Late August in New England is arguably my favorite time of the year. Although still summer, the triple H’s (heat, humidity, haze) are generally more tolerable, Cape traffic starts to wind down as kids go back to school, the Red Sox (as of late anyway) are in the hunt for a pennant, and most importantly the NFL regular season is right around the corner.
As a Philadelphia Eagles fan living in Boston, it is usually the only time of the year where I can A) say that the Eagles and Patriots are equal in the regular season standings (both 0-0!!!) and B) have a positive outlook on the rest of the season. I already have been heard saying things like, “I have a really good feeling about Chip Kelly’s offense with Nick Foles as QB”, and really crazy and contradictory things like, “I definitely think Vick will make it through a whole season without getting injured this year”.
Brady-envy and overly positive attitudes/blind insanity aside, NFL Football is undeniably America’s most popular sport. As such, I figured I’d piggy-back on some of that popularity to promote patient safety, and hopefully give some insight into the current drug safety landscape.
Lesson 1: Preseason is just practice. Preseason football consists of 4 games that are played at a much slower speed than the regular season. The games are designed to help coaches and other front office personnel evaluate a team’s strengths and weaknesses, and plan for when it counts. It is a generally accepted rule that preseason performance does not equate to regular season success. Take my Eagles last season as an example. They won every preseason game and then went on to a 4-12 record in the regular season. Real game situations cannot be simulated and until the season starts and real information and stats can be provided, a true evaluation of a team cannot be made.
In the world of drug safety, clinical trials are the equivalent to preseason football. They are important and necessary to ensure drugs are deemed to be reasonably safe and effective prior to being approved and introduced into the post-marketing world; the drug safety equivalent to the “regular season”.
However, unlike the NFL, decisions are being made every day by healthcare professionals based solely on information obtained from clinical trials because they do not have access to the regular season data.
Drug safety needs to put more emphasis on real-world safety signals.
Lesson 2: Great college players can be busts in the pros. First round draft picks in the NFL are always exciting to watch. Based on star performances in college, they are expected to come into the NFL and immediately make a positive impact on the teams that have spent millions of dollars for them to play. There are many instances where this is the case. Robert Griffin III (RGIII) and Andrew Luck, both rookies last year, added to their impressive college resumes with fantastic seasons. However, there are also many others that are considered busts. Looking back, a few names that come to mind are Ryan Leaf, Matt Leinart (and most other USC QB’s), JaMarcus Russell, Todd Marinovich, Tim Couch… I could keep going, but you get the idea. No matter how good a player looks prior to playing in the NFL, it’s not until they face real-world, game situations that they can be effectively measured.
Drug safety should be no different. No matter how safe a drug looks in a relatively small, homogeneous population of people, it can’t be effectively evaluated without seeing its performance in the real world. However, the reality is that due to a lack of information and tools, health plans are constructing formularies and health systems are prescribing drugs based on “college” performances, without taking into account post-marketing safety.
Imagine being prescribed JaMarcus Russell over Peyton Manning in 2009 based on Russell’s amazing year at LSU in 2006!
Lesson 3: A good head coach sets his players up for success. I’m going to talk about Bill Belichick despite my bitterness over the Super Bowl XXXIX. Throwing my almost decade long disgust aside, Bill is a fantastic coach for many reasons. One of the attributes I admire most is his ability to win games with otherwise unremarkable players. Aside from a few big names like Brady, the Super Bowl squad consisted of rookies and non-star players such as David Given, David Patten, Daniel Graham, Randall Gay, and Earthwind Moreland to name a few.
With a patchwork secondary and an injured receiving core, Belichick was able to use his knowledge of the game, along with the most current stats and data available, to call plays with a high probability of obtaining the best outcome, for the group of players he had. By pushing these plays from the top down, he was able to win, and build a dynasty in New England.
For a pervasive focus on drug safety, a Belichick-esque role needs to be played by Health Plans and Payers who are constructing drug formularies. Using all of the data, including post-marketing safety information, Health Plans and Payers can make sure they are “calling the right plays” and optimizing the formulary to drive safe prescribing behavior.
Lesson 4: Quarterbacks call an audible based on current information. I love watching Peyton Manning play quarterback. It always seems as though he knows exactly what is going on with the defense and has the ability to quickly adjust the offense accordingly, regardless of what play was initially called by his coaches.
He also has a Buick Verano commercial which highlights his signal calling skills.
Peyton Manning is a professional football quarterback. Both in his football play and in his Buick, he is expected to quickly interpret information and put it into action. He has worked hard to be where he is and has access to all of the data necessary to make appropriate decisions.
Doctors also have worked very hard to be where they are, and are skilled at interpreting information and making quick decisions. However, they do not have access to all of the information. Post-marketing safety data remains under virtual lock and key at the FDA. As I wrote in a previous post, Evidence Based Medicine without Access to All of the Evidence, prescription decisions are being made without all of the data.
Doctors do not have all of the information they need to call an audible and prescribe safer medications.
Lesson 5: Offense wins games, defense wins championships. Cliché? Yes. True? Not really. In a Freakonomics post back in early 2012 by the authors of Scorecasting, they say that when it comes to winning a title, offense and defense carry nearly identical weight. So why does this cliché continue to be perpetuated? They offer that no one needs to “talk up the virtues of scoring”. Everyone knows that you need an offense to score points and it is typically those point scorers that get put in the spotlight and take on endorsement deals. It is the defense that needs to get psyched up and supported by coaches, fans, and the media to incentivize them to keep the ball out of their own end zone.
We go on the offensive to cure diseases with powerful drugs. When those diseases are cured, or even controlled, those drugs get the spotlight, or keeping with the NFL theme make Sportscenter’s Top 10 Plays. However, we need more coaches, people in the crowd, and media yelling “De-fense, De-fense”, ensuring that all of the safety information possible is in the hands of those making prescribing decisions.
The Super Bowl in this case is patient safety, and we need defense to win.
Related Read: Moneyball for Drug Safety
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Executive Vice President