Michael Jonathan Grinfeld

Funding for mental health services has never achieved top legislative priority, and reforms requiring parity succeeded only after years of hard-fought battles. After the 2007 brush with economic collapse, the recession, staggering unemployment, budget deficits, and sparse tax revenues, however, the situation has grown significantly worse. Dire consequences are predicted for mentally ill individuals who need services and for the communities in which they live.

The degree to which things have deteriorated was outlined during a special Congressional briefing in March sponsored by the National Association of State Mental Health Program Directors (NASMHPD) and the National Association of State Alcohol and Drug Abuse Directors. While patient demands on the state public health systems rose 10% from 2009 to 2012, the budgets for 41 states were cut a total of $4.35 billion (the 9 other states have yet to provide data). More crowded emergency departments (EDs), increases in crime and in prison populations, and exponentially greater societal costs to prop up individuals who don’t receive adequate treatment will place even greater stresses on overtaxed systems.

“We have a perfect storm on our hands,” says Joel Miller, NASMHPD’s Senior Director of Policy and Healthcare Reform. “Instead of providing timely, evidence-based mental health services to consumers, we’re going to be spending money in all the wrong places.” The organization’s members-executives from all 50 states, 4 territories, and the District of Columbia-deliver $37 billion of public mental health services to nearly 7 million people each year. Funding, Miller says, will dry up even more over the next several years.

How both the federal and state governments decide to manage the funding shortage during the political battles in a presidential election year is a key question. Mental Health America (MHA), the Washington, DC–based advocacy group, chided congressmen in March and urged House members to reject Rep Paul Ryan’s (R-Wis) budget resolution that proposed slashing Medicaid expenditures.

“I don’t envy the legislators and governors who are making these decisions,” says Sarah Steverman, MHA’s Director of State Policy, “but the budget cuts are short-sighted.” She notes that the across-the-board impact on employers, schools, criminal justice, and homelessness will be magnified as reimbursements to psychiatrists and other mental health practitioners are reduced to meet declining funding.

In Miami-Dade County, Florida, the criminal justice system is feeling effects that are even unusual for a state that has historically ranked near the bottom of public funding for mental health services. In the past 4 years, there has been a noticeable increase in the number of people with serious mental illnesses who end up in the criminal justice system, says Judge Steven Leifman, who has played a key role in developing new ways to reduce unnecessary expenditures incurred when mentally ill people become involved with the justice system. Five years ago, Leifman chaired the mental health sub-committee as the Florida Supreme Court’s special advisor on criminal justice and mental health when it released a comprehensive report-

Transforming Florida’s Mental Health System 

But with declining resources, the situation has grown worse and won’t likely improve without a major transfusion of money spent appropriately. “The community mental health systems instead of growing are shrinking,” Leifman says. “Access to care was already limited before budget cuts and the systems were horribly fragmented. The budget cuts have only exacerbated the problem.”

Beds that were once available to provide psychiatric care for members of the community have now been diverted to forensic cases-individuals who must be restored to competency before they can stand trial on criminal charges. “We now spend one-third of all of our public mental health dollars on 1600 forensic beds,” Leifman says. “Not only has it grown exponentially, but it’s also sucking up all the money from the community side.”

Meanwhile, 80% to 90% of the people who pass through the forensic system are soon released back to the community-either because they receive credit for time served, are placed on probation, or have the charges dropped. These people walk out the door, Leifman says, without having ever received the mental health care they actually need. “Spending a third of your money to move them through the system to get them to take a plea and then not give them any services is absurd,” says Leifman. “It’s the definition of insanity, where we keep doing the same thing and expect a different outcome.”

Fixing the problem is difficult when resources are sparse or are used the wrong way, Leifman says. The mentally ill are now the fastest-growing population in Florida’s prisons. Current estimates predict that the state will need to build 10 more prisons in the next 10 years to house increasing numbers.

As mentally ill individuals cycle through the prisons, it’s getting faster and more expensive. “The only silver lining behind the economic downturn is that it’s forcing policymakers to take a look at these absurd policies that are allowing people to circle the drain.”

Nationwide, the numbers reflect Florida’s experience, according to NASMHPD’s report. Over the past 4 years, some 4500 state hospital beds have disappeared without any concomitant improvement in community-based care. As a result, EDs are having to take up the slack: 70% report that they’ve had to “board psychiatric patients” for hours, days, or even weeks at a time.

There are no easy answers to all of these issues, says Laurence Miller, MD, Medical Director for the Arkansas Division of Behavioral Health Services, so the coming round of budget cuts will continue to create a tumultuous environment for public mental health. Dr Miller also serves on the APA’s Council of Healthcare Systems and Financing and chairs the Assembly Committee on Public and Community Psychiatry.

Many states are now in more dire straits than before, and in the face of budget cuts, are making decisions that won’t, in the long run, make sense, he says. For instance, cutting the number of medications available can cause patients who don’t receive what they need to decompensate, which generates even more costs. So, policymakers are “beginning to see the light,” says Miller. “But we still need to compete for the dollars.”

Articles

 Funding for mental health services has never achieved top legislative priority, and reforms requiring parity succeeded only after years of hard-fought battles.

The Outlook for Mental Health Services: A Perfect Storm on Our Hands

Studies showing that more and more children are using psychiatric medications have generated reactions--some would say overreactions--with ritualistic sameness. A researcher, after examining a data set maintained by a regulatory body, government health care program, or private HMO or insurance carrier, determines that the number of children currently on psychiatric medications is greater now than it was a few years ago. When news media report those results, they suggest that the increase bodes ill for the nation's kids, even though the study itself draws no such conclusions.

article reporting on one such study intoned that it was "likely to inflame a continuing debate about the risks of using psychiatric medication in children." But should it?

Ultimately, mental health professionals agree that more research could help ensure that children's illnesses are properly diagnosed and that the right medications are given to the right kids. But if the studies that measure utilization rates without relating those numbers to outcomes make it appear as if there is overuse of psychiatric medications, do they play a constructive role in developing mental health care goals? Or might research funds, already in tight supply, be better devoted to clinical outcomes studies?

