Would you choose Gardasil or circumcision against HPV?

I know that guys who haven’t been snipped hate to hear this, but a new study in South Africa might make you want to revisit the subject of circumcision in terms of HIV, HPV, genital warts, etc. (and make women check out prospective partners a little more closely). The study shows that circumcision reduces the risk of contracting HIV by 76 percent.

76 percent. WOW. And of course, if you don’t get HIV, you’re not going to pass it along to your partner(s), either.

While it’s hard to say whether those statistics would hold up in the US, where life, health and risks are different, it’s hard to imagine that circumcision could make less than a very worthwhile difference in transmission rates. And it’s not just a matter of cleanliness. The cells in the foreskin are particularly vulnerable to viruses.

Oh, and then there’s the nasty subject of genital warts. Circumcision cuts (sorry) that chance by 28-34 percent, too, according to another randomized trial in Africa.

HPV? Not so much. One study found a 27.9% prevalence of high-risk HPV genotypes in uncircumcised males and only an 18.0% prevalence in circumcised males. Their female partners’ risk was 38.7% (uncircumcised partner) and 27.8% (circumcised partner) and it is, of course, impossible to know which way the infection went. But that’s still significant, either as an adjunct to the HPV vaccine series—whether Gardasil or Cervarix—or as part of a well-thought out strategy to lower risk.

As reported by Michael Smith for MedPage Today: “The procedure offers limited protection against most high-risk types, (researchers) noted, while the HPV vaccine is highly effective, but only against a limited number of genotypes. "The two interventions are likely to have important synergistic effects," they concluded.

The odd thing is that Medicaid, which serves some of our most vulnerable populations, doesn’t pay for circumcision in 16 states, and yet the US is currently paying for males to get circumcised in Swaziland to the total tune of $30 million. Talk about “things that make you go hmmmmmmm…”

The current pro-Gardasil campaign has perhaps made many people lose sight of the fact that there’s a heck of a lot worse things out there than HPV. With rates of women getting their annual check-ups already dropping in Australia, where Gardasil has been provided free by the national health system, it’s clear that the vaccine carries a subconscious feeling of… phew, I’m safe from STDs.

You’re not. Whether you choose Gardasil or not, just remember that a multi-pronged (sorry again) approach to sexual health is crucial. Keep your immune system healthy (get enough sleep and enough veggies and fruits, quit smoking etc.), use condoms (which will help against HPV and HIV but won't eliminate the risk, particularly for HPV), and apply the infamous Seinfeld “sponge-worthy” criteria to potential partners (is he/she really worth it?).

And guys, it’s up to you. If you’re not circumcised, think about it for your sake and your partner’s sake. Would you do it? If not, why not?

Health Authorities May Ditch Gardasil and Cervarix

Gardasil and its rival Cervarix cost governmental health programs, insurance companies and individuals billions. Most governments have approved vaccination programs on the assumption that if an HPV jab guards against the two viruses that cause 70 percent of cases of cervical cancer, then the vaccine will eliminate roughly 70 percent of new cancer cases.

Oops. Real-life study results don’t bear out that assumption at all, and now that Gardasil has been found in two placebo-controlled studies to reduce pre-cancerous cells by just a meager 17 to 45 percent, both Scotland and Germany are reconsidering their hugely expensive HPV vaccination programs.

13 leading scientists in Germany have said that the vaccine is leaving women vulnerable to other strains of the virus and that information about its effectiveness is misleading. The Robert Koch institute, which makes recommendations about publicly-funded vaccination programs in Germany, is reassessing Gardasil and expects to issue a report within about two weeks. As one expert said, "The results of the studies clearly contradict many overly optimistic pronouncements. Women are entitled to be adequately informed."

Women in the US are apparently not as entitled to be informed, as recent news reports about Gardasil have focused primarily on information that the vaccine has proved to be extremely effective against HPV strain 16 for up to 8.5 years—a statistic that now appears to be rather beside the point.

Senior public health experts in Scotland also warned that HPV vaccines might not be as effective as expected after reviewing the two large-scale studies of Gardasil. Although the competing vaccine Cervarix is administered by the National Health program in Scotland, Cervarix uses the same VLP-type vaccine along with a novel adjuvant to target the same cancer-causing viruses. Specific data about Cervarix’s efficacy is not currently available.

The randomized, placebo-controlled trials of Gardasil followed 17,622 women who underwent Pap testing at the start of the trials and then every 6 to 12 months. All the women showed no exposure to 14 common HPV types and had normal Pap smears to begin with. After 3.6 years abnormal cells were reduced by between 17 and 45 percent, depending on the type.

Colposcopies were reduced by 20 percent, cervical biopsies by 22 percent and surgery and other invasive treatments by 42 percent.

