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Tainted Pills Hit US Mainland

kdawson posted more than 6 years ago | from the time-for-some-yellow-journalism dept.

Medicine 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."

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More like Bioveil... (1)

phatvw (996438) | more than 6 years ago | (#22315580)

More like Bioveil...

Article Mentions Problems in U.S. Also (4, Insightful)

eldavojohn (898314) | more than 6 years ago | (#22315584)

Ok, so let's keep ripping on those foreign drugs even though the article mentions several times that this is also a problem on the mainland. It mentions several times that Puerto Rico is the epicenter of drug plants, shouldn't it have a higher number of incidences? Do they even do a ratio of incidences to plant comparisons. Honestly, they're under FDA inspection, just like all the U.S. plants.

Tainted Pills Hit US Mainland
How about a title more like "Tainted Foreign Pills Meet Tainted Pill Level Requirements on Mainland." What's the matter? Not quite as hard hitting and blood boiling at those damned cheap non-U.S. labor supporting foreign pills killing somebody?

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 (4, Informative)

dj.delorie (3368) | more than 6 years ago | (#22315698)

Puerto Rico is part of the USA. It's not foreign drugs they're talking about, its *domestic* drugs.

Re:Article Mentions Problems in U.S. Also (3, Informative)

Anonymous Coward | more than 6 years ago | (#22315732)

Puerto Rico is part of the USA.
RTFA, the article said the company selling the drugs is Canadian:

But the factory owner, Canadian drug maker Biovail Corp...
Sounds like those foreign drugs everyone is crossing the border to purchase.

Re:Article Mentions Problems in U.S. Also (2, Insightful)

Froster (985053) | more than 6 years ago | (#22316502)

Not quite. It takes a great deal of effort to sell drugs in the US market, and part of that is either FDA supervision of a Canadian or other foreign plant, or to make the drugs under US jurisdiction. In the case of Biovail, they chose the latter option. They chose that to be able to sell those drugs in the US. Otherwise, they could continue to produce drugs in Canada as they otherwise would have.

Re:Article Mentions Problems in U.S. Also (2, Funny)

palegray.net (1195047) | more than 6 years ago | (#22318596)

Wait... foreign companies, producing drugs at American facilities, for sale in foreign countries, that are illegal to buy in America... my head hurts. I think I need some drugs.

No, Puerto Rico is not a state,... (2, Informative)

msauve (701917) | more than 6 years ago | (#22316140)

and is not part of the United States of America (neither are Navassa Island, the US Virgin Islands, American Samoa, Baker Island, Guam, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Atoll, the Northern Mariana Islands or Wake Atoll). It is a commonwealth, and a US insular area [doi.gov] .

Re:No, Puerto Rico is not a state,... (0)

Anonymous Coward | more than 6 years ago | (#22316642)

I'm not sure you know what it means to be part of the United States of America. By your definition, Washington DC is not part of the USA either. Nor are military bases or embassies. Or even naval ships. Man, how did that happen!?! It's a good thing you were here to let us know. Now we can fix the fake state of The Commonwealth of Virginia.

For enlightenment, read over http://en.wikipedia.org/wiki/U.S._state [wikipedia.org]

Imperialism, by any other name... (-1, Troll)

Anonymous Coward | more than 6 years ago | (#22316786)

stinks just as bad.

Re:No, Puerto Rico is not a state,... (1)

bytesex (112972) | more than 6 years ago | (#22318534)

Oh, you mean a /colony/.

Re:Article Mentions Problems in U.S. Also (5, Informative)

BloodAngel_Au (449499) | more than 6 years ago | (#22316150)

Interesting Fact
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.

Re:Article Mentions Problems in U.S. Also (1)

Burning Plastic (153446) | more than 6 years ago | (#22318314)

Palmyra Atoll isn't actually uninhabited - it has researchers there all of the time and a few people who live there full time...

Re:Article Mentions Problems in U.S. Also (0)

Spokehedz (599285) | more than 6 years ago | (#22316716)

PR is not part of the USA. It is a territory that the US owns.

It is not a state. Therefore, it not part of the United States of America. That is why they said 'mainland' because that is what the USA is to PR.

If you are going to be a prick, at least be correct about it.

