Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Jay-Z’s creative wisdom for biotech brands

Jay-Z’s creative wisdom for biotech brands | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For any image or symbol or creative act to mean something, it has to touch something deeper, connect to something true.

― Jay-Z


In Jay-Z’s recent book, Decoded, the above quote struck a chord with me. As healthcare marketers, we always connect our products to scientific data, clinical studies, and P values. In addition, there are the numerous safety data, tolerability profiles, and dosing schedules to promote.


But when the physician has a patient experience that delivers on these claims, only then will that physician believe enough to be touched and, ultimately, to look to place that product on his or her mental short-list for future patients suffering from those particular symptoms. Let’s break down the images, symbols, and creative acts in our business and show how they drive the brand experience.


Image. In the past, the brand image often went a long way to cement the positioning in the physician’s mind. With DDMAC and the current marketing environment, interesting creative work is rare—and stellar creative work is even more unusual. This does not mean strong creative is impossible. There are people who can navigate the conservative medical-legal system and deliver a stand-out creative product. Don’t settle for an older couple walking their dog on a beach; your brand deserves more.

Pharma Guy's insight:


Agencies often strive to deliver deliver a "stand-out creative product" but fail to "connect to something true." For more on that, read this Pharma Marketing News article: Patient Storytelling Marketing: Creativity vs. Truth in Pharma Advertising

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Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public

Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AbstractBackground


Achieving transparency in clinical trials, through either publishing results in a journal or posting results to the ClinicalTrials.gov (CTG) web site, is an essential public health good. However, it remains unknown what proportion of completed studies achieve public disclosure of results (PDOR), or what factors explain these differences.

Methods


We analyzed data from 400 randomly selected studies within the CTG database that had been listed as ‘completed’ and had at least four years in which to disclose results. Using Kaplan-Meier curves, we calculated times from completion to PDOR (defined as publishing the primary outcomes in a journal and/or posting results to CTG), and identified explanatory variables predicting these outcomes using Cox proportional hazards models.

Findings


Among the 400 clinical trials, 118 (29.5%) failed to achieve PDOR within four years of completion. The median day from study completion to PDOR among 282 studies (70.5%) that achieved PDOR was 602 days (mean 647 days, SD 454 days). Studies were less likely to achieve PDOR if at earlier stages (phase 2 vs. phase 3/4, adjusted HR 0.60, 95% CI 0.47–0.78), if they only included adult subjects (adjusted HR 0.61, 95% CI 0.45–0.83), involved randomization (adjusted HR 0.62, 95% CI 0.46–0.83), or had smaller sample sizes (≤50 subjects vs. >50, adjusted HR 0.60, 95% CI 0.44–0.83). Industry-funded studies were significantly less likely to be published than non-industry or blended studies (adjusted HR 0.49, 95% CI 0.36–0.66).

Conclusions


A significant proportion of completed studies did not achieve PDOR within the four years of follow-up, particularly smaller studies at earlier stages of development with industry funding. This constitutes reporting bias and threatens the validity of the clinical research literature in the US.

Pharma Guy's insight:


Lack of transparency about negative clinical trial data is a manifestation of the "dark side" of pharma R&D. Dr. Ben Goldacre, author of Bad Pharma, has written and lectured extensively about this (see "Bad, Devalued, Distrusted & Defensive Pharma: A Tale of Two Books"). 

On this issue, former president of Pfizer Global Research, John LaMattina, recommended that all pharma companies make all clinical trial data available for 3rd-party analysis. Recently, Roche agreed to release all of the trial data for its controversial influenza drug Tamiflu to the Cochrane Collaboration (see here). Roche did this kicking and screaming and may have put limits on the data revealed. To the public, this sounds like "too little, too late"; i.e., another way of saying "the train has already left the station."


For more on that read: Fixing Pharma's Reputation: IMHO, the Train Has Left the Station


Some more history: As far back as March 29, 2001, a SmithKline (precursor to GSK) executive held back clinical trial data that suggested Avandia was "no better than Actos, but ... also provided clear signs that it was riskier to the heart." In an e-mail that the NYT recently received, this executive said "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." In another email message, this executive said "These [data] put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm. It is a difficult story to tell and we would hope that these do not see the light of day."


For more on that read : GSK's Coverup of Avandia's Heart Risk Data: Is This How the Entire Industry Views Its Responsibility to Patients?


NOTE: GSK has since pledged to make all its clinical trial data available to the public. 

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Rob Schneider Links Robin Williams Suicide To Parkinson's Drugs

Rob Schneider Links Robin Williams Suicide To Parkinson's Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Comedian Rob Schneider made a controversial statement about Robin Williams' death, suggesting the actor's suicide could be linked to medication taken to treat Parkinson's disease.

Pharma Guy's insight:


A couple of Schneider's tweets:


"Now that we can talk about it. #RobinWilliams was on a drug treating the symptoms of Parkinson's. One of the SIDE-EFFECTS IS SUICIDE!"


"The Evil pharmaceutical industry ADMITS TO OVER 100,000 people in the USA DIE A YEAR FROM "PRESCRIPTION" DRUGS!!"


Follow-up: 

Doctors Blast Rob Schneider's Parkinson's Drug Twitter Rant

Parkinson's disease experts say Schneider is out of line.

"Suicide is of no more concern in patients with Parkinson's versus those who don't have Parkinson's," said Dr. Irene Richard, a professor of neurology and psychiatry at the University of Rochester Medical Center and a science adviser to the Michael J. Fox Foundation for Parkinson's Research.

However, some Parkinson's drugs do list an increased risk of suicide as a possible side effect.

For example, the U.S. Food and Drug Administration warns that patients taking either levodopa or SINEMET, two drugs commonly used to treat Parkinson's, "should be observed carefully for the development of depression with concomitant suicidal tendencies.


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