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13 min reading time
We discussed the 21st Century Cures Act last week at http://bit.ly/21cures and linked to a US Energy and Commerce Committee (ECC) paper which included this passage:
“In a perfect world, R&D dollars would flow toward the areas of highest need where the severity or burden of disease was most pronounced. However, the current system in many ways discourages investment in therapies for scientifically complex diseases with longer development times.
Dr. Collins has encouraged Congress to tackle this problem since today’s patent framework often makes it economically unviable to bring such therapies to market, even when they have shown early promise. Title I contains a series of legislative proposals intended to address this imbalance, including the Dormant Therapies Act.”
Detractor Joseph Gulfo, author of “Innovation Breakdown: How the FDA and Wall Street Cripples Medical Advances” at http://medgroup.biz/cripples, takes issue with this approach.
In his http://medgroup.biz/against-cures-act opinion, Joseph writes,
“[The 21st Century Cures Act] wastes political capital that could be spent on effective solutions. Instead of incentivizing niche uses of devices and biopharma products, what if the development of novel multi-drug/device approaches to our most vexing health crises (like diabetes, obesity, and Alzheimer’s disease) were encouraged?”
What do you think?
Should legislation encourage development of cures for otherwise economically unviable diseases?
Should it instead concentrate on the world’s biggest killers?
Or is a place for legislation at all?
Here’s an otherwise economically unviable disease… Arthrogryposis Multiplex Congenita
Is setting up a not-for-profit the way to go?
See http://medgroup.biz/Magic-Arms to learn about this 3D orthotic and how one company is approaching it.
Can you help make their vision a reality?
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If you read MedCity News, you know this is going to be a quality event. See http://medgroup.biz/2015-CONVERGE for the speakers and agenda.
On tap: Talks, breakouts, demos on human-centered design, precision medicine, trends in healthcare investing, the future of Apple, collaboration across sectors, superbugs, health data and more.
You’ll meet innovators from Independence Blue Cross, Children’s Hospital of Philadelphia, UnitedHealthcare, Blueprint Health, Mayo Clinic Ventures, Boston Heart Diagnostics, and Mount Sinai Department of Medicine.
Use code DIGITALMED for a $399 ticket (full price $899 day of event) at http://medgroup.biz/2015-Converge
Thanks to my friend Chris Seper for the discount for Medical Devices Group members!
Make it a great week.
When it comes to looking good versus feeling good, I must say that I think a lot of people today might phrase that somewhat differently, which is that, if you can’t feel good, you may as well look good.
What the aesthetics crowd gets that the therapeutic crowd has a very hard time with is that is it all about what the patient wants. I don’t see what the patient wants as being anywhere on the healthcare agenda, nor do I find it in my own healthcare providers. Today whenever I hear the healthcare community talk about “patient-centered care,” this is the sort of image that comes to mind:
Paul M. Stein
Note the $600M paid for this “killer”:
As “Fernando” said on Saturday Night Live, “It’s better to look good than to feel good.”
As explained above here my own personal example: By approx. year 2000 we knew that nosocomial infections (Hospital infections) are a larger killer, much larger than death by car accidents. (50 000 death/a in the USA alone. 6 Million are affected worldwide ) Nosocomial infection are caused by pathogens but spread by humans. (Dirty hands, use of unsterile equipment, procrastination etc.) Consequently we decided to create a technology that reduces incidence of nosocomial infections. Together with a University we created a new sterilisation technology, a number of PhDs, IPR, a fast well tested process that eliminates every type of pathogens at room temperature and converts it in into small harmless molecules such as Methane CO2 etc. We formed a company, invested 11 Mio USD into R & D, participated in many VC pitches, got praise after praise, won various awards but….we were unable to raise the required USD 2.5 Mio to commercialize the new technology. None of the praiser, project evaluator, money distributor, VC, was responsible for an outcome! We approached many well paid surgeons and people that are potential spreaders of nosocomial infections to invest in our venture. What we got are “rational reasons” why this is not their problem. This is the picture of reality.
Burrell (Bo) Clawson
Arguably most real “research” (into the unknown) is done on college campuses where PHDs and students can afford to take a year or two to investigate an “idea” to see if it might have some positive result, with no idea whether it could be quickly applied or not.
Paul M. Stein
I remember coming to Medtronic back in 1988, a physiologist with enthusiasm and high ideals. I was told bluntly, “We don’t do research here.” But, they were already developing or later working on the development of dozens of blockbuster medical devices that revolutionized health care. That person way back when was correct to this day, about Medtronic and almost every other medical device company, they don’t do research. They do development with the knowledge and tools at hand.
