Another Breathalyzer to Detect Disease

First there was BreathLink, described as a breathalyzer for the detection of breast cancer and pulmonary tuberculosis. It's been 6 years since I first highlighted the concept of using breathalyzers for disease detection (see this blog July 4, 2011). BreathLink is currently undergoing extensive clinical trials. If all goes well, it may receive final FDA approval as a diagnostic test within another year or two.

Now there's another one, called Breath Biopsy. This one is at an earlier stage of development but is somewhat broader in scope. Breath Biopsy is, in effect, a platform to detect virtually any volatile organic compound (VOC) that might appear in the breath in a disease state. Current clinical trials about to get underway to validate Breath Biopsy tests for early-stage lung and colon/rectum cancers, and it is being considered for the possible detection of cancers of the bladder, kidney, esophagus, pancreas, prostate and brain. Several other possible uses have been proposed, including evaluating how patients with chronic obstructive pulmonary disease (COPD) are responding to treatment, and even studying a patient's microbiome - the bacteria in their digestive system - to determine which drugs might work best on their specific disease.

Compared to blood tests and biopsies, breath analysis would be safe and cheap. But before any breathalyser-based tests can be approved by the FDA, they will have to demonstrate their accuracy and reliability in extensive clinical trials. As the experience with BreathLink has shown, regulatory approval can take years or even decades, not days or months. You may encounter a breathalyzer test in your lifetime, but don't hold your breath.

A New Method for Treating Ventricular Tachycardia

One of the consequences of the damage to a heart caused by infection or a heart attack is scarring of cardiac muscle tissue. In some cases the scarring leads to a type of arrhythmia called ventricular tachycardia, in which the patient suffers from a rapid and uncontrolled heart rate and a feeling of dizziness and lightheadedness. The standard treatment is generally a surgical procedure, in which the scarred region is burned off via a catheter inserted into the heart. But the surgical procedure carries some risk, and in some patients it just doesn't work.

An experimental non-invasive technique offers hope to these patients. Borrowing a technique used to treat cancer patients, the new procedure uses targeted radiation to ablate the offending tissue. During the procedure the patient wears a vest that incorporates 256 electrocardiogram leads as opposed to the usual 10, allowing precise targeting of the region to be ablated.

The procedure seems to work well - the first five patients went from more than 6,500 episodes of tachycardia in three months to just four episodes in a year, according to an article in The New York Times. Further research will be needed to determine the long-term consequences and safety of the procedure, but some day, targeted radiation could become the method of choice for patients suffering from ventricular tachycardia.

The F.D.A. Cracks Down on Fake Opioid Addiction Treatments

Once again, the largely unregulated dietary supplements industry earns itself another black eye. The latest scam is products that purport to ease the symptoms of opioid withdrawal. Who stoops so low as to prey on victims of opioid addiction?

Case in point; a product called Opiate Detox Pro. The company's website claims that its ingredients ease opioid withdrawal symptoms, despite the fact that the company cites no research to back up its claim and has no intention of ever conducting any research. The company says that if the product doesn't work, the user can get his/her money back. Big deal!

The F.D.A. shouldn't have to keep ferreting these guys out and cracking down on them, but such is the current lack of effective regulation of dietary supplements in general. Anyone is free to market dietary supplements, as long as they don't claim to treat a specific medical condition.

With any dietary supplement, its buyer beware.

Digital Pills

The FDA recently approved a pill that will send an alert when the pill is actually taken, according to a recent article in The Inquirer. The pill contains a tiny sensor about the size of a grain of sand. When the pill is swallowed, acid in the stomach activates the sensor to send a signal to a skin patch worn by the patient. The patch then notifies a cell phone that the medication has been taken.

The first digital pill is expected to contain a drug used to treat schizophrenia and other serious illnesses - conditions in which patient compliance is often an issue. But one can envision all kinds of uses of the technology. Of course the pill raises issues of privacy and of how the ability to collect data about your pill use might lead to coercion. What if, for example, health insurers were to "incentivize" you by lowering the price for pills with sensors to get you to use them? How would they use the data they could collect on you? What if they were to insist on receiving data about your medication compliance as a condition of future health care? These are issues that should be considered before digital pill use becomes widespread, not after.

On the other hand, digital pills might be a real help for people who want to be compliant but just can't remember to take their medications, such as the aged. Like any new technology, it'll be how we use it that will determine its ultimate usefulness.

Of course, pills with embedded sensors will cost more, too...

First U.S. Baby Born After a Uterine Transplant

It was bound to happen sooner or later. A U.S. woman who was born without a uterus has just given birth to healthy baby after doctors at Baylor University transplanted a uterus into her last year, according to an ABC news report.

Transplant doctors see it as a significant advance, and indeed it may be. Once perfected, the technique could offer hope to women who for whatever reason do not have a functioning uterus and so cannot experience pregnancy and childbirth. However, it is important to note that the technique is still in the research stage. Several of the very few uterine transplants performed so far have had to be removed because they failed.

I've written about some of the ethical and financial issues related to uterine transplants before (see this blog, Nov. 23, 2015 and Feb. 29, 2016). What do you think?

A More Effective Shingles Vaccine

Shingles is a condition characterized by an itchy, painful rash that can last for weeks. It's caused by the same virus that causes chickenpox in children. In adults who had chickenpox as children, the virus can re-emerge later in life, causing shingles. Nearly a third of all untreated adults over 50 are likely to develop shingles at some time in their life.

There has been a vaccine against shingles, called Zostavax, since 2006. However, Zostavax has proven to be only 51% effective in preventing shingles. Consequently, many people who were vaccinated with Zostavax still came down with shingles.

Now there's a new, improved vaccine against shingles, according to a press release from GlaxoSmithKline. Last month the Advisory Committee on Immunization Practices recommended the new vaccine, called Shingrix, even for adults who have already been vaccinated with Zostavax.

Shingrix is reported to be 97% effective; nearly twice as effective as Zostavax.  Shingrix may be better in another way, too. Whereas the older vaccine consisted of live but attenuated (weakened) viruses, Shingrix consists of just a subunit of the virus, making it much less likely that the body will have a negative reaction to it.

The American Heart Association Redefines High Blood Pressure

The popular press (an NBC News report is an example) was full of the news yesterday that the American Heart Association (AHA) has come out with new recommendations for the treatment of high blood pressure (hypertension). According to the AHA, hypertension should now be defined as blood pressure above 130/80 mmHg. I'm sure the AHA has its reasons, but I'd be more comfortable with their recommendation if it wasn't the AHA's members (heart doctors) who stand to gain the most from the recommendations. The new recommendations summarily define nearly half the adult population as potential patients!

The new AHA recommendations are different from the recommendations of the Eighth Joint National Committee (JNC 8), an independent, unbiased group chosen from over 400 experts to examine the evidence and provide guidance to clinicians concerning the treatment of hypertension. The JNC 8 recommendations came only after an exhaustive review of the literature and were submitted to peer review by additional experts not on the panel before they were published.  JNC 8 recommends treatment of hypertension to the goal of lowering pressure to below 140/90, not 130/80.

The AHA argues that blood pressure above 130/80 doubles your relative risk of heart disease, compared to pressures below that level. That may be so, but there's a big difference between relative risk and absolute risk. A doubling of relative risk can be as little as an increase in absolute risk from one in a million to two in a million. Think about that before you commit yourself to a lifetime of antihypertensive medication.

Aaron Hernandez Suffered From CTE

Remember Aaron Hernandez, the standout football player at the University of Florida who played for the New England Patriots from 2010 to 2012? He was convicted of murder in 2015 and later hanged himself in his prison cell.

Now neuropathologists at Boston University have released his autopsy report. According to CNN News, the report indicates that Hernandez had the worst case of chronic traumatic encephalopathy (CTE) ever seen by BU pathologists in someone of his age. He was only 27 years old at the time of his death. Whether his behavior in the last few years of his life was related to the CTE is unknown.

There has been a lot of discussion lately about the effects of repeated head trauma, and how it might lead to CTE. The association between head trauma and CTE is so strong now that the NFL has set up a fund to provide up to five million dollars per retired player for medical expenses related to CTE. And there have been changes to the rules of football to try to reduce incidences of head trauma in current players. Nevertheless, CTE is likely to remain a problem for football for some time to come; Boston University pathologists have found evidence of CTE in nearly all of the brains of former NFL players that have been examined so far.

According to a USAToday news report, retired sportscaster Bob Costas predicts a decline in interest in the sport of football unless something is done to make it safe. It will be interesting to see whether he is right or wrong.

Alcohol and Cancer Risk

The American Society of Clinical Oncology, the professional society comprised of cancer doctors, has issued a statement to the effect that alcohol consumption is a risk factor for cancer. The society says that no amount of alcohol is completely safe; even small amounts can contribute to esophageal cancer, as well as breast cancer in women.

