Preventive Psychiatry E-Newsletter # 402

MEDICALLY CAUSED DEATH IN AMERICA:

AN EXCLUSIVE INTERVIEW WITH DR. BARBARA STARFIELD

“The medical system is the third leading cause of death in the US, behind heart disease and cancer”

By Jon Rappoport

www.nomorefakenews.com

As the national healthcare bill winds its way through the legislative process (now passed), one explosive factor is being ignored: the American health system, like clockwork, causes a mind-boggling number of deaths every year.

The figures have been known for ten years.  The story was covered briefly when a landmark study surfaced, and then it sank like a stone.

The truth was inconvenient for many interests.  That has not changed. "Medical coverage for all" is a banner that conceals ugly facts.

On July 26, 2000, the US medical community received a titanic shock to the system, when one of its most respected public-health experts, Dr. Barbara Starfield, revealed her findings on healthcare in America. Starfield was, and still is, associated with the Johns Hopkins School of Public Health.

The Starfield study, "Is US health really the best in the world?", published in the Journal of the American Medical Association, came to the following conclusions:

Every year in the US there are:

12,000 deaths from unnecessary surgeries;  

7,000 deaths from medication errors in hospitals;  

20,000 deaths from other errors in hospitals;  

80,000 deaths from infections acquired in hospitals;  

106,000 deaths from FDA-approved correctly prescribed medicines.

The total of medically-caused deaths in the US every year is 225,000.

This makes the medical system the third leading cause of death in the US, behind heart disease and cancer.

The Starfield study is the most disturbing revelation about modern healthcare in America ever published.  The credentials of its author and the journal in which it appeared are, within the highest medical circles, impeccable.    

On the heels of Starfield's astonishing findings, media reporting was extensive, but it soon dwindled.  No major newspaper or television network mounted an ongoing "Medicalgate" investigation.  Neither the US Department of Justice nor federal health agencies undertook prolonged remedial action.

All in all, it seemed that those parties who could have taken effective steps to correct this situation preferred to ignore it.        

On December 6-7, 2009, I interviewed Dr. Starfield by email.  

What has been the level and tenor of the response to your findings, since 2000?  

My papers on the benefits of primary care have been widely used, including in Congressional testimony and reports. However, the findings on the relatively poor health in the US have received almost no attention. The American public appears to have been hoodwinked into believing that more interventions lead to better health, and most people that I meet are completely unaware that the US does not have the 'best health in the world'.

In the medical research community, have your medically-caused mortality statistics been debated, or have these figures been accepted, albeit with some degree of shame?  

The findings have been accepted by those who study them. There has been only one detractor, a former medical school dean, who has received a lot of attention for claiming that the US health system is the best there is and we need more of it.  He has a vested interest in medical schools and teaching hospitals (they are his constituency).  They, of course, would like an even greater share of the pie than they now have, for training more specialists. (Of course, the problem is that we train specialists-at great public cost-who then do not practice up to their training-they spend half of their time doing work that should be done in primary care and don't do it as well.)

Have health agencies of the federal government consulted with you on ways to mitigate the effects of the US medical system?

NO.

Since the FDA approves every medical drug given to the American people, and certifies it as safe and effective, how can that agency remain calm about the fact that these medicines are causing 106,000 deaths per year?

Even though there will always be adverse events that cannot be anticipated, the fact is that more and more unsafe drugs are being approved for use. Many people attribute that to the fact that the pharmaceutical industry is (for the past ten years or so) required to pay the FDA for reviews---which puts the FDA into an untenable position of working for the industry it is regulating. There is a large literature on this.  

Aren't your 2000 findings a severe indictment of the FDA and its standard practices?

They are an indictment of the US health care industry: insurance companies, specialty and disease-oriented medical academia, the pharmaceutical and device manufacturing industries, all of which contribute heavily to re-election campaigns of members of Congress. The problem is that we do not have a government that is free of influence of vested interests. Alas, [it] is a general problem of our society-which clearly unbalances democracy.  

Can you offer an opinion about how the FDA can be so mortally wrong about so many drugs?

Yes, it cannot divest itself from vested interests. (Again, [there is] a large literature about this, mostly unrecognized by the people because the industry-supported media give it no attention.

Would it be correct to say that, when your JAMA study was published in 2000, it caused a momentary stir and was thereafter ignored by the medical community and by pharmaceutical companies?

Are you sure it was a momentary stir?  I still get at least one email a day asking for a reprint---ten years later!  The problem is that its message is obscured by those that do not want any change in the US health care system.

Do medical schools in the US, and intern/residency programs in hospitals, offer significant "primary care" physician training and education?

NO. Some of the most prestigious medical teaching institutions do not even have family physician training programs [or] family medicine departments. The federal support for teaching institutions greatly favors specialist residencies, because it is calculated on the basis of hospital beds. [Dr. Starfield has done extensive research showing that family doctors, who deliver primary care-as opposed to armies of specialists-produce better outcomes for patients.]  

Are you aware of any systematic efforts, since your 2000 JAMA study was published, to remedy the main categories of medically caused deaths in the US?

No systematic efforts; however, there have been a lot of studies.  Most of them indicate higher rates [of death] than I calculated.

What was your personal reaction when you reached the conclusion that the US medical system was the third leading cause of death in the US?

I had previously done studies on international comparisons and knew that there were serious deficits in the US health care system, most notably in lack of universal coverage and a very poor primary care infrastructure. So I wasn't surprised.

Has anyone from the FDA, since 2000, contacted you about the statistical findings in your JAMA paper?

