SFGate.com City Brights Blog
By Winston Chung, Child Psychiatrist
May 24, 2011
Psychiatrists convened in sunny Honolulu for the 164th Annual Meeting of the American Psychiatric Association (APA) last week, discussing, among other things, moving forward with plans to make the diagnostic criteria for ADHD less stringent: proposed changes include reducing the number of required symptoms from 6 to 4, for adults and teens, and increasing the age-of-onset criteria from 7 to 12.
Russell Barkley, Ph.D., and Joseph Biederman, M.D., have written about abandoning or generously broadening age-of-onset criteria, arguing that the current, precise age-of-onset criteria poses “unwarranted practical problems for the study of older adolescents and adults.” These two men are considered ADHD experts and contributed to the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ADHD, which serve as guidelines by which most child psychiatrists practice.
According to a story from the New York Times, Joseph Biederman did not tell university officials about more than a million dollars received from drugmakers from 2000 to 2007, and he promised Johnson & Johnson research results that would benefit the drug company. On the list of AACAP Conflicts of Interests for Practice Parameters not listed in the Practice Parameters, Russell Barkley receives or has received research support, acted as a consultant and/or served on a speaker’s bureau for Eli Lilly and Company and Shire Pharmaceuticals Group.
Shire Pharmaceuticals Group has a substantial focus on ADHD meds, and they have been pulling out all the stops to try and turn a profit in the face of competition from generic drugs.
Earlier this month, Reuter’s Health described how drugmakers, including Shire, have raised prices to make up for lack of new products and loss of patent protection.
“Prices were just shoved up every year to make more money and meet earnings, to be blunt,” Shire (SHP.L) Chief Executive Angus Russell said.
Shire’s CEO also indicated that the FDA is supporting their plan to study the use of their ADHD drug, Vyvanse, for use in depression and schizophrenia, hoping for billions of dollars in extra sales through expansion of potential indications. Amphetamines for schizophrenia? Hmmmm…..
Jim Edwards of BNET wrote about Shire increasing the price of one of their own ADHD drugs, Adderall XR, to encourage users to switch to their branded, cheaper and newer ADHD drug, Vyvanse, leading to increased sales.
Shire somehow sold more ADHD drugs during a recent, national shortage of ADHD medications – their sales of Adderall XR increased 21 percent in the first quarter of 2011 – a time when many of the patients in San Francisco’s public mental health system were unable to receive their regular ADHD medications.
BNET posted excerpts of separate lawsuits filed by Impax and Teva, manufacturers of generic forms of Adderall XR. They claim that Shire did not honor their contracts and hoarded product for themselves during this recent shortage. In the Wall Street Journal, the associate director of FDA’s drug shortages program reported that this national ADHD drug shortage mostly affected generic forms of ADHD meds. Coincidence?
Other ways of getting around stagnant drug development and generic competition include taking an old drug or active ingredient, and changing the delivery system or duration of action and presenting it as a new, patent-protected product. Here are a few examples that have been associated with Shire:
- Vyvanse: Also known as lisdexamfetamine, Vyvanse is a prodrug of dextroamphetamine. Dextroamphetamine has been used since 1937 to treat hyperactivity in children, so it is hardly new. Vyvanse was marketed as having lower abuse potential – specifically, preventing abuse from snorting, since the prodrug requires digestion to release the active form. In my clinical experience, most abuse of stimulants is due to people taking it without a prescription or shaping their symptoms to get a prescription, and a prodrug likely does little to curb college students from seeking stimulants to study for exams.
- Daytrana: The transdermal methylphenidate (methylphenidate is the active ingredient in Ritalin) patch is worn on the skin and was developed as a way of bypassing the digestive tract, and my experience prescribing this drug was met with equivocal reports from patients and families. I guess there is a reason I can’t remember anyone saying it worked – Shire gave up on the ADHD patch after 9 product recalls and a federal probe.
- Intuniv: An extended release form of guanfacine, Intuniv is touted as a new, non-stimulant treatment for ADHD. But child psychiatrists have been using guanfacine in ADHD for years, and this ‘extended-release’ form has a half-life of about 18 hours, while generic guanfacine has a half-life of about 17 hours – not a robust difference, in my opinion.
I liken these approaches to gimmicks utilized in the mass-produced, beer market: color changing labels to let you know if your beer is cold, wide-mouth beer cans, or vortex bottles. Do any of these ‘innovations’ really change the fact that you’re drinking cheap beer?
