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In an extraordinary move, the International Committee of Medical Journal Editors last week issued a proposal　to require researchers to share their clinical trial data as a condition for publication. And the researchers would also have to submit plans for how their data can be shared. The journal editors, who represent such periodicals as The New England Journal of Medicine and the Annals of Internal Medicine, believe data sharing "will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society." The move comes after protracted tussling over access due to safety scandals that revealed trial data for some products was never fully published or disclosed. We spoke with Harlan Krumholz, who runs the Yale Open Data Access project and works with companies to publish trial data, about the implications.

• Why does this matter?
• So how big a step is it for these journal editors to issue such a statement?
• Why do you think it took this long to take this step?
• Of course, a researcher may not follow through and share data even after submitting a plan, which raises a question about enforcing the requirement.
• What do you make, though, of the editors at The New England Journal of Medicine? In a recent editorial, they expressed reservations and set off a ruckus by saying that some researchers worry about　‘research parasites.’
• How much push back do you anticipate from industry?

Two Indian states have put sales of...Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat...Avastin (bevacizumab) is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the U.S. Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss...Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation...H.G. Koshia, the top drug controller in western Gujarat state, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad city...The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.

Patients may be more likely to retain information about their prescribed medications when the pharmacist-patient relationship becomes a 2-way conversation... A recent study published in the Journal of the American Pharmacists Association suggests that more interactive conversations between the pharmacist and patient can more than double the likelihood that the patient will understand how to take their medications properly....“The benefit of the interactive counseling technique is the fact that the patient can let the pharmacist know upfront what they know about their medications. The pharmacist can then fill in the knowledge gaps...The increased health literacy resulting from these more substantive conversations is strongly associated with greater medication adherence, which is widely considered one of the most crucial components of the value-based care model and optimized patient outcomes...This is the first real analysis to prove that [the interactive approach] works, and that the approach could be extremely important for health care in America...

Docket Alarm’s new suite of tools has components that help give Orange Book litigators a competitive edge…the first legal research platform to provide Orange Book litigators a suite of tools for their practice. The features include the ability to track changes to the Orange Book and related litigation, search correspondence between drug companies and the FDA, and analytics on Orange Book cases in the Patent Trial and Appeal Board…The "Orange Book,"…is the authoritative resource on FDA approved drugs for patent litigators. When a drug company wins FDA approval for a new drug, they submit an Orange Book listing detailing applicable patents covering the new drug and the drug’s labeling. Generic drug manufacturers engage in patent litigation with the branded company over whether the patents listed in the Orange Book are valid and properly cover the corresponding drug.

Next week, Drug Channels Institute will release our updated, revised, and expanded 2016 Economic Report on Retail, Mail, and Specialty Pharmacies...provides a sneak peek at the largest pharmacies, ranked by total U.S. prescription dispensing revenues for calendar year 2015…We estimate that total revenues of retail, mail, and specialty pharmacies reached $364.1 billion in 2015, up 12.1% from 2014. The top tier of dispensing pharmacies—CVS Health, Walgreens Boots Alliance, Express Scripts, Walmart, Rite Aid, and UnitedHealth Group’s OptumRx—accounted for about 64% of U.S. prescription dispensing revenues in 2015...many of the largest pharmacies are now central-fill, mail and specialty pharmacies operated by such PBMs and payers as Express Scripts, Caremark, and UnitedHealth. This reflects the growing role of specialty drugs in the pharmacy industry. We estimate that specialty drugs account for 35% or more of revenues at these pharmacies.

A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated...The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week...In total, 90 people took part in the trial of the drug made by Portuguese pharmaceutical company Bial, which is intended to treat mood and anxiety issues, as well as movement coordination disorders linked to neurological issues...It was not yet known what caused the tragedy, said Francois Peaucelle, the head of Biotrial, the company that conducted the trials for Bial.