This discussion was all about medical device companies devoting its supreme efforts to work on the biggest killers. For the most part, it’s not going to happen right now; not with research at least. Later on? With development? We’ll see.
Burrell (Bo) Clawson
For a medical device reference point, Theranos’ blood testing machines have started to reach Walgreens and it has taken 12 years for Elizabeth Holmes, the founder, to get to this point.
Paul M. Stein
I mentioned “the competition” above. There is this “fast follower” mentality out there, whereby if Number 1 is working on something, then we need to too. If Number 1 isn’t working on it, then we can afford to do nothing too. So, is [Insert Name Here] working on that list of Biggest Killers?
Regarding “Government” forcing anything, that’ll never happen due to the economic influence of Industry over Government. The only thing that will work are incentives, and there are plenty of those already, although more couldn’t hurt. All-in-all, right now the science is too early for anyone to risk a penny.
Paul M. Stein
Cardiac arrhythmias: pace or shock -> pacemakers and implantable cardioverter-defibrillators and their associated leads
I could go on for quite a while, but you get my point. Electrical stimulation, pumping, unclogging, attaching hardware… We fixed a lot of stuff, but these were, truly, easy pathophysiological entities to go after. Now what do we have left? Really, really tough stuff. Cancer, Alzheimer’s, ALS, dementia, kidney failure, liver failure, etc.? Where can medical devices even have a role in many of these?
They are mostly biological fixes as currently envisioned. Are there potential medical devices that anyone can think up? Maybe, but with the current state of science, it will take years and years of thorough basic and translational research, and everyone knows, that is not going to be initiated by any current medical device company CEO. Way, way, WAAAAAAY too much RISK of major expense and zero return, or being beaten by the competition. That much risk always trumps the massive payoff.
Now, are any CEO’s waiting in the wings with potential delivery systems for biological fixes that may soon come along? There isn’t too much risk there, so I would hope so, but who knows.
* Big diseases create widespread fear because the enemy is everywhere. Take, for example, stroke, which has a horrible reputation as a difficult area of medical therapeutic development. An infamous publication in the peer-reviewed literature is often used to support this belief: in that publication, only 1 of about 1000 medical therapies passed from scientific concept to FDA approval. The medical community – stroke neurologists in particular – point to this publication to justify their endless ‘woe is me’ claim to a difficult disease condition. However, the aforementioned figure compares very favorably against the pharmaceutical industry average of 1 success for every 5000 to 8000 candidate therapies, depending on the specific area of development. In this example, pessimism created largely by the practitioners responsible for treating the disease is infectious, creating negativity in funding sources in particular, and it undermines new therapy development in the field – thereby justifying the original misperception. There’s no better evidence of the vicious circle than the pathetic denominator of attempted therapies that such a field of medicine suffers
2) Rare diseases often have very dedicated patient groups and very vocal advocates. This often can be attributed to the diseases affecting children, which justifiably enrages the family. While working the pharmaceutical world, I personally have seen such advocates essentially bully the FDA into approving a niche product. Compare that again to stroke, where uncoordinated patient advocacy comes limply from multiple organizations, some of which aren’t even focused on stroke (i.e., the American Heart Association).
One hope is that, with the Affordable Care Act and federal government entering care delivery, some regulation and socialism will nudge this issue positively. NASA explores outer space and other planets, so why can’t FDA likewise perform research toward sensible policies? However, wherever the most is spent in Medicare claims wellness declines, although Social Security Administration is aware of it and has been addressing in its own glacial way. Individual advocates have the greatest immediate effect since they raise public’s hackles: take for examples partial successes in reducing smoking and texting and turn toward obesity and traffic management, which, when you examine further, are mostly due to infrastructure inadequacies, poor choices, poverty diets, and unfortunate subsidies.
Sorry to be so specific and vocal on a general thread, but this is truly a complex, thorny issue that demands far more discussion that people would rather ignore than manage.
Paul M. Stein
Paul, I’m not clear on why it is financially prudent to let go of the “biggest killers.” The amount of financial risk involved is not correlated with the number killed, as far as I know. On the other hand, financial reward is usually positively correlated with the size of the patient population.
Having been an regulatory consultant opened my eyes to how companies choose to address one need over another. Legal liabilities are weighed, constantly. It’s better to attack easy fixes or marginal health improvements than panaceas that both promise much but take on huge risks. Settlements against medical device makers and pharma houses have exceeded tens of billions. Take the J&J hip, for example, which leached metal ions into spinal fluid; though no patients were reportedly injured, the long range consequences were unknown and short term fix was to reoperate and replace joint, a definite harm considering how many patients die from anesthesia alone.
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