Lap Banders: Write a Letter to Washington!!
Are you kidding me? I don't even know where to begin to explain how factually incorrect just about everything in this paragraph is.
Do you SERIOUSLY suggest that but for the use of and then withdrawal of phen-fen, there would have been no spike in the obesity epidemic in the 90s? Wait - even THAT doesn't make any sense. Phen-fen just delayed the obesity epidemic? Or it caused it?? What are you saying?? How many people do you think were actually taking it???
Are you SERIOUSLY suggesting that phen-fen saved lives? Are you f'ing kidding me?? It didn't work. I was on it. I lost about 30 lbs and then I gained them again - just like with every other diet drug ever invented. So, it didn't cure obesity; it didn't even treat it very well long term; and it caused - or exacerbated pre-existing pulmonary hypertension.
I really hope you are not posting here in your ostensible role as a person knowledgeable about obesity, because this post is - let's just call it nonsense. There may well be examples of situations where risk did not justify overreaction by regulatory agencies - benzene in household cleaners comes to mind (I worked for the RAND Corporation for a while), but phen-fen? Really??
By the way, I read this (http://www.downeyobesityreport.com/latest-news/), in which which Morgan Downey, editor (and self-publisher) of the Downey Obesity Report (is he an MD or PhD?) quotes his own statement before the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA - presumably as a paid consultant to one or more of the three companies trying to get diet pills approved in 2010. (Note: NONE of them were approved.) I'm guessing that this document contains the "analysis" upon which you base your statements above.
He seems to take a grossly similar but far more nuanced stand about there being an overreaction to the PPH "caused" by phen-fen. First of all, I'm almost certain that many of the retrospective studies he cites about phen-fen were paid for by pharmaceutical companies defending themselves from class action suits. I doubt their impartiality. Second of all, this self-published statement appears to be a professional lobbyist trying to help his clients - pharmaceutical companies - get diet pills approved.
And nowhere do I see ANYTHING suggesting lives were saved by phen-fen, or that the obesity epidemic was triggered by its withdrawal. And you just made up numbers (or pulled them out of your ass) to make it look like you know what you are talking about.
For the record - I am a biotech patent attorney, and I represent pharmaceutical companies. I think SOME of them are trying to come up with good drugs to treat/cure obesity. But the ones that were up for review last year, one or more of which Mr. Downey seems to be flakking for, are not the ones - they are reformulations of old drugs, including phentermine in one case, or the active ingredient in Chantix, or Meridia for gawdsakes (even *I*, with life-long low blood pressure even at 290 lbs, got high blood pressure from that stuff). It appears to me that he has used creative language to try to discredit and dismiss failed clinical trials, and to convince the FDA to lower their standards for allowing diet drugs on the market.
And you seem to have misrepresented what HE said even further.
By the way, for all your stuff about including cites, where are YOUR cites for those imaginary numbers??
I'm feeling REALLY tempted right now to dig through some boxes in the garage. I'd want to find a dust mask first, and I'd probably find out fast that my stacking decisions were in violation of OSHA. Some economics journals in the mid 1990's that I was following had some good stuff. Hayekian stuff with some modern example.
My original point, though, was expressly tautological.
FDA is under control of lawmakers in congress.
There's the big $ factor -- campaign contributions -- at work, where "the masses" could have little influence, by comparison. (Old story there).
On the other hand, a factor that doesn't receive as much attention -- as far as the FDA is concerned -- is the clammor to do something about some emergency factor, wherein merely one tragedy (still a tragedy, but one) can effect immediate attention and regulatory action in ways that untold numbers of non-tragedies would never be able to muster attention for. Just simply mechanics. No reporter is going to make headline news investigating that any Fred Smith (or 1,000 Fred Smiths) lived an extra 3 months of quality life because a particular drug was available to him, or had an extra 5 months of semi-quality life before ultimately needing to have hip surgery. (Would probably need to have some other name).
Re weight and life -- anything that keeps weight down prolong life and health -- all other things held equal -- for as long as the impact lasts.
So, did the Jane Fonda workout tapes whose background music impacted my brain devleopment throughout elementary school as I fixed myself breakfast every morning with my mother in the other room... did they save or prolong or improve lives? Probably, over some period of time, to the degree they were part of some positive health intervention. But such are typically of finite duration. Same would be true of weight loss medications; they bring about benefits, but these only last -- at best -- for the duration of their being taken. And, when rebound sets in, that actually does harm, as the starvation response circuits become strengthened.
