Health

FDA Eases Access to DNA Screening for Inherited Diseases

Published

9 years ago

February 20, 2015

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology.

The Food and Drug Administration said late Thursday it will not require preliminary review before companies can sell so-called carrier screening tests to the public. The tests, currently administered by health care professionals, are used by prospective parents who are healthy but may be carriers of cystic fibrosis, Tay-Sachs and other rare familial conditions.

In the same announcement, the FDA said it cleared the first carrier screening test from 23andMe, which was forced to pull its health tests from the market in 2013 due to a lack of scientific evidence.

23andMe’s test screens for the genetic mutations that cause Bloom syndrome, a rare disorder that causes short stature, increased risk of cancer and a variety of other health problems. The disorder is more common in people of central and eastern European Jewish descent, affecting about 1 in 50,000.

The positive FDA decision is a victory for Mountain View, California-based 23andMe, which had recently become something of a poster child for the culture clash between Silicon Valley and Washington.

The company’s CEO Anne Wojcicki said in an interview that her company’s research demonstrates that patients can understand genetic testing results.

“Our user comprehension studies have shown that people can get this information on their own without a physician and that there’s potentially a real benefit to direct access,” said Wojcicki.

Bloom syndrome is one of about 250 conditions and diseases that 23andMe’s original DNA kit claimed to help screen for by analyzing users’ genetic code. Wojcicki says that her company has another 45 to 50 carrier screening tests that could return to the market under the FDA ruling, possibly later this year.

The FDA said in a statement it plans to file a notice of the change and will take comments from the public for 30 days.

“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, director of FDA’s office for diagnostics.

People are considered a carrier for a genetic disorder if they have one normal gene and one mutated gene related to the disorder. A child must inherit two genetic mutations to fully develop the disorder.

23andMe launched in 2006 amid a flurry of publicity and celebrity endorsements, marketing its saliva-based test kit as an affordable way for consumers to peek into their own genetic code. But the company’s aggressive marketing and lack of scientific evidence ran afoul of FDA officials.

In November 2013, the FDA ordered 23andMe to stop selling its health tests. FDA said that despite over a dozen meetings and “hundreds of email exchanges” the company had failed to show the tests were backed by science. Regulators also took issue with a number of claims used to market the technology, particularly calling it a “first step in prevention” against diseases like diabetes, heart disease and breast cancer.

23andMe continues to sell genetic ancestral information and raw, unprocessed DNA data through its basic kit, which costs $99.

Wojcicki is separated from her husband, Google-co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company.

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Report: Black Women Doctors are Underrepresented in Health Care Sector

Physician retention in California has decreased over the years for women doctors of color, a report by the Physicians for a Healthy California stated. According to the report, women physicians are more likely to experience burnout than their male counterparts, a trend that worsened during the COVID-19 pandemic.

Published

5 hours ago

May 3, 2024

Oakland Post

The report states that Black and Latino physicians are underrepresented in the healthcare industry. Only 2.8% of physicians are Black and 5.5% are Latino across the state of California.

By California Black Media

Physician retention in California has decreased over the years for women doctors of color, a report by the Physicians for a Healthy California stated.

According to the report, women physicians are more likely to experience burnout than their male counterparts, a trend that worsened during the COVID-19 pandemic.

The report states that Black and Latino physicians are underrepresented in the healthcare industry. Only 2.8% of physicians are Black and 5.5% are Latino across the state of California.

It also noted that women doctors of color are often assigned to serve in vulnerable and under-resourced communities.

“It is critical for health care organizations to implement effective strategies focused on the retention of this important group of clinicians,” the report stated.

Women doctors of color face career dissatisfaction, contributing to the low retention rates in California’s healthcare industry. The burnout particularly experienced by female doctors of color stems from workplace harassment and perceived lack of value at work.

Additionally, moral injury was another key factor driving women physicians of color away from the workforce. Unlike burnout, moral injury is defined as “the betrayal of what’s right by someone who holds legitimate authority in a high-stakes situation.”

