The goal is clearly stated: "Understanding a thought leader's needs will assist you in developing a strong relationship with him/her and it will enable you to properly manage that advocate to create win-win situations for both Merck and the thought leader."
But not all thought leaders are created equal in the Kafkaesque world of Merck. "Once you understand the factors driving a thought leader's beliefs, behaviors, needs and patient management approaches, you'll want to determine their sphere of influence...These spheres of influence can be used to help you determine how to best manage a thought leader. There are three different classifications...Local Thought Leaders...Regional Thought Leaders...National Thought Leaders."
The National Thought Leaders are the jackpot for the thought police because they may "be driving the treatment approaches and methods on a national level" and "Typically, a national thought leader influences physicians at all levels across the nation." Once the thought leaders have been studied, categorized and prioritized, the Merck thought police are to: "Determine how to interact with the thought leader; determine what activities the thought leader is best suited; how to best manage him/her based on this information."
Inducements to bring the thought leader on board as a Merck "Advocate" run the gamut of education grants, free travel to symposiums at resorts, a prestigious assignment as a clinical site investigator or a spot on the Merck Strategic Advisory Board.
Taken as a whole, the marketing plan attempts to provide strategic inducement to create a more sophisticated and influential extension of Merck's salaried sales force. That the public relies on its doctors for unbiased and unvarnished medical advice appears to be of no consequence to Merck.
And Merck is hardly alone. Industry watchers estimate that the pharmaceutical industry spends over $12 Billion a year under the dubious heading of marketing to doctors.
In Februrary 2007, a New York Times/CBS News poll found that 85 percent of survey participants thought it was "not acceptable" for doctors to be paid by drug companies to comment on prescription drugs and the same percentage said such payments would influence the decisions that doctors make about patient care.
At least one doctor has broken free of the Merck thought police recently on the issue of Gardasil. Dr. Diane Harper, a top level scientist and professor at Dartmouth Medical School in New Hampshire, has led clinical trials of the HPV vaccine and written widely on the topic. She is considered a pioneer in the field of HPV research and spent most of her adult life on this endeavor. Her work at Dartmouth is funded by both Merck and GlaxoSmithKline, which has its own HPV vaccine in the pipeline.
On March 14, 2007, in an article appearing in the Fort Wayne Daily News by Cindy Bevington, Dr. Harper is quoted as follows on the safety of Gardasil for young girls: "Giving it to 11-year-olds is a great big public health experiment...It is silly to mandate vaccination of 11- to 12-year-old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue...It's not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer -- they won't know for 25 years if they will get cervical cancer."
A week later, in an article by the same author, Dr. Harper attempted to soften her stance while not disputing that she made the earlier statements: "It is the mandate I am opposed to...For those parents and children who want the vaccine, it is safe -- as we know from the bridging studies. We still don't know if it is effective for more than five years, though." The bridging studies Dr. Harper refers to means the safety outcomes in older pubescent women were assumed to be the same for prepubescent girls -- a leap of faith by any measure.
In fact, Dr. Harper could simply have quoted from the Food and Drug Administration (FDA) to document that safety had never been proven in 11 and 12 year old girls. As a condition of licensing Gardasil, the FDA acknowledged that inadequate safety studies had been done on this age population by stating in its June 8, 2006 approval letter to Merck: “…a sufficient number of children 11-12 years of age will be studied to permit an analysis of safety outcomes. The final study protocol will be submitted by December 31, 2006. Patient accrual will be completed by December 31, 2008.”
In a breathtakingly reckless sweep of the pen, the FDA was licensing a product before a "sufficient" number of children had been studied to "permit an analysis of safety outcomes." Then the FDA sat back passively as Merck lobbied aggressively to get states to make the vaccine mandatory for 11 and 12 year old girls before these studies were completed.
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