Re the obesity epidemic, it has it's own course. Phen-fen slowed it down slightly for a few years (a slowing blip). Once it was withdrawn, a brief rebound "catch-up" blip ensued. I think I said "blip" above. I'd have to switch computers now to be sure (long story). Blip or spike. Pretty hard to argue (epidemiologically) with three or more decades of high fructose and trans fats.
Re: "First of all, I'm almost certain that many of the retrospective studies he cites about phen-fen were paid for by pharmaceutical companies defending themselves from class action suits." Would be interesting to see -- but, darn, one would have to probably buy a lot of articles on line. I was very disappointed recently when I visited my local library (University of California) looking for things I didn't want to spend $15 a pop for.
Re: "And you seem to have misrepresented what HE said even further." Yep, old Downey and I go way back... Anything he can do, I can do better. Actually, I never met the guy, but I do reconize the name from way back. I vaguely recall something like a previous incarnation of a type of OAC.
Re drug packaging, do you remember hearing "phen-pro"? I was wondering if that would ever make it to actual forumulation, with prozac and phentermine winding up as components within the same pill.
1) You MADE UP NUMBERS
2) You didn't CITE SOURCES
3) Throwing out words like "Hayekian" and "tautological," out of context and with no follow up, doesn't make you look smarter - it makes you look like you are trying to cover up that you are saying NOTHING about the topic.
4) Your comment about the FDA being under the control of the moneyed interests is EXACTLY what this issue is about - yet your previous comments seem to be taking the position that the FDA shouldn't block the well-intentioned efforts of drug and device manufacturers from quickly bringing drugs and devices to market, with no post-marketing surveillance that overemphasizes minor risks and thus prematurely and unnecessarily takes them off the market. Now you admit - again, out of context and in contradiction to your earlier position - that the FDA is inappropriately and unethically dominated by financial interests. Do you have an actual position? What is it?
5) I have no idea why you keep bringing up things like Jane Fonda - there is NO statistical evidence that I know of that Jane Fonda tapes or phen-fen had the slightest effect on any particular long-term obesity trends, or even short term blips or spikes. I don't know why you keep trying to interject nonsense like this into the discussion. Small short term changes in weight and exercise habits have NO effect that I know of on long term life expectancy, whereas yo-yo'ing has PROVEN negative effects. If you have a peer-reviewed study in your dusty garage, PLEASE go find it and post - otherwise, you are talking out of your left nostril, and we can SEE that! You are not helping your cause OR your credibility on the subject.
6) As a patent attorney, I can tell you that formulating combinations of old drugs into single pills is a strategy used to extend patent term. You try to get a patent on the combo pill itself, and the method of treating disease X with a combo of the two drugs. If the combo is obvious, e.g., both used for the same already-known indication, and doesn't provide synergistic effects, it is pretty hard to get a patent, and any efforts put into clinical trials will be unprotectable from generic competition. Oh yeah - and it has to actually WORK. So, I repeat - what was your point?? That was exactly the kind of stuff that the pharma companies were trying to bring to market last year - new formulations of old crap, and the FDA rightly turned them down, from what I can see. What does that have to do with the need for post-marketing surveillance of medical devices, including LapBands??
Sorry, I'd forgot to metion in my last post: I'd printed your some of your stuff for review. (I seem to be suboptimally paper-dependent whle in digest mode). Looked interesting.. Non-formal not intended as flippant. Nuance tends to leave me by Friday.
SO, if all my above were, say, on a separate thread, then coherence is more clear.
Love your numbering! I tend to be odd man out for myself doing such in my circles.
Perhaps temporarily on this thread (I should probably open up a Policy and Advocacy forum) versus elsewhere.. no disrespect intended....
+ I think that lower abdominal adiposity, fat, and related & underlying metabolic particulars are associated with a range of health benefits -- regardless of the cause of lowering (exercise, gastric baloons, drugs, histological intervention), with benefit duration concommittant with intervention duration. Past some small threshold, every little bit of abdominal adipose reduction tends to result in greater health and longevity for the duration of the reduction, while every little bit of increase tends to result in worse health and lower longevity for the duration of the increase.
+ I think long term trends are impacted by things including trans-fat and high fructose prevalence. Any shorter term intervention (medications, exercise routines) are only impactful for as long as they are in effect. Millions being on phen fen temporarily slowed obesity rates down by probably a few percent for a few years, only for rates to temporarily be sped up (weight regain) for a year or so following withdrawl from market. Zero net impact on any overall long term trends. Rather, I started noticing heightened use of the term "epidemic" at exactly the same time that so many millions were weight rebounding from phen-fen withdrawl. The ObesityHelp.com web site was recording a lot of that from member signup data (prevous weight histories). That was the spike I was referring to. Zero long term impact. [Analogy over a very different time span -- have a country like China under strict communism for 4-5 decades of near zero economic growth and then start liberalizing some of those controls and 10% growth rate per year is no surprise. Merely 'catch up'. Certainly can't last.]
