Hydrocephalus Mobile App hopes to be new mHealth Test

The DiaCeph Test was created in 1997 to evaluate CNS shunt performance in patients with the disorder, hydrocephalus. It is a mathematical formula and algorithm born out of my experiences as a patient and patient advocate, and from 18 years of experience in diagnostic nuclear medicine, including, with hydrocephalus and software.

DiaCeph’s algorithm uses a weighted probability of a patient user’s clinical complaints, or complaint markers, to the most likely of (17) types of malfunctions that can occur with a CNS shunt. The results are displayed and ranked in order of probability. In addition, the markers are plotted on time vs complaint level graphs, where they are compared to the patient’s baseline markers and earlier shunt outcomes. The impetus for creating the DiaCeph Test came from my poor post surgical outcomes and frustrating diagnostic experiences as a patient user for hydrocephalus following a 1992 auto accident. I’ve used my DiaCeph methodology (paper forms) to track the shunt outcomes, make shunt valve pressure predictions, and diagnose shunt malfunctions for my last (8) shunt revisions. Still in 2016, there is no reliable diagnostic means to determine how well a CNS shunt is working. The DiaCeph Test could readily be made into a mobile app, providing the necessary funding, administrative, and FDA regulatory requirements can be satisfied.

The DiaCeph paper methodology could easily be produced as a mobile data app.
The DiaCeph paper methodology could easily be produced as a mobile data app.

DiaCeph Test born out of FDA Petition/Unmet Need in Hydrocephalus

Hydrocephalus is the leading neurosurgical disorder in children, often resulting as developmental changes in utero, shortly after delivery, or by brain cysts early in life. It occurs in seniors in the form called NPH, or normal pressure hydrocephalus, and in the past NPH was often confused with dementia and/or Parkinson’s Disease. It can also occur following trauma and tumors in the brain. It is most often treated by surgical insertion of a “CNS shunt,” which the patient will live with the remainder of their life, and which are very problematic technology often requiring surgical replacement.

My DiaCeph data app slide above is from my original (1997) design of the DiaCeph Test. This came out of my research in authoring an important 1996 FDA petition on anti-siphon shunts. I was familiar with hydrocephalus and CNS shunts from my many years of diagnostic work in nuclear medicine, where I worked with software and regularly wrote procedures, and occasionally basic software code.

Stephen Dolle invented his DiaCeph Test following his 1996 FDA petition that was then used to direct this 1998 shunt surgery
Stephen Dolle invented his DiaCeph Test following his 1996 FDA petition that was then used to direct this 1998 shunt surgery

I had been a patient user of CNS Delta valve shunts for hydrocephalus since 1992, and had experienced unexplained poor outcomes from three surgeries over a period of four years. In 1996, I learned of a new critical study published in the Journal of Neurosurgery by a well known Japanese neurosurgery group, that cited specific safety & performance issues with Medtronic PS Medical Delta Shunts & Anti-siphon devices that seemed remarkably similar to complaints I was experiencing. Sadly, neither my treating physicians, shunt manufacturers, or the Food & Drug Administration were able to help me.

In November of 1996, I petitioned the U.S. Food & Drug Administration (FDA) Center for Devices and Radiological Health with this important FDA petition on CNS anti-siphon shunts, concerning problematic CNS shunt technology which I had been implanted for 4 years, and was experiencing unexplained poor outcomes. It was in 1996 that a critical study was published in the Journal of Neurosurgery regarding the risks of using anti-siphon devices. The petition took me almost a year to prepare, and required that I obtain supporting FDA records on microfiche, obtain and learn the federal government’s applicable CFRs to CNS shunts, pay a librarian consultant for many of the (52) cited studies, and carry on correspondence with Ralph Nader’s group Public Citizen.

What I learned, was that between 1976-1996, many thousands of patients had been implanted with Medtronic Delta valves & Heyer-Schulte anti-siphon shunts and that about one-third of these were experiencing the kinds of poor outcomes as cited in the Higashi et. al. J. of Neurosurgery study. Higashi and his team described these shunt performance issues as “functional obstructions” of the CNS shunt system, most of which occured in the upright posture. However, some were reported with sleeping and other external pressure over the body of the shunt valve. What made the problem particularly challenging, was that there was no available (in-vivo) diagnostic test to identify and quantify the issue in patients. Available CT/MRI and shunt patency testing was usually “negative” for shunt malfunction, which is termed a “false negative.” Higashi and his team then cited the need for a new type of diagnostic test to identify these shunt outcomes issues in affected patients. Once I authored my petition, my next challenge was in creating a new type of test to evaluate these shunt performance issues.

I sought out a method to chart & analyze non-invasive clinical markers in hydrocephalus in different postures, and during different times of the day. This was 1997, and the same year researchers at the U. of Pittsburgh and Henry Ford Institute, were quietly doing this to monitor sports concussion. It took me more than a year, during which I also consulted aerospace scientists on possible math formulas. Once it passed the first proof of design phase, I expanded my test to evaluate any type of problem with any type of CNS shunt. And then I aptly named it the DiaCeph Test. Dia– meaning to diagnose. And Ceph– meaning of the brain. The design and proof of concept were completed in Sept. of 1997. And then I began using it to evaluate my Delta shunt for corrective revision.

