Mike the Mad Biologist

AMA Seeks Ban on Ads For New Drugs

The American Medical Association has called for a temporary ban on all direct-to-consumer advertising for prescription drugs. Sounds ‘elitist’? Well, so are professional sports. But only an idiot would trust Madison Avenue over his or her doctor. (an aside: I’m not an MD. I just have the occassional good sense to listen to people who know what they are talking about).

From ScripNews (subscription only):

The American Medical Association is calling for a temporary ban on direct-to-consumer advertising for newly approved prescription drugs, with the length of the ban to be determined on a case-by-case basis.

An advertising moratorium is needed to give doctors time to be appropriately educated about a new drug, the physicians group said. The AMA’s house of delegates adopted the position on DTC ads during its annual meeting in Chicago, Illinois.

The duration of the advertising moratorium should be determined by the US FDA in its negotiations with a drug’s sponsor at the time of approval, the AMA said. The length of the moratorium may vary from drug to drug depending on various factors, such as the innovative nature of the drug; the severity of the disease that the drug is intended to treat; the availability of alternative therapies; and the intensity and timeliness of the education about the drug for physicians who are most likely to prescribe it.

The AMA delegates adopted additional guidelines on the content and placement of DTC ads, including FDA review and pre-approval of ads before they run. The ads should also:

. provide objective information about drug benefits that reflect the true efficacy of a product, as determined by clinical trials;
. show fair balance between benefits and risks by providing comparable time or space and cognitive accessibility, and presenting warnings, precautions and potential adverse reactions in a clear and understandable way without distracting content;
. clearly indicate that the ad is for a prescription drug and refer patients to their physicians for more information and treatment; and
. be targeted at age-appropriate audiences.

Product-specific DTC ads generally should not use an actor to portray a healthcare professional who promotes the drug because this may be misleading and deceptive, the AMA said. If actors are used to do this, a disclaimer should be prominently displayed.

Last year, the AMA’s house of delegates considered a number of resolutions relating to DTC ads but deferred action pending further study of the issues. The proposals included recommending a ban on all DTC ads and urging the FDA to require inclusion of comparative quality data in ads.

In the meantime, the US industry trade group PhRMA announced new guiding principles for DTC ads last summer. The principles took effect on January 1st and generally recommended that all DTC ads should be accurate and not misleading, and should make claims only when supported by substantial evidence. Ads should reflect a balance between risks and benefits and should be consistent with FDA approved labelling, the PhRMA guidelines stated.

The industry principles called for manufacturers to educate physicians about a new drug before launching a DTC campaign, although the guidelines did not set a specific time interval for this. Television ads should be targeted for audience and age appropriateness, and all ads should be submitted to the FDA before being aired or printed.

PhRMA said that the delay in launching ads for a new drug pending physician education should take into account factors such as the complexity of the product’s risk/benefit profile and healthcare professionals’ prior knowledge of the condition being treated. “The length of time this requires will vary from medicine to medicine, and companies will likely meet this goal in different ways,” the industry group said.

“While there are subtle differences between the guiding principles and the AMA’s report, both emphasise the critical need to educate physicians and other healthcare providers about a new medicine before it is advertised to the public,” PhRMA said.

The AMA’s board of trustees noted that most PhRMA member companies have agreed to abide by the voluntary guidelines, and some individual companies have announced specific initiatives, such as a time-specific moratorium, that go beyond the industry principles.

The physicians group also called for additional research on the effect of DTC advertising, including the impact on the patient-physician relationship, overall health outcomes and cost-benefit analyses.

Comments

  1. #1 quitter
    July 26, 2006

    We’ve been discussing DTCA with regards to PLoS over at Give Up. PLoS has really been kicking ass on this issue, and their focus on disease-mongering was really a death-blow to the idea that DTCA should be allowed. We are, after all, the only country in the world stupid enough to allow it, and ever since it was legalized, the cost of medicine has been increasing exponentially.

    But they don’t stop there, this month, they’re going after medical advertisements in scientific journals as a critical conflict of interest.

