U. S. GI Docs Are Only 40 Years Behind The Rest Of The World

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U. S. GI Docs Are Only 40 Years Behind The Rest Of The World

Post by tex »

U. S. GI specialists don't seem to be very concerned about patient comfort. It has taken them almost 40 years to approve a cleanout product that has been in common use all that time in the rest of the world. :shock:
P/MC has been used in other countries for nearly 40 years, with around 28 million exposures worldwide, but it was only approved for bowel preparation before colonoscopy in the US in July 2012.
The combination of sodium picosulfate and magnesium citrate (P/MC) is not a perfect product, but in comparison trials, it was definitely favored over a conventional cleanout solution.

http://www.medscape.com/viewarticle/778449

Why did it take 40 years? Don't they care at all about the ordeal that their patients have to go through when preparing for a colonoscopy exam?

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by desertrat »

I think the main thing we all have to wrap our heads around is that most doctors want to diagnose a problem, not find the cure/cause. Once they find the dx, they are content to shrug their shoulders as to why it happened. Nor are they interested in actually helping you. Their job is done. They found out what was wrong.

My gastro guy was such an arrogant jerk. If I even asked a question, he almost exploded with scoffs and waved his hand in a dismissive manner.

My only advice to everyone is to keep on searching/researching/experimenting. I slowly see the tide turning in our favor. Patients are waking up and looking for a doctor who is actually compassionate and will LISTEN.

This forum is a God send. Truly.

Mandy
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Post by jgivens »

I wonder how many of them have colonoscopies done by their colleagues and do the clean-out procedure? I have had them nod rather condescendingly and agree that it "isn't much fun", but in the long run, it is about how easy it is for them to visualize things.

My last colonoscopy in December was the first time that I actually felt like they cared about me as a human being and were not just interested in diagnosing and running. After a conversation with my doctor's nurse (see my other post about memory and frustration) my patience is wearing thin with this doctor and I really liked him!
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Post by Joefnh »

U. S. GI specialists don't seem to be very concerned about patient comfort. It has taken them almost 40 years to approve a cleanout product that has been in common use all that time in the rest of the world.


Tex I'm not quite sure, but I don't think it's up to the GI specialist to approve any treatment for usage in the US. If the treatment is not approved by the FDA first they cannot use it without serious legal repercussions including stiff fines, loss of medical license and potentially prison time. The FDA is the gatekeeper for the approval of all medications used in the US, including items like this.

I believe Dr. Katz and Dr Rex were working through phase 3 trials of this treatment once the FDA approved the trial process and the test methodologies Dr Katz's group were proposing to use. I'm glad Dr Katz responded to the request for Phase 3 trials once the FDA approved the continued testing.

Being phase 3 trials it would most likely be tested by several different groups at least as the next phase would be open clinical trials.

http://www.nature.com/ajg/journal/vaop/ ... 2441a.html
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Post by Zizzle »

Incidentally, a friend sent me this article after her pediatrician suggested she give her child Miralax EVERY DAY to address his constipation. She was freaked out. Is there truth to this? Could PEG be this toxic???

Miralax is practically given to kids like candy!!

http://www.gutsense.org/gutsense/the-ro ... eimer.html
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Post by tex »

Joe,

I realize all that you said is true, but the product (in generic form, most likely) has been available and in common use for almost 40 years elsewhere in the world. If the gastroenterology professional organizations in this country had shown any interest in using it, surely it could have been approved in less than 40 years, doncha think? It's not like it's actually a new idea. The FDA simply approved a new brand, known as Prepopik.

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by Joefnh »

Tex if they were all aware of it and wanted to sponsor the phase 1 through 3 trials yes they cold theoretically. I think the 'established' method of getting the product into the US starts with the manufacturer deciding to market the product in the US and going through the approval process with the FDA. If the manufacturer does not have a selling status in the US they would have to find a surrogate group to sell that for them. In this case, Ferring pharmaceuticals is marketing the product, paid for the phase 1 through 3 trials in the US etc. etc.. etc...

Tex your note suggested that the GI docs don't care....I find this comment a little disingenuous, the GI docs do not decide what is marketed or not in the US, they are not active participants. Actually no doctor in any specialty decides what products they can and cannot use from outside the US period.

Since the product was not approved for use in the US, the manufacturer could not market it in the US in the first place, so the vast majority of the GI docs probably never heard of it anyway.

I believe what the issue is, is NOT the doctors not caring about patient comfort Tex, it's the system of getting a new drug approved in the US, it is cumbersome, outdated, expensive and slow.

