Ok. This is a hot topic right now and getting plenty of press so I might as well jump on the bandwagon and throw out my two and a half cents.
Just as a little background, Gardasil hit the market in 2006 with much fanfare. The idea of vaccinating little girls and potentially little boys against high risk HPV (human papilloma virus) subtypes to prevent the sexually transmitted infection that causes cervical cancer. At one point the state of Texas had legislation heading to the books that would have made the vaccine mandatory for school-aged children.
The vaccine is effective against subtypes of the virus 6, 11, 16, 18. The first two are responsible for genital warts primarily whereas the last two are the major culprits behind agressive dysplasia (abnormally growing cells) and cervical cancer (the outcome if left unchecked). In 2008 there was approx. 11,000 new cases of cervical cancer. The pap smear has become one of the single most effective screening tools in modern medicine and has moved cervical cancer out of the top 3 causes of cancer related deaths for women. So the most natural step would be to try and prevent the known culprit from even getting a head start.
Now if you read my last blog about Herpes you know that it is very easy to spread STDs. It could not be any easier than with HPV. There is currently no testing for HPV in men and therefore no way to find out who is carrying the aggressive strain of the virus and stay away from him. The best way is to stay abstinent until marriage and then stay faithful to your spouse but of course this is not the way our free society views sex (sorry about the soap box...I'll put it away now).
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According to the package insert from Merck:
Serious Adverse Reactions in the Entire Study Population
A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9-through 15-year-old boys) who received both GARDASIL (N = 13,686) and AAHS control (N = 11,004) orsaline placebo (N = 584) reported a serious systemic adverse reaction following any vaccination visit during the clinical trials for GARDASIL.
Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic
adverse reactions were judged to be vaccine related by the study investigator. The most frequently reportedserious systemic adverse reactions for GARDASIL compared to AAHS control or saline placebo and regardless of causality were:
Headache [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Appendicitis [0.03% GARDASIL (4 cases) vs. 0.01% AAHS Control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. 0.04% AAHS Control (4 cases)],
Urinary tract infection [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pneumonia [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pyelonephritis [0.02% GARDASIL (2 cases) vs. 0.03% AAHS Control (3 cases)],
Pulmonary embolism [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)].
Deaths in the Entire Study Population
Across the clinical studies, 24 deaths were reported in 25,274 (GARDASIL N = 13,686; AAHS Control N= 11,004, saline placebo N = 584) subjects (9- through 45-year-old girls and women; and 9- through 15-year-old boys). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 AAHS Control subjects), followed by overdose/suicide (2 subjects who received GARDASIL and 2 subjects who received AAHS Control), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 AAHS Control subject). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, and 1 case of systemic lupus erythematosus in the group that received GARDASIL; 1 case of asphyxia, and 1 case of
acute lymphocytic leukemia in the AAHS Control; and 1 case of medulloblastoma in the saline placebo group.
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In the past year there has been much horrible press for Merck. Gardasil has been "associated with" several adverse events from painful injection sites, neurologic issues, immune disease, blood clots, pulmonary embolism, and death. I used the "quotes" because there has not been any 1:1 correlation between the vaccine and death. The CDC is standing by the statement that Gardasil is safe and the risk outweigh the benefits. To date there are approx 12,000 adverse events reported of which a few deaths have been included.
The question is does the overall good that the vaccine can bring to millions outweigh the small percentage of bad outcomes?
Well if it were my daughter I would say.... NO! Even though I truly believe that this is a giant leap forward for prevention of cervical cancer I can't, in good conscience, tell my daughter or my patients to get the vaccine.
Thursday, August 20, 2009
Sunday, August 16, 2009
A quiet epidemic
First of all, sorry for the delay in posting. I've been a little busy and haven't had the time to post. I thought that this would be a good topic and will definitely get you thinking.
Genital herpes is probably one of the most quiet epidemics in the U.S. to date. CDC states that that approx. 1:4 women are positive for herpes (1:8 for the men). One of the reasons that I believe that this disease continues to propagate is because there is no mandate to screen patients.
The disease is one that takes about 2 weeks to present itself after initial exposure. The problem is that only about 25% of infected patients will have the classic painful ulceration that will drive them to the doctor's office. The remainder of the patients will not have a single classic symptom. As a matter of fact the symptoms that most patients will have are similar to that of a yeast infection (women) or jock itch (men). What I have found in my office is that this is exactly what is happening on a daily basis. We have, in the past year to year and a half, started offering a full STD screening that includes herpes (Gonorrhea, Chlamydia, Trichomonas, Syphillis, Hepatitis, HIV, and Herpes). Just as an aside, if you haven't had blood testing for STD screening you probably haven't been tested for the last four diseases.
