What Social Media Has Done for Me Personally as Well as for the Diabetes Online Community

I don't want today's post to sound like a post script, because it isn't.  My post (see HERE) the other day was kind of an acknowledgement of something that had already been evolving over the past few years anyway.  Let me be clear: I'm not discontinuing Scott's Web Log, but I am putting my efforts into my other blog which has a higher priority for me at the moment.  I'll still return here when I have something relevant to say or share, or when I have news that someone else in the community hasn't already covered.

I seldom write about my personal life because my opinion is "it's personal, which means I don't necessarily want to share that with the rest of the world via the Internet!".  I have made occasional exceptions, of course, but generally, my coverage has been on the business of diabetes (and what a damn big business it is!) or things going on from a regulatory or legislative perspective that are likely to impact people with diabetes.

However, as I noted, I no longer find the same sense of gratification and pleasure in writing about that several times a week as I once did.  I have multiple reasons for that.  First, industries, regardless of which types, tend to move in predictable ways.  We've been hearing these promises and stories for decades now, but yet the only thing that seems to change is the costs for patients always seems to go up.  Moore's Law may apply to computers, but doesn't seem to translate (yet) to CGMS, insulin pumps or even 30 year-old biotechnology like insulin!

My Early Realization of Patient Empowerment via Social Media

I can still recall that October morning back in 2007 when I tuned into Pfizer's earnings release and the company's CFO announced it was discontinuing sales of Exubera, the first legally-approved inhalable insulin (see my post HERE).  Many on Wall Street were convinced that product was destined to become a $1+ billion blockbuster.  Naturally, I shared that news (which many of us in the patient community had predicted, including myself, Amy Tenderich, Bernard Farrell, Jenny Ruhl, many parents on CWD and a number of others) with the diabetes online community, and it was truly amazing, because that news spread like wildfire.  It was a real sense of empowement.  No longer were we as patients subject to the editorial decisions of the news media who might cover it if they had interest or space to fill, nor did we have to wait for our medical professionals to share news of that.  More recently, I also predicted (see HERE) the sale of Amylin Pharmaceuticals (which hasn't happened ... yet ... but the company HAS hired an investment bank to sell the firm to the highest bidder, so that seems very likely in the near future).

Sure, there can be revolutionary occurrences (major M&A activity, or executive changes at these companies, for example), but I think the lesson learned was that since most companies operating in the diabetes space are publicly-held companies, they're obliged to disclose things that "materially impact" their shareholders, including earnings statements which must be reported to the U.S. Securities and Exchange Commission (SEC) each and every quarter.  That data is all in the public domain via the EDGAR [http://www.sec.gov/edgar.shtml] database, although most (including me) find it easier simply to turn to the companies' respective"Investor Relations" pages on their websites.  Indeed, I like to think for people in the diabetes online community at least, I have succeeded in revealing this as one of the best sources for reliable information, which is revealed to investors, yet seldom noted in the advertisements for diabetes products and subject to the discretionary whims of the news editors of major media outlets.  In fact, we can sometimes also learn about products the companies are developing (at least those the companies feel are in later-stage development), issues with regulators like the FDA, learn of the sales growth (or decline) for their products.

Anyway, I believe those early experiences have forever changed the way many people with diabetes gather information about what diabusiness is doing.  And, company efforts to contain news aren't as easy as they were in the old days.

Second (I said there were multiple reasons!), while I believe we as a community can accomplish some great things when we work together, there are still some limits to what we can realistically accomplish.  For example, I think we have started to sound our collective voice with the U.S. Food and Drug Administration, but on that front, there is still much work that remains.  Some of that has little to do with things we can control or influence directly, but there's also a recent history among FDA reviewers that the agency's own concerns, and those of the industries the FDA regulates are really the only comments that matter.  We as patient advocates still need to learn how to compose our comments in a format the FDA is used to following, instead of mainly personal blather about our (or our child's) long-term health.  I HAVE found that following the format that pharma and medical device companies use, including citations from relevant medical journals can make for a compelling case.  But that's something we all really need to get better at doing.  However, I also think that "activist patient groups" are not going away, and I hope to use my role among the Diabetes Advocates to continue with this.  Yes, this blog will be a part of that when those events come up.  As I said, the sooner patient groups can learn to play the game by the FDA's vague formats, the sooner we as a group will become a force the FDA will regularly consider.

