India: False promises & regulatory breaches lead to demands for end to HPV vaccine licenses, and Print E-mail

an Independent Impartial Inquiry into all deaths and side effects suffered by girls following anti-cervical cancer vaccination in rural Andhra Pradesh and Gujarat

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Suspending PATH project or an eyewash to drown protest against HPV vaccines?

Scroll down to also read Uniformed Consent”, "Deadly Shots", "Drug Alert", and “US-based group demands Global Suspension of HPV Vaccination Campaign

April 10, 2010: We welcome the news that the Centre has told the state governments of Gujarat and Andhra Pradesh to suspend their ongoing trials with Gardasil, an HPV (human papillomavirus) vaccine made by Merck Ltd, being carried out among poor children in the two states. This research was being done by PATH, a US-based NGO and was funded by Bill and Melinda Gates Foundation. It is because of the protests from women’s organizations and health rights groups that this action has been taken. However, the Government  has to ensure the  well being of the children already covered under the programme.

We would also like to state that this move has been made too late, as at least in Andhra Pradesh, all vials have already been administered. In fact, when we brought up the matter of the death of the first girl before the concerned authorities, it simply fell on deaf ears. This is in direct contrast to experiences in other countries, where entire batches of the vaccine were withdrawn from circulation when deaths and hospitalization were reported following vaccination. We may point out that there may be problems with specific batches of the vaccine as, according to press reports, Merck has been issued warning by the Food and Drugs Administration in the US, for not observing good manufacturing practices.

Also, the agencies involved in conducting the clinical study have been found actively falsifying the benefits of the vaccine, as well as minimizing all the problems associated with it. These are in addition to the issue of protocol violations.

The written material used by PATH categorically states that there are no side-effects of the vaccine other than irritation at the injection site and fever and that it has been safely administered to millions of girls without complaints in developed countries.

This is in direct contrast to the package insert, which points out that at the very least, the vaccine has caused epilepsy-like seizures among girls, and the post-marketing surveillance has observed increase in the occurrences of blood clotting disorders, autoimmune diseases, respiratory and nervous-system disorders. In some cases, even deaths have been reported.

The PATH handouts also contradict the data from the US which shows that adverse effects of the HPV vaccine are far more numerous than those of all other vaccines being given to children. Side-effects among Indian girls are completely unknown because no studies have been carried out in India to assess the safety of Gardasil.

Another contradictory assertion made by PATH is that the vaccine will provide life-long protection. Data about sustained immune response of Gardasil is very sketchy ¾ it pertains only to five years of immunity ¾ as less than one percent trial subjects were followed up for this purpose. There is no assurance that, if required, booster shots would be provided. Needless to say, neither the children concerned nor their families would know of the booster shots, or be able to afford them. This establishes that these girls are being used as mere guinea pigs. We object to this gross violation of the human rights of children.

The third falsehood being propagated is that the vaccine will not affect the ability of these girls to produce healthy children. This has not been established any where in the world. There has been no study of the vaccine’s effects on the maturing reproductive systems of young girls.

The PATH project has thus been vaccinating girls under false pretexts. This is tantamount to criminal misconduct.


Although the Director General, ICMR, has tried to absolve his organization of all blame, we want to know how and why various agreements have been made with Merck and PATH, and why ICMR’s own cancer research organization ICPO has been sidelined in carrying out the trials.

We would also like to point out that licensing of Gardasil and Cervarix (HPV vaccine produced and marketed by GlaxoSmithKline in India) is on the basis of sketchy bridging studies, which have not even included the age groups for which the vaccines have been approved. While Gardasil has been approved for the age group of 10-27 years, it has only been tried in a very small sample of girls aged 10-14 years and not among adult women. Cervarix has been approved for the age group 10-45 years, but it has been tested only in a small study on women aged 18-35.

How has the Drugs Controller General granted approval to the vaccines without proper research in India? For a drug to be administered to children, it has to go through stages of clinical trial, including Phase 3 clinical trials in adults.

