Friday, August 19, 2016

The Addyi Report Card: Crooked Valeant Fools FDA Again

Click on image for enlarged view or get PDF here.
"Fool me once, shame on you; fool me twice, shame on me," should be FDA's response to a report card released by the National Women’s Health Network advocacy group and shown here.

FDA was first "fooled" into approving Addyi based on a dicey self-assessment questionnaire, which formed the basis for the drug's efficacy in clinical trials (read "The #Pharma-Developed Self-Assessment Questionnaire that Got Addyi Approved") and by "patient advocate" testimony (read "The Power of Patient Input: How FDA Learned to Love & Approve Addyi") sponsored by Sprout, the company that brought Addyi before the FDA and which was bought by Valeant after the drug was approved.

Finally, Sprout's “Even the Score” campaign claimed that there was sexism inherent in the number of FDA-approved treatments for sexual disorders (read "Flibanserin (Addyi): The Title IX of Drugs or the Pill for No ill?").

Will the FDA be fooled again by "crooked" Valeant, whose business and accounting practices are under criminal investigation by U.S. prosecutors (see here)? Evidence from the Report Card says "Yes!"

Monday, August 15, 2016

Now May Be the Time for Pharma to Get Serious About Instagram

Despite the fact that FDA recently cited Duchesnay for a violative Instagram Diclegis ad that featured celebrity Kim Kardashian (read "Kim Kardashian Instagram post draws FDA warning"), Instagram may be the social medium of choice of pharma marketers now that it has added a new feature.

Until now, I didn't think Instagram was good for pharma. While its demographics (see charts below) may skew too young for marketing most of the products pharma has to sell, it is a growing population. Plus, now that Instagram is owned by Facebook, the demographics -- especially among women (the best target for drug marketing) -- will likely shift to resemble FB's demographics.

Click on image for an enlarged view.
According to eMarketer, now that Instagram is open to all advertisers, by the end of 2016, 48.8% of marketers are expected to use the platform (read "Instagram Set to Rock the Social Media Marketing World").

Due to FDA regulations, the necessity to expend resources to monitor comments for adverse reactions (read "One (BIG) Reason Pharma Shouldn't Reconsider Instagram"), lack of expertise in measuring social media ROI, etc., pharma marketers have not given social media a warm reception no matter what the platform. But the new Instagram feature I just learned about, may make it more appealing to pharma marketers. Continue reading to see why I feel this way.

Friday, August 12, 2016

Do Desperate Consumers Believe Cancer Drug DTC Ads?

In a recent NYT OpEd piece, Matt Jablow, whose wife died of lung cancer, called the TV ads for BMS's cancer drug Opdivo "utterly misleading and exploitive" and said that if BMS really wishes to thank patients like his wife who participated in the Opdivo drug trials, it should pull the ads (read the OpEd piece here).

The Opdivo ad had already been criticized during an investor conference call by a Deutsche Bank analyst who questioned the value of direct-to-consumer (DTC) ads to promote Opdivo (here). Of course, the analyst was more concerned about BMS wasting money on ads that would have no effect on the sales of the drug, which are likely to grow "whether or not the company promoted the drug to patients."

The FDA has proposed (see here) to re-study the effect of superimposed text, or text placed over an image, on viewers' understanding of a DTC ad like that for Opdivo, which super-impose the words "A Chance to Live Longer"on buildings in big, bold text.

Meanwhile, some drug industry advertising experts have criticized Jablow's OpEd piece itself as being "disingenuous."

Wednesday, August 10, 2016

Total CME Funding Drops, But Income from Pharma Increases

The AMA & many other physician groups are lobbying in support of a Senate bill to exempt drug and device makers from reporting the value of continuing medical education (CME), journal reprints, and textbooks provided to physicians (see here).

At the same time, while total accredited CME income is decreasing, the pharma industry is upping its financial support of CME, according to the 2015 Annual Report of the Accreditation Council for Continuing Medical Education (ACCME).

Data from ACCME Annual Reports. Click on image for an enlarged, more readable view.
However, pharma may be channeling money to CME through organizations that are not required by law to report the value of their support for CME.

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.

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