OBR Daily Commentary

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FDA Alerts More Doctors Of Rare Cancer With Breast Implants

(Fox News/Associated Press) Feb 7, 2019 - U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease.

William McGivney, PhD (Posted: February 11, 2019)

quotesBreast Implants; Déjà Vu All Over Again Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”. For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage. The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer. It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers. quotes

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The Patient Had Bone Cancer. The Diagnosis Arrived 240 Million Years Too Late.

(New York Times) Feb 7, 2019 - The fossil of an ancient animal teaches a sad lesson: Cancer has been around for a very, very long time. Certainly the patient never knew where the hip pain came from, or why its left leg stopped working. The diagnosis arrived only 240 million years later, when a femur turned up in an ancient lake bed in Germany, one side marred by a malignant bone tumor. Cancer seldom appears in the fossil record, and its history among vertebrates is poorly understood. On Thursday, a team of researchers writing in JAMA Oncology have described the femur as the oldest known case of cancer in an amniote, the group that includes reptiles, birds and mammals.

H. Jack West, MD (Posted: February 08, 2019)

quotes"Paleo pathology" is cool. Cancer goes back to the Triassic period.quotes

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Bayer to Showcase New Data from its Growing Cancer Portfolio at 2019 ASCO GU Cancers Symposium

(Bayer) Feb 5, 2019 - First presentation of data from the pivotal Phase III ARAMIS trial with the investigational compound darolutamide in patients with non-metastatic castration-resistant prostate cancer.

Tomasz M. Beer, MD, FACP (Posted: February 05, 2019)

quotesDaralutamide would be the third agent with demonstrated efficacy in non-metastatic castration resistant prostate cancer if the ARAMIS trial yields positive results. Both efficacy and safety data will be of interest and clinicians evaluate a growing stable of options in this disease state where enzalutamide and apalutamide have been approved.quotes

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Tomasz M. Beer, MD, FACP

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