Transcript Direct-to-Consumer Advertising: Dangerous Game in Need of New

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.
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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.”
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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
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QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see 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.).”
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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
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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)
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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
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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.
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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
[email protected]
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