Los Angeles to Regulate E-Cigarettes as Cigarettes

Back in November of 2011 I reported that a federal judge had blocked the FDA’s proposal to regulate e-cigarettes in the same way as drugs and drug delivery devices (this blog, Nov. 15, 2011). The judge’s argument was that if e-cigarettes are to be regulated at all, they should be regulated in the same way as cigarettes, not as drugs or drug delivery devices. The judge’s ruling effectively opened the way for the importation and sale of e-cigarettes in the U.S.

Two years later, the FDA is still not requiring that e-cigarettes be regulated as cigarettes. But there’s nothing from stopping states or even cities from doing so.

Last week Los Angeles did just that. The city council of Los Angeles voted unanimously to regulate e-cigarettes as cigarettes, with all the same restrictions on sale and use. The L.A. city council felt it was better to err on the side of caution, given that the health effects (if any) of e-cigarettes are not yet known and that e-cigarette use is on the rise among high school students.

E-cigarettes were developed primarily as a product that could help smokers quit smoking cigarettes, which we now know increases cancer risk. Their primary active ingredient is nicotine, which is supposed to satisfy the craving that cigarette smokers experience. However, the e-cigarette companies soon realized that young non-smokers might also be attracted to e-cigarettes, and they were right. Some people worry that e-cigarette use by teens who never smoked could lead to a whole new generation of people addicted to nicotine, even if they are unlikely to get lung cancer. And that’s probably not a good thing if it could be avoided.

Presumably, L.A.’s restrictions would not deter current smokers who wish to use e-cigarettes to quit smoking. They are already accustomed to the rules for cigarette use, such as minimum age for purchase and where cigarettes can be smoked).

Score one for the regulators - this time, at least. (See this blog Nov. 16, 2013).

The FDA Approves an Oral Medication for Hepatitis C

The FDA has just approved the first oral medication (a pill) for the treatment of hepatitis C.  Hepatitis C is a liver disease caused by a virus.   It is usually transmitted by direct blood-to-blood contact.  For a primer on hepatitis C, see the CDC’s “vital signs” on the subject.

Doctors will soon be recommending this new drug, called Sovaldi, to their patients with hepatitis C.  But here’s the catch; treatment with the pill is expected to cost $1,000 per day.  Since the drug is supposed to be taken for 12-24 weeks, a full course of treatment will cost $84,000 to $168,000!   The stockholders of Gilead Sciences, the medication’s manufacturer, hope the drug will earn big profits for the company.  There are approximately 150 million people with hepatitis C worldwide.  Stock analysts think that annual sales of the drug could top peak annual sales of the best-selling drug of all time, Lipitor.   Patient advocacy groups have voiced concern that some patients will not be able to afford the drug, but there’s not much they can do.  We can complain that pharmaceutical companies are greedy, but it’s not that simple.   They have huge development costs and they have a right to make a profit.

But as health care consumers, we do have choices.  If I had hepatitis C, before I opted for the new oral treatment over any other treatment option I’d try to compare convenience, cost, and effectiveness.   Granted, the oral pill will be more convenient than the current standard of treatment, which requires intravenous injections.  What’s the difference in cost, and could I afford it?   And most important, what’s the difference in effectiveness?  I wouldn’t pay a lot more simply for convenience or for a marginal difference in effectiveness, for example.  But that’s just me; you might make a different decision.

New Clues to Archaic Human Evolution

The evolutionary history of humans just gets more interesting every day.

Last month (see "How Many Species of Primitive Humans Were There?") I reported on an anatomical analysis of a series of archaic human skulls that challenged the “multiple species” theory of archaic human evolution. The authors of the study concluded that despite marked anatomical differences between the skulls, they could in fact all have belonged to one species.

New evidence using DNA analysis seems to support the notion of interrelatedness of seemingly distinct groups of archaic humans. The oldest sample of human DNA ever analyzed comes from a fossil of an ancient human ancestor who lived in Spain nearly 400,000 years ago. As expected, this DNA shares many features with the DNA of the Neanderthals who lived on the same continent. However (and surprisingly), it most closely resembles the DNA of a group of ancient humans called the Denisovans, who lived in Siberia nearly 4,000 miles away and more than 300,000 years later.

In light of the new DNA findings, scientists are going to have to think seriously about how far archaic humans might have traveled, and about how much they might have interbred when they came in contact with each other. If in fact they did come in contact with each other and interbreed, it may be time to consider that archaic humans all belonged to one species, and not the multiple species generally described by most paleoanthropologists.

FDA Warns 23andMe

The FDA has sent a letter to a company called 23andMe, warning the company to stop selling its popular genome testing service to directly to consumers. For just $99, the company had been promising to analyze samples of saliva for nearly 300 different gene alleles, many of which are associated with increased risks of known genetic diseases.

People certainly have the right to their genetic information if they wish. The problem is that because the results could indicate that the person may be at an increased risk for specific genetic diseases, the results are more like medical tests than just interesting information, meant to satisfying ones curiosity. Any references to increased risks of genetic diseases associated with the results are tantamount to medical advice. The FDA is concerned that people may make medical or life-style decisions based on the unproven tests and unknown or inaccurate risk assessment. Risk of genetic disease, for example, may depend on family history and environmental factors, in addition to just the genetic component. Discussions of risk generally include a thorough medical history and discussion with a physician or genetic counselor, all of which are lacking when a test (and subsequent risk assessment) is done by mail order.

There are companies, such as dna.ancestry.com, that offer to test your DNA so that you can trace your ethnic origins or potentially identify specific ancestors. That’s not an issue for the FDA because it is essentially for entertainment, not medical diagnosis.

The FDA Moves Closer to Banning Trans Fats

The popular press was full of reports last month that the Food and Drug Administration (FDA) is likely to ban trans fats as ingredients in foods.  What the FDA actually did was make a preliminary determination (yet to be finalized) that partially hydrogenated oils – a major source of trans fats in foods – are no longer “generally recognized as safe” (GRAS).  Practically speaking, that is close to banning them, since anything not GRAS would have to go through all kinds of testing (at great expense) to prove its safety before it could be marketed and sold.

Trans fats (including margarine and shortening) have been around for over 100 years.  Their popularity soared in the late 1900s when it was discovered that they improved the taste, texture, and shelf life of many foods, including French fries, donuts, pizza, and coffee creamer.  In the past several decades, however, scientific evidence has accumulated to show that trans fats are linked to an increased risk of heart disease.  As a result, many food manufacturers have already taken steps to eliminate trans fats from their products.  McDonald’s, for example, hasn’t cooked its French fries in trans fats in over 10 years.

According to the FDA, the average American consumer’s consumption of trans fats has already declined to less than a quarter of what it was just nine years ago.  The recent FDA ruling is just the final nail in the trans fat coffin.  Hopefully, trans fats will continue to be phased out, and consumption in the U.S. (and elsewhere) will continue to decline.

To learn more about some of the alternatives to trans fats in foods, click here.

Global CO2 Emissions Continue to Rise

A recent report by the Netherlands Environmental Assessment Agency documents that global emissions of CO2 continue to the rise.  After declining 1% in 2009, CO2 emissions rose 5% in 2010 and increased another 3% in 2011, the latest year for which data are available.  Overall, the increase has averaged 2.7% per year over the past 10 years.  The top five CO2 emitters (in order of emissions) are China, the U.S., the European Union (27 countries combined), India, and the Russian Federation. China alone now accounts for nearly 30% of global CO2 emissions.

The overall upward trend masks wide differences between countries’ individual trends in CO2 emissions.   CO2 emissions rose much more than the global average in China (up 9%) and India (up 6%) in 2011, in part due to their increased reliance on fossil fuels, particularly coal, for power generation.   However, emissions in the U.S and the European Union actually decreased slightly (down 2% and 3%, respectively).  A shift from coal to natural gas by some power plants (which reduces CO2 emission), high oil prices (which discourage gasoline consumption), and weak economic conditions all appear to have contributed to the decline in CO2 emissions the U.S and the EU.   Whether CO2 emissions will swing upward again if/when economic conditions improve or the price of oil declines remains to be seen.

All in all, there’s not much good news here.   We’re still seeing a steady rise in global CO2 emissions.  Despite all the talk at international meetings about the need to halt the rise to prevent further global warming, little action has been taken.   In the future we can probably expect to hear that global warming continues unabated as well.

An Exception to the FDA’s Drug Approval Policies?

Princeton University has asked the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration) FDA for special one-time approval to treat Princeton students with a vaccine not yet approved in the U.S., according to university officials. The vaccine, called Bexsero, is currently used in Europe (but not the U.S.) to treat a particular type of meningitis bacterium known as serogroup B.