Re:Article Mentions Problems in U.S. Also (1)

hjf (703092) | more than 6 years ago | (#22316780)

shit, at least TRY not to sound so obvious, man! yes -- we know you cowboys don't like people like me, who talk foreign languages, especially that scum of a language, Spanish (my language, btw), the language of wetback, siesta-sleeping, lazy ass latins. but well, if you feel that way, why don't you write to your congressman and ask for Puerto Rico to be "freed" from the united states? maybe you could invade some other island with blonde people with blue eyes. maybe they even speak english, have serial murderers and everyone is fat and ugly.

fucking racist cunt.

Re:Article Mentions Problems in U.S. Also (1)

Spokehedz (599285) | more than 6 years ago | (#22316938)

I have no problem with PR at all, whatsoever. It wasn't a personal dig at the territory nor the people in it. I was simply pointing out that it isn't a state but a territory as the parent post indicated it was. Which is why they used mainland, even though the USA owns PR.

As another poster attempted to prove me wrong, AK and HI are also not part of the 'mainland' but they are indeed states.

Re:Article Mentions Problems in U.S. Also (1)

gEvil (beta) (945888) | more than 6 years ago | (#22316796)

I guess using your logic neither Alaska nor Hawaii are part of the United States of America.

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.

Re:Article Mentions Problems in U.S. Also (1)

Spokehedz (599285) | more than 6 years ago | (#22316912)

No. Alaska and Hawaii both have stars on the flag. Or did you miss that in your haste to try and correct me?

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 (1)

Jonathan (5011) | more than 6 years ago | (#22317224)

By that "logic" Washington, DC is not part of the United States of America either as it too isn't a state. Much like Puerto Rico, it doesn't have the full rights of a state (neither DC nor Puerto Rico get congressmen or senators), yet it would be absurd to say that the capital isn't part of the USA.

Re:Article Mentions Problems in U.S. Also (1)

moderatorrater (1095745) | more than 6 years ago | (#22315710)

You do realize that Puerto Rico is part of the US, right? That's why they say "mainland" and don't say "foreign" in the summary. What this really shows is that factories everywhere can fuck up.

Aint Offshoring/Outsourcing Wonderful!!! (1)

Anonymous Coward | more than 6 years ago | (#22315906)

The company was Canadian! And don't forget that Puerto Rico doesn't want to become a full member of the United States. THEY keep voting down becoming a STATE! They like all the money, but none of the responsibility...that spells Third World to me!

Got to love the rash of problems that are coming home from offshoring!

Better check your credit rating too since large numbers of people have had their identities stolen in Indian, Philippine, etc call centers.

Enjoy your New World Disorder suckers!

Re:Aint Offshoring/Outsourcing Wonderful!!! (2, Funny)

tomhudson (43916) | more than 6 years ago | (#22316232)

Got to love the rash of problems that are coming home from offshoring!

Hawaii called - they're a mite pissed with you.

... and also some people on a big island off the eastern shore, in the state of New York ...

Re:Aint Offshoring/Outsourcing Wonderful!!! (1)

blindseer (891256) | more than 6 years ago | (#22316500)

... and also some people on a big island off the eastern shore, in the state of New York ...


Of course, how could I forget about Rhode Island.

Re:Article Mentions Problems in U.S. Also (1, Interesting)

Anonymous Coward | more than 6 years ago | (#22315720)

You want the FDA to get anal retentive on your medications, fine

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.

Re:Article Mentions Problems in U.S. Also (1)

sumdumass (711423) | more than 6 years ago | (#22316742)

Well, sort of. The tests done on the foam initially was when the manufacturing process made use of some CFCs. The process had been changed but the foam was supposedly certified to be the same quality so there weren't any more extensive tests other then to see the differences in the properties.

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 foam retain most of the characteristics of the old version, it was actually structurally stronger in the center of the foam where closed cells containing pockets of air would be subjected to changes in pressure and temperatures. Supposedly, this meant that it was more rigid inside the structure of the foam and instead of popcorning with small piece flacking off, it would create a tear that would grow until enough force pulled large pieces off.

What this really means if that it was looked at and determined that the falling foam wouldn't present a problem but after the changes, the chunks got bigger and became a problem that was first noticed with an explosion that killed the crew and lost the shuttle. So it wasn't that they didn't start looking until one blew up, it was that they looked and determined it not to be a problem until one blew up. Unfortunately the CFC creation process is still in use and was used on portions of the shuttle but isn't being brought back into use large scale in the near future. But it wouldn't really matter because they look at the falling foam in a different light now anyways. It wouldn't solve or negate any of the added precautions in place today.

