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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Do You Have ADHD & Need a Drug or Are You Just Doing Too Much to Handle It All?

Do You Have ADHD & Need a Drug or Are You Just Doing Too Much to Handle It All? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Diagnosing attention deficit hyperactivity disorder can be difficult. The symptoms of the disorder, as defined by the Diagnostic and Statistical Manual, or DSM, have changed multiple times.

 

Even if you know what to look for, many of the symptoms are pretty general, including things like trouble focusing and a tendency to interrupt people. Discerning the difference between people who have a problem and those who are just distracted requires real expertise.

 

Which is why many people were excited when earlier this year a World Health Organization advisory group endorsed a six-question screening test that a study published in the Journal of the American Medical Association reported could reliably identify adults with ADHD.

 

A lot of people were intrigued by the seeming simplicity of the screening. We reported on it, including one implication of the study's findings: that there could be a significant population of U.S. adults with undiagnosed ADHD.

 

But that may not be the case, and even if it is, some ADHD researchers say the six-question screening test is not necessarily the simple diagnostic solution its proponents hope it will be.

 

"Despite the questions put out by WHO and mentioned in JAMA, in America if your talents and temperament don't match your goals and aspirations, that incongruity generates a series of feelings or behaviors that match quite nicely the diagnostic criteria in the DSM-V," explains Dr. Lawrence Diller, a behavioral pediatrician and ADHD specialist who has been following trends in ADHD diagnosis and medication since the mid-1990s.

 

For example, he says, some adult patients meet multiple criteria for ADHD, such as inattention, hyperactivity or impulsivity, but may not have the disorder.

 

"So you meet the criteria, but the question is, 'Are your goals realistic for who you are? Or are you trying to do too much?' " he cautions. "I think this culture absolutely encourages people to do too much."

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Teens Who Take ADHD Drugs Are at HIGH Risk of Substance Abuse Later

Teens Who Take ADHD Drugs Are at HIGH Risk of Substance Abuse Later | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Young children who take Ritalin, Adderall or other stimulant medications for ADHD over an extended period of time early in life are no more at risk for substance abuse in later adolescence than teens without ADHD, according to a University of Michigan study.

The findings also show that teens who start using stimulant medications for attention deficit hyperactivity disorder for a short time later in adolescence — during middle or high school — are at high risk of substance use.

The U-M research is believed to be the first national study to compare early-use and longer-duration stimulant medication therapy with non-stimulant therapy for ADHD.

A large sample size of high school seniors also meant researchers could separate doctor-prescribed ADHD medication use by gender. The results show no gender differences in the overall associations between stimulant medication therapy for ADHD and risk of substance use, said Sean Esteban McCabe, a research professor at the U-M Institute for Research on Women and Gender.

More than 40,000 individuals from 10 cohorts nationwide between 2005 to 2014, answered questions about ADHD medication use and recent substance use as part of the Monitoring the Future study.

Among the findings:

  • Nearly one in eight high school seniors in the United States have used stimulant or non-stimulant medication therapy for ADHD.
  • Males are more likely to use stimulant medication therapy for ADHD, while no gender differences were found for non-stimulant medication therapy.
  • Given that higher substance-use behaviors are associated with later initiation of stimulant medications for ADHD during adolescence, the researchers recommend monitoring this later initiation subgroup carefully for pre-existing risk factors or the onset of substance use behaviors.
Pharma Guy's insight:

Also read: “How #Pharma Targets Kids. Is It Education or Marketing?”; http://sco.lt/8mHpRJ  Also, maybe this "Real [Celebrity] Mom" may reconsider giving her teenage daughter ADHD drugs after reading this; http://bit.ly/1zJ7Axf One more reference: “Marketing Drugs to Teens Online - So Wrong!”; http://bit.ly/1VyNSnx

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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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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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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.

