Readers' Responses to "The Cost of Marginal Medicine Is Too High"

Gary M. Levin, MD, FAAO; William L. Blanchet, MD; Lisa A. Pawelski, MD; William M. Fogarty, Jr., MD, FACP; Marvin R. Beard, MD


May 15, 2006

To the Editor,

I am sure that there will be counterarguments in regard to the use of pegaptanib (Macugen) for the treatment of ARMD [age-related macular degeneration]. The status of treatment for ARMD is in a state of flux and evolution. Pegaptanib is but one arm of multiple therapies aimed at arresting this dreadful occurrence that affects older patients and reduces their quality of life. Some patients live 10 or 20 years with this handicap of vision less than 20/200. There are at least 5 or 6 other drugs in the pipeline for treating this entity, combined with photodynamic therapy.

At what point should Medicare approve funding for new treatments, which eventually become the standard: 6 months, 1 year, 2 years?

I would like to hear the opinions of experts from the American Academy of Ophthalmology and the Vitreous and Retina Society as well as the Macula Society. There have been several recent CME updates on Medscape covering the treatment of ARMD.

Gary M. Levin, MD, FAAO
Palm Desert, California




To the Editor,

EBT [electron beam tomographic] coronary imaging is anything but "marginal medicine."

I agree with the principle that avoiding expensive and minimally valuable procedures is a laudable goal to which we should all aspire. Unfortunately, Dr. Emanuel, in his MedGenMed editorial on "marginal medicine," chose a remarkably poor selection of examples.[1] To tell a rheumatoid arthritis sufferer that the anti-TNF [tumor necrosis factor] drug that is relieving her/his symptoms is marginal strikes me as both inaccurate and unkind. Referring to CT [computed tomographic] coronary screening as "marginal" is so indefensible that it marginalizes the entire content of his editorial.

Coronary artery disease is the leading cause of death in this country, killing 38% of Americans, and is listed as the primary or contributing cause of death on 60% of death certificates. Fifty percent of men and 64% of women who die from coronary heart disease had no "warning" symptoms prior to their fatal initial event.[2]

Standard Framingham risk predictors mischaracterized the risk for coronary events approximately 50% of the time.[3,4,5,6] Akosah and colleagues[4] have shown that a majority of young patients who are admitted with heart attacks did not qualify for primary preventive therapies based on the NCEP-III [Third National Cholesterol Education Program] guidelines prior to their heart attack. Further, many individuals who are actually at low risk for heart attacks are unnecessarily treated with statins[3,5] at a great annual cost, when NCEP-III guidelines are "appropriately" applied. Finally, clinicians often do a poor job of effectively treating patients at risk on the basis of the Framingham stratification and NCEP guidelines.[7]

Aside from EBT coronary calcium scoring and the less reliable conventional risk-factor stratification,[5] we have few if any other valid predictors of coronary risk. hs-CRP [high-sensitivity C-reactive protein], the highly touted marker for coronary risk,[8] is actually a very weak predictor of heart attack risk adding marginal value to conventional risk stratification,[9] and is neither additive nor incremental to EBT calcium score risk stratification.[5]

Stress testing, which is generally accepted as the standard for CAD [coronary artery disease] screening, is only positive when flow is significantly limited through a vessel with a 60% or greater obstruction. Contrary to historical wisdom, most heart attacks occur in vessels with less than a 50% blockage; therefore, screening for blockage is a poor technology to predict coronary events.[10,11,12] Stress tests would be negative today for a majority of patients who are at significant risk for heart attacks this year. This is true for the most expensive, most "accurate" nuclear stress tests.[11]

Stress testing is often abnormal in the absence of coronary artery disease, mandating more expensive and higher risk procedures. Many coronary angiograms are performed every year on the basis of false-positive stress tests. This creates unnecessary costs and unnecessary risk.

Stress testing in asymptomatic patients could be listed as marginal medicine of the worst type. It is performed with great frequency; it is of little benefit; it implies inappropriate reassurance when "normal"; there is significant potential for harm with false positives; and it comes at a great financial cost. Furthermore, no evidenced-based studies show the value of stress tests leading to improved outcomes. Despite these obvious problems with this outdated and inadequate procedure, it receives little adverse press and is covered by most insurance companies.

