Letter to Chief Justice Ramana of Delhi High Court in connection with Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena

18 September 2013

The Chief Justice of the Delhi High Court

High Court of Delhi

New Delhi

To the Chief Justice of the Delhi High Court,

REF: Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena

Dear Sir,

I am a lawyer and a member of the Delhi High Court Bar Association. On 17 and 18 September 2013, I mentioned the proposed party on 20 September 2013 at a five star hotel where the current DHCBA executive is inviting Delhi High Court judges to ostensibly felicitate certain judges.

I have requested you to discourage such ostentatious public relations exercises by the executive committee of the DHCBA and particularly by Mr A S Chandhiok, current President of this committee.

As I mentioned before you in court 1 on 18 September, 2013, this proposed party is also a public relations effort by Mr A S Chandhiok in view of certain grave complaints made against his wife, Dr Nomita Chandhiok. I refer to two emails dated 12 September 2013, an email dated 13 September 2013, and another email dated 16 September 2013 on the issue of the Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena.

These email petitions addressed to the President of India, to the Chief Justice of India, to the Chief

Justice of the Delhi High Court, to the Medical Council of India, to the Medical Council of Delhi, and to the Director General of the Indian Council for Medical Research requesr that the Chief Justice of India treat these emails are a public interest petition under Article 32 of the Constitution of India and initiate a public interest litigation into these illegal and unethical clinical trials which have exposed hundreds if not thousands of Indian citizens to HIV.

It is submitted that the proposed party on 20 September 2013 is being organised by Mr A S Chandhiok merely as a public relations exercise for him and his wife (Dr Nomita Chandhiok) in response to the grave complaints made against Dr Nomita Chandhiok.

I most respectfully submit that it will not be appropriate or proper for members of the Bench and for Delhi High Court judges to fraternise with Dr Nomita Chandhiok at the party on 20 September 2013.

Having brought these facts to your notice, I trust that you will take the right decision and not attend the party being thrown by Mr A S Chandhiok on 20 September 2013 at the Meredien Hotel.

Seema Sapra

Petitioner in Person in W.P. (Civil) 1280/ 2012 in the matter of Seema Sapra v. General electric Company & Others

Copies of emails (without annexures) dated 13 and 16 September are attached. It is requested that you ask the Registrar General of the Delhi High Court to place these email petitions with annexures before you so that you can take an informed decision on my request.
-----Original Message-----
From: Seema Sapra [mailto:seema.sapra@googlemail.com]
Sent: 13 September 2013 20:58
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Cc: Seema Sapra; Seema Sapra
Subject: Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena

To the President of India, to the Chief Justice of India, to the Chief Justice of the Delhi High Court, to the Medical Council of India, to the Medical Council of Delhi, and to the Director General of the Indian Council for Medical Research,

I am writing in connection with certain illegal and unethical clinical trials for “microbicides” being carried out in India on Indian citizens.

These clinical trials are unethical and illegal because they encourage and mislead HIV high risk groups like sex workers into not using condoms (which is the only proven method to prevent HIV transmission), and incentivise them to instead use these topically applied substances called microbicides (which are under development and are being tested for HIV prevention), even though these microbicides have not been proven to prevent HIV transmission.

These trials in fact expose these sex workers and their clients, families and future sex partners of those clients to a very high risk of contracting HIV.

As a result of these clinical trials, a large number of Indian citizens have been exposed to HIV risk or to the HIV virus, which could have been prevented by the use of condoms.

The Indian Council of Medical Research (ICMR) and specifically Dr Nomita Chandhiok from ICMR have played a pivotal role in facilitating and enabling these unlawful and unethical clinical trials in India.

It is pointed out that Dr Nomita Chandhiok (MBBS) is the wife of Additional Solicitor General Amarjit Singh Chandhiok and has close ties to Mr Montek Singh Ahluwalia.

I reproduce below (after my name) some recent news reports that highlight the dubious role played by the Indian Council for Medical Research (ICMR) in enabling PATH, a US NGO to use Indian citizens and children as guinea pigs for illegal vaccine trials.

Mr A S Chandhiok participated in an attempt to murder me because of my corruption complaints against General Electric and Montek Singh Ahluwalia (subject-matter of CM 428/ 2013 filed in W.P. (Civil) 1280 of 2012 and further described in IA 4813/ 2013 filed in OMP 647/ 2012

in the Delhi High Court). I am sharing these concerns regarding his wife, Dr Nomita Chandhiok who is a scientist at ICMR. Dr Nomita Chandhiok holds an MBBS degree and has practiced medicine as a gynaecologist. How can she be a scientist at ICMR? She is not qualified. She is involved in foreign funded clinical trials and HIV related Projects even though she is not qualified to do so.

Her prominent role at ICMR can only be explained as nepotism on account of her and Mr A S Chandhiok’s close links to Montek Singh Ahluwalia. (Apparently there are family ties between Montek Singh Ahluwalia and Mr A S Chandhiok and the families share a close

relationship.)

Dr Nomita Chandhiok has been attending and speaking at conferences on medical research topics that she is not professionally qualified to address.

She has received a large research grant (Rs 1.68 crores) from a US NGO CONRAD to prepare sites for conducting effectiveness trials for microbides in India. As a mere gynaecologist, how is Dr Nomita Chandhiok qualified to undertake this project which is connected to trials for products for HIV prevention ?

Dr Nomita Chandhiok also seems to be a major partner/ beneficiary of PATH’s projects and agenda in India.

PATH was/ is also involved with the autonomous private NGO PHFI (Public Health Foundation of India) which has been given unprecedented and unlawful access to the making of Indian health policies. Montek Singh Ahluwalia is also closely involved with the PHFI.

According to Dr Nomita Chandhiok’s cv posted on the ICMR website, she joined ICMR in 2007 as a “scientist” even though she only posesses an MBBS degree and at some point in her life might have practiced medicine as a gynaecologist.

It is pointed out that Dr Nomita Chandhiok is not qualified to work as an ICMR scientist or to conduct/ facilitate clinical trials for microbicides or indeed any other kind of clinical trials.

Further, Dr Nomita Chandhiok has in fact violated the hippocratic oath by enabling and facilitating clinical trials in India for microbicides as these trials involve putting human life at risk through exposure to HIV by encouraging/ misleading/ incentivising high risk participants (sex workers) to not use condoms even though condoms are the only proven and recommended means to prevent HIV transmission during sexual intercourse.

