This story about a business deal to support development of a test that can detect extremely low levels of cancer cells circulating in a person’s blood stream hits most of the points we want to see, yet our reviewers felt that readers are left with an overly positive and uncritical portrayal of the present state of this technology. We wish readers had been shown some excerpts from the hard-nosed evaluations of this approach that have been published in medical journals in recent months. Or even more of the cautious analysis given by the American Cancer Society’s Dr. Len Lichtenfeld on his blog. Excerpt:
“…this is an announcement of a research deal. Nothing more, nothing less. It is not a new breakthrough. It is not something that has been proven effective in improving cancer detection and treatment. Not that it is anything less than stunning to develop and demonstrate that this technology works – but as with all research it is a giant step to go successfully from the laboratory phase of development to the clinical phase of making a real difference in patients’ lives. So that in essence is what the fuss is all about: the researchers have signed a contract with a company to further develop this research and determine whether in fact it can be applied successfully to large numbers of patients in a more efficient and less expensive manner.”
Cancer is a leading cause of death. No disease incites greater fear. There is great demand for tests that could improve cancer outcomes. Stories about potential advances in this area should be careful not to stoke desperate hopes.
We’ll give the story a minimally passing grade on this criterion as well, because it does note that an earlier version of a test that uses some of the same principles costs several hundred dollars. The story would have been better if it more clearly differentiated between tests used to monitor treatment (where a new test might be compared to biopsies or imaging scans) and tests used to screen healthy people, where even relatively low-cost tests could lead to substantial individual and national expenditures on follow-up testing and treatment.
The story does point out that this sort of test for circulating cancer cells is just entering clinical trials. However, the repeated emphasis on the potential benefits obscures the lack of actual evidence. The amount of attention given to possible use to screen healthy people for cancer is out of balance with the more likely scenario that this sort of test will be used initially as a research tool to help track the effects of experimental treatments… and then in conjunction with conventional methods to monitor treatment in people with cancer. The lead sentence promise that this sort of test will be coming to “your doctor’s office” is out of step with the available evidence.
This story glosses over the substantial harms that tests can cause. The story could have referred to examples from PSA to mammography to remind readers that detecting cancer does not always improve outcomes and that generally many people are subjected to the harms of invasive follow-up testing and treatment for each one who benefits. As Dr. Susan Love noted on the ABC News website:
“Having the cells in the bloodstream does not necessarily mean that the cancer will spread and kill you. Just because you find them does not mean you know what to do with the information….We all have cancer cells in our body that are dormant,” Love said. “We need to be careful not to over react to the presence of cancer cells when the treatment may actually be worse than the cure.”
Here again, this story does tell readers that this type of test is just entering clinical trials. But as mentioned before, it tends to minimize the amount of research and investment of time and money that will be required before this sort of test could be considered for use outside of experimental settings.
This story does not exaggerate the threat of consequences of cancer. However, readers are likely to get the impression that the detection of circulating cancer cells means the person would benefit from early treatment, when actually researchers don’t yet know whether such a test result actually predicts the future health of an individual.
The story quotes an expert who was not involved in the development of this test, though he is going to be involved in upcoming clinical trails. The story makes clear that the developers of the test have struck a deal with Johnson & Johnson to do move toward marketing their invention. The story would have been stronger if it had included comments from experts who have written about the substantial hurdles and obstacles that face developers of this test. We would have liked to see a comment like one included in the article by Martin et al. mentioned above:
“Although fluid-based biomarkers seem promising, their reliability has not been determined. Assay sensitivity and specificity need to be improved, techniques must be standardized and validated, and biomarkers are not yet closely legally regulated. Pressing financial, political, and cultural issues have the potential to derail anticipated benefits.”
Or some of the cautious analysis offered by Dr. Len Lichtenfeld of the American Cancer Society, also mentioned above.
Finally, we notice that AP profiled the same patient that ABC News profiled. Did the hospital or the company provide their best case scenario? Where is the data on this test to date?
The story suggests that this test is inherently superior to existing tests that detect and monitor cancer. While developing a better test is the goal of this line of research, it has a long way to go to reach that goal. As Dr. Len Lichtenfeld wrote on his blog:
“…we are seeing many tests that are being touted as important in answering various questions about the future behavior of an individual’s cancer but we are not seeing the type of validation we need to know whether or not such claims are in fact clinically relevant. There are so many markers and genetic tests out there that even the most knowledgeable experts in the clinical treatment of patients with cancer are having a hard time separating the proverbial wheat from the chaff.”
This story sneaks by because it says only that experiments are set to begin and it doesn’t promise that this cancer test will be available within any specific timeframe. However, the overall tone of the story minimizes the difficult challenges ahead. The story started on a confusing note, mixing within the first two sentences phrases that the test is “moving one step closer to being available at your doctor’s office” – yet it’s “experimental” – yet big names are “joining forces to bring it to market.” We think readers heads would be spinning about the state of the research after that lead.
The authors of a recent journal article on this concept described the kind of research needed to know if this sort of test really has clinical benefits, ”Determining whether a program is effective could require large (i.e., multithousand patient) clinical trials lasting many years and requiring great expense.”
A Need for Basic Research on Fluid-Based Early Detection Biomarkers
Katherine J. Martin, Marcia V. Fournier, G. Prem Veer Reddy, and Arthur B. Pardee. Cancer Research July 1, 2010 70:5203-5206; Published OnlineFirst June 29, 2010; doi:10.1158/0008-5472.CAN-10-0987
The story points out that this test builds on an earlier technology that counted circulating tumor cells and it refers to research articles that have appeared in several medical journals. However, the news (as the story points out) is the business deal between John & Johnson and Massachusetts General Hospital; not any specific research revelation. Readers are likely to infer that there is some scientific advance being announced, when actually all of the facts about the test mentioned in the story were announced over the course of several years. The work was summarized in a Massachusetts General Hospital newsletter article last summer: “Advancers at the Mass General Cancer Center”, Summer 2010.
http://www.mgh.harvard.edu/cancer/assets/pdfs/FINAL_Advances at the MGCancer Center.pdf
The story does not appear to rely on a news release.