It should be remembered that last year the two drug companies had engaged in massive advertisement of these vaccines in the media and are continuing with giving incentives to doctors and holding promotional camps in schools among the paying segment of the market. There are reports that some company representatives are appoaching the CMOs/DCs/DMs  of different districts and influencing them to use NRHM flexipool funds to purchase the vaccines at subsidised rates. As per newspaper reports, the BMC is also planning to spend public funds on these vaccines.

A review of the whole process is in order as many conflicts of interest follow the trail of Gardasil approval and declarations of its safety.

According to us, the government is constitutionally bound to take care of the lives of all citizens and not subject them to new medical problems at the behest of foreign NGOs. Unless the government details a plan for cervical cancer control, with screening and treatment, this project is sheer experimentation with innocent, vulnerable and poor people of society who cannot afford this expensive vaccine.

No NGO should be given such permission for clinical trials/ demonstration projects, regardless of which vaccine or drug is being administered. Financial support from the industry or from an international organization should not be the criteria to introduce any vaccine, whether in a pilot project or in the universal immunization programme.

We reiterate our demands:

  • 1.    Complete suspension of all studies and trials with Gardasil and Cervarix and suspending their licence for marketing in India till such time that a public inquiry is held on their licensing in violation of the Indian law.
  • 2.    The government place in public domain:
*    All the documents pertaining to the agreement with vaccine manufacturers and all other bodies regarding the government’s plan to introduce the HPV vaccine.
*    The list of projects planned, proposed, approved and completed, and  the results of the pilot phase and  clinical trials
*    Documents pertaining to the licensing and marketing approval of the vaccines
  • 3.    The government should set up an independent impartial inquiry:
a. into the deaths of the four girls, and others if encountered in Gujarat.
b. into the side effects of the vaccine on affected girls, so that responsibility can be fixed and action taken. While this will provide the much needed information about vaccine safety, it will also detail the care that these girls require and the compensation they and their families deserve for having been actively misled.
  • 4.    All agencies involved in the project need to be held accountable and culpable for all ethical, legal and medical violations that emerge in such an enquiry.
  • 5.    The Government should take immediate action, including providing compensation to the families who have lost their children and to the children suffering side-effects.
  • 6.    All affected children should be provided proper medical treatment and long term follow up.
  • 7.    The government must issue an immediate circular to all NRHM officials and all other government bodies to desist from purchasing Gardasil and Cervarix and any other vaccines not included in the universal immunization programme.

Signatories:
All India Democratic Women’s Association
Committee against Violence on Women
Gramya Resource Centre for Women
Haq Centre for Child Rights
Jan Swasthya Abhiyan
Sama – Resource Group for Women and Health
Saheli Women’s Resource Centre

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Sunday Magazine ~ April 18 2010
THE OTHER HALF

Uninformed consent

By KALPANA SHARMA

What women need is basic healthcare. Not costly medical experiments involving vulnerable sections who don't know what they are getting into…

Were they informed about adverse health impact and were these monitored and treated?

Controversial: Tribal girls treated with the cervical cancer vaccine interact with Brinda Karat (G.N. Rao. THE HINDU)

Marie Antoinette told her people to eat cake when they needed bread. Our government encourages people to buy cars ­ from Rolls Royce to the Nano ­ when they need affordable public transport. And when people, especially women, want simple, basic health care ­ and clean water and sanitation ­ they are being urged to inject their daughters with a Rs. 9,000 vaccine against cervical cancer. If some of us conclude that the priorities of our decision makers are more than slightly skewed, we should not be blamed.

The recent controversy over the use of the Human Papilloma Virus (HPV) vaccine on tribal girls in Andhra Pradesh has once again brought into focus several ethical and gender-related issues in the arena of public health that need to be openly debated. In India, we have many recent examples of women, particularly poor women, being subjected to clinical trials for contraceptives, including injectable contraceptives. These women have suffered after-effects and not known fully what was happening to them. It is only when women's groups and health groups raised an alarm about the way these trials were being conducted did the government intervene.

