dras knowledge

Friday, August 24, 2007

"Who Killed Health Care?"

I read a review of new popular book on Health Policy (below.) Opinions about health policy and alternative medicine are often intertwined as both are impacted by similar influence.

I am still trying to decide where is the happy medium between health care controlled by "the managed care companies, hospital systems, large employers, and elitist academics" and health care with absolutely none of the checks and balances or consumer protections that such entities provide.

Who Killed Health Care?
By Regina Herzlinger,
Harvard Business School
304 pp

"She starts right out by declaring war on the health care establishment - the managed care companies, hospital systems, large employers, and elitist academics who think only they are smart enough to decide what care consumers should receive. She is explicit - "You and I are the victims of untrammeled vanity, greed, and self-interest of those meant to protect us." She goes on, "The real issue here is power: the less you and I know about the facts, the greater the power of those in the know - the hospitals, the insurers, and the health policy researchers."
--excerpt from a review by Greg Scandlin of Consumers for Health Care Choices. http://www.chcchoices.org

Thursday, August 16, 2007

Resonance and Placebo Effect: New Age Science

Here is an interesting article from the April issue of The Journal of
Alternative and Complementary Medicine:

Resonance, Placebo Effects, and Type II Errors: Some Implications from
Healing Research for Experimental Methods

The Journal of Alternative and Complementary Medicine. 2007, 13(3):

William F. Bengston, Ph.D.
St. Joseph's College, Patchogue, NY.
Margaret Moga, Ph.D.
Indiana University School of Medicine, Terre Haute, IN.

Background: Classical experimental design presupposes that subjects,
randomly separated into experimental and control groups, are independent
and distinct. Treatments given to the experimental group ought to have
no effect on the control group, which functions as a baseline to
illustrate “what otherwise would have happened.” Any change in the
control group is often labeled an “anomaly.” Examples of these types of
anomalous phenomena can be found in placebo research, which often shows
proportional unexpected and unexplained changes in control subjects.

In four previously reported experiments on anomalous healing using
“healing with intent” on mice injected with lethal doses of mammary
adenocarcinoma (source, The Jackson Laboratories, Bar Harbor, ME; code,
H2712; host strain, C3H/HeJ), a high percentage of both experimental and
control mice exhibited an anomalous healing pattern, most often passing
through stages of tumor ulceration to full life-span cure.

Objective: In order to explain tumor regression of control animals, I
posit the formation of “resonant bonds,” which can link spatially
separate groups. Healing given to the experimental animals can result in
an unintended treatment to the control animals, producing anomalous
healing akin to placebo effects.

Materials and methods: A recently completed experiment at the Terre
Haute campus of the Indiana University School of Medicine has produced a
successful test of resonance theory. One group of mice (n = 30) was
injected with mammary adenocarcinoma cells and randomly divided into a
treated group (n = 15) and untreated control group (n = 15). A second
group of age-matched controls (n = 25) was left uninjected. Mice from
each group were intermittently sacrificed to measure hematologic values
and spleen weight.

Results: As predicted by resonance theory, there were few differences
between treated and untreated animals from the first group, but there
were significant differences between these animals and the age-matched

Conclusions: Some implications for placebo research and the way we
normally conceptualize Type II errors will be discussed. Researchers are
invited to reanalyze past data in light of resonance theory.


Comment: often in science one includes not just a negative control
(where you expect nothing to happen), but also a positive control (where
something is supposed to happen). In this study, the positive control
(mice injected with adenocarcinoma cells) failed - most of the mice
recovered from their injections, whereas for this protocol in other
laboratories, the mice “normally have 100% fatality subsequent to

Most investigators would conclude from this that something has gone
wrong with the protocol, and try to correct the apparent error.
However, in this case the authors conclude that there is “resonance,”
such that the mystical “healing” (through mental effort alone) applied
to the treatment group also carried over to the control group.