A suspicion that alcohol can contribute to a variety of cancers is not new, but this is the first time that clinical oncologists have issued an official statement on the subject. In preparing for their statement, the group reviewed published studies on alcohol consumption and cancer and came to the conclusion that 5-6% of all new cancers and cancer deaths are due to alcohol consumption. That's not nearly the risk associated with smoking, for example, but it is significant. Higher levels of alcohol consumption are associated with higher cancer risk.

No one is saying categorically, "Don't drink". It's just something that one should be aware of if or when one chooses to drink.

A New Species of Great Ape

Scientists have confirmed that a group of great apes discovered nearly 20 years ago is indeed a different species from all the other known great apes, according to a BBC news report. It's the first documented new ape species in more than 100 years.

First discovered in 1997 in remote forests of Sumatra, the Tapanuli orangutan (genus/species Pongo tapanuliensis) is distinctly different from Bornean and Sumatran orangutan species. DNA evidence indicates that it split from a common ancestor of the Sumatran orangutan about 700,000 years ago. In addition, its skull structure is different from either of the other two orangutan species, and it vocalizes differently. A research paper documenting the new species is published in the journal Current Biology.

Now for the bad news. There are only an estimated 800 individuals of this new species, meaning that it is in danger of extinction.

Coronary Artery Stents Don't Reduce Angina Pain

For decades, cardiologists have been inserting stents into their patients' partially blocked coronary arteries in order to improve blood flow to the heart. Stents are particularly effective in patients who have already suffered a heart attack. But stents are also used to improve coronary blood flow in patients who have not had a heart attack but are suffering from angina, the chest pain that some patients feel when coronary blood flow is compromised. It makes sense, right? It's always a good idea to improve coronary blood flow.....isn't it?

Cardiologists generally think so. And it's a big business for them; more than 500,000 stents are performed every year at $14,000 - $40,000 a pop, according to some estimates. But now a new study by British researchers questions whether the patients are actually improved by the procedure.

The study is unusual in that it is a true double-blind study with a control group. Two hundred patients suffering from angina due to a severely blocked coronary artery were recruited. Half of them got a stent, and the other half underwent the same surgical procedure, but the stent was just inserted and then removed. It's hard to get approval for this kind of study in humans, because if you can show that a treatment works, you can't ethically withhold it from some patients just to prove a point! In fact, the stents did improve coronary blood flow in the patients that received them. But more to the point, there were no differences between the two groups in the ability to do exercise six weeks later or in their self-reported pain.

Cardiologists are busy assessing what it all means, according to an article in The New York Times. In all likelihood the clinical guidelines for the use of stents in patients with angina will have to be revised, or at least re-examined. And additional studies will probably be needed to try to determine whether there might be some other benefit of the stents, such as a reduced risk of heart attacks further down the road.

Head Trauma in Adolescence is Associated with Multiple Sclerosis Risk

Multiple sclerosis (MS) is a progressive, debilitating disease in which the body's immune system attacks the fatty layer that insulates some nerves, leading to permanent nerve damage. Based on studies in animals, there has been a suspicion that trauma to the central nervous system may be a risk factor for the development of MS. Now a Swedish study provides new evidence that repeated concussions during adolescence are associated with increase the risk of MS later in life. (Sweden keeps particularly good medical records on all its citizens, making comprehensive population studies possible).

The study's authors examined the records of all Swedes who had been diagnosed with MS since 1964 - over 7,000 people in all. Then they looked at the number of concussions each person with MS had had during adolescence, comparing it to the number of concussions in 10 other people without MS matched for age, gender, and county of residence. The key finding was that persons who had had two or more concussions during adolescence were more than twice as likely to develop MS as persons who had not had any concussions.

No one knows yet how concussions might trigger the development of MS, if indeed they do. One theory is that damage to central nervous system might lead to the release of nervous tissue breakdown products that cause the immune system to attack neural tissue. But that remains to be tested.

Underweight Women are at Higher Risk of Early Menopause

A study in Human Reproduction reports that women who are underweight are at higher risk than women of normal weight of going through menopause before age 45.

The study enlisted nearly 80,000 women starting back in 1989. Over the next 22 years, 2,804 of them went through natural menopause. After controlling for several factors including smoking, oral contraceptive use, and pregnancies, the study found that women who had a Body Mass Index (BMI) under 18.5 were 30% more likely to go through menopause before age 45 than women with BMIs between 18.4 and 22.4 (defined as normal weight).

The study does not tell us why a low body weight increases the likelihood of early menopause. And to be clear, menopause is a natural phenomenon for all women, eventually. However, early menopause does have implications for family planning, and it is sometimes associated with other conditions such as osteoporosis later in life. Women who are concerned should consult their doctor.

Restasis Patents are Invalidated by a Federal Court

A U.S. Circuit Court judge has issued a 136-page ruling that effectively invalidates four key patents for Allergan's blockbuster drug, Restasis. You may recall that Allergan tried to protect their patents from administrative review by the U.S. Patent and Trademark Office by transferring the patents to a Native American tribe (see this blog, Sept. ). The Circuit Court decision is independent of review by the Patent and Trademark Office, but experts agree that U.S. Circuit Court decisions generally take precedence over administrative review by the Patent and Trademark Office. In effect, Allergan's attempt to protect its drug patents by transferring them to a Native American tribe is, at the moment, a non-starter.

In his ruling Judge William Bryson wrote, "The court has concerns about the legitimacy of the tactic that Allergan and the tribe have employed" (to protect Allergan's patents). An Allergan representative would only say, "We are carefully reviewing the decision and are considering all options", according to an article in Business Insider. This story may not be over yet.

Ebola Infection May Lead to Cataracts in Children

The Ebola virus epidemic that swept through several West African nations from 2013 to 2016 killed more than 11,000 people. An additional 17,000 people were infected but survived. But now a new problem has surfaced, according to an article in The Seattle Times; in some patients, the Ebola virus remained in the fluid inside the eyes, leading eventually to severe inflammation of the eyes (uveitis), a thickening and scarring of the lens (cataracts), and a potential loss of vision. Cataracts are generally a condition found in the elderly. But they've been found in Ebola survivors as young as five, even if the child had seemingly recovered from the Ebola infection and the virus was no longer detectable in his/her blood.

The findings are disturbing, because they show that patients who were thought to have "recovered" from their Ebola infection can still harbor the virus in bodily fluids not normally tested by health officials. How and when those hidden reservoirs of infection might re-emerge is anybody's guess. You can be sure that health officials will be asking questions and following up.

How Much are Gene-Therapy Treatments Likely to Cost?

An article about the potentially high costs for cures for genetic diseases reveals a subtle shift in how pharmaceutical companies intend to justify their high prices.

In the past, the usual argument was that high drug costs were justified by the high costs of drug development. The standard argument was that since it costs upwards of a billion dollars to take a drug all the way from initial research through Phase I, II, and III clinical trials, drug companies justifiably needed to charge high prices to recoup their costs. In some cases, drug companies needed to recoup losses incurred by drugs that never made it to market at all.

The paradigm has shifted with the advent of genetic therapy. Now, cells can be removed from a patient with a specific genetic mutation, modified by gene therapy techniques for that patient (and only for that patient) and then returned to the patient, affecting a complete cure. Since these cures are specific to individual patients, the FDA has begun to approve these new gene therapy techniques when they have been shown to work on just a few patients (perhaps several dozen). Gone are those lengthy Phase II and Phase III clinical trials, with their thousands of patient at dozens of medical centers. And gone, too, most of the costs of drug development.

As a result, drug companies are being forced to come up with new arguments to justify their high prices. And their new argument is shaping up to be something along the lines of "What's it worth to you?" How much will you or your insurance company pay for what one drug company spokesperson calls "long-term transformative benefits"?

Potential prices ranging from about $475,000 to $900,000 have been floated by some companies. At some point we may have wrestle with the question, "What is the value of life"?

The First Gene Therapy to Cure a Fatal Brain Disease

Gene therapy has now been used to cure a fatal brain disease called adrenoleukodystrophy (ALD), a genetic disorder that occurs in approximately one in 20,000 boys. Even more startling is that the vectors used to deliver the normal form of the ALD gene to the boy's cells are disabled viruses similar to the AIDS virus, called lentiviruses.

In the new technique, hematopoietic (blood-forming) stem cells are removed from the patient's bone marrow and exposed to lentiviruses that contain normal copies of the ALD gene. (Lentiviruses are used because like the AIDS virus, they are better than most other viruses at inserting genes into cells.) The stem cells are then returned to the patient's bone marrow, where they grow and multiply.

Now for the really interesting part. Some of the corrected stem cells make their way to the brain, where (apparently because of the environment there) they develop into neural supporting cells called glial cells, correcting the original defect in glial cell formation.

