Shire plc – Statement Regarding the United States Food and Drug Administration Drug Safety and Risk Management Advisory Committee Meeting - Commentary by Fred A. Baughman Jr., MD

Shire plc – Statement Regarding the United States Food and Drug Administration Drug Safety and Risk Management Advisory Committee Meeting

    BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, February 10
  /PRNewswire-FirstCall/ -- As the leader in ADHD treatment, Shire plc (LSE:
  SHP, NASDAQ: SHPGY, TSX: SHQ), is supportive of the goals of yesterday's
  meeting of the US FDA Drug Safety and Risk Management Advisory Committee.
  However, we feel it is important to put several of the issues into
  perspective.
      The overall purpose of the meeting was to review the cardiovascular
  safety issues associated with medicines used to treat attention deficit
  hyperactivity disorder (ADHD). Data regarding the reported incidence rates of
  serious cardiovascular adverse events - both in patients taking ADHD
  medicines and those not taking ADHD medicines - were reviewed. Importantly,
  the reported incidence rates were similar in both groups.
      While recognizing that the reported incidence rates of the rare serious
  cardiovascular adverse events that were discussed are generally within the
  rates that would be expected from the untreated general population, the
  Advisory Committee nevertheless, in an 8-7 vote, recommended to the FDA that
  it include risk information about cardiovascular events in a "black box
  warning" for all stimulant medicines used to treat ADHD. While we fully
  support full disclosure and adequate warning, Shire believes that the
  interests of physicians and patients would be better served by further study
  to determine whether there is, in fact, a relationship between these
  medicines and cardiovascular events. 
  

[Fred A. Baughman Jr., MD:
"Further study" is always their suggestion. This lets the poisoning continue]

  Obtaining this information is crucial
  prior to taking what would be an unprecedented action to include something in
  a black box that is not been supported by sufficient data.
      Of note is the fact that our Adderall XR and Adderall already include a
  "black box warning" in their labels for safety concerns related to
  amphetamine abuse or misuse. The label also warns of the risk of sudden death
  in patients with structural cardiac abnormalities. We stand behind this
  labelling and believe that further action is unwarranted.
      Most importantly, the benefits of treatment should not be overlooked. As
  several participants pointed out, ADHD is a serious condition and if left
  untreated the disorder can result in serious consequences. 
  

[Fred A. Baughman Jr., MD:
a serious condition they say. But is it a disease? of course not, these are medically normal children being poisoned not "treated"]

  Stimulant
  medicines such as amphetamines and methylphenidate are highly effective in
  treating patients with ADHD and have been used for over 50 years. We have
  confidence in Shire's ADHD medicines - they have been prescribed over 50
  million times and more than 1 million patients have taken Adderall XR since
  its introduction in 2001.
      Shire looks forward to working with the FDA to examine ways to ensure
  that physicians and patients have all of the necessary information needed
  before deciding whether to prescribe or take Adderall XR and Adderall.
      IMPORTANT SAFETY INFORMATION
      About ADHD
  

[Fred A. Baughman Jr., MD:
Here is their insert with their FDA approved definition of ADHD]

  ADHD is a neurological brain disorder that manifests as a persistent
  pattern of inattention and/or hyperactivity-impulsivity that is more frequent
  and severe than typically observed in individuals at a comparable age and
  maturity level. 
  

[Fred A. Baughman Jr., MD:
saying neurological brain disorder is calling an objective abnormality = disease and this is a lie, totally untrue. It is comprise of behaviors listed in dsm iv, all subjective, no one or several of which are a disease]

  Because everyone shows signs of these behaviors at times, the
  behaviors must appear early in life (before age 7 years) and continue for at
  least six months, according to the ADHD diagnosis criteria as defined in the
  American Psychiatric Association's Diagnostic and Statistical Manual of
  Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TRO). 
  

[Fred A. Baughman Jr., MD:
here they say duration of persistence--6 mo--is what makes these behaviors abnormal = a disease. A brazen lie. And yet we read nothing of the validity or lack thereof re the FDA hearing. this is the central issue. without disease validation the children are normal, their "treatment" with these drugs--poisoning]

  Up to 65percent of children with ADHD may still exhibit symptoms into adulthood. In
  fact, approximately eight million American adults currently struggle with the
  inattention, impulsivity and hyperactivity symptoms of ADHD.
  

[Fred A. Baughman Jr., MD:
a great gig: invent a disease, say 8 million have it, sell a drug for it]

  Without an effective treatment program, the symptoms of ADHD may lead to
  potentially serious consequences. 
  

