Winter 2018 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

For a change of pace, In this issue of What’s Trending-in honor of President’s Day-we tackle some historical conundrums.

It seems so natural that we don’t even think about it.  365 days in the year (leap year makes it 366).  30 days in September, April, June and November; all the rest have 31 except for February (28/29).  New Year’s is observed on January 1st.  There are four seasons of the year with approximately three months each.

However, this apparent simplicity is deceiving.  The calendar is actually complex.

Our present calendar was first promulgated by Pope Gregory XIII in 1582.  It replaced the Julian calendar developed by Julius Caesar in 43 BCE.  The Julian calendar is a solar calendar with a year of 365 days except for leap year of 366 every four years.  This calendar corresponds to the solar year of 365.25 days.  This calculation is not 100% accurate and is off by approximately 11 minutes.  The error compounds over time, so by the time of Pope Gregory the calendar was out of synch by about 10 days.

Pope Gregory helped develop a calendar that standardized the start of the year to January 1 and added leap years only in a year divisible by four except when it is divisible by 100 (except when divisible by 400!).  Pope Gregory also accelerated the days of October by 10 days to correct the Julian calendar.

Since the Pope headed the Catholic Church, Protestant countries were reluctant to institute the calendrical change.  England voted to adopt the change only in 1750, with acceleration of days being instituted in 1752.  So in the American colonies in 1752, September 2 was followed by September 14. For many subsequent years, dates were shown both in the new Gregorian and old Julian calendars.  What a confusing time!

There are three cycles that are independent of the Gregorian calendar:

  • Days of the week
  • Months of the year
  • Seasons of the year

Days of the week: Seven days in a week is Biblically ordained and stretches back to antiquity in many cultures.  The French Republican calendar, instituted after the French revolution, had ten days in a week but it failed to achieve wide acceptance.

Months of the year: Months do not have the same number of days and contain lengths not divisible by seven.   Thus they will migrate in terms of which days of the week they occur.  There are 12 months in a year with names based on the Roman and Julian calendars.  The first six months of the year (January through June) are based on Roman gods.  July and August are named after Julius and Augustus Caesar; and their importance is noted by the calendar’s assigning them 31 days.  The last four months of the year (September through December) are named after their place in the old Roman calendar – months seven through ten.

Seasons of the year: The seasons of the year reflect start dates of the equinoxes–Vernal of March 20th, 2018 and Autumnal September 22, 2018; days in which daytime and nighttime hours are equal.  The shortest daylight day of the year—Winter solstice on December 21, 2018 and the longest –the Summer solstice at June 21, 2018 are not assigned special dates in the Gregorian calendar and occur mid-month.

Internationally, the Gregorian remains the most widely used civil calendar in the world.  Other calendars are primarily used to determine the dates of religious events and holidays.

The Islamic calendar is based on the lunar year and has either 354 or 355 years.  Because of the discrepancy in length versus the solar year, Islamic holidays such as Ramadan will shift in terms of the season in which they occur.

The Jewish calendar is a solar-adjusted lunar calendar.  There are generally 12 months a year.  A leap month (Adar II) is added in seven of every 19 years to help align the lunar with solar years so that Passover occurs in the springtime and the holiday of Tabernacles in the fall.  Additionally there are two months that contain either 29 or 30 days to help adjust the length of the year.

Hindu calendars are also lunisolar in nature as is the Buddhist calendar.  Other calendars have been based on the reigns of kings or emperors.

Before there was the holiday of Presidents’ Day and Presidents’ Day sales, there was George Washington’s birthday. But who was George Washington and what really happened during the American Revolution and afterwards? In this article we take a small step in separating myth from reality. It is in the form of a true (T) or false (F) test. Good luck and no cheating.

There Were 12 Original Colonies

True. At the time of the American Revolution, Delaware was still officially part of Pennsylvania. However, by the time of the ratification of the Constitution in 1787, Delaware was an independent colony. In fact, it was the first colony to ratify the Constitution.

George Washington Had Wooden False Teeth

This is one of the most enduring myths about George Washington, but it is False. George Washington lost his first tooth at age 22, had dentures constructed of cow and horse teeth, ivory, lead-tin, copper and silver alloys No wonder they were ill-fitting and uncomfortable!

George Washington Stood While Crossing the Delaware

Probably false, but if you need to mark yourself correct in choosing “True,” go do so.

You probably are aware of the Emanuel Gottlieb Leutze painting depicting Washington and the Continental army on their way to fight the famous battle of Trenton on Christmas Eve, 1776.

The painting has several inaccuracies: the American flag shown is wrong, the sky is unnaturally bright; the boat is of the wrong model and looks too small to convey all of its occupants and stay afloat. And as any good seaman knows, standing in a boat is not recommended.

George Washington Was an Excellent General who won More Battles than he Lost

False. George Washington was rarely victorious in battle. His greatest strengths were in keeping the Continental army functioning and living to fight another day. Early in the war he nearly had his army surrounded and destroyed by the British in the battles of Brooklyn and New York, but he escaped. (A remnant of the Continental army was surrounded and surrendered at Fort Washington in November, 1776).

Washington’s greatest victory at Yorktown was due to the participation of the French, headed by Admiral de Grasse, whose fleet cut off the escape of the British general Cornwallis.

There Were 12 Original Amendments to the Constitution

True. The first 10 amendments to the Constitution (the “Bill of Rights”) were accompanied by two other amendments that were not ratified in 1789. The first non-adopted amendment set a limit on the size of the population in each congressional district. If adopted, we would have a Congress of 6,000 or so representatives.

The second amendment that was not adopted at that time prevented Congress from giving itself a pay raise. Although not originally adopted, in 1992 it became the 27th amendment to the Constitution.

On His Famous Ride, Paul Revere Shouted “the British are Coming”

False. Paul Revere rode on April 18th, 1775 to alert the American militias at Lexington and Concord, Massachusetts that the British army were on their way. Most people at that time considered themselves British, so shouting “the British are coming” was patently absurd. He probably would have shouted that the regulars are coming.

In any event, Paul Revere never made it to Lexington to alert the militias. He was stopped on the way by the British; Samuel Prescott and William Dawes were the ones who alerted the militias.

America’s Revolution was a True Revolution

True. Although debated by historians, the American Revolution was a true revolution. A revolution causes a dramatic change, while a rebellion is the action or process of resisting authority. The Revolution ended up eliminating the monarchy, a radical idea at that time. After 1776, traditional elites (merchants, planters, lawyers) were challenged by artisans, small farmers, and other workers. Inherited political office and the rule of aristocracy were abolished.

The Liberty Bell in Philadelphia Rang Out American Independence on July 4th, 1776

False, sorry to say. It is more likely that the Liberty Bell sounded on July 8th, when the Declaration of Independence was read publically. Also, the bell was not called the Liberty Bell until the 1830’s when abolitionists adopted it as a symbol of the anti-slavery abolitionist movement.

The American Revolution was Supported by a Minority of the Population

True. John Adams said that one third of the population supported the revolution, one third opposed it and one third had no opinion. One third in support was an exaggeration at best. For many, taxes were inevitable in any case and it did not matter to whom the taxes were paid. In fact, some farmers equipped their homes with two flags—the British and the American.

Americans Won the War by Using Guerilla Tactics

Mostly False. Although the Americans did employ guerilla tactics, they were not the norm and certainly not in decisive battles. The war was won when the Americans learned to use European tactics, learned to pick its battles and got major assistance from the French. The British also wearied of the war which was a tremendous drain on their treasury.