Currently, two of the nine California regions used in the framework of the report — the Inland Empire and San Joaquin Valley — have less than 50 primary care doctors. Physician shortages are projected to get worse over the next few years.

By 2030, the report indicates, the demand for physicians will exceed the supply by at least 12%.

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Gov. Newsom, Attorney General Bonta Back Bill to Allow California to Host Arizona Abortion Care

Gov. Gavin Newsom and Attorney General Rob Bonta announced last week that they are backing a bill introduced by the state legislative women’s caucus that would allow Arizona-based doctors to provide abortion care in California to patients from Arizona. Senate Bill (SB) 233 was authored in response to the Arizona Supreme Court’s decision on April 9 that an 1864 ban on abortion in the state is enforceable.

Published

6 hours ago

May 3, 2024

Oakland Post

Gov. Gavin Newsom and Attorney General Rob Bonta.

By California Black Media

Senate Bill (SB) 233 was authored in response to the Arizona Supreme Court’s decision on April 9 that an 1864 ban on abortion in the state is enforceable. The bill also aims to counter growing support for anti-abortion legislation in states with Republican-majority legislatures since Roe v. Wade was overturned, according to supporters.

“California will not sit idly by. We’re urgently moving legislation to allow Arizona doctors to provide safe and reliable reproductive care to Arizonans here in California,” Newsom said.

Sen. Nancy Skinner (D-Berkeley), chair of the California Legislative Women’s Caucus said that abortion bans are based on laws that set women back to a time when they had limited human rights.

“Anti-abortion forces have resurrected a dead law passed at a time when women couldn’t vote and husbands beating their wives was lawful,” Skinner said.

On April 24, the Arizona House of Representatives voted to repeal the 1864 abortion ban. It now moves to the Arizona Senate for deliberation.

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Mind, Body, and Spiritual Well-Being for Women Addressed in NAACP Forum in Oakland

The Women In The NAACP Oakland Branch is proud to announce the upcoming “Total You – Mind, Body, and Spirit Women’s Health Forum” scheduled for April 27 at Acts Full Gospel Church. Running from 9 a.m.-2 p.m. at 1034 66th Ave., this forum aims to provide an empowering platform for women to engage in discussions, gain knowledge, and access resources pertaining to their health and well-being.

Published

2 weeks ago

April 20, 2024

Oakland Post

The panel will address various aspects of women’s health, including physical, mental and emotional well-being and relationships. iStock photo by Jorge Elizaquibel.

Special to The Post

The Women In The NAACP Oakland Branch is proud to announce the upcoming “Total You – Mind, Body, and Spirit Women’s Health Forum” scheduled for April 27 at Acts Full Gospel Church.

Running from 9 a.m.-2 p.m. at 1034 66^th Ave., this forum aims to provide an empowering platform for women to engage in discussions, gain knowledge, and access resources pertaining to their health and well-being.

The forum will feature renowned experts, healthcare professionals, and advocates from Genentech, John Muir Health, Sutter Health of The East Bay, Kaiser Permanente, and the Alameda County Public Health Department.

Our expert panel will address various aspects of women’s health, including physical, mental, and emotional well-being, and healthy relationships. The forum will encompass a wide range of topics such as breast cancer, menopause, reproductive health, nutrition, mental health awareness, preventive care, and much more.

Participants will have the opportunity to attend informative sessions, interactive workshops, and panel discussions led by experts in their respective fields. Additionally, there will be wellness activities, screenings, and informational booths offering valuable resources and support.

This forum is open to women of all ages and backgrounds, encouraging inclusivity and diversity in the conversation surrounding women’s health. Whether you’re seeking information for yourself, a loved one, or simply looking to connect with other women, this event promises to be enlightening and empowering.

For more information and to register for the Total You Women’s Health Forum, please visit https://www.naacpoakland.org/ or contact Dr. Delores Thompson. WIN chairwoman at (510) 328-3638.

The Women In The NAACP Oakland Branch is dedicated to empowering women, and young teen girls. We look forward to your participation in this important event.

To register, go to https://www.naacpoakland.org/events/the-total-you-womens-health-forum