Friday, February 27, 2015

Top Five Lessons from my Visit to Tesla Motors

Tesla's Headquarters

I recently visited Tesla's headquarters in Palo Alto, California with my daughter and came away truly inspired.  Tesla’s headquarters is located adjacent to the Stanford University campus in rolling green hills just south of the linear accelerator and the venture capital lined Sand Hill Road.  I am lucky to know one of Tesla’s elite engineers who was very gracious and gave my daughter and me a superb insider tour.





Here are my top five lessons from the visit:

Dream Monumental Dreams

Hire Amazing Talent

Stick to your Vision

Innovate and Execute

Create stellar products and have fun

Tesla is America at its best.  It is a visionary company that is trying to change the world with its electric vehicles and products.  Their newest car, the Model S is not a leaf sized lawn mower.  It is a super charged sexy sports car that makes you fell like you are in the Jetsons’ world when you drive it.  (More about that later)

The Model S from Tesla
Tesla is a place of monumental dreams and superior talent that is sticking to its vision of producing electric cars that are better than their gasoline counterparts.  They have already achieved some of that dream by winning Motor Trend’s car of the year in 2013.  (Reference)  The company is also working on a battery that could serve as an axillary power supply for your home and perhaps even support the entire electrical grid.  (Reference)


The people I saw working there have an infectious sense of purpose that is missing in my world of biomedical research and medicine.  They work together without walls or even cubicles.  This promotes a sense of a united mission.  Those of us who work in research and healthcare are too often siloed in our specific specialities.  We almost never cross over and discuss our problems with colleagues outside of our world.  We need to emulate companies such as Tesla.  Their way of executing in the electric car business could lead to breakthroughs in medicine that could be transformative.  I also think Nicola Tesla would be very proud of how his name is being used.


And by the way, I had a chance to test drive a Model S Tesla at the end of my visit.  It was like a magnetic bullet train on wheels.  I punched the accelerator and it felt like we were taking off for Mars.    #Awesome


Sunday, January 25, 2015

$87 Billion Dollars for Total Knee Replacements by 2030?

We have an epidemic of knee arthritis in the United States with over 10 million affected Americans (Ref).  Many treatments are prescribed with variable efficacy for this common problem.  When all else fails, knee replacement is often recommended.  This procedure is overall highly successful but also expensive.

In 2009, the CDC reported the estimated costs of knee replacement in the US to be $28.5 billion dollars (Ref).  Published reports suggest there will be a need for almost 3.5 million knee replacements in the United States by 2030 (See paper).  At a conservative total cost of $25,000 per surgery, that translates into $87 billion dollars. So, the projections suggest the costs will triple over the next 15 years.

That is $87 Billion Dollars just in the United States to treat end-stage knee arthritis.  That is just the cost of knee replacements.  It does not include other surgical or non-operative costs.  It also doesn't include treatment of other potentially arthritic joints such as the hip or shoulder.

We can and should immediately begin an all-in assault against arthritis.

Patients need to act on the first line of treatment.  They can help themselves with a program of diet and exercise.  Simple exercises such as the QuadCrunch and Hamstring Stretching can be quite helpful.  Riding a bike is another way to exercise with arthritic knees.  Losing even a small amount of weight can result in less pain and more function.

The good news is many new treatments are in development to treat this difficult problem.  The bad news is the effort is fractionated.  It is important to note that knee arthritis is not simply a disease of the cartilage.  There is dysfunction in muscle, tendon, ligament, cartilage and bone when a patient has arthritis.  A better understanding of the genetic and epigenetic causes of arthritis is also needed.  We will need a systematic approach to treating all of the components of the disease in order to be successful.

On the horizon are a plethora of biologic treatments including platelet rich plasma, stem cells and even gene therapy.  We need to embrace these novel treatments do the hard work that is needed to prove their safety and value.

A coalition of patients, providers, payers, researchers and industry need to come together and execute on potential treatments and prevention strategies.  We cannot afford to continue with the status quo and spend almost $90 Billion Dollars on knee replacements in 2030.

Please post your comments or suggestions below.

AM
TotalTendon



Sunday, January 04, 2015

Improve how your DNA works by Riding an Exercise Bike

The Epigenetics of Exercise


You can’t change your DNA but you can change how it works. DNA is the coding program for all of the enzymes and proteins that make your body function. 

Epigenetics is a rapidly evolving area of science that studies how modifications on or around your DNA alter the production of specific molecules. Your DNA is fixed but how it works is affected by the proteins and chemical groups that surround the famous double helix.  You can think of epigenetics as variable signposts on the winding tracks of your DNA that either suppress or promote specific genes.  The proteins and chemical groups have fancy names like a “histone” or a “methyl group”.  These "epigenetic" markers don’t change your DNA but rather change how it interprets the underlying genetic code.  They can turn on or off a section of DNA and dramatically affect YOU.  The science is called “Epigenetics” and in 2015 and beyond, it will alter the way we all approach medicine and wellness.  Multiple articles about epigenetics have appeared in Time Magazine, the New York Times and many other elite publications.