NO. Please remember that the problem is not only that some drugs are dangerous but that many drugs are overused or inappropriately used.  The US public does not seem to recognize that inappropriate care is dangerous---more does not mean better.  The problem is NOT mainly with the FDA but with population expectations.

... Some drugs are downright dangerous; they may be prescribed according to regulations but they are dangerous.

Concerning the national health plan before Congress-if the bill is passed, and it is business as usual after that, and medical care continues to be delivered in the same fashion, isn't it logical to assume that the 225,000 deaths per year will rise?

Probably---but the balance is not clear. Certainly, those who are not insured now and will get help with financing will probably be marginally better off overall.

Did your 2000 JAMA study sail through peer review, or was there some opposition to publishing it?

It was rejected by the first journal that I sent it to, on the grounds that 'it would not be interesting to readers'!

Do the 106,000 deaths from medical drugs only involve drugs prescribed to patients in hospitals, or does this statistic also cover people prescribed drugs who are not in-patients in hospitals?

I tried to include everything in my estimates.  Since the commentary was written, many more dangerous drugs have been added to the marketplace.

106,000 people die as a result of CORRECTLY prescribed medicines.  I believe that was your point in your 2000 study.  Overuse of a drug or inappropriate use of a drug would not fall under the category of "correctly prescribed." Therefore, people who die after "overuse" or "inappropriate use" would be IN ADDITION TO the 106,000 and would fall into another or other categories.

'Appropriate' means that it is not counter to regulations.  That does not mean that the drugs do not have adverse effects.

INTERVIEWER COMMENTS:

This interview with Dr. Starfield reveals that, even when an author has unassailable credentials within the medical-research establishment, the findings can result in no changes made to the system.

Yes, many persons and organizations within the medical system contribute to the annual death totals of patients, and media silence and public ignorance are certainly major factors, but the FDA is the assigned gatekeeper, when it comes to the safety of medical drugs.  The buck stops there.  If those drugs the FDA is certifying as safe are killing, like clockwork, 106,000 people a year, the Agency must be held accountable.  The American people must understand that.

As for the other 119,000 people killed every year as a result of hospital treatment, this horror has to be laid at the doors of those institutions. Further, to the degree that hospitals are regulated and financed by state and federal governments, the relevant health agencies assume culpability.

It is astounding, as well, that the US Department of Justice has failed to weigh in on Starfield's findings.  If 225,000 medically caused deaths per year is not a crime by the Dept. of Justice's standards, then what is?

To my knowledge, not one person in America has been fired from a job or even censured as result of these medically caused deaths.  

Dr. Starfield's findings have been available for nine years.  She has changed the perception of the medical landscape forever.  In a half-sane nation, she would be accorded a degree of recognition that would, by comparison, make the considerable list of her awards pale.  And significant and swift action would have been taken to punish the perpetrators of these crimes and reform the system from its foundations.

In these times, medical schools continue turning out a preponderance of specialists who then devote themselves to promoting the complexities of human illness and massive drug treatment.  Whatever the shortcomings of family doctors, their tradition speaks to less treatment, more common sense, and a proper reliance on the immune systems of patients.

The pharmaceutical giants stand back and carve up the populace into "promising markets."  They seek new disease labels and new profits from more and more toxic drugs.  They do whatever they can-legally or illegally-to influence doctors in their prescribing habits.  Some drug studies which show negative results are buried.  FDA panels are filled with doctors who have drug-company ties.  Legislators are incessantly lobbied and supported with pharma campaign monies.  

Nutrition, the cornerstone of good health, is ignored or devalued by most physicians.  Meanwhile, the FDA continues to attack nutritional supplements, even though the overall safety record of these nutrients is good, whereas, once again, the medical drugs the FDA certifies as safe are killing 106,000 Americans per year.

Physicians are trained to pay exclusive homage to peer-reviewed published drug studies. These doctors unfailingly ignore the fact that, if medical drugs are killing a million Americans per decade, the studies on which those drugs are based must be fraudulent or, at the very least, massively incompetent.  In other words, the whole literature is suspect, unreliable, and impenetrable.

Jon Rappoport has worked as an independent investigative reporter since 1982.  The LA Weekly nominated him for a Pulitzer Prize, for a interview he did with the president of El Salvador University, where the military had taken over the campus and was disappearing students and burning books.  He has written for In These Tines, Village Voice, LA Weekly, Spin Magazine, CBS Healthwatch, Stern.  

The Successful Creation of a Societal Delusion . . . and the Increase in Stigma It Has Spawned

By Robert Whitaker Created Nov 4 2010 - 12:17pm

Ever since the revised edition of DSM III was published in 1987, the psychiatric establishment in the United States -- i.e., the American Psychiatric Association, NAMI, the NIMH, and the pharmaceutical industry -- has been telling the American public that it is now known that major mental disorders are "biological diseases," just like "diabetes." The public has been informed that major mental disorders are caused by "chemical imbalances" in the brain, and that psychiatric medications are like "insulin for diabetes."

As this storytelling has occurred, the psychiatric establishment has run anti-stigma campaigns, arguing that if the public understood that mental disorders were brain diseases, then societal "stigma" toward the "mentally ill" would lessen.

A study published in the November issue of the American Journal of Psychiatry, which was led by Bernice Pescosolido at Indiana University, provides an interesting look at how this storytelling effort has worked out.