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Summer 2017 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

Since Frederick the Great of Prussia (1712-1786), if not earlier, domestic dogs have been called “man’s best friend.”  Their ability to provide their family members with unconditional love, loyalty and companionship is exemplary.

Now other benefits have been attributed to dog ownership.  In a Canadian study, babies with furry pets (especially dogs) were found to be more apt to have beneficial gut bacteria; bacteria that have been associated with reduction of allergies and obesity.  These bacteria are found in furry animals!

So have your baby snuggle with your dog.  We also await development by the pharmaceutical industry of a “dog in a pill” similar to the concept of probiotics.

Recent experimental work at Cedars-Sinai Medical Center demonstrated that utilization of virtual reality (VR) can reduce chronic pain by almost 25%.

Dr. Brennan M. Spiegel has treated 300 patients with virtual reality with surprisingly good results.  Although more research is needed, the analgesic VR treatment appears to have no side or addictive effects.  Those willing to try the treatment do skew younger.

So think of Iceland or swimming in the Caribbean using your VR glasses to relieve your pain!

Researchers at Worcester Polytechnic Institute (Worcester, MA) have turned spinach into working heart muscle.  Plants (including spinach) have a network of capillaries capable of delivering blood via their vascular system.

Researchers stripped spinach leaves of their plant cells (in a process called decellularization) using a detergent, leaving behind the vasculature.  Injecting a blood-like substance, they were able to culture beating heart cells.  The cells seem to have grown to a sufficient size to be able to treat injuries.

So, we now have justification to ignoring Popeye and not eating your spinach.  There is another important reason to disregard Popeye.  It seems that although spinach does contain iron, the amount that it contains was vastly over-stated.  In 1870 the German chemist Erich von Wolf measured the amount of iron in spinach.  But instead of recording 3.5 milligrams per 100 gram serving, he misplaced the decimal point and notated 35 milligrams!

Popeye the Sailor was created by Elzie Crisler Segar. The character first appeared in the King Features comic strip “Thimble Theatre” in 1929.  It latched-on to the exaggerated amount of iron in spinach and depicted Popeye as an ardent consumer of spinach.

Previous issues of What’s Trending have focused on new wearable healthcare devices (www.whitcupassociates.com/articles).  Continuing our coverage, we note several new wearable devices for pregnant and post-pregnant moms and babies (see The Medical FuturistSM newsletter, May 2017).

Reliefband® for morning sickness.

Nausea and vomiting can be among the first signs of pregnancy.  Beginning in the sixth week, nausea and vomiting affect more than 50% of pregnant women.

Reliefband® is an FDA-cleared device (similar to a wristwatch but worn upside down) that uses neuromodulation to treat morning sickness.  According to the developer, the device delivers gentle pulses to the median nerve at the P6 pressure point on the underside of the wrist.  It works by modulating the neural pathways between the brain and the vagus nerve.  It retails for about $100.

Bloomlife contraction monitoring.

Bloomlife consists of a small device and a patch that adheres to the baby bump.  It measures contractions by reading the electrical activity of uterine muscles.  Information is sent to your smartphone.  Clinically validated, Bloomlife can distinguish between “false alarms” (such as Braxton Hicks) and real contractions. Rental pricing is $49 for an initial set-up plus $24 per week.

Nuvo Ritmo Prenatal Pregnancy Sound System

The benefits of prenatal music have been widely debated.  Claimed benefits include better fetal brain development, prenatal learning, reducing stress levels during pregnancy, improving a baby’s sleeping habits after birth and providing a bonding opportunity in utero.

The Nuvo Ritmo prenatal system consists of a belt that securely positions speakers at strategic locations to ensure that the baby receives a high quality 360 degree audio experience.  The controller delivers music to the baby in the womb at a continuous safe and stable decibel level.  It is compatible with music devices that feature a standard 35mm audio headphone jack.  An extension belt for added comfort for the mom during pregnancy is included in the kit.

Sound Beginnings offers a comparable product.

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Spring 2017 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

Pharmapacks has come out with the first, and only, FDA-approved device for treatment of cold sores. Sold under the name of “Virulite©,” the device, based on LED light technology, is used three times a day to treat (“zap”) cold sores. It can even be used after the sore has appeared. At approximately $90 retail, the “zap” may be costly to some, inhibiting use for a malady which typically lasts only a short period of time (8-12 days).

Supermarket tomatoes sure look good. But they have lost much of their true taste, as farmers and breeders focus on shelf-life, firmness and resistance to disease.

Using 398 tomato varieties, a global team of scientists (from U.S., China, Spain and Israel) have identified the genetic code linked to enhanced taste of tomatoes. Analysis covered sugar content, weight, size, color and volatile components responsible for tomato aroma, among other factors. Researchers were able to identify the alleles in the tomato genome that promote tastier genomes. Using classical genetics (not gene modification), the “good” alleles were used to replace “bad” alleles which had been damaged over the centuries.

And voila! A tastier tomato may hopefully reach your palates soon.

There are over 30,000 proprietary drugs in the U.S., and coming up with a unique name that passes FDA scrutiny is no easy task. The manufacturer wants to communicate a “marketing message” that suggests product benefits/features.

Using a creative brief, a team of copywriters, linguists, verbal-identity specialists and others come up with candidate names. These names are tested in qualitative (focus group) and often quantitative research to arrive at final candidates.

The FDA Division of Medication Error Prevention and Analysis will conduct the (initial) review the potential name(s). The FDA received over 126,000 reports of medication error from 2000 to 2009, so there is great concern relating to selecting a name.

There are a variety of reasons why a name may be rejected by the FDA, including:

  • Overtly fanciful name that may imply unique effectiveness or composition.
  • Overstatement of product efficacy and/or minimization of risks.
  • Misleading implications of a name in terms of dosage or administration.
  • Spelling or pronunciation of a name that, when spoken, may lead to confusion with other similar-sounding or similarly-spelled medications.
  • Orthographic appearance of the name when written; leading to potential confusion with other medications (for example, an “a may look like a “c).

See: www.fda.gov/downloads/drugs/drugsafety/medicationerrors/ucm080867.pdf

So, choose your names carefully and speed up your approval process!

A technology developed at Ben-Gurion University in Israel for smart devices can assess sleep disorders such as obstructive sleep apnea (OSA) at home without the need to be hooked up to a host of machines.

The system could be installed on a smart device that uses ambient microphones. It works by analyzing patient speech and breathing sounds. Using the technology, it is possible to estimate the number of apnea and hypoapnea events per hour in sleep; even for awake subjects.

According to the American Sleep Apnea Association, 22 million people in the U.S. have sleep disorders, with 80% of these cases having OSA.

Medical applications for smartphones are proliferating at a fast rate, including:

  • Heart rate monitor that produces medical quality EKG’s.
  • Thermometer
  • Clinical quality stethoscope that captures heartbeat and breathing patterns.
  • Mini-microscope that can test sperm’s motility.
  • Blood pressure monitor.
  • Otoscope (ear checker).
  • Blood sugar monitor.
  • Air spirometer to assess lung function.
  • Smart-phone controlled arm patch that uses electric shocks to treat migraines.
  • Device that alerts caregivers when a diaper is full.

Aren’t these better than Candy Crush©?!

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Winter 2017 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

Oral medicines are almost by nature bitter-tasting. Product taste is an important issue for oral medications, particularly those indicated for children.

