Slashdot Mirror


Tainted Pills Hit US Mainland

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."

14 of 162 comments (clear)

  1. Article Mentions Problems in U.S. Also by eldavojohn · · Score: 4, Insightful
    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, 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.
    --
    My work here is dung.
    1. Re:Article Mentions Problems in U.S. Also by dj.delorie · · Score: 4, Informative

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

    2. Re:Article Mentions Problems in U.S. Also by Anonymous Coward · · Score: 3, Informative

      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.
    3. Re:Article Mentions Problems in U.S. Also by Jeff+DeMaagd · · Score: 4, Interesting

      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.

    4. Re:Article Mentions Problems in U.S. Also by TubeSteak · · Score: 3, Interesting

      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?
      --
      [Fuck Beta]
      o0t!
    5. Re:Article Mentions Problems in U.S. Also by BloodAngel_Au · · Score: 5, Informative

      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

      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.

  2. What a bunch of pansies by SwordFishData · · Score: 4, Funny

    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!

    --
    Check out Erie, PAs one and only industrial metal band: DisgraceD
  3. Two observations by Red+Flayer · · Score: 5, Insightful
    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.
    --
    "Trolls they were, but filled with the evil will of their master: a fell race..." -- J.R.R. Tolkien on Olog-hai
  4. Hyping one risk, ignoring another by Eukariote · · Score: 4, Interesting

    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. Close to a million deaths in the US, each year.

  5. Even worse are the counterfeit and low-strength. by Ungrounded+Lightning · · Score: 3, Informative

    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.)

    --
    Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way
  6. this time? by biased_estimator · · Score: 3, Interesting

    ...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...
  7. Revised options: by BeeBeard · · Score: 4, Funny

    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.

  8. Right. by Nick+Driver · · Score: 4, Funny

    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.

  9. Re: Prescription drug prices by timmarhy · · Score: 4, Insightful
    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.

    --
    If you mod me down, I will become more powerful than you can imagine....