The request was prompted by an unusual outbreak of serogroup B meningitis on the Princeton campus. Seven students have contracted the disease so far, but fortunately none has died. Unlike most strains of bacteria that can cause meningitis, this particular strain can be transmitted fairly easily. Princeton students have been advised not to share drinks and to avoid kissing. (?)

In the event that FDA approval is granted (which is likely) the vaccine will be available for free by early December to Princeton undergraduate students, graduate students living in dorms, and students with specific health problems. At the moment, the vaccine’s use at Princeton is considered by the FDA to be a one-time exception to its policies. However, perhaps this incident will cause the FDA to consider fast-tracking its approval process for this particular vaccine, because at the moment there are no FDA-approved vaccines to treat this particular strain.

The E-cigarette Industry Notches a Win

The fledgling e-cigarette industry has a lot of powerful enemies, including the tobacco industry, the pharmaceutical industry, government regulatory agencies, and even some anti-smoking groups.   The reason for opposition from tobacco companies is obvious; they fear a loss of sales of cigarettes.  Pharmaceutical companies see e-cigarettes as competition for their own smoking-cessation products, such as nicotine patches and gum.  The Unites States Food and Drug Administration (FDA) is worried about the possible long-term health effects of what is essentially an untested product.  Finally, some anti-smoking groups oppose e-cigarettes because they worry that if e-cigarettes become the next “in thing”, they might create a whole new generation of nicotine addicts who never smoked in the first place.

With this much opposition to e-cigarettes, how is it that the European Parliament recently suddenly dropped its plans to regulate e-cigarettes as “medicinal products”, to be sold only in pharmacies?  It turns out that e-cigarette users, many of them ex-smokers, believe passionately that e-cigarettes are a good thing.  Faced with growing opposition to e-cigarettes, they mounted a vigorous grassroots lobbying campaign that ultimately caused the European Parliament to back down.  They even have their own website, called saveecigs.com.  Although the website is hyped as a grassroots effort, it’s actually backed by at least one of the major e-cigarette companies, according to a New York Times article.

It’s not often that a fledgling industry and a few product users are able to take on the Goliaths of industry and win.  But the battle over e-cigarettes is just beginning.  In the United States the FDA is still considering whether or not e-cigarettes should be regulated as nicotine-delivery devices.  Since the e-cigarette lobbying effort worked so well in Europe, perhaps we’ll see a similar "grassroots" lobbying effort (backed by e-cigarette companies) in this country.

An Anti-HIV Protein in Human Milk

The HIV virus that causes AIDS is present in the milk of HIV-infected mothers, yet only about 10% of infants who nurse from HIV-infected mothers get infected. In the past it was thought that ingestion is simply a poor route to HIV infection. Now it turns out there’s another reason – human milk contains a protein that latches onto the surface coating of the virus, preventing it from infecting the infant. The protein, called Tenascin-C, normally plays a role in wound healing and fetal development. Its antiviral properties are apparently just a lucky coincidence; it couldn’t have evolved during the course of human evolution to combat HIV, because HIV didn’t exist until recently.

Will Tenascin-C become an important weapon in the fight against HIV infection? Probably not. HIV-infected mothers are already given antiretroviral drugs and they already have Tenascin-C in their milk, so purified Tenascin-C might not add much of a benefit to them or their infants. And it’s unlikely that Tenascin C would work if it were to be given intravenously to patients with established HIV infections. Nevertheless, the finding that a natural human protein can inactivate the HIV virus before it infects the host is leading to renewed hope that a drug with similar properties could be developed. An AIDS-free world may just be within our reach.

How Many Species of Primitive Humans Were There?

Based on structural differences between a few skulls and some partial skeletons, the prevailing thought among paleoanthropologists has been that once humans left Africa for the first time they evolved into at least five or six distinct species of primitive humans, including Homo erectus, H. georgicus, H. ergaster, H. heidelbergensis, H. rudolfensis, and H. neanderthalensis. Historically, paleontologists were quick to assign a new species name to nearly every unique skull or skeleton discovered. In part, that’s because discovering a new species generally advances the discoverer’s career. But were all these alleged species really all that different? Were they even different species?

As more skulls and skeletons are discovered, the “multiple-species” argument is beginning to be challenged. The discovery of the most complete Homo skull yet in the Georgia region of Russia brings the controversy to a head (no pun intended). The discoverers compared the newest skull to four others found previously in the same region. They note that there are substantial structural differences between them, even though they presumably belonged to the same species. Indeed, there are just as many differences between the skulls of currently living humans, all of whom belong to just one species (Homo sapiens). Based on these findings, the researchers hypothesize that all of the known skulls of primitive Homo belong to a single evolving lineage (a single species)

Generally speaking, a species is loosely defined as a group of organisms that under natural conditions tend to breed within that group. A key question, then, is whether individuals of the so-called different species could (or did) interbreed. So far we don’t know the answer. Absent that critical information, we can expect the “multiple species” versus “single species” controversy to remain with us for a while.

Canada Launches a National Public Umbilical Cord Blood Bank

Canadians are now able to donate umbilical cords to a national public cord blood bank instead of discarding them after the birth of a child, according to Canadian Blood Services. The first donation site is in Ottawa, but additional donation sites will open in three other cities (Toronto, Edmonton, and Vancouver) by next year. The cord blood will be made available to patients nationwide who need stem cells for medical procedures, such as bone marrow (stem cell) transplants following treatment for leukemia.

Canada has several other public and private cord blood banks, but this is the first one of a national scale. The new national bank will increase the likelihood that needy patients who are not able to locate a suitable donor among their relatives or friends will ultimately be able to find a match in a unit of cord blood from an unrelated donor. Currently, only about 30% of patients needing a stem cell transplant find donors within their own families.

Canada is the last of the G8 nations (U.S., Canada, Great Britain, Germany, France, Italy, Japan, and Russia) to establish a national umbilical cord blood banking system. Officials hope that the presence of a national bank will increase awareness about the value of stem cells derived from cord blood in treating diseases, leading to an increase in donations. Currently, nearly a thousand Canadians are waiting for stem cell transplants.

Human Milk Purchased Over the Internet May be Contaminated

Previously I talked about how a shortage of human milk has led some mothers to purchase human milk from sellers who advertise over the Internet (see "Buying Human Milk for Your Baby"). I pointed out that while milk obtained from milk banks affiliated with the Human Milk Banking Association of North America (HMBANA) is always pasteurized before it is distributed, unpasteurized human milk from unregulated Internet sites or from unscreened donors might pose a health risk to the infant. At the time, there was no evidence to support or deny the latter assertion.

Now there is. In a study just published in Pediatrics, researchers from Ohio State University ordered samples of human milk from individual sellers who advertised human milk for sale on two of the major Internet sites for milk sharing. For comparison, they also obtained samples of unpasteurized human milk donated to an HMBANA-affiliated milk bank. All samples were tested for bacteria and several viruses (HIV-1 and cytomegalovirus). 74% of the Internet milk samples (and 35% of the unpasteurized milk bank samples) were contaminated with pathogenic bacteria. No samples from either source were HIV-positive, but 21% of Internet samples and 5% of the milk bank samples contained evidence of cytomegalovirus contamination. In general, samples obtained over the Internet also contained higher mean bacterial counts than the milk bank samples.

The study clearly points out the potential risks involved in accepting unpasteurized human milk from unscreened donors who advertise over the Internet. Human milk banks affiliated with the HMBABA pasteurize all milk before it is distributed. In addition, the milk banks screen their donors carefully and instruct them in the proper shipping guidelines (milk is to be frozen, delivered overnight). In contrast, there was wide variability in how milk obtained from individual sellers over the Internet was shipped; over 10% of the milk samples took more than three days to arrive.

How many infants are put “at risk for negative outcomes”, as the authors so elegantly put it, by human milk purchased over the Internet is probably unknowable. Again, I say “buyer beware”.

Note: only the abstract of the research article is available for free; the full article is available for $12. I’d like to see all scientific research articles supported by grant funds available free of charge.

What Do Food “Sell By” Dates Mean?

Do you check the “sell by” dates of foods in the grocery store, avoiding anything that is past its “sell by” date?  Do you toss food items out of the refrigerator once the “sell by” date is passed?   If so, you’re not alone.   For many, it’s a perceived issue of food safety.   A commonly held belief is that those “sell by” dates are a legal requirement, determined by some federal government agency (the FDA?) to protect us from contaminated food.

In fact, food “sell by” and “best if used by” dates are not determined by the FDA, or by any other federal agency for that matter.  They are simply estimates by the food's manufacturer of when the food passes some arbitrary measure of quality, such as taste, texture, or nutritiousness.  After all, they don't want you buying their product and then not being happy with it.  Retail stores are not required to remove food items from their shelves once the “sell by” date is passed.  However, in order to maintain good customer relations many stores do discard them, or at least mark them down for quick sale.  Some states require that certain food products have "sell by" dates, others don't.

