Monday, May 23, 2016

The approval process: Women's Health Devices and Vaccines - Some Similarities

Some residents from Northwestern University recently published a study examining the approval process for various devices commonly used in or on women for various conditions which revealed some serious concerns about the process the FDA uses for new devices

As I read the description of the study's results (I did not have access to a full-text version) I was struck by some similarities in the deficiencies of the approval process between vaccines and the medical devices their study delineates. 

Of note, one device (now being investigated due to patient reports of complications post-approval) was approved on after "short-term evidence". This is similar to vaccines where most surveillance for adverse reactions is collected after short-term follow up. 

Here's an example: 
Hiberix Package Insert - see pages 6&7 (Section 6) where you will find that the longest (reported) follow-up was 31 days. 

Section 14 (starting on page 10) - Immunological studies - the approval was based on a randomized controlled study - though none of this is defined and what is most telling is the lack of blinding and in fact you can read on page 12 that at least one of the studies was open-label. 

Table 3 on page 11 shows antibody response 1 month following administration - the table describes this as "Seroprotection Rate" though I would describe this as an example of "science" (scare quotes deliberate) by proxy - in other words, not real science as science requires direct observation of an effect, not an inference of a desired result (reduced incidence of "x" infection) by indirect measurement of something else (mounting an antibody response). Measurement of an antibody response is not a randomized double-blind controlled trial. 

On page 11 you will see that data regarding race/ethnicity was incomplete (" ... among subjects for whom information on race/ethnicity was available ...") but that most of those were White/Anglo - what factors were "controlled" in this study? The age of children ranged from 12 months to 23 months - a 12 month old infant is far different from a 23 month old toddler immunologically! If age was not controlled, nor was race, and apparently data collection on at least one demographic variable was spotty (race) - just what exactly was "controlled"? 

Here's a pertinent quote: 
“Devices are a huge part of the medical care that we provide women on a daily basis,” said study first author Jessica Walter, MD, a resident in the Department of Obstetrics and Gynecology. “We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use.” 
I think you could easily substitute "Vaccines" for "Devices" and "people" for "women" in the above quote ... and that there is likewise the same "opportunity" in regards to strengthening the evidence needed for a vaccine's approval prior to use by anyone - child or adult. 

The article by Northwestern University connected the dots between what this study revealed and a law being considered in Congress - the 21rst Century Cures Act, which if passed would reduce regulation of medical devices and "broaden" the definition of scientific evidence used by manufacturers (this includes vaccines). In other words, this bill, if passed, would codify into law post-normal science. 

We all deserve so much better. And researchers are capable of so much more, as are companies making (and profiting) from medications and devices.   

With valid concern about the quality of research undergirding approval of vaccines it is reasonable and prudent for there to be great freedom in personal choice regarding their use. Even if the research were stronger no one should be forced or manipulated into the use of any medical procedure. 

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