As the DSM-V looms closer to becoming a reality, I can’t help but think of words from the man who chaired the committee for the DSM-IV. Allen Frances, M.D., wrote in the in the LA Times:
As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.
Our panel tried hard to be conservative and careful but inadvertently contributed to three false ‘epidemics’ – attention deficit disorder, autism and childhood bipolar disorder. Clearly, our net was cast too wide and captured many ‘patients’ who might have been far better off never entering the mental health system.
The DSM-IV was and the DSM-V will be published by the APA. The same APA that, in 2010, rejected internal recommendations – led by an APA past-president – to regulate or curtail individual psychiatrists’ relationships with the pharmaceutical industry.
Loosening the diagnostic criteria for ADHD, as proposed, will no doubt lead to more people being diagnosed and, inevitably, taking more ADHD drugs. I like to think that the APA and their doctors pushing for the changes are motivated by helping patients and not drug company profits.
After all, if anyone can identify and address unconscious conflicts or psychologically-defended, aggressive drives, it’s a psychiatrist, right?
Read article here: http://www.sfgate.com/cgi-bin/blogs/wchung/detail?entry_id=89494
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Why Drug Companies Are Shy About Sharing On Facebook
Tuesday, August 23rd, 2011NPR – August 22, 2011
by Nancy Shute
Drug firms fear that being "liked" on Facebook could get them in trouble with the FDA. iStock photo
People love how Facebooklets them comment on and share other people’s posts. But the idea of sharing on social media has got drug companies scared. When Facebook told drugmakers that they had to start allowing comments on their Facebook pages, some of those pages started disappearing.
“Take On Depression” suddenly disappeared. “ADHD Moms” vanished, too. So did “Epilepsy Advocate.” In the past, drug companies had been reluctant to create Facebook pages without a guarantee that they’d be closed to public comments — a unique accommodation on Facebook’s part. But that accommodation ended last week.
Diabetes blogger Amy Tenderichthinks it’s high time the drug companies quit walling themselves off. She’s the founder of Diabetest Mine, an independent site. She says: “The notion that they would be able to be able to put up these Facebook pages and then close them off to comments is ridiculous.”
On her site, people with diabetes comment a lot. They share information on what drugs they’re taking, give each other advices on dosages, and tell people which drugs are working for them, and which are causing side effects. For Tenderich and others, the whole point of social media like Facebook and Twitter is to comment on other people’s posts.
But drug companies have to play by different rules. The Food and Drug Administration requires that each a drug manufacturer mentions a prescription drug, they also have to list its risks and side effects. That’s called fair balance.
“You see some of those magazine ads that are three and four pages long and you wonder why they are?” asks Tony Jewell, who supervises drugmaker AstraZeneca’s social media efforts. “It’s because we’re communicating the full risks, benefits and appropriate use of the medicine. That’s a little bit harder to do in a social media channel like Facebook and Twitter.”
One big reason companies cite for killing Facebook pages is that they wouldn’t be able to adequately police comments with inaccurate information about prescription drugs.
“So they might say, ‘Lipitor’s great at whitening your teeth,’ which it’s not approved to do,” says Jonathan Richman. That’s his example of a potentially dicey comment. He’s a group director for the Possible Worldwide ad agency in Cincinnati, and he closely follows the drug industry’s social media efforts on his Dose of Digital blog. “The question becomes, What’s Pfizer’s liability? What action could the FDA take, based on somebody else posting that?”
So far, the FDA hasn’t come down on a single drug company for allowing public comments. The only action the agency has taken against use of social media was last year, when it warnedNovartis that a Facebook “share” widget for the leukemia drug Tasignaviolated fair balance.
But the FDA also hasn’t told the companies how to use social media and still follow the “fair balance” rule. In November 2009, the agency held public hearingson how pharma companies should use social media. But the FDA has yet to issue official guidance. Jewell says that because of that, his employer and other companies are erring on the side of caution.
Tenderich says patients would benefit from a rich interaction with drug makers. She sees more and more drug company employees interacting on her site, giving advice on behalf of their employers. That’s a huge benefit for patients, she says.
The pharmaceutical companies could benefit, too, she says, by learning what problems patients are having with drugs, and how to make them better.
“They could get so much fantastic, free, very high-value feedback,” she says.
http://www.npr.org/blogs/health/2011/08/22/139859210/why-drug-companies-are-shy-about-sharing-on-facebook?ps=sh_sthdl
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Tags: ADHD Moms, comments, Drug companies, drugmakers, Facebook, FDA, Take on Depression
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