The bottom line is that "sell by" dates are not designed to protect us from tainted food.  That would be next to impossible, because how a food product is stored and handled after it is produced (storage temperature, humidity, etc.) has a major role in how long it takes to spoil.

Granted, it’s hard to tell when a food actually has gone bad.  Those “sell by” dates can certainly be an important clue.  But in the final analysis, you the consumer are left to use your best judgment.   Buy foods with the best “sell by” dates that you can, and be aware of how they have been stored in your home.   If they’re supposed to be refrigerated, were they kept cold in transit?  What’s the temperature in your refrigerator?   Finally, use your senses.  If it’s got mold on it and smells or tastes a bit off (or is way past it’s “best if used by” date) throw it away.

For an in-depth look at this subject, see "The Dating Game: How Confusing Food Date Labels Lead to Food Waste in America", a joint project of Harvard Food Law and Policy Clinic and the Natural Resources Defense Council. 

Are Teens Getting Healthier? Maybe, Maybe Not

The prevalence of obesity in the U.S. has been rising for about as long as anyone can remember. Nevertheless, there are some indications that obesity prevalence may be stabilizing.

How (or if) changing trends in adolescent behavior could be contributing to this stabilization is not known. To find out, researchers examined some key variables related to diet and exercise among adolescents in grades 6-10 over an eight-year period. Their study, published recently in Pediatrics, shows that over the eight-year period there were significant increases in exercise (number of days with at least 60 minutes of physical activity) and consumption of fruits and vegetables. Television viewing and consumption of sweets and sweetened beverages both decreased.

Despite these slight improvements in diet and exercise, body mass index (BMI - a crude measure of obesity) continued to trend upward in adolescents. Nevertheless, the results are considered encouraging by public health officials, in that public education efforts to get kids to exercise more and eat a healthy diet may actually be working.

The decrease in television viewing may just be a reflection of changing tends in technology use. Significantly, adolescents continue to spend a lot of time on video games and on computer use (including chatting, internet, e-mail, social networking, etc.). Video games and computer use (assessed only over the last four years of the study) did not decrease over time; together, they now account for nearly two hours per day among this age group.

New Regulation Proposed for Compounding Pharmacies

A bill is currently making its way through Congress that could potentially give the F.D.A. more power to regulate compounding pharmacies. Traditionally, compounding pharmacies have not been regulated by the F.D.A. because they do not manufacture drugs, as pharmaceutical companies do – they only recombine drugs into specific combinations at the request of hospitals and physicians. Currently, compounding pharmacies are regulated solely by states’ pharmacy boards, even though they may ship their products across state lines.

But then last year a Massachusetts-based compounding pharmacy accidentally made contaminated batches of drugs. The result was more than 700 cases of spinal infections, including meningitis. Sixty-four people from 9 different states died.

The new law would give the F.D.A. much of the same power over the compounding pharmacies that it has over drug manufacturers. The F.D.A. would be able to review the companies’ records and inspect their facilities. In addition, the compounding pharmacy would have to alert the F.D.A. when something goes wrong. However, there’s a big catch; F.D.A. regulation would be voluntary. According to the specific language in the proposed bill, F.D.A. regulation would be available to compounding pharmacies “who wish” to be regulated.

Seriously? Supporters of the bill defend the voluntary nature of the proposed regulation by saying that the market will drive demand, because hospitals and doctors will choose to do business only with compounding pharmacies that are “F.D.A.-regulated”. Maybe, but price often trumps all other considerations. And you, the consumer, will never know where your doctor or hospital gets its compounded drugs.

This is a weak attempt to fix a serious problem. Why not just go all the way and require that all compounding pharmacies be regulated by the F.D.A.?

Running or Walking Decrease the Risk of Osteoarthritis

Several years ago a longitudinal study of 45 runners and 53 controls (non-runners) over an 18-year period reported that running does not lead to increased incidence of osteoarthritis later in life (see "Is Running Hard on Knees?").

Now, a much larger study shows that running or even just walking may actually reduce the risk of degenerative diseases such as osteoarthritis. The study examined the number of reported cases of osteoarthritis and hip replacements in over 70,000 runners, as well as walkers and persons who engaged in other exercises of equivalent energy expenditure, over a seven-year period. The authors report that the runners and walkers had fewer reported cases of osteoarthritis and fewer hip replacement surgeries than non-runners who engage in equivalent energy-expenditure exercises.

The decreased risk of osteoarthritis in runners and walkers was strongly associated with the lower BMIs (body mass index) of the runners and walkers. In other words, it may not be the running or walking per se that reduces the osteoarthritis risk. Instead, it may be that running and walking are just very effective ways to keep the weight off, putting less strain on hips and knees.

First Official Report on Deaths from Antibiotic-resistant Bacteria

The CDC has issued its first official report on the threat posed by antibiotic-resistant disease organisms. The report shows that over 2 million Americans develop antibiotic-resistant bacterial infections each year, and that over 23,000 people die as a result of those infections.

The number of deaths is actually a bit lower than previous unofficial estimates. That’s because the CDC deliberately took a conservative approach, including in its estimates only deaths that were a direct result of an antibiotic-resistant infection. Many more deaths were complicated by an antibiotic-resistant bacterial infection, but were not necessarily caused primarily by the infection. By including only deaths directly caused by such infections, the report will serve as an important baseline against which future changes in antibiotic resistance can be measured.

For some time now, health officials have been warning that over-use of antibiotics is encouraging the development of antibiotic resistance. Over 70% of antibiotic use in the U.S. is to prevent the development of infections in healthy animals that are at risk of infections because they are housed close together, such as cattle in feedlots. Many of the prescriptions for antibiotics written for humans are unnecessary as well. Antibiotics do not shorten the duration of a cold or the flu, for example, but people who are suffering from a cold or the flu still ask for them, and many doctors oblige.

Gut Bacteria May Contribute to Obesity

Why can some people lose weight easily, while others just seem to gain weight no matter what they do?   The standard explanation has been genetic differences in metabolism that affect how you store and use the energy in the food you eat.

But genetics doesn’t explain differences in weight between identical twins.  One hypothesis is that in identical twins, differences in the ability to gain or lose weight may be due to different populations of gut bacteria.  We know that the human body is home to trillions of bacteria, many of them in the gut.  Gut bacteria are involved in metabolizing what you eat, largely for their own purposes of course, but possibly also affecting your metabolism.

In a recent experiment designed to find out whether gut bacteria might be affecting metabolism enough to alter a person’s overall body weight, scientists transplanted gut bacteria from pairs of twins “discordant for obesity” (one heavy and one not) into germ-free mice.  They found that gut bacteria from the obese twin caused the mice to gain more weight than gut bacteria from the lean twin.

The obvious conclusion is that the type of bacteria that inhabit your gut might indeed have an effect on a your body weight.  The next step would be to find out which gut bacteria might cause people to gain too much weight or to stay lean, and then to culture the lean ones or learn how to inhibit the weight-gaining ones.  Perhaps someday, cultures of specific gut bacteria will become components of diet pills.   But don’t hold your breath - it could take decades to tease out which bacteria would work the best.

Call me crazy, but my guess is that some unscrupulous diet clinics may seize on this research and begin to promote an unproven "therapy" that involves transferring cultures of gut bacteria from lean people into obese ones, with the promise that it'll cure obesity.  I hope I'm wrong. 

Sloppy Science Reporting

It concerns me when reporters get sloppy when reporting science news, or try to make the news personal in order to attract readers (do they teach that in journalism school?).   Consider the article on The Weather Channel’s website entitled “Which state is the worst for your heart?”   The obvious implication is that some states are better than others for my heart.  I clicked on the article just in case there really were some states I should avoid (no, not really!)  I’m sorry to say I came away disappointed, and here’s why.

The article ranks the 50 states from best or worst in terms of deaths from heart disease, based on statistics from the U.S. Centers for Disease Control (the CDC).  The data are legitimate, but the the title of the article is misleading.  The number of deaths from heart disease in a particular state does not necessarily mean that I would have that same risk if I were to live there.   For the most part, my risk factors are my own, regardless of which state I reside in or am traveling through at the moment.  Statewide differences in deaths from heart disease are a complex mix of factors, including genetics of the state’s population, differences in local diets, job stresses, environmental pollutants, and other as yet unknown factors, spread out over an entire lifetime.  The differences between states are interesting in that they may help us identify these risk factors, but they have almost nothing to do with me personally.

