22 October 2007

To: Pfizer Inc.

As some of you may know I am a user of Exubera, the inhaled insulin product. I have written about this previously in:

Stem cells..."A cure is just around the corner" - and pointing out that good and useful treatement for a condition would be worth a lot without looking for a quixotic cure and no better treatment.

The first day of the day before yesterday... - and my start of the use of Exubera.

Today is tomorrow's yesterday - a follow-up on my use of Exubera.
Today I have some other news from Pfizer, which I was just made aware of, and I will give you the posting on their website for Exubera so that you may read it.

Yes, inhaled powdered insulin is: safe, effective and shows ill effects in very very few people. Pfizer couldn't figure out how to market an insulin product that did not require needles! Ah, the joys of marketing!

Now, how did they tell this to the company that helped develop this product with them? The following is from Nektar Therapeutics, that self-same company, and do take a gander so you can realize the absolute class that Pfizer has, and I will strip out some of the marketing and legal material about how this press release is not to be used for investment and what other great stuff we are working on:
Nektar Therapeutics Issues Statement on Exubera
October 18, 2007

SAN CARLOS, Calif., Oct 18, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Nektar Therapeutics (Nasdaq: NKTR) issued a statement today in response to Pfizer's announcement this morning to exit Exubera, the inhaled insulin product to treat diabetes.

"We first learned this morning of Pfizer's decision to walk away from Exubera from their press release," said Howard W. Robin, President and Chief Executive Officer of Nektar Therapeutics. "Nektar has been very disappointed in Pfizer's performance in marketing Exubera. Pfizer has publicly acknowledged its organizational difficulties and resulting poor performance in launching Exubera. This has culminated in their announcement today. We are evaluating all of our options with respect to Pfizer's Exubera announcement to protect the interests of Nektar.
We continue to believe Exubera is an important advancement for diabetic patients."

Nektar's business has multiple sources of revenue, important partnerships for products on the market and in development, and a diverse pipeline of innovative new proprietary therapies.

The company continues to develop NKTR-102 (PEG-irinotecan) for the treatment of solid tumors, NKTR-118 (PEG-naloxol) to treat opioid bowel dysfunction, and a number of other innovative PEGylation-based product candidates. In addition, progress is being made in the co-development of NKTR-061 (inhaled amikacin) to treat Gram-negative pneumonias with Bayer Schering Pharma AG. Nektar also has a number of other inhaled anti-infective programs in development.
There, just enough to let you know what they are doing without too much marketing material, just enough to show you that they know what they are doing.

Now, I will tell you how they marketed this stuff, in case you missed the ads. It was marketed to generally older, Type II diabetics, those depending on glucophages and oral means, with some injected insulin here and there to help them out. Type I diabetics (aka Juvenile Diabetes although that is only a major population not a true description) were left out in the cold. Those are the folks who need to manage their insulin use and compensate for meals.

Type II diabetics will have a widely varying use of human insulin (fast acting, real insulin, not basal metabolism insulin with slow absorption) that varies from NONE (those that utilize exercise) to a few units per meal. In general Type II is managed with glucophages, basal metabolism insulin or small amounts of fast acting insulin depending on individual, of course.

Type I diabetics, generally, will have a vanishingly small population that can get by on just basal insulin alone, and require faster acting insulin at each meal and *between* meals. That amount of need means that the average use is higher, per meal and much higher per day than Type II diabetics.

So, did Pfizer market the stuff to the high use or low use population?

Yes the LOW USE POPULATION! Those that don't need it as much! Isn't that lovely?

Then they did something even more asinine: they set the amount used by WEIGHT. Now, far be it from me to point out that different people have different metabolisms at the same weight. Ok, I will point that out. So that starts off on a bad footing right *there*.

Now if you are a Type I diabetic and actually get this stuff prescribed for you, the idea is to eliminate as many injections per day of the fast acting insulin (lispro/humalog) with Exubera. Weight makes ZERO play in this. There are exactly two variables that determine the dosing and (Pfizer if you are reading this pay attention) they are:
1) Blood Glucose level pre-meal: if you have a goal of a BG of 120 mg/dl and you are adjusting at, say, per every 25 mg/dl above that with 1U lispro, you want to use Exubera to replace that. I found that 1mg blister of Exubera does this just fine. Other goals and adjustment amounts will vary by individual, but this works for me.

2) Net carbohydrates per meal: here the adjustment is by net carbs (total carbs - fiber carbs = net carbs) and the divisor for that. So if you take 1U humalog per every 10 net carbs, then a basic two slice of bread sandwich is usually 30 net carbs or 3U humalog. And, yes, the 3mg blister of Exubera works just fine for this.
This is absolutely critical for Type I diabetics and you know what this does to doctors trying to PRESCRIBE Exubera? How about insurance companies where the company is telling them that people should only use this stuff by WEIGHT at set amounts?

