‘Locked-In’ to Their Decisions: Investigating How the States Govern Revocation of Advance Directives and How Three States Make Revocation Impossible for People with Locked-In Syndrome

The statutes governing revocation of advance directives in Colorado, Maryland, and Tennessee discriminate against locked-in patients and must be changed.  If those statutes are not changed, a person with locked-in syndrome in one of those states may not be able to legally revoke her advance directive, even if the directive ordered removal of life support.  While locked-in syndrome is a rare condition, advances in medical science are promising to make its diagnosis somewhat less uncommon in the future.  Coupled with developments in technology that aid in communication with people who have lost the ability to speak, write, or communicate by any traditional method, the more accurate diagnostic procedures bring to light a class of people who can and should be making important health care decisions, but are now hindered only by the law.  Colorado, Maryland, and Tennessee should change their laws governing revocation of advance directives before the scenarios described in this paper become a real life-or-death situation for a real person.

by Peter C. Harman*

Continue reading

A Pathway to Follow-On Biologics

Biologics are rapidly growing in importance in the medical world.  The ability of biopharmaceutical drugs to replace natural proteins produced by the body make them invaluable as therapy regimens to target major disease including cancer, infectious agents, and a variety of other health conditions  Consideration of the current drug approval system (the Hatch-Waxman Act) and the available options for a regulatory pathway for generic biologics (Waxman’s and Eshoo’s Bills) reveals that the bills currently pending before Congress still need revision.  Specifically, considering the importance of biologics as a growing field of medicine that treats many medical ailments, Congress should ensure an abbreviated approval process for follow-on biologics.  An abbreviated process with a mandatory one year clinical testing period that requires a follow-on biologic to be the same as its reference biologic would be the best option to address the issues currently facing biologics.

by Jeanne Yang*

Continue reading