September 12, 2007

National Vaccine Information Center
A young boy on the beach was throwing the washed-up starfish back into the ocean. A stranger passing by told him not to bother, because it would not make any difference, there were thousands of beaches and millions of starfish, and it would not be possible to save all of them. The boy reached down, picked up a starfish, threw it back into the ocean and said, smiling softly, " I made a difference for that one!"

NVIC E-news
"Gardasil may generate more than $3 billion in annual sales for Whitehouse Station, New Jersey- based Merck, analysts say. The best way to reduce cancer-causing HPV is to widen the pool of children vaccinated with Gardasil, the researchers say. Merck is studying the shot in boys and plans to seek U.S. approval for that use, said spokeswoman Kelly Dougherty. ``We would encourage industry and scientists to study the efficacy in boys and men so the vaccination program can be expanded,'' said Erich Sturgis, associate professor of head and neck surgery at M.D. Anderson and the report's lead author, in an interview..... ``Changing sexual practices such as more frequent oral sex in adolescents and young adults could contribute to an increase in oncogenic HPV- associated oropharyngeal cancers,'' researchers said in the report. Tonsil cancers have increased 4 percent and tongue cancers 2 percent a year in the past 30 years among adults younger than 45, according to studies cited in the review. Many of the cancers were among non-smokers, which points to HPV as the culprit behind the rise in the cancers, M.D. Anderson researchers said.....Approved in June 2006, Gardasil generated $723 million in sales during the first half of this year. Head and neck cancers are the latest malignancies tied to HPV infection generating attention from health experts that would like to see broader use of the Merck vaccine." - Angela Zimm, Bloomberg News (August 27, 2007)

"Almost all cervical cancers are caused by the sexually transmitted human papillomavirus, or HPV. Merck's Gardasil targets strains responsible for 70 percent to 80 percent of these cancers. Vaccinating girls before they are sexually active is useful because it can prevent infection from developing into cancer later in life. Mandating the shot may ensure wider use. ``Effective education programs and mandatory vaccination will probably provide the greatest and fastest reduction in the incidence of cervical cancer,'' Hopkins scientists Richard Roden and T.C. Wu wrote in the scientific journal Nature Reviews Cancer, published on line today..... The Hopkins scientists join a growing number of health and government experts calling for mandated HPV vaccination programs....``If you want to have a significant reduction, making the vaccine mandatory would generate the better impact,'' co-author Wu, a professor of pathology at Hopkins, said in an interview....." - Angela Zimm, Bloomberg News (September 26, 2006)

"It is worth noting that HPV vaccine trials have demonstrated only protection against HPV- related genital pre-cancers, not cancer. Is spending public money on HPV vaccination of all girls and young women appropriate, when cash-strapped communities could put the funds to other uses? This may be the most difficult question of all. It leads immediately to another question: Does Merck need to charge $360 per person for the vaccine as it does now? According to Glenn McGee of Albany Medical College, Merck could recoup in several years its development costs for this and other vaccines that never made it to market by charging one-tenth the current price (assuming that sales continue at the current rate). Merck says it calculated the price taking into account research and development costs as well as what the vaccine could save in terms of HPV-related treatment expenses. It argues that the long-term cost savings justify the unusually high price for this vaccine. Other analyses (for example, a British Columbia Cancer Agency report) disagree with these calculations and conclude that the cost of vaccination greatly outweighs the amount saved by avoiding treatment of HPV-related disease. As we consider how to proceed on HPV vaccination, a clear understanding of the research -- not marketing claims or lobbying funds -- needs to guide both our individual decisions and our public policy." - Judy Norsigian and Heather Stephenson, Women's E-News (September 7, 2007)
Barbara Loe Fisher Commentary:
If vaccine manufacturers can't generate the profits they promised stockholders by persuading state legislators to mandate a newly licensed vaccine, then they will find another way to bring in the money. In this case, Merck and the doctors in academia and research, who are developing and promoting widespread use of HPV vaccines, are going after the young boy market following a failure this year to get HPV vaccine mandated for pre-teen girls in every state.