Initially, I was going to “give my method away” to one of the shunt manufacturers. But it was a friend from little league baseball who convinced me to try and PATENT it. Which I did via the law firm Knobbe Martens Olson & Bear. The photo above was taken just days after my Feb. 1998 shunt revision where I used the DiaCeph Test to help determine which type of shunt would fit my CSF outflow needs.

 

My experience in nuclear medicine and working with hydrocephalus and diagnostic software proved invaluable in the creation of the DiaCeph Test. Over my 18 years of nuclear medicine (beginning in 1975), I had authored hundreds of diagnostic procedures, set up hospital imaging procedures, started and run an imaging company, and provided diagnostics for a wide range of medical conditions. Two of those tests for hydrocephalus were cisternograms and shuntograms.

In 1997, my DiaCeph Test was so new, it didn’t have a category name. But today, these type of applications are widely termed, “mHealth.” As such, my DiaCeph Test design was one of the earliest mHealth tests, and remains state of the art still in 2016. But, designing it was no simple task. I had to contend with frequent cognitive or memory difficulties, shunt malfunctions, terrible headaches, and lack of funding.

In 1998, I filed my full patent on the DiaCeph Test and formed the start-up, DiaCeph, Inc. DiaCeph was to be a dedicated PDA app, like the Palm Pilot that had just become available. The Internet at that time was just mature enough then to allow patient data and results to be sync’d with a PC either at the patient’s home, or at the physician’s office. I proposed how a server could allow uploading & sharing of patient results.

DiaCeph can analyze non-invasive user data and render a diagnosis of the type of shunt malfunction. I created a series of clinical markers (as can is seen in the slide above), and by establishing a patient’s baseline normal values, incident results could be compared and produce a diagnosis based on the change from normal. Where there was no comparitive data, the program still aggregated resulting data and compared it with the most likely data known by the program for the different types of shunt malfunction. I was advised that patients not be given access to the results by FDA and others involved in the project. Today we know its best to give patients this information. Below, is earlier web site information on the DiaCeph Test. Below that, an Orange County Business Journal‘s 1999 story about the DiaCeph Test entitled, “The Accidental Inventor.”

DiaCeph Test at DolleCommunications.com 

Stephen Dolle, Dr. Eldon Foltz, and Stephen Natawpski of Knobbe Martens are interviewed by the Orange County Business Journal regarding the invention of the DiaCeph Test, and Stephen's FDA efforts in Washington, D.C.
Stephen Dolle, Dr. Eldon Foltz, and Stephen Natawpski of Knobbe Martens are interviewed by the Orange County Business Journal regarding the invention of the DiaCeph Test, and Stephen’s FDA efforts in Washington, D.C.
Stephen Dolle interviewed in the Orange County Business Journal for his FDA efforts and DiaCeph Test invention Page 2
Stephen Dolle interviewed in the Orange County Business Journal for his FDA efforts and DiaCeph Test invention Page 2

DiaCeph underwent initial evaluation and development at the University of California Irvine (UCI). My lead physician was the long time neurosurgeon and professor, Dr. Eldon Foltz, who was excited about the DiaCeph Test and offered to mentor me. He shared he had been trying to develop a similar test since 1980. Dr. Foltz helped me form a board of medical advisers at UCI, and introduced me as an mHealth pioneer.

After the FDA granted my shunt petition in Sept. 1998, I was invited to attend the FDA’s STAMP Technology Conference in Bethesda, MD, which was to address shunt safety issues as cited in my petition. However, the conference never did! Nor were these CNS anti-siphon shunt challenges discussed, nor DiaCeph mHealth concept. And neither was I was not invited to appear on the conference panel, despite being the person who helped create the conference. As a result, my DiaCeph Test and similar solutions never received the exposure they deserved. It no doubt hurt prospects for the DiaCeph Test at a time it was badly needed, and amid my limited resources as a patient developer.

As time went on, I looked for new novel ways to utilize the DiaCeph methodology. Below, are SlideShare.net slides of new (July 2016) DiaCeph Test NPH Instructions, a NPH 6-Marker Form, and a new Chronological Outcomes Form or “flow chart” for creating a patient record of many years with various shunts, opening pressure settings, and hydrocephalus outcomes (complaints/status) in a patient. There are instructions on how to complete the historical flow chart in the back of the NPH instructions.

These materials are FREE to use. But if you have questions or would like my assistance with monitoring or related hydrocephalus and shunt issues, please contact me directly. My consulting rates are $125 per hour.

Diaceph 5 day 7 marker NPH hydrocephalus shunt monitoring form
Diaceph 5 day 7 marker NPH hydrocephalus shunt monitoring form

DiaCeph Test MONITORING INSTRUCTIONS

DiaCeph Test MONITORING FORM

DiaCeph Test FLOW CHART

DiaCeph, Inc. as a Brain Software Company

By 1999, I was exploring other brain apps & software and making plans for this as part of DiaCeph, Inc., to be an innovator in this space. This was prior to the advent of Google apps, social networking, and mobile tech leaders like Samsung and Apple. At that time, the only two mHealth apps under consideration were by Aetna’s health division for CHF and asthma. I was also in communication with Hewlett Packard, Microsoft, the Coleman Institute, and other institutions involved in assistive cognitive technologies. I presented DiaCeph to a number of university centers and medical device companies. But I could not get any committments to partner or fund it. Apparently, no one saw my vision.

