HPV vac­cine cited in in­fer­til­ity case

Wis. sis­ters say drug led to ovar­ian fail­ure by age 16

The Washington Times Daily - - Nation - BY CH­ERYL WETZSTEIN

Two Wis­con­sin sis­ters have asked a fed­eral court to find that a govern­ment-rec­om­mended vac­cine is re­spon­si­ble for them los­ing the abil­ity to con­ceive chil­dren.

At is­sue is Gar­dasil, a three-dose vac­cine rec­om­mended for chil­dren 11 to 12 years old to pre­vent in­fec­tion by cer­tain strains of hu­man pa­pil­lo­mavirus (HPV) that are linked to gen­i­tal and oral can­cers.

The case of Made­lyne Mey­lor, 20, and Olivia Mey­lor, 19, of Mount Horeb, Wisc., was pre­sented last week to a spe­cial master with the vac­cine pro­gram at the U.S. Fed­eral Claims Court in Wash­ing­ton, D.C.

A de­ci­sion from the spe­cial master is not ex­pected un­til early 2014, at­tor­ney Mark Krueger said Mon­day.

The women say the pre­ma­ture ovar­ian fail­ure they both ex­pe­ri­enced by age 16 was caused by the three doses of Gar­dasil they re­ceived in their young teens.

De­tails of their case — which may be the first to be heard by a spe­cial master — were not avail­able for re­view, but med­i­cal and sci­en­tific wit­nesses tes­ti­fied last week why Gar­dasil was re­spon­si­ble for the rare loss of fer­til­ity, Mr. Krueger said.

Depart­ment of Jus­tice at­tor­neys, rep­re­sent­ing the Depart­ment of Health and Hu­man Ser­vices, which pro­motes HPV vac­cines, ar­gued that Gar­dasil did not cause the women’s ovar­ian fail­ure, Mr. Krueger said.

Gar­dasil man­u­fac­turer Merck & Co., said the drug’s safety and ef­fi­cacy have been “stud­ied in more than 25,000 fe­males and males in clin­i­cal tri­als.”

The com­pany said it stud­ied re­ports of pre­ma­ture ovar­ian in­suf­fi­ciency (POI) af­ter ad­min­is­tra­tion of Gar­dasil and “con­cluded that the ev­i­dence does not sup­port a causal re­la­tion­ship to the vac­cine.”

“There have been no re­ports of POI in the clin­i­cal tri­als with Gar­dasil,” Merck said in a state­ment.

Pre­ma­ture ovar­ian fail­ure or in­suf­fi­ciency is a rare con­di­tion that strikes 1 in 1,000 women be­tween the ages of 15 and 29 and 1 in 100 women be­tween the ages of 30 and 39, ac­cord­ing to Re­solve, the na­tional in­fer­til­ity as­so­ci­a­tion. The sus­pected causes of the con­di­tion in­clude de­fects in re­pro­duc­tive or­gans, in­her­ited dis­or­ders and ex­po­sure to an­ti­cancer drugs and treat­ments, Re­solve said.

Women with ovar­ian fail­ure can still be can­di­dates for in-vitro fer­til­iza­tion us­ing donor eggs.

The Mey­lor sis­ters tested neg­a­tive for three ge­netic causes for their ovar­ian fail­ure, ac­cord­ing to a re­port Fri­day in the Wis­con­sin State Jour­nal. The sis­ters have lit­tle or no chance of get­ting preg­nant, but both be­lieve they “could carry a baby con­ceived through in­fer­til­ity treat­ments,” the ar­ti­cle said.

Mr. Krueger said the sis­ters be­lieve the three shots of Gar­dasil trig­gered an au­toim­mune dis­ease in them, based on the vac­cine’s in­clu­sion of sub­stances de­signed to boost the hu­man im­mune sys­tem.

These sub­stances — called ad­ju­vants — ap­pear to cause side ef­fects in some peo­ple, ac­cord­ing to Is­raeli re­searcher Dr. Ye­huda Shoen­feld, a spe­cial­ist in au­toim­mune con­di­tions, who tes­ti­fied on be­half of the Mey­lors last week. Dr. Shoen­feld has called the phe­nom­e­non “au­toim­mune syn­drome in­duced by ad­ju­vants” or ASIA.

Ac­cord­ing to the Wis­con­sin State Jour­nal, the Jus­tice Depart­ment re­jects the ASIA ar­gu­ment, say­ing it has not been ac­cepted in the med­i­cal com­mu­nity.

HPV is the na­tion’s most com­monly trans­mit­ted sex­ual in­fec­tion. Many HPV in­fec­tions re­solve them­selves without ill effect, but a hand­ful of HPV strains are linked to deadly gen­i­tal and oral can­cers, in­clud­ing cer­vi­cal can­cer.

Since 2007, the Amer­i­can Academy of Pe­di­atrics has rec­om­mended that girls age 11 or 12 re­ceive the HPV vac­cine; last year, it rec­om­mended the shots for boys that age too. The vac­cine is given to chil­dren be­fore they be­gin hav­ing sex, since the vac­cine can’t work against ex­ist­ing HPV in­fec­tions.

In July, pub­lic health of­fi­cials lamented the rel­a­tively low per­cent­age of youths re­ceiv­ing the vac­cine: In 2011 and 2012, only 35 per­cent of teen girls re­ceived the three shots of the vac­cine, said Dr. Thomas Frieden, di­rec­tor of the Cen­ters for Dis­ease Con­trol and Preven­tion. Parental con­cerns about HPV shots are un­war­ranted, he said, be­cause “no se­ri­ous safety con­cerns have been iden­ti­fied.”

Ju­di­cial Watch, how­ever, has tracked Gar­dasil out­comes — in­clud­ing two deaths that were com­pen­sated — based on a be­lief that the drug’s 2006 ap­proval was “rushed through” be­cause of po­lit­i­cal pres­sures, said Thomas Fit­ton, pres­i­dent of the watch­dog group. “If an adult fe­male wants to sub­mit her­self to the vac­ci­na­tion, that’s her choice,” Mr. Fit­ton said Fri­day. “But the idea that we would push this with chil­dren ... It’s just a huge pub­lic health ex­per­i­ment. We shouldn’t have chil­dren be­ing the guinea pigs.”

The Na­tional Vac­cine In­jury Com­pen­sa­tion Pro­gram said that, as of Nov. 4, some 62 claims against an HPV vac­cine have been com­pen­sated and 62 claims have been dis­missed.

In ad­di­tion to Gar­dasil, a Glax­oSmithK­line prod­uct called Cer­varix is avail­able for HPV preven­tion.

AS­SO­CI­ATED PRESS

Sis­ters Made­lyne Mey­lor, 20, left, and her sis­ter Olivia, 19, of Mount Horeb, Wis., have filed a fed­eral claim, say­ing they be­lieve a cer­vi­cal can­cer vac­cine caused their ovaries to stop pro­duc­ing eggs.

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