Que­bec’s new HPV vac­cine pro­gram di­vides ex­perts

The Globe and Mail (Alberta Edition) - - NEWS - CARLY WEEKS

New plan is ex­pected to save the prov­ince $3-mil­lion a year, but some say it puts sav­ings over health

Stu­dents in Que­bec are the first in Canada to be vac­ci­nated in a pro­gram that uses two dif­fer­ent vac­cines to pro­tect against the hu­man papil­lo­mavirus, a change that has di­vided ex­perts.

Un­der the new pro­gram, which started this fall, stu­dents re­ceive one shot of Gar­dasil 9, which pro­tects against nine strains of HPV, in­clud­ing 16 and 18, the two that cause the ma­jor­ity of cer­vi­cal, anal and other HPV-re­lated can­cers. Early next year, stu­dents will re­ceive a shot of Cer­varix, which pro­tects against HPV 16 and 18 only.

The new sched­ule is ex­pected to save the Que­bec gov­ern­ment $3-mil­lion a year.

Sev­eral ex­perts and or­ga­ni­za­tions call the change a risky ex­per­i­ment that puts sav­ings over health. None of the ex­perts dis­pute the safety of Cer­varix.

The con­cern is that stu­dents who do not get two doses of Gar­dasil 9 will not build suf­fi­cient im­mu­nity to seven of the nine strains. Cer­varix, pro­duced by Glax­oSmithK­line (GSK), costs about $110 a dose, while Gar­dasil 9, made by Merck, costs about $190.

“[The change] took a lot of us by sur­prise,” said Nancy Du­rand, a gy­ne­col­o­gist at Toronto’s Sun­ny­brook Health Sci­ences Cen­tre. “It’s a liv­ing ex­per­i­ment.”

But mem­bers of Que­bec’s im­mu­niza­tion com­mit­tee say clin­i­cal ev­i­dence shows the amended vac­cine pro­gram will pro­tect young peo­ple. Com­mit­tee mem­ber Vladimir Gilca says much of the back­lash orig­i­nates from Merck, which stands to lose if prov­inces re­duce use of its vac­cine. School-based HPV vac­cina- tion pro­grams in ev­ery other prov­ince use two doses of

Gar­dasil 9.

“It’s noth­ing new to change a vac­ci­na­tion pro­gram. Most of these changes pass with­out a lot of at­ten­tion,” said Dr. Gilca, a sci­en­tific ad­viser for the Na­tional Pub­lic Health In­sti­tute of Que­bec.

Some of the op­po­si­tion is be­cause Cer­varix has been ap­proved for use only in girls and women in Canada. That does not mean it is un­safe for boys, but it is un­usual for pol­icy-mak­ers to use vac­cines in this off-la­bel way, said Marc Steben, who works in the unit for sex­u­ally trans­mit­ted in­fec­tions of the Na­tional Pub­lic Health In­sti­tute of Que­bec.

Some ex­perts fear one dose of Gar­dasil 9 could leave stu­dents vul­ner­a­ble to gen­i­tal warts and other less com­mon forms of cancer not cov­ered by Cer­varix.

“This is based on pretty skimpy ev­i­dence, par­tic­u­larly in terms of long-term out­comes,” said Zeev Ros­berger, a psy­chol­o­gist who stud­ies HPV preven­tion and is on the board of ad­vo­cacy group HPV Aware­ness.

Que­bec’s health min­istry de­clined an in­ter­view re­quest.

But the im­mu­niza­tion com­mit­tee says there are good rea­sons for the change. The group’s rec­om­men­da­tions, pub­lished ear­lier this year, say two stud­ies con­ducted in Que­bec show stu­dents vac­ci­nated with Gar­dasil 9 and Cer­varix have high lev­els of im­mu­nity to the main cancer- caus­ing strains HPV 16 and 18. The shot of Cer­varix also boosted im­mune re­sponse to some of the other HPV strains in­cluded in Gar­dasil 9. How­ever, the com­mit­tee notes that im­mu­nity lev­els to HPV 6 and 11, which cause gen­i­tal warts, are lower in stu­dents vac­ci­nated in the mixed pro­gram. They may still build suf­fi­cient im­mu­nity against HPV 6 and 11, but the com­mit­tee says the prov­ince should mon­i­tor the is­sue.

Chan­tal Sau­vageau, a com­mit­tee mem­ber and med­i­cal con­sul­tant at the prov­ince’s pub­lic health in­sti­tute, said Cer­varix is ap­proved for boys in Europe. It is not ap­proved here be­cause the com­pany has not ap­plied to Health Canada, she said.

Dr. Gilca and Dr. Sau­vageau say Merck is try­ing to in­flu­ence pub­lic per­cep­tion of the new vac­ci­na­tion pro­gram.

In Septem­ber, Merck sent a let­ter to doc­tors in Que­bec stat­ing the com­pany “dis­agrees with the change in the pro­gram” be­cause Cer­varix is not ap­proved for boys. The same day, HPV Aware­ness is­sued a news re­lease urg­ing the pub­lic to ask Que­bec’s health minister to re­verse the change. HPV Aware­ness said it re­ceived a $30,000 grant from Merck this year to con­duct an HPV ed­u­ca­tion cam­paign.

Amélie McFadyen, the group’s ex­ec­u­tive di­rec­tor, said the com­pany has no in­put over con­tent.

A week later, the Fed­er­a­tion of Med­i­cal Women of Canada is­sued a state­ment crit­i­ciz­ing Que­bec’s HPV vac­ci­na­tion changes, say­ing the “new, untested” plan is “wor­ri­some.” In an e-mail, fed­er­a­tion pres­i­dent Kathee An­drews said Merck pro­vided the group with a grant to fund its HPV preven­tion ini­tia­tives.

Merck ran a na­tional ad cam­paign last week high­light­ing its role in pro­tect­ing Cana­di­ans against HPV-re­lated can­cers and dis­eases. In a state­ment, Merck Canada said Que­bec’s new pro­gram “could put chil­dren at risk by in­ad­e­quately pro­tect­ing them.” The com­pany said it abides by ethics rules when it col­lab­o­rates with health-care pro­fes­sion­als and or­ga­ni­za­tions.

Dr. Steben, who is on the board of di­rec­tors of HPV Aware­ness, was lead au­thor of a study on Gar­dasil pub­lished in Oc­to­ber and funded by Merck. In the study, he dis­closed re­ceiv­ing grants and per­sonal fees from Merck. In an in­ter­view, Dr. Steben said the re­la­tion­ship does not af­fect his views and the com­pany does not tell him what to say.

Dr. Du­rand said she has been on ad­vi­sory boards for GSK and Merck and speaks on be­half of Merck at ed­u­ca­tional meet­ings. She said the re­la­tion­ship does not pose a con­flict.

Dr. Gilca said he has not re­ceived fund­ing from GSK or Merck as long as the HPV vac­cines have been on the mar­ket, and said he has no fi­nan­cial re­la­tion­ship to any vac­cine man­u­fac­turer. Dr. Sau­vageau re­ceived fund­ing for pre­sen­ta­tions from GSK and Merck in 2010.

It’s noth­ing new to change a vac­ci­na­tion pro­gram. Most of these changes pass with­out a lot of at­ten­tion. VLADIMIR GILCA



Un­der Que­bec’s new vac­ci­na­tion pro­gram, stu­dents re­ceive one shot of Gar­dasil 9, and in­stead of booster shots of the same vac­cine, the stu­dents get a shot of Cer­varix the fol­low­ing year.

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