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Pre-Menstrual Dysphoric Disorder and Sarafem

Leslie Klein

 

 

                       

 

 

 

 

 

 

In 1994 Pre-Menstrual Dysphoric Disorder (PMDD) was introduced into the appendix the DSM IV to highlight it as a problematic condition, without recognizing it as a full-blown mental illness or disease.  The addition of PMDD raised consciousness of the severe and often debilitating symptoms that afflict some women a approximately a week before menstruation.  Pharmaceutical companies, in an effort to cultivate this new market, were quick to begin research on possible new medications that could administer relief to those afflicted by PMDD.  Lilly Pharmaceuticals (http://www.lilly.com/) was the first company to introduce a treatment in August of 2002, a new drug they called Sarafem.  Much controversy has since surrounded both PMDD and Sarafem.  Is PMDD a real disorder?  How can it be distinguished from Pre-Menstrual Syndrome (PMS), Major Depressive Disorder (MDD) and Anxiety Disorder (AD)?  Is Sarafem an effective treatment for PMDD?  Are pharmaceutical companies intentionally misleading and exploiting the public to gain higher profit margins?  This paper attempts to shed light on these difficult questions in hopes of making us all more informed consumers.

 

What is PMDD?

It has been estimated that roughly 3-9% of women suffer from PMDD; the onset of symptoms occurs seven to fourteen days before menstruation, and they subside a few days after menstruation begins.  The symptoms are divided into two categories, psychological symptoms and physical symptoms.  Physical symptoms of Pre-Menstrual Dysphoric Disorder include: breast tenderness, cramps, abdominal bloating, headaches, and starchy food cravings.  The psychological symptoms of PMDD are: markedly depressed mood, decreased interest in usual activities, lethargy/fatigability/lack of energy, hypersomnia or insomnia, depression, anger, irritability, anxiety, social withdrawal, difficulty concentrating or thinking.  A patient must exhibit at least five of these symptoms to be diagnosed with PMDD.  It is extremely important that the severity of these symptoms is addressed; women who suffer from PMDD are not mildly affected by their symptoms, they are particularly impaired as a result of the condition. 

Many individuals within the mental health field have expressed concern that the symptoms of PMDD are too similar to those of Major Depressive Disorder (MDD) and Anxiety Disorder (AD).  Perhaps the most distinguishing factor of PMDD is that its symptoms occur in a very predictable cycle, and only appear during a certain time frame (one to two weeks prior to menstruation).  Women who suffer from these symptoms all the time do not have PMDD, and are most likely suffering from another mental illness or condition.  Furthermore, Landen and Eriksson (2003) note that PMDD is a distinct diagnostic article, as opposed to a variant of AD or MDD, because its characteristic features are irritability and affect liability rather than anxiety or depressed mood. 

            Other clinicians contend that PMDD is not a real mental disorder at all, but rather a cultural fabrication.  Joan Chrisler PhD, president of the Society for Menstrual Cycle Research argues that, “ PMS and PMDD are both ‘culture-bound’ syndromes.  There is no evidence [that PMDD exists], though people have to find such evidence (Daw 2002, p.58).  Chrisler and many of her colleagues contend that PMDD’s inclusion in the DSM-IV is detrimental to women.  By recognizing PMDD as an abnormal condition, women are burdened with a stigma that suggests that emotional displays in men are normal, but are symptoms of a mental disorder in women (Daw 2002).  One study performed in 1992 by Sheryle Gallant and colleagues asked women to keep a checklist of PMDD symptoms; one group identified themselves as having severe symptoms of PMDD prior to the study, while the other group identified themselves as being asymptomatic.  At the conclusion of the experiment, the checklist responses of the participants failed to differentiate between the two groups.  Even more interesting, a third group consisting solely of men was asked to participate in the experiment; their checklist results also failed to differentiate them from the women!  This study provides compelling support for the notion that PMDD is not a mental disorder, but rather an unfounded social and cultural invention, since both men and women are equally susceptible and impaired by its psychological symptoms.

            One final concern with respect to PMDD is that the possible popularization of the disorder may prevent women from recognizing their primary problematic condition, e.g. depression or abuse.  The symptoms of PMDD are in many ways generalized and fairly vague; consequently, self-diagnosis may prevent women from seeking the help that they need to correct the source or cause of their problems.  For more information, consult: http://www.fda.gov/  or http://www.nlm.nih.gov/

 

 

 

 

 

 

 

What is Sarafem and is it effective in treating PMDD?                 

            Sarafem was introduced in August of 2000 by Eli Lilly pharmaceuticals as the first FDA approved drug to treat Pre-Menstrual Dysphoric Disorder (PMDD).  It contains the same active ingredient as Prozac, fluoxetine, but is packaged differently.  Prozac is administered in green pills while Sarafem is dispensed in purple/pink pills; besides this aesthetic difference, they are chemically identical.  Although fluoxetine was the first anti-depressant to be approved by the FDA for the treatment of PMDD, today almost all Selective Serotonin Reuptake Inhibitors (SSRI’s) including sertraline (Zoloft) are recognized as effective treatments. 