As I wrote in Anatomy of an Epidemic (and as others have written, too), the chemical imbalance hypothesis of mental disorders, which arose in the 1960s, basically fell apart in the 1970s and early 1980s. Researchers studying whether people with schizophrenia had overactive "dopamine" systems failed to find that this was so. Similarly, researchers failed to find that people with depression had low levels of serotonin in the brain. These chemical-imbalance investigations continued to sputter along throughout the 1980s and the 1990s, but the bottom-line never changed. As Kenneth Kendler, coeditor in chief of Psychological Medicine, explained in 2005: "We have hunted for big simple neurochemical explanations for psychiatric disorders and have not found them."However, that scientific finding -- that the chemical-imbalance hypothesis of mental disorders failed to pan out -- was never told to the public. Instead, Prozac came to market in 1988 and the public heard all about "chemical imbalances," and as the study in the November issue of the American Journal of Psychiatry reveals, this PR campaign by the psychiatric establishment was quite successful. In 2006, 87% of the adults surveyed believed that schizophrenia was due to a chemical imbalance, up from 78% in 1996. Eighty percent of those surveyed said that depression was due to a chemical imbalance, up from 67% in 1996.

This is data that tells of an extremely successful propaganda effort. The overwhelming majority of Americans have been led to adopt a false belief.

But -- and this shouldn't be a surprise -- the dissemination of this false belief has not led to a lessening of societal stigma toward people with psychiatric diagnoses. If anything, it has increased it. In their survey, Pescosolido and the other researchers asked a number of questions to flesh out attitudes toward the mentally ill, and in 2006, there was "no significant decrease in any indicator of stigma" compared to 1996. Moreover, "significantly more respondents in the 2006 survey than in the 1996 survey reported an unwillingness to have someone with schizophrenia as a neighbor."

Equally revealing was this: In both the 1996 and 2006 surveys, those who believed in a "neurobiological conception of mental illness" -- i.e., the chemical imbalance story -- were more likely to have a negative attitude toward those with mental disorders than those who did not.

While this finding confounded the researchers' expectations, it is easy to see why the chemical-imbalance story leads to negative attitudes about people struggling with mental illness. It tells the public that people with a psychiatric diagnosis have "broken brains," and that their moods and behaviors are governed by faulty brain chemistry. This is an understanding that separates the "mentally ill" from the rest of society. The "mentally ill" are different from "us."

Now imagine what societal attitudes might be if the public were told that the biological causes of major psychiatric disorders remain "unknown" (which would be a scientifically accurate message.) That conception of mental illness suggests that it may be possible for anyone -- faced with certain environmental stresses or setbacks in life -- to suffer a severe bout of psychiatric distress. Readers of Shakespeare might sum it up this way: To be human is to have the capacity to go "mad." That is an understanding of "mental illness" that evokes a sense of our common humanity, and a sense of a shared vulnerability to mental suffering.

The lesson to be drawn from this study seems to be this: If the psychiatric establishment wants to reduce stigma towards the mentally ill, all they need to do is run a pr campaign that -- and how else to put this -- tells the truth.

 

Source URL: http://www.psychologytoday.com/node/50110

Links:

[1] http://ajp.psychiatryonline.org/cgi/content/full/167/11/1321

                                                                 

http://ajp.psychiatryonline.org/cgi/content/full/167/11/1321#ABSAm J Psychiatry 2010; 167:1321-1330(published online September 15, 2010; doi: 10.1176/appi.ajp.2010.09121743)© 2010 American Psychiatric Association

"A Disease Like Any Other"? A Decade of Change in Public Reactions to Schizophrenia, Depression, and Alcohol Dependence

Bernice A. Pescosolido, Ph.D., Jack K. Martin, Ph.D., J. Scott Long, Ph.D., Tait R. Medina, M.A., Jo C. Phelan, Ph.D., and Bruce G. Link, Ph.D.

From the Schuessler Institute for Social Research and the Department of Sociology, Indiana University; and the Mailman School of Public Health, Columbia University, New York.

Abstract

Objective: Clinicians, advocates, and policy makers have presented mental illnesses as medical diseases in efforts to overcome low service use, poor adherence rates, and stigma. The authors examined the impact of this approach with a 10-year comparison of public endorsement of treatment and prejudice.

Method: The authors analyzed responses to vignettes in the mental health modules of the 1996 and 2006 General Social Survey describing individuals meeting DSM-IV criteria for schizophrenia, major depression, and alcohol dependence to explore whether more of the public 1) embraces neurobiological understandings of mental illness; 2) endorses treatment from providers, including psychiatrists; and 3) reports community acceptance or rejection of people with these disorders. Multivariate analyses examined whether acceptance of neurobiological causes increased treatment support and lessened stigma.

Results: In 2006, 67% of the public attributed major depression to neurobiological causes, compared with 54% in 1996. High proportions of respondents endorsed treatment, with general increases in the proportion endorsing treatment from doctors and specific increases in the proportions endorsing psychiatrists for treatment of alcohol dependence (from 61% in 1996 to 79% in 2006) and major depression (from 75% in 1996 to 85% in 2006). Social distance and perceived danger associated with people with these disorders did not decrease significantly. Holding a neurobiological conception of these disorders increased the likelihood of support for treatment but was generally unrelated to stigma. Where associated, the effect was to increase, not decrease, community rejection.

Conclusions: More of the public embraces a neurobiological understanding of mental illness. This view translates into support for services but not into a decrease in stigma. Reconfiguring stigma reduction strategies may require providers and advocates to shift to an emphasis on competence and inclusion.

