Medicalizing the Menstrual Cycle

I have blogged previously (see Menopause: Made in the USA) about the negative effects of the “corporatization” of health care in the US. “Disease mongering” is a particularly nasty one. This occurs when pharmaceutical companies “medicalize” common conditions in order to market drugs that supposedly treat them.

Thanks to skillful marketing, Eli Lilly has turned premenstrual syndrome (PMS) into a profit-making commodity nearly as lucrative as menopause and “childhood bipolar disorder” (see Drug Companies: Killing Kids for Profit).

In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual “as a possible mental disorder requiring more research.” They have continued the diagnosis in DSM V. Although DSM IV lists PMDD as a strictly “research” diagnosis, Eli Lilly immediately seized on it as a genuine disorder and devised a marketing strategy to profit from it.

The Difference Between PMS and PMDD

Approximately 80-90% of women worldwide report physical and emotional changes in the 7-10 days prior to the onset of menstruation. For most women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating).

Approximately 1/3 of women note mental and emotional changes (aka PMS) – depression, anxiety, fatigue, irritability, insomnia, difficulty concentrating – that have a minor impact on their daily functioning.

Although the APA has yet to agree PMDD even exists as a disorder, there are numerous claims in psychiatric and women’s health literature that approximately 3-8% of women suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if they experience a “marked” decrease in normal functioning due to premenstrual mood changes. A rigorous Swedish study ascertained that the true percentage of women experiencing a “marked” decrease in functioning before their period closer to 1.3%.

A Golden Marketing Opportunity for Eli Lilly

Once the patent on a drug expires, other manufacturers are free to produce cheaper generic versions, resulting in plummeting sales of the original brand name drug. In 1999 Lilly, facing the expiration of its patent on Prozac, exploited the new “diagnosis” of PMDD by re-branding Prozac as a feminine pink and purple tablet called Sarafem.

In 2001, the FDA approved Sarafem for “PMDD,” on the basis of double blind studies involving several hundred women. Lilly reported a 60% response rate in women who took it for five cycles, with greater effectiveness in women who took it continuously throughout the month (as opposed to 7-10 days before their period).

Hopefully psychiatrists aren’t quite so gullible as the FDA, given Prozac’s limited effectiveness in treating depression. Thirty years of double blind studies reveal that depressed patients who take Prozac have an average response rate of 38-40%. In fact, statistical analysis of all randomized controlled trials reveal that all SSRI’s (i.e. Prozac, Zoloft, Paxil, citalopram, etc) are only slightly more effective than a placebos, which works 33-37% of the time.

Skillful Marketing Adds Billions to US Health Care Bill

Charging three dollars per dose for their pink and purple Sarafem tablets (in contrast to 41 cents per dose for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. In 2001, the year Serafem came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits.

Given the soaring cost of health care in the US (the main reason millions of Americans go without medical care), it strikes me as unethical and immoral to trick doctors and women into wasting nearly a billion dollars on pink and purple pills with a fancy name, when generic fluoxetine would have been equally effective at 1/9 the cost.

Research Evidence for “Natural” Treatments

What I find really fascinating about the PMS/PMDD controversy is that it’s one of the few women’s health “conditions” in which there are more double blind placebo trials of “alternative” or “natural” treatments than medication trials. The three “alternative” treatments that have shown clear effectiveness in randomized controlled trials are omega 3 supplements, Vitamin D and the chaste tree berry or chasteberry. In fact, much of this research suggests that PMS-related mood changes may actually represent a nutritional deficiency of omega 3 and/or Vitamin D.

Omega 3 oil is the most studied in PMS-related mood changes, largely owing to its proven efficacy in depression and large cross cultural studies revealing that populations (for example Asians and Norwegians) consuming large amounts of fish (a primary source of omega 3) in their diets have an extremely low incidence of depression.

Vitamin D, has also proved helpful for depression in double blind studies, especially in elderly depressives suffering from documented Vitamin D deficiency. Other studies show that 1,000 – 2,000 international units of Vitamin D is helpful in alleviating premenstrual symptoms.

This finding correlates with an extremely low incidence of PMS in Asian women. The same oily fish that are a rich source of omega 3 are the only natural food source of Vitamin D (the majority of us derive Vitamin D from exposure to sunlight).

Three double blind studies in the British Medical Journal, the Archives of Gynecology and Obstetrics and the Journal of Women’s Health and Gender-based Medicine reveal that chasteberry helps approximately 52% of women with PMS. Chasteberry is an herbal remedy used by Hippocrates in ancient Greece for pre-menstrual symptoms. It’s believed to work by lowering prolactin (a pituitary hormone influencing milk production). High prolactin levels are a recognized, but infrequent, cause of depression.

