Skip to main content

One of the subplots behind the negotiations over the just passed stimulus bill is that, as Steven Pearlstein points outin the Huffington Post, the drug and medical equipment manufacturers joined forces with the disease advocacy groups ("like Easter Seals and the American Cancer Society") to attempt to gut the stimulus bill's money for research on the comparative effectiveness of treatments. Those groups don't want us to know whether some expensive treatments are worse or no better than cheaper treatments. They united to attempt to remove money for "comparative effectiveness research" from the stimulus package, and almost succeeded.

This unholy trinity want to replace money for "comparative effectiveness research" with support for "clinical effectiveness research."  That single word difference would have profound effects, to the benefit of the companies and the detriment of the rest of us. "Clinical effectiveness research"  merely determines if a treatment is better than doing nothing, without determining if it is better than alternative treatments. In their desired model of research, a new drug is compared to a placebo sugar pill. If it works better than the sugar pill, the drug company can launch a full campaign to get doctors to prescribe, and us to take, their newest drugs that, because they are still under patent, may cost many times more than the cheaper generic. The last thing the drug companies want us to know is if their new patented pill is any better, or even as effective as, the far cheaper generic. The medical equipment manufacturers similarly want doctors to use their latest inventions without any evidence that they are better than the last generation of medical devices.

While one can't help wondering about the influence of manufacturer money, the interests of the disease advocacy groups are apparently at least in part more benign, though equally dangerous. As Pearlstein explains:

The flames were also fanned by "disease groups" like Easter Seals and the American Cancer Society, which fear that any attempt to determine what works best will inevitably lead to a one-size-fits-all approach to treating people with serious chronic conditions.

Maintaining clinical flexibility is important. But it cannot and should not come at the expense of understanding what works best and what doesn't work as well. Only comparative research can answer these questions. The advocacy groups are doing the public a disservice by joining the drug and equipment manufacturers in their effort to stifle comparative research.

Pearlstein points out that the report of the House Committee on Appropriations explained the rationale for this research in clear language:

"By knowing what works best and presenting this information more broadly to patients and healthcare professionals, those [treatments] that are most effective . . . will be utilized, while those that are found to be less effective and in some cases more expensive will no longer be prescribed."

As with everything, there are dangers in comparative effectiveness research. Sometimes outcomes measures are tailored to produce desired results. The research can then be misused as a rationale for refusing treatments solely because they are expensive. But that is a misuse.

As the costs of medical treatment rise ever  higher, some type of cost controls are inevitable. It is simply not possible for healthcare costs to continue rising at the present  rate. Either such cost controls will be based upon the best available research or they will be based upon far less desirable criterion. It is in the interests of everyone other than those peddling expensive ineffective treatments for us to develop a rational, comprehensive, and sophisticated system for conducting high quality comparative effectiveness research.

While this may seem like an arcane issue, only if we use our health resources wisely to fund effective, and cost-effective treatments, do we have any hope of getting health care costs under control. Every dollar spent on an ineffective treatment is a dollar that could go to providing health care for all, or for meeting any of the numerous other unmet social needs. Without control of health costs, universal coverage will never arrive, it will always be defeated as too expensive. In fact, a health costs rise, increasingly we will find ourselves denied even effective treatments by irrational and ineffective ways of controlling costs.

Of course, the drug and medical equipment companies have no interest in getting health care costs under control. The more we spend, the more profit they earn. Whether that money leads to improved health is none of their concern. But it should be of  primary concern for the rest of us.

It is sad that the disease advocacy groups went along with this farce. We don't need only to spend more on the fight against cancer. We need to spend more wisely on cancer. Expensive treatments, costing tens or hundreds of thousands of dollars should only be paid for out of public funds if they work better than cheaper alternatives. "Comparative effectiveness research" would seem like a no-brainer, but it almost got defeated by this unholy coalition. These same folks will unite again to fight every improvement to our healthcare system. We cannot afford to let them win.

[Also posted on Psyche, Science, and Society.]

Originally posted to stephen soldz on Fri Feb 13, 2009 at 05:27 PM PST.

EMAIL TO A FRIEND X
Your Email has been sent.
You must add at least one tag to this diary before publishing it.

Add keywords that describe this diary. Separate multiple keywords with commas.
Tagging tips - Search For Tags - Browse For Tags

?

