Monday, July 25, 2016

FDA's Dependence on User Fees & "Institutional Corruption" Blamed for Dramatic Increase in Drug Adverse Events and Deaths

An estimated 128,000 hospitalized patients die each year from Adverse Drug Reactions (ADRs. aka Adverse Events, AEs), which matches stroke as the 4th leading cause of hospital deaths (see here). Deaths and serious reactions outside of hospitals would signicantly increase the totals. This does not include deaths and hospitalizations from over-dosing, errors, or recreational drug use. We know this because of  hundreds of thousands of drug "Adverse Event Reports" (AERs) received by the FDA every year directly from healthcare professionals (HCPs such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, lawyers and others), and drug companies, which are normally required to send AERs it receives from HCPs to the FDA.

The following chart shows the trend in AERs received by the FDA from 2004 through 2015.


I have analyzed data from 2003 through 2014 to look at the number of AERs submitted by HCPs versus consumers, the number of serious adverse events versus the number of adverse events involving death, and the correlation between serious AEs and user fees paid to the FDA by drug companies. I see some interesting trends in the data.

Saturday, July 23, 2016

Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent?

On Patientpower.eu, David Palacios, Head of Global Patient Relations, and Sanja Njegic, Head of Patient Advocacy & Relations in Europe at Novartis, explain how their company has moved from working with doctors and payers to working directly with patients. The interview was recorded at Eyeforpharma Barcelona 2016.



“We developed last year what we call the 'patient declaration,' which is a public statement about what patients can expect from us,” said Palacios. “It is an internal and external commitment. By having this document everybody in the company needs to work seriously to honor what we said in the patient declaration. That has triggered a lot of discussion internally.”

Some of that discussion must have been around "transparency" with regard to compensating patients -- especially patient bloggers and patient advocates -- for their opinion, much like pharma has traditionally paid physician Key Opinion Leaders (KOLs) for their opinions. Did that discussion result in any relevant disclosure in the "patient declaration?"

Thursday, July 21, 2016

Fifty Ways to Leave the GOP

This morning I saw this tweet by a journalist:

Talk about "Open Carry" in Ohio - This is "Open Nazism!"

Any way, here's my response that I couldn't make via Twitter:

Wednesday, July 20, 2016

Real Dog Patient Stories Send Sales of Sileo Rocketing!

"Data gives credibility, but stories provide truth," says Ash Rishi, Co-Founder and Managing Director of COUCH (read "Patient Storytelling Marketing").

Social media and patient stories are a "match made in heaven" and several pharma marketers are using social media to listen to REAL patient stories and to leverage those stories to help motivate other patients. This is as true for dogs as it is for humans as evidenced by Chase's story (see him on the left).

Before I get to that, some background.

It is estimated that one-third of dogs in the U.S. suffer from noise aversion and they especially hate the Fourth of July with all its fireworks, firecrackers, rockets and other noise makers. That "unmet medical need" was met by Sileo, an FDA-approved canine prescription drug developed by Zoetis. Sileo treats noise-averse dogs without sedating them.

Luckily for Chase, Sileo was approved just in time. Here's his story as translated by Google Translate.

Apple's ResearchKit Mobile Apps Make Strides in Clinical Research, But Is iPhone User Demographics an Issue?

As reported in the trade media, GSK developed an iPhone app for use in "clinical research" (read "GSK Develops Rheumatoid Arthritis App for Clinical Trial Using Apple's ResearchKit"). It is claimed that this "[marks] the first time a drugmaker has used the health system for the iPhone to conduct clinical research."

ResearchKit is a set of tools for collecting participant consent, conducting surveys and assigning active tasks to participants that they can perform to help researchers achieve specific study goals.

Keep in mind, however, that this use of a ResearchKit iPhone app is not part of a clinical study involving an actual medicine. As reported by GSK here:

"We are the first in our industry to use Apple’s ResearchKit as part of our research, this time looking at the impact a patient’s disease has on their day-to-day life. We’re not testing a medicine right now. The medicines development process starts with learning from real patients by including their insights and health goals into our research. That’s exactly the information we hope to gather about rheumatoid arthritis, a debilitating disease which can impact patients’ lives at many levels.

"The PARADE study will use the iPhone app to conduct surveys and iPhone sensors to collect and track common symptoms of rheumatoid arthritis: joint pain, fatigue, and mood. It will also track activity and quality of life measures for 300 patients over a three-month period."

This is not, however, the first use of Apple's ResearchKit in the development and use of mobile apps for "clinical research."

Related Posts Plugin for WordPress, Blogger...