CONRAD on its website has material available on its clincal trials for microbicides. CONRAD has admitted that: “Two Phase III trials of CS as a microbicide began in 2006, one in Nigeria conducted by Family Health International (FHI) and the other in Benin, South Africa, Uganda and

India

. A planned interim analysis of the CONRAD study data, presented to an independent data monitoring committee, showed that CS might be contributing to an increased risk of HIV infection. Although the number of seroconversions was small, the group in the CS arm of the

study contracted HIV at higher rates than did those in the placebo arm, and therefore the trial was stopped. FHI subsequently decided to close its CS study in Nigeria due to the safety concerns raised in the CONRAD trial, … Following the halt of the study, scientists from CONRAD conducted a study of CS in two groups of six monkeys each to try to understand why the microbicide was not effective in women. A placebo was used in one group, while 6% CS gel was used in the second group. Although 5/6 macaques were infected in the placebo group, none

of the animals in the CS gel group seroconverted. These data suggest that consistent vaginal application of CS gel effectively reduced the infectivity of the virus, significantly decreasing the rate of vaginal mucosal SHIV transmission following repeated virus exposures.

Why does CS have a protective effect in monkeys and not in humans? There is not a clear explanation at this point. However, certain hypotheses are plausible. Women may not have consistently used the gel with every act of intercourse. They used the gels more frequently than

in the monkey study, possibly irritating the vaginal mucosa or changing its microflora. Although scientifically sound, the monkey model has not been clinically validated yet and may differ from the actual human conditions of transmission in a way that affects its predictive power.

In spite of extensive preclinical characterization proving CS safety and efficacy, the CS-containing gel tested in Phase III clinical trials failed to effectively protect women from acquiring HIV infection. Comprehensive additional research is currently ongoing to try to verify hypotheses about the causes for such failure. The need for better, more predictive preclinical models and clinical biomarkers of microbicide safety and efficacy is evident.”

This constitutes an admission by CONRAD that women contracted HIV as a result of its clinical trials in Nigeria, Benin, South Africa, Uganda and India. This exposure to HIV of these women participants in CONRAD’s clinical trials was preventable by the use of condoms and

this exposure of these women to HIV was in fact a direct result of CONRAD encouraging these women to not use condoms.

The documentation on what CONRAD’s clinincal trials for microbicides do shows that these trials are unethical and illegal as they involve encouraging/ incentivising/ misleading healthy women who do not have HIV to not use condoms (which is the only established way of

preventing HIV) and instead asking them to use microbicides which have not been proven to prevent HIV infection. The clinical trials involve monitoring of these women over a period of time to see whether or not they then contract HIV. As no clinical trials for microbicides have

been successful, this means that women participants in all these clinical trials have contracted HIV.

Yet it appears that these clinincal trials for microbicides continue to be carried out in India.

These clinical trials are contrary to the work and objectives of NACO and the AIDS control mission in India where the medical advice especially for high risk categories like sex workers is to use condoms.

Further details of the CONRAD-ICMR microbicides clinical trial promoted by Dr Nomita Chandhiok in India show the envisaged use of sex workers in six sites in India: at National AIDS Research Institute, Pune; National Institute of Research in Reproductive Health Mumbai; Karnataka Health promotion Trust, Belgaum; Karnataka Health promotion Trust, Bagalkot; National Institute of Nutrition, Hyderabad for East Godavari and at National Institute of Nutrition, Hyderabad for Khammam.

The ICMR has been recently criticised by an Indian parliamentary panel for its dubious and illegal role in facilitating the PATH HPV vaccine clinical trials in India in which several Indian teenaged girls died.

Specifically the Parliament report criticises ICMR for supporting the PATH HPV vaccine for use in India in 2007 even before it was specifically approved for use in India. The parliamentary panel in its report titled “Alleged irregularities in the Conduct of Studies using HPV vaccines by PATH in India”, has stated that ICMR representatives apparently acted at the behest of PATH in promoting the interests of the vaccine manufacturers, and that the Department of Health Research/

ICMR “have completely failed to perform their mandated role and responsibility as the apex body for medical research in the country. Rather, in their over-enthusiasm to act as a willing facilitator of the machinations of PATH, they have even transgressed into the domain of other agencies which deserves the strongest condemnation and strictest action against them”. The parliamentary committee has questioned why ICMR “took so much interest and initiative in this project when the safety, efficacy and introduction of vaccines in India are handled by the National Technical Advisory Group on Immunisation.” The parliamentary panel has also questioned how ICMR

signed an MOU in 2007 supporting the use of the HPV vaccine even before it was approved for use in

India

in 2008. The panel has further questioned how ICMR decided to commit to promotion of the drug in the Universal Immunisation Programme (UIP) even before any

independent study on its utility and rationale for inclusuon in the UIP was undertaken.

It is pointed out that PATH was/ is a key partner to the dubious body the Public Health Foundation of India that appears to have been promoted by Dr Manmohan Singh, Mr Montek Singh Ahluwalia and the now exposed Rajat Gupta convicted for insider trading in the United

States. The country program leader for PATH in India is Mr Tarun Vij who was earlier the country director for the American India Foundation, established by the now discredited Rajat Gupta.

It appears that Mr A S Chandhiok has represented PATH in court proceedings in India.

There appears to be an illegal nexus involving Montek Singh Ahluwalia that is behind these illegal and unethical clinical trials in India. This nexus needs to be exposed.

I request the Chief Justice of India to treat this communication as a public interest litigation (PIL) and to inquire into these illegal and unethical clinical trials for microbicides in India and into the

ilegal and corrupt nexus that is placing Indian lives at risk and is facilitating the use of Indian women, men and children as guinea pigs for foreign interests.

The illegal and unethical clinical trials for microbicides in India must be immediately halted. Public disclosures must be made about how many Indian citizens have contracted HIV as a result of these clinical trials and how many other lives have been placed at enhanced risk of contracting HIV.

Dr Nomita Chandhiok has violated the hippocratic oath by facilitating these clinical trials for microbicides which have placed several lives at risk by misleading/ disincentivising participants from using condoms in the belief that micriobicides will protect them from HIV and by failing to provide appropriate medical advice to participants than only condoms can prevent HIV transmission.

The following evidence about Dr Nomita Chandhiok’s unethical and unlawful activities in promoting illegal and unethical clinical trials in India is available:

(i) Dr Nomita Chandhiok and Dr Sanjay Chauhan (from ICMR) attended a 2012 Global Forum on Multipurpose Preventive Technologies for Reproductive Health in London as part of the Initiative for Multipurpose Preventive Technologies (IMPT) set up in 2009. This forum recommended the following actions in India

“India: Relevant officers at the Indian Council for Medical Research and the Centre for Policy Studies will work with colleagues at the Federation of Obstetricians and Gynecologists and other groups to convene a workshop on MPTs in late 2012 or early 2013. The purpose of the workshop will be (a) to raise awareness of MPTs in India and to advocate for investment in priority R&D activities aimed at the creation of novel MPTs; and (b) to identify opportunities for strengthening the use of existing SRH technologies, especially in selected demographically vulnerable states. These efforts will be pursued with national and international collaborators. The protagonists will also work to familiarize government officials, scientific groups and pharmaceutical companies

in an effort to draw new actors into the field of MPTs.”

