Articles
The US Food and Drug Administration (FDA) is proposing to ease the approval process for direct-to-consumer genetic tests, saying that the diagnostics can increase consumer engagement in their health. “In its consideration of [genetic health risk] tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to …
FDA Proposing to Ease DTC Genetic Tests’ Path to Market Read More »
A Gleason score provides information on how aggressive a prostate cancer is. It is calculated when a prostate needle biopsy specimen is examined under a microscope. Depending on how normal or abnormal the cancer looks, it is assigned a number from 1 to 5, with 5 being the most abnormal and most aggressive. Different areas …
I will never forget the words from the oncologist when I was first diagnosed with metastatic breast cancer. “We can put out the flames but it will always smoulder,” the doctor said. “You will learn to live with cancer. You will have to overcome the stigma of cancer.” For a start, being diagnosed with breast …
According to Dr. John Timmerman, an oncologist and immunotherapy researcher at the University of California, the use of immunotherapies is a dangerous game. “We’re playing with fire,” he told the NYT, shortly after losing a female patient to the treatment’s after-effects. Weeks after the drug sent her cancer into remission, she suddenly developed cold and …
Juno Therapeutics is working on an immunotherapy for adults with refractory B cell acute lymphoblastic leukemia. Its phase 2 trial was recently placed on hold for the second time this year following the death of two patients who developed cerebral edema, just days after receiving their treatment.8 One of the patients was under the age …
Adult Leukemia Trial Put on Hold After Additional Deaths Read More »
The FDA’s Breakthrough Therapy program (and the European PRIME) worsens the situation. By rushing approvals, toxicology research ends up lagging even further behind, which means more patients end up being used as guinea pigs without actually being enrolled in a formal study. This is a particularly frightening prospect in light of the fact that drug …
Breakthrough Therapy Program Raises Stakes for Patients Read More »
A study published in 2010 found that ipilimumab — an immunotherapy drug that blocks cytotoxic T-lymphocyte antigen-4, used against advanced melanoma — caused severe side effects in nearly 20 percent of patients. Another study published in 2015 found adverse events in 24 percent of patients receiving ipilimumab, and when used in combination with nivolumab, another …
Immunotherapy Drug Trials Show Severe Side Effects Are Common Read More »
Immunotherapy drugs are considered the latest and greatest breakthrough in conventional cancer treatment. Chimeric antigen receptor technology (CAR-T) has raised a great deal of hope, and an equal measure of concern. CAR-T involves genetically reengineering a patient’s immune cells to target tumor-associated antigens, thereby destroying the malignant cells. Alas, while these therapies appear to be …
The New York Times (NYT) recently published a very comprehensive article well worth the read that details the struggles of Chuck Peal, who took part in a melanoma study at Yale. He received the ipilimumab with nivolumab combination. Seven weeks later, he developed acute-onset diabetes — a brand new form of type 1 diabetes, to …
Out-of-Control Immune System Attacks Healthy Organs Read More »
Inexpensive, simple and quick detection of pathogen antigens in human samples is a key global health objective. Limiting factors include the cost and complexity of diagnostic tests that utilize antibody probes. Herein, we present a method for label-free electrochemical detection of a protein from the enteric pathogen Entamoeba histolytica using cell-free yeast-embedded antibodylike fragments (yeast-scFv) …
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