Source: money.cnn.com
Author: Peter Loftus

A new study suggests Merck & Co.’s (MRK) Gardasil vaccine, which is primarily given to prevent cervical cancer in girls and women, may also be effective in preventing genital warts and penile cancer when given to males.

Merck hopes the company-funded study will support roughly doubling the target population for the vaccine, which could help jump-start sagging sales. The Whitehouse Station, N.J., company said it remains on track to apply by year end for Food and Drug Administration approval to market Gardasil to boys and men ages 9 to 26 for prevention of external genital lesions caused by certain viral strains.

“This is groundbreaking data,” said Anna Giuliano, professor of medicine and epidemiology at University of South Florida, who co-authored the study. “To demonstrate that Gardasil prevents infection and disease at a very high level in males - that’s the other half of the world.” It was the first study to demonstrate Gardasil’s effectiveness in males - prior studies had shown it could produce a positive immune response in males.

The vaccine, which was launched in 2006, is currently approved in the U.S. for girls and women ages 9 through 26 to prevent cervical, vulvar and vaginal cancers, as well as genital warts and other lesions caused by certain viral strains.

These diseases, in both males and females, share the same cause: Human papillomavirus, or HPV, which is transmitted through sexual contact. The cancers in men caused by HPV, however, are rarer than cervical cancer. Gardasil targets four types of HPV that are believed to cause many of the cases of these cancers and lesions. Gardasil is injected in three doses over six months, and costs about $360 in total.

After strong sales growth following its 2006 launch, Gardasil sales have slowed this year, partly because women ages 19 to 26 haven’t been as eager to get vaccinated as Merck had hoped. The vaccine also has been dogged by concerns about its safety, though federal health authorities recently concluded it was relatively safe. Gardasil sales fell 2% to $1.1 billion for the first nine months of the year.

One recent effort by Merck to expand the vaccine’s target population failed. In June, the FDA declined to approve Merck’s application to market Gardasil to women ages 27 through 45.

The new study in males is to be presented Thursday at a medical conference in Nice, France.

The study evaluated about 3,400 men aged 16 to 26 years old who had no signs of lesions at the start of the study. About half were given Gardasil and half were given a fake vaccine, or placebo. The study tracked rates of both genital warts and lesions on or near the penis that are considered potentially precancerous. The study included both heterosexual and homosexual males.

After nearly 30 months of follow-up, there were three cases of such external lesions in the vaccine group, versus 31 cases in the placebo group, for an efficacy rate of about 90.4%, Merck said. Most of the cases were genital warts.

No vaccine-related serious adverse events were reported in the study. A slightly higher proportion of vaccine recipients had injection-site adverse events versus placebo, or 60.1% versus 53.7%. The study is ongoing.

According to the Centers for Disease Control and Prevention, about 1% of sexually active men in the U.S. have genital warts at any one time. Penile cancer is rare, especially in circumcised men, affecting about one in every 100, 000 men in total. HPV also is believed to cause certain oral cancers, but the new Merck study didn’t evaluate Gardasil’s effect on oral cancer.

GlaxoSmithKline PLC (GKS) sells a competing HPV vaccine called Cervarix, which isn’t yet approved in the U.S.

Source: www.nature.com
Author: Alison Abbott

This year’s Nobel Prize in Physiology or Medicine honors three Europeans who discovered viruses that cause deadly diseases, and whose findings have led to major medical advances.

Harald zur Hausen, former director of the German Cancer Research Center (DKFZ) in Heidelberg, Germany, was honoured for his work on the human papilloma virus (HPV), which causes cervical cancer. A protective vaccine for this virus has now been developed and is in widespread use. Françoise Barré-Sinoussi and Luc Montagnier share the other half of the prize for their discovery of the human immunodeficiency virus (HIV-1), which causes AIDS.

Zur Hausen was the only one of the three who was at home when the famous call from Stockholm came. Montagnier, now director of the World Foundation for AIDS Research and Prevention, was working in the Côte d’Ivoire. Barré-Sinoussi, who is at the Pasteur Institute in Paris, was in Cambodia. The Nobel committee had been unable to contact either before the time of the announcement.
Search for the AIDS virus

Barré-Sinoussi — who, accompanied only by her mobile phone, found herself overwhelmed by the event — becomes the 36th woman to win a Nobel prize of any kind, compared with a list of 745 male laureates. She worked with Montagnier at the Pasteur Institute, from the beginning of the hunt for the virus causing AIDS in the early 1980s. The pair identified the virus, which they originally called LAV (lymphadenopathy associated virus), in 1983.

A bitter battle for credit soon began, with Robert Gallo of the US National Institutes of Health in Bethesda, Maryland, claiming to be the true discoverer. But in 1987, the heads of state of France and the United States brokered an agreement to share the benefits of the discovery, and the researchers had apparently buried the hatchet by 1990. Many believed that the Nobel prize could not be awarded for this field of research — despite its importance — while tempers were still high.

