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FDA declines approval of Lemtrada for the treatment of MS

On December 30, 2013, the US Food and Drug Administration declined to approve the use of alemtuzumab (Lemtrada) for the treatment of multiple sclerosis. The FDA stated that the manufacturer of Lemtrada “has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.” This was a surprising decision to some, as only a month earlier an advisory panel of experts convened by the FDA, while raising some objections, voted to have this medicine approved. The manufacturer of Lemtrada, Genzyme, a Sanofi company, intends to appeal this decision.
 
In response, a number of MS organizations and experts have voiced their concerns that with this step, MS patients are left without a potential choice in therapy. This decision is particularly difficult for ...

FDA approves 40 mg/mL Copaxone for 3 times a week

The U.S. Food and Drug Administration (FDA) has approved the three-times-a-week COPAXONE® 40mg/mL, a new dose of COPAXONE® on Jan 28, 2014.  This new formulation will allow for a less frequent dosing regimen administered by injection for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily COPAXONE® 20 mg/mL will continue to be available.

The FDA approval is based on data from ...

What you should know about multiple myeloma

Recent news about the health of the distinguished journalist, Tom Brokaw, has focused attention on multiple myeloma, a malignant disease of the bone marrow. Myeloma is characterized by an uncontrolled growth of marrow plasma cells, which normally produce antibodies for our immune system. In its advanced stages, the overgrowth of these cells and their associated proteins can cause anemia, painful bone destruction, and kidney failure.
 
Until about 10 years ago, advanced myeloma was uniformly fatal with a typical survival of about 3 years. Recent years, however, have seen a remarkable improvement in treatment possibilities for myeloma. This began with the discovery that autologous stem cell transplantation could produce complete remissions and longer survival. In addition, a variety of chemotherapy drugs administered in combination with corticosteroid drugs, now produce responses in up to 80% of patients. This means about 80% of patients are surviving longer than 3 years after chemotherapy and autologous stem cell transplant.
 
Not all patients with myeloma require chemotherapy. Myeloma can exist in an early stage for years. This is called smoldering myeloma. Chromosome analysis is routinely done on myeloma cells and allows us to identify patients with more aggressive forms of the disease, and those requiring treatment due to signs of organ damage or bone pain.
 
The Swedish Cancer Institute has been a participant in clinical trials leading to the development of some of the effective new treatments for myeloma. We are currently participating in a study of pomalidomide, a newly approved agent, for patients with relapsed myeloma. Another study offers an investigational drug, MLN9708, for newly diagnosed patients.
 
While the new drugs are more effective and better tolerated than previous chemotherapy, all  ...

Are you at risk for heart disease?

About half of all Americans have at least one of the three main risk factors for heart disease: high blood pressure, high cholesterol and smoking. Other risk factors include diabetes, overweight/obesity, poor diet, inactivity, alcohol use and family history.

More people die from heart disease than any other medical condition. Controlling these risk factors is the most effective method of prevention.

What is your risk for heart disease? Find out by taking a free online Heart Risk Test.

If you need care, we have a team of cardiologists who can evaluate your risk, show you how to reduce that risk, and help you take the first steps to a healthy future.

Five tips for finding a cardiologist:

  1. Convenience. Care close to home or work makes life easier. Swedish has more than 35 cardiologists in 20 locations throughout the Greater Puget Sound area.

  2. Credentials. Cardiologists at Swedish are board certified by their national professional organizations.

  3. Quality. The American College of Cardiology has recognized Swedish cardiologists for being leaders in safe, high-quality care that reduces the risk of death among heart patients. Find out more about our quality outcomes.

  4. Reputation ...

Breast Cancer Survival Guide: Physical & Clinical Updates

A diagnosis of breast cancer sets into motion a whirlwind of appointments, tests, surgeries and possibly chemotherapy and radiation treatment. A new study reviewed the timeline between surgery and initiating chemotherapy for different subtypes of breast cancer and found a survival advantage when chemotherapy was initiated within 30 days of surgery. Although treating within the 30-60 post-surgical window did not show a statistically significant survival advantage, there is a trend towards better outcomes. Exceeding 60 days post treatment had a negative impact on survival. The clinical impact of timing is most relevant for patients with stage II and III breast cancer, triple negative breast cancer and HER2-positive tumors.
 
Treatment for breast cancer can be exhausting and take a toll on the physical health of patients as treatment ends and they begin post-treatment life. Cancer survivors are at an increased risk of poor health, depression and physical disability. Approximately one third  ...

New Brain Stimulator Approved to Treat Epilepsy

On November 14th, 2013 the FDA gave its approval for an implanted brain stimulator to treat patients with medically refractory epilepsy. Epilepsy is one of the most common neurological disorders affecting nearly 1 in 100 Americans. This device has been under investigation for 10 years at the Swedish Neuroscience Institute (SNI) Epilepsy Center.

As principal investigator for the trial, I led  a team including Dr. Michael Doherty, Dr. Lisa Caylor and Dr. Alan Haltiner, along with the research department at Swedish to investigate the safety and effectiveness of the device through pivotal trials. The results showed that the responsive neurostimulator system (RNS) made by NeuroPace was indeed effective in treating patients with drug resistant seizures.

Why is this so significant? This device represents the first new non-medication treatment for seizures proven to be effective since 1997, and gives new hope to patients whose lives have been put on hold due to seizures. ...

Constraint induced movement therapy in MS may be equally effective as in stroke

Constraint induced movement therapy (CIMT), formerly called “forced use” is a treatment for impaired function of an upper extremity. It has been established as an effective evidence-based form of treatment for rehab of impaired upper extremity (UE) function for post stroke hemiparesis. The core features of CIMT are massed practice (high repetitions) and to overcome learned non-use thru behavior modification. The typical training protocol involves a 2 week period of physical restraint of the less-involved side (90% of the waking hours) and intensive training (3 hours/day) focused on movement patterns of the involved hand and arm. The physical restraint is usually a padded mitt, sling or glove thereby restricting stronger arm use.
At a recent ECTRIMS/RIMS meeting, this form of therapy was presented as being equally effective in

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