Shire hikes Adderall price as rumors fly

Amid new speculation that Pfizer might snag Shire in a buyout deal, the specialty pharma is following through on its strategy to switch patients to its newest ADHD med Vyvanse as blockbuster Adderall XR nears the end of its patent. Shire is hiking the price of Adderall by 20 percent, a boost that confounded analysts expecting a smaller increase.

The idea, of course, is that by making Adderall more expensive, Shire will shine the spotlight on Vyvanse, whose price is rising by a mere 7 percent. Cost-conscious patients will then switch to the cheaper brand, or so the theory goes. Then, firmly entrenched as Vyvanse users, the patients won’t move to generic Adderall when it hits the market.

Analysts apparently expect the switching to stick; Citigroup upgraded Shire stock on the prospect. But with insurers increasingly vigilant about drug prices, generic Adderall might woo away more Vyvanse users than Shire wants to lose. We’ll have to wait and see how that plays out.

In the meantime, though, investors are bidding up Shire stock on fresh rumors that Pfizer is kicking tires there. The U.K. company surfaces as a rumored Pfizer target from time to time, however, so it’s tough to know whether Pfizer is actually looking, or whether the habitual talk simply got stirred up when Pfizer chief Jeff Kindler made his “open to big deals” statement earlier this week.

Shire’s press release further states that:

The screening initiative, launched in Atlanta, GA, is designed to help raise awareness that ADHD is not just a childhood disorder. Research shows it is estimated that up to 65 percent of children with ADHD will continue to exhibit symptoms into adulthood. Adults who think they may have ADHD can take the first step toward recognizing the symptoms of the disorder by answering the 6-question World Health Organization (W.H.O.) adult ADHD screener. The screening initiative, known as the "RoADHD Trip," is housed, transported and anchored by the RoADHD Trip Tractor Trailer which expands into a tented area housing eight self-screening stations.

“Shire developed this mobile screening initiative as a forum to educate the public about ADHD in adults and provide information and resources to individuals about this disorder," said Gerardo Torres, M.D., Vice President and Scientific Lead, of Shire’s ADHD Business Unit. "This program demonstrates Shire’s on-going commitment to providing information for those who may be struggling with the symptoms of ADHD."

In each of the 13 cities, Shire is partnering with the Attention Deficit Disorder Association (ADDA), a leading adult ADHD patient advocacy organization, in an effort to assist up to 20,000 adults to self-screen for this disorder. Volunteers from ADDA will also be on-site to answer questions about ADHD in adults and to provide information about their organization. The W.H.O. adult ADHD screener, a questionnaire that is used to help recognize the symptoms of ADHD, will be available via on-site computers to help facilitate self evaluations. The W.H.O. screener is not designed to provide a diagnosis of ADHD but may provide information to participants regarding the symptoms of ADHD. Participants should discuss any questions they have regarding the W.H.O. screener results and other concerns about ADHD with their physician.

"Seeking information and speaking to qualified health care professionals are critical steps to diagnosis and management of ADHD," further explained Dr. Torres. "This initiative is an important first step to encourage that dialogue between patients and their physicians."

This should leave Shire’s competitors slapping their foreheads saying, “Why didn’t I think of this!”

Shire currently markets ADHD stimulant medication, Adderall. Adderall’s instant release formula is now available as a generic drug. The report states that Shire´s ADHD drugs will be dominate this market by 2017. The report attributes this, at least in part, to Shire’s launch of Vyvanse´s, a new ADHD drug which has been approved for both children and adults. Vyvanse may lower abuse potential compared with other psycho-stimulants on the market. The Pharmacor report predicts that Vyvanse will generate almost $ 1.2 billion dollars in sales in 2017.

Shire’s ability to take the lead, according to the report, will be because of Shire’s Vyvanse and its patch sold as Daytrana. Additionally, Shire is pursuing a non-stimulant medication called Intuniv that will compete with Lily’s Strattera and secure dominance in the burgeoning international ADHD market projected to be worth $4 billion.

To facilitate continued sales increases and increased market share, all major pharmaceutical companies are marketing heavily in countries that traditionally have not accepted ADHD as a neurobiological disorder or treated it with medication.