I have read reports that say the Foams cohesion wasn't the problem and I have read reports where it was and that the conversion from freon to non freon didn't make a difference. Most of those reports hinge around environmental activism so you have to take them all with a grain of salt.

Re:Article Mentions Problems in U.S. Also (0, Flamebait)

Red Flayer (890720) | more than 6 years ago | (#22315748)

Nice troll.

Not sure if your error was intentional, but I bet it was... sure to get a lot of responses.

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.
That's horsepoop. Manufacturing costs of prescription medications are a small fraction of the total cost, except for orphan drugs with low usage. High-volume drugs, such as the ones mentioned in TFA, have an extremely small unit cost in relation to market price. R&D, marketing, even admin overhead dwarf manufacturing costs.

Another fine post from EDJ. Full of inaccuracies, conjecture, and trite sentences devoid of real meaning.

/Disgusted with myself for feeding the troll.

Re:Article Mentions Problems in U.S. Also (4, Interesting)

Jeff DeMaagd (2015) | more than 6 years ago | (#22315814)

You're missing a significant issue. If paint flecks can get in, what else is getting in there? Why would you have any confidence in the quality of the pills if they can't be bothered to actually control what actually gets in there?

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 (3, Interesting)

TubeSteak (669689) | more than 6 years ago | (#22315850)

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.
I'd love it for the FDA to get anal retentive about inspection regimes.

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 (1)

adminstring (608310) | more than 6 years ago | (#22316134)

Pretty much all generic drugs are sold without a crazy profit margin, since there's a competitive free market in the manufacture of generics.

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 current system to make that "optimum" price level pretty high.

I think the important question to ask is "what system for developing and distributing drugs could maximize innovation and at the same time maximize everyone's access to these products?"

It's probably not the current system, and a lot of different factors are involved here - the nature of corporate-university relationships, current FDA regulations for testing (some of which are neither efficient nor safe), advertising, the influence of the corporate drive for profit on the actions of pharma companies, and the nature of the insurance industry.

Good luck getting all of that straightened out in our lifetimes...

Re: Prescription drug prices (4, Insightful)

timmarhy (659436) | more than 6 years ago | (#22316542)

common misconception.

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.

Re: Prescription drug prices (1)

sumdumass (711423) | more than 6 years ago | (#22316774)

I agree. Many things should be considered a utility more then a market. Gas, Home heating oil, electricity, Public water, Medication and so on. There should be no or little market force on them outside the costs to deliver the products.

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 reasons you mention, and Gasoline because public transportation in the US sucks donkey balls. People depend on driving to get to and from work. It may be because of bad decisions in the past as far as locating housing and so on but that it no reason to penalize the people of the present and future who are dependent on it today.

Re: Prescription drug prices (1)

zippthorne (748122) | more than 6 years ago | (#22317806)

"what price do you put on life?"

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 (2, Insightful)

hung_himself (774451) | more than 6 years ago | (#22318058)

if you know of a better system that capitalism to decide that number, let us know.

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 health of the population (eg antibiotics or AIDs drugs for Africans).

The question should be "If you know of a worse system to develop drugs and therapies, let us know..."

MOD PARENT UP!!!! (1)

NIckGorton (974753) | more than 6 years ago | (#22318446)

Not only are you right, but succinct. I can never say that in so few words. Can I copy that and use it later?

Re:MOD PARENT UP!!!! (0)

Anonymous Coward | more than 6 years ago | (#22318508)

LOL, be my guest - you might have guessed, that I'm not a very strong believer in IP...

Re: Prescription drug prices (0)

Anonymous Coward | more than 6 years ago | (#22318544)

And yet, it still is. If drug companies make drugs too expensive, fewer people can afford them -- that's still capitalism, though it make seem more gruesome than the cost curve for coffee beans.

Also, letting drug companies make money, like any other company, to offset the cost of developing the drugs (including all the failed attempts) has been the most effective way we've found to come up with new drugs. I don't see anybody with a superior alternative to capitalist pharmaceutical companies, when it comes to cooking up new drugs.

Capitalism might suck at health care, but for pharmaceutical research, it's still doing remarkably well. Or as they say about democracy, it's the worst possible system, except for all the others we've tried.

Drug patents and prices (1)

Reziac (43301) | more than 6 years ago | (#22316974)

Remember too that "cheap generic drugs" is a euphemism for "expensive namebrand drugs whose patent has expired".

