Allie Beatty, formerly of TheDiabetesBlog, has established a new multimedia site "Allies Voice" where she has launched a crusade. The issue at stake is a substance called C-peptide, which in a healthy body, is present in tandem with insulin, but is removed during the manufacturing process of human insulin analogs that we PWDs must inject. Allie and others believe that Big Pharma is doing Type 1 patients a grave disservice by removing this substance, and failing to make it available to us.
Why? There is some scientific evidence indicating that C-peptide can improve neuropathy, kidney function, and high blood pressure in Type 1 diabetics -- and yet insulin manufacturers have done away with the C-peptide, some say, because they don't find it profitable; Type 2 diabetics apparently produce plenty and don't need any more of the stuff, therefore the vendors don't bother adding it back into their products in order to make their insulins more marketable to a larger audience.
It's important to note the phrase "adding it back in." Because the process of creating injectable insulin is actually the act of breaking down a "prohormone" called proinsulin into insulin and C-peptide. The latter was traditionally considered nothing but a byproduct of the production process, until some researchers began investigating it not long ago. Most notably, Dr. J. Wahren of Karolinska Hospital in Stockholm, Sweden. He argues pro on the critical point: that C-peptide is indeed a biologically active molecule that can have proactive, positive effects on patients with diabetes. Obviously, he's quite convinced that C-peptide can be used successfully to treat long-term complications of Type 1 diabetes, as he's even co-founded a company around the concept.
"In contrast to his view, the general consensus has been that there is not much of a role of C-peptide per se," said Dr. Jay Skyler, Associate Director of the Diabetes Research Institute (DRI) in Miami and Chairman of the national Type 1 Diabetes TrialNet study, in a written response to my email last week.
In fact, to get to the bottom of this issue, I was very busy emailing an array of experts late last week. Here's a quick overview of what I learned:
* For a short time many years ago, Eli Lilly & Co. tested the use of proinsulin, the precursor molecule of insulin that still has the C-peptide component within it. Unfortunately the program was aborted after some of the studies suggested that proinsulin use was associated with an increased risk of heart attacks. (Dr. Steven Edelman of US San Diego and TCOYD can attest to this; his center was one of the research sites.) Millions of dollars were swallowed up in that research program.
* Even if there were compelling human studies confirming the benefits of C-peptide (which there current aren't), bringing it to market would involve HUGE investment costs, by some estimates up to $300 M to go through the full FDA submission process. "Money IS finite and these decisions have to be made," Dr. Nancy Bohannon of St.Luke's Hospital in San Francisco reminds us.
* According to Dr. Camilo Ricordi, Director of the Miami DRI, it's unlikely that manufacturers could even produce and mix these "already cleaved" products -- insulin and C-peptide. This means C-peptide would likely need to be sold separately, so patients would be forced to take a separate injection, as is the current case with Symlin. "I believe c-peptide could be valuable and so far there is no data indicating that it would be harmful, so I would certainly support the concept of producing it and administering it with insulin," Ricordi wrote me.
* Most of the experts queried (including some big names in diabetes research: Dr. Bruce Bode, Dr. David Klonoff, and Dr. Barry Ginsberg), agreed that A LOT more, far-reaching and very expensive research would be necessary to evaluate the true value of C-peptide. Since this money would be channeled away from other D-research pursuits, it's a matter of opinion, I suppose, whether one thinks exploring the potential benefits of C-peptide is worth the ROI.
So does the Pharma companies' failure to distribute C-peptide really constitute "blasphemy"? I know a lot of patients who believe in its value feel outraged, but in all honestly, my takeaway here is that this issue may not be worth all the gut-grinding. From the early research, it looks like the health risks could very well outweigh the benefits. If Dr. Wahren and others successfully manage to produce strong, unquestionable evidence that C-peptide is important, we may see a turn-around in our lifetimes. But for the moment, this looks like an uphill battle -- and our advocacy energies are probably better spent elsewhere.
That being said, I think it's important for the patient community to keep up the pressure on drug makers to keep their marketing practices clean and their motives and tactics transparent. Thank you, Allie, and thank you, Scott S, for your advocacy efforts along those lines!