Why is pain such a pain for P&G?

Why is pain such a pain for P&G?

This month brings the news that P&G is selling to Wyeth Thermacare, a product that established a whole new sub-segment of topical pain relief. When P&G launched Thermacare it had all the hallmarks that anyone looked for in a new brand: new technology, new name, “relatively” unmet consumer need. But, only six short years later, the brand was put on the block and jettisoned due to under-performance and a desire for brand portfolio rationalization.

For such a savvy marketer, P&G has a long inglorious history of finding pain painful as a product category.

P&G entered OTCs in 1982 by acquiring Norwich Eaton and marketing enteric-coated aspirin. Never went anywhere.

Then it teamed up with Syntex to launch naprosyn in the OTC analgesics market under the name Aleve. Much fanfare. Ballyhooed $100 million launch spend. Sold to Roche/Bayer.

Okay, so maybe systemic analgesics were too tough for this smart marketer.

Detergents, oral care, cosmetics – all deal with external structure and function claims. P&G is brilliant there.

Thermacare is external. Kind of like an OTC. Competes against Chattem’s Icy Hot and Pfizer’s (now J&J) Bengay. Maybe P&G would do well there. Nope. Sold to Wyeth, which has an extensive pain portfolio led by Advil.

Maybe P&G just doesn’t get consumer healthcare.

Pepto-Bismol, Metamucil, Vicks? All under-performers.

And you heard it here first: Someday soon P&G will sell Prilosec.

Consumer healthcare requires a different kind of sensitivity to the magic bullets that drive OTCs vs. consumer products. In OTCs, marketers sell active ingredients that actually do something to the health and wellness of the body.

These products don’t just thrive on new colors and new flavors. They live by claims supported with relevant line extensions and forays into a category adjacency. The ultimate promotion is the professional marketing of OTCs where a company markets its products to doctors based on claims derived from clinical trials published in a peer-review journals. That isn’t Home Made Simple as promoted in P&G’s online and offline magazine.

P&G knows this; it is very smart. The company regularly accomplishes feats of derring-do with Tide and Crest and Pampers.

But when it comes to products that require a higher level of scientific and regulatory understanding, P&G never gets it quite right. Prilosec was a year late because P&G hadn’t truly aligned its claims to its clinical trials.

There is a subtle difference between OTC and consumer products. OTCs demand that you really and truly understand the difference between what you do and what you say and how it affects the health of your brands and your consumers.

A Wii bit of medical advice: Try mABs

I am not going to get the Nobel Prize for this, but, I believe I have made a major scientific discovery: Wii-mABs.

Ordinarily, mABs or monoclonocal antibodies are monospecific antibodies that are identical to each other as they come from one type of immune cell that are all clones of a single parent cell. Since you can create monoclonal antibodies that specifically bind to most substances, they can then serve to detect or purify that substance. mABs are used in treatments for such diseases as rheumatoid arthritis, leukemia, and lymphoma.

So I got to thinking what I could do to help fight Wii-itis or inflammation of the elbow. I thought this would be a particularly important disease to fight given the Nintendo’s mission to turn couch potatoes into fried potatoes through the use of its motion sensitive game remote and the recent launch of its exercise-focused Wii-Fit board.

I posit that the Wii-itis or Wii elbow is a common affliction of Wii users. This injury is also common among tennis players and represents an inflammation of the elbow joint. I think it is probably under-diagnosed among Wii-ites, indicating a seriously under-treated population given the popularity of the game and a true unmet medical need.

However, upon further research, I also uncovered several other diseases associated with the Wii:

TNF-α factors, also known as, They Never Fail, which afflicts alpha males who are determined to win these games at all costs.

B cells: Small committed groups of users who try to bowl a 300 every time.

T cells: Similar to the bowlers, this group of tennis players never settles for love.

RSV proteins: These users are infected by Repeated Swinging Values caused by their single-minded desire to over and over again try to win their games.

Others have noticed a similar issue, and I would like to build on their research. In a past issue of the New England Journal of Medicine, Dr. Julio Bonis reported awakening with a sore shoulder. He was puzzled since he hadn't played any so-called sports recently, but he had played several long sessions of Wii tennis.

In the past, gamer joysticks have been known to cause arthritis, carpal tunnel syndrome, ganglion cysts and tenosynovitis.

Now, many patients can benefit from a Wii bit of exercise. The Wii console burns more calories than classic game consoles. For an average weekly use of 13 hours, 1,840 calories would be burned, that is 40 percent more than classic consoles. Plus the new Wii Fit offers ways to do yoga, balance games, aerobics and strength training.

So what is the solution: like so many sports injuries and people who suffer from such co-morbid conditions as diabetes, coronary heart disease and hypercholesterolemia, the best recommendation is changes to one’s lifestyle. In this case it is important to pursue those mABs, moderately active body breaks. In order to ensure that players get the most out of their mABs, they should actually consider reading something. Personally I am reading the new translation of War and Peace by Richard Pevear and Larissa Volokhonsky, and it is fantastic.

