Why is Adderall is growing, and how much is it growing?
Well, we've conducted a number of clinical studies working with experts in the
field of ADHD. These studies have looked at how long Adderall works. They've
also compared it to methylphenidate, and have demonstrated that. in many
patients, Adderall seems to work better than methylphenidate. ...
And how has it done in the marketplace? Can you give me a description of
its sales growth?
Since Adderall was first introduced by Shire, it's had about 10 million
prescriptions since 1996. So it's had a very good track record of safety and
efficacy, looking at both the clinical studies, as well as the widespread use
by physicians. In 1996, Adderall was used relatively sparingly for
ADHD. Based on the success that physicians have had using Adderall in their
practice and the results they've seen in their patients, it now represents
about a third of the medications that are used to treat attention deficit
hyperactivity disorder. ...
You're developing three other drugs for ADHD at the moment?
That's correct, yes.
What do they offer that Adderall doesn't offer?
Well, no one medication is going to be perfect for every single individual.
And there are different subtypes of Attention Deficit Hyperactivity Disorder.
Some have a more hyperactive component. Sometimes it's more of an inattentive
type. ... And often, ADHD has co-morbid, or coexisting conditions. So it's
important to have a range of available therapies that can help physicians to
target the specific types of challenges that particular individual is facing.
We feel it's important to develop a range of potential ADHD medications. Quite
frankly, many of the medications that we're developing may not turn out to
provide the benefit that we think they have. That's why we do the clinical
Who performs these clinical studies?
Researchers in the field of attention deficit hyperactivity disorder.
Can you describe a little bit more how that works? Who funds the research?
For products that we are developing, Shire bears the largest share of funding
that research. But it's important to point out that any studies that are
conducted for approval of a product undergo very close scrutiny by the Food and
Drug Administration. The studies, before they get published, have to go
through an extensive peer review process, to ensure that there is no bias, and
that research is being conducted in a very appropriate way.
So all the research that is sent on to the FDA is paid for by Shire?
Generally speaking, any studies that are conducted . . . to support a new
medication, and that are submitted to the Food and Drug Administration, have
the vast majority of their funding provided by Shire. But, for example, with
Adderall, there was a study conducted by Mike Manos, who's now with the
Cleveland Clinic. This study was published in the Journal of the American
Academy of Child and Adolescent Psychiatry. He conducted that study, and
had received no funding from Shire. ...
How much money is spent on those clinical studies by Shire, for instance,
for Adderall? Give me an idea.
It really varies, depending on the complexity of the study, how large it is.
... Before Adderall was launched, it had to go through this process of
Yes, any new chemical entity has to go through a fairly extensive process of
clinical studies, establishing the safety and efficacy of the product.
So how much did Shire spend on getting Adderall through clinical
... We considered that proprietary information, and just really don't share
that with individuals.
We just consider it proprietary information. I think that the important point
to look at is that the results from these clinical trials get published in peer
review journals, and have to go through a really incredibly intense review
process. And the research is published, and allows everyone to look at, "Okay,
how was the study conducted? What were the entry criteria? What was the
statistical plan? What were the results, etc., etc.?" Clearly, of course, in
the publication of any study, we always feel it's important to disclose
financial support of the study, so people are completely aware of that.
Don't you reveal information to your shareholders as to what you plow into
clinical studies for individual drugs?
Yes. For example, we communicate to them that we reinvest about 20 percent of
our total sales into research and development of all of our products. But we
tend to do it on a more general basis, not a specific basis. ...
Are you personally comfortable with the idea that the drug companies are
paying for the research, rather than independent entities?
I don't think that anyone else would be willing to take on the risk. Let's
face it, most new medications turn out to either not have the desired effect,
or to have a side-effect profile that makes them impossible to use. ...
Most of what started out as promising leads turn out to be failures, and it's a
very expensive and risky process.
With the safeguards that we have in place--both having regulators look at the
applications, as well as having the research have to go through a really
intense review process in terms of peer review of literature--I think our
system has had a very good track record.
What is the marketing strategy for Adderall?
... Conducting clinical studies that clearly established the benefits of
You're paying doctors to conduct clinical studies?
Yes, we compensate physicians for the time that they invest in conducting
clinical studies. Then the physicians themselves write up the results,
and they submit them to journals. And it goes through a fairly intense peer
review process. ...
How important are Adderall sales to Shire? How much of the overall pie of
products is it?
Adderall represents the single largest percentage of sales to Shire today. But
we're investing for the future, and not only in ADHD products. We have
products for seizure disorders, and the treatment of advanced breast cancer,
and many other disorders. We're looking at expanding out the number of
available medications that we have for disorders that we don't offer
medications for today.
This clearly puts you in the position of supporting medication as a
solution. And you're pumping a lot of money--significant amounts, millions of
dollars--back into development of new medicines. Who's doing the same thing to
develop non-medical solutions?
Actually, we advocate Adderall as part of a multimodal treatment program for
the treatment of individuals with narcolepsy, as well as patients who have had
an accurate diagnosis of Attention Deficit Hyperactivity Disorder.
But you're still marketing a medication in the treatment of ADHD, even if
you're calling for multiple modalities?
Absolutely. A landmark study was conducted by the National Institute of Mental Health. It was actually, I think, the single largest study that the
NIMH has ever conducted--certainly with children. And it clearly established
that medication was one of the most effective treatments available. But the
best treatment was medication in combination with certain counseling or
behavioral measures. So, really, the best treatment is ADHD medication in
combination with behavioral measures.
