Quickly, let’s just note that Gardasil, though heavily marketed and lobbied, is probably not the most heavily marketed and lobbied drug ever or even close, and that sales have started to grow again. And then let’s take a look at those 20,000 adverse events and 100 deaths and figure out what they mean. It’s absolutely clear that these are for the most part not side effects from Gardasil. Nor is the vaccine, which has been given to more than 10 million people, likely responsible for those deaths. The Vaccine Adverse Event Reporting System was put in place in 1990 as a result of a 1986 law that requires health providers to report harm that comes to patients within a specific time period after vaccination. (The same law also limits liability for vaccine manufacturers to prevent them from abandoning the category.) A great many of these reports can come from sales reps for drug manufacturers who hear about the incidents. Unfortunately, VAERS data is notoriously spotty – better than nothing, but there’s no way to insure that potential side effects are reported. When a product gets bad press, the number of reported “adverse events” goes up. And there is no way to tell if a particular side effect is linked to the vaccine. Some people will die after any vaccination, not because vaccines cause death but because people, even babies and adolescents, die with terrible regularity. It’s true that there have been 24,000 reports of adverse events with Gardasil. (All of these numbers come from the VAERS database, which you can search here.) There have also been 60,000 reports of death with the mumps, measles, and rubella vaccine, and 26,000 following vaccination with Pfizer‘s Prevnar, for pneumococcus bacteria. And yes, it’s true that there have been 106 deaths reported after Gardasil vaccination. There have also been 101 deaths reported after vaccination with Prevnar 13, a new version of Prevnar introduced in 2010. It’s normal for these reports to pour in for safe vaccines. You can’t directly link any of those adverse events or deaths directly to the vaccines, any more than you could blame it on my morning coffee if I got hit by a truck later today. So to try to make use of this data, researchers compare the rates at which negative side effects are reported for different vaccines. The CDC and FDA did this for HPV vaccines in 2009, looking at the first 12,424 reports to VAERS and publishing the result in the Journal of the American Medical Association. They did note 2 cases of unusual neurological symptoms similar to Lou Gehrig’s disease, and there was an increase in patients who had potentially dangerous blood clots, although 90% of those patients had a risk factor for those clots, such as taking birth control pills, that might explain the increase. The researchers specifically looked at Guillain-Barré Syndrome, a neurological disorder that had been linked to a bad batch of flu shots; there wasn’t a signal that this was a problem with Gardasil. The study did result in the FDA advising doctors to watch adolescents after they get their shots, because some faint. Based on that analysis, it seems that of those dozens of deaths, only a handful could possibly be linked to Gardasil. And based on the data available, it is unlikely (though not impossible) that even those deaths were caused by the vaccine. The risks from the vaccine are very small and may be limited to headaches and fainting caused by the needle, not the vaccine itself. Gardasil has been studied in clinical trials of more than 30,000 people; Cervarix, the competitor vaccine, has run a similar gantlet. It’s really important not to rely too much on VAERS, because it can lead to some totally Alice-in-Wonderland-type conclusions – fantastical results that we can tell aren’t true. Forbes commenter Rick Wobbe, a former pharmaceutical exec who is rarely shy about being critical of pharma, responded to my story by plunging bravely into the VAERS himself.
Posted on: Mon, 30 Sep 2013 23:51:58 +0000
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