  Introduction

 

TOPAbstractIntroductionMethodResultsDiscussionReferences

 

The past 20 years have witnessed a resurgence in clinical, policy, and research efforts to reduce stigma attached to mental illness. The White House Conference on Mental Illness and the Surgeon General's first-ever report on mental health (1), both in 1999, coalesced knowledge and fostered renewed action. These comprehensive assessments applauded the range and efficacy of existing treatments for mental illness brought by advances across the medical and social-behavioral sciences, particularly neuroscience. However, they also documented a "staggeringly low" rate of service use among those in need, a shortage of providers and resources, and continued alarming levels of prejudice and discrimination (1, p. viii; 2).

After reviewing the scientic evidence, the Surgeon General concluded that the stigma attached to mental illness constituted the "primary barrier" to treatment and recovery (1, p. viii). Stigma could be reduced, many believed, if people could be convinced that mental illnesses were "real" brain disorders and not volitional behaviors for which people should be blamed and punished. Many prominent reports emphasized scientic understanding as a way to reduce stigma. For example, the Surgeon General's report identied scientic research as "a potent weapon against stigma, one that forces skeptics to let go of misconceptions and stereotypes" (1, p. 454). Stigma reduction, based in part on disseminating information on neurobiological causes, became a primary policy recommendation of the President's New Freedom Commission on Mental Health (3) as well as of international efforts (4). Finally, while not intended specifically as an antistigma effort, commercial advertisements provided information on psychiatric symptoms, brain-based etiologies, and specific psychopharmacological solutions. In fact, direct-to-consumer advertising involved more U.S. resources than all those dedicated to educational campaigns (e.g., over $92 million on Paxil in 2000 [5]).

Deeply embedded in social and cultural norms, stigma includes prejudicial attitudes that discredit individuals, marking them as tainted and devalued (6). For individuals, stigma produces discrimination in employment, housing, medical care, and social relationships (79). Individuals with mental illness may be subjected to prejudice and discrimination from others (i.e., received stigma), and they may internalize feelings of devaluation (i.e., self-stigma [10]). On a societal level, stigma has been implicated in low service use, inadequate funding for mental health research and treatment (i.e., institutional stigma), and the "courtesy" stigma attached to families, providers, and mental health treatment systems and research (1113). Public stigma reflects a larger social and cultural context of negative community-based attitudes, beliefs, and predispositions that shape informal, professional, and institutional responses.

Antistigma efforts in recent years have often been predicated on the assumption that neuroscience offers the most effective tool to reduce prejudice and discrimination. Thus, NAMI's Campaign to End Discrimination sought to improve public understanding of neurobiological bases of mental illness, facilitating treatment-seeking and lessening stigma. Over the past decade, the American public has been exposed to symptoms, biochemical etio-logical theories, and the basic argument that mental illnesses are diseases, no different from others amenable to effective medical treatment, control, and recovery (14, 15).

Given projections of the place of mental illness in the global burden of disease in the coming years (for example, depression alone is expected to rank third by 2020 [16]), the unprecedented amount of resources being directed to science-based antistigma campaigns, and the frustration of clinicians, policy makers, and consumers in closing the need-treatment gap, it is crucial that the efficacy and implications of current efforts be evaluated. However, despite reported successes in launching campaigns and disseminating information, few studies have undertaken systematic evaluation of stigma reduction efforts (see references 17 and 18 for exceptions). The critical unanswered question is whether these efforts have changed public understanding and acceptance of persons with mental illness.

In this study, we assessed whether the cumulative impact of efforts over the past decade have produced change in expected directions. Using the mental health modules of nationally representative surveys 10 years apart, we examined whether the public changed during that interval in its embrace of neurobiological understandings of mental illness; its treatment endorsements for a variety of providers, including psychiatrists and general medical doctors; and its reports of community acceptance or rejection of persons described as meeting DSM-IV criteria for schizophrenia, major depression, or alcohol dependence.

  Method

 

TOPAbstractIntroductionMethodResultsDiscussionReferences

 

SampleThe 2006 National Stigma Study-Replication reproduces the 1996 MacArthur Mental Health Study; both data collections were fielded as modules in the General Social Survey (GSS). The GSS is a biennial stratified multistage area probability sample survey of household clusters in the United States representing noninstitutionalized adults (age 18 and over). Face-to-face interviews were conducted by trained interviewers using pencil and paper in the 1996 survey and a computer-assisted format in the 2006 survey. Mode effects were minimal and were unrelated to the data used here (19). GSS response rates were 76.1% in 1996 and 71.2% in 2006.

The 1996 and 2006 GSS modules utilized a vignette strategy to collect data on public knowledge of and response to mental illness. This strategy helps circumvent social desirability bias and allows assessment of public recognition by providing a case description meeting psychiatric diagnostic criteria but no diagnostic label. Respondents were randomly assigned to a single vignette describing a psychiatric disorder meeting DSM-IV criteria for schizophrenia (N=650), major depression (N=676), or alcohol dependence (N=630). The gender, race (white, black, Hispanic), and education (<high school, high school, >high school) of vignette characters were randomly varied.

Because of the adoption in 2004 of a subsampling design to capture nonrespondents, weighting that adjusts for the selection of one adult per household is required for cross-year comparisons (sampling error=±3%). All analyses were conducted in Stata, release 11 (20). Institutional review board approval for the GSS was obtained at the University of Chicago, as well as at Indiana University for secondary data analysis.

MeasuresRespondents were read the randomly selected vignette, given a card with the vignette printed on it, and asked questions in three broad areas.

