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Tilting at Windmills

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February 10, 2009

WHAT YOU DON'T KNOW CAN HURT YOU.... The Wall Street Journal reported today, "The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing."

Now, you may read this and wonder what's so bad about research comparing the efficacy of medical treatments. Paul Krugman, who called the push to gut the provision "truly vile" and "really unbelievable," added, "Because freedom is all about laying out vast sums on medical treatments without knowing whether they're actually doing any good."

But let's go a little further, because the $1.1 billion for comparative medical research has been an issue for a while. In fact, just last week, the Senate "centrists" specifically targeted this provision for elimination.

As Harold Pollack explained very well a few days ago, this issue should be a no-brainer.

Comparative medical research is a high priority by any conceivable measure. Candidate Obama and Candidate McCain both advocated major investments here to improve the quality and cost-effectiveness of care, and they were right. An astonishing proportion of American medical care has never been rigorously evaluated, or outright fails to meet reasonable thresholds of quality and cost-effectiveness.

As Ezekiel Emanuel put it in his book Healthcare, Guaranteed: "The United States spends over $2 trillion on healthcare, about $200 billion on prescription drugs, and nearly $100 billion on medical research and development, but only a paltry $1 billion to evaluate the comparative costs and effectiveness of medical interventions and their influence on health outcomes."

The two most responsible funding agencies for this research -- the National Institutes of Health and Agency for Healthcare Research and Quality -- are now getting many more high-quality proposals than they are able to fund. Their peer-review process is rigorous and highly competitive, sometimes excessively so. Many of my junior colleagues are suffering professional setbacks because they cannot find funding for excellent research that would have been supported five or ten years ago. Incidentally, both the loudest and the most dangerously silent opponents of comparative medical research have been surgical subspecialties, medical device manufacturers, and pharmaceutical companies afraid that their ox might be gored.

That the drug and medical-device industries hope to "gut the provision" is crazy.

Steve Benen 12:35 PM Permalink | Trackbacks | Comments (32)

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That the drug and medical-device industries hope to "gut the provision" is crazy. I work for a medical device maker and their on this like stink on a monkey. I remember 9 years ago a corp. suit came in to my plant and started railing against Al Gore and Universal heath care. It's only worse now.

Posted by: Rick on February 10, 2009 at 12:40 PM | PERMALINK

That the drug and medical-device industries hope to "gut the provision" is crazy.

They're putting their parochial interests ahead of the national interest. That's particularly abhorrent in this case, but hardly crazy.

Posted by: low-tech cyclist on February 10, 2009 at 12:41 PM | PERMALINK

That the drug and medical-device industries hope to "gut the provision" is crazy.

No. It's quite sensible from their viewpoint.

Posted by: Duncan Kinder on February 10, 2009 at 12:45 PM | PERMALINK

FYI, the Senate just passed their version of the stimulus bill, 61-37.

Re medical devices, why should we not want them to be tested and eliminate those that don't work. I remember reading an article last year about knee or hip replacement devices that had a great failure rate and that some doctors who were implanting these didn't know. This was of great interest to me since I had knee replacement surgery last year. (I had a great surgeon, very up on the latest and am doing well with it.)

I also have an acquaintance who is working on a PhD in bio engineering and will be inventing medical devices. I know that he would want them fully tested and safe for use.

Posted by: Me on February 10, 2009 at 12:47 PM | PERMALINK

Steve Benen wrote: "That the drug and medical-device industries hope to 'gut the provision' is crazy."

Steve, what is it with you and calling people "crazy" when they advocate measures that benefit themselves at the expense of everyone else?

The Congressional Republicans respond to Obama's economic stimulus by insisting on tax cuts that won't "stimulate" the economy, but will benefit their ultra-rich financial backers -- and you say they are "crazy". They are not "crazy" -- they know exactly what they are doing, and their proposals are proven policies that will accomplish what they hope to accomplish (i.e. enrich the rich). They are not "crazy" -- what they are is greedy and dishonest. Why not say so?

