Smaller studies can mean missed side effects

Pharmaceutical companies can't find patients for trials of experimental cancer drugs 

Dr. Peter Bach

Too few patients are available to cover all the clinical cancer drug trials being conducted.

That, at least, is the conclusion of a recent story by Gina Kolata in The New York Times.

Her article notes that the problem "is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients."

There currently are more than 1,000 immunology trials underway, for example.

But Kolata says "immunotherapy trials have proliferated so quickly that major medical centers are declining to furnish patients to them. The Yale Cancer Center participates in fewer than 10 percent of [those] it is asked to join." 

The writer cites words of Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center: "I think there is a lot of exuberant rush to market. And we are squandering our most precious resource — patients."

Dr. Roy Herbst

She also quotes Dr. Roy Herbst, the Yale center's chief of medical oncology, to the effect that the companies sponsoring the trials aren't addressing new research questions but are merely "trying to get proprietary drugs approved."

Some companies are working on experimental drugs that attack and block mutations that tumors need to grow and thrive. The mutations sought by those targeted therapies, however, are extremely rare so pharmaceutical companies "may be forced to undertake a worldwide search for subjects that can last for years."

It took Pfizer three years, for example, "to locate 50 lung cancer patients who carried a rare aberration called ROS1, found in just 1 percent of patients."

Many new trials involve a limited number of patients, which can be risky.

Bach, according to Kolata, maintains that "the smaller the study and the shorter its duration, the more likely that what looks like an effect in a trial might simply be the result of chance" — which "leaves some of us evidence geeks wondering if it works."

Dr. Scott Ramsey

The writer also quotes Dr. Scott Ramsey, an oncologist at the Fred Hutchinson Cancer Research Center, that "in tiny studies, serious side effects can be missed."

Details of many clinical trials can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Softening the impact of breast cancer chemo

Humorous photos don't appear in 'Rollercoaster' but helped couple deal with hair loss

Rhoda Draws in her studio.

Humor can help patients and caregivers cope.

So can artistic flights of fancy.

At a time when her breast cancer and chemo-induced loss of hair turned my wife, Nancy Fox, into a portrait of cheerlessness, Rhoda Draws, a painter-caricaturist-friend based in Mill Valley, California, superimposed some playfulness on half a dozen photographs.

Nancy couldn't help but smile.

Nor could I.

Nancy, digitally enhanced.

Rhoda, who's also an author and teacher, presented the re-imagined photos (aka digitally enhanced, or cyber-imaged) to Nancy as a gift.

Immediately, my wife for a while stopped mourning the loss of her shoulder length, red hair — what she describes in my new book, "Rollercoaster: How a man can survive his partner's breast cancer," as "the one part of my body that I have loved unconditionally."

None of the distinctive photos accompany my narrative. Not because Nancy doesn't appreciate them 20 years after her diagnosis and treatment, but simply because I, Woody Weingarten, didn't use any illustrations at all in the book.

Nancy used the six re-imagined, often whimsical photos on a one-page flyer she sent to friends and family members who aided her. She added this text: "Thanks for your helping hands…and your loving heart…during all my changes."

The front of our refrigerator is decorated with two of the images — on magnets. They still make us smile, every day.

And cope.

And remember the ups and downs of the past triggered by passages in "Rollercoaster."

Such as:

• "Her dread of going bald had careened off the charts. Just before turning out the lights she recalled that as a girl with braids down to her waist, she'd panicked when her mother demanded she cut them off."

• "I do wish she could consistently see herself as I do, as a beautiful creature with or without hair."

• Sadness about her missing hair — even though that loss was temporary — remained the biggie for Nancy. A year after her final treatment, she wrote in her journal that it 'was clearly the psychologically devastating part of the cancer."

• It had taken more than two years before she could look at images of her baldness…She agreed at last to put the photos of her hairless stage into two albums…[She] triggered my caregiver button: 'You and I will never see it the same way,' I replied sincerely. 'Your high cheekbones and eyes showed off better when there was no hair to look at. The fact is, you're lovely both ways.'"

Two decades after her breast cancer diagnosis, Nancy's loveliness still makes me tremble.

Even though her hair is draped around her shoulders again.