Friday, January 15, 2016

One more example why government support for ALL drug and medical device research should be the norm


Up until now a spectacular argument for government taking over all drug and medical device research has been the example of Sovaldi: the Hepatitis C cure. We all know the story.

Now, for the first time ever, all three million Hep C sufferers can clean the virus from their system — for only $300 billion dollars ($100,000 each) with 84 pills that costs $1 each to manufacture.

Seems the gov did the original (read: risky) research but once the researchers smelled money (er, uh, a cure) the law allowed them to continue with private funds and then make as much profit out of it as can be bled.

Hep C — PS: 30% more likely to come down with Parkinson’s — and who knows what else. Jingle, jingle, jingle goes the cash register.
http://www.medicalnewstoday.com/articles/304405.php 


Now we have a story supporting gov research from the opposite angle — if you ask me anyway.  

Until now, heart failure has been progressive and surely terminal. In 2012 a trial or an innovative medical device in England with 20 patients ended with 25% cured and everyone else improved. It involved a balloon like cuff wrapped around the upper aorta that aided pumping — and apparently allowed the less strained organs to heal.  

Now, a much bigger trial on two continents is being arranged (hopefully) but may potentially fall apart for lack of private funding.
Link to very long — what I can only call a — prospectus below

     [cut and paste]
Summary
Sunshine Heart develops the C-Pulse device for HF (Heart-Failure) patients. C-Pulse showed outstanding clinical results in the US feasibility study, and EU study, including improvement in HF condition, and recovery.  

Heart Failure is poorly treated, resulting in 5 year mortality rate of 60%. C-Pulse targets a huge unmet market of 5.2 million patients in relatively progressed HF stages.  

Slow enrollment in the US pivotal trial (the equivalent of an FDA phase III trial), and circumstantial pause and resumption of trial enrollment have lead to dwindling cash. 

SSH share price fell rapidly, fueled by panic, tax purposes selling, inability to raise additional cash, fears of approaching bankruptcy, and a poison-pill mechanism preventing an otherwise likely take-over.  

Sunshine Heart basically has no other option but pursuing a strategic move soon, that is explored in this article, and can result in substantial gains in the next 6 months.
      [snip]
Heart Failure condition overview
HF (Heart Failure) is a terrible disease , but unfortunately is very common. It is currently poorly treated, and is one of few diseases that increase in mortality YoY. More than 7 million HF patients exist in the US, with more than 800,000 new HF cases every year. The number of HF patients is expected to exceed 10 million by 2030. The HF increase in prevalence is driven by the epidemics of obesity, diabetes, and high blood pressure. Additionally, 7-10% of the aging population above 65 years old suffer from HF.  

The outcomes of HF are very poor: 5 year mortality rate is higher than 60% – worse than many types of cancer. There are 1 million hospitalizations per year due to HF in the US. HF accounts from more hospitalization-days than any other disease. HF is the number 1 cause for readmission within 30 days – higher than 20% re-admission rates. The current annual cost of HF to the US economy is a huge $31B, with annual cost projected to reach $70B by 2030.  

Figure 1 shows the poor outcomes of patient hospitalizations due to heart failure, as reflected by high mortality rates at 30 days, 12 months, and 5 years, and high rate of hospital readmissions. Figure 2 shows the poor and deteriorating median survival time after every HF hospitalization. Kidney failure accounts for more than 50% of mortality, as the kidneys heavily depend on sufficient blood pressure, and blood flow for their operation, which is obviously affected by HF.
     [snip]
PS. The insertion procedure is minimally invasive and there is no risk of clots as with other pumping aids, the whole device being outside the bloodstream.
     [snip] 
http://seekingalpha.com/article/3811136-sunshine-heart-a-speculative-biotech-play-for-substantial-short-term-gains?auth_param=17tckm:1b9fvn8:1e097e95787e20c025e6c8de8e008836&dr=1 

THE  LONG  POST  SCRIPT
Headline:  Drug shortages in American emergency rooms have increased more than 400 percent
     [snip]
"Of the nearly 1,800 drug shortages reported between 2001 and 2014, nearly 34 percent were used in emergency rooms. More than half (52.6 percent) of all reported shortages were of lifesaving drugs, and 10 percent of shortages affected drugs with no substitute."
     [snip]
"It seems simple enough: If companies produce more drugs, more drugs will be available to ERs. But given that the majority of drugs on shortage in emergency rooms are sterile injectables with low profit margins, don't expect that to happen anytime soon."
     [snip] 
http://www.chicagotribune.com/lifestyles/health/ct-emergency-room-drug-shortages-20160124-story.html 

SEE  ALSO  (long): 
http://www.nytimes.com/2016/01/29/us/drug-shortages-forcing-hard-decisions-on-rationing-treatments.html  

MORE:
“ Less than a year ago, Pearson’s cheerleaders—many of them professional money managers, such as Bill Ackman of Pershing Square Capital Management—were saying that he was revolutionizing the pharmaceutical industry. Pearson had long argued that the industry wasted too much money on unprofitable research and development projects. He said drugmakers were better off buying other companies and exploiting their portfolios. Accordingly, he had turned Valeant into an acquisition machine and, though he rarely discussed it, a serial hiker of drug prices, another pillar of the company’s strategy. ” (my emphasis)
     [snip]
 " Other pharmaceutical companies learned from Pearson’s model, too. Pfizer, the maker of drugs such as Viagra, was essentially going down a path blazed by Valeant when it announced it would buy Allergan in a $160 billion deal that would be the largest in the industry and that would transform (or “invert”) it into an Irish-domiciled company, enabling it to avoid American corporate taxes. ” 
http://www.bloomberg.com/news/articles/2016-03-03/valeant-s-boss-is-back-can-the-ceo-save-the-day-again

EVEN MORE
https://www.washingtonpost.com/news/wonk/wp/2017/02/10/an-old-drug-gets-a-new-price-to-fight-a-rare-disease-89000-a-year/?utm_term=.8da3618f14b3
” Less than a year ago, Pearson’s cheerleaders—many of them professional money managers, such as Bill Ackman of Pershing Square Capital Management—were saying that he was revolutionizing the pharmaceutical industry. Pearson had long argued that the industry wasted too much money on unprofitable research and development projects. He said drugmakers were better off buying other companies and exploiting their portfolios. Accordingly, he had turned Valeant into an acquisition machine and, though he rarely discussed it, a serial hiker of drug prices, another pillar of the company’s strategy. ” (my emphasis)
” Other pharmaceutical companies learned from Pearson’s model, too. Pfizer, the maker of drugs such as Viagra, was essentially going down a path blazed by Valeant when it announced it would buy Allergan in a $160 billion deal that would be the largest in the industry and that would transform (or “invert”) it into an Irish-domiciled company, enabling it to avoid American corporate taxes. ”
Read all about it here: http://www.bloomberg.com/news/articles/2016-03-03/valeant-s-boss-is-back-can-the-ceo-save-the-day-again
* * * * * *
” … but my experience in med-tech tells me that there is almost always a way around IP and that good ideas (or what companies think will be good ideas) are copied pretty quickly – notice how many companies got into renal nerve ablation once that seemed promising or how many companies have launched clinical programs in transcatheter heart valves. ”
http://seekingalpha.com/article/3934666-can-sunshine-heart-survive-see-dawn?auth_param=17tckm:1bd3k0r:1333c28776918ba740d9bea4d932addc&dr=1

Novel, implantable device ‘could slow, reverse heart failure’
Read all about first ever device to successfully treat or even for the first time ever even cure some patients with heart failure — with on add risk of stroke or clots because it is outside the bloodstream. Too bad under US research culture or whatever you call it it may lie neglected because investors are afraid it is too easy to copy.
http://www.medicalnewstoday.com/articles/283566.php
* * * * * *
We all know the story of Sovaldi where the company paid $11 billion to a company who was going to sell the $1-to-make pills for $350 so they could sell it for $1000 a pill. Cure for Hepatitis C permanently put on hold so Wall Street can gouge. The first company relied on government research funds until it smelled money than it was able to find investors to finish the job. The chief scientist made $446 million for himself — enough to manufacture the virus out of business.