Results Unsurprising

A study published earlier this year in the Journal of the National Cancer Institute (JNCI) looked at both early and invasive cervical cancers from 1980 to 1999 in a New Mexico population. The study found that HPV types 16 and 18 had caused 66.3 percent (not 70 percent) of cervical cancers and, more worryingly, that type 16 was already being replaced by types other than 16 or 18 (the two strains covered by both Gardasil and Cervarix).

Although this replacement was taking place pre-Gardasil, experts have long theorized that one or more of the many other strains of HPV could fill the biological niche left by elimination of 16 and 18. This kind of ‘replacement disease’ has already been seen with the pneumococcal vaccine Prevnar. It’s unclear at this point whether replacement diseases have been the cause of Gardasil’s disappointing results as Merck did not release an analysis of the types of HPV found to have caused the abnormalities in the study subjects.

Merck is having better luck with Gardasil’s efficacy against genital warts. Gardasil, unlike Cervarix, also guards against two wart-causing strains and reports from Australia show that new diagnoses of genital wart infections have dropped by 48 percent.

Meanwhile, women who are weighing the pros and cons of the Gardasil vaccine, now have more complete information, even if—distressingly—the results of the two studies have received little publicity. Reports have associated convulsions, paralysis, epilepsy, numbness etc. with the vaccine, although as yet no causal link has been established.

Why Gardasil Was Created: Jade Goody Dies of Cervical Cancer

Gardasil is such a controversial and flawed vaccine that it seems as if many people can think of it only as a much-hyped profit center for Merck.

But 27 year-old British celebrity Jade Goody’s death of cervical cancer on Sunday, Mother’s Day in Britain, reminds us that yeah, cervical cancer can kill. If an HPV infection is NOT shrugged off, as most are, and you don’t get an annual Pap smear to find pre-cancerous lesions early, then it can eventually kill. And we should take it seriously.

Which is why researchers probably saw the Gardasil vaccine as the Grail—regardless of what Merck did with it afterwards, by fast-tracking it to approval and marketing it aggressively; whatever your feelings about Gardasil, we have to give researchers credit.

Jade Goody was a dental assistant when she soared to fame on the reality TV show Big Brother which endlessly films contestants corralled in a house for weeks at a time. Born to drug-addicted and impoverished parents she was brash, ignorant, and opinionated, soon becoming notorious for malapropisms such as "They were trying to use me as an escape goat."

But her survivor nature won her many fans, and perversely, she soon became a celebrity just for being a celebrity. There was one hell of a row when she put a racist slant on bullying during the filming of a follow-up Celebrity Big Brother, calling Bollywood actress Shilpa Shetty “Shilpa Poppadum” and snickering at her accent. Mixed race herself, though, she not unreasonably explained that “I treat everyone like that.” The two made it up, and in fact Goody learned about her cancer on camera during the filming of an Indian Big Brother.

Her disease progressed in the glare of camera flashes. She was criticized roundly for selling her life, including the rights to film her fantasy wedding to fiancé Jack Tweed while she was dying: she answered that she was storing up as much money as possible for her two young sons so that they would never live as she did as a child.

Goody did a great deal in Britain to highlight the need for regular exams. Although cervical cancer is not prevalent—in the US it ranks 14th on the list of cancers—and it rarely presents itself in young women, serious lesions resulting from persistent HPV infection do appear to be increasing. In Britain the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.

Gardasil has its issues, and I won’t be getting it for my daughters. But at least Merck’s scare tactics have raised awareness of HPV and the need for precautions, and I thank them for leading me to look at the alternatives (February 9, March 10).

Hopefully my girls will be sufficiently aware of HPV that they will never suffer as Jade Goody has. My thoughts and prayers go with her.

Dear Blue Cross: Here’s Where to Send Our Gardasil Shots

An Open Letter to Our Health Insurance Company

Dear BlueCross/BlueShield,

Thank you so much for informing me that you would be happy to pay for the three Gardasil shots, and, I assume, booster shots as necessary, for each of my two daughters.

Imagine my joy at hearing this! Particularly, I might add, since over the last 10 years you have declined to pay for a cast for Daughter #1’s broken wrist, a splint for Daughter #2’s sprained ankle, and for most of the cost of an MRI after a head trauma. I am fortunate indeed that the $14,000 I pay you each year to insure our small and mostly healthy family means that you can now afford to pay up for Gardasil.

But here’s the thing. We’ve looked, endlessly, at the risk/reward ratio. In the US, 11,070 women will be diagnosed with cancer this year and 3,870 will die. According to the National Cancer Institute, that makes it the 14th most common cancer for women—pretty far down the list. And attention to lifestyle and regular Pap screenings can dramatically reduce even this small risk.

