Rallying the Troops to Confront Cancer

The recent blog “Stand Up To Cancer Research!” described some of the pitfalls of modern cancer research and the clinical trial process. It has engendered an active discussion. It may be helpful to address some of issues raised. For those of you who did not have the opportunity to read that blog, it defined the difficulty that many patients encounter when they seek experimental treatments. Clinical trials are often only available at select centers, sometimes at great distances from patient’s homes. There can be rigid inclusionary and exclusionary criteria, and the pre-entry evaluations e.g. re-biopsy, CT/PET, etc. can be daunting, time consuming and inconvenient. Travel and accommodations may come at great personal expense.

I penned the blog, in part, to remind patients that they are ultimately in control of the process. One patient asked how can “we stand up to the system” describing herself a consumer while “they’ve got the goods.” This is the frustration many people feel. It should be remembered, however, that a substantial portion of research support comes from tax dollars and charitable donations. These are your dollars. If the system is not working, then those responsible must be held accountable. The American public has the power of the vote. Patient advocates can approach and lobby their representatives and demand improvements in the clinical trial process. To wit, the level of scrutiny and restriction upon access to new drugs must be re-examined. There is an army of well-trained clinical oncologists capable of delivering experimental drugs today. Not just the fully vetted, just-about-ready-for-prime-time agents currently found in phase III trials, but the really new exciting drugs. Once a drug has passed Phase I and found to be safe in patients, open up the accrual process. “Compassionate use” has virtually disappeared from the lexicon of cancer research. Twenty years ago I made a discovery in the laboratory. Working with the pharmaceutical company and the FDA, we were almost immediately granted access to a yet-to-be approved agent. The combination proved so effective that today it is one of the most widely used regimens in the world. That would not happen today. We simply cannot get access to the best drugs for our patients.

Microscope Detail2-lo resWith the industrialization of medical care, growth of mega-medical systems and the increasing role of government, medicine must be viewed through a different lens. Changes in cancer research will require changes in cancer policy, and policy comes from political power. Cancer patients will need to identify legitimate spokespeople to take their concerns forward to their elected officials. While the current clinical trial process slowly grinds out new development, even the smartest, fastest trials take years to change practice. Every day, more than 1,500 cancer patients die in the United States alone. Cancer patients do not have time for clever doctors to pose interesting questions while they suffer the slings and arrows of ignoble, ineffective therapy. It is time for a change in cancer research, and patients must be the instrument for that change.

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.

3 Responses to Rallying the Troops to Confront Cancer

  1. Shaker Farhat, MSc, PhD(c) says:

    Your voice for ʺrallying the troops to confront cancerʺ eloquently expresses the conscience of the nation. Why not engage the media to spread the message? Next, policymakers can be influenced to move in the right direction if cancer patient advocacy groups and unbiased scientific experts speak together strongly with one voice. The pitfalls of slowly-moving cancer research and the clinical trial process should be immediately addressed by the highest authority in the land with the purpose of streamlining the entire process under a single effective and patient-proactive authority that has enough clout to effect change and influence direction. Such ACTION should be (1) urgent (accelerating the process dramatically), (2) massive (well organized), (3) devoid of politics and self-interest, (4) adequately supported (morally, financially, and scientifically), and (5) focused primarily on rapidly translating “promising” research results to the patient, not in 10 years, but as soon as possible. In the meantime, why not consider passing laws/policies to forbid companies from withholding “not-yet-approved” but safe, potentially-lifesaving experimental treatments to patients in late/terminal stage if so requested by their doctors on compassionate grounds (with reasonable and appropriate compensation and full legal protection to such companies)? See one such proposal here: http://bcaction.org/policy-on-compassionate-access-to-investigational-therapies/
    You suggested that, “There is an army of well-trained clinical oncologists capable of delivering experimental drugs today. Not just the fully vetted, just-about-ready-for-prime-time agents currently found in phase III trials, but the really new exciting drugs.” Your point should be pursued at the highest level in the hope of widening “compassionate use”, and could hopefully save many lives, which is the essential goal of medicine.

    • robert nagourney says:

      I am flattered and delighted with your thoughtful response. The broader availability of Phase II agents would dramatically accelerate drug development. The patients would benefit, the physicians would benefit and the pharmaceutical industry would benefit. Lets re-invigorate the compassionate use avenue. Patients and their doctors would be willing to take the risk. If the pharmaceutical industry could develop some form of “hold harmless” agreement with the regulatory agencies for those circumstances where they donated the drugs, allowing patients access to new classes of drugs, they could receive good quality (real world) data in return.

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