+ I think had phen-fen _not_ been withdrawn from the market as it was, then obesity rates would have probably stayed somewhat lower somewhat longer.
+ The decision to remove phen-fen from the market (or silicone breast implants, or anything else) is very often impacted by highly sensationalized attention drawn to some number of adverse events (which may truly be horrific) where voters and reporters and news crews in a congressperson's district can have an extremely high level of influence over what regulatory emphasis reaches the FDA from above. The chairman or members of one of the FDA oversight committees could have millions of of people in his/her district, experiencing tens of millions of positive and adverse impacts from hundreds of medications or devices where any measure of net benefit or net harm might be out there -- typically only through some effort -- to ascertain, but such is often completely bypassed by the call to do something about the one horror story at play.
+ Such is consistent with a non-sensational mindset held by many medical professions to be more accepting of bad things resulting from natural disease progression while being very un-accepting of risks of intervention. (For example, if a patient has a 1% chance of dying from poor health and a 0.5% chance of dying from a gastric bypass operation, the typical PCP will NOT typically support the operation, even though, in terms of actual numbers, the risk might be justified. (Subjective factoring in of time-horizon, of course, factors in). I've interviewed some PCPs who told me, flat out, that they wouldn't send a patient to have "unnecessary and risky" surgery -- referring at the time to a 2% mortality rate -- even if the patient had a 25% chance of dying without weight loss surgery. I empathize with that as normal human nature, especially amongst PCP versus surgical residency minded folk. The 2% who were said to be dying from surgery (this was 10 years ago) were getting far far more attention than the % -- much higher than 2% in the least healthy individuals -- dying from not having surgery. The intervention gets the attention.
+ I think that factors above result in a significant magnification effect which draws a significant degree of attention to a potentially relatively small number of adverse events.
+ The above isn't covered as well in the literature. The whole "Hayekian" school was one example to the contrary (some breif showing through the 30's and 40's -- I think there was some great debate with Keynes (sp?) early on.) Philosophically grounded in classical liberalism emphasizing (or some would say _over_emphasizing individual action toward self-interested well being (versus paternalistic regulation). It tended to not be afraid of making use of tautological arguments to define different factors at play. It was a step back from the mounting trend to ignore the individual human agents behind statistical abstractions. This is relevant today where any literature is cited as part of policy debate on how any single policy will impact countless individuals. Taking mesh (with or without bariatric context) for example... if people only knew all the facts (whatever that might be) there would certainly be some range of spread in the reaction of adversity, with perhaps some tail end to a bell curve remaining on the other side of any strict yes/no fence. Of course such tends to fall apart (or at least take an entirely different form) to the degree that people are stupid and/or undereducated -- which is why it is so great seeing your use of external links. Even for OH visits not, for whatever reasons, inclined to follow through to review the external materials cited, their very citing is important, constantly reminding visitors that at least some semblance of an objective reality is out there to be explored, in contrast to conversational castles built entirely on opinion. Years ago I was able to make peace with this, in a sense, by realizing that a lot of people are mostly in need of support, preferably in real time or close to that. Talking about things or facts or implied facts is often part of that, but -- I learned to remind myself -- very often not the core existential facet at hand on message boards. Reminds me of the classic "stop trying to solve my problems and just listen to me" quote. Good to be too forceful in stressing outside research, but really great to remind people, at the very least, that such exists.
+ The lawmaker sensitivity to sensationalism and PCP risk adversion I described above co-exist with the counterveiling argument that the masses require protection from big business interests. On one hand, while the majority are too busy going about their lives to have the time to afford to pay attention, big business -- or large numbers of smaller business -- can sneak in self serving legislation or bypass other regulation in ways resulting in overall public harm. (Jon Stewart had a skit about that last night, I believe. Consumer protection from banking interests, aparently gutted out and still inchoate as it approaches its first year of age). On the OHTER hand, however -- and this was my whole point -- some regulatory status quo could have overall social benefit across millions of people, but this could change for the worse with highly sensationalized attention being called to things impacting a potentially small number of individuals. Different people differ on how strong each effect is globally, and the balance is certainly also topic-specific (i.e., reality/data specific) as well. My point was that (a) they co-exist, and (b) the later is often overlooked.
+ For example, the FDA is, I believe, fairly week on surveillance of pre-approval, pre-marketing health problems resulting from the nom-approval of drugs and devices. The safety and effectiveness of the intervention must be proven, but there isn't much emphasis, from what I've seen, on how this compares with baseline of pre-approval.