D.A. Process for Press Releases Provides Good Practice for FDA Issues Going Forward

Having put this in perspective, on a positive note, the D.A. group has started to make our voice heard via the newswires.  We've done a few press releases so far this year, and we've developed a process to write those as a group, edit them and make sure the releases get picked up by the media.  We've also tried some things as far as handling comments and inquiries, etc. which is still a bit of a work in progress.  But I think we can be very proud of the effort we did on Diabetes and Mental Health Month back in May 2012 (see the press release at http://mwne.ws/MKrDqd or http://www.marketwire.com/press-release/diabetes-advocates-conclude-mental-health-awareness-month-increasing-awareness-about-1663874.htm).  But, I think having a refined process in place to write press releases and/or respond to other items in the media is very powerful, and we're getting better at it.

In the future, we as a community can proactively coordinate campaigns or even respond to issues that are important to people with diabetes.  The same learning process is something I'd like to see us do on FDA-related items, and I want to pursue this further.  Perhaps we can have a similar committee process to address responses to FDA guidance, for example, with a team that discusses the concerns/issues, coordinates preparation of written comments that can be shared and ultimately, distribute those with a well-rehearsed process to really let regulators know we are a group that wants to be taken seriously.  Beyond that, I even envision coordination among other patient groups to respond to issues like the FDA's draft guidance for biosimilar medicines.  Just imagine how we might be able to respond with the diabetes community, as well as the rheumetoid arthritis, multiple sclerosis, IBD, Lupus and various other patient groups.  The FDA has only seen a sampling of where things are going, but truthfully, they haven't seen anything, yet!!

In all, I would say I think the world of "empowered patients" is still very much in it's infancy.  But, having said that, I think we're quick studies because we have personal motivation behind our involvement.  I see great things ahead for us, and we've only started on this journey!

Keep On Truckin'

My loyal readers may have noticed the volume of my diabetes-related posts at Scott's Web Log during the last 2 years isn't quite what it was a few years ago. I'm OK with that. I started this blog back in 2005 at the suggestion of someone, and I've accomplished a lot, including much of what I hoped to do with it. Notably, I found this to be a new medium where I could actually have a voice, rather than have diabetes news spoon-fed to me from mass media who frankly don't cover the subject adequately and makes a lot of mistakes in the process. I still plan to cover subjects I feel aren't getting the coverage they deserve, but as Allison Blass WROTE earlier this year "I'm Just Not That Into This".

For me, it's NOT that I'm no longer "into" this, but to some extent, the joy of writing on the subject isn't there like it used to be. The Diabetes Online Community is pretty firmly entrenched, and while it saddens me to have to say it because I think we'd all like to be cured and move on to other, more enjoyable things, I don't think the need for such a community is going away anytime soon. Sure, progress towards curative therapies has been made, but I don't see anything imminent. The so-called "artificial pancreas" system is anything BUT a cure (still feeding diabusiness coffers with even more of our hard-earned money), and even when we can convince regulators that it's a good idea, it will still be far too overpriced, it will still require too much burden from patients, and above all else, unattractive: we'll still have to wear all that medial shit around 24/7/365, so frankly, that's a downright shitty cure.

However, I have given some thought to WHY I started blogging in the fall of 2005. As I noted, at one time, that blog writing brought me great personal joy. It's supposed to be FUN. I don't enjoy it when I want to cover a subject that 50 others are already covering, and it becomes redundant to some extent. When there's fodder for news coverage, I still plan to keep doing it on Scott's Web Log, but I'm doing something else which is likely to consume more of my attention.


A New Blog

I've been doing something else meant to replace the enjoyment I once had with blogging about diabetes. It's a totally unrelated topic, but one I find amusing with plenty of subject matter to cover: retro pop culture. Do I have any expertise in this area? No. Do I have opinions? Definitely!

I have a 25 year high school reunion next weekend, and while I'm happy with where my life is today, it's fun to look back at how things were when I was growing up. The '70s and '80s may not be publicly remembered as much as say the '50s and '60s (after all, we've all been forced-fed collective "recollections" of the so-called "good old days" of life back then by the enormous Baby Boom), but I can look back at things with a fresh perspective these days and look at things that have gotten better ... and worse ... since then.