There are a few other interesting aspects to the paper, such as
violations in protocols, and favorable citation of the psychokinesis
experiments of Jahn at Princeton (PEAR).

An editorial in the same issue, "Healing by Skeptical Trainee Healers,"
by Alex Hankey and Sara McCrum, is available for free:


I'm trying to put this in English, which is hard to do when I don't have all the referenced material they cite each time they use an unfamiliar word or phrase. There appears to be developing a distinct genre for this type of research complete with it's own scientifical-sounding terminology.

Is what I think they are trying to say is that any kind of relationship between groups in a study can create a "resonant bond" that will be a significant influence that generates positive outcomes. Beyond resonant bonds among study groups, any and all study intervention can create an impactual resonance. Thus, the fact that there is a study is enough to confound its conclusions due to protocols creating resonant bonds that impact outcomes.

Conclusion: Controlled clinical trials are no good, because they aren't real life. Resonant bonds created in studies are not the same as the ones in real treatments outside of clinical studies. Any data, by it's mere presence, is subject to differing resonant bonds discrediting any comparison to actual outcomes and invalidating predictions. That's why alt med modalities (that are probably uniquely dependent on real-life resonant bonds for success) consistently fail to prove their worth in randomized controlled trials. Therefore, we should refocus our clinical study toward retrospectively looking at what's working in individual cases, not comparing the case to any other case (else risk a confounding resonant bond), and build on the successes.

Comment: I wondered if this report boils down to a very detailed laboratory study creating a bunch of precise data to be manipulated in abstract ways. Personally, no matter how detailed and precise your information is about the planets, it won't convince me of the credibility of astrology.

I think I found the most relevant definition of "resonance" in wikipedia. After all quantum science is the new buzz of what is going to explain why all of alt med "works."

New Study: Vit A&E Don't Prevent Heart Disease

Following yesterday's announcement of a new study showing the phenomenal benefits of antioxidants for preventing heart disease in women, the mainstream media rallied behind a blatantly false distortion of the study designed to convince the public that vitamins E and C are somehow useless. The popular press, which maintains an incestuous relationship with the pharmaceutical industry, once again demonstrates it is little more than a mouthpiece for the pro-pharma propaganda machine. There is no scrutiny of the study's findings, no critical thinking and absolutely no independent journalism being conducted by the mainstream media on this particular topic. It's as if these media outlets just can't wait to be spoon-fed the latest propaganda from drug company collaborators and then parrot it out to the public as fact.
The distortion in question concerns the assessment of women who participated in a nine year trial measuring the effects of vitamins E and C. According to the results published in the Archives of Internal Medicine, women who took these vitamins on a regular basis experienced a remarkable and statistically significant reduction in stroke risk (31 percent) and heart attack risk (22 percent). Not all the women in the study, of course, actually took the vitamins on a regular basis, and when you count the results of those women who never took the vitamins, the study shows no statistically significant benefits for vitamins E and C. In other words, the vitamins didn't work on those who didn't take them. (Is this surprising to anyone?)


Firstly, this article does no present good evidence for a "incestuous relationship" existing between the press and pharmaceutical industry. If this person paid so close attention to the published study, they'd see some study sponsors are big names in in the industry, who, it's assumed, could benefit nicely by a positive outcome. Also, the press can't be expected to be too critical in parroting the printed results. The study report has a 3-sentence summary that includes, "Overall, we found no benefit on the primary combined end point for any of the antioxidant agents tested, alone or in combination."

This whole newstarget rant lost it's credibility in the conspiracy theory-laden first paragraph. Nevertheless, I considered their second criticism of the reporting of study outcomes that are based on intent-to-treat analysis. In this study, researchers wanted to know whether giving different anti oxidants to a large specific population made an obvious difference. It didn't. Intent-to-treat analysis are valid because they reflect what would probably happen in the population were it real versus a study. Does the study conclude an individual probably won't benefit by taking vitamins E and C? No, because that's not what the study was trying to determine. This is a large epidemiological study, where it will be inherently difficult to find valid statistical significances beyond the clearly obvious. The good data from such study are the almost sweeping generalizations about specific populations. Variability can clutter up the validity of conclusions that
are based on a drilled down analysis. So, the study results also cannot conclude that an individual taking E and C are probably a good thing (like newstarget infers) either.