Goverment intervenes
Once again, the government has intervened and stopped, for the moment, the project in three districts ­ Bhadrachalam, Kothagudem and Thirumalayapalem ­ of Khammam district in Andhra Pradesh where 14,000 girls, mostly tribal, between the ages of 10 and 14 have been given three doses of a vaccine that is supposed to protect them from cervical cancer. The project is headed by a well-known international NGO and is supported by the Indian Council for Medical Research (ICMR). The official district health authorities and health personnel have been fully involved in every aspect of the project. So it is not something that has been done clandestinely.

The alarm bells first rang when four girls died after they had received the vaccine. Whether they died due to complications caused by the vaccine, or from other factors, has not been established. Perhaps it cannot be conclusively established. But the very fact that the parents of one of the girls believes that her problems arose after she was administered the vaccine suggests that it is an issue that has to be investigated further.

Of course, there is little doubt that cervical cancer is an important health risk that millions of women face. A quarter of all deaths due to cervical cancer worldwide occur in India. The infection can lie dormant in a woman for 20 to 40 years before it manifests itself as cancer. Hence the belief that if young girls, before they become sexually active, are administered a vaccine, they might be able to avoid getting infected by HPV and thereby lower their risk of getting cervical cancer.

The first HPV vaccine came into the market in 2006 in the United States. After trials, it was declared safe for use in young women, and men. While it provided women cover against cancer and genital warts, it protected men from genital warts. However, once you were infected with HPV ­ of which there are at least 15 strains that can cause cancer while the vaccine protects you against only two ­ the vaccine was of no use. Also its efficacy in the long run has not yet been tested because the infection takes such a long time before it shows up as cancer. So young girls who have received the vaccine in the last years would have to be followed for that length of time before we can be completely sure that the vaccine actually works. Meanwhile, the best protection against cervical cancer remains regular checks ­ with or without the vaccine ­ to catch any early signs of the cancer.

So what then is the basis of the opposition to the project being conducted in Andhra Pradesh?

SAMA, a Delhi-based women's health group, has done a detailed study of the problem in Andhra Pradesh. Its members have spent time speaking to the girls who received the vaccine, to their teachers, to the health workers, to the parents and the district authorities.

What emerges is a disturbing tale of young tribal girls who are not necessarily in the best of health in the first place, given their background of poverty and under-nourishment, being given this vaccine. The information provided to them is in English, which neither they, nor their parents, nor the health worker giving them the vaccine, can read. Even the exact age of many of these girls is not certain as births are not regularly registered in large swathes of this country. Hence how were these girls chosen for the project? Were they informed about adverse health impact and were these monitored and treated? And did they really give “informed consent” to be a part of the project when they could not read the literature? In fact, many of the girls did not know the meaning of the word “cancer” or “cervix” or even “uterus”. So did they know what they were being given and why? It would appear not.

Of course, the company providing the vaccine does not deny contra-indications. Its website states: “The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care professional.”

But how do you deal with all this when the girls live in a tribal hostel, or in areas where the health facilities are abysmal? In the case of 13-year-old Sarita, who is one of the four girls suspected to have died from complications connected to the vaccine, by the time her parents managed to go to the nearest big hospital in Bhadrachalam, she was dead. This is what they said to the team from SAMA:

“Our child was active and happy. We lost our child, and we know the pain and the agony of that loss. We don't want any other child to die. We don't want any other parent to suffer. Care should be taken for other children who received vaccination. Even though some girls are suffering from side effects like severe stomach pain, teachers are not letting them go home… We want the government to take immediate action. This is our only appeal. This is why we are speaking out.”

Exposing vulnerability
Fortunately, this appeal has been heard and for the moment the project has been suspended. But it has brought into focus once again, the dangers of exposing poor women, in particular, to this kind of medical experimentation. By all means, efforts should be made to try out a new technology. But not at the cost of the health of the woman. And certainly not on the basis of exploiting her ignorance. What is more important? Women's health or promoting a new vaccine? If it is the former, then there is much more that can be done at a fraction of the cost ­ starting with ensuring that primary health centres have gynaecologists available at all times. Women in this country urgently need basic health care and nutrition, not necessarily advanced medical interventions whose efficacy has yet to be proven.
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 Mumbai ~ Volume 27 - Issue 03 :: January 30-February 12, 2010

PUBLIC HEALTH

Drug alert

By T.K. RAJALAKSHMI

An advertising blitz to promote a vaccine for cervical cancer says little about the efficacy or side-effects of the drug.

