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The Food and Drug Administration’s move to allow 23andMe to screen people for breast cancer risks may unleash a flood of new direct-to-consumer genetic tests.
But some genetic experts and members of the medical community are raising concerns about whether consumers can truly understand the test results — and how they will handle such sensitive information.
Emily Drabant Conley, 23andMe’s vice president of business development, called the FDA’s decision this month to let the private company offer the country’s first and only direct-to-consumer genetic health risk test for cancer an “enormous win.”
The company is hoping to expand its genetic testing offerings to allow people to understand more about how their DNA affects the risk of developing a certain disease.
“We as a company absolutely want to continue expanding. There are still things that are not in the product today where genetics can be quite informative to consumers,” Drabant Conley said. “We are absolutely in the process of working to get more reports cleared through the FDA on a variety of topics we know consumers care about.”
Rep. Thomas Massie (R-Ky.) praised the FDA's decision and told me such a test should not have been prohibited. He suggested legislative action may be a way to “keep the FDA from preventing people from knowing things about themselves.”
Massie suggested something like a “Right to Know” law to keep federal agencies from blocking individuals from learning information about themselves from a company. “I think it would be really popular, maybe 80 or 90 percent support because it wouldn’t really be a partisan issue,” he said in an interview.
Here's what Massie tweeted following 23andMe's announcement this month:
23andme’s product never should have been prohibited by FDA in the first place. When companies make it to the other side of the govt regulation barrier, they sometimes begin advocating for even higher barriers to keep out competitors; let’s hope that doesn’t happen in this field. https://t.co/IKEQ4enUcp— Thomas Massie (@RepThomasMassie) March 10, 2018
But the FDA has been cautious about allowing consumers to purchase such tests, and there are reasons the process is so rigorous.
In 2013, the agency sent 23andMe a letter warning some of its health-related tests lacked the proper clearances — and that some screenings were "particularly concerning, such as assessments for BRCA-related genetic risk." The FDA cautioned that a false positive "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist." In response, the company pulled some of its tests.
Last April, the FDA finally authorized 23andMe to sell genetic health-risk tests, but it wasn't until this month that the company was allowed to sell reports on breast cancer risks, specifically three mutations in the BRCA1 and BRCA2 genes most common for the Ashkenazi Jewish population.
But even as it approved the breast cancer test, the FDA warned consumers not to make treatment decisions based on the results – and stressed that patients should follow up with a physician or genetic counselor.
Some genetic experts say that warning might not be enough. Karen Grinzaid, a genetic counselor in the department of human genetics at Emory University, said she’s worried the government is conveying that medical follow-ups are optional.
“It’s good for people to have access to information. But the problem comes in when a patient may not have an understanding of their results and potential implications for their health,” Grinzaid said. “It puts them in a position of interpreting results and finding their own resources and puts their doctor, their primary care physician, in a position of explaining results they may not understand.” She added that some health-care providers may have a “limited understanding of genetics.”
Amy Sturm, president-elect of the National Society of Genetic Counselors, praised both 23andMe and the FDA for being “transparent” in warning consumers about the limitations of the breast-cancer risk test. For example, the company is careful to note the three cancer mutations that 23andMe tests are just a tiny fraction of more than a thousand known mutations of the BRCA genes. Still, Sturm notes, consumers may not understand these nuances without appropriate medical consultation.
“Even if an Ashkenazi Jewish person came back negative for these three mutations it doesn’t mean they don’t have a genetic risk for cancer,” she said. “I just want people to understand how limited these tests really currently are and that it’s not providing that much information, really.”
Yet Massie said he found the idea that individuals would be unable to handle information about their genetics hard to believe. He criticized arguments that patients may get unnecessary treatments, such as getting a mastectomy to prevent breast cancer, because of a test result.
“That on its face is ridiculous because you’d have to go see a doctor for a surgical procedure, and no doctor in their right mind would do a procedure on you without” complete information, he said.
Drabant Conley said testing for consumer comprehension was part of getting FDA clearance. The company, she said, had to prove consumers would understand what the test does and doesn’t do and also demonstrate the test is accurate.
Not everyone in the medical community is deterred, either.
Jane Lowe Meisel, an assistant professor of hematology and medical oncology at the Winship Cancer Institute at Emory University, called 23andMe’s latest test a step toward “democratizing genetic information.”
But she warned about future tests for genes the medical community does not understand as well.
“What does the patient do with that information? It’s like being given a complicated CT scan and not having a doctor there to interpret it,” she said. “The more complex it gets the more I worry a little bit about people having that information out there and drawing conclusions that may or may not be 100 percent correct. But I imagine the FDA will think about that, too.”
And if these tests become more mainstream, Meisel suggested doctors could incorporate questions about them into their exams. “The same way we ask if you smoke cigarettes [or] if you drink alcohol,” Meisel said, “is this one of those questions that — as this becomes more of a widespread thing — needs to be part of the conversation?”
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AHH: Health insurance must evolve away from acting only as a payment system for procedures and drugs when people are ill and toward interventions to help people stay healthy in their everyday lives, Aetna chief executive Mark Bertolini told The Washington Post's Carolyn Y. Johnson. Bertolini, who heads one of the biggest health insurers in the country, is on the cusp of a $69 billion megadeal to merge his company with pharmacy giant CVS.
He told Carolyn the future of health care is going to depend mostly on the time people spend outside the grasp of the traditional medical system. “Right now, we sell a warranty card. You come to us in case of breakage. We indemnify you against loss when you have breakage; you present your warranty card to the provider,” Bertolini said, noting that of the roughly 6,200 hours people spend awake each year, only about 20 of them are spent in the medical system.