By 2003, I had begun to move on to other neuroscience interests. My brain also remained significantly swollen due to unresolved and mis-understood hydrocephalus, and kept me on disability, working only part time. I could not get a neurosurgeon to undertake additional surgery without diagnostic documentation. It was a Catch 22! I believe if the DiaCeph Test were available then, it would have answered these diagnostic questions.

In the end, the DiaCeph Test was never made into a PDA app due to lack of fundingFDA regulatory barriers (costs), and lack of support from medical device companies in the field of neurosurgery. However, DiaCeph could still be produced today as a mobile data app. I wrote up a “creative brief” in 2014. The challenge now lies mainly in the FDA regulatory costs of mHealth apps, where estimates have said to be in excess of $1M. It is doubtful this cost could ever be recouped in sales of the app. So I prepared wider prospects for other neurological apps in my expanded Creative Brief.

Hydrocephalus today still faces considerable mis-diagnoses due to unavailability of imaging and mHealth solutions. Radiologists regularly mis-interpret CT and MRI brain scans, which leads to undiagnosed shunt malfunction and incorrect settings of programmable shunts. This in turn has resulted in significant quality of life issues and costs for patients living with hydrocephalus.

Below, is a screen shot of a CT/MRI mHealth Display method I’ve been using since about 2002. This helps to organize CT and MRI scans into useful formats for review by your physicians, especially when there are many scans over a period of years. At present, the link is to a blog I authored on LinkedIn. I hope to sometime elaborate further on this in a new company blog. I also consult on preparing these at my same $125 per hour rate.

Method of Organizing CT & MRI Images for Chronological Review

Innovative Dolle mHealth method allows CTs & MRIs to be chronologically oarranged and compared.
Innovative Dolle mHealth method allows CTs & MRIs to be chronologically oarranged and compared.

You should obtain CDs of all your CT/MRI brain scans. The method allows for review of 1000s of CT & MRI images by placing the most critical images in a chronoligcal sequence for comparison. These displays can also reduce interpretation medical errors.

To create these, I first create folders on my PC for each CT or MRI series. Then I export the images as JPEGs into the respective folders using the media software included in the radiology CD disc. Next, I review, select, and label the relevant images and copy them to special forlders where I arrange them in chronological order for better viewing. This format makes interpretation much more scientific, and it minimizes any human (visual) error during interpretation.

This method is particularly important in hydrocephalus care – where it is common to have dozens of studies and 1000s of CT and MRI images for review. This mHealth display method would benefit radiologists, neurologists, and neurosurgeons involved in hydrocephalus care and other care involving CT and MRI studies.

This method allows for more detailed evaluation of shunt settings, shunt performance, and shunt malfunction. I put these mHealth methods to good use in my hydrocephalus consults and shunt monitoring services.

Once you have assembled the critical MRI/CT Images Folders, they can be easily sync’d and copied to folders on your mobile phone and tablet device. Then when you see your physician, you’ve got all your CT and MRI images neatly organized for review.

Below, is a diagram of my current shunt valve, the Codman Certas valve, which was implanted in Nov. 2012. However, in May 2013, it was recalled due to stability issues during MRI exams.

Illustration of the Codman certas valve, an externally adjustable programmable CNS shunt valve with 7 pressure settings, and is used in the treatment of hydrocephalus.
Illustration of the Codman certas valve, an externally adjustable programmable CNS shunt valve with 7 pressure settings, and is used in the treatment of hydrocephalus.

The DiaCeph App today could be made as a mobile data app and text app (for use in developing countries). It would enable 24/7 monitoring of hydrocephalus and could be coupled with a variety of neurological, EEG wave, and other apps now available.

Additional Resources on Hydrocephalus Monitoring

Hydrocephalus NPH Monitoring by Stephen Dolle/Dolle Communications

NPH/ Hydrocephalus Monitoring

Mobile Apps, mHealth, and other Solutions for Hydrocephalus

 

I’ve been providing NPH/Hydrocephalus Monitoring Services & Patient Consults with DiaCeph paper forms/instructions since 2009. I also host FREE monitoring forms and information on hydrocephalus. My experience with hydrocephalus now spans 18 years of diagnostic work in nuclear medicine, and 21 years in FDA regulator affairs, CNS shunt reviews, mHealth design, cognition and assistive technology, drumming & music therapy, and global patient consults for affected individuals/families around the world.

I also host two consult reports on the top blog above (Hydrocephalus NPH Monitoring by Stephen Dolle)The first report was completed by a legally blind man. I provide each patient a custom set of forms and instructions. If an mHealth app were available, it would direct patients or users in the collection of this data, and then offer physicians the data in a finished format for earlier diagnoses, intervention, and surgery.

HydroPowered.org – Super Heroes

The Terminator is the ultimate super-hero for adults and children affected by hydrocephalus.
The Terminator is the ultimate super-hero for adults and children affected by hydrocephalus.

