Part 1 of this post described how the US Preventive Services Task Force’s (USPSTF’s) message about mammograms has been distorted by the press. Despite what you may have read, the Task Force did not recommend that women in their 40’s skip mammograms; it advised them to discuss the risks as well as the benefits with their doctors. And the USPSTF was not trying to save money; it is not charged with cutting the cost of care. Its only goal is to give women full information about the benefits and the limits–of mammography screening.
Below, I explain that what the task force just explained about the risks of mammography is something that it tried to tell us years ago. But Congress stood up and said “No—we don’t want women to know that.” Why? Because lobbyists for those companies who make mammography equipment did not want women to know that mammograms can lead to unnecessary surgery.
Below, I also note that some patient advocates as well as many disinterested physicians applaud the Task Force’s message. It’s just not as controversial as the media pretends. Indeed just one month ago the chief medical officer of the American Cancer Society was questioning the advantages of mammography in the pages of the New York Times.
Finally many in the media have claimed that under reform, the government will use “comparative effectiveness research” to ration care. This is totally untrue. Reform legislation is very clear: neither the USPSTF or any other government agency can use such research to deny coverage.
False Claim: The Task Force Pulled These Numbers Out of the Air and “Out of the Blue”
Washington Post columnist Dana Milbank suggests that the Task Force blindsided the American public with a radical recommendation: “In one cruel and clumsy blow . . .” the task force went “rogue with [a] surprise recommendation.”
Milbank offers a simple solution to the problem: Congress could “abolish the task force and turn it into a group that is more accountable to the public.”
Truth: This Is a Long-Standing Debate
University of Minnesota journalism professor Gary Schwitzer responds to Milbank’s charge that this was a “cruel and clumsy blow” on Schwitzer’s outstanding blog, Health News Review:
“How ‘cruel’ to try to ensure that women are fully informed about benefits and harms, and that this should be an individual decision based on individual values.” He quotes Fran Visco, president of the National Breast Cancer Coalition, a Washington-based patient advocacy group: “Women deserve the truth . . . and the truth is the evidence says that [screening for breast cancer] is not always helpful and can be harmful.”
Moreover, the Task Force report was far from a “surprise recommendation.”
“Read your own paper,” Schwitzer advises Milbank. “Don Eggen and Rob Stein reported that ‘the findings underscore a decades-long debate in the medical community about the risks and benefits of routine breast cancer screening for younger women. So this is not ‘rogue’ and it is not surprising for anyone who has made an attempt to follow the issue.” Schwitzer goes on to point out that Slate recently reprinted a 5-year-old article which included the the same warnings about the potential harms of mammograms:
“Though many believe that there can never be enough testing [for cancer],” Schaffer explained back in 2004, “the risks of false positives, overdiagnosis, and overtreatment are real.”
As to Milbank’s suggestion that the independent task force that bases its recommendations on medical evidence should be turned into a group “that is more accountable to the public,” Schwitzer writes:
“Oh that would be a grand idea. Make science accountable to the public? Let’s make science ignore the evidence and tell us fairy tales that we want to hear. That everything is terrific, risk-free and without a price tag? And let’s make the independent task force subject to federal government oversight. Then we can make science ignore the evidence and only spew out what is politically popular at the moment.”
This is, in fact, what happened in January 1997 when the National Cancer Institute sponsored a conference to discuss mammograms. Independent experts representing researchers, clinicians, statisticians, epidemiologists, and consumers testified and 12 independent experts reviewed the data. Their conclusion was "that the data currently available do not warrant a universal recommendation for mammography for all women in their forties." They recommended that women decide with their doctors on the best approach to take.
“Immediately a storm of acrimonious protest broke out,” reports pioneer woman’s health care activist and breast surgeon Susan M. Love. “Within days of the conference and with heavy lobbying by various special interest groups, the Senate voted 98 to 0 to endorse a nonbinding resolution that the presidentially appointed National Cancer Advisory Board recommend mammography screening for women under 50. By March, a press conference was held to announce the NCAB's recommendation that the NCI advises women age 40-49 to have screening mammograms.”