Help is now on the way. PepsiCo will be working with the TB alliance to make TB drugs more palatable. TB is one of the 10 deadliest diseases, with almost two million people dying of the disease each year.

Dr. Richard Chaisson, professor of medicine at Johns Hopkins University, has pointed out that “getting kids through treatment for TB is a nightmare.” The tuberculosis medications tend to be in pill form and too large for children to swallow. Parents are advised to crush the pills and mix them with food. However, this does not remove their bitter and otherwise objectionable taste, and thus inhibits compliance. Hopefully, PepsiCo will find solutions to the taste issue.

We at What’s Trending hope that cooperation between the food and pharmaceutical industries spreads to other children’s medications.

Since the 1980’s, Betty Hart and Ted Risley (University of Kansas) have focused on the number of words spoken to children. Their research has shown that the number of words spoken to babies does matter, citing “with few exceptions, the more parents talked to their children, the faster the children’s vocabularies were growing and the higher the children’s IQ test scores at age three and later.”

This is the premise of the Providence Talks municipal project, which is an intervention program that attempts to increase the number of words that young children hear so that when children enter kindergarten they are ready to succeed.

How can parents be sure that they are talking enough to young children? A new technological solution now exists to monitor this. The Starling, a wearable word counter from VersaMe, clips to a child’s shirt, jacket or pants and counts the number of words  it detects (it does not record the actual words). It also provides tips and activities to achieve a higher number of words received by the child.

But what should these words be? David Stillwell, at the University of Cambridge, found that people who curse are more sincere and less likely to lie. These seem to be admirable traits.

Should we communicate these traits to our babies and young children via cursing? Probably not. Luckily, the Starling will not record the exact curses!

Young parents, especially first time parents, are anxious about being able to read their baby’s crying and moods. Technology has come to the rescue.

The Sproutling is a wearable anklet device that monitors baby temperature, movements, heart-rate and other parameters, in addition to ambient noise. It attempts to predict when a baby will wake up and when a baby is upset. It does not provide readings on the parameters, but rather develops alerts for the parents as needed.

At just under $300, it is not inexpensive. But who can measure the value of reassurance given to parents?

As an alternative, parents could consider the Infant Cries Translator. Based on the analysis of a database of 200,000 cries, the app developers claim at least 84% accuracy in helping parents identify why babies cry. The app is heuristic and allows parents to correct the app in identifying the sounds emitted by babies and determining the reasons why these sounds are made. Ongoing results of the app can be transferred to a parent’s smartphone.

What’s Trending has previously highlighted upcoming trends in medical applications of 3D printing (Summer 2016 issue). 3D printing is the process in which objects are made by depositing or fusing materials (plastic, metal, liquids, etc.) in layers to produce a 3D object (it is also called additive manufacturing). The printer follows directions from a CAD file to build the object. The process enables customization for individual patients.

3D printing is rapidly advancing. Organovo has developed a 3D bio-printed liver tissue, now in pre-clinicals, that could be submitted to the FDA by 2019. While 3D-printed items have been used in hospitals to simulate bones or other body parts, it is still potentially a long way from seeing organs repaired and regenerated. CEO Keith Murphy claimed last year that Organovo would probably be printing partial livers for human implantation within four to six years.

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Fall 2016 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

Are we heading to a cashless society? Yes, and it may be sooner than you think.

  • Most of us walk around with less than $20 in cash, according to a 2014 Bankrate.com study.
  • According to a Gartner, Inc. study, by 2018, 50% of consumers in “mature” markets (U.S., Canada, Japan, parts of the EU) will use smartphones or wearables for mobile payments.
  • 34% of those 18-29 years of age are currently using mobile payments.
  • A MasterCard study of 33 economies found that the U.S. is now at a tipping point; with impending development toward a cashless society being almost inevitable.
  • According to the Federal Reserve System, cash now comprises only 14% of all transactions as measured by value of payments.

Existing forms of mobile money include mobile wallets (such as Apple Pay), person-to-person payments (such as Chase Quick Pay), branded payment apps (such as Starbucks, Uber) and electronic toll tags (such as EZPass).  As these and other mobile payment methods proliferate, pressure is put on society to go cashless.

If we want to see the future of a cashless society, we need only to study Sweden, where cash accounts for only 2% of the value of all payments.  As reported by The Guardian, 900 of Sweden’s 1,600 banks no longer carry cash or take cash deposits and many no longer have cash ATM’s. Swish, an app developed by the major banks in Sweden, now processes 9 million payments a month.  Swish can even process payments between individuals.

Many retail establishments are “cash-free zones.”  Some churches report that cash donations now only comprise a small percentage of their intake.

Cash may not go away completely in the U.S, but it will surely help tax revenue if we head in that direction.  The $100 bill is by far the predominant currency in terms of value.  Much of the cash in $100 bills goes into the underground economy and into the coffers of organized crime.  How many of us carry $100 bills around in our pockets?  Notably, India has recently eliminated its two largest currency bills, representing 80% of Indian cash, in order to fight corruption and the underground economy.

Furthermore, in the U.S., the older generations may not be sociologically prone to the use of cash alternatives.  In Sweden, a protest movement has arisen to counter the cashless trend.

Cashless alternatives offer convenience and security advantages.  Additionally, cashless alternatives offer non-banking avenues of payment to the 34 million poor who tend not to have bank accounts.  Nevertheless, there are serious privacy concerns about the personal information that a cashless society will generate, as detailed records will be created of where and when we purchase, what we purchase and amounts paid.

Are you prepared for the cashless society and your non-cash payment of your $3 tube of toothpaste?

(See the November 2016 issue of Consumer Reports for an excellent review of going cashless: “Cashing Out” by Jeff Blyskal.)

Have you ever wondered what those strange number codes on supermarket produce stand for?

The International Federation for Product Standards is a voluntary organization that, among other activities, creates price lookup codes (PLUs) for use by cashiers in transacting sales.  There have been 1,400 codes assigned since 1990.

The PLU codes indicate the type of produce and also include valuable information about the nature of the produce.

  • A four-digit code indicates that the produce was conventionally grown (e.g., 4011=bananas conventionally grown).
  • Genetically modified produce will add a leading fifth digit (e.g., 84011 for bananas genetically modified).
  • Organically grown produce will start with a “9”.

So, enjoy eating your produce, but avoid eating the labels!

Activity trackers have been touted as an excellent system for monitoring important aspects of your health and vitality.  Some have even suggested that these devices should be involved in medical treatment; directly communicating with one’s physician.

However, recent studies have called into question the accuracy of these devices.

  • The University of Queensland (Australia) tested activity trackers from Apple, Fitbit, Samsung and Mio Alpha. The results found that none of these devices had a relative accuracy advantage and underestimated electrocardiographic measurements between 9% and 43%.  These inaccuracies have serious implications for those using such trackers to lose weight or maintain and improve fitness.
  • Other studies (CNET for example) reportedly have shown inaccuracies in measuring heart-rate. This is because it is difficult to obtain heart-rate metrics from the wrist versus medical-grade devices which are typically worn around the chest.

TZOA has come out with a wearable device similar in size to an activity tracker that uses internal sensors to measure air quality, temperature, humidity, atmospheric pressure, ambient light and UV exposure in real time when paired with a smartphone app.

According to the manufacturer, the device will also give you “actionable” advice based on its readings.

Go venture outdoors with confidence wearing your air mask if needed!

For information about consumer wearable medical devices, please read previous issues of What’s Trending.

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com

Summer 2016 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

On May 1 the FDA issued draft guidance on 3-D printed medical devices. What’s the big deal?