Corporations that profit from selling pharmaceutical drugs and medical devices want to "gut" a provision that would likely reduce the sales of at least some of their most profitable products -- and you say they are "crazy". They are not crazy -- they are greedy and dishonest. Why not say so?

What is it with "sensible liberals" that they seem unable to confront the reality of ruthless, rapacious, relentless class warfare by the ultra-rich corporate aristocracy and their bought-and-paid-for Republican shills against everyone else?

Why call them "crazy" when they are quite obviously NOT "crazy" but are in fact quite intelligent and tough-minded about getting what they want? Why not acknowledge that they are far from "crazy" -- that they are greedy, callous, and reprehensibly, despicably dishonest? That they advocate policies that will enrich themselves to the detriment of the entire nation? That they are, in a word, evil?


Posted by: SecularAnimist on February 10, 2009 at 12:56 PM | PERMALINK

Well there's the free market for ya. Let's wrap a ball of shit in a nice shiny package and call it caviar. And when somebody gets sick eating it just throw up your hands and say how could we have known.

Posted by: Gandalf on February 10, 2009 at 12:59 PM | PERMALINK

Having a chronic disease, I would love this. I have through a dozen treatments/drugs that I was told would "really help"- and didn't. Then I would see an article about that same treatment/drug that basically said that there was never any reason to think it would work, other than drug company marketing.

Posted by: Personal Failure on February 10, 2009 at 1:00 PM | PERMALINK

Me: I also have an acquaintance who is working on a PhD in bio engineering and will be inventing medical devices. I know that he would want them fully tested and safe for use.

Already new devices are tested and the test results submitted to FDA (CDER)before the devices can be marketed.

Comparative medical research is a high priority by any conceivable measure.

Lots of comparative medical research is in fact carried out, some privately for insurance companies, health maintenance organizations and hospital chains, and some is federally financed in the VA and in universities. This is another step toward federalization, which is debatable in principle and which will not have a "stimulus" effect.

Posted by: MatthewRMarler on February 10, 2009 at 1:02 PM | PERMALINK

Make it $5 billion. Would anyone be surprised if the return would be 10 to 1? Cost is the elephant that makes ANY health care plan doomed to ultimate failure. The snake oil salesmen aren't crazy for wanting to avoid scrutiny, we are the crazy ones if we don't demand it. ANY endeavour, particularly one that relies on shared risk and government backing, that is essential to the welfare of the country requires oversight.

Posted by: Michael7843853 on February 10, 2009 at 1:05 PM | PERMALINK

Sounds a bit like this lobbying effort is focused on profits, profits, and profits instead of the Hippocratic Oath. Our citizens deserve cost-effective, procedure-effective, and recovery-effective medicine. Not just a lot of pill pushers and procedure gougers!

Interests who want this stimulus component cut are not working for the best interests of our nation and its citizens. Just say no to entrenchment! -Kevo

Posted by: kevo on February 10, 2009 at 1:07 PM | PERMALINK

Medical care in the U.S. is sometimes incredibly empirical rather than scientific. Radical mastectomies were the standard treatment for breast cancer for many years till a surgeon tried “super radicals” and found no increase in survivability. To his credit he then went the other direction and tried modified mastectomies and found for many cases the survivability rate is the same.

Similarly, every major hospital in the U.S. built a coronary catheterization lab before there was scientific data that there was a real increase in survivability. Years later when the study was run, it turned out the increase in survivability from angioplasty (stents and balloons) is nil to small, although the patients due enjoy increased quality of life due to reduced pain.

I worked as an engineer with start ups building angioplasty and biopsy devices. It was interesting how many new techniques are marketed initially to radiologists because they are viewed as early adopters of new technology. They got the ball rolling on balloon angioplasty and it was only when the procedure started becoming popular and lucrative that the more conservative cardiologists created the new category of “invasive cardiologists” to co-opt the radiologists.

Drugs and medical devices are definitely a for profit business. Those in the industry view all the regulatory hurdles as barriers keeping competitors out. The sad news is once a drug or device completes medical trials and is approved there is usually very little additional research or tracking of its efficacy and safety.

