NIHilism ResurrectedPart I: The Emperor Has No Data

A creative portrayal of the dynamic between inventor and marketer.

ByAnthony L. Almada, B.Sc., M. Sc.

Given the magic of technology, Proprietary Perspectives agents have been installing phone tapping (cell and in-office) devices, remote biometric sensors, and stealth video and web-en­abled cameras to capture the discussions, ruminations, physiological alterations and rantings in various forums of the natural products industry.

Additionally, our experimental NLC (Neurolinguistic Capture™) devices have been positioned be­neath the video cameras to extract the subtle, between-the-minds dialogue that is so often missed. We’ve been able to install this array of data capture tools in hotel suites at trade shows, on the A-pillars of golf carts and even in some select corporate board rooms. Let’s read what one of our transcripts (judiciously edited for family hour/Nutraceuticals World suitability) revealed about the spirit of innovation and proprietary positioning in the diverse natural products landscape…



(Corporate meeting room A234, Northeast USA)


Product marketer/R&D jockey (PMRD): We’ve invited you here because we’re looking for a product that we can obtain an exclusive on, with human clinical trials and some real IP, not the edentulous type.

Product inventor (INV): [NLC thought: This wannabe R&D guy just revealed his hand—of ignorance. HUMAN clinical trials. It’s like saying “Cold ice.” And then he throws in “edentulous.” OOOOH! A poly­syl­labic word. “I gots to impress the boss…”]

Well, I think we have the ticket for you. The PowerPoint I’m presenting de­scribes all that you want for Christmas, and then some. We are willing to entertain an exclusive in your specific sales channel, with a guaranteed minimum royalty. The clinical [emphasized] data speak for themselves. And as to the IP…well, 14 of our 16 claims have just been allowed. Why don’t we jump in?”

All meeting participants: Sure!

PMRD: [NLC thought: The human clinical data speak for themselves. I bet they are …mutes! This I gotta see…]

***

(Halfway through slide show)

***

INV: Here are the changes seen after using InflamaStat (pointing to bar graph on screen). The 12 patients in this (InflamaStat) group showed a statistically significant 34% improvement in their combined joint pain scores at week 2 and 42% at week 4. The 12 in the glucosamine sulfate group showed 9% and 24% improvements, respectively, while the placebo group of 11 patients showed only a 12…

Director of R&D, PhD (DrD): [NLC thought: InflamaStat... Now I know why. His stats are cooked!]

(Interrupting) What was the study powered to? Why did you enroll only 35 patients? You should have used a Bonferroni correction to account for…(continues with statistics verbal diarrhea for 23.2 seconds)

VP of Marketing and Product De­velopment (VPMD): (Tossing a sycophantic smile at DrD) Is this your only study, INV? Has it been published?

INV: [NLC thought: Rescued from the jaws of Mrs. Wizard (DrD). I owe you one, VPMD. Has DrD ever created and launched a dietary supplement in her life? How does she spell “consumer?” Was she hired as CIO…Chief Irrelevance Officer?]

This is our only completed study but we do have another protocol developed, which we would jointly fund with the licensee of InflamaStat. It hasn’t been published but we are planning to present it at ACR next fall.

DrD: [NLC: ACR. American College of Rubbish...] (Brain turns off…lost NLC signal)

Director of Purchasing (DP): What’s ACR?

INV: Sorry. American College of Rheumatology.

VPMD: Please continue…

***

(INV continues and finishes presentation. Thermosensors affixed to INV’s axillary region detect a 1.6 degree increase. DrD doodles with statistics in her mind [NLC signal returns, intermittently], VPMD waits to see the claims, while DP earnestly watches and waits for the per kilo cost. Slide presentation concludes, 14 minutes later, uninterrupted by questions)

***

DP: So our cost of ingredient per month supply, the same dose used in your study, is how much again?
INV: If your initial order for pipeline fill was 1,000 kilos, it would come to about $3.45.

VPMD (effecting a grimace): Ouch. We’ve got a $19.95 SRP on our SpiffyLube™, with BeforCetin™ COX-2 inhibitor. Add in encapsulation, bottle, seal, label and distributor costs and we’re putting an expensive prayer on the shelf with InflamaStat. That probably won’t work.

