HPV Immunization: Mired In Controversy

Patients with pre-teens and teenagers have been asking my opinion on the HPV (human papilloma virus) immunization, sold as Gardasil by the Big Pharma giant Merck. Young daughters, and now sons, are bringing home handouts from school, being pressured by the family pediatrician, and, oh those TV commercials.

Families who go online discover arguments for and against immunization that sound like two dogs on opposite sides of a cyclone fence barking furiously at each other. Actually, that’s an unfair comparison. Most of the scientists on both sides are fairly reserved, but you can sense their dismay that the view of their side hasn’t been accepted as universal truth.

“Why in heaven’s name would you not want to use a safe vaccine to protect your children from certain cancers that could kill them,” says one group of well-meaning (and generally Big Pharma-funded) scientists. The other side responds “Because we aren’t positive that the vaccine is safe, that it really does protect against cancer, and that the long-term effects are harmless.”

As a parent, your most sane conclusion is confusion

Regular readers of these Health Tips know that I’m highly skeptical of virtually all clinical trials and research studies testing any industry-funded pharmaceutical product simply because there’s so much money involved in terms of Big Pharma profits. Look at the following Gardasil numbers and prepare for a throbbing head trying to get a handle on the math.

The three Gardasil injections come to about $600, generally funded through health insurance and various government subsidies. Current CDC recommendations call for Gardasil to be given to all girls and boys between 11 and 12. This is for the US, but Gardasil is marketed worldwide (or at least in those areas of the world that can afford it). My pocket calculator can’t handle this, but let’s agree that Merck, which manufactures Gardasil, stands to make a lot of money. Along the way, Merck can also afford to pay its researchers, especially those who bring in good results, a great deal of money.

Before you have your daughter or son thrice jabbed by the pediatrician, consider:

• HPV is the most common sexually transmitted disease (STD). There are about 100 strains of HPV (some strains cause those harmless warts you had as a kid), but only a few, like #16 and #18, are linked to cervical cancer.
• Most HPV infections go away by themselves. The higher-risk strains take years to develop into cervical cancer.
• Gardasil does confer immunity against nine of the high-risk HPV types, but no one (not even Merck) knows exactly how long this immunity lasts. The best guess is that booster shots will be needed every four years.

There has been controversy about the phrasing used by Merck researchers. The ads say “Helps prevent HPV infection” and “expected to prevent cervical cancer” but this is not the same as “definitely prevents cervical cancer.” WebMD says that Merck now reports Gardasil does prevent cancer. In the same breath WebMD admits that Merck is a financial supporter of WebMD (get my drift?).

Deaths from cervical cancer are not all that common

This year there will be 12,000 new cases of cervical cancer (discovered by Pap smears) and most women will be completely cured. 4,000 American women will die from cervical cancer, compared to 40,000 women dying from breast cancer and 25,000 from colon cancer.

Deaths occur primarily in women who have never had a Pap smear and arrive at the doctor with advanced disease. In fact most cervical cancer deaths occur among medically underserved women of color. As the article at the link states, “NCI conducted a study of regions within the United States where cervical cancer incidence rates are high. They found that cervical cancer rates reflected a larger problem of unequal access to health care.” Death rates are even higher in underdeveloped countries.

Although most female patients at WholeHealth Chicago have their own gynecologists for Pap smears, we do quite a few ourselves and in 16 years we’ve never had a single Pap smear that revealed cervical cancer. A few patients have cervical dysplasia, some cases of which increase cancer risk, though most do not. This low incidence of cancer is the result of access to care, regular checkups, and healthy lifestyles.

Take-home message: get your annual Pap smear (and to protect against all STDs, HPV included, use a condom). You’ll be tested for HPV during your Pap smear and if you’re negative you can reduce the frequency of annual Pap smears to every three years for women between 21 and 30, and every five years between 31 and 65.

