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Jul
29

Florida law preventing doctors’ questions about firearms upheld

written by Tara Haelle

I don’t typically write about court cases or policy, but after writing the post a few weeks ago about the Ask Campaign, it’s hard to ignore one particular recent court decision that directs relates to children’s safety. In that post, I advocated that parents ask the parents of their children’s playmates whether there is a gun in the home. Today, I write about the law that prevents doctors from asking the exact same question.

More than 7,000 children and teens are injured or killed by firearms every year. Given the steady stream of tragic news stories about children finding unlocked guns, you would think it makes sense for pediatricians to ask parents whether they keep their guns locked up. But doing that requires pediatricians to ask whether the parents have any guns in the first place.

Should pediatricians have the right to ask whether you own one of these? Photo by Svend Damsgaard

Should pediatricians have the right to ask whether you own one of these? Photo by Svend Damsgaard

In Florida, that’s against the law. At least since June 2011, when Rick Scott signed into law the Florida Privacy of Firearm Owners Act.

You might think such a law would violate the First Amendment by restricting physicians’ right to free speech. Or, at least that’s what a bunch of physicians thought. Along with several Florida doctors, the state chapters of the American Academy of Pediatrics, the American Academy of Family Physicians and the American College of Physicians sued the state of Florida for a law they claimed violated their right to free speech (potentially including their right to pass along data in professional policy statements such as this one on firearms).

However, in a 2-1 ruling (pdf) today, a federal appeals court upheld the Florida law, arguing that a doctor’s questions about firearms violated a patient’s right to privacy. “The act simply codifies that good medical care does not require inquiry or record-keeping regarding firearms when unnecessary to a patient’s care,” the majority opinion stated in the case Wollschlaeger v. Governor of the State of Florida.

The problem is, good medical care always requires taking into consideration ways to reduce the risk of injury or death. When we choose our doctors, we let them ask us questions about private family issues in exchange for their help managing our family’s health. There is no reason firearms should be any different than asking parents whether they keep their household chemicals and medications out of children’s reach.

Professional medical associations in the U.S. agree that firearm violence represents a major public health problem in the U.S. Given that the U.S. has the highest rate of gun ownership and of firearm deaths and injuries in the developed world, it’s pretty hard to argue that point. Physicians are the stewards who help address public health issues. Arguing that a doctor’s questions about a family’s ownership of firearms violates the family’s right to privacy is akin to arguing that asking about the presence of lead paint – a standard well-child screening question – is a violation of their privacy. Why is it the doctor’s business whether a family has lead paint in their home? Because it presents a risk to children. So do firearms, so why are they any different?

The AAP thinks firearms in the home should be treated at least as seriously as lead paint. In a statement released today following the decision, James M. Perrin, MD, FAAP, the president of the AAP, said the following: “State legislatures should not stop physicians from practicing good medicine. This law has a chilling effect on life-saving conversations that take place in the physician’s office. More than 4,000 children are killed by guns every year. Parents who own firearms must keep them locked, with the ammunition locked away separately. In this case, a simple conversation can prevent a tragedy. The evidence is overwhelming – young children simply cannot be taught to overcome their curiosity about guns, and to suggest otherwise is, frankly, the height of irresponsibility.”

The president of the Florida chapter of the AAP, Mobeen Rathore, MD, FAAP, issued a similar statement: “We strongly disagree with the 11th Circuit’s decision. It is an egregious violation of the First Amendment rights of pediatricians and threatens our ability to provide our patients and their families with scientific, unbiased information. This dangerous decision gives state legislatures free license to restrict physicians from asking important questions about health and safety that are vital to providing the best medical care to patients.”

Ten other states have laws similar to Florida’s introduced in their legislatures. The plaintiffs have said they will appeal the case to the 11th circuit court. Perhaps that court considers the argument made by dissenting judge Charles Wilson: “This law is … designed to stop a perceived political agenda, and it is difficult to conceive of any law designed for that purpose that could withstand First Amendment scrutiny. Regardless of whether we agree with the message conveyed by doctors to patients about firearms, I think it is perfectly clear that doctors have a First Amendment right to convey that message.”