The timing of treatment is critical, however. It takes about a year between initial diagnosis and the time the treatment is effective. Unfortunately, ALD can progress so fast that patients who already have obvious symptoms of the disease may not be able to be saved. The best candidates for a cure are patients who (by virtue of hereditary history) are thought to be at risk for the disease, and whose only signs of the disease so far are changes in their brain scans.

HPV Vaccination Rates are (Finally) Rising

Vaccination rates against the HPV virus responsible for most cases of cervical cancer have been rising (finally), according to a recent CDC report.   Currently, more than 60 percent of teens have received at least one of the two recommended doses of the vaccine; that compares favorably to the 30% who had received the vaccine just ten years ago.

In 2016, the Advisory Committee on Immunization Practices (ACIP) updated its vaccinations recommendations to include a two-dose schedule instead of the previous three, making it easier for teens to be fully vaccinated.  Nearly 50% of all 17-year-old girls and 38% of all boys are now fully vaccinated, according to the new two-dose schedule.

Health officials are encouraged, but there is still room for improvement in vaccination rates. More than 40% of Americans aged 18-59 are infected with genital HPV.  There are nearly 40,000 new cases of cancers each year in areas of the body where the HPV virus is found (cervix, vagina, vulva, penis, anus, rectum, and oropharynx), according to the CDC.  Nearly 80% of these cancers could be prevented by vaccination.

Allergan Seeks to Preserve a Drug Patent

Here's a novel idea for protecting your drug patent: sign it over to a Native American tribe. Allergan is trying to do just that with its blockbuster drug Restasis, according to a news release from the company.

According to the news release, Allergan has transferred its patents for Restasis to a Native American tribe in New York. The deal stipulates that Allergan will pay the tribe royalties of about $15 million a year in exchange for exclusive rights to the patents. For its part, the tribe will argue to the United States Patent Trademark Office that they have sovereign immunity, and hence the patent cannot be challenged by the U.S. government.

The move, if it works, would shake up the drug industry and perhaps give Native American tribes a significant new source of revenue. But make no mistake; it'll be the drug companies that will be the big winners. Restasis had sales of more than $330 million in just the past three months.

H7N9 Bird Flu is Still Around

Have you forgotten about bird flu? Well, don't, because it's still around. In fact the 2017 flu season was the worst ever, according to the CDC. From Oct. 2016 to the summer of 2017, the H7N9 strain of bird flu infected 759 people. About a third of them - 281 people - died. That's nearly as many as the total number of deaths in the four previous years combined.

CDC officials consider H7N9 to "the influenza virus with the highest potential pandemic risk", according to a weekly report from the agency. Fortunately, the virus has not yet evolved to be easily transmitted between humans; nearly all cases to date have been the result of contact with infected birds. But if the virus ever does mutate to become more easily transmissible between humans, watch out!

Health officials continue to monitor the virus closely for any signs that it is changing in ways that would make it a worldwide threat. But so far, all cases have been in China, Hong Kong, and Macao.

Innate Fitness May Affect Cancer Risk

It's been known for several years now that being physically fit reduces a woman's risk of breast cancer. But how? Is there something about actively engaging in an exercise regimen that reduces risk, or is it just a function of being naturally fit (called "innate" fitness)? Or both?

To try to address this question, researchers took advantage of groups of rats that had been bred to be either genetically "fit" or genetically "not fit". The two populations were created over many generations by exercising rats on a treadmill; those that could run long distances were bred to other rats that also ran long distances; those that were poor exercisers were bred to other poor exercisers. Over time, the groups diverged in terms of innate fitness.

In recent experiments, then, female offspring of the "fit" and "not fit" groups were exposed to a known carcinogen. None of the rats in either group engaged in exercise after birth, so any differences between the two groups must be attributable to innate fitness, rather than exercise per se. The results were strikingly different - the incidence of breast cancer was reduced by more than 70% in the "fit" rats, compared to the "not fit" rats.

It's not known yet whether an active exercise regimen would reduce the risk of breast cancer in the "not fit" rats. Undoubtedly that will be tested next. But for now, the new information is that there's something about the metabolism of innately fit rats (and perhaps humans) that protects against breast cancer, even if they're not routinely exercising.

The researchers looked only at breast cancer as their measured endpoint in these experiments, but perhaps fitness affects the risks other cancers as well.

Childhood Leukemia Treatment to Cost $475,000.

Remember that new gene-based therapy for childhood leukemia that was approved by the FDA this past summer? (See this blog, July 15, 2017). Novartis, the company responsible for developing the therapy, has finally put a price to it; $475,000 for a full treatment regimen, according to an article in The Guardian.

Consumer groups are worried that prices such as this will usher in a whole new era of expensive medical treatments. At some point we have to ask - is the price for a health- or life-saving procedure just too high? How will we pay for such treatments? If health insurance companies cover the treatment, then surely they'll recover their costs by raising the price of health insurance for us all.

The company claims that the price is justified by its need to earn a return on its investment. Hmmm....

Sperm Count in Western Males is Declining

Is male sperm count declining? It's been a topic of debate for some time now. The problem is that the decline, if it exists, has been so slow that it has been difficult to measure.

To answer the question of whether or not male sperm count is declining, researchers conducted a massive meta-study (an analysis of many previous studies) of male ejaculate sperm concentration and total sperm count. Authors of the meta-study looked for all previous studies of sperm concentration and sperm count in Western men (men from North America, Europe, Australia and New Zealand) published between 1973 and 2011. In all, the meta-study included data from 185 previous studies involving almost 43,000 Western men over almost 40 years, making it the largest such study ever. In order to avoid problems associated with changing laboratory methods, the authors included only studies that used the same laboratory analysis method throughout.

The results showed a decline of sperm concentration of only 1.4% per year (that's why it was so hard to see in individual studies). But over the nearly 40-year time span, that's a decline of over 50% in ejaculate sperm concentration! Total sperm count declined even more; by 60%, in fact.

Of course, no one has any information yet on just why the decline might be occurring. But with fairly definitive evidence now that it is occurring, we can expect researchers to turn more aggressively to the question of why, and what might be done about it.

Driver Charged in Texting-While-Driving Incident

Criminal charges have finally been lodged against Jack Dillon Young, the young man who allegedly caused an auto accident in Texas that killed 13 people back in March of this year (see this blog, Apr. 2, 2017). At the time, Mr. Young admitted that he had been using his cell phone at the time of the crash and that he had taken prescription drugs, according to a news report.

Among the multiple charges against Mr. Young are 13 indictments for intoxication manslaughter and manslaughter; one for each of the accident's victims. There are no charges directly related to his cell phone use because apparently it was not a specific crime at the time of the accident.

Perhaps prompted by widespread media coverage of the accident, in June of this year Texas passed a law banning texting while driving. The law will take effect on Sept. 1, making Texas one of the last states to adopt some form of texting while driving ban. The three current holdout states are Arizona, Montana, and Missouri.

Mr. Young is currently free on $380,000 bail pending his trial. 

High Blood Pressure in Children

So, you thought that hypertension (high blood pressure) was a problem primarily for older adults, right? Think again. Although fewer than 5% of children and teens currently have been diagnosed with hypertension, soon you may hear about a startling increase in hypertension in these groups.

Why is this likely to happen? It used to be that guidelines for pediatricians suggested that they look closely at blood pressures in teens and children who were overweight or obese because these children were considered to be at risk for hypertension. Overweight children were considered to have hypertension if their pressures were elevated above the norm for their weight. But now, new guidelines published by the American Academy of Pediatrics encourage pediatricians to check pressures in all children, relying on data tables that include blood pressures for children of normal weight. No doubt, some normal weight children will now be diagnosed with hypertension as well. Furthermore, blood pressures of overweight and obese children will now look even worse, because normal weight childrenwho tend to have lower pressures on average. Add it all up and more children of all weights are likely to be diagnosed with (and probably treated for) hypertension.

Early diagnosis and treatment is good, right? Well, yes, if it decreases morbidity and/or mortality in these children later in life. The justification for treatment in children is the assumption that high blood pressure in a child will lead to high blood pressure and increased risk of morbidity/mortality as an adult. And that we can't know just yet, and probably won't for at least 20 years. Meanwhile, parents will stress out and health care costs will continue to rise....

It's an interesting risk/benefit conundrum. At least we know where pediatricians stand on this one.

Classifying Cells and Cell Types

How do we describe the types of cells that comprise the human body? Pick any textbook of human biology and you'll find that cells are generally described as belonging to one of four types of tissue (nervous, muscle, connective, and epithelial) based on their broad function. At the next level of complexity, cells within a tissue are further described by their location and more specialized function (smooth muscle surrounding blood vessels; skeletal muscle attached to bones; cardiac muscle in the heart). Beyond these rather broad descriptions, many subtleties between cells are probably lost for lack of a way to measure or define them.

