Coal In Our Stockings: The Destruction of Medical Innovation
Nonetheless, the likelihood that CER studies will be used one way or another is very high. This means that private-sector investors in new technologies will perceive four new or strengthened parameters. First, there will arise a need to expand private clinical testing to include preliminary CER analysis, as a means of acquiring information about future federal findings and government reactions. Second, increased pricing pressures can be expected as a result of CER analyses that are inconclusive or adverse. Third, CER raises the risk of non-approval or limited approval for federally-financed programs, perhaps as a tool with which to force ever-greater price reductions. Finally, CER is likely to yield a longer regulatory approval process, and thus a shortening of the effective patent period and a delay in expected sales revenues.
Recent research from the Pacific Research Institute examined the likely effects of these CER implications for R&D investment in new and improved pharmaceuticals and devices and equipment. Using data from the National Science Foundation and other sources, R&D investment would be reduced by about $10 billion per year over the period 2014 through 2025, or about 10-12 percent. Based upon the scholarly literature on the benefits of medical innovation, this reduction in the advance of medical technology would impose an expected loss of about 5 million life-years annually, with a conservative economic value of $500 billion, an amount substantially greater than the entire U.S. market for pharmaceuticals and devices and equipment.
This adverse effect would be concentrated upon technological advances likely to serve the needs of smaller subgroups within the overall patient population, upon riskier investments among new treatments, and upon drugs and equipment expected to prove relatively less profitable.
In short: An expanded federal CER effort — a top-down process — is likely to prove very unwise as a matter of public policy. A renewed emphasis upon a bottom-up approach of experimentation by many millions of practitioners and patients would be a more fruitful vehicle for the acquisition of information about the comparative effectiveness of alternative clinical approaches.
I have been involved in diagnostic imaging systems development for 25 years and the last 15 have been as a researcher in a teaching medical center. I agree completely with the author as to the inhibiting effect of federal control via the CER mechanism. The freedom to try new approaches in medical care is the wellspring from which inovation flows. We have lost much of this through overbearing Institutional Review Boards, research compliance departments and other imposed regulation. Even CMMS has turned back the clock on innovation by blindly reviewing published literature to sound the death-knell on cutting edge technologies by undoing previously approved procedure reimbursement. Innovation is slowing to a trickle, but CER will kill it completely.
I completely agree with the author and with Robert. As the founder of a medical device company, a pharma venture, and other much less-regulation controlled companies, I have found a major pscyhological as well as practical burden of the federal government’s unconstitutional intrusions on our ability to create value, and our ability to predict rational outcomes. There is no free market in health care anymore. And large tools that opposed it. Evidence Based Medicine is but a tool of large pharma and insurance companies, and a collectivist brain-child. Quality initiatives are great for Toyota transmissions–for making lots of identical parts–but are nigh useless when it comes to our very different patients (whom we don’t want to make identical, or treat identically). These CER’s are collectivist, not patient based. Collectivism and groupism is horribly counterproductive in economics, sociology, and certainly also in Medicine
Oh. But our president is the smartest guy in any room. If he says CER is the way to go, then that is the best way to go. We must defer to his infinite wisdom rather than the greedy and, no doubt, false claims of medical device manufacturers, drug makers, and doctors.
(On the other hand, if our president is not the smartest guy…)
(sarc) Racists (/sarc)
The medical technology advancements are already stifled by tort cases. Just look at the number of “new” antibiotics that the drug companies make in only limited quantity and are dispensed by the CDC to protect the drug manufacturers from the side effects. We are just adding another layer and smothering the entire profession. Not to say the profession is any good at coming up with cures but this will only make it worse. Another reason for the lemmings to cheer.
So-called Progressives are Luddites who are fond of eugenics.
“Eugenics” is a harsh word. Let’s redefine it as, “Since you choose not to be cured by the official treatment, you do not deserve to be cured at all.” With this a a guiding principle, the entire pharmacopeia can be reduced to aspirin, with great savings on medical treatment.
If you appoint a commitee to make a guideline or recommendation on a certain question they will make one. The problem is that they will do so even if there is insufficient evidence to support a definite conclusion. They will select data to support a conclusion because they have to. That is not research or “providing information”.
This kind of approach not only stifles innovation in equipment and therapy but in basic clinical research as well. In practice it near forces physicians to follow published guidelines even if they do not agree with them.
What is a Camel? . . .A horse designed by commitee! . . Anon
This will do to medical devices what the Certificate Of Need did to hospital beds. Entrench inefficient hospitals by not allowing competition. These Congressmen are dangerous fools.
My experience reviewing results of comparative effectiveness research on existing pharmaceutical products is that the authors cannot and will not draw conclusions in the absence of head-to-head clinical trials. Even where these HTH trials exist – as noted in the article – they are subject to never-ending second-guessing on design, methodology, patient severity, etc.
