Sunday, January 27, 2008

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.

Friday, January 18, 2008

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.

Sunday, January 13, 2008

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.

Saturday, January 05, 2008

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.

Tuesday, January 01, 2008

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.