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Jul
27

Guest Post: Water remains No. 1 among fortified drinks

written by Guest Author

Today’s guest post by Donald Bucklin (bio below) points out that the most important drink you can consume is good old fashioned water. This post is one of the few unsolicited blog posts I have decided to publish that came to me from a company, though I have no relationship with U.S. HealthWorks and do not necessarily endorse or oppose their business. I hosted this guest post because the message is simple, but the information is important and evidence-based.

It’s summer at last, which means it’s the perfect time to discuss hydration. Given the proliferation of the so-called science of hydration, one would expect only a Ph.D. could make an intelligent buying decision in the beverage isle at the local grocery store.

Despite all the marketing hype, water is still the best drink to consume for your body. Photo by Vjeran Lisjak

Despite all the marketing hype, water is still the best drink to consume for your body. Photo by Vjeran Lisjak

Au contraire! Do not underestimate the genius of the human body. The fluids in your body are very closely monitored, and the kidneys have a rather broad operating range to make the most out of almost any drink, because they are mostly water. Since it is hard to sell mostly plain water, other alternatives come in a lot of colors with a variety of micronutrients, vitamins, minerals and salts. And the appeal of these drinks are enhanced by some clever bottle shapes and contraptions.

Gatorade was the original mostly water-based sports drink. It initially came in powder, one flavor (lemon lime), and you had to add the water. It was a simple mixture of sugar, salt, artificial color and flavor. It was the brainchild of several scientists at the University of Florida (the Gators) College of Medicine, who were asked by the football coach to make a rehydration beverage. It was originally going to be called Gator-Aid, but the inventors thought the “Aid” would trigger FDA scrutiny and require scientifically validated testing.

Gatorade was intended for a different commercial direction where outlandish beverage claims were tolerated. Gatorade is a PepsiCo product and has 70 percent of the sports drink market in the U.S.  If you are not doing heavy exercise in the Florida heat, you can plan on an extra 3.5 pounds per year from drinking Gatorade daily.

Following Gatorade, vitamin-charged drinks were the next wave of performance water. And while in 25 years of medicine I have never diagnosed a single case of scurvy, pellagra, beriberi or rickets, the country is no doubt fractionally safer from these scourges. Excess vitamins, with very few exceptions, have no proven benefit to your health. And now there are cleverly designed bottles with the dry vitamin powder in a container at the top. Give it a twist, shake, and the result is a freshly-made vitamin fortified super drink. For pure placebo effect, this is hard to beat.

Is there good science behind these drinks actually increasing performance? No.

But if slightly modified, these mostly water beverages can sell as sports drinks – and they have! The list includes morning drinks, calming drinks, energizing drinks, drinks that make you smarter, stronger, braver and just a better human being. And if it were that easy, I would say “sign me up.” I could sleep in, buy a selection of hi-tech beverages and live a long and healthy life. Unfortunately, you actually have to do the work, which means you need to sweat.

My favorite rehydration drink is an inch of OJ in a big glass of ice water. It’s low in calories, thirst quenching, tastes pretty good, is almost free, and most importantly – it’s mostly water.

Donald Bucklin, MD (Dr. B) is a Regional Medical Director for U.S. HealthWorks and has been practicing clinical occupational medicine for more than 25 years. Dr. B. works in the Scottsdale, Arizona clinic of U.S. HealthWorks.

Jul
17

Guest post: Vaccines and “Unavoidably Unsafe Products”

written by Tara Haelle
Have you ever heard the term “unavoidably unsafe,” especially as it relates to vaccines or other pharmaceuticals? In this guest post by Dorit Reiss, this technical legal term is explained. This post is a bit different than the usual fare here, delving into meanings of a law, but it’s very important by those who misunderstand the term. A version of this post first appeared on the Moms Who Vax blog. Dorit is a professor of law and vaccine advocate, and a member of Voices for Vaccines’ Parent Advisory Board.

 

Those of us engaged in vaccine-related discussions online often hear vaccine critics claim the Supreme Court has declared vaccines “unavoidably unsafe” and thus incredibly dangerous. The critics are doubly wrong. First, the Supreme Court has said no such thing. Second, in the law’s eyes, an unavoidably unsafe product is not a “super-dangerous” product.  Quite the opposite, an unavoidably unsafe product is a product whose tremendous benefits justify the reasonable risks it poses.

