Urolift-off. The rewards associated with Doctors working together with Engineers.

Since 2005, I have in my spare time, been working on a project that I was invited to join by a start up company called Neotract Inc which is based in the Bay area of San Francisco.  The company was initially made up of a small group of engineers who had a great idea of how a minimally invasive device could be created to treat male lower urinary tract symptoms (LUTS).  Over the years, minimally invasive devices to treat LUTS as a consequence of benign prostatic hyperplasia involved destroying prostate tissue whether it be by freezing, cooking, steaming, lasering or even microwaving. Whilst less invasive than procedures that physically removed prostate tissue at the time of surgery, these still required a period of recovery and there was often a delay in deriving full benefit due to the need for tissues to recover after destructive energy or one sort or another had been applied to the prostate. The idea was to use a mechanical implant that would pull open the prostate urethra. 

(Screenshot taken from www.neotract.com)

Through my involvement with Neotract, I was able to provide clinical input as well as being part of the clinical trials. This has lead to a number of publications that can easily be found by searching under my name and the search term either prostate or urolift.  This month, we have seen this technology finally achieved US FDA approval. I wrote a piece about the benefits of clinicians and engineers working together for the BJUI Blogs.  I was deeply moved to receive the following letter from Josh Makower, Chair of the Board of Neotract, Inc.  I felt compelled to share this letter (with permission) which was addressed to myself and my co-investigator Dr Peter Chin.

Dear Henry and Peter –

This morning I opened my email and found this...  http://www.bjuinternational.com/bjui-blog/urolift-takes-off-from-down-under-the-potential-rewards-when-engineers-bring-you-into-their-inner-circle/

I must say, Henry’s words brought a small tear to my eye.   After 9 years of amazing struggle against many obstacles, our small team of passionate dedicated people have finally made it through a most significant hurdle towards bringing this technology to patients in the US.  It’s a milestone that for many years seemed almost un-attainable and there were many dark days,.. but perseverance, trust and a vision held us together. 

Henry and Peter – you were the first.  There are always those who go first and history thankfully will mark them as innovators and leaders. You went where no one had gone before and gave us your time, your ideas and your talent towards a dream.  That dream is one step closer to being realized and we would not be here if it were not for the two of you.  When procedures and technologies become mainstream medicine, people often forget what it took to get there.  They  forget, or do not even know, how much a toll such a process takes on our relationships as we invest our lives in bringing something like this to fruition.  But for those of us who were all in the trenches together; for those of us who hunkered down, re-grouped, re-engaged, re-energized and stood up again to regain ground when all appeared lost, we will never forget you and never forget the team that brought us here.

On behalf of all us, Henry and Peter, thank you for your leadership and your partnership.  Henry – you articulated something special that must be shared – the partnership between engineers, entrepreneurs and physicians needed to advance medical technology is an essential one that we must never lose.  Without it, medical innovation would not happen.  Thank you for sharing your thoughts and putting them to paper in such a special way.  I hope thoughts like these help preserve that special balance of talents, interests and shared goals that truly have the power to change the world and make it a better place.

From all of us at ExploraMed and NeoTract, and for all the patients who will benefit from all our collective efforts – thank you.

Sincerely -

Josh

How to Make Yourself Unpopular With the Pharmaceutical Industry

There are two drugs used for prostate treatments where potentially huge cost savings could be achieved.  Such savings will work unfavorably for the drug companies responsible for these medications in a financial sense.

The first drug is dutasteride.  This has been shown to be useful in treating lower urinary tract symptoms due to benign growth of the prostate gland.  It is generally taken at a dose of 0.5mg daily.  What few people recognize is the fact that the drug has a particularly long half life, or in other words, the time that it takes for half of the drug to be cleared from the system.  The terminal elimination half life of dutasteride is approximately 5 weeks.  This does not mean that you could take one tablet every 5 weeks as it needs to be taken often enough to achieve what we call a steady state level in the blood stream.  On a daily dose, about 90% men achieve a steady state level of the drug by 3 months.  The data however, implies that we could probably achieve adequate dosing of dutasteride at far less frequent dosing intervals.  The extent to which this is possible needs to be determined with clinical trials and we could potentially discover that dosing once a week or every two weeks might be more than sufficient.  One does not need to be a rocket scientist to understand the potential savings for a commonly prescribed drug for a hugely common condition.   Do not expect the drug company to support a study that has the potential to lead to a 90% reduction or more in earnings for the drug.  Will non-industry funding bodies support such a study?  Highly unlikely given the relative non-sexy nature of the drug and condition it treats as well as the fact that the cost is currently affordable to most individuals at around $30-35 per month.

The second drug is abiraterone.  This is a breakthrough treatment for advanced prostate cancer.  Compared to any chemotherapy agent for prostate cancer, it delivers substantial and clinically meaningful effects on disease progression and prolongs survival.  The thing that many people may not be aware about is the fact that the bioavailability of the drug is significantly enhanced by food.  Data has been collected on this with registered trial NCT01798628 (clinicaltrials.gov) that was completed in 2009 but the results do not appear to have been published in any journal on my attempt to find it on a Pubmed search.  The drug is administered on an empty stomach in the form of four 250mg tablets.  It has been anecdotally suggested that the bioavailability can be increased by anywhere between 5 to 17 fold by having the drug with a fatty meal – it is incredibly difficult to find a study to actually cite for these figures that are loosely verbally discussed at meetings.  The argument against having the drug with food is the inconsistency of absorption with a meal.  Just what if we could control how much and what food was administered at the same time?  There is clearly a potential for men to take one instead of four tablets each day in order to derive the same benefit.  This would certainly work against the efforts of the drug company who would stand to lose 75% of their income – the cost in Australia would fall from around $3000 per month to $750 per month.  Fortunately, the University of Chicago are doing a study to look at this very issue and as you would have guessed, it is being funded by the university and the National Institute of Health (NCT01543776) and not by the pharmaceutical industry.  This trial is currently in progress and the results could lead to huge cost savings for men with advanced prostate cancer.

In summary, we have two drugs for which there is the potential to deliver enormous cost savings.  One is cheap but is used on a large scale whilst the other is expensive and used on a smaller scale and it would not surprise me if it could be proven that the cost savings with both would be similar. It is certainly food for thought.