 
REUTERS

FOR almost a fortnight in December 2009, leading newspapers and private television and radio channels kept warning the public about the dangers of ignoring cervical cancer. The advertisements in the newspapers, targeted at young girls and their mothers, highlighted the need to get vaccinated against cervical cancer but did not mention the name of the vaccine. “It’s true! Vaccination can now protect your daughter from cervical cancer,” screamed a headline, with the sub-head saying that 200 women died in India every day from cervical cancer, a bigger cause of death than breast cancer.

The advertisements, which showed a mother and daughter in a loving clasp, were issued by a multinational pharmaceutical company in the form of a public awareness initiative. They advised readers to “act today” and contact their gynaecologist or paediatrician for vaccination. They clearly hinted that it was young women who were at the highest risk of contracting the infection that “might lead to cervical cancer”.

In the advertisement, it was explained that “for the best response, the vaccine should be taken by adolescent girls as early as possible”. But nowhere did the advertisements mention anything about the possible side-effects of the unnamed vaccine.

Ministry’s silence
Predictably, the advertisement blitz caught the attention of women and health groups. They felt that the studied silence of the Ministry of Health and Family Welfare over the advertisements was grossly misleading. The advertisements were brought to the notice of the Drugs Controller General of India (DCGI), whose office pulled up the pharma major for its unlawful propagation of the vaccine Cervarix.

The Drugs and Cosmetics Act, 1940, and the Drugs and Magic Remedies Act, 1954, do not allow any claim to prevent or cure diseases that include cancer. And drugs sold under prescription, which include vaccines, cannot be advertised. Even though Cervarix’s maker had not mentioned it by name, it still fell foul of the existing legislation. The advertisements soon stopped appearing.

Apart from Cervarix, which secured approval from the United States Food and Drug Administration in October 2009 (the advertisements in India started soon after), Gardasil, a version of the vaccine, was launched by another pharmaceutical major in the Indian market.

It was in December 2005 that Gardasil’s manufacturer and the Union Ministry of Health and Family Welfare, through the Indian Council of Medical Research (ICMR), announced their collaboration to assess the use of Gardasil. Under the agreement, the manufacturer would supply Gardasil for the study.

The manufacturer’s press release includes forward-looking statements, which are about product development, product potential or financial performance. These statements are defined in the Private Securities Litigation Reform Act, 1995. The press release, issued in 2005, cautioned that “no forward-looking statement can be guaranteed and actual results may differ materially from those projected”. This essentially means that Gardasil’s maker has no obligation to update publicly any forward-looking statement, whether as a result of new information or future events, or for other reasons.

It is interesting to note that even though the Union Ministry and the State Health Departments play a key role in vaccine introduction policies, it is the National Technical Advisory Group on Immunisation that finally advises the Central government on the feasibility of introducing a vaccine in India. The introduction also needs clearance from the National Drug Authority and a licence from the DCGI. However, State governments can introduce any vaccine that is not part of the national immunisation programme.

The international campaign around the human papillomavirus (HPV) is not very old. It began essentially three years ago following the development of vaccines against two types of HPV, which accounted for 70 per cent of cervical cancer cases worldwide. It was claimed that clinical trials had shown the vaccines to be 90 per cent effective in preventing persistent HPV infection and 100 per cent effective in preventing type-specific cervical lesions.

Even sources that push for the vaccines appeared to suggest that cervical cancer can be prevented if the precancerous lesions are detected and treated early on.

The international non-governmental organisation (NGO) PATH claims in recently published literature on the subject that along with other organisations such as the Bill and Melinda Gates Foundation, it is “seeking to help developing countries understand the HPV disease burden and determine how best to introduce the new vaccines…” and says that cervical cancer rates “are highest among the poor, in large part because effective screening and treatment programmes often are not available, and most women with cervical cancer only reach health centres when their disease is advanced – and incurable”.

