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Ethical Issues in Direct-to-Consumer Drug Ads
 (author retains copyright and responsibility for content)
subject:    W/A Premarin Ad Critique
From:         joan
Date:         1997/09/07

     visuals  major level text  2nd level text  osteoporosis info   body text and synopsis 

     Placement of 3/4 page glossy ad copy with FDA warning on -preceding- 1/4 page.
        Well, there it is for general circulation in the US today in Parade Magazine, coincidentally devoted to American attitudes about their own health. 

        Wyeth-Ayerst, the makers of Premarin and Prempro took out a full page ad touting their products. Except oddity number one is that the required FDA product warning text was found on the preceding 1/4 page and the glossy image ad with narrative text was found on the following 3/4 page.

         Now why didn't they spread the whole thing out on a single full page? They paid for a full page ad. Why didn't they use it? Was this an inadvertent or an intentionally deceptive choice?  The W/A ad placement required breaking up the text in an awkward manner of another article so this could not have been an editorial choice. Could it be that W/A did not want the reader to make the connection between the ad text and the FDA warning?

        Usually, (and equally deceptively) the required FDA product warnings follow the drug ads, but this time the FDA warning -preceded- the ad making it unread and unrelated without even a title heading, taking advantage of the typical reader response which is to read forward and not backwards to avoid making an obvious connection to the accompanying glossy photo ad. 

        Being careful to read all such drug ads word for word, it was not until the very bottom of the two pages of laudatory text for Premarin that this line was found: "Please be sure to read the important information preceding this ad".  I had to scratch my head a bit to figure out what they were saying and what they meant by "preceding information." When I turned the page backwards, there was the UNTITLED small print warning undoing pretty much of what the glossy ad tried to accomplish with appealing photos and soothing ad copy. 

        Caveat Emptor.

Joan L.
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Critique: The Visuals

        The Premarin ad shows a "menopausal" woman who looks closer to 30 than the picture in a preceding article of a 53 year old woman on an unrelated topic. Real pictures of menopausal woman versus ad copy pictures of menopausal woman leave a huge image gap. Intentional?

        The Premarin "menopausal" model has some odd looking crows feet over-emphasized in an other wise unlined face. The crows feet don't seem to follow any natural anatomical outlines and if in fact they were that extensive appearing to a row almost an inch in length dropping from the models eye, then why are there not more wrinkles on this model's face? 

        She looks fit and wondrously healthy in her jogging suit, demurely looking up from a squatted pose outdoors. Appealing, compliant, beautiful, even if badly air-brushed. The -new- Premarin woman and quite a contrast to the suicidal hags Premarin portrayed back in the 1960's. 

        And lo and behold, the model is not wearing a wedding ring. Hmmmm, maybe she looks so happy and young because she is not married, not because she takes Premarin. After all studies have shown the single woman is the happiest, with the married woman only coming in third, after the married man at second. 

        Or maybe this element is left intentionally ambiguous with one hand appearing to be the left hand showing, and the other hand ring finger draped over in the case the photo image was reversed.

        So here she is, Ms. Premarin. Unmarried, not a gray hair in sight, fit, slim, active, perfect teeth, and only a few inches of odd photo enhanced crow's feet to let us all know "she is one of us." Or what we would like to be?  Is there some sort of implied promise that we will look like that if we take Premarin? 

        Funny, the "important information" in the "preceding" page from the  FDA product insert says:

        RE: estrogens and progestins - When They Do Not Work
        You may have heard that taking estrogens for years after menopause
        will keep your skin soft and supple and keep you feeling young.
        There is no evidence for these claims and such long-term use may 
        have serious risks.

        The FDA talks and the Premarin ad visuals talk. Who is sending out the stronger message?

Joan L
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CRITIQUE OF PREMARIN AD: Scanning the major text

        The bold print, highlighted by being surrounded by the dominant burgundy color, like a deep rich glass of wine (or darkened menstrual blood? says "It's ........Premarin." 

        So this must be the primary intended text message to go along with the visual of the lovely youngish looking, demure, submissive lady. Desired association by glancing at the ad: You too can look this good with Premarin. 

        The entire line reads: "It's something I do for myself every day. I take my Premarin." Now who is saying this? The model who looks 35? No attribution is give for this quote, but the impression is that it comes from the model's own mouth as her personal testimony.

  Sounds like good -routine- advice like I get 8 hours sleep, I take my vitamins, I wear my seat belt. I care about myself and I take my drugs. But Premarin is not yet identified as a drug, just a good happy product. It is also presented at this point as the woman's choice alone because she wants to be good and even indulgent of herself.