It has been shown that EBT coronary calcium imaging is an extraordinarily powerful predictor of risk for future coronary events.[5,10,11,12,13,14,15,16] Once individuals at risk are accurately identified, primary prevention can be implemented, and, as we know on the basis of multiple studies, primary prevention is very effective in reducing future events.[17] In addition, there is an expanding volume of evidence that serial coronary calcium imaging with EBT technology can identify which of those individuals are being inadequately treated.[3,9]

Raggi and coworkers[14] found that with 500 individuals followed over 6 years with serial heart scans, stability of EBT calcium scores correlated with a 17-fold decreased incidence of hard coronary events compared to similarly treated patients with increasing EBT calcium scores. In a second study from Japan, Tani and coworkers[13] demonstrated a dramatic correlation between serial EBT calcium scores and angiographic progression of plaque. Of particular interest in both of these studies, differences in standard risk factors did not predict events or progression of plaque.

As one objectively evaluates the data in regard to EBT imaging, it becomes apparent that this is a dramatically underutilized technology that could save billions of dollars and tens of thousands (perhaps hundreds of thousands) of lives each year if understood and appropriately utilized.

Of the 927,448 Americans who will die from all forms of heart disease this year, 460,000 will die in the ER [emergency room] or before reaching the hospital. Of the > 350,000 Americans who will die this year from their first heart attack,[2] fewer than half will be on adequate primary prevention prior to their fatal event.[2,3,4,5,7,18] Had EBT coronary calcium imaging been used to discover that they were at risk and primary prevention with aspirin and a statin was started before their event, over 40% of those deaths could have been avoided.[17,19] Had statins, aspirin, lifestyle, diet, and improved BP [blood pressure] control been initiated, the reduction in premature deaths would be astronomic. Assuming a very conservative event reduction of 33%, we could see a reduction of over 115,000 premature coronary deaths per year only looking at a very conservative underestimation of individuals without treatment before their fatal MI [myocardial infarction]. This would be equivalent to eliminating all death from both breast cancer and colon cancer.[20] It is legally indefensible and considered medically inappropriate to not recommend routine mammography and colonoscopy. I believe that it is a greater error not to recommend EBT coronary calcium screening. For medical pundits to continue to marginalize EBT coronary calcium imaging without experience or adequate review of the literature is the worst form of medical negligence.

William L. Blanchet, MD
Boulder Internal Medicine
Boulder, Colorado

  1. Emanuel E. The cost of marginal medicine is too high. MedGenMed. 2005;7:67. Available at: Accessed December 12, 2005.

  2. American Heart Association. Heart disease and stroke statistics -- 2005 update. Available at: Accessed May 8, 2006.

  3. Hecht S. Electron beam tomography and national cholesterol education program guidelines in asymptomatic women. J Am Coll Cardiol. 2001;37:1506-1511. Abstract

  4. Akosah KO, Schaper A, Cogbill C, Schoenfeld P. Preventing myocardial infarction in the young adult in the first place: how do the national cholesterol education panel iii guidelines perform? J Am Coll Cardiol. 2003;41:1475-1479.

  5. Arad Y, Goodman KJ, Roth M, Newstein D, Guerci AD. Coronary calcification, coronary disease risk factors, C-reactive protein, and atherosclerotic cardiovascular disease events: the St. Francis Heart Study. J Am Coll Cardiol. 2005;46:158-165. Abstract

  6. Nasir K, Michos ED, Blumenthal RS, Raggi P. Detection of high-risk young adults and women by coronary calcium and National Cholesterol Education Program Panel III guidelines. J Am Coll Cardiol. 2005;46:1931-1936. Abstract

  7. Lai LL, Poblet M, Bello C. Are patients with hyperlipidemia being treated? Investigation of cholesterol treatment practices in an HMO primary care setting. South Med J. 2001;93:283-286.

  8. Tracy RP, Kuller LH. C-reactive protein, heart disease risk, and the popular media. Arch Intern Med. 2005;165:2058-2060. Abstract

  9. Miller M, Zhan M, Havas S. High attributable risk of elevated C-reactive protein level to conventional coronary heart disease risk factors. Arch Intern Med. 2005;165:2063-2068. Abstract

  10. Keelan PC, Bielak LF, Ashai K, et al. Long-term prognostic value of coronary calcification detected by electron beam computed tomography in patients undergoing coronary angiography. Circulation. 2001;104:412-417. Abstract

  11. Berman DS, Wong ND, Gransar H, et al. Relationship between stress-induced myocardial ischemia and atherosclerosis measured by coronary calcium tomography. J Am Coll Cardiol. 2004;44:923-930. Abstract

  12. Nasir K, Redberg RF, Budoff MJ, Hui E, Post WS, Blumenthal RS. Utility of stress testing and coronary calcification measurement for detection of coronary artery disease in women. Arch Intern Med. 2004;164:1610-1620. Abstract

