Breaking News
May 3, 2019 - Vaping and Smoking May Signal Greater Motivation to Quit
May 3, 2019 - Dementia looks different in brains of Hispanics
May 3, 2019 - Short-Staffed Nursing Homes See Drop In Medicare Ratings
May 3, 2019 - Study of teens with eating disorders explores how substance users differ from non-substance users
May 3, 2019 - Scientists develop new video game that may help in the study of Alzheimer’s
May 3, 2019 - Arc Bio introduces Galileo Pathogen Solution product line at ASM Clinical Virology Symposium
May 3, 2019 - Cornell University study uncovers relationship between starch digestion gene and gut bacteria
May 3, 2019 - How to Safely Use Glucose Meters and Test Strips for Diabetes
May 3, 2019 - Anti-inflammatory drugs ineffective for prevention of Alzheimer’s disease
May 3, 2019 - Study tracks Pennsylvania’s oil and gas waste-disposal practices
May 3, 2019 - Creating a better radiation diagnostic test for astronauts
May 3, 2019 - Vegans are often deficient in these four nutrients
May 3, 2019 - PPDC announces seed grants to develop medical devices for children
May 3, 2019 - Study maps out the frequency and impact of water polo head injuries
May 3, 2019 - Research on Reddit identifies risks associated with unproven treatments for opioid addiction
May 3, 2019 - Good smells may help ease tobacco cravings
May 3, 2019 - Medical financial hardship found to be very common among people in the United States
May 3, 2019 - Researchers develop multimodal system for personalized post-stroke rehabilitation
May 3, 2019 - Study shows significant mortality benefit with CABG over percutaneous coronary intervention
May 3, 2019 - Will gene-editing of human embryos ever be justifiable?
May 3, 2019 - FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
May 3, 2019 - Why Tonsillitis Keeps Coming Back
May 3, 2019 - Fighting the opioid epidemic with data
May 3, 2019 - Maggot sausages may soon be a reality
May 3, 2019 - Deletion of ATDC gene prevents development of pancreatic cancer in mice
May 2, 2019 - Targeted Therapy Promising for Rare Hematologic Cancer
May 2, 2019 - Alzheimer’s disease is a ‘double-prion disorder,’ study shows
May 2, 2019 - Reservoir bugs: How one bacterial menace makes its home in the human stomach
May 2, 2019 - Clinical, Admin Staff From Cardiology Get Sneak Peek at Epic
May 2, 2019 - Depression increases hospital use and mortality in children
May 2, 2019 - Vicon and NOC support CURE International to create first gait lab in Ethiopia
May 2, 2019 - Researchers use 3D printer to make paper organs
May 2, 2019 - Viral infection in utero associated with behavioral abnormalities in offspring
May 2, 2019 - U.S. Teen Opioid Deaths Soaring
May 2, 2019 - Opioid distribution data should be public
May 2, 2019 - In the Spotlight: “I’m learning every single day”
May 2, 2019 - 2019 Schaefer Scholars Announced
May 2, 2019 - Podcast: KHN’s ‘What The Health?’ Bye-Bye, ACA, And Hello ‘Medicare-For-All’?
May 2, 2019 - Study describes new viral molecular evasion mechanism used by cytomegalovirus
May 2, 2019 - SLU study suggests a more equitable way for Medicare reimbursement
May 2, 2019 - Scientists discover first gene involved in lower urinary tract obstruction
May 2, 2019 - Researchers identify 34 genes associated with increased risk of ovarian cancer
May 2, 2019 - Many low-income infants receive formula in the first few days of life, finds study
May 2, 2019 - Global study finds high success rate for hip and knee replacements
May 2, 2019 - Taking depression seriously: What is it?
May 2, 2019 - With Head Injuries Mounting, Will Cities Put Their Feet Down On E-Scooters?
May 2, 2019 - Scientists develop small fluorophores for tracking metabolites in living cells
May 2, 2019 - Study casts new light into how mothers’ and babies’ genes influence birth weight
May 2, 2019 - Researchers uncover new brain mechanisms regulating body weight
May 2, 2019 - Organ-on-chip systems offered to Asia-Pacific regions by Sydney’s AXT
May 2, 2019 - Adoption of new rules drops readmission penalties against safety net hospitals
May 2, 2019 - Kids and teens who consume zero-calorie sweetened beverages do not save calories
May 2, 2019 - Improved procedure for cancer-related erectile dysfunction
May 2, 2019 - Hormone may improve social behavior in autism
May 2, 2019 - Alzheimer’s disease may be caused by infectious proteins called prions
May 2, 2019 - Even Doctors Can’t Navigate Our ‘Broken Health Care System’
May 2, 2019 - Study looks at the impact on criminal persistence of head injuries
May 2, 2019 - Honey ‘as high in sugars as table sugar’
May 2, 2019 - Innovations to U.S. food system could help consumers in choosing healthy foods
May 2, 2019 - FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
May 2, 2019 - Women underreport prevalence and intensity of their own snoring
May 2, 2019 - Concussion summit focuses on science behind brain injury
May 2, 2019 - Booker’s Argument For Environmental Justice Stays Within The Lines
May 2, 2019 - Cornell research explains increased metastatic cancer risk in diabetics
May 2, 2019 - Mount Sinai study provides fresh insights into cellular pathways that cause cancer
May 2, 2019 - Researchers to study link between prenatal pesticide exposures and childhood ADHD
May 2, 2019 - CoGEN Congress 2019: Speakers’ overviews
May 2, 2019 - A new strategy for managing diabetic macular edema in people with good vision
May 2, 2019 - Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance
May 2, 2019 - Screen time associated with behavioral problems in preschoolers
May 2, 2019 - Hormone reduces social impairment in kids with autism | News Center
May 2, 2019 - Researchers synthesize peroxidase-mimicking nanozyme with low cost and superior catalytic activity
May 2, 2019 - Study results of a potential drug to treat Type 2 diabetes in children announced
May 2, 2019 - Multigene test helps doctors to make effective treatment decisions for breast cancer patients
May 2, 2019 - UNC School of Medicine initiative providing unique care to dementia patients
May 2, 2019 - Nestlé Health Science and VHP join forces to launch innovative COPES program for cancer patients
May 2, 2019 - Study examines how our brain generates consciousness and loses it during anesthesia
May 2, 2019 - Transition Support Program May Aid Young Adults With Type 1 Diabetes
May 2, 2019 - Study shows how neutrophils exacerbate atherosclerosis by inducing smooth muscle-cell death
May 2, 2019 - Research reveals complexity of how we make decisions
Some clinical trials may promote use of ineffective and costly treatments, researchers say

