Category Archives: HPV

01.22.12

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

It’s a question I’m often asked by my patients after I’ve told them that they have an abnormal Pap, which inevitably means also telling them that they have Human Papilloma Virus (HPV), a sexually transmitted infection.

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. Here is why -

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.

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,)

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.

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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21 Comments
09.07.10

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.

1 Comment
07.31.08

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.

2 Comments
05.07.07

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.

2 Comments
04.26.07

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.

3 Comments
01.31.07

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.

2 Comments
12.21.06

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

11 Comments
11.28.06

The HPV Test: A Piece of My Mind

What’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

41 Comments