The Nobel committee has now made its position clear in an announcement that includes a list of who discovered what, and when. It says the discovery of Barré-Sinoussi and Montagnier “was accepted by the research community and resulted in an explosion of scientific breakthroughs”. It then refers to Gallo’s “detection of a novel … virus from a vast number of patients with AIDS or pre-AIDS in 1984 … [which] showed considerable similarities with LAV-1″.

The work of the French scientists has led to the development of diagnostic tools and blood screening agents that have helped to fight the spread of the disease, particularly in western countries. It has also allowed the development of drugs to fight the virus in different ways. Combinations of these drugs have dramatically increased life expectancy.
Elegant experiments

Zur Hausen is Germany’s 79th Nobel laureate in the sciences, and is widely considered a modest and gentle man who raised research standards at the DKFZ during his time there between 1983 and 2003.

In the early 1970s, the reigning hypothesis held that it was a herpes simplex virus that caused cervical cancer, a disease already believed to be largely sexually transmitted. But the young zur Hausen preferred to trust his own eyes — and he failed to find the herpes simplex virus in cervical cancer cells. He fixated instead on the papilloma virus, ignoring the scorn of many colleagues who believed the virus to be nothing more than a generator of skin warts.

“Virologists, and for sure all gynaecologists, thought his idea about the papilloma virus was very strange,” says virologist Herbert Pfister, a former colleague who is now at the University of Cologne. “But he carried through his theory in a determinedly logical way, not caring about the controversy he was raising.”

In a series of elegant experiments over the next decade — during which he moved between universities in Germany, settling in 1977 at the University of Freiburg — zur Hausen identified many different types of HPV, which he linked to different diseases. In 1983 he described HPV-16, which occurs in more than half of all human cervical cancers as well as other anogenital cancers. A year later came HPV-18, which accounts for a further 25% of cases.

“His work has directly influenced our daily lives — for years we have been able to identify women at high-risk of developing cervical cancer,” says Marion Kiechle-Bahat, head of the department of gynaecology at the Technical University of Munich, who studied under zur Hausen in Freiburg. “And now, as a direct result of his work, we have a vaccine to protect young girls, before they start to have sex.”

Roughly 500,000 women worldwide now receive the vaccine each year. The disease is fatal in around one-third of cases, and the vaccine is expected to significantly reduce these figures.

Source: www.medicalnewstoday.com
Author: staff

The two HPV vaccines currently licensed for use in the UK were jointly awarded the coveted Prix Galien Medal for Innovation at a ceremony held on Wednesday evening in the Palace of Westminster, House of Commons.

“We are absolutely delighted at the recognition given to the world’s leading HPV vaccine Gardasil® - this award reflects the work of many people, all around the world, involved in making the dream of a cancer vaccine a reality”, said Dr Nicholas Kitchin, Medical Director, accepting the award on behalf of the Sanofi Pasteur MSD team.

“Both companies have developed the technology of HPV vaccines down different paths,” he continued, “we chose a quadrivalent vaccine strategy, targeting a broader range of HPV-related genital disease than cervical cancer alone, with the aim of delivering additional benefits for patients and healthcare systems.”

The joint award for the two HPV vaccines, developed by Sanofi Pasteur MSD and GSK, was presented by Andrew Lansley CBE MP, Shadow Secretary of State for Health. The distinguished panel of seven judges, chaired by Professor Sir Michael Rawlins, selected the HPV vaccines as the winners from seven innovative products that reached the final.

Vaccines have won in four of the last five Prix Galien awards and the UK award for Gardasil® follows similar success in Prix Galien competitions in the USA and France.

Current experience with the four-type HPV vaccine

Thirty years after the discovery that human papillomavirus (HPV) can cause cervical cancer, 15 years after the start of vaccine development and two years after the approval of the four-type (6,11,16,18) HPV vaccine Gardasil®, vaccination to prevent cervical cancer and other HPV-related diseases has been widely implemented.

Gardasil® is approved in more than 100 countries around the world. Thirty million doses distributed worldwide demonstrate strong endorsement by medical professionals, regulatory agencies, health authorities and physicians as well as mothers and daughters.

HPV vaccination is recommended in 18 out of the 19 European countries - Austria, Belgium, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom - in which Sanofi Pasteur MSD markets Gardasil®. The vaccine is funded, or soon to be funded, in 15 of these. It is also recommended and funded in the U.S., Australia, New Zealand and Canada.

Indication of Gardasil®

Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

Sanofi Pasteur MSD is the only European company dedicated exclusively to vaccines

Source: Reader’s Digest (www.rd.com)
Author: Julie Bain

Between the relay races and table tennis triumphs last week, there was some news coverage about the HPV vaccine. A study came out last Wednesday in the New England Journal of Medicine that looked at the economic impact of vaccinating young girls and women from the types of HPV virus that can cause cervical cancer.

Newsweek ran an informative Q and A with one of the study authors about who should get the vaccine and when. The New York Times did a big story, too, which I thought displayed a bit of bias in the disapproving tone of its headline: Researchers Question Wide Use of HPV Vaccines.

