Antoine Another health requirement for gay men, FDA approves vaccine.
By Antoine Craigwell
Early one fall morning, 32-year-old Mark Ramos (not his real name) walked into the New York-based Callen-Lorde Community Health Center for a routine medical check up. After several questions about his sexual practices, Mark consented to a rectal exam. He dropped his pants and underwear and climbed up on to the exam table in a kneeling position. The doctor cautioned that he would feel a slight discomfort as he swabbed Mark’s anus and took the male equivalent of a pap smear. Two weeks later, Mark, who came to the U.S. from a Caribbean country, received a call and was advised that the pap smear revealed that there was a suggestion of the presence of abnormal cells and was invited to come in for a colposcopy, a more thorough examination; the male equivalent of a cervical exam.
Anatomy of the anus
Except for that heightened fashion sense, creativity, artistry, and culinary skills, men who have sex with men (MSM) do have at least one thing in common with women: one of the effects of the human papilloma virus (HPV) which causes cervical cancer in women and anal cancer in MSM. Over the years knowledge and treatment for this virus has gradually “come out” of the classification as a women only problem, where more and more MSM are receiving examinations, screenings, and treatment, if precancerous cells are discovered. Anal cancer came to prominence recently with the death of Farah Fawcett.
In what was once in the medical domain of women, when high intensity focused ultrasound was used to treat ovarian cancer and is now used for prostate cancer in other countries and still in the U.S. FDA Phase Trials for use in men, that MSM are at an increased risk for anal cancer from the same virus that causes cervical cancer in women. Researchers have discovered that HPV, often present under the foreskin of uncircumcised men, when it comes in contact with the cells of the cervix or anus, mutates and leads to cancer in women and in men, who have unprotected penetrative sex. The U.S. Centers for Disease Control on their Website lists throat and neck cancer also related to the same virus.
When he arrived for his examination, Jeff Huyett a nurse practitioner specializing in anal health and gynecology at Callen-Lorde attempted to put Mark at ease. He explained that the issue of anal cancer in MSM is rising and that it is becoming more urgent that gay men be examined and treated. Showing a diagram of the anus and the rectum, Huyett said that immediately on the inside of the first anal sphincter muscle – a collection of cells similar to the point in women where the cervix transitions to the womb – where the anus becomes the rectum. These, he said, are a type of epithelial cells (similar to those found on the inside of the mouth) susceptible to HPV and if exposed and left untreated, develop into cancer.
Anus before infection and after
As he was being probed and prodded, and given assurances that the examination did not mean that he had cancer, Mark, recalled the story of David (not his real name), who migrated to the U.S. from Colombia, one of his close friends who had discovered late that he had anal cancer. After several unsuccessful chemotherapy treatments at St. Luke’s Roosevelt Hospital, David ended up going to the Cancer Treatment Center of America in Philadelphia, PA, to see what could be done for him. With his partner, Fred (not his real name) at his side, David, who recently celebrated his 50th birthday, was admitted with a high fever. His legs were swollen and the swelling seemed likely to spread upward to his abdomen, threatening his life, a tumor was discovered in one of his kidneys, and he was ruled out for surgery to install a colostomy bag. Fred, whose family came to the U.S. from Grenada, said resignedly that the Center advised them that with the different issues, there is no guarantee that they could help. He and David had to come up with about $2,000 to afford to go to the Center, since David’s insurance refused to cover any treatment. As of writing, David had been readmitted to the Center a week before the Christmas holidays and is on a morphine regimen to assist with pain management. A week prior to being admitted, he suffered a fall, fracturing his left femur. Doctors at the Center said that the cancer had spread to David’s bones, making them more fragile. From his previous admission, David’s treatment costs were more than $120,000. Fred said that David needed him now more than ever; he had to resign from one of his two jobs to help him with simple things, including getting dressed and going to the bathroom. For the first time Fred, who is with David for more than eight years, was suddenly thrust, involuntarily, into dealing with David’s family who didn’t trust him, and entering into the realm of talking with lawyers about a will, power of attorney, health care proxy, and making transparent financial decisions.
In an article “The Hole Thing: The Conspiracy of Silence About Gay Men’s Anal Health” published in the Spring 2007 issue of the White Crane Journal, Huyett said, “Nearly 2,000 men a year will be diagnosed with anal cancer. The cancer is treatable with chemotherapy and radiation treatments and it’s dangerous if it spreads throughout the body.”
Image of HPV
Huyett said in the article that that for the gay community which has become plague weary from dealing with HIV, that many are reluctant to address another health issue that is so closely related to sexual practices, which results in little or no advocacy.
“I find it astonishing that in the midst of the HIV pandemic, [that] we are unaware of another important health risk. Clearly, anal cancer prevention means we have to acknowledge we have “butt” sex. It dredges up the feelings of homophobia that we thought we had long ago dealt with. To screen, we have to admit to our sexual practices in order to achieve good health,” says Huyett.
The CDC acknowledges that anal cancer is rising and is a cause for concern for the gay community. The CDC says that of the 20 million Americans infected with HPV, an estimated six million are newly diagnosed each year; in men, approximately 1 percent infected develop genital warts, while about 1,700 men get anal cancer, “Most people who become infected with HPV do not know they have it. Usually, the body’s immune system gets rid of the HPV infection naturally within two years. This is true of both high-risk and low-risk types. HPV is also very common in men, and often has no symptoms…In general, HPV is thought to be responsible for about 85 percent of anal cancers, 70 percent of vaginal cancers, and 40 percent of vulvar and penile cancers.”
“While anal cancer isn’t that common it’s preventable. But you can only prevent anal cancer if you know you have HPV, are screened and have the precancerous areas treated. You can only do this if you live in an area where anal-pap-smear testing is available and resources exist to provide preventive follow-up,” says Huyett.
A Dec 9 article in POZ, a magazine for the HIV-positive community, pointed to a study article published in the Journal AIDS, which said that despite being one of the most expensive methods to screen for anal cancer, compared to the cheaper but least effective tests, a high resolution anoscopy (HRA) is more cost effective in producing a clear result. The HRA examination involves a provider using a plastic anoscope, a small camera, tissue staining solutions, and taking a tissue biopsy, which is sent for analysis.
The magazine said that rates of anal cancer are as much as 160 times higher in HIV-positive men who have sex with men (MSM) than the general public. For this reason, many experts recommend annual screening.
“For HIV-infected MSM and where resources permit, anal cancer screening should be initiated with the direct use of HRA,” the study’s authors concluded.
HPV Vaccine
However, on Dec 22, the FDA announced the approval of Gardasil as a preventive vaccination for anal cancer. Last year, on Oct 16, the government agency had issued an approval of the vaccination to prevent genital warts in men and boys. These warts are caused by HPV types 6 and 11 in men and were found to affect boys between nine and 26. At the time when the FDA approved the vaccination for HPV types 6, 11, 16, and 18, for cervical cancer in girls, between nine and 26 years old, some mothers had expressed strong reservations and concerns over the side effects on their daughters; there was no preventive for men and boys.
In a press statement by the FDA, Karen Midthun, M.D., director of the Center for Biologics Evaluation and Research, said, “Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure”.
Although it seems as though anal cancer is uncommon, the FDA said, rates of incidences are increasing with HPV associated with approximately 90 percent of these cancers. The press statement said that Gardasil’s ability to prevent anal cancer and the associated precancerous lesions caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of self-identified MSM. At the end of the study, the vaccine was shown to be 78 percent effective in preventing HPV infection. This population was studied because it has the highest incidence of anal cancer said the FDA. But, the statement cautioned, Gardasil would not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination and its efficacy is better for boys and men prior to becoming infected with HPV strains contained in the vaccine.
According to the FDA and Merck and Company, Inc., the New Jersey-based manufacturer, the vaccination is administered as three injections over a six-month period and has headaches, fever and pain at the injection site, itching, redness, and swelling and bruising as the most common side effects. The FDA said that receiving the vaccination does not preclude the need for continued anal screenings.
“We are pleased that with this new indication for Gardasil against HPV-related anal cancer and disease, both males and females can be protected against cancer, which further reinforces the importance of vaccinating both genders,” Richard M. Haupt, M.D., MPH, executive director, Merck Research Laboratories said in an interview with Business Wire. Merck’s stock on the New York Stock Exchange rose from $26.00 to $36.36 on Dec 22 following the announcement of the vaccine.
Following a biopsy of some abnormally appearing cells in his rectum and a caution by Huyett that it does not mean he has cancer, Mark’s doctor confirmed that he did not have anal cancer. The abnormal cells, he was told, appeared because he recently had a bout of Chlamydia, but was advised to do another examination in a year. Huyett said that as a gay man, every year he has an anal examination and urges all gay men who engage in anal sex to be examined and start treatment if necessary, before it becomes too late.
David and Fred are likely to be confined to a hospital room over the holidays, away from family and friends. Fred said the doctors advised that David is in stage four cancer and his future is dire.