The article also makes no distinction between the past and the future.  Take for example, the following statement about the best state, Minnesota; “In this state, 36.3 residents out of every 100,000 will die of a preventable heart condition this year, according to the most recent CDC data available.”  Wrong! First, a fraction of a person cannot die (Thirty six point three people will die?).  And second, the CDC is not in the habit of trying to predict future deaths; it simply reports deaths that have already happened.  A correct statement about Minnesota would have read, “In this state, between 2001 and 2010 an average of 36.3 residents out of every 100,000 died of a preventable heart condition each year, according to the most recent CDC data available.”  See the difference?

These may seem like minor errors, but if we’re going to report on science, why not try to get it right?  I, for one, will not worry if I ever move to Mississippi (the state with the most deaths from preventable heart disease, at 95 residents per 100,000).  My risk factors, whatever they are, are already pretty well set.

For more on this subject, go to a previous blog post titled "Journalistic Bias in Science Reporting."

A Carbon Tax to Curb Global Warming?

What’s the best way to reduce global emissions of greenhouse gases such as CO2? Appealing to people’s sense of social responsibility, such as asking them to buy cars with better gas mileage or turn down their thermostats, doesn’t seem to work terribly well. Most of us are more focused on how we’re going to pay the rent or buy that new car than on our personal contribution to global warming. Plus we have no idea how to calculate our carbon footprint, as its called. And targeted government action, such as requiring that cars achieve a certain mileage or demanding that we car-pool to work, are highly intrusive on our lives. Is there a better way?

One idea would be to put a price (okay, a tax) on greenhouse gas emissions, wherever and whenever they occur. That way, the cost of preventing global warming is uniformly distributed into everything we do that results in the increased release of greenhouse gases. We don’t even have to be aware of it. It just means that the prices of all goods and services that we use would go up by an amount that would reflect the actual cost of removing the amount of CO2 those goods or services produced. A carbon tax would mean that each of us would be paying for our carbon footprint, without having to go to extremes of a change in lifestyle. For more on why a carbon tax might be the best idea yet, see the essay by Harvard economist Gregory Mankiw.

Yes, it would be difficult to put the right price (or tax) on carbon emissions. Too much and it could stifle economic growth and prosperity. Too little, and we wouldn’t solve the global warming problem. That’s a topic for the future. Surely it could be done, if we put our minds to it.

Preventable Deaths from Dental Disease

People who don’t have dental insurance are more likely to delay going to the dentist than people who do have dental insurance.  As a result, early signs of tooth disease may go undetected in the uninsured.  Then when a medical or dental problem becomes major and the person is in enough pain, the uninsured tend to go to a medical emergency room rather than a dentist, where they can be assured of emergency care regardless of whether or not they can pay.

Perhaps as a result of this tendency to wait too long and then go to a medical emergency room, the number of hospitalizations from serious complications of dental infections, and even deaths from dental disease, are on the rise.   According to a recent study, between 2000 and 2008 more than 60,000 people were hospitalized for periapical abscesses, a condition that develops in untreated tooth decay in which the tip of the tooth’s root becomes seriously infected.  Sixty-six patients died from complications of the condition.  That’s unfortunate, because periapical abscesses are less likely to occur in persons receiving regular dental care.   In addition they can be treated effectively by root canal therapy or tooth extraction when diagnosed early enough.

Hospitals have no choice but to write off emergency room care given to patients who cannot pay.   What this means is that a lack of access to dental care (because of a lack of insurance or an inability to pay) may be driving up the cost of charity medical care instead.  And people are dying needlessly.  It’s worth thinking about when we discuss universal access to health care – what about dental care?

The NFL Settles Lawsuits with Former Football Players

We first mentioned the possibility that repetitive head trauma might cause a form of brain injury called chronic traumatic encephalitis (CTE) over a year ago (see this blog, May 17, 2012). Over a thousand lawsuits had already been filed against the National Football League by former football players, who claimed that their symptoms of brain injuries were caused by repetitive head trauma received during their playing years. At that time the NFL disavowed responsibility but agreed to look into it.

Well, the NFL did look into it, saw the handwriting on the wall, and did the right thing. This week the league settled all the lawsuits at once by agreeing to pay out $765 million over the next 20 years to diagnose and compensate former players who may have suffered brain injury during their playing years. The amounts each player receives will be determined by the player’s age, years of play, and medical condition, but ultimately there’s a cap on the payout to any individual player; $5 million for former players with Alzheimer’s disease, $3 million for dementia, and $4 million to the estate of players diagnosed after their deaths with CTE, which can only be diagnosed by examining the brain after death.

And what does the NFL gain, other than goodwill? The league does not have to reveal what it knew about a causal link between repetitive head trauma and CTE and when it knew it. In other words, it does not have to admit wrongdoing. Fair trade? You decide.

As a result of what we now know about repetitive brain injury and CTE, the NFL has instituted rule changes designed to prevent head injuries from occurring in the first place, and to prevent players who have been injured from returning to play until they have fully recovered. That means that it may be harder for current players who later develop CTE to recover damages.

BMI - an Imperfect Measure of Obesity-Related Health Risk

Finally, people are starting to recognize that the BMI (Body Mass Index) scale is an imperfect predictor of health risk as it relates to obesity.  Yes, in the very broadest sense it works for whole populations, but it seems to break down when it comes to being a good predictor of an individual’s risk for obesity-related diseases.

A recent analysis of the topic can be found in an article by two University of Pennsylvania researchers.  They argue convincingly that we need to know a lot more than just BMI to be able to predict a person’s future risk of diseases related to obesity and metabolism with any degree of accuracy.  The researchers point out that earlier research (by Flegal et al.) shows that being slightly obese is actually protective in some individuals.  Furthermore some individuals with normal BMIs are actually at high risk for obesity-related diseases because they are “metabolically unhealthy”.

You can’t pull up the article in Science magazine online without a username and password, so I’m passing the URL for the article on to you here.  The article can also be found in the Aug. 23 hardcopy issue of Science.

Were the Flores People a Separate Species?

Ever since they were first discovered in 2004, the skeletal remains of a diminutive group of humans found on the island of Flores in Indonesia have been at the center of a controversy. Did the Flores people belong to a previously undiscovered species of the genus Homo, or were they simply modern humans (Homo sapiens) who suffered from some sort of growth disorder?

New evidence strongly supports the new-species hypothesis. In a paper published in PLOS One, researchers used CT scans to compare the brain shape of the one available skull of a Flores person to primitive species of Homo, to modern humans, and to modern humans with various growth disorders. They conclude that the Flores people are most closely related to the primitive human species known as Homo erectus. Furthermore, the evidence did not support the hypothesis that the Flores people were modern humans with a growth disorder, and so it seems appropriate to consider the Flores people a separate species of primitive Homo. Scientists have named the new species Homo floresiensis in honor of where they were discovered.

That’s where we stand today, at least. But the fact is that all this talk of a new species is based on just one skull and a partial skeleton, plus a bunch of bones of other individuals of the same group. It would be nice to have a few more skulls to really nail this thing down. Perhaps in time….

Diagnosing Concussions in Athletes Quickly and Inexpensively

Imagine that a high school football player takes a hard hit during a game. He seems a little shaken up, and he's a little little wobbly as he leaves the field, but five minutes later he swears he’s fine and wants to be put back in the game. But if he’s had a concussion, he’s not supposed to return to play. What tools does the coach or trainer have to try to determine whether he’s okay to play or not? After all, not all hard hits result in concussions; he’s probably just fine….

A common finding after a concussion is that the person’s physical reaction time decreases. But how can one measure a decreased reaction time quickly and accurately on the sideline? Researchers at The University of Michigan developed and validated a simple technique - here’s how it works. The athlete rests his forearm comfortably on a table with his opened hand extended just off the front edge of the table. A trainer or coach holds a measuring rod such as a yardstick by its upper end, positioning the lower end at the athlete’s hand level. When he lets go of the stick, the athlete grabs it. Where the athlete grabs the measuring rod (the number of inches that the rod falls before he grasps it) is an indirect measure of reaction time. If measurements of reaction time are made on every athlete before the season begins, slower reaction times can be determined easily and quickly any time a concussion is suspected.

Of course, the method only actually measures the distance the rod falls before the athlete grasps it, so it’s not a true measure of reaction time. But that doesn’t matter; if the rod falls more than usual before the athlete grasps it, his reaction time is slower and he should be evaluated by a medical professional before he is allowed to play again.

For those who are interested, the method is described in a publication in the Brit. J. of Sports Medicine.

New Recommendations for Screening for Lung Cancer

The U.S. Preventive Services Task Force (USPSTF) has published a draft of potentially new recommendations for screening high-risk persons for lung cancer.  The USPSTF now recommends that smokers aged 55-80 who smoked at least one pack a day for 30 years should have a low-dose CT scan every year.   The draft recommendation is available for public comment until August 26, after which the recommendation is likely to be approved.

