Mags,
I'm sorry - I didn't mean to imply that there was anything wrong with your post, because we do indeed have to use our own personal experience as a reference, since that determines what works best for us individually. We've been through the Imodium/Lomotil comparison quite a few times over the years, and though the two drugs are claimed to have similar effects, some find that one or the other does not seem to help, while most people find that one works better for them than the other, but there's no clear consensus.
Love,
Tex
Immodium AD recalled?
Moderators: Rosie, Stanz, Jean, CAMary, moremuscle, JFR, Dee, xet, Peggy, Matthew, Gabes-Apg, grannyh, Gloria, Mars, starfire, Polly, Joefnh
Regarding J&J, I gotta chime in here. Before my forensic career, I was a Director of Quality for a tier one medical device manufacturer. J&J was my largest customer. And they were a good customer in most respects, especially with respect to quality.
What has happened in big pharma, medical device, etc. Is the lunacy of the FDA in imparting irrelevant and costly requirements on world class companies who dont need the government to tell them how to operate. When was the last time anyone ever saw a government run agency that didn't proliferate out of control, spend hoards of cash irresponsibly, and impart irrelevant and business killing requirements on firms? Let's name some examples of poorly run government agencies... Post office (stop the bleeding... Shut em down... Let Fed Ex carry the mail). Defense... I worked that too. Cut half the budget and you won't miss a beat. The waste and entitlement is unreal. The FDA. Where do I start. They audit the wrong process factors and don't understand those that are critcal to quality. They reject good product on bad statistics. They accept bad product because they are inept.
J&J is operating in an FDA imposed environment that actually creates more opportuniTy for poor quality to reach the customer. Trust me on this... Those companies that want to stay in business don't need the FDA to regulate them or to show them how produce world class products. The FDA is the principle reason why your knee implant costs 4X what it should. I marvel at how well J&J actually performs amidst all of these ridiculous constraints administered by less than competent associates.
Even the best companies will field with defects. There is no such thing as a zero defects in the world. Sorry folks... But this is a fact. Everything has a failure or defect rate. Period. even our drugs and implantable devices. If I told you what the real failure rate of your furnace was (ie the probability of it burning your house down), you would never turn it on. But that doesn't make the product unsafe or the company that produced it a villain. Business is risk. Life is risk.
I left medical device because I was being too constrained to do what I knew was best for the customer. The FDA imposed such costly and irrelevant requirements that I could no longer apply my engineering skills to produce the best product for the price. Sound a little (or a lot) like our educational system? Arguably, J&J operates in the most regulated industry in the US. Try running your small business with hundreds of poorly trained auditors breathing down your neck, imparting riduclous and subjective regulations, and requiring youmto maintain a very expensive cost structure.
I have many Fortune 100 clients. I have found that those who choose to stay in business, do so not because of regulation, but because they know they need to make qualiTy products to stay profitable. Those who don't make quality products, and those who don't want to fix their problems, lose market share and eventually fail. No business, IMO, needs the government to show them how to excel.
Off my soap box.
Rich
What has happened in big pharma, medical device, etc. Is the lunacy of the FDA in imparting irrelevant and costly requirements on world class companies who dont need the government to tell them how to operate. When was the last time anyone ever saw a government run agency that didn't proliferate out of control, spend hoards of cash irresponsibly, and impart irrelevant and business killing requirements on firms? Let's name some examples of poorly run government agencies... Post office (stop the bleeding... Shut em down... Let Fed Ex carry the mail). Defense... I worked that too. Cut half the budget and you won't miss a beat. The waste and entitlement is unreal. The FDA. Where do I start. They audit the wrong process factors and don't understand those that are critcal to quality. They reject good product on bad statistics. They accept bad product because they are inept.
J&J is operating in an FDA imposed environment that actually creates more opportuniTy for poor quality to reach the customer. Trust me on this... Those companies that want to stay in business don't need the FDA to regulate them or to show them how produce world class products. The FDA is the principle reason why your knee implant costs 4X what it should. I marvel at how well J&J actually performs amidst all of these ridiculous constraints administered by less than competent associates.