This proposed activity by Dr Nomita Chandhiok violates conflict of interest and ethical rules that apply to her position at the ICMR.

Other participants from India included Jaideep Gogtay; Cipla Limited India; Badri Saxena Centre for Policy Research (CPR); Mukul Singh Weill Medic College of Cornell University / BioRing LLC India.

(ii) Dr Nomita Chandhiok attended the 2012 International Microbicides conference in Australia. Out of 21 delegates from India at this conference, Dr Nomita Chandhiok (a mere MBBS) is the only Indian represented on the committees and was/ is a member of the

Scientific Program Committee. CONRAD was a financial sponsor of this conference. Dr Nomita Chandhiok chaired a symposium on biomedical prevention in concentrated HIV epidemics. Dr Nomita Chandhiok spoke in a session on “Multi-indication RH products in India and China: their

role and potential impacts”.

Other sessions on India were the following:

Lauren Katzen An evaluation of two methods for daily reporting of adherence in a placebo gel trial in Southern India

Jim Pickett Expanding the evidence base for ARV prevention strategies: community perspectives from India, South Africa, and the United States

Sanjay Mehendale What is the potential role of microbicides and other HIV prevention technologies in India?

Mallika Alexander Practice of anal sex and its associated factors among female sex workers: data from survey of FSWs from four states of India

Barbara Mensch Willingness to participate in a placebo gel trial among female sex workers in southern India

Agniva Lahiri Creating knowledge and mobilising transgender and Hijra community in India to support rectal microbicides development by sharing information and building linkages

Barbara Friedland Does advance knowledge of biomarkers improve adherence and/or the reporting of sexual activity, gel, and condom use among clinical trial participants? Results from a placebo gel trial in Andhra Pradesh, India

Elizabeth Tolley Adolescent and community perspectives on microbicide trial participation in Tanzania and India

Lauren Katzen Using a 2-stage strategy with respondent driven sampling to recruit a hard-to-reach population for a microbicide clinical trial in Nellore, Andhra Pradesh (India)

(iii) Mircobicide research and clinical trials feature prominently in the XIIth plan document for 2012-2017 for the Department of Health Research.

(iv) Dr Nomita Chandhiok is co-editor of the report titled “Socio-behavioural aspects of microbicide trials for HIV prevention” on the proceedings from a workshop in New Delhi in 2005 jointly organised by ICMR and by the Microbicides Development Programme, UK.

This document notes that participants in microbicide trials in

India

have contracted HIV: “Provision of ART to those become HIV positive during the trial is another major issues requiring prior agreements.”

This report itself hints at the ethical issues involved with microbicide clinical trials:

“This is a multi-site trial to determine whether participants at high risk of acquiring HIV can be protected by taking one 300 mg tablet of tenofovir every day. This trial has been the subject of an astonishing campaign of criticism by local and international activists. And these criticisms have been widely reported in the media, including the lay press, scientific journals and internet websites. Some of these criticisms highlighted aspects of the study that needed to be looked

at more closely, but for the most part these attacks were based on inadequate information,

misunderstandings and sheer ignorance.

Nevertheless, this propaganda and its knock-on effects caused the governments in Cambodia and Cameroon terminating the trials in these important sites. There were also plans to expand the trial into sites in Malawi but the government there recently decided to withdraw their approval. However, the reason for that is different: they are planning to introduce tenofovir as part of the second-line treatment regimen for HIV+ people who fail on the first–line regimen and are concerned that the trial will result in tenofovir-resistant strains emerging in the community. There is no indication that this decision has been influenced by activism as in Cambodia or Cameroon.

But overall, the evaluation of a promising preventive technology has been delayed, a technology which is potentially able to save the lives of millions of people at risk of HIV infection. What we should be worried about is that similar activism could disrupt other important trials of HIV interventions in the future, whether of oral prophylaxis, microbicides, vaccines or other technologies. So it is important to try to understand how this situation came about and to consider what can be done to reduce the chances of its happening again.

In the case of Cambodia, the activists argued that it was unacceptable for Western interests to exploit commercial sex workers in a poor country like Cambodia for experimental drug testing and asked why the trial could not be carried out in high-risk US and European populations. They even accused the researchers of providing inadequate HIV prevention counseling so that sufficient study end-points would be achieved. The use of placebo pills was either misunderstood or misrepresented and the researchers were accused of giving some women “dummy pills”. They had

also demanded 30-40 years’ medical insurance cover for trial-related injuries. Finally, they drew attention to insufficient community involvement in planning the study, and indeed this is one area that would have benefited by a more active effort on the part of the researchers.”

Another part of this report discussed the need to cut costs for microbicide trials in India in these disturbing terms:

“Microbicide clinical trials are complex as well as expensive. Various ways to reduce the costs were suggested such as: (a) evaluate more than one active agent within a trial rather than conducting individual separate trials; (b) enrol a larger number of study participants and shorten the duration of follow-up; and (c) collect concurrently sexual behaviour data for better understanding of the results.”

(v) Dr Nomita Chandhiok spoke on Multi-purpose Prevention Technologies for Girls and Women at the WHO conference on “Women Deliver 2013” in Kuala Lumpur.

(vi) Dr Nomita Chandhiok (ICMR) and Dr Badri Saxena (Center for Policy Research) were the two Indian participants at a 2004 Regional Meeting on Regulatory Pathways for Microbicides in Asia in New Delhi.

(vii) Dr Nomita Chandhiok is named as the contact person for receiving proposals under a June 2013 Call for Proposals for Inter-Institutional HIV Research Programme (IIHRP) as part of a

DBT-ICMR Collaborative effort on HIV/AIDS & Microbicides. These proposals are for research projects to study intricate relationships between HIV pathogenesis and immune defense in *Long Term Non-Progressors (LTNPs) elite controllers (EC), HIV-Exposed Sero-negative (HESN) and High Risk Sero-negative cohorts. How is Dr Nomita Chandhiok with only an MBBS degree qualified to act in connection with such a research project?

(viii) How is Dr Nomita Chandhiok qualified (with an MBBS degree) to serve on the Expert Committee for reviewing the projects received under the Joint Call for proposals by DBT-ICMR?

The terms of reference for this committee are:

- To consider, evaluate and recommend the projects under the DBT-ICMR joint call for proposals for financial support.

- To monitor and review the progress of ongoing and completed projects.

- Idea generation and identification of new priority areas of research.

- To act as special project formulation group in the priority disease areas.

- To consider any other matter relevant to this area.

