, mind and external circumstances work inextricibly together, and how difficult it is to discern any single cause of mental functioning, positive or negative, no matter how much we yearn for a simple, certain explanation. Perhaps the ancients and early moderns were better at living with uncertainty than we are.
The main theme running through the second half of Lawlor's book is the way in which our present understanding of depression has been increasingly simplified in the
Diagnostic and Statistical Manual of Mental Disorders
(
DSM
, and the power that drug companies seem to have had in the creation of some of those definitions. Checklists appear there which assist doctors (or anyone with the list to diagnose depression via elementary symptom spotting. Causes become irrelevant because they are so much harder and more expensive to know about and to treat. Humoral imbalance, a rackety childhood, who cares? If you have five of the designated symptoms every day over a two-week period, a doctor can confidently diagnose depression and medicate it.
Some people claim (as Freud would that this has resulted in the pathologising of normal sadness. Even grief is now subject to a time-limit.
DSM-V
, due out in 2013, will have a new condition called "complicated grief disorder", which allows doctors to treat excessive mourning (designated by a symptom list as depression within a few weeks of a bereavement, and puts a limit on normal mourning at six months. It isn't just that we want certainty, we seem to have come to the conclusion that feelings of sadness or a low mood are not just intolerable but actually abnormal.
Unfortunately, rather as if he were trying to make more simple sense of the subject than there was and is to be made, Lawlor's book is an overly brisk addition to the history of and thinking about melancholia and depression. It reads like a series of notes for a longer and more considered book and is broken into sub-headings in which major topics such as romantic melancholy and Christianity's influence on depression are wrapped up in little more than a page and a half of text.
There's a good bibliography, so I suppose anyone particularly interested can find more substance than is on offer here, but it isn't clear who the intended reader is who urgently wants these more considerable books boiled down. The long inquiry into melancholia and depression is so full of extraordinary writing – Ficino, Burton, Shakespeare, Donne, Milton, Keats and Coleridge, Freud, Styron, Kristeva – that this exiguous "what comes next" approach feels meagre.
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And now for some pure irony, we have a member of the Fed,
granted a gold bug, but a Fed member nonetheless, one of the same people who not only enacted ZIRP, but encourage easy money
every time
there is a downtick in the market, complaining about, get this, Wall Street's "
continued preoccupation, bordering upon fetish
" with QE3. The irony continues: "Trillions of dollars are lying fallow, not being employed in the real economy. Yet financial market operators keep looking and hoping for more. Why? I think it may be because they
have become hooked on the monetary morphine
we provided when we performed massive reconstructive surgery, rescuing the economy from the Financial Panic of 2008–09, and then kept the medication in the financial bloodstream to ensure recovery....I believe adding to the accommodative doses we have applied rather than beginning to wean the patient might be the equivalent of medical malpractice." So let's get this straight: these academic titans, who for one reason or another, are given free rein to determine the fate of the once free world with their secret decisions every two or three months, are
completely unaware
of classical conditioning, discovered by Pavlov nearly 90 years ago, also known as a salivation response. The same Fed is shocked, shocked, that every time the market dips, the red light goes off, and the "balls to the wall" crowd scream for more, more, more free money. Really Fisher?
Really?
Oh, and let us guess what happens the next time the S&P slides into the tripple digits: will the Fed a
do nothing, thereby letting the market slide to its fair value in the 400 point range
, or b
print
. Our money, in the form of hard yellow metal, is on the latter, just like we predicted,
correctly
, back in March 2009 in "
Bailoutspotting (Or The Search For The Great Financial Methadone Clinic "
that nothing will ever change vis-a-vis the great market junkie until it all comes crashing down.