The study authors admit that subject compliance is a real shortcoming in analysis of the data. And they do consider the impacts of using intent-to-treat analysis: "To examine the impact of lack of compliance, a post hoc sensitivity analysis censored women if and when they stopped taking at least two thirds of their study medication, reported taking outside supplements containing study agents, or were missing compliance information. Statistical analysis were conducted using SAS version 9 (SAS Institute, Cary, North Carolina), using 2-sided tests with a significance level of P < .05."


I thought Prof. Dallal's critical notes about "intention-to-treat" linked from wikipedia are excellent and very applicable in considering the data from this study: http://www.tufts.edu/~gdallal/itt.htm

Thursday, August 02, 2007

More on Socialized Medicine

I'm still working on a more full perspective of the "free-market" versus "socialized medicine" debate, and how each can effect CAM. I very much appreciate the insight in the discussion.

I think Monica's point about government endorsed CAM in Britain is important to think about. EBM, I argued, can take a back seat when politics and bureaucracy run healthcare.

Fixed reimbursements by Medicare and Insurers for services help to keep costs from responding to market influences. Govt. tariffs and subsidies have always been a part of US economic policy, though, and I need a brush-up course in economics. I do observe that if the "free market" analogy about the lowering costs of electronics is not analogous to health care, how about those health care services with no Insurance / Medicare coverage? Laser vision is not covered by most insurance, and has come down in price despite rapidly advancing technology. The same probably can't be said for things like ultrasounds and CT scans.

A US hospital must charge $700 for a bandaid and a tetanus shot at a hospital ER. First, the hospital won't (and under EMTALA perhaps can't) send a needy patient away without a bandaid and tetanus shot. Second, the hospital calculates that it will only get paid for maybe only one out of every 7 bandaids and tetanus shots provided. Hospitals are not really good collection agencies the same as say utility companies or banks, and there's very little cash up front. Many who come to the ER for a bandaid and tetanus shot don't have a ready means to pay for it. Insurance has become good at not paying for non-critical emergency room visits, and many government payers make a substantially reduced payment and restrict the hospital from collecting anything additional.

Nevertheless, getting back to the appeals of CAM. I do not think lower fees at a doctor's office, or for healthcare in general, will have much of an impact on the use of CAM as Paul suggests. People are willing to spend 10x more for a bottle of pills with the USANA label over the same ones with the WalMart label. Most CAM isn't covered by Insurance, but that doesn't stop people from shelling thousands out-of-pocket on CAM remedies in lieu of covered medical care. Making an MD visit cheaper than a Naturopath visit will not lure many more to choose the MD when their fingernail becomes infected. What will is:

Inner understanding

As our post-modernistic generation gets older, I think we're starting to learn and mature in understanding. We spent countless hours reading and listening to what others have to say, and this is making us wise and more capable of choosing the best opinions and sources of knowledge based on track-records. Getting the word out about how to use critical thinking, and exposing the silliness in CAM does it's part in changing John Q. Public from being "the mob."

Medicine is about being well. CAM is about feeling well. We can continue to be obsessed with a sense of entitlement that healthcare is a right. But only if we clearly understand what it is we are demanding. Feeling well comes from much more than being well. An inner understanding of that distinction is essential in defining our expectations and obligations about healthcare. We shouldn't confuse or over-mix the human need for what religion or philosophy has to offer with our need for a physically healthy body and mind.

At the same time, healthcare is in many ways synonymous with compassion. Many turn to CAM because they appear friendly, caring, and interested in the individual. In our zeal to promote science-based medicine and stamp out sCAM we can never lose sight of why we do it. We do it because we want the very best for people. That show of true compassion should be the overriding message that comes across in everything we do.


