Waxman Renews Call To Ban Ads For New Drugs
8 CommentsBy Ed Silverman // December 9th, 2008 // 6:34 am
Henry Waxman, the California Democrat who will soon head the House Energy & Commerce Commitee, wants to give the FDA the power to ban direct-to-consumer ads when a new medicine first reaches the market and risks are not fully known, Reuters writes. The idea is one of several he hopes to pursue come January after a new Congress convenes, he told an industry conference yesterday.
“It is in these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a conference sponsored by The Prescription Project, a group critical of industry marketing.
He supported congressional efforts in 2007 to allow the FDA to ban television commercials for a new medicine for up to three years if officials decided it was necessary to protect the public health. The ban would not apply to all drugs, but officials would decide case by case if limits were needed.
“That concept makes a great deal of sense and can provide FDA an important tool to protect the public health,” Waxman said. The 2007 attempt failed after some lawmakers objected it would violate constitutional protections of free speech. Instead, Congress gave the FDA authority to issue fines for running false or misleading promotions. Voluntary guidelines adopted by drugmakers call for refraining from consumer ads for new meds for “an appropriate amount of time” so docs can first be informed.
Justice in Michigan
As Ed reports, the proposal was originally part of FDAAA but excised during compromise. It was supported by Bill Frist, among others.
The exact time of the proposed DTC ban varied. Most typically, one heard two years or so, coupled with completion of any required phase IV studies and provisional approval until that point. There would also be some version of the UK’s “black triangle” on the drug until provisional approval had changed.
Dan A.
Published on http://www.brainblogger.com
DTC Advertising
Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state. Such commercials are sponsored by typically 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 advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. The industry ranks number two on their spending of media campaigns. 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.
The purpose of DTC ads are not education for 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 medication and, in this case, for a particular perceived medical condition or disease state. 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 for what may be an unconfirmed medical condition suggested with such 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.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe to 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 accurate, 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.
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 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.
“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 http://www.brainblogger.com
DTC Advertising and Disease Mongering to Supplement Front Groups
Often, usually on television, one viewing will often at times see an advertisement for some type of medication- usually one involved in a large market disease state. Such commercials are sponsored by typically 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 advertising, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry spends around 5 billion annually on this media source now. The industry ranks number two on their spending of media campaigns. 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.
The purpose of DTC ads are not education for 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 medication and, in this case, for a particular perceived medical condition or disease state. 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 for what may be an unconfirmed medical condition suggested with such 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.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe to 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 accurate, 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.
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 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.
“Ignorance is not innocence but sin.” — Robert Browning
Dan Abshear
Author’s note: What has been written was based on information and belief
pharmavet
Although I’m not a big fan of DTC, Waxman will lose this one based on First Amendment considerations. The Washington Legal Foundation will see to that.
Justice in MI
It will be an interesting debate. The WLF will be in with all guns blazing, no question. But there have always been contexts in which freedom of commercial promotion was limited, not simply regulated (which WLF would also like to see end, as I understand them).
Jim
Why do DTC ads start off with a chirpy female (or couple) on a sunny day…happy, happy , happy…oh how great this drug is and THEN, the day turns cloudy, the person speaking speaks faster and in a more muddled fashion as the risk part comes on? Just wondering.
harpy
I think Waxman has a strong argument. Cigarettes and hard liquor can’t advertise on tv anymore and pharma wasn’t allowed to until fairly recently, like 10 years ago? Add in the debacle of Vioxx, companies spending less on ads anyway, and more concern about post-marketing studies - not to mention Congressional support of limits - and I think he can do it.
As corporations aren’t citizens, I don’t see why the Bill of Rights would apply to them.
dan Fisher
I am a practicing psychiatrist and I recommend a spectrum of choices to clients who are moderately depressed. One of these, which has been validated in 22 European studies is St. John’s Wort. Yet recently, on two occassions when I recommended it, the client or their spouse said they wanted the real SSRI they had seen advertised on TV. I would like to see DTCA ended. It was ended for cigarettes.
Concerned Texan
As a concerned parent of a child who recovered from vaccine induced autism, I can say with certainty I am fed up with not only the flooding of drug commercials on my TV, but the power drug companies have attained over media outlets because of those dollars spent on advertising. When the media starts to read a drug ad, in the middle of a news report, like they have done numerous times…it confuses the public to believe they are talking about real news,and not parroting a paid drug ad.
Not only do we need to end the TV drug ads but we need to seriously clean up the FDA- drug industry conflicts. When a doctor can hold patents on a vaccine, then serve on a board that is voting on approval for that vaccine…something is seriously wrong with that picture. The same is true for drugs. Massive conflicts of interest with the same people who have a vested interest in the new drug, also given power to vote for it’s approval.
Either way, a good start is with TV…because these drugs are attained only through prescription. Mass advertising to a wide audience that is not a majority of doctors only adds risk of more people being harmed by pressuring their doctors into prescribing a new drug that hasn’t materialized to reveal all the risk that can occur with any new drug, much less one that is not tested for contraindications with the thousands of other drugs out there people are on.