Rapid tests for the Swine Flu, performed in a doctor’s office, fail to detect the H1N1 influenza virus more than half the time according to a small study, the New York Times reported.
And the bone cement commonly used to repair fractured vertebrae is no more effective than a placebo, according to a pair of other small studies reported in the Wall Street Journal (subscription).
Swine Flu tests
The rapid tests for Swine Flu “are missing a ton of flu,” Christine Ginocchio told the Times. She’s director of the division of microbiology, virology and molecular diagnostics at the North Shore-Long Island Jewish Health System in Lake Success, N.Y.:
“In a study published recently in The Journal of Clinical Virology, Dr. Ginocchio found that one rapid test detected only 10 percent of the swine flu infections that could be picked up by a more sophisticated laboratory culture. A different rapid test detected 40 percent. (Dr. Ginocchio is a consultant to Luminex, a company that makes a more accurate but slower test.)”
That’s bad news for companies like Inverness Medical Innovations, 3M, Thermo Fisher Scientific, Meridian Bioscience, Becton, Dickinson and Quidel, all of which make the rapid diagnostics.
The rapid tests use antibodies to detect a protein from the virus. But they only indicate the presence of influenza (in some cases distinguishing between the type A and type B strains) and don’t detect the specific A/H1N1 Swine Flu strain. And if the patient’s sample doesn’t contain enough of the protein, the tests can return a false negative result.
And that, in turn, means using a more sophisticated test to make sure. And even a positive result can mean more tests to determine whether it’s Swine Flu or another strain.
More accurate tests using the polymerase chain reaction require a lab and at least 48 hours to produce a result. A lab test made by Quest Diagnostics recently won emergency approval from the Food & Drug Administration.
Bone cement in vertebroplasty
Bone cement is no more effective than fake placebo procedures when it comes to vertebroplasty, according to two small studies of 131 and 78 patients, respectively.
Last year more than 100,000 U.S. patients received the treatment, in which radiologists inject bone cement into the fractured vertebra.
In the first study, one group of patients received the bona fide treatment, while the other half received only the numbing injection used just before the procedure, according to the Journal:
“After a month, both groups saw a substantial reduction in measures of disability and pain, assessed by a questionnaire. But the reductions were a statistical tie — the actual procedure yielded no gain beyond the placebo effect of the sham surgery.”
“A separate study, including 78 patients and conducted similarly, was funded by the Australian government and the manufacturer Cook Medical Inc., which makes bone cement. It reached a similar conclusion: vertebroplasty didn’t relieve pain any more than the sham surgery, measured three months later.
The studies are sure to fuel the comparative effectiveness fire raging inside the Beltway, which has one side claiming that millions of dollars are wasted on ineffective medical treatments each year. The other side claims that a massive, government-sponsored program will result in certain procedures being effectively legislated out of the marketplace, making them unavailable to individial patients who want them.