The PCRI’s New Medical Director

BY MARK SCHOLZ, MD

The Prostate Cancer Research Institute (PCRI) was co-founded by Dr. Stephen Strum and me in 1996. I have been volunteering as the PCRI’s Executive Director and Medical Director since 2007. I stepped into this dual role suddenly when our previous director, Brad Guess, passed away in 2006 from a heart attack.  As Executive and Medical Director, it has been my responsibility to fulfill PCRI’s stated mission, i.e. to improve the quality of men’s lives by supporting research and disseminating information that educates and empowers patients, families and the medical community.

Thanks to the excellent work of Angelique Guarneri in 2010, and subsequently the work of Cathy Williams who took over as Chief Operating Officer in 2011, PCRI has been growing quickly.  New programs include the Online Blue Community, The Mentor Curriculum and the Play for Blue Fundraisers, all of which operate in addition to existing programs, newsletters, website, helpline, and our annual conference.

Several new people have joined PCRI: Madhu Rajaraman, Staff Journalist; Laurie Sorrow our Programs Director; and Silvia Cooper our newest Helpline Counselor, who works alongside our longstanding Helpline Counselors, Nathan Roundy and Jan Manarite. Also part of the PCRI team includes Tom Gallatin, our Grant Writer, and Angelique Guarneri who now serves as a Social Media consultant.

With the creation and growth of these new programs, my functioning in the dual role of Executive Director and Medical Director has become far too demanding.  In fact, I have become concerned that without a fulltime Medical Director, PCRI’s continued growth and progress will be impeded.

Therefore, as of September 1st, Dean Foster, MD has been hired as the new Medical Director of the PCRI.  Dr. Foster’s resume is too extensive to review in detail. Briefly, he was educated in molecular biology at the University of California in San Diego (UCSD). He studied medicine at USC where he also completed residency in orthopedic surgery. Before retiring from medical practice to pursue missionary work, Dean was a specialist in reconstructive surgery in La Jolla and on the clinical faculty at UCSD. Having known Dean personally for many years, I am thrilled that he is willing to assume the leadership of this vibrant and growing organization. Please join me in welcoming him as the PCRI’s new Medical Director!

I plan to continue my labors to ensure the fulfillment of PCRI’s mission.  I am looking forward to working closely with Dr. Foster to assure the continued expansion and success of the PCRI. 

Introducing Color Doppler Ultrasound

BY RALPH BLUM

Accurate information about the status of your prostate cancer is essential for determining whether you need treatment, or whether you can safely continue with active surveillance. Although some centers of excellence like Memorial Sloan-Kettering and the University of California, San Francisco, use spectrographic MRI, most urology practices still rely on repeated random biopsies as their primary form of monitoring—despite the risks and discomfort involved.

As I have said before, I am no fan of biopsies. As far as I am concerned biopsies are a necessary evil. But under no circumstances should men allow themselves to be rushed into having one before less invasive diagnostic methods have been explored. Having said that, a S-MRI means traveling to a specialized facility, costs a small fortune, and involves having a probe that is called an “endorectal coil” inserted up your butt to improve the image quality.

Fortunately, there is another form of prostate imaging—color Doppler ultrasound—that is considered comparable in quality to S-MRI. It is also easier to perform, takes less time, can be done in the doctor’s office (Prostate Oncology Specialists, Mark Scholz’s office, has color Doppler capability), and requires a much smaller probe than the S-MRI. Big plus! Color Doppler ultrasound provides higher resolution images than the usual gray-scale ultrasound machine, and also “sees” areas of new blood vessel formation (angiogenesis) associated with higher-grade, more aggressive prostate cancers. (I will look more closely at this process in my next Blog.)

Color Doppler ultrasound will, in time, be widely used in clinical practice to evaluate blood flow through organs or tumors. Thanks to its simplicity, ease of use, speed, and safety, ultrasound imaging is being increasingly employed to monitor angiogenesis for diagnosis, treatment assessment, follow-up, and therapy guidance.

All monitoring tools have limitations, including biopsies. Color Doppler is only one of many tools that provide useful information about the status of cancer in the prostate. It was from the color Doppler imaging of Dr. Duke Bahn back in 2008 that I learned the reassuring news of no new blood flow and the stalled growth of my tumor. This accurate feedback, confirming how my cancer was behaving, made it safe for me to continue to watch and wait and avoid radical treatment. A blessing for which I will always be grateful.

Xtandi

BY MARK SCHOLZ, MD

It’s here!  Only 3 months after submitting the data from their phase III randomized trial, Medivation’s new prostate cancer super drug was approved by the FDA. Why so quick?  The FDA usually moves like molasses on a chilly morning. It can’t be simply because Xtandi (aka enzalutamide, aka MDV-3100) prolongs survival in men with life-threatening prostate cancer. We have all seen how the FDA ruminates, disseminates and procrastinates. Has the FDA suddenly grown a heart?

