11/29/2012 06:50 pm ET Updated Jan 29, 2013

Lessons From Meningitis


The recent outbreak of fungal meningitis, which has resulted in a steadily increasing number of deaths (36 as of Nov. 26, 2012), crystalizes the importance of vigilant regulation of the pharmaceutical industry and affirms the need for swift correctional mechanisms in the case of tainted medicines.

The Centers for Disease Control and Prevention, in collaboration with state health departments, have also identified more than 490 cases of fungal meningitis in 19 states that are directly attributable to a contaminated injection of an acute back pain steroid. They estimate that 14,000 patients have been treated with the faulty methylprednisolone acetate manufactured by the New England Compounding Center in Framingham, Mass., and that 97 percent of them have been contacted for a follow up.

Though it is unclear how the fungus contaminated the vials, it is clear that rapid response is necessary to contain and treat any outbreak. This case study provides excellent framing for the discussion in the regulatory and medical community about the need for strong pharmacovigilance, naming, and track and trace systems for drugs. These processes make it possible for regulators to identify which drug -- or even drug lot -- has a problem, know immediately patients who have received it, and begin contacting and treating them.

Currently, the U.S. Food and Drug Administration (FDA) is developing a regulatory pathway for a new type of medicine here in the country called biosimilars. Biosimilars are follow-on products of biologic medicines. In recent years, biologics have been the rising stars of the pharmaceutical community and are used to treat autoimmune diseases, cancers, diabetes, and arthritis. Unlike chemically-synthesized drugs like methylprednisolone acetate, biologics are enormous molecules comprised of living starting materials. Each pharmaceutical company uses a different set of unique starter materials, which makes the introduction of a biosimilar much trickier than a generic version of a chemically-synthesized drug.

The FDA released preliminary draft guidance earlier this year after consulting with relevant stakeholders. In the wake of a contaminated drug scare, further measures should be considered to guarantee the safety of biosimilars.

Biotechnology is extraordinarily temperamental and easily influenced by outside factors. One small equipment change could result in a radically different biologic, which could have a negative impact on a patient's immune system. To that end, the pathway must include unique labels for each approved biosimilar to promote strong pharmacovigilance. Labels help doctors and pharmacists distinguish between medicines and will allow a doctor to easily recognize if his or her patient has been given a biologic or biosimilar. If a patient is exhibiting adverse reactions to a treatment, it will be crucial that a doctor identifies the medicine promptly and notifies the pharmaceutical producer.

Finally, a vigilant track-and-trace system must be prepared in order to prevent future outbreaks like the fungal meningitis scare. Pharmaceutical companies must be able to find the production location of a strain of biosimilars and promptly shut it down. Malfunctioning medicines should be caught and removed from the market in a timely manner.

It is terrible when a medicine, designed to do good, fails. We must learn from this misfortune and apply stringent regulations to the new biosimilar pathway to promote safety. Though additional regulations might appear onerous today, they will help prevent future outbreaks in the future.

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