Anyway, my new "baby" blog is one I've been doing for the past month (no calendar for publication, I blog whenever I have time and/or feel like doing so) is known as "Harvest Gold Memories". The name comes from a popular color for kitchen design back in the '70s known as "Harvest Gold". Yes, my family's kitchen had Harvest Gold everything (my parents, however, remodeled and dumped that a while ago and went with a timeless color: white). But, as I note in one of my posts, you might look back at those hideous colors that were popular back then with derision, but I'd remind everyone that in 30 years, today's "Stainless Steel" kitchen appliances are likely to look just as dated as Harvest Gold, Avacado Green or Coppertone Brown appliances look today!


Using Blog Lessons Learned on Scott's Web Log

Anyway, since I already own my domain, I've simply assigned a new extension to my new blog venture. It can be found at http://hgm.sstrumello.com. Please, check it out! I've spent some time over the past month on the look and feel, and what's more, I've learned a few things from my experience with Scott's Web Log, so I hope I can put that experience to good use.

I try to keep posts fairly short (wow!), and include some kind of multimedia whenever possible. But I'm doing posts in a way that hopefully lures people over to my actual blog, as opposed to reading content primarily from an RSS feed. But, in respect to the content rights, I hope my links will be not only long-lasting, but also direct people to where they can view or listen ... legitimately, while including content I want to share on my actual blog (I told you I've learned a few things from my experience)!

I'm kind of excited about it since I was able to start from ground zero in terms of layout and blog design (I did most of it myself, and if I don't say so myself, looks really cool!), and I plan to add, expand and organize content as that new blog venture expands. So if my diabetes blog posts are fewer, you can still catch my writing on a totally unrelated topic on my new blog. That's where I'll be spending more of my time these days because I actually enjoy it! Maybe some of you will find it moderately amusing, too.

I'll still be here at Scott's Web Log, just not as often as I was, say back in 2007, when I did an unbelievable 141 posts! I plan to Keep On Truckin' as used to say back in the '70s, though, my thoughts may be on new subject matter a bit more. By the way, I have no plans to change my Twitter content anytime soon, so I'll still catch you there regularly!

New C-Peptide Assay Could Expand The Universe of Eligible Participants in Immune System Interventions

This month, diabetes researcher/immunologist and associate professor at Harvard Medical School, Dr. Denise Faustman's work is profiled in a trade magazine you've likely never encountered before: the American Association for Clinical Chemistry's Clinical Laboratory News, that article may be found at http://www.aacc.org/publications/cln/2012/June/Pages/BCellFunction.aspx. (It helps when your partner is a doctor at a school that teaches labwork!) That's a trade publication geared mainly towards people who work for clinical laboratories (you know, like Quest Diagnostics, LabCorp, hospital labs and others). However, the readership for this publication is diverse, ranging from chemists to phlebotomists, to the people who man the front desks at specimen collections facilities, so it's generally written for the layman.


Specifically, the article discusses how Dr. Faustman has developed a far more reliable assay to measure C-Peptide (used to measure endogenous insulin production) than the ones used presently by most labs. The dictionary defines an assay as follows: a quantitative determination of the amount of a given substance in a particular sample, so in this case, how much C-Peptide exists in someone's blood. Dr. Faustman and her colleagues recently used a new, ultrasensitive C-peptide immunoassay to measure serum C-peptide levels in people with long-term type 1 diabetes (Diabetes Care 2012;35:465–70) The assay being used in her clinical trials today is an ultrasensitive assay, which is available commercially in the U.S. as a kit from the manufacturer, Mercodia, which is based in Uppsala, Sweden, but whose U.S. ops are located in Winston-Salem, NC.

A number of years ago, when her well-discussed (and sometimes debated) human BCG clinical trials were still in the planning stages, I had the joy of speaking with Dr. Faustman by telephone for over an hour. She stressed the importance of having an appropriate assay or she felt the trials would be pretty meaningless, and indeed, she spent several years developing one. Whether you support her work or not, it's clear she understands the scientific method, and she didn't want the same old inaccurate assays used to measure the success or failure of these trial results, perhaps because she KNEW they wouldn't measure the results precisely enough.

