Wednesday, November 14, 2012

How & Why The FDA Harms the USA

Wheee... another general goes down for his partying ways.  Yes there is more to this than meets the eye, and we'll probably find out there was a slow moving military coup underway and President Obama masterfully saved the Union from a military takeover, or whatever.  But let's go on to important things.

We need to eliminate the FDA immediately.  They failed miserably again in their work, and as is always the case with Federal Agencies, when they fail to do their job, they ask for more power and budget.

11:45AM EST November 14. 2012 - The country's top medical regulator is preparing to tell Congress that laws are needed to police large specialty pharmacies like the one at the center of a deadly meningitis outbreak.

Really?  The FDA has been responded lackadaisically to complaints about this place for a decade.  They have known all along about the lethal threat clear and present. 32 people died because the FDA does not do its job.


Less than a year after it opened its doors in 1998, complaints about the New England Compounding Center began coming to the Massachusetts board that had granted it a license.
Complaints came from regulators, pharmacists and physicians from more than a half dozen states. Many were serious and warned of death or serious injury.

The media is reporting that there is a "regulation gap" and this is just a case that fell between the cracks.  Absolute lies.

The complaints, meanwhile, continued to come in to the FDA and the Massachusetts board. Many charged that New England Compounding was marketing and distributing drugs without patient-specific prescriptions as required by state and federal law.

So as usual, like in the financial industry, the regulators are owned by the regulated.  People have to die, family savings have to be destroyed, before anyone quits surfing the net for porn and begins to do his job.  Read the articles.  The FDA was regulating the place.  And inspecting.

A New York hospital complained that two patients contracted meningitis-like symptoms after treatment with NECC's injections. The two, who did recover, had been injected in 2002 with the same drug blamed for the current outbreak.

Hey who cares?  Same problem for a decade.  We work for the government and there are no circumstances in which we can ever lose our jobs, our pensions, our partay lifestyles.  Maybe generals, but not us.  How do we respond to dead people because of our failure to act?  Ask for more money and power!

So what happened when the FDA and the State regulators a decade ago were looking intently at this clear and present danger?


The board made clear in the letter that if the company turned down the consent agreement, the state would open formal disciplinary hearings. The agreement would have placed the company on probation for three years and included a formal reprimand...
But the threat to hold formal disciplinary hearings inexplicably evaporated, according to the report.

How come?  Someone got paid to make the investigation go away. Well, maybe it was who owned the company making the drugs, the next door neighbors.

Federal officials also drew attention to the company’s proximity to a recycling plant where excavators and freight trucks heaped old mattresses, plastics and other materials, generating large amounts of dust. The plant, which is owned by one of the same people as the pharmacy, has not always complied with regulations and has drawn complaints, according to records in Framingham, Mass., where the company is located.

Recycling and drug making.  Nice combination of talents.  With Romneycare, when it comes to medicine, who cares? And again, of course, there is this:

And as the death toll continues to rise, the F.D.A.’s commissioner, Dr. Margaret Hamburg, who was appointed by President Obama, has stayed mostly silent.

No kidding!  Politics as usual.  Tag 'em and drag 'em.  We'll deal with people dropping dead after the election. But here is where the real problem lies:


At Children’s National Medical Center in Washington, the hospital’s own pharmacy is compounding medications it used to buy from New England Compounding. The hospital trusted the company, said Dr. Gerard Martin, senior vice president, because it believed that federal and state regulators were making sure its products were safe.
“You believe that when a company is being regulated, they’re following good practices,” Dr. Martin said.

And there is exactly the problem, Dr. Martin is not doubt a fine doctor, but otherwise he is an idiot.  How can an agency the size of the FDA watch everything?  It is statistically impossible.  And if he is unaware the FDA is owned by such firms as new England Compounding, then he is probably too obtuse to be on the decision end of a stethoscope.  Even if anyone at the FDA desired to do their job, there simply is not the budget to do so.  As I have worked out elsewhere, to do so would require a budget of some 200 trillion per year to meet their mandate.  I suppose "impossible" and "uninterested" go hand in hand.

So is it impossible to have safe drugs?  No, it is just impossible to depend on an FDA.  In a free market, first, doctors as obtuse as Dr. Martin would not have patients.  We would have different people become doctors. Second, scientists would be attracted to the field of medicine, and as such they would make sure their supply chains were only the best.  Right now we live in a fantasy world where regulators assure quality and everyone is safe.  Serious scientists do not want to work in fantasy worlds.

"Regulation" is natural in a market, and the cost is borne by the patient, not the taxpayer.  It is extremely efficient, so the price to the patient is negligible, but the efficicacy of the supervision is near-perfect.   It is only when there is an FDA can those who could care less about customers get away with negligent homicide.

Do you really think this is the only such drug maker in USA?  Another reason we import is to make sure our quality is superior than what can be had in USA.

When we did the impossible and deregulated telecommunications we got an explosion of economic benefits.  It is time to unregulate medicine, and let a renaissance in health care bloom.  We'd get more, better, cheaper,  faster in all things medicine.  Our economy will grow out of our problems.  But no.  People want to pretend they can get the government to "fight their battles for them" instead of taking responsibility for themselves.

Bu there is a market for good medicine.  There is the opportunity.

Feel free to forward this by email to three of your friends.


0 comments: