Category Archives: HPV

HPV Myths – BUSTED

Myths

There’s an awful lot of misinformation out there about HPV and the HPV vaccine. Let’s see what I can do to clear up the confusion. Here are eight myths I find myself having to continually address with my patients. Let’s bust ’em!

Myth#1 – HPV is forever

Wrong. 90-95% of the time, HPV infections clear without any treatment. For those women with persistent HPV infection, we have pap smears to detect and treat precancerous lesions (dysplasia) years before they become invasive cancer.

Myth #2 – If I’ve had the HPV vaccine, I don’t need Pap smears.PAP

Wrong again. While the HPV vaccine is highly effective against the HPV strains it targets, and those strains together cause in excess of 70% of all cervical cancers, you are not 100% protected. Sorry. Until we have a vaccine that protects against all the cancer-causing subtypes, you’ll need to get your pap smears.

The good news in this front is that both Gardasil and Cervarix are showing cross-reactivity against other cancer causing strains of HPV so we may be getting a bigger bang for our buck than we initially thought. Stay tuned..

Myth #3 – The HPV Vaccine is dangerous.

danger

Actually, it’s quite safe. A recent comprehensive review of HPV vaccine safety studies to date, some with over a million subjects each, found no serious health risks from the vaccine.

Like all vaccines and injections, HPV vaccination can cause some local irritation on the arm, and some young girls faint afterwards. This is not serious.

Myth #4 – The HPV Vaccine is a Scamscam

No, it’s not.

There are valid arguments to be made as to whether the HPV vaccine is the most cost effective approach to eradicating cervical cancer in the US, where most women are already getting pap smears, and where those at highest risk (women who can’t afford pap smears) probably can’t afford the vaccine either. And we won’t get into the ridiculously high cost of the vaccine, or how fear mongering and politics have been used to market the HPV test and its vaccine. (I’ve written enough about this before). But that doesn’t make it a scam. The vaccine is real and it works.

Some have raised legitimate concerns that the vaccine’s efficacy could wane over time, effectively just delaying but not preventing cervical cancers. Fortunately, this has not panned out to date – the vaccine has shown no decline in immunity for up to 9 years. Time will tell on this one, but so far, so good.

Bottom line is that the HPV vaccine is safe and effective. I see no reason why young women should not get the vaccine. (My kids have gotten it, by the way.)

Myth #5 – The HPV Vaccine causes sexual promiscuity lips2

Nope. It doesn’t. (Research reference here)

Myth $6- If I have HPV there is nothing I can do about it.http://www.dreamstime.com/stock-images-emotion-2-image597604

You’re not powerless – there are some things you can do.  In addition to getting your pap smears, you can help your immune system clear the virus in three ways –

  • Use condoms. By decreasing the exposure of your body to more virus, you’ll free your mmune system up to clear the virus you already have.
  • Get 4-6 servings of fruits and vegetables a day. Women who do so clear the virus sooner than women who don’t.
  • Don’t smoke. If having HPV is your wake up call to quit the cigs, then so be it. Ask your doc for help if you need it to get off nicotine.

Myth #7 – All HPV Tests are the same.

technology

Not true. Some are FDA approved, some are not. Ask your doc which test he/she uses, and be sure its an FDA approved test.

Myth #8- I can’t get the HPV vaccine if I’m over age 26.

Actually you can probably get it if you really want it. But you may not need it.

The vaccine is only FDA-approved up to age 26. That’s because by that time, most women have had one or more HPV infections already. From a public health perspective, it doesn’t make much sense to vaccinate a population against a virus that most are already immune to.

But on an individual basis, the vaccine could be effective if you’ve had very few sexual partners and have never been infected with the HPV strains targeted by the vaccine or had genital warts. Even if you have, there’s no way to know what HPV strains you may already be immune to – the HPV test is not strain specific. (Although one test does detect HPV16/18). I do not recommend getting HPV tested just for this purpose.

I’m hearing that some insurers will pay for the HPV vaccine even in women over age 26. And if they don’t, you can pay for it yourself. Talk to your doctor and make your own choice.

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More TBTAM posts on HPV

The Not So Scary Truth About HPV

http://www.dreamstime.com/stock-images-emotion-2-image597604There’s a downside, I think, to educating the public about the link between HPV infection and cervical cancer.  And that’s scaring the bejesus out of every woman who happens to find out she has HPV.

It’s not surprising that you’re scared.

You see, we want you to know that HPV infection is linked to cervical cancer, and that we have a vaccine against HPV that can prevent cervical cancer. So we’ve been doing our best to get the word out. (With no small bit of help from the HPV test and vaccine manufacturers.)

But in our zeal to get you screened and vaccinated, we sort of forgot to tell you something equally important. And that something is this –

Pretty much everyone – 80% of US adults- will get HPV at least once, if not more than once, in their lifetime. At any given time, 20-30% of US women ages 14-59 have HPV. That’s right – a third of the female population. If you include men, there are about 20 million persons at any given time in the US who have HPV.

