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Tainted Pills Hit US Mainland
Posted by
kdawson
on Tue Feb 05, 2008 07:42 PM
from the time-for-some-yellow-journalism dept.
from the time-for-some-yellow-journalism dept.
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."
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More like Bioveil... (Score:2)
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)
Parent
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No, Puerto Rico is not a state,... (Score:3, Informative)
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.
Parent
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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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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.
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.
Parent
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?
Parent
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.
Parent
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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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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
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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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
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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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
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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.
Parent
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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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
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!".
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...
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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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"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.