Early on, after I was implanted with a VP shunt for hydrocephalus, I began to seek creative comfort in stories about Super Heroes. As an inventor, I also began to equate living with a CNS shunt implant to the Terminator character in the movie of the same name. Eventually in 2013, I created a fun web site and Facebook page for hydrocephalus – where I began to write about “super-heroes” for hydrocephalus. Here I am today pictured below in a current photo following a speaking engagement. My rates are very reasonable, and I have a list of topics I speak on. Contact me for more information of this.

I have undergone 12 brain operations, or shunt revisions as they are termed, since my initial diagnosis in 1992. I became a shunt device, hydrocephalus “expert,” and early inventor of an mHealth mobile app, the DiaCeph Test. It was my 1996 petition to the Food & Drug Administration as a CNS shunt patient that led to my designing the DiaCeph Test. My efforts then helped bring about the 1999 International STAMP Conference in Washington D.C. At that time, many in industry felt the conference and FDA upholding my petition were heavy handed actions designed to hinder innovation in industry. But in the years since, it has been shown to be just the opposite, that without mHealth tools and patient engagement, there will be less innovation, more challenges for physicians, higher costs & disability rates for patients, and a lower quality of life for those affected. It is time for industry, FDA, and Congress to stand in our shoes! In 2015, I also published my current health challenges with hydrocephalus and a related neuromuscular disorder on my blog in this case study.

Many of the CNS shunts in use today are programmable shunts, where pressure and flow rate can be externally adjusted for each patient. But, many of these devices have been susceptible to inadvertent reprogramming from household appliances and technology magnetic fields. At present, FDA does not allow patients to own the reader or programming tool to help manage these unforeseen events. I would love to develop a mobile app or accessory tool to allow patients to check the setting of their shunts.

Other Brain Apps

I use other brain apps on the Android Play Store to help with the management of hydrocephalus, including, a Decibel Meter, EMF Detector by Smart Tools, and a Weather & Barometric Pressure app by Elecont Software. The more recent availability of EEG readers has further elevated the prospects of brain apps in neurological care, and in meditation and mindfulness – SEE my other blogs for information on these.

I advise and write about brain apps, often helpful in hydrocephalus and other neurological disorders. In this blog, I share tips on design & using apps:

Design & Best Use of mHealth Apps

And in this very popular mHealth blog, I discuss how to use a weather app for management of migraine headache:

Weather Apps and Web Sites for Management of Migraine

The slide image below is the barometric pressure reading from my Elecont weather app.

The Elecont HD app provides an hour by hour barometric pressure reading that can be used to help manage migraine headache.
The Elecont HD app provides an hour by hour barometric pressure reading that can be used to help manage migraine headache.

DiaCeph Development Costs and Other Barriers

Estimates to develop a hydrocephalus mHealth app are as high as $1M. Requirements by FDA are driving these high costs. In developing countries, FDA guidance does not come into play. And for those regions, a “text app” version of the mobile data software could be created to do monitoring on a standard mobile phone, and text the results to a regional hospital or clinic. My DiaCeph Creative Brief is currently 16 pages. I understand this is too large for most reviews. So I am preparing a “short” and “long” version.

I understand there are organizations who could help develop or fund my mHealth app project. My wish would be to work with a mHealth software group and provide the guidance and expertise to develop the DiaCeph app, and then advise on other applications.

Currently, development of mHealth apps for disease management have become a political ball game between patient advocates, the Food & Drug Administration or FDA (backed by big corporations), and Congress. Earlier this year, a bill was introduced in Congress by Senators Deb Fischer (R-Neb.) and Angus King (I-Maine), identified as the PROTECT Act (Preventing Regulatory Overreach To Enhance Care Technology). The bill has garnered the support of IBM, athenahealth, the Software & Information Industry Association, and Newborn Coalition and McKesson.

Shortly after introducing the act, the legislators penned an editorial in USA Today calling FDA’s regulatory process burdensome and a hindrance to innovation. One organization, with connections to big pharma lobyists, calling itself the mHealth Regulatory Coalition (MRC), has come out and opposed it. But I suspect they don’t live with a medical condition like hydrocephalus, that would benefit from these mHealth app innovations.

PROTECT Act Bill S2007

Protect Act Story on Protect Act

Groups Opposed/Conflicts of Interest to mHealth

Protect Act under Fire

Pediatric Hydrocephalus Foundation supports PROTECT Act

Many individuals with hydrocephalus have had 100 and 200 surgeries, and live a very poor quality of life. Quality of live, and unnecessary brain surgeries, would no doubt be improved with the availability of mHealth app diagnostics.

If you are interested in development of the DiaCeph Test, obtaining a hydrocephalus consult, mHealth consulting, or my speaking at an event, please contact via the information below.

Stephen Dolle
Dolle Communications
Email: contact [at] dollecommunications.com
Tel. (949) 6424592
http://www.dollecommunications.com/
http://www.hydropowered.org

Contact Stephen Dolle
Contact Stephen Dolle
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Fundraising for Hydrocephalus: Follow the Creators of the Ice Bucket Challenge

This morning I received my usual TED talk email and was literally brought to tears watching the TED presentation by Nancy Frates, the mother of Pete Frates, who came down with ALS a couple of years ago. It was Pete and Nancy and their family who put together the ALS campaign that included the ALS Ice Bucket Challenge. It then became a smash hit this past Summer. In her TED talk, Nancy details how it all began with Pete’s diagnosis, Pete saying he wanted to get this in front of philanthropists such as Bill Gates, and to dividing up the various responsibilities of their campaign.