Posted by: J. Frank Parnell on February 10, 2009 at 1:13 PM | PERMALINK

Me: I also have an acquaintance who is working on a PhD in bio engineering and will be inventing medical devices. I know that he would want them fully tested and safe for use.

MatthewRMarler: Already new devices are tested and the test results submitted to FDA (CDER)before the devices can be marketed.

Well I know that, and probably should have said instead that he would want to make sure they actually work in a safe and effective manner.

But the FDA has OK'ed meds that are not safe due to pressure by big pharma, etc. and people have died. I have greater hope that that agency will actually work the way its supposed to under the Obama admin.

Posted by: Me on February 10, 2009 at 1:19 PM | PERMALINK

I'm with SecularAnimist. Crazy, they are not. Greedy, yes.

Don't forget -- almost every other modern-economy country has universal health care. It's cheaper per capita, cheaper as percentage of GDP, longer lifetime, less time sick, lower infant mortality. Our "free market" solution is not yielding the superior results that true believers claim it should. When theory diverges from experimental results, TWENTY TIMES, perhaps it is time to fix the theory.

Posted by: dr2chase on February 10, 2009 at 1:20 PM | PERMALINK

I have worked with numerous medical device companies and have been astonished at the profit motive over healthful benefit motive these corps operate under. Worse when faced with the simple question:" who benefits from this device besides you the manufacturer? " they are very often unable to answer it.

Case in point: one company had an alternative to an ordinary yet specific procedure. They had patented the process and developed the equipment for it as one big package. When they brought in a Surgeon who performs this procedure 2x times a week to review it, he pointed out the obvious shortcomings to their alternative and proposed changes and recommendations.

It became obvious that, had someone consulted with this Surgeon in the early stages of development and compared the true final benefits of the initial procedure to their alternative to it, it would have truly been a revolutionary and truly useful and better solution.

Naturally since so much was already invested into the "R&D", and the Corp insisted that they were smarter than the Surgeon, they went ahead and developed the product which promptly failed trials.

So in their infinite wisdom; in an attempt to recover costs and not hurt their stock offering, they paid off a few surgeons to okay their procedure. It went to market and it hurt people it was supposed to help. The company spent more money defending themselves from lawsuits and re-branding their failure as they did on the initial R&D. They are probably dumping cash into lobbying to strip this provision from the stimulus.

This is SOP in the Medical Device field. When you look at the R&D departments of a a typical Medical device Co its astonishing to see that Doctors and Surgeons are outnumbered 10 -1 by MBAs, Sales and Marketing

Posted by: Stented Growth on February 10, 2009 at 1:33 PM | PERMALINK

Marler, read up on the PMA process and go locate your conscience.

Posted by: Blue Girl on February 10, 2009 at 1:33 PM | PERMALINK

Here - I will even point you in the right direction, to a GAO report released last month.

(I got this one Gregory...)

Jackass.

Posted by: Blue Girl on February 10, 2009 at 1:35 PM | PERMALINK

Marler, read up on the PMA process and go locate your conscience.

To dream, the impos-sible dream!

Posted by: trex on February 10, 2009 at 1:46 PM | PERMALINK

Heh! And still he stays stonily silent on the Lancet study he promised to debunk. Yet doesn't have the stones to say "I was wrong." What a guy...

Posted by: Blue Girl on February 10, 2009 at 1:51 PM | PERMALINK

Re medical devices, why should we not want them to be tested and eliminate those that don't work.

I don't know. Go ask the aerospace firm that's working on invisible fighter bombers to counter the inevitable robot landwalkers that surely some superpower is developing to use against us. Never mind that there aren't any superpowers out there with that kind of military budget.

If you want to talk about real waste, let's talk about providing food stamps to people who spend 50 hours a week on their knees cleaning toilets for a sub living wage.

Freeloaders.

Posted by: lobbygow on February 10, 2009 at 1:57 PM | PERMALINK

Some states already have similar ideas on the books.

Oregon, for example, requires what it calls "evidence-based" treatment standards for drug and alcohol rehab centers.