We’ll never do anything about any of this — or anything else — if we don’t return to the union density of the 50s and 60s.
- See more at: http://angrybearblog.com/2016/03/open-thread-march-8-2016.html#comments
” Less than a year ago, Pearson’s cheerleaders—many of them professional money managers, such as Bill Ackman of Pershing Square Capital Management—were saying that he was revolutionizing the pharmaceutical industry. Pearson had long argued that the industry wasted too much money on unprofitable research and development projects. He said drugmakers were better off buying other companies and exploiting their portfolios. Accordingly, he had turned Valeant into an acquisition machine and, though he rarely discussed it, a serial hiker of drug prices, another pillar of the company’s strategy. ” (my emphasis)
” Other pharmaceutical companies learned from Pearson’s model, too. Pfizer, the maker of drugs such as Viagra, was essentially going down a path blazed by Valeant when it announced it would buy Allergan in a $160 billion deal that would be the largest in the industry and that would transform (or “invert”) it into an Irish-domiciled company, enabling it to avoid American corporate taxes. ”
Read all about it here: http://www.bloomberg.com/news/articles/2016-03-03/valeant-s-boss-is-back-can-the-ceo-save-the-day-again
* * * * * *
” … but my experience in med-tech tells me that there is almost always a way around IP and that good ideas (or what companies think will be good ideas) are copied pretty quickly – notice how many companies got into renal nerve ablation once that seemed promising or how many companies have launched clinical programs in transcatheter heart valves. ”
http://seekingalpha.com/article/3934666-can-sunshine-heart-survive-see-dawn?auth_param=17tckm:1bd3k0r:1333c28776918ba740d9bea4d932addc&dr=1

Novel, implantable device ‘could slow, reverse heart failure’
Read all about first ever device to successfully treat or even for the first time ever even cure some patients with heart failure — with on add risk of stroke or clots because it is outside the bloodstream. Too bad under US research culture or whatever you call it it may lie neglected because investors are afraid it is too easy to copy.
http://www.medicalnewstoday.com/articles/283566.php
* * * * * *
We all know the story of Sovaldi where the company paid $11 billion to a company who was going to sell the $1-to-make pills for $350 so they could sell it for $1000 a pill. Cure for Hepatitis C permanently put on hold so Wall Street can gouge. The first company relied on government research funds until it smelled money than it was able to find investors to finish the job. The chief scientist made $446 million for himself — enough to manufacture the virus out of business.

We’ll never do anything about any of this — or anything else — if we don’t return to the union density of the 50s and 60s.
- See more at: http://angrybearblog.com/2016/03/open-thread-march-8-2016.html#comments

2 comments:

Denis Drew said...

The second area of consideration is what I would call geo-strategic. This involves negotiating with our partners to make sure the EU recognises that with respect to Britain, Ireland occupies a special position and we need opt-outs where our national interest is specifically and disproportionately challenged. This type of “special position” is exactly the status David Cameron was afforded by the EU to try to keep Britain in, so there is precedent. It didn’t work for Britain, but the same understanding needs to be negotiated by our government.

Ireland is special not just because of the border but because the reality is that Ireland has not become fundamentally more European since 1973. We have remained part of the Anglo-American economic world economically. We do over €1 billion of trade with Britain every week. The US (not Germany or France) is our biggest trading partner, followed by Britain. When our people look for work, they go to London not Leipzig. We support English football teams, watch the BBC, tune in to English soaps and listen to English music. It’s not that our own culture is subservient but we are intertwined, economically, socially and ultimately politically with Britain unlike any other country.

Over 500,000 people left Ireland for Britain in the 1950s. This is why our football team today has English and Scottish accents. Those lads are the demographic echoes of the 1950s and 1960s migrants. Their grandparents didn’t head to Bordeaux or Galicia for work; they went to Birmingham and Glasgow. There has been an open trade and travel policy between Ireland and Britain for years. This is sacrosanct.

If the EU becomes vindictive and tries to block trade and travel with Britain in order to teach it and other would be “deserters” a lesson, we need to react. Such European truculence must be regarded as a “red line” for Ireland. Our national interest is at stake and Official Ireland must realise that being good Europeans and acting in Irish self-interest is not one and the same thing.

The third theatre for negotiation is with Britain itself. If the Scots vote to leave (as this column in recent weeks has suggested is the logical implication of Brexit), what happens to Northern Ireland? I’ve always thought that the DUP should be careful what it wishes for, as a UK without Scotland – the Northern Unionists’ fraternal brothers – will be, to use David Trimble’s expression, “a cold place” for Unionism. A little Englander is a very different creature to a One Nation Tory. Unionists might do well to consider that fact.

If the new England is prepared to accept that Scotland leaving the Union is a price worth paying to be out of the EU, I might suggest that the position of the far less loved – and considerably more expensive – Ulster Unionist is, to say the least, precarious.

Denis Drew said...

http://www.nytimes.com/2013/04/21/books/review/the-third-coast-by-thomas-dyja-and-more.html