There were some (many) needed health care that were beyond the capacity of even the well-off consumer to afford. That's why third party payers came into existence. The alternative was pain, suffering, and death at not getting the needed care, or a non-viable system for providing it.

1910: Worker's Compensation of New York is the first recognizable "third party payer"
1929: Baylor Hospital accepts pre-payment (capitated payment) for health care for 1,500 teachers
1937: Blue Cross Insurance provides direct ("first dollar") payment to providers for their insured. Kaiser invents what later becomes the "HMO"
1935: Social Security Act initiates epic government intervention into social programs
1944: McCarran Act defines Federal and State jurisdiction for regulation of health insurance industry
1946: Hill-burton Act subsidizes hospital construction and expansion with the intent to provide health care access for the needy
1965: Title XVIII, title XIX (Medicare and Medicaid) health care for retirees and disabled
1973: HMO act states rules and provides federal funding for employer-established insurance plans
1974: ERISA regulates how insurance can operate and use funds
1982: TEFRA establishes Medicare hospital payments based on "cost per case" rather than fee for service.
1986: COBRA further legislates employee coverage as well as provider obligations to provide care
1989, 1990, 2003: EMTALA amendments dictate additional legislation to insurers and hospitals based on concerns about access and coverage of emergency care
1986: Additional act that establishes Medicare APG prospective payment system of global payment for outpatient procedures
1989: OBRA: sets up RBRVS for Medicare physician payments based on the amount of "work" done for specific services.
1996: Mental health parity mandates and regulates mental health coverage
1996 (to be implemented in stages through 2003) HIPAA establishes wide-ranging 6industry regulation designed for consumer protection and also puts WHO's ICD-9 and AMA's CPT as the only code sets along with Medicare's own to be used to describe conditions and services on which third party payment is based.
1997: BBA is a huge federal expansion and overhaul of healthcare industry regulation

At risk of drifting off-topic, I'm not so young that I can't remember in the late 70's when people said our US system of healthcare was broken and in ruin. Discontent has come in waves since then. I hope someone can tell me when and why exactly did the US healthcare system start to suck - so to speak, and what event(s) caused it. Note that, for the most part, private insurance has predominantly followed payment methodology analogous to Medicare's evolutions due to Medicare being the "big kid on the block." Also that, for good or ill, healthcare is a highly regulated industry despite essentially following Medicare payment structure and rules.

dras (Pardon the errors and omissions in the above time-line due to faults in memory and time constraints versus google-based net resources)

Observations about CAM in socialized versus more-private healthcare is that CAM can flourish in either system based on the popular opinion of the voter stakeholders in the public system, and payer stakeholders in the private system. I agree completely with the listed motives people have to use CAM, along with advertising being the key to the propagation of CAM use. Correct me if I'm wrong that the inference is that CAM (or quackery) can flourish depending upon regulation of advertising in either a socialized or a more-private healthcare system. And that better consumer protection legislation and enforcement is the means to prevent quackery-based fraud in either system. This really makes a lot of sense. Yet, I'm skeptical that a shift to a federal-based healthcare system will not impact our society's use of science and EBM.

All of us as "payers" can demand that Aetna cover CAM therapies, and we can expect to pay a bit more in premiums the same way we as "voters" can demand the US govt. provide CAM therapies, and expect Congress to provide a bigger budget to pay for it. But, because the two processes above do not equally share all the factors that influence outcomes, I don't think science or EBM will be similarly disregarded by both.

The model for our current private healthcare system involves 3-parties: Consumer, provider, and payer. The provider must be sensitive to the demands of the consumer in providing care, as well as needing to be sensitive to the limits of the payer to cover it. The payer has to be sensitive to the consumer demands for accountability for payments, and sensitive to the provider demands about payment of services. Finally, the consumer controls the market by responding to changes in premiums made by the payer, balanced with the need for coverage of various healthcare services.