This is precisely what women and health groups in India are arguing – that it is screening that is required and not mass vaccination of adolescent girls.

According to the literature, PATH is working closely with ministries of health and civil society organisations to conduct clinical and operations research in India, Peru, Uganda and Vietnam. By its own admission in June 2006, it was given a “major grant to strengthen the capacity of developing countries to prevent cervical cancer”. A document titled “Shaping a strategy to introduce HPV Vaccines in India” details formative research results from the project, HPV Vaccines: Evidence for Impact Project, a collaborative effort of PATH and the National AIDS Research Institute (NARI).

The project was initiated in 2006 and the research undertaken in two States, Andhra Pradesh and Gujarat. The research was carried out by NARI of the ICMR with technical and financial support from PATH. The research concluded that policymakers, health care providers, parents and adolescents would accept vaccination against cancer of the cervix as long it was safe, effective, affordable and accessible.

Access to screening
Interestingly, PATH’s strategy report, of which Frontline has a copy, mentions right in its introduction that the incidence and mortality rates of cervical cancer have gradually decreased in developed countries, thanks largely to screening programmes (traditionally using Pap smears) that can spot the signs of precancer and treat them early.

It is strange that this line of prevention is not being explored in the developing world. The argument given is that “in developing countries, however, many women cannot access screening services or do not receive necessary treatment for precancer”.

The only reason that women do not have access to these services is that they are not there, and if present they are not affordable or easily accessible. With a public health system thus far focussed on controlling the fertility of women, rather than addressing problems relating to their reproductive health, screening is the last thing on the minds of policymakers.

Instead of arguing for more investment to strengthen the public health system with more accessible and better-quality screening services, including Pap smear tests, the study is pushing for the HPV vaccine.

In July 2009, it was from news reports that health groups in India got to know that two demonstration projects for vaccination were under way, in Andhra Pradesh and Gujarat. These were not private initiatives. They were carried out in association with the ICMR, PATH and the State governments concerned.

In both the States, 16,000 girls between 10 and 14 years were to be administered the vaccine in selected blocks of Khammam in Andhra Pradesh and Vadodara in Gujarat. In each case, three doses of Gardasil would be administered over a period of six months. The Gujarat project was longer; it was for two years.

PATH’s publicity material, which Frontline has accessed through some sources, has slogans like “Our protection is in our hands; vaccinate 10-14 years girl child to protect against cervical cancer”. Strangely, the same material states that sexually active women are more susceptible to this infection and that HPV spreads through sexual contact. It also says that the vaccine is not effective fully and that is why pre-pubertal girls are required to take it urgently.

It claims that the vaccine is very potent, that it is being promoted by the Indian government and the governments of other developed countries where millions of girls have been vaccinated without any adverse effects. It also asserts that the vaccine does not lead to infertility or other health problems, that there will be no difficulty in conceiving or delivering healthy babies. It says that health workers like auxiliary nurse midwives, anganwadi workers and accredited social health activists (ASHA) will be trained to vaccinate and that free and voluntary consent will be taken from girls and their parents.
Drug concerns

A woman undergoes external radiotherapy for cervical cancer in Hyderabad. The focus in tackling cervical cancer, women’s groups say, should be on preventive health care and screening (RAMESH BABU)

More than 50 women and health activists’ groups and many individuals across the country have written to the Union Health Minister expressing their concerns on the introduction of Gardasil. They have said that first, information about the efficacy of Gardasil is uncertain; and that it is admitted by the service providers themselves that the vaccine only prevents infections resulting from two HPV subtypes and another two subtypes that can lead to genital warts.

Secondly, they say, there are more than 100 HPV subtypes and that if the vaccine is successful in blocking two subtypes, then the other carcinogenic subtypes can become dominant. Thirdly, they point out, there is a lack of conclusive data regarding the duration of immunologic protection conferred by the vaccine.

Quoting a follow-up study of vaccinated subjects (Lippman A., Melynk R. et al, 2007) published in Canadian Medical Association Journal, the signatories to the memorandum have said that the vaccine offers protection only up to five years. Its long-term efficacy is therefore in doubt. They also point out that as cervical cancer in India occurs among women over 35 years, there is a lack of clarity on whether a three-dose schedule can provide long-lasting immunity or whether booster doses are required.