The overwhelming majority of HPV infections do NOT lead to cervical cancer. Around 95% of the time, the infection clears, usually within 1-2 years, without you, or anyone, doing anything

Yes, the problem with HPV disease awareness is that it ultimately makes every woman feel like she have a bull’s eye on her cervix. Which may a good way to get her in for HPV testing and vaccination, but is actually misleading women about an infection that basically everyone gets at some point in their lives.

The Not So Scary Truth About HPV

The truth is that while having HPV is a necessary precondition for getting cervical cancer, it’s also true that almost all HPV infections DO NOT lead to cancer

Think of it this way. Getting in a car is a necessary condition for having an automobile accident, but in fact, most of us will make it to our destination alive. Same thing with HPV. The chain of events that ultimately leads to cervical cancer starts with HPV infection, but almost all the time something intervenes to prevent cancer. That something is called your immune system.

If for some reason, your immune systems doesn’t do the job, and you’re in the 5% of women with HPV who don’t clear the infection, we have ways to monitor you closely so that if a precancerous lesion arises, we can treat it. Years before it becomes cancer.

But I have “High Risk” HPV 

So does everyone else with a positive HPV test.

“High risk” HPV subtypes are called that simply to distinguish them from the “low risk” types that cause genital warts.  Current HPV tests only screen for the “high-risk” types. So by definition, if you’re HPV positive, you have a “high risk” strain. (Someone really needs to change the name of that test…)

But if everyone has HPV, and most infections clear without treatment, then why do we test for it? 

HPV testing is better at finding precancerous lesions that Pap smear alone, so what the Pap misses, the HPV test will find. It’s so good that it’s being considered as a replacement for the pap smear as the first line test for cervical cancer screening.

The HPV test is also good for weeding out the false positive Pap smears. A mildly abnormal pap (ASCUS) can be safely ignored and repeated in a year if the HPV test is negative. This saves a lot of women unnecessary testing.

The other good thing about HPV testing is that if it’s negative, you’re really in the clear. So much so that if both the Pap and HPV test are normal, the risk for cervical cancer plummets, and you can safely wait up to 5 years between pap smears.

The problem with HPV Testing

The problem with HPV testing is that it has a very high false positive rate. Most of the women with HPV  actually do not have precancerous lesions. They just have HPV.

That’s what happened to NYC Councilwoman Melissa Mark-Viverito, who then went public with her HPV diagnosis on Twitter. Ultimately, when she had additional testing after her HPV diagnosis, she found out that she was fine.

Of course, you don’t want to ignore the fact that you have HPV.

You should take it as a sign that you, of all people, need to get your pap smears regularly. Or , if your doctor recommends it, have a simple office procedure called a colposcopy – a magnifying lens that looks for tiny abnormalities on the cervix that are too small to be seen by the naked eye, but if found, can be treated so that you never get cervical cancer.

But know that it would be exceedingly unusual for you to actually have cervical cancer just because your HPV test is positive. This is about finding precancerous lesions, and ultimately, preventing cancer.

So if you have HPV, don’t be scared. But be smart.

If you have HPV, odds are overwhelming that you’re going to be fine.  Between the HPV test and the pap smear, if you have anything precancerous, we’ll find it and we’ll treat it. Years before it becomes cervical cancer.

In the meantime, there are things you can do to help your immune system along. Things like not smoking, using condoms, getting enough sleep and getting 4-6 servings of fruits and veggies each day. Women who do these things clear the virus faster, although ultimately most will clear it anyway.

So do be smart and get screened. And follow through on whatever testing is recommended based on that result.

But please. Don’t be scared.

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More good info on HPV and cervical cancer.

A slightly modified version of this post first appeared on WebMD.

Is Your HPV Test FDA Approved?

bd sure pathSome doctors and their patients will be surprised to learn that the test they are using to screen for HPV may not be FDA approved, according to a special investigation by the Arizona Republic/USA Today.

HPV Testing can be performed on the same specimen as the pap smear, often after the pap result is found to be mildly abnormal, in a process called HPV co-testing.

But if your pap smear has been obtained using Becton Dickinson’s Sure -Path pap collection system, you and your doctor need to know that the specimen it is not FDA approved for HPV co-testing, due to higher than acceptable false negative HPV results resulting from specimen degradation in the SurePath media over time.

This has not stopped some of the nations largest labs, including Quest Dignostics, Lab Corp, Aurora Diagnostics, Sonic Health, Bio-Reference Labs and ARUP labs, from using the Sure-pap specimen off label for HPV co-testing, based on studies each lab has done to confirm the validity of the test in their hands. Although such off-label use is perfectly legal, the FDA and the manufacturer issued a letter in June warning the labs that they should be using an FDA-approved system test and not the SurePath for HPV testing.

BD LETTER

That letter, however, was only sent to the laboratories and not to the doctors using the Sure Path system, meaning that physicians and their patients were unaware of the issue until it was reported this week in the press.

