18 posts in the category “Drug Safety”

A PatientsLikeMe researcher’s take on the opioid crisis and new prescribing regulations

Posted January 25th, 2017 by

Meet Emily (EmilyMcNaughton), a PatientsLikeMe researcher with more than ten years of experience in both the private and public sector. She’s here to weigh in on the recent Boston Globe article addressing the aftermath of the opioid crisis. New prescribing regulations have some doctors hesitant to prescribe these drugs, but that could prove more harmful to the patients who rely on them for pain control.

Check out the Boston Globe article, and see what Emily has to say below.

 

A researcher’s perspective

Prescription opioid medications have been widely discussed over the past 15 years, especially with the surge of prescriptions dispensed during the 2000s, which created an epidemic of abuse and overdose-related deaths. Because the prescription-opioid landscape seems to be constantly changing, people all across the medical, public health, regulatory and pharmaceutical sectors have been working to find solutions that will still allow patients to access their prescribed pain medications while minimizing problems with abuse, misuse, death, and product diversion (when patients either share, give or sell their prescription medications, or medications are stolen).

Many would agree that it’s been helpful to increase awareness, education and open communication between doctors and patients about these medications, but some aspects of restricting the availability of prescription opioids might cause unintended harm to patients.  As this Boston Globe article highlights, many doctors are now prescribing fewer opioids than in previous years and in some cases doctors fear that these reductions may hurt patients.

With any public health problem, solutions are not always perfect and there are pros and cons to every decision. In terms of prescription opioid medication, here are some of my thoughts on public health recommendations, regulatory changes and how they might impact patients. 

Advantages

  • There’s more awareness around how to appropriately use prescription opioids, the potential risks they pose and the proper prescribing practices, both within the medical community as well as patients and the public.
  • We’re seeing recommendations for increased patient-doctor communication about goals for prescription opioid use as well as alternative treatments, when appropriate.

Potential Unintended Consequences

  • There’s a growing pressure among doctors who fear there may be consequences for prescribing opioid medications.
  • There’s a possibility that difficult regulatory hurdles might deter a physician’s willingness, or even ability, to prescribe opioid medications in appropriate situations.
  • Blanket regulations that set maximum prescribing limits do not take into account the individual needs of each patient or doctor expertise.
  • Patients might have insufficient access to or may be unable to afford alternative treatments or pain medicine specialists if a physician is reluctant to prescribe opioid medications.

Other Considerations

  • Regulatory changes don’t address the issue of opioid-deaths that are caused by abuse of non-pharmaceutical products, like heroin.
  • For individuals with opioid addiction, substance abuse treatment remains complicated and is not always affordable.

What do you think about this topic?

 

Share this post on Twitter and help spread the word.


Improving drug safety through the patient voice

Posted November 22nd, 2013 by

At PatientsLikeMe we’re interested in bringing the voice of our patients to the attention of those who make drug products and to the regulators that approve them. Since 2008 we have conducted a series of projects to collect safety information from some of our member communities. We’ve worked with our pharmaceutical partners to help them better understand the safety experiences of patients while they are using certain drug products.

I’d like to introduce you to a new acronym – P.R.O.S.P.E.R.  It stands for Patient-Reported Outcomes in Safety Event Reporting and it promotes the value of including patient experiences in monitoring the safety of drug products during clinical trials and after drugs are approved.

The PROSPER Consortium is co-led and supported by PatientsLikeMe and Pope Woodhead, a UK healthcare firm, with input from most global pharmaceutical companies, many clinical and academic groups, as well as regulators, researchers and patient advocates.

A report from the Consortium was recently published in the journal Drug Safety that provides guidance for using patient reported outcomes (PROs) for safety monitoring processes. These are just a few of the reports findings…

  • The patient perspective is an essential component of drug safety
  • Patient-centeredness and patient safety are emerging as core elements of any responsive health system
  • The potential clinical utility and value of real-world information obtained from real patients taking real drugs is great1

Although the U.S. Food and Drug Administration (FDA) has accepted safety reports from consumers for 20 years through its MedWatch program, other parts of the world only accept reports on adverse reactions to drugs from health professionals. While patient reporting has recently been encouraged there remain skeptics who doubt its value.