Some scientists think there may be a better way to identify and categorize cells. That's because what actually determines the differences between cells, both in terms of form and function, is the different proteins that they express. Those proteins are determined by the molecules of RNA that are present within the cell, which in turn are determined by which of the cell's genes are active. So to get a more refined measure of a cell's type and its true activity, it would make sense to measure not its shape, its location, or its broad function, but instead to determine which RNA molecules are present in the cell.

A group of enterprising scientists is attempting to do just that, according to an article in The New York Times. They've started with an organism (a type of worm) that has fewer than 1,000 cells. If all goes well, some day we may know a lot more about the incredible complexity of our various cells. And we may have to rethink how we classify cells and describe the relationships between them.

A New Antibiotic to Combat Antibiotic-Resistant Gonorrhea

Scientists have discovered an entirely new antibiotic that may be useful against strains of gonorrhea bacteria that are resistant to most current antibiotics. It's called closthioamide. It was discovered in 2010, but it has taken until now to learn how to produce it in large enough quantities to be useful.

To date, closthioamide has only been tested in the laboratory on samples of gonorrhea bacteria known to be resistant to most antibiotics. It worked on nearly all of the samples. The next steps will be to try it on animals (to demonstrate its safety) and eventually on humans (to reaffirm its safety and prove that it can cure gonorrhea infections in patients). If all goes well, some day closthioamide may be a new weapon in the arsenal against gonorrhea and other bacterial infections - at least until the bacteria develop resistance to it!

Prevalence of CTE in NFL Football Players

Repetitive blows to the head can lead to a debilitating chronic brain disorder called chronic traumatic encephalopathy (CTE) later in life. CTE is of particular concern to football players, boxers, and even soccer players. How common is CTE among certain athlete groups, and should we be concerned?

Of course we should be concerned. We would be remiss if we didn't try to find out how and why it is happening to our athletes, and how to prevent it in the future. But we should not scare people needlessly with sensationalist headlines. Take, for example, a CNN news headline: "Study: CTE in 99% of dead NFL players". Or this one in the Daily Mail (a British journal): "Biggest Ever NFL brain study diagnoses CTE in 99% of deceased players' brains". Read more closely and you find that the correct statement is that CTE was found in 99% of deceased ex-NFL players whose brains were donated to scientific research by their relatives (my emphasis). It's not a group that is representative of all deceased NFL players, by any means. It is likely that many if not most of these relatives donated their loved-ones' brains because they already suspected the presence of CTE based on their loved ones' behavioral symptoms while still alive. A definitive diagnosis of CTE can only be made at autopsy. CTE generally isn't looked for in a deceased player without symptoms of CTE, so in fact we really don't know how prevalent it is.

Clearly, CTE is present in many ex-NFL players, and its time to do something about it. The numbers may turn out to be higher than initially thought, and that would be sad. But there's no evidence that it's as prevalent as 99%, at least at the moment. Let's approach this problem with level heads and open minds.

Some Sunscreens Slow the Progression of MS in Mice

Sometimes it's better to be lucky than good. Quite by accident, researchers have discovered that ingredients found in Coppertone and other sunscreens may be able to slow the progression of multiple sclerosis (MS). The researchers were studying the known protective effect of UV light on the development of multiple sclerosis (MS) in mice prone to the disease. In the course of these experiments they administered various sunscreens to mice without exposing them to UV light, as controls. Surprisingly, several of the sunscreens slowed the development of MS all on their own. Coppertone was particularly effective. Further tests revealed that two ingredients in particular, homosalate and octisalate, were responsible.

These findings sound like a real breakthrough, but realistically they just represent interesting observations that are worthy of being pursued. A lot more work will need to be done before we will know how these compounds exert their protective effect in mice, and whether they ultimately might be useful in treating MS in humans. The findings also highlight the importance of doing proper controls, because in this case the most interesting findings came from a group of animals receiving sunscreen alone, as controls for mice exposed to UV light and receiving sunscreen. No one expected sunscreen to have an effect on its own.

You can read the abstract of the research paper here. Unfortunately, you'll need access to the Proceedings of the National Academy of Sciences journal in your library to read the entire text. Or you can read a news article about the paper in The Economist.

Usain Bolt's Unusual Running Stride

There's something unusual about Usain Bolt, other than he's the fastest sprinter, ever. He's also unusual in that his running stride is asymmetric. According to researchers at Southern Methodist University, his right foot strikes the ground with 13% more force than his left, and his left foot stays on the ground 14% longer than his right.

Most runners have close to symmetrical strides, with left-right differences of less than 3%. Running coaches generally assume that symmetry is desirable for speed optimization. But is it? It's possible that Usain Bolt has subconsciously stumbled onto something (no pun intended) that improves humans' running speed. On the other hand, it is just as likely that his body has adapted to the fact that apparently he has slight scoliosis; his spine curves slightly to the right, causing his right leg to be a little shorter than his left. If that's true and if asymmetry is generally not desirable, then his rise to the title of fastest human is all the more remarkable.

Washington State's New "E-DUI" Distracted Driving Law

The State of Washington has had enough of distracted driving.

Under a new law that takes effect today, using a hand-held electronic device of any kind while operating a motor vehicle is a primary driving offense, meaning that the police may stop you for that offense alone. The law goes beyond prohibiting texting or talking on a handheld phone; it prohibits checking Facebook, reading texts and e-mails, and even just holding an electronic device while operating a motor vehicle, even while stopped at a stoplight. Violators will be issued a distracted-driving citation and fined $136 for the first offense. The violation will go on the driver's record and their insurance company will be notified, which might cause their insurance rates to go up. A second offense will lead to a larger fine.

Drivers can still talk on their hands-free phone, and they can use a hand-held phone to contact emergency services. And they are still allowed to employ the "minimal use of a finger" to change an electronic device's function (preferably to turn it OFF).

The new law makes all forms of distracted driving secondary offenses, meaning that motorists who are stopped for a primary offense (such as running a red light) can be fined another $99 for "any activity not related to the actual operation of a motor vehicle". That might include reading a book or newspaper, eating, drinking, applying makeup, or reaching for something on the floor while driving.

So what are you supposed to do while driving? Concentrate. On driving.

FDA Set to Approve the First Gene Therapy Procedure

An FDA advisory panel voted unanimously this week to recommend that the FDA approve the first gene therapy procedure.  The procedure is for the treatment of B-cell acute lymphoblast leukemia in children that have resisted treatment by other methods.  Final FDA approval is expected by October.

The procedure involves removing millions of a type of white blood cells called T cells from the patient, genetically modifying them to enhance their ability to attack abnormal B cells (the type of cell that becomes abnormal in this type of leukemia), and then returning them to the patient.  So far the technique has been tried on 63 patients.  Fifty-two of them are still in remission (for an 82% remission rate); the other eleven died.  The very first patient to receive the treatment was 12-year-old Emily Whitehead.  She was treated 6 years ago and is currently cancer-free.

It would seem to be a no-brainer that this procedure should be approved.  However, although the FDA panel did recommend approval at this time, a word of caution is in order.  We still don't know how permanent alteration of a patient's T cells might affect the their health in the long-term.  To try to answer that question, patients who undergo the procedure will be entered into a registry and followed for at least 15 years.  But so far, at least, everything looks good.

Now for the bad news.  The procedure is likely to cost at least $300,000.

Baby Sickened Because Mother Eats Placenta

The Centers for Disease Control and Prevention (CDC) reports that a baby in Oregon was treated for Group B streptococcus infections - twice in a week! - apparently because its mother was ingesting improperly prepared placental pills.

Although the CDC does not recommend placenta consumption, it's a fad in some circles that just won't go away. According to CNN News, devotees include Kim Kardashian and Alicia Silverstone. There is even a group called the Association of Placenta Preparation Arts that claims to have "placenta preparation specialists" who know how to prepare the placenta properly for ingestion. As if there actually is a "proper" method for preparing the placenta for ingestion. Members of the group believe that placenta consumption has benefits including preventing postpartum depression and increasing milk production.

Pardon me, but there is no evidence that these people know what they are doing (see this blog July 19, 2007 and June 13, 2015). Feel free to check out their website, compare it to the CDC report and any available scientific evidence, and make up your own mind if you wish.

Experience Matters When It Comes to Driving

According to a study by the AAA Foundation for Traffic Safety, people become better drivers with age and experience, at least until old age sets in. For the same number of miles driven, rates of both crashes and deaths are relatively high among 16-17-yr-olds, decline steadily with age until 70, and then rise again.

