As someone who has suffered the abuse of medical guidelines as a chronic Lyme disease patient, I shudder to think what will happen if the *government* gets into the business of medical guidelines. Because of biased treatment guidelines by the Infectious Diseases Society of America (IDSA), I must drive 900 miles to a doctor willing to treat my chronic symptoms of Lyme disease, which have perpetuated for 13 years. I cannot find a doctor in my home town of over a million people who will treat me. The treatment is merely antibiotics.

The IDSA claims these are unnecessary, that the organism has long ago been killed. I would be happy to believe them -- but thirteen years into the disease I continue to experience Jarisch-Herxheimer reactions with the introduction of antibiotics! I know my own body and mind, and it is clear to me that the antibiotics keep me from deteriorating further neurologically.

Becaused of the IDSA guidelines and their iterations, Lyme disease patients are treated like pariahs. We cannot receive treatment from virtually any medical specialty. But IDSA cherry picked the medical literature, leaving out all of the publications on chronic infection, despite antibiotic treatment.

Unfortunately, there are no governmental bodies that have oversight over medical guidelines - no agency that takes complaints or does investigations. I have personally contacted the Justice Department, the NIH Office of Scientific Integrity, and DHHS. No one can lift a finger. Because there is no oversight, the IDSA guidelines are functionally "the law."

Physicians have been persecuted by State medical boards when they have deviated from treatment recommended by the IDSA guidelines. Insurance companies use them to deny payment for necessary antibiotic therapy.

We know that the Chairman of the IDSA Guidelines Committee, Gary Wormser, MD, knowingly failed to disclose that he has been consulting to a pharmaceutical company, Baxter, on Lyme disease vaccines. It has always seemed to me that the IDSA guidelines are biased so as to favor anyone interested in rolling out Lyme disease vaccines.

Yes, fortunately, we have CT Attorney General Blumenthal who has jumped in on the issue of the bias in the IDSA Lyme disease guidelines, but to have an AG willing to act on behalf of disenfranchised patients is an extraordinary event

http://www.ct.gov/AG/cwp/view.asp?A=2795&Q=414284

The theory of Blumenthal's case against IDSA is antitrust. But if the government is writing the guidelines, the concept of monopoly will be embraced and merely a matter of policy.

What oversight process will guarantee that governmental guidelines will not be biased? What appeals process will be incorporated?

It seems we have learned nothing from the banking fiasco, that **oversight** is a critical function. This is also true in health care delivery.

We know from publication after publication that individuals involved in writing guidelines are typically loaded with conflicts of interest. How will this be addressed in a government context?

While comparative effectiveness research sounds like a good idea, what have the advocates done to protect against abuses? Oddly, I will side with the Republicans until I hear more.

Lynn Shepler MD JD

Comparative Effectiveness Research: Garbage in…….Garbage out

Since no one claims that colonoscopies every 10 year saves more lives than simple, cheap, and safe stool blood tests each year, it is crazy for Medicare and private insurers to pay for the screening colonoscopies, let alone virtual colonoscopies.

Regarding the potential for public and private insurance denials to be based on comparative effectiveness guidelines, the experience in the UK is instructive. Googling “NICE guidelines legal challenges” yielded 869,000 hits of legal challenges in the pipeline, including osteoporosis drugs, chronic fatigue/myalgic encephalitis treatments and benefits, borderline or anti-social personality disorder treatments, population screening for mental illness, schizophrenia treatments, and breast cancer drugs. Compared with the USA, the UK is not very litigious. With a “national board of medical experts deciding on what medical interventions to cover here in the USA, the federal justice department will be doing little else but defending its top-down medical rationing decisions.

Regarding money for systematic reviews of published scientific studies, the medical establishment (academic researchers, medical journal editors, drug companies, FDA, NIH, etc.) have thus far ignored my recently published systematic reviews of anticoagulant therapy for 30 medical indications. The review concluded, “The efficacy and safety of anticoagulant drugs for 30 government regulatory agency approved and off-label indications are in question. At a minimum, 50,000 people have fatal bleeding episodes each year worldwide due to anticoagulant treatment or prophylaxis for these indications. An objective, transparent reassessment of the evidence base of all indications for anticoagulant use (regulatory agency approved and off label) should be carefully done by the government regulatory agencies, including the FDA in the United States and The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.” (http://www.medscape.com/viewarticle/584084) Why pay for more systematic reviews when medical special interests and regulators don’t have to pay attention to the results of ones already published.

Maggie--- while I can actually agree with a couple of your statements, by far the most frightening thing you have ever written is in your response:

"Death is natural and inevitable."

Thus we have the central planning, money saving doctrine of the future health care elite bureaucracy class.

Eric--

The notion that death is a "mistake"--that someone, the doctor, the hospital, or the HMO make a "mistake" (by not doing what was necessary, or denying necessary care) is all tied with our culture's denial of death--and the shame we feel about death.

The dying patient is a failure. Something went wrong. Often, his doctor stops visitng him.

Death is hidden away. It is an embarassment, this shameful mistake.