PatientsLikeMe is part of the PROSPER Consortium because we believe the patient voice – your voice – is essential to improving the safety of drugs and medical products. As we look ahead to 2014, we’ll be exploring opportunities to amplify your voice across all areas of health care to improve safety, starting with the FDA and the EU counterpart, the European Medicines Agency.

PatientsLikeMe member MollyCotter


1 http://link.springer.com/article/10.1007/s40264-013-0113-z/fulltext.html


Psoriasis, Adherence and More: An Interview with Dermatologist Dr. Steve Feldman

Posted January 18th, 2013 by

Dr. Steve Feldman, MD, PhD

Dr. Steve Feldman, MD, PhD, is Professor of Dermatology, Pathology & Public Health Sciences at the Wake Forest University School of Medicine. The author of more than 500 peer-reviewed medical articles, Dr. Feldman is well-known for his research studies focused on patients’ adherence to topical treatments as well as for founding www.DrScore.com, an online doctor rating and patient feedback website.

What does Dr. Feldman think about what we’re doing at PatientsLikeMe?  And what’s his take on the current challenges for psoriasis patients, as well as the treatment advances that may be ahead?  Find out that and much more in our interview.

1. As the founder of DrScore.com, tell us how rating doctors online can improve medical care.

Doctors want to give their patients great medical care.  Online ratings can help by giving doctors the feedback they need to know—from patients’ perspectives—such as what the doctor is doing well and what the doctor can do to enhance the quality of care in their practice.  www.DrScore.com was designed to help facilitate that feedback while also giving patients a better picture—more transparency—of the quality of care physicians provide, something that wasn’t nearly so easy to do in the pre-Internet era.

2. What do you think about PatientsLikeMe’s data-sharing platform and openness philosophy?

PatientsLikeMe does a truly wonderful job taking advantage of the capabilities of the Internet to permit data sharing among patients so they can learn from one another.  Another extraordinary accomplishment has been to develop ways to combine that data in order to better understand diseases and the benefits and risks of the treatments for those diseases.  Openness is a terrific attribute in this Internet age.  I am very optimistic about medicine and health care providers and think there’s nothing to hide (and if there were something to hide, it ought to be exposed)!

3. You’ve done extensive research around treatment adherence.  What are the considerations for patients?

Well, as the former Surgeon General put it, medicines don’t work if patients don’t take them.  Taking medicine isn’t easy, unless it is a habit.  And when a patient starts to use a new medicine, taking it isn’t a habit.  Patients forget their medicine, they may be fearful of their medicine, there are just all sorts of reasons why patients don’t always take their medications.  I think coming up with a plan, a system, for remembering is helpful. (I keep my own pills in a seven-day dispenser on the dinner table, which works great for me except when my family goes out to eat).

Dr. Feldman uses a seven-day pill dispenser box like this one to help with his own treatment adherence.  Image courtesy of Stock Free Images.

If patients are fearful, they should have an honest discussion with the doctor about it.  One thing is certain: patients should be honest with their doctors about how they use their medicines.  It does neither the patient nor the doctor any good for the patient to tell the doctor one thing but do something else.  If a doctor does prescribe a medicine that the patient thinks is too costly or too risky, the patient should let their doctor know.  The doctor wants to know and may be able to change things.

4.  We have a growing psoriasis community.  What challenges do psoriasis patients face?

Psoriasis has a huge impact on patients’ lives.  It affects how patients perceive themselves, how other people perceive the person who has psoriasis, and, in many cases, how someone with psoriasis thinks they are perceived by others.  The lesions aren’t just unsightly; they can be itchy and painful.  The condition is caused by an overactive immune system, which can also result in arthritis and increased risk of cardiovascular disease and depression.  There are good treatments, but the treatments have their downsides: they may be costly, inconvenient, messy, and risky.  One of the biggest challenges is getting educated about all the potential options.  It isn’t easy.

5. In our forum, patients have been discussing whether diet can affect psoriasis.  What’s your take?

Well, I don’t know of any particular dietary issues that have been definitively shown to affect psoriasis one way or the other (except perhaps that starvation temporarily improves the disease, probably by inhibiting the immune system).  But if a particular patient finds some particular dietary issue that makes their psoriasis worse (or better), they should eat accordingly.  Some patients tell me beer and/or wine makes their disease worse or that avoiding gluten has helped.  The PatientsLikeMe platform may be helpful in compiling the experiences of many people to see if these are issues for individuals or could truly help patients in general.

