Manufacturing Disease

         Although pharmaceutical companies spend more money on promotion and advertising than research, nevertheless, drug development is a time-consuming enterprise. When pharmaceutical companies need a quick jolt in their profit margin, it’s often easier to develop new diseases for existing drugs than new drugs for existing diseases.

         Susan sat quietly in the waiting room at Haven Medical. She didn’t take the offer of tea, and she refused the massage chair. Within moments of walking into the exam room, she began to cry. Susan told me she’d been given the diagnosis of PMDD and asked if I could help her find an alternative treatment to the medication her OB/GYN had prescribed and was trying to increase. “It makes me feel dead inside,” she said.

         Susan had been diagnosed with a disease generally unheard of before the year 2000, a diagnosis manufactured by pharmaceutical companies in order to expand the market for antidepressants. PMDD, or PreMenstrual Dysthymic Disorder, is not a diagnosis you will find in the DSM IV (the current guide to psychiatric diagnoses). You will find Premature Ejaculation (302.75), Pathological Gambling (312.31), and even Phase of Life Problem (V62.89), but not PMDD. The DSM IV does give criteria for research into this possible diagnosis, and these are both physical and emotional symptoms, which occur the week before, and end shortly after the onset of menstruation.

         Antidepressants provide big pharma with good profit margins: they are used continuously, often for years. Recognizing that the patent for its popular drug Prozac was soon to expire and become available as a much more affordable generic, Eli Lily repackaged Prozac in a pink and purple capsule, renamed it Sarafem, and began marketing it as a treatment for this new disease. Millions of women in the US were introduced to the diagnosis of PMDD by the company’s television ads. Pharmaceutical companies are only allowed to direct market to consumer in the US and in New Zealand, which is considering a ban.

         Despite Eli Lily’s success in the US, European regulators forced the company to stop selling Prozac for PMDD because it was “not a well-established disease.” In a letter to British doctors retracting Prozac, Eli Lily acknowledged that women “might erroneously receive a diagnosis of PMDD resulting in widespread inappropriate use” of the drug.

         The new American “epidemic” of PMDD and its reliance on antidepressants has been sparked not only by pharma, but by nonprofit organizations, generally heavily funded by big pharma. One leading online source for information is pmdd.factsforhealth.org, whose goal is to disseminate information on PMDD. Two years ago, it boasted an average of 40,000 unique visitors each month. In 2007, the website’s sponsoring organization (Madison Institute of Medicine, or MIM) received $152,500 from pharmaceutical companies. According to MIM’s 2007 tax return, their funding goal for 2008 was to be $184,000 in pharma grants, not counting a grant (amount unspecified) from Bayer Healthcare Pharmaceuticals. MIM is run by the same three physicians who write the literature for factsforhealth.org and who founded Healthcare Technology Systems, an organization that provides “clinical research consultation to pharmaceutical companies and healthcare organizations.”

         One of the articles you’ll find on the website is The Expert Consensus Guideline Series’ 2001 Special Report on the Treatment of Depression in Women, sponsored by unrestricted grants from Eli Lily, Bristol-Myers Squibb, and Pfizer. In addition to the program funding, the faculty for the program lists over 50 different relationships with various pharmaceutical companies. It is not surprising then, that these same experts list antidepressants as the only preferred initial strategy for treating symptoms of PMDD, which include depression, tearfulness, anxiety, anger and irritability, fatigue and poor cognition. For milder symptoms, antidepressants alone are recommended; for more severe symptoms, antidepressants along with analgesics or diuretics. For both, the initial recommendations are for daily drug use. These experts recommend “non-FDA approved indications” for the drugs, including usage for only 1-2 weeks out of the month, despite the fact that antidepressants used are known to require 3 to 5 weeks of continuous dosing to produce a physiological response. Additional drugs include hormone treatment (estrogen patch or birth control pills), even though the guidelines only recommend testing for hormonal imbalances in women over 40.

         Additional interventions are sparse. Nutritional recommendations are only general restrictions (alcohol, caffeine, etc) and there are no recommendations on vitamin or herbal supplements. Exercise, yoga, meditation, and cognitive-behavioral therapy are among the psychobehavioral treatments recommended.

         When I informed Susan that the Sarafem she’d been placed on was Prozac, she was stunned. Her OB/GYN never told her what the medication was. As we talked, she shared with me the tremendous stressors she’d been under over the past seven years. She didn’t sleep well, often awakening in the early morning hours, and never felt completely rested. She felt that part of her irritability was due to the fact she was always fatigued. Her menstrual cycle had been shortening over the previous five years, lasting only 24 to 26 days.

         I suspected that her menstrual problems reflected hormonal imbalances, due in large part to her high level of stress. I ordered salivary hormone testing and recommended she not resume the Sarafem the next month. Instead, I suggested dietary changes, guided imagery, exercise, and journaling, nutritional supplements, as well as some herbals geared towards balancing her hormones and replacing nutritional deficiencies. Her hormone tests reflected an imbalance in adrenal and female sexual hormones. We adjusted the supplements. The next month she was already feeling better and with within three, was feeling a little down only one day out of the month. Her cycle was back up to 26-28 days, and she felt like her old self. Most importantly, she didn’t feel “dead” inside.

         When doctors are given “Expert” guidelines, they rely on the experts to be unbiased and uninfluenced by conflict of interest. But when these experts are paid by the pharmaceutical companies as speakers, researchers, consultants, and advisory board members, it is hard to believe that no conflict exists. While bias in choosing one drug over another may not occur, it is evident that the bias of pharmaceutical over dietary, nutritional, and herbal interventions is strong. Our health care system minimizes the patient-doctor interaction, placing undue emphasis on expert guidelines and expeditious use of drugs, rather than the more time consuming patient-specific interventions of lifestyle counseling, nutrition, and natural products.

         Susan was lucky. Instead of increasing the antidepressants, she brought her body back into balance with a select choice of herbal products, improved nutrition, sleep, exercise, and meditation. Today she feels alive and barely notices when her menstrual cycle is due.