Awad traveled to India to explore the practice of clinical research being conducted there, and to examine what role, if any, United States regulatory agencies play in oversees clinical trials. New America health editor Viji Sundaram recently interviewed Awad about her findings.

Awad says she found that both individuals and hospitals and other medical facilities are benefiting from participating in clinical trials oversees. Patients are often illiterate or unable to understand if their physician is prescribing an approved drug, or a drug that is in a testing trial, she says. Some knowingly participate in clinical trials in exchange for payment, because they can earn more than they might in day laborer type jobs typically available to them. Also, some health care facilities actively recruit patients for clinical trials, and are paid for these efforts by pharmaceutical companies, Awad reports.

In her report, “Outsourced: Clinical Trials Overseas,” Awad interviews a family who lost two daughters after they received the Merck vaccine, Gardasil. Gardasil is marketed as a preventive treatment against human papillomavirus (HPV), which is linked to the development of cervical cancer. Awad reports the girls were part of a study to determine whether Gardasil or another HPV vaccine, Cervarix, manufactured by GlaxoSmithKline, was more effective.

This vaccine study was actually administered through the girls’ school, whose headmaster gave permission for his students to participate. A few other girls also died after being vaccinated with Gardasil. However, health care professionals who investigated the deaths said they could find no conclusive evidence to link the deaths to Gardasil, and the government issued a report in which it said it believed none of the girls died as a result of the vaccine. However, there was no adequate follow-up with the girls’ families, so no record of what actually went wrong, Awad reports.

In 2010, the U.S. Department of Justice began an investigation into alleged industry-wide corruption in overseas clinical trials.

Watch “Outsourced: Clinical Trials Overseas.”

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The report is based on the findings of the Australian Medical Association, published in Women’s Health Issues, part of the Australia’s Health 201 report. The Advertiser notes that according to the report, the number of women between the ages of 20-24 who get cervical cancer screenings has declined steadily since 2006, the year Gardasil was introduced and recommended for young women.

The paper quotes Dr. Andrew Pesce, president of the Australian Medical Association, as saying “Even though vaccination protects women against the type of HPV that causes about 70 percent of all cervical cancers, it is vital for women who have been vaccinated to continue regular screening. It ensures any cervical abnormalities which might develop into cancer are detected early whilst still easily treatable.”

While Pap smears are the most effective tool for identifying and treating pre-cancerous lesions before they develop into cancer, the introduction of a cervical cancer vaccine has made many women complacent about receiving the annual test, the news agency reports.

Source: The Advertiser

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Although not reported in most mainstream media, SANE VAX discovered the French government had banned Gardasil ads in August 2010. The drug, which targets and prevents four types of human papillomavirus (HPV) linked to cervical cancer, is produced by Merck & Co. and marketed in France by its partner Sanofli-Pasteur. On Jan. 4, 2011, SANE VAX issued a news release about the ban, which was handed down by the Director General of the French Agency for Safety of Health Products (AFSSAPS).

According to the news release, the AFSSAPS found Gardasil ads to be in “direct violation of the French public health code.” At issue are claims of longer efficacy for the drug than has been actually proving, and making false claims that the drug is a “cure” for cervical cancer.

In actuality, the French Committee on Immunization Practices (CTV) and the High Council of Public Health (HCSP) say “the vaccine’s impact on the incidence and mortality of cervical cancer will only become apparent in the long term, in 15 to 20 years.”

The American Chronicle reports that as a result of the French decision and ban of Gardasil ads, similar advertising for Gardasil and the GlaxoSmithKline (GSK) manufactured HPV vaccination, Cervarix, have been removed in the UK. In particular, the UK’s Advertising Standards Authority cited GlaxoSmithKline for making claims that the Cervarix vaccine would protect young women indefinitely against cervical cancer, using the slogan “Armed for Life.” The agency instructed the manufacturer to change the ad to clarify the language. Eventually, the local Primary Care Trust decided to remove the advertisements altogether.

Additionally, the publication reports India has had similar problems with HPV advertisements, and in December 2009 the Drugs Controller General of India (DCGI), which is the drug regulatory agency, took issue with the way GlaxoSmithKline was promoting Cervarix in India. The DCGI says the manufacturer was misleading the public and accused the drugmaker of “unlawful propagation of its cervical cancer vaccine, Cervarix, through mass media.”

American Chronicle reporter Christina England reports that other countries also have reported seeing false advertising for Cervarix and Gardasil, usually linked to claims that the drugs will prevent cervical cancer.

