On May 11, the New York Times published an article by Ian Urbina reporting false and misleading information on the changes proposed for substance use disorders in DSM-5. The article also wages inaccurate claims against members of the Work Group. APA’s response to points of the article are embedded below in blue.
Addiction Diagnoses May Rise Under Guideline Changes
By Ian Urbina
WASHINGTON — In what could prove to be one of their most far-reaching decisions, psychiatrists and other specialists who are rewriting the manual that serves as the nation’s arbiter of mental illness have agreed to revise the definition of addiction, which could result in millions more people being diagnosed as addicts and pose huge consequences for health insurers and taxpayers.
The work group has proposed that the DSM-IV categories of substance abuse and substance dependence be replaced with the category of “substance use disorder.” “Addiction” is not a proposed disorder for DSM-5.
Since early intervention can prevent more serious disorders, this is expected to be a significant public health benefit.
The revision to the manual, known as the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., would expand the list of recognized symptoms for drug and alcohol addiction, while also reducing the number of symptoms required for a diagnosis, according to proposed changes posted on the Web site of the American Psychiatric Association, which produces the book.
In the current proposal for DSM-5, substance use disorder would strengthen the diagnosis by increasing the number of symptoms required for a mild diagnosis to two symptoms (DSM-IV required one). Additionally, the DSM-5 draft criteria require that symptoms lead to clinically significant impairment or distress.
In addition, the manual for the first time would include gambling as an addiction, and it might introduce a catchall category — “behavioral addiction — not otherwise specified” — that some public health experts warn would be too readily used by doctors, despite a dearth of research, to diagnose addictions to shopping, sex, using the Internet or playing video games.
There is no intent or proposal to include a “catchall category” for other behaviors. This has never been recommended by the work group. The only behavioral disorder (non substance diagnosis) proposed is gambling disorder. Gambling disorder has been included in previous editions of the DSM as pathological gambling.”
Internet use disorder is currently proposed for inclusion in Section 3, an area of DSM-5 for conditions requiring further study before they should be considered disorders. The work group was very conservative with their proposals, even though there was pressure from clinicians to add this and other behavioral addictions. The proposal to include internet use disorder in Section 3 will hopefully encourage research on the condition.
Part medical guidebook, part legal reference, the manual has long been embraced by government and industry. It dictates whether insurers, including Medicare and Medicaid, will pay for treatment, and whether schools will expand financing for certain special-education services. Courts use it to assess whether a criminal defendant is mentally impaired, and pharmaceutical companies rely on it to guide their research.
While DSM has far reaching uses, its core purpose is as an authoritative guide for clinicians to use in the diagnosis of mental disorders. Another important role of DSM is to establish criteria for diagnoses that can be used in the research on mental disorders.
The broader language involving addiction, which was debated this week at the association’s annual conference, is intended to promote more accurate diagnoses, earlier intervention and better outcomes, the association said. “The biggest problem in all of psychiatry is untreated illness, and that has huge social costs,” said Dr. James H. Scully Jr., chief executive of the group.
But the addiction revisions in the manual, scheduled for release in May 2013, have already provoked controversy similar to concerns previously raised about proposals on autism, depression and other conditions. Critics worry that changes to the definitions of these conditions would also sharply alter the number of people with diagnoses.
The criteria are aimed at more accurately defining substance use disorders to better describe the people impacted by these conditions and improve diagnosis and clinical care.
While the association says that the addiction definition changes would lead to health care savings in the long run, some economists say that 20 million substance abusers could be newly categorized as addicts, costing hundreds of millions of dollars in additional expenses.
The current substance abusers would not be categorized as “addicts.” They would receive a diagnosis of mild, moderate, or severe substance use disorder.
The Work Group’s recent analysis of data from Dr. Grant’s NESARC sample of 43,000 randomly selected Americans indicates no significant change in prevalence. There have also been several smaller studies that also reported no significant change.
“The chances of getting a diagnosis are going to be much greater, and this will artificially inflate the statistics considerably,” said Thomas F. Babor, a psychiatric epidemiologist at theUniversityofConnecticutwho is an editor of the international journal Addiction. Many of those who get addiction diagnoses under the new guidelines would have only a mild problem, he said, and scarce resources for drug treatment in schools, prisons and health care settings would be misdirected.
“These sorts of diagnoses could be a real embarrassment,” Dr. Babor added.