The following extract from an article by Alan Stone (2009) – ‘Regulatory issues in microbicide development’ highlights how microbicides have so far not been demonstrated to be effective in HIV prevention:

“A diversity of microbicide candidates continues to advance through the development pipeline (Annexes 3 and 4). The first generation of products, many of which looked promising in the laboratory and in early human studies, met with little success in large-scale randomized

clinical trials to evaluate their protective effectiveness. The surfactant nonoxynol-9 was the first candidate microbicide to be the subject of such a trial. Unfortunately, it turned out that the women

receiving nonoxynol-9 gel were at higher risk of HIV than those receiving a placebo gel. Another surfactant-based microbicide, Savvy, also failed to protect, as did BufferGel, an acid-buffered gel

intended to reduce the risk of infection by maintaining the vagina’s acidic pH. Several polyanions have been intensively investigated as potential microbicides. In laboratory studies, these compounds work by blocking the attachment of HIV to its cellular receptors. Three of them, carrageenan, cellulose sulphate and PRO 2000, have been the subject of largescale trials to evaluate their clinical effectiveness. Unfortunately, all failed to demonstrate a protective effect.

Considerable attention is now focused on secondgeneration products – antiretroviral drugs initially developed for therapeutic use, including inhibitors of HIV reverse transcriptase and HIV-specific entry and fusion blockers. They may be formulated as gels for topical use or, depending on drug chemistry, loaded into intravaginal rings for sustained release. Several such products are in various stages of preclinical and clinical development. Combination microbicides are

also being investigated. These could, in principle, exhibit greater potency and a broader spectrum of activity than single-agent microbicides and may also reduce the chances of HIV resistance being a problem.”

This article also sheds light on the uncomfortable truth behind clinical trials of microbicides, - on the fact that these trials can only work if they discourage / disincentivise condom usage or if they

are carrried out in sites where condom usage is low. This uncomfortable truth is clear from the following statement in this article:

“The impact of microbicides on disease incidence will be largely realized, in practice, in settings where condom use is low or erratic; however, in settings where condom use is high, condom substitution with microbicides could be counterproductive from a public-health and disease-prevention perspective (43). Labelling and package inserts, as well as education around microbicide introduction, will need to find a balance that will not promote a substitution effect while, at the same time, avoiding giving the impression that microbicides are intended for use only with condoms.”

This statement admits that clinical trials for microbicides must necessarily mislead/ confuse participants into believing that microbicide use without condoms will offer protection against HIV.

An RTI document showing the salaries of ICMR officers for November 2008 shows that Dr Nomita Chandhiok as a Scientist E was earning (Rs 100977 per month) which was much more than the other eleven ICMR scientists falling in the same category E. Dr Nomita Chandhiok was

paid more than 23 other ICMR scientists all placed in higher categories i.e., in scientist categories F & G.

Seema Sapra

Supreme Court puts Centre in a spot over HPV vaccine trials by PATH

Our Bureau, New Delhi, Tuesday, September 03, 2013, 12:30 Hrs [IST]

After a Parliamentary panel severely criticized the role of the Indian Council of Medical Research (ICMR) and the Drug Controller General of India (DCGI) in the case of the trial of human papilloma virus (HPV) vaccines by international organisation PATH, the Supreme Court has

pushed the Centre to the wall by seeking a report on the whole episode.

The bench, headed by Justice K S Radhakrishnan, has sought a detailed report on the investigations conducted by the Centre and the action taken on complaints of unethical clinical trials of the HPV following a PIL filed by Kalpana Mehta based on the finding by the Parliamentary Standing Committee on Health.

The petitioner said the trials were a clear case of child abuse and violated fundamental rights. The court had last year issued notices to the Centre but the government has not yet come out with an adequate response. “The anomalies in their assumed safety and efficacy were brought to the fore by various women’s groups and health groups from across the country that included a member of the National Technical Advisory Group on Immunisation,” Mehta’s petition alleged.

The Parliamentary panel had severely came done on matter, questioning the roles of ICMR and DCGI in the trials conducted by two US-based pharmaceutical companies through PATH on tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010.

The trials were stopped only after the matter received media attention following the death of seven girls.

In its report on “Alleged Irregularities in the Conduct of Studies using HPV Vaccines by PATH in India” presented to Parliament, the committee has said ICMR representatives apparently acted at the behest of PATH in promoting the interests of the vaccine manufacturers, and recommended that the Health Ministry review the activities of the functionaries of the Council involved in the PATH project.

“The Department of Health Research/ ICMR have completely failed to perform their mandated role and responsibility as the apex body for medical research in the country. Rather, in their over-enthusiasm to act as a willing facilitator of the machinations of PATH, they have even transgressed into the domain of other agencies which deserves the strongest condemnation and strictest action against them,” the report said.

“The Committee is unable to understand as to how ICMR could commit itself to support "the use of the HPV vaccine" in an MoU signed in the year 2007 even before the vaccine was approved for use in the country, which actually happened in 2008. The Committee also questions the decision of ICMR to commit itself to promote the drug for inclusion in the Universal Immunization Programme (UIP) even before any independent study about its utility and rationale of inclusion in UIP was undertaken,” the panel said.

“The Committee’s examination has proved that DCGI has also played a very questionable role in the entire matter. Initially, it took a call that since human subjects, as part of the studies, were receiving invasive intervention like immunization, clinical trial rules must be enforced. However, it remained as a silent spectator thereafter, even when its own rules and regulations were being so fragrantly violated.

The approvals of clinical trials, marketing approval and import licenses by DCGI appear to be irregular. Therefore, the role of DCGI in this entire matter should also be inquired into,” it said.

___________________

A PATH to profit and violations

DINESH C. SHARMA | New Delhi, September 4, 2013 | 09:20

In the din over Coalgate and Asaram rape case, the Standing Committee on Health tabled in the Parliament an innocuous sounding but explosive report titled "Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine by PATH" last week. It appears to be a report on Vaccinegate-in-the-making, laying bare the unholy nexus between India's top medical research body and an American voluntary group solely to benefit two top drug companies.

It exposes how the Indian Council of Medical Research (ICMR) colluded with an American entity, Program for Appropriate Technology in Health (PATH) to push inclusion of a controversial HPV vaccine in the government's immunisation programme - an action which would have resulted in windfall gains for GSK and Merck. ICMR threw all rules governing introduction of new vaccines to the wind in order to help the American agency and vaccine makers. It chose to consign to dustbin its own ethical guidelines to facilitate testing of HPV vaccines among vulnerable adolescent tribal girls in Andhra Pradesh and Gujarat. HPV is one of the causes of cervical cancer.

The vaccination programme was camouflaged as "demonstration study" to bypass regulatory framework involving the Drug Controller General of India (DCGI) and the National Technical Advisory Group on Immunisation (NTAGI). Genuine informed consent was not taken nor were adverse reactions documented. Shockingly, PATH was not even registered to operate in India legally when ICMR signed the agreement with it. Not just this, ICMR committed itself to support the use of the HPV vaccines in immunisation programme in an agreement signed with PATH in 2007 even before the vaccine was approved by the drug controller for use in the country. What was the motive? We don't know yet.