  13. Tani T, Yamakami S, Matsushita T, et al. Comparison of coronary artery calcium progression by electron beam computed tomography and angiographically defined progression. Am J Cardiol. 2003;91:865-867. Abstract

  14. Raggi P, Callister TQ, Shaw LJ. Progression of coronary artery calcium and risk of first myocardial infarction in patients receiving cholesterol lowering therapy. Arterioscler Thromb Vasc Biol. 2004;24:1272-1277. Abstract

  15. Taylor AJ, Bindeman J, Feuerstein I, Cao F, Brazaitis M, O'Malley PG. Coronary calcium independently predicts incident premature coronary heart disease. J Am Coll Cardiol. 2005;46:807-814. Abstract

  16. Kondos GT, Hoff JA, Sevrulov A, et al. Electron-beam tomography coronary artery calcium and cardiac events: a 37-month follow-up of 5635 initially asymptomatic low- to intermediate-risk adults. Circulation. 2003;107:2571-2576. Abstract

  17. Cholesterol Treatment Trialists (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis from 90 056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267-1278. Abstract

  18. Libby P, Nissen S. Medical vs. interventional approaches to the management of coronary artery disease: the clinical application of current knowledge. Medscape. November 22, 2000. Available at: Accessed May 8, 2006.

  19. ASHP therapeutic position statement on the daily use of aspirin for preventing cardiovascular events. Am J Health Syst Pharm. 2005;62:1398-1405. Abstract

  20. Stewart SL, King JB, Thompson TD, Friedman C, Wingo PA. MMWR Surveill Summ. Cancer Mortality Surveillance -- United States, 1990-2000, 2004;53(SS03):1-108.


To the Editor,

Hello. I'm a dermatologist, and I was "with you" about marginal medicine[1] until I hit the part about anti-TNF [tumor necrosis factor] agents for RA [rheumatoid arthritis]. I treat a lot of psoriasis/psoriatic arthritis, and these agents have been literally life-restoring for many patients who have failed multiple other agents. I have psoriasis myself, and thankfully have not gotten the arthritis. If I were as limited as some of my patients have been, I would not be able to work. Twenty-five thousand dollars per year to keep me seeing patients and providing good jobs for the economy? Worth it, I think.


Lisa A. Pawelski, MD
Pittsburgh, Pennsylvania


  1. Emanuel E. The cost of marginal medicine is too high. MedGenMed. 2005;7:67. Available at: Accessed December 12, 2005.



To the Editor,

The piece on marginal medicine was right-on.[1] We are spending huge amounts on the margins with minimal benefit while millions go without basic services. There is no viable service to evaluate newer medications and technology and to disseminate this information to practicing physicians. One could go on and on about the takeover of academic medicine by the pharmacology and biotech companies, the prostitution of medical faculty to these companies, and the lack of independence of speakers at conferences and meetings and writers in medical journals. The result of this is that the practitioner is forced to recommend these marginal therapies or be characterized as a Luddite or sadly out of touch with "modern medicine."

Let's have a truly independent technology evaluation mechanism that will disseminate cost/benefit data. If practitioners know that a proposed therapy is of marginal benefit, they will be much less likely to recommend it to their patients.

William M. Fogarty, Jr., MD, FACP
St. Louis, Missouri


  1. Emanuel E. The cost of marginal medicine is too high. MedGenMed. 2005;7:67. Available at: Accessed December 12, 2005.




To the Editor,

I am not sure where you get your list of marginal, cost-ineffective procedures,[1] but I certainly would like for you to review with me why you think that anti-TNF [tumor necrosis factor] blockers are "marginal" therapies. (A review of your references does not address this treatment.)

As a practicing rheumatologist, daily I see the ravages of rheumatoid arthritis in patients. I have followed patients for up to 27 years!

I fully respect the enormous costs and risks of anti-TNF drugs, yet the risks and costs of unrelenting disease not controlled by less costly and less toxic treatments far outweigh the risks and costs of these drugs.

Most but not all patients so selected have significant improvement, and some develop complete arrest of their disease with these agents in combination with other DMARDs [disease-modifying antirheumatic drugs].

Please defend your inclusion of anti-TNF therapies for rheumatoid arthritis in your list of marginal therapies.


Marvin R. Beard, MD
Alcoa, Tennessee


  1. Emanuel E. The cost of marginal medicine is too high. MedGenMed. 2005;7:67. Available at: Accessed December 12, 2005.


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