The India HPV-vaccine suspension

The Lancet

August 21, 2010

*Heidi J Larson, Pauline Brocard, Geoff rey Garnett
Institute for Global Health, Imperial College London,
London SW7 1NA, UK

In response to demands from advocacy groups, the Indian Government has suspended demonstration projects for HPV vaccination in Andhra Pradesh and Gujarat.1,2 The episode provides salutary lessons about how a lack of public confidence can amplify if not quickly addressed.

The first lesson is timing. Too often, the response to citizen advocates who question health interventions, programmes, or studies, is too late. The April, 2010, memorandum3 from 68 Indian human rights and women’s groups, academics, and individuals sent to the Indian Minister of Health and Family Welfare should not have been a surprise. A similar memo had been sent 6 months earlier.4  The April memo called for the immediate halt of the demonstration projects until “concerns relating to safety, effi cacy and cost effectiveness of the planned interventions are re-evaluated”.3 It also
demanded an inquiry into, and compensation for, the reported side-effects and alleged vaccine-related deaths of four girls who participated in the study.

The deaths have since been investigated and confirmed as unrelated
to the vaccine.2,5  Similarly, the memorandum4 sent on Oct 1, 2009, demanded that “all trials and studies be immediately brought to a halt till in an open forum questions relating to safety, efficacy and cost eff ectiveness
of the planned intervention can be justified.”

On Dec 28, 2009, the groups continued their unanswered pleas and convened a public meeting that generated more attention than the October memorandum.6 By February, GlaxoSmithKline, Merck, and PATH had issued responses on the safety of the vaccine and on the process of the study.7–9

…..Consideration that the HPV-vaccine activities were in the interest of women’s health could have been more loudly articulated, but that argument would need a different type of evidence and argument than that used by the advocacy groups. Reluctance by public health authorities to respond to issues of public distrust for fear that they will exacerbate the problem is dangerous.13 Experience is increasingly showing that public distrust does not go away if unaddressed and can lead to programme disruptions and even disease outbreaks.

We need to find new ways to engage the public, early on, in health research and in the design and delivery of health programmes. That approach includes
taking the time to listen to societal concerns, public emotions, and politics that can derail programmes or research. We might not always understand them, but we cannot ignore them.

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Brava- the voices of the women and men involved in this issue are being heard….loud and clear.


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.