New Delhi: A petition currently before the Supreme Court alleges that the Drugs Controller of India issued licenses for Gardasil and Cervarix without adequate research on safety. The Parliamentary Standing Committee on Health and Family Welfare had asked for a premier investigating agency to enquire into it way back in 2010 and no action has been taken on it.
Petition number 558/2012, filed by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, seeks to resolve this and several other issues by asking the Supreme Court of India to rescind the licenses for marketing and administration of HPV vaccines, make provisions to identify and treat any girls left with chronic health problems and/or autoimmune disorders after their participation in HPV vaccine trials, and strengthen the regulation of the Program for Appropriate Technology in Health (PATH) and other foreign NGOs so that they do not flout the laws of the country with such impunity.
12 August 2014, Supreme Court Judges Dipak Misra and V. Gopala Gowda allowed Gujarat, Andhra Pradesh and Telangana to be named as respondents in the case because some villages in these states were chosen for administering HPV vaccines as an experiment and reports estimate 1200 girls were left suffering from adverse reactions to Gardasil and Cervarix.
The judges directed government agencies to produce the file(s) relating to licensing of Gardasil and Cervarix, the report(s) of the Parliamentary Standing Committee on Health and Family Welfare which dealt with issues relating to HPV vaccines, and any files from the Indian Council of Medical Research dealing with HPV vaccines.
The judges want to examine whether proper protocol and procedures were followed prior to the introduction of HPV vaccines.
They also wish to see what action was taken after the parliamentary committee submitted its report and what the reasons were for choosing the specific locations in Gujarat, Andhra Pradesh and Telangana for introducing Gardasil and Cervarix on an experimental basis.
The Court seeks to know what actually caused the deaths of some participants in the demonstration projects/clinical trials and whether proper consent was obtained from the girls and/or their families prior to their participation in the experiment.
MSD Pharmaceuticals Pvt. Ltd. (subsidiary of Merck) and GlaxoSmithKline Ltd. were served notices.
Judges Misra and Gowda set the case for final hearing on October 28, 2014.
HPV Vaccine History in India:
§ 2006: As part of a four-nation initiative against cervical cancer, PATH decided to launch ‘demonstration projects’ for the HPV vaccination in Peru, Uganda, Vietnam and India, using a grant of $27.8 million from the Bill and Melinda Gates Foundation. This decision was made by PATH with funding granted two years before HPV vaccines were approved for use in India.
§ 2008: Gardasil and Cervarix were approved for marketing in India, allegedly without following the standard government protocol for vaccine approval in the country.
§ July and August 2009: The Andhra Pradesh and Gujarat governments, in association with the Indian Council of Medical Research (ICMR) and the Program for Appropriate Technology in Health (PATH), launched what they described as a ‘demonstration project’ for vaccination against cervical cancer.
§ During these demonstration projects: Gardasil, manufactured by Merck Sharpe & Dohme (India) Pharmaceuticals Private Limited (MSD), was administered to 13,791 girls in Khammam district in Andhra Pradesh. Cervarix, manufactured by GlaxoSmithKline Biologicals (GSK) of Rixensart, Belgium, was administered to 9,637 girls in Vadodara district in Gujarat. An estimated 5% of those who participated were left with chronic health problems and/or autoimmune disorders.
§ Concurrently: Women’s groups, health networks, human rights groups and child rights groups in India voiced concerns about the safety, efficacy and public health value of both vaccines. Many joint memoranda enumerating these concerns were submitted to the Union Minister for Health and Family Welfare demanding an immediate halt to the demonstration projects.
§ 2010: The Ministry of Health and Family Welfare (MOHFW) conceded that the HPV vaccination project was in fact a “post-licensure operational research study.” The Indian Council of Medical Research (ICMR) admitted that their ethical guidelines had been flouted in the course of this trial. The trial was temporarily suspended by the government, and a committee formed to conduct an inquiry.
§ The investigation revealed the so-called ‘demonstration project’ to be a calculated, multi-level violation of all existing protocol on clinical trials, as well as a glaring breach of children’s rights.
§ 2012: Ultimately, the suspension and subsequent investigations allowed advocates in India to take their case to the Supreme Court. The Writ of Petition (#558/2012) was filed asking that the licenses for sale and marketing of both HPV vaccines be revoked because Gardasil and Cervarix are unsafe and the permits were granted without adequate research.
§ 2013: The petition for the case was formally admitted by the judges on January 7, 2013. By September 2013, the court had issued notices to all participants involved while the Indian Parliament issued a scathing comment condemning all organizations involved in the so-called ’demonstration projects’ calling them a case of child abuse expressly carried out to create a market for the two companies – Merck and GlaxoSmithKline.
