Merck's Gardasil clinical trials only recorded harms up to 14 days after vaccination

General Discussion
#1

Researchers Find HPV Vaccine Trials Put Safety on the Back Burner

<<The review is the most ambitious to date of the clinical trials of Merck’s Gardasil and GlaxoSmithKline’s Cervarix, two HPV vaccines that have been given to hundreds of millions of young people worldwide. It looked at studies that tested the vaccines against a nonvaccine solution or an already approved vaccine, a type of research design intended to gauge a treatment’s risks and benefits before it is licensed for marketing. While not conclusive, the findings do spotlight potential signs of rare neurological harms that outside experts say warrant a comprehensive look at the raw data, and they paint a damning picture of how the manufacturers evaluated their products’ safety. Dr. Tom Jefferson, Jørgensen’s co-supervisor at the Nordic Cochrane Centre in Copenhagen, where the research was done, said safety was reported “higgledy-piggledy” in the 22 industry trials he and his colleagues examined. He added that the trials were “all at high risk of bias” and not “a fair test” of the vaccines.

For instance, for nearly three-quarters of the trial participants, the reporting of serious harms was hampered by incomplete follow-up that lasted only a fraction of the studies’ duration—a flawed design that was directly dictated by confidential research protocols. In the Gardasil trials, some of which ran for years, study personnel were only required to report serious medical events for 14 days following each shot. Participants who developed life-threatening or disabling disease after, say, 16 days could not count on having their ailments thoroughly assessed and reported as a potential side effect (referred to in medical-speak as an “adverse event”).

The truncated safety follow-up in many trials meant that they found very few serious adverse events, whereas other trials, with longer follow-up, found lots. One four-year Cervarix trial with full follow-up reported such events for 9 percent of participants, for example, compared with less than 1 percent in the largest-ever randomized placebo-controlled trial of Gardasil, which also lasted years.>>

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#2

Merck: This vaccine is so bad. Looks like there’s a 10 percent prevalence of serious long-term harms. Don’t know what to do.
FDA: Give us something to work with.
Merck: We could exclude all serious long term harms if we stop recording after two weeks following vaccination but that’s just way too obvious. No-one will buy it.
FDA. No, that will work. It’s worked many times before.

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#3

Speech on vaccine safety, sickening!

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#4

Merck being Merck again, shocker

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#5

We need to write to this journalist and tell him that if he wants to definitively expose Merck’s and FDA’s corruption, he needs to do an expose on finasteride.

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#6

Not much of a reaction here. Are people afraid to call a spade a spade just because it has to do with a vaccine? This is a case very similar to Propecia.

The pharma industry has very successfully framed the debate to call anyone who legitimately questions the safety of their vaccines as “anti-vax” and equated that with “anti-science”.

Obviously that’s part of their propaganda campaign. We of all people should not be intimidated by these tactics.

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#7

The whole system is broken as the FDA allows drug companies to design their clinical trials and they just sign off on them. I think Sage Therapeutics only tested their drugs for 14 days in a very small group of patients. I thought was a ridiculous timeframe because you have to look at depression over months to get an idea of whether the drug is working.

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#8

The comments to the original article are quite interesting.

#9

Same with antidepressants–they do trials for only 6 weeks then say BOOM you are cured! A Crock Of $H!t.

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#10

LOL, I tried them many years ago and I was told they don’t even fully work for first 3 weeks.