3-D printing is the process in which objects are made by depositing or fusing materials (plastic, metal, liquids, etc.) in layers to produce a 3-D object. It is also called additive manufacturing. The printer follows directions from a CAD file to build the object. The process enables customization for individual patients; a goal that is often unrealistic now.

3-D printing is rapidly advancing medicine. The following can currently be accomplished via 3-D printing or will be possible in the foreseeable future:

• Dental crowns
• Skin cells interwoven with structural material that can potentially serve as blood vessels.
• Low-cost prosthetic parts.
• Drugs.
• Tailor-made sensors (for example, sensors for the human heart).
• Medical models (for example, cancerous tumors from CT or MRI scans).
• Bone scaffolds.
• Heart valves.
• Ear cartilage.
• Cranium replacement.
• Synthetic skin
• Human organs (particularly in situations where a human organ donor does not exist).

The list is rapidly expanding.

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The new mandated FDA food labels announced in May are an attempt to more accurately communicate what’s in the foods that we eat. Major changes to the labeling include:

• More realistic serving sizes. For example, the ice cream serving size on labels was ½ cup and is now ⅔ cup.
• A new line, the amount of “added sugars,” now appears below “total sugars.”
• Vitamin D and potassium will need to be reported along with calcium and iron.
• Package size will be used to help determine the number of servings per package. For example, a 20 oz. soda will be required to be described as one serving.
• Daily values for nutrients have been updated based on the latest scientific data; affecting the % Daily Values (DV’s) that appear on the labels.

So, should you feel guilty about the ½ cup of ice cream you just had? It’s still not a full serving!

There are approximately 100 million lab mice which are used in experimentation on pharmaceuticals, medical devices and medical operations. 95% of all lab animals are mice or rats.

There are a variety of reasons why these animals are used:

• Convenience; they are small and reproduce rapidly.
• They are inexpensive.
• Their lifespan is short, so that several generations can be observed in a relatively short period of time.
• They can be inbred so that their genetic nature is controlled across experiments.
• Their genetic and biological characteristics are similar to those of humans.

Until now, the observation and recording of mice data has been a labor-intensive process. Vium, a Silicon Valley start-up, wants to automate the process. The Vium system lab will reduce animal stress by minimizing human contact and deliver, through the use of sensors, real-time physiological and observational data that scientists need.

The tasks left to humans are to clean the cages and analyze the data!

(See Bloomberg Businessweek, June 6, 2016.)

Both Bloomberg Businessweek (June 6, 2016) and the New York Times (May 11, 2016) have reported on several new devices of interest:

• NuEyes is a combination of software and smart glasses (they look like sunglasses) that deliver enhanced vision to the visually impaired. Among its features are a 720-pixel autofocus camera, a trackpad and audio ports. Users are very satisfied. Its major limitation is cost; about $6,000.
• Sensoria Fitness has introduced socks with textile sensors that provide real-time information on cadence, foot landing, pace and speed.
• The Wilson X basketball tracks shots in real-time from various spots on the floor. The basketball is regulation in size and weight and will track up to 100,000 shots. The device has four training games.

So, keep on dribbling and shooting for your health!

For information about consumer wearable medical devices, please read the summer 2015 and winter and spring (2016) issues of What’s Trending. http://www.whitcupassociates.com/articles/

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

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Spring 2016 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

As everyone presumably knows from their high school chemistry class, common salt is a compound consisting of sodium and chloride. Humans have been processing salt for thousands of years. Salt became an important commodity for trade and was transported in caravans across the Sahara and across the Mediterranean Sea by boat.

Our word “salary” is derived from the Latin salarium, originally denoting a Roman soldier’s allowance to buy salt.

Salt is typically obtained through mining or evaporation of sea water. Only an estimated 6% of salt is utilized for food. Most is utilized in manufacturing and other industrial processes.

Salt is required to maintain human life, as it is involved in many physiological processes. There is no consensus as to how much salt per day is required to maintain human life; 500mg is an often quoted figure.

Unfortunately, ingesting large amounts of salt can lead to coronary issues, stroke, and other health problems. Many of our processed foods contain high amounts of salt. The World Health Organization recommends no more than 2,000mg of sodium per day. According to studies, 90% of U.S. adults exceed 2,300mg of salt per day. The average intake is much higher at 3,600mg per day.

The FDA has never moved to limit the salt content of foods. Voluntary FDA guidelines for sodium reduction in various foods are in the works. Some companies have already voluntarily begun the process of sodium reduction. For example, Walmart has reduced the percentage of salt in its house brands by 16% since 2011.

Stay tuned for further developments.

Since its founding, the 140 character limit has been the defining characteristic of Twitter®. Twitter® has over 320 million active users; an attractive target for marketers. According to reports, Twitter® is developing a 10,000 character version that should soon be ready. The 10,000 character limit would enable advertisers and others to provide more detail about their products and services; attracting greater web traffic.

For the pharmaceutical industry, the larger limit might enable companies to advertise on Twitter®. The 140 character limit now precludes the utilization of Twitter® for pharmaceutical advertising since the limited length does not allow for the FDA-required communication of medication side effects.

So Twitter® lovers, is a birdsong in your future?

A recent article in the GreenBook® blog by Patrick Comer has claimed that mobile interviewing will overtake traditional interviewing in 2016. While “What’s Trending” does not fully subscribe to this prediction, it is incontrovertible that the rapid growth of the mobile interviewing platform has changed the way we conduct interviews.

According to data based on the Fulcrum Exchange® (an online sample marketplace), 13% of online survey sessions in 2015 were from mobile devices, a 700% increase since the beginning of 2014.

The explosion in the use of smartphones has fueled this growth. According to Pew Research, as of 2014, 90% of American adults had a cell phone and 64% had a smartphone, with assuredly higher penetration rates for these devices in 2015.

The mobile platform has several advantages, including arguably higher completion rates and immediacy of response. However, it does matter how we conduct interviews.

Most online (pc-based) interviews are 15-25 minutes in length; a length that is purported to be too long for mobile interviews.

Screen size and usability factors for mobile devices impact how we use graphic elements. Moreover, several standard online question formats, including answer grids, are not readily compatible with mobile.

Designs that require long iterations of question components or elements probably do not work well with mobile devices. Choice-based questions (e.g., conjoint, discrete choice, MaxDiff) may require numerous iterations, incorporating several elements simultaneously.

In the near future, survey platforms and survey designers will need to address these limitations.

Consumer wearable medical devices are changing the clinical practice of medicine, with new applications being introduced at a fast rate.

Consider diabetic neuropathy (loss of feeling), the leading cause of amputation in the U.S., which costs the U.S. economy $10 billion annually. Researchers at the Hebrew University and the Hadassah Hospital in Jerusalem have come out with a “smart sock” that enables diabetics to “feel” pain, a crucial sensation for avoiding injury to the body.

Belts are not just for holding up your pants. For those not willing to wear a smart wristwatch device, at the Consumer Electronics Show (CES) in Las Vegas in January 2016, several smart belts were introduced. These devices monitor heart rate, breathing and calories burned, and transmit the data to your phone.

In development is a wearable bracelet that delivers a steady dose of caffeine for up to four hours so you can get your morning fix. The technology is similar to that of a nicotine patch.

One U.S. College has mandated that all students wear Fitbits® as evidence of exercise patterns. Moreover, the students will receive grades based on their fitness. We are waiting for the day in which students can minor in Fitbitology!

