Life Science Compliance Update

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February 28, 2013

Strict Conflict of interest Policies at Academic Medical Centers Lead to Prescribing Older Generic Drugs

Teacher with a Ruler
We have dedicated a large portion of this blog to covering “conflicts of interest” or COIs, and the various claims being made about the potential influence COIs may have on physicians, researchers, and CME providers.  COIs raise concerns because often, the latter group of individuals have relationships with industry—whether consulting, research, advisory, or other—that cause some to believe that those same individuals cannot remain impartial when writing prescriptions or teaching colleagues or even students. 

Consequently, a recent study, published in the British Medical Journal (BMJ) found that doctors who attended medical schools that limited gifts to students from pharmaceutical companies -- sponsored lunches, for example -- may be less open to drug marketing.   

The objective of the study was to “examine the effect of attending a medical school with an active policy on restricting gifts from representatives of pharmaceutical and device industries on subsequent prescribing behavior.” 

Interestingly, the study was funded by the National Institute of Mental Health (NIMH), the National Institute on Aging, the American Federation on Aging, and NIH.   Which we all know means the study is completely unbiased. 

Specifically, the authors looked at the probability that a physician would prescribe a newly marketed medication over existing alternatives of three psychotropic classes: lisdexamfetamine among stimulants, paliperidone among antipsychotics, and desvenlafaxine among antidepressants.  “None of these medications represented radical breakthroughs in their respective classes,” according to the authors. 

For two of the three medications examined, attending a medical school with an active gift restriction policy was associated with reduced prescribing of the newly marketed drug.  Physicians who attended a medical school with an active conflict of interest policy were less likely to prescribe lisdexamfetamine over older stimulants and paliperidone over older antipsychotics.  A significant effect was not observed for desvenlafaxine (1.54, 0.79 to 3.03; P=0.20).  Among cohorts of students who had a longer exposure to the policy or were exposed to more stringent policies, prescribing rates were further reduced. 

Thus, the authors concluded that “Exposure to a gift restriction policy during medical school was associated with reduced prescribing of two out of three newly introduced psychotropic medications.”   

One of the major weaknesses of this study is that the authors used students who have recently graduated from medical school within the last five years.  Thus, their prescribing habits are likely to change significantly over time as they gain more experience, training and knowledge about the diseases they treat and drugs they use.  It may seem obvious that these individuals are hesitant to prescribe these drugs because they have been brainwashed during medical school to think any brand-name medication is evil and if there is marketing on such drug to outright ignore that information—despite the harm this may have to patients about important safety updates. 

In fact, the authors acknowledged that “In instances where the newly introduced medication is a noticeable improvement over alternatives,” such an effect (e.g., not prescribing it) “could slow the diffusion of medical advances.”  However, in instances instances “where the newly introduced medication offers no additional benefit to patients, such an effect may limit the unnecessary use of newer, more expensive brand name medications, potentially slowing the escalation of healthcare costs.” 

Moreover, what is also problematic about this study is that it does not attempt to reconcile patient outcomes with these prescribing patterns.  In other words, we don’t know whether the patients not receiving these prescriptions are doing better, worse or the same.  For all we know, these recent graduates are prescribing drugs that might be harming patients or causing poorer outcomes, leading to higher costs in the future and lower quality of life. 

Additionally, another major weakness of this study--as was pointed out to us by our colleagues--is that the authors attempt to group pharmacetuical and medical device manufacturers and their relationships with AMCs and physicians into the same category.  While AMC policies may lump together pharma and device interactions, that does not mean they are equivalent to one another, something the authors failed to analyze or assess.  Nothing in the article justifies even the slightest mention of the medical device industry and the device industry is vastly different from pharma. 

Often, interactions with medical device manufacturers are required, and indeed necessary in some cases to achieve the proper standard of care to perform a procedure.  Moreover, and most often, the inventor of a particular device or technique must give hands-on training to physicians--either at the manufacturer's office or on-site, to ensure that physicians can implant or use the device in compliance with its FDA clearance.  In fact, many FDA clearance letters for medical devices--particularly for high-risk, Class III devices--mandate that the manufacturer provide specific training and show proof of such training through annual medical device reporting.  The study's failure to acknowledge this is problematic and shows their misunderstanding of the device industry and the importance of their interactions, training and education with physicians.