Almost exactly one year ago, scientists developing HPV vaccines at Johns Hopkins and elsewhere were joining with doctors in calling for mandatory vaccination of all young girls with Merck's newly licensed HPV vaccine, Gardasil. But the push for mandated use of Gardasil by all 11 year old girls was rejected by states due to parent protests against mandates after NVIC pointed out lack of scientific data proving Gardasil safety and efficacy in young girls and other parent groups protested mandates for a sexually transmitted disease that could not be acquired in the school setting.

Seeking to capture the numbers that will give them the projected profits they would have secured if they had succeeded in getting Gardasil mandated for all 11 year old girls in every state, Merck and HPV vaccine developers are attempting to widen the pool of vaccine candidates by alleging that more teens today are engaging in oral sex and that is why there has been an increase in HPV-associated cancers of the tongue, tonsils and throat in boys. This, say scientists at the M.D. Anderson Cancer Center, is reason enough to call for universal HPV vaccination of all young boys.

The call for all young boys to get a vaccine that was developed to prevent cervical cancer in women will help Merck out in its quest for the $3 billion dollar annual market it dreamed of when it tried to get the vaccine mandated for all young girls. It will also potentially help secure profits for GlaxoSmithKline when its HPV vaccine, Cervarix, is licensed. One of the authors of a recent article in Cancer, which pointed out that oral cancer increases among boys makes them perfect candidates for HPV vaccination, has been a consultant for Sanofi-Aventis, GlaxoSmithKline, Xemova and Pfizer.

I remember admiring scientists and doctors when I was growing up in the 1950's and 1960's. Everyone knew they worked hard to help people and make the world better even though they were not paid very much money. Now doctors and scientists are paid a lot of money and they have assumed positions of power in government, industry and academia, where they lobby in the media and state legislatures to secure predictable and lucrative markets for the pharmaceutical products they create or profit from promoting either directly or indirectly.

It is highly inappropriate for doctors or scientists to lobby for forced use of vaccines or any other pharmaceutical product. The people deserve better from the men and women we pay to provide us with wise and unbiased counsel about making informed health care choices for ourselves and our children. We should not feel like we need to check out their stock portfolio or origin of their university's research grants before deciding whether we should trust their advice or not.


 











Oral-Sex Cancer Link Suggests Boys Need Merck Vaccine (Update2)
Bloomberg News
August 27, 2007

by Angela Zimm

Click here for the URL:
(Bloomberg) -- Merck & Co.'s Gardasil vaccine, approved for preteen girls to prevent cervical cancer caused by a sexually transmitted virus, should also be given to teenage boys to help avert cancers linked to oral sex, researchers said.

A growing body of research shows that human papilloma virus, responsible for cervical cancer, is also linked to about half of certain throat, or oropharyngeal, cancers. In a research review in the journal Cancer, doctors from the University of Texas M.D. Anderson Cancer Center said scientists should step up studies of the HPV vaccine in boys to expand the vaccine's use.

Gardasil may generate more than $3 billion in annual sales for Whitehouse Station, New Jersey- based Merck, analysts say. The best way to reduce cancer-causing HPV is to widen the pool of children vaccinated with Gardasil, the researchers say. Merck is studying the shot in boys and plans to seek U.S. approval for that use, said spokeswoman Kelly Dougherty.

"We would encourage industry and scientists to study the efficacy in boys and men so the vaccination program can be expanded,'' said Erich Sturgis, associate professor of head and neck surgery at M.D. Anderson and the report's lead author, in an interview. "We know men are getting exposed and we know a major proportion of oropharyngeal cancers are caused by HPV.''

Recent findings also tie the virus to cancers of the penis, anus and vagina. The link to head and neck cancers, which mostly affect males, points to a need to vaccinate boys before they are sexually active, the researchers said.

Result Next Year

Merck expects to have data on use of the vaccine in teenage boys next year, Dougherty said. The Merck vaccine can already be used in boys in the European Union, Mexico, Australia, New Zealand, Indonesia, Costa Rica and Korea.

