FDA Warns Ovarian Cancer Tests Not Reliable
According to the American Cancer Society, the most common screening test is called the CA-125 blood test. In many women with ovarian cancer, levels of this protein are high. But the problem with using it is that common conditions other than cancer can also cause high levels of CA-125, the cancer society says.
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"Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results," the agency said in its warning.
"However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer," the FDA added.
But these tests may lead to delays in effective preventive treatments for high-risk women who have no symptoms, or result in unnecessary medical tests and/or surgery for those who do not have the disease, the agency noted.
According to the American Cancer Society, the most common screening test is called the CA-125 blood test. In many women with ovarian cancer, levels of this protein are high. But the problem with using it is that common conditions other than cancer can also cause high levels of CA-125, the cancer society says.
That's why women should not rely on ovarian cancer screening tests to make health or treatment decisions, the FDA said in its warning. This is especially important for women who have a family history of ovarian cancer or the BRCA1 or BRCA2 genetic mutations, which raise the risk of both breast and ovarian cancer, the agency added.
Doctors should not recommend or use ovarian cancer screening tests in the general population, and they need to understand they are not a substitute for preventive measures that may reduce the chances of disease in high-risk patients, the FDA said.
The warning was issued after a review of available evidence from clinical trials and the recommendations of health care groups and the U.S. Preventive Services Task Force.
The American College of Obstetricians and Gynecologists (ACOG) said Thursday that it supports the FDA warning.
"Obstetrician-gynecologists should be aware that tests currently marketed to screen women for ovarian cancer are not based on data," Dr. Thomas Gellhaus, ACOG president, said in a statement. "ACOG is in agreement with the FDA and recommends against using these offered tests to screen for ovarian cancer," he added.
"Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women," Gellhaus noted.
"Persistent and progressive symptoms such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated," he said.
Ovarian cancer is the fifth leading cause of cancer death in women. In 2013, almost 21,000 women in the United States were diagnosed with ovarian cancer, and more than 14,000 women died from the disease, according to ACOG. more
Complete article:
"Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results," the agency said in its warning.
"However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer," the FDA added.
But these tests may lead to delays in effective preventive treatments for high-risk women who have no symptoms, or result in unnecessary medical tests and/or surgery for those who do not have the disease, the agency noted.
According to the American Cancer Society, the most common screening test is called the CA-125 blood test. In many women with ovarian cancer, levels of this protein are high. But the problem with using it is that common conditions other than cancer can also cause high levels of CA-125, the cancer society says.
That's why women should not rely on ovarian cancer screening tests to make health or treatment decisions, the FDA said in its warning. This is especially important for women who have a family history of ovarian cancer or the BRCA1 or BRCA2 genetic mutations, which raise the risk of both breast and ovarian cancer, the agency added.
Doctors should not recommend or use ovarian cancer screening tests in the general population, and they need to understand they are not a substitute for preventive measures that may reduce the chances of disease in high-risk patients, the FDA said.
The warning was issued after a review of available evidence from clinical trials and the recommendations of health care groups and the U.S. Preventive Services Task Force.
The American College of Obstetricians and Gynecologists (ACOG) said Thursday that it supports the FDA warning.
"Obstetrician-gynecologists should be aware that tests currently marketed to screen women for ovarian cancer are not based on data," Dr. Thomas Gellhaus, ACOG president, said in a statement. "ACOG is in agreement with the FDA and recommends against using these offered tests to screen for ovarian cancer," he added.
"Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women," Gellhaus noted.
"Persistent and progressive symptoms such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated," he said.
Ovarian cancer is the fifth leading cause of cancer death in women. In 2013, almost 21,000 women in the United States were diagnosed with ovarian cancer, and more than 14,000 women died from the disease, according to ACOG. more
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Puneet, While prevention is better than cure [per Ravindran], blood tests do not and cannot tell the whole story. There are subtle signs that develop over time, that become the "new normal" for these women. We can't become a nation of hypochondriacs. We also cannot hide our heads in the sand. Check-ups every year are a start. That is the patients' responsibility to make and keep that appointment. But there is also the responsibility of the care provider to ask the right questions, to take the time to go over everything, and order lab tests as seem necessary. I've had both good and bad annual check-ups. It takes time to develop a rapport between doctor and patient. It takes time to perform a good physical. It takes time to follow up on things that seem out of step. It takes time for the practitioner to keep up with the latest information and to apply it to the person seated in front of him. There will always be unscrupulous people who offer lab tests that make them money, and doesn't help the patient. Sometimes the CA-125 is positive and yet there is no cancer. Non-symptomatic high risk women are being missed and no risk women are being treated for cancer with surgery or chemotherapy. The question here is what to with non-symptomatic women. We can't just trust the CA-125 and we can't do surgery without some physical evidence of disease. The FDA is warning practitioners to not just trust the tests blindly. A modicum of common sense, or more likely uncommon sense, is required. This finding also warns against using the blood test in the general population. It would seem to also infer that one should not order the test just because a woman has seen it on the internet and thinking it will help, is demanding it from the doctor. America is a very litigious society and doctors want to CYA [cover their arses]. This warning from the FDA may help bring to heel some of the ridiculous lawsuits that result from patients demanding, and expecting miracles. Like the woman who ordered hot coffee from McDonalds, put the cup between her legs as she drove away, and subsequently spilled on herself. What part of hot coffee did she miss? What part of personal responsibility did the jury miss when finding McDonalds at fault and rewarding her a great deal of money? So now the coffee cups must state that the contents are hot! Doctors who rely on blood tests rather than diagnostic thinking and sensible precautions are as much at fault as the 'hot coffee" woman. Thinking in this case is vastly underused and testing is vastly overused. No manufacturer of the blood tests is going to say that they are not reliable. Greed pays. Doctors who don't keep up and don't want to put the hard work necessary into physicals make money too. Greed pays. Patients who don't stay educated and who don't put time and effort into keeping themselves healthy, who don't ask questions and follow blindly also find that greed pays: for everyone but them. more
Sep 18
Dr Puneet Chandna you must have read Tarun's Mail please let us have your comment. How far that statement is correct. more
Sep 15
Thanks Puneetji for posting this..... I do believe and do say/explain to others that "almost all medical check-ups are methods to convert 'people' into 'patients'..."... The results obtained by such check-ups are 'results' (effects) and do not have any indication of the cause... Even in hospitalized cases of diseases, many tests are conducted to check various parameters, such that dosage of (poisons) medicines can be adjusted and/or surgery, etc. can be done as the case may be. This may be to follow the procedures & practices... more
Sep 14
