Is TEAL the New PINK?

January is Cervical Cancer Awareness month, and the color is TEAL. Did you know there are still over 12,000 women in the United States who are diagnosed with this cancer every year? And although our treatments have greatly improved, there are still over 4000 deaths from this cancer every year. The good news is that we have PREVENTION, and with this prevention, we hope to eliminate cervical cancer within our lifetime! Take this CDC Cervical Cancer QUIZ to test your knowledge.

The HPV vaccine is approved and strongly recommended for all adolescents- girls and boys- as part of their routine vaccinations at age 11-12 years. The second generation of Gardasil vaccine (Gardasil 9) now covers not the HPV strains that cause 90% of cervical cancers (as well as the two strains that cause 90% of genital warts.) If your child has started the series with the original Gardasil, they may finish out the series with the Gardasil 9 to increase the spectrum of their immunity.

YES, the vaccine is safe. YES, the vaccine is effective- extremely effective! YES, my daughters are immunized, and they are the two people my husband and I love and care about the most on this planet! Enough said.

Pap tests- are they still necessary? Yes, but NOT EVERY YEAR (and the crowd cheers)! Our current guidelines recommend Pap testing starting at age 21 years, and then every 3 years till age 65. There is also an option for 30-65 year olds to test only every 5 years when they do combined Pap and HPV testing.

Does the Pap check for all sexually transmitted infections? NO. The Pap test checks for early cervical cancer. To check for STI's such as HIV, gonorrhea, chlamydia, syphilis, and herpes, you will need additional testing (of blood, urine, and possibly a swab test performed during a pelvic exam.)

Are there support groups for women diagnosed with cervical cancer? Absolutely! For example, I'm honored to be in the picture above with Tamika Felder, the founder of a wonderful support group CERVIVOR- check out her website!

BOTTOM LINE: That magical "cure for cancer" has not yet been discovered for all cancers, but CERVICAL CANCER is preventable- let's end this disease for our children by vaccinating them now!

Gardasil- What's Up Down Under?

The HPV (Human Papilloma Virus) vaccine, Gardasil, was FDA approved in the United States for use in young women in June, 2006, then extended for males in October, 2009. In October of 2011, the Advisory Committee on Immunization Practices (ACIP- the group that creates our national guidelines that you see posted on your doctor's office walls) extended their official recommendations to include ROUTINE VACCINATION of both boys and girls at age 11-12 years, with "catch up" immunizations for those youth  ages 13-21 who had missed getting this vaccine series.

Why are we vaccinating?
We vaccinate primarily for CANCER PREVENTION. Each year in the United States, we have over 33,300 cases of HPV-related cancers (data from CDC, 2012). About 2/3 of these occur in women, primarily with cervical cancers, but also other genital, anal and oral cancers. In men, the majority of HPV related cancers are oral, but they, too, can have genital and anal cancer, though it is less common than in females.
Gardasil also protects against the two strains of HPV that cause 90% of genital warts, and with over one million cases of this malady each year in the US, you can see what an impact prevention can make here!

How well are we doing?
Not as well as we could do...because national immunization surveys have shown that in teenagers 13-17 years old, only 53% of young women had started the series, and only 1/3 of that group had completed the series. A bit more encouraging is an improvement in the very low percentage of teenage males getting the vaccine, which was at 8% in 2011 (the first year it was considered a "routine" universal vaccine) and more than doubled to over 20% in 2012.

How effective is this vaccine? Here is the GREAT news- the HPV vaccine is unbelievably effective when given to young adults not previously exposed to HPV (with no prior sexual intimacy). The CDC's data demonstrates efficacy nearing 100% protection for women in preventing cervical, vulvar & vaginal cancers and genital warts, and 90% efficacy in men for genital wart prevention and 75% efficacy preventing early anal cancers.