Are we starting to get the picture here?

Yes, this is an absolute nightmare. Pfizer made this worse by only providing two box types as 'sets': one box with 90 blisters of 1mg and one box with 90 blisters of 3mg, and a set with two of the 1mg and and one of 3mg. No matter how you juggle this stuff, even by their OWN WEIGHT CHARTS you would always be running low on either the 3mg or 1mg and have excess of the other left and the INSURANCE companies didn't like that. I fell sorry for the folks with leftover 3mg blisters as there isn't much you can do with those... I was able to finally learn how to compensate 1mg for 3mg blisters (and, contrary to Pfizer it is not 'overdosing' at 3:1 and, in fact, I found 4 x 1mg = 1 x 3mg).

So they had very few people getting the stuff? And they wonder *why*?

So here is the rundown of the failures of Pfizer:

1) Not marketing to the right niche - In theory there are a lot more Type II diabetics than Type I's, so this should work out, but, in fact, for steady and high use you want to get as much of the smaller population on the bandwagon FIRST. Steady and increasing production as folks see it used and are convinced of its safety, especially by those using it the most and you will have a larger win with the larger population over time.

2) Not targeting the product use - Not only did Pfizer get the dosage information incorrect, but did not consider the actual use of humalog insulin by diabetics and the fact that Exubera, being honest-to-god crystallized human insulin, REPLACES IT COMPLETELY. No more injections for anything but basal insulin!

3) Not figuring out there would be deviation from their incorrectly set guidelines - Insurance companies are brittle things and you can't get BUYERS if you are restrictive in your GUIDANCE for use. Because GUIDANCE becomes the ONLY think insurance companies will use. By keeping rigid guidance Pfizer killed off the ability of patients to get ENOUGH of this stuff through their insurance companies. Thus, fewer than expected sales.

4) What is the one category of diabetic that is an absolute, hands-down sale? Pediatric use. The marketing to that? ZERO. Children do not like injections, in case Pfizer missed the clue bus there. If you give children a neat way to take medication that is painless they will USE IT. Parents will be HAPPY and only worry about the basal injection. Yes it would have meant a 6 month trial, most likely. After 6 years of trials? Why this stuff was not in every endocrinologist's office that has patients between 5-18 is beyond me. The word is: hotcakes.

5) Missing the actual way humalog is used - I have another clue for Pfizer: bolus (the BG balancing injection) is only ONE part of the use of humalog insulin. You might have considered the carb compensation community and issued different guidelines.

6) Packaging - This should have been the hands-down easiest thing to address. Break up the freaking 'sets' and let pharmacies sell the Exubera by the blister pack box. That way doctors could prescribe this stuff more exactly for their patients instead of having to argue with freaking insurance companies all the time. Put the bi-monthly aerator as something that gets dropped in FOR FREE, two per month and charge an extra few bucks on the separate boxes. Doctors then know patients get those without charge, pharmacies see that patients get those as a 'drop-in' with nice smiley face from Pfizer, and Pfizer makes sure that they have long-term happy patients that will buy the stuff to replace all their humalog.

Basically Pfizer screwed up and badly on their marketing department, packaging and market niche concepts. The proper term is a CF, and those in the military or civilian DoD should know it quite well. By doing a couple of things wrong, everything fails simultaneously.

Now I will scramble around to get the last of the production to the end of the year and do my best to continue using this until Eli Lilly comes out with their inhaled insulin.

Dear Nektar - I am sorry you got partnered with such a group if idiots like the folks at Pfizer. If you can rescue this product, may I suggest seeing if you can get the production equipment shifted to a generic manufacturer or cross-license this to another company that can get its hands on the production line at Pfizer and actually have a CLUE as to how this stuff should be marketed?

It is the greatest product I have run across since becoming a Type I diabetic in 1983.

Dear Prizer - Please fire your marketing department and get some folks in that know what they are doing, at least in the diabetes area. You have some really nice products. The folks in charge of it seem to be out to ruin that portion of the company. You could do worse than actually LISTENING to your service reps seeing doctors as I know that my doctor has been giving you an earful monthly, if not more often. Some people who LISTEN and TAKE NOTES would help.


K T Cat said...

I'm so sorry this useful and easy-to-use product will no longer be available to you. I join you in saying, "Argh!"

A Jacksonian said...

KT Cat - My thanks!

I am in the firm belief that as soon as I like a product and begin to adapt it into my daily life, it will be yanked off the market. This is yet another in a long, long line of such things... but this is the worst.

Pfizer has bitten off more than they can chew, are in litigation over crystallizing glargine (lantus) and broke the patent laws and contract agreements on same... but any company that can't figure out how to maket human insulin that is inhaled? Something that was said could not be done for decades, and then turns out to be dead simple?

Safe, effective, absolutley human insulin without needles. Pfizer would starve if they had to figure out how to use scissors to get themselves out of a paper bag.