Thus the recommendations that preceded the recent update were “far from being scientifically based,” Love observes, but instead “were based on lobbying by interested parties.”
False Claim: The Only “Harm” Associated With Mammograms Is Anxiety
“What is the ‘harm’?” asks George Lakoff in his AlterNet post. “Anxiety and unnecessary biopsies from false positives are listed as the harms. My wife had such a false positive. . . . The biopsy when it came was simple: a needle inserted to withdraw fluid, like taking a blood sample. No harm.”
Truth: Mammograms Can Lead to Unnecessary, Invasive Treatments
First, biopsies are not always so simple. On its website, the Mayo Clinic lists the risks of biopsies for breast cancer: “Infection or bleeding at the biopsy site” and “altered breast appearance, depending on how much tissue was removed and how the breast heals.”
Meanwhile, Mayo reports, “In the U.S., 80 percent of women who undergo a breast biopsy learn that they don't have cancer.” This makes one wonder: how many of these biopsies were unnecessary?
Secondly, sometimes mammography discovers small tumors that if left alone, would never have developed.The Task Force notes that “Screening detects not only cancer that could lead to a woman's death but also cancer that will not shorten a woman's life. Women cannot benefit from—but can be harmed by—the discovery and treatment of this second type of cancer, which includes both cancer that might some day become clinically apparent and cancer that never will.”
Research published in the British Medical Journal (BMJ) this year, reported that if 2,000 women are screened regularly for 10 years, one life will be saved but 10 healthy women will be treated unnecessarily. “This treatment includes removal of part or all of their breast, radiotherapy or chemotherapy.”
A month before the USPSTF update was released, the New York Times’ Gina Kolata reported on the serious risks of overtreatment following screening: “The dilemma for breast and prostate screening is that it is not usually clear which tumors need aggressive treatment and which can be left alone. And one reason that is not clear, some say, is that studying it has not been much of a priority.
“‘The issue here is, as we look at cancer medicine over the last 35 or 40 years, we have always worked to treat cancer or to find cancer early,” the American Cancer Society’s chief medical officer, Dr. Otis Brawley, told the Times. “And we never sat back and actually thought, ‘Are we treating the cancers that need to be treated?’ ”
Kolata continues: “The very idea that some cancers are not dangerous and some might actually go away on their own can be hard to swallow, researchers say. ‘It is so counterintuitive that it raises debate every time it comes up and every time it has been observed,’ said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health. But Kramer points out that once screening was introduced, breast and prostate cancer rates soared—because th
e tests could detect those insignificant cancers. The result: overdiagnosis labeling innocuous tumors cancer and treating them as though they could be lethal when in fact they are not dangerous.
“‘Overdiagnosis is pure, unadulterated harm,’” Karmer told the Times.
“Dr. Peter Albertsen, chief and program director of the urology division at the University of Connecticut Health Center, said that had not been an easy message to get across,” Kolata reported: “‘Politically, it’s almost unacceptable,’ Dr. Albertsen said. ‘If you question overdiagnosis in breast cancer, you are against women. If you question overdiagnosis in prostate cancer, you are against men.”
Meanwhile, Dr. Esserman expressed the hope “that if research continues on how to advance beyond screening, distinguishing innocuous tumors from dangerous ones, people will be more realistic about what screening can do. Someone may say, ‘I don’t want to be screened,’ she said. Another person may say, ‘Of course I want to be screened.’ Just like everything in medicine, there is no free lunch. For every intervention, there are complications and problems.”
Over at the Atlantic, John Crewdson points out that in the article Kolata published just last month, Brawley, the Amercian Cancer Society’s (ACS’s) chief medical officer, admitted: "that American medicine has overpromised when it comes to screening. The advantages to screening have been exaggerated.'' But, Crewdson notes, since the task force released its recommendations on mammography, Brawley has backed off, telling The Times that “the cancer society had concluded that the benefits of annual mammograms beginning at 40 ‘outweighed the risks’ and that the ACS was sticking by its earlier advice.”