"On the basis of current trends in practice, one can't make judgments about the quality, the effectiveness, or the safety of care," says Mark Olfson, MD, a professor of clinical psychiatry at the New York State Psychiatric Institute of the Columbia University Medical Center in New York City, whose study showing a significant increase in prescriptions of antipsychotic medications for children and adolescents generated the 

article. But he insists that knowing the number of children using the drugs helps researchers better understand what they need to learn about safety, efficacy, and effectiveness.

Journal of the American Medical Association

 that reported prescription trends for psychotropic medications among preschoolers, articles in the media generated an apoplectic reaction. (See 

May 2000.) Reacting to the outcry, then First Lady Hillary Clinton convened a White House conference to consider the study's implications, although critics claimed that this action related more to election year politics than genuine concern.

Today, the questions those early studies raised about whether children with mental illnesses received correct diagnoses and proper treatment--including medications--are well known, though still largely unanswered. So do the utilization studies still make sense when resources might be better spent on outcome studies and clinical research, especially when their release is often accompanied by distorted reports in the news media?

Despite the usefulness of epidemiologic research, Olfson acknowledges that the attention these studies receive in the media can sometimes have an unanticipated impact. "I am aware that at times the press exaggerates and sometimes even distorts these findings in ways that do not serve the public interest," Olfson said. "For instance, relatively little attention is given to the problem of untreated psychiatric disorders in the community. Studies concerning unmet need for treatment do not tend to garner the attention I feel they deserve. At the same time, I think it's important to have an understanding of current treatment patterns. If we're to make well-informed decisions about mental health care policy, we need to understand who is receiving what treatments."

While there is some value in knowing how many children are receiving psychiatric medications, Ricardo M. Vela, MD, director of pediatric pharmacology at Boston University Medical Center, says they don't help anyone understand whether physicians are diagnosing children's ailments correctly or whether they are prescribing medications appropriately. As a result, there are likely problems with both overdiagnosing and underdiagnosing mental illness in children.

"It's much easier to go into a database of numbers of prescriptions issued for each medication and count them because there you don't have to design a research project and start measuring outcomes," says Vela. It's more difficult to design and implement studies that measure outcomes and generate the kind of data that would help physicians know what to do for children, he adds. Plaguing the field is a shortage of child and adolescent psychiatrists and of researchers who can design and conduct the kinds of studies that would answer the substantive questions raised by the utilization reports. Reductions in research funds and the ethical conundrums that arise when children are the subjects of studies add to the reasons why years go by without more answers to thorny questions.

Vela agrees that journalists' reports about the studies often create trouble. "The media will pick on this--the reports of the use of medications, and . . . when parents hear this they get very scared, and understandably scared, and sometimes they come to me with information they got in the media."

Despite concerns that some reports may not describe utilization studies accurately, Benedetto Vitiello, MD, a psychiatrist who is chief of the Child and Adolescent Treatment and Preventive Interventions Research Branch at the National Institute of Mental Health, says that continued monitoring of medication use is important. In the early 1990s, he said, the numbers did trigger more research into outcomes for children. Today, they still help set priorities.

"The survey itself cannot really document or comment on the appropriateness of the [medication] use; it just indicates [that] the utilization has increased," Vitiello says. "However, what it can do is point out that the utilization seems to be disproportionate compared with a lack of adequate controlled clinical trials of these agents in kids." Over the years, efficacy and outcomes research has increased, he added.

Part of the problem is that often only one side of the story gets told, says David Fassler, MD, a child and adolescent psychiatrist in Burlington, Vt, and a clinical professor at the University of Vermont College of Medicine. What's worrisome, for instance, is that the research showing reductions in suicides among teens since the introduction of SSRIs is often buried beneath the avalanche of stories that cover the link between antidepressants and increased suicidal ideation among young people, he says. A 20% reduction in the prescriptions for antidepressants following FDA hearings does not necessarily mean something good is happening, he added, because it is also likely that children who need medications are not receiving them.

"In my mind, the issue is not how many kids are taking particular medications. The real issue is [whether] the right kids [are] getting the right treatment," Fassler says. "So, I worry that as a result of the extensive and sometimes inaccurate media coverage of these studies and of the FDA hearings, parents and some physicians will become reluctant to use medications when appropriate for children and adolescents with significant psychiatric disorders, including depression."

For Bob Carolla, a spokesperson for the National Alliance on Mental Illness, the prospect that epidemiologic studies can contribute to the stigma surrounding mental illness is an important issue. There is a disconnect between one set of numbers showing that the use of drugs in children is on the rise and the Surgeon General's report that some 80% of children who need care aren't receiving it.

"It's legitimate to be concerned about how many prescriptions are written for children, but you have to be concerned about other things equally if not more," Carolla says. "The worst possible outcome is [that there is] an overreaction to inflammatory concerns and [that] people stop getting into treatment

 Zito JM, Safer DJ, dosReis S, et al. Trends in the prescribing of psychotropic medications to preschoolers. 

Studies showing that more and more children are using psychiatric medications have generated reactions--some would say overreactions--with ritualistic sameness.

Psychiatric Drugs for Kids: How Many Is Too Many?

Take years of research, clinical observations, technological advancements and scientific discovery, and then subject them to derision and skepticism during a celebrity rant that's part of a promotional tour for an upcoming movie, and suddenly it's a media event. Sounds odd, but it describes what happened after Tom Cruise decided to take on psychiatry while hawking his new movie, 

, and the news media decided to turn the story into the latest shouting match for talking heads. While the episode aired some important issues about mental health care's benefits and limitations, it also confirmed that stigma is alive and well.

In a way, the prime-time conflict epitomized the marketplace of ideas that a democracy with a First Amendment should generate. Hollywood beauty Brooke Shields has a baby, suffers postpartum depression, seeks treatment (including taking a selective serotonin reuptake inhibitor) and ultimately transforms into the loving mother she's always imagined. She also becomes an author, whose sentimental memoir 

Then, Hollywood heartthrob Tom Cruise, a long-time Scientologist who--true to his religious principles--abhors psychiatry, takes to the TV airwaves to pout over psychiatric treatment, insisting that it should be criminalized and that Shields endangered her health and undermined her acting career by seeking treatment following the birth of her child. "She doesn't know what these drugs are and for her to promote it is irresponsible," he told 

If the dispute had stayed grist for the entertainment gossip mill, the uproar likely would have faded as quickly as yesterday's blockbuster. But when the mainstream news media stepped into the fray, the controversy escalated beyond a mere actors' tiff. Ultimately, even the venerable New York Times chimed in, publishing an editorial by Shields in which she defended herself against Cruise's onslaught.

 on June 24, Cruise laid into interviewer Matt Lauer, accusing him of not understanding psychiatry or its history. Seemingly cowed, Lauer ultimately yielded. "It's very impressive to listen to you," Lauer complimented Cruise, "because clearly you've done the homework and you know the subject."