None of this should be a surprise; new drivers lack the experience that comes with a long history of driving, and older drivers are beginning to lose their sensory acuity and reaction times. But the numbers are startling. For the same number of miles driven, 16-17-yr-old drivers are about 6 times as likely to crash (and to die in a crash) as the safest group of drivers, 60-69-yr-olds. So, too, are drivers over the age of 80.

Traffic safety experts have been aware of these facts for some time. That is why some states now limit the conditions under which younger drivers can drive (forbidding driving with other teenagers or driving at night, for example). Most states require older drivers to have a vision test to renew their licenses, and a few states require older drivers to take a written test or a road test as well. All this seems to be working, as the number of people killed in automobile crashes declined more than 25% between 1995 and 2010.

Incidentally, teen crashes and deaths go up about 15% in the summer, when teens are out of school and may be driving more than during the school year.

A Skin Patch to Deliver the Flu Vaccine - An Update

Remember the skin patch (this blog, Mar 13, 2014) that was being developed to deliver vaccines without an injection? Back then, the patch had only been tested to see how well the dissolvable microneedles of the patch would be tolerated by patients. Last week the same researchers reported that it has now been tested with the flu vaccine.

In the latest study, healthy volunteers received the flu vaccine either by skin patch or by the usual syringe and needle, both administered by a health care worker. An additional group of volunteers were instructed to administer the skin patches themselves, to determine if self-administration was as effective as administration by a health care worker. The results were encouraging. Increases in antibody titers (a sign of immune system activation) were the same in both of the groups that used skin patches and the group that received an injection. Furthermore, the number of adverse reactions was similar in all groups. In other words, the skin patches seemed to deliver the vaccine safely and effectively, even when the patches were self-administered.

So are we done? Not quite. This was a Phase 1 study; a small number of volunteers was recruited to test the method's safety and potential effectiveness (in this case, potential effectiveness was assessed as an increase in antibody titer). A much larger study will be needed to see if the skin patch vaccine delivery method actually reduces the incidence of the flu. A much larger group of patients will be needed, since not everyone in a population gets the flu. This part of the study will probably take at least several more years.

Perhaps some day you'll be able to order a flu vaccine skin patch on the internet, have it delivered through the mail (or by a drone!), and administer it yourself. Today we're one step closer to that goal.

Compounding Pharmacy Executive Goes to Prison

The co-founder and head pharmacist of a now-bankrupt New England compounding pharmacy has finally been sentenced to prison. Under his direction the pharmacy failed to ensure the sterility and safety of its products, which ultimately killed 76 people (see this blog, Jan 2, 2015).

Although the executive's conviction and sentencing finally closes this unfortunate case, not everyone is satisfied with the verdict. The executive was cleared of charges of second-degree murder that might have resulted in a 35-year sentence. Instead, he was convicted of racketeering and fraud, for which he will spend only 9 years in prison.

Fear of Vaccines

Why does the notion that vaccines cause autism continue to persist, despite all the scientific evidence to the contrary? In a recent essay, a science writer and father argues that it's all about one of our most basic emotions - fear. According to the author of the article, fear is just too strong an emotion to be overcome by logic or evidence.

If he's right, then continuing to try to convince anti-vaccine advocates with more scientific evidence just isn't going to work. Their fear will have to be acknowledged and addressed. How to do that is a question for which the author doesn't yet have an answer.

New Treatment for Chronic Knee Pain

What are your options for reducing chronic pain? Certain drugs are good at reducing pain, of course, but some of the most effective ones are dangerously addictive when used for more than a few days. Cortisol injections can reduce the pain from certain types of arthritis. That used to be about it. But now there's a new method is called "cooled radiofrequency therapy", or CooliefTM for short.

Coolief is a non-invasive, outpatient technique designed to block pain for prolonged periods. Radiofrequency energy is applied to needles inserted into the site of pain. The radiofrequency energy heats sensory nerve endings, damaging them and blocking their ability to transmit pain signals. Because the radiofrequency energy heats up the needles, the needles are simultaneously cooled to avoid widespread tissue damage. The result is immediate relief from pain. And because damaged sensory nerve endings take a long time to heal, the pain relief can last for up to 24 months.

The technique is currently FDA-approved for the treatment of osteoarthritic knee pain, but it's been used to treat chronic back pain as well. It is likely that the technique will gain further FDA approvals in the not-too-distant future. The cost (about $4,000) is covered by some health insurance policies.

If the Coolief technique proves to be both safe and effective in treating different sources of chronic pain, some day physicians may be able to stop writing so many prescriptions for addictive pain-killers!

Chondroitin as a Treatment for Osteoarthritis

The dietary supplement chondroitin has been selling for a long time as a treatment for joint pain due to osteoarthritis.  Recently I've even seen advertisements promoting the use of glucosamine/chondroitin (chondroitin is almost always sold in combination with glucosamine) in pets.  I suppose the theory is that if works for humans, then it should work for pets.

And yet, chondroitin hasn't actually been shown convincingly to reduce joint pain (see this blog Oct. 6, 2010).  With that as background, a new study now purports to show that high-quality pharmaceutical-grade chondroitin (not the ordinary over-the-counter stuff) actually does reduce joint pain in people suffering from knee arthritis.  In fact, chondroitin allegedly worked as well as the popular prescription nonsteroidal anti-inflammatory drug, celecoxib.

So chondroitin works, right?  Not so fast. According to the footnotes in the article, the study was sponsored (i.e. funded) by a pharmacy company that makes pharmaceutical-grade chondroitin. It's not hard to imagine that the company has a financial interest in the study's outcome.  The company even provided "editorial assistance" to the author prior to the article's publication.

Putting all that possible bias aside for a moment, the data show a minimal effect of chondroitin at best.  According to Figure 1 in the article, at six months of treatment both chondroitin and celecoxib reduced patients' reported knee pain significantly. However, patients in the placebo group (receiving neither drug) also reported a reduction in pain, by nearly the same amount. In other words, most of the patients' reported pain reduction was caused just by being enrolled in the study and thinking that they might be receiving a drug that worked.

Before I accept that chondroitin definitively reduces the knee pain of arthritis, I'd want to see this study repeated in an independent study.

Advance Directives, and Suing for "Wrongful Life"

When it comes to their last moments, some medical patients would prefer to die gently without having their chest opened, their heart shocked, or their breathing taken over by a pump, especially if their chances of a meaningful recovery are low. To that end, many patients sign advance directives that are intended to provide a clear statement of their wishes. Hospitals often encourage patients to sign an advance directive because it can provide guidance to the medical team when (or if) patients can no longer speak for themselves.

But what happens when the medical team doesn't honor a patient's advance directive? This is not as far-fetched as it might seem. Physicians are trained to save lives, and it's difficult for them to watch a patient die when they know that a procedure might keep the patient alive, if even only for a while. If a patient is kept alive by medical measures specifically not wanted as documented by their advance directive, should damages be awarded for "wrongful life"? It all boils down to whether an advance directive should be viewed as only advisory, or whether it should be considered similar to a legal document.

This is a legal grey zone that is now being tested by several "wrongful-life" lawsuits. Traditionally, courts have been reluctant to punish doctors who aggressively work to save their patients. But recent court decisions suggest that the tide may be turning to favor the patient, according to an article in The New York Times. Time will tell.

Do you have an advance directive? You'll probably be asked that question the next time you visit an emergency room or are admitted to a hospital. The question is; even if you do, will it be honored?

Sunscreen Use in Schools

Did you know that in most states, teachers and school nurses in public schools cannot apply sunscreen to students? That's because the FDA classifies sunscreen as an over-the-counter drug. Technically, students can't even apply sunscreen themselves unless they have a signed note from a doctor and their parents.

The rule strikes most parents and school administrators as odd. It's hard to see who could be harmed by applying sunscreen to a child who needs it, unless of course the child were allergic to an ingredient in the sunscreen. And that would be an unrelated problem entirely.

A bill to allow students to use sunscreen in schools stalled in Congress last year. Not willing to wait for Congress, some states are taking action. Seven states have already passed laws that allow students to use sunscreen in school, and eight more states are considering such laws, according to a CBS news report. It makes sense; Congress has a lot on its plate, and this is something states can deal with on their own.

A New Outbreak of the Ebola Virus in 2017

On April 22 a 45-year-old man in a remote area of the Democratic Republic of the Congo (DRC) was diagnosed with the Ebola virus; call him the new "patient zero". In less than a month there were 20 more suspected cases and three deaths. Is this the start of a new outbreak? And if so, what is being done to prevent another outbreak like the 2014-2016 outbreak that killed over 11,000 people in Guinea, Sierra Leone, and Liberia?