From the
Dallas Fed
“Not to Be Used Externally, but Also Harmful if Swallowed”: Projecting the Future of the Economy and Lessons Learned from Texas and Mexico
Remarks before the Dallas Regional Chamber of Commerce
Dallas, Texas
March 5, 2012
I have been asked to speak about the economy. I am going to take a different approach than is typical for a Federal Reserve speech. I’ll eschew making the prototypical forecast, except to note that from my perch at the Federal Reserve Bank of Dallas, I presently see that: a. On balance, the data indicate improving growth and prospects for job creation in 2012. However, the outlook is hardly “robust” and remains constrained by the fiscal and regulatory misfeasance of Congress and the executive branch and is subject to a now well-known, and likely well-discounted, list of possible exogenous shocks—the so-called “tail risks”—posed by possible developments of different sorts in the Middle East, Europe, China and elsewhere. And b. While price stability is being challenged by the recent run-up in gasoline prices—which has yet to be reflected in the personal consumption expenditure and consumer price indexes but may well make for worrisome headlines when February data are released—the underlying trend has been converging toward the 2 percent long-term goal formally adopted by the Federal Open Market Committee (FOMC at its last meeting.[
1]
As to the outlook envisioned by the entire FOMC, you might wish to consult the forecasts of all 17 members, which include those of yours truly, that were made public after the January meeting—though I think a puckish footnote appended to the internal document laying out a component of the December 1966 FOMC forecast might still apply: “Not to be used externally, but also harmful if swallowed.”[
2]
Speaking of harmful if swallowed, I might add that I am personally perplexed by the continued preoccupation, bordering upon fetish, that Wall Street exhibits regarding the potential for further monetary accommodation—the so-called QE3, or third round of quantitative easing. The Federal Reserve has over $1.6 trillion of U.S. Treasury securities and almost $848 billion in mortgage-backed securities on its balance sheet. When we purchased those securities, we injected money into the system. Most of that money and more has accumulated on the sidelines: More than $1.5 trillion in excess reserves sit on deposit at the 12 Federal Reserve banks, including the Dallas Fed, for which we pay private banks a measly 25 basis points in interest. A copious amount is being harbored by nondepository financial institutions, and another $2 trillion is sitting in the cash coffers of nonfinancial businesses.
Trillions of dollars are lying fallow, not being employed in the real economy. Yet financial market operators keep looking and hoping for more. Why? I think it may be because they have become hooked on the monetary morphine we provided when we performed massive reconstructive surgery, rescuing the economy from the Financial Panic of 2008–09, and then kept the medication in the financial bloodstream to ensure recovery. I personally see no need to administer additional doses unless the patient goes into postoperative decline. I would suggest to you that, if the data continue to improve, however gradually, the markets should begin preparing themselves for the good Dr. Fed to wean them from their dependency rather than administer further dosage.
I am well aware of the salutary effect of accommodative monetary policy on the equity and fixed-income markets—remember, I am the only member of the FOMC who used to be on the other side. My firms’ record of substantially outperforming the equity and fixed-income indexes over a prolonged period before I hung up my investment business and entered public service in 1997 was achieved by focusing on the long-term fundamentals of the real economy and the underlying value of the securities we purchased or sold—not by depending on central bank largesse. Counting on the Fed to perpetually float returns is a mug’s game.
From my present perspective on the side of the angels, as a member of the policymaking team on the FOMC, I believe adding to the accommodative doses we have applied rather than beginning to wean the patient might be the equivalent of medical malpractice. Having never before pursued this course of healing, we run the risk of painting ourselves further into a corner from which we do not know the costs of exiting. It is my opinion that we should run that risk only in the most dire of circumstances, and I presently do not see those circumstances obtaining.
So much for forecasting and monetary policy. Let me now walk you through an overview of the Texas economy to set the stage for a broader discussion of what I believe continues to bedevil a lasting recovery and more efficient job creation in the United States.
I will use some slides to illustrate key points.
The National Bureau of Economic Research, the arbiter of when recessions begin and end, dates the onset of the Great Recession as December 2007. The economic performance of Texas since December 2007 can be summarized with the chart projected on the screen. It depicts employment growth in the 12 Federal Reserve districts. In the Eleventh Federal Reserve District?or the Dallas Fed’s district—96 percent of economic production comes from the 25.7 million people of Texas. As you can see by the red line, we now have more people at work than we had before we felt the effects of the Great Recession. All told in 2011, Texas alone created 212,000 jobs.[
3]
Only two other states can claim they surpassed previous peak employment levels: Alaska and North Dakota.
Readers of this speech abroad?say, in Washington or New York?might think our growth last year came only from the burgeoning oil and gas patch. They would be right to describe it as burgeoning: 30,000 jobs were added in oil and gas and the related support sector last year. Texas now produces 2.1 million barrels of oil per day, the same amount as Norway; we produce 6.7 trillion cubic feet of natural gas a year, only slightly less than Canada.[
4]
With 25 percent of U.S. refinery capacity and 60 percent of the nation’s petrochemical production located in Texas, we most definitely benefit from both upstream and downstream energy production.
