Given that caveat, what’s the source of the $2,500 figure? It comes from this memo, put out by three Harvard professors who are unpaid advisers to the Obama campaign. They cited RAND findings that investing in health IT could $77 billion a year, and improving management of chronic disease could save another $81 billion. Cutting administrative costs in the insurance industry could save up to $46 billion, the memo said, citing the Commonwealth Fund.

The memo points out that it’s impossible to predict actual savings, and cites a wide range of possible outcomes. But the authors say their best guess is annual savings of $200 billion.

They took that figure, divided it by the population of the U.S., multiplied to get a family of four, then rounded down to $2,500 to get a round number, the article says.

Whether all those savings estimates are realistic — and what time frame it would take to realize the savings — are both subjects of debate. Earlier this year, the Congressional Budget Office said stirred things up when it said that RAND may have overstated potential savings from investing in health IT.

And what about giving everyone else the same health care coverage members of Congress have? The plan would be paid for by cutting payments to doctors and hospitals. Obama's model for the national plan is not what his colleagues in Congress have but how states have tried to expand Medicaid to create universal health coverage.

Obama's National Health Exchange would set up a public planrequire all private insurers to accept everyone regardless of illness, pre-existing condition, etc. set premiums and then " require that all the plans offered are at least as generous as the new public plan and have the same standards for quality and efficiency. And that means price controls.

Obama claims this will eliminate bankrupcty from health care expenses and reduce uncompensated care expenses.

Not so. Rationing will force patients to sell off houses and pay out of pocket for services biggovhealth says no to. Just like in Canada and England. Allowing states to extend coverage to illegal immigrants and a new provision to provide health insurance to the children of illegal immigrants via SCHIP and Medicaid will see costs skyrocket and private hospitals will be forced to make up the difference between the federal reimbursement and what they have to spend on care, just as they do now.

Finally, "Obama will require that providers that participate in the new public plan, Medicare or the Federal Employee Health Benefits Program (FEHBP) utilize proven disease management programs. This will improve quality of care, give doctors better information and lower costs."

Is there any evidence of that? No. But we will have a government agency that will tell doctors what they can and cannot use based on one-size fits all and outdated studies of how to treat chronic illness. Such studies, because they ignore genetic, gender, racial differences will deepen health disparities. Combined with cuts in payments to doctors, care and coverage in the poorest areas will dry up.

Change. Yes we can.

Do “complete response” letters offer more clarity or ambiguity?  It depends who you ask.

If you are privy to what the letters say, they offer greater clarity as to what needs to be done to gain FDA approval.  (At least that’s the theory.)

If you are a reporter or a financial analyst or a patient or a physician, you only know what the sponsor tells you.  And that’s not much.

But it never has been and a lot of people find that frustrating.

Well, life is full of frustrations.

Consider the media.  They have a job to do.  Will complete response letters help them write a more complete story?  No, because the letters are not public and it is highly unlikely (for many good reasons) that "commercial confidential" communications with the FDA will be shared with anyone outside the confines of the sponsor.  (For more on the issue of complete response letters and commercial confidentiality, see, “Public or Private,” from the Journal of Life Sciences.)  

Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.”  Hogwash.

Here it is straight from the Bob Temple:

“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’  That’s what I would say.”

Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency. Easier said than done? Sure. But let’s stop with the lame “We’ll make FDA angry” excuses.

The strange silence that generally accompanies FDA communications is a tough nut to crack.  If “more” is desirous by the media, but problematic from the legitimate viewpoint of the sponsor, what can be done?

One incremental step forward is to help clarify what is not in a complete response letter.  Recently Johnson & Johnson received a complete response letter for paliperidone palmate.  In addition to the usual and customary, “We’re looking forward to working with the FDA to bring this important new product to market,” J&J also added one important piece of information – that the FDA had not asked for any additional studies.

Rather than sharing what was in the letter, J&J shared what was not in the letter.  Smart.

For more discussion of the complete response issue have a look at this excellent article from the July/August 2008 issue of the RPM Report.

 
Peter Pitts’ depiction of the almost ten year old “cost-effectiveness” wars in Germany (See Uncommon Denominator) is just an introduction to the debate over economic evaluation of medicine in Germany, Europe and beyond. While it is commonly believed that Europe had long ago fallen to the dark forces of cost-effectiveness analysis, the German defiance referred to in Peter’s article has highlighted that this is not really the case (and there are plenty more counter examples out there). 

Two key issues central to the German debate over economic evaluation are, (1) what methods constitute “best practice” in the economic evaluation of health care, and (2) what type of evaluation is needed for a system that is based on a combination of employer and private health insurance, albeit a system that is subjected to an increasing government presence – along with calls for major reforms to create (attention Obama-ites) a national health care system.

The Hanover Consensus Group has consistently taken the line that “everyone else is doing it, so why aren’t we?” (Although a cynic might read “other health economists are profiting from it and we want too as well!”) While cost-effectiveness analysis is a regularly accepted rule, it’s wrong to consider it as accepted best practice.  Even for those who herald its use, it is often understood as a “necessary evil”.  Furthermore, in an evidence base world, there has never actually been a technology assessment performed on cost-effectiveness analysis, hence we don’t know if it does or does not lead to better health care investments or lowers overall expenditures. Anecdotal evidence in Ontario indicates that it failed to decrease -- and potentially increased -- the rate of medical inflation following its implementation.  Based on the experience in Australia, cost-effectiveness analysis can decrease total expenditures -- but by delaying reimbursement decisions -- a de facto shortening patent life on drugs – or through the negotiation of major price discount, and not by weeding out bad practice. 

The more subtle point in this debate relates to the compatibility of cost-effectiveness with the German health care system.  Created by Otto von Bismarck at the end of the 19^th century, the system of Social Health Insurance was based on the principles of solidarity and subsidiarity.  While Angela Merkel’s health care reforms have threatened the latter to promote affordability, the Germany health care system remains essentially employer and employee sponsored, with a limited role for government.  Furthermore, the Social Code Book that defines the German health care system calls for efficiency to maximize within each disease state, which is at odds with the “priority setting” approaches (a more genteel way of referring to health care rationing) implicit in cost-effectiveness analysis. 

Having been a regular IQWiG watcher since its inception, I have to congratulate Dr. Kolominsky-Rabas for his efforts in searching for an alternative approach to cost-effectiveness analysis.  While I might not agree with the current approaches presented by Caro and colleagues, I find it refreshing that we are now entertaining alternatives. American policy makers  should not only pay attention to this robust debate in Germany, but should be active participants given that we too might find ourselves with our own version of IQWiG in the near future. 

Opposition to neo-Luddites consists largely of those who believe that technology is beneficial or, at worst, neutral. This opposition has sometimes been hindered by a focus on specific issues, and on occasion by a belief that the benefits of certain new technologies are obvious when in fact many people do not understand the technology in question.

A main concern of technological proponents is to question whether it is always worth saving those things that neo-Luddites seek to protect. The actions of the Luddites are perceived to be emotion-driven and therefore irrational. One form of this objection begins by noting their defense of traditional cultures, and then pointing out culture as a static force enslaves people to its strictures, and is counterproductive to adaptation resulting in cultural if not ethnic extinction. Further arguments would state that elements (real or imagined) of certain traditional cultures that modern societies find abhorrent, such as cannibalism and slavery. Another form is to note some problem that most people would like to minimize or eliminate - such as cancer (which many people agree can eventually be reliably treated or cured), or the sometimes crippling effects of advanced age (see Geriatrics) - and argue that the main effect of neo-Luddism would be to delay or prevent solutions to these problems.http://en.wikipedia.org/wiki/Neo-Luddism

I call the whole bundle of anti-commercialization forces Bio-Luddites because the they are a subgroup of the NL. Like the Luddites efforts of old, both the thinking and the administrative apparatus furiously being erected by today's Bio-Luddites will be swept away by a river of innovation that is spreading rapidly than any entity can control. Witness the note of exasperation in this op-ed in the Times of London about how NICE is unable to keep up with the current wave of new cancer drugs. I have highlighted the remarkable last sentence in this one section:

To judge from the genuine shock of oncologists, the decision may yet be revised - as has happened for several other drugs that NICE originally rejected. Yet even if this ruling turns out to have been misguided, NICE is going to have to make more tough choices of this nature. The reason is that the increasing success of medical research will make rationing an ever- greater challenge for the NHS.

http://www.timesonline.co.uk/tol/life_and_style/health/article4539008.ece

That's right... rationing must rise to beat back the increasing success of medical research. Anyone want to be on THAT side of the argument.

This won't happen. NICE and NHS are being besieged now by advancing innovation. What will the Bio-Luddites do when the next generation of genomic based medicines come flooding through a high-speed regulatory pipeline that is biomarker based?

It will crumble as all effort to stem innovation do. Unless we or they resort to a police state, a sort of Stalinist approach to health care where the both the intellectual freedom and the scientists who thrive in it are forced to investigate only government approved projects and private companies are reduced to merely formulating the compounds for a royalty.

But that won't happen. The Bio-Luddites are not just losing. The have lost. The equate vitriol and bullying with success. But the opposite is occuring. Innovation is on the march and market forces are and will play a key role in that victory. Just as they did when the Luddites became -- after a few decades -- a bunch of cranks meeting in dusty libraries and socialist bookstores.