Apparently one student had the drugs, gave one to another student who swallowed it and was taken ill. The sick student was then taken to the hospital and released. Other students were involved in the safekeeping of the drugs after they were brought to school.

The student that brought the drugs (Strattera and Concerta for treatment of ADHD) attempted to trade the drugs for alcohol.

The Denver Post says,

Two of the students have been charged with distribution and possession of a schedule II controlled substance and unlawful acts while the third was charged with possession of a controlled substance and unlawful act. Possession and distribution of a schedule II controlled substance is a felony, officials said.

While these students were apprehended, the incidence of ADHD drug sales and use is quite common among students at middle school, high school, and university.

The New York Times (www.nytimes.com) reported in 2005 in an article called The Adderall Advantage that:

At many colleges across the country, the ingredients for academic success now include a steady flow of analeptics, the class of prescription amphetamines that is used to treat attention deficit hyperactivity disorder [ADHD].

Since Ritalin abuse first hit the radar screen several years ago, the reliance on prescription stimulants to enhance performance has risen, becoming almost as commonplace as No-Doz, Red Bull and maybe even caffeine. As many as 20 percent of college students have used Ritalin or Adderall to study, write papers and take exams, according to recent surveys focused on individual campuses. A study released this month by the National Center on Addiction and Substance Abuse at Columbia found that the number of teenagers who admit to abusing prescription medications tripled from 1992 to 2003, while in the general population such abuse had doubled.

Dr. Robert A. Winfield, director of University Health Service at the University of Michigan, Ann Arbor, sees a growing number of students who falsely claim to be A.D.H.D. so they can get a prescription. At least once a week, a jittery, frightened, sleep-deprived student who has taken too many tablets for too many days shows up at his office. “Things have really gotten out of hand in the last four to five years,” he said. “Students have become convinced that this will help them achieve academic success.”

On campus, the drugs are either sold or given away by people with prescriptions, or they are procured by students who have learned to navigate the psychiatric exams offered by campus health centers, which usually provide the drugs at a discount. Unlike Ritalin, two newer members of the family of analeptics – Adderall and Concerta – come in time-release forms and can keep a patient medicated an entire day.

Louisiana State’s The Daily Reveille (www. media.www.lsureveille.com) reported that a survey documented in the journal Nature cites that one in five students used Adderall & Ritalin for a study booster.

Final exams traditionally have students studying long hours to cram for their final exams. But some students are now using a quick-fix for brain retention.

One in five respondents of adult professionals said they have used drugs to enhance brain power, according to a January survey in Nature journal. The online survey polled 1,400 people in 60 countries.

Ritalin and Adderall were the two drugs participants said they took.

Ritalin and Adderall are commonly used to treat attention-deficit hyperactivity disorder. They are also used to treat symptoms of narcolepsy and chronic fatigue syndrome. The stimulants are supposed to reduce impulsive behavior and facilitate concentration.

But people diagnosed with ADHD are not the only ones who can benefit from the drugs.

“It does work [for anyone]. We know that from lab studies,” said Martha Farah, director of the Center for Cognitive Neuroscience at the University of Pennsylvania, according to CNN.com

This is an international phenomenon. The reason is that low-dose stimulant medication is not a targeted approach to fixing ADHD. Instead, low-dose stimulant medication works the same for non-ADHD students. Here’s an example: if we have 50 ADHD students and 50 high functioning non-ADHD students, give them both a boring task, the both will perform better on that task.

Students know this and it helps the cram for exams. Will it help to prosecute all these students under felony charges? Not likely.

Research suggests that ADHD drivers have a greater likelihood of having or causing an accident. Obviously, hallmarks of the ‘disorder’ are inattention, distractibility, and sometimes hyperactivity. So, when their cell phone rings and they answer, bad things tend to happen.

According to Daniel Cox, Ph.D., professor of psychiatry and neurosciences at the University of Virginia Health System, as a group young ADHD drivers are two to four times more likely to have a car accident than non-ADHD drivers. Cox’ research will examine the effects of methylphenidate (MPH), a controlled-release stimulant worn as a patch, on young ADHD drivers facing real-life distractions.