According to Crewdson one of Brawley's colleagues explained: “"He's trying to save his job. He was broiled at home for the interview in which he said that we (the medical establishment) are 'overselling' screening."
False Claim: Cancer Survivors Are United in Denouncing USPSTF Guidelines
The news has been filled with statements from horrified cancer survivors who are convinced that they would be dead if they had not had regular mammograms. In truth, of course, no one knows how many of these tumors would have been discovered in some other way. And some of those tumors would never have spread.
Truth: Not all Cancer Survivors Support Routine Mammograms
The New York Times’ Gail Collins reports that she had breast cancer back in 2000, and mammograms never helped her. “I had mammograms every year like clockwork, and I had just gotten a clean bill of health from my latest one when I found a lump on my left breast while watching a rerun of ‘Buffy the Vampire Slayer,’ multitasker that I am.
“It turned out to be cancer, of a fairly low-grade variety. My oncologist felt strongly that it never would have developed if I hadn’t taken estrogen replacement therapy — another one of the medical marvels that has now been consigned to the Seemed Like a Good Idea at the Time category.
“So, in summary, the cutting-edge of medical thinking of the 1990s may have induced my cancer, and then the universally recommended testing protocol failed to detect it.” (Hats off to Collins who managed to write a low-key, funny, and truly informative piece on such a fraught topic.)
Collins adds: “I am going out on a limb to say that the real problem with a test that creates a lot of false-positive results is that it leads to a lot of other medical procedures, some involving hospitals. Unless you are genuinely sick, there is no more dangerous place to be hanging around than a hospital.”
Jane Flanders goes a step further. She regrets ever having been screened. Timesonline.co.uk reports that Flanders believes she was the victim of over-diagnosis.
The 56-year-old math teacher was diagnosed with ductal carcinoma in situ, a dormant cancer which was not spreading and may never have caused problems.
Doctors advised her to have radical treatment — including a mastectomy — in case it might spread. (In the U.S., more than 62,000 cases of DCIS are diagnosed annually, making it the most rapidly increasing type of noninvasive cancer. The majority of DCIS cases — about 90 percent — are discovered during routine mammograms. DCIS usually has no outward signs or symptoms. “DCIS isn't considered life threatening, but it should be treated,” the Mayo Clinic advises. “If not detected and treated, it can progress to a more serious form of invasive cancer. The best treatment approach is still being debated.”
Flanders doesn’t agree. “‘Screening has caused me considerable and lasting harm. It has certainly not saved or prolonged my life. The reality of this diagnosis has been two wide excisions, one partial mutilation (sorry, mastectomy), one reconstruction, five weeks’ radiotherapy, chronic infection, four bouts of cellulitis (a bacterial infection), several general anesthetics and more than a year off work.’”
In the UK, the National Health Service is publishing leaflets that explain the risks of screening and the facts about “ductal carcinoma in situ”:
“Much of the ductal carcinoma in situ diagnosed will never surface clinically. Therefore it constitutes overdiagnosis — that is, you are diagnosing something that would not have become an issue. Ductal carcinoma in situ accounts for 20% of the diagnoses made through screening. Less than half of the dormant cancers will progress to become invasive but 30% are treated with mastectomies.”
False Claim: U.S. Physicians Tell Women to Ignore the Task Force’s recommendations
have highlighted statements from oncologists who are “worried” or even “disgusted” by the USPSTF update. Few disclose possible conflict of interest.
Truth: Many Doctors—and Patient Advocates—Applaud the Task Force
Despite what some in the media report, U.S. oncologists are not uniformly opposed to the guidelines. “Dr. Amy Abernethy of the Duke Comprehensive Cancer Center told Fox News that she agreed with the task force's changes."Overall, I think it really took courage for them to do this," she said. "It does ask us as doctors to change what we do and how we communicate with patients. That's no small undertaking."
Over the past month, while turning a long-standing scientific debate about the risks and benefits of mammograms into a populist political fight centered on health care reform, the media has exaggerated the controversy within the medical profession.