Exercise is one way you can change how your DNA expresses itself via epigenetics in a positive fashion.  A recently published study required people to ride an exercise bike with one leg for 45 minutes four times per week for three months.  Before and after the exercise trial, the subjects had a muscle biopsy of both legs.  The researchers found "health enhancing adaptations" were induced by the "physiologic stimulus" of riding an exercise bike via epigenetic mechanisms in the leg that did the pedaling but not in the one that did nothing.  (Ref: Lindholm et al 2014)  The results are meaningful for anyone who wants to stay in shape and be active.  Importantly, the inherited proportion of physical performance has been shown to be about 50%. Therefore, about 50% of overall physical performance is dependent upon training and lifestyle.  (Ref:  Ehlert etal 2013)  This means that we are at least partially in control of how our bodies work and perform.  We can't blame all of our health problems on bad genes.  

Exercise has also been found to have positive effects on the central nervous system, the  cardiovascular system, the aging process, the prevention of type 2 diabetes and the prevention of cancer all via epigenetic mechanisms.  (Ref:  Ntanasis-Stathopoulos et al, 2013)

So, dust off the exercise bike in the garage, make time in your schedule to get to the gym, or join Soul-Cycle in 2015.

Specific immediate action items:  Consider starting your exercise routine with QuadCrunches and Hamstring Stretches.  They are simple exercises that can be done anywhere.  For the bike, try 20-30 minutes 3 times per week with moderate resistance.

Remember, exercise can literally change how your DNA functions and potentially save your life.

TotalTendon

ALWAYS consult your own physicians before beginning any exercise program.


Friday, December 12, 2014

Using a 3D Printer to Make a Knee Meniscus


Meniscus cartilage is the cushioning tissue between the femur and tibia bones of the knee.  Millions of Americans each year tear this cartilage.  Loss of the meniscus tissue can lead to arthritis.

In this novel approach, researchers in New York are using a 3D Printer to create a new meniscus.  They have studied in sheep so far with success.  In the future, it may be possible to use an MRI scan with a meniscus tear to help program a 3D printer to make you a new meniscus.  Treatment in human patients is not yet available but this is quite an intriguing possibility for the future.



Reference
TISSUE ENGINEERING

Protein-releasing polymeric scaffolds induce fibrochondrocytic differentiation of endogenous cells for knee meniscus regeneration in sheep


Read More

Read the scientific abstract

AM
TotalTendon

Tuesday, December 09, 2014

Microfracture Surgery Jadaveon Clowney

The Houston Texans' Jadeveon Clowney recently underwent "microfracture" surgery on his ailing right knee.  (See ESPN report)

The report suggests the talented Mr. Clowney will be out for 9 months or more.  Just what is microfracture surgery and why does it take as long to recovery as it does for a baby to born?

Microfracture Surgery
Let's start with the basics.  There are two types of cartilage in the knee.  The surface cartilage which covers the bone.  This is known as articular cartilage and can be thought of a type of cap or covering of the end of the bone.  This cartilage is present in any joint.  In the knee, there is another type of cartilage, the meniscus cartilage.  There are two menisci in the knee--medial (inside) and lateral (outside).  When the surface "articular" cartilage is damaged, the knee can become quite painful especially with loading and twisting.  Think rushing a passer for example.  Similar symptoms can occur when the meniscus is torn.  It is often difficult to distinguish between the two in terms of which one is the pain generator.

Microfracture surgery is an attempt to create a tire patch over a cartilage defect by poking a hole in the end of the bone and creating an access channel to the bone marrow.  The bone marrow then leaks out via the holes that are created and forms a clot which over time can help cover the defect.  It takes time, many months, for this surgery to work because the "patch" needs to mature.  This technique is useful for small defects in the cartilage but hasn't proven to be great for larger defects.  We do not know the size of Mr. Clowney's knee cartilage injury.

Recent evidence suggests that the addition of platelet-rich plasma can enhance microfracture surgery results.  This has been shown in basic science, preclinical and now clinical studies.

This type of surgery at such a young age is clearly not a good sign.  In the long run, he may require further intervention.  Please read the post below for further information about why we need to accelerate our regenerative medicine efforts.  Mr. Clowney is one of tens of millions of people worldwide with symptomatic cartilage damage.  We need to maximize outcomes of today's surgical techniques and develop new procedures to help keep our athletes and patients in the game.

AM

TotalTendon


Sunday, December 07, 2014

Will Kobe Bryant go to Japan to Treat his Knee Arthritis?