What is an “unavoidably unsafe” product?

Normally, in the United States, a person only has to pay damages if they caused harm to someone else with fault—in other words, if they acted negligently or intentionally. In the area of products liability, however, the United States adopted a different approach.

In 1965 the American Law Institute published the Restatement (Second) of the Law of Torts, §402A. A “restatement” is an essay of sorts written on specific legal subjects by experts. They usually summarize and explain existing law, but they can also suggest reforms or rethinking of it.

Understanding how the law uses precise technical terms can prevent misunderstandings about those terms. Photo by Marcelo Gerpe

Understanding how the law uses precise technical terms can prevent misunderstandings about those terms. Photo by Marcelo Gerpe

In this case, Section 402A, was an attempt by the ALI – a nonprofit organization of lawyers, judges and academics – to rationalize a growing number of court decisions that held manufacturers and sellers of defective products liable to the consumers that their defective products injured.  Section 402A adopted a standard of liability without fault when a business sells a product “in a defective condition unreasonably dangerous to the user or consumer or to his property.”

The qualification was important: not every product that causes harm is defective.  Well-made knives can cut fingers, and even the best whiskey can get you drunk!   To be defective, a product had to be unreasonably dangerous, either because it was poorly made, or because consumers weren’t aware of its dangers, or because a different design could have made the product safer.

Restatements are very influential (though not binding), and section 402A was quickly adopted by pretty much every state.

The Restatement’s drafters wanted to provide certain products with additional protection against liability because, although those products carried risks, they provided especially high benefits as well.  The Restatement’s drafters expressed this idea in a comment to section 402A, namely, in comment k:

“Unavoidably unsafe products: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.”

The last sentence is the important one: A vaccine whose benefits outweigh its risks is not unreasonably dangerous or defective – even if the risks are as frightening as those attributed to the Pasteur vaccine, let alone modern vaccines, with their much lower risks.

In retrospect, the Restatement’s drafters could have chosen better language to capture the idea that a product or a drug can be valuable even it if poses some risk to its users (and indeed, the drafters of the Restatement (Third) of Torts: Product Liability did away with the “unavoidably unsafe” language while preserving the same idea).

Saying a product is “unavoidably unsafe” makes it sound like the product is a bad one, when what the drafters meant was precisely the opposite: the comment was meant to apply only to ethical drugs or vaccines. That is, products where the benefits outweigh the risks.  But courts understood.  Some courts (California, New York, Alabama) adopted comment k wholeheartedly, exempting all properly manufactured prescription drugs and vaccines from strict liability.  Others (Idaho, Colorado, Hawaii) applied comment k selectively, requiring a case-by-case determination that there is no safer alternative design for a drug or vaccine before finding the risk unavoidable.  Some courts, inevitably, are unclear or take an intermediate position (Florida, Georgia, Indiana).

The message comes through clearly: these products are beneficial enough that society wants to encourage their manufacturing. Therefore, while strict liability would be applied to most products, a manufacturer that prepared a drug or vaccine carefully and warned consumers of its risks should not have to pay for the side effects of a drug or vaccine whose benefits outweigh the risks unless that manufacturer can be shown to have been negligent.

In other words,  “unavoidably unsafe” is the opposite of “unreasonably dangerous” in the Restatement’s categorization. It justifies a more favorable treatment because of those products’ extraordinary benefits.

What Did the Supreme Court Actually Say? Read the rest of this entry »

Jul
16

What the newest bedsharing study can and cannot tell us

written by Tara Haelle

I have written before about how the infant sleep recommendations of the AAP and the US public health community in general are unrealistic and even potentially dangerous in their effects, regardless of their intentions. A new study in Pediatrics explores the contribution of different risk factors to sleep-related infant deaths, offering findings which are certainly valuable in understanding how risk varies as a child ages. However, I see many of the same flaws, primarily missing data, that prevent the possibility of truly evidence-based recommendations.

So once again, I feel it’s necessary to review – in addition to what the study found – all the things the study neglected to consider. Again, the flaws are not so much a result of the analysis but of the data not available to the investigators. In analyzing this study, I had a number of questions that the lead author, Jeffrey Colvin, MD, JD, of the Department of Pediatrics at Children’s Mercy Hospital in Kansas City, MO, answered via email. One of the questions he generously calculated for me was particularly enlightening – the association of bedsharing as a risk factor across causes of death. (Spoiler alert: bedsharing was much less likely among SIDS cases than among suffocation/asphyxiation and undetermined causes.)