+ I first mentioned pubmed above thinking you could probably find, I'd imagine, all manner of very well documented peer review literature to support your case, with my thinking having included that the peer review documents themselves (not in the abstracts, but generally only within the full article) are a fairly verbose source of explicit documentation of industry involvement -- at least at the level of sponsorship of research. Personally, I've found some of the academic debates surprisingly spirited.
+ I had no idea one way or another on this topic if the mesh literature might cite any potentially long running debate on the magnitude of peer review published benefits (people better off because of the mesh) versus the magnitude of peer review published disadvantages.
+ My above was my reaction to your mentioning the en***** doing the review. Certainly, I suspected, they would be citing the same literatureure, which, in its potentially neglected retrospective nature, could potentially form an interesting raw data context.
+ Any analysis of such, by humans, of course, will be biased. Fundamentally, it might not be perfectly clear by any "rational objective" measure what the actual cost to benefit ratio is [note -- I have no opinion on this re the mesh, so I'm not referring to that here]. Next, even if there was exact objecgtive data, we all have different personal levels of risk tolerance. There is no individual basis for any exact one-size-fits all to what is "best for all people" for all cases, with each case being different. Next, within the FDA itself, there are all kids of biases. The chair of some review committee might just happen to be a mice-study fan, versus a pig-study fan, based on self-interested investment in one versus another line of academic work. Next, the FDA serves as a crossroads for concentrated impact, coming in on one hand from big bussiness, but also from congressional oversight circles whose members are far more likely to be influenced by sometimes sensationalized news of harm than they are by non-news of status quo health among potentially much larger numbers of individuals in their districts.
Ok... off to that printer.
Thanks a lot for calling attention to post approval surveillance -- in particular, the consistent structure with which such is implemented. That's a perspective I've been pretty weak on. There's SO much going on at the pre-approval stage it's easy to lose track of the longer term picture.
I wonder, across all surgery types, what, say RNY stapler or surgical retractor survellance is formally currently in place?, and how is such targeted by indication?
Oh, also, I was going to ask you... on that Wash DC person whose info you posted....what's your thought process behind directing attention on regulatory matters at a particular individual, versus...
a) any number of others (such as elected officials) upsteam of that individual, and/or
b) peers of that indivifdual who could be influenced directly?
The first starting point may certainly be not only efficient bu sufficient. I figured that this wasn't the first regulatory matter you've been great to draw people's attention to, so curious if you had war stories to share where grass roots mobilization extended into a or b -- or elsewhere.
Hmm, the quote function is not putting your quote in the message box - I'll have to copy it in order to respond within the quote - so I took out the original quote which made this unnecessarily long.
~~~~
+ I think that lower abdominal adiposity, fat, and related & underlying metabolic particulars are associated with a range of health benefits -- regardless of the cause of lowering (exercise, gastric baloons, drugs, histological intervention HUH? what is histological intervention?), with benefit duration concommittant with intervention duration. Past some small threshold, every little bit of abdominal adipose reduction tends to result in greater health and longevity for the duration of the reduction - exactly the point! only for the duration, which is almost NEVER long term, and doesn't account for what happens with regain!!, while every little bit of increase tends to result in worse health and lower longevity for the duration of the increase.
OK, fine - you can measure, e.g., short term bp reduction with 20 lb weight loss. But what does that have to do with long-term results? And are you including the long-term negative effects of damaging the metabolism by dieting and regain - do you end up worse off yo-yo'ing?? I think it has been shown to be the case.
+ I think long term trends are impacted by things including trans-fat and high fructose prevalence. Any shorter term intervention (medications, exercise routines) are only impactful for as long as they are in effect. Millions being on phen fen temporarily slowed obesity rates down by probably a few percent for a few years [I call bull****! I have NEVER seen data supporting this preposterous statement - a few percent?? That is an ENORMOUS change that is completely illogical and ridiculous - YOU ARE MAKING UP STATISTICS THAT ANYONE CAN SEE ARE NONSENSE!], only for rates to temporarily be sped up (weight regain) for a year or so following withdrawl from market [Prove it - I don't believe this for a second, in particular that ANY blip could be directly attributed to former phen-fen patients regaining - the numbers are not even possible]. Zero net impact on any overall long term trends [This statement is equally ridiculous - there are no studies that I know of (except perhaps ones commissioned by the lawyers defending the drug companies against the class action suits) demonstrating that people who took phen-fen and lost and then regained didn't end up WORSE off]. Rather, I started noticing heightened use of the term "epidemic" at exactly the same time that so many millions were weight rebounding from phen-fen withdrawl [wow - YOU noticed something, a correlation with press use of the word epidemic, and that makes it somehow a fact? Really Erik? This is an argument for a conversation at this level??]. The ObesityHelp.com web site was recording a lot of that from member signup data (prevous weight histories) [are you seriously suggesting this is a number that means anything in the real, scientific world??]. That was the spike I was referring to. Zero long term impact. [Analogy over a very different time span -- have a country like China under strict communism for 4-5 decades of near zero economic growth and then start liberalizing some of those controls and 10% growth rate per year is no surprise. Merely 'catch up'. Certainly can't last.] [utterly unrelated observations; no cause and effect or correlation; logical fallacy of post hoc, ergo propter hoc analysis]
+ I think had phen-fen _not_ been withdrawn from the market as it was, then obesity rates would have probably stayed somewhat lower somewhat longer. [OMFG - are you seriously proposing this to be a FACT??? I thought we were having a serious discussion here.]
+ The decision to remove phen-fen from the market (or silicone breast implants, or anything else) is very often impacted by highly sensationalized attention drawn to some number of adverse events (which may truly be horrific) where voters and reporters and news crews in a congressperson's district can have an extremely high level of influence over what regulatory emphasis reaches the FDA from above. The chairman or members of one of the FDA oversight committees could have millions of of people in his/her district, experiencing tens of millions of positive and adverse impacts from hundreds of medications or devices where any measure of net benefit or net harm might be out there -- typically only through some effort -- to ascertain, but such is often completely bypassed by the call to do something about the one horror story at play. And the FDA, as an independent federal agency (yeah, right, but that is their mandate) is supposed to look into things when a threshold of seriousness is reached. The question is not whether the FDA can be influenced to LOOK at certain issues by the media, congressional oversight committees or an inquiry from the Executive branch, but whether they have POLICIES AND PROCEDURES IN PLACE to deal with such questions, and more importantly, to identify them via rigorous reporting requirements which would identify trends LONG BEFORE it became newsworthy that problems were being ignored!!! And of course, scientifically valid policies and procedures for how to deal with the results of such reporting of problems, including appropriate risk analysis, including risk-benefit analysis, and whether warnings and patient stratification will suffice to allow the product/drug to remain on the market while lowering risk of use in inappropriate patients.
+ Such is consistent with a non-sensational mindset held by many medical professions to be more accepting of bad things resulting from natural disease progression while being very un-accepting of risks of intervention. (For example, if a patient has a 1% chance of dying from poor health and a 0.5% chance of dying from a gastric bypass operation, the typical PCP will NOT typically support the operation, even though, in terms of actual numbers, the risk might be justified. (Subjective factoring in of time-horizon, of course, factors in). I've interviewed some PCPs who told me, flat out, that they wouldn't send a patient to have "unnecessary and risky" surgery -- referring at the time to a 2% mortality rate -- even if the patient had a 25% chance of dying without weight loss surgery. I empathize with that as normal human nature, especially amongst PCP versus surgical residency minded folk. The 2% who were said to be dying from surgery (this was 10 years ago) were getting far far more attention than the % -- much higher than 2% in the least healthy individuals -- dying from not having surgery. The intervention gets the attention. [Blah blah blah - your repeated recitation of how you believe the risk assessment should be done is NOT relevant to the question of whether data-gathering on bad outcomes should be mandatory.]
+ I think that factors above result in a significant magnification effect which draws a significant degree of attention to a potentially relatively small number of adverse events. Often, by the time the press gets hold of the issues, something that could have been quickly, quietly and inexpensively fixed has become a PR nightmare - because nobody took action when the problems were first noticed. HENCE THE NEED FOR MANDATORY REPORTING OF BAD OUTCOMES!!