I earlier wrote about the ALS Ice Bucket Challenge fundraising campaign as it was becoming a Summer sensation. My interest is partly in that I’ve been involved in fundraising, but more out of my personal interests and challenges in living with the disorder, hydrocephalus, since 1992. The effects from my hydrocephalus have been considerable. I lost all of my work and related skills after an auto accident that caused it. And it took 16 years, 7 surgeries, and much of my own making to finally get a CNS shunt to do what they are supposed to do – properly clear CSF fluid & pressure from my brain. Out of survival, like the Frates did, I became involved in advocacy for hydrocephalus, and this led me to efforts with the Food & Drug Administration (FDA) and their oversight of problems with CNS shunts, which are the medical devices principally used in the treatment of hydrocephalus. In 1996, I learned of a leading CNS shunt having specific problems that I suspected was connected to my poor health, and I reported this to the Food & Drug Administration. Then I learned it was likely responsible for thousands of additional surgeries and poor outcomes over 10 plus years. Some in the field knew about this, but nothing was done to change it. So I petitioned the FDA. It took me over a year to gather the studies and assemble it all. And I did this all in spite of considerable health & cognitive challenges.

In 1998, FDA upheld this petition. But what followed was dishonest and troubling, and led to many of the ongoing failures in CNS shunt safety and progress in hydrocephalus care. Yet in 1997, in the two-year interim period it took for FDA to issue a ruling on my petition, I designed & patented a home software method to monitor hydrocephalus (the DiaCeph Test) and address many of these CNS shunt issues. It was a program to run on a custom PDA device. I presented it at the 1999 STAMP Conference in Bethesda, MD. But FDA, and much of the medical industry, scoffed at my efforts. Some of this correspondence is still on my main web site. At that time, few neurosurgeons believed in collecting & sharing medical data on PDAs or over the Internet. I suspect their sentiments are different today. I was also outspoken on the need for progress in hydrocephalus care. And it led to the Hydrocephalus Association, several partnering shunt manufacturers, and their key board neurosurgeons, “blackballing” me of sorts in the field. I was responsible for the 1999 STAMP Conference. But I ceased much of my advocacy after this, and by 2003 had moved on to other interests in the neurosciences. Meanwhile, shunt after shunt after shunt was introduced with problems, including, my current Certas valve which was recalled last year. My 1997 design of the DiaCeph Test would have been one of the earliest mobile apps. Today, it sits on a shelf.

Now when you watch Nancy Frates’ TED talk, you can see her passion, and hear her talk about confronting complacency, and poor colaboration on ALS research. She also instituted an “action plan” right from the start. I also earlier wrote about the ALS Ice Bucket Challenge, and cited the amazing efforts by Christopher Reeve on behalf of spinal cord injury. And there is one very very important element of their respective campaigns: THEY DID NOT COZY UP TO INDUSTRY & COW TOW TO THEIR WHIMS! They told it the way it was, engaged the masses, and industry then followed their lead.

So for those of you who truly want to bring progress to the care & treatment of hydrocephalus, stop cow-towing to industry and be unique and create your own fundraising and awareness campaigns. For me, last year I created the cool site http://www.HydroPowered.org for sharing fun & art on hydrocephalus, and for fundraising when the opportunity presents. Be unique, sincere, passionate, and organized.

Enjoy Nancy Frates TED talk.

FDA’s Proposed Reclassification of Hydrocodone a Dangerous Precedent for Patient Care

In an effort to apparently combat “misuse and abuse” of pain-killing drugs, the Food and Drug Administration has proposed new restrictions that would change regulations for some of the most commonly prescribed narcotic painkillers on the market, specifically, hydrocodone combination pills also known as opioids, which combine hydrocodone with less potent painkillers such as acetaminophen. One widely-used drug is Vicodin, or hydrocodone APAP with Tylenol.

Currently labeled as Schedule III drugs, hydrocodone combination drugs would, if the reclassification proposal is accepted, be labeled as Schedule II. This means patients would have to have a written prescription from a doctor, instead of a prescription submitted over the phone, to obtain the drugs. And refills would be prohibited. Instead, patients would have to check in with the doctor to get a new prescription for each refill. A Schedule II classification would also put manufacturing quotas in place for these hydrocodone products. Pure hydrocodone is already a Schedule II substance.

These new restrictions would no doubt make it much more difficult for sick patients with legitimate medical concerns to obtain access to these medications that they’ve used safely for years. These new restrictions, if passed, would no doubt put patients under unnecessary risks and stresses, delaying treatment and posing considerable additional costs to patients in time and more costly alternatives. Some patients may also turn to “street” forms of Vicoden, as well as those available over the internet, which can often not be the same drug. The federal government’s DEA agency also led a campaign on these proposed changes, as was the original bill drafted by Sen. Joe Manchin (D-WV).