But before I launch into all of that, it’s important to explain WHY this issue, and why pointing out flaws in these studies, is so important.

Is there really only one "safe sleep environment" for babies? Photo by Sam Hatch.

Is there really only one “safe sleep environment” for babies? Photo by Sam Hatch.

New parents receive a barrage of advice from every direction, solicited and unsolicited: their parents, other relatives, friends, virtual friends in online social networks, random strangers online and in real life – and of course all the experts: pediatricians and other professionals both in person and through media reports. Inevitably, this advice is conflicting, but hopefully most parents give a bit more weight to what their doctors say. After all, a doctor’s advice is supposed to be based on the evidence.

But what if the evidence base is horribly incomplete on an issue, a life or death issue, in fact? Vaccines are a life or death issue, but the research consensus is overwhelming, and studies have explored every possible avenue to examine the safety and effectiveness of official recommendations. The evidence base on bedsharing/cosleeping, SIDS and other infant sleep deaths, however, includes a large body of evidence yet remains woefully inadequate.

In addition, the research findings that have been published lack context. Just as there are risks – albeit tiny – to vaccination, there are risks to NOT bedsharing for many parents. Yet, I have yet to see a single study discuss this, or even consider the possibility that, at the population level, not bedsharing could carry any risk. Every single action and inaction carries risk, as do the opposite actions/inactions. It’s all a matter of balancing those risks, and parents need all the information they can get about risk to make informed decisions.

This most recent study does offer some information on risk factors for infant sleep deaths and these are no doubt valuable to other researchers and those shaping public policy, but because of significant gaps in the data, a lack of a control group and a lack of overall context, the findings cannot help parents or pediatricians much. (I will use “bedsharing” from here on because it’s the term used in the study and it eliminates confusion since “cosleeping” can mean sharing a room but not a bed.)

The study’s goal was to assess the extent to which established risk factors for sleep-related infant deaths vary by a baby’s age. The researchers analyzed data on 8,207 deaths in children less than a year old, all occurring during sleep but not resulting from a medical condition or firearm. The data came from cases voluntarily reported  between 2004 and 2012 in 24 states to the National Center for the Review and Prevention of Child Deaths Case Reporting System.

They divided the children into 5,677 younger (0-3 months old) and 2,530 older (4 months to 364 days old) infants. Although an autopsy was performed in 98% of the cases, the largest category of cause of death was “unknown/undetermined,” with 38% of the children. SIDS was listed for 35% and accidental suffocation/strangulation was listed for 27%.

On the one hand, it’s helpful to have these causes separated since these categories used to be collapsed into one. As the authors note, SIDS has declined since 2000 while accidental suffocation/asphyxiation has increased, but it’s likely this shift is due to the fact that suffocation/asphyxiation cases are often no longer categorized as SIDS. That said, this data is self-reported from across the country, and different regions have different criteria for classifying SIDS vs. suffocation vs. strangulation vs. unknown/undetermined, a limitation noted by the authors in their discussion.

The Findings

I’ll provide an abbreviated list of the findings to refer back to as I discuss the flaws in the study (including the definitions used for these categories): Read the rest of this entry »

Jul
15

How to explain to kids the passing of a pet

written by Guest Author

Today’s post is a guest post is from Hank McKinsey, a stay-at-home-dad blogger at Home By Hank. While the research literature does not contain much on helping children process the death of a pet, Hank has pulled together what is known from research about grief and child development in general to offer some tips.

Talking to your children about death is a scary topic. For many families the topic will first come up when a beloved family pet passes away. While this is certainly heartbreaking for many families, it is a great opportunity to take the time to talk to your children and teach them healthy ways to cope with their loss. Here are a few tips to help make the conversation a little easier:

Creating a memorial box can be one way to help children cope with the loss of a pet. Photo provided by Hank McKinsey.

Creating a memorial box can be one way to help children cope with the loss of a pet. Photo provided by Hank McKinsey.