The war and rants should be directed at the FDA not the local practitioners, they in the end can only choose products from the catalog so to speak that have been approved for use in the US by the FDA. It's easy to get upset at the doctors and sometimes they deserve it, but in this case they are not the issue.
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Post by tex »

Joe, while the details of everything you say are true, you're overlooking all the under-the-table deals that are made in order to get things done when projects involve other affiliated industries and/or the government. Are you trying to tell me that with so many physicians in this country collecting big paychecks on a regular basis from Big Pharma to promote specific pharmaceutical products in ads, at medical seminars, and various other gatherings, that physicians have no influence over decisions about products that Big Pharma chooses to develop/promote? I find that a bit disingenuous.

That's like claiming that deals are never made under the table in our government (or in the medical and pharmaceutical industries). I don't doubt for a second that there are behind the scenes relationships that offers plenty of opportunities for influencing decisions on the products that might be added to the mix for development. I'm pretty sure that a fair amount of reciprocal back-scratching goes on behind the scenes, in order to get things done. To claim that GI specialist organizations have no way to advocate or facilitate the approval of an advantageous drug that has been in common use for decades elsewhere in the world, is a rather naive way to view the situation, isn't it?

It's not individual GI specialists who are the problem, I agree that there are some good ones out there — it's the general attitude and agenda of the discipline as a group. You have to consider what they do for a living. If it was your job to peek into assholes every day, do you think that you would actually give a crap about anything? :lol: When you got back home after work every day, do you think that your wife would be likely to ask, "How was work today, honey?" I'm guessing that she would learn pretty quickly not to ask that question. :lol:

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by Joefnh »

Yeah the "what did you do at work today honey" conversations would probably not be the best table talk at dinner :shock:

Overall though while money is the influence that makes the world go round, in order for money to be involved, the doctor groups would need to be aware or the product first. While I'm not sure after what phase Ferring Pharmaceuticals decided to start spending money in the states to promote their product and pay for the about 8 years of trials, it would at some point though that products like this show up at the scenes of the conferences etc.... It would be then that the 'influence' is peddled and deals made to start the ball rolling. Tex they just finished phase 3 trials with the results published about 4 weeks ago, and it's my guess that only in the past year or so that anyone would here about this product in the states. The product as of today is not even in clinical trials yet, for most docs this isn't even on their radar.

I don't believe the docs have had a chance to ignore patient comfort as of yet....

I think here your chasing the wrong horse...getting good products into the states that were developed elsewhere is a long and arduous process as you work your way through the red tape laden halls of the FDA.

For all of the application fees, multi phased trials etc, the manufacturer foots the bill and at some point through that about 8 year process must decide to continue and when and if to advertise and market the products to the docs at the conventions and through representatives etc.

I'm sure through the process no one gets a halo or angels wings for their truly ethical performance, but unfortunately the manufacturer starts the process of influence, not the docs.

Years ago I worked in the medical industry as a developer for a product called Practice Partner (medical office software) and during that time I got a front row seat to the games and influence peddling at the trade shows. Like anywhere else it is about politics and influence and money....but by far the vast majority of the doctors only react to what products are approved in the US

The only reason I reacted to this article is that it like others tends to paint ALL doctors as working to not provide the best options or not take care of the patient and that simply is not true. Like in any industry, there are good ones, average ones and poor ones....we do, like many here have already done, find a good one and stick with that doctor.
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Post by Zizzle »

Hey boys,
Anyone care to comment on the FDA placing MiraLAX (and by extension, all PEG laxatives) on its Adverse Event Reporting System (AERS) in connection to “neuropsychiatric events?”

The article above mentions additional risks such as:

● Nephrotoxicity: PEG has been connected to nephrotoxicity, a euphemism for kidney damage [4] and it is counter-indicated for patients with kidney disease. This particular “side effect” is most likely related to the hydrolyzed (separated in water solution) molecules of ethylene glycol.

● Urticaria: PEG may cause allergy-related hives (urticaria) — raised red welts on the surface of the skin. Children are particularly susceptible to hives, and face a grave risk of anaphylaxis — a life-threatening allergic reaction that may develop within minutes or even seconds after ingesting a PEG-containing laxative. Links between PEG and urticaria have been documented as far back as 1991.

