Pharmaguy's Insights Into Drug Industry News
184.9K views | +32 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012

Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Source: JAMA Internal Medicine


Our study demonstrates that boxed warnings are common, affecting more than one-third of recent drug approvals. While nearly three-quarters of boxed warnings had been applied to novel therapeutics at the time of approval, more than 40% acquired the warning after a median market period of 4 years. Not surprisingly, the frequency of boxed warnings increased in the post-2004 period, which coincided with the aftermath of the rofecoxib (Vioxx, Merck) withdrawal and subsequent launch of FDA initiatives to strengthen drug safety surveillance, particularly postmarket reporting. Our finding that half of biological products had boxed warnings is consistent with literature suggesting that biological products pose greater risks of serious adverse events compared with other drug types. It should be noted, however, that our study was limited in sample size and excluded biological products under jurisdiction of the Center for Biologics Research and Evaluation. Furthermore, our study included only CDER-regulated drugs and therefore was not a comprehensive review of all drugs approved since 1996. Clinicians should be aware of the prevalence and growing numbers of boxed warnings and the importance of continued adverse event reporting for identifying new safety concerns.

Pharma Guy's insight:


This further supports Sidney Wolfe's viewpoint; i.e.,  

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided"
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Are Doctors Wary or Weary of Getting Drug Info from Pharma?

Are Doctors Wary or Weary of Getting Drug Info from Pharma? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
According to a new study from M3, you have an average of about 20 hours a week to capture a doctor’s attention while they’re online.  However, recently, the question hasn't been whether or not doctors areonline, but how do we reach them while they’re online.  Results of the M3 survey show that above all else, credibility may be the biggest factor in getting physicians attention. 

The study, which surveyed just over 1,000 general practitioners, shows that while doctors are spending time online and looking for a variety of information, many are weary [sic; I think the proper word is "wary," although HCPs may be growing tired of of the information being shoveled to them by pharma] of obtaining that information through pharma companies.  While two-thirds of respondents expressed at least some interest in relevant pharma products, a whopping 85% indicated that they prefer independent sources for their information.  In addition, 56% specified that a rep meeting would not be preferable to acquiring information online. 

More “anti-vendor” sentiment can be found in terms of where doctors are spending their time online.  Almost half (45%) said they never visit a device company website when sourcing information while 33% indicated the same for pharma company websites.  Consequently, 59% visit the website of a government body at least bi-weekly in obtaining this information. 

But what can pharma companies do to present themselves as more trustworthy?  Even hard data can often be manipulated and many have a hard time trusting statistics.  Certainly “unbiased” sources of information such as third party reports could be used to a degree.  Respondents also showed some openness to case reports with 39% citing them as useful. 
Pharma Guy's insight:


Quoting Any Yeoman on the LinkedIn discussion of this survey:


"Not sure their unwillingness to visit pharma sites is that closely linked to their level of trust in the industry but more a desire to find impartial information and reviews about the products they buy and use. It's exactly what I do when I am planning a significant purchase.


"The doctors polled in the M3 survey are users of Doctors.net.uk so they have a familiar and trusted platform to engage with pharma-sponsored and 3rd party content. Not all doctors have access to, or use, this facility so the results are not entirely representative. 

"However, the M3 report indicates that many doctors prefer concise information via independent platforms and if these platforms continue to provide the information why are doctors going to change their habits? What can Pharma offer that will catalyse a change in this behaviour? Why bother trying?"

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

more...
No comment yet.