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Photo: Stephen Dolle in front of the capital in Washington, D.C., while attending the 1999 International Food & Drug Administration STAMP Conference - he helped create.

The DiaCeph Story: A Memoir of Survival after Brain Injury, a look inside the U.S. Medical Industry, and One Patient's Journey to Invent New Technology, Motivate others, and Persevere His Dream.

The "DiaCeph Story" spans 14 years, requiring an ordinary man to overcome extraordinary odds, personal trials, and tribulations unimaginable in today's times. But, Stephen Dolle turned tragedy into triumph. Lemons into lemonade. His story follows a 1992 auto accident and brain injury, mysterious complications while in the care of a major university medical center (which reduced him to the functional level of a 12 year-old), his battles to regain his life, and the extraordinary new skills he developed along the way - that intrigue experts across multiple disciplines.

Stephen reveals in intricate detail how, through a series of CNS shunt surgeries, his health deteriorated and left him with a "disability sentence." Through his resourcefulness, determination, and inventiveness, he would make extraordinary discoveries in this area of medicine and public policy. He became an expert and  inventor of U.S. medical technology, an expert in U.S. Food & Drug Administration policy, in evaluating medical studies, matters of law, artificial intelligence (AI), and rhythm and hand percussion. He presented his findings of a four-year investigation into FDA and complex CNS shunt failures in a 1996 FDA Petition, and handed the industry a road map of recommendations and technology for the 21st Century. 

Post injury, he was forced to totally redefine who he was - and who he would become. There was no proven script. No rehabilitation program. No business model. He relied on his faith, perseverance, and a trust circle of family and friends. He created clever methods to retrain his memory to recall and process new experiences, and other methods to retrieve lost ones. He found humor in many of his tribulations. For instance, he viewed loosing memory as a blessing. He could watch favorite movies over and over - like seeing them for the 1st time. Should people offend him, he couldn't stay angry - because he couldn't remember events long enough to stay angry. He had more important things taking up his memory banks! When socializing, if any around him questioned as to why he was not drinking alcoholic beverages - he would response, "Why pay for what I already have for free."

Within a couple years of his injury, Stephen was reviewing complicated scientific, regulatory, and legal papers and books. He would only read a few pages at a time, and use highlighters and Post-It notes all over the papers. Every day - he watched as many political debate and baseball games on television as were available, so as to re-learn his language, comprehension, knowledge of national events, and baseball - all through repetition and emulating the speakers on TV. The repetition strengthened his short-term memory, and then he would attend his son's baseball games and talk more baseball with the other parents and kids - or anyone who would listen. In just a few years, Stephen began to sound like a sports commentator. If there was a word he didn't know or remember, he would look it up and make a note.

He eventually began to research CNS shunt technology and FDA regulatory affairs practices, requesting numerous FOI records on "microfiche" (pre-Internet era). In 1996, Stephen was told of a new critical study on anti-siphon shunts that appeared in the Journal of Neurosurgery. He then undertook his most impressive project since his accident. He compiled years of field data, published studies, findings and conclusions, and federal codes in authoring a petition to the FDA. As Stephen would learn - the FDA appeared "unfamiliar" with these findings. Why weren't these thing being reported by U.S. neurosurgeons, scientists, or any manufacturer? Had all sense of morality, safety, and ethics evaporated in the medical field? Stephen cites one reason in this Letter to the Editor that was published in the Los Angeles Times.

It took Stephen eight months to collect, review, and compile hundreds of pages of studies, federal codes, and notes, in preparing this 15-page FDA Petition. While reviewing hundreds of neurosurgery field studies on hydrocephalus and CNS shunts, Stephen observed a re-occurring serious problem: the unavailability of adequate diagnostic tests to document shunt malfunction, shunt failures, and a void in pre-surgical protocols for best matching of CNS shunts. This void in adequate diagnostics lead to "significant quality of life" issues for nearly all those with CNS shunts, added to the medical costs of treatment, and incurred associated disability.

The problems and issues were widely reported in major medical journals - but few appeared to "get it." During this time, Stephen began to speak often with John Holter, credited for pioneering silicone shunts to save his own son's life in the 1950s. In FDA regulatory language, CNS shunt device issues are measured in terms of "outcomes assessment." Stephen notified the FDA of the data he obtained on outcomes - and his intent to design a new CNS shunt monitoring system, which he completed one year later and termed the DiaCeph Test. It could capture critical shunt data on a user using a hand-held computerized device - and no attachments or invasive procedures. In 1998, he would use his new DiaCeph Test to direct his own corrective shunt surgery - as it provided diagnostic information not otherwise available.

Stephen's petition was said to change the way the FDA viewed the role of the public as a patient-consumer. His efforts were so compelling - the FDA held a special International STAMP Conference in Washington, D.C. in 1999 to address many of his findings and conclusions. Political meddling, though, prevented him from presenting his DiaCeph Test, research, and recommendations at the STAMP Conference. In place of speaking, he authored a special Paper on FDA Recommendations, and distributed nearly 50 copies at the conference. In 1999, he was termed both a pioneer, and hero, and written up in the Orange County Business Journal as "The Accidental Inventor." Later that year, he initiated a series of inquiries with the Commissioner of the FDA - that would reveal a bombshell of corruption.

Many have asked how he came to create the DiaCeph device and overcome so many obstacles. Few in the neurosciences field knew of Stephen's pre-injury career. That doesn't come up much when being treated for a serious brain injury. Perhaps it's too much of a sensitive subject, at a time when surviving the injury takes front and center. But, his pre-injury career spanned more than 15 years in science and medical imaging, owning a medical business, fundraising, and work in entertainment. He estimates that in his medical work he worked-up over 10,000 patients, and produced hundreds of discoveries, many of which were never published. Who would have thought it would matter later? Other accomplishments include rescuing a scuba diver in Hawaii in 1984, a stranger sure to die without heroic intervention, and 8 to 10 years as an accomplished youth baseball and soccer coach.

Today, Stephen has observed occasions where he understands languages he's never studied. It's unclear if this skill is due to his efforts with drum circles and percussion, or his new intellectual skills and spiritual disciplines. Drum circles, music and art are known to greatly affect neurological development, and well as recovery from trauma and changes in neuropathology. However, in consideration of his collective efforts in music, rhythm, the brain, and neurosciences, he produced a ground-breaking study that lends new insights into learning.

What does his future hold? It would seem clear, based upon these extraordinary accomplishments, that what lies ahead will be of great importance.

Stephen acknowledges the special efforts of Dr. Michael Muhonen of Children's Hospital of Orange County, Dr. Eldon Foltz of the University of California at Irvine, Dr. Michael Levy of Children's Hospital of Los Angeles, Pat McAllister, Ph.D. of Wayne State University at Detroit, and Dr. Alfred Aschoff, of the University of Heidelberg, for his center's critical studies which compared hundreds of CNS shunts. He endows personal recognition and appreciation to his son and former wife, his mother and father, extended family, and devoted friends for never giving up on him.

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