Tainted Pills Hit US Mainland 162
Tech.Luver notes an AP story on tainted pills that have arrived in the US from — not China this time — Puerto Rico. The article details a disturbing number of incidents of contamination investigated by the FDA over the last few years. "The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors. After the flecks were spotted again on the capsules, a blood-pressure medication called Diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas. But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated — or prevent future contamination, according to US regulators... FDA officials say the problems in Puerto Rico are proportionate with the large number of pharmaceutical plants here and generally no worse than those on the US mainland."
More like Bioveil... (Score:2)
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Article Mentions Problems in U.S. Also (Score:4, Insightful)
So you know, considering that most paint today is safe enough to use as a food coloring, in sunscreen or even toothpaste [wikipedia.org], I would prefer my elderly grandma consume the paint flecks accidentally with her medication instead of not being able to afford the medication.
So where's the story here? These paint flecks kill somebody? You want the FDA to get anal retentive on your medications, fine. Just realize those expensive drugs are going to get a little more expensive and sick people who are poor might not be able to afford them anymore.
Honestly I've heard of worse things being found in food than this.
Re:Article Mentions Problems in U.S. Also (Score:5, Informative)
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No, Puerto Rico is not a state,... (Score:3, Informative)
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Re:Article Mentions Problems in U.S. Also (Score:5, Informative)
The term "United States" when used in a geographical sense on official documents, acts and/or laws; includes the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa.
The U.S. has twelve unincorporated territories, also known as possessions, and two commonwealths. The major possessions are American Samoa, Guam, and the U.S. Virgin Islands. All of these have a non-voting representative in the U.S. Congress. The major commonwealths are Puerto Rico and the Northern Marianas. Commonwealths have their own constitutions and greater autonomy than possessions, and Guam is currently in the process of moving from the status of unincorporated territory to commonwealth. The residents of all of these places are full U.S. citizens, with the exception of those on American Samoa who are U.S. nationals, but not citizens.
U.S. Commonwealths/Territories include: American Samao (AS), Baker Island*, Howland Island*, Guam (GU), Jarvis Island*, Johnston Atoll*, Kingman Reef*, Midway Islands, Navassa Island*, Northern Mariana Islands (MP), Palau (PW), Palmyra Atoll*, Puerto Rico (PR), U.S. Virgin Islands (St. Croix, St. John and St. Thomas) (VI), and Wake Island*.
Puerto Rico has its own Olympic team and competes in the Miss Universe pageant as an independent nation.
* Uninhabited
quoted from http://welcome.topuertorico.org/government.shtml [topuertorico.org]
So, you have it correct dj. I'm sure this will suprise a few people, considering when most mention USA, they think of the mainland, hawaii & alaska. I know I did.
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As another poster attempted to prove me wrong, AK and HI are also not part of the 'mainland' but they are indeed states.
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Calling us Puerto Ricans "wetback, siesta-sleeping, lazy ass latins". How dare you mix up your ratial slurs!! Those are mexicans...
1. wetback: meaning they swam across the Rio Grande to get into the US (I guess cubans should be called the same)
2. siesta-sleeping: we don't have that tradition here, don't know if mexicans still do this, this tradition comes from Spain
3. lazy ass - I guess we all fit this category
If you want to refer to us please do some research. Consult
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Here's a hint: If you're going to tell other people to be correct about something, you'd better be damn sure you yourself know what you are talking about. And it's very clear here that you don't. Fucking dipshit.
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Both AK and HI are states in the USA. Even though they are not attached to the mainland, they are still part of the USA because they are a state.
If Puerto Rico isn't part of the USA neither is DC (Score:2)
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Hawaii called - they're a mite pissed with you.
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That's the thing. When you look, you find stuff that may or may not be relevant or a problem: take the foam issues with the shuttle. Who knows if all of the insulation issues are actually threatening or not, they didn't start looking until after the last one blew up, so there's no way of knowing if the foam always cracked up or not.