This is rather clever marketing as the research is funded by Shire Pharmaceuticals, the pharmaceutical mega-giant who makes Adderall and the MPH patch. As I’ve stated before, it’s always questionable when a pharmaceutical giant funds a university study on its own medications. In this instance, it will make great marketing if the good Dr. Cox finds that young adults drive better while on meds! But, heck, since stimulant medication has the same effect on non-ADHD people, shouldn’t we all take it prior to driving? Regardless of that fact, if young ADHD people can wear a patch and drive better, that’ll sell millions of dollars worth of medicine!

The study would likely be significantly more impressive if Dr. Cox used unmedicated non-ADHD young adults and medicated non-ADHD young adults as control groups. I’d be more than eager to see those results.

Or maybe, just maybe, ADHD or not, we should put our cell phones away, put out our cigarettes, not eat in the car, put our pet in a pet carrier, and focus on driving. Shouldn’t we demand that of our ADHD teens before placing a stimulant patch on their arms? 

In research published in Pediatrics, [December 2007; vol 120: pp 1494-1501], lead author, Almut G. Winterstein, PhD, assistant professor of pharmacy health care administration, University of Florida College of Pharmacy, Jacksonville, found that common stimulants used to treat attention deficit hyperactivity disorder (ADHD) don’t often cause serious heart complications in children. However, she warns that their safety is undetermined for prolonged use.

Winterstein found that stimulants such as Ritalin, Adderall, and Concerta frequently raise blood pressure and heart rate. The researchers analyzed health records from 55,000 children and teens newly diagnosed with ADHD from 1994 to 2004 with two significant findings:

1. Children who used stimulant medication had a 20% increase in visits to hospital ERs or doctors’ offices for heart palpitations and racing heartbeat, compared with children who didn’t use stimulant medication.
2. Stimulant medications did not appear to be associated with an increase in hospitalizations or deaths due to cardiac causes.

Last year the FDA took a special interest in the matter of heart safety when it announced a special Black Box advisory to be placed on stimulant medication. This was in part due to reports of the sudden deaths of 12 children who used ADHD Drug, Adderall.

The Canadian government quickly suspended sales of Adderall XR in Canada, but later permitted sales after further investigation.

Winterstein, PhD, in an interview with WebMD, notes:

… that because serious cardiac events are so rare among children and teens, a much larger study is needed to confirm the safety of these drugs.

“We can’t really say that there is no increase in risk (for serious cardiac events) among children who take these drugs,” she says. “What we can say is that if there is an increase in risk, it will not affect a large number of children.”

ADHD Drugs and Heart Risk

The CDC estimates that 4.4 million children between the ages of 4 and 17 have been diagnosed with ADHD, and as of 2003, 2.5 million were taking medication for it.

Children are increasingly taking the drugs for longer and longer periods, but little is known about their long-term cardiovascular impact, Winterstein says.

“The average exposure in our study was two years, but we see children who are on these drugs for five years, 10 years, and even longer,” she says.

She adds that it is also not clear if the drugs are safe for children with existing heart problems or with risk factors for heart disease.

Diller’s perspective is quite evenly balanced; he prescribes stimulant medication for ADHD when indicated, but only as part of thorough assessment and comprehensive management program.

It is clear that Diller believes that ADHD is being over diagnosed. He states that over the last 15 years brand name stimulant production has increased by an astounding 1700% and generic stimulants by more than 3000%!

The number of U.S. children taking psychotropic drugs has doubled over the last ten years. We currently have more than 4.5 million children under 18 taking psychotropic drugs – mostly stimulants. Perhaps even more alarming are the percentages of ADHD children being reported by the Centers for Disease Control (CDC): typically common rates between 5% to 7% are reported in children in Colorado and 5.5% in California. However, as many as 10.5% of children in Louisiana are diagnosed with ADHD as are 11% of children in Alabama.

Diller suggests that the rampant diagnosis and pharmacological treatment of ADHD might be related to the fact that, “The drug industry hijacked American psychiatry in the 1990s….Insurance companies structure doctors’ reimbursement so as to reward short visits, ones in which a prescription brings the session to a definite conclusion.”

Diller also suggests that the Individuals with Disability Education Act of 1990, actually accelerated pharmacological treatment as well as the ADHD diagnosis because its amendment in 1991 now included ADHD as a diagnosis that makes a child eligible for special services and accommodations in public schools. As parents quickly learned, an ADHD diagnosis could gain their child special services and testing accommodations.