It would be encouraging to think that "it'll be different this time", and maybe it will. For one thing, Merck has developed a vaccine that appears to be effective against the 2014-2016 strain of Ebola. There are already stockpiles of the vaccine on ice. But the vaccine is still considered "experimental". It has not yet been approved by the FDA, and so it can only be used in carefully monitored clinical study protocols designed to document the vaccine's safety and effectiveness. The DRC does not yet have an approved clinical study protocol on file, according to an article in Science. The government will need to decide whether standard containment strategies are likely to suffice, or whether it can establish an approved study protocol quickly enough to be able to vaccinate people at risk before the outbreak gets much worse.

You might think it would be a no-brainer to establish a clinical study protocol. It is not. Requirements would include the ability to keep the vaccine refrigerated the vaccine at all times - no small task in remote region of the country. Furthermore, an approved clinical study protocol would require extensive record-keeping, including follow-up of all vaccine recipients for an extended period of time. There's even a requirement for ethical oversight and for obtaining informed consent from all vaccine recipients.

And so we wait. We wait to see what the DRC does about this latest outbreak, and whether the outbreak spreads.

Creating Eggs From Skin Cells

Some day it may be possible to produce human babies from skin cells, according to an editorial in Science Translational Medicine.  It's all due to a new technique called in vitro gametogenesis (IVG).

IVG refers to the technique for producing eggs or sperm (gametogenesis) outside the body (in vitro). The technique only became possible because, a decade or so ago, scientists learned how to produce undifferentiated stem cells known as induced pluripotent stem cells (iPSPs) from mature somatic cells.  Since that time iPSCs have been used to create various kinds of specialized somatic cells, including neurons to heart muscle cells.  And just recently, iPSCs derived from mouse tail cells were used to create fully functional gametes (eggs).  When fertilized with sperm, these eggs created by IVG were able to develop into healthy baby mice.  Sperm have not yet been fully developed from iPSCs, but surely they will be.

The ability to produce eggs and/or sperm from somatic cells raises all kinds of possibilities for how the procedure might be used (or misused, depending on your perspective).  If an egg could be grown from a male's skin cell and then fertilized by IVF with sperm from a male partner, gay couples could have babies that were genetically related to both of the males.  Of course a female surrogate mother would be necessary to carry the embryo to term, but surrogate mothers are not uncommon these days. Taking it one step further, if both eggs and sperm could be created from a male's skin cells, the male could (again, with the help of a surrogate) have a child that was entirely genetically his. These are scenarios that may need to be dealt with in your lifetime.  (Note that since females have no Y chromosome, IVG could only produce eggs from a female; never sperm.)

On the positive side, the ability to produce eggs from skin cells could mean that overcoming infertility would become easier and cheaper.  Right now, women undergoing an IVF procedure must undergo a complicated cycle of ovary stimulation and egg retrieval; with IVG, that would be unnecessary.  Furthermore, IVG could be used to produce an almost infinite supply of eggs, whereas only a few eggs are produced with each IVF cycle.

How do you think IVG should be used?

A Second Drug is Approved to Treat ALS

The FDA has approved a second drug to treat amyotropic lateral sclerosis (ALS), also known as Lou Gehrig's disease. ALS is a progressive, debilitating, neurodegenerative disease that is usually fatal within 3-5 years. The new drug, called Radicava, slows the progression of the disease somewhat after six months of use; apparently that was enough for the FDA to approve the drug.

Before you get too excited, though, here are some facts about the new drug; 1) It must be given intravenously. That means that the patient must have a permanent IV port installed, which poses an infection risk. 2) The drug is only partially effective. Patients using the drug won't feel better; their health will just decline less rapidly. 3) It's expensive - $146,000 a year, according to its manufacturer.

The first drug to treat ALS, called riluzole, costs only about a tenth as much as Radicava.  Riluzole extends the life of ALS patients by 2 or 3 months; whether Radicava does the same isn't yet known.

If you had a fatal disease and were expected to live only 5 more years, would you pay $146,000 per year to slow the rate of disease progression just a little, or to live an extra 2-3 months? That's a judgment call only you can make. But your insurance company might balk at the price of this drug, considering its minimal effectiveness.

When Did Humans Reach the Americas?

Until now, the best available evidence had indicated that humans probably reached the Americas about 20,000 years ago.  But now a new paper published in Nature raises the possibility that humans reached the Americas as early as 130,000 years ago.  The new findings could force a re-thinking of when, how, and by whom the Americas were colonized.

The new paper focuses on an archaeological site in California, where smashed and broken bones of a mastodon were found intermingled with what are reported to be crude stone tools.  Uranium/thorium dating shows that the bones are a whopping 130,000 years old.  The authors propose that the bones were deliberately smashed, leading to the conclusion that humans must have been in California at least as early as 130,000 years ago.

The findings are intriguing, but we'll probably have to wait for corroborating evidence before everyone accepts the new date.  For starters, it would help if we could find human bones that old; so far, no human bones older than about 20,000 years have ever been found in the Americas.  And then there's the question of how they could have gotten to the Americas in the first place.  The humans who colonized the Americas about 20,000 years ago crossed over from Asia via a land bridge that existed at the time between current-day Russia and Alaska.  That land bridge probably didn't exist 130,000 years ago.  They could have arrived by boat, but that would presume a higher degree of sophistication than implied by primitive stone tools.

Finally, there's the question of who these people were, if indeed they ever existed.  DNA evidence indicates that Native Americans can trace their ancestry back to a common ancestor who lived about 20,000 years ago.  If a band of humans arrived more than 110,000 years before that, they must have died out without leaving a continuous line of descendants.

An artificial Womb

A baby that is born at 23 weeks of gestation (about halfway through the normal gestation period) has only about a 50% chance of surviving. The main problem for babies born prematurely ("preemies") is that they struggle to breathe, for their lungs are not yet fully developed. Their underdeveloped hearts, too, have a hard time pumping all of the blood that the baby requires outside of the womb. In the womb, the baby's still-developing lungs are filled with amniotic fluid, and so the baby doesn't breathe at all. Oxygen is delivered to the baby (and CO2 is removed) by the blood circulating between mother and baby via the umbilical cord.

In an effort to increase the chances of survival of very premature preemies, scientists are now working to develop an artificial womb. So far, the artificial womb has only been tried with premature lambs in an experimental setting, but the early results look promising. The artificial womb looks a bit like a large re-sealable bag. Upon delivery, a premature lamb is put into the bag, and the bag is then filled with artificial amniotic fluid and sealed to prevent infections. Ports provide access to the umbilical cord and allow for exchange of amniotic fluid. The umbilical artery and vein are cannulated so that blood can be exchanged with the lamb, just as it would be in the womb. Premature lambs have been kept alive in the artificial womb for four weeks; long enough to dramatically increase their chances of survival outside the womb.

It may be awhile before you'll see artificial wombs for human use. But perhaps some day, you'll have a grandchild that was delivered at 19 weeks of gestation then grown for four weeks or more in a plastic bag!

Are Vitamin D Supplements Effective in Preventing Disease?

Are you one of the millions of people who are taking vitamin D supplements? People take vitamin D supplements to prevent depression, muscle weakness, cancer, heart disease, and who knows what else. And yet, there is a lack of evidence that vitamin D supplements will prevent any of these conditions.

The trend to test for and treat alleged vitamin D deficiencies took off in 2011 with the publication of a book entitled The Vitamin D Solution - A 3-Step Strategy to Cure Our Most Common Health Problems. The suggestion by the book's author that vitamin D levels of 21-29 ng/ml are insufficient for good health were a bit of a shocker, since blood levels of vitamin D of greater than 20 ng/ml are considered normal.  The book and several studies that seemed to support its thesis led to an increase in vitamin D screening blood tests, and to recommendations by many physicians that their patients consider taking vitamin D supplements.

However, the Institute of Medicine says that there is no evidence that people who have vitamin D levels above 20 ng/ml (i.e. normal vitamin D levels) will benefit from taking additional vitamin D.  In addition, two studies published this year show that vitamin D supplements don't prevent heart attacks and don't protect women against cancer. An ambitious 5-year study is now underway to try to determine once and for all whether vitamin D supplements are of any use in preventing cancer, heart disease, and stroke.

I don't know about you, but I'm taking vitamin D deficiency off my list of things to worry about, at least for now.

'Subclinical' Hypothyroidism is Being Over-treated

What was the most prescribed drug in 2016?   If you guessed a blood pressure medication, a cholesterol-lowering drug, insulin for diabetes, or even a painkiller such as oxycodone, you'd have been wrong.  It was levothyroxine, a drug used to treat hypothyroidism. But not all physicians are using this drug correctly; many are using it to treat 'subclinical' hypothyroidism.

Subclinical hypothyroidism is generally defined as a slightly elevated TSH (thyroid-stimulating hormone; indicating perhaps an under-responsive thyroid gland), accompanied by a number of vague and highly subjective symptoms such as tiredness, lack of motivation, and muscle aches and pains. It's called 'subclinical' hypothyroidism because levels of the two thyroid hormones, T3 and T4, are still normal, as opposed to true hypothyroidism in which there is a clear deficiency in these two hormones.