Screening normal healthy people for lung cancer (with traditional chest x-rays) is generally not done. In part, that’s because x-rays generally catch lung cancers too late for lifesaving treatment anyway.  In addition, x-rays sometimes produce false-positive results, leading to needless stress and unnecessary medical procedures.  On balance, then, the benefits of routine chest x-rays for detecting lung cancers just don’t outweigh the risks.  However, modern CT scans can pick up smaller tumors than traditional x-rays, leading to earlier and thus more effective treatment.  That tips the benefit/risk balance, at least for smokers at high risk of developing lung cancer.  The USPSTF estimates that screening high-risk smokers every year could save about 22,000 lives per year.

If the USPSTF’s draft recommendation is eventually approved, insurance companies will probably pay for annual CT scans for smokers who meet the screening criteria.  So will Medicare.

Could Stem Cells Feed a Hungry World?

Scientists have succeeded in producing edible meat from stem cells taken from a beef cow, according to CNN news. The first “stem cell burger” cost over $300,000 to produce. It didn’t get rave reviews in terms of taste, but that’s to be expected; it was pure meat, without any fat at all. But it wouldn’t be hard to add a little fat back in. Perhaps someday scientists will be able to produce the fat from stem cells as well.

Despite its cost and taste, this first edible meat from stem cells represents an important “proof of concept”; it’s possible to produce animal protein in laboratories, rather than on the range. And that might just save a hungry world population if (heaven forbid) a shortage of range land or water ever limited our ability to raise enough animals for food.

Low HPV Vaccination Rate Among Adolescent Girls

A weekly CDC report indicates that fewer than 35% of adolescent girls aged 11-13 have been fully vaccinated with all three doses of the vaccine against the human papilloma virus (HPV).   The percentage did not increase at all between 2011 and 2012.   Officials have been pushing the HPV vaccine because it has been proven to be very effective in lowering a woman’s risk of developing cervical cancer later in life.

Officials are not sure why the percentage of girls who have been fully vaccinated remains so low.   Part of the problem, of course, is that full vaccination requires three visits, rather than just one.  Indeed, 53.8% of girls had had at least one vaccination by 2012, but then a lot of them failed to receive the other two.

The reason for the failure to receive the 2nd and 3rd doses of HPV vaccine clearly is not parental resistance to giving the vaccine to girls so young (before they are sexually active), because so many girls have already had the first dose.  Nor is it a lack of opportunity, since girls of that age do go to the doctor for other vaccinations.  Officials speculate that physicians are simply missing the opportunity to offer the vaccine.   Officials calculate that if girls had been offered the HPV vaccination during the girls’ regular doctor’s visits, the percentage of girls who had received more than one vaccination could have been as high as 92.6%.

And that means that the focus of the CDCs efforts may have to shift to physician education, rather than parental education.

A Next-Generation Artificial Heart

A French company called Carmat has developed a new artificial heart that may be a significant improvement over current models. Current models of artificial hearts tend to cause blood to clot, because blood is in direct contact with their metal or plastic inner surfaces. In the Carmat heart, all surfaces of the heart in direct contact with blood are lined with tissue derived from the pericardial sac of cows. The heart is a sophisticated pumping device controlled by sensors, microelectronics and software. It is powered by external batteries, making regular battery changes feasible. Testing of the heart in human patients is likely to begin in several European countries as early as this year.

Artificial hearts have entered the clinical testing phase before, only to prove disappointing later. The big stumbling block has been the tendency of all previous artificial hearts to cause blood to clot. Achieving a high long-term success rate in human patients has proven frustratingly elusive. Current artificial hearts are generally used only to keep the patient alive until a proper human donor heart is available.

It’ll be years before we know whether the Carmat heart will be the first implantable artificial heart that can be used successfully for the long term. We’ll be watching this one closely.

A New Class of Cholesterol-Lowering Drugs

Researchers have discovered a rare gene mutation that results in very low low-density lipoprotein levels (LDL is the “bad” cholesterol).  So far, only two people have been identified who are homozygous for (i.e. have two copies of) the mutated gene.  Both people have LDL levels around 15 mg/dl.   An LDL of less than 100 is considered optimal; over 160 is classified as high.

LDL is considered to be a major contributor to atherosclerosis and thus to heart disease and strokes.  The discovery that a genetic mutation can result in very low LDL levels has triggered a rush by several major drug companies to produce a drug that mimics the effects of the mutation.  At least three drug companies already have drugs in the testing stage.  The drug companies view anti-cholesterol drugs as potential blockbusters.  From the perspective of a drug company, drugs that are taken long-term for chronic conditions are far better profit-generators than drugs that are taken only for a brief period to cure a disease or condition (such as antibiotics, for example).  In addition, LDL-lowering drugs are likely to be expensive.

If/when LDL-lowering drugs are approved, who should take them?  Aside from people with high LDL levels, would people with what are currently considered optimal LDL levels also benefit from taking these drug?

When Should the Umbilical Cord be Severed?

It is standard practice when babies are born to clamp the umbilical cord immediately and then cut between the clamps, severing the connection between mother and infant in the first minute after birth.  It has been done that way for decades, in part because it was believed that doing so reduces the risk of hemorrhage in the mother.

Recent evidence suggests that it may be better to delay cutting the cord for a minute or two after birth.  After reviewing the outcomes of more than 3,900 women-infant pairs in 15 different previous studies, the authors of a recent study concluded that delaying cutting the cord did not increase the risk of maternal hemorrhage significantly.  On the other hand, delaying cutting the cord for just several minutes resulted in improvement in several measures of infant health; a higher birth weight, a higher hemoglobin concentration several days after birth, and a reduced likelihood of iron deficiency at 3-6 months.  The only negative was that delaying cutting the cord slightly increased the tendency for jaundice in the infant.  Overall, the results suggest that in many normal deliveries, delaying clamping the cord for just a minute or two is probably beneficial overall.

Why would delaying cord clamping for such a short time be beneficial?   The most likely explanation is that immediately after delivery the rate of cord blood outflow from the infant declines relative to inflow to the infant.  So in that first minute or two, the infant gains a significant amount of blood from the mother in preparation for an independent life.  Estimates are that the infant may receive as much as a third of its blood supply in that crucial first minute or two after birth. 

Increased Incidence of Melanoma in Young Women

The incidence of melanoma has risen dramatically in young persons in the past 40 years, especially in young women.

Researchers at the Mayo Clinic compiled data for the incidence of melanoma in persons aged 18-39 between 1970 and 2009 in a single county in Minnesota. They found that the incidence of melanoma has increased steadily each decade since the 1970s: the incidences were 4.8 (cases per 100,000 person-years) in the 1970s, 11.8 in the 1980s, 16.8 in the 1990s, and 30.8 in the 2000s (from 2000 to 2009). That’s more than a 6-fold increase in just 30 years.

One likely explanation for at least part the increase in reported cases of melanoma is that increased awareness of the disease has led to more frequent and more accurate diagnosis. Another is that the criteria for calling a lesion a melanoma has changed over time. However, when the authors broke the data down by gender they found that the incidence of melanoma differed dramatically between men and women; the incidence rose 4-fold in men, but 8-fold in women. In theory, a gender difference would not be explained by changes in awareness or definition over time.

Why is the incidence of melanoma increasing more in women than in men? The study’s authors speculate (and yes, it’s speculation at this point) its because young women use tanning beds more frequently than men. And despite what the advocates of tanning beds say, the UV rays emanating from tanning beds DO damage the skin and CAN lead to an increased risk of skin cancer.

Smoking Rates Continue to Drop

Except for a brief uptick in 2008 and 2009, the rate of smoking among U.S. adults continues its long-term downward trend. The latest figures show that only 18% of adults are current smokers, down from 24.7% just 15 years ago.

Researchers believe that a number of factors are contributing to the decline. Cost is one – research shows that as the cost of cost of cigarettes goes up, rates of smoking go down. Public policies that create smoke-free workplaces, restaurants, and even outdoor parks are taking their toll, too. Although such policies don’t actually require that smokers quit or even smoke less, they tend to create a culture in which smoking is discouraged, rather than encouraged. Advertisements, particularly those that educate people about the marketing efforts of tobacco companies (getting people to dislike tobacco companies) or that show in graphic detail some of the devastating effects of smoking also may be contributing to the decline in smoking, at least among adults.

Will we ever get the rate of smoking down below, say, 5%? Not anytime soon, apparently. One group that does not seem to be very amenable to anti-smoking educational programs is kids. Getting them to never start smoking in the first place has proven to be a tough nut to crack.