+ The above isn't covered as well in the literature. The whole "Hayekian" school was one example to the contrary (some breif showing through the 30's and 40's -- I think there was some great debate with Keynes (sp?) early on.) Philosophically grounded in classical liberalism emphasizing (or some would say _over_emphasizing individual action toward self-interested well being (versus paternalistic regulation). It tended to not be afraid of making use of tautological arguments to define different factors at play. It was a step back from the mounting trend to ignore the individual human agents behind statistical abstractions. This is relevant today where any literature is cited as part of policy debate on how any single policy will impact countless individuals. Taking mesh (with or without bariatric context) for example... if people only knew all the facts (whatever that might be) there would certainly be some range of spread in the reaction of adversity, with perhaps some tail end to a bell curve remaining on the other side of any strict yes/no fence. Of course such tends to fall apart (or at least take an entirely different form) to the degree that people are stupid and/or undereducated -- which is why it is so great seeing your use of external links. Even for OH visits not, for whatever reasons, inclined to follow through to review the external materials cited, their very citing is important, constantly reminding visitors that at least some semblance of an objective reality is out there to be explored, in contrast to conversational castles built entirely on opinion. Years ago I was able to make peace with this, in a sense, by realizing that a lot of people are mostly in need of support, preferably in real time or close to that. Talking about things or facts or implied facts is often part of that, but -- I learned to remind myself -- very often not the core existential facet at hand on message boards. Reminds me of the classic "stop trying to solve my problems and just listen to me" quote. Good to be too forceful in stressing outside research, but really great to remind people, at the very least, that such exists. [I dispute your application of armchair economic principles to situations that are non-analogous. How the hell is an even intelligent, informed, computer savvy patient supposed to learn about bad outcomes with a device, in order to make an informed, self-interested, STATISTICALLY SOUND decision, when almost all of the data is HIDDEN by financially interested parties having a monopoly the information?? THAT is a primary purpose of regulatory agencies for cripes' sake!!]
+ The lawmaker sensitivity to sensationalism and PCP risk adversion I described above co-exist with the counterveiling argument that the masses require protection from big business interests.[Yes, and in this context, it is a pretty straightforward analysis of "who is the least-cost provider of the information" vs. "who is the least-cost avoider of the harm" - and that puts the onus on the government to regulate the industry, not the consumers to try and ferret out the information individually.] On one hand, while the majority are too busy going about their lives to have the time to afford to pay attention, big business -- or large numbers of smaller business -- can sneak in self serving legislation or bypass other regulation in ways resulting in overall public harm. (Jon Stewart had a skit about that last night, I believe. Consumer protection from banking interests, aparently gutted out and still inchoate as it approaches its first year of age). On the OHTER hand, however -- and this was my whole point -- some regulatory status quo could have overall social benefit across millions of people, but this could change for the worse with highly sensationalized attention being called to things impacting a potentially small number of individuals.[It also is a check and balance on the system, allowing a voice of the few who are hurt to be heard over the loud and financially backed voices of the financially interested.] Different people differ on how strong each effect is globally, and the balance is certainly also topic-specific (i.e., reality/data specific) as well. My point was that (a) they co-exist, and (b) the later is often overlooked.
+ For example, the FDA is, I believe, fairly week on surveillance of pre-approval, pre-marketing health problems resulting from the nom-approval of drugs and devices. The safety and effectiveness of the intervention must be proven, but there isn't much emphasis, from what I've seen, on how this compares with baseline of pre-approval. Until you are able to get the Hippocratic Oath repealed ("First, do no harm"), then you're ******g into the wind. But even with the Oath, these analyses are taken into account as part of the FDA approval process, and - if they ever put one into place - as part of the post-marketing surveilance protocols. Informed consent requirements amply demonstrate that risks are acknowledged with any drug, device or procedure.
+ I first mentioned pubmed above thinking you could probably find, I'd imagine, all manner of very well documented peer review literature to support your case, with my thinking having included that the peer review documents themselves (not in the abstracts, but generally only within the full article) are a fairly verbose source of explicit documentation of industry involvement -- at least at the level of sponsorship of research. Personally, I've found some of the academic debates surprisingly spirited. Not sure what you mean here - if you think I have the time to look into the sponsorship of the hundreds of studies relating to the problems with the mesh by obtaining copies of the full documents, you must be kidding. I'm not interested in the details anyway - I know enough to doubt the independence of a significant percentage of the studies, and that POST-MARKETING SURVEILLANCE AND REGULATION IS NECESSARY!!
+ I had no idea one way or another on this topic if the mesh literature might cite any potentially long running debate on the magnitude of peer review published benefits (people better off because of the mesh) versus the magnitude of peer review published disadvantages. Sheesh. Don't you understand that this is the POINT? WIthout post-marketing surveillance, the only evidence is anecdotal reports, or narrowly focused studies. The question you suggest would be answerable NOW if post-marketing surveillance procedures were in place!!!
+ My above was my reaction to your mentioning the en***** doing the review. Certainly, I suspected, they would be citing the same literatureure, which, in its potentially neglected retrospective nature, could potentially form an interesting raw data context. [again - objective raw data would be available NOW if there were reporting requirements!]
