Recent News Concerning HPV in Men, HPV is now linked to causing Throat Cancer

Throat Cancer Linked to HPV
By LAURA LANDRO

A sharp rise in a type of throat cancer among men is increasingly being linked to HPV, the sexually transmitted human papillomavirus that can cause cervical cancer in women.

A new study from the National Cancer Institute warns that if recent trends continue, the number of HPV-positive oral cancers among men could rise by nearly 30% by 2020. At that rate, it could surpass that of cervical cancers among women, which are expected to decline as a result of better screening.

The study is to be presented this week at the annual American Society of Clinical Oncology meeting.

Between 1988 and 2004, the researchers found, the incidence of HPV-positive oropharynx cancers—those that affect the back of the tongue and tonsil area—increased by 225%. Anil Chaturvedi, a National Cancer Institute investigator who led the research, estimates there were approximately 6,700 cases of HPV-positive oropharynx cancers in 2010, up from 4,000 to 4,500 in 2004, and cases are projected to increase 27% to 8,500 in 2020. 

Find out more about HPV  Currently, Merck markets the vaccine Gardisil

Glaxo's cancer vaccine inches toward approval--Merck's Cervarix vs GSK Gardasil.

By MATTHEW PERRONE - AP Business Writer
Published: Fri, Sep. 04, 2009

WASHINGTON -- Federal regulators said Friday that a GlaxoSmithKline vaccine prevents the leading cause of cervical cancer in women, bringing the company one step closer to competing with Merck's blockbuster Gardasil, which has controlled the U.S. market for three years. GlaxoSmithKline(GSK) Google Finance

In documents posted online, the Food and Drug Administration said Cervarix - Glaxo's vaccine against human papilloma virus or HPV - successfully blocked the two leading strains of the virus nearly 93 percent of the time.

But even as the British drugmaker moves closer to competing in the U.S., Merck is poised to begin marketing Gardasil to boys and men. In a separate review, the FDA said that vaccine prevented genital warts in males 90 percent of the time.

The agency will ask a panel of vaccine experts next week to weigh in on both vaccines. The FDA is not required to follow the group's advice, though it usually does.

While Merck has suggested the approval for boys could double the potential market for Gardasil, Leerink Swann analyst Seamus Fernandez said the benefit likely will be minimal.

Genital warts caused by HPV usually clear up by themselves, and the cancers caused by the virus are extremely rare in men.

"If it's not preventing something serious like cervical cancer and there are questions about safety, I think parents' acceptance of the vaccine in young boys might be less urgent than for their girls," said Fernandez.

Glaxo has won a number of government contracts for Cervarix in Europe, but its U.S. launch was delayed in 2007 when the FDA said it needed more data about the vaccine. Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with an alternate treatment.

The FDA said Friday that outside experts have now determined Cervarix did not cause those problems.

"The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link," the agency said in its review.

FDA reviewers also noted a slightly higher rate of miscarriages in women taking Cervarix, but said "the data do not establish a causal relationship."

Glaxo wants its vaccine approved for girls and women ages 10 to 25. The FDA is expected to make a decision on the vaccine later this year, but analysts say London-based Glaxo may still have trouble making inroads into the U.S. market.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck's vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target.

The most common side effects with both vaccines were pain and swelling at the injection site.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year.

But sales have been slowing amid questions about the longevity of the vaccine's effect and its price tag of nearly $400. In the most recent quarter, Gardasil sales fell to $268 million, down 18 percent from the prior year period.

A government-funded study last year found that the HPV vaccine is cost-effective for young teens, but not for women in their 20s. And labeling for the vaccine notes that the "duration of protection of Gardasil has not been established." Company trials have only tracked immunity out to five years after receiving the three-injection regimen.

Whitehouse, N.J.-based Merck will make the case on Sept. 9 for approving the vaccine for boys and men ages 9 to 26.

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• Gardasil Vaccine Associated With 28 Deaths In 2008 According To Judicial Watch Report (drug-injury.com)
• HPV vaccine Cervarix approved by WHO (cbc.ca)
• Human papillomavirus (HPV) vaccination (alanhealthupdate.blogspot.com)
• Study Suggests HPV Vaccine Is Safe, but Doctors Still Wary (time.com)