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The ADHD #Pharma | Psychiatrist | Celebrity | Patient Complex

The ADHD #Pharma | Psychiatrist | Celebrity | Patient Complex | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While other books have probed the historical roots of America’s love affair with amphetamines — notably Nicolas Rasmussen’s “On Speed,” published in 2008 — “ADHD Nation: Children, Doctors, Big Pharma, and the Making of an American Epidemic” focuses on an unholy alliance between drugmakers, academic psychiatrists, policy makers and celebrity shills like Glenn Beck that Schwarz brands the “A.D.H.D. industrial complex.” The insidious genius of this alliance, he points out, was selling the disorder rather than the drugs, in the guise of promoting A.D.H.D. “awareness.” By bankrolling studies, cultivating mutually beneficial relationships with psychopharmacologists at prestigious universities like Harvard and laundering its marketing messages through trusted agencies like the World Health Organization, the pharmaceutical industry created what Schwarz aptly terms “a self-affirming circle of science, one that quashed all dissent.”

 

In a narrative that unfolds with the momentum of a thriller, he depicts pediatricians’ waiting rooms snowed under with pharma-funded brochures, parents clamoring to turn their allegedly underachieving children into academic superstars and kids showered with pills whose long-term effects on the developing brain (particularly when taken in combination) are still barely understood. In one especially harrowing section of the book, Schwarz traces the Icarus-like trajectory of Richard Fee, an aspiring medical student who fakes the symptoms of A.D.H.D. to get access to drugs that will help him cope with academic pressure. When he eventually descends into amphetamine psychosis, his father tells his doctor that if he doesn’t stop furnishing his son with Adderall, he’ll die. Two weeks after burning through his supply, Fee hanged himself in a closet.

 

“ADHD Nation” should be required reading for those who seek to understand how a field that once aimed to ameliorate the behavioral problems of children in a broad therapeutic context abdicated its mission to the stockholders of corporations like Shire and Lilly. Schwarz is sounding an alarm for a fire that looks nowhere near abating.

Pharma Guy's insight:

Speaking of celebrities, read "Patient Testimonials aka Anecdotal Experience #Pharma Marketing"; http://www.pharma-mkting.com/news/pmn1308-article01.htm 

 

Meanwhile, not only does Shire, which markets an ADHD treatment, "oversell" the product, it also has been caught marketing it illegally as it did on September 25, 2008, for a video testimonial featuring Ty Pennington posted on youtube.com. See here: http://bit.ly/KnLZqj 

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K.I.R.M. God is Business " From Day One"'s curator insight, June 26, 7:28 AM

There is room and reason for Street legalized pharmacies. There will be more options for customers as well as contract opportunities as well. Which could lower the cost of the drugs or atleast keep them at a fair price. Street cost v. Government cost.

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How #Pharma Targets Kids. Is It Education or Marketing?

How #Pharma Targets Kids. Is It Education or Marketing? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The makers of medical products are finding subtle and sophisticated new ways to target kids — a demographic that can bring them hefty profits now, and could grow up to be loyal, even more lucrative, adult customers.

 

Drug and device companies have been trying to reach kids for decades, but a STAT examination has found that these efforts are taking new forms. Medical companies are bankrolling classroom lesson plans and comic books, hosting events with costumed characters, and promoting smartphone apps. It’s all aimed at teaching children and teens about certain health conditions — conditions for which there just happen to be treatments marketed by the companies sponsoring the outreach.

 

Companies frame their efforts as a service to kids. But they also bring benefits to the company: Children might ask their parents for a certain medicine just as they would a cereal brand. And kids are valuable customers. The percentage of American children and teens taking prescription drugs has stayed fairly steady over the past two decades, but insurance companies are forking over more money for their pills.

 

Some of the initiatives are raising alarm among critics who say they’re indistinguishable from marketing.

 

Here are some of the ways kids are interacting, directly or indirectly, with medical companies.

 

The worksheets prompt high schoolers to report on recent meningitis outbreaks on college campuses, or answer a true-false quiz about the bacterial disease. At the bottom of every page: “Check with your doctor about getting vaccinated,” beside a small Pfizer logo. They’re sponsored by the drug maker, which markets one of two vaccines protecting against meningitis B. (Sally Beatty, a Pfizer spokesperson, said the company works “with a wide range of healthcare providers and health authorities to raise awareness of the disease” and the new availability of vaccines.)