Whether actors, particularly those with a religious agenda, can authoritatively comment on a field as broad as psychiatry and mental health is an important question, particularly when--in Cruise's case--it triggered appearances on prime-time television of "experts" who contended that vitamins and exercise are a better option than psychiatric care.

"If you sort of force things into this medium of 'we need two talking heads and they have to disagree with each other,' you can be mistaken, even if you're a fairly knowledgeable viewer, [into] thinking there's a good number of doctors and psychiatrists who think one thing and a good number who think the other thing," Ivan Oransky, M.D., deputy editor of 

and a board member of the Association of Health Care Journalists, told 

. "In fact, what this case demonstrates is that the format does not reflect current thinking at all. And it tends to highlight people who are a bit out of the mainstream."

In an effort to achieve balanced reporting, journalists will often treat medical reporting like political reporting, where the sides are clearly demarcated, Oransky said. "Medical reporting needs to be based, obviously, on solid critical thinking and great reporting. You will see the fringes of science and medicine because, for whatever reason, journalists are not able to distinguish between an either mainstream or prevailing opinion and not."

That may account for appearances by Julian Whitaker, M.D., a California physician trained in orthopedics, who promotes and markets a regimen of diet, exercise and nutrients for a variety of serious health issues. Whitaker acknowledges on his Web site that he's a practitioner of "alternative medicine," who's taken "the road less traveled." On both CNN and Fox News prime-time evening programs, Whitaker, representing the Scientology-sponsored Citizen's Commission on Human Rights, denied that mental illness had any basis other than the whim of psychiatrists.

"I didn't realize until just a couple years ago that all psychiatrist diagnoses are clusters of human behaviors that are voted on and then classified as a disease," Whitaker told CNN's Anderson Cooper. Later, on Fox News' 

, Whitaker praised Cruise for raising issues regarding "what I consider to be psychiatric abuse of children of a nonscientific, pseudo-science standing." Whitaker went on to say, "Well, if you look at psychiatry, it's not science. It's not even a pseudoscience. Most people don't know, and I only found this out a few years ago, that, in order to be labeled with a psychiatric diagnosis, [psychiatrists] vote on a cluster of human behaviors, and then label that as a disease."

Those kinds of statements surprised Carol T. Fletcher, assistant professor at Hofstra University's department of journalism, media studies and public relations, and a 20-year veteran health and science reporter. "I was expecting there to be very little information, but what I wasn't expecting is that there would be so much wrong information," she told 

. "I guess what is disappointing to me is that the interviewers don't seem to push points so that people can just pontificate and say ridiculous things and no one challenges them."

Fletcher not only cited Lauer's and other reporters failures to challenge erroneous information, but also pointed to claims by Sanjay Gupta, M.D., a neurosurgeon and senior medical correspondent for the health and medical unit at CNN, who attempted to controvert Whitaker's statements by showing brain images and saying that they revealed depression or attention-deficit/hyperactivity disorder. Fletcher said, "When a doctor throws scans up and says, 'See we can tell a depressed brain from a regular brain,' oh really, I've never heard of someone being scanned to see if they're depressed or not. Where are they doing that? No one pushes it further."

Although Lauer, through a representative, declined an interview request, Gupta defended his on-air segment to 

, saying that he was attempting to counter the claims that there was no science or objective evidence behind mental illness, and he was not implying that brain imaging was a readily available treatment or diagnostic tool. "What was being called into question was that there is no objective criteria at all by which any of these illnesses can be measured or diagnosed and therefore it must be a sort of pseudoscience," Gupta said. "In no way did I assert this is a widely available thing or that anybody could get this now."

The problem for Fletcher, however, is that news media have stopped making the effort to inform the public, substituting instead what she refers to as "pro/con" approach. Particularly when it comes to broadcast media, people don't tune in for information, she said, they tune in to watch people fight and to "get mad."

"Why was this such a big story? That's what interests me in a way," Fletcher said. "It plugged into things people wanted to get mad about. Interviewers are geared toward playing to that emotion in the audience. Commentators know that's what people want to hear. [Television] is giving the audience, in a way, what it wants, and what it wants is not necessarily information."

The harm in all of this, according to Fletcher, is that the stigma attached to mental illness is perpetuated, not only because it is not explained properly but also because the "experts" asked to interpret are often less authoritative, something usually not found when physical illnesses are the subject of news reports. "When media talk about mental health, any point of view is a legitimate point of view," she said. "They don't feel that way when they talk about oncology or heart disease."

Not everyone is ready to condemn the media over their handling of the Cruise/Shields dustup, particularly not Steven S. Sharfstein, M.D., American Psychiatric Association president, and president and CEO of Sheppard Pratt Health System in Baltimore. Invited to appear on NBC's 

three days after Cruise, he had the chance to tell the audience that Cruise's statements about psychiatry were "irresponsible."

"It was an opportunity for psychiatry to get the message out about psychiatric treatments, about the fact that mental illnesses are real and there is real suffering, that treatment works, that psychiatrists are physicians, and that what we do is based on science," Sharfstein told PT. "In that sense, Mr. Cruise provided a service."

But Sharfstein downplayed the circus atmosphere that sometimes surrounds news media coverage, accepting that it often requires head-on debates and promotes those whom he views as fringe elements. Sharfstein said that Scientology continues to recruit celebrity messengers, and whether in the news media or in legislative hearings, psychiatry has held its own by countering what he considers the more specious claims with science and evidence of treatment efficacy.

