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Shingles vaccine stats misleading

Watch out for the marketing spin

DRUG BUST by Alan Cassels

The people’s briefing note on prescription drugs

Portrait of columnist Alan Cassels
• Judy M., who lives in Victoria, sent me an email asking what I knew about a vaccine to prevent a truly nasty condition called shingles. Being the third such request I’d received in as many weeks, I figured it was time to take a closer look at the shingles vaccine. Shingles, also known as herpes zoster, can cause a serious and very painful rash.

Judy’s friend Jane was urging her to get vaccinated for shingles. Jane’s husband Stan had a case of shingles that Stan described as “worse than anything he has ever known, including spinal surgery.” Sometimes, open sores accompany the rash and the pain is so severe people have trouble walking and sleeping. In rare cases, the complications of shingles can last for months and sometimes years.

That fact surely caught Judy’s attention. In fact, she admitted she had a profound fear of the disease having seen her aunt go through postherpetic neuralgia where the pain continues to last even after the rash and blisters have disappeared. In her opinion, any level of pain seems bearable if you know it will eventually end, but the thought of living with such pain for life made a compelling argument for getting vaccinated.

So what could I say about the vaccine called Zostavax being promoted to prevent shingles?

I always like to start my research by looking at the pointy end of things: the marketing. If there is one principle in play, it’s that the marketing diverges from the science. And since the advertising is what patients and physicians will likely see first, that’s a good place to start. The ads for Zostavax, made by drug giant Merck, lay out the hook in bold letters: “Have you had your shingles vaccine yet?”

In typical marketing style, that innocent question is driven home by the fear factor, reminding us that this is something we all need to be worried about. In smaller print, the ad says, “In Canada, it is estimated that nearly 1 in 3 people will develop shingles in their lifetime.”

Ok, if true, this establishes that shingles doesn’t seem to be such a rare condition. Most of us who have had chicken pox as children are susceptible and it usually strikes people over 60, though no one is really sure how or why this happens.

Many of us know someone, maybe our mother, friend or neighbour, who has a horror story to tell about the unbearable pain shingles can deliver. I didn’t have to go far to hear some anecdotes. I asked my mother about it and learned that she had had shingles a few years ago that lasted several weeks, which included three visits to the hospital and incredible pain across her stomach. Treatment for shingles usually involves antivirals (drugs such as acyclovir), which, if given early enough, can help shorten the length and intensity of the rash.

The vaccine marketer captures the disease’s potential for serious pain with graphic ads featuring a lot of flames and thorns with a clear and unspoken question: “Do you want your life to be a living hell?”

Now that we’ve established the nastiness of the disease, the first question has to address the science: “Does the Zostavax vaccine work?”

If a vaccine is about protecting you from a disease, you need to know your likelihood of getting the disease in the first place. One study from the British Medical Journal says that for people over 50, approximately two to three people out of a thousand per year get shingles; that increases to about eight per thousand for those 70 and over. The average doctor with 1,500 patients in his care would see about three to five cases per year.

A 2005 study in the New England Journal of Medicine enrolled over 38,000 people over 60 and reported that, over three years, the vaccine Zostavax “reduces the occurrence of herpes zoster by 51.3%.”

Wow. So if you know 100 people who got vaccinated, the vaccine would prevent half of them from getting shingles, right?

Wrong. Remember, if the average doctor sees five cases a year in his practice and he manages to reduce that load by 50%, he’d only see maybe 2.5 cases per year. But how many thousands would he have to vaccinate to prevent those other 2.5 cases? A lot.

This study of the vaccine, which was a gold standard, randomized, double-blind, placebo-controlled trial, measured the incidence, severity and duration of the pain caused by shingles. Let’s focus on just one of those: incidence. Basically, how many people were prevented from getting shingles?

The study noted there were 315 shingles cases among those vaccinated and 642 among placebo recipients, concluding that it reduced the rate of shingles by 51.3 percent. Another way this is expressed is in “1,000-person years” where the effects are examined in 1,000 people for one year. The study found that the vaccine dropped the rates of shingles per 1,000 person-years from 11.12 (those on placebo) to 5.42 (those given the vaccine).