§ The Supreme Court issued notices to the Government of India and the Drugs Controller asking for their responses to the allegations in January 2013. By September, neither had bothered to file a reply.
§ 2014: As a result of continued investigations regarding clinical trials involving HPV vaccines in India, additional allegations of unethical conduct were lodged against Merck. The allegations pertain to Merck’s recent trials of the new V503 HPV vaccine, a proposed nine valent HPV vaccine. The additional allegations of multiple ethics violations were added to the currently ongoing Supreme Court Case via an affidavit added as an addendum to the brief previously prepared regarding the ’demonstration projects’
§ According to a press release written by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, there is documentary evidence that though PATH is a non-governmental organization (NGO), in this case it entered into a business agreement with Merck so Merck would have a ready market for HPV vaccines in resource poor countries. In fact PATH got funding for this purpose from the Bill & Melinda Gates Foundation in the same month that Gardasil was licensed in the USA, June 2006.
§ 12 August 2014: Supreme Court Judges Dipak Misra and V. Gopala Gowda sent notices to several respondents requesting further information as outlined above and set the petition for final hearing on October 28, 2014.
Will India be the first country in the world to revoke the marketing licenses for Gardasil and Cervarix?
Will the Supreme Court of India move to protect the health and welfare of their young citizens, or the interests of the HPV vaccine manufacturers?
Will PATH and similar agencies be banned from operating in India?
Will the victims of adverse reactions to HPV vaccines be located, treated and compensated for being forced to participate in a trial that violated their human rights?
Perhaps these questions will be answered on October 28th.
A few hours later she was dead.
With kids needing annual physicals to play sports in junior high and high school, it’s time for that annual trek to the doctor’s office. And many parents will be confronted with a recommendation that they have their daughter or son vaccinated with Gardasil while they’re there. What parent doesn’t want to protect his child from a virus that can cause cancer? That’s what Meredith Prohaska’s mom thought. So here’s a tragic but timely reminder of why you should just say “NO!”
Meredith Prohaska (age 12) loved sports – especially basketball and swimming. She was in excellent health and spirits (except for a slight cough) when her mom took her to the doctor’s office for a check-up on August 8.
A few hours later she was dead.
What happened? The doctor recommended that Meredith get the first (of three) Gardasil injections to reduce her risk of getting a type of human papillomavirus (HPV) infection that can cause cervical cancer. He was right about one thing: Meredith is no longer at risk of getting cervical cancer in 20-30 years.
She’s not the only healthy pre-teen who died within hours, weeks or months after being vaccinated with Gardasil. The U.S. media has been virtually silent about the number and severity of “adverse events” reportedly associated with Gardasil. The CDC, FDA and Merck, the vaccine’s manufacturer, have pooh-poohed any suggestion that Gardasil may have “caused” the number of deaths and disabilities reported to the Vaccine Adverse Events Reporting System (VAERS). And it’s true that the VAERS system is not designed to provide enough information to ascertain the precise cause of death. Many Gardasil-related adverse events may be simply coincidental; others – such as Guillain Barré, autoimmune disorders and blood clots – are reasonably linked to the vaccination.
There is, however, at least an implicit recognition that bad things can sometimes happen to good people who get Gardasil shots. By law, vaccine manufacturers are shielded from private lawsuits brought in American courts for vaccine-related harm. Instead, Health and Human Services (HHS) set up a National Vaccine Injury Compensation Program. To date, about $6 million has been paid out for “compensable claims” to the victims of Gardasil and/or their surviving family members.
Here’s what the VAERS reports (to June 2014) reveal:
35,270 “Adverse Events,” of which
11,705 required a visit to the Emergency Room, and
7,111 were conditions from which the victim has not recovered, including
4,920 conditions deemed “Serious,” of which
3,679 required Hospitalization, and
1,156 have left girls Disabled, and
640 were “Life Threatening,” and
251 required an Extended Hospital Stay and
169 girls Died.
Also, it should be noted, that doctors are finding a particularly disturbing side effect of Gardasil, that it increases pre-cancer and cancer: there have been 572 reports of abnormal pap smears; 243 cases of cervical dysplasia, and 78 cases of cervical cancer. As the vaccine reduces the risk of 4 strains of HPV (for betwen 2-5 years only), it is thought to increase the risk of cancer from the other strains.
Due to routine screening in the United States (Pap tests), the death rate from cervical cancer has declined by more than 70% in the past 40 years. The CDC reports that in 2010, fewer than 12,000 women in the U.S. acquired cervical cancer and fewer than 4,000 died from this type of cancer. It is not even among the top ten sites for cancer deaths among all women, and among White, Asian and American Indian women.
