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hpv vaccine trial - ethics, regulation and science

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The HPV Vaccine : Science, Ethics and Regulations :

The HPV Vaccine : Science, Ethics and Regulations 1

Human Papillomavirus:

Human Papillomavirus Human Papillomavirus (also called HPV) is the most common sexually transmitted infection (STI) Disease: genital warts , cervical cancer , vaginal cancer , vulvar cancer Prevalence : HPV is responsible for about 70% of all cervical cancer cases worldwide 2 Structure of HPV

HPV treatment:

HPV treatment Medicines : Podofilox or Condylox (topical sol n ) Imiquimod or Aldara ( imidazoquinoline amine ) Vaccine : Gardasil and Cervarix Wait and Watch : sometimes the disease gets cured by itself Cryotherapy : This involves freezing the abnormal cells with liquid nitrogen. Conisation : This procedure also known as a cone biopsy, removes the abnormal areas. LEEP or Loop Electrosurgical Excision Procedure : The abnormal cells are removed with a painless electrical current. 3

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4 Gardasil Cervarix

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Gardasil Cervarix Generic name Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Human papillomavirus (HPV) vaccine, bivalent Age group 9 to 26 years 13 to 26 years Indications Cervical cancer , vaginal cancer, vulvar cancer , Genital warts. Cervical cancer , vaginal cancer, vulvar cancer , Genital warts. Adverse effects constitutional symptoms and severe allergic reactions. constitutional symptoms and severe allergic reactions. Approved by US FDA(2006), fast track approval European union(Sep. 2007) & US FDA(Oct 2009) Project site in India Andhra Pradesh ( khammam ) Gujarat( vadodara ) 5

INTRODUCTION:

INTRODUCTION 2 year HPV (human papilloma virus) vaccine trial(mid of 2009) PATH and US based health organization (Program for appropriate technology in health) ICMR Bill and Melinda gates health foundation State governments Previously a “demonstration project” later called as a “post licensure study” or “PMS” 6

Q. In clinical trials phase IV studies are also called as….:

Q. In clinical trials phase IV studies are also called as…. Demonstration study Pivotal efficacy study Post-licensure evaluation Pre-licensure evaluation 7

Participants of “HPV trial”:

Participants of “HPV trial” Girls from the Aashram Pathshalas (boarding schools for tribal children) age group of 10 to 14 poor economic background, schedule tribes, schedule castes, Muslim and other disadvantaged communities Number of girls: 14091 in Andhra Pradesh & 10686 in Gujarat Seems to have Chosen without the Inclusion and Exclusion criteria 8

Q. Fast track approvals are not granted for …:

Q. Fast track approvals are not granted for … Emergency health care situation New cancer treatment New AIDS treatment New contraceptive drug or devices Any drug will develop to treat or prevent a disease with no current therapy. 9

Q. Fast track approvals of drugs are granted within------months.:

Q. Fast track approvals of drugs are granted within------months. 8 10 12 6 5 10

Discrepancies :

Discrepancies Who were against the trial? Jan Swasthya Abhiyan and Anthra and Sama resource group for women and health Ethical concerns about the trial Vulnerable population Girls aged 10 to 14 years from poor economic backgrounds Informed consent Not explained properly Adverse drug reaction not explained No treatment available for the adverse drug reaction Information not provided 11

Q. Researchers seeking informed consent must provide following information except …:

Q. Researchers seeking informed consent must provide following information except … Nature and purpose of study Contact details of chairmen of the IEC Risk and discomforts Policy on compensation Qualifications of the investigators 12

Scientific and Regulatory issues:

Scientific and Regulatory issues The trial was performed on children before adults The vaccine received approval in India outside the age group on whom they were tested. 13

Q. The D & C act and the ICMR guidelines states that the drug trials on children should be ……:

Q. The D & C act and the ICMR guidelines states that the drug trials on children should be …… Conducted concurrently with adult trials Conducted Earlier in younger children then in older Conducted Only after adult or older children trials. Conducted trials in adult females. 14