 

This comic book brought to you by Shire

 

The superheroes have names like “Skinderella” and “Gastro.” They hail from a planet shaped like the human body. And they’re the stars of a series of several dozen comic books aimed at explaining medical conditions like ADHD, type 1 diabetes, and growth hormone deficiency.

 

The books are produced by a company called Medikidz, which uses doctors to write and peer-review each edition. More than 3.5 million of the books have been distributed globally. Drug companies (as well as other organizations) often sponsor editions; the sponsor’s logo sometimes appears on the back cover.

 

Sponsors contribute funding and input on storylines. But Adam Schaeffer, a spokesperson for Medikidz, said that all the company’s content is “free of conflict of interest” and that there is never any mention of a specific medication.

 

In practice, the final product tends to be pretty nuanced. Take ADHD, a condition for which many in the medical community worry that kids are overmedicated. An ADHD-themed comic book — sponsored by Shire, which markets several ADHD drugs — does extol the potential benefits of medication, but it also talks about side effects and advocates therapy and counseling.

 

Pharma companies aren’t widely targeting children with drug ads. But a STAT review of ads for over-the-counter acne medicines show that their makers aren’t shy about explicitly targeting teens — particularly during prom season.

 

And that’s caught the attention of the FDA, enough so that the agency launched a study to understand how teens perceive risks and benefits from ads for acne and ADHD drugs [read “FDA To Study DTC Promotion Directed at Adolescents”; http://bit.ly/pmn131002p]. The agency is now analyzing the results and plans to announce what it learns, according to FDA spokeswoman Sarah Peddicord.

 

Then there are the many ads aimed at adults that get seen by kids anyway. Drug industry group PhRMA tells its members that ads “containing content that may be inappropriate for children should be placed in programs or publications that are reasonably expected to draw an audience of approximately 90 percent adults.”

 

That doesn’t always happen. A 2013 study found that children viewed TV ads for erectile dysfunction drugs Viagra, Cialis, and Levitra an estimated 30 billion times between 2006 and 2010 [“Pfizer Reneges on DTC Pledge: Afternoon Viagra Ads Appear on ESPN’; http://bit.ly/1ZfGNY9].

 

Health apps aren’t just collecting your info. They may be selling it, too

 

There are smartphone apps for more serious conditions, too. Drug maker Sanofi has released games aimed at kids with type 1 diabetes, a condition for which it markets treatments. There’s “Monster Manor,” which turns blood glucose monitoring into a game set in a creepy mansion, and “Mission T1D,” which gives players tips about managing their condition as they navigate through a school. [Listen to this podcast interview of Becky Reeve, Head of Professional Relations, Diabetes Franchise Sanofi UK & Ireland: “Pharma-Sponsored Mobile Health Gaming Apps: Sanofi's Mission T1D for Children with Type 1 Diabetes”; http://bit.ly/PMT226

Pharma Guy's insight:

IMHO, whenever a pharmaceutical company engages in "education" about a medical condition for which it has or plans to have a treatment, then that is part of the marketing effort. Most of the money for these programs comes from the marketing budget although it may be in the form of "unrestricted grants." But it's not "unrestrictive" if the sponsors also have input on storylines.

 

Related articles: 

“Will Kids Abandon This Diabetes Mobile Game App from Sanofi Before Reaching Level 2?”; http://sco.lt/5bRCNt

 

“Marketing Drugs to Teens Online - So Wrong!”; http://bit.ly/1VyNSnx

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Don't Blame Canada: FDA Can't See Drug Risks in Its Own Database!

Don't Blame Canada: FDA Can't See Drug Risks in Its Own Database! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
It’s become clear recently that another thing Canada does better than us here in the U.S. is drug safety. A systemic change needs to happen in the U.S.


