Lap Banders: Write a Letter to Washington!!
Thank you for more or less sticking to the topic this time, and not interjecting the distracting and difficult to understand musings on matters which were not pertinent to the topic of this thread, which is to provide notice to lapband patients that their input would be useful in the PENDING REVIEW of the adequacy of the FDA's 510(k) regulations.
However, your writing style STILL seems to be intended to obfuscate and confuse.
For those who cannot get through what Eric wrote, here is my summary, bolstered by pertinent information that was omitted, and put in an order that makes more sense:
1) The FDA regulates both drugs and medical devices (and other products, but that's the topic here)
2) They are two different things - don't get them confused. Also, don't confuse "post-marketing tracking" requirements for devices with "post-marketing surveillance" requirements. Tracking means that the FDA has to be advised of the serial numbers of CERTAIN implanted devices (not including any bands or any other bariatric-related devices) together with patient contact information - so they know how to contact patients in case of a recall; it does NOT mean that problems with the devices have to be reported!
3) The device approval process basically has two arms - completely new devices that require higher scrutiny, and the 510(k) procedure, used by 90% of submissions, that is an abbreviated path for devices that are similar to devices already on the market (NOTE: this is quite different from the still very high standards for generic drugs, which have to be essentially IDENTICAL to the drugs that they are copying).
4) The DRUG process has mandatory post-marketing SURVEILLANCE requirements - adverse events MUST be reported, for both new drugs and generics
5) The DEVICE process for NEW devices has mandatory reporting, but the 510(k) "similar" device process does NOT have a requirement for mandatory reporting of adverse events, AKA post-marketing surveillance. THIS IS ONE OF THE PRIMARY ISSUES THAT THE IOM IS CITING AS AN IRRETRIEVABLY BROKEN REGULATION, AND ONE WHICH LAPBANDERS SHOULD BE VERY CONCERNED ABOUT, because the lapband and other gastric bands have been approved through this less stringent process.
6) I *think* (but it's hard to tell) that Eric is suggesting that publications in journals about post-marketing problems are an adequate substitute for FDA oversight, including post-marketing surveillance. I vehemently disagree.
As for whether my confrontational style does or does not suit my purposes (and they are MY purposes, not yours), I'm comfortable with them.
I don't know why you chose to pick this thread to appear after months of silence, but your writing style is diffuse, off point, and obtuse, apparently intending to deflect focus and attention from the point of the thread, and most irritatingly of all, comprises multiple instances of asserting your opinions masquerading as facts, conduct that should NOT be associated with the owner of this board. To the extent your posts are understandable at all, you appear to be flakking a low threshold for FDA device compliance requirements in deference to your LapBand advertisers.
I submit that your inappropriate behavior justifies my derision and ridicule - which others have noted with approval.
http://www.ncbi.nlm.nih.gov/pubmed?term=(mesh)%20AND%20baria tric%20surgery
Upper left... "display settings", show abstract (my standard routine)...no way to force that into a URL on that site...
... can you find any particular articles that reference the particular risks at hand?
But I'm not looking at those links, because I think you don't understand what this is all about in the first place - it appears you just jumped in without reading the links and understanding the issues.
The original MSNBC article has nothing to do with bariatric surgery - it has to do with a type of surgical mesh used in vaginal or bladder surgery to repair weak pelvic floor or something like that - the specifics don't really matter. The problem is that surgeons are putting this crap (which is technically a medical device) in and it is causing all sorts of problems, BUT THERE IS NO FDA MECHANISM IN PLACE TO TRACK THESE PROBLEMS - and thus whether something needs to be fixed. So the IOM is looking into lobbying for legislative change to require post-marketing surveillance.
The issue that I brought up is that the same damned thing applies to LapBands. And I'm willing to bet that Allergan is involved in the medical device companies' attacks on the IOM report, which is what the second link was about.
As I said, I've had a bariatric surgeon share his frustration with me - as well as possible smoking gun emails - about having no way to report the band failures and severe medical problems caused by the bands. This is UNACCEPTABLE!
I'd just been reading about meshes as used in WLS, so the terms was fresh in my mind from that.
Re the link... things making the popular (or semi-popular) press sometimes have a pre-existing in peer review literature dating way back. Peer review authors might be debating or calling attention to things long before journalists do. Might or might not be anything apropos within those articles from bariatrics. (Or, for that matter mesh research not involving bariatrics).
Here's one recent one, with a full paper being available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021192/?tool=pu bmed
"The incidence of de novo urinary urgency after anatomic correction has been shown to be 5%–25% [16, 17] and the incidence of de novo dyspareunia is variable, but 15%–25% without mesh, and as high as 63% with a mesh augmented repair [18, 19]."
Uh, I'd say that's worth having the FDA review it, don't you??
Also,.. one thing I noticed for the first time (I'm kind of slow sometimes -- no news there) was an actual "normal" article, whose production itself might or might not have been supported by any particular sponsor, but which shows up in the "full text available" category due to some sponsorship. Most journals offer some minor fraction of their ware free on line (without having to be a subscriber to the journal).... ok, duh, you obviously from your above already know that, but this was the language I found : "Because the distribution of this artlce was sponsored by a 3rd party, it technically must be considered advertising, in accordance with {something something something}." You ever come across that on any full text articles? I think I noticed it in Diabetes Research.
