Ovasure sales halted

LapCorp stops selling the controversial ovarian cancer screening test, after being warned by the FDA:

The case has raised questions about the degree to which the F.D.A. can or should regulate diagnostic tests.
Doctors have long sought a test that could detect ovarian cancer early, when the condition would be more treatable. But some experts had said that LabCorp’s test, called OvaSure, had not been proved to work.

Screening for ovarian cancer has not been shown to save lives, and results in unnecessary procedures from false positives.

Having the FDA regulate diagnostic tests isn’t a bad idea. Many companies unscrupulously profit from the public’s “more screening is better medicine” mentality, especially with the advent of genetic screening tests.

Regulating tests can reduce unproven screening, which will cut down on the number of false positives leading to unnecessary procedures.

Comments

Anonymous
I go the opposite direction: that of FDA certifying just what it is the test does, making sure there are no false claims and that its limitations are correctly listed. The pubic consumer should determine his individual risk or benefit without carrying any burden of considering what is or isn’t good for someone else unconnected with him.
I might get a positive result and defer a procedure. I might get a negative result and feel better. These are risks I’d like to be able to calculate.
The truth is that late detection of ovarian cancer is a death sentence and the ONLY HOPE of survival is early detection and treatment. It’s possible a “mushy” test provides a pretext for interventions but watch and wait with greater care is always one of those. Unless what you are really opposed to is women having a “pretext” for a vaginal ultrasound they could otherwise be denied or not think to ask for.
Even a positive finding on ultrasound requires no one to take useless action. A woman can refuse invasive procedures, and might well if her risk was otherwise low or ambiguous.
Anonymous
Anon – the problem is that early detection for ovarian cancer hasn’t been shown to do any good. Just because a cancer is detected early doesn’t mean it’ll make a difference.
the ONLY HOPE of survival is early detection and treatment.
This is exactly what HASN’T BEEN SHOWN with ovarian cancer. Sure women whose cancer is detected earlier can live longer after diagnosis. But if the diagnosis is made earlier, than you are moving the point from which you start counting forward. If a woman dies at the age of 50 from ovarian cancer and her cancer is detected later at 48 she dies two years after diagnosis; if it is detected earlier at 44, she lives 6 years after diagnosis, but she isn’t better off, right?
Even if some women with early ovarian cancer indeed live longer, do women they live longer because their cancer was detected early or was the main reason their cancer was detected early is that it was slower-growing to begin with? Maybe even indolent? Cancers don’t all spread at the same rate. This is why early detection doesn’t always work. It works for some cancers, but not others. There is no evidence at all it works for ovarian cancer; there is some evidence to the contrary.
A woman can refuse invasive procedures, and might well if her risk was otherwise low or ambiguous.
Do you seriously think the woman who is afraid she may have cancer will refuse a procedure? Even if she does, her life is never going to be the same. I am a woman, and I’d probably go out of my mind worrying. In the meantime my blood pressure would skyrocket, and I may end up having a stroke.
And if you chose to do the invasive procedure, the risks can be large. Some women may end up losing their ovaries. Do you know the effect this has on overall health, on the risk of heart disease, osteoporosis, all-cause mortality? I lost my ovarian function at 35 for no reason, so I am very aware of the risks. My risk of osteoporosis is sky-high in spite of my being on HRT (and this may not be an option for a woman who removed her ovaries because of a fear of cancer), my risk of heart disease is higher, my risk of dying from any cause is higher as well.
You may say this is not as bad as cancer. But when you start screening a general population, you are bound to get a lot more women who get false positives, who are over-diagnosed than those from whom this early detection made a difference. Especially when there is no evidence that there will be a single woman for whom this will make a difference.
If anything, your post shows that most lay people don’t understand enough to correctly judge the risks of tests. The temptation of “being in control” and “doing something” and “empowerment” is too great as is our fear of cancer.