Re:Article Mentions Problems in U.S. Also (0)

Anonymous Coward | more than 6 years ago | (#22316452)

Not true. Big Pharma spends on average 16-18% of sales on R&D--R&D in Pharma is unbelievably expensive due to all of the misses firms have. Only like 40% of compounds that make it to phase 3 trials, make it to retail. Additionally, we're in Puerto Rico, because the government there allows us to pay next to nothing in taxes for product we make there. And it is a tricky environment to manufacture in, given the language barrier, and availability of qualified help on the island.

Re:Article Mentions Problems in U.S. Also (2, Informative)

TubeSteak (669689) | more than 6 years ago | (#22316766)

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 to Google shows that spending rose in 2005, 2006 and 2007.

Note: that study only looks at domestic sales & advertising, which means it doesn't show us the full picture. R&D would be even less as a percentage of global sales.

--R&D in Pharma is unbelievably expensive due to all of the misses firms have. Only like 40% of compounds that make it to phase 3 trials, make it to retail.
I can't speak to the truth of your 40% figure, but even if that is true, it is irrelevant at best. Pharmas are making money hand over fist even after you subtract their operating expenses from the >50% of their sales revenue that doesn't go to R&D and advertising.

Anyone capable of basic math can easily put the lie to your assertions.

Re:Article Mentions Problems in U.S. Also (1)

RexRhino (769423) | more than 6 years ago | (#22318182)

"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 exist (we just wouldn't call it "promotion").

In 2004, about $265 billion was spend on advertising. Not too much different than U.S. drug sales in 2004. Since drug ads make such a small percentage of advertising compared to other products, it is very clear only a small chunk of "promotion" is spend on TV commercials, print ads, and the types of frivilous things people think of as "advertising".

Anyone capable of basic math can easily put the lie to your assertions.
You do the math... there is no way that the drug industry is spending $58 billion a year on advertising. No way! Trying to imply that drug conpanies spend a quarter of their profits on advertising is very silly.

Re:Article Mentions Problems in U.S. Also (1)

Reziac (43301) | more than 6 years ago | (#22317406)

"I can't really think of anything other than vaccines that pharma companies sell without a crazy profit margin."

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.

Re:Article Mentions Problems in U.S. Also (1)

servognome (738846) | more than 6 years ago | (#22317858)

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.
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 higher priced ones are those which a company has been able to develop and no one else has developed a competitive alternative.

Not a tight regulatory sphincter in sight! (1)

MillionthMonkey (240664) | more than 6 years ago | (#22316426)

You want the FDA to get anal retentive on your medications, fine.

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 marriage!

Honestly I've heard of worse things being found in food than this.

When I was in fourth grade eating lunch in the cafeteria one day I saw a kid blow his nose into another kid's sandwich when he wasn't looking. Ever since then I've been eating dog kibble and saving $$$.

Re:Article Mentions Problems in U.S. Also (1)

angryfirelord (1082111) | more than 6 years ago | (#22316432)

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.
Why wouldn't you want the FDA to be anal retentive? Heck, that's their job, to make sure the food and medication I take won't kill me!
http://en.wikipedia.org/wiki/FDA [wikipedia.org]

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
So as you can see, the FDA has a pretty huge task and anything less then anal could potentially kill more people than those who couldn't afford it. Personally, I feel the drug companies shouldn't be allowed to advertise. (who actually goes to their doctor and specifically asks for Lipitor?) Perhaps that extra cash could be used to make the drugs a little more cheaper.

Re:Article Mentions Problems in U.S. Also (1)

servognome (738846) | more than 6 years ago | (#22317912)

Personally, I feel the drug companies shouldn't be allowed to advertise. (who actually goes to their doctor and specifically asks for Lipitor?) Perhaps that extra cash could be used to make the drugs a little more cheaper.
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 there, do their own research, and make informed decisions about their treatment. So no you don't go to the doctor and say "I want Lipitor," but you can do your research and tell them you're worried about the side effect of drug A, and would drug B be a viable alternative.

Re:Article Mentions Problems in U.S. Also (1)

KDR_11k (778916) | more than 6 years ago | (#22318532)

Advertising allows you to make informed decisions? I thought the whole point of advertising is to prevent those.

Re:Article Mentions Problems in U.S. Also (0)

Anonymous Coward | more than 6 years ago | (#22316506)

Yes!

Because everyone knows that in Puerto Rico all the paint is made with Polonium with a hint of nuclear waste for flavor.

Taking any pills that cost less than full USA retail will KILL YOU! Dont you know that! OMG! OMG! OMG!