True to form, however, Sharfstein did not get center stage on the 

 without having to confront an antagonist. Joseph Glenmullen, M.D., a psychiatrist at Harvard University Health Services and the author of two books, 

Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants With Safe, Effective Alternatives

The Antidepressant Solution: The Only Step-by-Step Guide to Safely Overcoming Antidepressant Withdrawal, Dependence, and "Addiction"

 (Free Press), defended Cruise to an extent, telling 

that some of his comments rang true, at least in a technical sense.

No one ever had a problem with celebrities who endorsed psychiatric care, Glenmullen said. Endorsements from Mike Wallace, Patty Duke and Dick Cavett, to name a few, never resulted in anyone challenging their claims, despite the potentially dangerous side effects caused by psychiatric drugs during treatment and after individuals attempt to stop their use. "It just happens that people can make outrageous claims endorsing the drugs and virtually no one questions it," Glenmullen told 

, "but it's the tenor of our times that the minute anyone raises doubts about the drugs, all of these objections get raised."

Although Glenmullen uses psychiatric medications in his practice, he has urged physicians to prescribe conservatively and to warn patients about the potential withdrawal side effects in advance. Those opinions have often put him at odds with drug manufacturers and the psychiatric mainstream. While disagreeing with Cruise's anti-psychiatry stance, Glenmullen said that he's correct in challenging the extent of data supporting claims of chemical imbalances and the rate of overprescription of drugs. By doing so, "some fundamental issues got coverage," Glenmullen said.

Most likely this will not be the last time mental illness and the quality of psychiatric care ends up in the crosshairs of news media coverage. For both the medical profession and the media, the challenge remains to better inform the public about the benefits and limits of treatment. As one observer close to the debate wryly noted, "To change the way the public thinks about something either takes a million dollars or a stack of bodies."

Celebrity Triggers Tumult Over Psychiatric Care: Did the News Media Make Things Worse? by Michael Jonathan Grinfeld When Tom Cruise accused Brooke Shields of being irresponsible by taking antidepressants after the birth of her baby, psychiatry was momentarily thrust into the spotlight. How did journalists and scientists handle the situation, and how can they do better in the future?

Celebrity Triggers Tumult Over Psychiatric Care: Did the News Media Make Things Worse?

By definition, medical researchers test their hypotheses because they are uncertain whether a procedure or medication will actually help patients combat illness. So when a promising technique fails to meet expectations, doctors then know that a particular treatment may not deliver, and that it is time to test other methods. But when an eight-year, multicenter study that cost nearly $30 million failed to show that cognitive-behavioral therapy (CBT) and enhanced social support following a heart attack had an effect on survival or the likelihood of recurrent cardiac events, it left investigators puzzling over what went wrong and what to do next.

Even the study's acronym, ENRICHD, which stands for Enhancing Recovery in Coronary Heart Disease patients, evoked the confidence teams of researchers brought to a project that ultimately enrolled nearly 2,500 subjects within 28 days of a heart attack. Those patients, recruited from 1996 to 1999, came from 73 hospitals affiliated with eight clinical centers across the country. Once evaluated with depression, low social support or both, patients were randomized to either receive usual care or a CBT-based psychosocial intervention. The researchers hypothesized that members of the treatment group would live longer and suffer fewer future cardiac events.

They didn't. In June, researchers published the results of the ENRICHD randomized trial in 

 (289[23]:3106-3116), concluding that the therapy-based intervention had no effect on mortality and did not reduce cardiac events during an average 29-month follow-up period. That result, however, was tempered by a finding that those patients who took a selective serotonin reuptake inhibitor antidepressant did have a lower risk of dying or non-fatal myocardial infarction. The antidepressant use, which was not randomized and was provided to patients who needed them in both groups, has now raised new questions about the way heart attack victims should be treated in a system that already shortchanges their mental health care needs.

In the aftermath of the study's negative results, researchers are shrugging off their disappointment and attempting to understand why patients who received treatment for depression failed to respond with longer lives or fewer heart attacks. With prior studies establishing a link between depression and low perceived social support (LPSS) and cardiac mortality and morbidity, it seemed likely that providing a mental health intervention would yield improvement. The treatment did help alleviate the group's depression and lack of social supports, raising the question of whether quality-of-life enhancement should have been the appropriate endpoint of the study.

"The questions of survival and cardiac events are still important questions," said Susan Czajkowski, Ph.D., ENRICHD's project officer and a research psychologist with the National Heart, Lung and Blood Institute (NHLBI), the agency that funded the study. She told 

, "One way of looking at ENRICHD is that it was a specific type of intervention for a specific group patients and a very specific time point in the course of disease, which was immediately after the myocardial infarction ... Therefore, what we are doing right now is taking a look and thinking about the parameters of that and whether there might be better or longer interventions at different time points in cardiovascular disease, and whether there might be different kinds of patients that might benefit."

That scientific soul-searching could be important because of the data that indicated treatment with an SSRI antidepressant could generate the survival and anti-recurrence effect sought by investigators. For the time being, the finding has raised more questions about what care heart attack patients should receive, since the use of antidepressants may have been a confounding factor that yielded the negative results in the ENRICHD study.

The antidepressant medication became a confounding factor by possibly masking the benefits of therapy, said Ranga Krishnan, M.D., chair of psychiatry at Duke University School of Medicine, one of the clinical centers involved in the study. Meanwhile, because administration of antidepressants was not randomized, the findings relating to the benefits of SSRI use could not be confirmed with a high degree of confidence.

"It is fair to conclude that [talk therapy] will treat depression but not the problem," Krishnan told 

. "At this point in time, probably the most positive way of putting is to say you can't tell one way or another whether it will affect survival and there's no data to support that it will affect survival." Since the CBT-based intervention helped treat the depression, however, it should not be rejected as a possible therapeutic intervention, particularly because there are individuals who will not take medication, he added.

The larger issue still remains the lack of integration of mental health care as part of the post-heart attack rehabilitation process, though Krishnan doubts that this study will crimp efforts to provide improved access to treatment. "They're not reimbursing for it anyway," Krishnan said, because once a diagnosis of depression is made "carved" out, benefits levels often do not measure up to the ones provided for the physical elements of cardiac care. So part of the problem is not only the uncertainty regarding the method of treatment, but the systemic barriers to care that have traditionally plagued mental health.