+ Any analysis of such, by humans, of course, will be biased. Fundamentally, it might not be perfectly clear by any "rational objective" measure what the actual cost to benefit ratio is [note -- I have no opinion on this re the mesh, so I'm not referring to that here]. Next, even if there was exact objecgtive data, we all have different personal levels of risk tolerance. There is no individual basis for any exact one-size-fits all to what is "best for all people" for all cases, with each case being different. Next, within the FDA itself, there are all kids of biases. The chair of some review committee might just happen to be a mice-study fan, versus a pig-study fan, based on self-interested investment in one versus another line of academic work. Next, the FDA serves as a crossroads for concentrated impact, coming in on one hand from big bussiness, but also from congressional oversight circles whose members are far more likely to be influenced by sometimes sensationalized news of harm than they are by non-news of status quo health among potentially much larger numbers of individuals in their districts. [This is the role of the policy IMPLEMENTORS - if there were a policy in place!! You can't seriously be suggesting that, because some decisions might be subject to interpretation, the data shouldn't be gathered and the decisions shouldn't be made.]
Ok... off to that printer.
Thanks a lot for calling attention to post approval surveillance -- in particular, the consistent structure with which such is implemented. That's a perspective I've been pretty weak on. There's SO much going on at the pre-approval stage it's easy to lose track of the longer term picture.
I wonder, across all surgery types, what, say RNY stapler or surgical retractor survellance is formally currently in place?, and how is such targeted by indication? [I don't know, but it should be - misfirings cause TERRIBLE damage when they happen.]
Oh, also, I was going to ask you... on that Wash DC person whose info you posted....what's your thought process behind directing attention on regulatory matters at a particular individual, versus... [her name is associated with the study that came out from the IOM - I sent her an email with the information, asking her if she was the right person to contact, and if not, to tell me who was - I haven't heard back from her yet, but I imagine she's having a busy week.]
a) any number of others (such as elected officials) upsteam of that individual, and/or
b) peers of that indivifdual who could be influenced directly?
The first starting point may certainly be not only efficient bu sufficient. I figured that this wasn't the first regulatory matter you've been great to draw people's attention to, so curious if you had war stories to share where grass roots mobilization extended into a or b -- or elsewhere.
[It's not - but I'm not allowed to talk about it just yet.]
In your opinion, how much of any requisite status improvement could correspond to changes here:
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postm arketRequirements/MedicalDeviceTracking/default.htm
?
Eric, did you even READ the site you linked to?
This site is about TRACKING of devices - putting serial numbers on them, and keeping track of which devices are in whom. It has NOTHING TO DO WITH POST-MARKETING SURVEILLANCE. It is about being able to issue a recall, and to identify a dead body by the device implanted in them. That's IT.
OH, AND BY THE WAY, GASTRIC BANDS AREN'T ON THIS LIST (WHICH IS EXCLUSIVE) FOR SOME REASON - PERHAPS BECAUSE ALLERGAN AND ETHICON MANAGED TO GET (bought?) AN EXEMPTION SOMEHOW?
How about you answer ME this, Mr. Former FDA Intern - why is the LapBand exempt from not only TRACKING, but also 522 Postmarket Surveillance?
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc e/PostmarketRequirements/PostmarketSurveillance/ucm134497.ht m
1. When does FDA require 522 postmarket surveillance?
Section 522 of the Federal Food, Drug and Cosmetic Act (the act) gives FDA the authority to require a manufacturer to conduct postmarket surveillance of a class II or class III device that meets any of the following criteria:
- its failure would be reasonably likely to have serious adverse health consequences;
- it is expected to have significant use in pediatric populations;
- it is intended to be implanted in the body for more than one year; OR
- it is intended to be a life-sustaining or life-supporting device used outside a device user facility.
Just keep the crap coming Eric - I need the entertainment, and you are exposing yourself to the membership's scrutiny. HINT: when you find yourself in a hole, it's time to stop digging.
Which does nothing to detract from the valuable insight and newsworthiness of your topic...
....which I started spending some time on (staying "on topic") as you seemed to prefer. [I still have other notes to post, but figured I'd first respect what, in retrospect, was a fairly pin-point topic prefernce, or rather, requirement, of yours]. Unlike others who might leave OH in distaste for your overtly adversarial hostility, I post some of my notes to self and others below.....
[ Backgrounder Resources
Incomplete, non-comprehensive backrounder information on product safety and regulation; no intent in the particular subset of points below to specifcally address any specific issue].
+ It is aparent that the FDA plays a key regulatory role in regimes divided into both before and after a medication or a device is approved, with a lot one can say about what is versus isn't done in each stage.