In this model, science and EBM can be an effective mediator between the 3-parties. The provider uses science and EBM to justify the care he provides to both the consumer and the payer. The payer can use science and EBM to rationalize restriction or denial of coverage to the provider, or non-coverage or rejection of benefits to the consumer. (Incidentally, the consumer is now being educated about the importance of scientific evidence in healthcare.)

A model for government-based healthcare is different, and takes the consumer out of much of the consideration: The federal govt. provider has a negotiated contract to be payed and does not have to directly respond to the consumer's demands about care. The federal govt. payer has a negotiated contract to provide payments and doesn't directly respond to consumer markets for payment accountability. The consumer, as a mere "voter", is left to go to their legislator with frustrations about healthcare, or excessive taxes due to the cost of healthcare. (The consumer is also encouraged to have a sense of entitlement that whatever healthcare is felt to be needed will be provided and paid for forthwith.) Meanwhile, as the the legislator listens to the constituents complaints, lobbyists, political or party allegiances, contracted providers, and contracted payers are some others that may be demanding attention to potentially conflicting considerations. The
consumer has traded in some
freedom for the reassurance that healthcare will be guaranteed.

In the federal-controlled model, science and EBM can be used, but only as an arguing point to a legislator, who, as noted, has other considerations. Decisions occur legislatively, based on many factors that may or may not give appropriate weight to the scientific evidence. There is no need for EBM or science to be a deciding mediator, and it is relegated to being a mere factor for consideration.

One opinion,

Wednesday, July 18, 2007

Oxygen Concentrators in Chiro Offices

I just saw the agenda for the next meeting of the Washington State
Chiropractic Quality Assurance Commission. They are considering adding
oxygen concentrators to the list of approved devices for chiropractors. Can
anyone tell me why a chiropractor would need such a device? The very idea
blows my mind... but maybe I'm missing something?



This will be a great new product for chiropractic office marketing!!! Think of all the angles. Take a lesson from these guys: http://www.thebigox.com/index.html

Oxygen from the concentrator as the latest sCAM medium for health restoration is going to be big, big, big.

We can flavor it. We can put the patient in hyperoxygenated rooms. It will look high-tech; there will be tubes and masks, and dials, gauges, and buttons. We can fill appointment books with repeating treatments and programs. We can list all the beneficial effects for it: it helps heal wounds, it sharpens the senses, and restores vitality. We can tout Oxygen as the fountain of youth, the giver of life, the ultimate detoxifier, the all-natural remedy for whatever ails you. We can put a picture on the wall of our favorite NFL star on the sidelines toking on it. We can even buy a pulse oximeter and show how that number goes up from 96, all the way to 100 when they're on oxygen therapy. PROOF.

Wow, and think: we can expose everything we have and sell in the office to oxygen and thus it will be "hyperoxygenated" for added potency and efficacy. We can even sell our own brand of freshly-brewed "oxygenated water" right out of our own tap!

Best of all, oxygen from a concentrator is fairly benign. At around 89% concentration up to a typical 4-liters per minute, concentrator oxygen is essentially non-toxic, and fairly safe aside from its risks associated with fire. Physician-prescribed commercial home oxygen concentrator machines are everywhere treating those with chronic lung disease. They have become fairly reliable with simple maintenance. And, best of all, oxygen concentrators are relatively cheap thanks to poor Medicare and private insurance reimbursement that has driven the technology to keep the prices down.

The time is truly ripe for the oxygen concentrator in the Chiropractors Office.

There might be a few questions the sCAM practitioner needs to learn to answer before taking this new idea on, for example:
1. How does the oxygen therapy interact with all those anti-oxidant supplements you've been selling me for years?
2. What's that tingling sensation in my fingers I got the first time I had oxygen therapy in your office, and why did I have a headache when I got home?
3. What's the difference between your $30 per hour oxygen, and Grandma's $30 dollar per week oxygen?
4. Why have MD's been prescribing oxygen for generations, but not in any way that you prescribe it?