I understand the fear of cancer too well. My never-smoking mother from very anti-smoking family (my father tried it when he was 15, his father saw and spanked him, my father never tried again) just got lung cancer. My father’s mother – no relation to my mother – died of lung cancer as well. So now I have lung cancer in non-smokers on both sides of my family, I supposed my risk is somewhat mitigated by the fact that they both were in their 70s when diagnosed. My fear is great; probably much greater than my risk; but I know that there is no evidence at all that screening for lung cancer does any good and there is a possibility of harm. No wishful thinking can change this which is why I am not going to do anything.
Anonymous
I think your response is well intended, but full of error and misperception, 12:48. First, I have, myself refused procedures when the risk outweighed my personal, and well informed calculation of risk vs benefit, even though warranted by “herd” rules. So it is within my realm of experience of understanding, obviously, that a well informed patient may make personal choices that exclude immediate invasive testing when there are reasonable alternatives.
Second, the “lack of increased survival” must be taken with a huge grain of salt. Survival chance is increased by removal of early stage, localized cancer, period. That this almost never happens is due more to the fact that “early” detection is relative in ovarian cancer, which is normally discovered at a later stage.
To be In control of information is valuable. It is separate from control of destiny, and you conflate the two as if they were the same to an individual faced. Remaining ignorant of risk is not the same as evaluating risk appropriately for one’s individual circumstance and duties and philosophy.
A clear indication of the effectiveness and limitations of a test is all that I need or wish any governmental director to provide me as a consumer.
I will judge how to act myself, in consultation with experts when required.
For myself, I would screen for ovarian cancer so long as the negative result was worthwhile in reliability. A positive result would send me straight for an ultrasound. Perhaps nothing would be noticed. An ambiguous result th would not necessarily result in any sort of surgery. First I would weigh my familial risk, the degree of ambiguity, the risk of waiting and my circumstances and stage of life.
Anonymous
“Survival chance is increased by removal of early stage, localized cancer, period. “
Again, are you talking about the length of survival after diagnosis which is meaningless because of lead-time bias, length bias and over-diagnosis bias — LOOK UP THESE CONCEPTS — or are you talking about overall mortality as in fewer screened people die of ovarian cancer then non-screened people? The latter is the only meaningful measure and it is exactly what has not been shown to be true for ovarian cancer.
All cancers aren’t the same. Some are so aggressive that they spread microscopically from the start, so it doesn’t matter how early they are detected. Some are indolent as if would never cause you any trouble if they remain undetected yet if they are detected by a screening test you’ll be treated for them and suffer the side effects of the treatment (this is called over-diagnosis and over-treatment). Some are very slow-growing so that they are still localized and curable when detected later e.g. when your doctor can feel it. Screening makes a difference if there is a particular subgroup of cancers — those that are sufficiently slow growing that they may be detected by screening tests yet are destined to spread in the period before they become noticeable. It is not at all clear that this last subgroup even exists for ovarian cancer: those that have been detected later and are still localized are likely to just be less aggressive.
As most people you believe that early detection matters for every cancer. This is not the case. Look up for example a screening program in Japan that screened infants for neuroblastoma – rare and very lethal childhood cancer. There was a test that was detecting it early, so the thought was that it’ll help to save children early cases of this cancer diagnosed skyrocketed. Sure, the large percentage of kids diagnosed early survived. But… The number of advanced cases in older kids failed to decline and the same number of kids died from this cancer. After it became clear that screening failed to help a single child, but resulted in huge overdiagnosis, the program was abandoned. But in the meantime a number of children died from treatment or had life-long side effects from the treatment. This was one huge example of a screening program that did more harm than good.
I strongly suggest that you go to the library and take the book by Gilbert Welch called “Should I be tested for cancer. Maybe not and here is why”. The book is not arguing for- or against- screening or tells you what to do. It just explains to you in very easy to understand language some of the concepts and uncertainties related to screening. The author is a well-respected doctor and researcher; the book’s reviews in medical journals were pretty positive. I’ll think you’ll find it informative.

Ovasure sales halted

Related Stories

More in Uncategorized

Comments

Site

Channels

Subscribe

Related Stories

More in Uncategorized

Comments

Site

Channels