Another similar study, published in the February Issue of Medical Care, found that “Psychiatrists exposed to conflict-of-interest (COI) policies while completing their residency program are less likely to prescribe brand-name antidepressants after completion of their residency. 

Andrew J. Epstein, Ph.D., of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues used 2009 prescribing data from IMS Health to compare the prescribing behavior of 1,652 psychiatrists from 162 residency programs. The authors sought to determine whether exposure to COI policies during residency affected antidepressant prescribing behavior after training completion. 

About half of the residents graduated in 2001, before COI training guidelines were implemented, and the remaining half graduated in 2008, after COI adoption.  The researchers found that prescription rates for heavily promoted, brand-name, or reformulated antidepressant medications were lower for those graduating in 2008, after COI adoption, but were lowest for those programs with the most restrictive COI policies. 

“In psychiatry, we found that physicians who were exposed to maximally restrictive COI policies during residency training had lower rates of prescribing heavily marketed antidepressants,” the authors write.  “Although physician-industry interactions may serve an important informational function, our results offer one piece of evidence that these COI policies have helped inoculate physicians against the persuasive aspects of pharmaceutical promotion.” 

BMJ Study  

As background for their study, the authors noted that the American Medical Student Association (AMSA) established a PharmFree Campaign to advocate for evidence based, rather than marketing based, prescribing in 2002.  In 2007, AMSA released the first “PharmFree scorecard”, which graded US medical schools on the presence or absence of a policy regulating interactions between students and faculty and representatives of the pharmaceutical and medical device industries.  Since the first PharmFree scorecard was adopted, the number of US medical schools with conflict of interest policies has grown exponentially and most now have policies restricting gifts. 

Studies conducted before the PharmaFree Campaign found that most medical students were exposed to marketing efforts during their medical education.  On average, students either received a gift or attended an industry sponsored event weekly.  “Exposure to marketing efforts by the pharmaceutical industry during medical school has been associated with favorable attitudes towards the pharmaceutical industry.”  

Furthermore, marketing efforts have been shown to reduce the time to new drug adoption and increase the probability that a physician will adopt a new drug.   

Research has found that educational interventions strongly influence students’ attitudes toward pharmaceutical marketing and are associated with increased support for policies banning interactions between representatives of pharmaceutical companies and students.  Similarly, students attending a medical school with restrictive marketing policies tend to have less favorable attitudes about promotional items than their peers who were not exposed to a conflict of interest policy and are less likely to trust the advice they receive from representatives of pharmaceutical companies.  

Although research has found that educational interventions and conflict of interest policies are associated with increased skepticism about pharmaceutical marketing, the effect of medical school gift restriction polices on subsequent prescribing remains unknown.  Accordingly, the authors studied the impact of attending a medical school with a gift restriction policy on the adoption of new drugs.   

Overview and Methodology  

To see whether attending a medical school with a gift restriction policy affected prescribing of new drugs, they used a difference-in-differences design to compare prescribing patterns of physicians who attended a school with a gift restriction policy when the policy was in place with those of physicians who attended the same school before the policy was in place, as well as with the prescriptions written by two matched control groups. 

The authors used prescribing data from IMS health on the three drug classes July 2008 and March 2009.  Using internet searches, as well as information contained in the Institute of Medicine (IOM) as a profession’s conflict of interest database and AMSA’s PharmFree scorecard, one investigator either determined the initial implementation date of the gift restriction policy for medical schools that had a policy or verified that the school did not have a policy in place by the end of the study period.  They also looked for revision dates if policies were changed or updated and verified these as well. 

The authors identified 14 medical schools with a policy that explicitly prohibited or restricted gifts as of 2004.  A restrictive cut-off date of policy implementation by 2004 was necessary to allow for the average time required to complete postgraduate residency training after graduation from medical school for physicians to be eligible to independently prescribe medications by July 2008, the beginning of our prescribing observation period.  Many of the schools that had a policy in place by 2004 had adopted policies as a result of state laws or military restrictions governing gifts.  The policies varied in strength from almost complete bans on gifts to much weaker and ambiguous restrictions.   