        The use of the first person and the possessive "my Premarin" gives a cozy, "I know what I am doing and I like it" sort of feel to this first scan of the text. No mention that she is also saying "I had my uterus taken out so I can take my Premarin."

        Woven into this personal declaration, later on (in the small print text) is the interchangeability of Prempro and Premarin for women still with their uteruses and the accompanying increased endometrial cancer risk to deal with.

        But on the surface we have this smiling, happy, pretty woman declaring she knows what she wants in life and she wants -her- Premarin. Good way to stimulate brand loyalty which is a major concern of Wyeth-Ayerst, Premarin makers, while Estraderm and other patches eat into their product shares, along with the "natural progesterone" marketing hype.

        Our lovely model is not quoted as saying "It's something I do for myself every day now that I no longer have my uterus which was surgically removed. I now take my pill made from horse's urine." 

Joan L.
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CRITIQUE OF PREMARIN AD: Second level text

        The next level of text the ad wants us to read is smaller, but still bolder print and in that nice, rich reassuring burgundy print:

        "Three years ago my doctor and I agreed that taking PREMARIN was right for me. I've been taking it ever since, with my doctor's approval. I feel wonderful ....my menopausal symptoms are gone and I know I am helping to prevent osteoporosis and protect my future. Taking PREMARIN is part of my daily future."

        "When I take my PREMARIN, I know I'm doing something good for myself. PREMARIN will continue to be -my- brand of estrogen.

         Again no clue as to who is making this quoted text, but assumed to be the wise conclusions of this lovely youngish model demurely smiling up at us.

        So what information do we have here?. She has only been taking it for 3 years, well within the deadly five years before the use of this drug becomes far more problematic.

        The doctor and she are in a partnership and the patient is the one asking for the drug. The doctor is only saying okay to the patient's request to take this drug. This takes the doctor off the hook for any future liability. The doctor after all adequately informed the patient of all the known side effects and risks, had her read carefully the product insert and respects the patient's fully informed choice to take this product.

        No doctor merely wrote out a prescription and handed it to her and said take these now that you are "that age." Or convince her it was time to take out all those useless body parts now that she was "that age" and take Premarin as a substitute for that hormone those useless ovaries still were producing.

        "I feel wonderful"......... good enough reason to take this drug, don't you think? And at this point, they are only talking about estrogen, and not the Prempro which throws in that nasty progestin component so that not all women think it makes them "feel wonderful."

        So at this point we will have to assume the disembodied voice making this personal quote has had a hysterectomy and most likely she does feel wonderful taking her Premarin after having her female organs abruptly removed.

        But do you think the intent of the ad was directed strictly to the surgical menopausal patient or was it a siren call to all menopausal women to "feel wonderful" on Premarin? No mention or imagery at this point in the ad indicates that this is a product to be used only by castrated women. Nope, this ad copy beauty is taking it to get rid of those pesky menopause symptoms and intends to take it for life to prevent osteoporosis. 

        And then if we flip the page backwards to find the FDA product insert information we read some not so wonderful feelings some women get from Premarin:

        FDA: When estrogens should not be used: When they do not work.  During menopause, some women develop nervous symptoms or depression. Estrogens do not relieve these symptoms. 

        FDA: Side effects for Premarin:
Nausea, vomiting, pain, cramps, swelling, tenderness in the abdomen
Yellowing of the skin or whites of the eyes
Breast tenderness or enlargement
Enlargement of benign tumors of the uterus
Irregular bleeding or spotting
Change in amount of cervical secretion
Vaginal yeast infections
Retention excess fluid
Headaches, migraines, faintness, changes in vision
Worsening of asthma, epilepsy, migraine, heart disease or kidney disease
Mental depression
Involuntary muscle spasms
Hair loss or abnormal hairiness
Increase or decrease in weight
Changes in sex drive
Possible changes in blood sugar.

       So who speaks with the loudest voice? Our castrated, disembodied, unaccountable voice quoted as saying she feels "wonderful"? Or the fine print one page removed which lists the FDA side effects for the drug? 
 

PREMARIN AD CRITIQUE: Second level text (cont)

        More of the burgundy highlighted text has our disembodied voice being quoted that after three years of being on Premarin (presumably hysterectomized and probably castrated) that "my menopausal symptoms are gone."

        Well, are they gone because they naturally subsided after three years or were they "cured" by taking the Premarin?

        What kind of "menopausal symptoms" are now gone" All 34 or them or did our disembodied voice only have a few? Which "menopausal symptoms"? The beautiful young lady is speaking far too generally here.

        Also if in fact this beautiful young lady was castrated so she could take Premarin, then her version of "menopause symptoms" may in fact be one brought on by the abrupt surgical removal of her ovaries which is really not truly a normally occurring menopause after all. So she is touting a drug of appropriate use in a surgical setting that is not appropriately touted for the normal menopause but she and the ad fails to make the distinction.

