- Chinese courts call for death penalty for researchers who commit fraud (statnews.com)
An eye for an eye, a tooth for a tooth — a life for a lab book?...In the past few months, China has announced two new crackdowns on research misconduct — one of which could lead to executions for scientists who doctor their data...Scientists have been sounding alarms for years about the integrity of research in China. One recent survey estimated that 40 percent of biomedical papers by Chinese scholars were tainted by misconduct. Funding bodies there have in the past announced efforts to crack down on fraud, including clawing back money from scientists who cheat on their grants...Chinese...Ministry of Science and Technology proclaimed a "no tolerance" policy for research misconduct — although it’s not clear what that might look like...the mass retractions "seriously harmed the international reputation of our country’s scientific research and the dignity of Chinese scientists at large."...courts approved a new policy calling for stiff prison sentences for researchers who fabricate data in studies that lead to drug approvals. If the misconduct ends up harming people, then the punishment on the table even includes the death penalty...
- Drugs approved with limited data aren’t always well-tested later (reuters.com)
New medicines that win U.S. marketing approval without conclusive evidence of their effectiveness aren't always proven to work after they go on sale, a recent research review suggests...Researchers focused on medicines approved for sale based on single pivotal trials or based on what's known as "surrogate markers," such as lab tests and signs of risk for disease such as cholesterol levels instead of true clinical outcomes like heart attacks or deaths. Many times no follow-up studies were published after these medicines went on sale, and when studies were published they often continued to rely on surrogate markers to suggest potential effectiveness...speeding up the approval process increases our collective uncertainty about drugs' benefits and safety...This exposes patients to risks - the risk that they are spending their resources on therapies that do not work as well as expected as well as the possibility that they are taking drugs that have underlying safety risks that have not yet been figured out… researchers examined published studies of 117 medicines approved for treating 123 medical conditions by the U.S. Food and Drug Administration...based on either a single pivotal trial or on trials that relied on surrogate endpoints...no follow-up studies were published for 43 of the 123 approved indications, or 35 percent...
- 20,000 leagues for biotech to explore (biopharmadive.com)
The sea covers around 70% of the earth, and contains around 97% of the world's water. It's also home to almost 240,000 species...as a resource, it is still untapped...Bioprospecting is the discovery and development of new products based on resources from the natural world...We are not marine organisms, so until about 1970, no one even thought of the ocean. It was left as a deep secret. It seemed ridiculous to me that the ocean — with such a vast habitat — had escaped anyone's notice. But there are good reasons. People fear the ocean; it has been considered a very hostile, inhospitable place...the history of drugs from the sea isn't particularly long. Red algae have traditionally been used to make a treatment for colds, sore throats, chest infections including tuberculosis, kidney trouble, burns, cancer and indigestion...There are plenty of high-profile drugs that have gotten their origins from the sea…There are more than 25 marine-derived molecules in clinical trials, with over a thousand in pre-clinical development...There are still many societal challenges that the marine environment could help us to meet, such as antibiotic resistance...It is a source of chemical diversity, with novel targets and novel modes of action...
A snapshot of late stage development:
- PharmaMar...Plitidepsin and lurbinectedin, both derived from sea squirts... T-cell lymphoma...
- BeyondSpring...linabulin...is based on a marine fungus…non-small cell lung cancer...
- Ohr Pharmaceutical...Squalamine...found in dogfish shark tissues...a wide variety of indications…antimicrobial against bacteria, fungi, protozoa and viruses, as well as in cancer, macular degeneration, diabetic retinopathy and fibrodysplasia ossificans progressive...
- Wex Pharmaceuticals...puffer fish...neurotoxin tetrodotoxin...a non-addictive and rapid-acting pain killer without opioid-like side effects....
- DNA computer brings ‘intelligent drugs’ a step closer (worldpharmanews.com)
Researchers at Eindhoven University of Technology present a new method that should enable controlled drug delivery into the bloodstream using DNA computers. In the journal Nature Communications the team...describes how it has developed the first DNA computer capable of detecting several antibodies in the blood and performing subsequent calculations based on this input. This is an important step towards the development of smart, 'intelligent' drugs that may allow better control of the medication for rheumatism and Crohn's disease, for example, with fewer side-effects and at lower cost...An analogy for the method presented…is a security system that opens the door depending on the person standing in front of it. If the camera recognizes the person, the door unlocks, but if the person is unknown, the door remains locked. "Research into diagnostic tests tends to focus on the 'recognition', but what is special about this system is that it can think and that it can be connected to actuation such as drug delivery...
