According to a report on U.S. News & World Report’s Health Day, the study involved a randomized control trial of nearly 18,000 women ages 16-26, and was conducted by the department of medical microbiology at Lund University, Malmo University in Sweden. Researchers report “significant protection” against the warts and other growths in “susceptible women.”

Gardasil entered the scene in2006 as a drug intended to protect young women against the development of cervical cancer by vaccinating against four strains of Human Papillomavirus (HPV). The vaccine is given as a series of three shots. It has an efficacy period of about five years.

However, since its introduction, Gardasil has come under fire as it has been linked to serious adverse events. Parents of young girls who receive the vaccine, or young women who received the vaccine, have reported experiencing side effects after receiving the vaccine, which they blame on the drug. Complaints range from fainting and muscle weakness to serious auto-immune deficiencies, chronic pain, Lupus, blood clots, seizures and even more than 50 reports of deaths. The makers of Gardasil deny any connection to the vaccine.

As of May 31, 2010, the Centers for Disease Control and Prevention (CDC) has received more than 16,000 reports of adverse side effects, reported by consumers through the FDA’s Vaccine Adverse Event Reporting System (VAERS). The CDC has record of 53 U.S. reports of death among females who have received Gardasil. Twenty-nine of these reports have been confirmed.

Now, it appears the push is on to add boys to this list. Merck generated more than $1 billion in sales during the first year Gardasil was available. Is it any wonder the drug maker is eager to expand its customer base?

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

In addition to Gardasil, which is marketed to prevent cervical cancer by targeting four types of human papillomavirus (HPV), Sinopharm will help distribute other Merck products including Januvia, for the treatment of diabetes, Cozaar and Hyzaar (heart drugs), Remicade (rheumatoid arthritis) and Singulair and Nasonex (allergy treatments).

According to a Merck news release dated July 27, 2010, the two companies have signed a statement of mutual intent. “Under the statement, Sinopharm and Merck will cooperate on HPV vaccine and other mutually selected vaccine products in China, and will also discuss the potential for promoting and marketing Merck’s pharmaceutical products in China,” the release reads.

The release describes Sinopharm as China’s largest pharmaceutical and health industrial group under State-Owned Assets Supervision and Administration Commission of the State Council. It has China’s largest bio-pharmaceutical manufacturing company and China’s largest (the world’s third largest) pharmaceutical distribution company.

Nearly 30 million doses of the Gardasil vaccine have been distributed in the U.S. since 2006, and Merck generates about $1 billion in revenues from the drug annually. It is marketed as a preventive treatment for cervical cancer, protecting against four of 40 strains of HPV. Recently, the drug also was approved for use in boys, to protect against the transmission of HPV and genital warts, which the company says could lead to penile and anal cancers.

However, the drug has come under fire from critics following a series of adverse events in girls who received the vaccine. These include serious side effects like blood clots and muscle weakness. There also have been reports of 53 deaths in girls and women who received Gardasil.

Perhaps most startling, recently one of Gardasil’s own primary researchers, Dr. Diane Harper, said she believes the drug is unnecessary at best, and dangerous at worst. She points out that 90 percent of HPV infections resolve themselves, and that annual Pap tests beginning at age 21 for women are effective at catching and treating precancerous lesions before cervical cancer develops.

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

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