Posted by: SocraticGadfly on February 10, 2009 at 2:00 PM | PERMALINK

Oregon really seems to be where it's at in terms of effective health care reform. That's why I'm sure the powers that be will never allow Oregon's governor/former governor to become HHS Secretary.

Posted by: Allan Snyder on February 10, 2009 at 2:09 PM | PERMALINK

I have family living in Germany. Many years ago, Germany did just this comparison and found that many herbs work just as well, or better than many manufactured meds. The Docs there often give prescriptions for one herbal tea or another, and many homeopathic remedies are used. We have found it to be a much better approach with far fewer side effects. And the medical community is not beholden to the drug industry. It is time the US did the same thing.

Posted by: Lynne on February 10, 2009 at 2:37 PM | PERMALINK

It is time the US did the same thing.

Somewhere a paramilitary unit of the AMA is being mobilized to cut your communications and do a night drop into your yard. You'd better take it back!

Posted by: uh oh on February 10, 2009 at 2:45 PM | PERMALINK

If Pharma would have a code of ethics anywhere near to what they claim in their wholesome company slogans and their fancy advertising campaigns, why do they feel it necessary to spend roughly twice as much on marketing compared to R&D?

Big Pharma knows that health care is an area where market forces are difficult to make to work in any case. What supply of health on offer is likely not to find a buyer, if only the offer is made in a half ways credible fashion?

At Bio 2002 in Washington, DC, (if memory serves right) a big marketing honcho from Pfizer proudly gave a presentation with the message 'Blockbusters do not come about by chance, they are made'. Well, how does that happen?

In addition, the complexity of human physiology and pathophysiology is such, that it takes a very dedicated effort from someone on the patient side of the market in order to obtain more than a fleeting and segmented picture of a therapeutic area.

As there is no incentive for Pharma to pull back once it has spend hundreds of millions to reach a late clinical development stage or even marketing authorization, any effort to objectively establish the relative efficacy of different treatment options will only come about if forced upon the drug and medical-device industry from the outside.

The interests of the drug and medical-device industry to 'gut the provision' in the stimulus bill is therefore rather obvious. What is the really ‘crazy’ aspect, is the willingness of members of Congress to be their willing servants in this regard.

Posted by: SRW1 on February 10, 2009 at 2:46 PM | PERMALINK

Well done, Blue Girl!

Yet doesn't have the stones to say "I was wrong."

I think most experienced readers of these threads view the following as an admission of wrongness: Posted by: MatthewRMarler

Personally, I love Marler's tacit admission that his so-called conservative princples (read" "More tax cuts, please!") can't be defended in good faith.

And while Blue Girl dealt superbly with Marler's other dishonesties, I'll pick up on this one: This is another step toward federalization, which is debatable in principle

As even you admit, Marler, regulation of pharma and medical devices is already a Federal responsibility. The principle you'd like to debate is that we shouldn't just take the industry's word for their safety and efficacy as opposed to submitting them to impartial federal regulation.

Shame on you, Marler.

Posted by: Gregory on February 10, 2009 at 3:05 PM | PERMALINK

Homeopathic "remedies" are the equivalent of placebos. There has never been a properly controlled scientific test that showed anything different. This doesn't mean that they may not be more effective than some drug that causes more harm than good, of course. And herbs are a whole different thing, though there are obvious problems with dosage control.

Posted by: DavidNOE on February 10, 2009 at 3:08 PM | PERMALINK

Lynne, I beg to differ. Germany has loose regulation of homeopathic "medicines." (The term has to have scare quotes.)

Most not only have not been proven, many have been scientifically disproven. As a left-liberal, the blind support for such inanity is one of the biggest "issues" I have with Greens.

Also, Lynne, the claims of "beholdenness" are just wrong. The supplements industry is a good example. It's largely based in Utah, because of Mormon connections, and hugely lines Orrin Hatch's pockets with campaign cash so he will fight to keep it largely unregulated.

