Merck decided to halt lobbying efforts for state legislation requiring vaccination with its human papilloma virus vaccine Gardasil for school entry following discussions with third party stakeholders, including CDC's Advisory Committee on Immunization Practices and the American Academy of Pediatrics, the company said.

Although such organizations support Gardasil, which prevents cervical cancer, they do not necessarily believe that there should be legislation mandating that girls be vaccinated, a Merck spokesman said Feb. 22.

The company announced Feb. 20 that it will stop its Gardasil lobbying program "in its tracks."

In an interview with "The Pink Sheet," AAP Section on Administration and Practice Management Chair Anne Francis said that AAP is "pleasantly surprised" Merck pulled back its lobbying efforts. While there is "no question" that the vaccine will prevent cervical cancer, it is a bit premature to be requiring vaccination for school entrance, she added.

The vaccine cleared FDA in June for prevention of cervical cancer and pre-cancers (¹ Also see "Gardasil Clears FDA, But Dosing May Pose Administrative Challenges" - Pink Sheet, 12 June, 2006., p. 3).

Merck has aggressively supported state legislation requiring mandatory HPV vaccination as a key component of the Gardasil launch strategy.

A Merck employee Political Action Committee (Merck PAC) contributed to 82 candidates in Texas during 2006 election cycle, according to a "Lobby Watch" newsletter published Feb. 14. The PAC contributed to the campaign of Texas Gov. Rick Perry, who signed an executive order Feb. 2 making Texas the first state requiring HPV vaccination for school attendance.

The fervor of Merck's lobbying efforts may have turned off stakeholders. In addition, the campaign may have upset conservative groups, which have been wary of mandating HPV vaccination since HPV is a sexually transmitted disease.

Merck's lobbying efforts appear to have been successful. According to the National Conference of State Legislators, lawmakers in at least 33 states have introduced legislation to require, fund or educate the public about the HPV vaccine.

However, Merck said the controversy triggered by the lobbying efforts created a distraction that overshadowed the intiative's ultimate goal, which is prevention of cervical cancer. Merck said it is focused on educating the public about the link between HPV and cervical cancer.

Merck said the decision will not impact marketing of the product. The company will continue its "One Less" direct-to-consumer advertising campaign and public education efforts.

During a Jan. 30 year-end earnings call, CEO Richard Clark reported that Merck increased marketing and administrative expenses during the fourth quarter, with spending on Gardasil DTC being a primary driver (² Also see "Merck Ups Marketing Spend For Januvia And Gardasil As Competitors Stumble" - Pink Sheet, 5 February, 2007., p. 10).

Francis noted that reimbursement issues remain for Gardasil, which is priced at $360 for a three-dose series. She said the largest insurer in Rochester, where she works at the Elmwood Pediatric Center, is reimbursing Gardasil at a lower price than the acquisition cost for the vaccine.

Francis' comments give further credence to reports of physicians being insufficiently reimbursed for the cost of vaccination. Merck expects Gardasil reimbursement problems to be resolved in early 2007 (³ Also see "Gardasil Reimbursement Issues To Be Resolved In Early 2007, Merck Says" - Pink Sheet, 1 January, 2007., p. 10).

During the Feb. 16 Wharton Health Care Business Conference in Philadelphia, Merck VP-Vaccines Division Mike Thomas cited Gardasil as an example of an opportunity for pharmaceutical companies to work with managed care in more creative ways.

Thomas said Gardasil is an opportunity for agreements between managed care and pharmaceutical companies to include quality measures. Noting that Gardasil is administered in a three dose series, he suggested that there could be an economic incentive for a managed care organization to complete the three dose series.

Such a program could move well beyond the "crude" price/volume relationships that have characterized some of the contracts between industry and managed care in the past, Thomas said.

- Kathryn Phelps (k.phelps@elsevier.com)

Merck Halts Gardasil Lobbying Efforts Following Discussions With ACIP, AAP

More from Archive

More from Pink Sheet