For more information:

American Chronicle article
SANE VAX website

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Gardasil, manufactured by Merck & Co., and Cervarix, manufactured by GlaxoSmithKline, are promoted for the prevention of the human papillomavirus (HPV), a sexually transmitted virus linked to the development of cervical cancer. However, the vaccines only treat four of the more than 40 types of HPV, and experts say studies show that the human body naturally eliminates more than 90 percent of HPV infections, making the vaccine irrelevant and redundant. Medical professionals also point out that pre-cancerous lesions can be safely detected with regular annual Pap smears, eliminating the need for the vaccine.

The columnist also points out that the HPV vaccine is controversial because of its spotty safety record. In the United States, the Vaccine Adverse Event Reporting System (VAERS) has logged consumer complaints about serious adverse events following the Gardasil vaccine, including pulmonary emabolism and Guillain-Barre syndrome, as well as more than 50 reports of death among girls who received the vaccine. It is estimated that the number of adverse events linked to these vaccines may be even higher, as not everyone who experiences a serious side effect reports it.

Gardasil was approved by the U.S. Food and Drug Administration (FDA) for use in 2006, and Cervarix by the FDA in 2009.

In addition to its concerns about the efficacy and safety of HPV vaccines, the Consumers Association of Penang is concerned about the plan for the MOH to work in conjunction with the Ministry of Education to administer the vaccine to the school-age girls without providing additional information about the vaccine to their parents. At the very least, Idris says, the MOH must provide parents with the opportunity to exercise their right to informed consent by supplying them with comprehensive information about the vaccination process and the risks involved.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

It’s a rhetorical question, but it makes you wonder if it’s somehow more permissible to be killed or injured by a drug than it is by a defective automobile.

Merck has lobbied federal regulators hard to make Gardasil mandatory for all American schoolgirls. Fortunately, the drug giant’s vision of requiring every girl in the nation to receive its three-tiered shot fell short of becoming law. Although many states require sixth-grade girls to receive the shot, parents have the legal right to refuse it. But very few of them know about the drug’s risks and how it has harmed and occasionally killed perfectly healthy girls.

According to the Washington Examiner, 20-year-old Mary Katherine Davison of Frederick, Maryland, became dizzy and nauseated after receiving her second Gardasil shot in January 2008. Although her two younger sisters had no reactions, Mary Katherine suffered a massive stroke and spent 2 months in rehab re-learning how to walk. Her mother, Mary Davison, said that she made no connection between her daughter’s stroke and Gardasil until Mary Katherine’s doctor refused to schedule her for the final Gardasil shot.

Days later, 17-year-old Jessica Ericzon of Alexandria Bay, New York, collapsed and died on the bathroom floor just 40 hours after receiving her third Gardasil shot. Jessica had complained of pain and dizziness after her second shot, but sadly nobody connected her symptoms to Garsdasil.

21-year-old Christina Tarsell of Sparks, Maryland, received her third Gardasil shot and spent more then 2 weeks feeling dizzy, nauseated and fatigued before she died.

“We had no clue that these were all symptoms of something,” her mother told the Washington Examiner. In all these cases, autopsies and toxicology screenings failed to determine the cause of death.

Naturally, Merck defends its Gardasil vaccine. The pharmaceutical giant also has a powerful ally in the CDC, which officially reported in 2008 that Gardasil recipients didn’t experience negative reactions any more than non-recipients.

That claim, however, was countered by the National Vaccine Information Center, which used the same CDC data to show that Gardasil was linked to “at least four times as many death and cardiac arrest reports” as Cervarix and “seemed to be associated with an unusually high number of reports of atypical collapse.”

“CDC is still saying this is a safe vaccine. With Pap smears, there was no medical reason for fast-tracking FDA approval. They made it (cervical cancer) sound like it was some kind of pandemic,” Christina Tarsell’s mother, Emily, told the Washington Examiner, adding that nobody from the CDC will respond to her calls.

Source: http://www.washingtonexaminer.com/opinion/columns/Time-for-the-truth-about-Gardasil-89466882.html

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

First, the vaccines are known to have serious risks. The threat of blood clots, seizure, paralysis, outbreak of warts, and sudden death has been documented in thousands of adverse event reports obtained by Judicial Watch under Freedom of Information law. The risks may be small for most of the women and girls who receive the vaccines (administered in a series of three shots), but they are nonetheless real.