If you don’t take my recommendation, then please note that the august British Chiropractic Association (BCA) has advised that a Wii player to take breaks every 20-20 minutes. The BCA also says that gamers should treat a 'Wii session' like any form of exercise and warm-up adequately beforehand to prevent stiffness and possible injuries." The Association has a five-point "Wii warm-up" for the shoulders, wrists, arms, neck and back that can be downloaded from its web site at www.chiropractic-uk.co.uk.

Now excuse me, I have to return to Rock Band. I believe I have nailed Blitzkrieg Bop.

Nothing Is More Natural Than Artificial Beauty

Nothing is more natural than artificial beauty.

Are you really reducing your carbon footprint (and your wallet) when you purchase natural cosmetics from Dr. Hauschka?

According to Mark Landler in The New York Times, stars like Julia Roberts, Jennifer Aniston, Richard Gere and Robert Downey Jr. use and advocate the use of Dr. Hauschka.

Now who can argue with this A-list who, by association, have helped WALA Heilmittel the maker of Dr. Hauschka, double sales to over $150 million in the last five years. Can these stars even pronounce the name of the brand?

WALA stands for Warmth, Ashes, Light and Ashes and is based on an early 20th-century European philosophy called anthroposophy developed by Rudolf Steiner that postulates the existence of a spiritual world that can be accessed by the human intellect. The practical aspect of this philosophy was organic farming, hence the natural production of natural ingredients.

This gets even better: natural, spiritual, expensive – a trifecta for beauty. You simply can’t refuse this offer if you worry about your looks, have money to burn and want to be trendy.

I do not believe that these stars are accounting for all this sales growth. Surely there are some less beautiful people buying into this product line.

So, in the end, we have class cosmetic marketing. A cosmetic brand supported by a reason why (in this case, natural ingredients) that is promoted by glamorous stars and riding a trend.

Decade after decade, year after year, this formula works.

Or maybe I should say millennia after millennia.

After all, look at the Egyptian hieroglyphics. You won’t see any overweight, unglamorous people depicted there. Those Egyptians really looked good on their People magazine pyramid walls.

And all they ever used was natural cosmetics; probably well along the line promoted by Rudolf Steiner.

I guess the formula works. But wouldn’t it be interesting to try something truly different.

Bill Clinton - Pump Head

When I attended my daughter’s graduation from the University of Michigan last year, there was great excitement among the audience. It was just about the pride of seeing your son or daughter on their university commencement day. It was also about the fact that former president Bill Clinton was going to give the commencement address. Not a bad gig for the husband of the woman was fighting for the presidential nomination in this battleground state (remember this was when, not now).

A great applause greeted his step to the podium. Then he began to speak. The sentiments and ideas about going out into the world and making a contribution toward a better world were fairly stock commencement sentiments nicely worded.

Surprisingly, though, they weren’t nicely said. Clinton hesitated, paused over phrases, stammered. I was wondering where was the fluidity of speech, the eloquence of man known as a great campaigner and speaker. I recalled his State of the Union speeches. He didn’t sound like this then.

And this past year, as the campaign continued, there was a whole series of remarks that seemed out of context and personal attacks against former friends and supporters that didn’t ring right.

As reported by Melinda Beck in the Wall Street Journal, aides to Bill Clinton last week denied speculation that the former president's intemperate remarks on the campaign trail were due to mild cognitive damage from his quadruple-bypass surgery in 2004.

"This theory is false and is flatly rejected by President Clinton's doctors, who say he is in excellent shape...." the statement said.

But the condition dubbed "pump head" or "bypass brain" is well known to doctors but few warn patients about it.

Symptoms include short-term memory loss, slowed responses, trouble concentrating and emotional instability. As noted by Beck, in the New England Journal of Medicine in 2001, researchers at Duke University Medical Center tested 261 patients before and after bypass surgery and found that 53% of them had significant cognitive decline when they were discharged -- and 42% still suffered from it five years later.

One explanation is that when a patient's blood is pumped through a heart-lung machine during bypass, tiny air bubbles, fat globules and other particles may enter the bloodstream. The pump can also damage platelets, which form clumps, and clamping the aorta loosens bits of plaque. That debris can travel to the brain and clog tiny capillaries, forming microscopic strokes.

So we may fix the heart, but, at the same, endanger the head. Surgery is always a risk, and it helps to really understand all the complications that occur.

The best answer lies in the prevention of coronary artery disease (CAD). There are approximately 30 million people in the US and top five EU countries who suffer from CAD. And, although, mortality rates are declining due to better therapies, it still remains one of the leading causes of death in the developed countries.

Lifestyle change and the use of drug therapies like statins clearly help, and, by aggressively managing against those initial symptoms of trouble and family history, patients can defer what used to be inevitable.

It is clearly better now to prime the heart pump into good long-term health than pay the consequences later. Yet while many patients think the surgery is a great fix (which it is), there are still many other risks that affect not just the heart but also the brain. There is no bypass there.