I called Maura Gillison, MD, a researcher at Johns Hopkins in Baltimore and one of the top experts on HPV, for her perspective. She said, “For those of us in the field, this study is not really new information. It is known that the HPV vaccine doesn’t have an impact on young women who have already been infected by the HPV types targeted by the vaccine (HPV6, 11, 16, and 18).”

While it was possible to measure a girl’s previous exposure to HPV in the study lab, it’s not possible in a medical clinic, she says. That’s why it’s not as cost-effective to give the vaccine to women who are already sexually active.

Still, she says, “only 4% of the 16- to 26-year-old women who were enrolled in the vaccine trials had evidence of exposure to all four HPV types targeted by the vaccine. So a young woman already infected by HPV6, for example, would still benefit from vaccination to prevent HPV infection by HPV 11, 16, and 18. But the older the woman, the higher the probability that she has been exposed to more of the virus types.”

So the bottom line, according to Dr. Gillison: “You get more bang for your buck by targeting vaccination to younger girls, before the onset of sexual behavior. It makes more sense, in terms of the overall cost and the overall impact of the vaccine for cancer prevention, to spend the health-care dollars to vaccinate a higher proportion of young women, than to extend vaccination to older women.”

The vaccine needs further study before researchers will know for sure how long immunity lasts and whether a booster shot may be needed, and when. The big question of the study was: Is the cost of vaccinating millions of girls worth the number of lives saved? Economic policy is one thing, but all any individual can answer is, “If it’s my daughter whose life is saved, the answer is yes.” By the way, Dr. Gillison has two very young daughters, and she says she plans to have them vaccinated.

But What About the Boys?

Some 20 million Americans are infected with the virus, including a high percentage of teenagers. And we know that the virus is easily spread through any kind of sexual contact, including oral sex. I’ve asked it before and I’ll ask it again: Why are we only talking about girls here?

Cervical cancer is not the only life-threatening hazard of the HPV virus. Oral cancer from the virus is on the rise, as we wrote about in A Father’s Brave Battle with Throat Cancer in the August issue.

“We don’t know yet if the vaccine protects against genital infection in boys or against oral infection in boys or girls,” Dr. Gillison says. “I’m doing all I can to see that such studies are done.” In the absence of such studies, she says, we’ll only know if the vaccine helps to prevent oral infection 20 to 30 years from now, if the rapid rise in HPV-related oral cancers switches directions and starts to decline.

I don’t want to see anyone suffer the way I saw Steve Reynolds, the subject of our story, suffer during and after his treatment. Last Wednesday, the day the vaccine study came out, Steve was in the hospital having a PET scan to see if any cancer cells have returned in the year since he completed his radiation and chemo. Then he and his wife and their 4-year-old son headed to Cape Cod for their annual vacation. He won’t have the results until he returns. Waiting and worrying means more suffering for him and his family. We need to find a way to prevent this cancer, too—in all people.

Source: news.com.au
Author: Kate Sikora

The new cervical cancer vaccine is expected to almost eradicate human papillomavirus (HPV) infections in Australian women by 2050 if the high rate of immunization amongst girls continues.

Research to be released today by the Cancer Council NSW reveals the number of new HPV cases in women will fall by more than 50 per cent in the next two years.

In 40 years, the number of cases will fall by 97 per cent.

A national program launched last April has seen 3.7 million girls vaccinated with Gardasil, which has the potential to prevent up to 70 per cent of cervical cancers.

Before the vaccination program, there were 108,000 new infections of HPV16 - responsible for 50 per cent of cervical cancers - every year, but that number is expected to fall to 47,000 by 2010.

Dr Karen Canfell, lead author of the study, warned the reduction in HPV would only occur if girls continued to be vaccinated.

“We expect to see a very fast reduction in the number of new HPV infections, largely due to the high school vaccination program, which we estimate has achieved high coverage of just over 80 per cent of 12-13-year-old girls,” she said.

“This reduction will only occur if we maintain this high vaccination coverage among younger age groups.”

Gardasil has attracted controversy over its rate of adverse reactions.

Nationally, there have been 1013 reports of adverse side effects from Gardasil to the Therapeutic Goods Administration.

Girls have reported allergic reactions, dizziness, fainting and nausea.

Dr Canfell said adverse reactions occurred with any new drug.

“The disease that it protects against is far more harmful than its side effects,” she said.

“It’s really important that parents of girls in school understand they need to have the girls vaccinated.”

Johanna Roberts, 12, is too young to understand the risk of HPV, but she is aware that three jabs from the school nurse could save her life.

“My mum signed the permission slip and I lined up with the other girls,” she said.

Her mother Allison said she would have paid to have her daughters vaccinated if the school program was not in place.

“I have never had a problem with the childhood vaccination program so I didn’t really have a problem with this,” she said.

“If it protects them from having an abnormal pap test then the positives absolutely outweigh the negative side-effects.”