For additional information, please read the summer and winter issues of What’s Trending which reported on the exciting and rapidly expanding world of wearable consumer medical devices.

http://www.whitcupassociates.com/articles/

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Winter 2016 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

As everyone knows, snow is precipitation in the form of flakes of crystalline water ice that falls from the clouds. It is granular material and comes in a variety of sizes and shapes. Snow is the substrate that enables many winter sports celebrated by the Winter Olympics. It also allows us to have fun building snowmen, tossing snowballs and sledding.

But snow also has a serious side, obstructing life, and causing death, injuries and property damage.

The highest average yearly snow accumulation in the U.S. –almost 54 feet—occurs on Mount Rainier, Washington.

There are 67 US cities/towns with populations of 50,000 or more that have at least 50 inches of snow per year. Of the top 25 of these cities, eleven are in New York State, headed by Syracuse.

Why does New York State merit these records? Explaining the high accumulations is the snow lake effect. Lake effect snow happens during cooler atmospheric conditions when a cold air mass moves across warmer lake water. The most affected areas include Central and Eastern New York State which are impacted by Lake Ontario. The snow lake effect causes the southern and eastern shores of the lake to have high yearly accumulations. There is also a Lake Erie snow lake effect, and in other geographic areas as well.

For many localities, there is substantial variation in yearly snowfall.

For example, New York City averages about 25 inches of snow a year. The heaviest snow months by far are January and February, trailed by December and March. However, snow has occurred from October 15th through April 25th.

Although the average is 25 yearly inches, there is great variability of annual accumulations, ranging from only 3 inches in the 1972-1973 snow seasons to about 76 inches in 1995-1996.

Not all heavy accumulations of snow are blizzards. According to the National Weather Service, a blizzard as a storm that involves a large amount of snow or blowing snow, with winds in excess of 35 miles an hour and reduced visibility of less than ¼ miles for at least 3 hours

So, stay out of the cold and be careful when snow shoveling even if it’s not technically a blizzard!

Falling response rates for telephone surveys and abandonment of landlines by consumers are complicating life for survey researchers.

An oft-quoted 2012 study by PEW Research Center, response rates to telephone surveys fell to an alarming 9% in 2012 (with response rate defined as the percentage of households sampled that yielded a completed interview.) In 2006, the response rate was a more robust 21%.

While there are many factors contributing to this decline, the increasing use by consumers of cell phones as replacement for household landlines has undoubtedly contributed to this response decline. According to the Centers for Disease Control and Prevention, 47% of the households contacted had only cell phones (and no landlines).

These cell-phone-only households are more difficult and costly to contact. The Federal Telephone Consumer Protection Act forbids calling cell phones using any automated calling system—so cell numbers to be called must be entered manually.

Furthermore, although area codes are part of a cell phone number, the owner of the cell phone could be using it in any US time zone or even in China!

Thus, the middle-of-the-night wakeup call may be yours.

For many companies, big data and big analytics were promised to yield deep consumer insights to drive profitability.

In reality, it has yielded high and potentially unseen long-term costs.

A recent report by Veritas, of the business data collected by companies, only 14% can be deemed to be business critical. 32% is redundant, obsolete or trivial data. The remaining data are “lurking far beneath the line of sight” and unclassified. The unneeded data will be costing EMEA companies $891 billion in storage costs by 2020.

Are these data costs worthwhile? Maybe there will be a counter-revolution in commercial data collection to “little data but better analytics!”

Wearable medical devices increasingly make news. In December, and the American Epilepsy Society’s annual meeting, the use of wearable medical devices for the continuous monitoring of epileptic patients was discussed. These devices include an EEG patch, brain sentinel GTC seizure detection unit, and other available wrist-worn already available commercial devices. It is hoped that these devices will not only monitor patients but moreover predict when seizures might occur.

Wearable medical devices face a somewhat rocky road ahead. The accuracy of such devices will need to be established. Although not intended as medical devices, the Fitbit Charge HR and the Fit Surge are defendants in a current lawsuit alleging inaccurate readings that might endanger patient health. Stay tuned to future editions of the Whitcup Associates What’s Trending newsletter for further developments.

For additional information, please read the summer issue of What’s Trending which reported on the exciting and rapidly expanding world of wearable consumer medical devices (“The Future of Consumer Medical Devices is Now!”).

http://www.whitcupassociates.com/articles/

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Fall 2015 Newsletter

An Episodic Publication of Whitcup Associates, LLC

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

In the summer issue of “What’s Trending” we reported on the exciting and rapidly expanding world of wearable consumer medical devices (“The Future of Consumer Medical Devices is Now!”).

Bloomberg News has recently reported that wearables (Fitbits and other devices strapped to participants wrists, chests and skin) are being used in nearly 300 clinical trials to “amass precise information and gather round-the-clock data” to better understand the efficacy of tested medications.

Will the iWatch enable us to live longer and happier lives? Wait for future installments of What’s Trending to keep you informed.

Water occupies a substantial portion of our planet. However, 97% of this water is salt water. Of the fresh water, two-thirds is contained in ice sheets. The remainder is surface water (rivers, lakes, etc.) and ground water in underground aquifers. In drought-stricken areas such as California, under-ground aquifers are being depleted at a rapid rate. These aquifers will not have their water replenished for hundreds, if not thousands, of years.

Water is never gained nor lost; it only changes location. 70% of fresh water is utilized for agricultural purposes. It is also estimated that across the U.S., 20% of available drinking water is lost through pipe leakage (see an example of this below).

Water that we actually drink accounts for less than one one-hundredth of the water we utilize. However, we are treating all available water sources as if they are destined to be drinking water. For example, New York City has 14 water treatment plants. These restore water to drinking-level quality before waste water is released; an energy intensive and expensive process.

In the U.S., we only recover 7% of the water we use. By contrast, Israel recovers 80%, and soon to be nearly 100%, of water used by households.

Professor Kartik Chandran at Columbia University envisions a time in which we will have two sets of pipes (in and out) in our homes; one for grey water (water from sinks, tubs and washing machines) and the other for black water (from toilets). Upon exiting a home, each of these types will be treated differently (and not automatically converted into drinking water) for re-use.

Remember, your next flush might soon be a re-usable resource!

(There is an excellent article about water in the Fall Issue of Columbia Magazine “Saving Water Won’t Save Us: Liquid Assets” by Paul Hond.)

According to the Pharmaceutical Development Group, based on Consumer Health Products Association data, the U.S. market for OTC’s more than doubled from 2007 to 2013; growing to $33 billion. According to forecasters, this market is expected to grow 5% per year. Global sales of OTC’s are expected to rise similarly as well.

Converting former Rx medications (“switches”) represents a viable engine to help spur this growth. The FDA has established an initiative, “NSURE”, to expand and accelerate switches.

Until now, the majority of switches are for episodic conditions with the warning not to use the product for more than 14 days without consulting with a physician. However, the FDA may be open to considering OTC switches in categories which are more chronic. Conditions such as migraines, high cholesterol (statins), BPH (benign prostatic hyperplasia), erectile dysfunction (ED) and sleep aids have been cited as possible areas for switches.

There already have been actual use trials in some of these chronic disease areas. Several have failed due to lack of consumer understanding of the continued need to take medication to treat the condition.

The genetic testing company, 23andMe, after receiving FDA clearance, will once again be marketing 35 genetic saliva-based tests that tell users whether or not they carry genetic mutations that potentially could lead to disease in their offspring (i.e., carrier status). The 35 genetic tests include Bloom Syndrome, Sickle Cell Anemia, Cystic Fibrosis, and Hereditary Hearing Loss.

