Elimination of Bias,
Not Disclosure of Bias,
Must be the Standard

On February 13, 2009 Judge Mark Ciavarella, who presided over a juvenile court in Pennsylvania, was sentenced to federal prison for 28 years after receiving kick-backs from the private company that built and maintained a youth detention facility to which he sentenced children as young as 10 for minor crimes.

A year earlier, 15 Baltimore police officers had been sentenced to prison terms of between eight and 42 months for receiving payment from the owners of an auto repair shop in exchange for the officers directing motorists involved in traffic accidents their way.

Had the Balitmore Police officers put a sign on their vehicle announcing “I accept kickbacks” or the Judge embroidered on his gown “I take cash for kids” would this have made their conflicts of interest acceptable? Is it likely that their views on best practice would become the standard against which others measured their practice?

Of course not. It is the actuality of their conflicts rather than the secrecy they maintained in respect of them which is the problem. It is the fact that their dispensing of justice was compromised by financial gain that is the issue, not merely their failure to make it explicit. Disclosure, as University of Massachusetts Associate Professor and residential research fellow at the Center for Ethics at Harvard University Lisa Cosgrove points out, is an insufficient strategy for mitigating bias because bias does not result from the concealment of financial ties but from their effects.^[1]

Even worse, social psychologists have demonstrated that when individuals disclose a competing interest, they give even more biased advice.^[1]  The degree to which disclosure can increase bias is recognized in a PLoS Medicine editorial that states

” …experiments have essentially shown that bias is considerably greater when conflicts of interest are disclosed.”^[2]

In the United States there exists the offence of Honest Services Fraud where a scheme or artifice deprives another of the intangible right of honest services in situations involving bribery or kickbacks. This offence does not require that any state law is broken in the acceptance of the bribe or kickback.

Earlier this year, the American Psychiatric Association (APA) published the DSM-V, a revised version of its diagnostic manual which included a range of new mental disorders and lowered the threshold for the diagnosis of others. The DSM-V is critical to pharmaceutical company profitability given that FDA approval for new drugs and new indications requires they target an identified mental disorder.

The power invested in members of the DSM-V working party is enormous. The PLoS Medicine editors comment that

“Their judgments define mental illness, thus legitimizing some disorders and denying others, and determine what warrants treatment and how. The DSM is used by insurance companies, hospitals, courts, prisons, schools, researchers, regulators, and government agencies to define who is sick/abnormal and who is not.”^[2]

Analysis of disclosure statements has shown that three quarters of the work groups involved in the development of the DSM-V, have a majority of their members with financial ties to the pharmaceutical industry. It further shows that the panels with the highest rates of financial conflicts of interest are those for which pharmacological treatment is the first-line intervention.^[3]  It is reported that 67% of the panel for Mood Disorders, 83% of the panel for Psychotic Disorders, and 100% of the Sleep/Wake Disorders have financial ties to the pharmaceutical companies that manufacture the medications used to treat these disorders or to companies that service the pharmaceutical industry.^[3]  The financial ties involved include owning shares in pharmaceutical companies, being paid consultants for those companies and receiving payment for promoting the products of those companies above the products of their competitors.

Cosgrove reminds us of the harm that can arise from bias in clinical guidance, such as that provided by the DSM-V, stating

“The distortion of the science underlying psychiatric diagnostic and treatment guidelines can result in significant social injury (that is, overdiagnosis and over treatment).”

Amid widespread concern about the influence these conflicts of interest have had on the development of new diagnoses and treatment recommendations, the APA moved not to eliminate conflicts of interest but to ensure those conflicts were disclosed.

In an effort to alleviate concerns that the inclusion of a range of new disorders in the DSM-V was based on financial gain for panel members and the pharmaceutical companies to whose fortunes many are linked, the APA required that DSM-V working party members disclose their ties to industry and put a cap of $10,000 on earnings, and $50,000 on company stock holdings from pharmaceutical companies for working party members during the period they worked on the development of new diagnoses and diagnostic criteria.