The problem is that many of the physical symptoms of hypothyroidism, such as tiredness and muscle aches and pains, are common complaints in older people.  So if their TSH levels are just a little over the normal level (which also often happens with age), physicians are increasingly putting their older patients on levothyroxine, regardless of what their T3 and T4 levels are.  As a result, fully 15% of older Americans are taking levothyroxine to treat their alleged symptoms.

However, recent evidence shows that other than lowering TSH levels to normal, levothyroxine doesn't have any effect on the actual "symptoms" patients are complaining about - no effect at all.  If this new evidence is correct, physicians could stop prescribing levothyroxine to treat 'subclinical' hypothyroidism entirely.  The proper use of levothyroxine is to treat patients with true hypothyroidism, in which T3 and T4 are demonstrably low.

Lyme Disease is On the Rise

People who live in the Northeast are aware of Lyme disease; a baffling, debilitating, bacterial infection spread by bites from certain types of ticks.  Lyme disease is difficult to treat if not detected and treated early.  The forecast is for an increase in the number of cases of Lyme disease this summer. The reason is an increase in the population of field mice last year; mice, it turns out, are a preferred host of the ticks that spread the disease.

Cases of Lyme disease in the U.S. have tripled in the past 20 years, according to the Centers for Disease Control and Prevention (CDC).  For more on why that is, see the recent article in The New York Times.

How can you prevent becoming infected? Your best defense is to avoid being bitten by ticks.  If you are outside in a tick-infested area, be sure to check yourself carefully for ticks after coming back inside.  Most ticks won't actually bite you in the first 12-24 hours or so, so it pays to get them off of you as soon as possible.

Updated Prostate Cancer Screening Guidelines

Just five years ago the U.S. Preventive Services Task Force (USPSTF) recommended that men 55-69 should be "discouraged" from having the PSA test to screen for prostate cancer (see this blog, May 27, 2012). At the time, the best evidence was that the risks of having a PSA test slightly outweighed the rewards. That's because the PSA test is not 100% accurate; sometimes it gives false positive results, meaning that the test indicates that prostate cancer might be present when in fact it isn't. According to the USPSTF, these false positive PSA tests were leading to biopsies (the next step in making a diagnosis), radiation, and sometimes even to surgeries for prostate removal, all of which carry some risk.

But just recently the USPSTF reversed course; now it recommends that men aged 55-69 should "have a conversation with their doctor" about the advisability of having the PSA blood test to screen for prostate cancer. Why the apparent about-face? Again, it's based on the best available evidence. The PSA test hasn't gotten any more reliable, but what has changed is what happens after a positive test result. Recent research has showed early, aggressive treatment after a positive PSA test isn't necessary and doesn't increase patient survival. That means that doctors can afford to wait, doing repeated PSA tests for years if necessary before recommending biopsies or treatment. As a result, the risks of having the PSA test (and everything that comes after) have declined to the point that the rewards now slightly outweigh the risks.

As before, the PSA test is not recommended for men over 70 (they're likely to die of something else before they would die of a slow-growing prostate cancer) or for men under 50 (prostate cancer is too rare in younger men for the test to be of much benefit).

Home Genetic Testing and Risk Assessment Approved by the FDA

Back in 2013, a company called 23andMe (referring to the 23 pairs of human chromosomes) offered a genome testing service that promised to analyze a sample of the DNA in your saliva for over 300 alleles, many of which were associated with increased risks of genetic diseases. At the time, the FDA claimed that providing information about future risk of genetic disease was tantamount to offering medical device, and ordered the company to stop selling the kits for medical purposes (see this blog, Dec. 5, 2013).

For a time thereafter, 23andMe survived by selling its kits for "entertainment", i.e. to provide insight into ancestry for those who were interested. But it kept working on the medical angle. In 2015 the company went back to the FDA and was given approval to provide genetic information regarding allele "carrier" status for 36 genetic conditions, such as cystic fibrosis and sickle cell anemia, as long as the company didn't make any statements about the risks of developing a genetic condition as a result of the alleles (see this blog Nov. 3, 2015).

Still, the company kept working on the goal of being able to provide customers with valid risk assessment data. And apparently they did a pretty good job, for this week the FDA gave 23andMe permission to identify 10 telltale markers of genetic diseases, including Parkinson's disease and late-onset Alzheimer's disease, and provide information about the likelihood that the customer will develop the genetic conditions associated with these markers (my emphasis added). It's a big win for a small company, and a testament to the company's perseverance.

A word of caution, however, before you decide to have your DNA analyzed. You should know that you may not be able to keep the results of your home genetic test private under certain circumstances (see this blog, Mar. 13, 2017).

A Texting-While-Driving Accident Claims 13 Lives

Here we go again. A lot has been written about the dangers of texting while driving, yet many of us just can't seem to resist the temptation. The death toll continues to climb.

Consider the most recent incident. Local sheriff's offices received several calls that a pickup truck was driving erratically on a two-lane highway west of San Antonio, Texas. One of the callers even recorded video footage of the truck. Although police responded to the calls quickly, they reached the pickup only after it had plowed head-on into a church van, killing 13 people. According to a Fox News report, the 20-year-old driver of the pickup truck (who survived the crash) said "I'm sorry, I'm sorry, I was texting."

Thirteen deaths is a lot to feel sorry for, especially when they could have been avoided so easily. And a lifetime of remorse is only part of what this young man will have to endure; what's the law going to do to him? I do truly feel sorry for him, because I'm sure he had no intention of harming anyone.

What's it going to take to get you to put down your phone while driving?

A New Vaccine Against a Diarrhea-Causing Virus

A new vaccine may represent an improvement over older vaccines against a deadly virus that causes severe diarrhea in children. The virus, called rotavirus, kills over 200,000 children under the age of five each year, mostly in Pakistan, India, and the African continent.

Current rotavirus vaccines have two drawbacks; they are only partially effective, and they require refrigeration. The need for refrigerated transport and storage of a vaccine or medicine is a real problem in very poor and very rural environments, where infrastructure is inadequate and even the availability of electricity may be sporadic. The new vaccine, called Rotasiil, is manufactured by an Indian company and was tested in Niger, where it proved to be 67% effective; as good or better other vaccines currently available. It does not need to be refrigerated, it can be delivered orally, and as an added bonus it's expected to be inexpensive, or at least cheaper than other available vaccines.

Over 200,000 childhood deaths a year, and you've probably never even heard of rotavirus! In the U.S., rotavirus infection is rare because vaccination against rotavirus is just part of the normal childhood vaccination schedule; its given as either one or two doses before the age of six months. Just goes to show that there are a lot of pretty nasty bugs out there, and not everyone in the world is equally protected against them.

Using Cellphone Photos for Medical Analyses

There's an app now for taking medical-grade selfies of a sort. Actually, they're selfies of urine dipsticks, useful for diagnosing and monitoring certain diseases and conditions.

Clinical diagnosis of certain diseases and conditions relies on simple dipstick analysis of a sample of urine. Typically, a paper dipstick that changes color when dipped in urine is compared to a color chart to determine the presence or absence of certain substances in the urine, such as glucose, blood, or protein. Diagnosis depends on a physical comparison of the color of the dipstick to a reference color chart.

It would be nice to be able to just take a photo of the dipstick and send it in to a health professional, so that diagnosis could be done remotely without the patient having to go to a clinic. But the problem with photo analysis of a dipstick is that the colors depend critically on lighting conditions and the angle at which the photo is taken. But now an app developed by an Israeli company called Healthy.io has gotten around that problem. First, a photo of the dipstick is taken against a proprietary color card. The app, called Dip.io, then color-corrects the background colors to mimic natural ambient light and reads the dipstick. The company hopes that Dip.io will provide patients and their physicians with an easy and inexpensive way to monitor certain diseases characterized by substances in the urine, such as diabetes (glucose), chronic renal failure and pre-eclampsia of pregnancy (protein), and urinary tract infections (blood).

The ability to standardize photographs for color and size opens up all kinds of possibilities. Take dermatological conditions, for example. If moles on the skin were photographed against a background card displaying objects of various sizes and colors, the results could again be standardized to allow long-distance diagnosis. The barriers to entry into this exciting new development in distance medicine are low (just the development of an app), so we can expect Healthy.io to have healthy competition in the future.

Disclosure: I have no financial interest in Healthy.io, nor do I expect to have one in the future. I'm just interested in new and interesting medical technologies.