Sarah Murnaghan had Two Lung Transplants

Well, it didn’t have to happen, but it did; Sarah Murnaghan’s first lung transplant on June 12 failed almost immediately. She was put back on the organ transplant list, and three days later she was given a second set of adult lungs.  Her condition is improving now.  But here’s the irony; in all the talk in the past several weeks over the landmark case that she represented (adult lungs given to a 10-year-old child), the pubic was unaware that it was her second pair of lungs that have helped her to get better. That fact only became widely known on June 28, nearly two weeks after the second transplant.

The basic problem with transplanting adult lungs into children is that the lungs need to be “resized” to fit the child.  It adds another level of risk to what is already a fairly risky procedure. That’s one of the reasons that the organization that oversees transplants, the Organ Transplant and Procurement Network (OTPN), had a policy of not approving adult lungs for transplant into children under 12 years old.  But Sarah’s parents sued, and so the OTPN decided to keep its “Under 12 rule” but create a special review option for one year to consider exceptions on a case by case basis.  So now we have a precedent that may embolden the parents of other needy children to sue for what they want.  We should all be happy that young Sarah survived the surgeries and is doing well, but make no mistake; that means that the two sets of lungs didn’t go to someone else.

When it comes to such rare and precious resources as human organs, the decisions regarding who gets them are likely to remain contentious. This is worth talking about; who should decide, and how should they decide? The OPTN’s special review option is set to expire in one year unless the full board of directors votes to keep it.  I’ll be interested to see what they do.  

The Supreme Court: Human Genes Cannot be Patented

The Supreme Court has finally reached a verdict; human genes in their natural form cannot be patented because they are “products of nature”, and not the invention or creation of a commercial company. The decision was a major blow to a company called Myriad Genetics, which has long held that it owns the patent rights to the two genes that confer a high risk of breast cancer, called BRCA1 and BRCA2. Based on its alleged patents, the company had vigorously defended its right to be the sole provider of lucrative tests for the two genes. In the process, it had prevented researchers from studying the genes and kept other companies from developing similar tests for the presence of the genes. That kept the price of the tests for the two genes (predictors of risk for breast cancer) high and earned big profits for Myriad.

However, the Supreme Court didn’t rule entirely against Myriad Genetics. In another part of its decision, the court ruled that synthetic forms of the genes (created in a laboratory) would be patentable. Myriad did indeed create synthetic forms of the gene, which could now fall under patent protection. Nevertheless, the two rulings taken together represent a partial defeat for Myriad Genetics and a victory for gene researchers and other biotech companies. The ruling means that the two breast cancer genes, as well as the all other genes previously “discovered” by researchers, remain in the public domain, available to anyone.

For more on the subject of gene patenting, go to a previous blog post titled "Can Genes be Patented?"

The Testosterone Replacement Therapy Craze

We’ve all seen the ads promoting gels and pills to treat “low T”, or testosterone deficiency. The ads make testosterone replacement therapy sound like a no-brainer (Hey, I can look better; feel better; get the girl; etc.), but do you really need more testosterone?

The number of men over 40 with prescriptions for testosterone has tripled since 2001, according to a report in JAMA Internal Medicine. And that raises concerns. Do all these men actually have “low T”, with symptoms of mood swings, hot flashes, fatigue, sexual dysfunction, and a reduced muscle mass/increased fat mass?

Testosterone deficiency is due to a medical condition called hypogonadism. The Endocrine Society recommends testosterone replacement therapy to treat hypogonadism, but a blood test for testosterone is required for accurate diagnosis. According to the JAMA report, more than 25% of the men who were prescribed testosterone never even had a blood test. And of those who were tested, it is not clear how many were actually “low T”.

This may be another classic situation where intense advertising has lead to increased demand, regardless of actual need. Men who think they need testosterone for their perceived symptoms should have a blood test first, and they should be prescribed testosterone only if their testosterone is below normal limits for their age. Testosterone levels decline naturally with age, by the way. Testosterone therapy was never intended to improve sexual prowess or make a 50-year-old feel like a 20-year-old again, despite what the advertisements imply.

Transplanting Adult Organs Into Children

On June 12 a young cystic fibrosis patient named Sarah Murnaghan finally received a much-needed transplant of an adult lung. What makes this news is that Sarah is only 10 years old.

Adult lungs are not readily available for transplant, and children’s lungs are just plain rare. Because children are smaller than adults, adult lungs have to be resized to fit them, adding an additional level of risk of failure. Therefore the organization that oversees transplants, the Organ Procurement and Transplantation Network (OPTN), had developed a policy of not considering adult lung transplants for children under the age of 12. But following an urgent request by her parents, last week, a federal judge ruled that younger children should be eligible for adult lungs, opening the way for Sarah to receive her lungs and for other children to be considered as well.

Not everyone is happy about the new development. For years, the OPTN has done its best to allocate scarce organs equitably and fairly. The recent ruling disturbs some people because it implies that seeking help from the courts (as Sarah’s parents did) is a legitimate way to deal with what are clearly complex medical and ethical decisions. I’m as glad as anyone that little Sarah was saved by a lung transplant. But given that there are too few transplantable organs available, do we want medical professionals and ethicists to make such decisions based on certain principles of fairness and medical effectiveness, or do we want the decisions made by judges and lawyers based on who shouts the loudest?

You decide.

DNA Samples Can be Taken During an Arrest

In 2009, a Maryland man named Alonzo King was arrested and charged with assault for pointing a shotgun at a group of people. Unfortunately for Mr. King, according to Maryland law a DNA sample can be taken from anyone who is merely arrested, regardless of whether or not he/she is later convicted. Mr. King’s DNA sample matched a sample taken from an unsolved rape case six years earlier. He is now serving life without parole.

The Maryland Court of Appeals overturned Mr. King’s conviction on the grounds that the DNA sample constituted an “unreasonable search” not linked to the assault charge. The case was appealed to the Supreme Court. And just this month the Supreme Court ruled by a 5-4 vote that yes, it IS constitutional to collect DNA samples from people who have merely been arrested for serious crimes, as opposed to eventually convicted. According to the Supreme Court, a DNA sample not that much different from other currently used forms of identification, such as fingerprints and mugshots. In the Supreme Court’s opinion, the state’s interest in identification outweighs a person’s expectation of privacy.

Taking DNA samples after arrests for certain crimes is already the rule in 28 states. So if you are arrested for a serious crime in the future, the police may take a cheek swab for DNA analysis. Your DNA can then be checked against DNA samples already in the state’s database, and also against a national database maintained by the FBI. I hope your record is clean…

Increased Atmospheric CO2, Pollen Counts, and Allergies

The increased use of fossil fuels (coal, oil, gas) in the past 60 years has caused a marked rise in the levels of CO2 in the atmosphere, from about 310 parts per million (ppm) in 1950 to nearly 380 ppm in 2013. The rise in CO2 has, in turn, resulted in a sharp increase in pollen counts.

It makes perfect sense from a biological perspective. As you know, plants require C02 for their metabolic processes, just as we require oxygen for ours. In the pant metabolic process known as photosynthesis, plants combine CO2 and water, producing sugars and oxygen releasing oxygen into the atmosphere. The 25% rise in CO2 over the past 60 years represents a rich new supply of CO2 for plant photosynthesis. As a result, many plants are growing faster and more vigorously than in the past. They’re also producing more pollen; pollen counts have more than doubled in the past five years in some areas, according to an article in USA Today.

Unfortunately, what has been good for plants has not been so good for allergy sufferers. There has been a noticeable rise in the incidence of allergies such as hay fever, and also allergic asthma, in areas with high pollen counts. That’s not likely to change any time soon, since nothing much has been done to curb the steady rise in CO2.

This might be a good time to consider a career as an allergist. Someone’s going to need to diagnose, test, and treat all those new allergy sufferers (smile)!

A Freshwater Aquifer is in Danger of Depletion

The High Plains aquifer, a vast reserve of underground water that stretches from Wyoming and South Dakota all the way to Texas, is slowly being depleted. Some wells in Kansas and Texas have become so non-productive that farmers have had to abandon them.

The culprit is the recent widespread use of groundwater for irrigation of crops. Starting in the 1940s, crop irrigation from wells became practical and widespread, and many farmers switched to high-value, water-thirsty crops like corn instead of crops that relied on natural rainfall. By 1990, about 95% of all water being drawn from the High Plains aquifer was for irrigation, according to a U.S. Geological Survey report. As a result, there has been a decline in the production of many wells. And once the groundwater is depleted, it could take decades or even hundreds of years to replenish it.

Farmers in the area are well aware of the problem, but there is essentially no easy solution. Some farmers have abandoned once-productive fields. Others have switched to less water-thirsty crops like milo or cattle, in the hope of continuing to farm for awhile longer. In the long run, the Midwestern states that have depended on the High Plains aquifer will have to learn to get by with less groundwater than in the past.

