San José, Costa Rica, since 1956

Caja Wants Name Removed from Study Forms

WORRIED that patients might associatethe public hospitals of the SocialSecurity System (Caja) with a phase IIIclinical test of a cervical cancer vaccineunder way in the northern provinceGuanacaste, the ethics committee hasrequested that the Caja’s name be removedfrom information provided to prospectiveparticipants.The members of the committee “do notagree with the reference to the Caja in the(information and consent) forms,” said Dr.Olga Arguedas, executive director of theCaja’s Center for Strategic Developmentand Information on Health and SocialSecurity.“If they are going to use the name ofthe Caja they have to send their protocols(to Caja authorities) and comply with therequirements (for Caja approval of clinicaltrials), or take the name off the forms,”she said.Arguedas, who does not sit on thatcommittee, told The Tico Times she hasnothing against the test and thinks its benefitssurpass any risks.THE experimental vaccine is directedagainst two types of approximately 40variations of Human Papillomavirus(HPV) that are sexually transmitted, types16 and 18. Together, they account for 70%of cervical cancers, of which Guanacastehas one of the highest rates in the world.That province makes a tight fit with theworldwide pattern of cervical cancer – it isthe most common kind of cancer in womenin most developing countries, where 80% ofcases worldwide occur, according to theNew England Journal of Medicine.Most women with HPV do not developcervical cancer, but the risk is higher indeveloping countries where the resourcesneeded to test women regularly are scarceand women are often diagnosed with cancerwhen it is already in advanced stages.THE clinical trial, called theGuanacaste Epidemiological Project, isone test among the latest – others wereconducted with nearly 700 women inBrazil and the United States, according tothe project’s head U.S. investigator, Dr.Allan Hildesheim, and similar vaccineshave been tested successfully on thousandsof women (TT, July 30).The project is funded by the U.S. government’sNational Institutes of Health(NIH) and carried out in conjunction withthe University of Costa Rica, the non-profitINCIENSA Foundation and the PublicHealth Ministry. The drug is manufacturedby GlaxoSmithKline Biologicals.For the next six years, health workerswill administer three shots over a six-monthperiod to a total of 20,000 womenages 18-25 who tested negative for thevirus and pregnancy. Half of them willreceive the HPV vaccine, the other halfwill receive an over-the-counter Hepatitis-A vaccine as the control group.EVERY participant is a volunteer, andeach is handed the 11-page informationand consent form that has irked the Cajaethics committee.“We never had the support of the Caja,”and don’t claim to, Dr. Rodolfo Herrero,head of the project’s research team, told TheTico Times. “If a participant has a healthproblem, we are going to refer them to theCaja so Caja doctors can see them. I don’tbelieve the Caja can have a problem withthat because that is what it does.”Participants undergo regular medicalexams and blood tests that could detecthealth problems not associated with thevaccine. The form advises them that doctorsinvolved in the project will treat themor refer them to a Caja clinic, part of thestate-funded health-care system.FOR any complications related to thevaccine itself, the form states participantswill be compensated by GlaxoSmithKline,up to an amount that will be “calculatedaccording to Costa Rican law.”Herrero explained the pharmaceuticalcompany independently covers eachpatient up to $1 million and is liable forany amount of patient compensation determinedin Costa Rica courts.The form, of which The Tico Timesobtained a copy, mentions the Caja seventimes, mostly repeating that participantswith health problems can go to publicclinics. In two references to the Caja, theform recommends that women who donot participate in the study visit publicclinics regularly to catch signs of cancerearly.The issue of health insurance has been asore spot for the study these last few weeks.Herrero repeated that GlaxoSmithKlinecovers participants at a press conferenceafter legislator Humberto Arce, of thePatriotic Bloc, publicly questionedwhether the women are protected.The Costa Rican Doctors’ andSurgeons’ Association is also looking intothe matter, but those involved in its investigationwere unavailable for comment.THE Caja’s Arguedas said people aresuspicious of GlaxoSmithKline’s involvementin the test.“The NIH sponsored the study andpeople have not interpreted correctly whatis the link to GlaxoSmithKline,” she said.The pharmaceutical company is the vaccine’smanufacturer, but the NIH has footedthe $18 million bill for the project,Herrero said.The company announced last month itis moving up the date it will file the vaccinewith the U.S. Food and DrugAdministration from 2008 to 2006, possiblyunder pressure to beat its arch rival tothe shelves, the financially embattledMerck, which is also in the last stages oftesting a similar vaccine.If GlaxoSmithKline does file in 2006,it can correctly claim that the vaccine preventsHPV infection, a known precursor tocancer, but not that it prevents cancer,Herrero said. Previous studies proved itprevents infection, but the longer-termGuanacaste study should prove its power against cancer.

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