Posts Tagged ‘USA’
The link between salt intake and high blood pressure has been known for decades. That’s why, if you have high blood pressure, your doctor will tell you to reduce your salt intake. The reason is that excess salt makes your body retain more water. And more water in your circulation means more fluid in your vascular pipes, making the pressure in the pipes higher. That’s also why one of the first line treatments for high blood pressure is a diuretic, a drug that makes your kidneys release more water into the urine. It’s one thing to put down the salt shaker and also reduce (or eliminate) your consumption of salty snacks. But there is a hidden source of salt we often don’t think about — the salt in processed foods. When you are cooking raw food you control how much salt you add. But you are not in control of how much salt is in processed foods, such as prepared things you might get in the frozen food section or out of a box. Food companies add quite a bit of salt to these since the perception is that doing so makes the foods tastier. Do they need to do that? How much different would foods taste if they didn’t? A recent study gives some answers to those questions.
The research was published in a recent edition of the British Medical Journal. The investigators used a national survey database to look at changes in the incidence of high blood pressure, stroke, and heart attacks over the past decade and found improvements in all of these. There are several possible explanations, including better treatment for these conditions. However, the investigators also had access to urinary salt values in many patients. The improvement particularly in blood pressure correlated with lower salt consumption. Of note, since 2003 the amount of salt in processed foods has been gradually reduced in the United Kingdom. Overall salt consumption fell by 15%. It is reasonable to conclude that at least part of the reduction in cardiovascular disease they observed was because of this salt reduction.
Although it would be difficult to accomplish, I don’t see any reason such improvements couldn’t be carried out in the USA. From everything we know, particularly high blood pressure is a long-term killer, and most people with it don’t know they have it because blood pressure needs to become very high before a person has any symptoms that would bring them to the doctor.
From time immemorial until about 75 years ago or so most babies were born at home. Now it’s around 1% in the USA, although it’s much higher than that in many Western European countries. The shift to hospital births paralleled the growth of hospitals, pediatrics, and obstetrics. With that shift there has been a perceived decrease in women’s autonomy over their healthcare decisions. There has also been an unsurprising jump in the proportion of Caesarian section deliveries, an operative procedure, and various other medical interventions in labor and delivery. So the debate over whether this is a good thing or a bad thing (or neither) is much more than a medical debate; it is also a social and political one. It is also to some extent an issue of medical power, a struggle between physician obstetricians who deliver babies in the hospital and nurse midwives who often deliver babies at home. I’m very interested in the social and political aspects, but as a pediatrician I’m particularly concerned with the safety question: Is it more dangerous for your baby to be born at home?
There have been many studies that attempt to answer that question. Many, even most, of them come from outside the USA. The results are mixed. Some say hospital birth is safest (this one, for example), others that there is no difference (this one, for example). One US study that found home delivery to be riskier has had its methodology heavily criticized. What we need are some well designed, large cohort studies from the USA, especially since healthcare systems differ substantially from country to country. I think this recent study from the American Journal of Obstetrics and Gynecology is very useful in that regard.
The main question the authors tried to answer was how the babies did. The measure they looked at was to analyze the frequency of two well-accepted markers of infant distress, things that correlate with trouble later in development. Bear in mind that there can be many reasons for these bad things to happen — some avoidable, some not. The notion is that if one can study a large enough group, then particular circumstances for individual births will wash out in the totals.
The potentially bad things that the authors chose were easy things to count and document. The first was a low Apgar score at 5 minutes after birth. The Apgar score, scaled 0 to 10 and recorded at 1 and 5 minutes after birth, has been a standard, well validated measure of infant distress for many decades. A value of less than 4 is potentially very bad for the baby. The other measure the authors chose was seizures, convulsions, immediately after birth. These can be caused by many things, but most of them are bad.
The study group consisted of over 2 million infants born in 2008. Of these only 12,000 were planned home births (0.6%). This shows how uniform hospital birth has become in the USA, but 12,000 is still a very large group of babies. They excluded babies born unexpectedly outside the hospital.
