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FDA's Lesko Says Dx Shops Should Follow Pharma's Sales Model to Sway MDs

NEW YORK (GenomeWeb News) – Molecular diagnostic companies who want physicians to prescribe their products should emulate pharma’s model of reaching out directly to MDs, a US Food and Drug Administration official suggested at a recent meeting.
“What does change physician behavior in study after study is direct selling to physicians, and that is something that doesn’t exist in the business model of today’s diagnostics world,” Larry Lesko, director of FDA’s Office of Clinical Pharmacology & Biopharmaceutics, said during the American Association for Clinical Chemistry’s annual meeting two weeks ago.
“There are no diagnostics companies that I know of directly selling tests to physicians,” Lesko said. “But that is the success of the pharma companies getting physicians to prescribe their drugs. We have to look into that.”
At least one diagnostic shop already follows this model, with some success: Genomic Health arms its sales force with published clinical data and dispatches it doctors’ practices to encourage them to adopt the firm’s Oncotype Dx breast cancer recurrence test.
Genomic Health President Kim Popovits last November said that the company had recently increased its sales force to better familiarize physicians with Oncotype Dx after the company committed itself to conducting and publishing multiple large clinical studies.
Genomic Health began 2006 with 30 representatives targeting oncologists. In the first quarter of 2007 the company plans to expand its direct field sales force to 50 reps.
Genomic Health also appears to be pumping more money into its promotional efforts, having spent $24.6 million in 2006 on sales and marketing, a 60-percent increase over the previous year.
The strategy has helped revenue to surge over the last two years from $327,000 in 2004 to $29.2 million in 2006. In 2006, Genomic Health sold 14,500 of its Oncotype Dx tests, more than double what it sold in 2005.
“The majority of the usage in the quarter has come from physicians who have used the test multiple times and we are seeing increasing penetration in the physician community,” Popovits said.
Some, particularly in academia, argue that unleashing armies of sales reps to sell diagnostics directly to physicians may not work.
“I do not believe that direct marketing to physicians is the right answer,” Raju Kucherlapati, scientific director of the Harvard Partners Center for Genetics and Genomics, told GenomeWeb News sister publication Pharmacogenomics Reporter.
“I think that it is important for physicians and patients to understand that genetic knowledge would help physicians to reach the correct diagnosis and would allow them to craft treatment regimens that have the highest likelihood of success,” he said.
The HPCGG recently launched a study to measure patient outcomes and cost when genetic information is used to make clinical decisions about the anticoagulant warfarin. According to Kucherlapati, the results of these large outcomes studies will be the most convincing to both physicians and payors. 

The complete version of this article appears in the current Pharmacogenomics Reporter, a GenomeWeb News sister publication.

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