Saturday, November 21, 2009

Mammograms: The Road to Rationing?



Four days ago, the New York Times reported on the updated recommendations for breast cancer screening as announced by the United States Preventive Services Task Force (USPSTF), an "independent panel of experts" commissioned by the Agency for Healthcare Research and Quality (AHRQ), a division of the Department of Health and Human Services.

New analysis of existing research led the task force to change their previous recommendations for breast cancer screening. In 2002, the USPSTF guidelines called for "screening mammography, with or without clinical breast examination (CBE), every 1-2 years for women aged 40 and older." The new 2009 recommendation for mammograms states: "For women aged 40-49 years, do not screen routinely. Individualize decision to begin biennial screening according to the patient's context and values."

Not all screening that is technologically available is cost effective. At some point, the benefit to be gained is outweighed by the costs, whether you measure the costs in terms of physical resources, negative side effects, price in dollars, or even just the time involved to have the test performed. Medical research is constantly advancing the base of data from which we evaluate this cost/benefit ratio. An analysis which provides us a more accurate assessment should be welcomed with cheers. Instead, this pronouncement has triggered an angry controversy. Why?

The ruckus is the result of the degree to which government mandates effect our health-care options. New recommendations from a government agency will in all likelihood have significant effects on reimbursement policies for government-financed medical care and quickly followed by reverberations throughout the private insurance industry.

From the NYT article:

The guidelines are not expected to have an immediate effect on insurance coverage but should make health plans less likely to aggressively prompt women in their 40s to have mammograms and older women to have the test annually.

Congress requires Medicare to pay for annual mammograms. Medicare can change its rules to pay for less frequent tests if federal officials direct it to.

Private insurers are required by law in every state except Utah to pay for mammograms for women in their 40s. But the new guidelines are expected to alter the grading system for health plans, which are used as a marketing tool. Grades are issued by the National Committee for Quality Assurance, a private nonprofit organization, and one measure is the percentage of patients getting mammograms every one to two years starting at age 40.

That will change, said Margaret E. O’Kane, the group’s president, who said it would start grading plans on the number of women over 50 getting mammograms every two years.


It is no idle concern that these recommendations will be adopted and enforced by the government. Provisions within the Medicare Improvements for Patient and Providers Act of 2008 (MIPPA) grants authority to HHS to use USPSTF recommendations in determining Medicare coverage. As experience with DRGs demonstrated in the post, how goes Medicare, so follows private insurance.

The recent drive for increased government control of payment for medical care (HR 3962) only heightens concern that what starts out as a simple dissemination of knowledge and informal recommendation will turn into legal mandates and rationing. A closer look at the full report from the USPSTF, and criticisms raised by other informed institutions, further increases suspicions that politics inordinately influenced the work of this "independent panel."

First, a little back ground on the disease of breast cancer.

According to the USPSTF's own article published in the Annals of Internal Medicine, breast cancer is the "most frequently diagnosed non-cutaneous cancer and the second leading cause of cancer deaths among women in the Untied States." A woman in her forties has a 1 in 69 probability of developing breast cancer. The risk increases to 1 in 38 in her 50s, and up to 1 in 27 in her 60s. In 2008, over 250,000 women were diagnosed with breast cancer, and just over 40,000 women died of this disease. Additionally, as the American Cancer Society points out, 17 per cent of breast cancer deaths occur in women diagnosed in their 40s.

The benefits

Developing breast cancer is a real and significant health risk for women in America. Early detection is known to improve survival. Routine mammography, instituted in 1990, has contributed to a 30 per cent reduction in the breast cancer mortality rate. Even the USPSTF report recognizes that annual screening of women in their forties will reduce breast cancer deaths by 15%--but it still concludes this reduction does not warrant routine, annual mammograms.

Here's some numbers presented in the study:

For women in their 50's, 1339 individuals must be screened in order to save one life. For women in their 40s, 1904 must be screened. An additional 565 women aged 40-49 must be screened in order to obtain equal life-saving results as for women in their 50s. Lives can be saved by earlier and more frequent screening...but is this benefit worth the cost?

Maybe. Screening costs money, resources and time, and is not risk free.

The harms

What "harms" did the task force look for? The task force ran no studies of their own but performed an extensive review (a meta-analysis) of the literature. Below is a brief summary:

1. Radiation exposure and risk of causing cancer
(No studies were found that looked directly for an increased risk of breast cancer due to the radiation exposure of mammography. Studies of other types of radiation exposure demonstrate a clear connection between high-dose radiation exposure and breast cancer, but inconclusive results for low-dose exposure. Mammograms are considered a low-dose radiation exposure.)