Well-informed physicians and medical researchers are just not that far apart on this issue. Writing in the most recent (November 25) issue of the New England Journal of Medicine, Doctors Ann H. Partridge and Eric P. Winer, of the Dana-Faber Cancer Institute explain: “The updated recommendations sparked substantial controversy and have had a polarizing effect in the breast-cancer community. There has been confusion, fear, and anger on the part of patients with breast cancer, their families, and women's health advocates. The intensity of the controversy is unfortunate,” they add “because there is far more agreement than disagreement about breast-ca
“How do we interpret the USPSTF's new recommendations, reconcile the divergent opinions, and advise patients?” Partridge and Winer answer their question: “First, we need to reassure our colleagues, our patients, and the public that the task force did not suddenly turn the long-debated topic of breast-cancer screening upside down. There has long been controversy about screening for women in their 40s, and in our view, these recommendations represent a modest adjustment.”
Granted, some large professional organizations have been vociferous in their attacks on the Task Force–including the American Cancer Society, the American College of Radiology, the American Society of Breast Surgeons and the American College of Obstetricians and Gynecologist.
What newspapers rarely report is that many of these groups have financial ties to companies that manufacture breast imaging products and equipment.
The Hastings Center Bioethics Forums reveals what the media fails to mention. There, Dr. Adriane Fugh-Berma, of the Georgetown University Medical Center and Alicia M. Bell, a member of the board of directors of the National Women's Health Network, note that “donors to the American Cancer Society Cancer Action Network (ACS CAN) . . . include Hologic, which makes breast imaging products, and Johnson and Johnson, which makes an image-guided breast biopsy product. Donors to the American College of Radiology Imaging Network (ACRIN) Fund for Imaging Innovation include Siemens, GE Healthcare, Phillips, Hologic, and many others that make mammography machines or related products.”
According to the American College of Radiology Web site, “the leaders of the ACR and ACRIN have been meeting with industry leaders from key donors to the ACRIN Fund to strengthen the relationships between the organizations and better determine how both parties can maximize this relationship.”
Individual physicians may also have vested interests. Fugh-Berman and Bell report that “Daniel Kopans, a Harvard professor of radiology who told Reuters that the new guidelines ‘are scientifically unjustified and will condemn women ages 40 to 49 to unnecessary deaths from breast cancer’ holds patents on imaging systems.”
“None of these conflicts of interest have been mentioned in news coverage.”
Meanwhile, the American Academy of Family Physicians, which has no apparent financial interest in mammography, has endorsed past USPSTF recommendation on breast cancer screening.
In 2007, the Academy recommended that screening mammography decisions in women aged 40 to 49 years should be based on individualized assessment of risk for breast cancer; that clinicians should inform women aged 40 to 49 years about the potential benefits and harms of screening mammography; and that clinicians should base screening mammography decisions on benefits and harms of screening, as well as on a woman's preferences and breast cancer risk profile. The Academy has not yet commented on the recent update.
Perhaps what is most striking is how many patient advocacy groups agree with the task force's guidelines. Recently, Barbara Brenner, executive director of the San Francisco-based Breast Cancer Action, told Fox News that her group was "thrilled" with the revisions. . . . “Mammograms, like all medical interventions, have risks and benefits,” she said. “Women are entitled to know what they are and to make their best decisions . . . These guidelines will help that conversation."
Brenner is not alone. The National Breast Cancer Coalition, Breast Cancer Action and the National Women’s Health Network (which Fugh-Berman and Bell note, is one of the few national health advocacy groups that takes no money from industry) all support the USPSTF update.
False Claim: Under Reform, the, Government Will Use Comparative Effectiveness Research to Ration Care
The Obama administration has already set aside funding for a panel of medical experts to review “comparative effectiveness” research which looks at the risks and benefits for alternative treatments for a particular disease.
Those who oppose reform claim that the administration plans to use this research to deny care, and they have seized on the USPSTF update as an early example of what reformers plan to do. The LA Times quotes Rep. Phil Gingrey, a physician: “This is really the first step toward that business of rationing care based on cost.”
