PATH and HPV Vaccines in India: The clinical trials that should not have been

[SaneVax:  Why attempt to establish an HPV vaccination program where the epidemiological evidence does not support the need? Why attempt to establish a vaccination program where there is no adequate surveillance system in place to monitor efficacy? Why attempt to establish a vaccination program with the most expensive vaccine on the market in a country where some of the major health concerns are lack of primary care facilities and malnutrition? What was PATH thinking?]

Controversial vaccine trial should never have been run in India

Posted in MedicalXpress.com

Necessary, Effective, Affordable?

Research published in the Journal of the Royal Society of Medicine raises further questions about a trial of HPV vaccines in India.

The trial, which has now been halted and is the subject of an investigation by the , was examining the safety and feasibility of offering a vaccine against the virus associated with .

The new study by researchers at Queen Mary, University of London and the University of Edinburgh suggests that lack of data on cervical cancer in India does not support a trial of the vaccine to prevent the disease.

The trial was run by the international health charity PATH and involved more than 23,000 girls from Gujarat and Andhra Pradesh states. A committee of scientists commissioned by the Indian Government to look into the trial said that the study involved a number of serious ethical violations.

The research by Professor Allyson Pollock and colleagues examined a series of claims made by PATH about cervical cancer in India, among them that ‘in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide’.

They found that cancer surveillance, registration and monitoring in India in general – and specifically in the Gujarat and Andhra Pradesh regions – was incomplete, meaning that it would be impossible to tell whether the vaccine would be successful in preventing the disease.

Read the entire article here.

Comments

  1. Mindanoiha says:

    http://jrsm.rsmjournals.com/content/105/6/250.full
    The original article (see link) includes the following recommendation:

    “HPV vaccination programmes should only proceed where there is both strong epidemiological evidence and where there are adequate surveillance and monitoring systems”

    So true! This actually means that HPV vaccination programmes should probably not proceed anywhere at all.

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