The Dream That Just Won’t Die

The Dream That Just Won’t Die

Question- What do all these things have in common- The Holy Grail – The Fountain of Youth and a Non-Invasive Glucose Monitor

They are all dreams; some would say myths, which people continue to pursue although no one really knows they even exist. Back in the days before Columbus discovered America, explorers set out to discover the mythical Fountain of Youth. In ancient times Crusaders set their sights on finding the Holy Grail. Today, inventors and investors have set their sights on another mythical quest, the non-invasive glucose monitor.

The theory has always been that the reasons patients do not monitor their glucose levels on a regular basis have to do with the pain involved when performing a glucose test. Most of these investors who do not have diabetes and have never tested their glucose levels regularly, see a system which requires that patients prick their fingers and draw blood as unnecessary. They look at average testing frequency which is below two tests per day and reason it is the pain of testing which prevents patients from testing more frequently.

From a business perspective they sucker investors into their delusion by noting that the BGM market is a $10 billion business, diabetes is growing at epidemic rates and one of the Big Boys will eventually come along and buy them out. Blinded by their greed, investors pony up millions funding these companies. They willingly buy into the science and ignore the overwhelming evidence that no one has ever been successful.

Typically these companies follow the exact same cycle. First they come up with what they think is a new approach an approach which on paper looks like it will work. With the backing of Angel investors they develop a prototype which appears to validate their science. They get an article published in some obscure journal and head back to the investment trail looking for even money to fund the next stage of development. Sure enough, new money comes in and more work is done.  This cycle repeats itself several times over as these companies consistently tell investors they are oh so close and with just a few million more they will reach their goal.  Ultimately something goes wrong and they close shop only to reappear again under a new name and the process starts all over.

The latest example of just how out of whack this quest has become is a yet another new company claiming they have the latest, greatest thing. Yesterday a patent was issued for something called the Pop Test, according to a press release issued by the company; “The U.S. Patent & Trademark Office awarded Pop Test, LLC its first patent, # 7,824,344, Method and Apparatus for Non-Invasive Analysis of Saliva. Pop Test is currently conducting clinical studies to obtain FDA approval. The patented system greatly enhances and simplifies the monitoring of glucose for diabetics.

The Pop Test product is a testing platform that provides a simple, self-administered, inexpensive, sensitive, non-invasive saliva test for monitoring of blood glucose in Type 1 and Type 2 diabetes. As simple to use as a child’s lollipop, the Glucose Pop Test detects glucose over the full range from hypoglycemia (equivalent to blood as low as 10mg/dL) to hyperglycemia levels.

Clinical testing and further optimization has resulted in a device that can not only replace blood based strips for Type 1 diabetics but provide Type 2 diabetics with a means of daily monitoring. This will enable people with diabetes to control their condition instead of being controlled by it.”

Diabetic Investor has spoken with the good folks at Pop Test and like so many others they believe they have solved the non-invasive riddle. Also like many others they too want to find an investor who will take their test into larger clinical trials and eventually onto the marketplace. Typical of many of these companies and Pop Test is no different, there are “several well established companies” interested in working with them. This is another common thread with all the non-invasive companies who meet with some low level person from the major companies, who expresses an interest in the concept and them extrapolate that interest into an endorsement of their technology. An endorsement they use to raise even more money. Never mind that all the major companies look at new technologies on a regular basis and that rarely do these meetings go beyond the exploratory stage, companies in the non-invasive space will use whatever they can to raise more money.

Wanting to give the folks at Pop Test the benefit of the doubt, Diabetic Investor reached out to experts in glucose monitoring asking their opinion of the Pop Test technology. While we are natural skeptics, we also are not experts on these technologies. Our panel of experts has two things in common; they are recognized experts in their respective fields and have no vested interest in the outcome.  Having been around the block a few times our experts are interested not in the money rather the science. More often than not our natural skepticism is confirmed and here too Pop Test was no different than the many others who have tried and failed.

One of our experts stated the following; “There’s way too little glucose passed across the buccal membrane, and it’s too variable over time to use for reliable glucose monitoring. Plus, there are too many opportunities for contamination from food particles. It’s a safe bet than anything that uses readily accessible fluids (saliva, tears, sweat, urine) has been thoroughly tested and found not to work, no matter what the next zealot tries to tell us.”

Another went even further and stated the following on this fascination with non-invasive;

“Why Are There So Many Noninvasive Glucose Investigations?

First of all, the need is great and getting greater. More and more people are being diagnosed worldwide with diabetes, and there is a reluctance everywhere to endure the discomfort and inconvenience associated with fingerstick blood glucose testing. Second, the opportunity is huge! Worldwide, glucose testing is over a $10 billion market and growing rapidly. Sadly, many businesses have exploited these two facts to create hype, raise money in the absence of sound science, and in more than a few cases, and defraud investors. Nevertheless, each year finds a new crop of investigations because:

  • Most ideas sound good! Both inventors and investors who lack in-depth experience with the difficulties involved in measuring glucose in the body have no basis on which to separate a good idea from a bad one.
  • Many inventors are unusually passionate about the pursuit—they either have a family member (usually a child) with diabetes, or are on a “mission from God” to relieve the suffering of mankind.
  • There is a severe shortage of readily-available information about what has not worked in the past (very few people publish accounts of failures), and many ideas wind up being investigated over and over by people who have no idea why they didn’t work the first time (or believe they have overcome the previous difficulties when a thorough analysis would indicate they have not)..
  • The exploration of an idea for noninvasive glucose measurement requires a multi-disciplinary team with advanced knowledge in many different scientific disciplines. This, coupled with the increasingly restrictive regulatory environment (especially in the U.S.), means that a meaningful investigation will cost $10-20 million, while most inventors believe it can be done for $1-2 million…
  • There are relatively few experts in the world who have the breadth of experience to efficiently determine what ideas might work; so many evaluations are performed without the necessary scientific rigor.

The few seasoned experts have seen many of the ideas (and an equal number of failures) run the risk of becoming more cynical than skeptical. Hiring one of these experts to vet a proposal is expensive and prone to bias from individual experience, so no inventors and relatively few investors take this step.”

One just might think with the millions wasted on this quest, the madness would end. That investors would stop investing their hard earned money in projects that have little chance of ever becoming commercially successful. That investors would conduct even a modicum of due diligence and realize if nothing else, that with the FDA being the way it is, getting a non-invasive system all the way to market, already a Herculean task, has only become more difficult.  

Having seen so many companies try, fail, re-emerge, try and fail again Diabetic Investor believes as long as there are investors dumb enough to keep funding these companies we will continue to see them. Frankly there are two types of investors in these companies; dumb and dumber; investors who deserve to lose their money, as they either are too lazy or blinded by greed to perform even the slightest due diligence. Just as John Dillinger robbed banks because that’s where the money is, companies in the non-invasive space have become experts at finding these overly stupid investors. Another common theme is the motto used by non-invasive companies which states a fool and his money should be parted.

Diabetic Investor has no sympathy for these investors as we have warned them time and time again.  The bottom line here is, as long as people believe the myth that patients do not test their glucose regularly because the act of performing the test is “painful,” the myth will be believed. Or as Walter Lippmann once noted; “What a myth never contains is the critical power to separate its truths from its errors.”