Honestly, if I could give the Washington folks some advice, DON'T DO IT. I've hinted at all the illegitimate, phony, needless and expensive ways it will be used and abused. Plus, oxygen can be toxic (it's a poison in nature), and there is a good scientific basis as to why it is regulated as a prescription only medicine in our country. I can't think of any legitimate use for oxygen in a chiropractors office that can off-set the risk of one fire, one hyperventilation mishap, or one CO2 rebreathing mishap from faulty use or equipment.

dras (Registered Respiratory Therapist)

Friday, July 13, 2007

Socialized Medicine (reply)

[D-]> Evidence-Based Medicine will fade with more socialized medicine. The
> bureaucratic committees and legislative sessions of socialized medicine
> will base decisions more on a consensus of what can be believed as right
> and wrong, and rely less on what is provable, probable or fallacy.

[BR] Socialized medicine exists in several countries around the
world. Are there any data to support the above assertions?

[D-] My assertion is that when there are public representatives, politicians, and delegates making the decisions about what is and is not provided as medical care, scientific analysis will tend to take a back seat because these people are accountable to the general will of their constituents. These decision-makers must ultimately choose the popular decision among those who hold them accountable, whether or not it's based on evidence, or is fiscally responsible. A private carrier is accountable to it's members, employer groups, participating hospitals and physicians, and sometimes stockholders. Scientific evidence is the impartial trump-card used when a coverage decision is unpopular with the majority or minority who hold them accountable.

>"Experimental" and "medically necessary" are touted as the evil tools of
>Health Insurance. Currently, and more so each day, these definitions are
>meticulously based on principles of EBM by Insurance Companies. But, be
>sure these "denials" will go-away with our new-found freedom in socialized
[BR] Again, is there any evidence for the above?

[D-]"Experimental" and "medically necessary" as tools for insurance villains to deny needed care are a theme I've read in reviews on the SiCKO film. Nevertheless, they are common and recurring expressions of disdain for private insurance companies when a claim is denied. That carriers use EBM in their definition of these terms is well-expressed in their documentation. BCBSA affiliates commonly use The Technology Evaluation Center analysis http://www.bcbs.com/betterknowledge/tec/tec-assessments.html, Aetna uses EBM in creating Coverage Policy Bulletins http://www.aetna.com/cpb/cpb_menu.html. That these elaborate mechanisms for creating coverage policy will go away with socialized medicine goes back to my first point. There is less accountability in socialized medicine and therefore less need for such elaborate and expensive systems, when it's much easier to base a coverage decision on the popular choice.

> Which brings us back to having less use for EBM in socialized medicine.
>We have Medicare and Medicaid, and the VA system as current representatives
>of socialized medicine.

[BR] VAs associated with medical schools provide considerable
research. I've sat on some of those committees and know how busy the VAs get
doing research.

[D-] My assertion wasn't that these entities do not contribute to research. I should have been more succinct in stating that with just one (or three) huge bureaucracies in charge of all the healthcare payments, it becomes easier for those who want epic influence, or a piece of the overall pie, to focus in and "buy" it. With all the new control and power, I'm thinking it will be harder for the government healthcare bureaucracies to keep their focus (and funding) on such things as research enterprises. They will be too busy being manipulated by legislators, unions, and others with a stake in healthcare dollar.

>What will qualifying everyone for one of these mean? If I'm a nurses union,
>I probably gain more power to direct wages, hours, etc., and have more
>political clout in other health-related issues. Congratulations, California
>Nurses Association. Can we trust a nurse's union to back the science to
>determine coverage for health care? Based on the record of the ANA in
>backing science, I'd say it will be no more a priority than for any other
>political lobby.
[BR] Does the ANA exist to foster research? Do you argue they are
opposed to research or think it irrelevant?

