Did Bad Government Policies Cause the Meningitis Outbreak?
In the past two weeks, 15 Americans have died of fungal meningitis and more than 200 have become infected from tainted steroid injections they received to treat problems with their spines…
Among the first policy issues that should be scrutinized is the Obama administration’s recent tightening of oversight of the manufacturing of generic versions of sterile injectable drugs. This tightening was rooted in some legitimate concerns that the Food and Drug Administration (FDA) had about the reliability of the manufacturing facilities. But it has prompted shortages of these drugs. In some cases, the shortages have forced doctors to seek these medicines from compounding pharmacies, which are less regulated than the generic drug firms. At the same time, the administration has created a contradictory set of policies that has diluted the regulatory authority required to ensure the safety of these compounded medicines.
The FDA is using regulation to penalize companies because of their pricing?
Meningitis vaccinations should be required, instead of blaming the president.
It’s unfortunate that people had to die for such a blatant example of policy and unintended consequences to be revealed.
I read about the fungal meningitis outbreak. It is very tragic when catastrophes like this occur. The particular fungus is so rare that most doctors will never encounter a case of it in the life of their practice. I would hate to see the FDA leap to the wrong conclusions and over-regulate compounding pharmacies, when most do not cause a problem. However, Dr. Gottlieb is correct that government regulations that resulted in a shortage of injectable medications is mostly to blame for this problem. But I doubt that the government will get sued like the compounding pharmacy.
I would say that blame for this is indirect. Is it possible that there was a better way to go about this? Maybe. Odds are this was a right choice, wrong time decision.
I think this is a stretch.
There is a shortage of drugs, which “forces” doctors to get their medicines from other less-regulated pharmacies, which in turn causes people to get more sick.
Bottom line: It’s better to give them perilous medicine than give them nothing at all, right?
can’t blame the gov for this one
The government cant regulate every risk away. Trying to do so creates more harm than good.
There were no reported shortages of Depo-medrol, the drug in question. However, if you want to go ahead and allow the pharma companies to put glass shavings in their drugs as a way of avoiding the use of compounded drugs, then make your case.
Steve
Some brain droppings:
1. There is no vaccine for fungal meningitis.
2. Fungal meningitis
2. The pathogenic fungus [fungi] will be genetically identified and traced back definitively to the source.
3. I’ve had patients who received FDA-regulated IV gamma-gloulin
My sympathy goes to all the families who have suffered as a direct result of the actions of the now defunct Framingham, Mass. New England Compounding Pharmacy.
Some brain droppings on this very important topic:
1. There is no vaccine for fungal meningitis.
2. Fungal meningitis is rare but virtually all physicians, who typically train for 7+ years after university, see fungal meningitis cases because so many severely immune-compromised are susceptible and require hospitalization.
3. Fungal allergy to non-pathogenic fungi, including allergic bronchopulmonary aspergillosis ABPA is common, and significantly underdiagnosed.
4. The pathogenic [human disease-causing]fungus / fungi in this recent catastrophe will be genetically identified and traced back definitively to the source(s). That is critical information as to really how something like this was even possible and prevented.
5. I’ve had patients, who received FDA-regulated IV gammaglobulin from Baxter Pharmaceuticals, who were infected with hepatitis C from the IV gammaglobulin. These catastrophic transmissions of pathogens in contaminated parenteral pharmaceuticals occur under BOTH state-regulated and federally-regulated prescription production.
6. When I was a pediatric resident, we had a cluster of healthy newborns who inexplicably developed seizures. The third largest baby formula manufacturer had failed to add chloride to specific lots. It turned out. . . something seemingly impossible to believe. . with that the same manufacturer had happened before – the same error with the same adverse outcomes ~ a decade earlier.
7. A Northern California physician’s patients got HIV from IV gammaglobulin injected in his office because his nurse, unbelievably, reused needles from other patients. There can be potential for contaminants and/or communicable disease at any point along the chain of custody.
My entire medical practice depends on my decades long relationship with a top community blood bank and my commitment to running my in-house lab with the highest degree of excellence. I produce a custom blood product for our severely-adversely impacted patients with catastrophic allergies and/or abnormal cell mediated immunity. There has never been any adverse consequence – no contaminant or communicable disease – and never will be because the blood product is properly prepared and rendered inert while remaining biologically active.
There are enormous ongoing threats TO ME & MY PATIENTS by bureaucrats and competitors in my profession who are dead set on taking power away from physicians and pharmacists and blood banks conferred by our State Medical Boards who approve and regulate practices like mine. This recent tragedy cannot and should not be used to destroy an important part of patient access to appropriate medical care – particularly for patients who are outliers.
Dorothy Calabrese MD
Allergy & Immunology, San Clemente, CA