Both Fox News' Glenn Beck and conservative author David Horowitz have chimed in, declaring that Democrats are responsible for the recent (USPSTF) update and citing this as proof that Democrats are, in Horowitz's words, "imposing a rationing system."
In fact, the Task Force is an independent panel. Members of the group are medical professionals, all of whom were seated or selected during the Bush administration.
Truth: Reform Legislation is Explicit: Effectiveness Research Cannot Be Used To Deny Coverage
First, it is crucial to distinguish between “comparative effectiveness research” and work which considers the “cost-effectiveness” of a particular treatment. When researchers compare the “effectiveness” of two procedures they are trying to determine which would provide the greatest benefit for patients who fit a particular profile—regardless of cost. Sometimes the most effective product or procedure is cheaper; sometimes it’s most expensive.
“Cost-effectiveness” research goes a step further to ask: Do the benefits of a given treatment justify the price tag?
This is how the UK determines what its single-payer system will and won’t cover. For instance, in 2007 the agency responsible for ruling on reimbursements decided that four drugs for patients suffering from early-stage Alzheimer’s disease (Aricept, Reminyl, Exelon and Ebixa ) were not “cost-effective” because they had “only a small clinical effect” on patients suffering the symptoms of early stage Alzheimer’s. The drugs would be covered only for patients in the later stage of the disease.
Are Americans ready to let a panel tell Medicare or other insurers which Alzheimer drugs should and shouldn’t be covered based on price alone? Probably not.
If we were going to apply cost-benefit analysis to healthcare, we would have to face up to some sticky questions. First, how much is an extra year of life is worth—in dollars? Is an extra year worth more for a twelve-year-old than an 80-year-old? How much more? What if the patient is bed-ridden?
Luckily, the U.S. does not have to confront such imponderables. The UK’s healthcare budget is much smaller than ours. This means that the UK must make some very difficult decisions. Because we have so much more money sloshing around in our bloated health care system, we can save billions just by concentrating on effectiveness. There is much low-hanging fruit to be picked.
Years of research suggests that one-third of our health care dollars are squandered on unnecessary treatments. If we redirect those dollars to products and procedures that actually benefit patients, we will have enough money to provide effective care for all Americans. This is of course does not mean that we should over-pay. Medicare has already announced that it plans to reduce how much it reimburses for certain tests because medical evidence suggests these tests are being done too often—which means that risks are beginning to outstrip benefits.
The administration recognizes that the majority of Americans don’t want to see health care rationed based on co
st. Its comparative effectiveness panel would only disseminate information about risks and benefit, creating guidelines (not rules) that physicians can follow, as they chose. When drawing up these guidelines the panel would not be looking at cost. It’s only goal: to help physicians choose the right treatment for the right patient at the right time.
Indeed, as the American College of Physicians (ACP, the organization that represents internists) explains, the legislation is explicit on this point: “Under the bills being considered by Congress, the USPSTF will have an important role in making evidence-based recommendations on preventive services that insurers will be required to cover, but the bills do not give the Task Force — or the federal government itself — any authority to put limitations on coverage, ration care, or require that insurers deny coverage. Specifically, the House and Senate bills would require health plans to cover preventive services based in large part on the evidence-based reviews by the USPSTF, but no limits are placed on health plans’ ability to offer additional preventive benefits, or in considering advice from sources other than the USPSTF in making such coverage determinations. Accordingly, patients will benefit by having a floor – not a limit – on essential preventive services that would be covered by all health insurers, usually with no out-of-pocket cost to them. . . . The bills specifically prohibit use of comparative effectiveness research to limit coverage or deny care based on cost.”
How did I find this information? By Googling.
I can remember a time when journalists who wanted to track down the truth had to go to a library, and crank through pages and pages of microfilm to find one fact.
Today, when search engines do the work for you, I have one question: Why are our newspapers, magazines, news shows and blogs filled with so much misinformation?