6. Any thoughts on what’s ahead in terms of psoriasis management and treatment advances?

As our understanding of the immune system improves, scientists at drug companies will be developing newer and perhaps better ways of controlling immune diseases, including psoriasis.  As our health care system changes to become more cost conscious, there may be greater reliance on low cost treatments, like generic creams and ointments for people with mild disease and more use of phototherapy for people with more severe involvement.  And with better data collection—like with PatientsLikeMe—we may develop a better understanding of what works, what doesn’t work, and what risks and benefits our treatments have.


A Day in the Life of Health Data and Patient Safety Clinical Specialist Christine Caligtan

Posted December 5th, 2012 by

What’s it like to work at PatientsLikeMe?  We are continuing to reveal just that with our monthly blog series “A Day in the Life,” which features PatientsLikeMe employees from different departments.  Today we’d like to introduce you to Christine Caligtan, RN, MSN, a registered nurse who has served as our Health Data and Patient Safety Clinical Specialist since May 2011.  Find out what that involves, why she made the switch to the health startup world and much more in our interview.

PatientsLikeMe Health Data and Patient Safety Clinical Specialist Christine Caligtan, RN, MSN

1.  What’s it like to be a registered nurse at a health startup?

I could not be happier as a registered nurse at PatientsLikeMe. It’s the best of both worlds: I get to interact with patients online, and I am satisfying the informatics side of my interests by working the patients’ data and fostering their ability to track and maintain their health with online tools.

When I started working as a nurse I never thought my career path would lead me to a health startup. As I encountered different clinical settings and patient experiences, I knew that technology was the key to advancing healthcare.  From that point, I decided I wanted to work in the field of nursing informatics. The first step in that direction was when I was asked to join a multi-disciplinary team to help build and design an electronic health record (EHR) for a hospital in New York City.  Linking the patients and the healthcare team to the power of technology is extremely satisfying.

I first learned about PatientsLikeMe when I was in grad school.  I was taking a course called Consumers and Interactive Healthcare, and my professor and advisor Lena Sorenson shared with us some of the innovative health companies for consumers, and PatientsLikeMe was one of them! In fact, Lena encouraged me to apply to PatientsLikeMe since I was looking for a shift in my career.  It has turned out to be a perfect fit.

2.  What kind of projects are you working on right now?

We have been working on some improvements for our epilepsy community, making existing tools easier to use and investigating how to better connect doctors and patients. Then, on a daily basis, David Blaser, our Health Data and Drug Information Clinical Specialist, and I curate the data that our users submit to us. Any time there is a condition, treatment or symptom that our users cannot find in our database, we review it and add it to our growing database of patient-reported data. Our job is to ensure we maintain structure and organization with all of the data.

3.  You lead weekly yoga classes for PatientsLikeMe staff.  Tell us about that.

One of the definite highlights of my job! Every Wednesday I have the privilege of leading a small group of staff in a 90-minute Hatha/Vinyasa yoga class. I completed my teacher training during the summer of 2011 at South Boston Yoga. When I came back from training, there was a lot of interest and support in having me teach at work. It’s been a lot of fun and has helped me grow my practice in so many ways.

Christine Leading a Yoga Class at PatientsLikeMe Headquarters

Every week we roll out our mats and practice yoga together. All of my office mates know that Wednesdays at 5pm in Siberia (our back office space) is yoga time.  To counter the frenetic energy in the office, I like to begin class with meditation and some grounding poses and then slowly turn up the heat with the more challenging poses. We practice together to honor the time and space that we create for ourselves so that we can be our best selves.

4.  What are your three favorite things about working at PatientsLikeMe?

I am in constant amazement of the dedication to creating a meaningful experience for our patients and clients. I like our office camaraderie and commitment to creating change within healthcare. And of course, I love our weekly Wednesday yoga days. We rock out, sweat and play, and that’s my ideal end to a work day.

““““““““““““““

Interested in making a difference in patients’ lives?  Check out our Careers page to see our current job openings.  Headquartered in Cambridge, Massachusetts, PatientsLikeMe is looking to hire an Analytics Strategist / Data Scientist, Chief Technology Officer, Data Visualization Engineer / Chart Developer and more at the moment.