Talk to your child beforehand, if possible: If your family pet is very old or very sick, you can help your child prepare for the loss of their pet by talking about what will happen before your family pet passes away. While this may seem morbid, by being honest and not hiding the truth, you are helping your children understand that all living things will eventually die. By helping them accept the passing as early as possible can make the grieving process a little easier. There are many resources available that can help guide this conversation.  Encourage your child to say goodbye and get their cuddles in while they are still able to.

Encourage your child to grieve: When an adored family pet passes away, young children may not understand why they can’t play with their favorite pal anymore. If your child cries, has nightmares, or seems very sad for a little while, recognize that this is pretty normal behavior. They may even want to sleep with one of their pet’s favorite toys. While these are all very normal parts of grieving, do make sure you encourage your child to get out and play. You may want to talk to a doctor if you are concerned that their grief seems more severe than typical.

Expect questions:  The hardest part for many parents is fielding questions about the death of the pet. “Did she feel pain?” “When is he going to wake up so we can play together again?” “Where do our pets go after they die?” And even “Are you (or am I) going to die too?” These questions are not only totally normal, they are a great segment into discussing the loss of a pet. Your answers should be truthful and succinct, as your child will take time to process your answers and come back later if they need any more information.

Remember to use simple language and help your child understand that just because their favorite pet cannot be with them anymore, they can always remember them and talk about them. Encourage your child to come to you with questions or concerns. Many times the security of knowing you will be there to answer their questions is helpful in helping them move on.

Create a memorial: Consider hosting a funeral or memorial service for the beloved family pet. You could include photos, video and handmade crafts. Encourage your children to tell about their favorite memories and say goodbye to their pet. You may consider burying your pet in your backyard.

Another simple idea that can help children grieve is to use a pet memorial box, like the one found here. Encourage your children to include their pet’s favorite toy, photos and other items that remind them of their lost pet. When your child feels sad they can sit down and look at all the items in the box to help them have happy memories about their pet.

Don’t get a new pet right away:  You may think that purchasing another pet for your child right away would be helpful. But, this is rarely the case. Allow your child the chance to be sad about the loss of their friend and broach the subject of a new pet when you feel they are ready to consider it.

The loss of a pet is a sad event. For young children it can be confusing and scary as well. By taking the time to help your little one say goodbye to their friend and teaching them that it’s okay to be sad will make the grieving process easier.

 

Hank McKinsey is a lifestyle and DIY blogger based out of central California.  When he’s not crafting or blogging, he can be found playing tennis or lounging with his dogs.  Follow Hank on Google + here.

Jul
8

Nope, the HPV vaccine doesn’t cause blood clots

written by Tara Haelle

As one of the newest vaccines, the HPV (human papillomavirus) vaccine is one of those plagued with some of the worst misinformation out there. Horrible anecdotes tell of strange illnesses and death that have struck down girls after they received their first HPV shot, and I’ve even written about Katie Couric’s irresponsible spotlight on these stories when there is no evidence that such tragic incidents are actually related to the vaccine.

This is a shame since this vaccine is one of the very few which can actually prevent cancer, of the cervix for women but also of the throat, mouth, neck, penis and anus. Yet the anecdotes are frightening and powerful, and researchers continue to study safety concerns to make sure nothing has been missed. A large, very well-designed study in JAMA today continues that research by looking at the risk of blood clots with the quadrivalent HPV shot, Gardasil.

The HPV vaccine is recommended for both girls and boys to prevent the virus, which can cause cancer. Photo by Milissa Thompson

Yay! No blood clot risk! The HPV vaccine is recommended for both girls and boys to prevent the virus, which can cause cancer. Photo by Milissa Thompson

Although many concerns associated with HPV vaccine have been addressed by the CDC, those who prefer to see the primary research can review the existing excellent studies showing no link between the vaccine and autoimmune, neurological or blood clot problems. But good science requires an accumulation of evidence, including evidence of no harm.

And that’s exactly what this new study shows: no risk of blood clots from the vaccine.

The researchers started with a population data set: all the women in Denmark who were aged 10 to 44 between October 1, 2006, and July 31, 2013, which included more than 1.6 million females. (Scandinavian countries’ nationalized health care systems make it conveniently possible to use data from an entire population’s medical records.)

