Healthy Skepticism Library item: 2735

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Publication type: news

Thomaselli .
$4 billion DTC drug ad fight finds a human face- Widowed Ad Exec Suing Pfizer Testifies at Charged FDA Debate
Advertising Age 2005 Nov 2
http://www.adage.com/section.cms

Keywords:
FDA Zoloft suicide DTCA

Notes:

Ralph Faggotter’s Comments:

The pharmaceutical industry in the USA argues that they have a Constitutional Right to advertise their products direct to consumers. Since such DTCA is banned in every other country in the first world (except New Zealand), it is likely that this Constitutional protection is the only thing that is preventing this undesirable practice from being banned in the USA too.

One suspects that the Founding Fathers of the American Constitution would be appalled by this unforseen consequence of their good intentions.

Full text:

ADVERTISING AGE

$4 BILLION DTC DRUG AD FIGHT FINDS A HUMAN FACE
Widowed Ad Exec Suing Pfizer Testifies at Charged FDA Debate
November 02, 2005
QwikFIND ID: AAR09G
By Rich Thomaselli

WASHINGTON (AdAge.com) — Amid the rhetoric calling for everything from tempering direct-to-consumer drug ads to abolishing them, the Food and

Drug Administration’s public hearings on the merits of DTC begged for a human voice. It found one today in Kim Witczak.
In between presentations from pharmaceutical industry advocates hoping to keep the status quo and opponents hoping to shut down the $4

billion category, Ms. Witczak delivered an impassioned speech about the suicide of her husband — a death she believes was triggered by his use of the antidepressant

drug Zoloft, from Pfizer.

But Ms. Witczak, who is suing Pfizer, did not call for an end to DTC, only that it “be held to a higher standard.”

Unique perspective Hers was a unique perspective: She was the only one of 39 speakers during the two-day public hearings listed as a

consumer, or part of the general public, but she is also in the advertising business as a senior art buyer and producer for Publicis Groupe’s Fallon, Minneapolis.

Standing in a near-empty room after a break scattered the crowd, Ms. Wiktczak was asked if her 15 years in the ad business stopped her from calling for an

end to DTC.
“Probably a little bit. I’m a realist. I know it’s big business,” she said. “But I came here on my own dime to talk about Woody, and all I was hoping to do was

be a voice of reason.”
During her speech, Ms. Witczak relayed how in 2003 her husband of almost 10 years, Timothy “Woody”’ Witczak, decided to start his own business. The

prospect was giving him restless nights, and his doctor prescribed Zoloft even though he was not diagnosed with depression. Several weeks later, after

experiencing several side effects, Mr. Witczak hanged himself in the garage of their home. Ms. Witczak was on a business trip; her father found the body.

‘New marketing environment’ “I believe DTC has influenced the prescribing habits on many levels,” she said during her speech. “DTC has created a mind-set that there is a pill for

every problem. DTC has shifted the paradigm away from the doctor to the consumer. This is the new marketing environment.”

Still, she would not call for the end of the practice, only for changes. One such change she proposed would be that print promotions be done on facing pages, so the ad is the left side and the side

effects, or brief summary, to the right, instead of on the back of the main ad.
“I’m looking to start small,” Ms. Witczak said. “But no matter how small, DTC ads must be grounded in truth.”
This might be the kind of change the industry is willing to accept because there was no happy medium otherwise during the second day of hearings,

called by the FDA in order for the agency to receive data and guidance on DTC advertising that could lead to more restrictive guidelines on the practice.

Controversial compromise One day after supporters acknowledged that DTC did need some tweaking, several opponents offered a compromise that will surely be summarily

rejected: no brand ads at all. “There are many risks to DTC advertising and the only answer is to use helpseeking ads, rather than profit-driven ads that link drugs and disease,” said

Dr. Peter Lurie, deputy director of the advocacy group Public Citizen and an outspoken critic of DTC. Dr. Lurie added that drug makers were turning consumers into “agents” for their own companies.

Judith Cahill, director of the Academy of Managed Care Pharmacy, said that her group supports DTC but only if the ads are educational about disease symptoms or alternative treatment options, not about specific brands. “It does

a disservice to the public if its aim is to induce name recognition and increase market share,” she said.

First Amendment rights “To say that’s a crazy idea is an understatement,” said an executive at one of the major pharma companies who attended the hearings but did not testify. “I

think everybody in our industry agrees — and it was reiterated several times — that DTC advertising needs to change. Not allowing us to advertise our brands is not ‘change,’ it’s restrictive and it’s against the First Amendment.”

Gary Ruskin, executive director of the Portland, Ore.-based advocacy group Commercial Alert, said that argument doesn’t have merit. “Only doctors can prescribe prescription medication, so there is no legitimate reason to have

DTC,” said Mr. Ruskin, who called for the end of all DTC.

Alex Sugarman-Brozan of the advocacy group Prescription Access Litigation asked that the FDA return to pre-1997 requirements that demand the full brief summary in TV ads, knowing that would mean the end of broadcast

ads. “If [the pharmaceutical companies] can’t do the summary, they shouldn’t be on TV or radio,” Mr. Sugarman-Brozan said.

Asked by Dr. Robert Temple, director of the FDA’s Office of Medical Policy, how drug makers would overcome such difficulties, Mr. Sugarman-Brozan said with a laugh, “Maybe the industry needs to purchase larger blocks of

[commercial] time.”
Mr. Temple replied: “I can tell you they won’t. They’ll tune out.”

Consumers Union, the Washington-based nonprofit publisher of Consumer Reports, further outlined its call for major reforms during its afternoon testimony. “Current ads often fail to present the benefits and risks of using

prescription drugs or medical devices in an accurate, non-misleading,

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