What We’re Reading at PatientsLikeMe

Posted November 7th, 2012 by

Here are some of the media items that grabbed our attention recently.

Four Things I Learned from Living with a Chronic Illness
Wise advice from a teenager who had to give up competitive gymnastics and find a new perspective on life after being diagnosed with a disease that causes chronic pain.

Access to Doctors’ Notes Aids Patients’ Treatment
A new study finds that patients better understand their condition and feel more in control when they can read their doctors’ notes (something you’re legally entitled to access).

Why We Need Ecological Medicine
Do we need exposure to a diversity of bacteria and germs for optimal immune health?  A thought-provoking essay about the “germ theory,” “hygiene hypothesis” and more.

What We're Reading at PatientsLikeMe.  Image Courtesy of Stock Free Images.

Coming Next:  Using an App as Prescribed
A New York Times piece about whether healthcare apps – now regulated by the FDA – could reduce costs and change the way we monitor health.

Help with ALS via Twitter
An article about our partner ALS Untangled and how they are applying scientific rigor to the investigation of alternative therapies in ALS, having reviewed 45 to date.

Mining the Internet for Speedier Alerts on Drugs
The Wall Street Journal examines the results of a study showing that Internet search algorithms can detect adverse events for certain drugs ahead of FDA warnings.


$70,000 at Stake in the “Reporting Safety Events Challenge”

Posted August 22nd, 2012 by

How serious is the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) about increasing patient safety?   So serious that they are running a contest challenging the best and brightest developers to create a platform that makes it easier to report a patient safety event electronically.

Learn More About the "Reporting Safety Events Challenge" for Developers Here

The Reporting Patient Safety Events Challenge is offering $70,000 worth of prizes, with $50,000 (and a demo opportunity) awarded to the first place winner, $15,000 to the second place winner and $5,000 to third place winner.  The submission deadline is August 31, 2012.  Learn more about the contest guidelines and 30+ participating developer teams here.

“Ideally, we would live in a world of optimal care delivery,” says the ONC.  “Physicians, nurses and care delivery organizations across the country are continuously working to minimize and eliminate errors.  But, until this ideal world exists, we need to invest in infrastructure that helps enable better care quality, risk management and shared learning – all to ensure better care for patients.”

PatientsLikeMe fully supports this goal, which is why we introduced our first-of-its-kind adverse event reporting platform in 2009.  As part of a two-year pilot program, our members with multiple sclerosis (MS) were able to submit adverse events related to a medication, medical product or medical device directly to the U.S. Food and Drug Administration’s MedWatch program through PatientsLikeMe.  Our system automatically pulled relevant data from the patient’s profile into a FDA 3500 form, dramatically reducing completion time.

Since then, we’ve also developed an integrated and comprehensive drug safety reporting platform that monitors patient data for potential adverse events when we are collaborating with a sponsoring partner in designated disease areas. These data are then clinically triaged and curated using the Medical Dictionary for Regulatory Activities (MedDRA), an industry standard terminology. Adverse events are submitted to our partners electronically in FDA 3500A format to meet regulatory timelines and reporting criteria.  Of note, PatientsLikeMe is the only online health data platform in social media that has successfully passed multiple drug safety audits conducted by our partners’ pharmacovigilance and drug safety experts.

What’s the difference between patient safety and drug safety?  And what do we see ahead in this critical area of healthcare?  Tune in to a podcast with PatientsLikeMe Chairman and Co-Founder Jamie Heywood on this very topic.


Bringing PatientsLikeMe into the Doctor’s Office: An Interview with Pediatrician Dr. Jim King

Posted August 20th, 2012 by

You may recall that in July we shared a video about Doctors 2.0 and You, a conference focused on how physicians are using web 2.0 technology.  Today we’d like to present a real-life example of this concept: Dr. Jim King, MSc, MD, FRCPC.  A pediatrician at the Children’s Hospital of Eastern Ontario (CHEO) in Ottawa, Dr. King runs a number of different clinics for rare diseases.  He also serves as the hospital’s Medical Director for Informatics.  Find out how he has used PatientsLikeMe as part of his practice and much more in our interview below.