Q. The clinical evaluation of a new drug in children can be conducted only after phase ……trials in adults.:

Q. The clinical evaluation of a new drug in children can be conducted only after phase ……trials in adults. Phase 0 Phase 1 Phase 2 Phase 3 Phase 4 15

SCIENTIFC AND REGULATORY ISSUES:

SCIENTIFC AND REGULATORY ISSUES 16 The data submitted for the marketing approval were not made available to the public

Q. Which ICMR principle states that research, experimentation, evaluations or results from the research should generally be made known? :

Q. Which ICMR principle states that research, experimentation, evaluations or results from the research should generally be made known? a) Principles of accountability and transparency b) Principles of maximization of public interest and distributive justice c) Principles of institutional arrangements d) Principles of public domain e) Principles of totality of responsibility 17

SCIENTIFC AND REGULATORY ISSUES:

SCIENTIFC AND REGULATORY ISSUES 18 Drug and Cosmetic Act considers that “all vaccines shall be new drug” unless certified by the licensing authority ,then why this trial was described as a phase IV trial?

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a) A new molecule is called as a “new drug” b) A “new dose” is considered to be a “new drug” c) Change in drug form(with increase in efficacy) is called as a “new drug” d) Change in indication of older drug is a “new drug” e) A fixed dose combination is a “new drug”. 19 Q. According to the Drug & Cosmetic Act, which of the following is not correct regarding “new drug” ?

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Phase 3 trials needed to generate the safety and efficacy Phase 2 trials needed to generate the safety and efficacy Phase 3 trials needed to generate the PK & PD Phase 2 trials needed to generate the PK & PD 20 Q. For new drugs approved outside India , what is necessary ?

SCIENTIFC AND REGULATORY ISSUES:

SCIENTIFC AND REGULATORY ISSUES 21 clinical data which was required for this trial before conducting it in to India was waived

Q. The toxicological and clinical data requirement may be abbreviated or omitted under the following conditions except…:

Q. The toxicological and clinical data requirement may be abbreviated or omitted under the following conditions except… For drugs indicated in life threatening diseases of special relevance to India In emergency health situations For drugs developed and approved outside India. None of the above 22

Outcome of the trial:

Outcome of the trial Result ADR : 4 post vaccination deaths in Andhra Pradesh and 2 from Gujarat On 7 April 2010 the government announced a halt on all trials of the HPV vaccine in India. 23

Q. Why did the regulatory authorities grant approval for HPV vaccine trials on children? :

Q. Why did the regulatory authorities grant approval for HPV vaccine trials on children? a) Because it was a life threatening disease of special relevance to Indian scenario. b) Because the US FDA and EMeA had already approved it c) Because they thought that this demonstration project would help with future planning on introduction of HPV vaccine e) All of the above 24

comments:

comments Ghulam Nami Azad (union minister for health and family welfare): “demonstration project in a working model to study the impact of public health and management of a particular illness in this age group of is a part of the operational research.” Press release of the PATH: the study was a post licensure observational study involving administration of HPV vaccine India. 25

More trials !!!!:

More trials !!!! In September 2009 : phase 4 trial launched- to compare a two dose regimen o f Gardasil with the standard 3 dose regimen 20,000 girls 10 to 18 years of age group India only trial suspended on US registry clinical trial.gov and not yet recruiting on CTRI (CTRI/2009/091/000137,NCT00923702) 26

PowerPoint Presentation:

In September 2009: Merck launched a phase 3 trial. to study about the tolerability and immunogenicity of 3 dose regime of Gardasil administered to healthy females. 16 – 23 years US FDA – currently recruiting the patients CTRI- temporarily on halt or suspended 27

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In 2009 : Trial of HPV vaccine on HIV positive women's Described as a phase I in CTRI but with no phase mentioned on US FDA registry Described as a currently recruiting patients 28

conclusion:

conclusion Improper informed consent from vulnerable population The content of “Schedule Y” need to be revised All trials on marginalized and vulnerable groups should be banned Concerns over the vaccines safety and efficacy Aggressive marketing strategies from the companies 29

Conclusion :

Conclusion 30

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