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."

Comments

Article Mentions Problems in U.S. Also

[eldavojohn]

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.

Re:Article Mentions Problems in U.S. Also

[Froster]

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.

Two observations

[Red Flayer]

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: Prescription drug prices

[timmarhy]

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.

Does this bother anyone else?

[HangingChad]

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...

Wrong question

[hung_himself]

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..."