The FDA has yet to approve marketing by 23andMe of tests that predict the potential for disease that would be ordered by consumers.

If you have any suggestions for topics you’d like covered, please email them to info@whitcupassociates.com.

Summer 2015 Newsletter

by Morris S. Whitcup, Ph.D. and Keith LaMattina

What’s Trending

A wearable medical device may be defined as a biosensor that attaches to the body in order to monitor and track physiological data or other environmental information for the user. These devices typically have remote/wireless communication and allow the collected data to be stored, analyzed and trended. Activity monitors, smart watches, smart clothing and patches are some examples; however, many other types and applications are possible and are currently in use today.

Most wearable medical devices to date have been concentrated in the arena of activity and exercise (walking, jogging or other exercise parameters such as muscle activity) and measure distance traveled, calories burned, heart rate, etc. Some even include GPS monitoring and tracking to enhance accurate measurement of distance.

From a business point-of-view, the size of the wearable medical device market is vast and fast-growing. Estimates predict it may range up to $53 billion worldwide, with 25%-35% annual growth within the next three years. Smart watches will dominate initial sales within the wearable device category according to many sources, with the Apple Smartwatch perhaps accounting for 40% of units shipped.

Without intending to provide regulatory guidance, it appears that most of the currently marketed consumer-directed wearable devices would not fall under the medical device regulations set by the FDA and these devices are not marketed as such. However, the boundary between consumer devices intended to support general health and fitness and true medical devices classified by the FDA is fading. In fact, several consumer medical device manufacturers have set up divisions specifically for the medical device marketplace.

Your Levi jeans may be your medical device at some future date! Google and Levi Strauss have entered into an agreement to make interactive garments. It is not too fanciful to think of extended medical uses for such interactive capabilities.

See the full article in the second quarter of 2015 Alert! Magazine:

http://www.marketingresearch.org/article/wearable-medical-device-your-future%E2%80%A6is-now

According to Reuters (03/30/15), the American Academy of Pediatricians has recommended that dosing instructions for children’s liquid medications be in milliliters rather than in teaspoons. But how well do U.S. consumers know the metric system? According to the CIA Factbook, the U.S. is only one of three countries that have not mandated the use of the metric system.

Consumers in the U.S. are familiar with the “customary measurement system” which is based on pre-metric United Kingdom measurements. However, the metric system is taught in our schools. Furthermore, metrics such as currency, liters (e.g., 2 liter bottles), kilometers (e.g., 5k/10k runs), grams (in nutrition labels) and technology-related terms (kilobytes, megapixels) are increasingly making their presence felt in the U.S. marketplace.

Presumably, many manufacturers of children’s medications will include dosage cups, with the correct dosage indicated in milliliters to help consumers. So carefully measure your children’s medications in those milliliters. And be sure to enjoy a good bottle of wine in a 750 ml bottle!

There has been much recent press about parental refusal to vaccinate their children out of unfounded fears of autism and neurodevelopmental problems. Concerns about vaccine efficacy (for the most recent flu season, the CDC estimates that the flu vaccine was only 23% effective) and taking vaccinations in combination have also been recently voiced.

From a historical viewpoint, fears about vaccination have predictably risen as first-hand experience with childhood diseases has receded. For example, in the U.S. in 1954, fear of polio drove parents to willingly involve over 600,000 children nationwide in the field trial of the Salk polio vaccine. Such a trial may not be possible today based on both scientific concerns and parental fears.

Vaccines are a big business, but not as big as one may think. The World Health Organization estimates that vaccines are only 2%-3% of the worldwide pharmaceutical industry. Some vaccines are administered only once in a person’s lifetime, and even with booster shots, fall short of the administration levels for other pharmaceuticals; particularly those medications for chronic conditions. In 1967, there were 26 vaccine manufacturers (making vaccines as their sole or primary business); that number fell to 17 by 1980, and there are only 4 in existence today.

One inhibiting factor in the growth of the vaccine industry is consumer fear of injections. At least 20% of consumers have a fear of needles and this phobia may be preventing these individuals from obtaining adequate medical treatment and getting inoculated.

But help is on the way. According to Businessweek (May 18-24, 2015), Mark Prausnitz, co-founder of Micron Biomedical, has developed a 15-minute patch to provide a needle-free vaccination. Patches are currently being developed to replace the flu, polio, measles and rubella vaccines. Trials of the flu vaccine will begin this summer.

A recent Time Magazine article (“Who Killed the Summer Vacation?” Jack Dickey, June 1, 2015) highlighted Americans’ unwillingness to take vacations. According to the Bureau of Labor Statistics, about three in four U.S. employees get some paid vacation. Even those fortunate enough to have paid vacations are using only an average of 16 days of vacation per year, a decline of 5 days from the early 80’s and leaving about 5 days “on the table.”

Top-cited reasons voiced in polls (see, for example, the Time-Off Project) for not taking vacation include heavy workload upon return, nobody else being able to do the work, lack of affordability, wanting to show dedication and the desire not to be seen as replaceable. Even on vacation, over 6 in 10 reportedly do some work, including emailing, accessing work documents, calling, texting and other activities interrupting vacation time.

So hopefully you are reading this edition of What’s Trending after having taken or planning to take some restful vacation!

For more information please contact info@whitcupassociates.com

Consumer Wearable Medical Devices

by Morris S. Whitcup, Ph.D. and Keith LaMattina

The Wearable Medical Device in Your Future…Is Now!

“From a business point of view, the size of the wearable medical device market is huge and fast-growing. Estimates predict that it may reach up to $53 billion worldwide2, with 25-35 percent annual growth within the next three years.”

A wearable medical device may be defined as a biosensor that monitors physiological data, usually with remote/wireless communication, as part of any wearable item that attaches to the body. Activity monitors, smart watches, smart clothing and patches are examples.

Most wearable medical devices to date have been concentrated in the arena of activity and exercise (walking, jogging, or other exercise parameters such as muscle activity) and measure distance traveled, calories burned, heart rate, etc. Some even include GPS monitoring and tracking to enhance accurate measurement of distance.

Other devices encompass a wide range of physiological measurements and, in the future, may incorporate enhanced functionality, including monitoring and/or analysis of:1

  • Blood pressure
  • Brain activity
  • Continuous glucose
  • EKG
  • Eye tracking
  • Hydration
  • Infant care
  • Ingestion
  • Oxygen level
  • Pain relief
  • Posture
  • Radiation exposure
  • Respiration
  • Skin conductance
  • Sleep
  • Temperature

Besides consumer and clinical/medical uses, there are also workplace and military applications.

From a business point of view, the size of the wearable medical device market is huge and fast-growing. Estimates predict that it may reach up to $53 billion worldwide2, with 25–35 percent annual growth within the next three years. Smart watches will dominate initial sales within the wearable device category according to many sources, with the Apple Watch accounting for perhaps 40 percent of units shipped.3 Google Glass and smart wristbands may also have billion dollar potential.4

What is Inhibiting Growth in the Medical Device Wearable Market?

Several factors inhibit the growth of this market, particularly in the clinical/medical category:

Many consumers see no need for consumer wearable devices or feel that the costs of these devices are unjustifiable given their lifestyle. Greater usefulness and perceived value of the devices – driven by more functionality and standalone capability like being able to operate without a Smartphone or other external device – will increase consumer acceptance.