The results showed that babies born in the hospital, as you would expect, had a very much larger percentage of obstetrical interventions of various sorts associated with their birth. Regarding the distress measures, 0.24% of hospital-born babies had Apgars of less than 4 at 5 minutes; this compared with a rate of 0.37% for babies delivered at home — 1.5 fold higher. This difference was statistically significant. Also significantly different was the rate of seizures: for hospital-born babies it was 0.02% and for home-birth babies it was 0.06%, or 3-fold higher.
So what does this mean? First, the incidences of both of these bad things, although statistically higher in the home-birth group, were still very low. That is encouraging. But to understand things better you need to dig deeper into the data and see who attended at these deliveries. In the hospital it was presumably a physician, but what about at home? After all, “home delivery” can mean many things.
In this study, 26% of the home birth attendants were certified nurse-midwives, 51% were other midwives, and the remainder something else. A key finding to me is that the outcomes for babies delivered at home by certified nurse-midwives were no different than for those born in the hospital. So proper training matters — a lot. One key thing a trained midwife should offer is the knowledge of which pregnancies are higher risk and unsafe to deliver outside a hospital.
Both the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists have issued policy statements about planned home births. The bottom line to me is that, while neither society is thrilled with the practice, both say properly selected (and they give lists of what that means, which is itself a bit controversial, such as if previous Caesarian section should be a disqualifier), low risk pregnancies can be safely delivered at home. As a pediatrician, I should point out that if you chose that there are some routine things that need to be done for your baby in the first days of life, such as a hearing screen. So you should bring your infant to the doctor promptly for a newborn evaluation.
I’ve been involved in several boisterous Twitter debates about vaccines, at least to the extent that one can debate using snippets of 140 characters or less. I’ve also been a Super Moderator at a very large Internet message board (AbsoluteWrite) for many years and have seen my share of passionate vaccine debates there. I’ve been a pediatrician for over 30 years and trained in the subspecialty of pediatric infectious diseases before I went into critical care. So I think a lot about vaccines and have watched controversies about them come and go for a very long time. It’s been interesting. One very interesting aspect for me is trying to understand how parents think about the relative risk of medical treatments and procedures for their children. It’s different from how physicians think of risk, and I think this difference is key to understanding the continuing ferment over vaccinations. I’ve previously written about the risk of a vaccine injury (about 1 in a million at worst) compared to the risks of everyday life, but there is another aspect to the issue: in my experience parents are uniquely worried about vaccine risk in ways they are not about other medical procedures and treatments. A few examples illustrate my point.
Stevens-Johnson syndrome is a severe skin reaction to something, most commonly a medication. It varies in severity but can progress to a very bad condition known as toxic epidermal necrolysis. This is a life-threatening condition and often requires a prolonged stay in the intensive care unit. I have seen several life-threatening cases over the years. The drugs that can cause it are quite common ones. Many are antibiotics; sulfa drugs, for example, are well-known offenders. How common is this condition? There are about 300 cases per year in the USA. This makes it much more common than vaccine injury, yet nearly all parents think of antibiotics as safe drugs. On balance, they are — but they are not risk free.
Medications like antibiotics can cause other kinds of allergic reactions, which can be severe or life-threatening. A very conservative estimate is that about 0.01-0.05 % of all people — about 1-5 per 10,000 individuals — will have such a serious drug reaction in their lifetime. Yet parents accept prescriptions without worrying about that.
Another example is anesthesia. As part of my practice I anesthetize many children for procedures, such as MRI scans. The risk of doing this is low, but it is well above zero. The actual risk of death from an anesthetic is around 1 in 250-300,000 — about 3 times the risk of a serious vaccine reaction. There also may be neuro-developmental risks to young children who receive anesthetics. That risk is very low, too (there are many studies ongoing to define it), but it is not zero. Of course if a child needs emergency surgery the balance of risk versus benefit overwhelmingly favors using the anesthetic, but there are many other situations that are not so clear-cut. Yet virtually all parents willingly allow me anesthetize their child.