That issue plagues cardiologists who must consider the mental health component of their patients' care. The systemic issues combine with the pragmatic elements of acute cardiac care to muddy the waters.

"Clinicians most often focus on the strictly medical during the acute phase of the heart attack. We have very little time and so we focus on those things that can impact acutely on patient morbidity and mortality during the acute event," Allan S. Jaffe, M.D., an ENRICHD study co-chair, cardiologist and professor of medicine at the Mayo Clinic, told 

. With cardiac patients now only spending between four to six days in the hospital, a physician has a limited time to interact and there is a tendency to give priority to acute rather than chronic problems. Cardiologists also recognize that secondary prevention problems are important and have implemented programs to address them for their patients. "But we need more definitive research findings showing mortality and morbidity benefits to mental health care. Even though I am an advocate, without hard data, it is hard to say that treatment of depression belongs in secondary prevention," Jaffe said. "We haven't shown that therapy changes outcomes. So for now I think the treatment of depression is indicated predominantly for its psychological benefit which can be substantial."

Even though Jaffe considers himself an advocate for integrating mental health care into cardiac rehabilitation programs, he also said that inadequate resources, low-level reimbursements and the unavailability of mental health care programs stand in the way. In addition, he conceded, "From the hard medical standpoint, therapy is not necessarily associated with improvements in hard medical events."

The statistics for heart patients under these circumstances are grim. According to the NHLBI, what justified the study were data showing that heart disease patients with depression or social isolation faced a risk of death three to four times higher. Despite the increased exposure faced by the 25% who fall into these categories, only an estimated 25% received treatment.

For Thomas N. Wise, M.D., the editor-in-chief of the consultation-liaison psychiatry journal 

 and professor of psychiatry at Johns Hopkins School of Medicine, the next step is to determine whether SSRI antidepressant medication can be proven to have the salutary effects sought but not attained in the ENRICHD study.

"The big question is then would we ever consider an SSRI as a prophylaxsis for heart disease," Wise told 

. "We're certainly not there yet, but you wonder whether in the future we might be. That's the research question now. Would it be useful to study the prophylactic effects of an SSRI with high affinity for serotonin reuptake inhibition?"

For Wise, the ENRICHD study finding that SSRI antidepressants did have an effect on lessening mortality and recurrence after a myocardial infarction, along with other research, suggests that there's not only a psychological effect, but also a possible physiologic influence. How that translates into practice guidelines for patients is still not clear, however.

"To date, all we know is that CBT in that [ENRICHD] sample did not improve mortality, except if you're on sertraline [Zoloft] [or other SSRI] and you were significantly depressed," Wise said.

"It's probably because the SSRI does improve clotting mechanisms," Wise added. "On the other hand, the physiology of depression affects the heart as well. ... When you're depressed, your heart rate isn't as elastic, and that can be bad." As a result, combined approaches that include therapy and medication may be the way to treat depression while at the same time reducing death and cardiac events.

The premise also makes sense to George I. Viamontes, M.D., Ph.D., a psychiatrist and cell biologist who is the regional medical director of United Behavioral Health in St. Louis. He said that the ENRICHD study results should not discourage health care systems from incorporating proper mental health care into their cardiac rehabilitation programs although he, too, acknowledged that there is still resistance to its inclusion. But whether psychotherapy alone can make the difference is a function of a number of psychological and physiological forces.

"It's not that I wouldn't support adjunctive psychotherapy for people who may benefit from that in some other way, say to improve quality of life, but I would certainly urge people to be on a medication," Viamontes told 

. With the research indicating that the risk of mortality and morbidity is highest within the first few months after a heart attack, it is possible that medication works faster than CBT.

It's a question of approaching the problem from a top-down or bottom-up approach, Viamontes said. In the case of CBT, it may show behavioral changes, but it will take longer for it to generate a physiologic response. In the case of SSRI antidepressants, which he agreed may have an effect on platelets and clotting, the drugs begin to work immediately on the cellular level and may have a positive impact even before noticeable behavioral changes occur in the depressed patient. Ultimately, what the study may be showing is that talk therapy takes too long to create the types of changes at the molecular level that will reduce mortality and morbidity in heart attack patients whose risk is highest after an event.

Despite what appears to be a setback, NHLBI's Czajkowski said that this is just the beginning. "What will happen now is that all the investigators are madly analyzing data in various aspects of the trial. Many publications are in the works that will be looking specifically at the depression outcomes, at the social support outcomes, at the subgroups of women and minorities, the pharmacology outcomes and those will hopefully be published in the coming year."

Research Fails to Link Talk Therapy With Heart Attack Survival - Poetry of the Times

Research Fails to Link Talk Therapy With Heart Attack Survival

 decided to run a story in July about refractory depression, the article was entitled "Some Still Despair in a Prozac Nation." Even after a decade on the market, and despite the availability of a host of competing drugs, the headline exemplifies the extent to which Eli Lilly and Company's popular antidepressant remains a pop culture icon. So when the Indianapolis-based pharmaceutical manufacturer launched a 30-minute program that featured Prozac (fluoxetine) in May-it avoids using the term 

-the cutting edge direct-to-consumer (DTC) ad naturally raised questions and a few eyebrows as the company sought to gain even wider exposure for the drug.

The program was originally scheduled to air through July on national cable channels and in select affiliate markets, and has been extended through at least mid-October, targeting the estimated 9 million adults in the United States who receive no treatment for depression. Combining education about depression, patient testimonials and product information, the infomercial was meant "to provide factual information about Prozac that may be useful to anyone whose life has been touched by depression," said Gino Santini, president of U.S. Operations and Global Marketing for Lilly, in a Lilly press release.

Lilly declined to release figures enumerating the number of times the infomercial was broadcast and how many individuals called the toll-free number to request an information packet, saying the information was proprietary. But Greg Kueterman, a Lilly spokesperson, told 

 "we are very happy with the response; we received more calls than we anticipated."

He also said that the reaction to the long format advertisement was generally positive. "The general response from the callers was that they were glad to learn more about depression and about Prozac. They felt the spots were up front about the drug, about what it does and doesn't do, and about its potential side effects."

