Going for the Throat: Hyping HPV Vaccine for Young Boys

"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.