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The FDA & the Board of Pharmacy Failed Us

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This sad story just won't go away because the numbers just keep climbing. At the time of this writing almost 500 people have been sickened by contaminated shots of the steroid methylprednisolone. Over 30 have died. It is a black mark on American medicine and regulatory authorities at both the state and federal level.

What is particularly scary these days is the ongoing outbreak of fungal infections. At first we thought the problem was restricted to back injections into the spinal column. We hoped the tragedy would end within several weeks.

Now we are learning that at least a dozen people have reported infections in their joints where they too got steroid shots. That means a huge number (up to 14,000) of those who got injections in their hips, shoulders, knees and elbows may also be at risk of developing this slow-growing fungal infection. The fungus could have been smoldering for weeks and is just now beginning to get a foothold. Patients are reporting redness, swelling, inflammation and abscesses at the general area of the injection.

What is particularly tragic is that the FDA apparently knew something was wrong for nearly a decade. In April, 2002 the feds became aware of complaints of symptoms after two patients received steroid injections made by the Massachusetts compounding pharmacy. In March of that year an inspection revealed compounding problems at the company, but as far as we can tell the FDA did not take any action.

The feds seemed slow to react and eventually passed the buck to the Massachusetts Board of Pharmacy. An FDA official noted at the time that there was a "potential for serious public health consequences if N.E.C.C's compounding practices, in particular those relating to sterile products, are not improved." Truer words were never spoken, but neither the FDA nor the pharmacy board cracked down on the unsafe practices.

The bottom line seems to be that this company fell through the regulatory cracks. Because doctors' offices, clinics and hospitals were looking for less expensive generic methylprednisolone, there was a big business opportunity all around the country. Although the brand name Depo-Medrol (made by Pfizer) was widely available, it did cost more than the generic methylprednisolone acetate compounded in the Massachusetts "pharmacy." It has been estimated that 75 medical facilities received some of the 17,000 suspect steroid vials in 19 states. Here is a link to the clinics and surgical centers that received vials of potentially contaminated medicine.

What most people have not realized is that both N.E.C.C. and its sister facility Ameridose were supplying clinics and hospitals all around the country with a wide variety of medicines. There is now a growing shortage of the drugs these manufacturers supplied in many hospitals. No doubt other compounding pharmacies will try to fill the void and that is the crux of the problem. The FDA does not even know how many such drug manufacturing facilities exist or where they are located. The state boards of pharmacy that are charged with regulating these so-called pharmacies seem incapable of inspecting and policing all of these organizations the way the FDA would monitor a drug manufacturing plant.

What's a patient to do? Ask your doctor, surgeon and anesthesiologist where they get the medicine they are going to put in your body. They probably won't know, but they can check. Make sure it is made by an actual pharmaceutical manufacturer rather than a compounding pharmacy. That way there should be some reassurance that the FDA actually inspected the plant.

Compounding pharmacies are great for making one prescription for one patient. They should not be formulating thousands of products for shipment to unknown patients in clinics or hospitals across the country. It's past time for the FDA and the boards of pharmacy to live up to their responsibility to protect the American public from companies that may be taking short cuts with quality.

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9 Comments

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Maybe you should now publish a book titled "Top Screwups Pharmacists Make."

PEOPLE'S PHARMACY RESPONSE:

Dear JNM,

Funny that you should mention that. Were you to look at the table of contents of Top Screwups Doctors Make and How to Avoid Them you would find the following:

Chapter 6 Top 10 Screwups Doctors Make When Prescribing
Chapter 7 Drug Interactions Can Be Deadly
Chapter 8 Top 10 Screwups Pharmacists Make
Chapter 9 Generic Drug Screwups

So...we have dealt with your point about pharmacy screwups! Check it out and let us know what you think.

In addition, it was MA governor Mitt Romney who was in charge the first time this pharmacy came under fire.

As a woman who has long trusted her bio-identically compounded [customized] thyroid formulation and with a husband who has received the Depo Medrol injection for severe back pain, I have been following this tragic story very closely.