        No mention that Premarin alone requires a hysterectomy which usually amounts to castration. No mention she is taking Prempro. No. Only Premarin. Ergo a surgically altered  lady. However, no mention that our lovely young model is castrated and was thrown abruptly into a surgical menopause. No, just this pretty face saying "she feels wonderful ...and my menopausal symptoms are gone." now that she takes Premarin. After a surgical menopause, no wonder she "feels wonderful" on her Premarin. 

        False, misleading and overselling a specialized drug for general use and failing to disclose the surgical status of the patient. 

        This ad has so far told us nothing of any substance besides the quote that this disembodied, unaccountable voice subjectively "feels wonderful." 

        So at this point the outer message is to sell indiscriminately a "feel good" drug. The hidden message so far is to sell youth and beauty. And to establish a sense of affectionate brand loyalty.  These are the first level messages.

        But there is more .........

We have established that our pretty young model is now castrated, feels wonderful on her Premarin after her surgical menopause but she doesn't stop there. She goes on to say "I know I am helping to prevent osteoporosis and protect my future."

        One wonders how she -knows- this when presently trials are now underway which will not be completed until 2005 before anyone really "knows" that Premarin will prevent osteoporosis in the castrated woman, let alone the non-castrated woman. Surrogate endpoints are being monitored but, according to bone researchers,  HUGE gaps still exist in our knowledge about tampering with bone density levels and eventual incidence of debilitating osteoporosis 

        We also know now, or can reasonably expect that our charming young lady model will be on estrogen far longer than 10 years and this is when the prolonged use of estrogen becomes problematic. She has already been on it 3 years. 

        Since the claim is that our model "knows" she is helping to prevent osteoporosis and protect her future, let's go back to the FDA product warnings and see what they have to say. Let's see what the FDA "knows."

        Drat, the print is so darn small and it is dark, I am having trouble reading the FDA warnings. Too bad they did not use the same print size type as they did for the lovely young lady model's quotes. I guess they thought what she had to say about "her" Premarin was more important than what the FDA said about their Premarin. 

        FDA: Cancer of the Breast:  However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogens for long periods of time (especially more than 10 years.) 

        So what are they saying here?. Pretty model is going to be taking her Premarin to prevent osteo and to protect her future. Does she plan to die within 10 years? I don't think so because she is the veritable picture of health and she "feels wonderful." So she is "protecting her future" with a drug that increases her risk of breast cancer, already pretty common in women as they get older. 

        Doesn't make a lot of sense does it? The ad says take this for a life time to protect your self. And the FDA warning says watch out after 10 years. Who do you trust? The perky model or the FDA?

        And now on to the osteo claims .......
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PREMARIN AD CRITIQUE: Osteoporosis information

        Lovely young model in the disembodied voice in highlighted large text says "I know I am helping to prevent osteoporosis."

        Now I realize she is not coming out and saying she is actually preventing osteoporosis. She is only saying she know she is -helping- prevent it. By how much? 1% increase in bone density? 50% increase in bone density? 

        Could she have said that a few years ago, before the definition of osteoporosis was so badly broadened that now practically all post meno women can be considered to have osteoporosis? Was this an example of enough pressure and politics and incestuous review board relationships among the bone "experts" to have created a definition to match what a drug is known to do? 

        Before this "consensus" definition that -any- bone loss post meno, physiologically normal or not, is now called osteoporosis? And the "cure" is estrogen (requiring hysterectomy) which has been shown to have some fairly minor effect on bone density readings. 

        But this is a surrogate end point and "bone density"  treatment is being substituted for "prevention of a disease" And a disease for which there is no known etiology, has complex secondary incidence manifestations and no long term studies to show getting castrated and taking estrogen even matters. Or if it matters, it may be a benefit specific to the castrated woman. 

        We don't know. Basic research does not know. But here in the Premarin ad, the disembodied voice "knows."

        So what does the FDA say about osteo and should this matter to us?  FDA: After age 40, SOME women develop osteoporosis. ...Taking estrogen (use of which alone implies castration) after the menopause SLOWS DOWN bone loss and MAY prevent bones from breaking.....Since estrogen use is associated with some risks, its use in the prevention of osteoporosis should be limited to women who appear to be susceptible to this condition. 

        FDA risks: white or Asian race, thinness, cigarette smoking, family history and early or surgical menopause.

        Hmmmm, interesting. Skinny white women. A current cultural ideal is unhealthy?  Asian? What! Don't they eat soy all the time and are protected from even experiencing menopause. Why they don't even have a word for menopause.  How can this be?

