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How Dangerous Are Merck's Thought Police by Pam Martens    

http://www.opednews.com

April 2, 2007

According to an internal training manual, Merck, one of the largest pharmaceutical companies in the world and the maker of the controversial new vaccine for children, Gardasil, has a highly sophisticated sales group dedicated to "managing" the thoughts and voices of influential doctors in America; a de facto thought police. [*]

Gardasil is touted by the FDA and Merck as a vaccine to prevent cervical cancers associated with the sexually transmitted human papillomavirus (HPV).  In the past few months, Merck has unleashed a firestorm of criticism when it was revealed that the company had funded a nonprofit group of state lawmakers, Women in Government, who were using their clout to get state legislation introduced across the country to mandate the vaccine for 11 and 12 year old school girls. The stated premise was that it would be most effective if given before girls became sexually active. Safety advocates countered that the vaccine's efficacy was never studied on this age population and clinical trials on safety issues were studied on just a few hundred 11 and 12 year old girls.  Additional researchers have noted, correctly, that HPV related cervical lesions take 8 to 12 years or longer to develop into cervical cancer and since Merck only conducted clinical trials for 5 years or less, there is no conclusive evidence that this vaccine will prevent cervical cancer.

The thought police documents are part of a trove of confidential internal Merck marketing strategies demanded by Congress to determine how sales of Merck's last big blockbuster, Vioxx, continued to skyrocket in sales long after evidence of heart attacks and strokes emerged.  The documents reveal an Orwellian marketing concept that goes like this: a team of "Specialty Representatives" gather intelligence on every aspect that motivates influential doctors in their assigned territories.  Once this information is developed, these Merck intelligence officers narrow the data down to the key "drivers" of "beliefs and behaviors," then provide inducements to turn the doctors into "Advocates" for Merck products.

  Merck has a revealing lexicon for this intelligence gathering and inducement strategy: influential doctors are called "thought leaders," and defined as doctors who, "due to their ability to influence their peers, drive therapeutic business at the national, regional or local level." 

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.

While Merck has attempted to hide from public view its marketing tactics in the U.S., it has taken an openly brazen approach in Europe to push for Gardasil vaccination mandates through its European distributor and joint-venture partner, Sanofi Pasteur.

According to an article in The Guardian newspaper,  quoting  Angela Raffle, one of Britain's leading public health experts, "They wrote to every doctor of public health, every chief executive, every pharmacy adviser, senior people in the faculty of public health, all infectious disease specialists and primary care staff."

Thought leaders in Europe would be paid 1000 Pounds (equal to just under $2000 U.S.) to attend meetings where they would help "plan the introduction of the vaccine." One such meeting was held in Paris. According to The Guardian, in addition to public health experts and celebrities, journalists were paid to attend. "A group of freelance health journalists from the U.K. had not only their travel, meals and accommodation but also their time paid for by the drug company."

The business model that clearly emerges at Merck is one where the infrastructure established to protect the public interest (doctors, public health experts, regulatory bodies and even journalists) must be sacrificed on the altar of corporate profits.

Merck's history of serial and systemic lapses of character and conscience demand that the left and the right of America stop sniping about peripheral issues raised by this vaccine and unite in debate on the overarching health issue: has this drug been proven safe for little girls.

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[*] See Document # 26: Merck, Specialty Foundations Participant Self-Study Workbook: Specialty Representative Advocate Development      http://oversight.house.gov/features/vioxx/documents.asp  whale