Sunday, May 23, 2010

How did Gardasil pass FDA review?

How did Gardasil pass FDA review?
May 21, 12:22 PMVaccines ExaminerNorma EricksonPrevious


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Consider the questions raised by Merck's prescribing information packet on Gardasil. Of the 20,118 people injected with either Gardasil, their 'proprietary' AAHS control solution (which contained the vaccine adjuvant), or saline solution (a real placebo--typically used for clinical trials of a new treatment) there were 463 new 'medical conditions' reported. All of these 'conditions' occurred after enrollment in Merck's clinical trial. All of these conditions occurred in previously healthy young women. According to the information packet, these new medical conditions were "potentially indicative of a systematic autoimmune disorder."

463 new medical conditions occurring in a population of 20,118 young healthy women--is that not unusual?

It is also important to note these new medical conditions are not listed in the 'adverse reactions' section of the information packet. They are enumerated near the end of a reasonably extensive prescribing information packet, where they could easily be overlooked.

Note that in the 'adverse site reactions' section, the vaccine, AAHS control, and saline groups are separate. Any reasonable person would ask why the saline placebo group and the AAHs control group were combined in the 'new medical conditions' section and the 'common systemic' reactions section.

Was it, perhaps, to lead people to believe the vaccine was just as safe as their 'control solution'? After all, by combining these two 'control' groups, Merck was able to show the same percentage of 'new medical conditions' for both the vaccine and the control groups.

New Medical Conditions Reported Arthritis/Arthralgia/Arthropathy 218

Autoimmune Thyroiditis 5
Celiac Disease 16
Diabetes Mellitus Insulin Dependent 4
Erythemia Nodosum (inflammatory skin disorder) 6
Hyperthyroidism (overactive) 48
Hypothyroidism (underactive) 73
Inflammatory Bowel Disease 17
Multiple Sclerosis 6
Nephritis (inflammation of kidneys) 7
Optic Neuritis (inflammation of optic nerves) 2
Pigmentation Disorder 7
Psoriasis 28
Raynaud's Phenomenon 7
Rheumatoid Arthritis 8
Sclerodoma/Morphea 3
Stevens-Johnson Syndrome 1
Systemic Lupus Erythematosus 4
Uveitis 4

Some of these new medical conditions are quite rare. Any reasonable person would question this many new medical conditions occurring in such a snall population of previously healthy young women.

There were also 37 deaths that occurred during the clinical trials. One would think this alone would have required further investigation prior to approval. Is this fatality rate not a little high for a group of 20,118 healthy young women?

Questions for the FDA:

Why were these new medical conditions not looked at as possible adverse reactions?
How could so many new medical conditions occur in such a small group of healthy women?
Why was Merck allowed to use their proprietary adjuvant as a control solution instead of a real placebo?
Why was Merck allowed to list their AAHS control group and the saline placebo control group separately under adverse site reactions, and allowed to combine them under new medical conditions?
Were the deaths examined closely? If not, why not?
Why was Merck not required to do further safety testing with this many new medical conditions occurring during their clinical trials.
Did Merck conduct any safety trials on their new proprietary adjuvant prior to using it in Gardasil?

For more info: Read Merck's prescribing information packet for Gardasil. or, Part 2: How did Gardasil pass FDA review?

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