Reading above.. hey... were you attributing Boolean incompetence to me? Well! I never was good at either/or thinking, or so I've been told.
Which types of FDA pannels do you think have done the best job in reviewing things? I remember back 20 years ago there was a lot of discussion about what authority levels which types of "advisory" convenings would have at which stages of things.
I remember a drug I was tasked to review research on at the time. I think it delt with angiotensin. I remember walking up and down from the library with pounds of animal data.I recall something to the effect of pigs, dogs, and sheep having done ok, but for some reason a lot of mice had died from liver problems. Mice had died first, and some $100m (or similar) and an extended 4 years later, enough advisors had figured that pigs, dogs and sheep experience, being more recent, were enough to allow progression to humans. (If the mice had done ok in the first place, dogs and sheep could have been skipped). I remember someone commenting that the pannel member who had ultimately held progression to human trials up more than anyone else had cut his academic teeth studying mice.
Re "Uh, I'd say that's worth having the FDA review it, don't you??" -- yeah, those academic writers are really aggressive about finding and arguing about such things. Not trying to down play here-and-now relevance, mind you. Rather, it's been interesting to me (but again, I'm kinda slow) how old certain concerns wind up having been in the academic literature prior to more main stream attention.
Sponsorship information is required by most, if not all journals. But of course you can't see that if all you can see is the abstract.
I'm not sure how decisions are made whether to make articles publicly available online, either for an entire journal or selected articles. However, I do know that PNAS (Proceedings of the National Academy of Sciences), one of the most prestigious journals in the world, used to ALL be available online, and were ALL marked with this disclaimer: "The publication costs of this article were defrayed in part by page charge payment. This article must therefore be hereby marked “advertisement" in accordance with 18 U.S.C. §1734 solely to indicate this fact." However, more recently, PNAS has changed their policy, and some articles are available online but not others, and the publicly available ones don't seem to have the disclaimer.
JBC (Journal of Biological Chemistry) is another very presigious journal that is freely available online with NO disclaimer.
My point is, figuring out who ACTUALLY paid for the research can be tricky, especially when only the abstract is available online.
Academic scientists have agendas too. Mostly, to get more grants. But not having obvious sponsorship of commercial interests gives at least a hope of being unbiased. But I still don't understand your last paragraph - what are you trying to say??
As for the rest of your post: I have no idea about which FDA panels do the best job - nor do I have the faintest idea of what you could possibly mean by asking that question. Your story about angiotensin and mouse studies is also a non sequitur - it has nothing discernable to me to do with the discussion about whether the FDA should be doing post-marketing surveillance of medical devices, but is just you telling an irrelevant story that makes it look like you have some sort of "expertise" on FDA issues.
Do you realize most of us can tell when you are trying to deflect attention from criticism of your postings? Your rhetoric is pretty obvious - is it deliberately incoherent as well? Can you please stick to the topic, so we can figure out if you know what you're talking about?
This issue of conflicts of interest, supported "research" and phase V reporting is pretty old and doesn't seem to be getting better. Even studies of the relevance of abstracts and the actual research it summarizes had been shown to have negative correlation.
Eric appears to have fat and stupid mixed up and as such provides a poor basis for patiient advocacy, asuuming that is actually what OH seeks to do.
You have done a superb job of being diplomatic. I'm not sure I could show as much restraint.
Good on you..
(Eric, I have been a scientific presenter at the WHO, CDC, NIH, and AASLD, invited member of many medical and scientific advisory boards to government and industry, just so you know there are a few of us around who know what we are talking about.)
t
This topic is quite simple and straightforward: the FDA commissioned a study on its 510(k) regulations by the National Academy of Sciences' Institute of Medicine. The IOM just issued a SCATHING report condemning the existing FDA process for its lack of adequate oversight of medical devices, including utter lack of mandatory postmarketing surveillance processes, and recommended that the FDA scrap the regulation and start over. The medical device manufacturers have rallied their troops and are throwing a huge amount of money at trying to discredit the IOM's report - which of course the FDA, embarrassed by the recommendations of a report THEY commissioned being so critical of what they are doing, is wholeheartedly embracing. The FDA posted a notice of an "intent" to collect public comment on the proposal yesterday, in a press release that was dripping with sarcasm and implied dismissal of the IOM proposal: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc m265908.htm
"The FDA commissioned the report in September 2009. While none of the IOM’s recommendations are binding, the FDA is planning a public meeting in the coming weeks to discuss recommendations made in the report, titled “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years."
“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them."
“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said."
SO MY QUESTION FOR ERIC KLEIN IS, WHY WOULD YOU SUPPORT THE FDA IN THIS MATTER, WHEN PEOPLE ON THIS SITE WHOM YOU SUPPOSEDLY CARE ABOUT WOULD BE BETTER PROTECTED BY A MORE ROBUST REGULATORY MECHANISM FOR MEDICAL DEVICES?
on 7/29/11 2:15 am - Califreakinfornia , CA
. Eric is totally rambling and he's all over the place with his replies. It's like he is purposely throwing out all kinds of **** and hoping some of it will stick.