What happened down under? 
From 2007-2009, Australia provided the HPV vaccine free of charge to all young women ages 12-26, and had extremely high vaccination rates as they utilized the school system to give out these shots. Follow up studies in 2011 and 2012 showed dramatic results, with 92% decline in genital warts in young women (< 21years old),  72% decline in women ages 21-30, and interestingly...an 81% delicate in young (< 21) heterosexual men and 51% decline in men ages 21-30. This is interesting because the young men saw improvement not because they had been immunized, but simply from the widespread immunization of all the women. Pre-cancerous cervical abnormalities also markedly declined in this short time period, and since cervical cancer typically is very slow growing, we expect to see dramatic falls in cervical cancer rates in the next few years and certainly, in the next decade.

BOTTOM LINE: HPV vaccination SHOULD BE a routine immunization for our sons and daughters- talk to your family physician about it at your next visit*

(In this day and age, I feel compelled to add two things: one, I in no way financially benefit from the makers of the Gardasil vaccine; two, yes, we chose to vaccinate our daughters.)

Gardasil- Not for the FAINT,,,

Continuing my discussion this week about the HPV vaccine, Gardasil, I'd like to address side effects. At this point in the United States, there have been over 46 million doses of HPV vaccine administered (the vast majority Gardasil), which implies over 15 million people (since a series includes three shots.)
Unfortunately, when you start involving a population this large, within that group there will be uncommon diseases that occur in the general population. For example, a disease that occurs in only one out of 500,000 will have 30 cases in this group. Sorting out which of these rare occurrences are random and which are linked to a cause such as a vaccine can be challenging.

We have multiple organizations that closely follow adverse reactions to vaccines. The VAERS (Vaccine Adverse Event Reporting System) accepts reports from anyone- patients, family members, clinicians, etc. The Vaccine Safety Datalink coordinates the CDC- Center for Disease Control and Prevention- with managed care systems through electronic medical records. The Clinical Immunization Safety Assessment (CISA) network hooks up the CDC with our academic medical centers. All of these organizations collect and analyze adverse reactions to vaccines, from minor issues like transient pain, redness, swelling or headache, to fainting, blood clots and even death. What have they discovered from Gardasil?

Let's address what was not found first. Although there have been over forty deaths reported, there is no common pattern in these tragic events to link the cause to this vaccine. Some causes of death included diabetes, illicit drug use, heart failure and viral infections (not HPV).

There is an increased incidence of serious blood clots in this group, but only 10% did not have other obvious identifiable risk factors for clotting (such as obesity, smoking, or oral contraceptive use.)

FAINTING (medical term, syncope) IS a real possible side effect of this drug. The numbers are not staggering, but they are significant. Although fainting after vaccination is reported in significantly less than 1% of Gardasil recipients, Gardasil is the most frequently reported vaccine to cause fainting (as a single vaccine), accounting for over half of vaccine-related fainting episodes reported. The good news is that half of the fainting episodes occur within 5 minutes of receiving the shot, and 80% occur within 15 minutes.

BOTTOM LINE: Make sure to wait the full recommended 15 minutes after injection to minimize the risk of fainting, but be assured that Gardasil is a safe vaccine.

Gardasil- What's IN it?

Continuing the discussion about the HPV (Human Papillomavirus) Vaccine Gardasil...I'd like to step back and talk about exactly what is IN this vaccine. Much of the fear about immunizations surrounds concerns about the makeup of the vaccine, and what peripheral damage could potentially be caused from the content.

First of all, can you "catch" HPV from the vaccine? NO. Absolutely NOT. There are vaccines (like chicken pox or measles) that contain essentially watered-down versions of live virus, and as such, can in the course of an appropriate response cause a mild version of the disease as the body reacts to the vaccine, causing long-term immunity. However, the HPV vaccine does not work this way. There is only a tiny portion of the virus  (a surface protein called L1), that scientists extract, multiply and wad up into a ball. Our immune systems "see" this balled-up material as the whole HPV, and make very effective antibodies to fight it off.