Dr. Jim King, MSc, MD, FRCPC, Medical Director for Informatics and Pediatrician at the Children's Hospital of Eastern Ontario (CHEO)

1. How did PatientsLikeMe come to your attention?

We were doing a presentation a number of years ago, in 2006 I guess. We were talking about a number of things, but more specifically the use of mobile technology in healthcare and research as well as personal health records. So we were sort of working up some information and then we came across PatientsLikeMe. We were basically looking at some of the business models around personal health records, specifically around Microsoft Vault and Google Health and those things, and we thought PatientsLikeMe had a little bit of a different spin.

2. As a pediatrician, how have you used PatientsLikeMe?

I specifically used it in one of my clinics. I follow a number of teenagers that have orthostatic intolerance and also chronic fatigue and fibromyalgia and other conditions related to orthostatic intolerance. I get a lot of questions about different medications. The families are very well versed in information and are always looking for new sites to visit. So I will often direct them to PatientsLikeMe. You can find sites with support groups, but you never really know how many people are involved. Then people are going online and looking up things by themselves. But I felt that all the information being presented back through PatientsLikeMe was pretty good.

One example was a 16-year-old patient with fibromyalgia. Their family doctor had recommended she take gabapentin based on a news article. So in the past, and even currently, one of the ways I would look at this situation and get as much information as possible would be to go on sites like PubMed or Bandolier, the Oxford site in the UK, and try to pull together what worked and what didn’t work. Some of these sites are pretty good because often they will tell you what the positive outcome is. But one of the difficulties is that they don’t always tell you what the adverse affects are.

Side Effects Reported by PatientsLikeMe Member for the Medication Gabapentin

It was nice because I sat down with this patient and we pulled up PatientsLikeMe. And I think at that time there were a couple hundred patients that had been on gabapentin and the actual number that had side affects, I’m just recalling now from a few years ago, was equivalent or slightly greater than the amount who had actually benefited from the medication. So we made a decision at that time not to actually go on gabapentin. Instead, we tried some other things. It was very helpful in my daily stream of care to be able to do that.

3.  We have a large community of fibromyalgia and chronic fatigue syndrome (CFS) patients at PatientsLikeMe. What are some of the challenges for adolescents with these conditions?

There are multiple challenges. I think the first challenge is that it’s really an undefined condition. There isn’t a specific diagnostic test, so labeling is a bit of a challenge. Sometimes it takes time for people to understand the impact. And, it’s the same as any chronic illness that doesn’t have overt physical symptoms. You know, everyone looks normal but they feel terrible. When you’re feeling bad all the time physically, or a lot of the time physically, that can make you feel unwell mentally. So having a place where you can go to actually hear that and learn how other people are coping and dealing with it is a big benefit. It certainly shouldn’t hurt, right? And there can be some pretty positive effects from having a community as well.

We are making a diagnosis based on a constellation of symptoms so there are probably a lot of different disorders or a lot of different reasons why someone has a diagnosis of chronic fatigue. So because it’s such a heterogeneous group, there are going to be a lot of different management and therapeutic approaches. So, you really need a large number of people to start understanding what’s working and what’s not working. And again, compiling and pulling that information together is quite beneficial.

4.  Do you have any thoughts on how large online data sets at PatientsLikeMe or other websites could shape the future of healthcare?

You can’t manage what you can’t measure, right? That’s quite obvious. So, if we can do better measurements along knowing what your population is, but have something on what the actual outcomes are, that should be beneficial in the long run. It’s like anything. You have to know your population really well. And if you can define your population really well, then these large data sets, and I would say sites like PatientsLikeMe, can be quite powerful. It is a definite movement and force going forward, for sure. You need thoughtful stewardship for this, and you need a thoughtful ability to analyze the data and make clinical sense from it.

5.  Anything else you want to add about PatientsLikeMe?

For me, there are two other things.  First, the actual connections for people from sites like this are quite important – you know, the support group piece. And also you will have people with multiple problems and they may be doing something that seems to be a bit unique but is beneficial. Also, say you have a condition which is rare and there are only a couple of hundred cases in the world. You learn so much more when you start connecting and you find that maybe a problem, like fever, is a normal part of the illness and people just haven’t gotten together to figure it out. Being able to share that information relieves a lot of stress for families – we hate the unknown – and is quite powerful.