More Tagging tips:

A tag is a way to search for this diary. If someone is searching for "Barack Obama," is this a diary they'd be trying to find?

Use a person's full name, without any title. Senator Obama may become President Obama, and Michelle Obama might run for office.

If your diary covers an election or elected official, use election tags, which are generally the state abbreviation followed by the office. CA-01 is the first district House seat. CA-Sen covers both senate races. NY-GOV covers the New York governor's race.

Tags do not compound: that is, "education reform" is a completely different tag from "education". A tag like "reform" alone is probably not meaningful.

Consider if one or more of these tags fits your diary: Civil Rights, Community, Congress, Culture, Economy, Education, Elections, Energy, Environment, Health Care, International, Labor, Law, Media, Meta, National Security, Science, Transportation, or White House. If your diary is specific to a state, consider adding the state (California, Texas, etc). Keep in mind, though, that there are many wonderful and important diaries that don't fit in any of these tags. Don't worry if yours doesn't.

You can add a private note to this diary when hotlisting it:
Are you sure you want to remove this diary from your hotlist?
Are you sure you want to remove your recommendation? You can only recommend a diary once, so you will not be able to re-recommend it afterwards.
Rescue this diary, and add a note:
Are you sure you want to remove this diary from Rescue?
Choose where to republish this diary. The diary will be added to the queue for that group. Publish it from the queue to make it appear.

You must be a member of a group to use this feature.

Add a quick update to your diary without changing the diary itself:
Are you sure you want to remove this diary?
(The diary will be removed from the site and returned to your drafts for further editing.)
(The diary will be removed.)
Are you sure you want to save these changes to the published diary?

Comment Preferences

  •  Tip Jar (19+ / 0-)

    Research such as that discussed here is an essential component of any comprehensive healthcare reform.

    •  Evidence based medicine (0+ / 0-)

      is absolutely essential to achieve good quality of care. America's balkanized system is enormously expensive but is not very effective for the average American. We are already rationing care despite having the most expensive system in the world.

      Comparative results research is one means of finding out how to waste less money and serve more patients. Good research will include the effects of individual variability. Genetic differences are no excuse for not pursuing sound scientific investigations.

      "It's the planet, stupid."

      by FishOutofWater on Fri Feb 13, 2009 at 09:21:38 PM PST

      [ Parent ]

  •  Well done (9+ / 0-)

    What really chaps my ass about this is that for the last at least eight years (or going back to 1994... 15 years), what we've been hearing from Republicans is that the reason that health care costs have risen so drastically is that people are consuming too much in medical services, that individuals need to become more responsible in weighing their treatment options and make more informed decisions about how to spend their health care dollars.

    So... exactly how are people supposed to make more informed decisions about how to spend their health care dollars if no comparable research is available comparing various treatment options.  To make a truly informed decision people need to be able to compare not only cost, but effectiveness of the treatment options.

  •  The problem with comparative research (2+ / 0-)
    Recommended by:
    barbwires, ladybug53

    is genetic variability.

    Namely, a given drug will not effect two people with the same efficacy.  So how do you take that into account?

    That is the problem with the one-size-fits-all problem.

    (-8.50, -7.54) Only the educated are free. -Epictetus

    by Tin hat mafia on Fri Feb 13, 2009 at 06:00:21 PM PST

    •  It depends. (2+ / 0-)
      Recommended by:
      cotterperson, earicicle

      Of course there is genetic, and other, individual variability. and, where possible, treatment should be tailored to the individual.  Can we determine what works for whom? That is the ideal.

      But short of the ideal, one should start with cheaper treatments, in the absence of evidence that more expensive treatments are more effective, for this person. If we don't know how individual variability affects efficacy, that is the only reasonable thing to do.

      Some efficacy research looks at subgroups. It's tough, because sample sizes get small. But researchers usually think of it.

      Better medical records systems will allow "data mining" to try and identify subgroups responding better, or worse, to specific treatments.

      In the absence of evidence, how does one have any idea that their "genetic variability" will lead them to respond better to one treatment vs. another.

    •  this is exactly why follow-up comparative (4+ / 0-)

      studies are needed.

      A drug company wants to convince doctors and patients that their new drug is better.  They can find some genetic markers that correlates with improved outcome, and then tweak their medicine and make a second study, with a selected group of patients.  Then they can get say, 3% improvement on the selected group.

