Friday, April 13, 2007

An Open Letter to Eli Lilly & Co. Chairman & CEO Sidney Taurel

Amy Tenderich's open letter to Steve Jobs certainly created something of an electronic storm. Whether it results in material changes remains to be seen, but its well known that political advisors and increasing numbers of businesses are measuring opinion via the blogging universe (or as I call it, the blogosphere). I am directing my own letter to Eli Lilly and Company's Chairman and CEO Sidney Taurel:

Dear Mr. Taurel,

I write to you as both a shareholder, and a former customer. Recently, The Wall Street Journal's health blog posted a note to board members, executives and others at Eli Lilly and Company saying "You're No Johnson & Johnson". That was a comment on the fact that Lilly benchmarks your salary based on an average of so-called competing companies, including the diversified health care giant Johnson & Johnson, which operates in three separate business segments through more than 250 operating companies. The comments were not pretty, as your company has not exactly delivered superior returns to investors in recent years. Nowhere is this more evident than in your insulin business, which has seen its market share plunge from 82% in 2000 to 43% in 2006 according to data from IMS Health! I don't need to remind you that insulin still accounts for just under one-third of your revenues. In addition, you have recently shelved plans for a Virginia factory to make insulin because executives now believe that existing plants can meet demand.

Although I prescribed a method for Lilly to restore its insulin business, so far, no one has even acknowledged my comments, let alone taken any of my suggestions to heart. As Allie Beatty recently discovered, although her focus has been directed towards the American Diabetes Association, no one at Eli Lilly and Company would even entertain the notion of speaking to her about commercializing C-Peptide in spite of a growing mountain of evidence to support its utility. Instead, Lilly has responded by developing more medicines to treat type 2 diabetes, as well as with drugs to treat diabetes complications, at least according to a letter to the Indianapolis Star from your Chief Operating Officer, John C. Lechleiter. Does he really think we we are going to be thanking Lilly for the company's response to the diabetes pandemic when that consists of trying to sell us more drugs for complications that you might actually have prevented? Sorry, but that just won't fly with me.

Then there is the little issue with the company's reported fix for the sagging insulin business, notably the introduction of several new insulin pens. The Humapen Memoir pen is quite nice, but does not dose in 1/2 unit increments. The Humapen Luxura does dose in 1/2 unit increments, but has no memory. If Matt Beebe, Humalog brand team leader at Lilly USA is reading this, or even if J. Scott MacGregor who handles public relations for the Humalog brand at Eli Lilly and Company is reading, you guys might want to check into an official company response on the issue of why your company has knowingly decided to abandon its research into possibly including C-Peptide in its insulin formulations. I would remind you that nearly a decade ago (back in July 1997), Lilly helped fund a joint study with Washington University at St. Louis and the National Institutes of Health, and your company's own researchers discovered that in diabetic rats, treatment with C-peptide reversed vascular and nerve damaged blood vessels and helped to repair them. In the rats treated with C-Peptide, the nerve cells worked normally and vessels almost completely stopped leaking. Since then, additional studies have confirmed the usefulness of this element in humans, but instead of commercializing it, Lilly has responded to the diabetes pandemic by developing more drugs to treat complications.

The blogosphere is rumbling about your insulin business, but the tone is not one of praise. (For more recent comments, just check out some of the posts by looking at the "Recent Diabetes Headlines" sidebar if you need direction.) For one thing, Lilly has almost nothing in its new drug pipeline for type 1 diabetes, not even a long-acting analog that would put the company on a competitive footing with rivals Novo Nordisk and Sanofi-Aventis. The impression seems to be that the ADA, Lilly and its competitors don't really care about the needs of people with type 1 diabetes. For example, no long-acting analog is in development at Lilly according to recent investor presentations (certainly not in phase II or III trials), so patients are forced to buy products from your competitors. But these days, managed care often has "preferred" brands, and on some healthplans (I'm thinking of the massive United Healthcare account), Lilly is not a preferred brand.

