Sunday, November 11, 2007

The Autologous Biologics Revolution

All around us we're seeing a revolution in information transfer that has the big established businesses quaking in their shoes. Digital music has meant that the recording industry has to figure out a new distribution model. Digital access to information has also changed the medical world. Researchers frustrated with publishing companies have started to publish their own "open" journals, meaning that they commit to free access to all of the research, rather than allowing publishers to pillage by charging high access fees for research articles. In fact, the existence of this blogging technology shows the decentralization of the traditional news and information sharing power base. Now anyone with a video camera or great ideas can get them to a worldwide access. The same thing will happen in medicine, and Regenexx and Regenerative Sciences are a case study.

In medicine, new technologies and therapies have been largely controlled by Big Pharma or the big device manufacturers, a collection of big corporations with the tens to hundreds of millions that it costs to push these new treatments through our American medical system. First, there is the FDA, then insurance companies, then getting doctors to change their prescribing habits. Each step takes big money. As a result, many promising treatments never make it to patients and small diseases get no effective treatments. Case studies in how this modern medical gantlet has failed society can be found in treatments like "The Ketogenic Diet". This effective treatment for pediatric seizures has been known about since the 1920's, yet it took a motivated a rich Hollywood producer with a severely epileptic child to expose this hypocrisy. He tried the best neurologists in the world who just placed his child on the next blockbuster drug that didn't work. He finally ended up hearing about this well researched diet in a waiting room. He tried the diet, the kid's seizures resolved, and then he went back to his neurologists with a film crew. On national TV, one said that he didn't know about the diet because the drug reps who frequently educate doctors failed to mention it as a therapeutic option. The problem was there simply was no way to monetize the diet in today's medical system.

The next ten years in medicine will see the rise of physician driven, highly technical medical break throughs that will have big pharma reeling, much the way that the RIAA is reeling from open source digital music. Why? Think about what it took to get to a medical break through just 15 years ago. Just to be able to sift through the published world medical literature on a topic took an army of library staff. I remember in medical school what was called, "Index Medicus". This massive book held special search terms that took an experienced medical librarian to interpret. If you knew the magic code, and if you could spend many hours, you could find a few paltry research articles. Compare that to today, when anyone can get daily downloads of hundreds of medical research articles at the touch of a button. Why does this increase in information transfer matter? As discussed by authors such as Ray Kurzweil, the instant access of all of this research data to more brains will result in a much accelerated rate of medical progress.
Where will this type of innovation occur? Autologous biologics are the most likely starting point. This science simply involves taking one part of the body like blood, minimally manipulating it, and transplanting it to another area to produce an effect. This is already happening in simple treatments such as platelet rich plasma, where surgeons are now using the growth factors isolated in this biologic to enhance their surgical results. The next big area will be autologous mesenchymal stem cells, as in the Regenexx procedure being used by RSI.
Part of the reason why this shift will occur is that physicians will also demand more control over care. This has already begun happening with physicians in droves leaving the hospital for out patient care settings like surgery centers. Again, the other reason as above will be that the "knowledge gap" once held securely by big pharma will erode.
My personal observations on this topic from development of the Regenexx Procedure fit this pattern. We were able to integrate this procedure into our practice with a small research team that was much closer to the ground than big pharma could ever muster. By this I mean, our doctors had certain clinical problems they faced that they had to solve. These problems drove development of this procedure. All of this occurred in a fraction of the time otherwise possible. Unlike big pharma, we weren't concerned about government grants or huge clinical trials. We knew we had an outcome endpoint we could observe on MRI (repair of tissue) and as doctors, we had clinical observations that could guide development (what worked in the past and what didn't work). In addition, the Internet and mass access to the latest worldwide research on mesenchymal stem cells allowed us to take the next steps in our studies. I have also seen this in my colleagues. I know many docs who are taking advantage of this new information technology to develop devices that meet their needs. Rapid computerized prototyping and Internet access to online patents has allowed these docs to take a good idea and move it to market quickly and inexpensively. I call these "development docs".
Who will be big winners and looses in this coming wave of autologous biologics? Big pharma will initially be confused by all of this, but will eventually come to understand that their research and development dollars will stretch much further by partnering with "development docs". Big pharma and the universities they partner with will be the air craft carriers of development world. They have the big firepower, but the big boat can't turn on a time. Eventually, this shift from big established research groups to smaller "development docs" will allow more innovation and much quicker medical break throughs to occur.