Attributions/causation.Respondents were asked how likely it is that the person in the vignette is experiencing "a mental illness" and/or "the normal ups and downs of life," as well as how likely the situation might be caused by "a genetic or inherited problem," "a chemical imbalance in the brain," "his or her own bad character," and/or "the way he or she was raised." Questions were not mutually exclusive, and respondents could endorse multiple attributions. Responses of "very likely" and "somewhat likely" were coded 1; "not very likely," "not at all likely," and "do not know" were coded 0. Analyses were run again with responses of "do not know" coded as missing as well as including controls for the vignette character's race, gender, and education, and substantively similar results were obtained (data available on request from the first author). A neurobiological conception measure was coded 1 if the respondent labeled the problem as mental illness and attributed cause to either a chemical imbalance or a genetic problem; it was coded 0 otherwise.

Treatment endorsement.Respondents were asked whether the person in the vignette should seek consultation with or treatment by "a general medical doctor," "a psychiatrist," "a mental hospital," and/or "prescription medications." Responses were coded 1 if "yes" and 0 if "no" or "do not know."

Public stigma.Two sets of measures, for social distance and for perceptions of dangerousness, were used. The first asked respondents how willing they would be to have the person described in the vignette 1) work closely with them on a job; 2) live next door; 3) spend an evening socializing; 4) marry into the family; and 5) as a friend. Responses of "definitely unwilling" and "probably unwilling" were coded 1 (i.e., stigmatizing) and responses of "probably willing," "definitely willing," and "do not know" were coded 0. The second measure asked respondents how likely is it that the person in the vignette would "do something violent toward other people" and/or "do something violent toward him/herself." Responses of "very likely" and "somewhat likely" were coded 1; responses of "not very likely," "not at all likely," and "do not know" were coded 0.

Covariates.Respondents' age (in years), sex (coded 1 for female, 0 for male), education (coded 1 for at least a high school degree, and 0 otherwise), and race (code 1 for white, 0 for other) were included as controls. In 1996, the mean age of respondents was 43 years (SD=16); 51% were female, 31% completed more than a high school degree, and 81% were white. In 2006, the mean age was 45 years (SD=17); 54% were female, 39% completed more than a high school degree, and 75% were white. Profiles are consistent with Census Bureau data. Differences between samples refiect changes in the U.S. population (e.g., significant but small changes in education and race).

Statistical AnalysisWe evaluated changes across years in public attributions, endorsement of treatment, and public stigma by comparing 1996 and 2006 unadjusted percentages. Because the data were weighted, a design-based F-statistic (20) that utilized the second-order Rao and Scott (21) correction was used to test the equality of the 1996 and 2006 percentages. To adjust for possible demographic shifts between survey years, we estimated logistic regression models for each outcome and for each vignette condition with controls for respondents' age, sex, education, and race. We then computed the difference in the predicted probabilities for a given outcome (e.g., mental illness) between 1996 and 2006 holding the control variables at their means for the combined sample; these are referred to as discrete change coefficients and are presented graphically. Ninety-five percent confidence intervals were computed with the delta method and are shown graphically with tic marks.

We used logistic regression to examine the association of neurobiological conception with treatment endorsement and stigma. Models included controls for age, sex, education, and race and were run separately by year and vignette condition. Odds ratios are presented. To evaluate changes in the effect of neurobiological conception on treatment endorsement and stigma over time, discrete change coefficients were computed from logit models that included interactions between neurobiological conception and year and controls and year. Traditional tests of the equality of coefficients across groups (in this case the equality of the effect of neurobiological conception across survey year) cannot be used because the estimated logit coefficients confound the magnitude of the effect of a predictor with the degree of unobserved heterogeneity in the model (22). Predicted probabilities are not affected by this issue of identification (J.S. Long, unpublished manuscript, 2009). Accordingly, we computed the discrete change in the predicted probability for a given outcome (e.g., treatment endorsement) between those who held a neurobiological conception and those who did not and then compared these discrete change coefficients across survey years. While these coefficients are not affected by the identification issue that makes it inappropriate to compare regression coefficients between times, the magnitude of the discrete change depends on the level at which the control variables are held. To control for differences in demographic variables between the survey years, we computed discrete change coefficients for each year with controls held at their means for the combined sample. To maintain metric consistency with the unadjusted percentages, predicted probabilities and discrete change coefficients were multiplied by 100 (e.g., 0.43 becomes 43%).

  Results

 

TOPAbstractIntroductionMethodResultsDiscussionReferences

Attribution/CausationMore of the public embraced a neurobiological understanding of mental illness in 2006 than in 1996 (Table 1). A large and statistically significant increase (6 to 13 percentage points) was evident across nearly all indicators and all vignette conditions. Neurobiological conception showed an increase of 10 percentage points for schizophrenia (from 76% to 86%; F=8.00, p=0.01), 13 points for depression (from 54% to 67%; F=9.94, p=0.002) and nine points for alcohol dependence (from 38% to 47%; F=4.06, p=0.04). Social or moral conceptions of mental illness decreased across most indicators, and a significant decrease in labeling the condition as "ups and downs" was observed for depression (from 78% to 67%; F=7.63, p=0.01). However, sociomoral conceptions of alcohol dependence were either largely unchanged or, for attributions of "bad character," significantly increased (from 49% to 65%; F=13.50, p<0.001). Findings were largely unaffected by the addition of controls for respondents' age, sex, education, and race (Figure 1). A slight attenuation of the year effect for chemical imbalance for alcohol dependence reduced the effect to nonsignificance. Further analyses (not reported) suggested that this was not due to the addition of any one covariate but to the addition of all covariates simultaneously.