● Esophageal perforations: Also known as Mallory-Weiss tear, esophageal perforations associated with polyethylene glycol electrolyte lavage solution have been reported as far back as 1991. These tears and related bleedings may occur in the mucus membrane of the lower part of the esophagus, or upper part of the stomach.
This particular side effect isn't directly related to MiraLAX which is taken in smaller doses, but the potential is always there, particularly among young children or patients with GI tract obstruction that may initially manifest itself as constipation.
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Post by Joefnh »

It's funny that this thread and your notes here Zizzle came up at this time, just about 8 days ago we had our yearly safety classes at MIT and as we work with some pretty nasty stuff, they are quite careful about updating safety info etc..

One of the topics was on Polyethylene Glycol (PEG). It's used in some processes as a cooling agent in our labs. This years briefing discussed the extreme dangers of ingesting any of this material....hmmm. Several of us in the auditorium audience asked about the use in over the counter products me of course the OSHA representative could not comment.

What was mentioned in the briefing is the neurological and kidney dangers of ingesting PEG. Yeah that raised more than a few eyebrows in the audience.

Thanks for this information Zizzle.
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Post by tex »

You don't believe that GI specialists should be aware of current trends in their specialty among their colleagues in other parts of the world? First of all, do you only read technical articles in your area of work/research that have been written by U. S. residents? I'm going to guess that you search out and read articles from all over the world, in order to stay on top of developments in your area of expertise. Right? By the same token, I would expect nothing less of any physician who claims to be an expert (as designated by her or his status as a medical specialist). Therefore, either the problem here is a failure to stay up with recent developments in their field (and 40 years is hardly recent :roll ), or a lack of desire to use the best methods available in the rest of the world. The excuse of shifting the blame to the FDA and/or the pharmaceutical industry certainly has some merit, and they could indeed stonewall such efforts, but the bottom line is that motivated people (or motivated groups of people) can certainly bring about changes, if they have a desire to do so, and physicians are certainly not devoid of influence.

Yes, the FDA, and first and foremost, the pharmaceutical industry, have to shoulder most of the blame. But I think it's pretty clear that if gastroenterologists kept up with technology in their area of expertise on a global basis, they would have to be well aware of what GI specialists in other parts of the world are doing. The FDA cannot approve any drug, unless it is at least proposed to them, and the drug companies are not going to waste any money proposing the registration of a product that has limited profit potential (which surely applies to cleanout solutions for colonoscopy exams. Therefore, it is incumbent upon the GI specialty to advocate for such products used in their own practice, or they will never be adopted, and that defines precisely what has happened — they haven't bothered to even attempt to promote the adoption of such products, because they don't consider it important. Why don't they consider it important? Because they are not particularly concerned about patient comfort or convenience.

We see posts way too often on this board, that clearly illustrate that point. For example, consider this recent one:

http://www.perskyfarms.com/phpBB2/viewtopic.php?t=17642

I realize they're busy. Most people are. But as a group, it's pretty clear that way too often, they don't demonstrate that they are particularly concerned about their patients' comfort and convenience. This may be a phenomenon that applies only to MC, and many of them probably put off consulting with MC patients because they are so uncomfortable about trying to treat an issue that they know so little about, and seem to have limited success with. But is that a legitimate excuse to postpone trying to help a patient? And since MC is the main focus of this board, and MC is a debilitating disease, that makes this is an important issue to us.

You have to remember that you may be getting expedited care, because you also have an aggressive form of Crohn's disease, and GI docs consider Crohn's to be a "serious" disease (and rightfully so). Therefore, YMMV. By contrast, most of the rest of us are treated as if we have a nuisance disease, which gives us a second class rating, right off the bat.

You say we should just find a good GI doc, and stick with her or him. That sounds good in theory, but it's not so simple in many parts of the country. Luck plays a big part in that, and an unlucky streak can make us feel devastated and hopeless. And when we're sick as a dog, why should we have to search all over the country to try to find a GI doc who gets it? That in itself says a lot about many aspects of the GI specialty, including attitude.

Yes, there are a substantial number of good ones out there (and some of them are on our list), but without the benefit of that list, they can be very difficult to locate, unless we just happen to be lucky. By contrast, I believe it's safe to assume that virtually all GI docs know how to treat Crohn's disease, or UC, with at least some degree of success. Therefore, when it comes to treating Crohn's and UC, I'm sure that most GI docs enjoy a relatively good rating by their patients. With MC, however, that rating tends to fly out the window in the majority of cases, and for good reason, IMO. The gratifying part is that whether due to patient complaints or their own initiative, more and more GI specialists are beginning to learn enough about this disease to at least understand it better, and that has to be a good thing.

