Saturday, October 20, 2012

Health Care

Critics call for more FDA oversight of compounding drug producers in the wake of the meningitis outbreak. I'm skeptical. This sounds like a government non-solution to a problem created by government, but I don't know how government created this problem yet. The hint in the article is here:
"Medicare's defenders say the agency may be reluctant to act for a number of reasons. Cutting off compounding pharmacies could aggravate drug shortages. Also it could open Medicare to a political counterattack from industry, even charges of rationing."
So these companies are filling a need that is not filled by Big Pharma.

Judge Napolitano blames the meningitis outbreak on too much regulation.
"It is well known that the state of Masachusetts is the most highly-regulated state in the union, with the government that is most in your face. It has a government that is physically present at the plants of the people and entities that they regulate…I don’t know if they have a person physically present in this facility, but they have the right to do so. So it is obvious that the state cannot keep its people — and others, when [the shots were] shipped outside the state — safe."
"The alternative is to have insurance companies do the regulating because they would be on the hook.Hear me out. When someone is injured because the state drops the ball, the state can’t be sued. when someone is injured because an insurance company drops the ball, the insurance company can be sued. So you darn well believe that they are going to be certain that every batch of chemicals that is mixed in that facility is safe because if it is not, they are going to pay for it."
That's a fine argument, but I bet there's more to it. I bet there was corruption involved.
"The thousands of pharmacies across the country that practice compounding, a method of remixing medicines to cut down on prescription costs, are currently outside of the FDA’s regulatory power. If the FDA had the authority to oversee compounding pharmacies, the agency could ensure that compounded products — like the contaminated steroid shots that were produced in Massachusetts and shipped to over 20 states — adhered to the same safety guidelines they uphold for drug manufacturers’ products. But the pharmaceutical industry has resisted further regulation, even as health advocates have called for increased FDA oversight into a sector of the drug industry they say is ripe for a public health disaster."
FDA regulation is no better than state regulation. Look how deadly Big Pharma has been. Also, heavy regulation drives up the price of drugs. The compounding pharmacy business came into existence to produce lower priced drugs. That's how government created this problem. I still bet there's actual corruption involved.

It looks like the company broke state law.
"Health authorities haven't yet said how they think the medication was contaminated, but they have ruled out other suspects - other products used in administering the shots - and the focus continues to be on that pharmacy, the New England Compounding Center.
Compounding pharmacies traditionally supply products that aren't commercially available, unlike the steroid at issue in the outbreak. And Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said it appears the company violated state law governing those pharmacies, which aren't supposed to do large-scale production like a drug manufacturer. Instead, they're supposed to produce medication for patient-specific prescriptions, she said."
So the problem isn't a lack of regulations. The problem is the regulations failed. I still bet the regulator was corrupt.
"The fungus is difficult to grow in lab analyses, and health officials on Thursday issued an unusual piece of advice to doctors: If a patient who got the injection starts to develop meningitis symptoms, he or she should be treated, even if testing is negative for the fungus."
"Health officials are hurriedly trying to determine the best way to treat this kind of an illness, and have settled on two very strong anti-fungal medications. Consulting with experts, they're making a best guess as to the dosage and length of time patients will have to be treated."
That doesn't sound promising.

Here are more examples of regulatory failure.
"Officials at the Massachusetts Department of Public Health said NECC was in violation of its license and noted that the company's shipments to other states "bears looking at at a federal level."
Yet the company did not conceal the fact that it was shipping nationwide. The company's website claimed the business was licensed in all 50 states."
"A current employee posted on his online resume that NECC adhered to "USP 797" which is the safety and sterilization standard set by the United States Pharmacopeia that sets standards for pharmacies. Massachusetts is one of 18 states that mandates the 797 standard, according to an expert who advises US Pharmacopeia.."
This just shows again that regulations don't protect us. They make us less safe.

People outside of the western world don't need health insurance because they can buy great health care super cheap.
"The whole experience is also very private. I use an assumed name at the hospital. I’ve never given them any ID. And obviously there’s no insurance company or government agency demanding my records."
That would be awesome.

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