Vaccination, it is argued, cannot be a substitute for screening as even those who are vaccinated are required to undergo regular Pap smear tests as the vaccine’s preventive effect on cancer has not yet been demonstrated. Quoting another June 2007 study on HPV published in Prescrire International, the letter to the Union Minister points out that it is rare that HPV infection has led to a progression to cancer.

More importantly, critics of the vaccine point to its side-effects, of which there is no mention in the advertisements. According to the U.S.-based Centres for Disease Control and Prevention, 12,424 adverse events have been reported by the Federal Vaccine Adverse Reporting System.

Says Kalpana Mehta from Saheli, a women’s group: “Gardasil itself doesn’t declare that it may protect everyone.” She points out that the official website states that it does not treat cervical cancer or genital warts.

The website also lists side-effects such as pain, swelling, itching, bruising and redness at the injection site, headache, fever, nausea, dizziness, vomiting and fainting. Sometimes fainting is accompanied by falling, as well as shaking or stiffening and other seizure-like activity. Cervarix’s website also lists side-effects, which, not surprisingly, were missing in the advertisements.

The other important argument posed by the drug’s critics is the cost of the vaccines themselves. The current cost is Rs.3,000 a dose, so the total cost of three doses (Rs.9,000) and booster shots every five years would be around Rs.33,000. Public health activists are wondering whether the Ministry can afford an injection that will cost Rs.9,000 for every woman in the country where the system has failed to give the basic DPT vaccine to almost 50 per cent of the population. Independent studies have shown that the cost-effectiveness of the vaccine is yet to be proved.

Critics say the advertisements themselves create fear and the feeling that there is a public health emergency. The letter has demanded that the government review its decision to conduct an HPV vaccine demonstration project in its mass immunisation programmes in the absence of sufficient evidence of the vaccine’s long-term effectiveness.
Preventive health care

The focus, the writers of the letter correctly argue, should be more on preventive health care, such as Pap smear tests, population-based outreach screening for women in rural and tribal areas, measures to promote awareness, and measures to detect cervical cancer at an early stage. Of paramount importance, they say, is making public health services available to all, with stress on women’s health through measures such as filling vacancies of gynaecologists and paramedical workers.

The organisations have also expressed concern that there is no information available about the status of the trials that have been under way as a result of the memorandum of understanding (MoU) between the Health Ministry and the makers of Gardasil. They have categorically rejected the idea that financial support from industry or an international organisation should be the criterion to introduce a vaccine either in the pilot phase or in the Universal Immunisation Programme.

The organisations are awaiting a response. None has come as yet. One public health activist put it: “Earlier, they used to show some interest in what we had to say. They used to come to our meetings and express their point of view, right or wrong. Even that doesn’t seem to be happening now.”

The question here is one of priority, of cost, of the health of lakhs of girls and women, and, more importantly of transparency. 

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 Tuesday 06 April 2010

Deadly shots

''The regulatory system can be made stronger.''

The death of four tribal girls in Khammam, Andhra Pradesh, who were vaccinated with the human papiloma virus (HPV), shows, yet again, the lack of control over clinical trials in the country. The vaccination was a demonstration project and was intended to prevent cervical cancer. It was undertaken by an NGO on behalf of a pharma multinational and the vaccine was administered to thousands of girls. The authorities have denied the deaths were caused by vaccination and have claimed the girls committed suicide. But there are serious doubts about the project. Though the authorities have denied any side-effects, it has been confirmed that many girls suffered from problems like epileptic fits and nausea after the vaccination. As in the case of many clinical trials, the full truth is not revealed to the public.

In the strict sense of the term the HPV vaccination programme was not a clinical trial as the vaccine is ready and is even sold in the country. But the demonstrative nature of the project makes it a clinical trial. It has now come to light that the vaccine has not undergone country-specific safety trials. The International Agency for Research in Cancer (IARC) is conducting these trials and before the results are known the vaccine was administered to thousands of girls and is being sold over the counter. The dangers posed by unregulated clinical trials to human lives and health are well-known. Many of the companies that undertake such trials are known for their unethical conduct.