Posted by: SocraticGadfly on February 10, 2009 at 3:14 PM | PERMALINK

How many pain killers and anti-depressants could weed replace? How much money saved, when grown in the home with taxable seeds and kits sold by regulated wholesalers and retailers? How much less violence and incarceration? Efficiency and efficacy at a bargain price. Stop the tragedy and heartbreak of spurious ditchweed!

Posted by: Michael7843853 on February 10, 2009 at 4:11 PM | PERMALINK

Mixed feelings on more gov't oversight of MY personal med records. How will it square with HIPPA?

AND....as someone with emerging diseases (lyme & babesia duncani), where the research still has a long way to go...I shudder when the IDSA or any other gov't body tries to dictate one size fits all. One size (one treatment) doesn't do the trick for tick borne illnesses and it doesn't for TB or many other infectious diseases.

Posted by: Evergreen2U on February 10, 2009 at 5:28 PM | PERMALINK

"The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing." -- Wall Street Journal

Even if it (govt rationing as the final goal) were true...How does govt rationing differ from "health plan" rationing and why is one worse than the other?

2.5yrs ago, my doctor prescribed "Drug A". After 3 months of trial, he checked for efficiency and side effects and, as everything was fine, we went on with the drug, and the health plan covered a big chunk of the cost.

Then, about 15 months ago, the U (where I'm insured), switched, from "Plan 1" to "Plan 2", to save on costs. The very first thing "Plan 2" did, was to deny payment for "Drug A", demanding that I switch, to "Drug B". If my doctor (and I) insisted on continued use of "Drug A, I'd have to pay the full price myself.

Well, the full price of "Drug A", on top of the payments for the insurance was just too much, so we switched. Another trial period, another round of testing (for efficiency and side effects) and, "Drug B" proving to be as good as "Drug A", that's what I'm on now.

But, please don't talk to me about *possible* "government rationing", when an insurance plan is already overriding a doctor's judgment. And not even on the basis of efficiency or cost -- "Drug B" costs twice as much as "Drug A" did, while my co-payment has remained the same -- *this* rationing is based on which pharmaceutical company the insurance plan has the sweetest deal with.

Universal. Single Payer. Not For Profit. That's the Healthcare We Need.

Posted by: exlibra on February 10, 2009 at 8:26 PM | PERMALINK

me: But the FDA has OK'ed meds that are not safe due to pressure by big pharma, etc. and people have died. I have greater hope that that agency will actually work the way its supposed to under the Obama admin.

People have also died while awaiting FDA approval of drugs that subsequently proved to be both safe and effective. Some of the pressure for FDA to approve drugs rapidly comes from the doctors who want to prescribe them. With imperfect information and random variability (this is where statistics comes into play, and FDA has excellent statisticians), there will never be a time that FDA or anybody else can guarantee that the approval process will approve drugs both rapidly enough to save everyone who needs them and safely enough to prevent all deaths due to unwanted effects.

Posted by: MatthewRMarler on February 10, 2009 at 8:28 PM | PERMALINK

Of course it comes as a surprise to no one that, confronted with his dishonesty, Marker changes the subject.

People have also died while awaiting FDA approval of drugs that subsequently proved to be both safe and effective.

Yeah. They've also died waiting for pharma companies to develop drugs (and by the by, let's also not forget those who die because pharma companies won't develop drugs for which there isn't a perceived profit). So what? That doesn't justify the changes the med device companies are pushing and you know it.

Some of the pressure for FDA to approve drugs rapidly comes from the doctors who want to prescribe them.

"Some," maybe, but doctors also know that said drugs must be proven safe and effective -- after all, they're liable if they wind up pushing snake oil. Your citation of this fact is a blatant appeal to emotion but again, has no relevance to the topic.

How lovely of you to deploy yet more dishonesty in defense of your odious philosophy, Marler. Thanks for demonstrating your bad faith once again to the readers of these threads -- it's yet another reason you fool no one into thinking you're an honest commentator. We're on to your bullshit, Marler. Shame on you.

Posted by: Gregory on February 11, 2009 at 9:04 AM | PERMALINK




 

 

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