You should know that the BD specimen is just fine for the pap testing itself, comparing favorably to its competitor, the Thin Prep System, and perhaps having lower rates of unsatisfactory specimens than Thin Prep. SurePath is also FDA-approved for co-testing for gonorrhea and chlamydia. But not HPV co-testing.

How big is the potential problem?

Just how high the false negative rate is with SurePath is not clear – since the FDA applications for HPV co-testing with SurePath were withdrawn, the data are nowhere in the public domain. The Republic article tries to estimate the potential impact, but they do not cite the study they are using to make their estimates, so I quote this with some reservation update – see reference in comments –

SurePath accounts for about a third of the HPV tests, or about 3 million a year, estimated Michael Farmer, a market analyst who specializes in the pathology and histology laboratory markets. … extrapolating from the findings of a Johns Hopkins University study (unfortunately, not cited – MMP) suggests a thousand or more women tested each year using SurePath may be told they are HPV-free when they are not.

Why would a lab use a non-fda approved test over one that is approved?

Most leading national labs would not explain to The Republic why they use SurePath despite the warning. But each kit costs labs between $1 and $2 less than alternatives that are FDA-approved for HPV tests.

Both Quest and ARUP labs reported doing their own internal validation before using the SurePath for HPV testing, and Quest’s validation included patient samples, as if they were running their own little FDA trial. BIo Reference Labs states they switched 90% of their clients to an fda-approved test when they got the warning from the FDA. ARUP apparently sent letters to clients in October notifying them of the FDA’s warning.

There appears to be support in the pathology community for using the SurePath system for HPV testing, since the College of American Pathologists states the following  –

Non-FDA approved off-label methods for hrHPV DNA detection are commonly used in laboratories, and are acceptable under CLIA ’88 assuming appropriate self-validation studies are performed. Such off-label use most commonly consists of approved methods (Qiagen or Hologic) used with different non-FDA approved transport medias ( e.g., BD SurePath). In addition, non-FDA approved methods such as polymerase chain reaction (PCR) and in situ hybridization have been used for high risk HPV DNA detection. Because of the high volume of hrHPV testing performed and the implications for clinical management of patients based on the results, guidelines for validations have recently been published and include both analytic and clinical components.

However, Phil Castle, PhD, a cervical cancer researcher who was interviewed for the article, had this to say in his blog about using the BD pap for HPV testing –

Currently, there are 4 FDA-approved HPV tests for cervical cancer screening. However, none of them have approval for use with a liquid-based cytology (Pap) buffer called SurePath. Many pathologists like SurePath for Pap testing. But there is no approval for HPV testing because the buffer degrades the quality of the HPV DNA very quickly. A manufacturer of one FDA-approved HPV test has failed to get FDA approval for use of SurePath several times. Even the company that makes SurePath, BD, is urging clinical labs to stop this practice.

What is disconcerting is that there are plenty of alternative choices for valid HPV testing. So it is unethical to offer women less than optimal care just because a pathologist wants to use SurePath.

I myself would not be satisfied with a lab’s internal validation of a non-FDA approved test when an FDA-approved alternative exists. I had always assumed (naively it seems), that any test a lab uses must be FDA approved. If not, then the result I receive from that lab should indicate to me what test they are using, why it is being used and what issues exist with that test.

I do not use the BD Pap Collection Kit

My patients can be assured that the pap collection system I use in my office (Thin Prep) is FDA approved for both Pap and HPV co-testing.

What should you do with this information?

Ask your doctor what Pap smear collection kit he/she uses – it will be prominently labelled on the collection vial for you to see. If it’s BD’s test, and you need HVP testing, make sure a separate specimen for HPV is taken using an FDA-approved collection device.

If you’ve had a recent negative HPV test, ask your doctor how the specimen was obtained. If it was done using the BD pap system, ask your doctor if there is a need for repeating the test using an FDA-approved collection device. If your doctor thinks it is prudent, then retest. In most cases, so long as your pap was normal, simply doing a pap and repeating the HPV at your next checkup will be all that is needed. If the negative HPV was used, however, to triage an mildly abnormal pap, then a sooner repeat pap or repeat HPV test might be indicated.

Logistically, not being able to to an HPV on the pap vial is problematic, since we often do not know until after the pap is read whether or not HPV testing is needed.  By default, then, docs may end up either moving to another pap system or getting HPV routinely with every pap using an FDA-approved collecting system.

Kudos to Bob Ortega at the Arizona Republic for some of the best health reporting I have ever seen.

His article not only gives me almost everything I need to know on this issue as a clinician, but includes information on how the article was complied, and excellent info for patients wondering what to do themselves with this information. Unfortunately, however, he did not link to the Hopkins study that he cited, and I’ve been unable to find the study myself. UPDATE – see reference in comments. Thanks, Dr Austin!

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Recommended Reading

 

HPV in Menopause – Old Infections or New Relations?