Get me some amoxicillin and yogurt, stat

Who doesn’t want fast, convenient, inexpensive healthcare?

So what a great idea in-store health clinics are. Big benefit to consumers/patients. Perfect sales alignment for retailers between their pharmacy counters and OTC aisles.

The number of clinics boomed in the last three years from 125 clinics to 963.

In the cosmetic business, you count distribution by how many doors you are in. The more doors, the more sales potential, filling the rack and offering access.

Think about that for health clinics. More access for sore throats, colds, rashes, blood pressure monitoring, diabetes supplies. With great convenience.

But now growth is slowing. The Wall Street Journal reports that Shopko, Meijer, and Wal-Mart and Cardinal Health’s Medicine Shoppe is actually closing units. Maybe as much as 70 clinics. And CVS is talking about scaling back their expansion plans.

Why?

Oh, it something as simple as estimating the break-even on your investment.

According to Tom Charland, for VP for Strategy at Minute Clinic, “The big mistake was for people to think they could break-even in six months. People are learning this is an 18-24-month process to get to break-even.”

Now how many product launches do you know of that break-even in six months?

Now think of how many capital-based retail fixture-based store-based assets break-even in six months?

Maybe those hard plastic theft prevention boxes that protect Gillette’s Fusion razor blades from thieves with wide and deep-sleeved coats, but not much else.

Now reality is settling in. The financial teams are making their lists and checking them twice trying to figure out what clinics have been naughty and which have been nice.

Business reality and metrics here are necessary and good.

However, they will not ultimately slow down the need for people to have access to fast and easy health care.

Compare these clinics to the current distribution of general medical practice:

• Call for the appointment
• Set in the waiting room for thirty minutes
• Speak to the doctor for 20 minutes
• Drive to the drug store to get the prescription filled
• Wait for the prescription.

One stop health care for minor ailments is a need that is here and will continue to grow.

The challenge for the retailers is to get their economics right and for drug and consumer healthcare manufacturers to get their targeting and merchandising right to help their retail partners succeed.

The patient is waiting.

The Other Guy Blinked, Part IIA

It is just a matter of time before the Rice Riots affecting developing markets turn into the Water Riots. Though I expect that that was something Noah already knew.

Those “bad” guys keep banging on the doors of the ark, seeking imitative ways to profitable salvation.

Last week, PepsiCo acquired Britain's V water to protect its European flank from Coke.

V water states that it is made from spring water, comes in different flavors and includes additives like vitamin C, zinc and ginseng.

Can anybody spell vitaminwater? The same US brand that Coca-Cola paid $4 billion to Glaceau for last year and is planning to launch overseas in such countries as, surprise, surprise, the UK.

After all, when you buy a regional brand, the easiest way to make money on your shiny new brand asset is to launch it in new geographies. The launch pipelines are pure incremental money and whatever sales you get are gravy against that expensive roast beef you purchased.

How rare is success? Actually quite frequent as long as you get the local temperature right.

The main challenge? Of yeah, when the competition is there ahead of you. Like what Pepsi just did to Coke. Nothing like landing on a foreign shore and seeing that someone was there before, like the Vikings welcoming Christopher Columbus to the new world.

This kind of strategy/counter-strategy cuts across consumer categories. Reckitt-Benckiser buys Mucinex in the US and is “banking” on rolling it out globally. What they really bought was not a unique decongestant (as guaifenesin is as old as the hills) but an advertising property called Mr. Mucinex that they better hope will play as well in Sao Paulo as it does in San Diego.

In the mean time both Coca-Cola and Pepsico are trying to defend their “water substitutes” against contamination and resource defoliation in India, as Nestle tries to gain control of new water access points in the US Pacific Northwest.

Pepsi, already owns SoBe Life Water, Gatorade sports drink and Aquafina bottled water.

The question will be do they truly believe that they can grow V water or are they just trying to pick Coke’s pocket, leaving the company with less money to invest.

Water polo anyone?

The Donnybrook Fair: Apple, Blackberry and Google

One touch of nature makes the whole world kin,
That all, with one consent, praise new-born gauds.
And give to dust that is a little gilt
More laud than gilt o’er dusted;
The present eye praises the present object.

Troilus and Cressida, William Shapespeare

The emerging battle between RIM, Apple's iPhone and Google Android have all the classic hallmarks and of a true marketing melee. That’s great to see and instructive for all.

RIM’s Blackberry, for years, has made the market for smartphones, being the corporate darling for its ease of email use. How many times have you sat in a meeting, suddenly see the flashing light on your Blackberry go from green to red and feel the need to know and to answer?

Oh, and who did Blackberry pass on its leg around the track? Palm, which came late to smartphones. While Blackberry software and third party apps were not as robust as Palm and even though Palm had a huge installed base of users tracking their calendars, the functionality of its email system and the alignment with corporations won that race thumbs down, even though its first devices were black-and-white and clunky.