Congress May Curtail GINA's Protection of Your Genetic Information

A law passed in 2008 called the Genetic Information Nondiscrimination Act (GINA) prohibits employers and health insurers from requiring you to submit to genetic testing as a condition of employment or to receive health insurance (see this blog, June 2, 2008).  It also prevents employers or health insurers from requiring you to answer questions about any previous DNA tests you may have had.  GINA was designed to prevent discrimination based on genetic information about your future health risks.  (Interestingly, GINA does not apply to life, disability, or long-term care insurance; see this blog, Apr. 17, 2014).

Now a bill introduced in the republication-controlled Congress is attempting to take away the protections written into GINA.  H.R. 1313 would allow employers to ask employees intrusive questions about the employee's health, as well as about the health and any genetic tests they or their family members have undergone in the past.  Although refusing to answer still can't be used against the employee in terms of employment, those who choose not to answer could be required to pay 30-50% more for their company-provided health insurance.  In effect, H.R. 1313 would require employees to choose between privacy of their genetic information and the cost of their health insurance.

By the way, the definition of "family member" used originally in GINA and adopted by H.R. 1313 goes way beyond just parents or children.  It extends to the fourth degree, meaning from great-great-grandparents to great-great-grandchildren, as well as generations of aunts, uncles, and cousins.  H.R. 1313 could potentially expose your extended family's entire genetic history, to the extent that it is known.

I'd be wary of agreeing to any genetic tests if this bill passes. You can't answer what you don't know.

Colorectal Cancer is Increasing in Young Adults

Colorectal cancer is generally considered to be a cancer of older people - so much so that the current recommendation is for colorectal cancer screening (a colonoscopy) every ten years after the age of 50. Most cases of colorectal cancer occur in people over 6O. Overall, the incidence of colorectal cancer has started to decline. However, in recent years there has been a sharp rise in colorectal cancer in the young. According to a report published in the Journal of the National Cancer Institute, adults born around 1990 (now in their 20s) have twice the risk of colon cancer and four times the risk of rectal cancer as a person who was born around 1950 when they were in their 20s.

The reason for this startling increase in risk for young people is not known. To be fair, the actual risk of colorectal cancer for persons in their 20s is still very low; about 1 case/yr. (per 100,000 population), compared to the over 50 cases/yr for persons over 60.  If you're young, it's probably not worth worrying about.

However, the trend toward an increase in risk for the young is of concern to scientists, if only because we don't understand why it is happening when overall risk across all age groups is declining.  It's worth keeping an eye on.  At the very least, physicians should not rule out the possibility of colorectal cancer in their younger patients.  Perhaps persons who have a family history of colorectal cancer should consider being screened before age 50.

Bird Flu is On the Rise Again

A deadly type of bird flu known to be transmissible to humans, called H7N9, seems to be breaking out again this flu season in China. H7N9 has caused only modest outbreaks since 2013, the year it was first identified (see this blog, Apr. 17, 2013). The intensity of yearly H7N9 outbreaks peaked in 2014 and then seemed to decline in 2015 and 2016, leading some health officials to think that the worst was over. Not so, it seems. The current 2017 outbreak of H7N9 (which began in October, the typical start of the winter flu season) is the worst outbreak yet. According to the World Health Association (WHO), more than a third of all cases of H7N9 flu ever recorded have occurred during this year's outbreak, and flu season isn't over.

H7N9 bird flu is not easily transmitted from birds to humans, but it is quite virulent. The death rate from confirmed H7N9 infections in humans is nearly 40%. So far, there are no confirmed cases of human-to-human transmission. Health officials worry that if/when the virus mutates in a way that makes it easily transmissible between humans, we could face a worldwide pandemic.

For now, H7N9 outbreaks have been confined to China, where close contact with poultry is much more common than it is in this country. Are we prepared for a H7N9 bird flu pandemic? The short answer is "no". At the moment there is no vaccine against it. Let's hope that a change to human-to-human transmission of H7N9 doesn't develop anytime soon.

Supreme Court Nominee Gorsuch Opposes Death With Dignity Laws

Judge Neil Gorsuch, president Trump's nominee to the U.S. Supreme Court, is not a supporter of death with dignity (also called medical aid in dying) laws. In his 2009 book entitled The Future of Assisted Suicide and Euthanasia he defends his position, writing "...all human beings are intrinsically valuable and the intentional taking of human life by private persons is always wrong."

Five states (Oregon, Washington, Vermont, Colorado, and California) currently have death with dignity laws, and several others are considering them. In general these laws allow a person to terminate his/her own life under certain very narrow circumstances, which generally include the presence of a terminal illness, adequate counseling, and the consent of a physician. The Supreme Court has not yet considered a case involving these laws, so for now the states can make their own decisions.

Not every state is likely to pass death with dignity laws; indeed, some state's legislatures or legal counsels actively oppose them. The deputy solicitor general of the state of Wisconsin, for one, is already thinking about strategies for opposing death with dignity laws, should one ever be challenged in the federal courts.

The first challenge to a death with dignity law in the Supreme Court is likely to have a friend in Justice Gorsuch, should he be confirmed by the U.S. Senate. Just sayin'.

Microdosing With LSD to Treat Depression?

There seems to be a lot interest these days in the possible use of hallucinogens for medical purposes. Last month I reported that in a clinical study, the hallucinogen found in "magic mushrooms" seemed to reduce the symptoms of depression and anxiety, specifically in cancer patients (see this blog, Jan. 9, 2017).  Now it appears that very small doses of another potent hallucinogen, lysergic acid (LSD), are being used by some people as a self-cure for more common forms of anxiety and depression.

It's called "microdosing".  The trend started with the publication of the 2011 book, The Psychedelic Explorer's guide: Safe, Therapeutic, and Sacred Journeys.  More recently, microdosing moved into the mainstream, more or less, with the publication of one woman's memoir, entitled A Really Good Day: How Microdosing Made a Mega Difference in My Mood, My Marriage, and My Life.

Wow, who wouldn't want a better mood, marriage, and life!?  To be fair, microdosing with halucinogens might actually have some positive effects.  But skeptics such as Richard Friedman would say that it's not a good idea to self-treat depression with psychogenic drugs just because someone wrote a self-help book about it.  Microdosing with hallucinogens is untested; it's not even in the preliminary clinical research stage.  Anyone trying it is taking unknown risks.

First Vaping, Now "Dripping"

A study by researchers at Yale University reveals that about a quarter of all Connecticut teenagers who have tried vaping have circumvented e-cigarettes' design to deliver a stronger and more potent nicotine experience.  It's called "dripping"; instead of allowing the e-cigarette's wick to deliver a controlled amount of liquid to the cigarette's coils, the coil is exposed so that nicotine liquid can be dripped directly onto the hot coils, producing a much heavier nicotine vapor cloud.

Regulators aren't sure how to respond to this recent trend.  Although e-cigarettes certainly aren't as harmful as cigarettes, their long-term harm (if any) is still not known simply because they haven't been around long enough.  The concept of e-cigarettes has been around since the 1930s, but the first commercially successful product wasn't created until 2003.  For a complete timeline of the development and regulation of e-cigarettes, see this file.  I can't confirm or deny the accuracy of the timeline, but the file was compiled by a group called Consumer Advocates for Smoke-Free Alternatives Association, so please be aware of possible bias.

Gaining Ground on Clostridium difficile Infections

One of the most dangerous of all gut bacteria is a bacterium called Clostridium difficile.  C. difficile can cause diarrhea so severe that it can lead to death, especially in older patients in hospitals and nursing homes, in whom it is most common.  To make matters worse, it is difficult to treat because it is resistant to most antibiotics.  Although it is present in most people, its population is normally kept in check by the presence of other "good" bacteria, which tend to out-compete it.  But when nearly all of a person's gut bacteria are wiped out, for example when the person is given antibiotics, C. difficile can reproduce explosively, overwhelming the body's defenses.

Although C. difficile was first identified over 80 years ago, it wasn't until this century, when a strain of C. difficile developed resistance to most antibiotics, that the bacterium became a serious clinical problem.  In a 2015 study published in the New England Journal of Medicine, the Centers for Disease Control and Prevention (CDC) reported that in 2011, C. difficile infections caused about 15,000 deaths directly and contributed indirectly to another 14,000 deaths.

But now health officials are seeing signs that C. difficile infections may be on the decline.  One of the key factors may be our more enlightened use of antibiotics; i.e., only when truly needed.  By reducing the indiscriminate use of antibiotics, especially in hospitals and nursing homes, there have been fewer opportunities for C. difficile to gain a foothold.  But there are other signs of hope, too.  Several vaccines are in the works, and Merck has a new (and expensive) drug called Zinplava that is at partially effective at reducing recurrent infections.  Even fecal transplants (to reintroduce competing bacteria; see this blog, Feb. 23, 2014) seem to help, though these are still just in the experimental stage.

Progress is being made, though sometimes it seems slow.  All we can do is keep trying.