Wednesday, November 19, 2014

Cost to Bring a New Drug to Market Is $2.6 Billion According to Tufts - 3X More Than in 2003!

According to a new study by the Tufts Center for the Study of Drug Development (CSDD), which receives funding from the pharmaceutical industry, the estimated cost to develop a new Rx drug for marketing in the U.S. is $2,558 million or $2.6 billion (see press release). That 3.25 times the $800 previously estimated and frequently cited by the pharmaceutical industry, pharma trade publications, and the general media.

I have tackled the estimated $800 million drug develop cost gorilla before and garnered a lot of comments from readers, including Dr. Joseph DiMasi, whose team at Tufts came up with that number way back in 2003 (for more on that, read "Tufts Hangs Tough on Opportunity Cost Analysis").

It's about time CSDD threw out the old number and came up with a new, much larger number! But Tufts is not the only academics who have tackled the problem. As I reported in 2011, the London School of Economics and Political Science (LSEPS) cam sup with quite a different - much lower! - estimate of $59 million (see "A New Estimate of Drug Development Cost") and the Office of Health Economics (OHE) at the University College London estimated the cost to be $1.5 billion in 2013 (see here).

These various historic estimates are summarized in the following chart:

Click on chart for an enlarged view.
No doubt the new Tufts estimate will reign supreme in coming PR campaigns launched by the pharmaceutical industry and repeated ad naseum in the press.

You'll never guess who said the oft-cited 2003 Tufts estimate was  "one of the great myths of the industry".

Wednesday, November 12, 2014

FDA Plans DTC TV Ad Torture Test!

The FDA plans to to study the "Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads" (see Federal register Notice).

"Generally," says FDA, "it has been argued that first exposure to an ad results in attention, second exposure affects learning of the advertised message, and third and subsequent exposures reinforce the learning effects of the second exposure. To our knowledge, the literature concerning ad exposure frequency has not been extended to include specific attention to prescription drug ads."

To fill that void, FDA's Office of Prescription Drug Promotion OPDP) plans to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads.

The experimental design calls for volunteers to be randomly assigned to view a prescription drug ad one, three, or six times as part of "clutter reels" embedded in a 42 minute TV program.

My concept of a volunteer participating in this study is shown on the image above.

Guess how many "volunteers" FDA plans to torture in this experiment.

Tuesday, November 11, 2014

Taking Social Media Listening a Step Too Far

Today, I learned about a Twitter app called Samaritans Radar that was "pulled" because it took social media "listening" a step too far. According to a petition (here), the app "breaches people’s privacy by collecting, processing and sharing sensitive information about their emotional and mental health status."

"Samaritans Radar is a surveillance system that collects people’s tweets, analyses them to judge whether the person may be vulnerable or in distress, and then sends emails to people’s Twitter followers alerting them to that fact. This happens without the knowledge or consent of the people whose tweets are being collected and analysed by the Samaritans. As of 30 October 2014, Samaritans Radar was monitoring and analysing over 900,000 Twitter accounts.

"Anyone can sign up to receive an email when someone appears to be sensitive or in crisis," noted the petitioner. "While this could be used legitimately by a friend to offer help, it also gives stalkers and bullies and opportunity to increase their levels of abuse at a time when their targets are especially down. Just as bad, not everyone apparently wanting to help may be able to do so effectively or has the person’s best interests at heart."

Wow! Talk about the road to hell being paved with good intentions!

The "creative" agency that designed the app may have been part of the problem suggests a article. Why?

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