Among these 1.6 million girls and women, about a half million (31%) had received Gardasil. Also out of this 1.6 million, a total of 5,396 individuals had experienced a venous thromboembolism during that study period. (A venous thromboembolism is blood clot that breaks free in the veins and starts traveling up toward the lung, where it could become a pulmonary embolism).

Then the researchers excluded all the women who had been pregnant with the blood clot or who had had surgery in the past month or been diagnosed with cancer in the past year – pregnancy, cancer and surgery all increase the likelihood of a blood clot. These exclusions left 4,375 women, about one in five of whom had been vaccinated against HPV.

Those 889 women are the ones the researchers focused on. Read the rest of this entry »

Jul
8

When lucky 13 isn’t enough to protect some kids from disease

written by Tara Haelle

The tricky thing about pathogens is that some of them can wear a lot of different costumes. The sexually transmitted virus human papillomavirus (HPV), for example, has more than 100 strains. Fortunately, not all of these cause cancer, so the two HPV vaccines available target the strains that cause the most cancer.

But sometimes when vaccines target some strains of a bacteria or virus, the strains that weren’t included in the vaccine become more common. That phenomenon is partly the reason the PCV13 vaccine was developed to replace the PCV7 vaccine (which, by the way, prevented about 65,000 deaths a year in the US after it arrived). Both protect against the Streptococcus pneumoniae bacteria, which causes pneumococcal disease, but PCV13 protects against six additional strains. The PCV7 had covered the strains that initially caused more than 80% of illness, but after it was introduced, the illness caused by strains not covered increased by 140%. So, enter PCV13. Now a new study in Pediatrics calls into question whether protection against 13 strains is enough either.

The PCV13 vaccine is successfully preventing pneumococcal disease in more children. But it may not be enough for the kids already at risk with other health problems. Photo by Julia Freeman-Woolpert

The PCV13 vaccine is successfully preventing pneumococcal disease in more children. But it may not be enough for the kids already at risk with other health problems. Photo by Julia Freeman-Woolpert

Although pneumonia is the most common illness to result from this disease, those who become sick from this bacteria can also develop meningitis or blood stream infections, all of which can be fatal. That’s why it’s included on the CDC’s recommended schedule for childhood immunizations. And that’s why it’s important to understand whether we’re successfully protecting against enough of the strains.

There is another pneumococcal vaccine, PPSV23, which protects against almost twice as many types of pneumococcal bacteria. It’s recommended for adults aged 65 and older and for anyone who is at a higher risk for disease, including those who are smokers or have asthma. This vaccine is not currently recommended for everyone, but the this new study shows why it may be helpful for those with underlying conditions who are at a higher risk for getting sick.

To learn the effect the PCV13 vaccine was having on pneumococcal disease, researchers looked at all the cases of the disease among children aged 5 and younger in Massachusetts a couple of years before and after the vaccine was introduced.

The good news is that the total number of pneumococcal disease cases did drop: there were 168 cases in 2007-2009, before PCV13 came on the scene, and there were 85 cases after PCV13 was introduced. That means the vaccine sliced in half the number of kids getting sick – not a bad result for bumping up from the old PCV7 vaccine. And the reduced illness did appear to result from the new vaccine because the strains covered by PCV13 dropped 18 percent in the two years after it was used. Read the rest of this entry »

Jul
2

Keeping a study in perspective: C sections, stillbirth & ectopic pregnancy

written by Tara Haelle

You may have caught a headline some time yesterday telling you that having a C section will increase your risk of having a stillbirth or an ectopic pregnancy in a future pregnancy. Before you freak out (if you have or may need a C section) or tout the findings while lamenting high C section rates*, there’s a lot more you need to know about that study. A LOT more.

Fortunately, the study doesn’t seem to be getting a lot of press so far, which is good. It’s an example of one of those studies written for other researchers, not for the lay public (even though it’s open access, so you can read the whole thing yourself without paywall). The findings in it may have some significance for future research, but they don’t have much clinical significance, which is to say they don’t affect how prenatal care, fertility care and birth planning are practiced.

No, you don't need to worry about stillbirth or ectopic pregnancies after a C section. Photo by Roberta Lott.

No, you don’t need to worry about stillbirth or ectopic pregnancies after a C section. Photo by Roberta Lott.

