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."

Re:Article Mentions Problems in U.S. Also

[dj.delorie]

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

[Anonymous Coward]

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.

Even worse are the counterfeit and low-strength.

[Ungrounded Lightning]

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.)

No, Puerto Rico is not a state,...

[msauve]

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:Article Mentions Problems in U.S. Also

[BloodAngel_Au]

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

[TubeSteak]

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:Right.

[Anonymous Coward]

it's cold poison, actually... and you forgot that you also had to pay the mill owner to work there!