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subtlegrey) wrote2019-01-13 03:10 pm
subtlegrey) wrote2019-01-13 03:10 pm
The Bleeding Edge documentary (2018)
After hearing about this documentary from a friend of a friend, I wanted to watch it myself since it's one of the few topics I might have a prayer of an informed opinion on given my employment in clinical research. I started hijacking the OPs threads, but fortunately they have comments on a screen process, so I was able to dodge that faux paux and bring my yammerings here.
ETA Credentials: I worked for a contract manufacturer of Class I Medical Devices for 5 years as Quality Control before moving to a contract research organization performing Phase I and early Phase II Clinical Research (in-human trials) in 2016. I transitioned from Quality Control into Quality Assurance in 2018. Both industries are heavily and intimately regulated by multiple bodies, including the FDA and the European Union. Paperwork is my life.
The documentary itself was very much in line with any documentary - skating the edge of sensationalist exploitation of personal tragedies by way of Serious Faces and some text-on-screen data. Near as I can tell, that's what good documentaries do, so fair enough?
I took issue with a couple points, but overall I'm glad I watched it. I learned some interesting and depressing things. I will definitely pay closer attention to any Class III devices being foisted upon me, and I will thoroughly vet my surgeon's qualifications using any devices should that situation come up.
Under the cut is a very extensive breakdown of my take on a few of the movie’s points, including links to FDA websites specific to issues at hand.
I was initially skeptical of the OpenPayments site, but a quick peek into the background assuaged my fears that it would be another scam site (like the "sexual offenders" maps that claimed we had several convicted offenders living in the fields around my mom's house back in the 2000s). The site is solid, although data inaccuracies are apparently rampant and cause a great deal of problems for physicians and users.
What surprised me (and also didn't) was the creative ways in which medical device manufacturers were exploiting the 510(k) device exemptions. The video had an amazing graphic that illustrated the tremendous range of design changes on a hip replacement that could be brought to market with minimal oversight based off an initial, approved "predicate" design. (More about 510(k) and predicates). I want to see some proof of the claim that even if a predicate device is removed from market, the subsequently permitted exemption-driven devices aren't scrutinized or withdrawn as well, because if that's true, then we have a space-station-sized loophole in the system that needs closed POST-HASTE.
For the DaVinci robot, my takeaway wasn't that the robot itself was bad, but that the surgeons using the robot were inadequately trained and experienced. I think that falls on the medical licensing communities, personally. Whoever certifies humans to chop on other humans should probably have a robotics-assisted certification requirement with stringent training and testing. A half-dozen surgeries wouldn't clear a surgeon for anything else, why would the robot surgeries be qualified differently?
Speaking of training vs the device itself - This CRO website does a decent job of summing up the FDA's expectation of adequate training and use of devices (emphasis mine):
While sponsors of medical device trials are not required to submit an Investigational New Drug Application (IND, per 21 CFR Part 312), they are subject to 21 CFR Part 812, Investigational Device Exemptions. Notably, the Investigational Device Exemption (IDE) requires hands-on device training for investigator and site staff, in addition to protocol training, because the efficacy and safety of the device may be highly dependent upon physician technique.
The meat of the documentary was focused on Essure birth control/sterilization implants, with a heavy side dish of mesh inserts for tissue support that went horribly wrong. Fucking hell. I am SO GLAD I had a boring old hysterectomy instead of one of those torture devices! Essure was pulled from the US market right around the premiere of the documentary (Wikipedia says a week before, the documentary says a week after).
I was deeply disturbed by the repeated examples of men leaving their wives over not being able to have sex, and the obvious guilt the women felt. “I couldn’t be a wife to my husband… so he left.” Compounding this was the subtext that women were being punished for making decisions about their reproductive health, even though the husbands in these cases agreed and were supportive of the choice. I don't know if that message was intended to be there but it was, and it made me ill.
