Hope all is going well and that you are enjoying the last few weeks of summer. Most people feel like once Labor Day hits, the party is over. But, in reality, summer lasts into late September and where we are located, comfortable temperatures can go all the way through October. Sometimes mother nature can play some tricks on us but on average, our weather can be really nice even into November. The nice thing about having adult children is that there is no more school schedule so Tina and I can really take advantage of those latter months, which we try to do.
I was recently reading an interesting article from the New York Times entitled “The Long, Long Wait for a Diabetes Cure” (https://www.nytimes.com/2022/08/09/health/diabetes-cure-type-1.html). It is about a filmmaker named Lisa Hepner who discusses hers and others struggle of dealing with diabetes. The running “joke” for those with diabetes is that the cure is 5 years away, the same promise of a cure has been told to her for over 3 decades. The article discloses that Mrs. Hepner has put together a documentary with her husband called “The Human Trial” (https://www.thehumantrial.com/watch) that chronicles the struggles of two patients Greg Romero and Maren Badger, who became among the first patients to have experimental cell pouches implanted under their skin in an attempt to control their diabetes. I haven’t had time to watch the film but I am going to check it out.
This article got me thinking about all of the things that need to go right to bring a device to market to help patients. I am sure there are other factors but I think the three that I present in the title of this week’s blog really drive the issue. For those of you who are like me and have a long memory (a.k.a. more mature/older), these topics sound like the old Warren Zevon song “Lawyers, Guns and Money.” I really believe that all of these factors play a critical role in what will eventually get to the patient. These areas (patients, science and money) seem to be inter-related and need to be met in order for new therapies to move forward. Let’s take the case of diabetes. According to the CDC, there are 37.3 million Americans—about 1 in 10—that have diabetes. About 1 in 5 people with diabetes don't know they have it. In this scenario, you have a significant patient need driven by all of the issues associated with diabetes, both early (Type 1) and late (Type 2) onset. Thus, the patient need is evident. There are two questions related to money: 1) is there enough to tackle the problem? and 2) is there enough money to be made if a product is made? The answer to these questions for diabetes is a resounding yes.
Where there is a disconnect is in the science. This is not anyone’s fault. There has been a lot of funding, time and some very brilliant folks trying to tackle this problem. I do think sometimes that a wider swath of scientists should be brought into this effort. Similar to many areas of the workforce, sometimes only the “thought leaders” are leading the charge exclusive of the outside groups which tends to narrow what potential solutions can be developed since only a few viewpoints are followed. Another example of this is related to research focused on Alzheimer. A majority of the main companies doing research in this space are targeting one protein in the brain. To date, there have been 0 drugs that have been effective in these patients. I do think that this process needs to change in order to get ideas outside of the “main stream” so that all avenues can be pursued.
As you know from my previous blogs, one of the technologies we are developing centers on cell delivery for such applications, what we call our Bio-Spun™ Cell Chamber. It is not an area that we initially pursued when we started the company. We realized, based on how our Bio-Spun™ materials heal in preclinical trials when used in different devices, that this could be an application. One of our collaborators had significant interest in this space so we decided to pursue developing a prototype cell chamber. We were coming at this with a fresh approach not “jaded” by any of the “thought leaders.”. I am not telling you that we are the only ones out there that could provide potential options. I think all of these need to be explored, with funding allocated for new ideas to see if any of these ideas could be options. Trying the same old approaches will, similar to Alzheimer’s research, not yield a cure. We are also not saying that we have the solution, but we think it is something worth exploring based on data our group and others are getting with our chamber.
Diabetes is not the only disease where patient, science and money do not align. Patients that suffer from rare diseases have the issue of having limited number of people afflicted so companies willing to dive in are limited. The other issue is that a lot of money has to be spent and if a successful solution is achieved, the issue then becomes how do you pay for it? A recent example of this is Bluebird Bio, which recently developed a treatment for a rare blood disorder. There are only 1,500 patients in the United States so treatment is expected to cost $2.8 million per patient. While this seems excessive, the healthcare industry pays $6.4 million per patient for blood transfusions for these patients. Even with these results, insurers in Europe did not cover this and the company pulled the treatment for those overseas patients. We will see how this therapy is received in the US. This is just one example of many where there is no alignment between the “holy” trinity. These will be areas that we continue to align as we look to work with partners to bring our technology to patients one day. Our focus has been and will always be the patient and we will continue to fight for them.
Please check out our next one on August 26th. We’ll see you back here on September 2nd, just before the long Labor Day weekend.