Second is the explosion in clinical information, especially the way things are going with genetics, molecular biology and bioinformatics. The ability to be diagnosed or know your risk and response to treatment with one or multiple diseases based on your genetic material is fantastic.  While there is tremendous potential, this is extremely complex and what we are going to see is that our phenotypes, our observable characteristics or traits, may or may not match our genotypes, the inherited instructions within our genetic code. I think sites that can link large groups are going to become more powerful.

So, as we are pulling all those things together, it will be important to have a source where you can actually be able to make sense of it and make it a lot easier to get some prognosis for guidance for people about what’s going to happen. Because a lot of times, you’re sort of in the dark with a lot of uncertainty for some conditions. So I think pulling that information together can be quite powerful and liberating.


Information Wants to Be Free

Posted February 22nd, 2012 by

This Editorial by our R&D Director, Paul Wicks, PhD, Was Published in the Scientific Journal Clinical Investigation.  Click to Read the Full Article.

(This post has been repurposed from an article written by PatientsLikeMe’s Paul Wicks for the scientific journal Clinical Investigation.)

But when it comes to clinical trials, can we afford to let it be?

“Information (or data) wants to be free” – so goes the mantra of hackers and data activists. In the past this meant computer geeks hacking into secure private networks to fulfill their own curiosity or liberate secret knowledge. Today, voluntary “data liberation,” as practiced by governments and corporations, is relatively commonplace and semiorganized groups with data freedom agendas, such as Wikileaks and Anonymous, have entered the mainstream consciousness.

For me, it feels increasingly challenging to delineate the margins where free data is good or bad. A highly networked, mobile-enabled popular uprising is considered a “revolution” when it’s against an oppressive regime, but considered a “menace” when it is a disenfranchised mob rioting in a western democracy. Bravely recorded videos of civilians attacked by autocratic regime military forces are essential in prosecuting crimes against humanity, but videos leaked from within a democratic military are a “threat to national security.” So while data itself may want to be free, we don’t always want it to be. And so, to clinical trials.

The Clinical Trials Search Feature at PatientsLikeMe

From a societal perspective, the requirement for any trials conducted in the USA to register on ClinicalTrials.gov can only be a good thing in preventing past sins, such as suppressing negative trials or changing end points. As the US government makes this data open, it also allows repurposing. For instance, PatientsLikeMe imports the complete dataset from ClinicalTrials.gov every night to let our membership know (free of charge) about the 30,000+ active trials for which they may be eligible. So far, so good. But what if even more clinical trial data were free?

Read the rest of R&D Director Paul Wicks’ editorial in Clinical Investigation here.

PatientsLikeMe member pwicks


PatientsLikeMeOnCall: Tapping into a Treasure Trove of Information

Posted July 29th, 2011 by

Dr. Kevin Dykstra, PhD, President and CEO of qPharmetra

Last Friday we kicked off our new weekly podcast series called “It’s Friday – Let’s Journal Club.” Thanks to everyone who tuned in. This week’s guest interview is with Dr. Kevin Dykstra, PhD, who is President and CEO of qPharmetra, a pharmacometric consulting company. Dr. Dykstra stopped by PatientsLikeMe headquarters to talk to our team about the use of modeling and simulation to aid drug development.

After this insightful “Journal Club” session, PatientsLikeMe’s Aaron Fleishman sat down with Dr. Dykstra to learn more about how his team is working to measure the clinical utility of treatments in a systematic, quantitative way. Listen in to hear what exactly that involves and why Dr. Dykstra feels PatientsLikeMe is a “treasure trove of information” that is “incredibly useful” for both patients and drug developers


PatientsLikeMeOnCall: From Open Data to Actionable Data

Posted July 22nd, 2011 by

Pillbox's Rapid Identification System for Unknown Pills

Every Friday, PatientsLikeMe holds “Journal Club” in our Boston headquarters with a different guest speaker. Last week we were privileged to hear from Dave Hale, Project Manager for Pillbox, a National Library of Medicine (NLM) and Federal Drug Administration (FDA) patient safety initiative. And thanks to PatientsLikeMeOnCall’s new podcast series “It’s Friday – Let’s Journal Club,” you’ll get to hear from him too.

After Journal Club last week, PatientsLikeMe’s Aaron Fleishman sat down with Hale to learn more about Pillbox’s goal of creating a one-stop resource for identifying unknown pills as well as how the project aligns with the Open Government Initiative enacted by President Obama. Tune in below to hear how Hale and his team took drug labeling data from “open to actionable” by listening closely to affected communities.