The role of health ministry too is under cloud. When the parliament forced it to investigate the deaths of seven girls during the trials, it appointed a committee with members having direct conflict of interest. One of them was funded by Merck to work on Health minister Ghulam Nabi Azad with Bill Gates, founder of the Bill and Melinda Gates Foundation. The parliamentary panel wants the Gates supported agency PATH to be probed. the very same vaccine the committee was

investigating.

The government must immediately launch a criminal investigation against ICMR, PATH and health ministry officials involved in this murky deal, as recommended by the panel. Pending this investigation, heads must roll in ICMR and the health ministry.

Incidentally, PATH study was funded by the Bill and Melinda Gates Foundation which has been poking its nose in all major health programmes in India and advocates introduction of a slew of new vaccines.

The rot in our health administration is not limited to this particular deal. Several international agencies, Alliances and Foundations have uncomfortably cosy relationship with top brass in ICMR, health ministry and other agencies. Millions of dollars of funding, frequent foreign jaunts, academic postings and lucrative postretirement assignments are facilitating penetration by foreign agencies serving interests of drug companies. Our health policymaking is being compromised and is greatly under the influence of vested interests. At stake is health of billion plus people.

-----Original Message-----
From: Seema Sapra [mailto:seema.sapra@googlemail.com]
Sent: 16 September 2013 19:55
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Cc: Seema Sapra; Seema Sapra
Subject: Additional facts and documents in support of Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena

Additional facts and documents in support of “Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena” sent by Seema Sapra on 13 September 2013 to the President of India, to the Chief Justice of India, to the Chief Justice of the Delhi High Court, to the Medical Council of India, to the Medical Council of Delhi, and to the Director General of the Indian Council for Medical Research.

The statement in Dr Nomita Chandhiok’s CV posted on the ICMR website to the effect that she joined ICMR on 31 July 2007, appears to be incorrect. Dr Nomita Chandhiok has been working with ICMR since before 31 July 2007.

The cited 2009 article by Alan Stone (2009) – ‘Regulatory issues in microbicide development’ is a WHO publication funded by the WHO and CONRAD, and contains the following disclaimer: “this document does not necessarily represent the views, decisions or policies of the World

Health Organization, CONRAD or any other institution.”

Due to the bad press that microbicides have received on account of the failure of all clinical trials uptil now, a new term appears to have been coined to replace microbicides in advocacy literature. This new term is “Multipurpose Prevention Technologies for Reproductive Health” (MPTs). The Final Report of the Global Forum on Multipurpose Prevention Technologies for Reproductive Health (2012) whose objective was “Advancing the MPT Agenda”, (and which was attended by Dr Nomita Chandhiok), describes MPTs as:

“ … some of the most innovative health products under development to simultaneously prevent unintended pregnancy, sexually transmitted infections (STIs) including HIV, and provide additional health benefits. These promising innovations include vaccines and gels as well as easier to use vaginal rings and single‐sized diaphragms that could lead to marked declines in unintended pregnancies and disease. By addressing multiple health needs, MPTs would offer an efficient approach to delivering and accessing services and would also provide social and economic benefits that would have a major impact on the health and lives of women and their families worldwide .”

The above statement shows that advocacy for microcibides is now being camouflaged through rebranding these products as MPTs. Proven MPTs that prevent HIV (except condoms) do not exist at present. MPTs efficacious in preventing the transmission of HIV are still very much

in the realm of fantasy.

Since the definition for MPTs includes vaccines, how is Dr Nomita Chandhiok using her ICMR position to act as a lobbyist in India for MPTs? Lobbying for vaccines does not fall within the ICMR job description of Dr Nomita Chandhiok.

The guidelines issued by the US FDA for the development of vaginal microbicide products define vaginal microbicides as “intravaginal drug products that reduce the risk of HIV acquisition”

The position of US authorities on microbicides is that even if eventually established as effective and approved for HIV prevention, microbicides will only be recommended for use with condoms and not for use without condoms.

Further, FDA documents record that even the biological mechamism for transmission of HIV in the vagina remains unknown.

Trials for microbicides and MPTs that prevent HIV remain in the realm of experimental drug testing on vulnerable populations most at risk of contracting HIV. Such trials disincentivise the only proven method for HIV prevention (condoms) and also divert funds, resources and attention away from HIV counselling aimed at promtion of condom usage.

Dr Nomita Chandhiok attended the XVIIth International AIDS Conference in Mexico City in 2008. She co-chaired a session on “The Future of Microbicides: From Vaginal ART to PREP. The conference program describes this session as” - “This session will specifically look into the future of female controlled prevention methods after negative results of some recent trials. An overview will be delivered on possible new products showing promising results in the laboratory, as well as the status of clinical studies with microbicides containing ART. The concept of “low dose oral intake of ART as prophylaxis” called Pre-exposure Prophylaxis (PREP) will be reviewed in terms of progress with clinical trials as well as issues such as viral resistance development, impact on future treatment options and side effects.”

It is perplexing how Dr Nomita Chandhiok was co-chairing a session in the XVIIth International AIDS Conference when she only posseses an MBBS degree and does not work in the field of HIV in India. She has no technical or professional qualifications or expertise related to HIV. There was no represenation by NACO or NARI at this conference which are the designated government bodies for HIV related work and research in

India

Dr Nomita Chandhiok availed of a research grant in 2008-2009 for Rs. 0.88 lakhs to attend a Brown/ Tufts University Program for enhanced HIV prevention training of ICMR researchers. How was Nomita Chandhiok eligible for and selected for this program/ grant with a mere MBBS

degree and with no qualifications/ expertise in HIV research or prevention?

The Ethical Guidelines for Biomedical Research on Human Participants (ICMR, 2006) define a Conflict of Interest in the following terms:

“A set of conditions in which professional judgment concerning a primary interest like patient’s welfare or the validity of research tends to be or appears to be unduly influenced by a secondary interest like non-financial (personal, academic or political) or financial gain is termed as Conflict of Interest (COI).

Academic institutions conducting research in alliance with industries/ Commercial companies require a strong review to probe possible conflicts of interest between scientific responsibilities of researchers and business interests (e.g. ownership or part-ownership of a company developing a new product). In cases where the review board/ committee determines that a conflict of interest may damage the scientific integrity of a project or cause harm to research participants, the

board/ committee should advise accordingly. Significant financial interest means anything of monetary value that would reasonably appear to be a significant consequence of such research including salary or other payments for services like consulting fees or honorarium per participant; equity interests in stocks, stock options or other ownership interests; and intellectual property rights from patents, copyrights and royalties from such rights. The investigators should declare such conflicts of interest in the application submitted to IEC for review. Institutions and IECs need self-regulatory processes to monitor, prevent and resolve such conflicts of interest. The IEC can determine the conditions for management of such conflicts in its SOP manual. Prospective participants in research should also be informed of the sponsorship of research, so that they can be aware of the potential for conflicts of interest and commercial aspects of the research. Those who have also to be informed of the secondary interest in financial terms should include the institution, IEC, audience when presenting papers and should be mentioned when publishing in popular media or scientific journals.”