The alternative is not looking at all, and I'd trust the drug companies even less in that situation.
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Last I heard, it turns out that there is a small difference in the cohesion which causes the new style of foam to fall in larger chunks with more of a cascade effect then the original versions. Evidently, while the foa
Re:Article Mentions Problems in U.S. Also (Score:5, Interesting)
I for one don't think it's expensive on a per-pill basis to keep a plant like that clean, they should have been clean in the first place.
Re:Article Mentions Problems in U.S. Also (Score:4, Interesting)
If you knew anything about the pharma industry, most of those expensive drugs cost next to nothing to manufacture. The sick and poor can usually get subsidised/free drugs through pharma company programs.
The high retail price of drugs bears almost no relation to its cost, partially because the drug industry spends more on advertising than R&D, but mostly because the market will bear it.
I can't really think of anything other than vaccines that pharma companies sell without a crazy profit margin. Can you?
Re: Prescription drug prices (Score:2)
For brand name drugs, good business sense would dictate that they set the profit margin wherever it nets them the highest total profit - too high and not enough people will buy it, too low and they don't make as much as they could per pill, but if they get it just right they make the most money. Apparently there is enough demand for some of these drugs in the curre
Re: Prescription drug prices (Score:5, Insightful)
health issues aren't ruled by supply and demand, especially on brand name drugs since the supplier can artifically restrict the supply without fear of competition. it's not like someone dieing has any choice (what price do you put on life?) and drug companies exploit this.
capitalism is a decent system. but it's not an answer to everything, and one of those things is health care.
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Utility seems to be a generic term I like to use. But I like to use it because it is the one thing in a capitalist society that people don't mind regulating the profit margins of. We should be including Gas to some extent and medication into those groups. Medication for the r
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Of all of the things you mentioned, medication has the least elastic demand of all. Even home heating has an elasticity to it since you can (however undesirable) turn the thermostat way down and wear a coat to reduce use. Gasoline can be conserved through carpooling, cutting out unnecessary trips, and in some cases teleworking and walking.
OTOH, if you need life saving medical care, you have no viable alternatives. Taking it every other day or taking half doses may be worse than not taking it at all.
Capi
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Well, not to the extent your wanting to make it. Sure you can turn the heat down but what is a reasonable amount? I mean if you got kids and are keeping the house at 50
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Sure. But lets compare apples to apples and not skew the situation. The vast majority of medical care doesn't treat life threatening conditions. Pain medication of instance treats a quality of life situation and so on. Not all medication or medical car is life or death and for the purpose of comparing life and death, we need to rule out excess in home heating, gasoline and so on. If your ride doesn't show, you have to make it to work or get fired which means you lose your house or something else that ends
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well, it is a good thing we don't live in a true capitalist society. Pain medication might mean no work, but then you would be poor and the government already steps in and it becomes a quality of life thing.
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I wasn't educated on their products at all, I made a choice at the recommendation of someone I worked with and found the differences in the quality and costs soon after.
What we have here is a terminology problem. Initially, your boot choice was uninformed, then your friend informed you and you made a better choice.
If by elasticity, you meaning all the fluff in the layers above, then you might be right
More terminology. The fluff is the elastic part. Your demand will stretch and contract based on yo
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But you see, I wasn't fully informed until after owning the boots for a little over a year. I don't think capitalism suffered. And besides, the old boots were adequate if you didn't wear them for long periods of time and perhaps only needed to used them occasionally instead of every workday. Sure becoming informed helped me make a choice but it wasn't determin
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Let me turn that around for you. What price DO you put on life? Should drugs cost only what it costs to produce? Or should they cost what it's really worth? Keep in mind that the drugs only extend your life if they exist to do so.
Obviously, the price should land somewhere in between those values. If you know of a better system that capitalism to decide that number, let us know.
Wrong question (Score:3, Insightful)
Essentially, the present system is to publicly (under)fund the difficult work of the basic science and then allow the private sector to patent the discoveries, remove them from the public domain, and massively profit.