Now we have the iPhone, a cooler piece of hardware and software than the Blackberry. But not the winner out of the gate. The functionality and ease of use (my thumbs are just too big for the accurate and fast touch screen typing) do not match the Blackberry, limiting its ability to gain a broad base of users. Who bought the iPhone first? Consumers, the bedrock of Apple users.

Now it is getting interesting:

· Apple is preparing to launch a 3G iPhone and use Microsoft corporate email technology, a needed move to get corporate IT departments to sign on to iPhones.

o But you have to wonder how much this pains the purist in Steve Jobs?

· Blackberry is also preparing a 3G version and a better piece of hardware (bigger screen, better processor with a better browser).

· Google is licensing its Android operating system, based on Linux, to gain “screen share” on cell phones globally.

Google is operating under a totally different business model, fighting on only one battlefield. They are hardware-agnostic, freeing themselves of tactical hardware tactics, desiring share of eyeballs for its many apps. Google margins should be better. Their design focused on the visual look and click-throughs as they eschew plastic, metal and processors, leaving Nokia, LG, Motorola etc to the battle of the tiny boxes.

So the battle of flanks and enfilade goes to Blackberry and iPhone as they strive to win the minds and thumbs of both consumers and corporate users. The Blackberry Pearl and Curve are okay consumer phones, but they ain’t no iPhone.

When all things about performance are equal, great design wins. In a world of parity claims about superiority, whether it is soap or cosmetics or furniture or drugs, the cool-ness factor can win. Just ask Ideo.

The real and complex battleground here will go to the winner who must strive for superiority on both hardware and software. That is not an easy task. There are a thousand different cell phone sku’s in the mobile telephone category, but few offer truly differentiated in performance. Design becomes key. Remember the success of flip phones vs. candy bars? The first Razrs vs. everything else? Even the StarTAC. What makes this new evolution so interesting between iPhone and Blackberry is that it requires a skillful combination of both performance and design.

In the thirteenth century, King John gave a license to hold an annual fair in Donnybrook, outside Dublin. By the eighteenth century, it had become a huge two-week assembly for horse dealers, fortune-tellers, beggars, wrestlers, dancers, fiddlers, and food sellers. It was known for its rowdiness and noise, particularly for the whiskey-fueled fighting that went on after dark. The traditional advice for an Irishman going to the fair was, “Wherever you see a head, hit it.” Eventually the fair was closed by the Irish government in 1855.

I don’t know if you can combine the idea of a donnybrook with a Smartphone (since smart and donnybrook seem antithetical), but that it what this category is re-shaping itself to be.

Saving Winston Churchill's Chilly Heart

Lady Nancy Astor: Winston, if you were my husband, I'd poison your tea.
Winston Churchill: Nancy, if I were your husband, I'd drink it.

Having a defibrillator at home does not protect heart attack survivors against a cardiac arrest any better than having someone at home with good cardiopulmonary resuscitation training.

Dr. Gust Bardy of the Seattle Institute of Cardiac Research and colleagues studied 7,001 people at moderate risk of sudden cardiac arrest, each of whom had a spouse or home companion willing and able to perform CPR and use an AED. He presented the results of the study of automated external defibrillators or AEDs used in the home at a meeting of the American College of Cardiology in Chicago.

In public places such as airports, AEDs have helped people survive sudden cardiac arrest, when the heart stops pumping blood. Without immediate treatment with a defibrillator or a bystander who knows CPR, most die within minutes.

As about 80 percent of sudden cardiac arrests occur at home, researchers wanted to see if putting defibrillators in the home could save lives.

One group was told to call an ambulance and perform CPR, while the other group was told to use the defibrillator first, then seek emergency help. They were followed for three years.

What a gamble to participate in this study? Will I live because I depended on skill vs. a device? What’s my risk for sudden cardiac arrest anyway? What’s the book in Vegas on my chances of the big bang and then surviving it.

Wait a moment. Wow. How much faith does it take to trust that your spouse knows enough CPR to save you vs. having the AED in your home. Or that she'll even make the attempt at all. Basically, if she fails, it is okay because it was only a clinical trial that didn't work.

Now that’s love. As you lie there on the floor, clutching your chest, you look up with pleading eyes that say save me.

And then she (oh yes, we assume it is a she) remembers all the garbage you didn’t take out, the beer on your breath when you came home at 2 am, the mess your buds made after the Giants won the Super Bowl and a thousand other slings and arrows that outrageous fortune rained down on her because of you.

"There was no mortality benefit," said Dr. Gust Bardy of the Seattle Institute of Cardiac Research, whose study was published in the New England Journal of Medicine.

No benefit? Someone still lived.

Out of 123 arrests, just 63 of those were witnessed and a defibrillator was used in just 32 people. The device, which can assess a patient's rhythm, called for a shock to be delivered in just 14 patients, and only four survived long enough to be discharged from the hospital.

Bardy told reporters the rate of cardiac arrests occurring at home was lower than expected, and many occurred when the victim was alone.

