In 2010 the US Drug Authority (the FDA) chose to deny a request from Cephalon Pharmaceuticals to have Nuvigil labeled as a prescriptive cure for jet lag. The practice, commonly known as an off-label prescribing, had been in consideration for approximately three months.
Having been refused off-label status due to questions raised over the PGI-S data (Patient Global Impression of Severity), Cephalon responded saying it would schedule a meeting with the FDA to resolve the matter in the near future. The meeting didn’t go Cephalon’s way. In this instance it would seem reason prevailed. Taking an inconvenience such as jet lag and turning it into a treatable illness is not a recipe for success unless you are a drug company. Commonsense won the argument this time, but the question is, for how long?
How long before other drug companies try to exploit the need for a cure for jet lag with other drugs. How long before they turn a genuine concern about healthy flying in a globalised economy into an all out frenzied feeding ground for revenue hungry drug companies? It is certain other pharmaceutical companies were watching this outcome with keen interest. No doubt they will be keeping an eye on Cephalon’s next move.
Drugging fliers first and asking questions later is not the answer. If the price of success for business travellers means being constantly drugged while executing the company’s business the prognosis is dire. What we need now more than ever is a responsible solution to jet lag that comes from the idea of healthy flying or at least a solution that doesn’t leave you with side effects that chronically undermine your health. When you consider that a greater percentage of flight diversions or in-flight emergencies are due to medical problems, the last thing you want to do is give every flier carte blanche to self medicate. Doing so would be a recipe for disasters waiting to happen. As things stand airlines incur additional fees and expenses for diversions and wouldn’t relish the extra burden of having to take on this additional responsibility.
A health centered solution is the only solution worth considering and it starts with seeing jet lag for what it really is. Jet lag brings about a unique set of circumstances not least the total alienation from the environment we live in at sea level. As science pushes forward to understand the inner workings of Man, the nature of our relationship and connection to the Earth is being understood in different ways. Some of which are useful to understanding how to fly better. For example the relatively new science of Chronobiology, which is the study of timing in biological systems, is shedding light on how circadian rhythms are disrupted when we fly. Taking research a step further the California Institute for Human Science (C.I.H.S) says research it conducted confirms the human being checks its reference to the Earth every 90 seconds – something you would definitely find hard to do at 36,000 ft! What does this data mean? I don’t have all the answers but it definitely points out the need to look at the challenge of jet lag with fresh eyes.
Pharmaceutical companies trying to peddle drugs to alleviate jet lag are playing the age-old game of tinkering with nature and getting less than satisfactory results. They understand details about the cause and condition without placing the detail in its proper context. Nuvigil, the drug under consideration was touted to be valid only for east bound travel (what fliers were supposed to do on their return journey is anybody’s guess!). As long as an approach sees Man and his functioning as a law unto himself, and not subject to the laws of nature, any solution will always fall short.
Getting to an equitable solution is neither the sole responsibility of the employer in its role of defining travel policy or the sole responsibility of the traveller. Both have to come together to address the issue anew. The difficulty may lie in the employers concern about potential cost while the flier’s priority may focus on performance and health. Without discussion and dialog about all of these perspectives it is harder to reach a consensus.
Given this brief reprieve a new debate about jet lag and healthy flying needs to take place before we expand the powers of Big Pharma to drug us for every little inconvenience that dares to cross our path. As the globalised world we live in gets more complex and uncertain this is a conversation sorely needed.
New York Times – Regulators Reject a Drug Makers Plan to Use it’s Alertness Pill to Overcome Jet Lag. http://www.nytimes.com/2010/03/30/business/3…
Washington Law Blog – Provigil and Nuvigil: FDA denies Jet Lag, FTC denies Lawsuit Drop, Cephalon appeals.http://www.phillipswebster.com/blog/2010/03/…
Fierce Pharma – FDA denies Cephalon’s bid for Nuvigil in Jet Lag. http://www.fiercepharma.com/story/fda-denies…