Qi Spot

LONDON – British drug giant GlaxoSmithKline said Tuesday it was working with health authorities here investigating the death of a schoolgirl following a cervical cancer vaccination.

The 14-year-old died on Monday when the Cervarix vaccine was administered at her school in Coventry, central England, as part of a national vaccination to protect women against the disease.

Health authorities have isolated the batch of vaccine used in the school involved against the Human Papillomavirus (HPV), a sexually-transmitted virus which is the primary cause of cervical cancer.

“The incident happened shortly after the girl had received her HPV vaccine in the school,” said Dr. Caron Grainger, joint head of public health for the National Health Service (NHS) in Coventry and Coventry City Council.

Late Tuesday Grainger said test results revealed the teenager had a “serious underlying medical condition” and the vaccination was therefore “most unlikely” to have caused her death.

“The preliminary post-mortem results have revealed a serious underlying medical condition which was likely to have caused death,” she said.

“We are awaiting further test results which will take some time. However, indications are that it was most unlikely that the HPV vaccination was the cause of death.”

The Department of Health said the vaccination program would continue as planned, stressing that more than 1.4 million doses had been given out in Britain and the vaccine had a “strong safety record”.

“The quarantining of this batch is a purely precautionary measure,” a spokesperson said, adding: “The HPV vaccination program can continue as planned — there is no reason for the campaign to be suspended or interrupted.”

In a statement GSK, which produces Cervarix, said it was working with health authorities “to better understand this case, as at this stage the exact cause of this tragic death is unknown.”

It added: “To date the vast majority of suspected adverse reactions (to Cervarix) have related either to the signs and symptoms of recognized side effects listed in the product information or were due to the injection process and not the vaccine itself.”

Awareness of cervical cancer was boosted earlier this year by the death from the disease of a reality television star, Jade Goody, who garnered publicity notably for the need for women to have regular cervical smear tests.

Natalie Morton died a few hours after being injected with a dose of Cevarix.  Strictly speaking, Cevarix and Gardasil are not vaccines for cancer, but for strains of HPV that are supposed to cause cervical cancer.  A recent Journal of the American Medical Association article with a stated objective of summarizing reports from the Vaccine Adverse Effects Reporting System (VAERS) has led the authors to the following findings:

1) There were 12,424 reports of Adverse Effects.

2) Of these, 772 were considered serious.

The reporting rates per 100 000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.

Note the word “disproportional”.  Keep in mind that this is a PASSIVE data system, meaning it doesn’t actively seek out side effect reports, but it sits there waiting for doctors to report them.  I am trying to imagine how many more cases out there are unreported.

and 3) There were 32 deaths.

Okay, 32 deaths out of millions of doses given… that’s not very large.  However, what comes to mind is that I have a daughter of my own.  How would I feel if that daughter of mine were one of that 32?  One of the 772 with “serious” side effects?

Of course, I could look at the other side of the fence and think, what if my daughter gets exposed to HPV?  Develops pre-cancerous lesions?

How to balance the two?

There are two factors that make me lean towards avoiding this vaccine for now.

First is the fact that this vaccine is still relatively new.  Thus, it’s long term effects are still in question.  People now do not recall the Polio Vaccine snafu that happened in the 1950s, when it became apparent that Salk’s polio vaccine actually CAUSED more cases of polio.

Second is the fact that the incidence of cervical cancer is actually lowering.  Instead, we have a rise in detection of carcinoma-in-situ (only seen cellularly).  Why? Pap smears, that’s why!  With regular screening, we can find pre-cancerous lesions, treat early, and prevent cancer.  With diseases like Hepatitis B, we don’t have that luxury.

Methinks I will wait ten years before pronouncing HPV vaccines as safe and reliable.

In the meantime, let’s also look at the applicable Chinese Medicine principles here.  Behaviors influence disease.  In the case of HPV, one is most at risk by having promiscuous sex with several partners.  (Well that was redundant… promiscuous sex with several partners…)  Logic dictates that proper behavior not only protects against HPV but other sexually transmitted infections as well.

Final seemingly-unrelated-thought: I also find it amusing that if a person with an underlying medical problem dies and is found to have been infected with H1N1, authorities are quick to assume that H1N1 caused the death by complicating the underlying problem.  Yet, when a person with an underlying medical problem is jabbed with a vaccine and dies, the same authorities are quick to rule out the vaccine as a cause of death because of the presence of the underlying problem.  As my good friend Garrick would say, “Huh?”