Re:Article Mentions Problems in U.S. Also (0)

Anonymous Coward | more than 6 years ago | (#22318066)

'Scuse me, but pills manufactured in Puerto Rico aren't, by definition "foreign," but DOMESTIC. Puerto Rico is a self-goiverning commonwealth under the jurisdiction of the United States - a technical part of the United States, but not one having statehood, like Guam and the U.S. Virgin Islands and FULLY under U.S. federal jurisdiction.

The pills, de facto AND de juris, are NOT "foreign manufacture," but the company that OWNS the plant that manufactures them IS.

A fine distinction, but a very critical one.

Re:Article Mentions Problems in U.S. Also (1)

DerekLyons (302214) | more than 6 years ago | (#22318114)


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.
 
 

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.

Good. That's the FDA's whole job.

Re:Article Mentions Problems in U.S. Also (1)

cyberzephyr (705742) | more than 6 years ago | (#22318162)

Question. The pills did not come from the U.S., but they came from us?

I better check my blood pressure medicine for paint or something else.

DO NOT WANT! (0)

Anonymous Coward | more than 6 years ago | (#22315600)

Not our little territory!

How naive (0)

Anonymous Coward | more than 6 years ago | (#22315636)

"They're making products that save or support lives, so it's not in their interest to make products that are unsafe or ineffective," he said. "I think they're good corporate citizens by and large and want to do right by their patients."
Ahahahaha!! Oh jeez, that's a good one -- wait, you thought you were being serious?

Ask anyone in the pharmaceutical industry - there's no money in actually curing people.

What a bunch of pansies (4, Funny)

SwordFishData (1233916) | more than 6 years ago | (#22315644)

A little paint never hurt anyone! When I was a child, paint was considered a delicacy! It was like getting a piece of plasterboard with a prize!

Re:What a bunch of pansies (2, Funny)

Red Flayer (890720) | more than 6 years ago | (#22315834)

A little paint never hurt anyone! When I was a child, paint was considered a delicacy! It was like getting a piece of plasterboard with a prize!
I think the lead in that paint may have had more of an effect than you think.

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. (4, Funny)

Nick Driver (238034) | more than 6 years ago | (#22316178)

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.

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.

It's not the paint (0)

Anonymous Coward | more than 6 years ago | (#22316142)

I, for one, would be more than a little disturbed if I thought I was getting the blue pill, but was in fact getting the red pill.

Amazing (0)

Anonymous Coward | more than 6 years ago | (#22315660)

We need to get the drug's manufacturing back into countries that can control their QA; USA, EU, Canada, Australia, japan, etc. This is absolutely insane.

Re:Amazing (0)

Anonymous Coward | more than 6 years ago | (#22315798)

Let's bring it back into the USA... from the USA. RTFA.

Two observations (5, Insightful)

Red Flayer (890720) | more than 6 years ago | (#22315692)

FTA:

The FDA's San Juan office has 22 inspectors who devote about a quarter of their time to pharmaceutical plants. They typically visit the factories once every two years, more often if there are consumer complaints or the company has repeated infractions.
[snip]
Scharmann, a consulting editor for the watchdog publication Dickinson's FDA Review, said the FDA is concerned by anything that affects drug quality but considers the likelihood that the companies may file legal challenges to enforcement actions.
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.

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.

Re:Two observations (1)

repapetilto (1219852) | more than 6 years ago | (#22315862)

That's what I was thinking. So at what point is the FDA accountable for letting something bad be distributed?

Re:Two observations (1)

Red Flayer (890720) | more than 6 years ago | (#22315990)

Well, it is possible for states to sue a federal government agency for failing to uphold the law. The tricky part is proving damages and culpability. As long as the FDA comples with the letter of the law, no chance.

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.

Re:Two observations (1)

conlaw (983784) | more than 6 years ago | (#22316532)

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.

Re:Two observations (0)

Anonymous Coward | more than 6 years ago | (#22317040)

TXT available here [gpo.gov]

Re:Two observations (1)

compro01 (777531) | more than 6 years ago | (#22317818)

eh. i've known about that insect stuff for years, and honesty, it doesn't bug me. i'd still be more worried about the paint (and if paint can get in, what else?)

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.

Re:Two observations (0)

Anonymous Coward | more than 6 years ago | (#22317568)

So at what point is the FDA accountable for letting something bad be distributed

Sometime after the people actually responsible for distributing it get held accountable?

Oh, but actually holding people who do the damage responsible for the damage they do, why that's anti-american communist talk there.