No, I think the quick approval of Medivation’s pill can be credited to the nature of the pill itself. It has an amazingly benign side effect profile.  The FDA is charged with two responsibilities: Confirming that a pharmaceutical company’s claims of anti-cancer effectiveness are valid and, ensuring that new products placed on the market are safe. In the latter case Xtandi made the FDA’s job simple.  The results from the study data submitted to the FDA for review showed that men taking Xtandi had fewer side effects than men treated with placebo.

What? Less side effects than placebo?  That sounds impossible. How can an active pharmaceutical agent that is potent enough to block cancer have absolutely zero side effects?  Even aspirin (stomach ulcers) Tylenol (liver damage) and Benadryl (drowsiness, slow urination) have known toxicity.

Actually Xtandi does have a significant side effect profile.  However, the side effects were completely masked because all the men being tested in the study—the men taking placebo and the men taking Xtandi—were also taking Lupron to block their testosterone. So the typical side effects of blocking testosterone (low libido, hot flashes and fatigue) already preexisted in everyone in the study. Therefore Xtandi’s side effects were “cloaked” by the Lupron.

The above explanation can account for Xtandi having the same side effect profile as a  placebo. However, in the study, Xtandi had fewer side effects than placebo. This mystery can be unraveled by considering the generally advanced stages of cancer present in the men being studied.  Uncontrolled cancer can cause “side effects” that are indistinguishable from drug-related side effects.  Xtandi works. It controls cancer and reduces “side effects.”

Medivation deserves enthusiastic commendation for developing this lifesaving new medication. The company should also be recognized for its generous community spirit because while waiting for FDA approval they have been distributing Xtandi free of charge to hundreds of patients through a compassionate-use research protocol.

 

Three Cheers for the Humble Placebo

BY RALPH BLUM

“If we look ahead far enough we can see that placebos may be the best medicine of all.” So wrote Deepak Chopra, in his book Creative Health.

We have all heard of the “placebo effect,” the beneficial results that a substance, like a sugar pill, can produce if the patient is assured by his doctor that it will bring relief or healing. The pill might be nothing but sugar, but with the suggestion of healing and the patient’s belief in a positive outcome, there are often amazing positive results.

Norman Shealy, M.D., Ph.D., has said there is no drug as good as the placebo. According to Shealy, the “average” placebo effect is 35%. To be as good as the placebo, a drug would need to be 70% effective, and this is seldom the case. To give an example, Viibryd, a drug being promoted for Major Depressive Disorder, proved to be only 8% better than a placebo. And furthermore, sugar pills produce none of the complications and side affects associated with most drugs.

In his book The Biology of Belief, cellular biologist Bruce Lipton, Ph.D., writes that our cells respond to our perceptions, and that it is not our genes but our beliefs that control our lives. It is hard, however, for most people living in the 21st century to accept that what we believe and think and feel is manifested in our bodies. And despite the fact that real physiological effects can often be measured, by and large the medical community essentially ignores the significance of the placebo effect.

 One possible reason the placebo effect has not been studied more is because it cannot be manufactured or marketed. Yet when you consider the trillions of dollars spent on health care in this country, and the billions more spent in remedies to treat drug side effects, I would think it is time to look more closely at placebo responses.
 
Over the past three decades, I have met and talked with many men who had been diagnosed with prostate cancer. Some of them were told to “go home and set your affairs in order,” because their days were numbered. Setting your affairs in order is never inappropriate, especially if you are of advanced age. But the threatening manner of the suggestion is unfortunate, if not to say, malevolent.  Many men—among them, even the newly diagnosed—were told they had a fixed time to live. 18 months seems to be a popular time frame. When I hear that kind of threat, I tend to ask the doctor if he could show me his license for making predictions.

When you are diagnosed with cancer, the manner in which your doctor delivers the diagnosis actually has the power to influence the course of the disease.  Most of our generation was taught as children to believe in the infallibility of doctors. So if your doctor’s words are positive, they can plant within you, at a very deep level, the positive expectation that you can beat the cancer. As Dr. Bernie Siegel has said, it is the expectations aroused in the patient that ultimately determine the outcome.  So be sure to put the placebo effect to work by choosing a doctor you trust, and one who gives you large doses of confidence and hope. One who, with appropriate humility, understands the “placebo” effect he transmits to his patients through his demeanor and attitude.  

The physician as placebo. Now there’s a thought. A life-encouraging doctor should be the embodiment of an effective placebo in human form.