Tech & Science

'A Pill for Every Ill'

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Bottles of prescription pills go through an automated packaging machine December 2, 2010 in the Medco pharmacy plant in Willingboro, New Jersey. Medco’s state-of-the-art automated pharmacy, the largest in the world, can dispense up to one million prescriptions a week. The plant prepares up to 10,000 packages a day that are mailed to customers who get their prescriptions through Medco. AFP PHOTO/Stan HONDA (Photo credit should read STAN HONDA/AFP/Getty Images) Stan Honda/AFP/Getty

If there were fewer possible psychiatric diagnoses, would fewer people consider themselves ill? A growing number of health experts suspect that psychiatric care is drifting toward "diagnostic inflation," in which the rate of mental disorders balloons as a result of new diagnoses - and not due to an increasingly troubled population. What's worse is that this process may be fueled by the very document that is supposed to control it.

The Diagnostic and Statistical Manual of Mental Disorders (DSM-5), a 1,000-page behemoth that is now in its fifth edition, gives researchers and clinicians across the country a common language for discussing the ins and outs of a mind that is not well, ideally allowing everyone to agree on who is and isn't ill. The manual is produced by the American Psychiatric Association (APA).

Although the APA has insisted that its signature document should not be read as a rulebook, with definitions set in stone, a publication of this scope and caliber inevitably shapes the field. If the DSM-5 says your pain doesn't align with its definition of pain, you can be certain that, in the eyes of most psychiatrists, lawyers and policy makers, you're not in pain.

Now consider the opposite: What if the DSM-5's definition of pain illuminates a problem you didn't know you had - a pain you didn't know was even considered a real issue?

When the APA released the fifth edition of its manual in May 2013, it was instantly criticized by several researchers and clinicians, who claimed that some of the revisions and modifications reflected the agenda of an editorial panel that did not have the public's best interest in mind. For example, many therapists and parents denounced the decision to define Asperger's syndrome as a part of the autism spectrum rather than a stand-alone diagnosis. Some said it would skew statistics. Others said it would mess with identities.

"I personally continue to believe that Asperger's stands alone from autism," Andy Novis, a 50-year-old artist, handyman and personal trainer who received his Asperger's diagnosis shortly before the publication of the DSM-5, wrote in an email to Newsweek. Save for a few social anxieties, Novis navigates the world with ease, communicates about his experiences with aplomb, and prides himself on independence as he awaits the right time to start a family of his own. "While I accept that Asperger's may be part of the autism spectrum as a whole.... I personally do not see myself as autistic in any way."

That, however, wasn't the biggest concern. Other experts, including Sheldon Krimsky, professor of Urban & Environmental Policy & Planning at Tufts University, have pointed out that changes to the DSM can also be big business, with lots of downstream profit for everyone involved. If, for example, the DSM-5 finds a new "indication" for a particular drug, the developer can renew its patent and keep generic competitors off the market for another three years. For most industries, this would have a pretty modest impact on revenue. But in the business of curing ills, in which price tags can be very high and demand is often buoyed by nature, those three years can make a huge difference.

Take, for example, the drug Cymbalta - one of a group of drugs referred to by the industry as "blockbusters" - drugs that rake in at least $1 billion in annual revenue. Cymbalta, which is prescribed for major depressive disorder and generalized anxiety disorder, earned its blockbuster title almost five times over in 2012, bringing in nearly $5 billion to developer Eli Lilly. Lilly's patent on Cymbalta expired in December 2013, and the developer should soon begin to lose revenue to generics.

But thanks to the changes made by the APA to the DSM, the money will likely keep rolling in.

In past editions of the DSM, a so-called bereavement exclusion from major depressive disorder recommended that actively grieving individuals not be diagnosed with depression. In the DSM-5, this recommendation has been erased, giving rise to "bereavement-related depression" - a subset of major depressive disorder that is treatable by all the standard methods (and drugs) that ease depression. But if you didn't need to treat the loss of a loved one with medication in 2000, is it really necessary in 2014?

Companies like Lilly certainly want it to be - and they may just get their way. Public records regarding clinical investigations show that Lilly's expired patent on Cymbalta will in all likelihood be renewed, as it is currently the focus of a new trial for the pharmacological treatment of bereavement-related depression. In other words, it's going to end up being the drug of choice for treating what was merely called "grief" at the time of Lilly's original patent filing.