INV: [NLC: SpiffyLube. Oh yeah. The in vitro “proven” product. Proven to work only in glass. The magician’s wand was waved over the “witches brew” of ingredients, rendering it synergistically formulated…Where’s my air sickness bag?]

If you let go of price for a second and focus on the benefit the consumer will experience—reduced pain, increased activity, even mood from just being able to walk up a flight of stairs on a cold day, without using the hand rail—the value commands the price point. The data on InflamaStat tell the whole story. No other supplement product for arthritis shows significant efficacy after TWO WEEKS of use!

***

(DrD suddenly awakens from semi-narcoleptic state, as if on the receiving end of a defibrillator wielding cocktail waitress in a biker bar)

***

DrD: We don’t feel comfortable taking on a product with a small scale study with questionable statistics. (Proudly looks over at VPMD) If we choose to commit substantial resources to this product, we want to have more compelling data.

VPMD: I agree with [DrD]. With our launch of SpiffyLube we had a six-month ad/promo spend of over $200K. We’ve invested a lot into that product and don’t want to cannibalize it. [NLC: Our sales have been arthritic. Wal-Mart sent us back $740K in returns. I knew we should have done a clinical trial first, to prove it works!] We have a number of testimonials on the product and it’s the only COX-2 inhibitor made from a fruit—cherries—so it could be considered GRAS.

INV: [NLC: It must be the stuff she’s drinking from that Super Size 42 oz. cup. I bet its Bacardi 151 and Diet Coke, blended with a precision measured 0.5:1 ratio. Now VPMD is getting high, from just the vapors coming out of the straw!]

(Defensively) Don’t you just have in vitro data on BeforCetin? Do you have any clinical studies on SpiffyLube?

***

(DrD: is Visibly miffed. Infrared transcutaneous adrenaline sensor detects robust adrenal medullary spike. Adrenaline concentrations approach that of an animal rights activist/20 year militant vegan forced to eat at a steak house)

***

DrD: I did the in vitro COX-2 inhibition assays with a colleague I worked with at the NIH, who has done thousands of these assays! It was more potent than Vioxx® or Celebrex®! Her lab has published 18 papers, in some very esteemed…

DP: [NLC: Gee, I’d like to try this product. I think we could sell it…]

INV: [NLC: NIH. Yeah—Not Invented Here]

VPMD (interrupting): I have another meeting that I’m already late too. [NLC: If we take InflamaStat on, the CEO will put my butt on the Hibachi after I buffaloed him to believe that we could capture 18-20% market share of the glucosa­mine/chondroitin market just by adding BeforCetin to a gluco­samine/chondroitin/MSM blend…] We’ll give it some thought. Can you not talk to other companies while we make a decision?

INV: (insulted, straining to retain composure and not open a can of Vitriol)

If you want us to stand still we’d need to have some good faith deposit. You are the biggest in your channel and we elected to come here first, since I was coming back from London.

VPMD: [NLC: Never hurts to try and tie him down.]

We have a policy of not paying for standstill agreements. We’ll get back to you after the holiday…

(Meeting adjourns. INV leaves the building)
VPMD: What did you think? PMRD, I haven’t heard from you since the beginning?

PMRD: [NLC: You haven’t heard from me because I’ve been thinking about my ad budget for next quarter] The ingredients aren’t new—no sizzle. I’m not sold yet. Heck, DrD and I could have done the same formulation in our sleep.

DP: I like it. I think we can sell it, even though it is more expensive than BeforCetin. I think we can position it without SpiffyLube being viewed as a stillborn. [NLC: We don’t have any data on ANY of our own joint health products. SpiffyLube should be buried. It was roadkill from day one…]

DrD: [NLC: One study with 30 people. Tsk, tsk…] I’m not convinced of the data. They didn’t evaluate the mechanism of action. And they haven’t published the data…

VPMD: [NLC: I like it, too, but if we keep on bringing in other people’s technologies, why do we need an R&D staff? What if consumers start asking us about clinical studies on SpiffyLube?] I think we should try to go back to the rheumatologist who said he’d write a consumer book and mention SpiffyLube by name throughout the text. Let’s try to engage him first before we revisit InflamaStat…

PMRD: He wanted royalties off the sale of SpiffyLube.

VPMD: That’s OK. I’d rather pay him than InflamaStat, as long as the product sells…NW