Merck's shares fell 70 cents, or 1.4 percent, to $50.12, in New York Stock Exchange composite trading. The stock has increased 15 percent this year.

GlaxoSmithKline Plc, which is seeking U.S. and European approval of a similar vaccine called Cervarix, said it's focusing the product on girls and women.

Head and neck cancers, closely linked to smoking, have declined as the number of people who use tobacco dropped. However, oropharyngeal cancers, including the tonsils and back part of the tongue, are rising, especially among younger adults, studies show.

"Changing sexual practices such as more frequent oral sex in adolescents and young adults could contribute to an increase in oncogenic HPV- associated oropharyngeal cancers,'' researchers said in the report.

Tonsil, Tongue Increases

Tonsil cancers have increased 4 percent and tongue cancers 2 percent a year in the past 30 years among adults younger than 45, according to studies cited in the review. Many of the cancers were among non-smokers, which points to HPV as the culprit behind the rise in the cancers, M.D. Anderson researchers said.

"This was once a disease exclusively of smokers and drinkers,'' Sturgis said. ``Our experience is between a third to a half of oropharyngeal cancer patients have never smoked.''

More than 90 percent of HPV-positive throat cancer tumors show infection with the HPV-16 form of the virus. Merck's and Glaxo's vaccines target strains HPV 16 and HPV 18. Merck's Gardasil also targets two additional HPV strains that cause genital warts.

Approved in June 2006, Gardasil generated $723 million in sales during the first half of this year.

Head and neck cancers are the latest malignancies tied to HPV infection generating attention from health experts that would like to see broader use of the Merck vaccine.

Every year, about 650,000 people worldwide are diagnosed with head and neck cancers, and 350,000 die from the diseases, according to the American Cancer Society, based in Atlanta.

`Emerging Area'

"This is an emerging area,'' said Joseph Bocchini, chairman of pediatrics at Louisiana State Health Sciences Center in Shreveport, in an interview. ``As the data evolves, it would add the possibility of not only genital cancer control but oropharyngeal cancer control as well.''

Bocchini who heads the American Academy of Pediatrics committee on infectious diseases, which makes recommendations on childhood vaccines, said it's too early to say whether boys should be vaccinated until more data is available.

"At this point there is nothing to suggest it would act differently,'' he said. ``There is a very good chance it will be as effective in boys as girls and women.''

Cancer is the medical journal of the American Cancer Society.

To contact the reporter on this story: Angela Zimm in Boston azimm@...
Merck Vaccine Should Be Required, Global, Experts Say (Update1)
Bloomberg News
September 22, 2006

By Angela Zimm

Click here for the URL:
Sept. 22, 2006 (Bloomberg) -- Merck & Co.'s vaccine against cervical cancer should be mandatory for preteen girls and available worldwide for the shot to be effective in reducing the No. 2 cause of cancer death among women, researchers said.

Such an initiative offers the best hope for eliminating the disease, especially in poor countries where about 80 percent of deaths from cervical cancer occur, according to researchers from Johns Hopkins University in Baltimore.

Almost all cervical cancers are caused by the sexually transmitted human papillomavirus, or HPV. Merck's Gardasil targets strains responsible for 70 percent to 80 percent of these cancers. Vaccinating girls before they are sexually active is useful because it can prevent infection from developing into cancer later in life. Mandating the shot may ensure wider use.

"Effective education programs and mandatory vaccination will probably provide the greatest and fastest reduction in the incidence of cervical cancer,'' Hopkins scientists Richard Roden and T.C. Wu wrote in the scientific journal Nature Reviews Cancer, published on line today.

The U.S. Food and Drug Administration on June 8 approved Gardasil for females ages 9 through 26. A federal panel recommended a month later that it be given routinely to 11- to 12-year-old girls.

European regulators approved sales of the vaccine today. Merck and its partner Sanofi-Aventis SA will introduce the shot toward the end of October in Germany, the U.K. and Scandinavia. British drugmaker GlaxoSmithKline Plc is developing an HPV vaccine called Cervarix and plans to seek U.S. approval before the end of this year.