- Researchers aim to repurpose former experimental cancer therapy to treat muscular dystrophy (unr.edu)
Researchers at the National Institutes of Health's National Center for Advancing Translational Sciences and the University of Nevada, Reno School of Medicine have demonstrated that a drug originally targeted unsuccessfully to treat cancer may have new life as a potential treatment for Duchenne muscular dystrophy...The candidate drug, SU9516, represents a different kind of approach for treating DMD, a degenerative muscle disease that usually begins in childhood and has no known cure...NCATS Chemical Genomics Center Acting Branch Chief Juan Marugan, Ph.D., and UNR Med Professor of Pharmacology Dean Burkin, Ph.D., led a team that screened more than 350,000 compounds to find SU9516, which had been previously developed as a treatment for leukemia. The research demonstrated that this compound improved muscle function in both laboratory and animal DMD models. The results, published recently in Molecular Therapy, may provide a promising approach against the disorder and other muscle-wasting conditions...Our findings open the door to develop new drug treatments for DMD...
- Limits on doctor-drug rep interactions tied to prescribing changes (reuters.com)
Policies that limit or regulate interactions between doctors and pharmaceutical company representatives may affect what drugs are prescribed to patients, according to a new study...Drugs promoted by pharmaceutical representatives - known as detailed drugs - lost market share after hospitals enacted such policies, while drugs that weren't detailed gained market share...the findings suggest institutions and organizations can play a role in relationships between doctors and the drug industry..."Detailing" visits from drug representatives are one way to educate doctors about new drugs and treatments they would need to learn of elsewhere...those visits are linked to increased use of brand name and costly drugs even when less expensive generic treatments are available...The million dollar question is whether drug detailing and restrictions on detailing are affecting patient outcomes...
- Obamacare plans’ drug spending rose faster than other plans in 2016: Express Scripts (in.reuters.com)
Spending on prescription drugs for health plans created under the Affordable Care Act increased last year at a rate more than three times that of other commercial plans and most government-run plans managed by Express Scripts Holding Co...year-over-year spending per person for individual insurance plans sold on the Obamacare exchanges where it manages the pharmacy benefit rose 14 percent in 2016, driven by higher drug prices and utilization...Express Scripts said per-capita spending for other commercial plans it manages, mostly for employers, rose just 3.8 percent last year, despite an 11 percent increase in list prices for brand-name drugs...Drug spending for plans the company manages under Medicare...increased 4.1 percent last year while the rise for Medicaid...was 5.5 percent.
- Cancer drug prices are so high that doctors will test cutting doses (washingtonpost.com)
A group of prominent cancer doctors is planning a novel assault on high drug costs, using clinical trials to show that many oncology medications could be taken at lower doses or for shorter periods without hurting their effectiveness...they point to their pilot study involving a widely prescribed drug for advanced prostate cancer. Cutting the standard dose of Zytiga by three-quarters was as effective as taking the full amount…Szmulewitz (University of Chicago oncologist) and others now want to run full trials to see whether the doses of other oral oncology drugs can be ratcheted back because of the “food effect,” which can alter how a medication is absorbed. They also plan to explore whether the duration of some prescriptions can be shortened and whether some cheaper non-cancer drugs can be substituted for expensive cancer ones. They recently created a nonprofit organization, the Value in Cancer Care consortium, to organize their work...
- Illuminating drug discovery by mapping all known drugs (pharmaceutical-technology.com)
A comprehensive map of all existing drugs and how they work, created from information from several huge datasets, could be used to kick-start the next wave of drug discovery. Not only could scientists use the map to suggest promising new targets for diseases as diverse as cancer, mental illness and inflammatory conditions, it could also provide invaluable insight into where existing drugs can be used to treat different diseases...Jointly led by scientists at the Institute of Cancer Research...the research brought together vast amounts of information from datasets including the canSAR database...the ChEMBL database...the...DrugCentral database to create a map of all 1,578 licensed drugs and their mechanisms of action...Dr Bissan Al-Lazikani, explains how this first-of-its-kind map could help tackle one of the biggest challenges facing the drug discovery field: how do you innovate without taking risks that make the whole system unviable?
- Why did you decide that a comprehensive map of all existing drugs and their mechanisms of action was needed for the drug discovery community?
- How did you put the map together? It must have been quite a task!
- What were the most interesting findings of the latest study?
- What are the biggest challenges facing the drug discovery field at present and how will your comprehensive map help overcome these?
- Deadly, Drug-Resistant ‘Superbugs’ Pose Huge Threat, W.H.O. Says (nytimes.com)
The World Health Organization warned on Monday that a dozen antibiotic-resistant “superbugs” pose an enormous threat to human health, and urged hospital infection-control experts and pharmaceutical researchers to focus on fighting the most dangerous pathogens first...Many consider the new strains just as dangerous as emerging viruses like Zika or Ebola...the...European Center for Disease Prevention and Control estimated that superbugs kill 25,000 Europeans each year; the C.D.C. has estimated that they kill at least 23,000 Americans a year...New antibiotic candidates are in short supply...because 70 years of research have made it harder to find new ones, and because they are not very profitable for pharmaceutical companies...In the United States, although constant vigilance is crucial, the problem has actually declined in the last decade...