- Science Takes a Fresh Swat at Zika (bloomberg.com)
Among the trial methods: genetic engineering, radiation, larvicide...Until there’s a vaccine or treatment for the Zika virus, the quickest way to control its spread is to attack the mosquitoes that carry it. Biotech companies and governments are wielding their best weapons, all of which involve breeding the bloodsuckers in labs and applying treatments that render them unable to reproduce or spread viruses, then releasing them into the wild...In Brazil, Oxitec says it expects approval within weeks to sell the government a bioengineered mosquito incapable of having offspring...The United Nations International Atomic Energy Agency has offered to show Brazilian authorities how to sterilize male mosquitoes with radiation...Australian scientists say they might be able to block transmission of Zika by infecting mosquitoes with a naturally occurring bacterium. And MosquitoMate...is experimenting with a way to dust the bugs with a hormone-based larvicide...These strategies mark a sharp departure from the old pesticide-centric method of "spray-’n’-pray." So far, "we don’t really have any method that’s working,"...
- Drug development crisis linked to bad technology choices, experts argue (worldpharmanews.com)When Quality Beats Quantity: Decision Theory, Drug Discovery, and the Reproducibility Crisis (journals.plos.org)
The search for new medicines is becoming unsustainably expensive despite huge technological advances because researchers are using the wrong methods, experts say. They say drug discovery should focus on 'validity' - how well the results of experiments predict results in sick people. Instead, it has focused on methods that are easy to industrialize or methods that are academically fashionable...Jack Scannell...and...Jim Bosley approach drug discovery using mathematical tools that are used by economists to study decision making. They show that the chance of discovering an effective drug is surprisingly sensitive to the validity of the experimental methods. Small changes in validity can have a bigger effect than running 10 or even 100 times more experiments...There is a nasty puzzle at the heart of modern biomedical research. On one hand, the technologies that people think are important have become hundreds, thousands, or even billions of times cheaper. On the other hand, it costs nearly 100 times more to bring a drug to market today than it did in 1950. New drugs can be very expensive, yet the industry is closing labs and firing scientists. Our work goes some way towards explaining the puzzle. Governments, companies, and charities should focus on identifying and funding predictive methods, even if they don't match current scientific fashion...
- SafeMed: Using pharmacy technicians in a novel role as community health workers to improve transitions of care (japha.org)
...the SafeMed program, which uses certified pharmacy technicians in a novel expanded role as community health workers (CPhT-CHWs) to improve transitions of care...The SafeMed experience demonstrates that...CPhT-CHWs are well suited for novel expanded roles to improve care transitions...can play a key role in care transition programs targeting superutilizing patients with complex medical and social needs. As CMS intensifies readmission penalties and providers bearing financial risk seek to reduce overall health care costs, low-cost CPhT-CHWs serving as pharmacist extenders may become an increasingly attractive component for health systems...CPhT-CHWs can assist with identification and reporting of potential DTPs identified during home visits and telephone follow-up and can coordinate with pharmacists in real time to enable patients to get targeted MTM when and where they need it. They can also assist pharmacists in scheduling outpatient CMRs and support sessions for the patients...In collaboration with state pharmacy boards, pharmacist associations, and regional community colleges, the SafeMed model can be successfully scaled to serve superutilizing patients in readmission hotspots throughout the country.
- Key to predictive analytics in population health: planning and flexibility (healthcareitnews.com)
Curation and quality are essential, because if the data isn’t right it can wreak more harm than good…While the development of accurate predictive analytics has the potential to head off debilitating and costly conditions among patients...it’s important not to rush in without the proper planning...The first thing to understand is you need to have the right technical infrastructure components in place and it has to address what you are looking to do with it...Is the data you have good enough to even do predictive analytics? Because if it isn't, that prediction may actually harm you more than it helps...other factors, including the presence or absence of skilled data scientists; a thorough understanding of how to localize predictive models from other health systems; and how to best integrate existing investments in electronic health records with analytics technology, must be carefully considered...even a platform that offers great analytics capabilities...may not be popular with either clinicians or financial executives if the caregivers need to toggle back and forth between an EHR and an analytics platform...If I'm looking at a patient in front of me right now, I don't have time to go somewhere else, and when I've gone somewhere else I've already lost the advantage of this massive investment in my EHR...So it has to be part of your system's ecosystem...
