Companies that make 3D mammography equipment have spent millions on marketing the devices, even though scientific evidence of their superiority to traditional mammography is lacking, according to a new report.
The report by Kaiser Health News says that Hologic (NSDQ:HOLX), GE Healthcare (NYSE:GE), Siemens Healthineers and Fujifilm (TSE:4901) have paid doctors and teaching hospitals a collective $9.2 million related to 3D mammography, also known as tomosynthesis. About half of that money was spent on research, with the rest going toward speaking fees, consulting, travel, meals or drinks, according to the news service, which obtained the data from the Medicare Open Payments database. The database also revealed that often-cited journal articles on 3D mammography were written by doctors who had financial ties to the industry, the report said.
The 3D mammography industry also spent $14 million in the last four years in marketing directly to women, the news agency found. Hologic used Grammy-winning singer-songwriter and breast cancer survivor Sheryl Crow in its ad campaign. The industry also mounted lobbying efforts nationwide to extend insurance coverage for the procedure and donated money to the American Society of Breast Surgeons for educational grants. That organization recently recommended 3D mammography as a “preferred sole modality” for women at normal risk for breast cancer and that women with higher-than-average risk undergo 3D screenings annually.
According to the U.S. Preventive Services Task Force, 3D mammograms have not been shown to be more effective than traditional mammograms. The National Cancer Institute is enrolling up to 18,000 asymptomatic women in a randomized study comparing 3D and traditional mammography to determine if 3D is better than 2D at finding breast cancers before they become more difficult to treat.
A Mayo Clinic patient education page says that 3C mammograms can “detect slightly more cancers than a standard mammogram alone. Studies indicate that combining a 3D mammogram with a standard mammogram can result in (detecting) about one more breast cancer for every 1,000 women screened when compared with standard mammogram alone.”
Hologic has given educational grants to the American Society of Breast Surgeons, a medical association that recently recommended 3D mammograms as its “preferred screening method,” according to the group’s website.
Hologic objected to the Kaiser Health News story as confusing to patients and reaffirmed its position that breast cancer screening with 3D mammography offers women the best chance of early diagnosis.
“It is touted as an investigative piece, yet fails to recognize the more than 250 peer-reviewed clinical studies that consistently demonstrate the benefits of 3D mammography over 2D mammography,” said Pete Valenti, president of breast and skeletal health solutions for Hologic, in a news release. “Articles like this have the potential to confuse and mislead women into questioning the fact that early detection saves lives. Ultimately, we have to ask, ‘if we don’t screen, what is the alternative?’ At Hologic, we are not willing to wait and let women present with late-stage cancer, when we know breast cancer screening with 3D mammography offers women the best chance of early diagnosis.”
Hologic maintains that the clinical benefits of 3D mammography are “indisputable” and that, like many medtech companies, Hologic compensates healthcare providers for their research and educational efforts. “Any payments we make to healthcare providers are reported to public databases, as required, and in all cases, physicians are free to communicate their research findings and individual opinions,” the company said in an email to MassDevice.
Hologic said its 3D mammography exam has been clinically proven and FDA-approved to detect 20% to 65 % more invasive cancers, reduce unnecessary callbacks by up to 40% compared to 2D mammography, and is “approved as superior for women with dense breasts compared to 2D alone,” according to studies published in the Journal of the American Medical Association and Lancet Oncology.
“3D mammography is unquestionably a superior mammogram,” added Dr. Nila Alsheik, section chief of the breast imaging division at Advocate Lutheran General Hospital (Park Ridge, Ill.) and a member of Hologic’s scientific advisory panel. “In my practice, I still see 2 to 3 centimeter cancers that are completely occult on 2D mammography, and only visualized on 3D mammography. Even after the tens of thousands of mammograms I’ve read, and the thousands of patients I have counseled, each cancer I detect is like the first one I have ever seen: devastating to that patient, her family and her community. I will do anything to mitigate the confusion that articles like this create.”
Since the FDA approval of 3D mammography in 2011, breast cancer mortality rates in the U.S. have dropped by 10% “due to advancements in both screening and treatment,” Hologic noted. “Yet, there are still far too many women dying from breast cancer,” the company said. “In 2019, 41,760 women are expected to die from breast cancer in the U.S. alone, and more than 500,000 globally.”
Other companies mentioned above and in the Kaiser Health News article did not provide comments to MassDevice.
Shares in HOLX have dropped 3.7% to $47.71 since the news service article was published Tuesday.