The government has claimed that the regulatory system is strong. But it can be made stronger. The testing procedures and processes should be more transparent. The rules are not implemented effectively. Otherwise how can a vaccine which is only undergoing trials in controlled conditions be administered to thousands of school girls? The authorities even tried to defend themselves with the claim that the girls’ parents had given their informed consent for the vaccinations. What does consent from illiterate tribal parents mean? Such trials have resulted in deaths in the past, including in the premier medical institution AIIMS. A Delhi court issued a notice to the health ministry last year for giving permission for use of untested vaccines. All this underlines the need for more caution and vigil in dealing with clinical trials. Poor and ignorant people should not be allowed to become victims of the use of untested vaccines and unsafe trials.
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 Thursday April 15 2010

HPV Vaccination Campaign Suspension Demanded Globally

U.S. Called on to Take Lead

NORTH HOLLYWOOD, Calif., April 15 /PRNewswire-USNewswire/ -- The global outrage at reports of injustices inflicted on the children of India from unethical trials and experimentation of HPV vaccines in socially disadvantaged groups extends to women and children worldwide subjected to similar violations. False advertising/claims made by pharmaceutical companies, and legislation mandating vaccination without informed consent, are totally unacceptable, say members of TruthAboutGardasil.org.

The TruthAboutGardasil.org group members Leslie Botha, Cynthia Janak, Freda Birrell, Janny Stokvis, Karen Maynor, and Rosemary Mathis, who presented research on HPV vaccine dangers to the FDA on March 12, provided information to SAMA, a New Delhi-based Resource Group for Women and Health involved in the suspension of the HPV vaccine program in India. According to Botha, "Efforts to educate women in industrialized nations about the dangers have been successful. Now, Pharma is targeting uneducated, low-income, minority women - populations even more vulnerable to adverse reactions."

Media reports from Mumbai, India, state: "The [HPV] vaccine is mandatory for girls in Australia, France and the US." According to TruthAboutGardasil.org, this is a deliberate lie that cannot go unchallenged. No country to date has mandated HPV vaccination, nor should it. Any falsehoods generated by governmental agencies, vaccine distributors, or the media that encourage uninformed females to accept HPV vaccinations are deceitful and false advertising perpetrated upon innocent victims.

Why have the deaths of four girls in India halted the HPV vaccine campaign while the 67 deaths reported to VAERS been ignored by the US government? Mathis states, "We consider this a human rights violation, and request the US take the lead in protecting fundamental human rights by calling for a congressional hearing." The group endorses the following demands set forth in India:

1. Governments immediately suspend HPV vaccinations/programs until safety, efficacy, and cost-effectiveness of planned interventions are re-evaluated by independent entities.

2. Governments establish inquiry committees into vaccine-related deaths.

3. Governments establish an inquiry into side effects so that culpability is established and action can be taken.

4. Any agencies involved in HPV vaccination projects must be held accountable and culpable for ethical, legal, and/or medical violations exposed during investigations/hearings.

5. Governments initiate immediate action, including providing compensation to families that have lost children, and to children suffering side effects.

6. All victims should be provided proper medical treatment and follow-up immediately.

7. Governments and regulatory agencies place any and all documentation pertaining to clinical trials, agreements with pharmaceutical companies, and/or sponsors regarding HPV vaccine introduction or distribution in their respective countries in public domain.

8. Governments implement a national policy regarding vaccine trials and medical "experimentation," along with a vaccine policy based on public health needs - not pharmaceutical-sponsored research and conflicts of interest.

The group further recommends that any national/federal/state government agency involved with the distribution of any HPV vaccine implement the above guidelines immediately to halt the unfolding travesty on the unsuspecting, innocent women and children of the world.
    
    Contact:
    Bobbi Cowan Public Relations
    Phone: (818) 980-2372
    Email:
    Truth About Gardasil Web Site: HERE

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SOURCE TruthAboutGardasil.org