[D-] The ANA exists for many of the same reasons other professional occupation associations exist. http://www.nursingworld.org/ In particular, the ANA has let EBM take a back seat to other motives in regards to their endorsement of therapeutic touch and healing touch. The ANA will continue to avoid any initiative that jeopardizes the support of their constituents, like any other political lobby. In socialized medicine, their voice is much louder than it is among the current hundreds (thousands?) of private health care institutions.


[BR] Arguing by asking questions sheds no light but makes points,
again, without evidence.

[D-] Agreed. But, points that can be arrived at based on common sense or practical reasoning can be as credible as the well-referenced ones. My intent is to get new thoughts and ideas considered, not necessarily proved. Proponents of a US socialized medicine system don't seem to practically consider what will influence and drive the healthcare dollar in such a system. My assertion is that EBM will be less meaningful. Clinical trials are expensive. A popular vote can take the place of study results. EBM is not needed as an impartial arbitrator when practice and payment decisions are based on an accountability to the system rather than accountability to the payor and patient.

[D-] >>>snip<<<

[BR] Can you provide more information about the kind of system you
would prefer?

[D-] I mentioned in a prior post that I do not know where is the best place between federal-run healthcare and a total free market; the happy medium between socialism and anarchy. Hopefully, I don't let my established bias against socialized medicine prevent a true understanding where that is. At present, I see a benefit of our current system where the market holds provider, payor, and patient collectively accountable for the healthcare provided.



Thursday, July 05, 2007

Nurses and Michael Moore's Sicko

I received a brochure via US post mail from the California Nurses Association complete with paid postage "Business Reply Mail" requesting that I "educate [SiCKO] moviegoers about Guarenteed Healthcare in America" by sponsoring a SiCKO screening. (see: www.guaranteedhealthcare.org/sicko) Even though I'm sure the movie is entertaining and full of facts that are well presented, I'm not sure this presentation should represent a medical organization. I question the political sales tactics of the above web site, and this one as well: http://americanhealthcarereform.org/.

There are two common themes at the above sites. One: Our healthcare system is full of problems. Shocking problems, too horrible to think about problems. And the biggest blame goes to the Health Insurance Companies. Two: socialized medicine ("guaranteed healthcare" - to use the more palliative, new age term) is all-American, it's patriotic, it's right, and it's about breaking the bonds of tyranny for freedom. These strike me as the same kind of sensationalistic / feel-good emotion-based arguments like those we see all the time that hack EBM in support of sCAM.

Evidence-Based Medicine will fade with more socialized medicine. The bureaucratic committees and legislative sessions of socialized medicine will base decisions more on a consensus of what can be believed as right and wrong, and rely less on what is provable, probable or fallacy. "Experimental" and "medically necessary" are touted as the evil tools of Health Insurance. Currently, and more so each day, these definitions are meticulously based on principles of EBM by Insurance Companies. But, be sure these "denials" will go-away with our new-found freedom in socialized medicine.

To digress for those who believe Insurance Companies have a sick and twisted sense of EBM. I must say, yes, some companies sometimes do. But, it's much more complicated than that. First, "Investigational" and "medically necessary" are subjective terms, even in the strictest sense of EBM. Our courts and legislative sessions argue them all the time. There is no sure line when something crosses over to being accepted and proven; it's a place of opinion. Second, Insurance Companies process hundreds of thousands of claims per day. The systems must be automated, thus based on analog logic of a computerized system, where all aspects and descriptions of medical care are forced into sets of numbers put into fields on a Medicare-based claim form. I attest to having years of first-hand knowledge of the difficulty of making this kind of complex system accurately and fairly identify, adjudicate, and pay for the medical care provided. (Not the least of problems is the shear potential for human error, and intentional fraud and abuse by any party with a touch in the system.) Even when all works flawlessly, there will always be the occasional square peg in a round hole, where a claim is accurately but wrongly denied. Finally, third, Insurance Companies are beginning to give up the "investigational / medically necessary" fight. They too often lose in courts and in lobbying, despite having the best EBM science backing them up. So instead, they're beginning to write and broadly apply more "exclusions" to benefits. These allow them to contractually carte-banche deny claims and services no matter how necessary they are, or how senseless the exclusion is applied. Remember, this is happening ironically because we are taking EBM out of the payment-process of health care, and the alternative is proving to be unscientific, often nonsensical and more money-driven.

