Shire trying to convince Europeans, like Americans, that most kids have ADHD...and then most adults?

Sometimes children are fidgety. Sometimes they have lots of energy. Sometimes parents and adults can't find a time or place for them to run around. Sometimes children can't focus on what adults would like them to read, either Dr. Seuss or Shakespeare.

Sometimes all of that is also true of adults.

Shire Pharmaceuticals argues that much of that fidgeting is because of attention deficit hyperactivity disorder (ADHD) and people should be prescribed Shire's medicine. And once those children grow up, having gotten used to the medicine, they should stay on it forever. Or at least until they die.

That is the cradle-to-grave hope of Shire. The company is registered in Jersey, one of the Channel Islands, has its headquarters in Dublin and  has a big operation in Chesterbrook (post office address is Wayne, Pa.).

The Affordable Care Act, budgets of employers and insurers (public and private) are prompting efforts to improve and measure health outcomes. This is pushing drug companies to change their business models. However, though vaccines are one exception, drug companies generally only want to cure you if they can charge big money. Otherwise, they prefer maintenance medicine, which you have to take and pay for as long as possible. The best example is Pfizer's multi-billion dollar cholesterol drug Lipitor.

Shire is the leader in selling ADHD medicine, with its Vyvanse pill being the latest best seller, and it generated that revenue by convincing American doctors and parents that children need the medication, versus running around on the playground, a healthy diet and a good night's sleep. Sometimes Shire pays doctors.

Shire also now contributes money to ADHD advocacy groups, including in the Philadelphia region, to hold seminars to help adults deal with this apparent problem. Shire-paid researchers sometimes speak at such events.

Shire is trying to take that lucrative franchise back to its corporate roots, meaning Europe. But as Bloomberg News reported earlier in the week, it is running into resistance from European doctors and parents. The story, a link is here, notes that ADHD is prescribed 25 times more often in the United States than in Europe.

Some of the European concern is because of the addictive nature of amphetamines, which is a key ingredient in Vyvanse. The potential danger is also why it is a controlled substance The Vyvanse web site, which has smiling people and three bubble/links for would-be patients in three groups:

A) Kids 6 to 12

B) Teens 13-17

C) Adults

Farther down on the site is also this cautionary information:

Mental (psychiatric) problems including:

  • new or worse behavior and thought problems

  • new or worse bipolar illness

In Children and Teenagers

new psychotic symptoms such as:

  • seeing things or hearing voices
  • believing things that are not true

  • being suspicious

new manic symptoms

A 2012 PhillyPharma blog post, link here, noted that in June of 2012, FDA researchers published in Pediatrics the results of a study on prescription use in children 17 and under from 2002 through 2010. They found that 7 percent fewer prescriptions overall were written in 2010 than in 2002, but there was a 46 percent jump in prescriptions written for attention deficit/hyperactivity disorder. The only bigger jump was in contraceptives (93%).

In August of 2012, then-Shire CEO Angus Russell was asked by the Inquirer if there really are that many children who genuinely need ADHD medicine. Russell said yes and that Shire was conducting trials in hopes of getting FDA approval for other mental health conditions.

"There is a tremendous lack of knowledge about these diseases from a societal attitude," Russell said. "We are really bothered by these diseases of a psychiatric nature. We really don't understand them and that is part of the problem. And even when we do, we get nervous about them. Mental health and psychiatric disorders are often very poorly diagnosed and there are huge prejudices against people who have those kinds of diseases."

But compared to, say an X-ray of a broken leg, there are fewer ways to measure and define mental illness, even among experts.

"The brain is the most complex organ the body, we don't know a lot about how the brain works and, like a lot of things in life, you become fearful of what that means," Russell said. "We back away from psychiatric diseases because they are not as easily understood. To me, that is not responsible. These people suffer real problems."

Russell said Shire has run trials in hopes of showing that its drugs are not just safe, but better than competitors.

"If we can't prove it, we can't prove it," Russell said. "But I would rather fail trying to prove it than have people walk around saying, 'You just kind of dreamed up this thing and you're treating people with it just to make money.' That's horrible and I don't want that."