Mandated Vaccination

The Hopkins scientists join a growing number of health and government experts calling for mandated HPV vaccination programs. In the U.S. earlier this month, Michigan lawmakers began considering a proposal to require all girls entering sixth grade to be vaccinated against HPV.

HPV is the most common sexually transmitted disease in the world, and it's estimated that almost 11 percent of all women are infected, the researchers wrote. The infection is also linked to genital warts, and vaginal, penile, and some head and neck cancers. HPV is estimated to cause 5.2 percent of cancers worldwide, according to the Nature report.

Programs to bring the vaccine to poor countries offers the best for significantly reducing the 274,000 cancer deaths worldwide, researchers said. About 80 percent of the deaths occur in poor countries where women lack medical care that can detect and treat HPV before it becomes cancerous.

Reduce Deaths

With widespread use of the vaccine, deaths from cervical cancer may be reduced by 70 percent to 80 percent, the researchers said.

"If you want to have a significant reduction, making the vaccine mandatory would generate the better impact,'' co-author Wu, a professor of pathology at Hopkins, said in an interview.

In the U.S., where Pap smear screening is widespread, about 14,000 women are diagnosed with the disease each year and 3,900 die from it. Only breast cancer strikes more women globally than cervical cancer.

Cooperation between drugmakers, governments and nonprofit groups will be crucial to making the HPV vaccine available to the poor. The vaccine is expensive. Given in three shots over a six- month period at a cost of $120 each, the full cost of protection is $360.

More studies also are needed to determine how long the vaccine can protect against HPV infection before one can determine the true impact of mandatory vaccination, researchers said. The longest duration of immunity seen to date is five years, according to Merck's research.

"A lot of political and practical cost issues must be considered as well,'' Roden, an associate professor of pathology at Hopkins and the study's co-author, said in an interview.

To contact the reporter on this story: Angela Zimm in Boston azimm@...


HPV Vaccine Flags Need for More Pap Tests
Alert Net
September 7, 2007

by Judy Norsigian and Heather Stephenson

Click here for the URL:
A little more than a year ago, the nation's first vaccine against some human papillomavirus (HPV) infections was released.

This medical progress against cervical cancer got swept up by fear-based marketing that helped to generate premature calls for government mandates.

"You could become one less life affected by cervical cancer" is the mantra in most of Merck's ads for its vaccine, called Gardasil. The ubiquitous marketing campaign may leave viewers thinking that cervical cancer is more prevalent than it really is.

Merck also lobbied behind the scenes to make its vaccine mandatory for school-age girls, quietly funding groups such as Women in Government that promoted mandatory vaccination bills in state legislatures. Such a mandate, if passed quickly, would have increased the firm's sales before a competitor's product -- soon to hit the market -- was available.

When Merck's funding was exposed, the tactic backfired, fanning suspicions that profit motives were overwhelming public health concerns.

Opposition came from other camps too. Some parents pointed to the new vaccine's side effects (which are usually minor and transient) and questioned whether it should be required. Social conservatives raised concern that the vaccine could lead to increased sexual activity among America's youth.

HPV vaccination has been approved for females ages 9 through 26 and appears to be most beneficial for girls with no prior sexual activity. Studies show that vaccination after virus exposure is only minimally effective. The vaccine is not recommended for pregnant women, anyone with moderate to severe acute illnesses or anyone with sensitivity to vaccine components.

All of this has left a number of questions simmering.

Would a Mandate Reduce Cervical Cancer?

The U.S. Centers for Disease Control and Prevention predict a 22 percent to 60 percent reduction in cervical cancer attributable to this vaccine. However, for these reductions to be realized, a high proportion of young women will have to be vaccinated. Even then, reductions in invasive cervical cancer won't be measurable for several decades.

Many believe mandates are premature. Gardasil appears safe and effective up to five years, the length of time studies have covered so far, and if its effects are as strong over the long term as early results suggest, then requiring and funding vaccination for school-age girls (with exceptions for families who opt out) may become the best way to ensure access and protection for all girls, regardless of class or race.