Japan Accelerates Regenerative Medicine with Regulatory Reforms

Why the United States Must Follow Their Lead


Kobe Bryant, an elite professional athlete from the National Basketball Association’s Los Angeles Lakers, has gone to Germany multiple times to be treated with a portion of his own blood for his creaky, arthritic knees.  The reason why he went to Germany is simple.  He wanted to have the best chance to play at the highest level in the NBA and he had exhausted all his options in the United States.  He went there to be treated with a component of his own blood that targets the inflammation associated with knee osteoarthritis.  The treatment he received is not approved here in the United States. 

Will he go to Japan next time to get the most advanced therapy?  That may happen because in November 2014 Japan enacted legislation creating a new pathway that accelerates the approval process for regenerative medicine products.  We here in the United States need to figure out how to best accelerate our own regenerative medicine efforts or continue to watch our elite athletes and other patients seek treatment beyond our shores.  Let’s explore why Japan acted boldly in favor of regenerative medicine. 

A Nobel Prize was awarded to Japanese researcher and former orthopedic surgeon, Dr. Shinya Yamanaka in 2012 for his pioneering work on how to reprogram mature skin cells into pluripotent stem cells.  His potentially life saving work and the national pride associated with it helped Japan become a worldwide leader in stem cell research.  Importantly, Japan has also prospectively pursued and passed legislation that will dramatically stimulate regenerative medicine.  The country took a leap into a bright future last week with the implementation of regulatory reforms directed at accelerating the development of cell-based treatments. 

The new law established a separate pathway for regenerative medicine products apart from traditional drugs and medical devices. The regulations also created a system that fosters faster commercialization of novel biologic products and can lead to time limited approvals for up to seven years.   Post market data analysis will continue to confirm the safety and efficacy of the regenerative medicine products with the potential to revoke approvals. 

The action by the Japanese government creates the proper equilibrium between the need for accelerated approvals for cell based therapies that have established efficacy while ensuring product safety.  The typical phase one, phase two and phase three trials for new drugs are not a proper pathway for cell-based therapies that have highly complex mechanisms of action that may or may not be identified even with elite preclinical models.  Importantly, many cell-based products come directly from a patient’s own body and therefore have a dramatically higher safety profile. 

Americans are screaming for new treatments for a variety of difficult problems such as arthritis, heart disease and diabetes.  Regenerative medicine and especially cell-based treatments have a chance to help treat and potentially cure these problems.  We need to follow the Japanese lead and create similar pathways in the United States.  Last year during a visit to Japan and its PMDA (the equivalent of the FDA), I was staggered by how engaged they were about regenerative medicine and receptive they were to understanding how to bring safe and effective biologic products to their populace.

The United States can learn a great deal from Japan’s enlightened approach to regenerative medicine.  Safety of course should be paramount.  The idea of a conditional, time-limited approval with reimbursement strikes a perfect chord as we seek better treatments for our patients at more affordable prices.  Competition will arise to obtain approvals based on phase two trials that confirm safety and show a solid degree of efficacy.  Importantly, more competition will lead to better options and faster innovation similar to the computer industry over the last several decades. 

We need to also emulate our Silicon Valley technology colleagues and call for a Medical Moore’s Law.  Identify a specific clinical problem, create a novel solution and within five years double the efficacy and decrease the price by fifty percent.  Data analysis via powerful graphical algorithms should assist with new discoveries and also help with better management of many diseases.  

We must seek dramatically higher horizons instead of being satisfied with iterative improvements.  The Japanese government should be congratulated for passing regulatory reform and implementing transformative solutions.  Sooner, not later, we need to find ways to execute our own regulatory reforms here in the United States to help our patients and to remain competitive on the world stage in regenerative medicine.

Perhaps, then Kobe will be treated in California instead of Germany or Japan.


TotalTendon


Sign the online petition supporting Regenerative Medicine



Please post any comments or suggestions about how to safely accelerate regenerative medicine.

References

Accessed 11/30/14


Accessed 11/30/14



Wednesday, November 12, 2014

Google Trends for Platelet Rich Plasma Rose 107% Last Week

The interest in Platelet Rich Plasma  (PRP) rose dramatically last week according to Google Trends.  This autologous biologic product and treatment continues to gain traction as a simple way to address challenging problems such as chronic tennis elbow.  As more clinicians, researchers and patients gain experience with it, better formulations and protocols will be developed to treat injuries and disorders safely and effectively.

We are now in the second decade of using PRP therapeutically and this trend is a signpost of worldwide interest.  This interest will also spark new innovations surrounding the use of blood therapeutically.

Patients and even payers will benefit from blood based breakthroughs because many newer biologic procedures will be as or more effective than surgery and less costly.

AM
Total Tendon

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