And he noted that patients' spouses and companions in the control group had been well educated in how to respond to a heart-stopping event, something that could have improved survival in the group that did not have an AED.

Interestingly, the devices were also used by neighbors who borrowed one of the defibrillators to revive a family member. Two out of 7 of those people survived. Bardy said whenever the devices were used, they worked well.

AEDs for use at home cost $1,200 to $2,000 per unit. AEDs used in the study were made by Philips Medical Systems, a unit of Royal Philips Electronics, which are the only AEDs available without a prescription.

Bardy said most of the devices are purchased by the "worried well," and confessed to personally owning four.

Global Walgreen-ing

Whatever is the world coming to but the Walgreen-ing of the global mass market retail drug store distribution channel.

Global OTC manufacturers need to start thinking hard and smart about playing with global retail chain drug stores. The death knell of decline is starting to sound for independent pharmacies, and, when you couple this change in the retail distribution channel with General Sales Ledger (GSL) and Pharmacy (P) brands that provide consumers with easier access, you can start to count on

· Improved public health benefits

· Lower prices

· Great business opportunities

Nicholas Hall is a very smart and astute observer of consumer healthcare and the retail pharmacy.

Here are four data points from his latest OTC newsflash:

1. According to local press reports, the Spanish government risks being taken to the European Court in the next couple of months, in a move to change its pharmacy model to reflect EU legislation guaranteeing the freedom to set up European-wide businesses.

2. Meanwhile, a report by Dutch audit company Ecorys and the University of Maastricht, defending liberalization and deregulation, concludes that the elimination of all rules that regulate pharmacies would provide significant economic savings. The report suggests deregulation of pharmacies could improve their productivity by one-third and reduce prices by 30-40%.

3. In Japan, Drugstore chains Welcia, which has 95 stores in Shizuoka and Kanagawa, and Tokyo-based Takada are in talks to merge later this year. The merger will create Japan's ninth-largest drugstore chain, with sales of about Y130bn (US$1.2bn) and around 395 stores.

4. Speaking at a retail sector conference this week, Alliance Boots executive chairman Stefano Pessina announced that the roll-out of the Boots name in Europe. Although the Boots brand is very powerful in the UK and known elsewhere, it has not been exploited advantageously in international markets. Pessina said the brand will be developed in Europe over time, starting with Norway, where 7 of its Alliance Apotek pharmacies have been rebranded under the Boots the Chemist format, with all 125 Norwegian stores set to follow suit.

This man knows what he sees.

Now it is up to OTC manufacturers to also see these beacons of change and convert them into cogent sales, branding and distribution strategies. The pain of Wal-Mart has already been well felt in the US. Similar distribution and pricing are emerging in Europe, while, similar opportunities loom large in emerging markets like China (viz. Nep-Star) and India. The challenge will be capitalizing on this emerging wave of drug store capitalism.

Life-Profiles: The Patient Is Waiting

All of us are so similar in our differences.

It’s the Jordache, L.L. Bean, Gap, Gloria Vanderbilt, Calvin Klein and, of course, Humanity approach.

In the Wall Street Journal, Robert Lee Hotz neatly summarizes the impact and non-impact of variations in our DNA.

The Max Planck Institute reported that any one of 11 variations in a single gene can make it harder for common anti-depressants to adjust serotonin.

The University of Alabama reports that any one of 9 variations in another gene can double the risk of lupus.

The US, China and the UK have jointly launched the 1000 Genomes Project in which scientists will exhaustively detail the DNA of 1000 people from around the world, producing 60 times as much genetic detail in the three years than all of that produced in the previous 25 years.

In her book, The Human Condition, Hannah Arendt defines vita active (active life) as composed of labor, work and action in the political, social, public and private worlds.

In his book, The Human Comedy, William Saroyan illustrates how the grounded-ness of a well-rounded human support system of Homer Macauley enables him to live a full and fulfilled life

With all this data about who we intrinsically are, physically, socially and spiritually, the challenge remains on understanding and developing pills, products and ideas to continue to help us survive and thrive.

At SmartAnalyst, we are evolving an approach called Life-Profiles ™ where we can combine the best of consumer/patient, scientific and commercial research to provide pharmaceutical and consumer healthcare companies with an understanding of their ultimate target, us.

At Warner-Lambert, we used to have a saying that The Patient Is Waiting. The world is waiting for help with better vaccines, better courses of therapy and better care.

Understanding the complexities of genes and psychologies is so critical to this success that Life-Profiles is designed to help shine a light on who we are, creating a real blend of both scientific and psychological insight.

In his The Actor’s Studio, Lee Strasberg refined and taught method acting as way in which actors would recall real, personal emotions to help them get inside the personalities of their characters.

Life-Profiles is all about getting inside the life of our patients, both physically and emotionally. That is our motivation.

Thinking Your Way Through A Recession

Sorry for not posting sooner, but I have been working in India for the last couple of weeks and am just catching up.

