Pharmaguy's Insights Into Drug Industry News
186.0K views | +16 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!

Patients Blamed for Pfizer's Pfailure to Launch OTC Lipitor

Patients Blamed for Pfizer's Pfailure to Launch OTC Lipitor | Pharmaguy's Insights Into Drug Industry News | Scoop.it

To meet the FDA requirements for OTC approval, Pfizer ran a large clinical trial to determine if patients taking OTC Lipitor would get their own blood tests at a pharmacy to see if the drug improved their cholesterol profile. The trial then would determine if patients would indeed make the correct health decisions based on their results. Most OTC drugs, such as pain relievers, heartburn drugs, and anti-allergy agents, all relieve symptoms quickly and patients know right away if the drug is helping them. However, high LDL cholesterol, while harmful over many years, is symptomless and the FDA was concerned that patients would either misdiagnosis themselves or not be motivated to get their blood tested in the first place.


As part of their recent second quarter 2015 financial results, Pfizer announced the disappointing results of this study.


“A Phase 3 ‘actual use’ trial intended to simulate the OTC use of Lipitor (atorvastatin calcium) 10 mg was completed in December 2014. The study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results. Based on dialogue with the FDA about the program and the analysis of this data, the program was terminated.”


Perhaps it is not surprising that patients didn’t take personal control of their healthcare as had been hoped.

Pharma Guy's insight:

One wonders if the study was properly designed and conducted to make it easier for patients to "take personal control of their healthcare." Pharma often cites the need to "go beyond the pill" to increase adherence. Was there any of that "beyond" stuff in the trial?

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

It’s Time to Turn Off TV Doctors

It’s Time to Turn Off TV Doctors | Pharmaguy's Insights Into Drug Industry News | Scoop.it
From shady business deals to the lust for fame, television doctors are among the last people we should trust when it comes to health advice.


Though many of television doctors’ pedigrees are, in fact, impressive, it doesn’t exclude them from succumbing to the power trip that is the cult of celebrity.


The most recent example is Dr. Mehmet Oz, whose shilling of various ineffective weight loss supplements ultimately landed him in a congressional hearing that has cost him a fast-vanishing reputation. For Congress to call upon Dr. Oz is to essentially ask that a publicist be present and willing to issue a statement for green coffee.


Lucky for us, Oz somehow has a conscience and basic understanding of how the law works, forcing him to come clean. He further shamed the empire he’s built with statements made on the record against the exact things he’d been uttering on television. It’s a testament to the fever dream haze of celebrity that Dr. Oz’s defense lies squarely in the ability to prop up his audience, even through pseudoscience. To say that Oz is using a white lie to better the public would be letting him off too easy, however.

Pharma Guy's insight:


Remember, Dr. Jarvik, the erstwhile "real" physician that Pfizer hired to recommend Lipitor in its TV ads back in 2007? Since he was outed as an unlicensed physician (read the story here), the drug industry has been reluctant to use real physicians in TV drug ads (the exception is that Restasis doctor, the sight of whom drives me to flip the channel). 


There are, however, fake doctors portrayed by unknown actors in drug commercials and there used to be famous TV doctors -- e.g., Dr. Geiger played by Mandy Patinkin -- starring in TV drug ads. Haven't seen any of those lately.


You might like to read this: 

While Real Doctors Prescribe Placebos, Fake Docs on TV Prescribe Drugs Off-Label
more...
No comment yet.