In exchange, they do the technically simple tasks of clinical trials, production and assessing which drugs to release back to the public using the criterion of maximizing profit (eg viagra) rather than the h
MOD PARENT UP!!!! (Score:2)
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An entirely publicly run research effort may very well have decided that a treatment for ED was a luxury, and ceased any effort beyond a note in a database, or an
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You may be right that a publicly run research effort may have decided ED was a luxury but even so - what likely would have happened is what did happen - people testing the drug for hypertension would have reported its side effect and then people would have started using it without big pharma. Google melanotan and PT-141 and tanning if you wan
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And again, in that particular case, you're way off the mark. The money spent marketing it is irrelevant precisely because it's a good deal smaller than the profit made from that marketing. That profit
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C'mon, think that one through please. That really is nonsensical. That money was spent - it came from drug sales (and expensed so part of it came from potential tax revenue). It could have been put to better use. The whole sum, not just the profits. If it had been a public enterprise for example, the revenue from drug sa
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The system is not best which funds all diseases equitably. It is best which provides the most benefit to the most people. It must distribute resources between medical research, medical service, and other sectors which are necessary as well. And even on the research side, while there is certainly r
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The last mile work *is* fantastically expensive - no argument there *but* it is also fantastically profit
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common misconception.
it's not like someone dieing has any choice (what price do you put on life?) and drug companies exploit this.
You don't have a choice to avoid death, but in some places like the US you do hav a choice as to how much you spend to stay alive.
capitalism is a decent system. but it's not an answer to everything, and one of those things is health care.
Healthcare isn't free market. Most people are in insurance pools funded by employers (and I gather most of these plans are required by law). That means health benefits that at least partially seperate the cost of providing healthcare from the demand for healthcare. Demand will go up when someone else is paying for your healthcare.
Drug patents and prices (Score:2)
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Erm... new vaccines have the same crazy profit margin as any other drug that's still under patent. I've seen newly-developed animal vaccines retail for as much as $60 PER DOSE. Ask any horse person how much they had to cough up for West Nile vaccine the past few years, you'll get an earful.
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Advertising has little relation to the cost of drugs. Advertising is used for drugs that are competitive, for example $250M spent on Tylenol. The high priced drugs are those where there is no effective alternative, so no advertising is necessary.
So yes, R&D does have a relation on the cost of medicines, because the
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I'd love it for the FDA to get anal retentive about inspection regimes.
If you knew anything about the pharma industry, [...]
You are like the pot calling the kettle black when you acuse someone of not knowing anything about the pharmaceutical industry and then make a dumb statement like you'd "love it if the FDA got [strict] about inspections". The FDA is *very* strict about GMPs (Good Manufacturing Practices) in the pharmaceutical industry. What happened here is that the company violated the regulations in 1)allowing the contamination in the first place, 2)not reporting it to the FDA immediately, and 3)not recalling the drug
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Not true. Big Pharma spends on average 16-18% of sales on R&D
In what years?
http://www.sciencedaily.com/releases/2008/01/080105140107.htm [sciencedaily.com]
"The researchers' estimate is based on the systematic collection of data directly from the industry and doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4% of the sales dollar on promotion, versus 13.4% for research and development, as a percentage of US domestic sales of US$235.4 billion."
Assume those percentages are off by an enormous 10% margin of error... advertising still outstrips R&D.
A quick trip
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"The researchers' estimate is based on the systematic collection of data directly from the industry and doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4% of the sales dollar on promotion, versus 13.4% for research and development, as a percentage of US domestic sales of US$235.4 billion."
Assume those percentages are off by an enormous 10% margin of error... advertising still outstrips R&D.
A quick trip to Google shows that spending rose in 2005, 2006 and 2007.
Except that "advertising" != "promotion".