The first issue of Elsevier's new open access journal Contemporary Clinical Trials Communications features a new method to make cancer clinical trials more effective, a better way of determining whether a trial was successful and a dashboard that helps patients enroll in trials... Contemporary Clinical Trials Communications publishes methodology and statistics that answer these questions, helping researchers build on each other's work and design better trials...I trust that the readers will find the journal a valuable source of recent advancements in clinical trials...this knowledge can facilitate the design, conduct and analysis of their trials...The journal also aims to tackle the problem of publication bias towards positive results by making all trial data open access...A major objective of the journal is to reduce publication bias, which is a major issue in the field of clinical trials...provides a platform for trialists around the world to share their knowledge on all aspects of clinical trials. We're making scientifically valid and technically sound original research findings freely accessible regardless of their perceived importance or impact.

Naturally occurring clay from British Columbia, Canada - long used by the region's Heiltsuk First Nation for its healing potential - exhibits potent antibacterial activity against multidrug-resistant pathogens, according to new research from the University of British Columbia...The researchers recommend the rare mineral clay be studied as a clinical treatment for serious infections caused by ESKAPE strains of bacteria (Enterococcus faecium, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species) - cause the majority of U.S. hospital infections and effectively 'escape' the effects of antibacterial drugs...Infections caused by ESKAPE bacteria are essentially untreatable and contribute to increasing mortality in hospitals...After 50 years of over-using and misusing antibiotics, ancient medicinals and other natural mineral-based agents may provide new weapons in the battle against multidrug-resistant pathogens..

One person has been left brain dead and five others have been hospitalized after taking part in a clinical trial in France of an experimental drug made by Portuguese drug company Bial, French Health Minister Marisol Touraine said...90 people have taken part in the trial, taking some dosage of the drug aimed at tackling mood and anxiety issues, as well as movement coordination disorders linked to neurological issues...The six men aged 28 to 49 had been in good health until taking the oral medication at the Biotrial private facility that specializes in clinical trials..."This is unprecedented"..."We'll do everything to understand what happened."...The brain-dead volunteer was admitted to hospital on Monday...For three of the five others...there are fears of irreversible handicap...One of the six had no symptoms but was being carefully monitored...The medicine involved is a so-called FAAH inhibitor that works by targeting the body's endocannabinoid system, which is also responsible for the human response to cannabis...Bial said in a statement it was committed to ensuring the wellbeing of test participants and was working with authorities to discover the cause of the injuries, adding that the clinical trial have been approved by French regulators.

IBM's cognitive computing system, Watson, has graduated from winning "Jeopardy" to predicting hypoglycemic events for diabetes patients and providing the brains for a customer service robot…IBM CEO Ginni Rometty discussed three partnerships involving IBM's Watson during her keynote speech at CES 2016 (Consumer Electronics Show ) on Wednesday in Las Vegas…Rometty talked about how Medtronic, Under Armour and SoftBank Robotics are using Watson's big data analytics capabilities in vastly different ways.

• Medtronic…is using Watson technology for diabetes management. In a new app rolling out this summer, medical technology firm Medtronic will track a diabetes patient's blood-sugar levels and predict life-threatening hypoglycemic events up to three hours in advance of symptoms.
• Under Armour…hooked up to IBM's Watson because he wanted his customers to get more meaningful data-backed health and fitness insights…The company's UA Record app will provide athletes with timely, evidence-based coaching around their sleep, fitness, activity and nutrition, including outcomes achieved based on others "like you."
• Watson also is providing artificial intelligence for a social humanoid robot called Pepper from SoftBank Robotics. Pepper currently is being used as a customer service robot in a limited number of Mizuho Financial Group's bank branches and Nestle coffee shops in Japan.
• Pathway Genomics unveiled a test version of the Pathway Genomics OME app, powered by Watson. The app merges cognitive computing and deep learning with precision medicine and genetics to enable Pathway Genomics to provide consumers with personalized wellness information...