Some clinical trials may promote use of ineffective and costly treatments, researchers say

A new paper published by McGill University researchers in JAMA Internal Medicine suggests that some clinical trials may promote the use of ineffective and costly treatments. That’s the opposite of what clinical trials are aimed at, namely preventing ineffective and costly treatments from being taken up by physicians and patients.

The researchers focused their attention on the blockbuster pain drug pregabalin (Lyrica). One of the world’s bestselling drugs, pregabalin is widely used for conditions that are not approved by Health Canada or the FDA (“off-label”). Relying on the published record of trials, they reconstructed the timeline of pregabalin drug development to understand what evidence was available to clinicians and clinical guideline creators when they were making treatment decisions and recommendations, and how testing was coordinated. Their underlying finding was that after pregabalin received its first approval, research was often better at creating the perception that pregabalin might work against other diseases than it was at proving it. For example, they found that despite nearly a decade passing since the publication of a small study suggesting that pregabalin might work to treat patients with low back pain, no large, rigorous follow-up trials have been published to date.

McGill Professor Jonathan Kimmelman, Director of the Biomedical Ethics Unit in the Faculty of Medicine, and the study’s senior author, first came up with the idea for the study after watching the documentary film “The Merchants of Doubt.” The film showed how the tobacco, chemical, and oil industries have manipulated science to sow doubt among regulators and the public about the relationship between their products and public health. Prof. Kimmelman wondered whether there might be an analogous process going on in medicine. Instead of sowing doubt, he thought pharmaceutical companies might want to create the perception that their drugs might be useful for conditions other than those for which they are approved. The researchers found something more complex at work, however, with many of the studies in their sample being publicly funded and others not reporting any industry funding at all. “We were surprised to find that the problems we document are partly driven by researchers who are receiving funding from federal research agencies and/or their own medical centers,” notes Carole Federico, a PhD student under Prof. Kimmelman’s supervision and the study’s lead author.

“Drug development is like a relay race, where the first runner is trying to show a drug might possibly work, and the second runner is proving that a drug really does work,” explains Prof. Kimmelman. “This relay race works really well before a drug is approved, because drug regulators like Health Canada and the FDA prevent companies from marketing their drug until they have run the whole race. Once a drug is already approved, however, the second runner in the relay race, the one whose job it is to prove that drug works in another disease, often drops the baton. Physicians are free to use the drug for conditions other than what it is approved for and there are no obligations for companies to prove a drug works in other diseases. That means that research testing already approved drugs for new diseases often encourages the use of treatments that may not be effective.”

Federico is quick to add that, “there is nothing inherently wrong with off-label use of drugs. In fact, many drugs that are given off-label are supported by strong evidence. However, when drugs are prescribed off-label based on weak evidence, patients might be harmed because they are taking drugs that are ineffective for their condition. Likewise, healthcare systems are harmed if they are reimbursing for the costs of such ineffective treatments.”

“We want to underscore that probably most, if not all researchers would argue that all of the individual trials in our sample were both reasonable and ethical,” says Prof. Kimmelman. “Our point is not to condemn these individual trials. Instead, we are saying that–when you zoom out and look at what’s happening at the level of the forest–the trees begin to look less healthy.”

Tagged with:

About author

Related Articles