There were some significant omissions in this policy however. First, The APA disclosure policy allowed panel members to hide speakers’ bureau membership under the term “honoraria.” Membership of a speakers’ bureau generally involves being contracted by a company to give an industry created or controlled presentation about the company’s product rather than payment for presenting the clinician’s own views.  It is reported that “an internet search of the 141 panel members . . . found that 15% had disclosed elsewhere that they were members of drug companies’ speakers bureaus or advisory boards.^[4]

In respect of the ceiling placed on receiving funds from pharmaceutical companies during their time on DSM working groups, what is often not well understood is that panel members are permitted to resume their financial relationships with industry as soon as their tenure on the DSM panels is over.

I am not aware of any analysis of the impact on earnings from the industry for panel members arising from their involvement on a DSM working group, but suggest that the worth of these individuals to pharmaceutical companies is likely to increase as a result of having been involved in a DSM revision and that they are likely to grow their income from industry following their involvement. Foregoing payment while working as a panel member may have the same positive impact on earnings that taking time out to earn a degree has for employees.

The APA disclosure rules importantly do not require working party members to reveal how many free dinners, concert tickets, airfares to conferences and other kickbacks they have received.

So how is it that a judge who accepts payment for sending children to prison and police officers who receive payment for referring accident victims to a specific repair shop, are criminals while psychiatrists who create diagnoses that increase revenues for pharmaceutical companies from whom they receive payment are not?

Is the difference in intent or proven gain? No, it is not. Judge Ciavarella denied that his financial relationship with the prison to which he sentenced children influenced his sentencing and it was neither necessary nor possible to prove otherwise. The fact that it could have influenced his decision making was sufficient for him to be convicted.

Is there perhaps a reason that Judges should be held to a higher standard than psychiatrists? Hard to argue given both have the power to deny individuals their liberty and that the ‘honest services’ delivered by psychiatrists are, if incorrectly administered, potentially fatal. Is it a matter of impact – does unwarranted  imprisonment cause more harm than unwarranted diagnosis and treatment or detention in a psychiatric facitlity? Most certainly it does not.

I am not a lawyer and can provide no explanation as to why the offence of Honest Services Fraud could not be applied to the members of DSM working groups who receive kickbacks from the pharmaceutical industry and whose prescribing practices have been proven in numerous research studies to be influenced by their financial ties to the industry. As a layperson however it seems clear to me that whether the conduct of these people falls within the ambit of this statute or not, their behavior breaches the intent of Congress to prevent those receiving services from being deprived of ‘the intangible right of honest services.’

The Health Board responsible for the mental health treatment my son received, treatment which both my government and the drug manufacturer admit was the probable cause of his suicide, are open about their reliance on pharmaceutical company sponsorship.

Their disclosure is worth nothing to me. It did not protect my son’s life. I do not want disclosure of financial conflicts of interest, I want their elimination. I want those providing healthcare to make decisions on the evidence, not under the influence. Telling people you are compromised does not remove the risk that compromise poses. I do not want to be told that 67% of those who developed this round of mood disorders had ties to the industry, I want 100% of those who do this work to have no financial conflicts of interest.

I am not alone. Carl Elliot, a professor in the Center for Bioethics at the University of Minnesota, states that what is required is

“a focus on eliminating practices that allow for corruption rather than a focus on requiring individuals to disclose industry ties.”^[5]

Lisa Cosgrove believes that the APA  should

“institute a policy ensuring that no panel is dominated by members with ties to the pharmaceutical industry and that critics of industry are actively recruited on the various panels.”^[4]

(New Zealand’s) Institute of Medicine’s most recent recommendations for guideline development recommended that    Whenever possible guideline development group members should not have conflicts of interest and that

“Members of the Guidelines Development Group should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG recommendations.”^[6]

The New Zealand Judicial Code of Conduct requires judges to disqualify themselves from hearing cases “in circumstances where a fair-minded, properly informed lay observer would have a reasonable apprehension that the judge might not bring an impartial mind to the resolution of the question the judge is required to decide.”

I believe that psychiatrists and researchers should similarly be excluded from the development of the DSM and practice guidelines where a fair-minded, properly informed lay observer would have a reasonable apprehension that they may not bring an impartial mind to their work.