Menopausal couple cropped
New love comes at all ages.
So can HPV.

When HPV occurs in the menopause, is it due to reactivation of a previous HPV infection or a newly acquired infection?  That’s the question asked, but not properly answered in this doc’s opinion, by a new study published this week in the Journal of Infectious Diseases.

Researchers performed HPV testing in 843 women age 30-60, and found an increased prevalence of HPV infections among women in the peri-menopausal age group who also reported having had >5 lifetime partners, but not necessarily a new partner within the past 6 months. They concluded that this second lifetime peak of HPV infections (the first peak occurs in the second decade) was due, not to new HPV infections, but to infections acquired in the earlier years that were now re-emerging with older age and waning immunity.

The fact that we have not seen this peri-menopausal HPV peak in prior population-based studies, they say, is because most women in this age group until now have not had so many sexual partners.

The study’s findings contradicts what we are now telling women, which is that most HPV infections permanently clear within two years of an initial infection that occurs primarily during the second and third decades.

Erroneous conclusions based on a flawed study design

I take strong issue with the study’s conclusions, based on over two decades taking care of peri-menopausal women in a country where 50% of marriages end in divorce.

The flawed conclusions of this study stem from what I believe to be a flawed methodology – namely using 6 months as a cut off for defining women as having had a recent new partner, an artificial categorization that makes no sense socially or biologically. As a result, the researchers may have missed much of the important new sexual activity in their cohort that could explain an increase in HPV infection around the age of menopause.

Sex, HPV and the Middle-Aged Woman

Many women in their middle years have new relationships through divorce, dating and often, remarriage. HPV infection can occur at any time in a recent relationship, not just in the first 6 months (a part of which time many couples use condoms). These infections can persist up to 2-3 years before they clear and be diagnosed any point in that time frame.

In my own clinical practice, the overwhelming majority of HPV infections in this age group occur in women who have had a clear change in partnership within the past 1-5 years. Not surprisingly, theses HPV infections clear in the same 12-36 month time frame as the infections I’m diagnosing in the younger crowd.

Remember too, that it is at middle age that some of the husbands will start to wander – bringing home a new infection to a woman who has not had a new sexual partner in decades. The study does nothing to address this possibility. Not that any study can, of course, but you get my point.

A better study design would have been to ask how long the subject has been in her current relationship , and correlate that with HPV prevalence.

Bottom Line –

The study raises interesting questions, but unfortunately its design limits its conclusions, which to this clinician don’t make sense given what we know about HPV infection and the social lives of women.

While we cannot completely discount the possibility of reactivation of dormant HPV, this study, in my opinion, does little to answer the question it raises.

Unfortunately, the publicity around this study is sure to drive anxiety among every menopausal woman out there, especially as we are now telling them that they can back off on pap smears if theirs have been normal up till now. (I myself am not 100% comfortable with the new pap recommendations, by the way...)

What if you have a positive HPV and have not had a new partner?

I see two possible ways that a women can have HPV and not have a new HPV infection.

One is a longstanding persistent HPV infection that is only now causing precancerous changes, which as we know can take decades to appear. Is this reactivation of a dormant HPV infection or just delayed detection? After all, we only recently began testing for HPV, so unless we have a prior negative test, it’s hard to say, isn’t it?

The second is that menopause itself can lead to low grade pap abnormalities related to estrogen deficiency rather than true pre-neoplastic changes.  In women without HPV, these are so called false positives. But in women who may have a persistent HPV infection, this estrogen-deficient pap may be the first time she has ever had an HPV test.

The important point with these two scenarios is that not every HPV infection necessarily comes from a new partner (or a wayward husband).

Which is good to know.

Are You Obligated to Tell Your Partner(s) that You Have HPV? This Doc Says No.

One of the most common questions I get from my patients who have had had an abnormal pap due to HPV infection is this –

Are they obligated to notify their past, current, future or potential sexual partners that they have or have had HPV?

I believe the answer is a qualified no. And here are the reasons why –

1. HPV is ubiquitous.

Close to three-quarters of adults have had HPV at some point in their lives. Ninety five percent of the time, that infection will clear within 1-2 years with no long-term consequences to themselves or their partners.

Although we can offer treatment or removal for genital warts and precancerous pap smears, there is no medical treatment to clear the HPV virus itself in an infected individual without these conditions. That’s the job of the immune system, which can be helped along in this regard by using condoms, avoiding tobacco and eating a diet rich in fruits and vegetables.

2. Unlike women, most men with HPV have no way of knowing they are infected.

Unless they have a visible genital wart, or a much, much rarer HPV-related cancer, most men who have HPV have no idea they are infected. That’s because there is no available HPV test for men. 

