Wednesday, March 14, 2007

Lilly Responds

As a follow-up to yesterday's post, I am pleased that J. Scott MacGregor who handles public relations for the Humalog brand at Eli Lilly and Company, actually contacted me to share the company's official perspective on the question I posed, and I felt it was worthy of sharing that response with my readers, so here it is:


The development of Memoir spanned 7 years and cost millions of dollars to bring to market here in the U.S. The task of developing the sophisticated electronics -- and then determining how to fit the chip into a pen device that would be both accurate and reliable, dose after dose, and then manufacturing it on a broad scale -- was a daunting hurdle overcome by top-flight device engineers and scientists, both at Lilly and our partner in development, Battelle Medical Device Solutions in Columbus, OH. This was no standard task, and Memoir is no standard pen. Its electronics and memory feature are unlike any pen on the market for the delivery of insulin.

Developing a pen with a memory feature was the direct result of feedback from patient research. Patients told us they wanted an insulin delivery device that would deliver simple and accurate dosing and could help them simplify the daily management of diabetes by easing the burden with a memory feature. Our engineers then set out to deliver on those patient needs, and we're pleased that patients who use Humalog here in the U.S. can now benefit from this innovation.

Could these same engineers design a device with memory that could dose in half-unit increments? Possibly, yes, in the future. But that will require additional years of development, and we didn't want to delay the introduction Memoir to patients here in the U.S.

Clearly, there are some people using insulin who may benefit from half-unit dosing -- in particular, we believe a half-unit pen may be attractive to people who don't need large amounts of insulin or parents of some children with diabetes. HumaPen Luxura HD was developed to fill this need. We're very pleased to be launching Luxura HD in April, and recognize that some people may benefit from a half-unit pen and others from a device with memory such as Memoir.

In the end, the answer is simple: we listen to patients and try to develop new devices that will meet their needs. But the story of the development of these two pens is not nearly as simple as it may seem.

One additional clarification -- Memoir is manufactured in Clinton, MA. The Luxura HD is manufactured in Wisconsin by a different manufacturer.



First, I would like to extend my sincere appreciation to Scott MacGregor for sharing that with us. It certainly clarifies the company's thought process and what led to the two pen delivery device products that Lilly is now introducing. However, I would like to call attention to a few elements.

If Lilly began development of the HumaPen Memoir 7 years ago, yet researched the wants and needs of patients in January 2007, there is something of a disconnect unless other research was done during the product development phase. It would appear that the research was done to prove there was a need for the product and its features, rather than investigating what patients actually wanted or needed. In other words, the horse was put before the cart.

To be sure, the Memoir was a great idea, and there is no doubt that Lilly spent considerable time and resources developing it in order to better meet the needs of patients, but it seems painfully evident that the needs of patients with type 1 diabetes, most of whom remain sensitive to small changes in dosage, have fallen behind the massive type 2 market in the eyes of company management. The real question is whether this is the wisest choice for the management of the Humalog franchise?

In terms of overall patients, type 1 patients remain a key constituency for the insulin franchise, and one I would argue that the company can no longer afford to ignore or consider as secondary to the massive type 2 market. Why? There is no doubt that insulin-using type 2 patients buy much more insulin -- some type 2 patients are so insulin resistant that they require U-500 insulin vs. the standard U-100 -- but their purchase volume does not align quite so well with the overall number of buyers. There are an estimated 4 million insulin users in the U.S., and we know that all 1.1 million type 1 patients are included among them. That means that while the type 1 market consumes less insulin volume overall, they still account for 27.5% of all the people who actually buy insulin. It is already well documented that most type 2 insulin users have far less risk of hypoglycemia than patients with type 1, therefore a half-unit difference in dosage is unlikely to have a material impact. But for many type 1 patients (including many adults), a half unit can literally mean the difference between hyperglycemia and hypoglycemia.

Clearly, many type 1 patients choose an insulin pump because it delivers insulin with a level of precision that they cannot obtain in any other way. Pen devices are clearly aimed at patients who do not pump insulin, whether by choice or due to economics, or because they are recently diagnosed. But the number of new users with type 1 is increasing almost as quickly as the type 2 market. Why? For the type 2 market, many endocrinologists see the hyperinsulinemia which is a symptom of many type 2 patients as part of the problem, rather than the solution. After all, excessive insulin contributes to inflammation as well as elevated lipids and blood fats and other co-morbidities associated with the metabolic syndrome. Among type 2 patients, insulin sensitizer drugs such as metaformin will always be a first-line treatment because they are effective yet inexpensive. As more modern treatments including incretin based treatments like exenatide (Byetta) which Lilly co-markets with partner Amylin Pharmaceuticals emerge, insulin will decrease in relative importance for treatment among the type 2 market. Lilly has been a key beneficiary of this trend (as the marketer of Byetta), but it also suggests that the ever-expanding treatment options for the type 2 market will further erode the need for insulin among this group except among patients with long-standing type 2 diabetes.