About 10,000 cases of cervical cancer will be diagnosed this year in the United States, and about 3,700 of these women will die from the disease.

Most who die of cervical cancer never had regular Pap tests. These screening tests can detect pre- cancerous tissue, which can be removed to prevent the development of cervical cancer.

In the United States, there are 6.6 cases of cervical cancer for every 100,000 white women and 10.5 cases for every 100,000 African American women. The racial disparity is due at least in part to women of color having less access to screening.

Globally, in regions where screening is much less common, the numbers are much worse. In areas of Africa, Central and South America, and Micronesia, there are more than 50 cases of cervical cancer per 100,000 women.

We don't know yet if requiring vaccination could reduce cervical cancer deaths and reduce racial and ethnic disparities in terms of HPV prevalence, cervical cancer incidence and cancer mortality. It is possible that women who do not get regular Pap screening and follow-up now will also be those least likely to be vaccinated, even with legislative mandates in place.

If there's one thing the discussions make clear, it's that we need to try harder on Pap tests. Cervical cancer used to be a leading cause of cancer deaths among U.S. women. But since the introduction of the Pap smear in the 1940s, those deaths have dropped about 75 percent, even as the population has grown.

What Does the HPV Vaccine Achieve?

HPV is the most common sexually transmitted infection in the United States, affecting about 1 in 4 women between 14 and 59. Exposure usually occurs within the first few years of sexual activity, but infections often go unrecognized because there may be no symptoms. The vast majority of HPV infections clear up on their own.

Worldwide, 70 percent of women who develop cervical cancer have been infected with either HPV 16 or HPV 18, two of the strains the Gardasil vaccine targets. But most women infected with even such "high- risk" strains of HPV will not develop cervical cancer.

In addition to effectively protecting against HPV 16 and HPV 18, Gardasil protects against types 6 and 11, two strains that can cause genital warts but not cervical cancer.

Cervarix, a vaccine that GlaxoSmithKline expects to introduce in the United States soon, also protects against HPV types 16 and 18, but not the strains that can cause genital warts. Both Gardasil and Cervarix may provide partial cross-protection against some additional HPV types.

Neither vaccine protects against all strains of HPV that can lead to cervical cancer. In addition, testing of Gardasil has shown that it is far less effective if women have been exposed to HPV before vaccination. This is one reason why vaccination of girls as young as 9 has been recommended.

Regular Pap tests and follow-up care are still needed, even for women who are vaccinated, because they may have prior exposure to HPV or may in the future become exposed to strains that are not covered by the vaccine.

It is worth noting that HPV vaccine trials have demonstrated only protection against HPV-related genital pre-cancers, not cancer.

Should HPV Vaccines Be Made Available to All?

Is spending public money on HPV vaccination of all girls and young women appropriate, when cash- strapped communities could put the funds to other uses? This may be the most difficult question of all.

It leads immediately to another question: Does Merck need to charge $360 per person for the vaccine as it does now? According to Glenn McGee of Albany Medical College, Merck could recoup in several years its development costs for this and other vaccines that never made it to market by charging one-tenth the current price (assuming that sales continue at the current rate).

Merck says it calculated the price taking into account research and development costs as well as what the vaccine could save in terms of HPV-related treatment expenses. It argues that the long-term cost savings justify the unusually high price for this vaccine. Other analyses (for example, a British Columbia Cancer Agency report) disagree with these calculations and conclude that the cost of vaccination greatly outweighs the amount saved by avoiding treatment of HPV-related disease.

As we consider how to proceed on HPV vaccination, a clear understanding of the research -- not marketing claims or lobbying funds -- needs to guide both our individual decisions and our public policy.

Judy Norsigian is the executive director of Our Bodies Ourselves. Heather Stephenson is the editor of "Our Bodies, Ourselves: A New Edition for A New Era" (Simon and Schuster, 2005); "Our Bodies, Ourselves: Menopause" (Simon and Schuster, 2006); and "Our Bodies, Ourselves: Pregnancy and Birth" (Simon and Schuster, forthcoming in 2008).


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