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TABLE 1. Unadjusted Survey Year Differences in Attributions of Mental Illness, Treatment Endorsement, and Stigma, by Vignette Condition, 1996 and 2006a

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FIGURE 1. Adjusted Survey Year Differences in Attributions of Mental Illness, by Vignette Condition, 1996 and 2006a

a Graphs indicate the discrete change in the predicted probability for a given outcome with respect to year (multiplied by 100), calculated with controls held at their means for the combined sample. Data are from the mental health modules of the 1996 and 2006 General Social Surveys and are weighted. Tic marks indicate 95% confidence intervals.

Treatment EndorsementAn across-the-board increase in public endorsement of medical treatment was reported (Table 1). In 2006, a large majority supported both general and specialty care for individuals with mental illness. Over 85% indicated that the major depression vignette character should go to a psychiatrist (from 75% in 1996; F=9.27, p=0.002), and 79% recommended psychiatric treatment for alcohol dependence (from 61% in 1996; F=17.78, p<0.001). A significant increase in endorsement of prescription medicine was reported across all vignette conditions. Only treatment at a mental hospital remained unsupported by a majority of respondents for depression or alcohol dependence (27% and 26%, respectively). However, for schizophrenia, not only was hospitalization endorsed by a majority, but support for hospitalization significantly increased (from 53% to 66%; F=8.97, p=0.003). Findings were largely unaffected by the addition of controls for respondents' age, sex, education, and race (Figure 2). The slight attenuation of the year effect in the endorsement of prescription medication for depression reduced the effect to nonsignificance.

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FIGURE 2. Adjusted Survey Year Differences in Treatment Endorsement, by Vignette Condition, 1996 and 2006a

a Graphs indicate the discrete change in the predicted probability for a given outcome with respect to year (multiplied by 100), calculated with controls held at their means for the combined sample. Data are from the mental health modules of the 1996 and 2006 General Social Surveys and are weighted. Tic marks indicate 95% confidence intervals.

Public StigmaNo significant decrease was reported in any indicator of stigma, and levels remained high (Table 1). A majority of the public continued to express an unwillingness to work closely with the person in the vignette (62% for schizophrenia, 74% for alcohol dependence), socialize with the person (52% for schizophrenia, 54% for alcohol dependence), or have the person marry into their family (69% for schizophrenia, 79% for alcohol dependence). In fact, significantly more respondents in the 2006 survey than the 1996 survey reported an unwillingness to have someone with schizophrenia as a neighbor (from 34% to 45%; F=6.31, p=0.01) or to have someone with alcohol dependence marry into their family (from 70% to 79%; F=4.01, p=0.05). Furthermore, a majority again reported that the vignette character with schizophrenia or alcohol dependence would likely be violent toward others. While stigmatizing reactions did not significantly decrease for the depression vignette, levels remained comparatively lower. Findings were unaffected by controls (Figure 3).

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FIGURE 3. Adjusted Survey Year Differences in Stigma, by Vignette Condition, 1996 and 2006a

a Graphs indicate the discrete change in the predicted probability for a given outcome with respect to year (multiplied by 100), calculated with controls held at their means for the combined sample. Data are from the mental health modules of the 1996 and 2006 General Social Surveys and are weighted. Tic marks indicate 95% confidence intervals.

Association of Neurobiological Conception With Treatment Endorsement and StigmaIn both survey years and across all conditions, holding a neurobiological conception of mental illness tended to increase the odds of endorsing treatment (e.g., for schizophrenia, from 1996 to 2006, the odds of endorsing a psychiatrist increased by a factor of 7.61; 95% CI=2.43–23.77, p<0.001; see Table 2). However, in both years and across all conditions, holding a neurobiological conception of mental illness either was unrelated to stigma or increased the odds of a stigmatizing reaction. In 2006, holding a neuro-biological conception of schizophrenia increased the odds of preferring social distance at work by a factor of 2.20 (95% CI=1.02–4.76, p=0.05), and for depression it increased the odds of perceiving dangerousness to others by a factor of 2.70 (95% CI=1.53-4.78, p<0.001). In no instance was a neurobiological conception associated with significantly lower odds of stigma. Furthermore, for all but three indicators, the difference in the predicted probability between those who held a neurobiological conception and those who did not was larger in 2006 than 1996. For the depression vignette, a neurobiological attribution increased the predicted probability of perceived dangerousness to self by 20 points in 1996 and by 35 points in 2006, for a difference of 15 points (marginally significant, 95% CI=–1 to 31, p=0.07).

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TABLE 2. Neurobiological Conception of Mental Illness as Predictor of Treatment Endorsement and Stigma in 1996 and 2006, by Vignette Conditiona

  Discussion

 

TOPAbstractIntroductionMethodResultsDiscussionReferences

 

Public attitudes matter. They fuel "the myth that mental illness is lifelong, hopeless, and deserving of revulsion" (14, p. xiv). Public attitudes set the context in which individuals in the community respond to the onset of mental health problems, clinicians respond to individuals who come for treatment, and public policy is crafted. Attitudes can translate directly into fear or understanding, rejection or acceptance, delayed service use or early medical attention. Discrimination in treatment, low funding resources for mental health research, treatment, and practice, and limited rights of citizenship also arise from misinformation and stereotyping. Attitudes help shape legislative and scientific leaders' responses to issues such as parity, better treatment systems, and dedicated mental illness research funds (23). Assumptions about these attitudes and beliefs have defined most messages of stigma reduction efforts (14, 15).

