The FDA finally approved Addyi, the controversial drug known as the female Viagra, for the treatment of flagging sexual desire in women. Efforts to make such a drug available to women have been ongoing since the introduction of medications to treat sexual dysfunction in 1998, and despite the FDA's rejection of the drug in 2010 and 2013.
However, Addyi is no Viagra. Viagra, the blockbuster drug by Pfizer, is indicated for erectile dysfunction in men, which occurs as a function of age and illness (such as diabetes and prostate cancer), and produces dramatic effects with very low risk of serious side effects. Viagra is a proven drug that treats an irrefutable condition.
In contrast, Addyi has only modest therapeutic benefits and a significant risk of adverse effects. Moreover, Hypoactive Sexual Desire Disorder, the condition that Addyi is intended to treat, is specious. HSDD is defined as persistent or recurrent deficiency of sexual fantasies and desire for sexual activity, and resultant marked distress or interpersonal difficulty. Even as a staunch defender of the Diagnostic Statistical Manual (DSM), I have to admit that this definition seems arbitrary and vague. At present, there is no laboratory test or radiologic procedure by which to confirm the diagnosis, so how is a doctor to know if a paucity of sexual ardor is a bona fide disorder or the proverbial "headache" excuse of an uninterested partner?
Nevertheless, the approval of Addyi is being hailed as a victory for women's rights and equal treatment (rather than a clinical advance or pharmacologic innovation). Sally Greenberg, executive director of the National Consumers League, called this "the biggest breakthrough for women's sexual health since the (birth control) pill," while Dr. Cheryl Iglesia, a physician representing the American Congress of Obstetricians and Gynecologists, said that "women are grasping and ... we need to offer them something."
This seems a curious rationale, and while it does not necessarily diminish the drug's value, it does illustrate how drug development and regulatory decisions can turn on social attitudes and cultural trends rather than solely on scientific and medical considerations. The needs/demands of a major segment of the population can't be ignored even in the absence of sufficient scientific evidence. The fact that there is no identified physical cause of HSDD does not mean it is not a condition that merits clinical attention and therapeutic efforts.
But flagging sexual desire isn't the only medically unsubstantiated condition begging for pharmacologic treatment. We have a long history of these diseases: Gulf war syndrome, chronic fatigue syndrome, irritable bowel syndrome, multiple chemical sensitivity, fibromyalgia, to name a few. What these "challenged disorders" have in common is that they are a constellation of distressing and disabling symptoms without any known biologic basis that can be detected by any diagnostic test. To a physician they are symptoms of an unknown cause and therefore suspect. However, that does not mean that they are not real or even that they are all in the patient's head, which, as a psychiatrist, is a common refrain that I hear when patients are sent to me for consultation. Many bona fide diagnoses are made based on clinical criteria without benefit of confirmatory laboratory tests, X-rays or pathological analysis. These include most mental illnesses as well as neurologic disorders like headaches and vertigo, and many pain conditions.
Perhaps the most notorious of the challenged conditions that exhibit no biologic stigmata is PTSD. And while it may currently be well known and acknowledged as a distressing and disabling disorder affecting large numbers of people (particularly in the military), PTSD was staunchly ignored and disputed for a long time. The first description of what we now call PTSD appeared in the medical literature during the Civil War and was called "Soldier's Heart" due to the rapid heart rate of its victims. In World War I it was called "Shell Shock" and then in WWII "Battle Fatigue" and "Combat Neurosis."
Not until Vietnam did the military and medical establishments finally take seriously and accept the legitimacy of the injurious effects of traumatic experience. Prior to Vietnam, soldiers suffering from PTSD risked being viewed as cowards and malingerers, in some cases court martialed and executed. In fact, the diagnosis of PTSD was not included in the medical nomenclature until 1980, and only then after aggressive advocacy by two sympathetic psychiatrists, Chaim Shatan and Robert Jay Lifton. By attending "Rap Groups" with Vietnam vets, they meticulously assembled a clinical picture of wartime trauma.
On May 6, 1972, Shatan published an op-ed piece in the New York Times, of what he called "Post-Vietnam Syndrome." In the article, Shatan wrote that Post-Vietnam Syndrome manifested "growing apathy, cynicism, alienation, depression, mistrust of people, as well as an inability to concentrate, insomnia, nightmares, restlessness, rootlessness, and impatience with almost any job or course of study."
Shatan's characterization became fodder for the media and popular culture. A 1975 Baltimore Sun headline referred to returning Vietnam veterans as "Time Bombs." Four months later, New York Times columnist Tom Wicker told the story of a Vietnam veteran who slept with a gun under his pillow and shot his wife during a nightmare: "This is only one example of the serious but largely unnoticed problem of Post-Vietnam Syndrome." Martin Scorsese's 1976 film Taxi Driver portrayed the image of the Vietnam vet as a "trip-wire killer." The main character, portrayed by Robert De Niro, is unable to distinguish between the New York present and his Vietnam past, impelling him to murder. In the 1978 film Coming Home, Bruce Dern plays a traumatized Vietnam vet, unable to readjust after returning to the States, who threatens to kill his wife (Jane Fonda) and his wife's new paramour, a paraplegic vet played by Jon Voigt, before finally killing himself.
After having seen the invisible wounds of war firsthand, Shatan was outraged when he learned that there was no diagnosis for this condition in the medical nomenclature. He sought out Robert Spitzer, the Columbia University psychiatrist, who chaired the Committee on Diagnosis for the American Psychiatric Association, who agreed to have his committee review the evidence for Post Vietnam Syndrome. In doing so the committee noted the similarities between the Vietnam vets and descriptions of holocaust survivors, and disaster victims. Ultimately, the committee agreed with Shatan that the enduring effects of experiential trauma did constitute a real disorder that warranted study and treatment. However, since the condition was not limited to combat experience, and occurred in civilian life, they termed it Post Traumatic Stress Disorder.
Since then, it has been much easier for military personnel and civilian victims of experiential trauma to obtain the medical attention they needed. However, the effort and resources devoted to the study and treatment of PTSD has been too little and too late. We still don't understand how an incorporeal incident can produce brain changes that deleteriously alter cognitive and emotional functions. Moreover, our treatments are only modestly effective. By now we should have learned much more and developed more effective treatments to prevent and alleviate PTSD.
Consequently, we are now experiencing the consequences of our past denial and negligence in the form of burgeoning rates of PTSD (and its various complications such as suicide, substance abuse and domestic violence) in our military personnel in Iraq and Afghanistan. In light of this, and the other challenged disorders whose victims had to fight for their legitimacy, there is a lesson to be learned, which is to listen, take seriously and investigate the basis of cries for help, when they arise, even if they do not meet our preconceptions.
If we can learn this, then all we need is to develop an Addyi or Viagra for PTSD.
Jeffrey A. Lieberman, MD, is the Lawrence C. Kolb Professor and Chairman of Psychiatry at the Columbia University College of Physicians and Surgeons and Psychiatrist in Chief of New York Presbyterian Hospital. He is the past President of the American Psychiatric Association and the author of Shrinks, The Untold Story of Psychiatry (Little, Brown and Company, March 2015).