+ The FDA has at least two categories or tracks of interest here: drugs and devices, both of which it follows, in distinct but related ways both before approval and after approval, where after approval is associated with the term "post marketing", meaning that the device or drug manufacturer has the formal approval of the FDA to market the device or durg for a particular indication. PRIOR to such approval, the device might be sold and marketed in the US for one indication, and used by providers for other indications, but the manufacturer is strictly forbidden from endorsing, much less advertising, this.
+ One source of insight as to efficacy / safety findings is the public domain of peer review literature. (One place to peruse abstracts of such is www.pubmed.com ). Such generally provide a large number of smaller patient sample, shorter time frame coverage of adverse risks. For example, 30 patients might be enrolled in a study which, once published, might show how a couple of these might have experienced a perioperative issue within the first month of surgery and a few more some adverse issue within the first six months of operation.
+ The academic community typically clammors for, and on the whole tends to aspire to, and even -- very rarely -- achieve, a more longer term, larger sample size of tracking. The results of this are generally very transparent, where the journals require some explicit detail as to the exact nature of any associations that any of the reachers have with any commercial interests (ex: Author #3 is a non-paid consultant for company X; Author #2 has received a research grant from Company Y). Viewing such information typically requires paying to view the full article. While generally very limited in their coverage of the whole, they can, on occasion, provide significant documentation of pre-existing debate (in some cases decades old) over particular outcome concerns. One might assume the manufacturer to be complete alware of any of such. (Ex: The current regulatory news story for any given month could be tied (perhaps journalistically) to questions about how the issue was well known for many years; such could be used against, or in some cases possibly in favor of any argumentd put forth by the manufacturer. Some potential, in some cases, for overal case history, in any case).
+ While the above academic coverage, arguably comparatively transparent, may coincide with both pre-approval and post-approval regimes, they offer mere partial glimpses into the whole of clinical outcomes, particularly in the post-approval regimes.
+ Once a device is approved, the domain of peer review literature rapidly becomes far less valuable to a public seeking information, on one hand, or, more often, consumer protection stemming from regulation.
+ The FDA's self-stated rule in post approval regulation is clearly deliniated (as would be required for regulatory agencies) within its web pages. For example, the URL(s) above interlink with pages with the following navigation heading.
"Home> Medical Devices> Device Advice: Comprehensive Regulatory Assistance> Postmarket Requirements (Medical Devices)"
This shows how the FDA current provides some postmarket regulation of devices.
+ The FDA pages above provide cursory insight into at least four things that caught my attention (each one of which, of course, could no doubt be profoundly ridiculed on any number of grounds by anyone with such orientation)....
(1) If one searches on the very highly specific topic of "post marketing survelliance", various fda web sites come up as search results. These matches, however, tend to pertain to "Tracking". The topic of postmarket "tracking" would seem to offer a more general context within which post market "survelliance" exists. Specific FDA URLs exist (not offered in this current post) which clarify the difference. The topic might be muddied somewhat by use of "postmarket" within the context of things that need to be lined up prior to approval. People interested in learning more have at their dispoal a combination of pages on one hand that describe and define the overal regulatory, and, on the other hand, various pages that illustrate various particular processes in action, such as
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cf m .
(2) The FDA offers separate tracks for medications on one hand and devices on the other hand. People learning about the topic could be careful to not inadvertently be thinking about one track while reading content on the other track.
(3) The FDA does offer particular identification of which particular device types it holds to higher regulatory standards. One FDA page specifically lists about 20 different device categories, several of which are cardiatrogenic. For those interested in devices pertinent to bariatric surgical interventions, one might notice this cagegory absent from the list. Those interested in the topic could potentially frame debate within the context of very specific policy fine points, or changes to such.
(4) Evolution in these types of things sometimes show up on .gov pages. Here for example is something about 10 days old
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMa terials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Circu latorySystemDevicesPanel/UCM265244.pdf
Here a particular medical society, in this case the American Heart Association, is describing device surveillance goals: "Primary goals are the assessment of effectiveness and safety when applied in clinical practice for ALL patients *****ceive the device, not a subset." Those interested in any bariatric devices might suspect that such ongoings could impact or illustrate similar future discussions involving the ASMBS, ACS, SAGES, SRC, IFSO or similar.
This author reiterates appreciation for one instance of this general topic having been brought up, and, further, invites any assistance in fleshing out any introductory information on the device safey and regulatory process. Such could become standing educational content on ObesityHelp.com, to which interested parties could be referred -- in the weeks, years, or decades to come -- in conjunction with any particur topics of interest.
Pertiment essage board content (above and forthcoming) could/should be parsed into distinct, non-comingled, categories:
a) Current issue involving a particular medical device.
b) Information illucidating the overall process of device safety and regulation
c) Other general issues of policy and regulation.