It ranks as the 10th leading cancer cause of death only among Blacks and Hispanics. However, breast cancer is 12 times more likely to cause death among Black women and 9 times more likely to cause death among Hispanic women than is cervical cancer.
Improved (free) screening
– which carries no health risks at all – in rural areas and among undocumented immigrants reluctant to seek routine medical care, could reduce mortality rates to the minimum possible.
While U.S. agencies are reluctant to halt the always aggressive marketing and sales of Gardasil, other countries are fighting to protect the health of their young women and girls:
• JAPAN suspended the use of Gardasil and is beginning an inquiry into safety issues.
• AUSTRIA has refused to include Gardasil on its vaccination schedule.
• SPAIN has filed a criminal complaint against Merck.
• INDIA’s Supreme Court is poised to rule on Merck’s alleged fraud in marketing and in continuing to test a vaccine-booster after the Court mandated that Merck cease all vaccine testing on its people.
• ISRAEL’s Health Ministry is considering cancelling its vaccine program due to Gardasil’s side effects.
• FRANCE – over a dozen women have filed criminal complaints against Merck due to their injuries.
An interview of a French pharmaceutical industry physician who formerly worked for Merck, Dr. Bernard Dalbergue, is published in the April 2014 edition of Principes de Santé (Health Principles). A few excerpts follow:
“I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, ... has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.”
“Gardasil is useless and costs a fortune! In addition, decision-makers at all levels are aware of it.”
“The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless. Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all.”
Dr. Harper was employed by Merck as the “Principal Investigator” for Gardasil’s clinical trials. What has she to say about Gardasil?
She points out that Gardasil protects against only 3 of the many cancer-causing strains of HPV and is assumed (but not yet proven) to prevent acquisition of HPV 16 for up to five years.
Its ability to protect against HPV 18, 11 and 6 degrades after 2-3 years, however.
If Gardasil prevented these strains of HPV for 15 years, then it could reduce the incidence of cervical cancer when given to an 11-year-old girl.
But if it protects against only one strain for only as long as five years, “then no cancers are prevented, only postponed.” She continues:
There will be “no population benefit in reduction of cervical cancer incidence in the United States with HPV vaccination as long as screening continues.”
“If the vaccinated person is not sexually active during the five years of its efficacy, then the vaccine has not protected her from disease.”
Which is the greater threat – cervical cancer or Gardasil side effects?
Dr. Harper had this to say:
“Pap smears have never killed anyone. Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone. Gardasil is associated with severe adverse events, including death.”
“The rate of serious adverse events reported is 3-4/100,000doses distributed. The current incidence rate of cervical cancer in the United States is 7/100,000 women.”
But note that compares DOSES, not 100,000 WOMEN who’ve received, presumably 3 doses each. So the true figure would be 3-4 adverse events/33,333 women if all women using Gardasil received all 3 shots, or 9-12 serious adverse events/100,000 women – a higher incidence (9-12/100,000) than the incidence of cervical cancer (7/100,000).« Previous
A study by researchers at the University of British Columbia found that the U.S. death rate from cervical cancer (2.4/100,000) is also exceeded by the rate of reported serious adverse events per dose, including death (3.34/100,000).
A few final points: An estimated 25 million women have already been exposed to HPV. If a woman then receives a vaccination, her risk of developing pre-cancerous lesions is -44.6%. (See Table 17 of the Vaccines and Related Biological Properties Advisory Committee background document, dated May 18, 2006.)
The FDA stated in a 2008 “Closing Statement” that 73.3% of the girls in the clinical trials developed new medical conditions following their Gardasil shot and 17 girls died. And yet the vaccine was fast-tracked to approval and marketing in record time. The deaths may well have been unrelated to Gardasil, but many of the "new medical conditions" reported to the FDA appear to be closely linked to vaccination.
There is growing evidence of the existence of other horrendous "side effects": premature menopause or infertility, Guillain-Barre syndrome, stroke, venous thromboembolism, appendicitis, seizures and epilepsy. For further information, see Med Alerts data from the National Vaccine Information Center.
A study at the Duke University School of Medicine found that the strains of HPV against which Gardasil is supposed to offer protection do not include the strain primarily responsible for cervical cancer in Black women. Gardasil offers virtually no protection to Black women.
The million dollar question: Why, given the above, is the Administration intent on promoting Gardasil use across the country? Well, here's a possible reason: Merck’s vaccine business brings in about $5 billion annually, from that, it gives back much, e.g., a "royalty" to the National Institutes of Health on sales of Gardasil and, of course, donations to political campaigns.
These local news media, possibly covering the HPV vaccine for the first time, were all quick to interview and provide links to the official CDC view of the vaccine. But here are some other facts regarding the vaccine that they failed to disclose, probably because they did not take the time to look outside of the standard government response to events like this, or their station managers did not allow them to give any other news outside of what the CDC claims.