Advertising is a much smaller subset of promotion. Promotion means things such as providing training in the use of drugs for doctors and nurses, distributing free samples of the drugs, having highly trained professionals on call to answer technical questions a doctor might have about a new drug. This type of promotion is pretty much a nessicary part of selling a drug, and even if we had an entirely socialist model of drug development a lot of these costs would still
Not a tight regulatory sphincter in sight! (Score:2)
Is that where these little pills are coming from?
Just realize those expensive drugs are going to get a little more expensive and sick people who are poor might not be able to afford them anymore.
And since pharma companies spend twice as much on advertising as they do on research, it would mean fewer TV commercials to inform "guys like me, with eeee-deee", about the latest penis pills available. I'll have to turn off my spam filters to save my
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Um, no. One ingredient used as a pigment is also used for those purposes - nothing is said in the linked article about all the other ingredients used in paints.
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eldavojohn, I'm with you.
Considering the fact that the parties that stand to benefit the most from this story are the Big Pharma companies, and considering that 99 percent of all news stories come from press releases put out by flacks, I'm not the least convinced that this isn't part of a FUD campaign to counter even John McCain's willingness to stop Pharmas price-gouging of the US market.
I'm alive today because of an outrageously expensive
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As long as Hilary or Obama wins, the gov. is going to pay for all my meds anyways!
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It won't make drugs cheaper, because most of the advertisement goes towards medication that are competitive. It's cold, pain, and sex medicine that's being advertised, not the really expensive cancer treatments. Advertising does help let the patient become more informed about what is out
What a bunch of pansies (Score:4, Funny)
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Besides, when I was a young'un, the plasterboard would have been the prize. We had to make our own drywall from gypsum lumps and the paper we made by chewing up wasps nests and spitting out the eggs, larvae, and wasps to make pulp.
Right. (Score:5, Funny)
Right.
I had to get up in the morning at ten o'clock at night, half an hour before I went to bed, eat a lump of dry poison, work twenty-nine hours a day down at the mill, and when we got home, our dad would kill us and dance about on our graves singing Hallelujah!
You can't tell the young people of today that. They won't believe you.
Two observations (Score:5, Insightful)
Other interesting point is that the FDA chooses not to fine companies/enforce regulations because of the cost of responding to legal challenges from the manufacturers. What excatly is the point of having oversight and inspections, then? Basically, the FDA must have crystal-clear evidence of plant-to-market malefeasance before they can do anything.
I guess the pharma industry has gotten their money's worth with their campaign contributions. A hamstrung FDA on a shoestring budget means strong profits for big pharma.
How about a patented medication tax? (Score:2)
How about a moderate tax on patent protected drugs, to help fund the FDA, who can then improve their inspection process. That can help keep out counterfeit drugs, ensuring that potential customers will only get your genuine products.
That is, in exchange for the government granted monopoly, you give the governm
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There are different kinds of oversight. It doesn't make sense to do plant inspections all the time because what you really are inspecting are the systems not what is getting made. Ther
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Good point.
I think that plant inspections should follow more on the line of financial audits. Full process audits as done now, audit of process adherence regularly at more frequent intervals. Wh
Penalties are cheaper than safety (Score:2)
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Two interesting things there -- first is that plants are only inspected every two years unless they are flagged due to poor prior performance or consumer complaints. Why not have inspections with a random interval? Yah, I know -- cost. But considering how many pills these plants pump out, you'd think there'd be stricter oversight. Or is it that we just trust pharmaceutical companies to do the right thing (which means avoid the nightmare of tainted pills splashed across the evening news)?
Other interesting point is that the FDA chooses not to fine companies/enforce regulations because of the cost of responding to legal challenges from the manufacturers. What excatly is the point of having oversight and inspections, then? Basically, the FDA must have crystal-clear evidence of plant-to-market malefeasance before they can do anything.
Usually I would agree that it is not possible to over-estimate US industry's willingness to get around regulations to save money (lead in toys is the most recent example), but as far as the pharm industry's manufacturing practices I have to disagree. I have several decades of experience in pharmaceutical safety so I know a bit about this.