      Then they have a study to cite to market the new stuff to everybody.

      This is somewhat of a conjecture, but I read that it is pretty much what happens with anti-depressant studies.  On a random sample of people complaining about depression, the drugs are hardly better then placebo, so perhaps most people should be offered placebo (say, homeopathic or, ayurvedic medicines or some such) plus a monthly meeting with a lowly paid therapist (remember, placebo effect requires doing something helpful that the patient knows is helpful).  But from earlier studies the companies know how  to select patients who really respond to psychoactive drugs better than to placebo, so they can show higher effectiveness.  And, of course, they market the anti-depressants for all patients.

      We cannot rely on companies to do all the necessary research, because their motivation only partially agrees with better health of patients, not to mention a better economy of medical spending.

    •  Red Herring (0+ / 0-)

      For most medications, the only differences are very minor side chain variations to get a patent to rake in the bucks.
      If one size fits 90%, then you can try that size on first, and then go to alternatives if it doesn't "fit". But there is no excuse to spend money on the more expensive meds if the cheaper ones are as effective.

      On this day, we gather because we have chosen hope over fear, unity of purpose over conflict and discord" President Barack Obama 1/20/2009

      by UndercoverRxer on Fri Feb 13, 2009 at 07:23:14 PM PST

      [ Parent ]

  •  This story is amazing (2+ / 0-)
    Recommended by:
    A Man Called Gloom, earicicle

    And that they have no shame.

    We must pick ourselves up, dust ourselves off, and begin again the work of remaking America.

    by Minerva on Fri Feb 13, 2009 at 06:14:59 PM PST

  •  A great area for Government Funded Research (6+ / 0-)

    Comparitive effectiveness reseach would be great - as long as it is done with sufficient sophistication.

    It should also test various substances that are not on patent, or could not go on patent - as industry does not.

    Testing for likely ineffective treatments such as homeopathic, and others should be tested as well so if shown to be ineffective - they can remove FDA loopholes that allow ineffective products from being sold as medical products and in some cases prosecute for fraud.

    The most important way to protect the environment is not to have more than one child.

    by nextstep on Fri Feb 13, 2009 at 06:15:37 PM PST

    •  I agree. (5+ / 0-)

      testing should include "natural" haelth aids. Some probably work. Some do n ot. an some probably cause harm. We need to find out. That was one big loophole forced through by the billion dollar supplement makers removing any requirement for examining safety and efficacy.

    •  Oooh!! Undercutting the patents (1+ / 0-)
      Recommended by:
      earicicle

      and making them less lucrative would be a good thing. I like the patent system in general, but it's thoroughly abused and perverted by big pharma.

      Denny Crane: But if he supports a law, and then agrees to let it lapse … then that would make him …

      Shirley Schmidt: A Democrat.

      by Jyrinx on Fri Feb 13, 2009 at 07:37:41 PM PST

      [ Parent ]

    •  For hospitals, comparitive efficacy is no joke. (0+ / 0-)

      I worked for 20 years providing independent comparative efficacy information to the healthcare industry for big bucks. The reason is that most insurance has a fixed payout by disease, and using less effective drugs can mean a longer stay, and the hospital will have to eat the expenses. So maybe when it comes to giving you a hard-on, they can get away with it, but ultimately, there is little room for ineffective drugs in the hospital market.
      Also - don't knock homeopathy - I have used it effectively for decades.

  •  Hugely important topic! (4+ / 0-)

    This importance of this subject cannot be overstated, especially when it comes to the introduction of new drugs. It SHOCKS me that all Big Pharma has to do is test against a sugar pill. Do they spend lots on drug research? Yes, because they're in a constant and desperate race to invent new stuff before the old stuff goes off patent. New is the key for their profit margin. Better--not so important, if you only have to beat a sugar pill.

    Take the extremely lucrative asthma and allergy market. Ever use a generic inhaler? Yep, I didn't think so. I have a fairly extreme allergic reaction to cigarette smoke, and a steroid nasal inhaler called Vancenase used to help curtail the reaction when I was exposed. When Vancenase went off-patent, it disappeared from the market. I've tried every other inhaler since, and nothing works remotely as well. They all are hugely expensive. I've talked to many patients with a variety of allergy and asthma issues who felt Vancenase also better controlled their symptoms. But Big Pharma wouldn't make much money licensing its generic manufacture. So, guess what? We're shit outta luck.

