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NewslettersBrainstorm Health

U.S. Panel Says More Women Should Get BRCA Gene Testing for Breast Cancer: Brainstorm Health

By
Sy Mukherjee
Sy Mukherjee
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By
Sy Mukherjee
Sy Mukherjee
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August 20, 2019, 6:27 PM ET

Good afternoon, readers.

An independent expert panel of scientists specializing in prevention says that many more American women can benefit from genetic screening for BRCA genes associated with breast and ovarian cancers—but caution that it’s not for everyone.

The U.S. Preventive Services Task Force (USPSTF) has released its latest guidelines for BRCA1/2 gene mutation-related cancers, which make up about 5% to 10% of breast cancers and a higher share of ovarian cancers.

“The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool,” wrote the panel in the journal JAMA. “Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing.”

This builds upon existing recommendations by emphasizing that women who have already had breast cancer, or other kinds of BRCA-associated cancers, or those whose families and ancestries put them at particularly high risk of BRCA mutations that can lead to such cancers, should be genetically screened by primary care physicians.

With this information in hand, the panel says, the women can make personal decisions with the help of a genetic counselor on the best ways to reduce the risk of cancer or cancer recurrence.

The USPSTF’s guidelines carry weight—services with a high enough level of recommendation tend to be covered by private health insurance.

On the flipside, the group appeared to acknowledge that over-testing can also do harm. “Women whose personal or family history or ancestry is not associated with potential harmful BRCA1/2 gene mutations” were given a far lower, D-level recommendation for BRCA screening and genetic counseling.

Read on for the day’s news.

Sy Mukherjee, @the_sy_guy, sayak.mukherjee@fortune.com

DIGITAL HEALTH

Report: Apple Health grapples with leadership shakeups. CNBC's Chrissy Farr has another scoop on the Apple beat, reporting that the Apple Health team has gone through substantial shakeups over the last year over various cultural and strategic tensions. Apple has put significant resources into its health efforts, including via its EKG-armed Apple Watch and partnerships with multiple research centers on heart disease and other conditions. (CNBC)

INDICATIONS

Teva rolls out a generic version of EpiPen for kids. Generic drug giant Teva in unveiling a generic version of the EpiPen for young children, right in time for the start of the school year. Teva's generic of Mylan's flagship deadly allergic-reaction fighting epinephrine injector will cost about $300 for a two-pack at most pharmacies; Mylan has seen its share of the epinephrine auto-injector steadily shrink with the arrival of new generics (and after a scandal involving rampant price hikes on the life-saving product). (Reuters)

Sarepta plummets on FDA setback for Duchenne drug. Shares of rare drug maker Sarepta Therapeutics plunged 15% in Tuesday trading following an unexpected Food and Drug Administration (FDA) rejection of its second therapy for the muscle-wasting disease Duchenne muscular dystrophy. Called Vyondys 53, the therapy was a followup of sorts to Sarepta's Exondys 51, which was approved for the same condition several years ago. The rejection is interesting for several reasons: 1) Exondys 51's approval was granted despite the FDA's own advisory panel recommending a rejection, which some observers took as a sign the agency was more willing to green light rare disease treatments; 2) The latest development could suggest a change in that dynamic after several years of burgeoning drug approvals. (MarketWatch)

AstraZeneca diabetes drug cuts heart-related death risk in landmark study. A critical trial finds that AstraZeneca's Farxiga, a diabetes drug in the so-called SGLT2 space, cuts the risk of cardiovascular death and hospitalizations in certain patients when added to an existing treatment regimen for heart failure (regardless of whether or not the patients have diabetes, according to the company). It's a potent silver lining following an earlier Farxiga setback in the type 1 diabetes space. (FiercePharma)

REQUIRED READING

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Translating Success at a World-Changing Company, by Clifton Leaf

An Insider Takes Aim at Corporate America's 'Elite Charade', by Adam Lashinsky

Why It's So Hard to Regulate the Idealists, by Polina Marinova

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By Sy Mukherjee
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