The pharmaceutical industry parleyed this trend by targeting parents with direct ADHD drug advertising. Parents, having diagnosed their child via the effects of the advertising campaign, could now approach their family practitioner to request stimulant drugs as a remedy. Diller suggests that many parents welcomed a brain-focused diagnosis that relieved them of responsibility for problem behavior.

The book encompasses far more than I’ve described here and is well worth reading. It is an excellent, balanced perspective that provides insight into the staggering $3 billion juggernaut known as ADHD.

By ANNA WILDE MATHEWS
Staff Reporter of THE WALL STREET JOURNAL
August 24, 2005; Page A1

DOWNEY, Calif. – When Eli Lilly & Co. wanted to get the big California health-maintenance organization Kaiser Permanente to use its new antidepressant, it ran straight into Debbie Kubota.

As the cost of drugs in the U.S. approaches $250 billion a year, pharmaceutical companies are running up against a growing breed of detective trained to see through marketing spin. Working for insurers, state Medicaid programs and nonprofit bodies, these detectives cast a wary eye on published studies in medical journals, once considered an unimpeachable source. They search for subtle aspects of clinical-trial design that might show the drugs are not all they’re cracked up to be.

“You could be duped,” says Siri Childs, who oversees pharmacy policy for the Washington state Medicaid program. “We know now that just because it’s published in a medical journal, that doesn’t assure its quality.”

The Cochrane Collaboration, a nonprofit that analyzes the quality of studies and collects the ones it considers good into broader analyses, has a volunteer corps of about 7,500 reviewers, mostly doctors and academics. That’s up from about 2,800 five years ago. Another player is the Drug Effectiveness Review Project, an effort by an Oregon nonprofit. It issues reports summarizing all the studies in a particular treatment area and often criticizes individual studies for failings such as inadequate controls and high dropout rates.

Some journals are trying themselves to help readers discover marketing messages slipped in amid the scientific data. Last year BMJ, a British journal, published a piece called “Users’ guide to detecting misleading claims in clinical research reports,” which came with a picture of a reader dumping salt on a medical journal. One piece of advice: Beware when the authors break out one subgroup of patients and claim benefits from the treatment that weren’t evident in the whole group.

Dr. Kubota, a 26-year Kaiser veteran who holds a doctor of pharmacy degree from the University of Southern California, is based in the industrial city of Downey, southeast of Los Angeles, across the street from an abandoned movie set. Kaiser tries hard to keep her and her colleagues away from the influence of the companies whose products they evaluate. Before meeting with Dr. Kubota, a representative of a drug company must fill out a form indicating who will be coming, what they plan to discuss and why the information can’t be relayed in written form. No gift pens, mugs or other trinkets are allowed. Dr. Kubota’s business card doesn’t show her direct phone number.

When Dr. Kubota started her current job in 1997, she says she “would just read the abstract,” the summary at the beginning of a study. “I guess I was naive,” she says. “You kind of assume everything is there for you in the abstract.” Today, she quickly homes in on details that aren’t mentioned in the abstract and generates a 6-inch stack of papers studded with Post-it notes for each drug.

When she reviewed Adderall, a stimulant now marketed by Shire Pharmaceuticals Group PLC to treat attention deficit hyperactivity disorder, she noted that one of the major trials included only people who had responded well to Ritalin, another ADHD drug. She thought the move likely improved the results. Dr. Kubota recommended leaving Adderall off Kaiser’s formulary. The physician committees partially overruled her, putting Adderall on the Northern and Southern California formularies but only for patients who failed to respond to another stimulant. Adderall later was added to the preferred list as a first-line treatment after a once-daily formulation went on the market.

A spokesman for Shire, Matt Cabrey, said that the designers of the trial, which was conducted when Adderall belonged to another company, felt that for ethical reasons they should give the drug to people with a “reasonable anticipated reaction.” James Swanson, the lead author of the article that described the trial’s results, said the trial was designed to show whether Adderall works faster than Ritalin.

HealthNewsDigest.com – August 29, 2005 (HealthNewsDigest.com) reports that ADHD likely affects 3% to 7% of the entire child population in the US. However, girls are frequently overlooked because they often do not display hyperactive symptoms.