- One-Third of Clinical Trial Results Never Disclosed, Study Finds (bloomberg.com)
One-third of clinical trials conducted at 51 major U.S. universities and academic hospitals were never published in a peer-reviewed journal or in a government registry online, according to a new study...The researchers looked at 4,347 trials that were completed between October 2007 and September 2010. Of those, only 29 percent had results published within two years of finishing data collection, and 13 percent were posted on the government database ClinicalTrials.gov within the same period...about 67 percent of the studies disclosed their results by...2014...You’d like to think that academic institutions are role models for science...The truth is we’re not doing very well...University of Florida and Ohio State University joined Yale with some of the highest rates of publication in peer-reviewed journals...Boston University, Cornell and Oregon Health and Science University...had among the lowest rates...Pharmaceutical companies, the government and foundations invest a lot of money in clinical trials...If the results aren’t made public, that’s wasted money...Disclosure of results is critically important to advance science...Whether those results are positive or negative, and are important as a part of our agreements with funders as well as the participants in clinical trials...Beyond creating a data void that makes future research more difficult, unpublished results also may represent an ethical issue. Patients in clinical trials undergo experimental treatments with the understanding that doing so will advance medical knowledge, which can’t happen if the results aren’t published...
- 7 Drug Shortage Findings Health-System Pharmacists Should Know (pharmacytimes.com)
Health-system pharmacists can play a critical role in managing drug shortages to prevent medical errors and adverse events...[Pharmacists] can often prevent shortages from impacting their institution by proactively managing inventory...When a shortage situation impacts hospital inventory, pharmacists should inform providers early...Pharmacists can also develop protocols for emergency department staff on what to do if a drug is not available. These protocols should include information about the best alternative medication, dosing recommendations, proper administration of the drug, and contraindications...Pharmacists can also take the following steps:
- To prevent errors, place specific labeling on a medication if a different concentration than what is normally stocked is being used.
- Help develop protocols for the ethical distribution of medications on shortage.
- Minimize waste of medications while compounding.
- Assist emergency medical services providers and directors with out-of-hospital protocols during shortages.
- Monitor and report adverse outcomes and medication errors.
...researchers examined data from the University of Utah Drug Information Service...Here are 7 things pharmacists should know about these findings:
- Of the 1789 drug shortages, about one-third (610) were within the scope of emergency medicine practice.
- From January 2008 to March 2014, emergency medicine drug shortages rose by 435%, from 23 to 123.
- The reason behind shortages remains unknown for around half of the 1789 cases.
- Infectious disease medications were hit hardest.
- Around 40% of drug shortages affect emergency care, according to a report from the Health and Human Services’ Emergency Care Coordination Center.
- The median shortage time for emergency medicine drugs was 9 months.
- The most common reasons for a drug shortage were related to manufacturing delays or problems.
- The Startup Tracking ‘Valuable’ Doctors for Big Pharma (bloomberg.com)
Physicians are worth billions of dollars to drugmakers, who see the prescription pad as a path to profits. But it’s growing harder for Big Pharma to get doctors’ appointments. Since 2010, Obamacare has slowly curbed the mass travel junkets and fancy meals that drug companies once used to sway the doctors most valuable to their efforts to sell products...Pharmaceutical companies are now searching for ways to refine their marketing efforts, to target the doctors most compatible with the medications they’re pitching. "You’re desperate for data to make those key decisions,"..."But while there’s lots of data out there, it’s really challenging to bring it together."...Zephyr Health...promising to help drugmakers identify key medical personnel and find ways to approach them…Zephyr builds digital dossiers on individual doctors. It starts with basic information on prescription patterns from data clearinghouses...Then its software...scours the Web for more details...Zephyr generates profiles that score each doctor’s influence and ability to drive sales on a scale of 1 to 10. The software’s slick, mobile-friendly interface lets a drug company search in broad or specialized disciplines and ranks each person’s influence in the chosen field. It also specifies whether a doctor appears to influence colleagues or simply writes a lot of scripts..."There’s nothing private anymore,"...While doctors may not be exactly psyched about Zephyr tracking their every move...even they should appreciate the company’s ability to narrow marketing campaigns. For a physician, "working with Pharma is akin to getting pecked to death by a flock of ducks," he says. "Do you want nine salespeople queued up to call on you?"