Many individuals with substance use disorders would have only a mild problem as they do under the current diagnostic criteria. Those with both mild and severe substance use problems have had great difficulty in obtaining adequate services in the present health care system and it would be health care reform and not the diagnostic criteria that would make the most difference in increasing access to care. The characterization of the severity levels for these conditions, rather than the current artificial distinction between abuse and dependence, has the potential to better guide the type and intensity of prevention and treatment services.
The scientific review panel of the psychiatric association has demanded more evidence to support the revisions on addiction, but several researchers involved with the manual have said that the panel is not likely to change its proposal significantly.
It’s not clear where this claim originated. The proposed criteria are being evaluated at multiple levels, including reviews by the Task Force and Clinical and Public Health Committee. The APA Board of Trustees will weigh the proposals, along with these evaluations, in making their final decisions on the content of DSM-5.
The controversies about the revisions have highlighted the outsize influence of the manual, which brings in more than $5 million annually to the association and is written by a group of 162 specialists in relative secrecy. Besieged from all sides, the association has received about 25,000 comments on the proposed changes from treatment centers, hospital representatives, government agencies, advocates for patient groups and researchers. The organization has declined to make these comments public.
APA has deliberately made the DSM-5 development process open and inclusive of as many voices as possible. This includes presentations, studies and articles by the 162 volunteer Task Force and Work Group members and three online postings of the draft criteria inviting comment and feedback from outside professionals, patients and consumers. In the three open comment periods, nearly 12,000 submissions have been received. Additionally, APA has accepted other emails and letters about the proposed changes throughout the development process.
The viewpoints expressed in this feedback have been diverse, including critical perspectives as well as supportive perspectives on many of the draft proposals. APA has welcomed these critiques as part of the scientific review process—including those from patients, advocacy groups, and clinicians whose lives are affected daily by these disorders.
While other medical specialties rely on similar diagnostic manuals, none have such influence. “The D.S.M. is distinct from all other diagnostic manuals because it has an enormous, perhaps too large, impact on society and millions of people’s lives,” said Dr. Allen J. Frances, a professor of psychiatry and behavioral sciences at Duke, who oversaw the writing of the current version of the manual and worked on previous editions. “Unlike many other fields, psychiatric illnesses have no clear biological gold standard for diagnosing them. They present in different ways, and illnesses often overlap with each other.”
Dr. Frances has been one of the most outspoken critics of the new draft version, saying that overly broad and vaguely worded definitions will create more “false epidemics” and “medicalization of everyday behavior.” Like some others, he has also questioned whether a private association, whose members stand to gain from treating more patients, should be writing the manual, rather than an independent group or a federal agency.
The revised criteria proposed for DSM-5 are aimed at providing disorder criteria that more accurately define mental disorders. Our hope is that with more accurate disorder criteria we will be able to improve diagnosis and clinical care and in turn address some of the issues Dr. Frances noted as deficits in the current DSM-IV.
Under the new criteria, people who often drink more than intended and crave alcohol may be considered mild addicts. Under the old criteria, more serious symptoms, like repeatedly missing work or school, being arrested or driving under the influence, were required before a person could receive a diagnosis as an alcohol abuser.
The criteria are minimally changed. The symptoms listed in DSM-IV under “substance abuse” and “substance dependence” were combined to create the list for substance use disorders. The only change to the list was the removal of legal problems, since these are not included in the World Health Organization’s International Classification of Diseases (ICD)—because of marked variations in international as well as in local U.S. jurisdiction standards.
Dr. George E. Woody, a professor of psychiatry at the University of Pennsylvania School of Medicine, said that by describing addiction as a spectrum, the manual would reflect more accurately the distinction between occasional drug users and full-blown addicts. Currently, only about 2 million of the nation’s more than 22 million addicts get treatment, partly because many of them lack health insurance.
Dr. Keith Humphreys, a psychology professor at Stanford who specializes in health care policy and who served as a drug control policy adviser to the White House from 2009 to 2010, predicted that as many as 20 million people who were previously not recognized as having a substance abuse problem would probably be included under the new definition, with the biggest increase among people who are unhealthy users, rather than severe abusers, of drugs.
The revised criteria increase the number of symptoms required for a diagnosis. In addition to these symptoms the criteria require that the person exhibit clinically significant impairment or distress. It is unlikely that by strengthening the criteria, an increase in prevalence would occur. The Work Group’s own analysis, as well as studies by outside groups that have supported this point.