While the HumaPen Luxura HD does put Lilly on a more competitive footing with rival Novo Nordisk (and they've lost a LOT of market share to Novo Nordisk in the last 5 years), it really does little to differentiate Humalog or to make prospective users say "I really want to use Humalog because Lilly's pen device helps me in a way that Novolog cannot". And then there is Sanofi Aventis' Apidra, the newest rapid-acting insulin analog. Apidra will clearly continue growing from its tiny sliver of the insulin market, but the real question is where the growth will come from. Although Sanofi's OptiClick pen is not much of a threat today, that could be modified fairly easily. Its painfully evident that more precise dosages were obviously an afterthought for the product developers, not something that was incorporated right from the very beginning. Yet in spite of the Lilly's research, which included both type 1 and type 2 patients, which revealed that 84% said a memory feature would be valuable, and fully 94% said its important to know if they missed an insulin dose, the HumaPen Luxura HD fails to address these needs -- a lost opportunity at establishing customer loyalty.

The most important take away is that while the type 1 market may be smaller in terms of purchase volume for insulin, insulin manufacturers simply cannot afford to overlook the fact that they remain very large in terms of number of overall users. That's something that a company selling insulin cannot afford to overlook.

9 comments:

BetterCell said...

Hello Scott.....I could not send this message to you via Email because you do not have that feature enabled on your Site. Whenever I go to your Site :
sstrumello.blogspot.com, an Audio comes on automatically which sounds like a review for a movie. Are you aware of this?

BetterCell said...

Hello Scott......Whenever I go to your Website:sstrumello.blogspot.com. an Audio feature automatically comes on that sounds like a review for a movie. Are you aware of this?

Bernard said...

Scott

Thank you for this additional information about Lilly's thinking regarding their Memoir pen.

Overall I agree that those of us with Type 1 are not getting much coverage due to the constant news about the diabetes epidemic (Type 2 assumed) and the growing numbers in that area.

I think there's a good many Type 1 bloggers, and I hope that this may change how the care industry treats the disease.

RandyB said...

I guess the truth will be told when we see how many of these pens Lilly actually sells, and then the market will have spoken. At the discounted price of $45 or so for the Memoir, that's a chunk of pens. I've yet to see any proposed pricing for the Luxura HD. Granted, both pens incorporate desirable features, but by themselves I don't see that they offer enough bang for the buck. By comparison, the OptiClick pen from Sanofi-Aventis works ok, but its performance is not revolutionary. I have a harder time knocking it, since Sanofi-Aventis didn't expect me to pay for the pen; they just wanted me to use their insulin. Hmmm.....

RB

Scott said...

Thanks for your comments, everyone. Barry, you're the first person to mention this issue, and I'm not sure I know what to look for here -- I wonder if its a Macintosh issue? I'll check my template settings, but since no one else has reported the issue, I'm not sure I'll have any luck resolving the issue, but thanks for bringing it to my attention nevertheless.

Regards,
Scott

BetterCell said...

Hi Scott.....I found out where the Audio was coming from every time I loaded your Blog Site. It was from:
February 12, 2007
The Role of the Media with Diabetes
The Audio that was automatically turning on was Osmosis Jones which you have on your Site.

Anonymous said...

Scott,

Thank you for your devotion to provide an outlet for diabetics to learn more about their disease. To your credit, You have a very engaging and authoritative writing style, which makes it even more important that you ensure the accuracy of the information you provide. Unfortunately your comments about hyperinsulinemia are at least ill-informed and at best outdated. Over 3 years ago, the following study was published: http://atvb.ahajournals.org/cgi/content/abstract/24/2/325
You'll note that the researchers came to the exact OPPOSITE conclusion that you mentioned in your blog above. Furthermore,
The United Kingdom Prospective Diabetes Study, which has been published for many years now, makes it very clear that lower blood sugars do more to reduce micro and macro-vascular complications than the method by which those sugars are reduced. Thank you for your blog, please do your homework.

Dave

Scott said...

Thanks for your comments. You will note that I said "many endocrinologists" see hyperinsulinemia as part as part of the problem, rather than the solution to type 2 diabetes but that does not mean those views apply to all. We can safely say that the evidence is conflicting.

I should have made it clear that we know type 2 diabetes is a progressive disease meaning that the beta cells will become increasingly impaired over time, and ultimately, these individuals will essentially have the same beta cell function – little or none – as a type 1 patient, which necessitates insulin replacement. But insulin resistance can make replacing that insulin much more of a challenge for these patients, and we know that the dosage for many patients with type 2 is significantly higher per kg of body weight than it is for most with type 1. Skilled clinicians frequently find that insulin must be combined with other drugs for truly effective treatment.

In at least one study, high levels of insulin were associated with increased colorectal cancer risk. The association with hyperinsulinemia is also supported by several large clinical studies showing a direct relationship between high insulin levels and cardiovascular risk. Notably, the Paris Prospective Study and the Multiple Risk Factor Intervention Trial (MRFIT) reported positive relationships between insulin levels and atherosclerotic events. In addition, the Veterans Affairs High Density Lipoprotein Intervention Trial (VA-HIT) demonstrated the highest incidence of cardiovascular events in the subgroups with highest levels of insulin. Finally, the landmark Insulin Resistance Atherosclerosis Study (IRAS) provided further evidence for an inverse relationship between carotid intima-medial thickness and insulin sensitivity. The molecular mechanisms are not yet completely understood, and many patients have additional comorbidities such as obesity which complicate matters, but the real key is to measure beta cell function, which can be done with a simple lab test measuring C-peptide.

Anthill said...

Hello Scott and thanks for sharing the pen debate.
I would love to know if the humapen is conpatable with the lantus vile? As I live in Australia and don't get the humalog insulins here.
At the moment the lantus uses the Autopen24 which is poor performance pen to use and I hate it as the humapen is so attractive.