Last week I saw that Barnes & Noble Inc warned of "recessionary pressures" and estimated that 2008 earnings would be well below Wall Street estimates.

As reported in Reuters, the world's largest book retailer already faced a high sales hurdle in comparison with a boost last year from the last Harry Potter book. The company said it had a weak holiday season despite generous discounts aimed at cash-strapped consumers. Also, Barnes & Noble saw its share of the music business pressured by online offerings like iTunes.

Okay, so clearly no one has a monopoly on knowledge, but think about the damage if a recession can make stagger your acquisition of knowledge because you can’t afford books.

But Barnes & Noble is more than just books. It is music, magazines, Starbucks coffee, calendars, and knick-knacks. B&N is also an easy of source for gift-carding when your knowledge of the recipient exceeds your capacity to think of a gift and you desperately hope that the person you are buying a gift for knows how to read. Given this recessionary pressures, reading and amusement are going down the tubes.

But look what Americans have learned in the last six months: Continual growth and investment in home equity is no sure thing and “Guaranteed” as-good-as-cash investments are subject to auctions.

What we learned is that we live in an “e-bay” world, where everything is an auction and you are either a buyer or a seller – and you always need a partner. These partners assign a certain value to your asset, and it may not be a value you like. This is the efficiency of markets coming home to roost.

To quote the sagacious Yogi Berra, it is déjà vous all over again. It is tulipomania all over again, from the passion for buying and selling tulips bulb in 17^th century Holland. A good tulip bulb could cost thousand times the average Dutch salary.

More recently we had internet stocks. Now we have something even more pernicious, the roof over your head, the foundation and the driver for much of recent US economic growth.

I love Anthony Powell, and, in his twelve-novel sequence called A Dance to the Music of Time, his tenth novel is called Books Do Furnish A Room. Now, according to Barnes and Noble, it looks like our shelves will be as a thread-bare as our home investments. If we don’t learn from the lessons of history, we are doomed to repeat them. Okay, for ten points and your next best investment, who said that?

Keeping Your Head When Those All Around You Are Losing Theirs

Kudoes to J&J's Rogaine. Sales are reported to be up 25% following the launch of Rogaine mousse foam.

Form does follow function.

Before the launch of the foam, Rogaine was oily, didn't necessarily stay on the top of your head and didn't leave hair looking shiny and free.

So what did J&J do? They reformulated the product into a more consumer friendly version and sales shot up.

The Minoxidil active didn't change. Just the way the product was delivered to the consumer.

In the consumer healthcare operating space, you rarely get novel new actives unless you are switching a compound from Rx to OTC status, such as GSK successfully did with its alli, the weight-loss product formerly known as Xenical (orlistat).

So what you can in consumer healthcare is a lot of development effort put behind forms, flavors and condition-specific indications. That's a lot of effort and most of the time all it does is keep your market share in place and add mopre sku's to your product line-up.

But when you can truly introduce a form that improves your product's consumer-friendly usage you have a real winner.

I only hope pharmaceutical marketers begin to understand more deeply the roles than form can play with product adherence. Using Rogain everyday really is all about compliance and adherence.

Why can't we say the same for statins or blood pressure meds?

Beauty Is the Eye of the Beholder for Allergan and Estee Lauder

How perfect is the deal between Estee Lauder and Allergan to develop an upscale skin-care line in dermatology offices?

All too often pharma companies forget about the role of patient/consumer decision-making in their product development.

And you wonder why 30% of prescriptions go unfilled? That is a dire lack of compliance.

Allergan gets the consumer side of marketing better than many pharma companies. From Botx and to Refresh, they appreciate how to speak with consumers.

Now they have a brilliant tie-up with a premier premium marketer in Estee Lauder.

The new line will carry a variation on the Clinique name and may be priced at a premium over Clinique's retail-store brand as well as Allergan's existing physician-dispensed skin-care products, including Prevage MD, M.D. Forté and Vivité. Some new products will be created to complement and speed recovery from aesthetics procedures, such as laser treatments and microdermabrasion. The products may include medical-grade ingredients that tend to add to the cost and the effectiveness of skin-care products.

This deal also works for Estee Lauder, giving them a new premium channel to see upscale beauty.

And, of course, the physicians win as well with new more patient-friendly lines to sell.

If only more pharma companies thought this way about their products.

Celebrity Skin: Childhood Leukemia Discovery

Cells don’t take a holiday. Your body keeps moving. Cells in the laboratory continue to need care. What do you do when you are born with “pre-leukemic cells?”

“Oh, make me over
I’m all I want to be
A walking study
In demonology.

Hey, so glad you could make it
Yeah, now you really made it
Hey, so glad you could make it now.”