Even the best companies will field with defects. There is no such thing as a zero defects in the world. Sorry folks... But this is a fact. Everything has a failure or defect rate. Period. even our drugs and implantable devices. If I told you what the real failure rate of your furnace was (ie the probability of it burning your house down), you would never turn it on. But that doesn't make the product unsafe or the company that produced it a villain. Business is risk. Life is risk.
I left medical device because I was being too constrained to do what I knew was best for the customer. The FDA imposed such costly and irrelevant requirements that I could no longer apply my engineering skills to produce the best product for the price. Sound a little (or a lot) like our educational system? Arguably, J&J operates in the most regulated industry in the US. Try running your small business with hundreds of poorly trained auditors breathing down your neck, imparting riduclous and subjective regulations, and requiring youmto maintain a very expensive cost structure.
I have many Fortune 100 clients. I have found that those who choose to stay in business, do so not because of regulation, but because they know they need to make qualiTy products to stay profitable. Those who don't make quality products, and those who don't want to fix their problems, lose market share and eventually fail. No business, IMO, needs the government to show them how to excel.
Off my soap box.
Rich
"It's not what I believe. It's what I can prove." - A Few Good Men
It seems we are digressing into a conversation about political ideologies, which I hate to enter, but I have to say something...
IMHO, world class companies are motivated by one and only factor: money...and greed. Would coal companies offer to decrease their smog and mercucy emmissions just because electricity buying consumers asked them to? Would Americans vote with their pocketbook and buy more expensive electricity to get that outcome? No. Would companies stop polluting our waterways just because it's the right thing to do and American consumers want it? The American public is too powerless and unimformed to have any impact on the "market" of these companies.
In the case of big Pharma, our government is the single largest "customer" they have (due to Medicaid, Medicare, etc), so I beleive government has every right to oversee what they do. The FDA is inept, but mostly because they are captured by the industry they are trying to regulate, just as the USDA is a servant to the meat industry. Bad drugs get approved because FDA panels are stacked with "experts" with financial stakes in the very companies making the drugs. Conflicts of interest abound, as does cherry-picking of favorable studies over perhaps countless more unfavorable ones for any given drug. These are the studies bought and submitted for consideration by these world class companies that have only our best interests at heart.
The American people are the unwitting victims, and our declining health is the proof.
In the case of the J&J recalls, without the FDA tracking adverse events and consumer complaints, how many children would need to be injured before the company admitted wrongdoing and changed it's manufacturing processes? If the events were not deadly, how long would people be consuming contaminated meds before anyone noticed?
Yes, our government spends and wastes far too much money. But the budget of the Department of Health and Human Services (after you take out Medicare and Medicaid), is a pittance compared to defense and other agencies. Science and rational decision-making are going out the window, and the American public will pay a heavy price.
IMHO, world class companies are motivated by one and only factor: money...and greed. Would coal companies offer to decrease their smog and mercucy emmissions just because electricity buying consumers asked them to? Would Americans vote with their pocketbook and buy more expensive electricity to get that outcome? No. Would companies stop polluting our waterways just because it's the right thing to do and American consumers want it? The American public is too powerless and unimformed to have any impact on the "market" of these companies.
In the case of big Pharma, our government is the single largest "customer" they have (due to Medicaid, Medicare, etc), so I beleive government has every right to oversee what they do. The FDA is inept, but mostly because they are captured by the industry they are trying to regulate, just as the USDA is a servant to the meat industry. Bad drugs get approved because FDA panels are stacked with "experts" with financial stakes in the very companies making the drugs. Conflicts of interest abound, as does cherry-picking of favorable studies over perhaps countless more unfavorable ones for any given drug. These are the studies bought and submitted for consideration by these world class companies that have only our best interests at heart.
The American people are the unwitting victims, and our declining health is the proof. In the case of the J&J recalls, without the FDA tracking adverse events and consumer complaints, how many children would need to be injured before the company admitted wrongdoing and changed it's manufacturing processes? If the events were not deadly, how long would people be consuming contaminated meds before anyone noticed?