2. Pain during the procedure ("but few would consider this a deterrent from future screening.")

3. Anxiety, distress and other psychological responses. (Important to note but difficult to translate into policy decisions due to their subjective nature.)

4. Over-diagnosis (Studies were "too heterogeneous" to provide statistically significant results.)

5. False-positive results leading to additional imaging and biopsies; false-negative results leading to missed diagnoses.

Let's take a closer look at the findings for false-positives as this "harm" is the only one with measurable consequences and appears to have significantly influenced the task-force's evaluation of the cost-benefit ratio.

False-positives occur more frequently in women aged 40-49 (97.8 per 1000 women per screening round) vs. 86.6/1000/round for women aged 50-59 years. This led to more frequent "additional imaging" in the younger age group (though fewer biopsies), increasing the number of tests and thus the expense of detecting each additional case of cancer. The category "additional imaging" includes tests widely varying in cost and time. It could simply refer to one additional x-ray or to obtaining an ultrasound, or it could indicate referral for the more involved and expensive procedure of contrast MRI. These tests were not distinguished in the paper so there is no way to tell what proportion of the "additional images" were simply a single extra mammogram view. This omission severely hinders the ability to discern just how burdensome "additional imaging" is and undermines the value of this finding.

The benefits not accounted for

Another very important limitation of the task forces' review is their use of mortality as the only end-point for assessing benefit. No effort was made to consider the increased morbidity and disfigurement, or the increased cost (either in money or in personal suffering) of therapy necessary to induce cure following delayed diagnosis. Mortality does provide a more easily determined objective end point than measuring for morbidity. However, it is curious that the pain and suffering resulting from delayed diagnosis was ignored but the pain of the mammogram procedure was taken into account.

Professional Criticisms

The new USPSTF recommendations do provide useful information to consider when weighing the personal cost-benefits of obtaining breast cancer screening. Two important professional organizations, The American Cancer Society and the American College of Radiology, have released statements (here and here) strongly disagreeing with the task force's conclusions. This is all part of healthy and necessary debate which should be encouraged.

American College of Radiologists (ACR) claims that the USPSTF report is seriously flawed:

Ignoring direct scientific evidence from large clinical trials, the USPSTF based their recommendations to reduce breast cancer screening on conflicting computer models and the unsupported and discredited idea that the parameters of mammography screening change abruptly at age 50. In truth, there are no data to support this premise.

Also:

The task force commissioned its own computer models that had never been subject to critical peer review, ignoring previously published computer modeling studies and direct scientific evidence from large clinical trials that contradict their conclusion. The recommendations also ignored peer reviewed journal articles that critiqued studies on which their recommendations rely. They did not consider literature that didn’t evaluate mortality as an endpoint.

Notably, the USPSTF does not even mention the actual published data from Sweden and the Netherlands that directly show what happens when new therapies and mammography are introduced into the population. These studies demonstrate that it is mammography screening and not new therapies or practices that are responsible for most of the decrease in deaths over the past 20 years.

And elsewhere, an ACR statement confronts the unspoken implications of the task force recommendations:

Although USPSTF states that their recommendations were not motivated by cost savings, based on the above, we cannot help but draw the conclusion that the taskforce recommendations amount to rationing on the basis of financial costs. The USPSTF’s analysis evaluates the number of lives lost under a variety of screening scenarios and then blatantly recommend the most “efficient” (i.e. less expensive) screening interval, not the one that saves more lives. Not only are these numbers based on the lowest estimate of benefit, but they have no meaning for the women being screened. Each woman has a single screening study each year regardless of the yield of cancers. Numbers only suggest the relative “cost” of curing a cancer by early detection and the USPSTF has, arbitrarily, decided that the cost of saving women ages 40-49 is too high. (Emphasis added.)

It is this real and reasonable fear of government limitations restricting or even prohibiting free choice in medical decision-making that has many clinicians alarmed.

Dr. James Thrall, chair of the American College of Radiology Board of Chancellors, stated in his initial response:

I am deeply concerned about the actions of the USPSTF in severely limiting screening for breast cancer. These recommendations, in combination with recent CMS imaging cuts, jeopardize access to both long proven and cutting-edge diagnostic imaging technologies. Government policy makers need to consider the consequences of such decisions. I can’t help but think that we are moving toward a new health care rationing policy that will turn back the clock on medicine for decades and needlessly reverse advances in cancer detection that have saved countless lives.