Women, on the other hand, if they happen to get an abnormal pap smear during the time they are infected, may very well find out that they have HPV. (I’m not going into the management of abnormal paps here, but suffice it to say that the overwhelming majority of abnormal paps due to HPV will resolve without treatment just as the virus itself resolves. Those that don’t, and which carry precancerous changes, can be effectively treated,)

3. Why then, should a woman be obligated to tell her partner that she has HPV? 

Given the ubiquitous nature of HPV infection, unless her partner is a virgin, the odds are pretty darned high that he already has had HPV. He may actually have the infection right now and be the one who gave it to her. On the other hand, he may have had it in the past and already be immune to the strain of HPV she has. Or be infected with another strain she does not have, so that she may actually be the one taking the risk by sleeping with him.

She’ll never know, and he’ll never know. Because he cannot be tested. Or treated.

4. HPV is not like chlamydia.

There is no role for partner notification and  treatment in preventing the spread of HPV. The only thing that partner notification accomplishes is to turn women with abnormal paps into pariahs, while the rest of the HPV infected men and women out there continue to copulate in blissful ignorance.

Which is why I don’t believe that every abnormal pap needs to turn into an STD confessional.

I do believe that all sexually active adults have an obligation to themselves and others to  prevent the spread of HPV and other STD’s by practicing responsible sexual activity.

That means being tested and treated for those STD’s whose spread we can stem through screening and partner notification, being vaccinated against those we can prevent, using condoms and limiting our numbers of sexual partners.

It’s not a moral message, unless morality means acting responsibly and maturely, and respecting one’s own health and that of others. By limiting one’s partners, I mean confining intimate physical relationships to those who we really care about. (Dare I use the word love?…)

In this context, some women may take HPV infection as a sign that it’s time to stem the one night stands.  A few may choose to hold off on relations altogether until their infection clears. The majority, who are already limiting their sexual activity to caring relationships, will make no changes in their behavior except perhaps to use condoms until the infection clears. And if they are already in a caring relationship, they usually end up discussing it with their partner. Because that’s what couples do – they talk about their lives, their health and their fears.

Which is very, very different from mandatory STD partner notification and treatment.

The Good News

The good news for HPV-infected women is that almost all HPV infections will clear. Once HPV is gone, your increased risk for cervical cancer goes with it. As does your risk for transmitting the virus to others. Which takes care of the issue of future partners.

The other good news is that getting regular pap smears will prevent the uncommon but important consequence of HPV infection – cervical cancer.

Genital warts are worth discussing with your partner.

I do think it’s worth discussing with your current partner if you discover that you have genital warts.More often that you’d think, the male partner may have  small, previously undetected genital warts that are amenable to treatment. He can visit his doc for a careful exam and get treated if warts are present. That in turn may help you clear the infection faster yourself, since your immune system won’t be under constant barrage with high viral loads from your partner.

Condoms are also worth discussing.

If you have an abnormal pap due to HPV, and you are not using condoms, it’s worth discussing the matter with your partner and asking him to use protection when you have sex. Women with HPV whose partners use condoms will clear the virus and return to normal paps faster than those who have unprotected sex.

There is a role for HPV vaccination.

I also support the use of HPV vaccination. Despite my objections to how it has been priced, marketed and legislated, the vaccine is safe and effective. Getting vaccinated after you’re infected won’t help you clear the infection faster, but can prevent new infections with the 4 strains that the vaccine targets.
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Cervical Cancer Screening – The Jade Goody Effect

The Telegraph reports that the number of screening pap smears performed in the UK has declined, after an 8% blip upwards in 2009 when publicity surrounding the death of Jade Goody from cervical cancer may have led more women to have this important screening test.

NHS laboratories processed 415,497 tests in 2009-10, about 35,000 fewer than the previous year when 450,522. Miss Goody’s death in March last year prompted a 20 per cent increase in the number of Scottish women taking tests. More than 122,000 were processed between April and June last year, the statistics revealed.

The irony of course, is that British reality TV star Jade Goody did have pap smears, but chose to ignore her doctor’s recommendations for treatment when her pap smears came back abnormal.

Nonetheless, the decline in pap smears has led NHS of Scotland to initiate a campaign to reach the up to 25 % of young women who do not respond to invitations to have pap smears.

In England, women are invited to start pap smears start at age 25, while in the rest of the UK, they start at age 20. Britain’s guidelines are in line with the WHO’s, and it has been reported that Ireland may raise the start age for paps there to 25.   There are less than 60 cases of cervical cancer annually in the UK in women under age 25.  Is this enough to justify nationwide screening in women in the 21 to 25 age group?

Jade’s Mum thinks so. She has backed a local British campaign to lower the age when pap smears are initiated in Britain from age 25 to age 21 to bring it in line with the rest of the UK.

Decisions about when to initiate cervical cancer screening must weigh the risks of false positives and the risks of treatment, which can impact fertility, against the risk of missing the opportunity to prevent cervical cancer by treating precancerous changes in the cervix before cancer develops.