We first noticed this when we began our work in 2011 to optimize the FDA’s Adverse Event Reporting System (FAERS). As we’ve documented numerous times, raw FAERS data is a real nightmare and nearly impossible for everyday citizens to use, search, and draw meaningful value from. About a year ago FDA launched OpenFDA to make these data a little more accessible, but there are still a number of issues.


By contrast, the Canadian health authorities maintain a simple, easy to use, searchableonline database of drug adverse events reported in Canada.   It’s nothing too fancy, just what you’d expect from a modern online search tool – with data properly mapped and optimized, very recently updated, and immediately accessible.


You know, all the things that FDA somehow isn’t able to do with FAERS.


With these data more readily accessible and available, the Canadian authorities are able to better monitor for drug safety issues. For example, an article in the Globe & Maillast week detailed Canada’s plan to add a suicide label warning on ADHD drugs.


In our analysis of data from FDA’s FAERS database, we see active safety signals on all of the main ADHD drugs for a number of suicide risks (meaning that the reported rate of these adverse events is a lot higher than we’d otherwise expect) and yet no such label changes have been warned or issued in the U.S.


Why? It’s not hard to assume that it has something to do with FDA’s inability to properly access their own FAERS data and identify these risks. We can see them, so why can’t they?

Pharma Guy's insight:


Speaking of ADHD drugs such as Adderall, you might be interested in how this drug is promoted to US citizens using celebrities and even children of celebrities.


Pharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. 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? 


Read the full article here: http://bit.ly/pmn1308-01a 

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The Devil in the Details of Payments to Physicians by ADHD #Pharma Companies

The Devil in the Details of Payments to Physicians by ADHD #Pharma Companies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In total, the 10 pharmaceutical companies I considered (see Table 1), who manufacture and/or market the most popular brand names in the ADHD drug market, as well as their generic counterparts, were reported to have paid approximately $34.6 million in 2013 to prescribing physicians. This number seemed rather small to me given that some of these companies report profits in the billions annually. But also, given that the ADHD drugs they produce are rumored to be the golden goose for many of their bottom lines, I expected I would find that the majority of these 10 companies’ payments reflected efforts to incentivize the popular ADHD drugs prescribed. But this was not the case.


The detailed Open Payments dataset allows one to actually break down the payments not only by how much each pharmaceutical company paid to each provider, but also by what drugs they discussed during the complimentary lunch, or junket to Spain. When I did an analysis exploring the payments received for discussions specifically on ADHD drugs, the total paid by the 10 pharmaceutical companies specifically for the ADHD drugs they sell was only $634,106.91. Yes, according to the Open Payments report we are expected to believe that these 10 ADHD drug companies spent less than 2% of the mere $34.6 million they contributed to dowry gifts pertaining to ADHD drug promotion.

Pharma Guy's insight:


The author of this piece (Michael Corrigan, Ed.D.) says he "came to the conclusion that we shouldn’t assume the 'Open' Payments report is actually forthcoming when it comes to how much money and courtship was put toward incentivizing doctors to prescribe ADHD drugs for kids."


Dr. Corrigan is a psychologist, author, statistician, and professor whose mission is to "discredit the mythic propaganda and doodoo behind the ADHD diagnosis and the dangerous drugs so often prescribed."

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Shire to pay $56.5 million to settle improper marketing probe

Shire to pay $56.5 million to settle improper marketing probe | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Shire Plc, which is in the process of being acquired by AbbVie Inc, has agreed to pay $56.5 million (34.5 million pounds) to resolve allegations of making false claims in themarketing of its ADHD drug Adderall XR and other medicines, the U.S. Justice Department said on Wednesday.


The settlement involved charges that Ireland-based Shire, between January 2004 and December 2007, promoted its extended release Adderall with claims of superiority over rival medicines that were not supported by clinical data, the Justice Department said.


The company was also accused of promoting the drug for unapproved uses and of making other false claims not supported by data, such as that Adderall XR would prevent poor academic performance, loss of employment, criminal behaviour, traffic accidents, and sexually transmitted disease.

Pharma Guy's insight:


Meanwhile, you might like to read how Shire marketing is "reeling" in parents and children to consider ADHD treatment: 

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