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John Galt Is Everywhere and His Killing Spree Continues

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On Thursday, I wrote about the central role that absolute free market libertarianism, as personified by the fictional John Galt, played in the horrific explosion in West, Texas that took the lives of fourteen people, most of whom were volunteer firefighters fighting a fire at an unregulated fertilizer facility. We have now learned that the facility had a checkered history of ignoring regulations and had 1350 times more ammonium nitrate on hand than the amount that triggers a legal requirement to report the facility to Department of Homeland Security. Of course, the facility’s owner chose to ignore that regulation along with the many other regulations he chose to ignore. Sadly, some press accounts of the owner chose to focus more on his role as a church elder (Update: he was even at Bible study when the fire broke out!) than on how his choice to flout regulations and good sense led directly to this tragedy. Whatever the cause of the original fire that eventually triggered the explosion, the plant owner’s decision to maintain such a large and unreported amount of highly explosive ammonium nitrate so close to so many people played a huge role in how this tragedy played out.

Those deaths, and their roots in blatant disregard for government regulation in the belief that it harms business, are sadly just a small part of the larger picture of how free marketeers have corrupted the public marketplace of ideas to sow widespread death and destruction so that the “job creators” can go about their usual business of pocketing massive profits while refusing to make microscopic investments in small steps that would save many lives.

Remember the other, larger Massachusetts tragedy that killed at least 50 and injured 722? No?  It was discovered last fall that New England Compounding Center in Framingham, Massachusetts had been flaunting the rules on drug manufacturing and in their haste to reap maximum profits shipped out vials of steroids contaminated with fungus. Thousands of patients around the country were injected with contaminated material and deaths and injuries followed.

You would think that since this tragedy played out last fall, the government would have realized the error of letting companies call themselves compounders when they are in reality manufacturing drugs on a large scale. Drug manufacturers are subject rigid FDA standards while compounders are regulated as if they are simple neighborhood pharmacies where the druggist might mix single vials of drugs into a form a local doctor has requested for individualized treatment of a patient. But no, because of massive lobbying on the part of compounders, who have become a huge presence because of the vast sums of money they can earn by working the margins of regulation, lawmakers pocket the proceeds of the lobbying and proclaim themselves powerless to harm the job creators as they bring these products to market. It should be viewed as no surprise then, that a different compounder, this time in Florida, now is recalling all of its products because it has been found to have been shipping product that was contaminated with bacteria. It is not yet known if any patients have been harmed by products from this compounder, but at least today’s article on the recall was able to update the death toll from the Massachusetts compounder to 53.

The Boston Marathon bombing and the subsequent search for the perpetrators also was touched by John Galt. Technology has existed for nearly 20 years that can make individual production lots of explosives traceable. But when it came time to implement the technology, the NRA and other gun enthusiasts managed to limit the inclusion of taggants to plastic explosives and to specifically exempt black powder (otherwise known as gunpowder) from being required to be traceable. The Boston bombs used black powder. If investigators had been able to know within hours of the blast where and when the black powder was purchased, would they have been able to arrest the bombers sooner and without the subsequent death of one police officer and near death of another? The full shutdown of Boston on Friday would not have happened if the brothers had been arrested Wednesday or Thursday through tracing the black powder they purchased. But no, John Galt said that gunpowder manufacturers shouldn’t have to spend the extra pennies to tag production lots and the inclusion of taggants in gunpowder infringes the rights of gun owners in a de facto registration of their ammunition, so society has to suffer the consequences of this freedom.

Oh and all that gun freedom. It appears that we have five more gun freedom victims in Seattle today.

John Galt is a very busy guy, sowing death and destruction from one side of the country to the other. But since he continues to make good money, we have to give him his freedom and keep those markets wide open. Praise the lord of the free market and pass the untagged ammunition.

Fourteen Dead and 170 Infected: Poor Regulation Built That

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The latest figures indicate that fourteen people have died and at least 170 have been sickened by fungal meningitis arising from an injectable form of the steroid drug methylprednisolone. The bulk of the cases have occurred from patients receiving spinal injections for back pain but there is now at least one documented case of an infection arising from injection of an ankle. At a time when Republicans running for office all across the country routinely deride “job killing regulations”, we now have a sadly perfect example of how lack of regulation kills people.

The tainted drug causing the infections in these cases comes from a single compounding pharmacy in Massacusetts. Compounding pharmacies exist in a regulatory gray area and have pushed further and further away from their original form due to an absence of regulatory push-back. The FDA strictly regulates the manufacturing of pharmaceuticals and assures that they are produced without risk of contaminating microorganisms that could cause infection upon use of the drug. However, compounding pharmacies are regulated only at the state level, mostly because their original role was to provide unique mixtures of drugs produced in response to prescriptions for individual patients. Sensing opportunity to operate in a regulatory gray area, “the free market” has moved in and compounding operations now openly flaunt the single patient idea. In the current case, CNN reports a CDC estimate that as many as 13,000 patients may have been injected with the tainted drug compounded by New England Compounding Center in Framingham, Massachusetts.

The CNN article describes that the regulatory gaps are well-known but Congress has refused to act:

If Sarah Sellers’ warnings had been taken seriously 10 years ago, 12 people might be alive today.

Sellers, a pharmacist and expert on the sterile compounding of drugs, testified to Congress in 2003 about non-sterile conditions she’d witnessed.

“Professional standards for sterile compounding have not been consistently applied,” she told the Senate Committee on Health, Education, Labor, and Pensions. “The absence of federal compounding regulations has created vulnerability in our gold standard system for pharmaceutical regulation.”

Nearly 10 years later, there are still no federal sterility guidelines for compounding pharmacies that make and distribute drugs all over the country.

Further, we see that the court system has acted to weaken the poor regulations that previously existed:

In the 1990s, FDA regulators began to more closely scrutinize the industry, as some compounding pharmacies grew into larger operations that resembled small pharmaceutical companies.

In 1997, Congress passed a law bringing compounded drugs under FDA oversight, requiring that they meet certain standards for production, labeling and advertising. Specifically, the law banned compounding pharmacies from advertising their products.

A 9th Circuit court ruled that this last requirement was unconstitutional, and the Supreme Court upheld the decision in 2002. The court did not rule on the other portions of the law, though the FDA has not actively enforced them.

We learn from USA Today that problems from compounding pharmacies lowering safety standards while chasing higher profits through high-volume compounding have led to many known cases of infections and other medical complications over the last ten years or so: Read more →