With House Joint Resolution 174, the U.S. Congress designated the 1990s as the "Decade of the Brain," premised on the assumption that the advancement of neuroscience was the key to continued progress on debilitating neural diseases and conditions, including mental illness. An explicit goal of the bipartisan measure was to enhance public awareness of the benefits to be derived from brain research. One of these benefits was to come in the area of stigma, and the Decade of the Brain "helped to reduce the stigma attached" to conditions, including "mind disorders" (24). With a neurobiological understanding of mental illness, people would see that symptoms denote real illness and not volitionally driven deviant behaviors. As a consequence, people with mental disorders would be understood and treated rather than blamed and punished. This view found resonance in the Surgeon General's optimism for the stigma-reducing potential of neurobiological and molecular genetic discoveries (15, 25). Similar optimistic statements have been common in medical journals (2628).

From a scientific perspective, claims that stigma was dissipating were optimistic and speculative, based on narrow, anecdotal, or unsystematic observation. Whether or not there has been a decrease in stigma is subject to empirical social science evaluation. Mental illness occurs in communities where "the public" is defined beyond political representatives, advocacy groups, and scientific organizations (29).

Our analyses of data from the GSS, the premier, longest-running monitor of American public opinion, reveal that intensive efforts through the 1990s to 2006, mounted on the promise of neuroscience, have been rewarded with significant and widespread increases in public acceptance of neurobiological theories and public support for treatment, including psychiatry, but no reduction in public stigma. Furthermore, in surveys from both 1996 and 2006 and across all vignette conditions, holding a neurobio-logical conception of mental illness either was unrelated to stigma or tended to increase the odds of a stigmatizing reaction. Our most striking finding is that stigma among the American public appears to be surprisingly fixed, even in the face of anticipated advances in public knowledge.

The patterns reported here are bolstered by a growing body of similar international studies reporting mixed findings (3032). In a trend analysis in eastern Germany, Angermeyer and Matschinger (30) documented an identical pattern of increases over time in public mental health literacy and the endorsement of neurobiological causation coupled with either no change or an increase in public stigma of mental illness. In Turkey (33), Germany, Russia, and Mongolia (34), the endorsement of neurobiological attributions was also associated with a desire for social distance, although it had no effect on social distance in Australia (35) and in Austria (36).

Our effort is not without limitations. First, vignette approaches can be sensitive to large and small changes in core descriptions (10, 37). How the public would react to individuals at different places along the diagnostic spectrum remains unanswered. Our "cases" met DSM-IV diagnostic criteria and simulated what individuals in the community encounter—a person with "problem" behaviors but no medical labels or history. This vignette strategy allowed us to explore the association of a neurobiological understanding of current or active "problem" behaviors with stigmatizing responses. However, the assumption underlying many antistigma interventions is that embracing a neurobiological understanding of mental illness will increase support for help-seeking behavior and subsequently lead to treatment that can mitigate symptoms. This in turn would reduce others' stigmatizing responses. Testing this idea of recovery and stigma reduction would require a different set of vignette circumstances than ours. It stands as an important hypothesis for future research. Second, attitudes are not behaviors, and predispositions may or may not closely track discrimination (38). Both classic and recent studies suggest that attitudes reveal more negative tendencies than individuals are willing to act upon in real situations (39, 40). While important, these limitations are unlikely to have affected our observed results.

Clinical, Research, and Policy ImplicationsWhat appears to have been mistaken is the assumption that global change in neuroscientific beliefs would translate into global reductions in stigma. Our analyses suggest that even if the embrace of neuroscience had been more pronounced, a significant and widespread reduction in stigma would not have followed. We are not the first to suggest that there may be unintended consequences or a backlash effect of genetic explanations of mental illness (41). Even in 1999, the Surgeon General's report cautioned against a simplistic approach, noting that most recent studies suggested that increased knowledge among the public did not appear to translate into lower levels of stigma.

The critical question centers on future directions. As an alternative to our focus on neuroscience, we also considered another approach that pervades public debates. Given the efforts of the Treatment Advocacy Center to link violence in mental illness to policy changes necessary to improve the mental health system, we did a post hoc analysis that looked at the associations among public perceptions of dangerousness, social distance, and public support for increased funding. As Torrey (42) has argued, people who recognize the potential dangerousness of untreated mental illness will support the infusion of more resources to the mental health system. Americans' assessments of dangerousness are high and, as in previous research, significantly related to social distance (43). However, a measure of public support for federally funded services is not significantly associated with public perceptions of danger. Far from providing the public support needed to improve the mental health system, such fear only appears to have a detrimental effect on community acceptance.

We stand at a critical juncture. Neuroscientific advances are fundamentally transforming the landscape of mental illness and psychiatry. Given expectations surrounding the Decade of the Brain and the blame that pervaded earlier etiological theories of individual moral weakness and family deficits, it is hardly surprising that antistigma efforts relied on neuroscience. The "disease like any other" tagline has taken clinical and policy efforts far but is not without problems. It is our contention that future stigma reduction efforts need to be reconfigured or at least supplemented. An overreliance on the neurobiological causes of mental illness and substance use disorders is at best ineffective and at worst potentially stigmatizing.

