Many SBM readers will remember the late, great Barry Beyerstein, a luminary of the skeptical movement and author of a classic article that has been cited many times on SBM, an explanation of why bogus therapies seem to work.
One of his greatest personal accomplishments is not as well known: he produced an exceptional daughter, Lindsay Beyerstein, a freelance writer, philosopher, and polymath who stepped into her father’s shoes as a faculty member of the annual Skeptic’s Toolbox workshop after his death and has done a truly admirable job there.
Among Lindsay’s many other activities, she works for the Sidney Hillman Foundation, a nonprofit that honors excellence in socially conscious journalism. One of her goals has been to reward excellence in science journalism. Bob Ortega has just received a Sidney Award for his exposé of a widely used HPV (human papillomavirus) test that is not FDA approved and has an unacceptably high rate of false negative results. Her interview with him was published on the Hillman Foundation website. On SBM, we frequently criticize journalists who get the science wrong. For a change, I’d like to congratulate Mr. Ortega for not only getting the science right, but for accomplishing something that could potentially save lives.
As with so many discoveries in science and journalism, this one started with a chance observation. A senior reporter at the Arizona Republic, Ortega was working on an unrelated story when a pathologist happened to mention a patient who had been diagnosed with cervical cancer after getting two negative SurePath tests in a row. He mentioned that the test in question was not even FDA approved. Ortega could have overlooked that as irrelevant to the story he was investigating, but he was astute enough to recognize the germ of another story and to pursue it diligently.
Screening for cervical cancer today involves two tests: the long-familiar Pap smear and the newer HPV test. The Pap test identifies abnormal cells that may develop into cancer if not treated. The HPV test identifies the presence of DNA or RNA from HPV virus types that are associated with high risk of cancer. The results of both tests affect clinical decisions about further diagnostic procedures and the timing of repeat screening tests.
Typical procedure is for doctors to collect a single sample that the lab can use for both Pap and HPV tests. The Pap test is usually done right away but the HPV test may not be done until a later date. A common practice has been to await the Pap results before instructing the lab to run the HPV test on the same sample (because depending on the Pap results, the HPV test might not add anything that would affect management).
BD SurePath is a preservative used in test kits. It is FDA approved for Pap tests, but not for HPV tests. SurePath was submitted for FDA approval for HPV testing 3 times in the last 10 years. Each time the application was withdrawn; we don’t know why. There is a competing product, ThinPrep, that is FDA approved for both. Doctors usually don’t know what product their lab is using or whether it is FDA-approved.
Withdrawal of the FDA applications means the in-house data were not made public, but Ortega’s sources indicated that the SurePath test had a false-negative rate as high as 50%, compared to 10% for FDA-approved brands. In other words, as many as 50% of women who had high-risk HPV infections were being falsely reassured that they did not. The company claims that false-negatives aren’t a problem unless testing is delayed for 8 weeks. But Ortega found 17 independent medical studies, most of which showed that the samples began to degrade after a few days or even within 24 hours. He learned that the manufacturer and the FDA were aware of the problem long before any action was taken. And the action that was finally taken didn’t amount to much.
On June 8, 2012, the manufacturer, in collaboration with the FDA, sent a bulletin to laboratory customers stating SurePath is not FDA-approved for use with the most common HPV test, hybrid-capture II. “Use of the SurePath sample may under certain conditions produce false-negative results … (that) could lead to inappropriate patient management and potentially compromise patient safety,” the bulletin stated.
The warning was only sent to labs; not to doctors or patients. Ortega interviewed numerous gynecologists 5 months later; none of them were aware of the warning.
SurePath has a 30% share of the market, selling 3 million test packs a year. Why do so many labs choose SurePath? One possible explanation is that it costs $1-2 less than the FDA-approved tests. And using the test off-label is perfectly legal, as long as the individual lab does the required in-house validation studies to convince itself that it is getting good results.
This highlights not only the problems with this one test, but also the deficiencies in FDA oversight and notification procedures in general. The test is still in wide use, and FDA procedures have not changed, but at least the information Mr. Ortega dug up is now available to doctors and patients.
Ms. Beyerstein says:
Ortega engaged deeply with the peer-reviewed literature, interviewed numerous experts, and delved into complex medical and regulatory issues to report this story. He eschews sensationalism and innuendo and focuses on the facts, which are damning.
some of the best health reporting I have ever seen. His article not only gives me almost everything I need to know on this issue as a clinician, but includes information on how the article was complied, and excellent info for patients wondering what to do themselves with this information.
So kudos to Bob Ortega, and thanks for an outstanding piece of science journalism that can serve as an example to his colleagues everywhere. And thanks to Lindsay Beyerstein for publicizing his accomplishments.
This article was originally published in the Science-Based Medicine blog.