Health Highlights: July 12, 2018
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Heart Disease in Dogs May be Linked to Certain Pet Foods: FDA
A possible link between heart disease in dogs and certain pet foods is being investigated by the U.S. Food and Drug Administration.
"We are concerned about reports of canine heart disease, known as dilated cardiomyopathy (DCM), in dogs that ate certain pet foods containing peas, lentils, other legumes or potatoes as their main ingredients. These reports are highly unusual as they are occurring in breeds not typically genetically prone to the disease," Martine Hartogensis, deputy director of the FDA's Center for Veterinary Medicine's Office of Surveillance and Compliance, said in an agency news release.
"The FDA is investigating the potential link between DCM and these foods. We encourage pet owners and veterinarians to report DCM cases in dogs who are not predisposed to the disease," Hartogensis said.
Large dogs such as Great Danes, Newfoundlands, Irish Wolfhounds, Saint Bernards and Doberman Pinschers have a genetic risk for canine DCM, a disease of the heart muscle that often leads to congestive heart failure. The disease is less common in small and medium breed dogs, except American and English Cocker Spaniels.
The FDA said it's concerned about recently reported cases of DCM in Golden and Labrador Retrievers, a Whippet, a Shih Tzu, a Bulldog, Miniature Schnauzers, and mixed breeds.
Early reports suggest that for periods ranging from months to years, these dogs' main source of nutrition were foods with peas, lentils, other legume seeds or potatoes as their main ingredients, the FDA said.
FDA Creates Task Force to Tackle Drug Shortages
A new task force to help deal with drug shortages in the United States was announced Thursday by the Food and Drug Administration.
The task force will expand upon the work of a group created by the Food and Drug Administration Safety and Innovation Act of 2012, which gave the agency new powers to address drug shortages.
They included expanding requirements that drug makers notify the FDA of a permanent discontinuation or temporary interruption in manufacturing that could result in a shortage of prescription drugs for serious illnesses.
"Being notified of these issues has been critically important. It has allowed the FDA to work with manufacturers to address and prevent hundreds of shortages in the past few years," FDA Commissioner Dr. Scott Gottlieb said in a statement.
"However, challenges around drug shortages persist. We must work to find new and creative ways to tackle the issue," he added.
The new task force, led by Keagan Lenihan, the FDA's associate commissioner for strategic initiatives, will "delve more deeply into the reasons why some shortages remain a persistent challenge. The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages," Gottlieb said.
Along with senior FDA officials, the task force will also include officials from the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, which provide or pay for prescription medicine for millions of Americans.
Several work groups will be formed to examine various aspects of drug shortages, including assessing the FDA's current powers and evaluating reimbursement policies of CMS and other payors that could be make it difficult for companies to manufacture certain drugs profitably.
"I also want the task force to explore possible incentives to encourage expansion of manufacturing capacity and enhanced quality," Gottlieb said.
New Cancer Immunotherapy Technique Could be 'Game Changer'
A new approach to immune therapy for cancer could be a "game changer."
Currently, disabled viruses are used to carry new genetic material into immune cells called T cells in order to get them to target cancer. But these disabled viruses are in short supply, resulting in long wait times for them, the Washington Post reported.
A team of scientists say they've developed a new, faster method to reprogram T cells, which normally target bacterial or fungal infections, into cancer fighters.
Rather than using disabled viruses, the scientists found that shocking T-cells with electricity relaxes the membranes that surround the cells, enabling the insertion of new genetic material, the Post reported.
The research by James Wilson, director of the gene therapy program at the University of Pennsylvania's School of Medicine, and his colleagues was published Wednesday in the journal Nature.
"It's a turning point," Vincenzo Cerundolo, director, Human Immunology Unit, Oxford University, U.K., told the Post. He was not involved in the new research.
"It is a game-changer in the field and I'm sure that this technology has legs," said Cerundolo, who added that the research could lead to cheaper and faster immunotherapy.
Being able to quickly reprogram T cells to become cancer fighters is "extraordinarily significant," Fred Ramsdell, vice president of research at the Parker Institute for Cancer Immunotherapy in San Francisco, told the Post. He was not involved in the study.
But the scientists who developed the new approach noted that they need to conduct more research.
"There will have to be discussions with regulatory agencies," study co-author Kevan Herold, an endocrinologist and immunologist at Yale University, told the Post.
"All of us are aware of the potential pitfalls here," and there is a "critical first question: Are these cells safe to be put back into people?"
"We will begin to see this kind of technology brought forth in human clinical trials" in the next one to three years, Ramsdell told the Post.
Herold said it is too soon to assess how much the treatment may cost, but noted that immunotherapies are not inexpensive.
Since 2017, the U.S. Food and Drug Administration has been approving genetically altered immune cells for small groups of patients with cancers such as aggressive non-Hodgkin lymphoma or a rare form childhood leukemia, the Post reported.
Experimental trials using immunotherapy to treat cancers such as multiple myeloma and melanoma skin cancer have yielded promising results.