The problem of maintaining adequate supplies of freshwater is, of course, worldwide. As water gets scarcer, efforts to conserve it will only intensify.

Angelina Jolie’s Voluntary Double Mastectomy

Actress Angelina Jolie revealed recently that she chose to have a double mastectomy followed by reconstructive surgery with breast implants, to reduce her chances of dying of breast cancer.  Ms. Jolie, 37, says that she chose a double mastectomy because she tested positive for the mutated BRCA1 gene, which gave her nearly a 65% chance of developing breast cancer.   She explains her choice in an op-ed piece in the New York Times on May 14.  In the piece, Ms. Jolie says she wants other women to know they have choices.

Some readers hailed Ms. Jolie for her bravery and her willingness to speak so openly about such a personal decision.  A few readers, however, questioned the notion of choices.  For the average woman with a fear of cancer, a voluntary double mastectomy is probably not an option because of the cost.  Testing for the BRCA1 gene, genetic counseling, surgery, and breast reconstruction can cost tens of thousands of dollars.  Most insurance companies won’t pay for it if it’s done voluntarily, before the patient first develops any breast cancer.

Angelina Jolie says that for her it was a good choice, even though she had never been diagnosed with cancer.   On the positive side, her very public announcement may help other women make informed choices.   But practically speaking, it’s a choice that will remain out of reach of many women because of cost.   Even under Obamacare, testing for the BRCA gene (about $3,000) and genetic counseling will only be covered only “if appropriate”.  How that will be interpreted is anybody’s guess.

For more on this subject, see a previous blog post titled "Double Mastectomies Are On the Rise."

Scientists Clone Human Cells

Using essentially the same techniques that resulted in the first cloned adult animal (Dolly the sheep), scientists at Oregon Health Sciences University have cloned human cells and coaxed them into developing into human embryos. Their intent was to be able to produce cloned cell lines from the embryos strictly for therapeutic purposes. The research is published online in the journal Cell. The researchers started with eight human eggs from a single human donor, and after enucleating the eggs, joined them with human skin cells. From these they obtained five blastocysts (early-stage embryos) and ultimately produced four cloned cell lines.

So far, human embryos produced by these techniques (known as somatic cell nuclear transfer) have not been allowed to develop into full-term human babies. The cloning of humans, of course, raises some serious ethical issues. Society will have to grapple with the issue soon, because it’s now clearly within the realm of possibility.

The basic idea behind reproductive cloning research is to be able to produce human tissues that are an exact match for the human patient from which the cloned cell was taken. Tissues produced these techniques could be used to produce skin for treating burns, or perhaps heart, or liver cells to repair a damaged organ, without fear of tissue rejection.

Do the potential medical benefits outweigh the ethical concerns associated with the creation and ultimately the sacrifice of human embryos? You decide.

The NTSB Recommends Lower Blood Alcohol Limits

The National Traffic Safety Board (NTSB) is urging all states to lower the blood alcohol concentration that constitutes drunk driving, to 0.05%. Currently, the limit is 0.08% in all 50 states. The NTSB estimates that lowering the limit to 0.05% would save nearly 1,000 lives per year.

The NTSB estimates that even at 0.05% blood alcohol there is some impairment of depth perception and other visual abilities, resulting in a 39% increase in the chances of an accident while driving. At the current level of 0.08%, the chance of an accident is increased by 100%. Most countries in Europe and also Australia already have a 0.05% limit.

However the NTSB can only recommend the change; it has no legal authority to force states to adopt new laws. The last time a reduction in blood alcohol was recommended (from 0.10 to 0.08%), it took 21 years before the last state made the change. Nevertheless, most states do pay attention to the NTSB’s recommendation and to public opinion. We can expect many states to set new limits at 0.05% by their next legislative session.

Do you know how many drinks you would probably have to consume to surpass the current 0.08% limit? It’s worth knowing if you ever drink and then drive.

Products Containing DMAA are Still Available

General Nutrition Centers (GNC) is still selling dietary supplement products containing dimethylamylamine (DMAA), a full month after the FDA issued a health warning about the drug. DMAA is an amphetamine-like stimulant found in the workout-boosting product Jack3d.

The FDA says there have been over 80 reports of adverse health effects associated with DMAA, and urges consumers to stop using it. In addition, the FDA argues that DMAA does not qualify as a dietary supplement according to the accepted definition of a dietary supplement. The FDA has already convinced the product’s manufacturers to stop making these products. But the retailer GNC says it does not believe that DMAA is unsafe, and so it continues to sell its stock of workout products containing DMAA.

Whether DMAA qualifies as a dietary supplement may have to be decided in court, if GNC continues to push the issue. Even so, it’s unusual for a company to refuse to take a product off its shelves when it’s labeled unsafe by the FDA. Most companies would err on the side of caution by removing of the product from store shelves immediately. A company that continues to sell a product considered dangerous by the FDA would be risking future lawsuits. Indeed, there’s already one lawsuit against GNC for a death allegedly related to Jack3D.

What is GMC’s logic in continuing to sell Jack3d?!

Atmospheric CO2 Levels Reach a Milestone

According to the National Oceanographic and Atmospheric Administration (NOAA), atmospheric CO2 levels rose to a weekly average concentration (rounded to whole numbers) of 400 parts per million (ppm) last week. The actual weekly average for May 5th was 399.52 ppm.

Atmospheric CO2 measurements have been taken every hour of every day at the top of Mauna Loa in Hawaii since the 1950s. The accumulated data show quite convincingly that CO2 levels have risen rapidly over the past 60 years and are now higher (compared to historical averages estimated by other, indirect methods) than the levels at any time over the past three million years.

It is widely believed that the rising CO2 levels of modern times are a direct result of human activities, including especially the burning of fossil fuels (coal, oil, and gas). 400 ppm is just a number, of course; it does not necessarily signify an important level in and of itself. It’s just another signpost on the road of continuously rising CO2 concentrations. Despite all the talk over the past decade or so about the need to stop it to prevent global warming, little action has been taken so far.

So CO2 levels will probably continue to rise for awhile, until we actually get serious about doing something about it.

Morning-After Pill Ruling is Appealed

As expected, the Justice Department has appealed the ruling last month by a U.S. District Court judge that the morning-after pill should be made available to girls under the age of 17. Predictably, social conservatives and anti-abortionists are supporting the appeal.

President Obama himself is “comfortable” (now) with the pill being made available to girls as young as 15, according to an NBC news article. But he seemed to be against it back in 2011 (see this blog, Dec. 11, 2011). Perhaps his apparent change of heart was influenced by the fact that he is no longer facing an election?

The available scientific evidence supports making the morning-after pill available to all ages. The pill has proven to be safe enough that were it not a contraceptive pill, it would have been approved for younger girls long ago.

Like it or not, availability of the morning-after pill remains a political issue, not a scientific one.

Autism and antidepressants

What are the reasons for the more than six-fold increase in reported cases of autism in the past 20 years? Changes in diagnostic criteria are thought to account for up to 25% of the increased number of cases. Increased awareness of the condition may also mean that more autistic children are being diagnosed as having the condition; some of these children that might have been missed in the past. And there is some evidence that parents of advanced age are more likely to have an autistic child, accounting for some of the cases. Finally, some parents continue to believe (against an overwhelming body of scientific literature) that autism may be caused by something related to childhood vaccinations, and so they refuse to have their children vaccinated. It’s as if lacking an adequate explanation, they’d rather clutch at straws rather than admit that we just don’t know yet.

Two recent studies suggest that some cases of autism may (and I stress may) be related to the mother’s use of certain antidepressant medications during pregnancy. The most recent study is out of Sweden, where national health statistics make large population studies feasible.

The results should be interpreted with caution, however. It will prove difficult to separate out whether it’s the mother’s clinical depression itself, or the drugs used to treat it, that may be increasing the risk of autism. After all, women generally don’t take antidepressants unless they’re clinically depressed. It will be some time before we have a definitive answer, if ever. In the meantime, women who are clinically depressed should discuss the risks and benefits of antidepressant drugs with their physician if they anticipate becoming pregnant.

One final note: the use of antidepressants can’t account for much of the overall rise of autism, because so few pregnant women actually need and use antidepressants. The Swedish study points out that although any woman who uses antidepressants during pregnancy may be doubling the risk of autism in her child, the use of antidepressants during pregnancy probably accounts for less than 1% of all cases of autism in the whole population.

FDA Blocks Generic Oxycontin

When a drug’s original patent expires, the FDA usually approves generic versions of the drug.  There are winners and losers when this happens.  Patients win because generics cost less than the patented drug.   Generic drug manufacturers win too.  The only loser is the original patent-holder, whose profits usually fall dramatically when a blockbuster drug’s patent expires.  But don’t feel too bad for them; they’ve made plenty of profit from the drug already.  The high profit they make while the drug is under patent protection (up to 20 years) is supposed to compensate them for the high costs of drug development and testing, which the generic drug companies don’t need to do.