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by tex »

Hi Zizzle,

I think it's bad stuff that has been ignored and swept under the rug for decades. Any country boy can tell you that you don't leave antifreeze lying around when you're working on engines, because it will kill any cat that can't resist the urge to lap it up, and the mechanism by which it does so is exactly what you describe (kidney damage). The pharmaceutical and food industries use far too many chemicals that are derivatives of, or relatives to other chemicals that are known to be toxic, but they assume that since the molecular structure is slightly different, that somehow makes them safe. Sometimes it does, sometimes it doesn't.

Tex
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It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Post by gluten »

Hi Desertrat, The MDA has raised over 2 billion dollars in the past forty years and that does not include all the money raised by individual support groups. So far, no treatments but they have developed DNA tests to dx which one you have. When, you are diagnosed they tell you there is no treatment and good luck make an appointment in a year so we can check your muscle loss. Medical definition for "dystrophy" defective and faulty nutrition, especially in the muscular dystrophies. Talking to a MDA patient coordinator she told me that 95% of people with a dystrophy have G.I issues. IBS or one of the "ittis's. Jon
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Post by Joefnh »

So tex for instance lets say I'm a physician in a private practice and I do see articles in Gut or AJM etc. or even an article published in a Swiss medical journal about this medication or treatment protocol which of course as Ferring pharmaceuticals is based in Switzerland it probably started its trials there many years ago.

Lets say I have a house, a wife, 2.8 kids and the dog. I work my 60+ hour week, stay current with my boards, work another 20 hours of clinic duty and keep up with my CME credits.

I like this treatment and am interested in it, so what do, I contact Ferring pharmaceuticals who tells me the drug is still in phased trials and not available for clinical use yet in the US.

Well my choices are to express interest in the product so the company knows that from a marketing perspective it will most likely sell well within the US. I even let them know once it goes to clinical trials that I would be interested in participating in my practice. We know this already happened, as the product for years has been going through the FDA mandated procedures for Phase 1 - 3 trials and the US based doctors have agreed to run the trials, by doing so they want to test this product and if approved want their patients to be more comfortable. So where is the fault Tex?

Ok so now Ferring pharmaceuticals knows that doctors are interested and that helps them know about the marketing potential. I as a clinician have done all I can do...I need to wait, I cannot pull strings with Ferring or the FDA, I can write letters to the FDA...ok so I do and they now know, like Ferring knows, that there is interest in the product, no great secret. Ferring would not be spending this time or money if the doctors were not interested in the first place.

Remember the first step is that Ferring has to be wiling to climb 'mount FDA' in the first place and spend the time and millions of dollars to get this product in the states.

Tex you make it sound like there is this 'other' method of getting a product into the states and I just don't see how. The clinicians are the customers and are willing to try a product once it has met FDA approval, but all they can do is wait while it works it's way through the system, they offer to be trial participants, which they already have and have been and are doing for the last ?? many years as they are already in phase 3 trials.

Overall I don't see that the doctors have any great pull other than telling Ferring pharmeceuticals that they are interested, which they must have already at some point done, otherwise they would not be in phase 3 trials to begin with. Why Ferring chose not to approach the FDA in the US much earlier is the real question Tex, they have to intiate the process, the local doctors cannot do this, they can only express interst in the product to Ferrings marketing and sales department.

Of course what we do not know is how hard it has been for Ferring Pharmeceuticals to get approval from the FDA for phased trials. If many of the horror stories are true, it can take many many years and many dollars just to be told no. I again feel this is a complaint that should be aimed at big pharma and 'mount FDA' not the local clinician.


I go back to my original question about the statement
U. S. GI specialists don't seem to be very concerned about patient comfort. It has taken them almost 40 years to approve a cleanout product that has been in common use all that time in the rest of the world.
I just don't see how 'them' the US GI specialist approve any product or ever had, or that they took 40 years to do so....it's not up to the doctors.


Like you Tex I wish there were a better system of getting various other meds approved in the US from overseas, it seems like every few years medical groups do complain to congress about this and like many things in politics all that is accomplished is lip service. Recently many drugs that are already in use in the US has been in short supply.

Even with manufacturers in places like Europe or Australia having this exact drug available, the FDA blocked the exact same drug from being sold in the US by a vendor that had not been though the FDA testing process, but they had been through the testing agencies in these well regarded countries. Why do we have to do without with such a good source available?? Simply put the system of testing and acceptance is broken at the FDA
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