The dangers of marketing genetic tests.

Some months ago, scientists sent samples of the same DNA to several direct-to- consumer (DTC) genetic testing services. When the reports came back the interpretations of the findings were wildly different. This has just been confirmed by the General Accounting Office and was reported on this week in Washington. So if you want to know if you’re predisposed to some ailment, don’t bother spending the $300 to $1,000 that these tests cost.

Even worse than the rotten results were the horrific marketing practices that the GAO uncovered: One firm claimed that the product they sold could “repair DNA.”  Others claimed they could tell parents which sports their children would do well in. One woman was told she would definitely develop breast cancer, while another was assured that the company would test her fiancé’s DNA secretly.Read full post...

Regulatory approval for genetic tests.

The week of May 10th was not a good one for Pathway Genomics. That’s when the FDA sent a letter saying it was looking into Pathway’s genetic test offering. And it’s not the only interested party.

According to Genome Web, the House Energy and Commerce Committee wants more information about Pathway’s test,  and about similar tests from other companies, 23andMe and Navigenics. Key questions are how the test is analyzed and how accurate those analyses are. The firms are being asked to come up with proof that they have regulatory approval or convince regulators that they don’t need it.

The accuracy of the analysis may go directly to the interpretation of the tests. While it might be possible to send the same sample to all three of these companies, all of which may get similar results, it’s the interpretations that can be wildly different. Responses are required by May 25, 2010. Hold on!

Read our previous blog about this issue.

The danger of marketing without FDA approval

The strange story of drug store–based genetic tests.

It was a quick trip on and off the shelves at several thousand Walgreens drug stores for Pathway Genomics direct-to-consumer genetic testing kit. Less than 48 hours after announcing the availability of the test kits, Walgreens pulled back due to an intervention by the Food and Drug Administration saying that the test was without regulatory approval, telling Genetic Pathways that it would be an “illegally marketed device.” In Act II of this genetic drama, CVS also pulled out of marketing the same product a few days ago.

For my money, I can’t believe they went to market without considering the FDA’s reaction. Naivety? Cockiness? When you work in a regulated environment, particularly one in which the regulations are under development and fluid, assume nothing. I have clients that have worked with the FDA, not around them, even thought their product did not require FDA approval. They obtained the guidance they needed to move forward and both parties were better off for the interaction.

Imagine all that must have been involved in doing two deals of this magnitude. But, according to the FDA, “if a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”

Duh!

Read another blog entry about this issue.

Sometimes you have to get mean.

If your communications department has been enlisted to shore up compliance with hand hygiene requirements (pre- and post-patient contact), take a lesson from Denver Health. As reported in the February 2009 issue of the Journal of Communication in Healthcare, Colorado’s primary “safety net” institution tried humor, incentives, prizes — but nothing worked until they got mean. They put a button on the home page of their intranet so employees could report offenders anonymously. Communication professionals are taught to rely on positive messaging to initiate change. But the Denver example shows that sometimes you have to slap a few hands to get them washed.

Medical Marketing Becomes an Origami Crane.

Authors: Kathleen Dunn and Peter Gordon

Part V. Now is it a crane?

It is if you can take each of your different edges and planes and decide that they meet at well-defined creases, and that the combination of folds results in a recognizable final offering and a structure to support it. This structure is evaluated by testing each of the message streams to ensure that they are believable (each target audience must be convinced that what you say about the offering is true — and that it has true value to their particular area of expertise) and supportable (all claims must be supported by legitimate data that are relevant to each prospect’s particular needs).

If your final figure withstands this multivariate scrutiny, then maybe you do have a crane. Or a bird that better suits your offering. It may not necessarily be symmetrical. In fact it may be a bit messier than you would like; life has a way of not conforming to the exact strictures of an artificial system. But don’t be bothered by the little wrinkles — it means you have tested this construct and found it robust. Now it’s time to see if it flies….

Medical Marketing Becomes an Origami Crane.

Authors: Kathleen Dunn and Peter Gordon

Part IV. Is it a crane yet?

Marketers need to keep in mind that each prospective audience comes to the party with its own set of contextual variables, as well as its own set of conceptions — and misconceptions. Obviously, you begin with a thorough analysis of the needs of each target audience. The critical questions and message streams that flow out of this analysis guide the communication with each.

Are you done? Do you have an origami figure? No, you only have several target-specific efforts or campaigns. Now comes the really hard part — the heavy folding. Just as when you’re creating an elaborate origami bird, you now have to rationalize the various facets of the offering into a cohesive branding structure.

Each message stream and the strategy that underlies it must be tested and evaluated from the perspective of each of the target audiences. Where are the touchpoints? How does this message impinge on the world of target A, on target B, on target C? Once you have taken all of your messages together and cranked them through each of the targets, you should have discovered where the commonalities are (this is the gold we seek, those key messages that serve as the foundation for the brand across all segments) and where the differences are (this is where you show your value, by creating expressions of the brand that serve different purposes, and different prospect needs, without contradicting each other).

In Part V, I think we’ll find the Crane.

Medical Marketing Becomes an Origami Crane.

Authors: Kathleen Dunn and Peter Gordon

Part III. Origami marketing – folding the messages

It is not critical to understand how all of these scientific disciplines function. However, it is necessary to know where the hinges are — those areas of convergence that connect you with the disciplines that will further the efforts of all.

The challenges may be biggest for pharmaceutical marketers. Accustomed to communicating with prescribing physicians and pharmacists, these marketing professionals must set their sights on a much wider audience, and probably a smaller patient population. They must craft new messages and be able to understand and communicate with other healthcare disciplines: radiology and molecular imaging, pathology and laboratory medicine, oncology, cardiology, even genetic counseling.

The challenge now is folding the messages into an integrated whole that is both creatively compelling and scientifically supported. It’s a lot like Air Traffic Control, in which managers are evaluating a host of vehicles in three dimensions, in every conceivable vector — often extremely close to one another. And of course everything must be done on time, regardless of the weather.

In Part IV we’ll talk about approaching the “Crane State.”

Medical Marketing Becomes an Origami Crane.

Authors: Kathleen Dunn and Peter Gordon.

Part II. From quantum leap to fold change.

Diagnostic and genomic tests are now being applied to pharmaceutical decisions. Today, the use of genomic data can optimize the ability to identify discrete subpopulations in clinical trials, leading to the development of highly targeted drug therapies, such as Her-2/Neu measurements to optimize the therapy decision-making for a breast cancer patient. In fact, 10% of pharmaceuticals now have pharmacogenomic data in their labeling.

What are the implications for marketers? There are no longer simple boundaries, but intersections where several disciplines are folding back on one another. Your marketing challenge is now a kind of origami puzzle, with different shapes meeting others at odd angles, with small or large junctions and hinges connecting them. What at first seems like oddly configured folds on a piece of paper eventually emerges a beautiful bird, like the classic origami crane.

Part III takes on Origami Marketing itself.

Medical Marketing Becomes an Origami Crane.

Authors: Kathleen Dunn and Peter Gordon

Part 1. A head-on collision.

Over the last several years, marketing the Life Sciences has meant different things to different people, encompassing pharmaceuticals, diagnostics, molecular diagnostics, molecular imaging, medical devices, bioinformatics, genomics and proteomics, to name the major players.

Ironically, as the disciplines named above have become more defined, they have started occupying the same space. As developments in many of these fields begin to integrate, they also begin to collide. These disciplines are now affecting each other — and affecting each other’s developments.

Marketers of these products are now faced with having to think outside their own discipline — outside their own box. It means they have to start thinking inside someone else’s box (maybe a lot of them at once).

In Part II we’ll see where these collisions are happening.