        Cigarette smoking and don't forget the alcohol, sodas, insufficient dietary calcium, antacids, etc and you have a totally voluntary life style etiology and not an incipient disease all women need to fear. So is the idea to get a hysterectomy (likely with castration) to be able to take the Premarin so then you can keep on smoking, drinking and consuming sodas when your hands are free?

        Or, we now come around full circle to the surgical menopause woman being at risk for the very disease it takes a surgical menopause to allow you to take the Premarin to prevent. Gosh, darn confusing isn't. But not to worry, because beautiful model "knows" it works for her. Good enough to sign up for a life time drug dependency isn't it?

        Or do we have a specialized drug appropriate for specialized and primarily surgical situations?  The ad doesn't tell you this, but bothering to read the fine print from the FDA tells you an entirely different picture. 

Joan L
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PREMARIN AD CRITIQUE: Body of text

        Synopsis: In the most prominent parts of the Premarin ad, we have  the pretty demure young lady allegedly quoted as saying she feels  wonderful, has no menopause symptoms and is helping to prevent  osteoporosis by daily taking her Premarin. 

        Of course we really do not know much about who is actually saying  this, it may not even be the young model. We know this voice has been  castrated as she is only taking Premarin and that she has been taking it  for 3 years. She may well feel wonderful taking artificial estrogens after  her abrupt surgical menopause, but we don't know why she "knows"  she is  preventing osteoporosis. The FDA insert is not so bold as to say this will  be the case. They only say it MAY help SOME women. So this osteo claim  according to the model could be  a bit far fetched for general therapeutic  advice.

        So now let's see what the body of the text has to say to back up  what the model has said about "her Premarin" which oddly has been somewhat contradicted by the accompanying FDA warning label. Maybe the drug company  itself can help straighten things out. So what do they say about these  important therapeutic claims being made by the pretty model for their  drugs?  It is time for W/A and their banks of research scientists to hit  home run.

        So now, at last given their chance, here is what W/A says:

Premarin has been prescribed for over 50 years.
Premarin is the most studied of all estrogens.
Premarin has earned your confidence.
Premarin is taken by more than 9,000,000 women in the US alone.
Premarin is a brand you can depend on.
Wyeth/Ayerst is a world leader in health care.
W/A goes to great lengths to ensure quality.
Not one of the 40 billion Premarin tablets sold has been recalled.  Not one.
This is why so many women and so many doctors have confidence in Premarin.

        Well, what a list of credentials. Pretty model makes the  therapeutic claims in quotes, but when it comes time for the manufacturer  to clear up the confusion between pretty model and the FDA contradictions,  we get instead testimony saying we have been around a long time and  everyone loves us. And we have never had a recall. 

        We have a product that the FDA says is dangerous, especially if  used long-term, but we have never put out a bad batch and pretty model says it works great for her bones and she intends to take it forever. Sure Premarin has been the most studied estrogen. That is how we  learned about it causing an increase in uterine cancer, seen its  association with stroke, breast cancer and gall bladder disease. And its  failure to show consistent results for heart disease prevention, specious  results for bone surrogate end points and a flimsy, flimsy relationship  with Alzheimers. 

        The studies have virtually all been on castrated women who must have been healthy  enough to take estrogen by not having other health risk factors and then their health status is compared to other castrated women who were not for  various reasons able to take estrogen in the first place. The vast amount  of them have been very short term. 

       Premarin has studied itself in highly flawed selection studies. And even the product FDA insert claims: the heart protection shown may have  been caused by the characteristics of the estrogen-treated women and not  by the estrogen treatment themselves. In general, treated women were  slimmer, more physically active and were less likely to have diabetes  than the untreated women. These characteristics are known to protect  against heart disease.

        And finally, after 50 years of massive testing, confident by  generations of physicians and women they have written prescriptions for,  for the very -first- time independent trials are being done on this drug  and  the final answers will not be known until the year 2005. 

        Someone must not have had much confidence in all of this  exceptional track record and have felt an eensy, teensy bit more investigation  was needed. In fact one of the most massive, long term, expensive trials  ever conducted, because -someone- was just not satisfied with W/A's self  serving claims. 

        So what did this ad really say? A personal testimony by an unknown voice, a picture of a pretty woman and testimony from the manufacturer  that their drugs have been loved for a long time by lots of women and lots of doctors. 

        And then there are those WHO statistics that have found the  American woman is now dying earlier than other women in industrialized  nations. Has 50 years of Premarin as America's number one selling drug and  a 1 out of 4 US hysterectomy rate created this declining longevity rate? 

        Is it time for a divorce from this match made in marketer's  heaven? Well the pretty castrated model "knows" her answers. But the rest  of us may just have to wait until 2005. 

Joan L.
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