'New frontier' blood tests to find cancer may create risks for patients, N.Y. Times story says

Blood tests that detect cancer can create risks for those who use them, according to a story by Gina Kolata a while back in The New York Times.

The article indicates that "the tests screen for cancers that often go undetected, but they are expensive and some experts worry they could lead to unnecessary treatments without saving patients' lives."

Some companies, Kolata's piece says, aren't waiting for Food and Drug Administration approval before they sell the tests. One of the companies, Grail, is selling an annual version, and a second company, Exact Sciences, plans to do the same, using a loophole provision "known as laboratory developed tests."

The tests, the story contends, "are a new frontier in screening. Companies developing them say they can find dozens of cancers."

Supporters of the tests insist they can "slash cancer death rates by finding tumors when they are still small and curable. But a definitive study to determine whether the tests prevent cancer deaths would have to involve more than a million healthy adults randomly assigned to have an annual blood test for cancer or not. Results would take a decade or longer."

While standard screening tests "are commonly used to detect cancer of the breast, colon, cervix and prostate," Kolata's article notes, "73 percent of people who die of cancer had cancers that are not detected by standard test."

The story quotes Dr. Tomasz Beer a cancer researcher at Oregon Health & Science University who is directing a Grail-sponsored study of the test. "We're at a point now where the blood tests are in their early days," he says, but "I think there's promise for a real impact."

Dr. H. Gilbert Welch

Dr. H. Gilbert Welch, a senior investigator in the Center for Surgery and Public Health at Brigham and Women's Hospital, raises a red flag: "Grail proposes to test every Medicare beneficiary every year, making it the screening test that could bankrupt Medicare."

Among other risks the story attributes to some doctors are that "some will have a positive test, but doctors will be unable to locate the cancer. Others will be treated aggressively with surgery or chemotherapy for cancers that, if left alone, would not have grown and spread and may even have gone away."  

Dr. Barnett Kramer, former director of the Division of Cancer Prevention at the National Cancer Institute and a member of the Lisa Schwartz Foundation for Truth in Medicine, according to Kolata's story, "fears that the tests will come into widespread use without ever showing they are beneficial" and hopes that "we are not halfway through a nightmare." 

Once the tests are being used broadly, he adds, "it is difficult to unring the bell."

More information about clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at caregivers.

AP story suggests liquid biopsies may be 'a new frontier in cancer screening for healthy people'

Liquid biopsies, or blood tests that look for cancer by checking for DNA fragments shed by tumor cells, are being billed "as a new frontier in cancer screening for healthy people."

A story in this week's San Francisco Chronicle by Associated Press medical writer Carla K. Johnson notes that these tests already are being "used in patients with cancer to tailor their treatment and check if tumors come back."

But one California-based company, Grail, is promoting the $949 test, the article says, "as a way to detect tumors in the pancreas, ovaries and other sites that have no recommended screening method."

Most insurance companies do not cover the cost, and the tests are being marketed "without endorsements from medical groups or a recommendation from U.S. health authorities," Johnson's piece says.

The Associated Press also observes that Federal Drug Administration "authorization, clearance or approval of such tests is required by law, but the agency historically has not enforced most regulatory requirements for ones – like Grail’s – that are designed, manufactured and used within a single laboratory."

The story quotes FDA spokesman Jim McKinney as reporting that the agency is working with Congress on legislation "to update the regulatory framework, which would include active oversight for such tests."

Although Grill intends to get FDA approval, it currently is marketing its test "as it submits data to the agency."

Meanwhile, Johnson's piece says, "U.S. government researchers are planning a large experiment — with 200,000 participants and possibly lasting seven years — to see if the blood tests can live up to the promise of catching more cancers earlier and saving lives."

Dr. Lori Minasian

"They sound wonderful, but we don't have enough information," the story quotes Dr. Lori Minasian of the National Cancer Institute's Division of Cancer Prevention, who is involved in planning the research. "We don't have definitive data that shows that they will reduce the risk of dying from cancer."

Whereas screening tests — mammography, PAP, colonoscopy, for example — look for one cancer at a time, claims Dr. Joshua Ofman, an executive at Grail, the new blood tests look for many cancers at once, a definite advantage.

More information on testing for disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.