What else is in the vaccine as a by-product? Is there thimerosol? NO. Is there Mercury? NO. Is there a tiny bit of aluminum? Yes. 225 micrograms of alum, to be exact, which is the same tiny amount that is allowed in infant formula (and yes, there is even aluminum in breast milk, though less than formula.) Why is there any aluminum in there at all? Well, aluminum is the most common metal found in nature- present in our water and much of our food. In vaccines, aluminum is an "adjuvant"- something added to improve the immune response.

BOTTOM LINE: The HPV vaccine Gardasil creates very effective immunity against the strains of HPV that cause 90% of genital warts and 70% of cervical cancers, and does NOT contain other byproducts that have raised concern in other immunizations.

PS Full disclosure: I am not on Merck's payroll in any fashion. I am a family physician with a special interest in STDs & I believe this vaccine will help prevent much disease & heartache.

Gardasil & Increased Promiscuity? NOT an Issue

The Gardasil vaccine is back in the news. Gardasil is the vaccine recommended for both boys and girls to protect them against the Human Papillomavirus (HPV), which causes genital warts and cervical cancer) Yesterday, an article published in Pediatrics confirmed that girls who had received this vaccine did not, in fact, have any increased sexual promiscuity compared with their peers who did not receive the vaccine. Why was this study done? One reason for lower vaccination rates with this recommended vaccine (compared to other vaccines recommended in this age group) was parental concern that giving their preteen and teenage daughters this shot would appear to be giving "permission" to be more sexually active since they would be protected.

This study looked back at roughly 1400 girls over three and a half years. Almost one third of these girls received the Gardasil vaccine, while the other 2/3 did not. After the immunization, medical issues that can result from increased sexual activity- pregnancy and sexually transmitted diseases- were measured and compared between groups. Results? No significant difference in the two groups.

The results are not surprising, but I am happy to have this data to help reassure any parents who may have this concern. I have not yet found a teen who believes that the Gardasil vaccine somehow makes them bullet-proof in the sexual arena, although I have seen many who falsely believe condoms will do so- but that is a different discussion. If teens are aware of Gardasil, they know it is "for cancer". Only the rare teen (and parent, frankly) seems to realize that this vaccine also protects against genital warts- a disease that affects over a MILLION sexually active people each year in the United States; a disease that often destroys the self-image of young people just as they are trying to make critical life decisions. Genital warts make people feel "dirty" and "gross", and although we can treat warts to make new outbreaks resolve more quickly, we do not have a cure. And if you've ever had a wart frozen off your knee or finger, you know it hurts, so add painful plus embarrassing when that wart is in the genital area.

BOTTOM LINE: Gardasil is recommended as part of our routine vaccinations for both girls and boys to protect them from HPV-related cancers and genital warts. If your child is not yet vaccinated, talk with his or her doctor at the next visit.

HPV: Not Just for Genitals...

A recent study published in JAMA has created a buzz about the Human Papilloma Virus- HPV- again, but this time, the focus is on the mouth. Researches have noted that despite a significant decrease in smoking, head and neck cancer rates are not falling in proportion. It turns out that not only does HPV cause cancers in the genital area (cervical, penile, anal, etc.), but HPV also plays a significant role in causing head and neck cancers.

The study is titled "Prevalence of Oral HPV Infection in the United States, 2009-2010." Over 5000 people (ages 14-69) participated in the study, and it turns out that roughly 7% of them had HPV detected in their mouths. (They swished mouthwash in their mouths for 30 seconds, then this liquid was DNA analyzed for the the presence of different HPV strains.) Men had a higher rate- 10% in men vs. 3.6% in women, and infection was much less common in those people with no history of any type of sexual contact (less than 1% in "virgins" vs. 7.5% in others.) The good news is that the primary cancer causing strain- type 16- was only present at a 1% prevalence rate across the board. (Let's step aside and note here that with HPV, certain strains cause warts, and others cause cancers, so not all strains are equally medically dangerous.) How does the HPV even reach the mouth? Mostly through oral sex. Use barriers (condoms) for ALL sexual intimacy, please. 'Nuff said.

