Sunday, June 19, 2016

Will 500,000 Americans a year die -- for lack of $30 million?

Fatalities from accidents and homicides in the US every year are a far distant second and third to the half a million Americans (and uncounted millions around the world) who die from heart failure.  There now there looks to be a stabilizing procedure for most all and an actual cure for many … but from Sunshine Heart, C-pulse device e-news I get, being $20-30 million short to fund final clinical trials stands between those millions and the rest of their lives.
It goes like this.  A trial with 20 very ill patients (stage III, stage IV HF, with at least one hospitalization and considered for another device) ended in 2012 with 5 complete cures (device removed), the majority improved and none worse.

Novel, implantable device 'could slow, reverse heart failure', Honor Whiteman,  Tuesday 7 October 2014
”Around 50% of people who develop heart failure [5.2 million Americans] die within 5 years of diagnosis. But could a novel, implantable heart device change this? In a clinical trial, the C-Pulse - a cuff that wraps around the aorta and pumps blood from the heart around the body - has proved effective in reversing heart failure, even in some patients with severe cases.”

No problems with clots or strokes with the C-pulse balloon outside the bloodstream.  Implanted non-invasively too.

Sunshine Heart has been working up a final trial with 200 patients to win FDA approval but can’t seem to get past 100.  Money seems the bigger obstacle.

“Unfortunately, there don't appear to be easy solutions to Sunshine Heart's primary problem - it lacks the resources of major cardiology companies like Boston Scientific (BSX), Medtronic (MDT), or St. Jude Medical (STJ) that could otherwise support and encourage enrollment. Getting the FDA's permission to run an interim analysis would certainly help, and the shares do appear undervalued, but the company is...”

One email from Sunshine Heart (can’t dig it out) made out private investors to be reluctant for fear any patent could be too easily worked around.

Here’s the thing.  I figure 5 million currently terminal patients (we all know somebody) would gladly pony up $6 apiece.  :-)  More sensible path – government supporting this and all clinical trials from now on – possibly neutralizing big pharma’s biggest gouging excuse without hampering innovation (encouraging) – in this case, with 10,000 American deaths every week, pronto.  Maybe states could get together and pitch in.  Maybe GoFundMe.  ???  Whatever, soon.

 * * * * * * * * * *
“To use Sovaldi to treat each of the 3 million hepatitis C patients in the United States, it would cost around $300 billion, or about the same amount we annually spend for all other drugs combined.”

Thus the opposite end of the pharma-out-for-pharma cruelty scale.  Federal legislation exists* to put and end to what-should-be a $300 billion joke right now.  Be a nice Democratic campaign issue – if that’s what it takes. 

Bydureon (once a week) keeps my blood sugar down, my insulin up and caused me to lose 50 pounds in as many weeks without effort.  [Late animal studies note: GLP-1 drugs like Bydureon may prevent the gradual loss of beta cells which characterized Type II diabetes.] The VA endocrinologist (right hand man to a Nobel Prize winner) who discovered the prized molecule in the saliva of a Gila Monster is likely still working on salary.  Pharmasset's chief Sovaldi researcher made $446 million dollars for himself …
… made possible only because the "Gilead Monster" could fork over $11 billion in the expectation of getting back $1,000 a pill (that cost $1 to make).

$30 million or $300 billion short, America's wonder drug machine needs major redesign -- and in a hurry.

Late additions:


Follow up  --  FWIW?:

From what admittedly little I gleaned from Goggle, neuromodultion seemed not to carry much promise -- at least in the context of the trials shown.


Gilead again.  This time Gilead halted research on an improved version off its HIV drug for six years to stretch its current patent.

" The foundation had argued in the lawsuit that millions of patients could have benefited years earlier from the less harmful drug if the company had not delayed its development.

" The older drug’s label has long warned that it can damage a patient’s kidneys and bones. In a large study in 2012, doctors at UC San Francisco analyzed a database of more than 10,000 HIV patients at the Department of Veterans Affairs, finding the risk of chronic kidney disease rose 33% each year a patient took the medicine."

" Lucentis is just as good as slowing the progression of macular degeneration as Avastin. There’s just one little problem with Lucentis, however. Instead of costing Medicare $50 per pop, it costs up to $2,000. " 

Unfortunately Genentech wont manufacture Avastin in ready-to-use form and there is a very slight risk of infection with current application of Avastin.  No high priced research needed here -- simply manufacture easy-to-use.  But big loss of over priced sales. 


Denis Drew said...

ADDENDUM TO "300 million live for $22 TRILLION? -- 500,000/yearly die for lack of $30 MILLION? -- USA drug research!"

A cheaper side step to heart failure treatment because investments for the extremely promising C-pulse technology dries up? Neuromodulation not practicably successful elsewhere I have read.

Sunshine Heart CEO takes phone in question from investor:

"Okay. I guess my one real question is, my past experience suggest that neuromodulation is a really tough road to go in terms of clinical trials and specifically endpoints and a placebo effect. I think some companies in the past have tried to - had really good early clinical data against their pivotal trial and all of a sudden the placebo effect is sort of blown everything up. How do you - so neuromodulation may sound simple, but it’s been tough in the past. How do you feel about your approach you have going forward and specifically in the clinical sense?"

Denis Drew said...