Attached is a presentation by Dr Toye Brewer from the University of Miami Miller School of medicine clearly showing that microbicides can be no substitute for condoms in the prevention of HIV.

In 2012, Dr Nomita Chandhiok and ICMR hosted an International Symposium on Accelerating Research on Multipurpose Prevention Technologies for Reproductive health sponsored by Indian Council for Medical Research (ICMR); Coalition Advancing Multipurpose Innovations

/Initiative for Multipurpose Innovations (CAMI/IMPT); US Agency for International Development (USAID) and World Health Organization (WHO).

The objectives of this meeting were defined as:

Review the current status of MPT development and highlight needs and potential challenges, including increasing the utilization of existing products;

Expand multisectorial input into possible product development plans, including the perspectives of product developers, end users and providers;

Identify the research priorities relevant to India and define a clear agenda for MPT research and development (R&D) that would provide both the scientific rationale as well as concrete information for developers, scientists, regulators, donors and advocates on accelerating MPT R&D.

The conference program shows that Dr Nomita Chandhiok was the key facilitator from ICMR for this conference. She not only delivered remarks on the objective of the meeting; but also chaired the session on ‘Product prioritisation’; moderated the round table on ‘advancing support for MPTs R&D in India’; and delivered the vote of thanks.

The ICMR Annual Report for 2005-2006 states the following:

“A Memorandum of Understanding (MOU) has been signed between ICMR and Merck for initiation of clinical trial of HPV vaccine in different regions of the Country. The Institute of Cytology and Preventive Oncology (ICPO) located in NOIDA has been designated as National

Coordinating Centre for Indian HPV Vaccine Initiative.”

The fact of this MOU between Merck and ICMR is not mentioned even in the attached 72nd report of the Rajya Sabha Department-related Parliamentary Standing Committee on Health and Family Welfare on the “Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine by PATH in India”.

A commentator (Dinesh C Sharma) has noted in an article on the PATH HPV vaccine scandal (A PATH to profit and violations) recently published (September 4, 2013) by several mainstream news-outlets that:

“The rot in our health administration is not limited to this particular deal. Several international agencies, Alliances and Foundations have uncomfortably cosy relationship with top brass in

ICMR, health ministry and other agencies. Millions of dollars of funding, frequent foreign jaunts, academic postings and lucrative postretirement assignments are facilitating penetration by foreign

agencies serving interests of drug companies. Our health policymaking is being compromised and is greatly under the influence of vested interests. At stake is health of billion plus people.”

PATH appears to have a close relationship with the United States Agency for International Development (USAID). A PATH messaging document on Multipurpose prevention technologies (MPTs) which is essentially a lobbying document states that:

“Support for this project is made possible by the generous support of the American people through the United States Agency for International Development (USAID) under the terms of the HealthTech Cooperative Agreement # AID-OAA-A-11-00051, managed by PATH. The contents are the responsibility of PATH and its partners and do not necessarily reflect the views of USAID or the US Government.”

This document contains the following statements:

“The following framework for messaging was developed to support Indian advocates as they raise awareness and build support for multipurpose prevention technologies (MPTs) for reproductive health in India. These messages were designed specifically for use with policymakers, researchers, and family planning/reproductive health program managers.

By using a shared messaging framework, MPT advocates in India can build a coordinated approach to advancing support and development of MPTs in India, using a common voice and shared terminology.

PROCESS

The messages were developed by the Initiative for Multipurpose Prevention Technologies (IMPT) in 2012 in collaboration with Indian MPT advocates and stakeholders. The messages were tested with representatives of the target audiences in India to assess their effectiveness and impact.

INTENDED USE

MPT advocates in India should view the following messages as a menu of options. Each message is designed to be a complete thought that can be used by itself or as part of a longer narrative. MPT advocates can therefore choose individual messages or a series of messages to be used for a particular communication or advocacy effort, depending on the audience and purpose. These messages can be used in presentations, brochures, websites, speeches, or other outreach efforts to help advance support for MPTs in India.”

This PATH document is essentially a foreign organization promoting lobbying and advocacy in India for MPTs.

Dr Nomita Chandhiok’s speeches/ presentations on MPTs essentially reproduce/ parrot the message incorporated in this PATH document. She is acting as a lobbyist for PATH, CONRAD, USAID, and other foreign interests.

It is important to note that the message in this PATH document is not currently available medical advice. It is nothing but advocacy for solutions that remain in the realm of fantasy and which are under development or proposed to be developed and all of which will need large scale clinical testing.

As one example the following statements that this PATH document suggests be used for messaging in India are all entirely speculative and in the ream of medical fantasy:

“Multipurpose prevention technologies (MPTs) that simultaneously prevent pregnancy and sexually transmitted infections can help reduce the significant unmet need for family planning and further reduce HIV and sexually transmitted infections.

Products, including microbicide gels and vaginal rings, that address more than one reproductive and sexual health need could greatly improve convenience and reduce costs over products intended for only one health need. Family planning solutions that include MPTs can help India achieve and maintain its national goals to bring down the total fertility rate and significantly reduce sexually transmitted infections and new HIV infections.”

The following anti-condom messaging in ths document is competely contrary to the position of the Indian Government on AIDS control and to medical advice on HIV prevention:

“The two products that exist to simultaneously prevent pregnancy and HIV or sexually transmitted infections have not been sufficient to address women’s reproductive health needs.

Male condoms are not always used consistently, even though they are inexpensive and widely available. Issues of trust and power make it difficult for women to negotiate condom use. Even though female condoms effectively protect against pregnancy and sexually transmitted infections, low awareness, lack of availability, and cost have inhibited widespread use.”

The government agenda should be aimed at overcoming these hurdles to condom usage and to devise strategies that promote condom usage. I refer to the attached presentation by Dr Toye Brewer from the University of Miami Miller School of Medicine which states how Thailand, Brazil, Cambodia and

Uganda

have promoted condom usage successfully in some cases with 100% success,

The real intent behind such advocacy (in the PATH document) is to create a constituency in India which can be used to support clinical trials for such substances/ devices among the Indian population.

Also attached is another PATH document titled “Marketed Vaginal Products as Microbicides: A Strategy in India”. This document appears to be dated around 2004.

It states that PATH was developing a microbicide for use in India and this document sets out the strategy for this product in India. The document talks of an escalating claim strategy which “provides the means to reduce risk and attracts commercial partners whose involvement from the start of the development process is integral to an efficient project timeline, optimized product development, and successful marketing.”