    Sweet are the uses of adversity...Find tongues in the trees, books in the brooks, and good in everything. -Shakespeare, As You Like It.

    by earicicle on Fri Feb 13, 2009 at 06:27:17 PM PST

    •  I had no idea. (3+ / 0-)
      Recommended by:
      A Man Called Gloom, earicicle, Jyrinx

      I was part of a clinical trial for Vancenase back in the '80s or so. It was the first effective medication I took for allergies. After reading your post, I was curious and found they sell the generic in Canada.

      http://www.canadadrugs.com/...

      Big Pharma needs extensive regulation to ensure that a transnational corporation isn't working against the "general welfare" of We the People.

      Aaargh!

      •  I think this is generic Beconase, which is one (1+ / 0-)
        Recommended by:
        cotterperson

        of the several inhalers I have tried. Slightly different, and not as effective. I had a couple of pharmacists research the issue for me, but will follow up again when I'm not so tired. Thanks so much for looking it up for me. I live just 30 minutes from Canada, and could easily pop up there to get meds if needed. I'm up there a lot in the summer anyway--my mom lives in Quebec for several months each year.

        Fortunately, I rarely come into contact with smoke anymore. Just, ironically, outdoors now--since it's banned everywhere indoors in VT, even bars. Sadly, when I visit my sis in Michigan, smoking is still allowed in places like restaurants and bowling alleys, which makes it hard to do stuff with the kids.

        Sweet are the uses of adversity...Find tongues in the trees, books in the brooks, and good in everything. -Shakespeare, As You Like It.

        by earicicle on Fri Feb 13, 2009 at 07:14:55 PM PST

        [ Parent ]

    •  It's not always a race. (1+ / 0-)
      Recommended by:
      earicicle

      I mean, why release version 2.0 when you can sit on 1.0 for twenty years without facing competition? Then you can just make a once-a-day extended-release form (a popular way to repatent a drug; Ritalin becomes Concerta, Adderall becomes Adderall XR, etc.) and sit on the patent for 2.0 for another twenty years.

      Of course, this all flies in the face of the way patents are supposed to work — a simple modification of the delivery system of a drug that just makes it release more slowly should not be enough of a modification to grant a new patent. And if it is enough, someone should be able to make someone else's patented drug by creating their own extended-release version. But the oligopoly keeps everyone from wanting to rock the boat like that …

      Denny Crane: But if he supports a law, and then agrees to let it lapse … then that would make him …

      Shirley Schmidt: A Democrat.

      by Jyrinx on Fri Feb 13, 2009 at 07:42:41 PM PST

      [ Parent ]

    •  How about albuterol? (0+ / 0-)

      I bet that's the number one asthma inhaler, and quite cheap.

      •  I don't have asthma. (0+ / 0-)

        But thank you.

        I need an anti-inflammatory nasal inhaler, and for whatever reason, nothing else seems to work as well as the darn Vancenase.

        Sweet are the uses of adversity...Find tongues in the trees, books in the brooks, and good in everything. -Shakespeare, As You Like It.

        by earicicle on Fri Feb 13, 2009 at 07:56:42 PM PST

        [ Parent ]

  •  I sure hope so! (3+ / 0-)

    "By knowing what works best and presenting this information more broadly to patients and healthcare professionals, those [treatments] that are most effective . . . will be utilized, while those that are found to be less effective and in some cases more expensive will no longer be prescribed."

    If that indeed becomes the case, longer dialysis treatments will be prescribed and followed, and for-profit dialysis clinics will no longer be able to cycle chairs as often as once every three hours. (Four hours of treatment should be a bare minimum.) In fact, since longer, slower treatment more often is more effective, more and more dialysis patients will be steered towards home treatments such as short daily treatment and (best of all) nightly nocturnal treatment. And then Medicare will actually PAY for treatments 5-7 nights a week, instead of only paying for 3 days a week, which is the minimum required to sustain life.

    Let's get away from doing the minimum for people who have to live with chronic diseases. Give us the MOST effective treatment.