However, as a patient advocate, neuroscientist, and long-time hydrocodone user for complications relating to hydrocephalus, I view this proposal as a dangerous new precedent and example of government, as an outside 3rd party, over-extending its authority in interfering in patient care in a matter where there is no clear product safety issue. The same could be said for guns or gasoline, where a consenting adult lawfully chooses to shoot him or herself, or drink gasoline. Do you ban the guns and gasoline? They will merely find another alternative, and very likely one that is more problematic.

And it gets even worse. Dr. Sidney Wolfe, long time medical director of the group, Public Citizen, spoke out in favor of the proposed changes saying he thinks it will curtail drug overdoses and mis-use. But, we know that such reasoning has not worked in the past where there is a rational need, no clear risk, and the alternatives, street and internet drugs, then become the new problem. Dr. Wolf’s comments can be found via this link:

http://www.aboutlawsuits.com/public-citizen-vicodin-restrictions-40746/

The reality is that there is a true medical need in a vast number of the prescriptions amid an aging population, with arguably limited care & alternative options available to the millions of users, and with a pretty widespread lack of understanding of pain management practices by prescribing physicians. Plus, in countries with fewer pain medication problems, they have far more alternative & Eastern medicine modalities at their disposal. In the U.S., such “alternative” therapies like acupressure, massage, energy healing are not covered by insurance. So in these regards, it would appear the U.S. has created many of its own problems.

Most recently, Janet Woodcock, M.D., Director, Drug Evaluation and Research at the Food & Drug Administration, authored a “statement” in support of this hydrocodone reclassification. She takes more the position of the DEA than that of a treating physician on safety and efficacy, and she offers no alternate solution. Her views are unprecedented in patient safety and access to care, where government can see a problem and take action without there being an issue of product safety. Here statement can be found via this link:

http://www.fda.gov/Drugs/DrugSafety/ucm372089.htm

As you can see, I do not support the government’s position in restricting access to a medical drug or device where there is no safety issue in the drug or device or medical treatment when used according to the labeling. In my view, the problems are more a misunderstanding of pain management practices, poor & failed care, and a lack of available funded alternatives. Pain management is in fact a medical specialty, where there are specific courses to follow, too few physicians follow these, and where patient and physician widely use drugs like hydrocodone because of economic reasons….. which may amount to one more reason for ObamaCare.

There are many medical products that are safe when used as directed. But, casting a restrictive blanket policy over a class of safe products because of physician expertise or available care dollars, or because “the nation” is suffering a health & mental health crisis, is ludicrous!

Further, these new restrictions will compromise the care of user patients. Some will seek illegal street and cross border drugs, and drugs thru the internet, which pose much higher risks & costs, while others such as myself, will face compromises and a deterioration of their care, and for no other reason than the DEA wants to curtail illegal drug use. This is a failed policy used in the 1930s!

As for the group, Public Citizen, I earlier worked on a shunt device safety issue with them in 1996, and upon their urging, I petitioned FDA on widespread safety issues with CNS anti-siphon shunts. The petition was considerable and took me 9 months to complete. FDA sided with me, and then held the 1999 STAMP Conference on High Risk CNS Shunt Devices in Washington, D.C. But as I had criticized a medical device company (Medtronic Inc.), someone saw to it that I was never placed on the STAMP advisory panel. And in the years since, CNS shunt safety issues have been atrocious, and despite my repeated inquiries to FDA on these safety problems, including, a request in 2003 for new Postmarket Surveillance of CNS shunt technology used in the treatment of hydrocephalus, no new safety initiatives were ever undertaken, and there were clear device safety issues. I find it odd that FDA could not act on CNS shunt safety where there were clear product safety issues, yet, was happy to over-step its authority in this hydrocodone matter where there is no product safety issue. In the latter, the issue is more one of physician oversight and a lack of health care dollars. I do not see how restricting the product solves this!

My latest CNS shunt which was implanted last November 2012 has already been recalled. Oddly, my earlier model like this in 2007 that kept loosing its setting and had to be surgically replaced, never faced any recall, and that issue was much more substantial that the most current model. I cannot wrap my head around the safety views adopted by FDA today. It really is shocking!

As for Public Citizen, I no longer have any relationship with them, in part because they never took any interest in my revelations of widespread failures of CNS shunt devices in the field, some of them involving criminal misconduct. And I felt they’d become too political. Their misguided activism in this recent hydrocodone bill only solidifies my concerns.

But I think my bigger concern now is WHAT’S NEXT? I mean, we already have massive authorization and reimbursement problems with drugs, devices, and many medical tests. And hydrocodone is very cheap in price compared to the alternatives. So how will this new government philosophy concerning medical care more forward, where a 3rd party group with no connection or standing in the care of a patient, is allowed to champion restrictions in patient care merely because they fear the a particular product poses a secondary social issue?

The reality is that this new bill is much bigger than hydrocodone use or misuse. It’s about the government’s prerogative to interfere in one’s access to medical care and treatment, not to mention one’s civil rights pertaining to health & happiness as protected under the Constitution! No doubt this proposed new legislation is a shocking invasion by government into one’s private life and medical matters, and represents a dangerous precedent over matters of patient care.

