Direct-to-Consumer Advertising A Dangerous Game of

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					  Direct-to-Consumer Advertising:
A Dangerous Game of Pitching Products
             to Parents



         Lynne Wells Graziano
         Department of History
    Case Western Reserve University
  Direct-to-Consumer Advertisements
                (DTCA)

Pharmaceutical DTCA are used in
 newspapers, magazines, internet websites
 and on television.

Nearly one-third of Americans asked their
 doctors about an advertised medicine, and
 82% of those who ask say their physician
 recommended a prescription.
    -USA Today, Julie Appleby, March 4, 2008

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         STUDIED PRODUCTS
• Vyvanse – a medication to control
  Attention Deficit/Hyperactivity Disorder
  (ADHD)
• Gardasil – a vaccine designed to prevent
  certain types of Human Papillomavirus
  (HPV) that can cause cervical cancer and
  genital warts
Both contain hidden dangers which
  parents and caregivers may not know


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                   THESIS
The best interests of the American public are not
  being protected with current drug approval and
  advertisement practices. Parents are not always
  aware of hidden pharmaceutical dangers.

Changes are needed in both the approval process
 of new drugs and the advertisement procedures
 related to pharmaceutical products.


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      Who oversees advertisements?
United States Food and Drug Administration
                  (FDA)
Pertinent Legislation
 1938 FDCA Act: medications proven safe prior to
  marketing
 1962: medications “safe and efficacious” prior to
  advertising
 1992: Prescription Drug User Fee Act (PDUFA) -
  $300,000 fee for new drug application before review
 1997: advertisements in broadcast and electronic media
  no longer require “brief summary;” “adequate provision”
  needed met

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    2002/2007 Best Pharmaceuticals for
               Children Act
During a one year period beginning on the
 date a drug receives pediatric exclusivity,
 all adverse event reports associated with
 the use of the drug will be reviewed by the
 FDA and reported to a Pediatric Advisory
 Committee in a public forum.



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                     Vyvanse
• Received FDA approval for use in 6 – 12 year
  old children in February 2007
• Schedule II controlled substance (CII)
• Advertising violates 1971 Convention on
  Psychotropic Substances (UN initiative): an act
  approved by 159 countries agreeing not to use
  consumer-targeted marketing of psychotropic
  drugs which carry the potential for addiction or
  dependency
• Vyvanse, 2007, begins advertising in women‟s
  magazines
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  Vyvanse requires FDA “Black
      Box” Warning Label
                       WARNING
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE.
  ADMINISTRATION OF AMPHETAMINES FOR PROLONGED
  PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND
  MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE
  PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING
  AMPHETAMINES FOR NONTHERAPEUTIC USE OR
  DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE
  PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND
  SERIOUS CARDIOVASCULAR ADVERSE EVENTS.



                 Graziano   March 2009              8
Graziano   March 2009   9
Hidden dangers found with a close study of
        materials about Vyvanse
• “new psychotic symptoms (such as hearing
  voices, believing things that are not true, are
  suspicious) or new manic symptoms”
• Under “indications and usage”
   – “the effectiveness of Vyvanse for long-term use, i.e.,
     for more than 4 weeks, has not been systematically
     evaluated in controlled trials. Therefore, the
     physician who elects to use Vyvanse for extended
     periods should periodically reevaluate the long-term
     usefulness of the drug for the individual patient.”


                    Graziano    March 2009                    10
    What some consumers say:
• “My 11 year old…cannot sleep…major mood swings,
  hating herself, saying she wishes she could die, major
  anger…do not give your child this medicine…”
• “My 13 year old daughter, suddenly wanted to
  die…wanted to be alone all the time…lost all her friends
  and dropped everything she ever loved…”
• “weight loss, emotional breakdowns, unhappiness,
  thoughts of suicide… my 13 year old daughter… she
  says she does concentrate better, but at what expense?”
• “My 9 year old daughter…was sullen and zombie like on
  30 mgs… just not herself…”


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                     Gardasil
• Non-infectious recombinant, quadrivalent
  vaccine against HPV types 6,11,16 and 18
• Approved by the FDA in July 2006
• Designed for girls and young women, ages 9 –
  26; clinical tests on boys/men recently
  completed
• CDC recommends that all girls ages 11 and 12
  receive the vaccine
• Efficacy thought to be 5 years; booster may be
  required


                 Graziano   March 2009             12
           Quic kTime™ and a
TIFF ( Un compress ed) decompres sor
   ar e neede d to s ee this picture.




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 Hidden dangers after a close study of materials
               about Gardasil
Listed under “Pregnancy” area of brochure:
“It is not known whether Gardasil can cause fetal
   harm when administered to a pregnant woman
   or if it can affect reproductive capacity.”
   (emphasis mine)

Also listed in the literature:
“Vaccination does not substitute for routine
  cervical cancer screening (i.e. Pap testing -
  which has decreased cervical cancer by 75% in
  the U.S.).”
                 Graziano   March 2009              14
  The New England Journal of
       Medicine says…
“The cost-effectiveness of HPV vaccination
  will depend on the duration of vaccine
  immunity and will be optimized by
  achieving high coverage in
  preadolescent girls, targeting initial
  catch-up efforts to women up to 18 or 21
  years of age, and revising screening
  policies.”
NEJM, 359:8, August 21, 2008

               Graziano   March 2009         15
  Early reports, after 16 million
           U.S. doses
• “The immunity of Gardasil will not last…”
 Dr. Diane Harper, Dartmouth Medical School, principal
 investigator/Gardasil trials


• FDA VAERS - 9,749 reports: 94% not
  serious, 6% serious - blood clots,
  paralysis, death (20 cases- none directly
  linked)


                      Graziano     March 2009            16
                            FDA
“The FDA is understaffed, underfunded, and under
  pressure, according to its employees. Even
  worse, the FDA has fallen under the influence of
  the drug and medical-device industries, so much
  so that it was labeled „a servant of industry‟ by
  Dr. Richard Horton, the editor of the British
  journal The Lancet.”

“The FDA‟s capacity to enforce regulations has
  weakened in recent years.” – finding of a 2007
  article in The New England Journal of Medicine


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        Options for Change: Advertisements
• An outright ban on DTCA in the United States (New
  Zealand is the only other industrialized nation that allows
  DTCA)

• A ban on new-to-market pharmaceutical products
  advertising within the first one or two years of usage

• Improved oversight of advertisements by the FDA

• Enforcement of 1971 Convention on Psychotropic
  Substances


                     Graziano    March 2009                18
       Options for Change: Approval Process
• Approval process needs to be funded independently,
  either with government funding, or with pharmaceutical
  companies paying into a pool of funds – rather than
  directly paying for a specific product‟s approval
  application.

• Streamlined approvals need to be limited to the rarest of
  innovative drugs, not every drug billed by its
  manufacturer as a “breakthrough.”

• Probationary periods should be set based on the
  potential side-effects of the drug approved, with closer
  monitoring of the new drug during that period.
                     Graziano   March 2009                   19
                  Conclusion
Pharmaceutical products can greatly enhance lives
  by increasing both their quality and quantity;
  however, dangers inherent to some of these
  products should be more clearly communicated,
  particularly when children are targeted.
  Conflicts of interest must be eliminated from the
  drug approval process and advertisements need
  tighter restrictions and regulation. The FDA
  needs to be retooled to enable it to better serve
  the needs of 21st century American consumers.


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           The End

     Lynne Wells Graziano
     Department of History
Case Western Reserve University
     Jagraziano@aol.com




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