Here in the US, we recently upped the age for initiating cervical cancer screening  to age 21 in normal women, because cervical cancer is so exceedingly rare in women under that age unless there is some immune compromise. Abnormal pap smears in women under age 21 are almost certainly due to transient HPV infection that will never progress to cervical cancer, but which leads to thousands of unnecessary colposcopies and biopsies annually.

Cancer Stats Deliberately Altered

Someone’s been messing around with the cancer statistics in Maryland. Apparently a private vendor, which had contracted to collect the statistics, was responsible.

Here are specifics from the FHA report itself.

..MCR data (for 2001 and 2002) had been deliberately altered between August
2004 and December 2004. Specifically, over 13 percent of all cases in diagnosis
year 2002 showed some sign of alteration, especially cervical, prostate, and melanoma cancer cases. The investigation disclosed that the changes were made
after the cases were initially entered into the MCR by the laboratory facility or provider (such as, changes to the codes from non-invasive cancer to invasive cancer and changes to the year that the diagnosis was made)…

The vendor concluded that these changes were methodical and were made by one or more persons with broad access to the system, and not a result of a random set of events.

As a result of the aforementioned changes, recipients of the MCR data (such as, federal Centers for Disease Control and Prevention, NAACCR, other states, and researchers) were obtaining and using incorrect data.

It’s unclear as to what the motivation was for over-reporting of cancer statistics.

Given all the politics around cervical cancer vacination at this point in time, this information is sure to cause concern, although I’m not sure to what use, if any, the 2002 data may have been put in this regard. Studies I’ve seen that examined the cost effectiveness of HPV screening and vaccination used much earlier cancer incidence data.

HPV Mandatory Vaccination – "Private wealth should never trump public health"

Lawrence Gostin, JD and Catherine DeAngelis, MD have co-authored an extremely well-written editorial outlining the arguments against mandatory HPV vaccination in the May 2, 2007 issue of JAMA. The editorial can be accessed for free from the JAMA website.

Public health authorities, pediatricians, and infectious disease specialists, rather than political bodies, should drive mandatory vaccination decisions and policies… Since the manufacturer stands to profit from widespread vaccine administration, it is inappropriate for the company to finance efforts to persuade states and public officials to make HPV vaccinations mandatory, particularly so soon after the product was licensed. Private wealth should never trump public health.

The authors are careful to steer clear of arguments that oppose the vaccine on moral grounds. In my opinion, groups using these arguments have muddied the waters by framing this as a moral issue, when in fact, the most cogent arguments against mandatory vaccination are made from a public health perspective, and are medical, economic and scientific.

Hopefully this editorial can be used to combat the continuing attempts in states across the country to introduce mandatory HPV vaccination.

The driving force behind mandatory legislation has been Women in Government, a group of female state legislators that receives funding from HPV vaccine manufacturers for it’s “Campaign to End Cervical Cancer”. According to their map above, mandatory HPV vaccine legislation has been introduced in half the states as of March 14, 2007. To my knowledge, such bills have been vetoed in Texas and New Mexico, withdrawn in California and tabled in South Carolina, but approved in Washington DC.

Today’s Health News from TBTAM

These news stories came my way today via my list servs and friends (thanks, Susan!).

Texas Legislators vote down mandatory HPV vaccine.

In a 135-to-2 vote that appeared veto-proof, the Texas House gave final passage on Wednesday to a Senate bill that bars the state from ordering the shots until at least 2011. Even many supporters of the governor resented Mr. Perry’s proposal as an abuse of executive authority.

It was the right thing to do. The push for mandating the vaccine was coming from Big Pharma, and not the healthcare community.

BTW, Did you notice the Gardasil ad aimed at teenage girls on American Idol this week? Direct marketing to teens! I had a patient who says her daughter is wondering if she should get the vaccine because her friends “are all getting it”. Who would have predicted that a vaccine would be the new teen trend? Maybe they could combine it with a tatoo….
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New York Governor Elliot Spitzer proposes legislation to strengthen abortion rights in my home state.

Mr. Spitzer’s proposal would remove abortion from criminal statutes and make it a matter of professional and medical discretion. It would also repeal an old statute “that criminalizes, among other things, providing nonprescription contraception to minors,” according to the governor’s office..

While the proposed legislation will not change the new laws, it will create an environment in New York where doctors can feel freer to practice medicine that does not place their patient’s health in conflict with their own fear of recrimination .
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We’re all on the take from Big Pharma.

Nearly 95 percent of physicians in the United States receive free food,beverages, drug samples, sports tickets or other benefits from drug company sales representatives eager to influence their prescribing habits, according to a report today in the New England Journal of Medicine.

I stopped seeing reps this past year, and haven’t missed ’em. I admit, I still take lunch when they show up to see the docs who practice down the hall. I think I’ll stop that now.

More on Merck and Women in Government

Apparently, I am not the only one to be a bit taken aback at the speed with which Merck’s HPV vaccine is being legislated into healthcare.

