Scant Oversight of Drug Maker in Fatal Meningitis Outbreak

[xchrom]

http://www.nytimes.com/2012/10/07/us/scant-drug-maker-oversight-in-meningitis-outbreak.html?ref=health

Eddie C. Lovelace, a Kentucky judge still on the bench into his late 70s, had a penchant for reciting Shakespeare from memory and telling funny stories in his big, booming voice. But a car accident last spring left him with severe neck pain, and in July and August he sought spinal injections with a steroid medicine for relief.


Instead, Judge Lovelace died in Nashville in September at age 78, one of the first victims in a growing national outbreak of meningitis caused by the very medicine that was supposed to help him. Health officials say they believe it was contaminated with a fungus.

The rising toll — 7 dead, 57 ill and thousands potentially exposed — has cast a harsh light on the loose regulations that legal experts say allowed a company to sell 17,676 vials of an unsafe drug to pain clinics in 23 states. Federal health officials said Friday that all patients injected with the steroid drug made by that company, the New England Compounding Center in Framingham, Mass., which has a troubled history, needed to be tracked down immediately and informed of the danger.

“This wasn’t some obscure procedure being done in some obscure hospital,” said Tom Carroll, a close friend to the Lovelace family, and their lawyer. “They had sought out a respected neurosurgeon who had been referred by their family doctor, at a respected hospital,” he said, referring to the St. Thomas Outpatient Neurosurgery Center. “How does this happen?”

[no_hypocrisy]

1. Republicans want "loose regulations" if any at all.

Then they neuter the state AG's so they won't sue the corporations that made harmful products.

Then they have states change their laws to limit mass tort actions (products liability) by labeling them frivolous lawsuits.

Don't they realize that republicans die as often as democrats from these defective products?

[global1]

2. 17,676 Vials Is A Manufactured Lot Not A Compounded Prescription....

It seems clear to me by reading this NYT article that this New England Compounding Center was a manufacturing operation and not a small compounding pharmacy. A compounding pharmacy serves the public by making a custom dose of a medication for a specific patient.

A compounding pharmacy serves the public by making custom doses where the patient for some reason can't take a commercial medicine (i.e., can't swallow a tablet or capsule so they make it into a liquid format; the commercial product is unavailable and that life saving product is necessary for the patient; etc). There are countless examples of situations and needs for drugs on a one on one basis that are necessary and vital for the health and welfare of a patient.

One patient, one doctor, one compounded prescription. Compounding pharmacies serve small communities and are a necessary entity to the health care system.

In this case it appears that this New England Compounding Center was making large batches of a drug product and selling these batches all over the country - just like a major pharmaceutical manufacturer would do. The difference is that the major manufacturer has to go through an FDA approval process for that drug they are making. In this case they didn't go through that process and were trying to use the guise of a compounding pharmacy to skirt that process. In essence they were weaseling around the regulations to make a buck. They were competing with these small compounding pharmacies in the communities - perhaps even putting some of them out of business - just to make a buck.

Well a large batch of product can hurt a lot of people and this is what happened here. The FDA regulates manufacturers to prevent that from happening. Large manufacturers have recalls all the time because of this regulation and surveillance by the FDA. Large manufacturers have caused major outbreaks like this in the past. But using the guise of a compounding pharmacy to avoid regulation and surveillance by the FDA is wrong.

Be careful not to damn all compounding pharmacies because of the greed of large operations such as this one trying to work in the creases of the laws. We have to be careful now that a necessary part of the health care system - the compounding pharmacy - doesn't get caught up in this situation and is put out of business. There is no substitute for a good compounding pharmacy. Major manufacturers would like to see these small pharmacies put out of business - but they offer no suitable solution to the millions of people that need the services that are provided by small compounding pharmacies.

What needs to happen is that these large so-called pharmacy operations - that use the guise of a compounding pharmacy to skirt the regulation by the FDA need to be put out of existence. These are the pharmacy operations that should be focused on going forward and care needs to be taken that we don't throw the baby out with the bathwater by clamping down on all compounding pharmacies.

I'm sure there are people here on DU that use the necessary services of their local compounding pharmacy to serve their individual needs or members of their family's individual needs where no suitable alternative is made available by the large manufacturers. If you use a compounding pharmacy - tell your story here.

Remember folks that in the beginning all pharmacy was compounding pharmacy because there were no large pharmaceutical manufacturers. It is only when patented medicine was being made in large quantities that the FDA came into existence to avoid situations such as this one to not happen. The FDA came into existence to regulate and scrutinize these large operations. A lot of us lose sight of that fact - because we're not old enough to remember the way this all came about.

Again - large operations that are skirting the laws to make a buck like this one in question need to be stopped. Don't be fooled into thinking that all compounding pharmacies are at fault.

On edit: This is not a Democrat or Republican issue. This is an issue that effects all of us equally and is important for the public health of this country. Please don't try to politicize a situation like this. That would be wrong.

[Sgent]

3. I don't understand how this happened

the doctor's office I worked in and a local pharmacy that did the compounding got into trouble with the board of pharmacy for two practices -- both of which seem pretty innocuous.

1) The doctor stocked a compounded form of an anti-nausea drug which allowed to to be applied to the skin rather than oral or mucosal (suppository) absorption. She would give the drug to the patient and the patient was billed by the pharmacy in question. Insurance was never involved, as the pharmacy charged something like $10 for it. The board called this distribution and eventually the patients went back to needing suppositories or pills.

2) The doctor used a blistering agent for treatment of certain skin conditions -- it was dangerous to be handled by someone untrained, and to have at home / elsewhere. She applied it directly to the patient, and the agent isn't available mixed commercially. The pharmacy board wanted a new bottle created for every patient, but eventually backed down (a bottle would typically get thrown out yearly just "cause", but would still be 3/4 full after multiple treatments).