And yet other sectors gained more jobs than the oil and gas sector and its support functions in 2011: 58,000 jobs were added in professional and business services, nearly 46,000 in education and health services and more than 41,000 in leisure and hospitality. Manufacturing?which accounts for approximately 8 percent of total Texas employment?added over 27,000 jobs.
All told, the private sector in Texas expanded by 266,400 jobs in 2011, while the public sector contracted by 54,800, due primarily to layoffs of schoolteachers. In sum, Texas payrolls grew 2 percent, significantly above the national rate of 1.3 percent.
This performance is not unique to last year. As you can see from this graph of nonagricultural employment growth by Federal Reserve district going back to January 1990, the Eleventh District has outperformed the nation on the job front for over two decades. Note the slope of the top line, which depicts job growth in the Eleventh District compared with each of the other districts and, importantly, relative to employment growth for the U.S. as a whole?denoted by the black line, the seventh one down.
As was pointed out in high relief by the media when a certain Texas governor was briefly in the hunt for his party’s presidential nomination, we do have some serious deficiencies in the Lone Star State. We have a very large number of people earning minimum wage; we have an unemployment rate that, while trending downward, is still too high, abetted by continued inflows of job seekers from less-promising sections of the country. But I’ll bet you that those who constantly enumerate our deficiencies and are given to habitual Texas-bashing would give their right—or should I say, left—arms to have Texas’ record of robust long-term job creation instead of the anemic employment growth of other megastates such as California and New York. Or even the job formation record of many other countries! The following chart shows that over the past two decades, the rate of employment growth in Texas has exceeded that of the euro zone and its two anchors, Germany and France, as well as that of two natural-resource-intensive countries with populations comparable to Texas’, Canada and Australia.
Now, is all this just prototypical Texas brag, or are there lessons the nation can learn from the success that is enjoyed here? Texans are hardly given to modesty, but I believe there are some undeniable lessons being imparted here.
One lesson I draw from comparative state data is that monetary policy is a necessary but insufficient tonic for economic recovery. The Fed has made money cheap and abundant for the entire country. The citizens of Texas and the Eleventh Federal Reserve District operate under the same monetary policy as do our fellow Americans. We have the same mortgage rates and pay the same rates of interest on commercial and consumer loans, and our businesses borrow at the same interest rates as their brethren elsewhere in the country. Which raises an important question: If monetary policy is the same here as everywhere else in the United States, why does Texas outperform the other states?
The answer is no doubt complicated by the fact that Texas is blessed with a comparatively great amount of nature’s gifts, a high concentration of military installations and what some claim are other “unfair” advantages.
But many of these “unfair” advantages are man-made: They derive from a deliberate approach by state and local authorities to enact business-friendly regulations and fiscal policy. For example, if you examine the differences between Texas and two states that have been underperforming for a prolonged period—California and New York—you will note that these former power states have less-flexible labor rules. Due to local taxes, differences in zoning practices and myriad other factors, the cost of housing and the overall cost of living in California and New York are significantly higher than they are here. And due to differences in policies governing education, the scores measuring middle-school students’ proficiency in math are lower in both California and New York than they are in Texas, and in reading, are lower in California and only slightly higher in New York.[
5]
Taken together, these factors, alongside whatever natural advantages we may enjoy (though it is hard to compete with the physical beauty of California and the Great Lakes region or the cultural splendor of New York , affect where firms choose to locate and hire and where people choose to raise their families and seek jobs.
I would argue that an additional factor favors Texas: We have a Legislature that under both Democratic and Republican governors has over time deliberately crafted laws and regulations, and tax and spending regimes, encouraging business formation and job creation.
Just last month, Fairfield, Calif.-based vehicle reseller Copart Inc. announced that it will move its headquarters to Texas, citing “greater operational efficiencies.”[
6] The CEO for the owner of Hardee’s and Carl’s Jr. restaurants, Andy Puzder, claims it takes six months to two years to secure permits in California to build a new Carl’s Jr., whereas in Texas, it takes six weeks. These two anecdotes from California alone clearly illustrate that firms and jobs will go to where it is easiest to do business—not where it is less convenient and more costly.
Both state and federal authorities need to bear this in mind as they plot changes in the fiscal and regulatory policy needed to restore the job-creating engine of America. As an official of the Federal Reserve charged with making monetary policy for the country as a whole, I am constantly mindful that investment and job-creating capital is free to roam not only within the United States, but to any place on earth where it will earn the best risk-adjusted return. If other countries with stable governments offer more attractive tax and regulatory environments, capital that would otherwise go to creating jobs in the U.S.A. will migrate abroad, just as intra-U.S. investment is migrating to Texas.
Thus, even if one were to somehow have 100 percent certainty about the future course of Federal Reserve policy and be completely comfortable with it, without greater clarity about the future course of fiscal and regulatory policy and whether that policy will be competitive in a globalized world, job-creating investment in the U.S. will remain restrained and our great economic potential will remain unrealized.
I pull no punches here: We have been thrown way off course by congresses populated by generations of Democrats and Republicans who failed the nation by not budgeting ways to cover the costs of their munificent spending with adequate revenue streams. The thrust of the political debate is now—and must continue to be—how to right the listing fiscal ship and put it back on a course that encourages job formation and gets the economy steaming again toward ever-greater prosperity. No amount of monetary accommodation can substitute for the need for responsible hands to take ahold of the fiscal helm. Indeed, if we at the Fed were to abandon our wits and seek to do so by inflating away the debts and unfunded liabilities of Congress, we would only become accomplices to scuttling the economy.
I was in Mexico last week. Mexico has many problems, not the least of which is declining oil production, low school graduation rates and drug-induced violence. But on the fiscal front, the country is outperforming the United States. Mexico’s government has developed and implemented better macroeconomic policy than has the U.S. government.
Mexico’s economy contracted sharply during the global downturn, with real gross domestic product (GDP plummeting 6.2 percent in 2009. But growth roared back, up 5.5 percent in 2010 and 3.9 percent in 2011, with output reaching its prerecession peak after 12 quarters—three quarters sooner than in the U.S. Mexico’s industrial production passed its prerecession peak at the end of 2010; ours has yet to do so.
Now hold on to your seats: Mexico actually has a federal budget! We haven’t had one for almost three years. Furthermore, the Mexican Congress has imposed a balanced-budget rule and the discipline to go with it, so that even with the deviation from balance allowed under emergencies, Mexico ran a budget deficit of only 2.5 percent in 2011, compared with 8.7 percent in the U.S. Mexico’s national debt totals 27 percent of GDP; in the U.S., the debt-to-GDP ratio computed on a comparable basis was 99 percent in 2011 and is projected to be 106 percent in 2012. Imagine that: The country that many Americans look down upon and consider “undeveloped” is now more fiscally responsible and is growing faster than the United States. What does that say about the fiscal rectitude of the U.S. Congress?
Here is the point: As demonstrated by the relative and continued, inexorable outperformance by Texas—which is affected by the same monetary policy as are all of the other 49 states—the key to harnessing the monetary accommodation provided by the Fed lies in the hands of our fiscal and regulatory authorities, the Congress working with the executive branch. As demonstrated by the fiscal posture of Mexico, a nation can effect budgetary discipline and still have growth.
One might draw two lessons here.
The first comes from Germany’s finance minister, Wolfgang Schauble, who from my perspective was spot on when he said, “If you want more private demand, you have to take people’s angst away” by having responsible and disciplined fiscal and regulatory policy.[
7] Clearly, there is less angst involved in conducting business in Texas.
The second is a broader, macroeconomic truism: that fiscal and regulatory policy either complements monetary policy or retards its utility as a propellant for job creation. Mexico is proof positive that good fiscal policy enhances the effectiveness of thoughtfully conducted monetary policy, which is what the Banco de Mexico—whose independence, incidentally, was enshrined by a constitutional amendment in 1994—has delivered under its single mandate of inflation control and by applying the tool of inflation targeting.
I should be injecting some levity into the event, though it is hard to do so when one talks about our feckless fiscal authorities. But there are witty people who have found a way to do so. Take a look at this parody of Congress that my staff found on YouTube:
www.youtube.com/watch?v=Li0no7O9zmE.
There you have the prevailing modus operandi of our fiscal authorities: pass the bill rather than the American dream to our children. What a sad tale!
You asked me to talk about the economy. In a nutshell, my answer is this: Monetary policy provides the fuel for the economic engine that is the United States. We have filled the gas tank and then some.
And yet businesses will not use that fuel to a degree necessary to realize our job-creating potential and create a better world for the successor generation of Americans until Congress, working with the executive branch, does the responsible thing and pulls together a tax, spending and regulatory program that will induce businesses to step on the accelerator and engage the transmission mechanism of job creation so they and the consumers they create through employment can drive our economy forward.
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