When teaching at the elementary level, I found this particularly true. Girls with ADHD often were simply daydreamers with poor time management skills. While some did display the outward social and behavioral problems that their male peers did, it was not very frequent.

HealthNewsDigest.com is published by the American Psychological Association. I’ve cited bits of this report and am alarmed by its look and feel. It reads like an endorsement and advertisement for Adderall XR.

Their report, edited down:

The federal Food and Drug Administrations (FDA) recent nod to ADDERALL XR for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 spotlights an underidentified and under treated population with this disorder, experts tell Health NewsDigest.com.

If left untreated, the symptoms of ADHD can have a profound effect on a child’s life, both inside and outside of a classroom setting.

For Janice Lowder, a quiet, well-behaved child, learning was always stressful.

“My husband and I hired a one-on-one tutor to help Janice with her studies. We also tried to help her, and all dreaded the nightly battle of completing a homework assignment. Janice would get so frustrated with her homework and the fact that she didn’t ‘get it,’ that she would cry,” said her mother Beth Lowder.

“By the time Janice reached the seventh grade, a nurse at her school suggested we talk to a doctor. Janice was diagnosed with ADHD and was started on treatment,” Beth explained.

“I knew my daughter just needed the right help,” said Beth.

By the tenth grade, Janice had improved from a C to a B student but homework was still challenging. In addition, she had low self-esteem and was embarrassed to take her medication at school. Her psychiatrist prescribed Adderall XR®, an extended-release formulation that enabled Janice to take her medication once a day at home.

With continued tutoring and medication, her grades improved.

“She came home from school one day and said, ‘Mom, I’m smart,’” said her mother.

A recent study presented at the American Psychiatric Association annual meeting showed that girls with ADHD demonstrated significant improvement in both behavior and attention with Adderall XR.

“The study suggests that girls with ADHD can benefit from Adderall XR and that this treatment will help them control symptoms all day while they are in the classroom, during after-school activities or doing homework with relatively few side effects,” said Joseph Biederman, M.D., professor of psychiatry, Harvard Medical School and Chief of Pediatric Psychopharmacology at Massachusetts General Hospital. “While ADHD in girls is becoming more recognizable it is still often overlooked, and there is a need for safe and effective treatments that will allow girls to interact more effectively with other children and adults, to concentrate in school and to focus on finishing tasks.”

I’d expect to find a more diluted version in Parents Magazine or Family Journal as an outright advertisement. Makes one wonder who wrote this? Shire Pharmaceuticals?

The drug was originally approved for treatment in ADHD children aged 6 to 12 years in October of 2001 and since August 2004 in adults 18 years and older. ADDERALL XR is currently the most commonly prescribed brand of ADHD medication in the United States.

“There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD’s potential impact on quality of life. Therefore, approval of an ADHD treatment for this underidentified age group is an important milestone,” explained Dr. Timothy Wilens of Massachusetts General Hospital. “The symptoms of ADHD often continue past childhood into adolescence and adulthood, where they can have a significant impact on an individual’s family, academic performance, and overall quality of life. Stimulant therapies are effective and generally well tolerated, and have been used medically in patients for more than 60 years.”

This directly contrasts with Health Canada’s decision to remove ADDERALL from the Canadian market (Health Canada Suspends ADHD drug Adderall XR) due to 20 or so deaths associated with the drug’s use. According to Shire Pharmaceuticals, “ADDERALL XR may not be right for everyone. ADDERALL XR was generally well tolerated in clinical studies. The most common adverse events in pediatric trials included loss of appetite, insomnia, abdominal pain, and emotional lability. The most common side effects in the adolescent trial included loss of appetite, insomnia, abdominal pain, and weight loss. The most common adverse events in the adult trial included dry mouth, loss of appetite, insomnia, headache, and weight loss.

The effectiveness of ADDERALL XR for long-term use has not been systematically evaluated in controlled trials. As with other psychostimulants indicated for ADHD, there is a potential for exacerbating motor and phonic tics and Tourette’s syndrome. A side effect seen with the amphetamine class is psychosis. Caution also should be exercised in patients with a history of psychosis.”

One must wonder whether the side effects are worth using a drug whose efficacy has not been evaluated for long-term use. Terms like ‘emotional lability’ appear as an attempt to obfuscate. It is much clearer to say, ‘emotional change or breakdown.’