guardasick

About ten years ago, I learned that cervical cancer was caused by exposure to a virus. I used this as an excuse to opt out of Pap smears. Last year, I got a new primary care physician who did not accept my get out of Pap free argument. Halfway through my first one in a decade, she stopped.

“One of your ovaries is enlarged. You need a sonogram.”

She contacted the radiologist before I did and I got an appointment very quickly. After the sonogram, the technician said “Your primary care physician will call you in a few days.” Ten minutes later, my phone rang. It was the nurse in my doctor’s office. “You need to meet with a surgeon. How’s next Tuesday at 11?”

I hypothesized that the surgeon would present me with a complex multi-attribute decision about whether or not to have surgery and I would need to weigh costs, risks and benefits. I pored over “Making Hard Decisions” by former UO professor Bob Clemen (now at Duke University) and “Value-focused thinking” by Ralph Keeney. I reread “Thinking and deciding,” the hefty tome written by my dissertation advisor Jon Baron.

I showed up at the surgeon’s office with an excel spreadsheet in my mind, ready to gather the relevant data for the decision I anticipated having to make.

“It’s probably benign but it might not be. We can’t tell from the sonogram, although usually we can.”

”Does the fact that you can’t tell increase the chances it’s not benign?”

”Yes.”

"Hmm. Since you’re not 100% sure it’s benign, there’s a 100% chance it needs to come out.”

”Right. Plus, even if it’s benign, it’s big and it could erupt so it still needs to come out. How’s next Tuesday at 11?”

I put away my mental spreadsheet and tried to wrap my mind around the idea that I had to have surgery for the third time in 15 months. Prior to my surgery in May, 2007 to insert a whole bunch of metal into my finger to fix the break on the hypoteneuse of a bone caused by grabbing my dog’s metal mesh collar to abort his non-consensual dental-dermal contact with a dog named Razzie at the Wayne Morse Dog Park and my surgery in February(?), 2008 to remove one of the screws inserted, I’d never had surgery – I’d never even had stitches or even a single stitch. Now I was looking at abdominal surgery, albeit outpatient laproscopic abdominal surgery.

The first point of the story is that you would be hard pressed to find someone who hates Pap smears as much as me (talk about hard pressed!) or someone who is as pro-Pap smear as me. The second point is that even if Gardasil were 100% effective in preventing cervical cancer, it would not eliminate the need for annual pelvic exams. Since Gardasil is only 70% effective, it does not even eliminate the need for annual Pap smears.

If Gardasil eliminated the need for Pap smears, I might be singing a different tune. (50% of people die immediately from the vaccine? Hey – no pain no gain!) But it doesn’t. So the question is whether Gardasil plus annual Pap smears is more cost-effective than annual Pap smears.

The probability of detecting non-metastasized (i.e., treatable) cervical cancer via Pap smear is >95%, I would think. The probability of surviving non-metastasized cervical cancer is also very high, I think.

So the benefit of Gardasil is very low, given that cervical cancer is pretty easy to detect and treat. If cervical cancer was as difficult to detect and treat as pancreatic cancer, it would be a very different story.

So the starting point for considering the cost-effectiveness of Gardasil is that the health benefits are very modest and it does not reduce the need for annual Pap smears. Then you start thinking about the risks.

Deborah Kotz at U.S. News and World Reports has written two articles since Jenny Tetlock died on March 15, 2009.

She writes:
Through their efforts to publicize Jenny's case on their blog, Jenny's parents have connected with two other sets of parents whose daughters developed what appears to be ALS after being injected with Gardasil. One was 22-year-old Whitney Baird, who died last August, just 13 months after receiving Gardasil. Another is Alicia Olund, a 12-year-old who began having trouble walking after getting her third shot last September. She now uses leg braces and a walker at home as her muscles continue to deteriorate. After ruling out other conditions, her specialists at the University of California-San Francisco Medical Center—who also treated Jenny—suspect that Alicia may have the same condition.
I should point out that juvenile ALS is extremely rare, affecting just 1 in 2 million young people. It's impossible to say at this point whether these girls would have developed the condition regardless of whether they received Gardasil, but government officials—who still strongly maintain that the vaccine is perfectly safe and potentially lifesaving—are now starting to investigate. Scientists from the Food and Drug Administration met recently with Jenny's neurologists at UCSF to discuss whether it's scientifically plausible for a vaccine to trigger ALS.
Turns out, warnings concerning ALS and vaccines have been raised before. John Iskander, the CDC's associate director for immunization safety, tells me the agency previously has received reports of ALS following the anthrax vaccine. This, in addition to the deaths of Jenny and Whitney, "kind of tells us that we need to look more broadly at this issue," he says. He's quick to add that "we're doing just an initial review at this point; we don't have suspicions that these are casually related."
How will the CDC ever be able to know whether there's a true connection between Gardasil and ALS if this disease is so rare? And just how much evidence is needed? Iskander tells me he doesn't make that decision but passes on all the information he has to the government's vaccine working group, which makes recommendations about the national immunization schedule. "They are aware of these cases and that we've started discussions with neurologists and immunologists to determine if there are mechanisms that could explain how a vaccine could cause ALS," Iskander says, adding that "I haven't heard a good answer yet from these experts" when it comes to explaining a mechanism.
--
Wow. Dr. Iskander can’t imagine a mechanism by which a vaccine designed to trigger an immune response could trigger an autoimmune disease. And no matter how hard he scratches his head, he can’t see any commonality between anthrax-vaccine induced auto-immune disease and HPV-vaccine induced auto-immune disease, even though both contain aluminum hydroxide, an additive to some vaccines that is not contained in the typical childhood vaccines. MMR vaccine has no additives and DPT has Thimerosal, a mercury based preservative. Neither the MMR vaccine nor the DPT vaccine has ever been linked to an autoimmune disease. The anthrax vaccine and HPV vaccine both contain aluminum hydroxide and both have been linked to autoimmune diseases.

Also, Mr. Iskander never heard of google.

Unbelievably, in the clinical trials assessing the safety of Gardasil, the placebos contained aluminum hydroxide, making it impossible to assess the risk associated with this component.