From Dr. Phil Evans, M.D., president of the Society of Breast Imaging:

The USPSTF recommendations are a step backward and represent a significant harm to women's health. To tell women they should not get regular mammograms starting at 40 when this approach has overwhelmingly been shown to save lives is shocking. At least 40 percent of the patient years of life saved by mammographic screening are of women aged 40-49. These recommendations are inconsistent with current science and apparently have been developed in an attempt to reduce costs. Unfortunately, many women may pay for this unsound approach with their lives. (Emphasis added.)

From Otis W. Brawley, M.D., chief medical officer, of the American Cancer Society.:

The American Cancer Society continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40. Our experts make this recommendation having reviewed virtually all the same data reviewed by the USPSTF, but also additional data that the USPSTF did not consider. When recommendations are based on judgments about the balance of risks and benefits, reasonable experts can look at the same data and reach different conclusions. (Emphasis added.)

This table (see pg 35 AHRQ Evidence Synthesis) summarizes the current recommendations of various professional medical organizations for breast cancer screening for average-risk women:



Task-force Study vs. Task-force Recommendations

Perhaps most telling, however, are the details mentioned in the "Limitations," "Future Research" and "Conclusions" sections of the Systematic Evidence Review Update for the USPSTF
published by the task-force itself. The different tone and the overall impression one gets from these sections of the report emphasizes the danger of drawing conclusions from press releases and "executive summaries." The full story is so much more complex. It is worth quoting those sections at length:

Breast cancer is a continuum of entities, not just one disease that needs to be taken into account when considering screening and treatment options and when balancing benefits and harms. None of the screening trials consider breast cancer in this manner. As diagnostic and treatment experiences become more individualized and include patient preferences, it becomes even more difficult to characterize benefits and harms in a general way. Many patients would consider quality-of-life an important outcome, although it is a more difficult outcome to measure and report in trials...
No screening trials incorporating newer technologies [digital mammography and MRI] have been published, and estimates of benefits and harms in this report are based predominantly on studies of film mammography. No definitive studies of the appropriate interval for mammography screening exist, although trial data reflect screening intervals of 12-33 months...

Additional research on benefits and harms of mammography screening with quality-of-life outcomes, as well as morbidity and mortality outcomes, would provide further understanding of the implications of routine screening...

Our meta-analysis of mammography screening trials indicates breast cancer mortality benefit for all age groups from 39-69 years, with insufficient data for older women. False positive results are common in all age groups and lead to additional imaging and biopsies. Women age 40-49 years experience the highest rate of additional imaging whereas their biopsy rate is lower than older women. Mammography screening at any age is a trade off of a continuum of benefits and harms. The ages at which the trade-off becomes acceptable to individuals and to society are not clearly resolved by available evidence. (Emphasis added.)

Cui bono
?

This brings us back to the original question: Are the benefits worth the cost?

That depends on how you answer the questions: Of benefit to whom? Of cost to whom?

And that is the entire crux of socialized medical care.

In a system dominated by third-party payers, cost is distributed beyond those who directly benefit. At least with private insurance, an individual still retains a significant degree of choice: How much coverage am I willing to pay for? Which plan will I choose to participate in? In contrast, the more government steps in to regulate insurance and medical care (or even go so far as to provide payment and/or care directly) the more those decisions must and will be taken away from the individual patient and shrink toward a one-size-fits-all policy.

The more that "society" picks up the tab, the further removed the real-life effects on the individual patient will be from cost/benefit calculations, and the less the unique circumstances of the individual most affected by the decision will determine the decision.

Medical research and analysis is fluid and rapidly changing. Attempts to legislate standards of care are slow, cumbersome and unable to account for individual variation. Government-controlled medicine must lead to unnecessary delay in implementing the latest knowledge. Lives will be lost and suffering will be increased while Congress or some bureaucrat work to catch up with medical progress.

Additionally, it is dangerous for government to step between a patient and his doctor, especially for critical life-and-death decisions. Yet, if government is paying for medical services, the requirement of protecting taxpayer money demands that it do precisely that. Recommendations from government-sponsored panels must always be suspect of putting budget needs before patient needs--its part of their job!

Fortunately, there is an affordable alternative to government-guaranteed medical care that preserves individual choice, protects the patient-doctor relationship, allows for a quick response to advances in medical knowledge and technology, encourages innovation, personal responsibility and the efficient use of resources: the free market1. And for those unfortunate few who are hit with disaster above and beyond their ability to provide for themselves, history has shown this country to have the most generous people in to the world.

