Published On: Fri, Oct 26th, 2012

New Laws Add a Divisive Component to Breast Screening

New Laws Add a Divisive Component to Breast Screening – In a move that has irked medical groups and delighted patient advocates, states have begun passing laws requiring clinics that perform mammograms to tell patients whether they have something that many women have never even heard of: dense breast tissue.

New Laws Add a Divisive Component to Breast Screening

New Laws Add a Divisive Component to Breast Screening

Women who have dense tissue must, under those laws, also be told that it can hide tumors on a mammogram, that it may increase the risk of breast cancer and that they should ask their doctors if they need additional screening tests, like ultrasound or M.R.I. scans.

The issue is pitting angry patients against the medical establishment. Advocates say women have a right to know, but medical groups argue that the significance of tissue density is uncertain and that reporting it may panic women and lead to an avalanche of needless screening tests and biopsies.

Laws requiring disclosure have been passed in Connecticut, Texas and Virginia, and most recently in California and New York, where they will take effect next year. A bill calling for a federal law has been introduced in the House.

The laws owe their existence mostly to Nancy M. Cappello, 59, of Woodbury, Conn. She was not told that she had dense breast tissue until after doctors found an advancedcancer that mammograms had missed. She took her story to legislators, and in 2009, Connecticut became the first state to require that women be told if they have dense breasts and that insurance companies cover ultrasound scans for those women.

“I want to help other women,” said Ms. Cappello, formerly the state’s chief of special education. “I can’t help myself. My cancer should have been detected at a much earlier stage.”

“Dense” breasts have a relatively high proportion of glandular or connective tissue, which blocks X-rays. Non-dense breasts have more fat, which X-rays penetrate easily. Over all, about 40 percent of women who have mammograms have dense breast tissue. It is not abnormal, just one of nature’s variations. Younger women are more likely to have dense tissue, but as many as 25 percent of older women do, too. Density cannot be judged by touch; it shows up only on mammograms.

For many women, the legislation will bring about a big change. Though some radiologists already tell women about density, in most cases the letters sent to patients about mammogram results do not mention it.

Though some doctors favor the laws, others resent them, and professional societies of radiologists, gynecologists and cancer experts have raised medical concerns.

The medical groups say telling a woman she has dense breasts may not help her and might even do harm by propelling her into unnecessary tests and treatment. The groups argue that identifying dense breast tissue is subjective, and so two doctors reading the same mammogram may rate the tissue differently. And information about density may confuse women, scare some needlessly and give others a false sense of security, the groups say.

Detractors also warn of a flood of phone calls to already-overburdened doctors and a demand for additional tests that will strain the health care system. There is already a shortage of experts in ultrasound screening, and many doctors simply bristle at the idea of laws controlling what they tell patients.

“I’m always worried when politicians start legislating the medical conversation, especially when it’s a medical conversation where the experts don’t know what needs to be said,” said Dr. Otis Brawley, the chief medical officer and executive vice president of the American Cancer Society and a professor of medicine at Emory University in Atlanta.

But Dr. Brawley said doctors should tell women if they have dense breasts, and he freely admitted that his position seemed contradictory.

“I’m saying I object to legislation that says doctors should have a conversation with their patients that I believe they should have with their patients,” he said.

The National Cancer Institute calls dense breasts “a strong risk factor for developing breast cancer.” Various studies have estimated that compared with other women, those with dense breasts are two to six times as likely to develop breast cancer. The reason is not known. But dense breasts have more milk ducts and lobes, where most cancers form, so some researchers think the added risk may come from having more of that tissue.

On mammograms, dense breasts look white, and so does cancer, so the tissue can hide tumors. Fatty breasts show up mostly black, so tumors stand out.

Studies have found that when women with dense breasts were given mammograms and then ultrasounds, the ultrasound found tumors that the mammograms missed — but also produced many false positives that led to biopsies.

Studies of women with dense breasts that were published in June in the journal Radiology and in April in The Journal of the American Medical Association found that for every 1,000 women screened, adding ultrasound found three to five cancers that mammograms missed. But in one study, 63 biopsies or other invasive procedures were performed to find three tumors.

Studies of women with dense breasts that were published in June in the journal Radiology and in April in The Journal of the American Medical Association found that for every 1,000 women screened, adding ultrasound found three to five cancers that mammograms missed. But in one study, 63 biopsies or other invasive procedures were performed to find three tumors.

M.R.I. exams can also find tumors that mammograms miss, but they produce even more false positives.

Despite its shortcomings, mammography does find some tumors in women with dense breasts — including some that ultrasound misses — so doctors emphasize that these women should not skip mammograms.

No studies have been conducted to determine whether finding the hidden cancers with ultrasound or M.R.I. scans saves women’s lives. In theory, the tumors found could be the kind that never would have killed the patients anyway. The United States Preventive Services Task Force, which makes recommendations about screening tests, has not given any advice on breast ultrasound.

This year, 226,870 new cases of breast cancer and 39,510 deaths from the disease are expected in the United States.

Dr. Thomas Kolb, a radiologist in Manhattan, said that like mammography, ultrasound can find early cancers and therefore should reduce the death rate.

“It doubles the detection rate in women with dense breasts,” he said.

But Dr. Carol H. Lee, a radiologist at Memorial Sloan-Kettering Cancer Center in New York and a spokeswoman for the American College of Radiology, said that while there is an increased overall cancer risk for women with dense breasts as a group, it is not known whether the risk is borne equally by every woman in the group. So the best advice for an individual woman is not clear.

Dr. Lee said that the radiology group did not oppose the idea of informing women but did not think it should be mandated by law. The group issued a statement warning of “possible harms and unintended consequences” of the state laws, including confusion, “undue anxiety,” a loss of faith in mammograms and “demands for additional non-mammographic screening.”

Some insurers may not cover the additional tests, so women who cannot pay out of pocket may not be able to afford them. Even when insurance does pay, the reimbursement rate is often so low that many doctors say it does not come close to covering the time and expertise needed to perform and interpret the exams. In addition, while mammography centers must meet strict standards, there are no such requirements for ultrasound screening, so the quality may vary.

Ms. Cappello, the woman who started the movement to inform patients, began having yearly mammograms at age 40. In 2004, when she was 51, her doctor felt a lump in her breast — only six weeks after a mammogram had looked normal. Even after the lump was detected, mammography still could not find it. Only then was Ms. Cappello told that she had dense breast tissue. The cancer had already spread to 13 lymph nodes. She needed a mastectomy, chemotherapy, radiation and hormone treatment.

Ms. Cappello was outraged. If she had known she had dense breast tissue, she said, she would almost certainly have had an ultrasound exam. She believes that the tumor would have been found earlier, perhaps even before it had begun to spread.

“It was probably growing for four or five years,” she said, “and it was missed.”

Source: The New York Times