Stephen Dolle
Dolle Neurosciences
Newport Beach, CA

How’s your Implant Functioning (My BWE Sub-title to Terminator 3 Movie)

This is my Brain Awareness Week (BAW) photo which illustrates what we need to aim for in our brain science efforts: “Self Sufficiency.”

If you recall, oTerm3 Hows your Implantne of the primary themes of the Terminator movie series was the Terminator’s wherewithal to correct its own body breakage & malfunctions. For more than 50 years, Western Medicine has been surgically putting in a wide array of medical implants from bone screws and plates, to heart valves, CNS shunts for hydrocephalus, and neurostimulators for Parkinson’s Disease and seizure disorders. The most problematic of these are CNS shunts, which I have been living with for 20 years.

Over the last 20 years, I have worked feverishly to educate medical science of the needs for self-sufficiency and home diagnostics & solutions to keep the shunt and individual functioning. But medical science in nearly every branch, from FDA to device mfrs to practicing physicians, have remained oblivious to the needs of the patient, and what is technologically possible today.

In 1997, after petitioning the Food & Drug Administration on widespread oversight and needless failures with many CNS shunt devices, I designed and patented a home monitoring system for hydrocephalus and CNS shunt users based on non-invasive methodology which I named, the DiaCeph Test. When I introduced it to scientists at the University of California at Irvine (UCI), I was heralded as a pioneer and visionary by Dr. Eldon Foltz, a long-time practicing neurosurgeon & researcher in hydrocephalus. And when I showed my concept to NIH, they fell in love with it and urged me to find a credentialed university scientist or physician to write the NIH grant application. Later, however, UCI would inform me they would have to own everything, or it wouldn’t be possible for UCI staff to write the grant. I was given no other alternative other then giving it to them, which didn’t make any sense. So I continued to show my DiaCeph system to companies and others in the field, all to no avail. Back then, it was going to be a stand alone software device where we’d be seeking insurance reimbursement, a Medicare code, and industry distribution.

Today, however, the DiaCeph Test could be an app for a mobile phone! The future is now and we need to grasp it! We need to develop cost-effective neuro-technologies for common disorders of the brain, take mind-body modalities, music therapy, mobile apps & AI technology to the next level!

In support of my Terminator 3 BAW photo, I added the caption, “How is your Implant functioning?” I added this from years of frustrating experiences w/ CNS shunt implants where one is left w/ a malfunctioning CNS shunt implant, yet limited to no means to get it fixed. It would seem the age-old saying applies here, “IF you want something done right, do it yourself!” So goes the Terminator! — with hydrocephalus association and national hydrocephalus foundation.

Stephen Dolle

20-year hydrocephalus survivor

Inventor & Neuroscientist

Drum Circle Facilitator

Medical Intuitive

http://www.DolleCommunications.com

Newport Beach, CA

Help Me Kick Off Brain Awareness Week 2013

Brain Awareness Week 2013!
Brain Awareness Week 2013!

Today, kicks off Brain Awareness Week 2013. I selected this image as my favorite for this year’s campaign. I feel the image demonstrates the electrical & energy dialogue both inside our brain, and with the world and environment around us. We are connected, “on-line,” whether we like it or not, even when we’re sleeping and dreaming. So I ask this 2013, what are YOU doing for your brain and the collective consciousness this year? Our BRAIN is the most valuable asset we have. But in 2013, we still invest more dollars in guns & bombs and ways to kill people, than care/defense for our brains. Help me make “peak brain performance” a national priority in 2013.

In 1992, I suffered a brain injury that led to the condition, hydrocephalus, which has required 12 CNS shunt brain surgeries in the 20 years since my accident. During that time, I undertook research in hydrocephalus, neurological devices, assistive technology, music therapy, sensory processing disorders, and today drumming and the brain. In 1997, I designed and patented a AI type of monitoring system for hydrocephalus, that could be produced as a mobile phone app today. Help me make this app possible!

The last several years have been particularly troubling for me with unresolved hydrocephalus and numerous CNS shunt malfunctions & related brain surgeries. And when I’m out around my city and region, as well as watch national & world news on television, I am troubled with the lack of attentiveness to those with injury and impairment of the brain, and the level of commitment of financial resources towards research and ultimately, new treatments in this area. Brain injury and related disorders will effect each of us in our lifetime, either directly, or through an affected family member. The time is NOW to meet this CALL TO ACTION and get the better of brain injury & disorders, instead of the reverse. YOU can help your OWN cause by taking an interest in brain awareness and related research spending.

We are in desperate need of implantable diagnostics in today’s CNS shunt devices. We are in need of a “flow sensor” that would provide continuous readings on CSF flow thru the shunt, and could then be incorporated with patient day to day and clinical data to ultimately know how & whether the shunt is working 24/7. It would provide more timely medical intervention in instances of shunt malfunction, a very common occurrence, dramatically raise quality of life, improve patient outcomes, and pave the way for newer and better shunt devices. Wall Street and medical manufacturers should not have to choose between investing in shunt devices that they make money on today, versus a new implantable sensor that they’d make money on tomorrow!

Help me make brain awareness and scientific investment in brain treatments & technologies a priority in 2013 and beyond, and especially for the disorder hydrocephalus.

