Friday, November 23, 2012
The FDA & the Board of Pharmacy Failed Us
November 22, 2012 in Editorial, The Soapbox
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.
Source found here