A Public Health Conundrum: Boys, Cervical Cancer and HPV Vaccines
Late last week, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s cervical cancer vaccine Cervarix for use in girls and women ages 10 to 25 and also approved Gardasil —Merck’s cervical cancer vaccine previously approved in 2006 for use in girls and women—for boys and men ages 9 to 26. For those of you who may not know, over 99% of human cervical cancers are caused by infections with cancer-causing strains of the human papilloma virus (HPV) which also causes venereal warts. Vaccination with Cervarix protects against cervical cancer by inducing immunity against HPV 16 and 18 (which cause most cervical cancers in developed nations) whereas Gardasil affords protection against HPV 16 and 18 as well as HPV 6 and 11, strains that cause venereal warts (which don’t lead to cancer).
Despite FDA’s approval to vaccinate boys with Gardasil to prevent HPV infections, the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP)— which guides national policy on use of vaccines—decided yesterday to recommend the use of the vaccine in girls and women but didn’t fully endorse its use in males. Typically, ACIP recommendations are adopted by professional medical associations and set the standards of practice for physicians. Also, its recommendations play a major role in determining whether or not insurers and third party payors will reimburse patients who are vaccinated. The new recommendations mean, in effect, that physicians and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. In contrast, vaccination of girls and women ages 10 to 25 will be strongly recommended, readily available and reimbursable. This means that parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots—an option which is sure to severely limit the numbers of boys and men who are vaccinated with Gardasil.
The ACIP committee decided not to include Gardasil immunization for boys and men on its recommended list because several members, most notably a medical economist, questioned whether vaccinating boys would be cost effective in the long run. At the heart of the debate was whether or not it was appropriate and cost-effective to vaccinate boys for a problem (venereal warts) that can be embarrassing and uncomfortable but is not life-threatening. For those of you who may not know, Gardasil immunization is expensive and requires a series of three injections that cost $130 each ($390 total). Cervarix, which also requires a series of three injections, is planned to be offered for $385.
Last year in the United States, about 37 percent of girls ages 13 to 17 started the Gardasil vaccine series, a national immunization survey showed, and about half of them completed it. Not a great track record for a vaccine demonstrated to prevent cervical cancer and dramatically reduce the transmission of venereal warts. Nevertheless, yesterday’s decision to recommend vaccination for girls and women but not boys and men makes no sense to me from a public health perspective and it almost smacks of gender bias. Let me explain.
Like all other sexually transmitted diseases (STDs), HPV is transmitted from men to women and visa versa. Based on years of epidemiological studies, the only effective way to reduce the overall incidence of STDs is to implement strategies that prevent infections in both females and males. While boys and men can’t develop cervical cancer, they do contract venereal warts and perhaps, more importantly, can serve as carriers or reservoirs of HPV infection in the population. In other words, infected males (who may or may not show symptoms of HPV infection) still possess the potential to transmit it to sexually-active, unvaccinated girls and women. Consequently, while the incidence of HPV infections may begin to decrease among women after immunization, it will never be completely eliminated and the possibility of developing cervical cancer will continue to be a public health concern.
While the ACIP’s understanding of the transmission of STDs is tragically flawed, its willingness to publicly disclose cost effectiveness as a reason to not endorse HPV vaccination for males is even more egregious! The agency’s decision begs the question: Which is more costly; 10,000 American women developing cervical cancer each year (and countless others going for unnecessary cervical biopsies because of “bad” Pap smears) or a heads up to insurance companies that they ought to cover the costs of male HPV immunizations?
The ACIP’s reluctance to recommend male HPV vaccination based on economic and health care cost concerns rather than on public health implications is yet another example of how broken the US healthcare system is and how drastically it needs to be reformed. Allowing 3,700 women to die each year in the US from cervical cancer when there is a safe and effective way to prevent these deaths is, in my opinion, unconscionable!
Until next time...
Good Luck and Good Job Hunting!!!!!
I have refrained from commenting on healthcare reform until now because there wasn’t much I could add to the debate. That said, while reading an article in a local paper on bacterial antibiotic resistance and how to minimize it, the author—an infectious disease doc—offered a telling statistic that identified the root problem with our current healthcare system. According to the article, 65% of the time, physicians will prescribe antibiotics to patients suffering from upper respiratory tract infections who demand them, whether or not they are warranted. In marked contrast, 12% of patients with upper respiratory tract infections who don’t ask for antibiotics receive antibiotic prescriptions. The bottom line: physicians give patients the drugs and treatment they demand because they are afraid of losing them as customers knowing full well the patients will go to another physician who will give them what they want! After all, physicians are in business and to stay in business they need to make enough money to cover their overhead and make a profit. However, over prescribing antibiotics is one of the main reasons why we are in the midst of an epidemic of infections caused by multiple drug resistant bacteria. In my opinion, business outcomes should never supersede or trump medical or public health outcomes..jpg)
Last week, I took a group of 
The 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) is currently taking place in San Francisco. For those of you who may not know ICAAC, is an annual meeting mainly attended by infectious disease physicians and researchers where the latest and most cutting edge research on infectious agents is reported. Things must have been a little slow at this year’s meeting (except for H1N1 of course) which led the newswires to pick up a story about the isolation of 
Vincent Racaniello, an intrepid virologist and .gif)
Rumors are rife that Novartis is going to purchase Lexington, MA-based Cubist for $1.6 billion. Wall Street analysts are speculating that Novartis may announce the deal as early as Monday..gif)
That methicillin resistant Staphylococcus aureus (MRSA) is in the news again is not surprising. However, to my knowledge, Nicholas Kristof‘s article in today’s New York Times may be the first Op-Ed piece written by a non-scientist about the growing threat and seriousness of MRSA infections. Mr. Kristof apparently became aware of MRSA when he was contacted by Tom Anderson, MD, a Camden, Indiana physician who was experiencing “phenomenal levels of MRSA infections" in his community.
Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it 
.jpg)
A Food and Drug Administration (FDA) advisory panel Thursday rejected a proposed antibiotic by Arpida Ltd. (ARPN.EB) to treat serious skin infections, a Food and Drug Administration spokeswoman said. The rejection was expected because results from Phase III clinical trials showed that patients taking iclaprim (a trimethoprim-like antibiotic) had lower cure rates than Pfizer's 
A friend of mine accidentally gashed his leg on an open dishwasher door and thought nothing of it for several weeks until he noticed that the wound wasn’t healing and it hurt really badly. He eventually went to the emergency room at a local, where the ER docs cultured the wound and sent him home with a prescription for oral antibiotics. The antibiotics stopped working several days later and he wound up in another local hospital–this time he was admitted and the spent the next 5 days on a variety of intravenous antibiotics. Despite the treatment (they could not find the right antibiotic combination at first because they never recultured the wound) his leg turned black from his ankle to his knee and they almost had to amputate. He is back at home now and will be treated with a regimen of iv antibiotics for the next 6 weeks or so. I talked with him last week and I learned that his leg wound is still not completely healed and the infectious disease docs are worried!.jpg)
Sinus infections are diagnosed in about 31 million Americans each year and are among the most common reasons for doctor visits. The infections affect the air spaces (sinuses) around the nose and in the lower forehead. Inflammation and excess mucous can cause nose congestion, headaches and eye and face pain. Causes include bacteria, viruses, fungal infections and allergies. 