... Is equal money going into
developing strategies other than medication?
In that landmark study by the National Institute of Mental Health that I
referred to, behavioral interventions were clearly one of the treatments that
were being studied by itself. ... So the National Institute of Mental Health examined not only medication, but also
behavioral interventions. The conclusion from the study was that ADHD
medications were very, very effective, but the ideal treatment was ADHD
medication in combination with behavioral interventions. ...
If all the money from your company is for medication research, then wouldn't
the results be skewed towards the efficacy of the medication?
Actually, I think the layperson would be very comforted to know that each piece
of research has to be done by people who have a track record of conducing very
good research ...
Some of the physicians that you have participating in "Experts on Call" will
be receiving honoraria for this event. ...
Let's face it--a physician has to be willing to take the time out of their
practice, and instead of being able to see their patients, be willing to come
and participate in a program like "Experts on Call." Literally thousands of
parents and grandparents and teachers that have concerns and questions about
ADHD get a chance to speak directly with someone who's on the frontlines of
dealing with ADHD every day.
Yes, we feel that it is appropriate to compensate them for their time. But we
have no illusion that we feel that can control the content of what they say.
As a matter of fact, the only direction we give them is, "Please, do not
dispense any specific medical advice. Obviously, you haven't seen the patient,
so you couldn't know the specifics regarding that individual." ...
How big is your sales force for Adderall?
We have 150 sales representatives.
And what do your sales representatives do?
Our representatives will visit physicians and present to them the attributes
of Adderall. ... The physician has many, many different choices, and the
sales representative is simply communicating the benefits of a particular
product in very fine detail, and often providing copies of clinical studies if
the physician so requests it. ...
Are they paid on a commission basis?
No, their primary compensation is in the form of a salary.
Their compensation is in the form of a bonus that is contingent upon certain
So they make more money when they sell more? The more they sell, the more
money they make?
The better they're able to communicate the benefits of a particular product
that they're representing, generally, the better they do.
Why would a doctor not want to go to peer review journals and make up their
own mind? What's the incentive to the doctor? What benefit do the sales reps
I think physicians go to a multitude of sources. They go to peer review
journals. They listen to what sales representatives have to say. They attend
medical conferences. They talk with their peers. So I really think that
physicians really tend to seek information from a variety of sources in
helping them to determine what particular product they're going to prescribe or
not prescribe for a particular patient.
I'm trying to understand the system, though. Do they provide coffee cups,
pencils, bags? What sorts of tricks are there in the trade to get the doctor's
attention? I'm trying to understand why a doctor would answer the door and
have them admitted.
The primary reason is because the sales representative is bringing the
physician information about the products that they represent. I think that's
the primary motivation that physicians are willing to invest some time with
sales representatives, to augment their reading of clinical studies and
attending the conferences, et cetera.
That's the primary interest?
Actually, we do invest quite a bit in providing what we call educational
material. These are pamphlets that physicians can provide to their patients.
For example, one of the most recent ones we have is a booklet that ... talks
about learning disabilities, because that is a condition that frequently
occurs in combination with attention deficit hyperactivity disorder. We had
gotten some advice from some of our experts that, really as a service, we
should consider providing to physicians to hand out to their patients.
In layman's terms, would that be called "advertising"?
Actually, really it would be called "education." There is not a single product
mentioned, and Adderall is not specifically appropriate for the treatment of
learning disorders and disabilities. So it truly is education.
But why do that, if it doesn't benefit the company? You're wasting
shareholders' money if you're just providing education. Your bottom line is to
But we take a very long-term view. We consider ourselves an ADHD support
company. We provide products, services, and programs that help physicians
treat the entire ADHD patient. Sometimes it more directly benefits Shire, and
sometimes it doesn't benefit us directly. But it has an indirect benefit to
us, and we're willing to make that investment.
What relationship do you have with CHADD?
... Just as we do essentially with every disorder or medical condition, such
as epilepsy and breast cancer, we do feel an obligation to support the patient
advocacy and support groups.
Can you describe, in numbers, what support you give them?
I don't have the specific figures with me. But we support their annual
meeting. For example, CHADD has Attention, a magazine that they
develop. We provide a grant to them, an unrestricted educational grant, and we
actually purchase copies of that, and provide it as a service to physicians to
give to their patients. So those are some of the specific ways that we help
support CHADD. And we support other patient advocacy and support groups, both
within ADHD, as well as in say, breast cancer or seizure disorders, et cetera.
Is it true to say that the reluctance of HMOs to pay for talk therapy has
That's a good question. We always communicate that Adderall, as with all ADHD
medications, should be part of a multimodal treatment program, combined with
behavioral therapies and whatever additional counseling is required. ... I
think physicians make a determination on what an individual patient needs, or
make that recommendation to the child's parent, based on that individual
child's needs. ...
The First Lady said she was going to start studying whether or not it was
being prescribed to children that were too young. How many kids in America
under the age of five do you believe are receiving your product?
We don't really know. When you look at the overall incidence of attention
deficit hyperactivity disorder, approximately 3 percent to 5 percent of
school-age children, or approximately 2 million children, are estimated to have
attention deficit hyperactivity disorder.
But you don't know who's taking your product?
No, we don't have specific knowledge of specific individuals that are taking
the product. ...
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