What this means is the vaccine ‘helps’ about 5.7 people per thousand per year (11.12 minus 5.42= 5.7). Where did the “51.3 % reduction” come from? Well, when you drop the rate from 11.12 to 5.42, that’s about half the rate, or a 51.3% reduction.

To summarize, here are two ways of presenting the same data: 1) “The vaccine helps five people per thousand vaccinated. Or 2) “The vaccine helps 50% of the people vaccinated.”

Hmmm. You can imagine which one gets the most traction with the marketers.

So let’s talk cost. If you have to vaccinate 1,000 people per year at $150 a shot, it would cost $150,000. That’s a fair bit of money to save five people from getting shingles. In other words, the cost of avoiding shingles is about $30,000 per person per year.

Does that sound like a bargain? Depends on whom you ask. If you asked Judy’s friend Jane, she’d probably say that not seeing her husband in such pain is “priceless.” If you ask governments to pay for the vaccine, seems they think it’s too high a price to pay and it isn’t covered in BC. It’s not that the vaccine doesn’t work; it’s that it hardly works.

And that’s before you wander into the other side of the equation: the vaccine’s potential for adverse effects. By August 2011, in the US, the federal Vaccine Adverse Event Reporting System (VAERS) had received 442 serious vaccine adverse reports following Zostavax vaccination, including 36 reported deaths. While these are ‘associations’ and not causations, it still makes one pause before hitting the “jab” button. The kinds of serious shingles vaccine reactions included things like joint and muscle pain, fever, abnormally swollen glands and so on.

Some might ask, “Is it possible the vaccine can actually cause shingles?” A good question to which there is no definitive answer, but rashes akin to chicken pox are mentioned on the vaccine’s label as one of the potential adverse effects.

At the end of the day, facts can be twisted in any way to make a point, especially when the ‘point’ comes at the end of a syringe.

But back to Jane who was caring for her husband and his very nasty bout of shingles. Seeing Stan in such pain was enough for her. She begged Judy and her other friends to get vaccinated. She went and paid the $150 to get herself vaccinated.

And a few weeks later? You guessed it; she too came down with a new diagnosis.

That’s right, shingles.

Alan Cassels is a pharmaceutical policy researcher at the University of Victoria and the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease (Greystone, 2012). You can follow his interests on Twitter at AKECassels or read more of what he’s writing about at www.alancassels.com.

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11 comments

  1. Ashley /

    Thank you for this, my great Aunt recently questioned whether or not to get the vaccine. This was the only article I could find not funded by the Government or Pharma with a clear analysis to the actual vaccine. I’m still in search of an ingredient list of the vaccine, and other information for her. Thanks again.

    Like or Dislike: Thumb up 2 Thumb down 0

  2. Tara Charles /

    Do you have any thoughts, or found any evidence that the rate and intensity of Shingles is increasing in North America? From what I’ve read, the U.K. didn’t implement the chickenpox vaccine for children because it feared that doing so would affect the cases of Shingles.

    And OMG…I work in healthcare and although this is only my anecdotal observation, Shingles is now extremely prevalent, painful, and can even lead to vision problems. (I’ve also talked to a GP who firmly believes it to be rather self evident that there has been a dramatic upswing and severity in cases of Shingles. She points to the vaccine as a likely candidate. )

    Like or Dislike: Thumb up 4 Thumb down 0

  3. mary alexander /

    I got the vaccine about 4 years ago. I currently have a very painful Shingles. My breast and back have the rash – no itch, but horrible, horrible pain. The vaccine did not work for me

    Like or Dislike: Thumb up 0 Thumb down 0

  4. Is it possible that the injection is a money scam and of
    all the people who have received the vaccine
    The ones who did not get shingles, would probably
    never have gottem them in their life Anyway?
    Is there any proof to show that it really helps?

