Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Shire to Defend Its Binge Eating Disorder Screener at 2016 APA Annual Meeting

Shire to Defend Its Binge Eating Disorder Screener at 2016 APA Annual Meeting | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shire will present new research on Binge Eating Disorder (B.E.D.) and Attention-Deficit/Hyperactivity Disorder (ADHD) at the upcoming 169th Annual Meeting of the American Psychiatric Association (APA) in Atlanta, GA, demonstrating its ongoing commitment to furthering the understanding and management of psychiatric disorders.

 

“The data being presented this year at APA will address several important topics within the adult psychiatry therapeutic area, including the characterization of eating behaviors in adults with binge eating disorder, as well as patterns of prescription medication use in two psychiatric disorders,” said Barry K. Herman, MD, MMM, DLFAPA, Global Medical Team Lead, Senior Medical Director for Shire. “These presentations underscore our long-standing commitment to furthering knowledge of psychiatric conditions and advancing research into the unmet needs of people with B.E.D. and ADHD.”

 

Posters presented during the conference will include:

 

Poster Number P6-048; Monday, May 16, 2:00pm EDT: The Use and Value of the 7-Item Binge Eating Disorder Screener in Clinical Practice; Presented by Barry K. Herman, MD, MMM, DLFAPA

 

“Continued research on binge eating disorder in adults is crucial to expanding our understanding of the disorder,” said Cynthia Bulik, PhD, FAED, Distinguished Professor of Eating Disorders, Department of Psychiatry, University of North Carolina at Chapel Hill, and co-author of P6-136. “We value our collaboration with Shire to enhance efforts to educate health care professionals who evaluate adults living with B.E.D.”

Pharma Guy's insight:

Shire makes it easy for anyone to convince their docs to prescribe Vyvanse for their B.E.D. (Binge Eating Disorder), which I described in Pharma Marketing Blog: "How Virtually Anyone Can Get an Rx for Amphetamine... Sorry, I Meant to Say Vyvanse"

 

Shire's B.E.D. symptom checklist, IMHO, is a perfect aid for people who wish to abuse a dangerous Schedule II controlled stimulant.

 

According to my more or less truthful answers to the screener, I may suffer from B.E.D. and be able to convince my doc to prescribe me Vyvanse. 

 

I suggested (http://bit.ly/BEDchecklist) that Shire remove this tool from its website to prevent possible abuse of this medication, but now I see Shire wants to "prove" to the medical community that this bogus test has value in clinical practice!

 

"The strategy for a new drug to treat binge-eating disorder reveals how a pharmaceutical company can influence the treatment of a medical condition," said Dr. Lawrence H. Diller, a behavioral pediatrician in Walnut Creek, Calif. Read: "Shire Makes It Easy for the Public to Learn About the ‘Glories of Amphetamine’"; http://sco.lt/7xiqtl 

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Shire Makes It Easy for the Public to Learn About the "Glories of Amphetamine"

Shire Makes It Easy for the Public to Learn About the "Glories of Amphetamine" | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The strategy for a new drug to treat binge-eating disorder reveals how a pharmaceutical company can influence the treatment of a medical condition.


With the approval of Vyvanse for binge eating, “now we have another reason for the public to learn about the glories of amphetamine — it’s very worrisome,” said Dr. Lawrence H. Diller, a behavioral pediatrician in Walnut Creek, Calif., who has written about A.D.H.D. drugs. “My hat’s off to Shire. They’ve done it again.”


[The image shows a 1954 advertisement for an methamphetamine-based appetite control drug called Opidice. Shire's new drug Vyvanse also uses a type of amphetamine.]


Dr. Diller and others said Shire appeared to be following a familiar drug industry playbook by promoting awareness of a disorder, in this case binge eating, before more directly marketing its treatment. A company website, BingeEatingDisorder.com, makes no mention of Vyvanse but provides detailed information about how to talk about the disorder with a doctor, including a printable symptom checklist and sample opening lines to start the conversation. The site also tells patients “don’t give up” if a doctor initially resists.


Pharma Guy's insight:


Shire also makes it easy for anyone to convince their docs to prescribe Vyvanse for their B.E.D. (Binge Eating Disorder), which I described in Pharma Marketing Blog 3 weeks ago: "How Virtually Anyone Can Get an Rx for Amphetamine... Sorry, I Meant to Say Vyvanse"


BTW, this story illustrates how major news sources like the NYT and WSJ follow the lead of bloggers like me rather than vice versa. I wrote about this on Feb 5. The NYT writes about it on Feb 24 and the WSJ (Pharmalot) writes about what the NYT wrote on Feb 25. Argggh!

