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Revoke potentially dangerous vaccine programme

The Consumer’s Association of Penang has repeatedly objected to the proposal and decision by the Ministry of Health (MOH) to vaccinate all 13-year-old girls in the country from the human papillomavirus (HPV) virus - a sexually transmitted virus - on the grounds that it is unnecessary, unscientific and unsafe.

Despite numerous valid objections by many quarters, RM150 million is to be spent annually by the government beginning this year on HPV vaccinations for an estimated 300,000 girls in the country as protection from only two of the 40 different cervical cancer-causing HPV’s.

HPV is contracted through sexual contact. Instead of inoculating our young against a sexually transmitted disease (STD), the government should instead focus on prevention by education and religious and moral values on sexual abstinence. As recipients of a vaccine against STD, ill- informed young girls could be lulled into a false sense of security that the HPV vaccine would protect them against other sexually transmitted diseases.

The risk of cervical cancers itself has been blown out of proportion. It is a known fact that about 90 percent of all HPV infections are removed by the immune system within two years. This in itself makes the vaccine irrelevant and redundant.

The vaccine itself is highly controversial with an unusually high incidence of adverse reactions worldwide and 53 reported deaths in the US alone as reported by Vaers (Vaccine Adverse Event Reporting System of the US Food and Drug Administration and the Centers for Disease Control).

This completely unnecessary and dangerous vaccine’s safety and efficacy have never been established in Malaysia. It has been described by World Health Organisation consultant, Dr. Diane Harper as more of a risk for adverse and dangerous side effects than the risk of cervical cancer itself.

One or both of the HPV vaccines that will be administered to our children are Gardasil by Merck and Cervarix by GlaxoSmithkline. Gardasil which targets cancer causing HPV types 16 and 18 was approved by the Malaysian Drug Control Authority (DCA) in 2006 and was in 2008 investigated for its link to paralysis, seizures and deaths.

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) knew about the link between vaccines and autism in 2000. As of 2008, Gardasil has been found to be linked to higher rates for syncope (fainting) and venous thromboembolic events (blood clots) among recipients. In the US, venous thromboembolic events were noted in 56 reports and included 19 cases of pulmonary embolism (a blockage of the main artery of the lung), 4 of which were fatal.

Overall, 772 events were described as serious and included 32 deaths resulting from the condition. A small number of cases of Guillain-Barr é Syndrome (GBS) have been reported following vaccination with Gardasil. Other problems associated with Gardasil are headaches, hypersensitivity reactions, and urticaria (hives).

In 2009, the Health Ministry of Spain suspended the use of Gardasil after health authorities reported that two girls had become ill after receiving the injection. As of May 31, 2010, there were 16,140 adverse events reported in the US following vaccination by Gardasil in Vaers.

Cervarix which targets the cancer causing HPV types 16 and 18 was approved by the DCA in 2007 but by the FDA only in 2009. Due to its narrow target of only 2 HPV types, experts continue to recommend routine cervical Pap smears even for women who have been vaccinated. In England, there have been cases of dizziness, nausea and even death associated with Cervarix.

Once again, we call upon MOH to revoke its ill-conceived plan to subject our children to this completely unnecessary and dangerous vaccine. The rakyat would be better off if RM150 million of their tax money is used to educate their children against early sexual activity as a deterrent to HPV infection. With this allocation by the government, campaigns for HPV testing and Pap smears as proven early detection procedures can be reinvented and enhanced instead of resorting to the simplistic solution of vaccines.

Since these vaccines only cover some high-risk types of HPV, experts still recommend regular Pap smear screening even after vaccination. This only goes to show that screening remains relevant and is undeniably a better method of prevention than vaccination.

In 2009, we stated that with regards to HPV vaccinations, parents around the world are frequently brainwashed, bullied, threatened or intimidated to vaccinate their children by government’s intent on profiteering for pharmaceutical companies. This is often done without accurately informing parents of the adverse vaccine risks, or their parental rights.

As recently as November last year and March this year, in meetings with MOH, CAP repeatedly objected to the unnecessary and potentially dangerous HPV vaccination program. Recently, at a briefing given by MOH in Penang on its strategy for the launch of its national HPV vaccination program, we were shocked to be informed that MOH, in collaboration with the Ministry of Education (MOE), would only brief 13-year-old school girls and teachers on the vaccination process and in the process ‘allay their (the children’s) fears’ about the vaccine.

These young children would then be expected to explain the process in detail to their parents to enable them to decide for or against vaccination by signing a consent form. Going by MOH’s glowing appraisal of its program, its eagerness to ‘allay fears’ and its deliberate omission of parental involvement, it appears that MOH is only interested in promoting the program favourably while concealing the negative aspects of these controversial vaccines from the parents of these children.

It would seem that parents as the primary decision makers who are responsible for determining the safety and health of their children are to be intentionally kept in the dark about the controversial nature of the vaccines by MOH. This is a gross disregard for parental rights.

MOH is duty bound to practice the principle of Prior Informed Consent (PIC) and treat with paramount importance, its responsibility and obligation towards the parents of these children by according them their rightful privilege to exercise their right to informed consent.

They must be informed not only of the vaccination process and the risks involved but of the right to education against HPV and cervical cancer, deterrents, preemptive and preventive medical screening against HPV infection and cervical cancer.

If MOH insists on persisting with this gravely misguided vaccination program, we call upon them to make it compulsory that all parents of 13-year-old girls in the country be given comprehensive and objective information about the adverse reactions and deaths linked to these vaccines prior to their consent or rejection.

Parents must then be encouraged to ask for and be given unbiased, crucial information in question-and-answer sessions organised by MOH. As is their right to know, it is imperative that they be also informed of all negative aspects of the vaccines which include documented serious adverse reactions and even deaths as reported by the The Journal of the American Medical Association (JAMA) and the Vaccine Adverse Event Reporting System (Vaers).

We reiterate our call for MOH to revoke this unnecessary and potentially dangerous vaccination programme. If MOH persists in launching this unnecessary programme despite all the known controversies and dangers surrounding the vaccines and the potential harm to our children, we urge MOH to include all parents of children who are to be vaccinated, in the decision-making process and to inform them of the associated risks to their children.

We also call upon MOH to provide a written guarantee to all parents that in the case of any vaccinated child suffering any adverse reaction, MOH and MOE shall take full responsibility and liability and bear all the consequences.

The writer is president, Consumers Association of Penang.

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