I would also add my own recent posting about why are insulin manufacturers not working to resolve the issue of mixing their insulin analogs (or for that matter, adjunctive therapies such as Symlin, which your company jointly markets with partner Amylin Pharmaceuticals) in the same syringe or pump reservoir? This is a patient need that your company has not bothered to consider. Looking for a way to increase market share in insulin? Why not work on a Humalog/Symlin combination drug? We know that the development timeframes are usually shorter on these, and Lilly seems to like selling premixed insulin formulations (Humulin 70/30, Humulin 50/50, Humalog Mix 75/25, Humalog Mix 50/50, etc.) anyway, in spite of the evidence to suggest these don't really deliver superior glycemic control for patients with diabetes. But you ARE marketing two popular products which cannot presently be mixed, which is surely a lost opportunity. Consider funding studies like the one done at the Barbara Davis Diabetes Center in Colorado that showed that Humalog could indeed be mixed with Sanofi Aventis' Lantus long-acting insulin analog without adversely impacting glycemic control. After all, if you cannot offer a full product portfolio, at least you can make a compelling argument as to why its ok to use your insulin with one from a competitor, thus mitigating some advantages rivals have.

The bottom line is that the opportunity for Lilly to restore your insulin business does not necessarily mean more salespeople, although I realize you must restore those that were cut in 2001 when the patent for Prozac expired and to respond to Novo Nordisk's announcement to expand its salesforce by another 800 people. But the fact is that the Associated Press recently reported that New Hampshire has already, and other states (including my home state, New York) are also moving to ban pharmaceutical companies from using physician-level sales data in marketing to physicians. Besides, our doctors now have so many salespeople that they don't know what to do with them. And patients suffer by waiting a month or more for an appointment while your salespeople are consuming our doctors' time trying to sell your products.

I won't even comment on your Zyprexa business other than to note that this business may not have such an easy turn-around as Lilly's sagging insulin franchise. But in order to turn the insulin business around, you need to start listening to the needs of your customers!

Yours Truly,
Insulin Dependent

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14 comments:

Kathleen Weaver said...

Yikes! Combination Symlin/Humalog?

Ouch. Have you taken Symlin? It has a different pH then Insulin they can't be mixed. Symlin burns!

I play around too much with the dosing anyway, but then again, I hate the Humalog mixes for the same reason.

BetterCell said...

Hi Scott......great letter.
C-Peptide does not need to be mixed with Humalog since this would take even more time regarding FDA approval to have this on the Market. It would be easier and quicker to have C-Peptide made available the same way Symlin is, in a separate vial.
Complications wait for no man.

Anonymous said...

Being a Type 1 diabetic who is constantly searching the net for new treatments, new insulins,etc., I happened to run across information on C-peptide about 2 years ago. It sounded fabulous!!
I asked my endocrinologist about it, and she had heard of it, but she said to me: " Do you really think the drug companies are looking out for the patient?
Not a chance! They only look at financial statements and do whatever is best for the shareholders." I was completely floored by this.
I learned a very good lesson that day. You certainly can't trust the drug companies. After all, wasn't insulin discovered in 1926?
Since then, Type 1's have pretty much been put out to pasture, in my opinion.

BetterCell said...

Hello Anonymous.......You and ALL of Us then have to decide
whether to keep grazing in the open field or turn it into a Bull Run.

Anonymous said...

I wouldn't say that ALL drug companies aren't patient focused! I am a type 1 diabetic and work for an awesome (privately-held) drug company that sells type 2 diabetes oral pills who are very much patient focused. I agree with the need for Lilly to pick up the pace and I think that C-peptide would be awesome, but I don't think it's correct to say that all drug companies aren't patient focused. In fact, the drug I sell has just done a landmark study that shows that it delays the onset of type 2 diabetes. How is that not patient focused?

Scott said...

I vote for Bull Run!

Melissa P. Ford said...

Hi Scott, good work. Two queries for you:
1) Lilly and Amylin are working together on Byetta for sure. I have never heard of an offical Amylin/Lilly partnership re Symlin and would appreciate a link to any Amylin or Lilly press releases re Symlin collaboration. (Searching Lilly.com for exenatide gives 421 hits while I get 0 hits for pramlintide and 0 for Symlin)
2) My Humalog vials say the product is manufactured for Lilly by Hospira. Hospira was spun off of Abbott a few years ago. Perhaps we should not equate a good contract manufacturing deal with lack of investment?


Melissa
Type 1 14 years; pumper 10+ years; diabetes care industry 4 years

david said...