When Kaiser Permanente studied its members’ records, they found that more than half of the women who had been diagnosed with cervical cancer had not chosen to take advantage of their Pap smear test coverage. That’s not us. We look after ourselves, we eat our veggies, we don’t smoke and we get regular check-ups. And I appreciate Merck’s drawing our attention, albeit rather dramatically, to HPV, but with care the rewards gained by this vaccine appear to be minimal.

On the risk side, I see multiple reports of auto-immune disease and many other side-effects that may or may not be connected to Gardasil. I see evidence that side-effects in susceptible women apparently increase with each of the three shots, and I see that no-one knows if fourth, fifth, and even sixteenth booster shots, or reformulated shots, will be necessary over my daughters’ lifetime. I look at Prevnar, and think about the risks of perhaps even more vicious replacement diseases gaining ground when a shot vanquishes only a few strains of HPV out of more than 100.

So I’m going to decline your kind offer. But wait! You’re not off the hook yet.

Cervical cancer, though not a huge issue in the US, even with some 40 percent of women unable or unwilling to have regular Pap tests, is indeed a big issue in developing countries. In these countries it is the leading cause of cancer-related deaths among women, accounting for 85 percent of the 253,500 annual deaths from cervical cancer worldwide. Clearly the risk/reward ratio is turned on its head in developing nations.

So here’s what I propose. Just send our doses of Gardasil to one of those countries. Africa would be good; I’ve been there and I’m fond of it; but honestly, you can send it wherever the need is greatest. Maybe other Blue Cross/Blue Shield members, or Kaiser Permanente members, or JoeBlow down the street members—in fact anyone who chooses not to get the shots despite coverage—would like to ask their insurance companies to do the same.

How about it, ladies?

The Outrageous Jade Goody: Food for Thought about Gardasil and Cervical Cancer

Jade Goody, Britain’s brash reality TV celebrity, is still sparking controversy and discussion even while she’s dying.

Goody’s personal tragedy has done more to highlight the importance of regular smear tests and the risks of casual sex and smoking than perhaps anything else in the UK. When she found out—very publicly—that at the young age of 27 she is unlikely to survive the cervical cancer that has metastasized to her bowel, liver and groin, the rate of women seeking Pap smears in Britain soared by 21 percent.

So what’s to think about? Well…

Is HPV Getting Worse?

International focus on Jade Goody’s case threw up some unpleasant statistics.

Smear tests detect pre-cancerous changes, called CINS, as well as actual cancer. CINS are caused by persistent cases of HPV (human papillomavirus), a very common STD that normally resolves itself. However, in Britain the incidence of cases of the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.

This seems to suggest that any or all of the following are true:

· HPV incidence and virulence is worsening.

· Young women’s immune systems—healthy immune systems are the reason that most HPV cases clear up on their own—are weakening. Britain’s diet has notoriously deteriorated in the past decade, while the prevalence of smoking in the UK is greater in the 20-24 year old age group than in any other, and girls are now more likely to smoke than boys. Smoking increases the chance of an HPV infection becoming persistent by up to 27 times.

· Girls are having more unprotected sex with more partners at a much earlier age.

Bottom line: Regardless of whether you think Gardasil’s a good thing or not, take HPV seriously. Consider that it may be worsening (one of the fears about Gardasil is that it may create fiercer replacement diseases) and take the necessary steps to protect yourself.

Screening Age Row

And then there’s the NHS row. According to the Journal of Family Planning and Reproductive Health Care, researchers are upset with the 2004 NHS (Britain’s National Health Service) decision to quit offering Pap smears to women younger than 25 in England (women in the rest of Britain can still have the test at 20).

The NHS says that it is following guidelines set by the International Agency for Research on Cancer because cervical cancer in under-25s is extremely rare, but changes in the cervix are very common. Screening at 20 could therefore result in unnecessary, frightening, and potentially harmful interventions.

But Professor John Shepherd, a cervical cancer specialist and spokesman for the Royal College of Obstetricians and Gynaecologists, notes that some ten percent of cases are found in women under 30, and believes that younger women should be screened. Experts also note that fewer women come for the test when they start later, perhaps because it has not become a regular part of their adult life; they’re also concerned that women who have had the Cervarix vaccination will think they are fully protected and ignore the necessity for smear tests. Would Jade Goody be looking at a happier outcome had she gone for a Pap smear at 20 or even 25?

Bottom line: The American Cancer Society currently recommends starting regular screenings by three years after becoming sexually active, or by the age of 21, whichever comes first. Do it, whether or not you’ve had the Gardasil shot. Or, if the NHS/IGR guidelines make sense to you, discuss them with your doctor and, at the very outside, get the test by age 25.