    Want to be a living kidney donor? I need one from someone with a bloodtype of B or O. Drop a note at riverheart.livejournal.com.

    by Kitsap River on Fri Feb 13, 2009 at 06:34:46 PM PST

  •  alternative suggestion (1+ / 0-)
    Recommended by:
    longtimewatcher

    There is value in showing something is better than a placebo.  This is the present standard for approval.  Sometimes a marginally effective medication with minimal side effects is a better choice than a more effective medication with a more substantial potential for side effects.  If we only approve the more effective medication we miss a theraputic choice.  Perhaps there could be a longer patent for medications found to be more effective with fewer side effects giving the manufacturer an incentive to do this additional testing.

    •  I DO like choice (0+ / 0-)

      I'm not sure if ACS and Easter Seals are right in thinking that this is a slippery slope we are heading down, or whether there is already public policy to support these fears.  The idea of compariative testing sounds great.  My bottom line, though, is choice.

    •  Ummm...some of these new flashy meds are (1+ / 0-)
      Recommended by:
      Jyrinx

      the worst of both: marginally effective AND more side effects.

      My rule: take the oldest damn thing on the market that does the trick. Give me the KNOWN quantity.

      Sweet are the uses of adversity...Find tongues in the trees, books in the brooks, and good in everything. -Shakespeare, As You Like It.

      by earicicle on Fri Feb 13, 2009 at 07:58:53 PM PST

      [ Parent ]

  •  "Me too" drugs (0+ / 0-)

    Me too drugs are drugs that are extremely similar to drugs that are on the market. "Me too" drug approvals make up the majority of drug approvals, and count for a huge amount of R&D money. I could, if I cared to, write a diary about why this is the case, but it certainly recapitulates this diary's thesis.
    See http://www.fool.com/... for a good article on it. From, oddly enough, the Motley Fool.

  •  I would not be so quick to condemn.... (2+ / 0-)
    Recommended by:
    vcmvo2, slouchsock

    I am so sick of the phrase "they have no shame"--it has become so trite and overused it has become worthless.

    I am all in favor of electronic medical records and documentation of "best practices". But, just like unions are suspicious of giving too much control to management, I also have some concerns about the reflexive nature of government bureaucracy to try and exert increasingly inflexible control and to protect its turf.

    I don't know what the ultimate motivation of the ACS is in opposing this bill--it could be entirely self-serving and petty--but given the variability of response to various cancer treatments, I would have some questions about the ultimate goal of a government "best practices" database.

    Funny, because I am arguing a somewhat opposite position with conservatives who are claiming that this means that "the socialist Obama government wants to ration your health care". I tell them that their health is being rationed RIGHT NOW--by acccountant and MBAs, based not on research, but on profit.

    So I am in favor of proceeding down the path, but I do want to know more about how this information will be collected, stored, ultimately used, and how privacy of personal medical records will be built into the system.

    If there is anyone out there who still doubts that America is a place where all things are possible...tonight is your answer.

    by Azdak on Fri Feb 13, 2009 at 07:43:41 PM PST

  •  drug effectiveness in cancer (2+ / 0-)
    Recommended by:
    vcmvo2, meralda

    I have been fighting ovarian cancer for 13.75 years. For 7 years my disease was kept stable by off-label use of a breast cancer drug. I was treated for 15 months with a colon cancer drug, and the disease I had was reduced by 2/3's.

    If we had stopped treating me when the approved drugs were exhausted, I would have died 7 years ago.

    For illnesses which are life-threatening and affect a not-large part of the population, we can't waste time on comparative studies when what is needed are MORE effective drugs. We just don't have a high enough incidence rate to test out everything and all the possible combinations.

    However, if all of the treatment histories were anonymously put into a data base, lots of comparative studies could be done.

    •  The idea isn't to hold up approval. (0+ / 0-)

      It's to give doctors more data to use when there is a choice.

      Denny Crane: But if he supports a law, and then agrees to let it lapse … then that would make him …

      Shirley Schmidt: A Democrat.

      by Jyrinx on Fri Feb 13, 2009 at 08:31:13 PM PST

      [ Parent ]

      •  my worry is that ONLY (1+ / 0-)
        Recommended by:
        Jyrinx

        drugs with good comparative data will be allowed to be used. That means all the "orphan illnesses" will be left out of the picture.

        It is already a problem. Drug companies get approval for one drug and then don't do the studies on other illnesses because the process is time consuming and expensive and they can only reap the Patent money for a relatively short time. I'm no advocate for big pharma--I just want to say that not all drugs fit into the comparative data model.

Subscribe or Donate to support Daily Kos.

Click here for the mobile view of the site