    I’m really falling in love with PLoS. But the advice I’d give you as a non-MD trying to figure this stuff out is simple. Never believe a drug advertisement, and whenever a doctor prescribes you a drug, ask if there is a generic equivalent. Every wants to believe the newer drugs are better, safer, etc., but the opposite is usually true. Older drugs are time-tested and thoroughly studied, and newer drugs rarely beat one of the classics. And, they often cost a fraction of the on-patent medications, hence the pharmaceutical company interest in making you believe their new drug is better then the old drug.

  2. #2 Doc Bushwell
    July 28, 2006

    The AMA’s board of trustees noted that most PhRMA member companies have agreed to abide by the voluntary guidelines, and some individual companies have announced specific initiatives, such as a time-specific moratorium, that go beyond the industry principles.

    Here’s an article which reports one company’s initiative in such a DTC moratorium. This makes financial sense, too, since the costs for DTC advertising is not exactly chump change.

    Bristol-Myers Squibb to limit direct to consumer advertising (Wednesday, June 15, 2005).

  3. #3 Rita
    September 9, 2008

    All these DTC ads are pushing new drugs when the old drugs or the generics are much, much less expensive. Iíve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. Iíll bet they are charging more than $18 for this new drug! The unthinking public is going to pressure their doctors into giving them something just because itís new, when something old or generic would do the job for cheaper.

  4. #4 Dan
    September 29, 2008

    Drugs & Clinical Trials
    A Television As Your Doctor?
    May 19, 2008 | By Dan AbshearcloseDan Abshear Name: Dan Abshear
    Site: http://discoverwhatyouthink.blogspot.com
    See All Articles by Author (6)
    About: Mr. Abshear recently divorced himself from “big pharma” after working for three of the largest pharmaceutical companies in the world for over a decade. He continues to write primarily opinion pieces regarding what may be little known facts about the health care system- particularly the pharmaceutical industry, and his writings also include responses to the related writings of others as well on various internet sites. Before his pharmaceutical career, he was a patient caregiver for over a decade, which included being a medic (hospital corpsman) in the U.S. Navy and Marine Corps. | Bookmark and Share | 1 Comment

    We often see advertisements on television for some type of medication ó usually one involved in a large-market disease and the commercial is sponsored by a big pharmaceutical company. This is called direct to consumer (DTC) advertising, and doctors would prefer they did not exist.

    Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of these commercials greatly increased. Now, the pharmaceutical industry spends around $5 billion annually on this gigantic media effort. Normally, the commercial airs within a year of the drugís approval, which raises safety concerns and involves money spent that could be applied to greater uses, according to many. But, we are dealing with a corporation here.

    The purpose of DTC ads is not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective ó to increase sales and grow their market ó 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. The most interesting ones are for erectile dysfunction (ED) during primetime TV, with the real possibility of children watching. Further surreal is that these particular commercials seem to have ED sufferers portrayed as those who could probably run marathons, which is not realistic from a clinical perspective.

    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. It is illustrated by the drug companies through exaggeration and embellishments via various media sources as an avenue for propaganda ó often seen with DTC advertising. Though the flaws may not be medical, the corporate creation of these questionable human ailments that do not require treatment, possibly, may be an attempt to develop a particular medical condition to acquire profit.

    One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. It is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments being advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.

    Also, DTC ads normally discuss a single treatment option when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the physician, as they assess your health, not your TV or another media source. Thatís why most of the world does not conduct DTC advertising, with the exception of America and New Zealand.

    Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professionals remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. After viewing a DTC ad, many seek out a doctor visit and request whatever product that was advertised, which makes the doctorís situation quite cumbersome. So the doctor and patient relationship is altered in a negative fashion since most DTC advertised drugs require a prescription.

    Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some of our over-prescribing habits, which will benefit all of us in the long term. And the health care system can regain control of its purpose, which is far from financial prosperity.

    Men of ill judgment oft ignore the good that lies within their hands till they have lost it.
    ó Sophocles

    Dan Abshear
    Author’s note: what has been written is based upon information and belief.

  5. #5 sex shop
    April 15, 2009

    thanks for all

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