Thus, although this is not the first I've seen that illuminates the glaring lack of officious oversight, I want to sincerely thank The People's Pharmacy for specifically pointing out that "compounding pharmacies are great for making one prescription for one patient" so as not to denigrate ALL compounding pharmacies. In other words, compared to what the corporate pharmaceuticals produce with their synthetic chemicals [which don't work for me] these customizing specialists do have a meaningful and long-term-safe place in the market, in spite of the 'bad apple' we now know in N. E. C. C.

My heart goes out to all who have been so tragically harmed.

Good info thanks

Individually compounded prescriptions prescribed by physicians-filled by registered pharmacists are frequently used-and may often be a great help for the pediatric patient, the geriatric patient and those unable to take standardized doses of medication. There are many reputable and capable pharmacists who perform these com poundings with skill and competence. These are usually recommended on an individual basis but there should not be"compounding factories" done on mass scales usually put together by techs with minimum oversight of registered pharmacists. This is where the problem has arisen (in my mind it is a system gone awry perpetuated by greedy individuals). These types of operations should be outlawed!

There is a strong political element to this sad story, which continues to grow. It is a particularly egregious example of what can happen when regulation of manufacturing in general, and things people ingest in particular, lacks proper regulatory oversight.

As related briefly in the copy/paste excerpt below, the MA Board of Pharmacy agreed to the NECC lawyer's request not to discipline the company for what was documented evidence of continued problems with that company. Following the withdrawal of disciplinary action, this business was, incredibly, allowed to "self-regulate." Another example of the consequence of lax oversight would be the BP Gulf oil platform explosion. Those who would favor “getting regulation off the backs of business” need to make a stronger case.

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from US Today, 10/26/12 http://www.usatoday.com/story/news/nation/2012/10/26/meningitis-outbreak-compounding-center/1660503/
New England Compounding did face an investigation from the state pharmacy board in 2004, and under a staff recommendation would have faced three years of probation and an official reprimand. But the board in early 2006 overruled the staff, approving a consent agreement under which the firm was placed on probation for a year but the probation was immediately stayed. The action followed a plea from Cirel, the company attorney, that the probation would have placed an undue financial burden on the firm and would trigger punitive action in other states where the firm was licensed.

"The collateral consequences to many if not all of NECC's other licenses in 42 states would be potentially fatal to the business," Cirel wrote.

State officials agreed not to report the reduced action to regulators in other states.
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see also - http://www.salon.com/2012/10/30/romneys_lax_regulation_fueled_meningitis_outbreak/?source=newsletter
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I'm still not understanding this. What was contaminated, the ingredients, vials, pharmacy tools, or what? Has that been determined yet? Can someone tell me where to find those details? It could mean other products of theirs are contaminated also, which I think the People's Pharmacy should discuss.

Lack of enforcement indicates that for some reason our government watchdog agencies, whether federal or state, are not interested in promoting consumer protection when it comes to the pharmaceutical industry, whether the company is small or large. I don't think that means compounding pharmacies are bad. There is a clear distinction between what a compounding facility should be doing vs what this one was doing with this particular product. The use of waivers made available and condoned by those who obviously have a conflict of interest in that they all benefit in some way from lack of enforcement means the underlying problem is in the system and like any other industry, it comes from the fox guarding the henhouse.

But still, what is the original source of the contamination? Has it been determined, contained, isolated?

I received an injection in my left knee several months ago. Within a month I had scab-like sores [15 - 20] on that leg*, with large cores of a thick white material. Until I could remove that core & get a dark sliver out of the site they recurred. *Eventually I had a few sores in other locations on my body.

I realized a few weeks ago that my injection of methyl... might have caused this weird outbreak and will ascertain w/ my ortho MD the source of the methyl... used.
I WILL write back to correlate my body's reaction w/ the outbreak.

Lack of enforcement indicates that for some reason our government watchdog agencies, whether federal or state, are not interested in promoting consumer protection when it comes to the pharmaceutical industry,

It also indicates we don't care enough to make it happen; we don't want to pay taxes high enough to make it happen, and we want new drugs on the market as soon as the popular press suggests that they will make any difference at all.

The FDA has a complicated mandate.

As Lincoln said about a different matter, "Not all prayers could be answered."

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