[Fred A. Baughman Jr., MD:
not a disease, they speak medically of it, say it has serious consequences--a prognosis]

  A survey has shown that when compared to
  adults without ADHD symptoms, adults with untreated ADHD were more than twice
  as likely to have been arrested, 47 percent more likely to have received more
  than one speeding ticket in the last year, twice as likely to have been
  divorced and twice as likely to have held six or more jobs in the past
  decade. Further, evidence suggests that many adults with untreated ADHD may
  be at risk for other problems, including poor performance in the workplace
  and poor self-image.
      Although there is no cure for ADHD, physicians and advocates are finding
  ways to help people with the condition learn to adapt to their school, home,
  social and work settings. ADHD usually can be successfully managed with
  behavioral therapy, structured coping techniques and medication.
  Psychostimulant medications are thought to stimulate areas of the brain that
  control... 

[Fred A. Baughman Jr., MD:
where now the patient lacks control due to his ADHD ]

...attention, impulses, and self-regulation of behavior, remain among
  the most successful treatments for people with ADHD. Up to 70 percent of
  children with ADHD respond positively to psychostimulants. Medication should
  be considered part of an overall multi-modal treatment plan for ADHD. 
  

[Fred A. Baughman Jr., MD:
Regardless of how the drug--in this case Adderall--is described, the lie saying/implying/leading patient to believe ADHD is a disease/objective abnormality within the patient, in and of itself abrogates informed consent and makes the subsequent treatment (without informed consent) medical malpractice, and (attorneys) assault and battery.]

      For further information on ADHD please visit http://www.adhdsupport.com,
   http://www.CHADD.org or http://www.NMHA.org.
      About ADDERALL XR 

[Fred A. Baughman Jr., MD:
as above, it doesnt matter what they now say about adderall, informed consent has already been abrogated.]

      ADDERALL XR was generally well tolerated in clinical studies. The most
  common side effects in studies included: children - decreased appetite,
  difficulty falling asleep, stomachache, and emotional lability; adolescents -
  loss of appetite, difficulty falling asleep, stomachache, and weight loss;
  adults - dry mouth, loss of appetite, difficulty falling asleep, headache,
  and weight loss.
      Adderall XR may not be right for everyone. Patients should speak with
  their doctor if they have a history of high blood pressure or any heart
  conditions, glaucoma, thyroid problems, emotional instability, mental
  illness, or a known allergy to this type of medication. Abuse of amphetamines
  may lead to dependence. Misuse of amphetamine may cause sudden death and
  serious cardiovascular adverse events. These events have also been reported
  rarely with amphetamine use.
      If you are currently taking or have recently taken a type of
  antidepressant called a MAO inhibitor or have a pre-existing structural heart
  abnormality, you should not take Adderall XR. There is a potential for
  worsening of motion or verbal tics and Tourette's syndrome. A patient should
  report any new psychological symptoms to his or her physician.
      Notes to Editors
      SHIRE PLC
      Shire's strategic goal is to become the leading specialty pharmaceutical
  company that focuses on meeting the needs of the specialist physician. Shire
  focuses its business on central nervous system (CNS), gastrointestinal (GI),
  general products (GP) and human genetic therapies (HGT) - all being areas in
  which Shire has a commercial presence. The structure is sufficiently flexible
  to allow Shire to target new therapeutic areas to the extent opportunities
  arise through acquisitions. Shire believes that a carefully selected
  portfolio of products with a strategically aligned and relatively small-scale
  sales force will deliver strong results. Shire's focused strategy is to
  develop and market products for specialty physicians. This approach aims to
  deliver increased returns and lower risks. Shire's in-licensing and merger
  and acquisition efforts are focused on products in niche markets with strong
  intellectual property protection either in the US or Europe.
      For further information on Shire, please visit the Company's website:

http://www.shire.com.

      "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
  ACT OF 1995
      Statements included herein that are not historical facts are
  forwarding-looking statements. Such forward-looking statements involve a
  number of risks and uncertainties and are subject to change at any time. In
  the event such risks or uncertainties materialize, Shire plc's results could
  be materially affected. The risks and uncertainties include, but are not
  limited to; risks associated with the inherent uncertainty of pharmaceutical
  research, product development, manufacturing and commercialization; the
  impact of competitive products, including, but not limited to, the impact of
  those on Shire plc's Attention Deficit and Hyperactivity Disorder ("ADHD")
  franchise; patents, including but not limited to, legal challenges relating
  to Shire plc's ADHD franchise; government regulation and approval, including
  but not limited to the expected product approval dates of DAYTRANATM
  (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCETM (SPD476)
  (ulcerative colitis), ELAPRASETM (idursulfase) (Hunter syndrome) and NRP104
  (ADHD), including its scheduling classification by the Drug Enforcement
  Administration in the United States; Shire plc's ability to benefit from the
  acquisition of Transkaryotic Therapies Inc.; Shire plc's ability to secure
  new products for commercialization and/or development; and other risks and
  uncertainties detailed from time to time in Shire plc's and its predecessor
  registrant Shire Pharmaceuticals Group plc's filings with the US Securities
  and Exchange Commission, including Shire Pharmaceuticals Group plc's Annual
  Report on Form 10-K for the year ended December 31, 2004.

  SOURCE Shire PLC