After seeing his first effort thwarted by a governor's veto, state Sen. Joe Simitian on Wednesday reintroduced a bill requiring women who undergo mammograms to be informed if they have dense breast tissue.
The legislation, Senate Bill 1538, was inspired by one of Simitian's constituents as part of the senator's annual "There Ought to be a Law" contest. Amy Colton, a nurse and a cancer survivor from Santa Cruz, said she was never informed about the fact that she has dense breast tissue during mammograms and only discovered this after completing her treatment from breast cancer, according to a statement from Simitian's office.
"No one should have to go through what I did unnecessarily," Colton said in the statement.
"Women have the right to know about the risk factors they face and the limits of mammography."
The bill would require women with dense breast tissue to be informed after mammograms that dense breast tissue can obscure abnormalities such as cancer on a mammogram. They would also be notified that they "may wish to discuss the potential value of additional screening(s) with their doctors."
"This two-sentence notice enables women to be effective advocates for their own health," Simitian said in a statement. "These are two sentences that can save lives."
Though Gov. Jerry Brown vetoed a similar proposal last year, Simitian said he was encouraged by events since then, including Virginia's adoption of a similar law. Connecticut had adopted a notification requirement a year earlier. Simitian pointed to studies that showed Connecticut detection rates for breast cancer going up by 100 percent for women with dense breast tissue since the law was adopted.
Simitian, D-Palo Alto, said he is reintroducing the bill and, at the same time, talking with Brown's office to "see whether there is a path forward on which he and the Legislature can agree.
"While I was disappointed in the governor's veto, I was encouraged that his primary concern appears to have been the precise language of the proposed notice," Simitian said. "Looking ahead, I'm hopeful we can find common ground.
"Based on the latest findings in Connecticut, I am even more convinced it's a life saver."
Comments
Another Palo Alto neighborhood
on Mar 29, 2012 at 8:48 am
on Mar 29, 2012 at 8:48 am
Why is Joe Simitian insinuating himself, and "the law" into health care issues that he can know nothing about? The basis for this law seems to be one person's anecdotal claims about her own situation. What evidence does Simitian have that this woman was telling the whole truth? Did Simitian contact the Doctor, and demand to see the patient records, and the case notes that the Doctor doubtless filed for her case? Did the Doctor mis-diagnose this nurse's case, did he make an honest mistake, or was it his policy to not be very communicative with patients to begin with? Did the nurse/patient sue the doctor because she ended up with cancer, even though she had a mammogram?
Towards the bigger issue--how big a problem is this in California? Does Simitian have the slightest idea? Why does California need a law to prevent every bad thing that ever happened to just one person? This is another example of how Simitian has helped to create the "Nanny State". Will Simitian be moving to dictate, by law, the script that every doctor must say, verbatim, when diagnosing, patients?
Every case (whether involving cancer or not) very well might involve different details that other cases, and might well involve different resolutions. How can Joe Simitian begin to believe he knows more than the medical care professionals?
In this day and age of digital technology, there is no reason that all mammograms should not be analyzed by computer software, at least as a part of the diagnosis. There is no reason why the patients should not be provided hard copy from these examinations, including copies of the images, and the doctor's analysis, and recommendations. Did this doctor provide this sort of service to this nurse/patient?
How much the legislature of any state should be involved in defining the level of health care is very, very, questionable, since the qualifications for election to the legislature do not even require a high school diploma. Simitian's ham-fisted attempts to control our lives is another example of people who have failed to understand the nature of good law/public policy--even though Simitian is well educated.
Hopefully Gov. Brown will veto this bill too, should it pass through the legislature again.
Downtown North
on Mar 29, 2012 at 9:40 am
on Mar 29, 2012 at 9:40 am
Maybe there should be a law that medical doctors must be competent.
Menlo Park
on Mar 29, 2012 at 10:55 am
on Mar 29, 2012 at 10:55 am
Sally- More importantly- maybe there should be a law that our elected representatives must be competent. They are more into our lives than our doctors are.
At least they think they should be more into our lives- and Simitian leads the way in this regard. Doesn't he have anything better to do?
another community
on Mar 29, 2012 at 11:37 am
on Mar 29, 2012 at 11:37 am
SO...you folks think it's ok for doctors to withhold information about your health? A local doctor thought he'd wait and see, without telling me, about my benign brain tumor. Is this ok?
YES -- It is the patient's responsibility to make the final decision about further tests, treatments, or procedures....but to do that you need the truth about your situation.
The sad state of affairs is that the patient/doctor communication is no longer straightforward for a myriad of reasons, and many of those reasons are not medical.
Midtown
on Mar 29, 2012 at 11:47 am
on Mar 29, 2012 at 11:47 am
When is Simitian going to bring up a bill to kill High Speed Rail?
When is Simitian going to bring up a bill to revise the ABAG housing allocation?
When is Simitian going to bring up a bill to help solve the state budget Deficits?
When is Simitian going to bring up a bill to solve the looming public employee pension funding?
