The 5 Myths of Pharmacogenomics - Pharmaceutical Executive


The 5 Myths of Pharmacogenomics

Pharmaceutical Executive

5. Marketers Need Not Worry The last misconception is that, because it will be years before pharmacogenomics is applied in clinical practice, it will take even longer to affect marketing. But some pharma marketers have been dealing with, or reacting to, pharmacogenomic issues for several years. Even though there are only a handful of such tests in the marketplace, there is a groundswell of PGx research, reports, and opinions that could influence how physicians and other stakeholders view the efficacy and safety of particular products. There are three primary sources of PGx information: scientific researchers, pharmacogenomic companies, and pharma companies.

Researchers have published numerous scientific articles that have been covered in the lay media. Consider, for example, the many stories about "individualized hormone replacement therapy," based on a 2002 New England Journal of Medicine article about women taking estrogen who have a particular genetic variation in the estrogen receptor. Those women therefore obtain higher HDL (good cholesterol) responses and presumably better cardio-protective effects than women without the genetic variation. That information could potentially explain some of the controversy surrounding the differential responses of women taking HRT.

Pharmacogenomic testing companies are also interested in publicizing their data for specific products to demonstrate their capabilities. For example, Genaissance has been conducting a highly publicized trial of the statins Lipitor (atorvastatin), Zocor (simvastatin), and Pravachol (pravastatin). It is no accident that Genaissance selected the lipid-lowering category-it is the chemical class with the highest annual sales. Although the company has distributed press releases announcing that it has "discovered genetic markers associated with responses to individual statin drugs," it has not yet released information about which statin drugs have the greatest cholesterol-reducing effects in patient populations with certain genetic profiles. If Genaissance or another testing company were to publicize the significant differential effects of those drugs, it would likely influence physicians' prescribing behavior long before supporting scientific studies and tests became available.

And pharma companies themselves are conducting or sponsoring PGx studies to differentiate their products. In 2000, Craig Fitzgerald, vice-president of applied genetics for GlaxoSmithKline, wrote about such activities in Advance Tech Monitor: "At Glaxo, we intend to generate evidence for pharmacogenetic claims and use them as a novel and unique way to differentiate our products. For example, Glaxo intends to publish its first differentiation study later during the year 2000. This study will use pharmacogenetics to differentiate Glaxo compounds from competing products and make additional claims or superiority claims for the company's products. Hopefully, the FDA will be willing to discuss the results of this study and allow us to use them for marketing purposes."

Clearly, marketers cannot wait until PGx tests become widely available. Nancy Lurker, former group vice-president of Pharmacia's Global Prescription Business, said it best at the 2002 Pharmaceutical Marketing Congress: "If you want to be a leading executive in the industry, then you need to know about pharmacogenomics. It is coming. Marketers need to be aware of these changes as they are going to alter the landscape of marketing."

So what can marketers do to prepare? Initially, they should become better educated about pharmacogenomics, particularly in their therapeutic areas. Next, they should work with their teams and other experts to determine the potential implications and applications for their products. Specifically, marketers need to determine what clinical trials their company initiated or completed for specific products and what the competition is doing or could do to differentiate its products using pharmacogenomics. See "Marketers' Checklist" on page 74 for a more complete list of activities.

Senior executives and strategists have their own list of priorities. (See "Executives' Checklist," page 72) They need to understand and appreciate PGx's business implications for the industry and their company. It is important that they develop an overall corporate pharmacogenomic strategic plan. The company should monitor PGx developments and identify potential partners to assist in research and test development. Executives also need to ensure that their company trains and develops internal staff and embeds PGx in the company's business processes, not just R&D.

Perhaps the most important thing that pharma executives and marketers need to understand is that the prevailing notions about pharmacogenomics are often based on myths. Pharmacogenomics is not a futuristic force. It is a reality of doing business in the pharmaceutical industry today, and its impact is likely to grow dramatically.


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