Re:Two observations (0)

Anonymous Coward | more than 6 years ago | (#22315894)

Vote for Ron Paul! We'll just let the market sort this one out.

Puerto Rico? Racist to complain (-1, Flamebait)

Anonymous Coward | more than 6 years ago | (#22316000)

What the plant is in Puerto Rico?
Well then, it would be racist to complain about this.
If you complain yo must be a Jew-loving ReThuglican.

Fucking racist white people!

What does La Raza say about this?

Re:Two observations (1)

jdanton1 (1178389) | more than 6 years ago | (#22316600)

22 observers at San Juan strikes me as light, given the number of plants on the island. However, the every two years thing isn't that bad. When the FDA comes in for in audit, they aren't just sampling product and doing QA testing on it. They are insuring that you as a pharmaceutical company have processes and procedures in place to ensure the quality and efficacy of your product. Basically, they are auditing your process more than your product. Even down to an IT level, extensive change control is necessary to be in compliance with FDA cGMP (current Good Manufacturing Practices)

How about a patented medication tax? (1)

Kaenneth (82978) | more than 6 years ago | (#22317422)

Since pharma companies make a TON more money on a drug before it's patents expire (Example, Zyrtec cost me $2 a 10 mg pill. Now that generics are out, you can get 100 for $14.99, about 15 cents a pill)

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 government a small extra share of the profits. A percentage for every patent license. So that a patent owner pays a tax on what he gets from a 3rd party manufacturer.

Not a tax on aquiring the patents, or on the drug itself. Once the patent has expired, the tax no longer applies to anyone, inventor or copycat. If you want to not have to pay the tax, you can simply disclaim your patent rights, and allow competition; or just not make and sell the product, in which case you have little claim to damages for 'lost market share'.

Complications could include a patent on a non-therapeutic aspect of the drug, such as capsule design, coloring, labeling etc.

But once I had this idea, I thought: 'Hmmm, what if this applied to ALL patents?'

Claim your expensive software is 'patented', pay an few extra % to Uncle Sam. Patent your corporate 'Business Method', any revenue from that method is taxed a bit more.

I guess that wouldn't stop patent trolls who don't actually make or sell a product... and it would add costs to 'defensive' patents. But an extra few % from every court judgement, or out-of-court settlement to fund the patent office could got a long way towards speeding up the process, and making it more accurate. Ideally companies would think before filing "Is this patent worth the added taxes".

As a bonus to patent holders, anyone producing counterfeit goods would also be commiting tax fraud, meaning legions of IRS agents will help them find illegal copiers.

No idea how/if this would mesh with internation patent law treaties, but it's not like the U.S. gives a damn about those.

Still have the 'rule' that targetted taxes often affect unintended targets more than the intended ones. But what stops the drug companies from raising prices higher than they already are?

Re:Two observations (1)

servognome (738846) | more than 6 years ago | (#22318048)

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)?
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. There should, however, be more regular oversight of what is getting made in terms of reviewing documentation and quality test results.

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 agree, the FDA shouldn't have to fight things in court. Unless you give them absolute authority, the system breaks down.

Hyping one risk, ignoring another (4, Interesting)

Eukariote (881204) | more than 6 years ago | (#22315712)

Certainly, we should beware of iffy medication imported from abroad. But are the approved domestic drugs and treatments that safe? Have a look at these statistics: http://www.wnho.net/deathbymedicine.htm [wnho.net] . Close to a million deaths in the US, each year.

Re:Hyping one risk, ignoring another (0)

Anonymous Coward | more than 6 years ago | (#22316046)

Read those stats again. You'll notice that drugs were only *part* of the total. And having an adverse reaction to a drug is not the same as dying from that drug. Please don't be so alarmist when you don't even know how to read and think.

Re:Hyping one risk, ignoring another (1)

mrbluze (1034940) | more than 6 years ago | (#22316334)

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 and eat chocolate.

Re:Hyping one risk, ignoring another (1)

maxume (22995) | more than 6 years ago | (#22316484)

At most, 500,000 of those deaths are drug related(the others are related to problems endemic to being sick and in the hospital -- bad care, infections, etc). Of those 500,000, if you don't know how many of them were simple allergic reactions, you really can't say much about the safety of the drugs(to the general population -- or is peanut butter not safe?). It would probably also be good to separate out both accidental and intentional overdoses(because the notion of an overdose implies that a safe dosage is known).

Until you do at least that much, you also are hyping.