- Engineers 3D Print Tissue That Mimics How The Human Liver Functions (forbes.com)
Engineers at the University of California...say they have successfully 3D printed life-like liver tissue that simulates how the human liver functions and is structured. The researchers say the tissue could be used as a platform for drug screening...In the case of Federal Drug Administration approval for a drug, on average it takes around 11 to 14 years and $2.6 billion to get a drug to market...Around 90% of drugs don’t pass animal tests or human clinical trials. In the case of the new 3D printed tissue, the researchers say pharmaceutical companies could use the tissue as platform in the lab to focus on drugs that appear to be more promising and eliminate drugs that have less efficacy...To create the liver tissue that mimics real human liver tissue, the engineers created a diverse combination of liver cells and supporting cells systematically organized in a hexagonal pattern under a microscope. But to print that complex tissue, they needed a 3D printer that could accommodate the 3D micro-structures found in biological tissue. The team created their own bioprinting tech in the lab capable of reproducing the elements and features of the tissue…I think that this will serve as a great drug screening tool for pharmaceutical companies and that our 3D bioprinting technology opens the door for patient-specific organ printing in the future. The liver tissue constructed by this novel 3D printing technology will also be extremely useful in reproducing in vitro disease models such as hepatitis, cirrhosis and cancer...
- UFC donates $1M to Ruvo center for brain trauma study — VIDEO (reviewjournal.com)
In the fight against brain disease, the UFC (Ultimate Fighting Championship) is putting its money on the Cleveland Clinic Lou Ruvo Center for Brain Health...The mixed martial arts organization...announced a $1 million donation over five years in support of the center's Professional Fighters Brain Health Study, which aims to understand the long-term effects of brain trauma...UFC Chief Operating Officer Ike Lawrence Epstein announced the donation....The goal of the study is not just to gather data on trauma but also to determine if brain damage can be detected early enough for intervention...CTE (chronic traumatic encephalopathy) is a degenerative brain disease found in people who have suffered repeated head trauma..."We're really pushing all of our athletes to make sure they come to this facility and get tested and be part of this study because that's the key to all of this," Epstein said.
- New CRISPR/Cas9 delivery method could offer a clinical pathway (fiercedrugdelivery.com)Therapeutic genome editing by combined viral and non-viral delivery of CRISPR system components in vivo (Abstract, sub req) (nature.com)
CRISPR/Cas9 gene editing is a rapidly developing technique that is thought to provide revolutionary new ways to manipulate genes for the treatment of a number of diseases. Delivering the CRISPR therapeutic in an efficient, safe and predictable way, though, has been difficult--to this end, researchers at UMass have created a means of administering the gene editor that could help send it to clinical trials...CRISPR/Cas9 is a natural immune system in bacteria used to protect them from foreign genetic material, and scientists have used its components to cut and repair DNA sequences to replace faulty, disease-causing portions with corrected versions...The difficulty comes about in getting the separate components to the genetic material in a target cell. Previous attempts at delivering the system through disruptive, high-powered injection has caused damage to the liver...The new delivery method involves a two-part process. The researchers loaded both the CRISPR guide RNA and the DNA template into a viral vector...A week after the first injection, the scientists deliver the Cas9 messenger RNA wrapped in lipid nanoparticles...Until now it's not been possible to deliver CRISPR/Cas9 in a way that was suitable for clinical trials. By using an RNA guide and DNA repair template delivered via viral vector followed by a Cas9 in a lipid nanoparticle, we've take a huge step forward to overcoming this hurdle.