My point is that vaccine risk, compared with the risks of other medical interventions, causes particular concern among parents, and I am not sure why that is. However, it is not new. Since the introduction of the very first vaccine, Edward Jenner’s use of smallpox vaccine, people have been particularly suspicious of vaccines. (The name “vaccine” itself is derived from Jenner’s use of the vaccinia virus, the cowpox virus, as a protection against smallpox.) As noted in the essay linked above:
Although the time periods have changed, the emotions and deep-rooted beliefs—whether philosophical, political, or spiritual—that underlie vaccine opposition have remained relatively consistent since Edward Jenner introduced vaccination.
I suppose the notion of putting a foreign substance into a child’s body with the intention of provoking the body to react to it is philosophically distinct from giving a child a medication that is not intended to do that. But I would be very interested in what other people think makes vaccines unique.
The measles virus is among the most infectious of all known viruses, with an attack rate of well over 90%. That means that over 90% of susceptible people — those who have not been vaccinated or who have not had the disease — will get it if exposed. I’ve seen one case, and that was thirty years ago, although my parents showed me a picture of what I looked like with measles in 1958. It was like the picture above.
Before the introduction of a vaccine in 1963 measles caused about 4 million cases annually in the USA, leading to 48,000 hospitalizations and 500 deaths. That’s a lot of kids in the hospital and a significant mortality. The measles vaccine has nearly eliminated these things, but not entirely. I recently ran across an interesting article from a couple of years ago that investigated a measles mini-epidemic that happened in Southern California. One thing that caught my eye, something I had not considered before, was the economic cost of the epidemic.
The outbreak happened when an unvaccinated seven-year-old child returned from Europe after being exposed to measles there, and proceeded to expose other children. Like many viruses, people who are infected shed virus before they know they are sick; think of it as a crafty strategy the virus uses to spread itself.
Although 879 people were exposed, most of these were vaccinated so only 12 secondary cases occurred, all in unvaccinated children. Nine of these children were deliberately unvaccinated, but three of them were too young to have received the vaccine. One three-month-old had to be hospitalized. Forty-eight children too young to be vaccinated had to be quarantined at home for several days.
The authors estimated the economic costs of the entire epidemic, including lost work time for parents, costs of treatment, and time spent by the health department investigating it, at nearly eleven thousand dollars per case. So besides saving lives, measles vaccine reduces healthcare costs significantly.
Bronchiolitis is the leading cause of hospitalization for very young children in the USA. You’ll find various definitions of what bronchiolitis is, but a standard one is a viral illness that starts in the upper respiratory tract with runny nose, congestion, and cough. This is soon followed by symptoms in the lower respiratory tract — the lungs — such as rapid breathing, wheezing, and sometimes the need for extra oxygen. The culprit in half to three-quarters of cases is what we call respiratory syncytial virus, or RSV, but a variety of viruses can do it. Interestingly, 10-30% of children with bronchiolitis and RSV have another respiratory virus, too. Researchers aren’t sure if this combined infection contributes to how severe the symptoms are.
Any child can get bronchiolitis, but children who were born prematurely or who have some preexisting problem with their lungs are particularly susceptible to experiencing severe cases of it. But even otherwise normal children can get critically ill. I just cared for such a child, one who needed a week of a mechanical ventilator for it, and all pediatric intensivists have now and then had similar cases.
Because it’s so common, and because some of the symptoms of bronchiolitis resemble asthma, physicians for many years treated it with asthma drugs. Unfortunately, these drugs rarely help. But the urge to do something, anything, for this often frustrating illness is a strong one, and I still often see full-bore asthma treatment given for bronchiolitis. Indeed, in spite of multiple recommendations by panels of experts, more than a few American doctors seem reluctant to concede that little in the way of drug therapy helps. It’s hard-wired into our nature to treat things. The problem is that no drugs are risk-free, so we shouldn’t use them unless there is a reasonable chance they will do good.
What helps bronchiolitis? For a child at high risk of getting a severe case of RSV we can give a monthly shot of a drug called Synagis that can reduce the chances of getting RSV, or, if it happens, having a less severe case. For the rest, we use frequent suctioning of all the nasal mucus, oxygen if a child’s blood oxygen level shows it to be a bit low, and time. For now, that’s about it.