PatientsLikeMeOnCall™: “A Look Ahead” at Patient Safety (Episode 3)

Posted April 1st, 2011 by

“What are the things that affect a patient’s safety? It’s everything – it’s not just whether the drug is good or bad, it’s the whole process.” –Jamie Heywood

Co-Founder and Chairmain Jamie Heywood

Why does the healthcare industry need to shift from drug safety to patient safety? PatientsLikeMe Co-Founder and Chairman Jamie Heywood explains his view in this week’s edition of our podcast series entitled “A Look Ahead.”

No stranger to this topic, Jamie has written about patient safety on our blog before.  “By using structured data collection tools within the PatientsLikeMe platform, overseen by a drug safety professional, industry partners can improve patient safety,” he wrote.

In this edition of PatientsLikeMeOnCallTM, Jamie discusses the difference between drug safety and patient safety, why it is so important for the healthcare system to adapt more to patient safety and what this shift would mean for the future of healthcare.  He also makes the case for why pharmaceutical manufacturers need to follow up on any drug safety events when a new treatment has been developed.

To hear more, listen to Jamie’s full interview:

PatientsLikeMe member afleishman


How Patients Like You Use Your Treatments in the Real World: Two New Studies

Posted January 31st, 2011 by

Ever wonder how many patients like you are using drugs off-label?  Or how hard is it to take MS medications as prescribed?  You’re about to find out.

In January, the PatientsLikeMe R&D team published not one but two studies in the Journal of Medical Internet Research (JMIR) in an effort to provide answers about how patients like you are actually using your treatments.  We’ll highlight both studies here on the blog today and tomorrow.  (Note: Because JMIR is an open-access journal, the articles are free for you or anyone to read in full, without fees or subscriptions or a library card.)

Study One:  Off-Label Drug Usage

Our first study looked at the rates of off-label drug usage in our communities.  What do I mean by “off-label”?  When a drug is approved by the FDA (or outside of the US, by other regulators such as the EMEA), it is “indicated” for the treatment of a specific condition, which permits the manufacturer to market it to doctors who treat that condition and patients diagnosed with it.  This indication is described on the medication’s label.

Any physician may choose to prescribe a treatment for a purpose that has not been indicated, however.  This is known as “off-label” use.  Manufacturers are not allowed to promote such use, though, and because most research focuses on new drug development, there are few systematic ways to discover how common off-label drug use is or to quantify its effects.  Yet at PatientsLikeMe, thousands of patients like you are sharing data on this very practice.  So, the R&D team decided to take a closer look.

This led to our JMIR study entitled “Patient-reported Outcomes as a Source of Evidence in Off-Label Prescribing: Analysis of Data From PatientsLikeMe” (which I am proud to report was the winner of the inaugural Medicine 2.0 award).  We started by identifying two widely used drugs to study:  amitriptyline (a tricyclic antidepressant indicated for the treatment of depression) and modafinil (a wakefulness-promoting drug indicated for the treatment of narcolepsy).  Then, we examined how patients like you were using them used across five condition-based PatientsLikeMe communities: MS, fibromyalgia/chronic fatigue syndrome, ALS, mood disorders (depression, bipolar disorder, and anxiety disorders) and Parkinson’s disease.rd1

Our data revealed that less than 1% of almost 2,000 patients taking modafinil and only 9% of nearly 1,400 taking amitriptyline are taking each drug for its approved indication.  That means the vast majority of you are taking these drugs “off-label.” You also reported higher perceived efficacy for off-label uses than for approved indications, surprisingly. Another interesting discovery is that many of you cited what are normally considered the side effects of amitriptyline (e.g. dry mouth) as your purpose for taking the drug (e.g. to treat excessive saliva).

If researchers are only looking at clinical trial data, they’re missing the whole story because they don’t know what’s being prescribed off-label. To be clear, off-label prescribing is commonplace and standard practice in many conditions, with safety and efficacy established by clinicians’ experience rather than formal studies. However, whenever we can improve upon the status quo by unlocking a new data source (such as what you share via our site), we should seek to maximize that information.

Up next tomorrow…how you’ve helped develop patient-reported outcome instruments.