Cost may inhibit growth in the clinical sphere. It is not clear to what extent payers (e.g., insurance companies) will cover such devices.

Perceived inconvenience of the device plus complex usage instructions.

Consumer Privacy and Security Concerns

Challenges in integration of devices and information processing systems. For clinical/medical devices, the information systems must be able to handle large amounts of data in real time. Paradigms of how patients and their physicians discuss and share information will also have to be changed.

Clinical medical devices need to be highly accurate and reliable, with recording times stretching to a year or more. Better long-lasting micro batteries may need to be developed.

Low consumer adherence/compliance, especially for a device that has to be worn 24/7. Some studies have shown that, within 18 months, fewer than 50 percent continue to use the device. We suspect that the fall-off is even steeper and occurs earlier and that wearing a device on a 24/7 basis may be considered too difficult, interruptive or unreasonable for some consumers.

The difficulty of engineering a consumer device that works for a large-scale population. For example, advanced health features such as EKG, stress monitors, or blood pressure monitors have been cut from the Apple Watch. Although Apple is said to have had meetings with the FDA about these advanced features, engineering challenges are the chief cause of their elimination. The applications supposedly did not perform well on individuals with dry skin and hairy arms. Furthermore, performance varied substantially depending on the fit of the watch on the arm.5

Some Interesting Consumer Devices

Smart watches and advanced versions of these devices will dominate sales. Several devices now available are innovative and worth mentioning.6

Lumbo Lift measures your posture. When you slouch, it vibrates and thus indicates the need to change your body position. The small sensor cube can be worn as a fashion accessory or hidden under clothes. The retail price is around $100.

Jabra’s Heartrate Tracking Earbuds. The originality of this device lies in the form factor being earbuds rather than a smart watch. According to the manufacturer, they are the only device of this nature to deliver clinical grade data. It integrates training management and has three fitness tests. The average retail price is under $200.

Mimo Baby Monitor measures respiration, skin temperature, body position, sleeping and activity of infants. It is washable and you can check on your baby from anywhere in the world. The retail price of the starter kit is around $200.

Withings Aura Sleep Tracking Device tracks REM and light sleep, wakeups and total sleep duration and makes suggestions regarding how to improve the quality of your sleep. It also serves as a daytime activity monitor. The retail price is around $125, depending on the model.

More innovative devices will undoubtedly be introduced in the near future.

What Does the FDA Have to Say About Wearable Devices?

The Food and Drug Administration (FDA), which has regulatory control over medical devices, categorizes wearables into three classes:7

Class I are simple in design and have no potential risk. Examples are tongue depressors, band aids, etc. Such devices must be registered, exhibit proper branding and labeling, and be produced using proper manufacturing techniques.

Class II are more complicated in design and have minimal risk. Examples are x-ray machines, powered wheelchairs and surgical and acupuncture needles.

Class III are intricate in design and have the strictest guidelines because they pose the greatest risk. Examples are implanted pacemakers, heart valves, etc.

Without intending to provide regulatory guidance to anyone, it appears that most of the currently-marketed consumer wearable devices would not fall under the regulations set by the FDA and are not marketed as such. For guidance, one is encouraged to consult the FDA database and other appropriate sources of information.

Consumer wearable products that do not need to register with the FDA are in effect considered to be general wellness products; that is, they have an intended use that is related to maintaining or encouraging a general state of health or a healthy activity and are not intended to cure or treat specific illnesses or conditions. They are not presently seen by the FDA as posing any risk to the consumer.

As wearable medical devices become more sophisticated and complex, consumer health and wellness devices may end up in a grey area or beyond and may need to shift to fall under FDA purview.

The FDA has recently issued guidance about general wellness claims for low risk devices.8

Market Research Implications

Device screens, such as those available on Smartphones, are currently too small and lack sufficient clarity to serve as vehicles to respond to market research surveys conducted via mobile interviewing platforms. This may change in the future. The iPad and other tablet-style devices have already revolutionized the manner in which online research studies are undertaken. Interactive Voice Response (IVR) surveys can currently be conducted via wearable devices with voice capabilities, but such interviews are inherently limited in what they cover.

Despite these current limitations, the health and wellness information provided by wearable medical devices can be quite usable in clinical and market research applications.

One of the greatest challenges in healthcare is patient adherence/compliance.9 Lack of patient adherence can potentially lead to increased emergency room visits, hospitalizations and other inefficient uses of the healthcare system. Pharmaceutical companies lose out on sales when patients fail to renew medications on time, follow prescribed dosage or use prescribed medications at all. Estimates of yearly lost revenue for the pharmaceutical industry are $564 billion worldwide and $186 billion in the U.S. alone.10

Much research attention has been paid to addressing lack of patient adherence. Wearable devices can serve as vehicles for measuring adherence in terms of such things as monitoring patient activity, calorie intake, or health-related regimens. Furthermore, reminder messages to help increase adherence can be sent out via wearable medical devices. Using wearable medical devices to identify the more effective adherence programs is a vital healthcare need. It is also possible that, in the future, wearable medical devices will be able to enhance patient adherence. For example, if a device could communicate patients’ physiological data directly to their physician, patients may not need to take measurements or keep a log of these levels or track progress over time.

In Summary

Wearable medical devices are a fast-expanding and here-to-stay phenomenon that should be carefully watched for new developments. Although pundits’ estimates of market expansion may be over- or under-stated, wearable medical devices are sure to impact consumer healthcare and medical delivery systems in the very near future. As wearable devices expand in the medical arena (see for example, Apple Researchkit11), increased FDA scrutiny will undoubtedly follow.

 References

  1. The Future of Biosensing Wearables, Rock Health Slide Presentation, June, 2014 and Wearable Technology and Digital Healthcare Strategies Should Shift Focus to Chronic Medical Illness, Forbes.com, November 20, 2014.
  2. Launch of the iWatch Expected to Galvanize the Fledging New Sector, Juniper Research, September 9,, 2014.
  3. Davona, Tony, The Wearables Report: Growth Trends, Consumer Attitudes and Why Smart Watches Will Dominate, Business Insider, February 12, 2015.
  4. Wearable Technology 2014–2014, Technologies, Markets & Forecasts,idtechex.com. (See also their 2015–2025 forecasts.)
  5. The Apple Watch Won’t Keep the Doctor Away: Advanced Health Features Get Cut Prior to Launch, FierceLife Sci Weekly Digest, February 20, 2015.
  6. 14 Health and Fitness Wearables and Gadgets Worth Giving, Mashable.com, December 2, 2014.
  7. About FDA: What Does It Mean for FDA to “Classify” a Medical Device? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm.
  8. General Wellness: Policy for Industry and Food and Drug Administration Staff: Draft Guidance, FDA, Center for Devices and Radiological Health, January 20, 2015.
  9. Whitcup, Morris, and Garcia-Lopez, Joaquin, Patient Adherence Update: New Approaches for Success, Guideline Trend Report, October, 2008. (In conjunction with MedAd News.)
  10. Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence, Capgemini Consulting, November 20, 2012.
  11. Apple announces ResearchKit, a New Service for Medical Studies, CNET, March 9, 2015.

