Saturday, February 2, 2008

HPV poised to be a major cause of oral cancer in men


The sexually transmitted virus that causes cervical cancer in women is poised to become one of the leading causes of oral cancer in men, according to a new study. The HPV16 virus now causes as many cancers of the upper throat as tobacco and alcohol, probably due both to an increase in oral sex and the decline in smoking, (the historically dominant risk factor) researchers say.

The only available vaccine against HPV, made by Merck & Co. Inc., is currently given only to girls and young women. But Merck plans this year to ask government permission to offer the shot to boys. Experts say a primary reason for male vaccinations would be to prevent men from spreading the virus and help reduce the nearly 12,000 cases of cervical cancer diagnosed in U.S. women each year. I might add that by not doing gender based vaccination, we will reduce the overall reservoir of the virus in the US which is currently ubiquitous in the population. But the new study should add to the argument that there may be a direct benefit for men, too. The study was published February 1, 2008, in the Journal of Clinical Oncology.

“We need to start having a discussion about those cancers other than cervical cancer that may be affected in a positive way by the vaccine,” said study co-author Dr. Maura Gillison of Johns Hopkins University. Of course she is referring the the rapidly rising numbers or oropharyngeal, base of tongue, and tonsillar cancers we are seeing in both males and females.

Human papillomavirus, or HPV, is the leading cause of cervical cancer in women. It also can cause genital warts, penile and anal cancer, and oral cancers — risks for males that generally don’t get the same attention as cervical cancer. Previous research by Gillison and others established HPV as a primary cause of the estimated 5,600 cancers that occur each year in the tonsils, lower tongue and upper throat. It’s also been known that the virus’ role in such cancers has been rising. It is in fact, the primary cause of cancers in these anatomical sites.

The new study looked at more than 30 years of National Cancer Institute data on oral cancers. Researchers categorized about 46,000 cases, using a formula to divide them into those caused by HPV and those not connected to the virus. They concluded the incidence rates for HPV-related oral cancers rose steadily in men from 1973 to 2004, becoming about as common as those from tobacco and alcohol.

The good news is that survival rates for the cancer (when caused by a viral etiology) are also increasing. That’s because tumors caused by HPV respond better to chemotherapy and radiation, Gillison said. “If current trends continue, within the next 10 years there may be more oral cancers in the United States caused by HPV than tobacco or alcohol,” Gillison said.

Studies suggest oral sex is associated with HPV-related oral cancers, but a cause-effect relationship has not been proven as the only viral transfer mechanism for these cancers. Other researchers have suggested that even unwashed hands can spread it to the mouth as well. Gillison however pointed toward sex as an explanation for the increase in male upper throat cancers. In women HPV-related upper throat cancers declined significantly from 1973 to 2004.

Merck’s vaccine, approved for girls in 2006, is a three-dose series priced at about $360. It is designed to protect against four types of HPV, including one associated with oral cancer. Merck has been testing the vaccine in an international study, but it is focused on anal and penile cancer and genital warts, not oral cancers, said Kelley Dougherty, a Merck spokeswoman. “We are continuing to consider additional areas of study that focus on both female and male HPV diseases and cancers,” Dougherty said. Merck officials praised Gillison’s research, saying it will elevate the importance of HPV-related oral cancers.

In a typically guarded observation, Government officials and the American Cancer Society say they don’t know yet whether Merck’s vaccine will be successful at preventing disease in men. No data from the company’s study are available yet. Indeed, it’s not clear yet that the vaccine even prevents the HPV infection in males, let alone cancer or any other illness, said Debbie Saslow of the American Cancer Society. However in speaking with experts in the virus research community, I believe that if Merck’s current trials show that it can prevent persistent HPV 16 infections, that the logical extension of that fact would indicate that without the persistent infection, there would also be no mechanism for the disease process to take place. Keep in mind that tobacco will still be a major player in the incidence of oral cancers, and we are looking at a subset population of people with oral cancer when speaking of HPV16.

Merck plans to seek U.S. Food and Drug Administration approval for the vaccine in men later this year, meaning a government decision would be likely in 2009.

Friday, January 25, 2008

Who Should Get Experimental Drugs?


When I started writing this site, I was sure that it was something that would remain non-political, but in this post I break that choice.

This week I had the opportunity to talk to a family that has recently lost their son to oral cancer. A man in his early thirties, a non smoker, athlete, and a father of two daughters. There are many aspects to this tragedy that I could explore here. The lack of early detection screenings in his dental appointments, his ignoring some hoarseness that persisted for several months, the treatments that were conducted initially by a small, local city hospital with minor cancer capabilities - which did not bring to bear all the potentially beneficial medical assets soon enough, and much more. But this particular entry is about the recent ruling by the high courts related to who in our population may have access to drugs which are not yet approved, but have shown potential in the trials to date and may even save a life. The current state of the situation is that there has been a ban on their use, regardless of the willingness of a patient to fully accept the risks associated with that use. Most of the patients who have petitioned for this ability have been in terminal disease states with no other hopes. Certainly the drug manufacturers have been quiet about much of this as they are regulated by the FDA’s rulings, but you have to believe that they too would be interested to see if a particular drug had impact or not, if only from a scientific perspective and not a compassionate one.

I can think of no greater means by which this administration, under the leadership of President Bush (and those that support his power base) has debilitated our country, for decades into the future, than his appointments to the judiciary and specifically to the supreme court. US Court of Appeals judge Thomas Griffith has ruled this week that “there is no right, deeply rooted in this nation’s history and tradition, of access of experimental drugs to the terminally ill.” It must be noted that Griffith, recently appointed by Bush, is a relatively young man. As such he has the potential to be making inane comments like this for decades to come. It is no surprise that Bush’s newly conservative weighted Supreme Court supported this ruling, and refused to hear the case themselves.

This is yet another instance, Iraq comes to mind immediately, in which “compassionate conservatives ” are willing to kill people in order to protect them. This distinction is not just academic, it is much more. What conservatives on the courts refuse to comprehend, is that the Bill of Rights is a list of rights that the citizens of this country grant to the government, NOT vice versa. The ruling should have been that the government has no fundamental right to deny potentially life saving or life extending drugs and treatments to dying patients… particularly when all parties concerned are cognizant of the inherent risks, willing to accept the consequences of their decisions, and no others are harmed through the process in any manner.

There were options and opportunities, granted with significant inherent risks for this young man with oral cancer. We will never know if those options would have given him a few more months with his family to communicate that which is now forever unsaid, or even to have defeated this disease and lived on. Thank you judge Thomas Griffith, I wonder how you would feel were this you in a life and death battle, and how that might impact your decision making process. One only has to remember the reversal of opinion from other compassionate conservatives, like Ronald Regan and his wife, when they found themselves on the other side of a disease issue that they failed to champion when the chance was theirs.

Monday, January 7, 2008

Stealth Marketing of Tobacco on the Web

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