Lies, Damn Lies, and Statistics (1)

NIckGorton (974753) | more than 6 years ago | (#22318414)

OK, I had a look. From that article:

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, right lower quadrant pain, and vomiting, 50 of whom have appendicitis and 50 of whom don't, you do 100 appendectomies. There is no way to know who really has appendicitis till you open them up. If you operate on no one, 50 people will die. If you operate on all of them none or very few will die.

However, you can say retrospectively that you did 50 unnecessary surgeries.

The same can be said for Cesarean Section. If you have 100 babies in distress, 50 might come out fine if you don't do a section. The other 50 are placed at risk of serious complications or even death. If you know prospectively who will do great, then you will never do an 'unnecessary section'. However neither the OB or the patient knows that so both usually choose to err on the side of caution.

Of course that caution saves lives but allows fear-mongering pseudo-scientists whack-jobs to make statements like the World Natural Health Organization you cite. Its no wonder if you go to the main page they also don't believe in global climate change, are anti-gay-marriage, anti-vaccination, anti-flouride, anti-abortion, and anti-aspartame, whack jobs. They also hawk ministerial credentials, have a 'Responsibility in Free Speech' banner, a homeland security threat advisory, and a fetus near the bottom of their main page. http://www.wnho.net/ [wnho.net]

Those are definitely the people I'd go to for my health care info. I'm sure that's completely unbiased.

As a constructive suggestion though, the next time you'd like to make that point, you could do so without having to quote whack-jobs like those. The 1999 Institute of Medicine Report "To Err is Human" gives reliable figures, though the number of deaths is an order of magnitude less than the figure you quote. Its still an issue that needs to be addressed by systems change, but the sky isn't falling.

Re:Lies, Damn Lies, and Statistics (1)

Eukariote (881204) | more than 6 years ago | (#22318854)

World Natural Health Organization you cite. Its no wonder if you go to the main page they also don't believe in global climate change, are anti-gay-marriage, anti-vaccination, anti-flouride, anti-abortion, and anti-aspartame, whack jobs.

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 shows that these are in fact quite toxic/damaging. For vaccines, a good well-sourced overview can be found here: http://astore.amazon.com/medical-bookstore-20/detail/1881217302 [amazon.com] . Fluoride toxicity has long been known. And for aspartame you only need to know that it metabolizes to formaldehyde to know enough.

Of course, you will still think it to be nonsense because it implies something quite unbelievable: that millions of people are being knowingly put at risk, damaged, and poisoned. That can't be, can it? Well... there is a simple explanation for it all: this world is being run by genocidal maniacs. To see who these people are, take a look at the following big genocide that is not being reported on, yet is being executed more or less out in the open http://www.globalresearch.ca/index.php?context=va&aid=7957 [globalresearch.ca] . Yup, Henry is still at it.

Of course, in the west, we can't have overt genocide. It is essential that we believe ourselves to be free. Hence the deal with medication. It is perfect for covert genocide, and you can even have victims themselves pay for it.

Three Letters (1)

alphasubzero949 (945598) | more than 6 years ago | (#22315780)

GMP or in this case the lack thereof. Where was their QA in all of this?

Re:Three Letters (1)

Attila Dimedici (1036002) | more than 6 years ago | (#22316644)

GMP or in this case the lack thereof. Where was their QA in all of this?
For those who don't know, GMP stands for Good Manufacturing Practice. There is an important point mentioned in the article that comes further down than most people read.
"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.

Mmmmmm... (1)

largejunglecat (947016) | more than 6 years ago | (#22315784)

Blue is my favorite flavor of paint chips. Need to score me some of these drugs. Seriously though, I think this is ridiculous. I mean, sure, a little paint is probably not going to hurt anyone, but if paint chips are mixing in with the drugs, you have to wonder what else might fall in there (i.e. rodent droppings, etc.). It amazes me that the FDA is tolerant of operations that just leave bins full of drugs open out on the manufacturing floor.

Even worse are the counterfeit and low-strength. (3, Informative)

Ungrounded Lightning (62228) | more than 6 years ago | (#22315788)

Another problem has been pills that have low (or nill) active ingredient concentration. Some of these are generics - others are just flat-out counterfeit.

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 (1)

thelexx (237096) | more than 6 years ago | (#22317014)

"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]

Re:Even worse are the counterfeit and low-strength (1)

The One and Only (691315) | more than 6 years ago | (#22317724)

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.