Having followed Lilly for several years I truly enjoyed your comments. Happen to be in Seattle for the AACE meeting and have seen nothing from the company that indicates things will get any better. Keep writing maybe one day they will listen.

David Kliff
Publisher - Diabetic Investor

Anonymous said...

Scott—

Let me introduce myself. My name is Brent Hoadley; I have a Ph.D. in plant science with emphasis on environment, chemistry, biochemistry & traditional scientific investigation. Even though I am not a writer, I felt compelled to write a book called “Too Profitable to Cure” which addresses the fact Sidney Taurel and Eli Lilly are ONLY interested in keeping the diabetic population chronically ill.

Eli Lilly is a corporation you, I and the rest of the diabetics in this world should never trust again. In fact, this pharmaceutical company may represent the coming of the anti-Christ. Let me give you a few scientific facts that have led me to this conclusion:

First, and most importantly, if you are thinking in terms of success of treatment please consider that since 1972, Eli Lilly has been giving a 50-year award for insulin-taking survivors who reached/passed that milestone. From that 1972 introduction to present, Lilly has presented this award to approximately 2,500 people. Considering the fact that in this same period of time, over 400,000 insulin-taking diabetics have died during various stages of “less-than-normal” quality of life. Anyone who thinks that Eli Lilly and the production of insulin was a complete success when less than ½ of 1% of all patients live even close to a normal lifespan should wonder why more hasn’t been accomplished.

You mentioned Humalog and many of the other new analogs, which are presently on the market, and touted to be far superior to natural (bovine and porcine analogs) products—products that were completely eliminated from the U.S. marketplace gradually, but with finality last year. Lies were told that rDNA analogs were BETTER clinical protocols, when in fact, they do not have the efficacy and safety records of many of the older, natural analog insulins. The only reason Lilly and the rest of the insulin cartel did away with natural analogs was to FORCE EVERYONE to switch to high-priced, patented but less safe synthetic analog insulins.

In terms of science, the last sentence above needs description. Please consider that insulin is an anabolic hormone. Basically we’re talking about a protein with hormonal activity and you should recognize that a much bigger protein molecule with just a single amino acid out of place causes sickle-cell anemia. In a small molecule protein/hormone like insulin, playing around with amino acid structure is tantamount to courting disaster relative to cancer, immunologic responses, and many of the things we are beginning to see in diabetics who have now been taking synthetic insulins for more than 20 years. Even the European Medical Agency has cautioned about the possible cancer-causing effects of many of the new analog insulin-like products, including Lantus, NovoRapid, and Apidra. The fact remains—no one has done long-term studies to either verify or vilify the answer to this question.

Your interest in pro-insulin and C-Peptide is certainly justified but I feel certain that Eli Lilly may have already buried the truth regarding the potentials for these important links in the process of insulin absorption and usage within the human body. You and I take shots that in a manner of thinking, goes backward through our system in order to aid blood-sugar be accepted through the cells’ insulin receptors. When insulin is produced through the pancreas with whatever OTHER adjuvants are involved, the insulin goes through the portal vein into the liver where it is further metered out along with by-products that help protect our system.

As far as I am concerned, Yes, I feel lucky to have lived 50 years because of the availability of insulin, but I also know how many of my friends and fellow diabetics have been nowhere nearly as fortunate. Their fates must solely rest on the likes of Eli Lilly, Novo Nordisk, Aventis and the medical community that is so willing to keep us chronically ill, using the highest-priced, patented drugs possible. I would certainly believe if we can send a man to the moon, that finding a cure for diabetes should be simpler than solving a Rubik’s cube—if the incentive was sufficient. Sending the insulin cartel’s researchers—along with most of the bought-and-paid-for medical institution researchers—into this problem-solving puzzle called diabetes is rather like sending a backyard mechanic with a screwdriver and a hammer to fix some of today’s high-tech, complicated automobiles.