Girls and women who are not sexually active are not at risk of contracting HPV. Merck lobbyists pushed to make the shots mandatory for all school girls as young as 9 years old. However, unless those 9-year-olds are sexually active, their chances of becoming infected with HPV and developing cervical cancer are zero.

Women who receive regular pap screenings are at minimal risk of developing cervical cancer because testing will detect precancers if they are present. Precancerous cells can be treated safely and effectively with traditional therapies to prevent the development of cancer.

The incidence of cervical cancer among women who do not receive screening or vaccination is about 90 per 100,000. According to Dr. Diane Harper, who is widely regarded as the top expert on HPV and the Gardasil vaccine, “the combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level.” That assertion contradicts the claims of some HPV vaccine advocates.

So who might HPV vaccines benefit? Sexually active women who don’t receive regular pap tests would benefit the most, but only if they are willing to assume the risk of being either injured by the vaccine or, in the rare event, killed. For the vast majority of women, the risks of receiving Gardasil or Cervarix vaccinations simply outweigh any benefits.

Sources:

http://www.infonews.co.nz/news.cfm?l=1&t=0&id=23815

http://www.stuff.co.nz/timaru-herald/news/3228514/Concerned-mum-sets-up-vaccine-site

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

The directive went into effect in July of last year, mandating Gardasil shots for immigrant females despite mounting evidence that the shots could cause serious injury and death. The shots were also required of females who posed no risk of contracting or spreading HPV to the wider population.

In determining which vaccines immigrants are required to have, the CDC’s rule of thumb is that the vaccine must target viruses that could potentially cause an outbreak and viruses that either have been eliminated from the United States or are in the process of elimination. HPV does not fit any of the criteria.

Immigrants are still required to undergo a series of 15 other vaccinations before gaining U.S. resident status and citizenship. Neither federal health officials nor the pharmaceutical companies have tested the safety of vaccinations in combination. No research has been conducted on the interaction of Gardasil vaccines with other vaccines and what adverse effects such cocktails could have on the recipient.

Soon after the CDC added Gardasil to the list of required vaccines for immigrants, more than 100 advocacy groups representing women, immigrants, and consumer health challenged the requirement, protesting that it was unfair to require HPV vaccines for immigrants but not all U.S. citizens.

Merck had been lobbying hard to make the vaccines mandatory for all school-age American girls, but their plans were strongly opposed by an unlikely band of abstinence-only conservatives, Big Pharma critics, individual parents and parent groups, a growing anti-vaccine movement, and a number of consumer advocacy and women’s rights groups.

The 3-shot series costs between $300 and $1,000, putting a financial strain on immigrants already burdened by thousands of dollars in application fees and mandatory medical exams. Mandatory Gardasil vaccinations would have provided Merck with a revenue stream of at least $4 billion annually.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site

Although the committee did not press for the use of Gardasil in men, it did advise U.S. doctors to use the vaccine at their discretion. It also recommended that the shot be included in the federally funded Vaccines for Children program for boys 9 to 18 years old.

The FDA approved Gardasil on October 16 for use in preventing genital warts in males age 9 to 26. Men may carry HPV and never know about it unless it develops into warts, and even then there are no long-term effects. On the other hand, women infected with genital warts are at risk of developing cervical cancers.

Gardasil only protects against 4 strains of HPV that cause cancer and 2 strains that cause warts.

Vaccinating boys and men with Gardasil would primarily be done to reduce the number of females exposed to HPV. However, the serious risks that the Gardasil shots carry, combined with their steep cost – about $500 for a complete regimen – leave many health professionals and patients questioning whether the vaccines are worth it.

Since 2006, when the FDA approved Gardasil for use in females, more than 15,000 girls have reported adverse side effects to the FDA’s Vaccine Adverse Event Reporting System (VAERS). Reactions that have been officially reported include brain inflammation, seizures, blood clots, paralysis, lupus, Guilliane Barre Syndrome, and several others. 44 deaths attributed to the vaccine have been reported to the Centers for Disease Control and Prevention (CDC).

Merck, which stands to earn billions from the shots, maintains that the vaccine is safe and that the benefits outweigh the risks. But for thousands of girls and women injured by Gardasil, the vaccines were anything but harmless – a fact made more frustratingly tragic by the lead developer’s own admission that Gardasil is ineffective and unnecessary.

SOURCE: the Truth about Gardasil">Beasley Allen Case Site