Simitian has had 12 years in Sacramento to address these issues.
Crescent Park
on Mar 29, 2012 at 10:29 pm
on Mar 29, 2012 at 10:29 pm
I'm a breast cancer survivor whose breasts were so dense at time of diagnosis that the doctor had trouble finding the correct spot for my first biopsy (which was negative, btw). Those of you barking about Sitimian so called intrusion into what doctors must disclose to women as part of their mammogram reports can only hope that breast cancer won't show its ugly head in your families. Please do your research. Dense breast tissue is one of the highest risk factors for the disease and women need to know about it just like we are told about the other risk factors. Omitting this information to women is causing many cancers to be diagnosed later than they could.
another community
on Mar 30, 2012 at 9:49 am
on Mar 30, 2012 at 9:49 am
Here are the facts Morris:
40% of all women who get mammograms have dense breast tissue.
71% of all breast cancer diagnoses are in women with dense breast tissue.
The medical community does NOT dispute the fact that the dense breast tissue DRASTICALLY reduces the mammogram's ability to detect cancer.
Dense breast tissue is the STRONGEST risk factor we know of for developing breast cancer, stronger than age or family history.
The addition of a simple, supplemental screening method raises the detection rate to 97% in women with dense breast tissue.
And finally, to answer your question regarding my honesty: my story is 100% truthful. But even more importantly, it is an extremely common, tragic scenario - every year 45,000 women in the US receive a "normal" mammogram result, but actually have invasive cancer.
You seem to be in favor of MD's providing full information to patients...good for you! Currently, that is not the standard of care, but that is exactly the bill's intent.
another community
on Mar 30, 2012 at 10:40 am
on Mar 30, 2012 at 10:40 am
Good response Amy. Over 40,000 women have cancer that is overlooked by mammogram, and 10,000 women will die every year due to these missed mammograms, that is not anecdotal and not specific to one case. (See the good work from the Institute for Health Quality and Ethics on this issue at inhqe.com) Two studies in Connecticut show that detection rate doubles with the new law that Simitian's law is modeled after.
You don't need access to all of Amy's medical records. When CNN did a piece on my missed cancer because of breast density, I provided them with the radiologist's report to my gynecologist (NOT sent to me) that said my mammogram was unreadable, and the contradictory letter that they sent to me saying my mammogram was normal. CNN provided links to both documents, so you don't have to rely on my word.
Web Link
The federal Mammogram Quality Standards Act requires that patient's mammogram results be communicated in clear language. "Normal" is not synonymous with "unreadable." It doesn't take any kind of diploma to understand that. As a matter of standard protocol, radiologists are withholding information from patients. Senator Simitian has proposed a law to rectify this breach of medical ethics. Shame on Jerry Brown for vetoing this law the first time, and thanks to Senator Simitian for re-introducing it.
Another Palo Alto neighborhood
on Mar 30, 2012 at 11:30 am
on Mar 30, 2012 at 11:30 am
I am glad that Simitian is pursuing disclosing information about the veracity of mammograms to patients. There is the opposite case where DCIS can be found by mammograms and lead to standard treatment: mastectomy, radiation, and chemo. But DCIS used to be a rare diagnosis prior to mammograms but now is located by looking for minute calcium deposits leading to numerous false positives. Even if DCIS does become cancerous, it can clear up on its own or may never threaten the life of the patient. Women should be able to know the pros and cons of mammograms. Simitian is right to help get the information to the patient.
another community
on Mar 30, 2012 at 12:37 pm
on Mar 30, 2012 at 12:37 pm
Dear Morris (above) and others who are interested,
Here’s the funny thing about your comment, Morris, “In this day and age…there is no reason why the patients should not be provided a hard copy from these examinations, including copies of the images, and the doctor's analysis, and recommendations.” This view indicates you agree with this bill! That is precisely the point of SB 1538. Although the bill can’t go to quite the lengths you suggest, it does require that women be informed of the most critical piece of information-- which is whether they have dense breast tissue--the strongest risk factor we know of for developing breast cancer.
As to your other concerns:
Re: “Why is Joe Simitian insinuating himself, and ‘the law’ into health care issues…” and “how big a problem is this in California?”
Obviously, you’re aware that women make up ½ of our community and our world. But perhaps you’re not aware that: “12.29% of women born today will be diagnosed with breast cancer at some time during their lifetime. This number can also be expressed as 1 in 8 women will be diagnosed with breast cancer during their lifetime,” according to the National Cancer Institute. So, this issue directly affects the livelihoods of all of Senator Simitian’s constituents who are women, or who have mothers, grandmothers, wives, daughters, and/or sisters.
Re: “The basis for this law seems to be one person's anecdotal claims about her own situation.”
