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

Merck

As head of Merck’s $5 billion global vaccine arm, Dr. Gerberding will likely be responsible for revitalizing Gardasil’s waning sales. Merck won FDA approval for the vaccine in 2007 and immediately launched an aggressive campaign to make Gardasil shots mandatory for school girls as young as 11. However, the ambitious plan ultimately failed, thanks to the outcry of consumer and health advocates who challenged the vaccine’s safety profile.

Other critics say that the Gardasil vaccine is useless and that its risks exceed its benefits.

Dr. Charlotte Haug, the editor-in-chief of the Journal of the Norwegian Medical Association criticized Gardasil in an editorial published last month in the Journal of the American Medical Association (JAMA).

“Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened…”

Dr. Diane Harper, the lead researcher in HPV vaccine development, announced at a conference in October that she considered Gardasil a useless vaccine, and that Merck’s efforts in pushing the Gardasil vaccine amount to what she called “a great big public health experiment.”

Gardasil’s side effects include fainting, redness and inflammation at the vaccination site, dizziness, and fever. However, the most dangerous side effect reported so far has been an increase in the risk and rate of blood clots. According to JAMA, blood clots resulting from Gardasil may have caused 32 unconfirmed deaths so far.

Gardasil sales have been floundering recently, down 22 percent in the third quarter at $311 million.

Dr. Gerberding’s controversial tenure at the CDC was rife with allegations that she put party politics before science and public health, and that her strategic decisions crippled the agency’s ability to respond effectively to public health crises. In December 2005, five former CDC directors jointly wrote a letter to Dr. Gerberding, expressing alarm over the departure of key staff members and warning that her leadership jeopardized the agency’s ability to perform effectively.

If the concerns of the CDC’s former directors and leading scientists are valid, then Dr. Gerberding may be the right person to shore up Gardasil’s place in the drug market.

“As a preeminent authority in public health, infectious diseases and vaccines, Dr. Gerberding is the ideal choice to lead Merck’s engagement with organizations around the world that share our commitment to the use of vaccines to prevent disease and save lives,” Merck Chief Executive Officer Richard Clark said in a statement.

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