20 posts from January, 2011

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


What’s Your Experience with Polybion?

Posted January 29th, 2011 by

Polybion is a balanced B complex vitamin manufactured by Merck, Germany.  Available in syrup, ampoule or tablet form, Polybion contains eight different B vitamins:  thiamine (vitamin B1), riboflavin (vitamin B12), niacin (vitamin B3), panthothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin (vitamin B7), folic acid (vitamin B9) and the cobalamins (vitamin B12).  All types of Vitamin B play a vital role in cell metabolism and help unlock the energy from foods.

At PatientsLikeMe, where more than 120,000 patients are sharing their experiences with prescription drugs, supplements and more, we currently have just one patient who reports taking Polybion daily for “general health.”  If you’ve taken – or are currently taking – Polybion, we encourage you to share your experience to help other patients.  PatientsLikeMe’s unique data-sharing platform allows you to share detailed data about all types of treatments, interventions and lifestyle modifications that have helped you or simply had no effect.

For example, was Polybion effective?  Did you have any side effects?  How long did you take it?  All of these things can be reported on our comprehensive treatment evaluations, which also cover dosage (how much did you take?), cost (what was your co-pay or out of pocket expense?), burden (was it easy to take the drug?) and adherence (were you able to take it as prescribed or did you skip/forget sometimes?).  If you’ve got other comments, you can share your tips and advice in a free-form manner for the benefit of other patients.

Check out the 73 patient evaluations for Vitamin B (all formulations and types, including injections of Vitamin B12) as an example.

JOIN PATIENTSLIKEME TODAY

Have you taken Polybion – or another formulation of Vitamin B?  Join PatientsLikeMe and add your experiences to our growing body of knowledge.  Then, stay to exchange advice, research common treatments and learn from other patients like you.

Join PatientsLikeMe Now