What goes on inside drug-making plants? You might not want to know

Mixing up the medicine

Whenever some medical mainstreamer gets a bug up his stethoscope about dietary supplements, we hear the same lame arguments…

Supplements aren’t regulated. (Of course they are. They’re regulated differently than drugs because they’re not drugs.)

Supplements aren’t held to the rigors of “gold standard” science. (That gold standard is a sham. In drug trials, placebos are often “active placebos,” and time and again we’ve seen drug companies hide data — most recently, Roche stonewalled the release of complete research data for Tamiflu.)

Supplements don’t have a safety track record. (Every new drug that goes on the market — especially drugs that have been fast-tracked — is an unknown quantity when it comes to safety. Meanwhile, supplement-related deaths are rare, but drugs cause deaths every day. Every. Single. Day.)

And finally: The FDA doesn’t oversee supplement manufacturing facilities, but drugs are made with strict quality and safety controls.

Turns out this last one may be the biggest joke of all.

Purge your medicine cabinet!

When you think of a pharmaceutical plant, you might imagine workers in white lab coats, protective face masks and gloves, working in pristine, air-tight processing labs.

Some of them, possibly, really do look like that. But it appears that a few of them bear a closer resemblance to an unruly frat house on a Saturday night.

A few days ago Pfizer recalled one million packets of birth control pills that may have contained insufficient doses. Oops! Nobody seems to know how long customers might have been taking the low-dose pills.

In this recall, safety wasn’t an issue (unless you count exposure to soiled diapers). But safety was a MAJOR issue four years ago with Johnson & Johnson’s Ortho-Evra birth control patch. It appears that company executives knew that the patch’s estrogen dose was much higher than claimed, putting women at risk of strokes and heart attacks.

Multiple deaths were attributed to that “mistake.”

Two years later, we began to find out that many Johnson & Johnson products were potential safety nightmares.

In 2010, J&J recalled Tylenol, Motrin, Zyrtec, and Benadryl for children and infants. The FDA reported that even after many customers complained about specks in the medicines, J&J did not follow up with an investigation.

There was also a potential bacteria problem in these products. According to the FDA, someone at J&J knew about the potential contamination, but allowed the medicine to be used anyway.

Later in 2010, a J&J Acuvue contact lens product was recalled due to traces of stinging acid, some Tylenol cold products were recalled, several Mylanta liquid products were recalled, and particles of wood and metal were found in some lots of Rolaids.

That same year, GlaxoSmithKline paid $750 to settle a criminal and civil complaint stemming from problems at a large manufacturing plant in Puerto Rico where Paxil, Avandia, Tagamet and other best selling drugs were made. The New York Times reported that the plant was “rife with contamination” for years.

(I don’t know about you, but if this is what we get with careful oversight and regulation, this is making me yearn for LESS of both for supplements.)

Pfizer, Johnson & Johnson, GlaxoSmithKline — these three international drug giants are now joined by Novartis.

Just a few days ago, Novartis recalled several lots of Excedrin, Bufferin, Gas-X, and NoDoz due to possible contamination with other Novartis drugs, such as the powerful painkiller Percocet. The Nebraska plant where these drugs are made has been shut down.

All of these offenses are bad enough. What’s worse is that in several of these cases FDA inspectors issued warnings that were initially ignored. And these are just the incidents we KNOW about. You can be pretty sure that other unchecked contamination horrors are going on out there this very minute.

You know, it’s ironic, but I’m starting to think the adverse side effects they mumble at the end of the commercials might actually end up being the safest things about these drugs!

Sources:
“Pfizer Cites Packaging Flaws in Birth-Control Pill Recall” Jonathan D. Rockoff and Jennifer Corbett Dooren, Wall St. Journal, 2/2/12, online.wsj.com

“Pill Mix-Up Means Excedrin Could Be a Lot Stronger Than You Think” Adam Martin, The Atlantic Wire, 1/9/12, theatlanticwire.com