Take Home Message: Try Natural Remedies First

In light of all the above studies, common sense would dictate that women who suffer from PMS should try a combination of omega 3 and 1,000-2,000 IU of Vitamin D for a minimum of six months before resorting to either Sarafem or generic fluoxetine. Both have potentially serious long term side effects. Owing to their effect on serotonin receptors in the brain, SSRI’s can be very difficult to stop. Moreover they are associated with a loss of bone density, which increases the risk of osteoporosis and hip fracture in later life, and possibly linked to breast and ovarian cancer

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Drug Companies: Killing Kids for Profit

(Thanks to the corporatization of health care, Americans pay double what other countries pay for health care but have much worse health. The recent Obamacare roll-out has heightened public awareness about the role of private insurance companies in sucking billions of health dollars out of the health care system. There is far less scrutiny of the role of Big Pharma in driving up health care costs.

This is the second of several posts on “disease mongering” by pharmaceutical companies  – i.e. the invention of fictitious diseases to market drugs that supposedly treat them.)

Practicing psychiatry for eight years in New Zealand has given me a unique perspective on childhood bipolar disorder. Also known as pediatric bipolar disorder (PBD), this is a condition virtually unknown outside of the US. Australian psychiatrist Dr. Peter Parry has undertaken detailed research into this condition, and a “conspiracy” by Eli Lilly and other drug companies to promote off-label use of antipsychotic drugs to children under 12. Yet another example of “disease mongering” by Big Pharma (see link) to encance their profits.

As well as publishing numerous papers on the PBD controversy, Parry also has a Powerpoint presentation he gives at grand rounds and conferences around the world. It includes internal Lilly and Janssen memos (available from his Healthy Skepticism website) about their innovative campaign to “medicalize” children’s misbehavior.

Thanks to their aggressive marketing of PBD to US doctors and parents, American children as young as two are being started on antipsychotics for extreme anger and behavioral problems

Breaking the Law: Good Business Practice

Prescribing “off-label” refers to using medication for an indication that hasn’t been approved by the FDA. As yet no antipsychotics have been approved for use in children. Moreover, it violates federal law for drug companies to market medications to doctors or the public for “off-label” uses. Yet because the fines imposed are minuscule, compared to the massive profit potential of off-label marketing, it’s considered good business practice to pay the fine and keep on doing it anyway.

Diagnostic Criteria for Bipolar Disorder

Parry’s slideshow starts with studies comparing US attitudes about BPD in the UK, Germany, New Zealand and Australia. Most foreign psychiatrists either don’t recognize pediatric bipolar disorder as a diagnosis or regard it as extremely rare. According to Parry, the discrepancy revolves mainly around an insistence (outside the US) that both children and adults manifest symptoms of true mania to be diagnosed bipolar. Over the past 10-15 years, an increasing number of industry-funded psychiatric researchers have been claiming that extreme temper outbursts, rages and rapidly changing moods are a “manic” equivalent in children.

They also claim that children with extreme mood swings will go on to develop true bipolar illness in adulthood, making early treatment essential. This despite studies showing that most kids with PBD  “outgrow” it as adults. (Although it seems more likely they never had it to begin with.)

What Parry finds particularly horrifying is that American child psychiatrists are diagnosing kids bipolar and starting them on antipsychotics without taking a developmental history to rule out the most common cause of extreme anger and behavioral problems – namely child abuse and attachment difficulties.

Putting Psychiatric Experts on the Payroll

That being said, he puts the blame for the dangerous fad of prescribing unapproved antipsychotic drugs for children squarely where it belongs: on multinational drug companies. In the US, most child psychiatrists are naturally uneasy prescribing dangerous antipsychotic medication for kids. They have to be egged on by esteemed researchers issuing stern warnings about ruining a child’s future life by “missing” a the diagnosis of bipolar disorder.

Too bad these self-proclaimed PBD experts are so careless about disclosing conflicts of interest, in the form of hundreds of thousands of dollars in of drug company research grants and consultant fees. This has only come out in subsequent lawsuits and ethical investigations.

Death and Other Dangerous Complications

The complications of antipsychotic treatment in children fall into four broad categories: death, severe medical complications, social exclusion and delayed emotional development.

1. Death

15 years of FDA adverse incident reports (which typically capture only 1% of adverse drug events) directly implicates antipsychotic use in children with scores of deaths:

2000-2004: 45 deaths (source)

2006: 29 deaths (source)

2.  Severe Medical Complications

Antipsychotics tend to cause massive weight gain – often as much as 100 pounds – a common cause of diabetes. In addition a disfiguring neurological disorder called tardive dyskinesia that occurs in 6-9% of children who take antipsychotics. The tics and writhing movements associated with tardive dyskinesia often persist permanently, even after the medication is stopped.

3. Social exclusion

Labeling a child with a mental illness, particularly if they are taking a medications that cause sedation, extreme weight gain and/or tics has an extremely detrimental effect on social relationships that are absolutely vital to normal child development.

4. Delayed emotional development

Sedating a child who has difficulty regulating anger and extreme moods only further delays the process of learning to regulate their emotions themselves.

Below a video from a mom whose son died from antipsychotic complications:

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