Yes, our government spends and wastes far too much money. But the budget of the Department of Health and Human Services (after you take out Medicare and Medicaid), is a pittance compared to defense and other agencies. Science and rational decision-making are going out the window, and the American public will pay a heavy price.
Thanks to everyone for the good information. We don't seem to have any Immodium AD at all in the little town I live in. And I cannot use Lomotil, unfortunately it makes me worse instead of better. And Pepto does the exact same thing. So no Immodium AD means I take nothing. I'm still on one Entecort a day at this time, but running out fast. They'll be gone in three weeks and that means I'm again done with meds for the year. That runs my prescription limit on my insurance to absolute 0 and I still have other meds I now have to pay for for the rest of the year. Unforunately, and I'm not sure exactly why, I've never achieved remission, or anything close to it. All it takes is a little stress (and my mom has stage four cancer, so there's a whole lot of stress), and I'm back to severe D, regardless of diet. I can eat chicken and rice all day, every day and lose 10 to 20 pounds a month, and STILL have the big D. At this point, I'm starting to think I'm never going to get to normal. Ever. It just sucks!
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Gabes-Apg
- Emperor Penguin
- Posts: 8332
- Joined: Mon Dec 21, 2009 3:12 pm
- Location: Hunter Valley NSW Australia
In 2003 there was a major recall of a product marketed as 'travelcalm' made by Pan Pharmaceuticals as there had been adverse reactions and hospitalisations and it was later proven that the product did not meet the TGA Guidelines (Aussie equivalent of the FDA). (It did not meet spec and lack of quality control in the facilty meant a dodgy product made it to the market place. As part of the TGA investigation they found various ingredients in the Pan Pharmacueuticals factory that did not meet the specification they had been approved on.
at this time i was working for the market leading vitamin company in Australia , our company got 40% of its raw material from Pan Pharmaceuticals. We had to recall ALL the products in the market place that any ingredient that had been supplied by Pan. After 3 weeks of managing a 24 hour naturopathic support hotline to talk to sometime hysterical consumers to confirm if the product the consumer had in their home was affected by the recall or not, 30% of the worksforce of that company were retrenched (i was one of them and 10 other close friends at the time were also retrenched)
below is the outcome - the fact remains that this manufacturer was selling ingredients that did not meet spec and were a danger to consumers. In 2003 the owner of this company had houses worth $5Million or more on the harbour in sydney and lived a very comfortable lifestyle. THis man was not held accountable for his actions.
This event (people hospitalised and various companies retrenching employees) meant the guidelines for medications, vitamins etc and their labelling did get tightened. (this is part of the claim claim by big pharma why they cost so much)
at the time it was sad to lose my job. But now that i live in the MC bubble with multiple intolerances, the quality of a product and its labelling is critical to my wellness.
at this time i was working for the market leading vitamin company in Australia , our company got 40% of its raw material from Pan Pharmaceuticals. We had to recall ALL the products in the market place that any ingredient that had been supplied by Pan. After 3 weeks of managing a 24 hour naturopathic support hotline to talk to sometime hysterical consumers to confirm if the product the consumer had in their home was affected by the recall or not, 30% of the worksforce of that company were retrenched (i was one of them and 10 other close friends at the time were also retrenched)
below is the outcome - the fact remains that this manufacturer was selling ingredients that did not meet spec and were a danger to consumers. In 2003 the owner of this company had houses worth $5Million or more on the harbour in sydney and lived a very comfortable lifestyle. THis man was not held accountable for his actions.
This event (people hospitalised and various companies retrenching employees) meant the guidelines for medications, vitamins etc and their labelling did get tightened. (this is part of the claim claim by big pharma why they cost so much)
at the time it was sad to lose my job. But now that i live in the MC bubble with multiple intolerances, the quality of a product and its labelling is critical to my wellness.
THE Federal Government will pay $67.5 million in compensation to Pan Pharmaceuticals customers and service providers who lost money when the company closed.
The settlement, finalised and approved yesterday by Federal Court Justice Geoffrey Flick, was negotiated without admissions of wrongdoing by the Government, said Andrew Thorpe, the legal adviser to the class action of 170 members who claimed their businesses suffered loss and damage.
"However, it does end an eight-year saga that commenced on April 28, 2003, when the government shut down Pan Pharmaceuticals without notice," Mr Thorpe said outside the court.
"On that day, hundreds of people lost their jobs, $350 million was wiped off the Sydney stock exchange and scores of business, customers and service providers of Pan were very badly affected."
In March 2003, the government's Therapeutic Goods Administration (TGA) suspended Pan's licence and urged a recall of all its products after excessive amounts of some ingredients were found in its Travacalm tablets, to which 87 people suffered adverse reactions, including hallucinations, and 19 were admitted to hospital.
The company collapsed soon after the recall. Criminal charges were laid against Pan's chief executive, the late Jim Selim, but a Supreme Court judge directed an acquittal in April 2007 and an appeal court upheld that direction in September 2007. The following year Mr Selim successfully sued the government for $50 million, claiming the TGA had acted negligently and outside the limits of its statutory powers.
Mr Thorpe said yesterday it was Mr Selim's "courage and resilience which opened the door to this class action", begun in December 2008 by sponsors, creditors, distributors and retailers of its products. "I think it's fair to say that the industry descended into a state of chaos from which it's never fully recovered," he said, adding that Mr Selim, who died last year, would have been delighted with the result.
"Compensation can now be delivered back to custom- ers and service providers of Pan for what they have had to endure. "This was one of the prime reasons he settled his case when he did, to enable other people to take steps before the limitation period cut in and operated to prevent them from doing it."
The parties said jointly the sum consisted of $32.5 million for the class members' alleged loss and damage, $30 million interest and $5 million costs.
Gabes Ryan
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
More about the current drug-shortages. It's very far-reaching and affecting life-threatening conditions. Some industry represenetatives blame the FDA's increasing role in production oversight, but the FDA has had to tighten that leash due to the overwhelming cases of production flaws and contamination. Many companies are no longer producing old drugs that don't involve a high profit margin. So much for industry policing itself...
http://www.washingtonpost.com/national/ ... story.html
http://www.washingtonpost.com/national/ ... story.html
Call me a devil's advocate, but IMO, it's no coincidence that all these shortages are becoming more and more of a problem at the same time that most of the profit is being squeezed out of drugs as their patents expire. Big Pharma can't stomach cheap drug prices, and they're smart enough, (and ruthless enough), to realize that shortages inspire people to open their pocketbooks and ante up whatever is necessary to obtain a supply of the drugs that they want/need.
Of course, if it weren't for FDA's stranglehold on drug importation, the logical solution would be to obtain the drugs from overseas manufacturers, since domestic manufacturers are apparently importing the ingredients from there, anyway. It makes more sense to import the finished product. Of course, that's not likely to happen, since it would undercut the FDA/Big Pharma alliance, and our government would lose too much tax money that they now receive from the manufacture and distribution of vastly overpriced drugs.
I'm guessing that the outcome of all this will be much higher drug prices, and then abundant supplies will "magically" reappear. After the dust settles, generic drugs will no longer be "cheap" drugs.
At least that's the way I see it.
Tex
Of course, if it weren't for FDA's stranglehold on drug importation, the logical solution would be to obtain the drugs from overseas manufacturers, since domestic manufacturers are apparently importing the ingredients from there, anyway. It makes more sense to import the finished product. Of course, that's not likely to happen, since it would undercut the FDA/Big Pharma alliance, and our government would lose too much tax money that they now receive from the manufacture and distribution of vastly overpriced drugs.
I'm guessing that the outcome of all this will be much higher drug prices, and then abundant supplies will "magically" reappear. After the dust settles, generic drugs will no longer be "cheap" drugs.
At least that's the way I see it.
Tex
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.