No. Actually, the basis of this law is the current medical protocol of withholding breast density information from all women who receive and pay for mammography. Though radiologists already note whether patients have dense breasts and the ordering physicians are privy to this information, the current standard of care is for this existing breast density information to be omitted from the requisite mammography reports that patients must receive. So the 40% of women who have dense breast tissue are never made aware of it nor of the other more effective screening techniques for women with dense breast tissue. Rather, all these women are left at best with a false sense of security from a (potentially false) negative mammogram, and with a death sentence at worst.
Re: “Why does California need a law to prevent every bad thing that ever happened to just one person?”
As you can see from early comments, “Every year 45,000 women in the US receive a ‘normal’ mammogram result, but actually have invasive cancer.” And “10,000 of those women will die every year due to these missed diagnoses in mammograms. Studies looking into Connecticut’s version of the law found a 100 percent increase in breast cancer detection rates in women with dense breast tissue!
Re: “How can Joe Simitian begin to believe he knows more than the medical care professionals?”
Actually, last year’s measure was supported by the California Nurses Association, the Association of Women’s Health, Obstetric and Neonatal Nurses, the California Association of Health Underwriters, Breast Cancer Fund, the California National Organization for Women, Ravenswood Family Health Center, Democratic Activists for Women Now, the Shelia R. Veloz Breast Imaging Center and the California Communities United Institute.
So, Morris, I hope on behalf of the women in the world or at least those in your life, you will actively support SB 1538, and urge the Governor to sign this life-saving bill into law.
another community
on Mar 30, 2012 at 12:57 pm
on Mar 30, 2012 at 12:57 pm
Dear Morris,
It appears that you support a patient’s right to have access to all material medical information and you support the individual’s right to make informed medical decisions.
Our organization, the Institute for Health Quality and Ethics, has done a significant amount of research in this area, and we have made this information available to the public on our website at www.inhqe.com. The fact that high breast tissue density means that mammograms miss an average of 50-75% of cancers has been well documented by peer reviewed scientific studies. There are proven methods of increasing screening reliability for women who would choose to pursue additional or alternative screening if they were aware of mammography’s limitations.
Unfortunately, because this material medical information about breast density is withheld from women, they are denied the right to make an informed medical decision. Between 40,000 and 50,000 women receive a false negative mammogram report each year, most often due to the fact that the tumor was obscured by dense tissue. Due to the delay in diagnosis, 10,000 of those women will be dead within 10 years. The rest will be subjected to entirely unnecessary, painful, and debilitating (not to mention costly) treatments for late stage cancer.
Patient advocates have introduced this state legislation (in California as well as in many other states) because the professional medical organization responsible for providing this information, the American College of Radiology, has spent considerable time and resources lobbying against requirements to provide it to women. There is existing federal legislation (within the Mammogram Quality Standards Act) which requires imaging facilities to provide mammogram results directly to patients in terms “easily understood by a layperson.” This amendment was only enacted after years of spotty reporting during which many women with positive results were never properly notified. The onus for reporting the results to women now falls squarely on the imaging facility; excluding material medical information from this report that is sent to patients violates not only this federal statute, but it also violates AMA ethical guidelines.(AMA Code of Medical Ethics, Opinion 8.082, “Withholding medical information from patients without their knowledge or consent is ethically unacceptable.” )
The issue here is that the material medical information that women must have in order to make an informed decision is being deliberately withheld from them. The justifications for withholding this information (officially submitted by the ACR to the FDA as recently as November 2011) are without medical, legal, or ethical merit. The ACR's formal position and our response are available in their entirety on our website.
While the ACR has deliberately and systematically withheld this information from women, the FDA has neglected its oversight responsibilities. I urge any interested parties to review the research available on our website and to join the Citizen’s Petition which simply requests the FDA to terminate this practice of withholding material medical information from patients.
Our current system of medical care is predicated on the principle of informed consent; any policy or practice which systematically denies patients access to material medical information necessarily violates this principle, and it violates well-established ethical guidelines.
Regards,
Julie Marron
President
Institute for Health Quality and Ethics
www.inhqe.com
another community
on Mar 30, 2012 at 1:01 pm
on Mar 30, 2012 at 1:01 pm
pamom I agree with you but just want to underscore that overtreatment of non-invasive cancers like DCIS is not a flaw in the mammogram itself but what doctors and patients do with the information they get from the mammogram, whereas frequency of false negatives due to breast density is a flaw in mammogram technology itself. It's missed invasive cancers that are the target of Simitian's legislation, not non-invasive cancers (aka "Stage Zero").
DCIS should not be treated as aggressively as it has been in the past, but that's a separate issue. You probably know all this, but just clarifying for other readers.
Another Palo Alto neighborhood
on Mar 30, 2012 at 7:01 pm
on Mar 30, 2012 at 7:01 pm
Hallie, you are correct. But I wanted to add that there are other issues surrounding mammograms where women are not informed. Getting a DCIS diagnosis is very intimidating and when a doctor strongly urges mastectomy, most women will not even think to question that advice. Simitian's bill is focused on one aspect and I think he's right. I guess it would be difficult to add anything else to that bill. But I hope that his bill does start women to do research and question their diagnoses carefully.