Which brings us back to having less use for EBM in socialized medicine. We have Medicare and Medicaid, and the VA system as current representatives of socialized medicine. What will qualifying everyone for one of these mean? If I'm a nurses union, I probably gain more power to direct wages, hours, etc., and have more political clout in other health-related issues. Congratulations, California Nurses Association. Can we trust a nurse's union to back the science to determine coverage for health care? Based on the record of the ANA in backing science, I'd say it will be no more a priority than for any other political lobby.

If Insurance Companies are beginning to rely less on EBM to adjudicate claims anyway, what's wrong with taking them out of the picture? Because doing so will do nothing to re-emphasize EBM. The burden of being the evil denier of care will now be the US Government. We can no longer gripe at our employer who gave us the benefits in the first place, or call the insurance to give them a piece of our mind, demand independent medical review of the claim, or threaten to sue. Can we expect a legislator, who is no longer in the pocket of the Health Insurance Company, to lend us an individual ear? Or, will s/he now be in the pockets of other remaining commercial entities in the globally capitalistic health care industry? Can we expect the Government bureaucracy to run the tighter ship than commercial companies? Will the primary goal be to altruistically provide medical care that is fair to the patient and provider? Will it operate with financial responsibly and appropriately address errors, fraud, and abuse?

Personally, I like the accountability inherent in a private health care system, admitting to the horribleness we see in it currently. Even though I know the AMA has made statements in support of socialized medicine, I'm on board with their current recommendation for public health policy that advocates a consumer driven, market based system. http://www.ama-assn.org/ama/pub/category/7834.html)


Friday, June 29, 2007

Unexplained Medical Syndromes

The Feb. issue of FASEB Journal (Vol. 21, pp. 299-301) had an
interesting editorial by Gerald Weissman entitled "'Chronic Lyme' and
other medically unexplained syndromes." Here is one excerpt:

Groups of patients and advocates march against medical science under the
banners of "chronic fatigue syndrome," "myalgic encephalitis,"
"irritable bowel syndrome," "total chemical allergy," etc. There is no
question that patients suffer—and often terribly—from conditions to
which these labels have been given. There is also no question that their
disability is real. Skeptics worry, however, that the hallmark of these
"diseases" is that diagnosis requires the complete absence of objective
physical or biochemical derangement. They wonder whether such patients
are not really victims of a complex set of socially and medically
constructed diseases—much as the "railway spine," "chronic
appendicitis," or "female hysteria" favored by 19th century clinicians.

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Pfizer announced (June 22, 2007) that the FDA approved Lyrica [Pregabalin] for the management of fibromyalgia. According to the company, in the 2 clinical trials with more than 1800 subjects, Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. Lyrica’s approval for fibromyalgia represents the eighth Pfizer treatment to receive “priority review” status from the FDA over the past two and a half years, the company said. http://www.fdanews.com/newsletter/article?articleId=94987&issueId=10352

A Priority designation is intended for those products that address unmet medical needs. http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm

Pregabalin is a schedule IV controlled substance (low potential for abuse) and was initially approved in December 2004 for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Pregabalin is also indicated as an adjunctive therapy for adult patients with partial onset seizures. More than 5 million patients worldwide have been prescribed the drug, according to Pfizer.

So, not only do we have a medical condition that is defined in the absence of objective physical or biochemical derangement, we have a drug to treat it that has "priority" FDA approval in the absence of an understood mechanism of action. I really think a third study arm should have used gummy bears.