PatientsLikeMe member pwicks


Drug Safety: It’s About More Than Just Compliance

Posted September 30th, 2010 by

pillsEngaging in social media presents a number of uncertainties to pharmaceutical companies. In a world where much of the medical dialog has moved online, these uncertainties have emerged due to absent or unclear guidelines from the Federal Drug Administration (FDA), privacy and regulatory concerns about engaging directly with patients, and the potential for significant consequences.

When I recently spoke before the FDA, we highlighted how our pharmaceutical partners are taking a leadership role by navigating through these issues. In so doing, our partners are learning about real world experiences of patients and how to meet their adverse event reporting responsibilities in the PatientsLikeMe Epilepsy, Organ Transplant and Multiple Sclerosis communities.

“…as the FDA contemplates the Internet and social media as an emerging source of drug safety data, it is essential to consider what characteristics distinguish a social media site as being capable of contributing to drug safety in a meaningful, computable and quantifiable manner.”

Meaningful, computable and quantifiable are three words that underscore all that we do at PatientsLikeMe. This includes the creation of our patient safety program. Early on, we approached patient safety proactively with a pilot program in our Multiple Sclerosis Community. Launched in 2009, this program allows patients to voluntarily report adverse events that funnel to the FDA’s MedWatch system. Our system automatically pulls relevant data from the patient’s existing profile into an FDA 3500 form, dramatically reducing form completion time.

Going beyond that in areas where we work deeply with our pharma clients, we developed an integrated and comprehensive drug safety reporting platform that monitors patient data and free-text for potential adverse events. This data is then medically curated into standard MedDRA terminology and submitted electronically to meet regulatory timelines and reporting criteria. Of note, PatientsLikeMe is the only online health data platform in social media that has passed multiple drug safety compliance audits.

The reality today is that patients are sharing their real-life experiences with post-marketed drugs online. By using structured data collection tools within the PatientsLikeMe platform overseen by a drug safety professional, industry partners can improve patient safety.

This is about more than just compliance, though. We believe it’s about leadership – patients and pharma working together in new ways. Listening – to understand the positive and negative patient experience – is the right step in developing a trusted relationship. And this trust-based relationship is the only foundation upon which to build your social media strategy.

PatientsLikeMe member jamie


PatientsLikeMe – Out & About and OnCall

Posted April 2nd, 2010 by

The PatientsLikeMe team has been traveling around the globe recently talking about the power of real-world patient data in changing healthcare.  You may have heard about our executives at industry conferences, government hearings, or even on TV.  Highlights below.

Last month, PatientsLikeMe Co-founder and President Ben Heywood was on Fox Business News talking about how industry is engaging directly with patients and tuning into the “unvarnished truth” patients are sharing about their real-world disease experiences.

Earlier in March, we launched our PatientsLikeMeOnCallTM podcast series to bring to you our leaders’ perspectives on topics that impact you, the patient, and the healthcare industry as a whole.  We kicked off the series with Ben’s interview regarding Fast Company recognition.  You can check out that one and the rest of our podcasts on iTunes or click on the links below to start listening to a specific interview.  As podcast host Aaron Fleishman says, “thanks for stopping by and listening and we’ll talk to you next time.”

  • headphones_icon Listen | Ben Heywood (Co-founder, President) answers questions about the launch of our new organ transplants community and our collaboration with Novartis
  • headphones_icon Listen | David S. Williams III (Chief Marketing Officer) shares industry best practices in using social media for clinical trial recruitment (recently presented at the CHI SCOPE conference)
  • headphones_icon Listen | Paul Wicks Ph.D. (R&D Director) discusses nexus of personalized medicine and information technology (highlights from his presentation given at a Personalized Conference event by ASU, Mayo Clinic, AAAS, FDLI)
  • headphones_icon Listen | Jamie Heywood (Co-founder, Chairman) visits “on call” to talk about the impact of real-world experience on drug safety
  • headphones_icon Listen | Sally Okun RN (Health Data Integrity Manager) gives her perspective on improving patient engagement and fostering patient-provider partnerships through tools like the Doctor Visit Sheet (highlights from her presentation at the Patient E-Centered Health event by The Stevens Institute of Technology)
  • Watch | Maureen Oakes (Product Manager) shows you cool new website functionalities making their debut with the new transplants community
  • Watch | Paul Wicks Ph.D. (R&D Director) talks about the value of patients measuring quality of life through online patient-reported outcome