New Cancer Drug: Breakthrough or Just Hype?

Having just passed through Ontario’s Pearson International airport on route from eastern Canada, I was struck by an email from one of my patient’s mothers who shared with me a 6/20/2013 article from the Toronto Globe and Mail, “Take news of cancer breakthrough with a big grain of salt,” by staff writer André Picard.

The author describes an announcement by two prominent cancer researchers, Tak Mak, PhD, of Princess Margaret Hospital Toronto, CA and Denis Slamon, MD, from UCLA, who reported the results from a new class of compounds known as “polo-like kinase 4 inhibitors.” Picard goes on to note, “This seemingly miraculous ‘breakthrough’ drug has not been tested on a single person. The experimental drug CFI-400945 has ‘prevented cancer growth’ in a bunch of mice.”

What troubles the author (and should probably trouble us all), is the lack of substance in this report. After all, many drugs reveal activity in animal models, yet most seemingly promising drugs fail to provide clinical benefit. Only 8 percent of cancer chemotherapy drugs that enter the earliest form of human clinical trials (Phase I) ever achieve FDA approval. According to a study published in the New England Journal of Medicine, fully 50 percent of drugs that make it to the final stage (Phase III) of clinical testing nonetheless fail to gain approval. Thus, there is ample reason for concern when “breakthrough” drugs achieve this level of public recognition, because it is distinctly unlikely that they will ever deliver on their promises.

When I attend the AACR meetings, I’m impressed by the level of scientific discovery. When I then attend the ASCO meetings, I’m even more concerned by the lack of clinically relevant progress. The divide between clinicians and scientists seems to grow ever wider. While TIME magazine and The New York Times (to use Andre Picard’s term) genuflect before these scientists’ reports of dramatic advances, most cancer patients continue to suffer through largely ineffective toxic therapies. The disconnect is becoming painfully evident. What we need is a better pathway from discovery to clinical application. What we don’t need is more hype.

About Dr. Robert A. Nagourney
Dr. Nagourney received his undergraduate degree in chemistry from Boston University and his doctor of medicine at McGill University in Montreal, where he was a University Scholar. After a residency in internal medicine at the University of California, Irvine, he went on to complete fellowship training in medical oncology at Georgetown University, as well as in hematology at the Scripps Institute in La Jolla. During his fellowship at Georgetown University, Dr. Nagourney confronted aggressive malignancies for which the standard therapies remained mostly ineffective. No matter what he did, all of his patients died. While he found this “standard of care” to be unacceptable, it inspired him to return to the laboratory where he eventually developed “personalized cancer therapy.” In 1986, Dr. Nagourney, along with colleague Larry Weisenthal, MD, PhD, received a Phase I grant from a federally funded program and launched Oncotech, Inc. They began conducting experiments to prove that human tumors resistant to chemotherapeutics could be re-sensitized by pre-incubation with calcium channel blockers, glutathione depletors and protein kinase C inhibitors. The original research was a success. Oncotech grew with financial backing from investors who ultimately changed the direction of the company’s research. The changes proved untenable to Dr. Nagourney and in 1991, he left the company he co-founded. He then returned to the laboratory, and developed the Ex-vivo Analysis - Programmed Cell Death ® (EVA-PCD) test to identify the treatments that would induce programmed cell death, or “apoptosis.” He soon took a position as Director of Experimental Therapeutics at the Cancer Institute of Long Beach Memorial Medical Center. His primary research project during this time was chronic lymphocytic leukemia. He remained in this position until the basic research program funding was cut, at which time he founded Rational Therapeutics in 1995. It is here where the EVA-PCD test is used to identity the drug, combinations of drugs or targeted therapies that will kill a patient's tumor - thus providing patients with truly personalized cancer treatment plans. With the desire to change how cancer care is delivered, he became Medical Director of the Todd Cancer Institute at Long Beach Memorial in 2003. In 2008, he returned to Rational Therapeutics full time to rededicate his time and expertise to expand the research opportunities available through the laboratory. He is a frequently invited lecturer for numerous professional organizations and universities, and has served as a reviewer and on the editorial boards of several journals including Clinical Cancer Research, British Journal of Cancer, Gynecologic Oncology, Cancer Research and the Journal of Medicinal Food.

5 Responses to New Cancer Drug: Breakthrough or Just Hype?

  1. Elaine L. says:

    Dr. Nagourney, was there any treatment research presented at ASCO, regarding ovarian cancer, that impressed you?

  2. Frank Wiewel says:

    The road to the Nobel is littered with those who cured cancer in mice. Men with vision would take a different road. This year 1,500,000 Americans will be diagnosed with cancer and 750,000 will die despite the best conventional therapy. As a country, and a world, we can not afford to overlook any alternative for any reason.

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  4. JIm says:

    What should trouble you is why no research or data is published on surviving cancer patients (not those you consider survivors at 5years) but those that have used alternative medicine. And have cured themselves for more than 15 or 20 years.

  5. JIM says:

    Dr. Nagourney , you say we cannot afford to overlook any alternative and that puzzles me. Many cancer cures have been overlooked because they could not be patented and if you can’t make a dollar there is no interest.

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