For psychiatrist Freda Lewis-Hall, M.D., director of Lilly's Center for Women's Health, however, the issues of professionalism versus commercialism were particularly important. Asked by her employer to host the program, Lewis-Hall had to reckon not only with the impact she could have on individuals, but also with her own reputation as a physician.

"Actually, I did think about it a lot," said Lewis-Hall in an interview with 

 "What finally won out was my passion for reaching out to people who otherwise would not receive treatment...Television reaches people where they sit. You can't educate people in 30 or 60 seconds about things that are hugely complex, like diabetes, hypertension or depression. This was an opportunity to give people the story and to tell them how serious a disease depression is, and to show them how hard it is to [be diagnosed] by your physician. I was able to tell people how difficult it is to step up to the plate, admit that something's wrong and to seek medical help, to recognize that this is a medical condition and not a weakness."

To get her message across, Lewis-Hall said, she was "willing to suffer whatever hits came," though she added no one has criticized her participation thus far. "I started out as a physician thinking I was going to end up as the ethics police," but the collaboration with the production and marketing personnel turned out what she believes is a tastefull and informative program. The infomercial included statements that there were any number of treatments for depression and that Prozac is not right for everyone. It consistently urged viewers to discuss their concern with their doctors, important qualifiers Lewis-Hall said.

"When I went to the APA [American Psychiatric Association] annual meeting in Washington, D.C., in May, I was a little nervous because that was around the time the program would premier," said Lewis-Hall. "I expected at least a couple of colleagues-ones who knew me really well-to pull me aside in the hallway of the convention center and say, 'You've really crossed the line and have gone to the other side.'" Instead, she continued, "the company and I were congratulated for having participated in something like this. So my fears have been unfounded."

Michael Blumenfield, M.D., the chair of the APA's joint commission on public affairs, told 

 that the organization has not taken any official position on the use of infomercials, although he recognized that any effort to help educate the public about depression is welcome. "There is always a possibility that there will be pressure but you have to weigh that against the positive effect of education and destigmatization of depression and mental illness," he said. "There are potential problems. Psychiatry will have to look closely at them and weigh in with [its] opinion and influence."

Nevertheless, Blumenfield added, if the ad could encourage people to seek treatment, then ultimately the physician would take over the role of educating the patient. "Physicians will have to pick up where the infomercial leaves off. They're going to have to make the diagnosis and educate the patient about the options for treatment. This may include no medication or a different medication," he said.

The National Alliance for the Mentally Ill reacted favorably to the effort. In a Lilly-prepared press release, Laurie Flynn, executive director of NAMI, said that the program raises "awareness and reduces the stigma that some people still associate with depression." Later, NAMI spokesperson Bob Carolla told 

 that NAMI does not endorse any particularly treatment as a matter of policy, but "anything that promotes awareness and that educates people and helps to break down stigma fits in with what NAMI tries to do each and every day."

Carolla added, "People need to remember there is someone here selling a product," though he cautioned against becoming too cynical. Ultimately, he agreed that when individuals seek treatment, they will listen to the more authoritative voice of the psychiatrist "who may tell them some other treatment is more appropriate."

Although the Lilly infomercial created a stir in the national media, none of the pharmaceutical manufacturers contacted by 

 said they were planning to develop long format ads, though some conceded they will consider all options. Generally, each company makes a choice about whether to market to physicians or DTC based on evaluation of its own best interests.

Pfizer Inc., for instance, recently launched an education initiative for panic disorder in conjunction with the Anxiety Disorders Association of America. Singer Naomi Judd, who disclosed using Pfizer's selective serotonin reuptake inhibitor Zoloft (sertraline) to treat her condition, is a spokesperson. "We had a very successful press event in July," said Celeste Torello, a spokesperson for Pfizer. "She is very touching when you hear her speak about it." 

"We don't do any DTC ourselves," said John Eggers, a spokesperson for Forest Pharmaceuticals in New York City, makers of the antidepressant Celexa (citalopram), whose marketing strategy is directed toward physicians. "We find that for most pharmaceutical products, DTC is really a strategy of the market leader, and Prozac has the largest share of the market."

Keeping the market growing is important to Lilly, Eggers added, but it also helps all of the manufacturers of antidepressants. "We get our share of those new patients who are coming in and our share is growing. I don't view it as an unfavorable thing for us, and it's probably what they [Lilly] should be doing."

When The New York Times decided to run a story in July about refractory depression, the article was entitled "Some Still Despair in a Prozac Nation." Even after a decade on the market, and despite the availability of a host of competing drugs, the headline exemplifies the extent to which Eli Lilly and Company's popular antidepressant remains a pop culture icon. So when the Indianapolis-based pharmaceutical manufacturer launched a 30-minute program that featured Prozac (fluoxetine) in May-it avoids using the term infomercial-the cutting edge direct-to-consumer (DTC) ad naturally raised questions and a few eyebrows as the company sought to gain even wider exposure for the drug.

Infomercial for Prozac Takes DTC Ads to New Level

America's pop culture can send a dizzying blur of mixed signals. On the one hand, its massive restaurant and food industries serve up an abundance of calorie laden, often unhealthy processed meals that have turned Americans into the most overweight people in the world. On the other hand, fashion designers and other purveyors of style pound home images of lean and muscular men and waiflike women, creating a national yearning for body types that rarely approach the reality of what most of us will ever look like.

Mediating between these two contradictory forces is a burgeoning weight-loss industry whose own feeding frenzy consumes billions of dollars each year. According to a report last summer in the 

 Americans spent nearly $500 million on prescription and over-the-counter diet drugs in 1996. Meanwhile, they disgorged another $30 billion annually on diet programs and products, according to a National Task Force on the Prevention and Treatment of Obesity. The cost of excess isn't only economic-an estimated 300,000 people die each year from obesity-related causes. 

But a combination of serendipity and science last summer threw the medicine and business of weight reduction into turmoil. As researchers scurried to determine what mechanisms in a combination of weight reduction drugs cause cardiac damage to millions of people, Eli Lilly and Co., the manufacturer of Prozac (fluoxetine), landed in the center of a controversy, though one not of its own making. Pitted against Nutri/System Weight Loss Centers, which is heavily marketing Prozac in combination with phentermine (Adipex, Fastin) as a weight-loss drug, Lilly now finds itself in a public relations, legal and public health quagmire as physicians and consumers agonize over what to do next. 