First, let’s discuss what the actual study found and how some news media may be unfortunately likely to report it. In plain context-less terms, the study found that having a C section for a first birth increases the risk of stillbirth by 14% in a future pregnancy and increases risk of a future ectopic pregnancy by 9%, compared to having a spontaneous (non-induced) vaginal delivery for a first birth. The findings were based on analysis of 832,996 women who had a first-time live birth between 1982 and 2010 in Denmark and were followed until they had another baby, they died or left the country, the study ended or they had a miscarriage, stillbirth or ectopic pregnancy.

Broken down by type, the increased risk of stillbirth was 15% for emergency C sections; for elective C sections, it would have been an 11% increased risk, but this finding did not reach statistical significance, which is to say they couldn’t rule out the possibility that the increased risk was just chance. The increased risk of later ectopic pregnancies was 9% for first-time emergency C sections and 12% for elective ones. Interestingly, the risk of a miscarriage in a later pregnancy after having a C section in a first birth was 28% *lower*, compared to first-time vaginal births. That seemingly contradictory finding (C sections increase stillbirth risk but decrease miscarriage risk?) ought to give you pause, but we’ll get to that in a moment.

Already, these numbers are VERY small, but they’re also relative risk, which isn’t terribly helpful if you don’t know the absolute risk of having a stillbirth or ectopic pregnancy. The actual risk is incredibly small.  The rate in this study, with 1,996 stillbirths across all the women, was 2.4 stillbirths per 1,000 women. Then, only 0.03% more women having C sections had a stillbirth than women having vaginal births, based on these results.

Or, put another way, it would require 3,333 women to have C sections before even ONE of them has a stillbirth that would not have occurred among 3,333 women having vaginal births. Yet another way to look at it: If 10,000 women have a baby vaginally and none have a stillbirth later, then, according to the findings of this study, among 10,000 other women who have a C section, three would have a stillbirth later.

Tiny numbers. Read the rest of this entry »

Jul
1

New systematic review assesses ALL the serious risks of US childhood vaccines

written by Tara Haelle

When parents have questions or concerns about vaccines, they are often seeking certainty, even if they do not consciously recognize that is what they want. They want a guarantee that the vaccines they give their children are completely safe and effective, a completely understandable desire – but one which science can never deliver.

Neither can science deliver certainty that their child will not catch a disease and suffer serious consequences, or death, from it. Science is in the business of uncertainty, but in that sea of uncertainty it offers solace in the consensus, the coming together of study after study after study which, taken together, can provide the fullest picture possible of a particular issue.

When it comes to vaccines, we are fortunate to have so many thousands of studies that the consensus is overwhelming. It is impossible to have a single massive study showing the safety and effectiveness of vaccines, but it’s also undesirable. Strength is in numbers, in the many studies that investigate all the little details related to vaccines so that we have that giant picture.

Original photo by David Pyatt

Original photo by David Pyatt

Yet what I love about science and research is that it never stops. Because we can never have 100% certainty, we never stop seeking more information, or, at the least, more confirmation of what we already know. So I was thrilled to see another systematic review from Pediatrics which reviews all the safety evidence for every vaccine on the CDC recommended childhood immunization schedule.

Systematic reviews bring together all the most current evidence and assess it together, and this one uses data from 67 studies to seek out everything we know about possible side effects from recommended vaccines. It essentially updates the findings published by the independent Institute of Medicine in 2011 on Adverse Effects of Vaccines, adding in information published since then and about four vaccines not included in that review.

The authors – who have no pharma ties – searched eight medical research databases, the IOM report, vaccine package inserts, review articles’ bibliographies and statements from the FDA and the CDC’s Advisory Committee on Immunization Practices to locate more than 20,000 possible studies.

From these, they narrowed it down to 67 papers by selecting only studies that actively looked for possible adverse events involving currently recommended childhood vaccines available in the US. All included studies needed a control group or to compare vaccinated children to unvaccinated children, and no animal studies were included. The data from the IOM report was considered along with the new data in these 67 studies.