I would like to ask you this: Would you really trust a pharmaceutical company like Eli Lilly—who tried to bring a product like Oraflex (anti-arthritic drug) to the U.S. marketplace with full knowledge that it had already killed many patients in Europe. Lilly also brought us Prozac—which is little better than a placebo, but in some cases product information was withheld regarding the nature of this SSRI’s build-up in the body of some patients lacking proper enzymes. Additionally, they introduced Zyprexa—reported to actually CAUSE diabetes in psychotic/bipolar individuals. Lilly produced enough LSD for use by our government (military) to make the whole damn world hallucinatory. And they also brought us methadone—which many scientists consider to be as bad as the condition it is used to treat. If you look even further into Lilly’s history, you may discover there may be a connection going back to I.G. Farben and der Fuhrer. Doesn’t this give you a lot of confidence that the antichrist will bring you yet another new insulin-like product to hasten your demise?

BTW, I have a friend who has been pumping Humalog since it first entered the marketplace; he now is suffering immunologic response to the product, switches to Apidra for short intervals, and then experiences immunologic responses to it, which has him then switching back to Humalog. The doctor’s answer to my friend has been to re-define him as either a Type 1 ½ or a Type 3 who will now need to take some of the Type 2 oral medications to reduce his insulin resistance response. Medicine, it appears, is now using LANGUAGE as well as medicine to control and define us. Diabetics are all individuals; why can’t we have FREEDOM OF CHOICE of all insulins—both natural and synthetic?

Scott said...

Thanks, Brent, I look forward to reading your book "Too Profitable to Cure".

You raise many valid points, and neither me nor many other people with diabetes would disagree with them. In fact, I addressed the concerns you raise about insulin analogs in my 2006 Year-End Review posting, where I noted that there is now a possibility of returning to regular human insulin rather than analogs, as both a rapid-acting and long-acting version that is structurally regular human insulin with additives to address the absorption issue that analogs are supposed to address. Both are in Phase III clinical trials at this time, but neither is from Lilly, Novo Nordisk or Sanofi Aventis!

I wrote my letter with the intent of providing a CEO with a better direction to address a business that is not doing so well these days. Today, Lilly announced its Q1 2007 earnings and reported a 39% drop in Q1 profit on costs for an acquisition, drug-license pact and plant closings, although revenue rose 14% on higher sales of treatments for mental illness and impotence (the insulin business showed only marginal growth). Lilly continues to have drug-pipeline difficulties. Lilly disclosed on Monday that the FDA rejected the company's appeal of an approvable letter issued last year for the experimental Arxxant, a new drug for diabetic eye disease, and the agency reiterated its request for a 3-year study of the drug before considering approval. Lilly said it's considering its next steps for Arxxant, and has withdrawn its application for European regulatory approval of the drug. The Arxxant setback also contributed to an increase in expenses for Q1.

Scott said...

Just a reply for Melissa P. Ford:

1) Lilly and Amylin are working together on Byetta for sure. I have never heard of an offical Amylin/Lilly partnership re Symlin and would appreciate a link to any Amylin or Lilly press releases re Symlin collaboration. (Searching Lilly.com for exenatide gives 421 hits while I get 0 hits for pramlintide and 0 for Symlin)

The best place for info. on this is to visit it Web Archive site for the former website (which no longer exists) at http://web.archive.org/web/20060205184317/amylinlilly.com/index.jsp


2) My Humalog vials say the product is manufactured for Lilly by Hospira. Hospira was spun off of Abbott a few years ago. Perhaps we should not equate a good contract manufacturing deal with lack of investment?

I cannot really comment on the Hospira issue you mention, as this is the first I've heard of it. In fact, Lilly does not subcontract manufacturing for its insulin sold in North America at all. Manufacturing is done at plants in Indiana for Humulin, and Puerto Rico for Humalog. I don't know if the same situation applies outside the U.S.

Bernard said...

Scott

Did you ever get any type of response from Lilly about this letter?

Scott said...

Bernard,

No, I didn't. I suspect its because they want to avoid what might be perceived as public scrutiny on the company's (mis)management of their insulin business as they pursued erectile dysfunction drugs instead. Dave Cliff's (of the Diabetic Investor) comment from the AACE meetingthat he saw nothing from the company that indicates things will get any better in the short-term suggests the company has yet to reconcile the loss as anything other than due to a reduction in the number of salespeople. I suspect it won't be that easy, especially given the increased scrutiny caused by a former Lilly Zyprexa salesperson (see http://youtube.com/watch?v=nj0LZZzrcrs) suggests the company has some issues to resolve there.

Jim said...

This is a very nice post, and I want to see how others react to this.