A mere five years ago, it seemed as if researchers had discovered a magic bullet that could decimate fat and bring relief to millions who had fought the battle of the bulge unsuccessfully. A combination of phentermine and fenfluramine (Pondimin), according to University of Rochester investigators, caused people to lose more weight and keep it off for longer periods of time than those taking placebo. Weight-loss companies, always hungry for new injections of capital and for a sharper marketing angle, jumped on the bandwagon, and the "phen-fen" diet blossomed into a fad that swept the country. Last year alone, doctors wrote 18 million prescriptions for the combination. In the 14 months since the Food and Drug Administration narrowly approved Redux (dexfenfluramine), a more refined version of fenfluramine, physicians have written approximately 4.2 million prescriptions. 

Even earlier concerns about side effects, the most troubling of which was a connection to primary pulmonary hypertension (PPH), did not stem the growing tide of individuals willing to manage weight with pills. And despite warnings that phen-fen should not be used for long periods of time and only in patients who met medical criteria for obesity, the combination nevertheless became a panacea for moderate weight gain.

In July, when the Mayo Clinic first reported that fenfluramine and dexfenfluramine were linked to heart valve defects in women who had used the drugs, the bottom began to fall out of the phen-fen craze. As more and more doctors began to back off the combination, the FDA intensified its investigation into the disturbing reports, ultimately withdrawing the drugs from the market in mid-September. Weight-loss centers had to consider options. 

Nutri/System turned to Prozac. Hanging its hat on claims made by two physicians, it replaced the "fen" portion of the phen-fen combination with Prozac. By the end of the summer, it was marketing its newly revised NutriRx program that featured "phen-Pro," a combination of phentermine and Prozac it claimed was a "clinically tested prescription medication that targets the source of the problem, the part of the brain that controls hunger."

In a media blitz that included advertising and extensive press coverage, Nutri/System did something Lilly could never do because of strict federal laws prohibiting manufacturers from making off-label claims about prescription drugs. The weight-loss company, with over 500 locations in 47 states, began touting an off-label use for Prozac, at one point even suggesting that Lilly found the combination of its antidepressant and phentermine to be "very promising." Despite the view of many experts that the data supporting the "phen-Pro" combination was largely anecdotal, Nutri/System promoted its NutriRx program as a "medical breakthrough" offering "proven medications." 

In a stinging letter sent in September to Nutri/System's Joseph DiBartolomeo, Ph.D., vice president for scientific affairs, Lilly officials denounced the use of Prozac in combination with phentermine for weight loss. Observing that Prozac "is not authorized for the treatment of obesity or weight control by the U.S. Food and Drug Administration," the letter accused Nutri/System of embarking "on a public campaign-including direct-to-consumer television advertising-that misrepresents the antidepressant Prozac."

Referencing statements attributed to DiBartolomeo during a Sept. 18 interview on ABC's "Good Morning America," the letter said that "Lilly has not indicated a belief that the combination of fluoxetine plus phentermine is 'very promising,' nor does Lilly have data from adequate controlled clinical trials that would characterize the combination as 'very safe' or 'something that could be very effective for people to lose weight with.'"

And in a final, more ominous warning that signaled that the dispute between the two companies has more to play out, Lilly alleged that the weight-loss company's "references to Prozac and Lilly for Nutri/System's commercial gain are violations of federal and state trademark law..." that "infringe Lilly's rights and misappropriate Lilly's good will." The letter then charged that "Nutri/System's advertising campaign creates potential public health issues and could mislead consumers."

In an interview with Psychiatric Times, DiBartolomeo, whose doctorate is in health education, nutrition and weight management, defended the off-label use of Prozac, arguing that there is no FDA prohibition against physicians using any approved drug for any purpose. He added that Nutri/System physicians prescribed the drugs only after customers met certain medical criteria.

Although he would not provide a copy of his company's protocols, calling them a "trade secret," DiBartolomeo said that individuals needed to weigh at least 20% more than their recommended body weight before receiving the drugs. In addition, he said, consumers undergo a complete physical exam and history before a physician determines the drugs are appropriate. 

To support his company's use of the "phen-Pro" combination, DiBartolomeo relied on the reports of two physicians: Richard L. Atkinson, M.D., at the University of Wisconsin-Madison Medical School, and Michael Anchors, M.D., Ph.D., a Rockville, Md., family practitioner and a Georgetown University Medical School professor of medicine. 

Atkinson's study, conducted several years ago, but reported in an abstract published in the March 1996 issue of 

, involved 68 patients who took either Prozac and phentermine, or fenfluramine and phentermine over a 20-week period. The 42 patients who received Prozac lost 8.9% of their baseline body weight compared to 12.2% for the 26 individuals taking fenfluramine. Based on these results, Atkinson concluded that "in combination with phentermine, both fluoxetine and fenfluramine produce weight loss and improvement in complications of obesity, but fenfluramine is more effective."

In an interview with Psychiatric Times, however, Atkinson, a professor of medicine and nutritional science and director of the medical school's clinical nutrition program, denied that his study justified giving the phentermine/Prozac combination on a mass basis. "I feel uncomfortable in the position of senior author on this [abstract] if it is used as a justification for much of anything," he said. "[This] is clearly an anecdotal abstract, and I think it would be hazardous to draw any great conclusions about the safety or effectiveness from that. And this is, to my knowledge, the only thing in the literature that has used phentermine and Prozac." 

Atkinson balked when told Nutri/System described his study as one "conducted at a major university medical school" that "determined that a combination of two medications made participants feel more full and less hungry." 

"It's pretty scary, to say that," Atkinson said. Although the investigation was done with careful follow-up, he added, "what's in that abstract was not designed as a formal scientific protocol. It was a collection of cases and a comparison...I do feel uncomfortable with my abstract-not even a paper, an abstract-being cited as evidence for the safety and efficacy of this combination." 