Conveniently, they organized the findings by vaccines in alphabetical order, and so I’ll do the same in reviewing what they found. Their only goal was to look for serious adverse events that were likely caused by a vaccine. Therefore, on the one hand, this could be a frightening blog post – it literally lists every possible thing that evidence has shown could go wrong after vaccines. On the other hand, seeing all the worst case scenarios and seeing what’s NOT on this list should be encouraging.

However, the researchers did *not* usually report on the rates of these adverse events, only on the possibility that they could occur. Some of these adverse events occur to 1 in 1,000 children. Others occur only to 1 in several millions or only to those who are immunocompromised and are therefore not supposed to receive that vaccine anyway (such as contraindicated conditions for the MMR, which is a live vaccine). I have added after each paragraph what rate is reported by the CDC for each adverse event described here, when available. Those rates are based on what has been found in research studies as well. Read the rest of this entry »

Jun
30

Bug Off: Facts for parents about mosquitoes, bug repellents & health risks

written by Guest Author

This guest post was written by Matt Shipman, a science writer and public information officer at North Carolina State University. He blogs at Communication Breakdown on SciLogs, and you can follow him on Twitter at @ShipLives.

For parents, summer is when we take our kids on hikes, get them to play in the yard or take them to the pool. All that time spent outdoors increases the likelihood that we’ll come into contact with mosquitoes, ticks and other pests. And bug bites aren’t just annoying; they can transmit diseases ranging from malaria to West Nile virus.

So to help keep our kids safe (and itch-free), we apply insect repellent. But a lot of parents want to know whether the repellents themselves are safe. And how do they work, anyway?

Which insect repellents actually work?

The U.S. Centers for Disease Control and Prevention (CDC) lists several mosquito repellents as being at least moderately effective at repelling mosquitoes, based on data provided by the Environmental Protection Agency (EPA). However, the CDC lists only two of those repellents as providing “longer-lasting” protection: DEET and picaridin. (And, it’s worth noting, the words “EPA approved” are no guarantee of effectiveness.)

Protect your family from disease-carrying insects by using bug repellent with DEET or picaridin. Original photo by Gabor Bibor

Protect your family from disease-carrying insects by using bug repellent with DEET or picaridin. Original photo by Gabor Bibor

Research has shown that neither is 100% effective, but they are pretty good at keeping blood-sucking arthropods at bay. In short, they are the best (and most common) active ingredients used in U.S. mosquito and tick repellents. (And don’t bother with electronic devices that say they repel insects. They don’t work. For that matter, don’t bother with citronella candles either – unless you want to sit directly in the plume of smoke they put out.)

How do they work?

How does DEET work? That is such a good question that scientists have been arguing about it more or less since the U.S. Army developed it in the 1940s. For a long time, many researchers thought DEET worked by preventing mosquitoes from smelling the chemicals that humans produce, essentially making people “invisible” to the bloodsuckers.

But a 2008 paper published in the Proceedings of the National Academy of Sciences reported that mosquitoes could smell DEET – and tried to avoid it. And in 2011, researchers reported in Nature that DEET confuses the way insects smell things – so that the blood-feeders don’t respond to odors that would normally trigger feeding behavior. And, of course, it may be some combination of all of those things.

Picaridin is much newer – though I couldn’t determine just how new: There are research references to the chemical at least as far back as 1999, and references to its use as an insect repellent dating to 2000, though it has only been available in the U.S. since 2005. And there appears to be even more uncertainty about how it works than there is with DEET. The best I could find was that “it seems to block mosquitoes from sensing their prey” (from the National Pesticide Information Center.)

Are these chemicals safe for my kids?

If your question is “Should I use insect repellent if my kids are going to be outside?” the answer is yes. The risks associated with bug bites are significant.

Mosquitoes and ticks are responsible for transmitting a host of diseases. Around 1,500 people are diagnosed with malaria every year in the U.S., nearly all cases in people who have returned from traveling abroad**. In 2012, 5,674 people contracted West Nile virus – of whom 286 died. And more than 19,000 people have contracted Lyme disease every year since 2004. And those are only a few of the diseases that can be transmitted by ticks and mosquitoes.

There are other risks as well, such as allergic reactions to mosquito bites, which are more common among infants and young children. And, of course, the skin infections (such as impetigo) that can result from kids scratching their itchy bug bites until they’re raw.

But are repellents totally harmless? No. Read the rest of this entry »



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