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Clinical Trials and Personalized Medicine - Interpreting Studies

Medicine does not search for truth. It searches for cure. It does not look for the universal, it tries to create exceptions.

Medicine emerged from witchcraft. It has always utilized the most advanced technology of its day. Medical models and reasoning always evolve and that evolution makes the previous model obsolete. One of the foundation models of modern medicine is the randomized controlled clinical trial.

The principal of the randomized controlled clinical trial is that a single observation needs to be validated and reproduced. The clinical trial provides an estimate of how often a particular observation will occur. It tells us that chemotherapy improves survival for patients with non-small cell lung cancer at one year from 20% to 29%. It tells us that FOLFOX treatment for advanced colon cancer gives a median time to progression of 8.7 months, response rate of 45%, and median survival time of 19.5 Months. This is accurate information about populations. It's use for the individual is a difficult problem.

Every person is a unit, no one is 20% or 29% or 45%. The question is...

SNI Research Aims to Expand Cerebral Palsy Therapy Options

Before they learn to crawl or walk, about 10,000 babies every year in the United States will develop a condition that will change how they will do just that. Cerebral palsy (CP) is a neurological condition caused by a brain injury before birth, during delivery or before a child’s second birthday. An estimated 800,000 Americans live with CP.

The most common symptom in CP is spasticity, an increase in muscle tension that impairs proper movement. Abnormal postures or movements, weakness or loss of muscle control and rigidity are also part of the constellation of CP signs and symptoms. While physical therapy remains the cornerstone for treatment, new medications and therapies for CP are being developed to help improve and manage symptoms.

Currently, Swedish Neuroscience Institute is participating in a study to determine the safety and tolerability of one such medication. Dalfampridine (AMPYRA ®) is a medication currently used to help improve walking speed in multiple sclerosis (MS) patients. This phase I clinical trial aims to evaluate AMPYRA’s® safety, tolerability and its effect on sensorimotor function of adults with CP. The study will look at how single and multiple doses of the medication have on CP patients, including:

  • Hand strength
  • Manual dexterity
  • Walking speed
  • Gait

There is no cure for cerebral palsy. Therapies for CP ...

Lung Cancer Screening

We screen for breast cancer with mammography, colon cancer with colonoscopy, and prostate cancer with blood tests and exams – why not lung cancer?

If you’re a smoker or a former smoker, or even if you’ve had significant second-hand smoke exposure, you’ve probably worried about your chances of getting lung cancer, and whether there is anything you can do about it. Perhaps you even asked your doctor about getting an x-ray; he or she may have told you that there is no proof that it helps. That’s because a national study done years ago showed no benefit from getting chest X-rays, and therefore it’s not recommended.

The studies

However, since 2000, Swedish has participated in an international study – the International Early Lung Cancer Action Project (I-ELCAP) - to see whether CT scans or CAT scans – very highly detailed X-rays – might be able to find lung cancer earlier and improve cure rates. The study was begun by a group of investigators from Cornell University in New York. They knew that CT scans were very sensitive and would probably show a lot of abnormalities, and that most of them wouldn’t be cancer, so they worked out a system to determine which abnormalities were likely to be cancer. Their system worked, and they showed that when lung cancer was discovered through their screening system the cure rate was over 80%. That’s remarkable, because the normal cure rate for lung cancer is only 15%.

Because of their success, the National Cancer Institute (NCI) began a randomized study with over 50,000 participants. Half of them got annual CT scans and the other half got only chest X-rays. The results were just completed and were very exciting. The group that got CT scans had 20% fewer deaths from lung cancer than the other group!

The results are still being analyzed and there are concerns about safety from too many interventions, radiation exposure, and cost. It will take time to work through these issues, and there is still no general endorsement of lung cancer screening. However, several national organizations now cautiously support screening in high risk groups that meet the criteria for the national study.

Who should get screened, and how?

Change your clock this weekend: it may help your ticker

Here’s a great reason to remember to turn your clocks back and sleep in an extra hour this weekend: it may be good for your heart.

More than 1.5 billion people reset their clocks every year, turning clocks backward by an hour in the fall and forward by an hour in the spring. These transitions can disrupt internal biologic rhythms and influence the duration and quality of sleep. But does losing or gaining that one hour have health consequences? A 2008 report in the New England Journal of Medicine by Dr. Janszky and colleagues suggests that it does. The authors showed that there is a significant increase in the daily rate of heart attack in the first few days after we “spring ahead” and get an hour less of sleep, but that in the first few days after we “fall back” and gain an hour of sleep, there are fewer heart attacks.

Sleep deprivation carries a high risk. Sleeping less than 5-6 hours per night is associated with significant increase in the risk of heart disease, stroke, diabetes, obesity and depression. But 40% of Americans...

Early warning device for heart attacks

The symptoms of a heart attack can vary from person to person, but what if you had an early warning system that would alert you to go to the hospital before the first sign of trouble? Doctors here at Swedish are testing out a new device they hope could do just that.

In early January 2010 Swedish became the first medical center in western Washington to begin participation in the ALERTS Pivotal U.S. Trial for the AngelMed Guardian implantable cardiac monitor and alert system. The system is designed to reduce the time it takes patients to get to an emergency room during an impending heart attack.

The AngelMed Guardian System ® is designed to track significant changes in the heart’s electrical signal and then alert patients to seek medical attention. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.

“If the Guardian system proves to be effective in the early detection and warning of potentially life-threatening heart conditions, we may be able to shift the paradigm for early treatment at the onset of heart attacks,” said Swedish Heart & Vascular Institute interventional cardiologist Mark Reisman, M.D., principle investigator for this study at Swedish.

According to the American Heart Association, one of every five deaths in the United States is attributable to coronary heart disease. Further, 50 percent of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

SNI award from NIH - 2.2M

Swedish Neuroscience Institute was awarded a 7-year, $2.2M grant by the National Institute of Neurological Disease and Stroke (NINDS) to participate in the NeuroNEXT program, a national consortium of 25 neuroscience centers of excellence that will conduct early-stage clinical trials. John W. Henson, MD, FAAN, and Daniel S. Rizzuto, PhD, will lead the effort at Swedish. Swedish Neuroscience Institute was the only non-university hospital chosen to participate, highlighting the value of Swedish’s investments in research and clinical infrastructure. For more information about NeuroNEXT click here

David Newell, M.D., co-authors cover article in Journal of Neurosurgery

David Newell, M.D., neurosurgeon and co-executive director of the Swedish Neuroscience Institute (SNI), co-authored the cover article in the September Journal of Neurosurgery on the results of a study using ultrasound for the treatment of brain hemorrhage. The study involved 33 patients with spontaneous intracerebral hemorrhage who were screened for inclusion in a SNI clinical study known as “SLEUTH” (Safety of Lysis with Ultrasound in the Treatment of Intracerebral and Intraventricular Hemorrhage). Read the abstract and full text of the article. Read background information on the study. Watch a related video on WebMD.

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