According to a press release from the Great Ormond Street Hospital (GOSH), a group from the Medical Research Council Molecular Haematology Unit at Oxford, studying four-year old twin girls in Bromley, UK, has identified a rogue cell that is the root cause of childhood leukemia. Both twins had “pre-leukemic” cells but, to date, only one has developed leukemia.

http://www.ich.ucl.ac.uk/pressoffice/pressrelease_00598

“Oh, look at my face
My name is might have been
My name is never was
My names forgotten

Hey, so glad you could make it
Yeah, now you really made it
Hey, there’s only us left now.”

It is believed that it takes another genetic mutation, possibly caused by an infection, and is required to create the disease. Leukemia occurs when large numbers of white blood cells take over bone marrow and the body is unable to produce enough normal blood cells. 1% of the population is believed to contain “pre-leukemic” cells and of this population, 1% has the second mutation occur and get cancer.

“When I wake up in my makeup
It’s too early for that dress
Wilted and faded somewhere in Hollywood
I’m glad I came here
With your pound of flesh.
No second billing cause you’re a star now
Oh, Cinderella
They aren’t sluts like you
Beautiful garbage, beautiful dresses
Can you stand up or will you just fall down.

You better watch out
What you wish for
It better be worth it
So much to die for.”

One of the twins has now developed acute lymphoblastic leukemia, but the other twin is healthy. Doctors are continually testing the healthy twin, and they believe that when she reaches adolescence, the rogue cells will disappear.

“Hey, so glad you could make it
Yeah, now you really made it
Hey, there’s only us left now.

When I wake up in my makeup
Have you ever felt so used up as this?
It’s all so sugarless
Hooker/waitress/model/actress
Oh, just go nameless
Honeysuckle, she’s full of poison
She obliterated everything she kissed
Now she’s fading
Somewhere in Hollywood
I’m glad I came here
With your pound of flesh.”

Current treatments are too aggressive to eradicate the “pre-leukemic” cells, so screening is not likely, according to doctors. Study leader Professor Tariq Enver has been quoted as saying that now that doctors know about the cell, they hope to some day find a way of targeting the disease.

According to Dr. Phil Ancliff of the Great Ormond Street Hospital (where my son was treated for his eyes and the hospital to which J.M. Barrie donated the royalties from Peter Pan), 90% of children survive leukemia because of intensive chemotherapy. However, that therapy can come at a price. The treated twin has lost sight in one eye.

Such is the kind of research that kinds us all one step closer to cures.

“You want a part of me
Well, I’m not selling cheap
No, I’m not selling cheap.”

Song lyrics from Celebrity Skin, written by Courtney Love of Hole.

Exotic Juices Free Radical Marketing

How about some exotic juices for some exotic pricing?

Snapple has Noni Berry from Polynesia, which is naturally bad-smelling with a nasty taste. But Snapple makes it with other juices to create a better taste.

Snapple does the same thing with Acai. I bought Snapple Acai but when I read the label there was barely any Acai there. Just other juices. Bossa Nova also has an Acai drink, but mixes it with raspberries.

Then there are drinks with yang-mei fruit from China, and Goji berries from Asia. None which taste particularly good.

And this started with pomegranate juice. When you drink POM straight (known as POM Wonderful), it doesn’t taste very wonderful at all. POM Tea tastes better, barely.

I think that what this really tastes like is money.

In The Great Gatsby, Jay Gatsby tells his friend, Nick, that Daisy’s voice sounds like money. Surely that’s what these manufacturers must be hearing when they put these exotic juices into bottles. And why, do they do so?

Novelty, trendiness, jumping on the health bandwagon.

Why? To provide anti-oxidants that fight the free radicals. I wonder what the Weathermen and the Baader-Meinhof gang would think of this. Now those people were free radicals.

Antioxidants are substances that may protect your cells against the effects of free radicals. Free radicals are molecules produced when your body breaks down food, or by environmental exposures like tobacco smoke and radiation. Free radicals can damage cells, and may play a role in heart disease, cancer and other diseases.

Do you get this from these juices? No. As a matter of fact, whatever vitamins or anti-oxidants there are in these juices passes through your body so fast few healthy ingredients ever escape the chutes and ladders of your digestion.

The biggest benefit is hydration from the water in the juice.

It can’t be the taste. And it can’t be the desire to throw good money after poor health.

There is no benefit here that you can’t get from eating nine fruits and vegetables a day.

Talk about SKU proliferation, even at a premium. This isn’t good marketing or good health. All those free radicals really do come at a cost to the marketer and the consumer.

The Zen Koan of Cancer and Lab Testing

How do you study for a test where you are never asked a question?

Sounds like a zen koan.

Koans are a method of training the mind in order to achieve the state of Satori or enlightenment into the nature of reality.

That's great. But what if you are getting a cancer diagnosis?

The Wall Street Journal on January 4 had an article about how thousands of breast-cancer patients may be getting the wrong treatment because of lab test errors.

Sounds scary. Talk about the nature of reality.

The tests are used to determine if women with invasive breast cancer will receive Herceptin, Tykerb, Arimidex, Faslodex or generic tamoxifen.

Not exactly the kind of test you want to fail.