Calling some of Nutri/System's ad claims a "lot of hype," Atkinson lamented the commercialization of the treatment of obesity. "I'm sorry that medicine and physicians for so many years neglected obese people [to the extent] that obese people feel they have to go to a shopping mall to get their really severe disease treated," he said. "This is America. If there is a demand, whether it's for marijuana, or crack cocaine, or obesity treatment, people will seek it, and people will supply it. And that's what's going on here. I don't approve of using the tiny little abstract that I had, which was not even a formal study. I think they [Nutri/System] are vastly overblowing the data." 

Anchors' claims for the phentermine/Prozac combination are the subject of his just-released book called Safer than PhenFen. A description of his clinical experience with more than 500 patients who were prescribed the Prozac combination over the past two years, Anchors' book concludes that "obesity is a biochemical problem in the brain and it can only have a chemical answer." In a letter published in the June 9 issue of Archives of Internal Medicine, Anchors concluded that "fluoxetine and some other selective serotonin reuptake inhibitors are just as effective and probably safer than fenfluramine in the combination with phentermine in the medical treatment of exogenous obesity. They should be used exclusively, instead of fenfluramine, until the results of large randomized, double-blind trials of both drugs become available." 

It is this reliance on preliminary, largely anecdotal reports, lacking the scientific rigor of long-term, double-blind, placebo-controlled research, that has some experts seething at the mass marketing of the phentermine/Prozac combination. Even DiBartolomeo concedes that there is no long-term data. "What I anticipate happening is that now that there is some data on phen-Pro short term, that it's very effective and without side effects...we'll find that more researchers will begin to test this on a longer-term basis. But we do not have very long-term data at this point," he said, although he denies that using the drugs now is an inappropriate off-label treatment regimen. 

But Paul Hamburg, M.D., an assistant professor of psychiatry at Harvard Medical School, and associate director of the eating disorders program at Massachusetts General Hospital in Boston, disagrees. "The thought that anyone's response to this surprise [the discovery of valvular heart disease]-which is going to result in death and a tremendous amount of morbidity, especially for obese patients who can least afford to have open heart surgery-should be to plunge ahead and try another untested combination of drugs, even for the medically obese... is the height of foolishness." 

Peter D. Kramer, M.D., a Providence, R.I., psychiatrist and 

 columnist whose best-selling book Listening to Prozac helped turn the antidepressant into a household name, agrees. "This is one of many approaches you'd rather have studied than just done for large numbers of people," he said. "When you see that there's a side effect that can occur in a large percentage of people-there were up to 30% of the people on phen-fen [who] had suffered some change in the heart valve-you really know that there can be less frequent side effects that only emerge from systematic study. So it does seem difficult to recommend this. It does seem worrisome. These are powerful medicines." 

Despite the lack of studies, Anchors discounts the potential for side effects similar to those encountered by phen-fen users. Arguing in his book that, since its introduction in 1987, Prozac has been connected to only eight instances of PPH out of 19 million users worldwide, he surmises that the differences in the way Prozac and fenfluramine affect serotonin levels account for the prevalence of cardiac effects in phen-fen users. But even Anchors can't be sure. 

Although controlled studies are already underway to determine the actual cause of the cardiac effects, results are months, if not years, away. American Home Products, through its subsidiary Wyeth-Ayerst Laboratories, manufacturer of the withdrawn drugs, has already begun a clinical trial aimed at targeting the cause of the valvular damage. 

Nutri/System's nationwide campaign to boost sales of phentermine/Prozac combinations, without waiting for the hard, scientific data, according to Thomas Wadden, Ph.D., professor of psychology and psychiatry at the University of Pennsylvania School of Medicine, is "terribly irresponsible." Wadden, also director of the school's weight and eating disorders program, provided some of the subsequent data the FDA used to justify withdrawing fenfluramine and dexfenfluramine from the market. Rather than marketing a new, largely untested product, he said, Nutri/System ought to be giving echocardiograms to customers who got their phen-fen through its weight loss programs. 

When Stanley Hertz, M.D., director of the eating disorders center at Schneider's Children's Hospital, at the Long Island Jewish Medical Center, first heard of the Mayo Clinic results at a Harvard conference over the summer, he immediately stopped prescribing the phentermine/Prozac combination. 

"We don't know what the pathogenesis of the cardiac effects are of serotonin agonist medications and phentermine. So I, in good conscience, could not see giving it to patients...I took all of my patients off of it three months ago," Hertz said. "What is the mechanism that causes the cardiac effect? I would rather be conservative and do nothing from a lack of knowledge than be cavalier and do something." 

The American Medical Association has also taken a cautious approach; acknowledging the physician's right to prescribe Prozac and phentermine for uses they deem appropriate, but at the same time warning doctors that there should be separate indications for each drug. If there were reasons to prescribe phentermine and Prozac to a single individual, for instance to treat obesity and depression, then the AMA would support it, said John C. Nelson, M.D., an AMA trustee. "But the combination of the two for weight loss we couldn't support. The reason we couldn't support it is because there's no clinical evidence for that...no studies done." 

Nutri/System's marketing plan has its risks. Already, more than 100 lawsuits have been filed by individuals claiming injuries from phen-fen, and there are likely to be substantially more. Estimates are that the potential claims could reach over $3 billion as lawsuits spread beyond the manufacturers of phen-fen and Redux, to distributors, weight loss companies and physicians. DiBartolomeo declined to respond to questions regarding potential liability issues, including those claims asserted by Eli Lilly in its letter, despite numerous requests. 

Four years ago, Nutri/System entered into a consent decree with the Federal Trade Commission (FTC) after it charged several weight loss firms with deceptive advertising by making unsubstantiated weight-loss and weight-loss maintenance claims. By the terms of the settlement, Nutri/System agreed not to misrepresent the performance or safety of any future weight-loss program, and was required to have scientific data to back up future claims about weight loss and maintenance. 

"I can't confirm or deny whether we are looking at any company for possible order violations, but I can say that we monitor compliance very carefully," said FTC spokesperson Bonnie Jansen. "We monitor [weight- loss] program claims in general, and we've really focused on this area in recent months," she added. The FTC is empowered to seek monetary penalties of up to $11,000 per day, per violation. 

America's pop culture can send a dizzying blur of mixed signals. On the one hand, its massive restaurant and food industries serve up an abundance of calorie laden, often unhealthy processed meals that have turned Americans into the most overweight people in the world.