That’s how it usually works.   But this week the Food and Drug Administration (FDA) refused to approve a generic version of the popular pain-killing drug OxyContin, on the very day that the drug’s patent was set to expire.   Why?   OxyContin (a narcotic) has become an abused prescription drug, in part because the pills could be crushed and then injected or snorted, releasing high levels of narcotic all at once.   The FDA feared that widespread availability of generic OxyContin would lead to even more abuse of the drug.  So in an unusual move, the FDA chose instead to approve a newly-patented, reformulated version of OxyContin that is harder to abuse.   When crushed, the new OxyContin becomes a jelly-like mass that can’t be injected or snorted.  The potential safety benefits of the newer version were so compelling that the FDA was willing to phase out the old version.

But don't expect the old version of OxyContin to disappear just yet.  It turns out that generic OxyContin has been approved for sale in Canada.   Canadian pharmacies are likely to have it for sale within a month.

Workout Supplement Ingredient Banned

The Food and Drug Administration (FDA) issued a warning last week that several workout-booster and fat-burning products should be pulled from the market immediately because they contain an ingredient called DMAA (dimethylamylamine). The products, Jack3D (pronounced Jacked) and OxyElite Pro, are both marketed by USPlabs.

Back in 2011 the FDA sent letters to all 10 marketers of DMAA products, asking them to voluntarily stop marketing such products. All but USPlabs complied. The company continues to claim that the products are safe and legal.

According to the FDA, there have been 86 reports of health problems, including 5 deaths, among persons taking products containing DMAA. That does not prove that DMAA is dangerous, of course, and its not even the primary reason the FDA is asking that the products be removed from shelves. The FDA simply argues that DMAA does not fit the legal definition of a dietary supplement, and therefore it cannot be sold without prior FDA approval. I would agree; it's a drug. DMAA was actually developed by a pharmaceutical company in the 1940s and sold as a nasal decongestant until the 1980s. It stretches credulity a bit to suggest that it is a natural “supplement to the diet” when added to a workout-boosting product.

Judge Rules the Morning-After Pill Must be Made Available

What happens when politics and science clash? You may recall that back in 2011 the Food and Drug Administration (FDA) recommended that the morning-after pill known as Plan B be made available without a prescription to all women, including those under the age of 17. The FDA’s recommendation was based on good scientific evidence that the pill was both safe and effective. But then the Secretary of the Department of Health and Human Services (DHSS) nixed the idea for what appeared to be political reasons (see this blog, Dec. 11, 2011). The FDA is a government agency within DHSS, so the secretary of DHSS effectively overruled the FDA.

The decision pleased conservatives and pro-life groups. But it didn’t end there. The Center for Reproductive Rights filed a lawsuit against the 17-and-older age restriction, and the whole issue went to court. Finally, just last week a U.S. District Court judge ruled that the morning-after pill must be made available to women of all ages. Judge Edward Korman wrote in his opinion that the pill is being withheld from younger women due to “political pressure emanating from the White House.”

The morning-after pill could become made available to women of all ages within a month, unless the decision is appealed - first to the U.S. Court of Appeals and then perhaps the U.S. Supreme Court. This may not be over yet.

New Bird Flu Virus, H7N9

A second strain of bird flu virus, called H7N9, has now made the jump from birds to humans. According to the World Health Organization (WHO), there have been 18 reported cases of human infection so far, all in China. Six people have died.

Like the other bird flu virus (H5N1), the H7N9 virus is not capable of being transmitted from human to humans.  But unlike H5N1, the new H7N9 virus is not very virulent in birds. That makes it more difficult to detect than H5N1 (which kills most infected birds), because birds infected with H7N9 may not even appear to be sick. In humans, however, six deaths out of 18 infections is pretty virulent!

Authorities in China are handling this new outbreak better than they did the original outbreak of H5N1. The Chinese authorities are informing Chinese citizens, working with health officials around the world, closing bird markets in infected areas and slaughtering birds when it is deemed advisable. 

The U.S. is monitoring the situation and is working on a vaccine. In the meantime, the virus seems to be treatable with Tamiflu.

By the way, have you ever wondered how flu viruses get their unique names of letters and numbers? All Type A influenza viruses have two types of proteins on their surface, called hemagglutinin (H) and neuraminidase (N). Each of these proteins comes in multiple forms (16 different forms of H and 9 different forms of N are known in birds). So every flu virus's name reflects its unique combination of H and N protein forms. That’s probably more than you wanted to know, but at least it will make their names less mystifying to you.

Soot Contributes to Global Warming

According to recent research, the second-most significant contributor to global warming (after carbon dioxide), is not methane, as previously thought.  It’s carbon-black, also known as soot.  Black soot contributes to global temperature by absorbing sunlight and converting it to heat.  Soot is especially damaging when it falls on frozen and snow-covered regions of the Earth, because it causes snow and ice to melt more rapidly than they would otherwise.  Soot may be the reason why arctic ice is melting much faster than most climate models had predicted, based on elevations of greenhouse gases alone.

The good news is that correcting the climate problem caused by soot would be easier than dealing with methane and carbon dioxide.  Soot is a solid, so it is removed from the atmosphere much more quickly than either methane or carbon dioxide.  Within weeks of soot’s emission, it simply falls to the surface of the earth, whereas carbon dioxide and methane may hang around in the atmosphere for years.  In addition, most of the soot comes from diesel engines, inefficient stoves, and dirty diesel fuel; all problems that could be dealt with fairly easily if we had the will to do so.  Improving the efficiency of diesel engines to reduce soot emissions would have a significant impact within weeks.

You can read the entire comprehensive study of soot and its role in climate change in the Journal of Geophysical Research: Atmospheres.  But I warn you; it’s 286 pages long!  For a quick look, read the abstract.

Gardasil Vaccination Rates are Below Expectations

In 2006 the FDA approved Gardasil, the first vaccine against the sexually transmitted human papilloma virus (HPV). HPV is responsible for most cases of cervical cancer. The hope was that most girls would be vaccinated against HPV at about age 11, before they began sexual activity.

At first, Gardasil seemed destined for widespread acceptance (see this blog, Oct. 14, 2010). But more extensive data show that the rate of vaccination has remained lower than expected. According to the most recent data from the Centers for Disease Control and Prevention (CDC), only 35% of all girls 13 to 17 years of age have received all three of the required shots. And an article in Pediatrics this month reports that the number of parent planning to have their girls vaccinated is declining, rather than increasing.

The new findings are of concern to health officials. No one knows why vaccination rates are still so low. Possibilities include the uneasiness of parents to address the issue of sexual activity in girls as young as 11; concerns about vaccine safety; the need for three shots rather than just one; the fact that Gardasil is not administered at the same time as all other childhood vaccinations; even the cost ($400-$500).

Health officials are struggling with how to encourage parents to have their pre-adolescent girls vaccinated. Ideas include providing more education about the value of the vaccine in preventing cancer; lowering the cost of the vaccine; making vaccinations more convenient by requiring only the first dose to be delivered in a health care setting (the others could be given in schools or at pharmacies). Only time will tell which if any of these strategies will work. But it’s a shame that we now have a vaccine that would prevent about 4,000 deaths per year from cervical cancer, and a lot of girls just aren’t taking advantage of it.

Antibiotic-resistant Enterobacteriaceae

We’ve all heard about how bacterial resistance to antibiotics could cause real problems for us down the road. Most reports of antibiotic resistance have focused on a bacterium called MRSA, or methicillin-resistance Staphylococcus aureus, a highly resistant strain of bacterium that infects the skin as well as the lungs and other vital organs.

Now there’s another one, called CRE, or Carbapenem-resistant Enterobacteriaceae. Enterobacteriaceae typically reside in the gut (a very common enterobacteriaceae is E. coli). Some strains of enterobacteriaceae (like MRSA) have become resistant to most known antibiotics, including carbapenem, which is generally an antibiotic of last resort.

According to the Centers for Disease Control, CRE infections are still fairly rare. They tend to occur primarily in patients who are hospitalized for other conditions and who are on ventilators, have bladder catheters, or are connected to IV (intravenous) catheters. However, when CRE infections do occur they are exceedingly dangerous because they are so hard to treat – according to one estimate they contribute to death in perhaps half of all patients who are infected.

The fact that CRE is currently limited to certain types of hospitalized patients is mildly reassuring, for now. But because enterobacteriaceae are fairly common in humans, health care workers are concerned that resistant strains like CRE could make the jump to the wider human community. Prevention strategies are being worked out as we speak.