At least for the major pharm companies, Good Manufacturing Practices are of paramount importance. Yes FDA inspectors may come by on average once every two years to a faci
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I agree, by-and-large, that the major players play by the rules.
I guess I got caught up a little bit in the sensationalism of the article
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It's kind of tough when the regs governng the FDA are written by the people they are supposed to regulate... take a look at who gets to serve hgh up in the FDA. Almost all of them are ex-pharma execs.
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So at what point is the FDA accountable for letting something bad be distributed?
This all depends on your definition of "something bad." If you really want to have your stomach turned, read the FDA regulations (Title 21, Chapter 1 of the Code of Federal Regulations, available from http://www.gpoaccess.gov/cfr/index.html [gpoaccess.gov]) on how many insect parts are allowed in your daily bread (or crackers or cookies). After reading those regs for a while, a few paint chips will seem innocuous.
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interestingly, a pound of ants is healthier (higher in protein and practically 0 fat) than a pound of lean ground beef. also, I've never heard of anyone having adverse effects from ingesting bee/wasp/whatever venom.
Hyping one risk, ignoring another (Score:5, Interesting)
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Add to this death by non-compliance with medication, lack of medication/not being on medication, despite medication, non-prescription medication, over-the-counter medication, poisoning (all poisons are potentially medication!), suicide by medication, choking on medication and avoiding all of the above including food and water which potentially contains medication (anorexia), and you can pretty much include all deaths in the US and declare everything to be bad.
I think I'll just get all depressed now and go
Lies, Damn Lies, and Statistics (Score:2)
It's very difficult to obtain accurate statistics when studying unnecessary surgery. Dr. Leape in 1989 wrote that perhaps 30% of controversial surgeries are unnecessary. Controversial surgeries include Cesarean section, tonsillectomy, appendectomy, hysterectomy, gastrectomy for obesity, breast implants, and elective breast implants.
This is a good example of why Mark Twain was right. Take for example appendectomy which they cite as a 'controversial' unnecessary surgery. There is no controversy that an appendectomy is necessary for real appendicitis. Without it, you will likely die from complications. However, especially in the era before CT scans (when the article they cite was written) the certainty of the diagnosis of acute appendicitis was always in question.
Faced with 100 patients with fever
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The page I linked to was an abstract/introduction of a book by authors not associated with that website. If you have an issue with the book, take on the book and the statistics and references therein. For vaccinations, fluoride, and aspartame there is good research that sh
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Ah, yes. That cutting-edge research from 2002 with one out of three reviews on the page commenting on how biased it is. There's a good source of information.
Actually, there have been a number of studies recently looking at the association between vaccines and various illnesses/diseases/symptoms, particularly vaccines and autism. Every single one that I've seen publis
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Oh, I fully agree. Do you have that context and did you trace the sources of the charts? Nope, you did not. You read a review and deferred to its authority. Did you verify the research you quote that found no association between vaccines and risks? Nope, you believe them as they have been published by "reputable scientists".
Consider that studies are easily bought and corrupted. If the reason for it all is what I say, the interests are so larg
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Your response? To quote only the last comment and then say: Oh, I fully agree. Do you have that context and did you trace the sources of the charts? Nope, you did not. You read a review and deferred to its authority. Did you ver
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Well, you can take your own arguments as sufficient to leave the subject rest. Or you can reserve judgment and take in further data. As to your first point: the book I directed you to is anything but sketchy, it is very well-referenced. If you don't trust the book, you can still trace the source material it references. If you don't care to invest money in it, here is a freely downloadable article that covers part of the topic, and it is well-referenced too: http://www.jpands.org/vol11no2/ayoub.pdf [jpands.org]
As to a
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And vitamin B12 metabolizes to free cyanide. Therefore, I assume you will stop ingesting food with it?
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Don't compare apples to oranges. One Diet Coke contain 135 milligrams of Aspartame. The recommended daily intake of vitamin B12 is 15 micrograms. Moreover, the toxicity mechanism is quite different: cyanide is an inhibitor of a specific enzyme, formaldehyde can cause many a-specific reactions, e.g. cross linking of protein chains.