Please tell me they didn't make a full minute long version of "Head On! Apply directly to the forehead!".

this time? (3, Interesting)

biased_estimator (1222498) | more than 6 years ago | (#22315912)

...tainted pills that have arrived in the US from -- not China this time -- Puerto Rico.
Have tainted pills come from China before? I know about all the other hooplah...

Re:this time? (1)

ScrewMaster (602015) | more than 6 years ago | (#22316276)

I'm not sure about tainted ones, but there's been a number of reports of counterfeit drugs coming from China. I read about one a while ago where the pills were the right shade of blue but were made from plaster! A woman died from it (well, not from the plaster but from her condition, which the fake pills didn't treat too effectively.)

meh (1)

akirapill (1137883) | more than 6 years ago | (#22316064)

I've been seeing tainted foreign pills for years. If you're lucky you just get a bunk roll or a speed bomb, but this one blue Chanel I had was bad news and I don't think it was paint chips.

Revised options: (4, Funny)

BeeBeard (999187) | more than 6 years ago | (#22316138)

1. You take the blue pill and the story ends.

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.

Re:Revised options: (1)

Jarik_Tentsu (1065748) | more than 6 years ago | (#22318454)

Neo: There's blue speckles in my red pill...
Morpheus: What!? Cypher, you been buying those cheap damn Puerto Rican made stuff again?

Simple Solution (1, Interesting)

Anonymous Coward | more than 6 years ago | (#22316164)

Simple solution:
First offense: The company has its patent for this specific drug revoked. Second offense: ALL drug patents of the company will be voided.

Make an example of the first one or two corporations that feel like testing the waters concerning this and see how now one else will be stupid enough to pull this off again.

Some preemptive refutals:

"The corporations have a right/obligation to turn a profit for their inventions": No, in this case they don't. The manufacturing company is clearly and maliciously not holding up their side of the contract, so why should the society need to?

"Drug corporations will simply not sell their drugs anymore in this country": If you make a good enough case, Europe and Japan will follow suit and react in the same way, since it will lower their healthcare costs. China is still too small a market for expensive medicamentation, so where will the drug corps sell their expensive products then, if they boycott North America, Europe and Japan?

Re:Simple Solution (0)

Anonymous Coward | more than 6 years ago | (#22316188)

You're a total idiot. You should know that the government is in the pocket of big pharma. Keep dreaming.

Re:Simple Solution (1)

tomhudson (43916) | more than 6 years ago | (#22316278)

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 ...

Re:Simple Solution (1)

servognome (738846) | more than 6 years ago | (#22318086)

Problem 1 is define what an offense is. Manufacturing processes can have all sorts of issues and can range from minor - the sorting machine jammed and some pills are broken when shipped to major - this pill is actually poison.
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.

I Had To Read The Summary Twice (1)

milsoRgen (1016505) | more than 6 years ago | (#22316200)

I had to read the summary twice, I could of swore it said:

The first warning sign came when a sharp-eyed worker snorting pills...

Whoah! Don't taint me bro! (1)

bobdotorg (598873) | more than 6 years ago | (#22316226)

Keep my pills away from your taint!

Do the managers of the US know what maintenance is (1)

Yaa 101 (664725) | more than 6 years ago | (#22316376)

http://en.wikipedia.org/wiki/Maintenance [wikipedia.org]

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 (1)

compro01 (777531) | more than 6 years ago | (#22317854)

http://en.wikipedia.org/wiki/Maintenance [wikipedia.org]

I begin to wonder reading all these stories.

In the long run it is actually cheaper to do maintenance.
who cares about long term? we need to raise that stock price 2 more cents this quarter!

These drugs are bad... (1)

enoz (1181117) | more than 6 years ago | (#22316490)

Mmmm'kay!

At First... (1)

rekab (990669) | more than 6 years ago | (#22316606)

I thought it said a sharp-eyed worker snorting pills...

Yeah but.... (1)

pajeromanco (575906) | more than 6 years ago | (#22316832)

does this affect viagra?

Does this bother anyone else? (2, Insightful)

HangingChad (677530) | more than 6 years ago | (#22317024)

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 surprised (1)

annerajb (1155635) | more than 6 years ago | (#22317296)

i am sorry saying this but i am from puerto rico and i am not surprise to hear FDA not being ... proper in their stuff its not common to hear stuff like this but is not surprising some places especially inspection companys like FDA and USDA do some strange stuff. like picus chiken factory they closed because of if i recall right bad chickens or soemthing. :S
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