Monday, October 24, 2016

Clinical trial on lymphoma is suspended

Cancer researcher's work put into question by his failure to file timely report on deaths

It's no secret that new research can frequently contradict old — even when the latter has only been public for a few days or weeks.

But now comes a new wrinkle: Researchers may be invalidating their work by failing to file appropriate reports.

Or, at best, bringing their tests into question.

Case in point: An early-stage clinical trial sponsored by the National Cancer Institute on an experimental drug, ibrutinib, that involved lymphoma of the central nervous system, a blood cancer that to date had no effective treatment and was often deadly.

According to a story this week by Laurie McGinley in The Washington Post, the lead researcher failed to tell authorities in a timely manner that "two patients had died of fungal infections that might have been caused by the experimental treatment."

That failure, which led to the researcher being suspended "until he undergoes additional training," meant the trial was suspended — despite what McGinley's story called its "impressive results" in which eight of the 18 patients enrolled in the study "continue to be in complete remission, including six whose disease had not responded to previous treatment — a situation that usually causes death within a matter of months."

Dr. Francis Collins
The reporting lapses were reported by Dr. Francis Collins, National Institutes of Health director; Dr. Doug Lowe, NCI director; and other officials.

The study, which was begun in 2013, centered on ibrutinib being used in conjunction "with a cocktail of chemotherapy medications. In addition, steroids were used to reduce swelling in the patients' brains."

The principal investigator, Kieron Dunleavy, had reported concerns — after the second fatality — and "ordered CT scans in other patients in the trial to try to catch fungal infections early, before they became deadly," but he allegedly delayed filing "an official 'unanticipated problem' report" for months.

That kind of report is supposed to be filed within 24 hours of suspecting a problem caused by the treatment.

When the Federal Drug Administration — which regulates trails — learned of the problem, it "conducted a review that concluded there also were several other adverse events that weren't promptly reported," McGinley's story indicated.

Collins said "that it appeared that the combination of ibrutinib and steroids 'seemed to place patients, many of whom have compromised immune systems, at an enhanced risk of infection,'" the article said.

Information on research, and how it often flip-flops, can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a book I, Woody Weingarten, aimed at male caregivers.

Friday, October 14, 2016

Overdiagnosis worries research project leader

New study renews the question of whether mammograms provide more benefits or harms 

A new study has led to amped up questioning of mammograms as appropriate breast cancer screenings.

The study, published this week in the New England Journal of Medicine, heightens discussions of recent years of whether the screening benefits outweigh the harms.

Clearly the jury's still out.

Dr. H. Gilbert Welch
According to an Associated Press story by Marilynn Marchione about the study, Dr. H. Gilbert Welch of the Dartmouth Medical School, a leader of the research project, said whether to have a mammogram "is a close call, a value judgment."

The study, the AP wrote, had concluded that women were "more likely to be diagnosed with a small tumor...not destined to grow than she is to have a true problem spotted early."

Many experts believe that improved treatment has rendered early detection less important, and that screenings are worth it only when they detect life-threatening cancers whose treatment would increase survival rates beyond what would occur if the disease were treated only when it became absolutely necessary.

The new thinking, advocated by Welch, is that many early cancers will never grow or spread or become a health threat.

Screenings can lead to overdiagnosis and overtreatment.

Welch, in fact, was the lead author of a recent book titled "Overdiagnosis: Making People Sick in the Pursuit of Health." And the new study, Marchione's story says, "parallels work he published from the same data sources four years ago."

At least one aspect of the new study — its assumption that there's been no change in cancer incidence — has been severely challenged by Dr. Robert Smith, American Cancer Society vice president of cancer screenings, who says cases have increased.

His perspective, according to the AP story, is that "when we find breast cancer early, women have a much, much better prognosis."

The study, the article continues, applies only to screening mammograms when a problem is suspected.

More details about the long-running mammogram controversy can be found in "Rollercoaster: How a man can survive his partner's breast cancer," the VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Sunday, October 2, 2016

Column talks of cancer's fiscal, emotional costs

NBC newscaster Tom Brokaw reveals what it's like living with an incurable blood cancer

Tom Brokaw
Tom Brokaw has used The New York Times as a bully pulpit by writing an op-ed column titled "Learning to Live with Cancer."

In today's piece, the NBC special news correspondent talks of being diagnosed, three years ago at age 73, with "an incurable [blood] cancer called multiple myeloma" and a statistical probability of five years to live.

He's since had "chemotherapy, a spinal operation…infusions of bone supplements and drugs to prevent respiratory infection" that put the cancer into remission.

At a cost. 

Financially and emotionally.

"Combating cancer," he writes, "is a full-time job that, in my case, requires 24 pills a day, including one that runs $500 a dose."

Still, the bone damage "brought persistent back pain and unwelcome muscle deterioration."

And, of course, there's the content fatigue. 

But he also talks of befriending others (in person and via email) with terminal diagnoses, some of whom have already died — but focusing on one in particular who's "doing well" 14 years after then-new treatments were applied.

Last year, Brokaw published a book, "A Lucky Life Interrupted," that he said he hoped would help others battling the disease that affects some 27,000 Americans annually.

To learn more about having cancer and aiding a patient with it, consider reading "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.