- “There is nothing either good or bad, but thinking makes it so.”
- William Shakespeare, Hamlet
Posted: July 30th, 2014
Shakespeare may have been thinking more of the innate nature of things when he penned this particular sentiment; but in the world of clinical trials, “attitude,” or merely what a patients thinks about a treatment can have a serious impact on how that treatment works, or doesn’t.
- “…FDA has demonstrated its commitment to supporting access to experimental therapies for patients living with serious diseases. The agency is an important part of the process, helping to ensure that patients are protected from potentially harmful drugs or one that doesn't work. Allowing access to investigational therapies requires the cooperation of others, including drug companies and doctors, not just FDA. In cases where a company has initially denied access, FDA has stepped in to help. FDA is proud of its record facilitating access to safe, effective therapies for patients who need them as quickly as possible.”
- Margaret Hamburg: Commissioner, U.S. FDA
Posted: June 6th, 2014
This is from the first written comment that Dr. Hamburg has made with respect to the Right to Try (RTT) bill, recently signed into law in Colorado, now making its way across the country. To those of you who follow this area, it may surprise you to know that Neuralstem agrees with Commissioner Hamburg; the FDA is an indispensable party in this process. Indeed the RTT bill relies heavily on their expertise and diligence. That is why the bill only applies to fatal diseases, and only to drugs or therapies that have passed an FDA-approved safety trial, and are still actively being developed under the FDA umbrella in further trials. Any drug that dropped out of this legislative “inclusion” criteria would no longer be eligible for delivery under the legislation. At Neuralstem we are involved in developing our cell therapies all over the world, and I can attest to the fact that the FDA’s science and processes are considered the gold standard. Again, this is exactly why this important safeguard is incorporated into the RTT bill.
- "Most men would rather deny a hard truth than face it"
- George R.R. Martin, Game of Thrones
Posted: May 27th, 2014
Washington is roiling this week with calls for the resignation of General Shinseki, the Secretary of the Veterans Affairs, amid new allegations that VA facilities covered up long patient wait times for veterans. It will be a national disgrace if General Shinseki is forced to resign, and would only provide further proof that our society would rather deny hard truths than face them. In many ways the dispute over treatment options for veterans is too little too late. The search for scapegoats has, as it almost always does, led us away from looking at the real causes of year-long wait times for appointments and years-long appeals.
- “I've learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.”
- Maya Angelou
Posted: April 15th, 2014
When Ted Harada started blogging about his experience in our Phase I ALS trial, his remarkable improvement lent early hope to an entire population of patients and caregivers. Several months ago, a patient in our Phase II trial named April started blogging about her experiences. Both of these patients started on their public journey well before their surgery, and before they had any idea of how they would do. Their sole concern was to share their experiences with their community. It takes an amazing amount of courage to share the terror and pain of a diagnosis like ALS, and as they began to understand that they were improving, to share their joy and even private feelings of guilt combined with their hopes and fears in even greater detail and depth. No one knows better than they, what hope can do for members of this community.
- “Every man gotta right to decide his own destiny”
- Bob Marley
Posted: December 3rd, 2013
The “Right to Try” bill is making its way through the (now infamous) Arizona State Legislature. The basic premise of the Bill is that patients with fatal and incurable diseases should be able to choose for themselves whether or not to try an experimental drug. The Bill’s authors state that they should not be constrained by the FDA’s approval process.