Tuesday, August 9, 2016

NYTimes: Cancer-Drug Ads vs. Cancer-Drug Reality

TOWSON, Md. — Two days into a long-dreamed-of family vacation to Italy in August 2013, my wife, Ronna, became nauseated, unusually tired and short of breath. One of the great non-complainers in American history, she insisted that it was no big deal and valiantly tried to join in on various outings in the Italian countryside. But, after a few increasingly difficult days, even Ronna knew that it was time to go to the emergency room.

In a small hospital in Tuscany, doctors identified the apparent source of the problem: a pericardial effusion, or a buildup of fluid around the heart. Ronna was transferred to a larger medical center in Arezzo, where a pericardial tap was performed. Immediately afterward, in a scene that still plays on a loop in my mind's eye, the hospital's chief of cardiology informed me that, while the fluid was gone, he was quite sure that Ronna had lung cancer.

A few weeks later, when we were back home in Maryland, doctors at Johns Hopkins Hospital confirmed his suspicion: My healthy, active, 48-year-old, never-smoker wife had Stage 4 non-small cell lung cancer.

Over the next two years, Ronna underwent several rounds of grueling chemotherapy and, when the cancer spread to her brain, several rounds of radiation treatment. She also took part in a clinical trial at Johns Hopkins for Opdivo, an immunotherapy drug made by the pharmaceutical company Bristol-Myers Squibb. Briefly stated, immunotherapy is a recently developed, highly promising treatment that helps a person's immune system identify and attack cancer cells. But it did not work for Ronna, and last Sept. 25 she died as her parents and I held her hands and whispered in her ear.

Needless to say, it has been a difficult year for my two children and me. But, knowing that Ronna couldn't abide self-pity, we have been slowly moving forward by doing our best to cope and trying to honor, whenever possible, her remarkable memory and legacy.

A few weeks ago, though, I saw a television commercial that dealt that process a setback. It was a 90-second ad for Opdivo that began with soaring music and shots of older people in warm sunlight, gazing upward at a building on which the words "A chance to live longer" were superimposed. The voice-over said, "Opdivo significantly increased the chance of living longer versus chemotherapy." The wording may be a little clumsy, but the velvet-voiced narrator made his point, bolstered by actors portraying lung cancer patients playing with babies and watching Little League games.

It would be incredibly uplifting if it weren't so utterly misleading and exploitive. To date, only about one in five patients with Stage 4 non-small cell lung cancer has seen any measurable response to Opdivo; and, in those patients who do respond, the median increase in life expectancy is only about three months compared with standard chemotherapy.

More ...


Sunday, August 7, 2016

NYTimes: Why ‘Useless’ Surgery Is Still Popular

Before a drug can be marketed, it has to go through rigorous testing to show it is safe and effective. Surgery, though, is different. The Food and Drug Administration does not regulate surgical procedures. So what happens when an operation is subjected to and fails the ultimate test — a clinical trial in which patients are randomly assigned to have it or not?

The expectation is that medical practice will change if an operation turns out not to help.
If only.

It looks as if the onus is on patients to ask what evidence, if any, shows that surgery is better than other options.

Take what happened with spinal fusion, an operation that welds together adjacent vertebrae to relieve back pain from worn-out discs. Unlike most operations, it actually was tested in four clinical trials. The conclusion: Surgery was no better than alternative nonsurgical treatments, like supervised exercise and therapy to help patients deal with their fear of back pain. In both groups, the pain usually diminished or went away.

The studies were completed by the early 2000s and should have been enough to greatly limit or stop the surgery, says Dr. Richard Deyo, professor of evidence-based medicine at the Oregon Health and Sciences University. But that did not happen, according to a recent report. Instead, spinal fusion rates increased — the clinical trials had little effect.