“A lot of us are worried it’s a little early to be pushing a mandated HPV vaccine,” said Dr. Martin Myers, director of the National Network for Immunization Information. “It’s not that I’m not wildly enthusiastic about this vaccine. I am. But many of us are concerned a mandate may be premature, and it’s important for people to realize that this isn’t as clear-cut as with some previous vaccines.”

He added, “It’s not the vaccine community pushing for this.”

Who is pushing it? Merck, of course. Via a group called Women in Government. More at the Baltimore Sun.

Update:
Mandatory HPV Vaccine legislation in Maryland has been pulled (Via Pharmalot) and The Associated Press has picked up on the connection between Merck and WIG.

Big Pharma and Women in Government – Partnering for HPV Legislation

Much of the push to mandate coverage of the HPV testing and the HPV vaccine is coming from the Women in Government’s Challenge to Eliminate Cervical Cancer, a campaign that appears to be funded in part by the makers of the HPV test and HPV vaccine.

The Challenge, begun in 2004, has an ambitious agenda to eliminate cervical cancer in the United States, and seeks to “mobilizes state legislators to address cervical cancer prevention in their states.” According to a recent NEJM article entitled “Ethics and the HPV Vaccination“:

Women In Government, a Washington-based, bipartisan organization of female legislators, is leading a push to make HPV vaccination compulsory in every state. The group has issued recommendations for ensuring that the vaccine is accessible and affordable, including a recommendation that states add it to their Medicaid programs and encourage private health plans to cover it. The group follows in the tradition of breast-cancer activists, who have mobilized through many political channels to combat an illness that disproportionately burdens women.

Membership of the WIG, a 501 (c)(3) non-profit entity, includes female state legislators from all over the US. The group has a large list of policy issues they consider important – quite extensive and quite impressive. They appear to be taking on chronic kidney disease and higher education funding with a similar energy to their cervical cancer campaign. It’s an ambitious agenda that most certainly requires funding.

Who funds the WIG?

Like every non-profit, the WIG has lots and lots of corporate partners, and most of Big Pharma is there. But what the WIG also has is something called the Business Council, a tiny group of sponsors who seem to be much more intimately involved in the organization than most corporate sponsors of non-profits. From the WIG website –

The Women In Government Business Council is comprised of a small, select group of industry leaders. Business Council members support the overall mission of Women in Government and provide a private sector perspective to our programs. Members also play an integral role in planning for future growth, have the ability to attend our regional conferences, and support the financial stability of the organization.

Here’s the corporate membership roster of the Council – Digene (makes the HPV test), Merck (HPV vaccine maker), GlaxoSmithKline (HPV Vaccine maker), Wellpoint (heads the council), Exxon Mobile and Verizon. A full 50% of the membership stands to benefit from the legislative efforts of the Challenge to Eliminate Cervical Cancer. And one of the Council’s members, Digene, has a bit of a sordid past when it comes to partnering with women’s groups to forward favorable legislation.

Digene and the European Women for HPV

In 2004, a group called The European Women for HPV Testing began to campaign for legislation in England for national HPV screening. High profile female celebrities were recruited to the group to be spokespersons for the group and to lobby for legislation to approve the HPV test as primary cervical cancer screening. The European women for HPV Testing group even got mentioned in the British Medical Journal, in a manner similar to the NEJM mention of the WIG.

The problem was, the European Women for HPV Testing did not actually exist. As revealed by the Guardian Observer, the “group” was actually a front organization created on paper by the advertising company Burson-Marsteller and entirely funded by, you guessed it – Digene.

Partners with Aligned Interests?

Digene makes no bones about its strategy, which, according to their 2006 annual report, is to “expand beyond published data and medical guidelines to change the way healthcare is practiced“.

The WIG makes no bones that its strategy for tackling the issue of cervical cancer is “a collaborative approach… enlisting the support of stakeholders from across the globe” in its efforts. In their most recent report, the Challenge to Eliminate Cervical Cancer clearly stated that the publication was made possible by funding from Digene. But on none of its press releases about HPV does the WIG reveal its relationships with Digene, Merck or GlaxoSmithKline.

One could argue that without such funding relationships, the agenda of the WIG could not be forwarded. One could argue that in the case of cervical cancer, the interests of women and those of Big Pharma are aligned. One could argue that without Big Pharma to fund it, the Challenge to Eliminate Cervical Cancer would be nothing more than a nice name for a good cause.

But one could also ask whether the Challenge to Eliminate Cervical Cancer would even exist without Big Pharma. Both Merck and Glaxo have used PR firms to create advocacy groups whose mission is to increase awareness of HPV, and who “partner” with existing health and women’s advocacy groups. One is called The Partnership to End Cervical Cancer, and the other (which now appears defunct) is called Make the Connection.

And one could also argue that the financial ties between the WIG and Big Pharma puts the WIG in the position of being a lobbyist for Big Pharma rather than being political advocates for women.

