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

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

to Parents

Lynne Wells Graziano

Department of History

Case Western Reserve University

Graziano March 2009 2

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


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


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.


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


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.


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


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.


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.”


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…”


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


QuickTime™ and aTIFF (Uncompressed) decompressor

are needed to see this picture.


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.).”


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


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)


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


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


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.


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.


The End

Lynne Wells Graziano

Department of History

Case Western Reserve University

[email protected]

mailto:[email protected]

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

Documents

Transcript of Direct-to-Consumer Advertising: A Dangerous Game of Pitching Products to Parents Lynne Wells...