1. There are many more reported side effects than just death from the HPV vaccine.
Premature menopause or infertility
· Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. July 2013, American Journal of Reproductive Immunology
· Dr. Deirdre Little, a pediatrician in Australia, was the first one to sound the alarm over the HPV vaccine causing premature menopause when she observed it in one of her 16 year old patients in 2012.
· Two sisters from Wisconsin say a cervical cancer vaccine shut down their ovaries and almost certainly left them unable to get pregnant
Narcolepsy and Autoimmune Disorders
Guillain–Barré syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope (fainting), and allergic reactions.
2. Countries Outside the U.S. Are Halting HPV Vaccines: Lawsuits due to Damages are Mounting
3. You Cannot Sue the Manufacturer of Vaccines in the U.S. – They have total legal immunity
Most of the U.S. public is unaware that a U.S. citizen, by law, cannot sue a pharmaceutical company for damages resulting from vaccines. Congress gave them total legal immunity in 1986, and that law was upheld by the U.S. Supreme Court in 2011. There is a special “vaccine court” called the National Vaccine Injury Compensation Program that is funded through a tax on vaccines. If you are injured or killed by a vaccine, you must hire an attorney and fight tax-funded government attorneys to seek damages, as you cannot sue the drug manufacturers. It can take 10 years or longer to win your case and be compensated. The U.S. Department of Health and Human Services usually publishes a report every couple months on settlements on their website. Here is the latest one.
4. The U.S. Government Earns Royalties from the sale of the Gardasil HPV Vaccine.
Dr. Eric Suba tried to use the Freedom of Information Act to find out how much money theNational Institute of Health (NIH) earned from the sale of Gardasil, but they refused to report the amount of revenue the government earns from this vaccine (although not denying they do earn royalties). Did you know that the government earns royalties from the sale of the Gardasil vaccine? Does your doctor promoting the HPV vaccine know this?
5. Julie Gerberding was in charge of the CDC the years the FDA approved Gardasil as a vaccine and is now the president of Merck’s Vaccine division, a $5 billion dollar a year operation
Julie Gerberding was in charge of the CDC from 2002 to 2009, which includes the years the FDA approved Gardasil as a vaccine. Soon after she took over the CDC, she reportedly completely overhauled the agency’s organizational structure, and many of the CDC’s senior scientists and leaders either left or announced plans to leave. Some have claimed that almost all of the replacements Julie Gerberding appointed had ties to the vaccine industry.
Gerberding resigned from the CDC on January 20, 2009, and is now the president of Merck’s Vaccine division, a 5 billion dollar a year operation, and the supplier of the largest number of vaccines the CDC recommends (article here).
6. Black Women who are Vaccinated with Gardasil are Vaccinated Against the Wrong Strains
Scientists at the Duke University School of Medicine discovered that African American women carry HPV strains not found in the Gardasil vaccine. Study here. Moshella Roberts, a 20-year-old African American woman died needlessly from the HPV vaccine.
Do your own research!
While it is encouraging to see local news affiliates report deaths and injuries due to the Gardasil vaccine, they need to do more research to present all of the facts, rather than just parroting what the CDC says. Of course to raise the issue of the “Gardasil controversy” could jeopardize your journalistic career, and force you into apologizing for suggesting the vaccine is anything but totally safe. Just ask Katie Couric.
In the meantime, do your own research before making any decisions on the Gardasil vaccine!
See Also: http://sanevax.org
Is the FDA ignoring new scientific evidence?
Below is a list of scientific information presented to government health officials around the world. None of the presentations below have brought forth a response from FDA officials. Please keep in mind this is by no means a complete list; it is simply a sample:
· February 2014, information presented to Japanese Government health officials by Dr. Sin Hang Lee, Director Milford Medical Laboratory, Inc. (Dr. Lee’s presentation in Tokyo)
· February and May 2014, information presented at a meeting of Japanese Senators by Lucija Tomljenovic, PhD; her and Professor Christopher Shaw presented similar data to health officials in France (Lucija Tomljenovic’s presentation in Tokyo)
· May 2014, presentation to French health officials by Christopher Exley PhD (Chris Exley’s presentation in Paris)
· December 2012, Professor Joe Cummins, Institute of Science in Society, writes DNA Contamination in HPV Vaccines.
How long are medical consumers supposed to put their faith in an agency that repeatedly ignores standard scientific methodology, not to mention scientific evidence? Medical consumers need to remember every single medication that has ever been pulled from the market was first approved ‘safe and effective’ by the FDA. Can you trust them with your life?