To date, finger-pointing rather than action has resulted from the widespread occurrence offungal meningitis due to human error in the United States this summer and fall. A fracas at Wednesday's hearing of the House Committee on Energy and Commerce demonstrated both the intensity and some of the longstanding controversies underlying the situation.
"Let's not lose sight of the wrongdoer as we go around blaming the regulators," Rep. Henry Waxman, D-Calif., said in reacting to this fall's meningitis crisis. "The regulators deserve blame, but the primary blame, in my mind, is the company."
In the search for culprits, pharmacies, drug manufacturers, physicians, the U.S. Food and Drug Administration, state pharmacy boards, loose interstate-federal relations, loopholes in the law, and Congress itself have taken the heat for the unprecedented infections that have sickened and killed hundreds of patients receiving epidural steroid injections of 80mg/ml preservative-free methylprednisolone acetate in the latter half of this year.
Blame it on the doctors
For once, it's not the doctors' fault. Physicians throughout a 23-state region where the tainted drugs were shipped by the New England Compounding Center had no idea what was going on with the medications they prescribed. The warning about contamination did not become widely known until the beginning of October. For constant, severe back pain unresponsive to other therapies, primary care physicians and specialists followed protocol. They prescribed suffering patients a shot containing the steroid. Usually, a physician assistant or nurse would administer the shot right at the office, and the patient would return to normal life in greater comfort. Standard Operating Procedure.
Only this time, many injected patients started feeling ill, usually after a couple of weeks to a month. (Fungal infections are rare and slow to develop.) When the symptoms seemed like only flu or the effects of a heavy night out, some patients sought the simplest solution: ignore the problem and put off seeking medical help. While a few sufferers felt no symptoms at all, many of those affected developed fever, headache, a stiff neck, nausea and vomiting, slurred speech, photophobia (sensitivity to light), and altered mental status. And some of them started to die.
Blame it on big government
The 1938 Food Drug and Cosmetic Act established the U.S. Food and Drug Administration with a very broad mandate:
"FDA [an agency within the federal Department of Health and Human Services] is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation."
The devil is in the details, however. Under the nation's current drug policies, only companies that make large quantities of a drug are considered "manufacturers" and subject to federal regulation. "Compounders," including NECC, have vigorously backed the distinction for years.
Specialty pharmacies like NECC traditionally respond to individual requests from health careproviders by making drugs to order: compounding small quantities of needed medication (usually formulations or dosages unavailable from the larger companies that mass-produce). The United States has no central data bank on licensed pharmacies.
Because they typically operate on a smaller scale and technically by request only, compounding pharmacies do not have to observe FDA's standards on "manufactured" pharmaceuticals, even if their products are sold nationwide, as NECC's steroids were. Compounding pharmacies are only regulated on a state-by-state basis by the states in which they produce drugs.
"Large-scale pharmacy compounding has greatly expanded since the early 1990s," say New York Times reporters covering the NECC case, "partly because hospitals are increasingly outsourcing the making of the compounded drugs that they need and also because of widespread shortages of medicines made by the big drug manufacturers."
A question basic to this situation is whether NECC should have been, or whether similar companies should be, considered a compounder or a manufacturer. “This is the worst and most tragic case [of a compounder causing iatrogenic illness] and should be the last,” said FDA commissioner Margaret Hamburg of the human-caused meningitis outbreak. “It should be a wake-up call that there is a gap in regulatory oversight. We really need strong, clear, and appropriate legislation." She also said that different rules in different states are not sufficient to handle situations like this one.
Some point to FDA lack of follow-up in similar cases and lay the blame on weak federal enforcement. Those who take FDA to task are often the same legislators who deny funding and/or regulatory teeth to the agency. The Department of Health and Human Services oversees the FDA. This month, HHS publicly noted the agency's limited powers over compounders and urged Congress to strengthen FDA's authority.
Blame it on the state pharmacy board
So if the FDA was not responsible for the tragedy, was it the Commonwealth of Massachusetts? Certainly the Commonwealth possessed regulatory authority to inspect and shut down any compounder doing business there.
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