Stephen Dolle DolleCommunication.com

Newport Beach, CA

Availability of Patient Medical Apps in U.S. now under new FDA Regulations

After more than 75 years, medical questionnaires that patients use to share information to physicians, are yet to innovate. Here’s what our FDA is doing now in regards to this innovation. See the accompanying story link.

 

Having spent many years in clinical nuclear medicine, and more recently, the neurosciences, I always viewed myself as an innovator. But, when I’m a patient undergoing any type of medical treatment, I’m less forgiving of an industry’s unwillingness to innovate, and their insistence to hold the marketplace hostage for their failures.

 

Way back in 1997, some 5 years and four failed surgical attempts later to get one of my CNS brain shunts to correctly drain CSF fluid needed for my hydrocephalus condition, I designed a patented a software-based monitoring system & named it the “DiaCeph Test.” It was to be a stand-alone software device. Fourteen years later, the DiaCeph Test still sits on a shelf, while new diagnostics needed for hydrocephalus and many other disorders, are not brought to market. This, and tech monitoring of many other disorders today, could be done via mobile phone apps.

 

Here’s the link to info on my DiaCeph Test, though it’s not been updated in a while: http://www.dollecommunications.com/DiacephPatent.htm

 

Also, visit your Android or Apple store to see what’s available today.

 

My frustration boiled over recently as I was passed between physician specialists and a slew of lab and other diagnostic tests. Truly the medical field is failing to innovate both in the collection of relevant patient information, and in IT systems that should be mining patient tests results for the appropriate steps to follow. Widely today, physicians still use the same patient questionnaires that were introduced over 75 years ago. And no to very few clinical apps have made much of a dent in care in the doctor/patient relationship. And with all the money spent in health care in the U.S., and all of the political wrangling over Obama Care, why is no one talking about these key failures to innovate, and the difference it could make in care today?

 

I’ve enclosed a link to an industry story on the Food & Drug Administration’s new law and guidance regarding health apps. It remains unclear whether these regulations will help or hurt the cause for innovation. But it is certainly a story and topic you should follow, at least if you think there’s chance you might need medical treatment any time soon.

 

Of course, you could seek alternative medical care for what ills you, such as the drum circles and healing (that I do), or chiropractic, meditation, energy work, essential oils, vitamins & herbs, and energy water, to name a few of the alternative options that are available today. These each have some efficacy in bringing about positive outcomes. But, if you have a serious or more chronic illness, you probably want a more proven medical treatment. But, you’ll need supporting technology to make this all work, and you had better stay atop these developments in the industry, and in Washington.

 

Enjoy the reading.

 

http://www.informationweek.com/healthcare/mobile-wireless/new-fda-law-paves-way-for-mhealth-regula/240004268

 

The Real Truth about Why We’re not Getting mHealth Apps

Earlier today, I spent the time to comment and refute the claims of a so-called expert on mHealth, claiming that we’re going to being seeing all kinds of cool new mHealth health apps in the coming years. The expert is Chad Udell, and his projects appeared today in the on-line journal Health-Care IT News, and under the title, “mHealth Poised to Explode, Expert Says.”

http://www.healthcareitnews.com/comment/reply/46506

Why am I bringing it up here? The publisher removed my comment, no doubt because I questioned the expert in their story. So, I am reposting my comment below for you all to read it objectively. And then you can read what the article and expert said that I disagreed with.

“I’m sorry, but I can’t disagree more with this author on his mHealth story. For an (health care) industry that consumes far more of the nation’s GDP than any other sector, the availability of mobile apps is really off the mark, and I don’t see it changing anytime soon.

The Food & Drug Administration two years ago drafted new guidance that will complicate and slow the introduction of mobile health apps, no doubt at the bequest of big insurance, the AMA, and big pharma and medical device companies. The only hope I see of a change in these policies lies in if consumers (patients) scale back the use of drugs and medical procedures, and this would require a lot of consumer frustration. But, the increasing copays and deductables are fueling such sentiments.

At the end of the day, consumers are being asked to pay an ever-increasing share of their medical care, while having limited control, objective information, and patient tools needed in their care. Eventually patients will DEMAND new patient care and mHealth tools. But it hasn’t occurred yet in Western Medicine.
Any writer or analyst who purports to know WHEN and HOW this will occur would now doubt be poised to be a billionaire. And I don’t see investors lining up!

I’ve had ten CNS shunt surgeries since 1992 for a post traumatic hydrocephalus disorder. In 1997, I designed and patented a software monitoring system for this disorder, much like the Impact Test for post concussion. It took a lot of push to bring the Impact Test into widespread use, though it did’t eliminate clinical care & core hospital care like my hydrocephalus app would. A lot of the care eliminated by the Impact Test were neuropsych and unnecessary rebab for affected patients. Today, sports concussion is now widely diagnosed and cared for via the Impact Test.

Arguably, an app like my DiaCeph Test would have a similar impact on hydrocephalus care. Yet, hydrocephalus doesn’t have the same push as did concussion. Most people today still don’t know what it is. So the prospects of an mHealth app anytime soon for hydrocephalus look bleak.

We’re in for a long fight as to getting the kind of mHealth apps needed today. But, please share your thoughts and ideas here.

Stephen Dolle
Dolle Communications