Gardasil is probably a good idea in those US regions (and other countries) where women don’t have access to Pap smears or don’t get them regularly for other reasons. However, until there’s better data on actual cancer prevention (like the results of tracking immunized vs. non-immunized girls), I recommend not rushing into this. One fear is that once immunized, women might not be as stringent about getting their annual exams—a definite mistake as the pelvic exam done with a Pap smear can diagnose a variety of conditions unrelated to cervical cancer (including ovarian cancer, fibroids, and endometriosis).

Then, of course, there’s always the question of safety. Is the Gardasil three-shot immunization series completely safe? Naturally, Merck says yes and that the most commonly reported side effects (lightheadedness, fainting, and pain at the injection site) are harmless events that occur with many young girls receiving any type of an injection. These complaints are being reported at a frequency no different from when the young girls are injected with a placebo.

But we should be skeptical

It often takes years for serious issues related to any new medication to appear. For example, the permanent tendon damage that can occur with quinolone antibiotics (like Cipro and Levaquin) wasn’t reported until the drug had been out for several years. No one ever connected an antibiotic with tendon inflammation. Now, 30 years later, tendon damage is such a risk that there’s a black box warning (high risk, dangerous) printed on the package insert.

What caught my eye about Gardasil was a series of reports from around the world that told of a syndrome appearing in young women who had received the Gardasil vaccination. The symptoms seemed indistinguishable from the fibromyalgia/chronic fatigue syndrome I’ve been working with for years.

“Oi veh!” I mumbled to myself. “We need this vi ein loch in kopf.” I will translate. “Oh woe! We need this like we need a hole in the head.”

As if teenagers didn’t have enough tsuris (troubles) with pimples, hormones, bullies, and getting into the college of their parents’ choice, now we’re going to give them fibromyalgia? Chronic fatigue?

Other reported symptoms include orthostatic hypotension (fainting when rising from a seated to a standing position, also called postural orthostatic tachycardia syndrome, or POTS), complex regional pain syndrome (CRPS, a horror show of constant and difficult-to-relieve pain in one specific limb), memory and cognitive problems, sleep disorders, and so forth.

Or you could simply watch one teenage girl describing her life after Gardasil, though I’ll be the first to acknowledge that it’s possible she could have developed these symptoms without Gardasil. Certainly most fibro-CFS patients have no history of using Gardasil. Warning: the video at the link is emotionally wrenching and I notice there are at least a dozen others.

Naturally, those involved in the promotion of Gardasil stand by their guns, saying basically that such symptoms can appear in anyone and that the frequency of fibromyalgia-chronic fatigue in those who have been vaccinated with Gardasil is no different than in the female population at large. The European Medical Agency (EMA) reassures EU patients and physicians not to worry, but the EMA has real issues with financial conflicts of interest.

Some countries are very concerned, not thrilled about trading protection from a low-risk virus for a lifetime of pain, fatigue, and disability. In 2013, Japan withdrew its Gardasil recommendations to the public and initiated a system for physicians to report on side effects. After a study was published in Denmark about the link between Gardasil, POTS and CRPS, the Danish government ordered its own independent study, separate from the bland reassurances of Merck and the EMA. Glaxo (a second vaccine manufacturer) vehemently denies everything and I’d link you to their article but it’ll cost you $35 to read it.

So there it is

You’ve got a kid at home who’s soon going to be flooded with sex hormones and you don’t want her or him to develop cancer related to sexual activity. (For men, BTW, it’s prevention of penis cancer, which is rare in North America. I saw it just once in my career at Cook County Hospital in an elderly, malnourished skid row alcoholic.)

You’ve got a pharmaceutical industry with one goal: shareholder profits. Their track record for manipulating clinical trials and withholding information about side effects is shameful.

If your health insurance covers regular Pap smears for your daughter and she is getting them, your son or daughter is clear that a condom must always be used to prevent STD transmission, and your daughter doesn’t smoke (yet another risk), well, make the best decision you can.

Be well,
David Edelberg, MD