For new agents, why take the risk of a new HTH trial against competitors if it won’t be sufficient to answer CER questions ?
If you think our current state of medical technology is good enough – you’re in luck ! We may have to live with it for a long, long time. Imagine if something like Obamacare had been implemented in 1955 …
Patient-Centered Outcomes Research Institute = Patient Analyzed Closure Outcomes.
Denizens of Tim Blair’s site will recognize the reference.
You’re clearly not paying any attention to this P-CORI. It’s focus and pace of work is nothing near your ominous description.
Also, a curious comment by you: “a bottom-up approach of experimentation by many millions of practitioners and patients would be a more fruitful vehicle for the acquisition of information about the comparative effectiveness of alternative clinical approaches.” So, you support the combing of medical records on interventions and outcomes to make comparative effectiveness assessments? That would be some pontentially high quality real world data and results. Good thing the government is sheparding the industry to universal electronic medical records to make this possible.
At this point, I am actually rooting for other countries, including China, to out-innovate the US.
If a technology to save my life is in another country, screw the no-longer-great USA.
Just be careful what you wish for. China may out innovate the US, but their innovation may be in developing new ways to fool the metrics used by people to make decisions. After all, they have 20 years head start with the methods and goals of misleading bureaucrats
If that happens, your decision to use China’s services or products will assuredly be incorrect.
Doing statistical sampling of outcomes is a very good idea. But the results need not be forced on doctors and patients, which is one of the biggest problems with Obamacare: it uses force to achieve its ends. The results of the testing of medical outcomes should be published widely so that the population of doctors and patients is aware of the results. This way the doctor and the patient can come to better decisions about what treatment works and what doesn’t. This is particularly the case in the treatment of back pain.
Of all the bad things in ObamaCare, the squashing of progress and innovation will be the worst. Untold numbers of people will suffer unknown agonies and heartbreak because medical progress will become (even more) a plaything of politicians and bureaucrats.
If there is a hell, the perpetrators of all this will spend eternity there.
oh, c’mon, they spend all their money on advertising, the government knows best.
cheap is better!
i will work to screw over every Dem constituency if Obamacare stands.
Homosexual nonmonogamy will be outlawed.
No smoking, pot or cigarettes.
Study the health effects of abortion.
And keep TB ridden Mexicans and Central Americans out of this country.
All to help the Volk and lower overall health costs.
Be careful what you wish for.
The entire health care debate centers upon one common cause: the science of health care has gotten too darned good.
We’ve long since solved the bulk of the health questions that ever arose. We’re left, now, with the more complex health problems that require years of research and oodles of money to address, and even more to treat.
After millions are spent in research, we find that a form of ______ disease can be cured using a strange and rare chemical that is only produced in the pineal glands of Panamanian albino toads. It takes 300 toads to make one dose, the toads must be wild, and you need that dose daily. It’s fantastic that they’ve found this cure, but realistically, we cannot afford it.
Now, convey “we can’t afford it” to the father of a kid dying of that disease.
Or, worse, tell that father that, while millionaires can afford it for their kids, people who depend upon insurance or public funds to pay for health care are not going to get that kind of money from those sources, so HE can’t afford it.
We accept that rich people can buy safer cars than poor people. We accept that rich people can afford a healthier diet than poor people. Rich people can afford to live in safer areas, they can live further from pollution, they can hire personal protection, they can put GFI outlets in their bathrooms, they can join health clubs and stay in shape, they can buy expensive weapons for protection . . .
But there’s something that hits at us viscerally when a poor person dies from a disease but a rich person who can afford the treatment is cured.
If we cannot realistically afford to find millions – or billions? – of Panamanian albino toads, and thus we cannot treat all people afflicted with this disease, we can either stick with capitalism, and let the rich buy their toads with their own money – or we can move to a more communal approach, controlling and dispensing health care with no regard to personal resources.
But the communal approach will only work if we can deny people the right to acquire health care resources for their children with their own money, and order them to watch their kids die even though they could afford to buy the cure.
So, good luck with that. Death panels truly are in our future, and there’s really no way to avoid them.
Yes, here here ! — better that more die than there be inequality.
Public health be damned — what’s important is that no one — NO ONE — have an advantage that everyone can’t also have.
Better that 1000 citizens die than 800 “privileged” citizens live.
Let’s just quit the gamesmanship, collect the taxes and cut checks to give everyone else their share. Oooops ! That would eliminate the need for all those gubmint jobs to tell you how to spend that money. What to do then ?
Since the Hillarycare debacle, the US pharma industry has operated defensively: Abandoning true innovation to creating “me-too” drugs; and moving the bulk of drug R&D to China and India–two countries which have ZERO respect for intellectual property. IOW, the pharma industry has determined that the risk of losing their IP to thieves is less than losing their business to US over-regulation.
We are so screwed.
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