The start of Dr Nomita Chandhiok’s sustained lobbying and advocacy in India for microbicides coincides with this strategy launch by PATH. Once again, material demonstrates that Dr Nomita Chandhiok is essentially a lobbyist for interests like PATH and CONRAD.

She has no qualifications or expertise in HIV, yet with a mere MBBS degree and helped by her malleability and her considerable influence within the Indian Government (extending to the PMO and to Montek Singh Ahluwalia) she has usurped the role of advocate/ lobbyist for foreign

interests who are interested in using the Indian population for experimental drug testing and who are eventually interested in the vast potential market for such experimental drugs in

India

As stated all microbicide trials have failed to establish even the efficacy (for HIV prevention) of the product under testing.

The US FDA position is that even if approved, the medical advice for microbicides for HIV prevention will be for use of microbicides as an addition to and along with condoms.

It is extremely unlikely that clinical trials for microbicides as currently designed will ever result in approval of a microbicide for use for HIV prevention by itself and without concomitant use of a

condom. These trials are poorly designed to establish efficacy in HIV prevention and are completely experimental in nature.

Two PATH strategy documents on its HPV vaccine stategy for India are also attached. These documents shed more light on the collusion between ICMR and PATH in the illegal and unethical clinical trial for the HPV vaccine that was carried out in India and which resulted in several deaths and which has attacted the critical attention of not only the Rajya Sabha Committee on Health but also the attention of the Supreme Court of India. One of these documents describes the collaboration between PATH and ICMR in these terms:

“Acknowledgments

This document is a synthesis of the research report:

PATH and National AIDS Research Institute (NARI). Assessing Introduction of HPV Vaccine in

India

: Phase I Formative Study. New Delhi, India: PATH and NARI; 2008.

The formative research that serves as the basis for this report was conducted by the National AIDS Research Institute (NARI) of the Indian Council for Medical Research (ICMR) in collaboration with PATH, as part of the HPV Vaccines: Evidence for Impact project. Generous

financial support for this work was provided by the Bill & Melinda Gates Foundation.

The following people contributed to the formative study in India:

The formative study team at NARI and PATH: Co-principal-investigators Martha Jacob (PATH) and Nita Mawar (NARI), and team members Irfan Khan (co-investigator, PATH), Lysander Menezes (research advisor, PATH), Manoj Patki (program officer, PATH), Neelima Karandikar (research scientist, NARI), Rajani Bagul (co-investigator, NARI), Sanjay Gandhi (co-investigator, PATH), Satish Kaipilyawar (co-investigator, PATH), Tuman Katendra (co-investigator, NARI), and Varada Magde (research scientist, NARI).

Project advisors at ICMR, NARI, and PATH: Anjali Nayyar, Bela Shah, Deepali Mukerjee, Kishore Chaudhry, Lalit Kant, Ramesh Paranjape, Sujit Kumar Bhattacharya, and Vinay Kumar. Jeff O’Malley and Nirmal Kumar Ganguly provided leadership and guidance. Amitrajit Saha, Smita Joshi, and Tensing Donyo, all of PATH, also provided input in the early stages of the study.

Expert reviewers: Ajesh Desai, Amar Jesani, Mohammed E. Khan, Prakasamma M, Ravi Verma, Tilly Sellers, and Yesudian CAK.

The PATH HPV Vaccines project team in Seattle: Allison Bingham, Carol Levin, D. Scott LaMontagne, Scott Wittet, and Vivien Tsu.

The ICMR-PATH Project Advisory Group, including the Andhra Pradesh State Advisory Group chaired by the Commissioner of Family Welfare, Government of Andhra Pradesh, and the Gujarat State Advisory Group chaired by the Commissioner of Family Welfare, Government of Gujarat.

Colleagues at the International AIDS Vaccine Initiative: Antara Sinha, Jayanti Natarajan, and Preeti Kumar.

This report was prepared by Jennifer Kidwell Drake of PATH. The teams at PATH, NARI, and ICMR provided technical review of this document. The report was designed by Patrick McKern (PATH), and proofread by Teri Gilleland Scott and Beth Balderston. The map of India was

produced by Jodi Udd (PATH). Christina Smith, Emma Abrahams, Kalpana Sharma, Naveena Ambatipudi, Neha Vohra, Sucheta Soares, and Yogita Shingate provided administrative support throughout the research process.

Particular thanks go to all the field investigators in Andhra Pradesh and Gujarat for their diligence in completing the tasks assigned.

Finally, PATH and NARI would like to express our gratitude to the formative research participants who shared their time and thoughts and who made this project possible.”

Annexed is a Meeting Report from a PATH sponsored meeting on microbicides in India in 2007.

Annexed is an extract from the Annual Report of ICMR for 2007-2008 which sheds more light on the collusion between PATH and ICMR for the HPV vaccine clinical trial.

Attached hereto is a synopsis of a Rajya Sabha debate on 22 April 2010 on the issue of the HPV vaccine with then Health Minister Ghulam Nabi Azad defending the clinical trials.

Annexed hereto is a presentation by Dr Nomita Chandhiok at the Women Deliver 2013 conference in Kuala Lumpur. The entire presentation incorporates the messages on MPTs advocated for India by foreign interests including by PATH in the attached strategy documents. Dr Nomita Chandhiok acknowledges assistance from six foreign researchers/ advocates/ representatives of foreign donor institutions. This entire presentation is an advocacy/ lobbying attempt that imagines effective MPTs that do not exist. The only effective MPTs today that have proven efficacy are condoms.

Dr Nomita Chandhiok is described in this presentation as Deputy Director General/ Scientist F, in the Division of reproductive & Child Health, ICMR.

The conflict of interest in Dr Nomita Chandhiok’s using her ICMR position to lobby for MPTs and to speak as if she were articulating the official Indian position on this is clear from her role and association with CAMI and with the Initiative for Multipurpose Prevention Technologies (IMPT).

Dr Nomita Chandhiok is part of the “Drug-drug/Drug-Device Product Prioritization Working Group Coordinating Committee” under the Scientific Agenda Working Group of the Initiative for Multipurpose Prevention Technologies.

CAMI or the Coalition Advancing Multipurpose Innovations (CAMI) is a coalition of researchers, biotech developers, advocates and providers working to promote innovative prevention strategies that enhance reproductive and sexual health in the US and the globe. According to CAMI’s website, its work is done through collaboration, convenings, advocacy and research.

CAMI acts as the secretariat for the Initiative for Multipurpose Prevention Technologies (IMPT).

CAMI is headquartered in California and its contact details are:

CAMI/Public Health Institute

312 Natoma Street

Suite 150

Folsom, CA 95630

916-673-9777 | cami@cami-health.org

CAMI’s website contains the following information:

“IMPT MISSION

To advance the development and introduction of technologies that simultaneously address multiple reproductive health needs, namely unintended pregnancies, sexually transmitted infections, including HIV, and other reproductive tract infections.