So, will the HPV vaccines (Gardasil and Cevarix) protect against head and neck cancers, too? We certainly hope so! As we get more "herd immunity" (which means more people are vaccinated than not, and so live disease is passed less and less) we hope to see not only a decrease in genital cancers, but hopefully a parallel decline in oral cancers, too.

BOTTOM LINE: HPV is COMMON, both "top" and "bottoms"...let's use our knowledge to prevent the cancers HPV can cause! For me, this is yet another good reason to immunize against HPV.

CDC Now On Board for GARDASIL for BOYS

This week the Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend that 11-12 year old boys be vaccinated against HPV (the Human Papilloma Virus)- hooray! Girls have NO monopoly on genital warts, which affect over one million Americans each year. They are COMMON. Sadly, in my clinical experience, little harms self-image like a young person developing these genital lesions, especially because we cannot simply cure them and make them go away forever.

Genital warts are transmitted by direct skin-to-skin contact, and though this usually occurs during sex, actual intercourse is certainly not required to pass them on. They are very contagious, with transmission rate of up to 65%. Warts typically recur despite treatment, and frankly, the treatment is unpleasant at best- we burn the warts chemically or with liquid nitrogen. If you've ever had a wart frozen/burned off your knee, you know what that feels like, and the genital area has more nerve endings. Enough said!

The Gardasil vaccine immunizes recipients against the two strains of HPV (6& 11) that cause 90% of genital warts. Additionally, Gardasil protects against the two strains of HPV that cause the majority of cervical cancers. While males don't have a cervix to get cancer, they do have other parts that get HPV-related cancers (anal & penile, as well as some head and neck cancers,) although certainly these cancers are less common.

Gardasil was approved for use in males over two years ago, but the public has mainly been aware of the use in females. I'm glad the CDC and ACIP are on board, and hope that with increased education, we can help protect the next generation against HPV-related diseases.
BOTTOM LINE: Gardasil- it's not just for girls! Talk to your family doctor about immunizing ALL your kids.

PS. I am NOT on anyone's payroll for this vaccine- but I absolutely do recommend it.

How Safe is Gardasil?

Parents are appropriately concerned about vaccines, but I get frustrated with the enormous amounts of negative popular press that immunizations are receiving these days. Vaccines are not only saving lives, but they are improving the quality of our lives dramatically with every decade. Today I'd like to discuss the statistics with Gardasil, a vaccine that protects against four strains of the human papilloma virus which cause genital warts and cervical cancer.

Gardasil was FDA approved and recommended in June of 2006. Since that time, over 32 million doses of the vaccine have been administered. There have been over 17,000 "adverse events" reported, including roughly 1000 "serious" events. The mild to moderate events (over 90%) include transient local swelling or pain, mild and moderate fevers, and nausea or fainting.

So what about the serious events, including 56 deaths? The serious events included primarily Guillian-Barre syndrome (a severe neurologic disorder) and blood clots. The numbers of GBS are no higher than expected in the age group receiving the vaccine, and the girls with blood clots typically had other risk factors for clotting, such as taking the birth control pill. Though deaths in young people are tragic REGARDLESS of the cause, there has been no identifiable pattern in these deaths to suggest that the vaccine caused them. If you look at any age population of 10 million people (32 million doses divided by the 3 shots in a series), sadly, you will see certain lethal cancers, neurological diseases, and other rare ailments.

It is important to understand that in order to figure out side effects from vaccines, any and ALL events that happen within a month (or up to a year) after receiving an immunization can and should be reported- even if it looks like they are completely coincidental. For example, if you get a flu shot today, and are diagnosed with advanced leukemia tomorrow, it gets reported as an "adverse event" of the flu shot- even though it obviously was going on before your shot. Why do this? Because we want to be SURE that there is NOT a relationship between any serious diseases and vaccines, and the only way to know is to collect all the data.