Changes like the bereavement-related depression clause are a cause for concern, Krimsky told Newsweek. After all, the APA is made up of professionals whose diagnostic preferences shape not only the psychiatric landscape, but also the revenue and stock profile of the pharmaceutical industry. The problem is that a striking number of key decision makers within the APA openly profit from this industry.

"In such sensitive areas, where new clinical indications are introduced for behavioral conditions, even the appearance of conflict of interest can affect public confidence," said Krimsky, whose new study -- conducted at the lab of Dr. Lisa Cosgrove, lead author and researcher at the Ethics Center of Harvard -- takes a closer look at 13 ongoing drug trials for broad, newly introduced diagnoses like bereavement-related depression. "The absence of biological markers - there are no blood tests or scanning techniques to determine the presence of binge eating disorder' or even 'major depressive disorder' - makes the risk of subjective bias stronger and the opportunity for the DSM to play handmaiden to industry even greater."

The DSM-5, like all scientific publications, comes with something called a "disclosure statement." In it, everyone involved in the publication discloses his or her affiliations with potentially conflicting entities (such as, say, a pharmaceutical company). A staple of good research, these statements serve to boost transparency and public confidence.

The APA's disclosures regarding the DSM-5 include several instances that appear to support the contention that the public's best interest has fallen in the shadow of financial gains. Take, for example, the Cymbalta trial: Of the 43 APA panel members involved in the implementation of this new diagnosis, 20 had disclosed financial conflicts of interest with drug manufacturer Lilly. These disclosures, which range from stock holdings and consultancies to honoraria and research funding, suggest that more diagnoses ultimately means more money for everyone involved. So, has the U.S. psychiatric authority been reduced to an intellectual grift, or does Cosgrove and Krimsky's study illuminate a more complex issue that warrants a second opinion?

"The issue that they are raising is completely legitimate and worth worrying about," says Dr. Allen Frances, a psychiatrist and former DSM chairman whose book Saving Normal takes a closer look at a public health landscape that has come to rely on a pill for everything. "But I know the people working on the DSM-5, and I think they've made simply terrible decisions, but that they've done it with pure heart."

Frances believes that while pharmaceutical companies may indeed pounce at every opportunity to drive revenue and retain exclusivity, the panel members themselves have also been blinded by their desire to help "the missed patient" - the individual in pain who, for one reason or another, disappears through cracks in the system. "The experts on the DSM-5 were given a tremendous amount of freedom, and what this resulted in was a kind of dream list of new diagnoses that turned the everyday problems of life into mental disorders," he tells Newsweek. "They are naive about how something that may work in their hands will be misused in the average practice."

The Cymbalta trial isn't the only case involving financially conflicted APA decision-makers. Cosgrove and Krimsky's new study identifies similar conflicts of interest across its entire sample, with board members as well as principal investigators disclosing ties to Lilly, Forest, Cephalon and many others. But Frances is quick to point out that greed is not the only thing coaxing panel members towards a broader view on mental illness.

"The biggest risk is not financial conflict of interest, but intellectual conflict of interest," he says. "The pressure of experts is always to expand their area."

What makes this prospect of diagnostic inflation so unsettling is that, from some distance, the development looks like a service to those in pain, a panacea from the tippy top of the system. Judging by Frances's thoughts on the matter, that's what it looks like to many high-ranking APA members, too. But as both he and Krimsky point out, a "pill for every ill" is an unsustainable dream that may ultimately do more harm than good.

"We have more deaths in emergency rooms now for prescribed psychiatric medication than we do for street drugs," Frances explains. And, as broad diagnoses will have psychiatrists and primary-care providers prescribe these pills to younger and younger patients, hospitals across the country may soon face a patient generation that has come to think of the pains of everyday life as treatable ills.

Historians have noted that when the Austrian philosopher Ludwig Wittgenstein worked as a hospital porter tasked with delivering psychiatric medication to World War I veterans, he would tell his patients not to take the drugs he brought them - supposedly out of a belief that, once illness becomes the norm, no one is really sick anymore. Although the strategy is a bit extreme, the idea behind it goes to the very core of the problem at hand: If there is a pill to cure all ills, will there no longer be such a thing as a healthy mind?

The story has been clarified to reflect that Dr. Lisa Cosgrove and Sheldon Krimsky conducted a study exploring 13 ongoing drug trials for newly introduced diagnoses like bereavement-related depression.  

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