See the article in the second quarter of 2015 Alert! Magazine:

http://www.marketingresearch.org/article/wearable-medical-device-your-future%E2%80%A6is-now

For more information please contact info@whitcupassociates.com

Seven Ways to Fail a Consumer Label Comprehension Study

by Morris S. Whitcup, Ph.D. and Keith LaMattina

The Food and Drug Administration (FDA) is charged with ensuring the safe use of prescription (Rx) and over-the-counter (OTC) drugs in the United States. The FDA is vitally concerned that consumers understand the correct use of OTC medications and has issued detailed Guidance about proper drug facts labeling. The Guidance requires that the outside packaging, and/or the container itself, have information about:

  • The name of the medication
  • Its ingredients
  • Uses
  • Warnings and contraindications
  • Dosing
  • Other information that may be deemed pertinent by the manufacturer 1

The FDA usually requires that a consumer label comprehension test be conducted.

  • When a product switches from Rx to OTC status
  • Is newly introduced
  • When there is a new indication or target market
  • If changes are made in directions or warnings
  • Or there are other substantial changes in formulation or dosing

Guidance for this type of research was issued in August, 20102, and forms the basis for this article. Commentary is also included based upon actual experience in conducting such studies. Although the manufacturer’s following of the FDA guidance is not mandatory, the Guidance is evidence of the FDA viewpoint on these matters and any deviance from the Guidance should be carefully considered.

Potential Failure #1: Not (Adequately) Specifying Primary and Secondary Communication Objectives

The Guidance specifies that both primary and secondary communication objectives (if any) be detailed before conducting label comprehension research. Endpoints, based on comprehension levels in specific questions, are also included in the protocol that companies prepare before conducting a label comprehension study. Sounds easy, right? Actually, setting these objectives is a complex task:

  • The endpoints should be based on clinical criteria and pre-study discussions with the FDA. Correct communication is critical for clinically relevant items (such as warnings and contraindications), and less important for “nice to know” information.
  • Including too many objectives may lead to failure, inasmuch as success or failure will be judged based upon achieving each of the endpoints.
  • Having too many questions or items addressing each endpoint may result in only a partial success; with lack of correct consumer comprehension for some and higher levels of correct understanding for others.

Potential Failure #2: Conducting Internet Interviewing

For many business decisions of consequence, internet interviewing predominates. Such interviewing is cost and time efficient. However, it is inappropriate for consumer label comprehension studies:

  • • Internet interviewing has no built-in visual verification that a real respondent exists and may have serious population skews.
  • The internet population excludes respondents who have no access to the internet and is thus a biased population.
  • Actual consumer reading and attention to actual packaging during an in-person interview is far different than perusal of packaging shown on a screen in internet interviewing.

Potential Failure #3: Interviewing Only the Target Market

Marketers are traditionally taught to focus marketing efforts on the “target market” for a product3. The target is often based upon prior category or brand use, age or other demographics, attitudinal or psychographic segments, family life-cycle, etc. 4. FDA Guidance, however, stipulates a broader audience than the medication’s target: “Because the non-prescription drug products are available for purchase without a learned intermediary, and since no drug product is administered in the study, exclusion factors should be minimal (e.g., inability to read and understand English) and should be justified in the study protocol.”

At first blush a broader sample may seem to place an undue burden on companies. A priori one may assume that target consumers and actual users of the category are more familiar with the medication. However, actual experience conducting label comprehension studies also indicates that target consumers may be less attentive in the reading of drug facts labeling; canceling out any familiarity advantages in understanding that target consumers may have.

Potential Failure #4: Conducting a True “All Comers” Study

The Guidance states that the study should include all subjects who can potentially use the drug product, regardless of age, sex, underlying medical conditions and use of concomitant medications. Logically this implies what is known as an “all-comers” study without any restrictions.

However, such a “random” sample would not be truly random!

  • Shopping malls, where consumer label comprehension studies are typically conducted at interviewing facilities, do not yield a random population. The mall population skews female and younger. Depending upon the specific malls involved, the mall population may have little representation of various minority ethnic populations (e.g., African Americans, Hispanic heritage, etc.) and lean towards a middle-class population.
  • Furthermore, the mall population may have few respondents with lower levels of literacy. Guidance specifically states that label comprehension studies should have adequate inclusion of such low-literacy respondents (who score at the 8th grade reading level or lower based upon reading tests such as the Rapid Estimate of Adult Low Literacy in Medicine 5). Although augment (“supplemental”) interviewing is often needed to enroll an adequate number of low-literacy respondents, prudent mall site selection can boost the number of low-literacy respondents who naturally would be screened and interviewed.

Study population controls are therefore necessary for a supposedly random sample to be more representative.

Potential Failure #5: Not Pretesting the Questionnaire and Study Procedures

As marketers and social scientists, many of us could construct good questionnaires in our sleep. Pretests thus seem an unnecessary cost and slow down study implementation. However, this is not the case.

  • The Guidance assumes that study questionnaires will be pretested.
  • Pretests may uncover lack of understanding of the issues due to questionnaire wording or question/item placement (and not what is to be elicited from reading the medication package). Improving correct understanding even by a few percentage points can mean the difference between obtaining an acceptable level of comprehension or not.
  • Label design can also be improved through pretesting, even by something as simple as highlighting a label facts item that is inadequately comprehended.
  • Pretesting may discover questionnaire items whose levels of comprehension may be increased through use of techniques such as flash cards showing response alternatives, patient scenarios and other items.

Potential Failure #6: Accepting a Correct Response as a Correct Response

A correct response is a correct response, isn’t it? Actually, Guidance states that correct responses should be probed (“why do you say that?”) to ascertain that consumers correctly understand the drug facts labeling.

This process does lead to classification of “correct” responses as, in fact, incorrect when consumers give invalid reasons why they answered a question seemingly correctly. However, conversely, some apparently incorrect answers may be uncovered to be, in fact, correct, whereby the respondent evidenced correct understanding, but for idiosyncratic reasons answered incorrectly.

Potential Failure #7: Assuming that a PowerPoint® Presentation is the Final Product

The typical marketing research study is not normally a full report but a not overly-detailed presentation. Label comprehension studies, however, require a detailed report in MSWord® or other similar software with many appendices; including the protocol, questionnaires, study procedures, drug facts labeling tested, etc. as well as detailed statistically-tested tables of question responses.

What Other Potential Sources of Failure Are Important to Note

While not typical, other avenues of potential label comprehension studies do exist, in particular:

  • Arguably, the greatest addition pitfall is changing packaging wording/graphics after the label comprehension study is conducted. This may necessitate redoing the label comprehension study, adding to project cost and potentially delaying the submission to the FDA. The best way of guarding against changes is to fully pretest the package before the label comp study is conducted.
  • Using a comparator in assessing your own label communication is dangerous. There is sometimes the temptation to test an additional label (a competitor) to serve as a benchmark against which to measure the results for your own label. If your label is superior to the competitor, perhaps, to a limited degree, the FDA would be more inclined to judge your own label’s correct communication to be “successful.” However, the ultimate onus is on the manufacturer to demonstrate the success of their own label. Moreover, any ways in which the competitive label is superior would be potentially damaging to the acceptability of your own label’s results.

In Summary

Label comprehension studies are, in many ways, radically different than many primary marketing research studies. Much forethought and adherence to Guidance are the best ways to help assure successful results.

References

1. “Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products,” Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August, 2010.
2. “Guidance for Industry: Labeling OTC Human Drug Products- Questions and Answers,” Food and Drug Administration, Center for Drug Evaluation and Research (CDER), December 2008.
3. Small Business Encyclopedia, “Target Market Definition,” ND.
4. Wikipedia, “Target Market,” December 14, 2014.
5. Davis, TC et al, “Rapid Estimate of Adult Literacy in Medicine: A Shortened Screening Instrument,” Family Medicine, 1993, Vol. 25: 391-395.

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