“This represents the single biggest expansion in the quality and quantity of addiction treatment this country has seen in 40 years,” Dr. Humphreys said, adding that the new federal health care law may allow an additional 30 million people who abuse drugs or alcohol to gain insurance coverage and access to treatment. Some economists have said that the number could be much lower, though, because many insurers will avoid or limit coverage of addiction treatment.
It is the new health care law and not the proposed revision of the DSM that may constitute the biggest expansion in the quality and quantity of treatment. The DSM-5 will be in a better position to help guide treatment than the current artificial distinction between substance abuse and dependence—which are eligible for treatment under the better current health insurance policies including the Federal Employees Health Benefit Program (FEHBP).
The savings from early intervention usually show up within a year, Dr. Humphreys said, and most patients with a new diagnosis would get consultations with nurses, doctors or therapists, rather than expensive prescriptions for medicines typically reserved for more severe abusers.
Many scholars believe that the new manual will increase addiction rates. A study by Australian researchers found, for example, that about 60 percent more people would be considered addicted to alcohol under the new manual’s standards. Association officials expressed doubt, however, that the expanded addiction definitions would sharply increase the number of new patients, and they said that identifying abusers sooner could prevent serious complications and expensive hospitalizations.
“We can treat them earlier,” said Dr. Charles P. O’Brien, a professor of psychiatry at the University of Pennsylvania and the head of the group of researchers devising the manual’s new addiction standards. “And we can stop them from getting to the point where they’re going to need really expensive stuff like liver transplants.”
Some critics of the new manual have said that it has been tainted by researchers’ ties to pharmaceutical companies.
“The ties between the D.S.M. panel members and the pharmaceutical industry are so extensive that there is the real risk of corrupting the public health mission of the manual,” said Dr. Lisa Cosgrove, a fellow at the Edmond J. Safra Center for Ethics at Harvard, who published a study in March that said two-thirds of the manual’s advisory task force members reported ties to the pharmaceutical industry or other financial conflicts of interest.
The APA Board of Trustees has gone to great lengths to limit relationships member of the Task Force or Work Groups have with industry sources. These members have responded by severing many of these relationships and disclosing all potential conflicts of interest since long before work on DSM-5 began.
Dr. Scully, the association’s chief, said the group had required researchers involved with writing the manual to disclose more about financial conflicts of interest than was previously required.
Dr. O’Brien, who led the addiction working group, has been a consultant for several pharmaceutical companies, including Pfizer, GlaxoSmithKline and Sanofi-Aventis, all of which make drugs marketed to combat addiction.
Dr. O’Brien took part in a smoking study for Sanofi in the 1990s, and has not been involved with the company since. The consultation for Pfizer and GlaxoSmithKline ended before the DSM work began. The only relevant relationship is occasional consultations for Alkermes, a firm that makes depot naltrexone, a treatment for heroin addiction and alcoholism.
He has also worked extensively as a paid consultant for Alkermes, a pharmaceutical company, studying a drug, Vivitrol, that combats alcohol and heroin addiction by preventing craving. He was the driving force behind adding “craving” to the new manual’s list of recognized symptoms of addiction.
Dr. O’Brien and his group at Pennsylvania University were the first to report on the beneficial effects and craving reduction with naltrexone in the 1980s, but no patent was filed. There is no financial benefit to any researcher from the sales of this medication.
“I’m quite proud to have played a role, because I know that craving plays such an important role in addiction,” Dr. O’Brien said, adding that he had never made any money from the sale of drugs that treat craving.
Dr. Howard B. Moss, associate director for clinical and translational research at the National Institute on Alcohol Abuse and Alcoholism, in Bethesda, Md., described opposition from many researchers to adding “craving” as a symptom of addiction. He added that he quit the group working on the addiction chapter partly out of frustration with what he described as a lack of scientific basis in the decision making.
This statement is inconsistent with the resignation email distributed to a large group of colleagues by this former member of the Substance Use Work Group. In that email he conveyed that his reasons for his resignation from the APA and the DSM-5 Task Force were based on APA’s support for the National Institutes of Health (NIH) Director’s proposed merger of the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse which he opposed—a merger that is currently in progress. Now, years later, he is suggesting that he resigned because of “a lack of science in the decision making.”
“The more people diagnosed with cravings,” Dr. Moss said, “the more sales of anticraving drugs like Vivitrol or naltrexone.”
Given the enormous damage substance use disorders have on people’s lives in this country, the search for more effective treatments across a wide range of addictive substances is one that the NIH Director hopes to achieve with the merger of NIAAA and NIDA, and with the new Institute on Translational Research which is intended to bring new pharmacological treatments for these and other disorders.