The Initiative for Multipurpose Prevention Technologies (IMPT) is a global coalition involving a multi-disciplinary and multi-national cadre of stakeholders who share the similar goal of advancing technologies that simultaneously prevent unintended pregnancies, HIV and other sexually transmitted infections. Through a cross disciplinary approach, the IMPT aims to:

Mobilize and monitor financial and scientific resources;

Enhance synergies and cooperation between scientific disciplines that will help generate new ideas, facilitate collaborations and expedite product development and implementation; and

Build political will by increasing awareness about the importance of MPTs and communicating scientific findings for important nonacademic audiences, including policymakers, program managers, health care providers and respected journalists.

The Initiative for Multipurpose Prevention Technologies (IMPT) was established in 2009 to unite researchers, health care providers, policymakers, advocates, product developers, and donors to advance the development and introduction of products that simultaneously address multiple sexual and reproductive health needs, namely unintended pregnancies, sexually transmitted infections (STIs) including HIV, and other reproductive tract infections. Such products are referred to as Multipurpose Prevention Technologies (MPTs; see below). The IMPT works

to: mobilize financial, scientific, and political resources to advance the development of and access to MPTs; build synergy and collaboration among scientific disciplines to expedite product development and implementation; and use a cross-disciplinary advocacy strategy to promote increased support for MPTs.

The IMPT Secretariat is housed at the Coalition Advancing Multipurpose Innovations (CAMI).

Scientific Agenda Working Group (SAWG): The goal of the Scientific Agenda Working Group (SAWG) is to provide guidance for developers and donors which can advance the development of MPTs. The SAWG is focused on:

a. MPT Drug-Drug and Drug-Device combinations

b. MPT-Vaccines

Communication and Advocacy Working Group (CAO WG): This activity focuses on raising global awareness and support for MPTs.

a. Communications, Outreach & Education

b. Advocacy & Fundraising

Acceptability and Access Working Group: The goal of this working group is to ensure MPT products are acceptable, accessible and adhered to among those with highest unmet need. The work of this activity is on the affordability, availability, acceptability, adoption and

regulatory issues of MPTs in development.

The Initiative for Multipurpose Prevention Technologies (IMPT)

International Support for MPTs

In 2010, IMPT identified and secured regional support for MPTs in nearly a dozen non-US regions. In each region, a highly respected and influential HIV or reproductive health expert has been selected as a Chairperson to represent IMPT and help raise awareness and support for

this effort.

Key areas of focus include Australia, China, India, Kenya, and South Africa, among others. Support for MPTs is also growing in the UK.

To help stimulate in-country, regional and international collaboration and support for MPTs, the Initiative has partnered with regional chairs and helped to organize non-US consultations that address MPTs and help increase advocacy and donor support.”

CAMI’s website contains the following information about the Scientific Agenda Working Group:

“Scientific Agenda Working Group (SAWG) - Activity #1:

The first and highest priority of the IMPT is development of an MPT Scientific Agenda for MPTs that can inform and guide donors, product developers, and regulators about MPT priorities & investment needs. Focus areas for the Scientific Agenda are:

Evaluation of the current product candidate pipeline for combined drugs (MPT Drug + Drug), combined drugs and devices (MPT Drug + Device) and a subsequent gap analysis;

Evaluation of the current potential MPT vaccines a subsequent gap analysis;

Assessment of end user priorities in different global regions and a subsequent gap analysis.

SAWG's recent activities

SAWG members, a working group of primarily donors, recently attended the MPT Product Prioritization Stakeholder Meeting with 35 donors and technical experts on October 26, 2012 in Washington, DC.

Members are also considering issues surrounding the development of a multi-purpose vaccine. Keying from concepts presented by scientists in a September Washington D.C. meeting, SAWG maintains that increasing the efficiency of vaccine development is crucial. Currently a draft

development strategy is being discussed.”

Dr Nomita Chandhiok is part of the SAWG.

CAMI’s website has the following information on the Communication, Advocacy and Outreach Working Group (CAO WG):

“Communication, Advocacy and Outreach Working Group (CAO WG)

- Activity #2:

This activity focuses on raising global awareness and support for MPTs. Focus areas are:

Communications, Outreach & Education

Advocacy & Fundraising

Update on MPT Messaging work in India and Sub-Saharan Africa:

India

: CAOWG members have been working with an exceptional group of regional representatives from India to develop key messages that resonate with Indian stakeholders to raise awareness and support for MPTs in India. After testing the messages among target audiences to

ensure clarity, relevance, and persuasiveness, the next step is to work on how best to incorporate these messages into advocacy materials and strategies for further MPT outreach in

India

Sub-Saharan Africa: To help shape messaging work in Sub-Saharan Africa, members are in the early phases of developing a regional stakeholder matrix in collaboration with MPT African regional representatives.”

CAMI’s website has the following information on the Acceptability and Access (AAWG):

“Acceptability and Access (AAWG) - Activity #3:

The goal of this working group is to ensure that MPT products are acceptable, accessible and adhered to among those with highest unmet need. As there are no MPTs besides condoms yet approved, the work of this activity is on:

Acceptability

Access & delivery

Regulatory issues of MPTs in development.”

The Coalition Advancing Multipurpose Innovations (CAMI) itself is a program of PHI. The Public Health Institute (PHI) is an independent, nonprofit organization headquartered in California and according to CAMI’s website is “dedicated to promoting health, well-being, and

quality of life for people throughout California, access the nation, and around the world. The mission of the Public Health Institute is to generate and promote research, leadership, and partnerships to build capacity for strong public health policy, programs, systems, and

practices. Spanning a broad range of interest areas within public health and conducting a variety of types of work, our programs and project add to the growing body of knowledge critical to our mission.”

CAMI’s website states the following on MPTs:

“Microbicides: there are no commercially available microbicides, but significant opportunity exists to combine microbicides with commercially available contraceptives and devices.

Devices: Condoms are prime examples of MPTs and their potential. Devices combined with microbicides may provide acceptable and sustainable protection independent of coitus.

Vaccines: there are many examples of MPTs in pediatric vaccines, but none exist for STIs. Nonetheless, evaluation of individual product pages will reveal multiple opportunities, e.g. combination of the commercially available HPV and HBV vaccines may increase acceptability

and lower costs.”

Annexed hereto is a Tehelka article titled “The cervical cancer bazaar”.

Seema Sapra

(the attachments will be sent in two emails.

Seema Sapra - General Electric corruption whistle-blower: the Truth prevails

Pages

Wednesday, 18 September 2013

Letter to Chief Justice Ramana of Delhi High Court in connection with Complaint regarding unethical and illegal clinical trials for microbicides in India and the dubious role of Dr Nomita Chandhiok and Dr Badri N Saxena

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