So Much for Comparative Effectiveness

by GoozNews ~ 19 Nov 2009 09:38am

The Obama administration's commitment to cost control in health care can now be summed up in four words: Not on our watch.

Health and Human Services Secretary Kathleen Sebelius told American women yesterday that they have nothing to learn from the science that led to the U.S. Preventive Services Task Force guidelines on mammography. Insurance companies won't change their payment policies, and the independent doctors and scientists who made up the USPSTF task force "do not set federal policy" or "determine what services are covered by the federal government."

What a golden opportunity has been missed to educate Americans about the implications of their health care choices. Otis W. Brawley, the chief medical officer of the American Cancer Society, in an op-ed in today's Washington Post condemning the USPSTF guidelines, confirms that mass screening would only save at a maximum 600 out of the 4,000 women under 50 who die of breast cancer annually. What he failed to point out is that 1.14 million American women would have to be screened annually for ten years to achieve that goal. To cover the entire cohort (all women between 40 and 49) to replicate that benefit every year would require screening 11.4 million women annually. The cost, at $200 per mammogram (my initial estimate was accurate, according to this New York Times business section article), would come to $2.24 billion annually for the health care system.

I repeat my argument from Tuesday. Let's start on day one and ask this question: The health care system (you can't say the government in our mixed public and private payer system) has just come up with an extra $2.24 billion to spend on reducing breast cancer mortality in the U.S. population. Not only that, we get to spend it year after year. Should we spend it on mammography for women under 50? Or should we target that money for free mammograms for women of all ages who smoke, who are obese and who have a family history of breast cancer? Should we target that money to free mammograms for women of color, who have a much higher risk of breast cancer (perhaps because they are more likely to smoke or be obese)?

And as far as the coverage is concerned, I have yet to see a single story that quantified the harms of mass screening. How many false positives and unnecessary biopsies are there for every breast cancer caught early? How many actual, treated positives turn out to be very early stage ductal carcinoma in situ, minor breast duct growths that may dissolve on their own? A recent AHRQ analysis suggested that was about 20 percent of all growths identified during mammograms. According to Greg Pawelski's most recent comment on GoozNews:

Research by the Nordic Cochrane Centre in Denmark raised questions about the effectiveness of mammography. In a study of 2000 women, they found that one woman would have her life prolonged but 10 would undergo unnecessary treatment and 200 women would experience unnecessary anxiety because of false positive results.

Health care is complex. Most treatments that "work" only work in a fraction of the people who get that treatment. Each has risks, which also affect a subset of those treated. Evaluating value is a trade-off between risks and benefits. Because breast cancer is such a high profile issue, the new mammography guidelines offered the Obama administration a chance to educate the public about the trade-offs involved in making those choices, and how the nation might wring more value out of the money it spends on health care.

Alas, the administration punted. In the midst of a political battle over health care reform, where nihilist Republicans are braying about profligate spending on the one hand and letting nothing stand between you and your doctor on the other, the politicians in charge of health care policymaking saw that offer as one they had to refuse.

Correction: An earlier version of this post mistakenly said there were 4,000 deaths from breast cancer per year among women under 40. I meant women under 50. And Greg Pawelski is not a physian or a Ph.D.

Comments

One retired medical

One retired medical oncologist noted that many years ago, the NCI tried to convince everyone not to screen women younger than 50 but were given such a tongue lashing by Congress that they went home, licking their wounds and withdrew their recommendation.

Likewise, the American Cancer Society (ACS) avoids looking clearly at the data and continues to recommend screening for women under fifty. The ACS doesn't want to enrage its donor base and Congress didn't want to upset constituents. I think that could include the Office of the President.

It is important to note that companies like General Electric and DuPont, both which manufacture mammography equipment, are large donors to organizations that are against any change in the recommendations.

Yes, some of the reasons for this are political and financial.

The other side of the

The other side of the coin, presented to me from an oncologist friend, is radiation risk imposed by mammography, is not simply of negligible value in younger women, but may have a net harm effect, if women who have mammograms at age 40 start having higher rates of cancer in irradiated breasts 25 or 35 years later.

The recommendation not to begin mammography until age 50 has to do with medical issues, more than cost effectiveness issues. Mammography is not harmless. You are subjecting women to annual doses of ionizing radiation to the breasts, with some unavoidable scatter to chest wall and lungs. We do not know how many women who are irradiated by mammography in their 40s will develop radiation-induced breast cancer (or even lung cancer) in their 60s, 70s, and 80s.

The other problem is that women in their 40s tend to have very dense breasts, making it more difficult to get an accurate exam. These women often are called back for additional views, giving them even more radiation. There are more false positives, leading to breast biopsies and sometimes unnecessary lumpectomies, in cases where the biopsies are technically suboptimal.

In contrast, in older women, their breasts are less dense, making the examination more accurate, with fewer false positives, and there are fewer years of remaining life to develop a radiation-induced malignancy.

The fact is that we have no truly long term follow up studies to determine very long term risks of carcinogenesis from radiation exposure in mammography.

1. J Radiol Prot. 2009 Jun;29(2A):A123-32. Epub 2009 May 19.

Mammography-oncogenecity at low doses.

Heyes GJ, Mill AJ, Charles MW.

Department of Medical Physics, University Hospital Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK.

Controversy exists regarding the biological effectiveness of low energy x-rays used for mammography breast screening. Recent radiobiology studies have provided compelling evidence that these low energy x-rays may be 4.42 +/- 2.02 times more effective in causing mutational damage than higher energy x-rays.

The risk/benefit analysis, however, implies the need for caution for women screened under the age of 50, and particularly for those with a family history (and therefore a likely genetic susceptibility) of breast cancer. In vitro radiobiological data are generally acquired at high doses, and there are different extrapolation mechanisms to the low doses seen clinically. Recent low dose in vitro data have indicated a potential suppressive effect at very low dose rates and doses. Whilst mammography is a low dose exposure, it is not a low dose rate examination, and protraction of dose should not be confused with fractionation. Although there is potential for a suppressive effect at low doses, recent epidemiological data, and several international radiation riskassessments, continue to promote the linear no-threshold (LNT) model.

Merrill---I am in no position

Merrill---I am in no position to judge the quality of the research relied upon by the USPSTF. What disappoints me is the Task Force's (and AHRQ's) lack of interest in being understood. The firestorm was very predictable...but they don't appear to have done anything to anticipate it and show why their logic and facts are meaningful to women who fear breast cancer (which is, I believe, all women). 


Announcing such recommendations in an academic journal or through a white paper that requires a google search to find...doesn't cut it. Further, your argument about how best to spend $2.2 billion on preventing breast cancer was a better defense of the TF position than anything they offered. No wonder they got clobbered.


All this is not hopeless, doomed to opposition. Later in the week, ACOG announced revised cervical screening guidelines. They had clearly taken the time to talk with affected interests and to make sure the context of their recommendations were clinically-based as well as cost-effective. I explored these issues in my latest post at: http://www.fdamatters.com/?p=653.


I recommend that USPSTF hire you. They would be so much better served. Steven


 

Our government, Sec'y

Our government, Sec'y Sebelius in particular, was shameful.  They rejected their own task force.  The USPSTF, while not perfect, is known for its caution and objectivity.  This past week was a huge defeat for comparative effectiveness research, an endeavor that the administration stated was a high priority item.  See http://bit.ly/656CwP