This week's announcement of the new breast cancer screening recommendations from a government-sponsored review panel set alarm bells ringing: Watch out for rationing! Whether or not the fears are justified in this particular instance, the fears are definitely justified by the accelerating trend toward greater and greater government control of medical care. Let's hope that Congress starts listening to its constituents and allows medical care to return to a private matter between patients and their doctors.


Update 11/24/09 WSJ has an editorial which makes many of the same points as here, but without the detailed analysis. A Breast Cancer Preview

Notes

1. Much has been written on free market solutions to the rising cost of medical care. See my current reading list for books which address this topic. Brief papers include:
Cannon, Michael "Yes, Mr. President, A Free Market Can Fix Health Care", Cato Policy Analysis No. 650, Oct., 2009
Friedman, Milton "How to Cure Health Care" Hoover Digest, 2001, No. 3
Whitman, Glen and Raad, Raymond, "Bending the Productivity Curve: Why America Leads the World in Medical Innovation" Cato Policy Analysis No. 654, Nov. 2009
Conko, Gregory and Klein, Philip, "Political Malpractice: Health Insurance Misdiagnosis and the Destruction of Medical Wealth" CEI
Issue Analysis 2009 No. 5

Bibliography

Bourque, Steven "Just Take the Blue Pill, Lady" One Reality
Nov.17, 2009

Kolata, Gina "Panel Urged Mammograms at 50, Not 40"
NYT, Nov. 17, 2009

Mandelblatt, MD et al., "Effects of Mammography Screening Under Different Screening Schedules: Model Estimates of Potential Benefits and Harms," Ann Int Med, 2009;151:738-747

Nelson, Heidi D., et al., "Screening for Breast Cancer: An Update for the U.S. Preventive Services Task Force, Ann Int Med 2009;151:727-737

Nelson, Heidi D., et al., "Screening for Breast Cancer: Systematic Evidence Review Update for the U.S. Preventive Services Task Force," AHRQ Publication No. 10-05142-EF-1, Nov. 2009

USPSTF, "Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement," Ann Int Med, 2009;151:716-726

USPSTF, "Screening for Breast Cancer: Recommendations and Rationale," 2002 statement

American Cancer Society Responds to changed to USPSFT Mammography Guidelines
http://www.cancer.org/docroot/MED/content/MED_2_1x_American_Cancer_Society_Responds_to_Changes_to_USPSTF_Mammography_Guidelines.asp

"Detailed ACR Statement on Ill Advised and Dangerous USPSTF Mammography Recommendations"
http://www.acr.org/HomePageCategories/News/ACRNewsCenter/UPSTFDetails.aspx

"USPSTF Mammography Recommendations Will Result in Countless Unnecessary Breast Cancer Deaths Each Year"
http://www.acr.org/HomePageCategories/News/ACRNewsCenter/USPSTFMammoRecs.aspx

6 comments:

Sue said...

Bravo Beth - thank you. My mom and grandmother both had breast cancer. I know it only increases my chances by 10% or so, but you can be I will be getting my mammogram once a year.

But will my daughters be able to do the same?

Amy said...

Thank you for doing all this research. I wonder if any of the professional medical associations are trustworthy. Even if the current health care bill doesn't pass, the system is already so highly regulated that in many cases you can't trust your doctor. I wish I knew where to go for solid information.

Beth said...

Amy,
I think it is a good idea to be skeptical of the associations (the AMA especially) but I wouldn't go so far as to say you can't trust your doctor. It's always a good idea to ask them questions to get a sense of their knowledge of the literature--or see if they are just following the recommendations of the professional organizations. Dialogue between the organizations can bring some of the complexity of the research more to light though, so its good to see them challenging each other. For so many of these matters, there is no one-size-fits-all, which only increases the need for freedom.

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Stephen Bourque said...

This is terrific, Beth. In my post on the matter, I had limited myself to the moral aspects of the issue because I didn't know enough facts to evaluate the USPSTF recommendation. Now, thanks to your thorough research, I do.

The injustice of the government intrusion is infuriating. They are fiddling with our lives.

Beth said...

Stephen,
Glad you found the post useful. Just another concrete example that the moral is the practical (and vice versa.)

Where to draw the line as to whether a test is "cost effective" or not will always be a highly individual matter. The general research data can help inform that decision, but in the end it must depend on the individual's circumstances, including their finances. I can't imagine that owning a top-of-the-line Mercedes will ever be "cost effective" for me----though if I was 10x richer, it might.
If I had more money and more spare time, being screened more often and for other cancers could become "cost effective" for me personally, but for now I think I will stick with annual mammogram and the recommended colonoscopy.
It is both infuriating and frightening to think that politicians are working to take those decisions away form me.