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How to Use Shire's Binge Eating Disorder Symptom Checklist to Score a Controlled Substance Rx

How to Use Shire's Binge Eating Disorder Symptom Checklist to Score a Controlled Substance Rx | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After writing yesterday's blog post about Monica Seles helping Shire promote Vyvanse for Binge Eating Disorder (B.E.D.), which is a new indication for the ADHD drug, I wondered if this would make it easier for young people to obtain prescriptions for Vyvanse, which is a Schedule II controlled substance with a high potential for abuse.

Like overweight college students, I too could use a little "pick me up" pill from time to time.

Since there is no lab test to confirm a B.E.D. diagnosis, all I have to do to get a prescription for Vyvanse is convince a doctor that I meet all of the DSM-5® diagnostic criteria for binge eating disorder, which Shire provides here on the BingeEatingDisorder.com website.


Anyone can use Shire's handy "Binge Eating Disorder (B.E.D.) Symptom Checklist," which you can find on the "Talking With Your Doctor" page where "Starting the Conversation Is Key." 

It's easy to use the Checklist and get a printout (pdf file) to bring to your doctor. Here's how I filled in the Checklist and the advice I got from Shire on "starting the conversation" with my doctor - a surefire way of getting a prescription for Vyvanse and the boost I need during my busy day.


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Pharma Guy's insight:


This is not the first time Shire has used a symptom checklist to get people to visit their doctor and get their drug. Key to Shire's "Keep Momming" campaign is to get site visitors to take the "Symptom Checklist" (here) and bring the results to their doctor. "If you’re concerned your daughter might have ADHD [and who wouldn't be after watching the videos?], complete the ADHD Symptom Checklist based on her symptoms for the past 6 months, and share the results with her doctor."

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Article: Online e-Patient & Celebrity Patient Video Testimonials: Anecdotal Experience Marketing

Article: Online e-Patient & Celebrity Patient Video Testimonials: Anecdotal Experience Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it
This article asks the question: Can anecdotal 'evidence'/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects?
Pharma Guy's insight:


Topics include (partial list):

  • Real Stories from Real Moms & Daughters
  • Symptoms & Undocumented Anecdotal Evidence
  • The Selling of ADHD and Ethics of Disease Awareness Advertising
  • Persuasive Celebrity Patient Video Testimonials
  • Overstating Efficacy
  • Declaration of Health Data Rights
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Is It Alzheimer's Disease or ADHD? Whatever! A New Market for Vyvanse.

Is It Alzheimer's Disease or ADHD? Whatever! A New Market for Vyvanse. | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Once seen as a disorder affecting mainly children and young adults, attention deficit hyperactivity disorder is increasingly understood to last throughout one’s lifetime.

In 2012, in one of the only epidemiological studies done on A.D.H.D. in older adults, a large Dutch population study found the condition in close to 3 percent of people over 60.

Yet we know little about how A.D.H.D. affects older people, or even who has it.

“We hardly have any literature,” said Dr. Thomas Brown, associate director of the Yale Clinic for Attention and Related Disorders at the Yale School of Medicine. Almost none of the clinical trials and epidemiological studies on A.D.H.D. have included people over 50. “But I see quite a few people turning up in my office with these complaints. It’s reasonable to assume that a lot of elderly people have A.D.H.D.”

Heightened awareness of A.D.H.D. is bringing increased referrals of elderly adults to specialty clinics. “A child had been treated, then a parent, then everyone started looking at Grandpa, and saying, ‘Oh my gosh,’ and they would bring him in,” said Dr. Martin Wetzel, associate clinical professor of psychiatry at the University of Nebraska Medical Center.

Yet many general practitioners and mental health experts mistake symptoms like impaired short-term memory or an inability to stay focused on a task as something else.

“We do a horrible job of training health care professionals about adult A.D.H.D.,” Dr. Wetzel said.
Pharma Guy's insight:

This article could have been written by Shire, which has been trying to make a case for treating ADHD in adults for a long time. Read, for example, Shane Victorino: Adult ADHD Poster Boy;  http://bit.ly/pgdaily121513-1C I'm sure many docs read read the Well blog (the origin of this piece) and be convinced to prescribe Vyvanse off-label to treat elderly patients who they originally thought had early signs of Alzheimer's Disease.  