    Like or Dislike: Thumb up 0 Thumb down 1

  5. Lilla /

    I am 68 year old woman with rheumatoid arthritis and diabetes. I’m just getting over Shingles and I still have pain and can’t sleep because of that even if I take extra strength Tylenol…! After reading your studies regarding the Shingles Vaccine, I’ve decided to not get vaccinated for any future bouts with Shingles…! (Hopefully it won’t find me again…!)
    Do you have any information on how to alleviate this pain???
    Thank you
    Lilla

    Like or Dislike: Thumb up 1 Thumb down 1

    • Beth Gessinger /

      According to my book “Prescription for Nutritional Healing”, it advises to “avoid taking medications that contain acetaminophen (Tylenol, Datril, and others), as they may prolong the shingles. Perhaps you should try another pain killer? Good Luck, Beth

      Like or Dislike: Thumb up 0 Thumb down 0

  6. I am 86, had shingles about 5 years ago.I had mild chest pains over my heart for about two weeks, A doctor that I went to see, spotted one blister on my back. He gave me a prescription for valacyclovir 500mg

    I started the pills right away and had no further pain or blisters.After reading this article I may not get the vaccination that I was contemplating.

    Carol

    Like or Dislike: Thumb up 2 Thumb down 0

  7. Chard Breed /

    brilliant, and so true. Thanks!

    Like or Dislike: Thumb up 1 Thumb down 0

  8. Revised (to fix some small typos):

    In your article, you pose the question: “Is it possible the vaccine can actually cause shingles?” A good question to which there is no definitive answer…” Well, I know of one case in which the vaccine indisputably did cause the very illness it was intended to prevent. And neither the pharmaceutical company that made the drug (Merck Canada), nor Canada’s or Ontario’s health ministers, nor the FDA in the United States showed the slightest interest in investigating or reconsidering (or even quantifying) the vaccine’s potential risks. My published op-ed article on the case appears at this link — though you will have to scroll down to find the article, titled “When the Cure Causes the Disease…”
    http://artsforum.ca/ideas/regional-perspectives
    John Arkelian
    Canada

    Like or Dislike: Thumb up 3 Thumb down 0

  9. Larry Phillips /

    Like the author and many of the readers, I too have my doubts about the efficacy of the shingles vaccine.
    However, I question the $30,000 calculation cost to prevent one case. I believe the vaccine lasts for 10 years so wouldn’t the cost per year be $3,000. Certainly still a significant sum.

    Like or Dislike: Thumb up 0 Thumb down 0

  10. Kevin Friesen /

    While most of the numbers stated are correct (although the $30000 per person is not right, but 30000 per case of shingles avoided may be), the 5 cases per 1000 patient years is slightly misleading. By the time you are sixty, you have a 30% chance of having shingles, if you live to 80, you have a 50% chance.
    Imagine 100 patients observed for 60 years. This is 6000 patient years. If you have 5 cases per 1000 patient years, this ends up with 30 cases. Thirty cases in 100 people is 30%.
    The thing is that citing incidence rates can be very misleading unless you know how to interpret them.
    When I was first learning how to do population research I started by learning about zoster. When I heard about the vaccine, I to thought that if the incidence is only 5 per 1000 patient years why even bother, especially since it is only 50 to 65% effective (different studies have had different results, but the 50% is pretty good). But when you consider that you have a 30% chance of getting it by the time you are sixty, and 50% by the time you are eighty (I plan on living that long anyways), then it seems a bit more likely. More important though, in my mind, is that it is 67% effective in preventing post herpetic neuralgia, which is that intense burning nerve pain that is so extremely difficult to treat that can follow shingles.
    It is true that there are adverse reports, most of them are mild, but yes, a self limited rash is possible. Whether full outbreak of shingles could occur is not so obvious. We already have the virus, all of us, sleeping in all of our spinal nerves, it is not like the vaccine will wake it up, rather, it will cause the immune system to suppress it. That being said, anything can happen, but just because she got it does not necessarily mean it was from the vaccine, she might have gotten shingle anyways.
    Whether I think the public should pay for it, well, it is pretty expensive on a nationwide basis for how well it works, so I don’t know.

    Like or Dislike: Thumb up 4 Thumb down 0

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