- Participants in rogue herpes vaccine research take legal action (fiercepharma.com)
Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments...SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine...in 2016 and 2013 without safety oversight that is routinely performed by the FDA or an institutional review board...The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments…Rational Vaccines has said it considers the 2016 trial a success—though it is unclear what data it used to support that claim...SIU has...acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university.
- How Medicare Part B ‘Value-Based Pricing’ Would Work (realclearhealth.com)Obama proposal to revamp Medicare Part B faces more opposition (statnews.com)
...Centers for Medicare & Medicaid Services spends $20 billion a year for drugs under Part B, which are those given in doctors’ offices and hospital outpatient centers. Many cancer treatments are provided that way, as are some treatments for rheumatoid arthritis, macular degeneration...Under a proposed rule, different methods would be tried in selected geographic areas over a five-year test period. Some of these experiments would begin this year, with others added in 2017...Dubbed "value-based pricing," such largely unproven ideas are the latest tactics being tried to slow growth in prescription drug spending amid rising public alarm about drug prices...The goal is to test whether alternative approaches will lead to better value...There is no perfect payment system, they all have upsides and downsides...What we don’t want to do is create a world where doctors only prescribe the cheapest stuff even if not in the interest of the patient...Here are four concepts the government is investigating:
- Cut drug reimbursements for doctors and outpatient hospital centers.
- Level payments.
- Tie payments to effectiveness.
- Cut patients’ out-of-pocket costs.
- Lab-Grown Mini Organs Could Speed Up Drug Discovery (forbes.com)
The thought of lab-grown organs conjures up Frankenstein-like imagery. The reality however, is somewhat less visually dramatic, with the term ‘organoids’ used to describe tiny 3D structures of human tissue, a millimeter or so in diameter...these tiny lumps of cells are creating a lot of excitement in the world of medical research...Cells in dishes and animal models have been used for preclinical testing of drugs for decades. Success in these experiments is a key hurdle for any new medicine to overcome before being given the green light for all-important human clinical trials...Organoids are most commonly made either from a small sample of tissue needled out of a person or from stem cells cultured in a cocktail of nutrients intent on pushing them towards becoming a particular tissue type. So far, organoids have been made resembling several tissues including lung, liver, brain, kidney and intestine...as a relatively new innovation they are being used to investigate dozens of conditions from infectious diseases to cancer.... A study published last year in Science Translational Medicine by scientists at the University Medical Centre, Utrecht generated organoids formed from the rectal tissue of 71 people with cystic fibrosis and exposed them to experimental drugs. By observing changes in the organoids, the scientists accurately predicted which patients would respond to the therapies in just one week at a cost of around $1200 per patient. The results were so convincing that a positive organoid test is now considered sufficient evidence for insurance companies to fund the new therapies in the Netherlands...
- Most scientists believe there is a ‘crisis’ reproducing experiments (statnews.com)1,500 scientists lift the lid on reproducibility (nature.com)
Placing trust in science can be easier when findings are confirmed, but a new survey finds that most scientists believe there is a "crisis" in reproducibility...Specifically, 52 percent reported that replicating results is a "significant" problem and another 38 percent believe a "slight crisis" exists. More than 70 percent of researchers have tried and failed to reproduce another scientist’s experiments, according to Nature, which canvassed 1,576 researchers. And more than half of the respondents reported that they failed to reproduce their own experiments...Yet one-third believe that failing to reproduce results means that a study is probably just incorrect, and most of those asked say that they continue to trust published findings. Moreover, 73 percent think that at least half of the papers in their own fields can be believed...Merck executive recently suggested that drug makers should be entitled to get their money back for potential treatments licensed from universities if the company is unable to reproduce the results in subsequent experiments...the pharmaceutical industry has been under pressure to release trial results in order to verify claims about their medicines. The issue accelerated in the wake of several scandals about undisclosed side effects...