Beware of Medical Witchdoctors

BY RALPH BLUM

Words don't just have an impact on our thoughts and feelings, they have direct implications for our bodies, a fact that all of us should keep in mind every time we step into a doctor's office. What is said to us in times of stress can positively or negatively affect our health and well being.

Most of us, as children, are taught to believe in the infallibility of doctors, so the manner in which a doctor delivers a potentially life-threatening diagnosis can have a profound effect, and actually has the power to influence the course of the disease.

The stress of a cancer diagnosis can throw patients into an "altered state" in which they are particularly vulnerable to suggestion--both good and bad. During these critical intake moments, if the doctor's words are positive, they can plant within us, at a very deep level, positive expectations that we can beat the cancer, that we will be cured. Unfortunately, the reverse is equally true. When we are in this altered state the doctor can adversely affect our healing  and, in some cases, literally scare us to death by quoting negative statistics, relating the gruesome side effects of treatments, or worse, by using the dreaded word "terminal."

This latter behavior is a form of "hexing," the medical equivalent of a voodoo curse. If a witch doctor leapt out of the jungle, pointed a bone at you and told you that you were going to die in two months, you'd probably laugh, albeit a trifle nervously. But when a modern-day witch doctor, wearing a white coat, carrying a stethoscope, and supported by state-of-the-art scans and test results, tells you that you have only two months to live, his "curse" can significantly raise the chances that you will die. And often right on schedule.

Everyone has heard of the placebo effect, the beneficial results that a little sugar pill can produce if the patient is told by an authority figure (usually a doctor) that it will bring relief or healing. The mere suggestion actually causes the body to manufacture the chemicals necessary for the desired result. However, the placebo (Latin for "I will please") has a lesser known evil twin, the nocebo (Latin for "I will harm"), which can produce equally powerful negative effects. Suggestion can be a formidable tool, and a significant part of any doctor's job is to create a relationship with his patients based on trust, confidence and hope.

Hippocrates, the father of western medicine said, "A patient who is mortally sick may yet recover from his belief in the goodness of his physician." Although it is our own thoughts, our own beliefs that can either harm or heal us, it is often the doctor's words that start the process. And when the doctor arouses negative expectations, that is medical hexing.

Prostate Cancer Clinical Trials

MARK SCHOLZ, MD

Clinical studies are primarily performed on men with advanced prostate cancer (the Royal Shade of Blue). Why?  The FDA.   FDA only approves new drugs when survival is proven to be prolonged compared to similar men treated with a placebo. The FDA’s insistence on a survival endpoint forces pharmaceutical companies to limit their research to men with a short life expectancy. If survival has to be the endpoint and the study participants live a long time, the cost of performing the study goes up exponentially.

Undergoing experimental therapy with a new medication is reasonable consideration when standard treatment is either no longer working or is causing unacceptable side effects.  However, it’s rare for doctors to recommend an experimental medication before other FDA-approved drugs on the market have been tried.  The commercially available treatments already proven to extend survival are Lupron, Provenge, Xtandi, Zytiga, Xofigo, Taxotere and Jevtana.

Getting Involved in a Trial Can Be Challenging

Eligibility requirements for participation can be rigorous. Trials have carefully specified pretreatment and health status criteria: Eligibility may be denied if the patient is either too sick or not sick enough, if there is too much previous treatment or not enough previous treatment. Criteria are pre-specified so that the final results of the trial are not skewed by a lack of uniformity among patients.  Other requirements designed to achieve trial uniformity include stopping all other anti-cancer medications and the use of placebos, both of which at times may be at variance with a patient’s best interest.

An additional challenge is finding the right trial that matches a patient’s need. The clinical trials landscape changes quickly.  New trials are initiated with limited fanfare and close as soon as they have met their pre-specified number of participants. Trials available at one center may not be so at another.  Another difficulty patient’s face is how to determine the effectiveness of a prospective study drug. Is it likely to work or not?  Due to a study drug’s newness, its functional characteristics are often unclear to patients and doctors alike.

There are different types of study designs to consider each with different goals.  Phase I studies, for example, are primarily designed to learn more about a drug’s side effects. Phase I studies sequentially escalate medication dosages up to determine the point of dosage intolerability. Phase II studies treat a group of patients at a fixed dosage to get a preliminary sense of a drug’s response rates. Phase III studies are the final step that leads up to FDA approval.  Phase III trials are the placebo-controlled trials.

The Business of Clinical Trials

Patients contemplating participation in a clinical trial should be aware that the clinical trial world functions like a business.  It’s funded primarily by the pharmaceutical industry. As such, doctors working in academia are highly motivated to find participants in their research.  If trials are not completed in a timely fashion funding for new trials will be harder to come by in the future.

Participating in a clinical trial has become more attractive over the last ten years as the pharmaceutical industry has made significant strides toward understanding cancer.  Now that they have access to cancer “blueprints” it’s feasible for brilliant biochemists to design “software patches,” new drugs that are far more effective and far less toxic than what has been traditionally available.  However, patients need be careful they don’t mistake a “new” drug for being an “effective” drug.  Despite the tremendous advances in research, most phase I and II drugs still fail to meet minimum standards of clinical effectiveness and never even advance to phase III testing. Sadly, many of the potential prostate drugs that have been tested in Phase III studies over the last ten years have failed to meet the FDA minimum threshold of showing a survival advantage.

Dr. Scholz is the Principal Investigator at Prostate Oncology Specialists - a list of the active trials are found at http://www.prostateoncology.com/clinical_trials