Tuesday, May 28, 2013

New FDA Inspection Plans & Other Notable Headlines

I was tempted to name this post “Six Really Cool Health Science Headlines You May Have Missed” but I wanted to give my “new post announcement” email a fighting chance to get through our subscribers’ spam filters.

I’ve been exploring Twitter lately, learning about the opportunities it presents and about the conventions and etiquette of the micro-blogging community. My last blog post blew the dust off of a 7-year old TED talk about big data. This post is rooted firmly in the present, because, as I have found, nothing on Twitter is very old…except for some of us tweeters. To build a context for the Twitter topics I’m following, I’ve been clicking a lot of links, reading articles, blog posts, newsletters, and white papers about the advances of this amazing industry as they happen. Many of these advancements do not directly relate to the work we do at Polaris, but rather than read about them, marvel, and move on, I thought I’d share them with our readers in case, as I say, you missed them.

FDA Plans to Use Big Data to Help Identify Highest Risk Manufacturers
I like the symmetry here. PatientsLikeMe, GNS Healthcare, and others are using big data to predict what treatments would have the most benefit for a given patient. Now, big data may soon be used by FDA to determine the best way to ensure the safety of those treatments. FDA has issued an RFI (Request For Information), and is looking for a vendor to supply an off-the-shelf, risk-analysis system to identify high-risk manufacturers. The system would analyze inspection and REMS (Risk Evaluation and Mitigation Strategies) reports, bioequivalence data, pre and post approvals, and other sources to help decide who should be “next on the inspection list.” To read more: http://bit.ly/ZggT6R.

.PHARMACY Domain To Weed Out Non-compliant Online Pharmacies
Here’s another headline related to patient safety and drug efficacy. The National Association of Boards of Pharmacy (NABP) found that 97% of the 10,000 online pharmacies they analyzed were out of compliance with US pharmacy laws and practice standards. They have applied for a new domain name, .PHARMACY, which would be available only to legally operating online pharmacies. To read more:

Edible Electronic Medical Devices Could Be Swallowed Like Regular Pills
This is a fun one. You may recall that in August of 2012, FDA granted approval to Proteus Digital for its edible sensor, the Ingestion Event Marker. Developed to ensure that medication is taken correctly and on time, the sensor is encased in a pill. Before it is digested, the sensor relays information to a skin patch, which sends it to a mobile app, to create an ingestion data log. Now, less than a year later, Carnegie Mellon researchers have developed a non-toxic edible battery that could be used to power biodegradable electronics. The result could be tiny electronic medical devices that, when swallowed, would provide non-invasive treatments, like drug delivery or tissue-stimulation. To read more: http://bit.ly/10IB1iH.

Protocol Development via CrowdsourcingTransparency Life Sciences (TLS) is designing clinical protocols using input provided by a diverse set of doctors, researchers, patients, and caregivers. Protocol Builder, a technology TLS developed for crowdsourcing its study designs, encourages open dialog among communities of interest and collects participant input. Believe it or not, you can view the crowdsourced protocol they are developing to study Lisinopril, an adjunct treatment for multiple sclerosis, at http://bit.ly/10JDqfY. They’re not kidding about the “transparency”thing.

GlaxoSmithKline Opens its Patient-level Clinical Data to Other Researchers
In keeping with the theme of transparency and collaboration, the homepage of GSK’s new data sharing platform reads, “Access to the underlying (patient level) data that are collected in clinical trials provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding. Researchers can use this site to request access to anonymized patient level data from our clinical studies to conduct further research.”

Currently, the site includes all GSK global studies since 2007, with plans to include all the studies conducted since the company’s formation in 2000. You’re even free to view studies included on the site before creating an account at http://bit.ly/16FVsor.

Open Government Data Exposes Hospital Billing and Healthcare Costs
I’ll bookend this blog post with another story about big data. On May 8, Alexander Howard wrote on E Pluribus Unum, “
The Department of Health and Human Services (HHS) has released open data that compares the billing for the 100 most common treatments and procedures performed at more than 3000 hospital in the U.S. The Medicare provider charge data shows significant variation within communities and across the country for the same procedures. One hospital charged $8000, another $38,000 –for the same condition. This data is enabling newspapers like the Washington Post to show people the actual costs of health care and create interactive features that enable people to search for individual hospitals and see how they compare… According to Steven Brill, this end to hospital bill secrecy was prompted, at least in part, by his mammoth special report on healthcare pricing practices in the March 4 issue of TIME Magazine. If so, it’s one of the most important outcomes of a single feature of investigative journalism in this new century.” According to Brian Cook, an HHS public affairs director, the data release did, in fact, come in part as a response to Brill’s article. Now that’s noteworthy.

Thanks to my new Twitter community members for calling these stories to my attention, especially: @RebarInter , @Ivsin,@GCPWorks, @trialsonline, @eClincial_Jen, @Clin_Trials, @Medidata, @KGKSynergize, @Clinical_Tech, @AnnexClinical, @eclinical, @LaurieAHalloran, @Altus_Research, and @DrugSafetyNavig. You can follow them, too!

By Laurie Meehan

This blog discusses trends and issues in the pharmaceutical, medical device, and dietary supplement industries. Click the SIGN UP link to subscribe to notifications of new blog posts, or follow us on Twitter @ConsultPolaris.

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