The experimental blood test that found Jim Ford's cancer was at an early stage. It is one of the most deadly of all common cancers.
Mr. Ford, a 77-year-old man who lives in Sacramento, has no signs of cancer after undergoing a number of procedures.
He said that he hit the lottery.
President Biden made testing for cancer a priority of his Cancer Moonshot program. As soon as the FDA approves the tests, Medicaid and Medicare would be able to pay for them.
Companies don't have to wait for regulators to approve them. One company, GRAIL, is selling its annual test for $949 in advance of approval, and another company, EXACT Sciences, expects to follow suit, using a provision known as laboratory developed tests.
There is a new frontier in screening for cancer with the tests. According to companies developing them, they can find a lot of cancers. 73 percent of people who die of cancer have cancers that are not detected by standard tests, despite the fact that standard screening tests are commonly used to detect cancer.
The tests can find tumors when they are small and curable. A definitive study to determine if the tests prevent cancer deaths would have to involve more than a million people. It would take a long time to get results.
The blood tests that found Mr. Ford's cancer are in their early days, according to Dr. Tomasz Beer, a cancer researcher at Oregon Health & Science University. Some people can decide to be early.
If the tests are approved with less rigorous studies, the companies will make a lot of money.
The screening test that could bankrupt Medicare is being proposed by GRAIL.
With 44 million Medicare beneficiaries and an annual test costing about $1,000 a year, the price tag could be substantial.
The risks of unleashing the tests are significant. With the same timing as without early diagnosis, finding cancer earlier could mean more deaths. Cancers destined to kill are not always cured if found early.
There are other dangers. Some people will have a positive test but doctors won't be able to find the cancer. If left alone, these tumors would not have grown and spread and could even have gone away.
The risks and costs of a cancer blood test are acknowledged by Dr. Beer.
He thinks there is promise for a real impact.
Experts are concerned.
The Lisa Schwartz Foundation for Truth in Medicine and the former director of the Division of Cancer Prevention at the National Cancer Institute fear that the tests will come into widespread use without ever being shown to be beneficial. He said it was hard to unring the bell once that happened.
Dr.Kramer hopes that we are not halfway through a nightmare.
Susan Iorio Bell, a 73-year-old nurse who lives in Forty Fort, Pa., signed up for a study after seeing an ad on Facebook. She believes in clinical trials and advocates for preventative medicine.
Women who are patients with a large health care network were part of the study. The test looks for cancer-causing genes.
Ms. Bell had alpha-fetoprotein in her blood which can be a sign of cancer.
Her father and mother had both been diagnosed with cancer.
Ms. Bell had seen what could happen when a patient gets a bad diagnosis. She said that your life can be changed quickly.
The abdominal M.R.I. did not find a tumors. Is the test positive for something, or is it a false positive? It is not possible at the moment. Ms. Bell can't do much except have cancer screenings.
She said she just went day by day. I am a believer and believe God has a plan for me. It's his will.
Ms. Bell's experience shows a concern with the blood tests. Most people who are tested will be told their test didn't find cancer. Scans or biopsies can be used to find cancer when a test finds it.
When large numbers of people get tested, false positives become a real problem and we need to know what to do with those results.
The situation is referred to as a Damocles syndrome because it is not clear what to do about it.
The only published question about the blood tests is if they find early, undetected cancer.
The study involved 10,000 women who had the blood test and were encouraged to have cancer screening as well.
There were 26 patients who had cancer, with two of them having two different types of cancer.
More than half of these women had early stage disease.
There were 24 cancers that the blood tests missed.
The study was not designed to show the risks and benefits of the test. It will require a lot of studies.
The study involved 6,629 people. The test found cancer signals in 92 people, according to interim data presented at a professional meeting. The researchers concluded that 29 of the subjects had cancer. Nine of the cancers were early stage. People who had previously had cancer were the ones who had the rest.
A follow-up is on the way.
The false positive question is something that we are interested in. When a test result is suggestive of cancer, we'll find out what happens. There is a possibility of a cancer coming up in the next six months.
Reducing morbidity and mortality from cancer is the goal. That is an important endeavor.
Donald Berry was invited to be on the scientific advisory board by GRAIL's leaders.
Dr. Berry said that they needed a skeptical person. I told them I wasn't a good believer. They need to run large clinical trials and have a survival goal. They need to show that detecting cancer early isn't the only thing that counts. Something has to be said.
The company restructured its scientific advisory board a few years later and Dr. Berry is no longer a member. He doesn't know why.
Being generous, I think they no longer need my expertise. They were tired of hearing that finding cancer early wasn't enough.
Difficult questions from him and others are still unanswered.
Overdiagnosis is the finding of small tumors that may not be harmful. The immune system destroys some cancers. Without knowing if the cancer is dangerous, it will be treated as if it is, subjecting people to therapies that are often difficult or burdensome.
This can happen with standard screening tests, which can lead to the removal of small tumors that are harmless.
A screening test for babies in Japan that found benign tumors but missed the deadly ones is one of the more sobering examples.
With blood tests looking for dozens of cancer, it is going to be worse.
It will be more and more difficult to find leukemias that look like a cancer to the pathologist but may not have the same natural history.
It's not possible to find the most aggressive cancer early enough for a cure. The tumors that shed the most blood are the ones with the biggest tumors.
The cost of adopting things before we know if they work is a real cost.
A randomized clinical trial is what the doctor thinks is needed. It doesn't have to take 20 years according to him. He said that it wouldn't have to be large to reduce mortality. The company that owns the test he worked on is talking with the F.D.A. about proper test design.
Dr. Joshua Ofman, president and chief medical officer at GRAIL, said the company has started a study with institutions in Britain that should have results within a few years. 140,000 people will be randomized to have the GRAIL test in addition to the standard cancer screening tests. The goal is to reduce the incidence of cancer in people who take the test.
He said they're expecting to find it.
Dr. Berry is worried that the public's faith in early detection will rule the day even without good evidence.
Early detection comes with harms.
He said that the harms were known. The benefits are not known at this time.
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