The clinical trials portrayed in the documentary for Essure would have been issued 483's (FDA inspection Warming Letters publicly available and searchable on the FDA website) if inspected for adulteration of data, at the very least. Key here is "if inspected." (I didn’t immediately find any 483s for Conceptus or Bayer related to Essure, but that doesn’t necessarily mean they weren’t inspected.) ClinicalTrials website shows 23 Essure-related studies, if anyone’s inclined to dig further.
The documentary was just wrong about how many studies are required for drugs, so I thought they'd be wrong about how many are required for devices and the answer is... maybe not? It’s Class-dependent, among other things. Bandaids and gloves are Class I medical devices; makes sense there’d be exemptions for new versions of those kinds of “devices.” It's the Class III's you need to worry about, and those are the ones this documentary was focused on. That distinction was never made. Class III's especially are more complex, you can't ethically do placebo-blinded trials, to start with!
Many complaints in the documentary focused on what amounts to a lack of funding for the FDA, even if they didn't realize it. I had a real *headdesk* moment when the Serious Voice earnestly pointed out how research funding is primarily private industry. FDA is funded by.... wait for it..... the government. Which keeps lowering taxes and shutting down and cutting funding to the FDA and government-run research organizations in favor of military spending. While corruption is arguably everywhere, I’d be in favor of a more balanced public-vs-private funding model for medical research, even if it mean higher taxes and fewer wars (o darn what would become of humanity if we had fewer wars).
A few times the Voices hammered home the idea that "industry" said devices were safe, yet didn't specify which industry. If it's the manufacturing industry, well, sadly, duh. To say we can't rely on medical device companies to do what's in the best interest of patients is like saying we can't rely on the congressman to vote on a salary package for himself that's in the best interest of his constituents.
In the end, this is yet another example of how people who like to have lots of money exploit and harm everyone around them for the chance to get more of the money they like so well. I'm seeing this everywhere, just fucking everywhere, and I don't believe it's a new or unique social crisis. When will we learn? What is it going to take?
In the end, I just wanted to thank the people who shined light on these issues. Bless you, brave, courageous women and men who have devoted your lives to exposing corruption and demanding change from our governing bodies. I’m grateful to each of you for sharing your stories on camera like this and protecting your fellow humans. Namaste.
ETA Credentials: I worked for a contract manufacturer of Class I Medical Devices for 5 years as Quality Control before moving to a contract research organization performing Phase I and early Phase II Clinical Research (in-human trials) in 2016. I transitioned from Quality Control into Quality Assurance in 2018. Both industries are heavily and intimately regulated by multiple bodies, including the FDA and the European Union. Paperwork is my life.
The documentary itself was very much in line with any documentary - skating the edge of sensationalist exploitation of personal tragedies by way of Serious Faces and some text-on-screen data. Near as I can tell, that's what good documentaries do, so fair enough?
I took issue with a couple points, but overall I'm glad I watched it. I learned some interesting and depressing things. I will definitely pay closer attention to any Class III devices being foisted upon me, and I will thoroughly vet my surgeon's qualifications using any devices should that situation come up.
Under the cut is a very extensive breakdown of my take on a few of the movie’s points, including links to FDA websites specific to issues at hand.
I was initially skeptical of the OpenPayments site, but a quick peek into the background assuaged my fears that it would be another scam site (like the "sexual offenders" maps that claimed we had several convicted offenders living in the fields around my mom's house back in the 2000s). The site is solid, although data inaccuracies are apparently rampant and cause a great deal of problems for physicians and users.
What surprised me (and also didn't) was the creative ways in which medical device manufacturers were exploiting the 510(k) device exemptions. The video had an amazing graphic that illustrated the tremendous range of design changes on a hip replacement that could be brought to market with minimal oversight based off an initial, approved "predicate" design. (More about 510(k) and predicates). I want to see some proof of the claim that even if a predicate device is removed from market, the subsequently permitted exemption-driven devices aren't scrutinized or withdrawn as well, because if that's true, then we have a space-station-sized loophole in the system that needs closed POST-HASTE.
For the DaVinci robot, my takeaway wasn't that the robot itself was bad, but that the surgeons using the robot were inadequately trained and experienced. I think that falls on the medical licensing communities, personally. Whoever certifies humans to chop on other humans should probably have a robotics-assisted certification requirement with stringent training and testing. A half-dozen surgeries wouldn't clear a surgeon for anything else, why would the robot surgeries be qualified differently?
Speaking of training vs the device itself - This CRO website does a decent job of summing up the FDA's expectation of adequate training and use of devices (emphasis mine):
While sponsors of medical device trials are not required to submit an Investigational New Drug Application (IND, per 21 CFR Part 312), they are subject to 21 CFR Part 812, Investigational Device Exemptions. Notably, the Investigational Device Exemption (IDE) requires hands-on device training for investigator and site staff, in addition to protocol training, because the efficacy and safety of the device may be highly dependent upon physician technique.
The meat of the documentary was focused on Essure birth control/sterilization implants, with a heavy side dish of mesh inserts for tissue support that went horribly wrong. Fucking hell. I am SO GLAD I had a boring old hysterectomy instead of one of those torture devices! Essure was pulled from the US market right around the premiere of the documentary (Wikipedia says a week before, the documentary says a week after).
I was deeply disturbed by the repeated examples of men leaving their wives over not being able to have sex, and the obvious guilt the women felt. “I couldn’t be a wife to my husband… so he left.” Compounding this was the subtext that women were being punished for making decisions about their reproductive health, even though the husbands in these cases agreed and were supportive of the choice. I don't know if that message was intended to be there but it was, and it made me ill.
The clinical trials portrayed in the documentary for Essure would have been issued 483's (FDA inspection Warming Letters publicly available and searchable on the FDA website) if inspected for adulteration of data, at the very least. Key here is "if inspected." (I didn’t immediately find any 483s for Conceptus or Bayer related to Essure, but that doesn’t necessarily mean they weren’t inspected.) ClinicalTrials website shows 23 Essure-related studies, if anyone’s inclined to dig further.
The documentary was just wrong about how many studies are required for drugs, so I thought they'd be wrong about how many are required for devices and the answer is... maybe not? It’s Class-dependent, among other things. Bandaids and gloves are Class I medical devices; makes sense there’d be exemptions for new versions of those kinds of “devices.” It's the Class III's you need to worry about, and those are the ones this documentary was focused on. That distinction was never made. Class III's especially are more complex, you can't ethically do placebo-blinded trials, to start with!
Many complaints in the documentary focused on what amounts to a lack of funding for the FDA, even if they didn't realize it. I had a real *headdesk* moment when the Serious Voice earnestly pointed out how research funding is primarily private industry. FDA is funded by.... wait for it..... the government. Which keeps lowering taxes and shutting down and cutting funding to the FDA and government-run research organizations in favor of military spending. While corruption is arguably everywhere, I’d be in favor of a more balanced public-vs-private funding model for medical research, even if it mean higher taxes and fewer wars (o darn what would become of humanity if we had fewer wars).
A few times the Voices hammered home the idea that "industry" said devices were safe, yet didn't specify which industry. If it's the manufacturing industry, well, sadly, duh. To say we can't rely on medical device companies to do what's in the best interest of patients is like saying we can't rely on the congressman to vote on a salary package for himself that's in the best interest of his constituents.
In the end, this is yet another example of how people who like to have lots of money exploit and harm everyone around them for the chance to get more of the money they like so well. I'm seeing this everywhere, just fucking everywhere, and I don't believe it's a new or unique social crisis. When will we learn? What is it going to take?
In the end, I just wanted to thank the people who shined light on these issues. Bless you, brave, courageous women and men who have devoted your lives to exposing corruption and demanding change from our governing bodies. I’m grateful to each of you for sharing your stories on camera like this and protecting your fellow humans. Namaste.