Insurers generally assume that every test is done right, and they pay accordingly. More critically for patients, many of them will also pay for second-opinion breast cancer tests.

But many doctors don’t order them.

In 2007, ~178,000 patients are expected to be diagnosed with invasive breast cancer in the US, according to the American cancer Society, and the tests that these patients will require are not straightforward lab procedures. These tests require pathologists to make judgment calls after looking at a tissue through a microscope. That ain’t a simple yes or no.

Oversight in this area is as demanding as one might think. While the FDA must approve every drug, it allows laboratories more freedom in the designing tests. Even when the FDA does approve a test, the lab can still tweak it.

If the pharmaceutical, government and clinical laboratory industries are going to get this right, then a greater emphasis on standardization and review is critical.

How much goes for naught if a pharmaceutical or a biotech spends $1 billion to design and test the drug, and then it doesn’t get into the right person.

Last week, I talked about the power of micro-trends. If more and more people ask questions and request second-opinions and more and more companies focus on improved testing protocols, we can have a very powerful trend that will only be for the better.

This is a move for enlightenment. This is how you study for a test where you are the question and you really want and you really need the right answer.

Microtrends, Orphan Drugs & Evidence-Based Medicines

Here’s a political statement for the new year:

Mark Penn, Hilary Clinton’s campaign strategist, has a book in which he identifies the power of Microtrends to start a political movement or launch a movement. Penn says you only need three million people or one percent of the population. His premise is that by detecting small changes in behavior has a large impact on business, politics and political lives. www.microtrending.com

Okay, now what about orphan diseases. Talk about Microtrends. Orphan diseases affect less than 200,000 people in the US or less than 5 people in a community of 10,000.

Some of the diseases include various types of cancer, TB, cystic fibrosis, Karposi’s sarcoma, Huntington disease, smallpox, idiopathic pulmonary fibrosis, lupus.

Not a bad list, not a good list. Depends on how you look at it from a public health need, disaster, commercial opportunity or roll the dice for yourself, your loved one or your pharmaceutical company.

Sure soccer moms, according to Penn, can be a potent voting block. Others include extreme commuters (90+ minutes to work), Protestant Latinos, Caffeine Crazies.

Now think about some of the people suffering from these orphan diseases.

The granting of the orphan drug status by the FDA and the EU is to encourage the development of drugs to address these diseases, but, normally, these drug developments would be prohibitively expensive/un-profitable to develop under normal circumstances. www.fda.gov/orphan/oda.htm

The idea behind the US Orphan Drug Act is to encourage companies to invest money in research. Under the act many drugs have been developed, including drugs to treat glioma, multiple myeloma, cystic fibrosis, phenylketonuria and snake venom. In the US, from January 1983 to June 2004, a total of 1,129 different orphan drug designations have been granted by the Office of Orphan Products Development (OOPD) and 249 orphan drugs have received marketing authorization in the US. In contrast, the decade prior to 1983 saw fewer than ten such products come to market.

Leading orphan drugs include Amgen’s Erythropoietin and Novartis’ Gleevec. And these products aren’t cheap.

According to a 2003 article in the British Journal of Cancer, Gleevec® (imatinib mesilate), a tyrosine kinase inhibitior, emerged as the most effective non-transplant treatment available for patients with chronic myeloid leukemia (CML).

Yet researchers in the United Kingdom reported that the costs per quality adjusted life year (QALY) is approximately $40,000 more than conventional therapy for patients treated in accelerated phase and almost $60,000 more for patients treated in blast crisis.

Gleevec® has been evaluated as salvage therapy for patients in the accelerated or blast phase of CML., and studies determined that initial treatment of CML patients with Gleevec® is superior to treatment with alfa interferon plus chemotherapy.

Yet paying for Gleevec is expensive. Researchers in England compared the economic impact of Gleevec® compared to standard chemotherapy for the treatment of patients in accelerated or blast phase of CML. They used a computer model which took into account 5 years of treatment from the start of treatment. They estimated that a patient in accelerated phase would accrue an additional 2.09 QALYs with Gleevec® compared to conventional therapies, while patients in blast crisis will accrue an additional 0.58 QALY.

They also report that this improvement comes with a price, approximately $40,000 per additional QALY more than conventional treatment for patients in accelerated phase. For patients in blast phase, the cost was almost $60,000 more per additional QALY. These projected costs were highly dependent on the price of Gleevec®, improvements in quality of life, and duration of haematological response.

Now if you REALLY want to think about microtrends. Think about the impact of the really beneficial use of this drug. And then think about its impact on patients, their families, their doctors, their governments, their payors.

What we talk about when we talk about evidence-based medicines is really this.

And no political candidate, let alone pharmaceutical company or payor or legislator is fully undertaking the challenge of addressing these issues. The government recognizes the need. The law is there. But the research and the issues are still being addressed on an ad hoc basis.

The evidence is there and it is continuing to emerge and evolve. The basis for a sound policy and a sound strategy still needs to be developed.