Life Science Compliance Update

« Previous article | Home| Next article »

January 12, 2018

Media Has it Out for Pharma…Still

Media

Many would say that the media is no friend to the pharmaceutical industry. However, CNN has recently started to (seemingly) build a case against Avanir Pharmaceuticals for its promotion and marketing of its pseudobulbar affect (PBA) drug, Nuedexta.

In October 2017, CNN published its first article on the subject, where it was noted that the company “aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.” While PBA afflicts less than 1% of Americans, it is most commonly associated with patients who have multiple sclerosis (MS) or ALS.

Then, in December 2017, CNN published another article on the company, once again dinging them for payments made to physicians and alleging that physicians had criminal convictions in their history for illegal prescribing.

According to CNN, Nuedexta's financial success is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company.

Avanir Pharmaceuticals paid nearly 500 doctors to speak or consult on its drug, Nuedexta, between 2013 and 2016, according to government data. Through a review of the top prescribers and top paid physicians in this group, CNN identified a dozen who have been disciplined by state medical boards. These offenses included the harmful treatment of nursing home residents and "grossly negligent acts" involving the inappropriate prescribing of dangerous and addictive drugs -- resulting in probation, suspension, fines and revoked licenses.

Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.

CNN noted that between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. Paying doctors for promotional speaking is legal and is defended as a way for experts in their fields to share important experience and information about medications, but it's long been a controversial practice.  

In an emailed statement, the company said PBA is often "misunderstood" and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. A company website states PBA can afflict up to roughly 40% of dementia patients -- a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts interviewed by CNN, including some of those paid by Avanir.

Avanir said it "vehemently oppose(s) any mischaracterization" of its interactions with physicians and other members of the medical community, explaining that these relationships are ethical and are used as a way to share important information and raise awareness of medical conditions and treatments that could help patients.

In response to the articles, the Pharmaceutical Research and Manufacturers of America, which represents drug makers across the country, said companies should strive to work with speakers who meet ethical and professional standards. "In the rare instance where there is an outlier," the group said on its website, "companies take corrective action."

This is one example of the way the media can use Open Payments to support cases against pharma companies. The ease with which Open Payments can be found highlights the need for companies to vet to whom they give money.

« Previous article | Home| Next article »

Comments

Feed You can follow this conversation by subscribing to the comment feed for this post.

Verify your Comment

Previewing your Comment

This is only a preview. Your comment has not yet been posted.

Working...
Your comment could not be posted. Error type:
Your comment has been saved. Comments are moderated and will not appear until approved by the author. Post another comment

The letters and numbers you entered did not match the image. Please try again.

As a final step before posting your comment, enter the letters and numbers you see in the image below. This prevents automated programs from posting comments.

Having trouble reading this image? View an alternate.

Working...

Post a comment

Comments are moderated, and will not appear until the author has approved them.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
April 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30