• “To be or not to be”

Posted May 1, 2012

“To be or not to be”
- Hamlet

In this most famous of soliloquies, Hamlet broaches the dark subject of suicide.  Just last month, yet another retired NFL player, former Atlanta Falcons’ Ray Easterling, ended his own life; a life that seemed blessed with all the success and happiness our society bequeaths to our sports heroes.  There are now more than 1,000 ex-football players who have become plaintiffs in various lawsuits alleging irreparable damage from the constant battering of their brains.  The worst of these cases have led to depression, cognitive losses and, ultimately, suicide.  In 2011 Dave Duerson, an ex-Chicago Bear All Pro Safety, famously shot himself in the chest presumably to preserve his brain, which he asked be donated to the NFL’s brain bank for study.  His condition was known as chronic traumatic encaphalopothy, or CTE.  Common sense, of course, tells us that repeated head collisions are bad for you.  But just how bad is something we are only now discovering.

• “We love, we live
  We give what we can give
  And take what little we deserve”

Posted April 19, 2012

“We love, we live. We give what we can give. And take what little we deserve”
- Christine Daaé, “Love Never Dies"

If spring is the season of Passover and Easter, it is also the season of charitable events. Races and walks, golf tournaments and bike rides. Across the country people turn out to support causes like brain tumor research, breast cancer research, and of course ALS research. In the Washington, D.C. area many of these events have taken on almost a “reunion” personality. One such (truly) amazing Race is the Cassidy/Turley Race for Hope in Washington, D.C. on May 6th.

• “An invasion of armies can be resisted, but not an idea whose time has come.”

Posted April 2, 2012

“An invasion of armies can be resisted, but not an idea whose time has come.”
- Victor Hugo

The FDA has approved Neuralstem moving on to the cervical region injection phase of our ALS trial, and we have successfully transplanted two of the three patients in the initial cervical cohort, with the third scheduled for later this month. These first three patients in this cervical phase each received, or are scheduled to receive, five injections of neural stem cells in the upper spinal cord, or cervical, region. These segments ultimately control the breathing function. It is here that we believe we can really help ALS patients. It is here that we have the best chance of not only prolonging their lives, but also significantly improving the quality of their lives. Almost all ALS patients reach a stage where they need mechanical help to breath before they die. Our goal is to keep that from happening.

• “Never tell me the odds.”

Posted March 19, 2012

“Never tell me the odds.”
-Han Solo to C-3PO, Star Wars Episode V: The Empire Strikes Back

In his (always) readable and (often) insightful www.FDAMatters.com blog, Steve Grossman recently posed this question, “Why is drug discovery so Hard (and expensive)?  I am going to focus on the “expensive” side in this commentary.

Steve was commenting on a story in Forbes that confirmed and bemoaned the fact (that it IS so expensive). The article made the case that the real cost in the industry may be as high as several billion dollars per drug when one takes into account all of the drug failures.  The article focused on the preclinical drug development process and costs -- the ”front end” of discovery, not the clinical side of drug development.  We have all heard the industry figures for average clinical costs ($100 million per drug) and how tough the clinical trial side is (only one out of ten candidates that actually get to Phase III becomes a drug). These statistics have become an article of faith for those who defend the high costs of drugs.  Here, however, an additional focus was placed on the cost of preclinical development as a culprit.  And here the numbers dramatically increase into costs that begin with a “B.”

• “…Beware the Ides of March”

Posted March 14, 2012

“…Beware the Ides of March”
(Julius Caesar)

There have been neither comets in the skies, nor other natural portents of grave consequence that I have observed lately.  But a court in India issued a ruling recently which may have a seismic impact on the future of drug development worldwide.  India did not issue patents to drug makers at all for about 35 years, up until 2005.  It used this “hiatus” to become the world’s largest “generic” drug manufacturer, and exporter of cheap drugs to the undeveloped and emerging countries of the world, as well as to service its own enormous population.  In this case, a lower Indian court ruled that Bayer must license a cancer drug to an Indian manufacturer, and mandated a price basically one fifth of that which Bayer was charging.  This generic will be for use in India only, on paper.  But there is little doubt that it will make its way around the world in this form at this price.