Smartphones and mHealth:
Source: Pew Research Center
Source: Pew Research Center
In its release of new industry guidance, the FDA has acknowledged a need for progress in the treatment of female sexual dysfunction. The current treatment for the condition, Addayi, from Valeant Pharmaceuticals, is struggling due to its undesirable side effect profile, which includes severely low blood pressure and fainting. Talk about a mood killer. Palatin Technologies is set to release the results of its drug in late phase trials by the end of the year. Measures include changes in satisfying sexual relations and the female sexual function index. According to Bloomberg, treating female sexual dysfunction is more complicated than erectile dysfunction in males because treatments focus on neurotransmitters – like in depression and anxiety – instead of simple blood flow – like the hydraulics on a dump truck. Stay classy, InsightCity.
In a move lauded by clinical trial transparency activists, the EMA has begun to release the full clinical study reports (CSRs) submitted for drug approval on their website. These aren’t the paired-down, not-quite-as-public-relations-focused-as-a-press-release-but-still-not-the-whole-picture versions submitted in scientific journals, and they include all the info a sponsor might not want to publish themselves—like the details of a drug’s adverse effects. The reports will be redacted for patient data and commercially confidential information, and the EMA will be retroactively posting CSRs for products (approved, or otherwise) submitted to the agency for review since Jan. 1, 2015. In the meantime, maybe try some light reading with the 260,000 pages released so far.
A study published in the journal Pain shows that an “honest” placebo (one given to a patient and fully disclosed) can still influence a patient’s symptoms. The study looked at 83 people who suffered from back pain – half of the group continued their daily routine of painkillers and rest, the other half knowingly added a placebo. When asked to rate difficulty in daily activities, the placebo group noted less difficulty, which translates to less pain. But it’s not just back pain; an earlier study showed a reduction of symptoms occurring in patients with irritable bowel syndrome. Sounds like some real “mind over matter” stuff going on here. While interesting, don’t expect a shift toward prescribing placebos anytime soon.
The city of Chicago is getting even more serious about snuffing out an epidemic that has claimed the lives of hundreds of Chicagoans so far. In a continued effort to stem opioid addiction, the city may soon require pharmaceutical sales reps to carry special licenses in order to pitch medications. “Oh just a piece of plastic to flash around, not a big deal!” the young unsuspecting sales rep might muse. Um, no. License requirements call for representatives to report back to the city on several measures including how many doctors they contact and whether these doctors receive payout. Patients and doctors can also report unethical behavior. Add this to Chicago’s record of opioid crackdowns, which includes a lawsuit filed against several drug makers’ misleading opioid marketing in June of 2014.
The FDA has proposed an experiment to measure whether the use of animation in DTC drug advertising has effects beyond just getting you to look at the TV. Specifically, how does the use of an animated character to represent the patient, condition, feeling, etc. affect the retention of important drug information such as benefits and side effects? The agency put the proposal out for comment last week and let’s just say that if the FDA is skeptical of the industry’s motives, the feeling appears mutual. Several comments expressed concern over such a specific experiment informing FDA guidance and policy. One comment posited that the research “may be unnecessary for the proper performance of the FDA’s functions.” “On the contrary,” began the FDA’s response. It seems they disagree.
Source: American Cancer Society