The FDA’s decision to approve both fluoxetine and sertraline followed the publication of several studies that showed both medications to be more effective than placebos in treating PMDD (Lin and Thompson 2001; Journal of Women’s Health and Gender-Based Medicine, Vol.10, No.8; Mechcatie 2002).  But it is important to note that the effectiveness of fluoxetine and sertraline in treating PMDD only refers to the alleviation of the disorder’s psychological symptoms and not its physical symptoms.  Furthermore, the studies have not examined the drugs’ effectiveness for periods longer than 6 months, so long term effects of taking either medication for PMDD is still unknown.  A new drug study has also provided some support for PMDD’s identity as an autonomous condition as opposed to a variant of depression or anxiety disorders.  When fluoxetine (Sarafem) is administered to treat PMDD, it begins working almost instantly, and the patient experiences relief within a few hours.  Conversely, when fluoxetine is used to treat depression (Prozac), it takes days for the medication to accumulate and provide relief; it may not be taken intermittently like Sarafem; it must be taken daily (Merchcatie 2002).  Some researchers therefore conclude that fluoxetine works on two different systems when it is used to treat PMDD and depression respectively.  Yet one could also argue that perhaps Major Depressive Disorder is characterized by a greater dysregulation of the serotonergic system than Pre-Menstrual Dysphoric Disorder and therefore requires higher dosages and more constant dosages to alleviate the same See this Magnet Framed!symptoms. 

            But what happens when the side affects of a particular drug are very similar to the symptoms of the condition that the drug is intended to treat?  The side effects of Fluoxetine are: insomnia, anxiety, nervousness, and somnolence (Elliott, Chan 2000).  These side affects are very similar if not identical to some of the symptoms of PMDD.  As a result, patients may become dangerously confused about the cause and effect relationships between the treatment and the illness itself.  Other considerations, similar to those surrounding the validity of PMDD as a real condition, address the possibility that just as with any other drug treatments, patients may seek the treatment without identifying the cause.  Although an abused woman may take Prozac or Sarafem and successfully elevate her mood, she unintentionally fails to address and assuage the true cause of her condition.

 

Are pharmaceutical companies misleading the public?

            Sarafem along with Prozac Weekly were introduced to the American public shortly after Lilly’s patent on Prozac expired.  In the fist year since the patent expired, sales of Prozac decreased by over 80%.  One tangible reason for these losses is that insurance companies are encouraging the consumption of the generic form of Prozac, fluoxetine, by assigning higher co-pays for prescriptions of brand name anti-depressants such as Prozac.   Lilly’s introduction of these “new” products (Sarafem and Prozac Weekly) grants them extensions on the patent of these modified forms of fluoxetine helping them to maximize possible profits.  Sarafem costs 50% more than Prozac and Prozac costs more than generic fluoxetine, leading many to question whether Sarafem is worth the extra money.  Market research suggests that both depression and Prozac carry negative stigma; Lilly Pharmaceuticals is most likely attempting to cash in on Sarafem’s unique market niche and novelty.  But are women willing to pay more money to not have a “mental disorder”?  Pharmaceutical companies have historically increased sales by either elevating the importance of an existing condition, redefining an existing condition to reduce a stigma, or developing a new condition to build recognition for an unmet market need.  Numerous experts believe that Lily Pharmaceuticals, with others closely in tow, are capitalizing on the final method. 

 

 

 

 

 

 

 

 

 

 

 

Conclusion

 Sarafem successfully treats the psychological symptoms of PMDD; yet whether PMDD is a condition that warrants attention as a true mental illness remains a hot topic among psychologists and clinicians. It is clear however that the characteristic symptoms of Pre-Menstrual Dysphoric Disorder can be alleviated by most any SSRI, especially fluoxetine and sertraline who have received the most scientific support to date.  Many market analysts have recognized Lilly Pharmaceuticals’ introduction of Sarafem as an astute business maneuver.  Although Sarafem has barely made a dent in the profit losses incurred after Lilly lost its patent on Prozac, the pharmaceutical giant is gambling that women will prefer not only to have PMDD rather than a proper mental illness, but also that they will prefer the brand name to the generic.  Only time will tell whether Pre-Menstrual Dysphoric Disorder will be upgraded to a legitimate mental illness and gain recognition as an abnormal psychological condition.  It also remains unknown whether Sarafem will become another cornerstone in Lilly’s drug arsenal or whether consumers and doctors will bypass the “new” drug to opt for its cheaper generic version, fluoxetine.  Today both the identities of PMDD and Sarafem remain in question, leaving their subjective assessments and usage up to clinicians, doctors and consumers.


 

References

1. Daw, Jennifer. “Researchers, physicians and psychologists fall on various sides of the debate over premenstrual dysphoric disorder.”  APA Online. Vol. 33, No. 9 October 2002.

2. Elliott, William T.; Chan, James. “Fluoxetine Capsules (Sarafem-Eli Lilly).” Internal Medicine Alert, August 15, 2000. v.22 il5 p117.

3. Goetzl, David. “Sarafem.” Advertising Age. October 8, 2001.Vol.72 issue 41; p.S12.

4. Goode, Erica. “Antidepressants lift clouds, but lose ‘miracle drug’ label.” New York Times. June 30, 2002 pg.1.1.

5. Gupta, Sanjay. “Beyond premenstrual syndrome.” Time. New York: June 3, 2002. Vol.159, Iss.22; p.83.

6. Landen, Mikael; Eriksson, Elias.  “How does premenstrual dysphoric disorder relate to depression and anxiety disorders?”  Depression and Anxiety 2003, vol.17(3); p.122-129.

7. Lin, Julia; Thompson, Diane S. “Treating premenstrual dysphoric disorder using serotonin agents.” Journal of Women’s Health and Gender based Medicine 2001, vol.10(8); p.745-750.

8. Mechcatie, Elizabeth. “Sarafem”. OB GYN News. August 15, 2000 v.35 il.6; p.23.

9. Napoli, Maryann. “Born-again prozac: not worth the extra cost.” Health Facts. New York: July 2001. Vol.26, Iss7; p.1.

10. Wolfe, Sidney M. “Profitability inventing new diseases.” Health Letter. August 2003. Vol.19 Iss.8; p.1.

 

 

 

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