We refuse to give the dying patient enough pain-killer. He should fight death! The Good Patient doesn't given in easily. He stays conscious fighting (and screaming out in pain) until the end. We ignore his screams. They, too, are embarassing.

The palliative care movement was created to counter this notion that death is an error. Diane Meier (a pioneer and heroine of palliative care) puts it death is "natural, and inevitable" It does not mean that someone made an error.

Merrill-
I have 2 excellent cases where CMS 'conclusion' nearly cost people their lives.

1. 66y man on PLAVIX and aspirin, history of bypass, forced to stop his plavix and aspirin for an actual colonoscopy, since 'virtual is not covered'.
result: 3 weeks later-- heart attack, emergency stent
another 4 weeks later --- cardiac arrest, fortunately witnessed, and miraculously saved by a defibrillator
--------another stent and an implanted defibrillator.

question-- how many virtual colonoscopies could have been paid for with the cost of that treatment?

2. 68y woman inflammatory arthritis with long history of prednisone use. Again, not covered for virtual.
Routine colonoscopy results in perforation of colon (prednisone can severely weaken tissues)--- emergency partial colectomy, colostomy, sepsis.

1 month of hospital care--- eventual 'takedown' of colostomy.

The 'cost' to CMS of these 2 cases alone-- which I assure you are REAL-- could pay for virtual colonoscopy for hundreds.

So, please a bit less smugness on the decision for CMS to deny an equal alternative to patients--- someday that patient might be someone you know, and even care about.

Merrill--
Excellent post. I agree cost-effectiveness analysis is not in the cards at this time--American public not ready to discuss what a year of life is worth.

But when it comes to comparative-effectiveness, there is plenty of long-hanging fruit. And we aleady have much evidence in various areas . ..

My question for you is this: giving the wording that you quote, I don't see how CMS
woudl be able to use comparative effectiveness to either decide whether or not to cover,or to set fees (lower for less effective treatments).

But it seems to me that CMS could set higher co-pays (even much higher co-pays) for things like very expensive treatments for early stage prostate cancer where we have no evidence than they are more effectve than less expensive treatments-- or no treatment at all (watchful waiting) in the case of average-risk patients . . .

Similarly, one could set high co-pays for MRI breast scans for average risk women, mammograms for average risk women under 40 and over 59;
PSA tests (which neither the American Cancer Society or NCI or the Preventive Services Task Force recommend for average-risk patients), etc. .

Is there something in the language that I am
missing that would prevent CMS from using co-pays to steer patients to more effective treatments?

Is there anyway around the language you quote that would allow CMS to deny coverage based on
comparative-effectiveness reserach?

I suppose a second piece of legislation could address that problem??

Eric--

The examples you cite do not justify the virtual
colonoscopy. There will always be cases where the colon is perforated (though there should be far fewer). But we can't pay for virtual colonoscopies for everyone just becuase 1 person in X,000,00 will suffer perforation and sepsis.
(Through probably we need a checklist and guidelines to make it much less common).

In your first example, one cannot be at all certain as to what "caused" the heart attack.

Bottom line: medicine is shot through with ambiguity. Any proceduure carries some risks.
Some of us will die of risks associated with a
medical procedure. We cannot eliminate all risks---even if you or I or our loved one happens to be the one person in x,000,000 who succumbs to the risk.

Your thinking suggests that no one should die--ever. That death is some sort of error that could be avoided if we just used a more expensive medical technology.

Death is natural and inevitable. The fact that someone dies does not mean that someone made a mistake; the doctor, the hospital, Medicare or an HMO refusing to cover something. . . .

I read what Eric wrote and was unable to find anything to support the interpretation that he is in denial of death. He simply cited two cases in which patients with potential risk factors for standard colonoscopy had bad outcomes related to same.

Guidelines are not standards of care. It is recognized that there are cases that fall outside the scope of most guidelines. Individual patients may have particular circumstances that can be documented as making a certain intervention appropriate in their cases. Rigidity is a threat to the nuances of clinical medicine. George Bush (as he told Joe Biden at the outset of the Iraq war) didn’t do nuance. Flexibility in the application of guidelines is necessary.

http://www.shef.ac.uk/scharr/ir/def.html gives a definition of evidence-based practice by Gray Muir and colleagues which is worth quoting: "Evidence based clinical practice is an approach to decision making in which the clinician uses the best evidence available, in consultation with the patient, to decide upon the option which suits that patient best".

No one can be absolutely certain that the cases Eric cited would have had different outcomes with virtual colonoscopy than with standard colonoscopy. Subgroup analyses, even when specified in advance, often lack the statistical power to show measurable differences in outcomes that clinicians are interested in.

Good evidence is hard to come by. Think of the number of times you looked at a Cochrane review and read that “most studies were of poor quality.” This is not because researchers are a bunch of incompetent turkeys, but because of the great difficulties that are inherent in making randomized trials work the way one hopes they will. Better funding may play a role in seeing that adequate numbers of patients can be recruited, that pertinent outcomes may be measured, and that methodological weaknesses can be overcome.

Support for research is needed. Transparency about the process and about potential competing interests must be preserved. And vigilance about how the information will be used will be required.