Now, the problem with offering testing for herpes is not the patient that comes in with problems but it is the patient who is asymptomatic. My problem has been telling a 43 year woman with no symptoms that she is positive for herpes. How does she tell her significant other, lover, husband that she is positive? When I have posed the question to some of my medical colleagues about screening the response has been, "Why open a can of worms?" For the asymptomatic patient why should she be screened for a disease process that may never cause her a single problem in her life (remember that the majority of patients will be asymptomatic)? The answer is HIV. Wait, wait, wait... I thought that we were talking about HSV (herpes)! HSV can increase any patient's susceptibility being infected with HIV. The thought is that because of the lesions the virus has a easier access.
Let's throw another wrench in the thinking. Herpes is classically understood to be classified as HSV-1 (oral) and HSV-2 (genital). It does not take a rocket scientist to understand this concept: anyone who participates in oral sex makes theirself a candidate for a outbreak of HSV-1 on their genitals. I bring this thought up because most would consider a new outbreak of herpes as a sign of infidelity of their partner. The truth is that the outbreak may be a HSV-1 or HSV-2. I adamantly oppose telling any patient that their partner has been unfaithful based on a positive test or symptoms pointing towards herpes. The reality is that the patient could have been infected with their first sexual experience.
So what's my recommendation? If you have been with one partner for the past several years and have never had a single outbreak don't run to the doctor to try and find out your status. Why?... Ignorance can be bliss in this situation. If you are positive more than likely your partner is positive and neither one of you can get more positive. What I have seen more than once is strife and fear being brought into a situtation that need not happen. Now if you are planning to hit the dating scene it would behoove you to know what you are bringing to the bedroom. For my patient's that either practice serial monogamy or that ... well don't I want them to know where they stand.
[At the risk of sounding preachy I must fall back to the biblical principal of one husband and wife concept. It's old fashioned but if you have a true covenant between the two this won't be a concern.]
Genital herpes is probably one of the most quiet epidemics in the U.S. to date. CDC states that that approx. 1:4 women are positive for herpes (1:8 for the men). One of the reasons that I believe that this disease continues to propagate is because there is no mandate to screen patients.
The disease is one that takes about 2 weeks to present itself after initial exposure. The problem is that only about 25% of infected patients will have the classic painful ulceration that will drive them to the doctor's office. The remainder of the patients will not have a single classic symptom. As a matter of fact the symptoms that most patients will have are similar to that of a yeast infection (women) or jock itch (men). What I have found in my office is that this is exactly what is happening on a daily basis. We have, in the past year to year and a half, started offering a full STD screening that includes herpes (Gonorrhea, Chlamydia, Trichomonas, Syphillis, Hepatitis, HIV, and Herpes). Just as an aside, if you haven't had blood testing for STD screening you probably haven't been tested for the last four diseases.
Now, the problem with offering testing for herpes is not the patient that comes in with problems but it is the patient who is asymptomatic. My problem has been telling a 43 year woman with no symptoms that she is positive for herpes. How does she tell her significant other, lover, husband that she is positive? When I have posed the question to some of my medical colleagues about screening the response has been, "Why open a can of worms?" For the asymptomatic patient why should she be screened for a disease process that may never cause her a single problem in her life (remember that the majority of patients will be asymptomatic)? The answer is HIV. Wait, wait, wait... I thought that we were talking about HSV (herpes)! HSV can increase any patient's susceptibility being infected with HIV. The thought is that because of the lesions the virus has a easier access.
Let's throw another wrench in the thinking. Herpes is classically understood to be classified as HSV-1 (oral) and HSV-2 (genital). It does not take a rocket scientist to understand this concept: anyone who participates in oral sex makes theirself a candidate for a outbreak of HSV-1 on their genitals. I bring this thought up because most would consider a new outbreak of herpes as a sign of infidelity of their partner. The truth is that the outbreak may be a HSV-1 or HSV-2. I adamantly oppose telling any patient that their partner has been unfaithful based on a positive test or symptoms pointing towards herpes. The reality is that the patient could have been infected with their first sexual experience.
So what's my recommendation? If you have been with one partner for the past several years and have never had a single outbreak don't run to the doctor to try and find out your status. Why?... Ignorance can be bliss in this situation. If you are positive more than likely your partner is positive and neither one of you can get more positive. What I have seen more than once is strife and fear being brought into a situtation that need not happen. Now if you are planning to hit the dating scene it would behoove you to know what you are bringing to the bedroom. For my patient's that either practice serial monogamy or that ... well don't I want them to know where they stand.
[At the risk of sounding preachy I must fall back to the biblical principal of one husband and wife concept. It's old fashioned but if you have a true covenant between the two this won't be a concern.]
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