Update on this issue here.
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Disclaimer: I use the HPV test in my clinical practice, although only for ASCUS triage and not for routine screening. I have not yet given the HPV vaccine to any patient, although we are discussing it, and given the recent recommmendations of the immune practices committee of the CDC, I expect I will be giving it. I still have a lot of concerns about the high cost of the vaccine, how long immunity will last, what will happen when the next generation of vaccines hits the market, and if it will really make a difference in the health of my patients, who for the most part, recieve regular pap smear screening.

Both the speed and sense of urgency accompanying the recent movement of the HPV test and vaccine into the healthcare arena has been startling to me, and I believe heralds a new age of unprecendented pharmaceutical marketing and influence. Physicians, patients and yes, even lawmakers need to be aware of these new strategies that are being used to influence us.

Category: Second Opinions

The HPV Test: A Piece of My Mind

peace of mindWhat’s the new mantra for marketing health care testing to American women? “Peace of mind”.

That’s right. Forget medical necessity. Forget that your doctor feels it is not needed. Or that your insurance may not cover it. Get the test “for your peace of mind”.

Digene is tapping into women’s inherent anxiety and fears about cancer by suggesting that they routinely get the HPV test, even if their pap is normal, so that they can sleep at night.

Digene’s web site for women is a cross between Women’s Day Magazine, 20/20 and a pharmacetical rep training manual. It’s absolutely brilliant marketing. Chock full of anectodal survivor stories to warm the heart and scare the bejesus out of the reader. If you weren’t worried about cervical cancer before you came to the site, you sure are now. Then, once they’ve got you good and scared, they sweep in on the white horse to offer you the cure – the HPV test.

But there’s one problem – Routine HPV testing, although FDA approved, is not the only strategy recommended for cervical cancer screening. And there’s the little problem of that darned doctor…

Not to worry. Digene is going to coach you so you can convince your doctor to give you the test. Here’s just a little bit of their advice:

Call your doctor’s or nurse’s office before your next exam to find out if the HPV test is offered as part of routine screening for cervical cancer, along with the Pap. Remember: Make sure the office understands that you want the HPV test no matter what the Pap test shows. Some doctors and nurses only order an HPV test when your Pap results are inconclusive (called an “ASC-US” Pap).

If your doctor or nurse says the office does not order HPV testing for all of its patients who are 30 and older, indicate you’d like them to make an exception for you.

If your doctor or nurse (or the office staff) responds by saying he/she doesn’t think routine HPV testing is necessary, the simplest way to respond is to say that you would still like to have the test “for my extra peace of mind.”

That didn’t work? No problem. Digene has a full page of strategies for women to use to convince their doctor to give them the test. I swear, it reads like a pharm rep training manual. Every possible response from the doctor is covered, and Digene has an answer for each one of them. And they all end with telling the doctor that you want the test for “extra peace of mind.”

“Talk to your doctor” has turned into “Sell our test to your doctor”.

And the survivor stories? Well, if you have ever read the cancer stories in Women’s Day or Glamour, you know how they read. Anectodal horror stories that will convince anyone reading them to run out and get the HPV test right away. All implying that if these women had gotten an HPV test, things would have been different. Maybe…

Digene can take the story of a woman whose HPV test added absolutely nothing to her health care and make it sound like a survivor story. This woman got not just one, but four HPV tests over three years for a transient HPV infection that never resulted in a single abnormal pap smear or any need for treatment. Here’s what she says about it:

This experience taught me the importance of not being afraid to ask questions and make decisions with my doctor, rather than letting him make all of the decisions for me. Demanding the HPV test may have saved my life.

She never had an abnormal pap. She did not develop cervical cancer or even cervical dysplasia. But the HPV test “may have saved her life”.

Now, I could give you a few anectodal stories about women whose HPV test was negative, but whose pap showed high grade dysplasia. (No test is perfect, not even the HPV.) Or women whose relationships were broken up by an HPV test that added nothing to their health care. Or physicians who do the HPV test on every patient, only to have patients get angry at them for finding a condition that basically has no cure and hasn’t changed anything except to creat anxiety. I could even make a website about it, and coach you into talking your doctor out of that routine HPV test.

But I won’t.

Because you should talk to your doctor about the HPV test, not me. Someone who hopefully knows you, knows about the test, and together with you can decide if having the test is right for you. Because routine HPV testing is not necessarily the best strategy for every patient and for every medical practice.

And for the record, do I ever order HPV testing on a woman with a normal pap smear? Sure I do. But that’s a decision I make on a case by case basis, one that the patient and I make together after discussing the reasons for and against the test, the cost implications, and what we will do about the results if they are abnormal.

It’s not a decision she has been talked (and coached) into by a company trying to market that test.
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For patient information about the HPV test, see the American Cancer Society Website.

Clinician information from the Centers for Disease Control.

Financial disclosure: I used to own Digene’s stock, and even made a few bucks on it back before the test was being used in clinical practice. I knew HPV testing was going to become part of women’s health care. I didn’t know Digene was going to annoy me this much…

Category: Second Opinions