For decades, the clinical trials vital to developing new drugs have followed a central principle: Researchers and patients must both be “blinded” as to who is getting the experimental drug and who a placebo or standard therapy.
If patients know who has the new drug, or learn too much about how others in the trial are faring, this knowledge could influence how they report symptoms and make it hard to tell whether the drug is working. Staying in the dark throughout a trial is a standard held sacrosanct by researchers. But lately, not so much by patients.
On Facebook groups, online forums and blogs, some patients are effectively jeopardizing the blind. In trials for hepatitis C, multiple sclerosis and ALS (Amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease), patients have been sharing details of their reactions and trying to figure out whether they are getting the active drug.
Patients also swap tips on how to get accepted into trials, even if they don’t meet all the requirements. Some who are in trials collect and analyze their medical data and others’ to get an early indication of whether a drug will be a success.
Drug makers and researchers are increasingly concerned that online chatter could unravel the carefully built construct of the clinical trial, and perhaps put patients in danger. They worry that patients may drop out if they suspect they aren’t getting the drug being tested, or may report symptoms inaccurately because of the influence or suggestions of others in the trial.
Patients who share too much “could effectively chill a new drug before it ever gets to patients by misinterpreting early signals,” says Craig H. Lipset, head of clinical innovation at Pfizer Inc., PFE -1.83% who wrote an opinion piece in Nature Medicine in March calling on trial sponsors and regulators to study the effects of social media. “It’s scary.”
Patients, for their part, often say they have the right to talk about their experiences. In life-threatening diseases such as ALS, patients “want, need and deserve to know” how others are doing, says April Moundzouris, a Chattanooga, Tenn., woman whose“April’s ALS Blog” chronicles her experience with an experimental stem-cell treatment. The early-stage research by Neuralstem Inc. CUR -4.76% isn’t blinded.
Neuralstem Chief Executive I. Richard Garr , a close reader of April’s blog and those of other patients, says the sharing may pose a challenge later on when it comes time for a trial designed to prove efficacy to the Food and Drug Administration. That trial would likely have to be blinded.
A patient who blogs that he or she isn’t feeling well, isn’t improving or has some symptom can sway how other patients report or their willingness to join a trial, Mr. Garr says.
This is just one of the ways the Internet and social media bear on the drug-discovery process. Richard Bedlack, who runs the ALS clinic at Duke University, is involved in a project that asks patients to tweet tips about alternative and off-label treatments that he and other doctors assess to see if they might make promising research candidates.