BOTTOM LINE: For Gardasil, look at these numbers and remember there are 1 million new cases of genital warts per year, 12,000 cases of cervical cancer and 4000 deaths from cervical cancer. You do the math. We are choosing to immunize our daughters.

Dodge This Bullet...HPV

Yesterday I mentioned that the New England Journal of Medicine recently published a study regarding HPV vaccine efficacy in boys. Today I'd like to explain the study. The title is "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". "Quadrivalent" refers to the fact that the vaccine targets four strains of the Human Papilloma Virus: strains 6 & 11, that cause 90% of genital warts, and strains 16 & 18, which cause the majority of cervical cancers (roughly 70%).
I'll start by saying that yes, the study was partially funded by Merck, the manufacturer of the vaccine. That being said, I do not feel it negates the study, although obviously it introduces some bias. They took over 4000 boys/young men age 16-26, from 18 countries, and gave half a placebo vaccine series, and half real. The study was double blind (no one knew what they were giving or getting), and randomized (which raises the quality of the study.) Some of the participants were fully screened initially to determine if they already HAD any HPV strains, and others were not. Note that in "real life medicine", we have no way to test people ahead of time to see if they have already contracted HPV.

In the young men with unknown prior HPV status, the vaccine had an efficacy of 60%. In those known to be HPV negative initially, the efficacy was 90%. It is not surprising that the vaccine would appear to work better in those that did not already have some strain of HPV, and this supports the reasons to vaccinate youth BEFORE they are sexually active. I thought it was interesting that they ended up with 1% of the placebo subjects developing genital warts- the same as in the general population. I am encouraged that the incidence in those vaccinated dropped to 0.1%.

The devil is always in the details, and how people pull out statistics. I could note, for example, that 3 patients in the placebo group received gun shot wounds, while only one in the vaccine group did- but obviously the vaccine did not prevent gun shot wounds! The good news here is that true adverse events were minimal and of uncertain relationship to the vaccine.

BOTTOM LINE: HPV vaccination can significantly reduce the incidence of genital warts in young men as well as young ladies, with minimal side effects.

HPV Vaccine (Gardasil)- Don't Forget the BOYS!

I'll bet you could quote the commercial for the HPV vaccine, Gardasil, about choosing to be "one less"- one less woman to get cervical cancer. This is one time where I am pleased that the media is playing a role in pharmaceutical awareness! We absolutely want EVERYONE to know about cervical cancer and the exciting news that we now know not only how this cancer is caused and spread, but most importantly, we know how it can be PREVENTED.

Did you know, though, that this vaccine also protects against genital warts? Two strains of HPV (6& 11) cause 90% of genital warts. Every year there are over a MILLION cases of genital warts in the United States alone. They are COMMON. These warts are transmitted by direct skin-to-skin contact, and though this usually occurs during sex, actual intercourse is certainly not required to pass them on. They are very contagious, with estimates up to 65% transmission. Warts typically recur despite treatment, and frankly, the treatment is unpleasant at best- we burn the warts chemically or with liquid nitrogen. If you've ever had a wart frozen/burned off your knee, you know what that feels like, and the genital area has more nerve endings. Enough said!

While males don't have a cervix to get cancer, they do have other parts that get HPV-related cancers (anal & penile, as well as some head and neck cancers,) although certainly these cancers are less common. Obviously, males can also get genital warts. In my clinical experience, little harms self-image like a young person developing these genital lesions, especially because we cannot simply cure them and make them go away forever.

Gardasil was approved for use in males over a year ago. A study recently published in the New England Journal of Medicine demonstrated that the vaccine had good efficacy in prevention of genital warts in males. More on this study tomorrow...

BOTTOM LINE: PREVENTION is KEY for HPV disease- talk with your doctor (or your child's doctor) about HPV vaccinations for your SONS & DAUGHTERS.

PS. I am NOT on anyone's payroll for this vaccine- but I absolutely do recommend it.