Historians, looking to instances in the past where stigma decreased, suggest that continued advances in neuroscience that will prevent, cure, or control mental illnesses are critical to developing treatments that will render them less disabling (44). In fact, the past decade has witnessed major policy and clinical progress, including the passage of the Mental Health Parity and Addiction Equity Act in 2008 and inroads into the genetics of schizophrenia (45). However, clinicians need to be aware that focusing on genetics or brain dysfunction in order to decrease feelings of blame in the clinical encounter may have the unintended effect of increasing client and family feelings of hopelessness and permanence.

Antistigma campaigns will require new visions, new directions for change, and a rethinking of what motivates stigma and what may reduce it, a conclusion reached at a 2009 meeting of stigma experts at the Carter Center. While new research will be needed, current stigma research suggests that a focus on the abilities, competencies, and community integration of persons with mental illness and substance use disorders may offer a promising direction to address public stigma (46).

  Footnotes

 

Received Dec. 9, 2009; revision received April 28, 2010; accepted June 3, 2010

All authors report no financial relationships with commercial interests.

Address correspondence and reprint requests to Dr. Pescosolido, Schuessler Institute for Social Research, Indiana University, 1022 East Third St., Bloomington, IN 47405; This email address is being protected from spambots. You need JavaScript enabled to view it. (e-mail).

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http://m.philly.com/phillycom/db_/contentdetail.htm?contentguid=2hWkpsxl&full=true#display Big Pharma executives facing legal threatPosted:  11/01/2010By Christopher K. Hepp Inquirer Staff Writer Rats that infested a Philadelphia warehouse 40 years ago have found their way into the legal nightmares of the nation's drug companies.

Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds.

Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to "change the corporate culture" of firms that have thus far shrugged off other penalties.

In one area the FDA is targeting are companies that have illegally promoted products for unapproved uses, a practice know as off-label marketing.

"I don't know when, where, or how many cases will be brought," Blumberg told a gathering of the Food and Drug Law Institute, "but if you are a corporate executive - or counsel advising such a client - I would not wait for the first case to decide now is the time to comply with the law. They won't get a mulligan on their conduct."

In an interview Thursday, Blumberg was pointed.

"They need to take this seriously and find out what is going on in the marketing and sales divisions of their companies," he said of pharmaceutical executives. "In my view, one thing that will get executives' attention is a few cases in which we have convicted two-legged defendants."

He singled out firms, including Pfizer Inc. and Eli Lilly & Co., that have paid multiple penalties in recent years.

Eli Lilly, for instance, was hit with a $1.4 billion fine last year for illegally marketing Zyprexa, a antipsychotic drug. The same year, Pfizer was fined $2.3 billion for illegally marketing the pain reliever Bextra. Neither company's stock price suffered significantly, leading some to conclude that even massive fines are viewed by investors and executives as simply the cost of doing business. Neither firm responded to calls for comment.

"It is clear that fines are not working here," Blumberg said. "We need to put something else on the scale to make people think twice, three times, before they promote drugs for unapproved uses."

That something is the threat of prison and industry debarment, which could result from a successful prosecution using the Park Doctrine.

Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.

It stems from a case involving John Park, president of Acme Markets Inc. in 1970, when the company was cited for rodent infestations at a warehouse here.

The FDA charged Park personally with violating sanitation laws after other rodent infestations were discovered despite a number of agency warnings.

Park argued that as company president he was too far removed from warehouse supervision to be held responsible.

The U.S. Supreme Court ultimately agreed with the FDA that Park, as president, was responsible for ensuring rodent-free warehouses.

Park got off relatively easy: a $250 fine.

Prosecutors now hope to extract stiffer penalties under the doctrine, including up to a year in prison and $100,000 fines.

Those are the possible punishments facing four executives of Synthes Inc., a West Chester firm that pleaded guilty early this month in connection with illegal clinical trials of a bone cement. Charged under the Park Doctrine by the U.S. Attorney's Office in Philadelphia, the executives have also pleaded guilty.

The Park Doctrine can be "a very powerful tool," said Assistant U.S. Attorney John Pease, who supervises criminal prosecutions involving pharmaceutical-industry fraud cases in eastern Pennsylvania. But it also presents prosecutors with a number of hurdles, he said.

The crimes under scrutiny have a five-year statute of limitations, for instance. Often, prosecutors are not even alerted to them for several years, he said.

"And with multinational pharmaceutical companies with billions in revenue, you find responsibility is very diffuse," Pease said. "The real challenge is finding a person who was in a position to know about and prevent the conduct that occurred."

Scott Gottlieb, a former FDA commissioner who is now a partner with Arcoda Capital in New York, said another challenge would be assuring that an off-label case would hold up in court, particularly if it involved executives several layers above the departments that committed the illegal acts.

"There are clearly cases where the management is so far removed from the activity, they have no direct knowledge of the issue," he said. "To hold them criminally liable is a significant policy step that needs to be done with great care."

He agreed, however, that bringing criminal charges against executives "would be a significant deterrent."

James Prutow, a consultant to pharmaceutical companies on regulatory matters, said just the talk of charges had caught the attention of his clients.

"Executives are really stepping back and asking, 'OK, how can we ensure that we are doing, both, the right thing as a company and also as individuals so we are not on the FDA's radar screen?' "

Prutow, a partner with the management-consulting firm PRTM, said he expected that the FDA would bring a high-profile off-label case under the Park Doctrine sometime in the next six months.

"When that happens, it really is going to wake people up," he said.

Contact staff writer Christopher K. Hepp at 215-854-2208 begin_of_the_skype_highlighting              215-854-2208      end_of_the_skype_highlighting or This email address is being protected from spambots. You need JavaScript enabled to view it..