Anyone who works in a children’s hospital, and particularly in a PICU, soon comes to know many children we call technology-dependent. This term includes a wide variety of children with a wide variety of problems, but a good working definition is a child who requires some item of technology to stay alive. This requirement need not be minute-to-minute. For example, some children require feedings delivered by a mechanical pump, either into their veins or into their intestinal tract. If the technology fails for some reason, the parents usually have several hours at least to bring their child to the doctor to fix the problem.
For some technology-dependant children, however, their reliance on machinery really is minute-to-minute — if the equipment fails, it’s a life-threatening emergency. These usually are children on mechanical ventilators — respirator machines. The day-to-day life for these children and their families is complicated. For example, everyone who cares for the child must be trained in how to trouble-shoot the machinery as well as in more than basic CPR if everything quits working. The machinery takes power to run, and every family needs to have a plan for what to do in the event of a power failure. These are only a few of life’s complexities for these children.
How many of these children are there in the community? Those of us who work in pediatric intensive care believe the number is increasing steadily as our technological capabilities increase. Are there any data about this? The answer is some, but not as much as we’d like.
For large university children’s hospitals, the prevalence is quite high. One recent such study estimated 20% — 1 in 5 — of all the children discharged from the hospital were dependent upon technology in some way, and 1% of these needed a ventilator. Of course large, tertiary children’s hospitals see only the sickest of children: what about the general population? The only comprehensive data I could find for the USA are twenty years old, when a study from the federal Office of Technology Assessment estimated the total as 50,000 children (or about 5/100,000 persons) were technology-dependent, 2,000 of these needing ventilators. A 2006 study of just home-ventilated children for the state of Utah found a 25-fold increase over the intervening decades in the prevalence of this most fragile subgroup of children. There is no reason to doubt that what is going on in Utah is not going on in the rest of the country.
Besides complicated lives, these children and their families also have very expensive lives. How expensive? Ten years ago I looked at the bills of several of my ventilator-dependant children, and they ranged from $75,000 to $300,000 per year. At that annual cost many families quickly reach the cap on their health insurance policies. There is help for them, although it varies from state to state (and the process is long and complicated), with such things as Medicaid waiver programs and Supplemental Security Income from the Social Security Administration.
With the number of these children increasing dramatically, accompanied by a corresponding increase in cost to our cash-strapped healthcare system, what are we to do? Anything? In the abstract, I think it is unethical to deny anyone care based upon cost. But the example of technology-dependant children is a real-life example of where the abstractions of the healthcare debates meet the reality of children’s lives. As a society, we can’t buy everything for everybody. Yet amid all the hub-bub of the debate, we can’t lose sight of the plight of these children and their families.
The FDA (Food and Drug Administration) has been battered with another serious incident, this one involving bad batches of the drug heparin (a blood thinner) that originated in China. Nearly a hundred people have died and many others experienced serious reactions after receiving heparin which appears to have been deliberately adulterated with a dangerous (and much cheaper) chemical. Until I read about it I had no idea such a large proportion of our drug manufacturing, like our clothes and our children’s toys, has been outsourced, primarily to China. In fact, now over 80% of the medicines you take, or at least the major ingredients in them, come from abroad. How can we be sure those medicines are safe?
As it turns out, we cannot — assuring the safety of these products is nigh impossible. The FDA is charged with inspecting all factories that make drugs. This was at least manageable when these facilities were in the USA, although staffing cutbacks at the FDA have even made this very difficult. In the case of foreign sites, it is unclear where some of these factories even are, and there are four times as many of them as there were 25 years ago. You can read a good discussion of the FDA’s woes here.
What to do? As one knowlegable person has pointed out, playing “kick the FDA” is not the answer. At its current level of funding, the agency will never have enough inspectors to scour the globe inspecting all these facilities. Increasing this surveilance will cost money. Where should that money come from? Drug manufacturers have reaped the financial benefit of outsourcing — I think it is time they either shoulder a major share of insuring the safety of our medicines, or else bring the manufacturing process back to this county where at least it will be easier to monitor. The recent heparin tragedy shows us what can happen if we do not do this.