My readers should also know that ALL insulin sold via pharmacies or to hospitals in the form of IV bags, regardless of whether that insulin biosynthetic or derived from abbatoir animal pancreas glands, has had any trace of C-Peptide completely removed from it during the HPLC (high-pressure liquid chromatography) purification process. Insulin that we use to treat diabetes comes as the mature protein, not as proinsulin that needs additional processing. There is an entire debate about whether removing it is beneficial or not (the growing consensus seems to be that removing C-Peptide also eliminates something which helps keep tiny blood vessels to remain flexible, therefore removing it also contributes to microvascular complications in people with diabetes that were once blamed exclusively on glycemic control, or lackthereof). Regardless, if you use exogenous insulin of any kind, there's no such thing as C-Peptide in that, so that means a C-Peptide assay measures only the insulin that your body makes on its own, but nothing else.


C-Peptide Assays Today: High Margin of Error


Medical Profession Has Been Largely Indifferent to Existing C-Peptide Assay Reliability

However, the article discusses how the error ratio for standard C-Peptide assays is surprisingly large. In clinical terms, the standard C-peptide assays have lower limits of detection of 15 pmol/L and 33.1 pmol/L, respectively, whereas the ultrasensitive assay Dr. Faustman and colleagues developed has a lower limit of detection of 1.5 pmol/L with inter- and intra-assay coefficients of variation of 5.5 and 3.8% at 37 pmol/L.

She also posits as to the various reasons doctors have been so willing to tolerate C-Peptide assays with a level of accuracy that might not be acceptable in say, for example, blood glucose or glycosated hemoglobin results is because there's a sense that the end result doesn't impact how they will ultimately treat patients. In plain English, doctors have really never pushed for greater accuracy in C-Peptide because frankly, they didn't see much reason for anything more accurate. After all, there wasn't a damn thing they could do about it, so what's the point?

Dr. Faustman called [it] therapeutic nihilism. She said the thought has been that the pancreas is not functioning after about one-to-two years, so our treatment approach has been kind of fatalistic. 'Oh, your pancreas is dead, we don't have anything to save the remaining pancreas'," she explained. Dr. Faustman is director of immunobiology at Massachusetts General Hospital and an associate professor of medicine at Harvard Medical School in Boston.

But doctors and researchers really SHOULD care.

Notably, in virtually every clinical trial used for immune system interventions for autoimmune diabetes (type 1), researchers have struggled to enroll newly-diagnosed patients, when millions of other patients who might have been prefectly viable trial participants have been casually dismissed as ineligible. In fact, with better assays, immune system interventions might have a far larger universe of would-be trial participants. Presently, her assay is not yet FDA approved for commercial laboratory use, but a spokesperson for Mercodia indicated that the company may seek additional Food and Drug Administration clearance for the assay as a marker of ß-cell decay, based on findings from this study.

Hence, future clinical trials might be able to draw from a significantly larger pool of potential trial participants. Today, potential therapeutic interventions always seem to target those newly-diagnosed, often when patients (and/or their caregivers) are overwhelmed with the news and least-able to consider trial participation. In the article, Dr. Faustman agreed that the findings could reshape diabetes-related research. 

"The standard C-peptide assay drove every clinical trial protocol in this field for the past 25 years because everybody thought that if were you're going to do an immune intervention trial in type 1 diabetics you had to get the kids within a week, or a month of diagnosis or do very complicated things and try to identify them in populations before they even get a high blood sugar. That's because the drugs being developed weren't stopping the disease, they were slowing the disease. So that meant you had to have C-peptide present to slow the destruction of the pancreas," she explained. "This new assay will open up the field tremendously to say people who have had the disease two to even 40 years shouldn't be rejected from these kinds of trials and we should be doing more clinically for these people."

So that's a fresh perspective on Dr. Faustman's contributions. Even if the BCG trials go nowhere, having a more reliable assay available commercially will enable future immune system interventions to be trialled on a much broader audience of people with type 1 diabetes. That could be an even more important contribution, particularly as the field of immune system interventions for a host of different autoimmune diseases emerges in coming years!

Also see my posts http://goo.gl/vOAd0 and http://goo.gl/TrkDX for more background.