Let me ask you a question. Would you buy a pair of shoes from a store that wouldn't tell you the size or let you try them on first? If your only option was to make a purchase, bring the shoes home and take your chances, would you be a satisfied customer?

I don't think so. Regardless of quality or price, a shoe that doesn't fit your particular foot is of no use to you. Using a trial and error approach to find a pair that fits would be both unproductive and frustrating.

	And yet, that's more or less the way the majority of drugs are prescribed in America today: Take it home, try it on, hope it fits.

If you have a problem, bring it back to the "store" and try something else. That's the traditional blockbuster approach.

Fact: Most drugs prescribed today are effective for fewer than 60% of treated patients. Indeed, according to a study by Spear, Heath-Chiozzi and Huff, and cited in this month's Harvard Business Review, "standard drug treatment provides a therapeutic benefit only to a limited percentage of patients who receive it."

How limited? Here's a sampling of the rates of efficacy cited in that same study: Cancer (all types): 25%; Alzheimer's disease: 30%; Incontinence: 40%; Hepatitis C: 47%. The list goes on, topping out at Depression, the leader at just 62% efficacy.

This kind of trial and error medicine extends from the way pharma companies develop and market drugs, to the way doctors prescribe, to the incentives in place in the health care marketplace. It's nobody's fault alone, but together, we've created a less than effective system.

The good news is that things are beginning to change. The move towards personalized medicine on a broad scale is beginning to happen.

Consider that…

• The identification of genetic markers for drugs such as Coumadin® and Herceptin® now allows us to test patients before the fact for the correct frequency and dosage required, specific to a particular patient's molecular pathway and genetic makeup. In the case of Coumadin, the test has already been recognized by the FDA and, while not yet a requirement for prescription, we're seeing progress.
• Through the passage of HR 3580, the FDA will now play a more aggressive role in the post-approval monitoring of drugs throughout the entire product lifecycle.
• Our industry is waking up to the fact that each pharma company going it alone is not going to get us there. The International Serious Adverse Events Consortium (SAEC) is researching the use of biomarkers that will enable better targeting of prescribed medications.

Where does this lead us?

1. The reactive pendulum of FDA actions has created an environment which sends mixed signals to both the Industry and patients.

   The FDA needs to better define a long term collaborative mission, set explicit expectations and demonstrate consistent decisions and incentives to guide the Industry towards a new model of development and in-life product monitoring.

   Under new regulations, the FDA will now be able to mandate that pharmaceutical companies take appropriate steps to more closely monitor, evaluate and support approved drugs once they are in the marketplace.

   Perhaps the most positive outcome of this new regulatory environment is the potential for the inevitable partnership between the regulators and the pharmaceutical industry, as their combined efforts strive for long-term, lifecycle monitoring of drugs. Ultimately, for both parties, it's all about the patients.

2. Pharmaceutical companies will reap strong rewards from investment in comprehensive treatment packages.

   This includes improved diagnostic tools, personalized patient education and support, and patient-physician feedback to stimulate better communications. (More than half of physicians in a recent TNS study consider Pharma Industry services which emphasize patient management, education, and support services highly valued.)

   I'm confident that a new FDA/industry collaboration focused on product life-cycle monitoring and patient support services will drive us toward better risk/benefit analysis of each drug and lead to more personalized treatment and better outcomes.

3. Shifting resources to more targeted patient populations early in the development cycle will yield more focused and effective comprehensive treatment solutions.

   While the Industry will need more proof of concept and time to make this major shift in its thinking and business models, I believe it will ultimately prove to be more productive. Investing resources in targeted, higher yielding development and patient support services — as opposed to investing in increasingly extensive, time consuming and expensive Phase III trials which continue to support the blockbuster model — will carry the day.

In the end, our challenge is to adopt comprehensive treatment strategies which take advantage of scientific innovation and technologies, and which allow us to customize treatments for specific patients. Absent that, we'll all be trying on lots of shoes until we find a pair that fits.

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Paul LeVine, InfoMedics Vice President, Analytic Services, will speak at the 4th Annual Summit on Patient Adherence & Persistence USA, offered by eyeforpharma, November 12–13, at the Pennsylvania Convention Center in Philadelphia.

Paul will speak at 10 a.m. on November 12th, on the topic of, "Creating Partnerships Virtually: The Role of Patient Feedback Programs."

Supported by real-world examples of successful patient feedback programs, Paul's presentation will cover:

• The asymmetry of information between physicians and patients
• The variety of uses for patient feedback
• The link between patient feedback and lift
• How structured patient feedback allows the brand to respond to changing market conditions.

Follow this link for more information and to register for this must-attend conference.

Patient willingness to participate in surveys and programs is influenced by their understanding of how the results will be used:

"If I knew other people would benefit from it, I would be more likely to participate. I would like to help others in my situation."

— Epilepsy Patient, InfoMedics Research,
Fall, 2006

InfoMedics creates an interactive, real-time means for helping patients and physicians better communicate about a diagnosed condition or prescribed treatment.

This results in improved health outcomes and consistent increases in prescribing levels for new prescriptions and refills.

September 2007

July 2007

June 2007