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Shire Needs to "Educate" Consumers & Physicians About BED, Analyst Says

Shire Needs to "Educate" Consumers & Physicians About BED, Analyst Says | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shire's ADHD treatment Vyvanse won a label expansion into treating moderatetosevere bingeeating disorder BED Friday. One analyst says that disease awareness and detailing efforts are crucial to the drugs commercial plans in the category.


Jefferies analyst David Steinberg wrote in an investor note Monday morning that he estimates the US patient population for BED at 2.8 million and that unmet need in the category is substantial. He added that the drug's success largely hinges on Shire's ability to spread awareness of the disorder and its patient and physician education efforts.


Steinberg expects the Dublin-based drugmaker's commercial strategy to focus on “physician and patient education with substantial early efforts focused on disease awareness, unmet patient and physician detailing.” He noted that the second step in Shire's marketing plan is likely a DTC campaign.


Steinberg also expressed some confidence that Shire will be able to make this expansion a commercially successful one. “While this market will largely need to be ‘built' from the group up, Shire has a strong track record in this regard—as evidenced by its key role in establishing the ADHD (Adderall and Vyvanse franchises) category,” he explained, estimating sales of $24 million in 2015 and $73 million in 2016.

Pharma Guy's insight:


I think it's less a matter of "education" and more of a matter of "convincing" docs to prescribe Vyvanse to any tom, dick, or harriette patient who walks in the door with Shire's "Symptom Checklist." For more on that read: How Virtually Anyone Can Get an Rx for Amphetamine... Sorry, I Meant to Say Vyvanse

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Shire & Seles Team up in B.E.D. to Promote Vyvanse. Celebrity Endorsement at Its Worst!

Shire & Seles Team up in B.E.D. to Promote Vyvanse. Celebrity Endorsement at Its Worst! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

OMG! Is there nothing old athletes won't do for money?

Remember Monica Seles who was famously stabbed on the tennis court in 1993? No? OK, whatever. She's celebrity enough to hawk for Shire, which recently won PRIORITY approval from the FDA for a new indication for Vyvanse, it's ADHD drug:

Binge Eating Disorder or B.E.D.

According to Seles & Shire, which is hosting the website BingeEatingDisorder.com ("A Resource for Understanding B.E.D. in Adults"):

"Binge Eating Disorder (B.E.D.) is not just overeating. It is a real medical condition [my emphasis] that was formally recognized in 2013. B.E.D. is the most common eating disorder among US adults."

How many times have you heard the phrase "It is a real medical condition" before? Aside from Seles & Shire, who says B.E.D. is a real medical condition? Who "formally recognized" it in 2013 (just in time for Shire to ask for FDA approval)?


To find out, read more here.

Pharma Guy's insight:


This reminds me of another sports celebrity endorser: Is Phil Mickelson Shilling for Enbrel?

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Are Patient Stories Becoming Anecdotal "Evidence" in Pharma Marketing Campaigns?

Are Patient Stories Becoming Anecdotal "Evidence" in Pharma Marketing Campaigns? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Social media and real patient stories are a "match made in heaven." Combine that with a celebrity spokesperson who is also a patient or a caretaker of a patient and you got gold! 

That's how I see campaigns such as Shire's "Keep Momming," which was featured in the September 2014 issue of MM&M. According to the article (find it here), "The unbranded 'Keep Momming' campaign has more of a straightforward educational thrust: It seeks to help mothers better identify the symptoms of ADHD in young girls and to make them more cognizant of the inattentiveness aspects of ADHD (as opposed to the easier-to-spot hyperactivity ones)."

Shire, you may recall, markets Vyvanse, a drug indicated for the treatment of ADHD in children and in adults.

This campaign includes a celebrity spokesperson: actress, singer, and NFL wife, Holly Elizabeth Robinson Peete who says her daughter has ADHD. Her story is featured in a video on Shire's KeepMomming.com Website, the title of which is "Real Stories from Real Moms & Daughters."

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Keith McGuinness's curator insight, September 19, 2014 2:52 PM

This article is not about mbHealth per se.  But it describes how mbHealth apps are being sold to us.  Most of what glitters is not gold.  But then again, who really knows; all of the evidence is anecdotal.