Illy-chan,

When the drug in question is a vaccine for a sexually transmitted disease, then it's really not so clear that its benefits outweigh the side effects, even if the side effects occur in a small percentage of patients. We're not talking about hair falling out when a cancer patient gets chemotherapy; we're talking about a product being represented as safe after inadequate clinical trials, presented to parents (relentless in TV ads, I might add) as the best course of action to prevent an STD that almost always clears up on its own without causing the oft-mentioned cervical cancer, and then causing paralysis, convulsions, death, etc. in thousands of patients.

There is no clear evidence that any girl needs to be vaccinated against HPV, particularly since this vaccination doesn't protect her against the always-lethal HIV or against unwanted pregnancy (so she should still be observing safe sex practices). An unnecessary vaccination that kills and paralyzes some people? Not really cause for a flip "all drugs have side effects" remark.

You do realize that side effects happen in general, right? I mean, you're talking about 2 girls out of how many doses have been given? In the US, there have been about 15,000 adverse side effects reported. That's out of 24 million doses and only 7% of the adverse effects reported were serious and even then, they could not be positively linked to the vaccine.

It's dangerous to cling to relatively small instances of problems and then call it "wrecking havoc" when the drug's benefits still far outweigh the dangers. I can't believe how many parents freak out every time they hear about what is basically a statistical inevitability.

By the way, I had all three of my shots and am totally fine months (if not years) later. :P

Here's another one for the "Merck's check cleared" file...
Yale Alumni Magazine reports on the work of epidemiologist Alison Galvani, who does her work at the Yale School of Public Health but has been on Merck's payroll since 2003, according to her CV. Galvani did a marketing study for Merck on Gardasil that she somehow passed off as research; her study asked parents whether they thought their daughters would become more promiscuous if they were given Gardasil. Yale Alumni Magazine's writer (Jenny Blair, who is a Yale-educated MD) apparently didn't read the published results from the *Proceedings of the National Academy of Sciences* because she says "Side effects were a minor concern" for parents in deciding whether to give their daughters Gardasil--I read the published results, and nowhere in the paper does Galvani mention asking survey participants about side effects... although she does fleetingly note that parents have concerns in her introduction to the paper.
Dr. Blair's pro-pharma writeup of the research also calls Gardasil "a safe and effective vaccine against HPV"--I wonder who told her that? Merck, or their paid-off researcher Galvani?
The icing on the cake is that Galvani asserts in her paper that "There is no evidence that perceptions of increased adolescent sexual promiscuity are based on reality." No evidence is given for this statement; it is just pronounced, as if thinking makes it so. I am unaware of *any* data on the promiscuity effects of STD vaccines given to preteens and teens--maybe because Gardasil is the first STD vaccine given to a sexually active (or soon-to-be sexually active) group!
Beyond the fact that no one has ever evaluated the promiscuity consequences of STD vaccination of teens, Galvani didn't ask her survey participants a more important question: whether they believe HPV vaccination will make their daughters less likely to use protection such as condoms when engaging in sexual activity. Even if you think your daughter is just as likely to be promiscuous whether or not she receives Gardasil, you might believe (and you might be right) that she will be more careless about protecting herself from pregnancy, AIDS, etc., when she does have sex.
The alumni magazine's Dr. Blair concludes (parroting from Galvani's market research for Merck), "a targeted public health education campaign would likely counter fears of increased promiscuity. And a little financial aid wouldn't hurt." Given that both insurance premiums and the federal government's Vaccines for Children Program currently subsidizes Gardasil's production and administration, I guess Galvani and Merck are really asking for a little *more* financial aid... and maybe the reason Merck (and the government) haven't been running ads to the effect of "your daughter won't be any more promiscuous if you give her Gardasil" is that there is no data to back up that assertion, however much Galvani and Merck want it to be true.
(Links here:
http://www.yalealumnimagazine.com/issues/2009_03/findings_hpv.html
http://www.ncbi.nlm.nih.gov/pubmed/19015536?ordinalpos=18&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
I paid $10 for access to the article to make sure nothing about side effects was left out of the abstract... No surprises there.)

Pharma: "It was a bad batch. Here's a new Lot. That should solve the problem."

Pharma is in denial that they are the cause of this problem. Public is beginning to have a distrust and they are only exacerbating it. Stupid, just plain stupid.

The two Spanish girls, Raquel and Carla (15 and 14 years old respectively) have been in and out of the ICU since they received the third round of their Gardasil shots a month ago. They suffer from repeated episodes of convulsions that don't seem to go away for good. The population has been offered reasurance by the European Union that the Gardasil shot is most likely not to blame. But the parents of the two girls are threatening to sue the manufacturer on the basis that "the connection between the vaccine and the appearance of the convulsions is so evident that denial of a connection can only be understood if there are special interests involved that are difficult to justify".

Spain's secretary of health is personally involved in the ongoing investigation and has claimed that they will look at all possible causes, vaccine and non-vaccine related.

The information above has been translated from the Spanish from the following sites. These belong to "EL PAIS", the spanish equivalent to the NY Times.

http://www.elpais.com/articulo/Comunidad/Valenciana/pesadilla/Carla/Raquel/elpepiespval/20090303elpval_3/Tes

http://www.elpais.com/articulo/Comunidad/Valenciana/Bernat/Soria/crea/grupo/tratar/chicas/papiloma/elpepiespval/20090306elpval_12/Tes

In my opinion, there is a massive crisis control campaign by the Spanish Health instuitutions and you can feel the pressure by the manufacturers and their allies in the health industry. The special attention given to the families may help avoid a lawsuit. I hope they sue and that they get a fair trial.

"The regional health service has meanwhile restarted vaccination with the Gardasil product, but with a different lot number, but the parents are now advising others not to let their children be injected with Gardasil."

It doesn't make sense to me as to why these parents would do that. Could it be that they don't want other people to undergo the same fate as their daughters? What's a seizure or two, right Dr. Christopher Thomas?