Impatience along the way in biomarkers' long march from lab to clinic

     Howard Lovy

Biomarker research takes a hit this month in the Journal of the American Medical Association. A study basically says that most biomarker claims are hyped up too much initially, then later prove to be less than accurate in subsequent studies. Stanford researcher John Ioannidis says this is all so confusing to physicians, they might make some bad clinical decisions based on inaccurate biomarker research.

I'll get to that last point in a minute. First, it must be frustrating for many people who follow biotech research news to know that much of the research we report on here at FierceBiomarkers will never make it to the clinic. And those that do will likely go through as much as two decades of development before an actual, approved drug makes it onto the market--or even a generally agreed-upon biomarker. It does seem frustrating, and maybe things should go faster, but this has traditionally been the pace of progress. Most medical technologies take about 20 years of research and clinical trials before they're ready for prime time.

For example, we're about 12 years into development of gene-silencing RNAi technologies. It has gone through cycles of hype and disappointment in the media. Meanwhile, development continues. The same can be said for gene therapy and stem cell therapy. Both will be alternately elevated as saviors and demonized as dead ends in the impatient popular and financial press while the slow, careful pace of scientific discovery and FDA approval plods along.

Why would biomarker research be any different? Yet, Ioannidis talks about this time lag as if it is something new. "There is a huge literature, with thousands of studies being published every year and with lots of highly promising claims being made in prestigious journals," Ioannidis tells Nature News. "Yet very few make it to the clinic."

Yes, of course. That's the way scientific research is supposed to be. If it were easy to go from lab to drug, then everybody would be doing it, right?

Then Ioannidis goes further. As a result of all this experimental biomarker research in the literature, "clinicians may be making decisions for their patients based on inaccurate conclusions not supported by other, larger studies," according to the press release that accompanied the study. In other words, a doctor might read the latest academic or medical paper on biomarkers, then rush to the office to apply what he just learned.

I am not a doctor, but three of my six brothers are (We can all be happy that I chose not to go into the family profession--safely writing about medicine, instead). So, I took my own extremely unscientific poll of two out of three of my doctor brothers (I misplaced the other one's phone number) and asked them whether they have ever changed the way they diagnosed or treated a patient based on an article they read in a journal.

Both say that it depends on the preponderance of evidence, the quality of the study, the applicability to a range of patients, etc. In other words, "no." There has to be a great deal of evidence or an independent organization needs to make a recommendation that a piece of research be put into practice. For example, PSA (prostate specific antigen) is a widely used biomarker for prostate cancer. Lately, there have been some warnings by independent organizations that PSA can lead to problems with overdiagnosis, or false positives. Competent doctors know this and view PSA levels in the context of other information about individual patients.

Of course, says one of my brothers, there are last-ditch efforts to cure cancers after everything else has been tried. In that case, doctors might go to the literature and see if they can get lucky. But that is done in rare cases.

Most doctors understand that research can be biased. Those doing the research want to live to see another grant to follow it up. So, the press releases will often focus on the positive, or the novel, to grab some headlines. But that is not science. That is public relations and marketing. Can scientists and physicians understand the difference? I hope so. - Howard Lovy (email)

- read the article in Nature News
- Bloomberg filed this report
- here's the news release from Stanford
- and here's the abstract in JAMA

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