Also, consider that we have evolved to cope with a diet that includes vita
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So, that is lesse here...
A whopping
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OK, point granted: the body can cope with the formaldehyde produced during normal metabolism. Does that mean that the formaldehyde from the potentially rather different aspartame metabolism can be coped with? Not necessarily. In fact, there is data that shows that it cannot.
A Spanish research group has managed http://www.ncbi.nlm.nih.gov/pubmed/9714421 [nih.gov] to trace where the formaldehyde produced during aspartame metabolism binds. They did so by radiolabeling the methanol group of aspartame. The formaldehyde
Even worse are the counterfeit and low-strength. (Score:4, Informative)
A particular problem is thyroid hormone - which even normally has significant variation of activity between brands. Fine tuning of the concentration during is necessary to prevent serious ill effects (including permanent brain damage or death). So substituting a pill with a different strength can be a serious hazard. (That is why endocrinologists prescribing it will normally specify the brand or manufacturer and "do not substitute".)
Unfortunately, both generics with virtually no active ingredient and actual counterfeit pills with no active ingredient at all have been making their way into insurance company pharmacy plans from foreign manufacturers. (Recently a doctor studying this had the experience of cutting a pill in half and finding that it was fake. The real manufacturer's product had an internal layer that was missing in the counterfeit.)
Re:Even worse are the counterfeit and low-strength (Score:2)
Yep, they're called 'homeopathic remedies'. Seen a couple of ads on tv, one was at least a full minute long, pimping homeopathic crap. Very disturbing.
http://www.youtube.com/watch?v=BWE1tH93G9U [youtube.com]
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Please tell me they didn't make a full minute long version of "Head On! Apply directly to the forehead!".
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"Another problem has been pills that have low (or nill) active ingredient concentration."
Yep, they're called 'homeopathic remedies'. Seen a couple of ads on tv, one was at least a full minute long, pimping homeopathic crap. Very disturbing.
http://www.youtube.com/watch?v=BWE1tH93G9U [youtube.com]
Homeopathic remedies are a separate issue.
What I'm talking about is products sold as a particular drug and strength which in fact are fakes with either a different (typically lower) strength or just no active ingredient at all.
this time? (Score:3, Interesting)
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Revised options: (Score:5, Funny)
2. You take the red pill and you stay in Wonderland, and see how deep the rabbit hole goes.
3. You take the blue speckled pill and develop serious health issues.
Whoah! Don't taint me bro! (Score:2)
Do the managers of the US know what maintenance is (Score:2)
I begin to wonder reading all these stories.
In the long run it is actually cheaper to do maintenance.
Re:Do the managers of the US know what maintenance (Score:2)
I begin to wonder reading all these stories.
In the long run it is actually cheaper to do maintenance.
Does this bother anyone else? (Score:3, Insightful)
FDA officials say the problems in Puerto Rico are proportionate with the large number of pharmaceutical plants here and generally no worse than those on the US mainland.
Wow, I'm sure glad there isn't any more paint in our meds here on the US mainland than Puerto Rico.
Remind me why the US pharmaceutical industry told us we were paying more for the same meds in this country? Something about safety...
Not as dangerous as herbal supplements (Score:2)
Supplementary, Complementary and Alternative Medicine should be subject to the same controls (including proofs of efficacy) as actual medicine.
My HMO sells through own pharmacies. (Score:2)
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Problem with your plan is, where will we get our medications from? China?
After all, if you're going to make them liable for manufacturing here, they'll just offshore it, and we all know how much contaminated stuff (toys, hard drives, etc) has come from China lately ...
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Problem 2 is that by revoking patents you essentially turn the industry into low cost generic manufacturers, which are the ones who will more willingly cut corners to save cost.
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"David Elder, director of enforcement in FDA's regulatory affairs office, said pharmaceutical companies generally fix problems on their own and issue recalls if necessary once notified."
This is the important point.