"Bertolini sketched a vision of the future of health care in which a combined CVS-Aetna could instead be a gateway to health, a first stop for consumers with health issues," Carolyn writes. "Pharmacists or medical professionals in a neighborhood health hub could help schedule people's appointments or focus on nonmedical forms of help, such as coordinating rides, meal assistance, nutrition counseling or social supports. Wearable technologies monitored by health professionals could help people stay on the right medication regimens or flag health problems before they evolve into an emergency."
OOF: American adults are continuing to put on weight, indicating efforts to educate people about the health risks of a poor diet don't seem to be working. According to new data published in the Journal of the American Medical Association, 40 percent of American adults were obese in 2015 and 2016, compared to 33.7 percent of adults in 2007 and 2008. The latest data also indicate the rate of severe obesity jumped from 5.7 percent of adults in 2007 and 2008 to 7.7 percent of adults in 2015 and 2016, the New York Times reports. The study measured individuals with a body mass index of 30 or higher as being obese and 40 or higher as severely obese.
"While the latest survey data doesn’t explain why Americans continue to get heavier, nutritionists and other experts cite lifestyle, genetics, and, most importantly, a poor diet as factors," NYT's Matt Richtel and Andrew Jacobs report. "Fast food sales in the United States rose 22.7 percent from 2012 to 2017, according to Euromonitor, while packaged food sales rose 8.8 percent."
But here’s one positive. The study found younger people in America are gaining weight at a lower rate compared to adults. The percentage of youths who are obese and severely obese rose slightly from the 2007-2008 time frame, but not enough to be statistically significant, Matt and Andrew write. The research found 18.5 percent of Americans ages 2 to 19 were obese in 2015 and 2016, and 5.6 percent were severely obese.
OUCH: The number of kids and teens killed by gunfire has spiked 30 percent since 2013, our colleague Christopher Ingraham reports. There were 1,637 deaths in 2016 -- representing more than four deaths every day -- up from a low of 1,258 deaths in 2013, according to data from the CDC. At least 26,000 of those under age 18 were killed by gunfire in the United States in the years between 1999 and 2016. Out of those, 1,678 were under the age of 5.
Christopher writes the availability of firearms is closely related to childhood gun fatalities. “At the state level, for instance, there's a clear correlation between rates of gun ownership, as tallied in a 2015 study in the journal Injury Prevention, and rates of childhood gun fatalities, as tallied by the CDC: more guns, more childhood gun deaths,” he writes.
— Senate Majority Leader Mitch McConnell (R-Ky.) says he wants to remove hemp from the controlled substances list that associates the crop with its cousin marijuana, the Associated Press reports. McConnell told hemp advocates in Kentucky yesterday he would introduce a bill to legalize hemp crops — which have been grown experimentally in several states in recent years — as an agricultural commodity. “It’s now time to take the final step and make this a legal crop,” McConnell said.
Hemp has been making a recent comeback in states such as Kentucky. Several dozen processors in the state are helping turn the versatile crop into many different products. But because hemp is classified as a controlled substance related to marijuana, farmers can't grow it without a federal permit, even though hemp has only a negligible amount of the compound that gives pot users a high.
—Speaking of controlled substances, our colleague Christopher explains when a person could hypothetically be given the death penalty for trafficking illegal drugs. While drug trafficking alone has never triggered capital punishment in the United States, Attorney General Jeff Sessions issued a memo last week encouraging federal prosecutors to seek it as much as possible under current law.
Just under 0.6 kilograms of LSD could trigger the death penalty in a federal drug trafficking case, Christopher writes. While such a pocket-size quantity may not seem like much, it works out to about 6 million standard (100-microgram) doses of the drug. For meth, the threshold is three kilograms. The capital threshold for fentanyl is 24 kilograms, enough to squeeze into one or two backpacks. And the capital threshold for heroin is 60 kilograms — small enough to move in a few suitcases or the trunk of a small car.
— Two discussion drafts of opioids legislation have been introduced by Sen. Lamar Alexander (R-Tenn.) with the aim of curbing the overprescribing of prescription painkillers and halting the rapid flow of fentanyl — a drug many times more potent than heroin — into the United States. Alexander plans to lead the Health, Education, Labor and Pensions Committee this spring in marking up legislation to respond to the opioid epidemic.
The draft bills, released yesterday, aim to boost the FDA's ability to respond to opioid abuse by allowing the agency to require drug manufacturers to package certain opioids in smaller supplies, making it easier for doctors to write prescriptions for a smaller number of opioids. They also aim to prevent unneeded or unused opioids from falling into the wrong hands by encouraging manufactures to provide a safe way to dispose the leftover drugs along with the packaging.
-- A few more good reads from The Post and beyond:
- The Physician-Focused Payment Model Technical Advisory Committee Meeting continues.
- The Center for Strategic and International Studies holds an event on “Celebrating Women and Girls: Change Agents or Food and Nutrition Security in Conflict Settings” on Wednesday.
- The National Food Policy Conference begins on Wednesday.
- FDA Commissioner Scott Gottlieb is scheduled to speak at the National Food Policy Conference on Thursday.
- The Atlantic hosts “Cancer and the Community” in Pittsburgh, Pa. on Thursday.
- The American Enterprise Institute holds an event title “What happened to compassionate conservatism — and can it return?” on Thursday.
White House deputy press secretary Raj Shah repeatedly refused to answer questions about Veterans Affairs Secretary David Shulkin:
Trump and Stormy Daniels: How the White House is handling the scandal:
White House calls Stormy Daniels "inconsistent" and denies claims: