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      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

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    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

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    « FDA Approval Track Record Since Advent of Complete Response Letters | Main | Full Disclosure on Complete Response Letter by Targanta »

    December 09, 2008

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    Dan

    DTC Advertising

    Not long ago, usually on television, one viewing will often at times see an advertisement for some type of medication- usually it is a drug involved with the treatment in a large market disease state. Such commercials are sponsored by large pharmaceutical corporations for particular networks on television. This is called direct to consumer advertising, and both doctors and citizens largely prefer that they do not exist.
    Since 1997, when the FDA relaxed regulations regarding this form of DTC advertising for the pharmaceutical industry, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry has spent around 5 billion annually on this media source. The industry ranks number two on their spending of media campaigns- next to automobiles, I believe. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns typically associated or possible with newer medications, as history has shown.
    The purpose of DTC ads are not to educate and inform the viewers, in my opinion, as others have claimed. Any advertising of any type shares the same objective- which is to increase sales and grow their market for a particular product and, in this case, for a particular perceived medical condition or disease state that may or may not exist, as a television is not by definition a health care provider for the viewer. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment soon for what may be an unconfirmed medical condition or disease suggested with such DTC advertisements. Furthermore, the FDA has admitted that they are ignorant as far as the content of such DTC ads before they are presented to the public, in relation to their accuracy and clarity, as well as possibly their effect on the health care system, as the FDA allows the DTC advertising to continue, yet now it is becoming more restricted, I understand.
    DTC advertising is also a catalyst for and similar to disease mongering.
    Disease mongering is the creation of what some believe should be medical flaws, and illustrated by the creators through exaggeration and embellishments through such media sources as an avenue for what appears to be propaganda often, as is often seen with DTC advertising. The content of the advertisements appear to be medically absent, yet realistically they are in fact corporate creations of these questionable human ailments that do not or may not require treatment, possibly, and may be attempts by the makers of certain drugs to develop or embellish a particular medical condition to acquire additional profit. One of my favorite DTC advertisements is the new concept for the use of an anti-depressant for a social disorder. Social disorders appear to be another phrase for what are known as introverts- a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease, many believe. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators of these commercials again wish to grow the market for a particular, and possibly fictional, disease state. Then there is also baldness treatments advertised, as another example by the advertisers who attempt to create a need for treatment. Lifestyle medications are not treatment options for illnesses, and should not be portrayed as such in certain direct to consumer advertisements. Then there are the Viagra commercials with the happy man who is fully energetic on the advertisement for this drug is not your typical man who has erectile dysfunction. So DTC advertisements are intentionally deceiving to grow the markets for the benefits of the makers of the drugs advertised.
    Also, DTC ads discuss only one treatment option normally, so it seems, when likely there are several treatment options that exist for authentic medical disorders. The options for treatment should be left to the discretion of the health care provider, as they are the ones who assess your health, not your television or another media source. That’s why most of the world does not allow DTC advertising, with the exception of our country and New Zealand.
    Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the creators of direct to consumer advertising. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome if not awkward for the health care provider chosen by the viewer of a DTC ad for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription. Also, in some situations, the sponsor will speak and acquire a dormant/inactive actor, perhaps, or a former athletic celebrity, to fuel their intent.
    Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world utilizing media outlets such as television. Perhaps this will save some over-prescribing of expensive medications that progressively has been occurring recently, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which should be far from financial prosperity. This elimination of DTC advertising would only be a start to achieve control in the U.S. Health Care System as it exists today.
    “Ignorance is not innocence but sin.” --- Robert Browning
    Dan Abshear
    Author’s note: What has been written was based on information and belief
    Published on www.brainblogger.com

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