Next the authors identified two cohorts of physicians to permit comparisons among those who attended the same medical school before and after implementation of a gift policy.  The first cohort included physicians that graduated two years before the policy was implemented and therefore were not exposed or affected since the policy was enacted after they had graduated.  The second cohort graduated in 2003 or 2004, after implementation of the policy.   

To account for changes in prescribing over time, the authors created a matched control sample composed of physicians who graduated from 20 different medical schools that adopted a policy restricting gifts in 2008.  These physicians were never exposed to the policy since they graduated before implementation.  

To determine the effect of gift restriction policies during medical training on prescribing as physicians, the author examined physicians’ propensity to prescribe newly introduced and marketed psychotropic medications over older medications in the same class.  During the study period, antipsychotics, antidepressants, and stimulants were among the top selling classes of medications, with US sales ranks of 1, 5, and 15, respectively.  Stimulants, antidepressants, and antipsychotics were also among the most promoted classes of medications.  

Given the importance of these three classes of medications to the pharmaceutical industry, the authors identified a newly marketed medication in each class for our study: lisdexamfetamine (Vyvanse; Shire, Wayne, PA) among stimulants, paliperidone (Invega; Janssen Pharmaceuticals, Titusville, NJ) among antipsychotics, and desvenlafaxine (Pristiq; Pfizer, New York, NY) among antidepressants. Lisdexamfetamine was introduced in March of 2007, paliperidone in December of 2006, and desvenlafaxine in February of 2008.  

Although the drugs examined in the study vary in their level of innovation, none represented radical breakthroughs in their class and all relied on mechanisms of action already available on the market.  These medications were the only oral medications within the three classes of data that we had access to that were approved within our study period. 

Results 

In total, 27.8% of prescribers wrote at least one prescription for lisdexamfetamine, 8.7% at least one prescription for paliperidone, and 6.9% at least one prescription for desvenlafaxine.  There were compositional differences between schools that adopted gift restriction policies before 2004 and later adopters, as well as between cohorts, in specialty composition and methods of payment. 

Stimulant Prescribing:  Physicians who were exposed to a gift restriction policy during medical school were significantly less likely than non-exposed physicians to prescribe lisdexamfetamine over older stimulants.  Of prescriptions written by physicians who attended a medical school with an active gift restriction policy, 5.9% were for lisdexamfetamine, in contrast with 7.4% among physicians not exposed to a policy who graduated from the same school before the policy was implemented.   

Among matched controls attending a school that implemented a policy in 2008, 8.3% and 9.1% of prescriptions were for lisdexamfetamine among earlier and later graduates, respectively.  Using a difference-in-differences approach showed that attending a medical school with an active conflict of interest policy significantly reduced the odds that a physician would prescribe lisdexamfetamine, the newly introduced stimulant, over older stimulants.   

In addition, for physicians who attended a medical school in which they would have been exposed to a policy for longer than the group exposed to the policy, the odds of prescribing lisdexamfetamine was further reduced.  Attending a school with a strong active policy also reduced the odds of prescribing lisdexamfetamine. 

Antipsychotic prescribing—paliperidone:  Physicians who were exposed to a gift restriction policy during medical school were significantly less likely than non-exposed physicians to prescribe paliperidone over older antipsychotics.  Of prescriptions written by physicians who attended a medical school with an active gift restriction policy, 0.5% were for paliperidone, in contrast with 1.7% among physicians who were not exposed to the policy and graduated from the same school. 

Among matched controls attending a school that implemented a policy in 2008, 1.2% and 1.4% of prescriptions were for paliperidone among the earlier and later cohorts, respectively.  Using a difference-in-differences approach, attending a medical school with an active conflict of interest policy was associated with a significantly decreased odds of prescribing paliperidone, the newly introduced antipsychotic.   

Antidepressant prescribing—desvenlafaxine:  Exposure to a gift restriction policy during medical school was not associated with differential prescribing of desvenlafaxine.  In all three models using a difference-in-differences approach, attending a medical school with an active gift restriction policy was not associated with significantly decreased odds of prescribing desvenlafaxine, the newly introduced antidepressant.   

In the main model, the odds ratio for students exposed to an active conflict of interest policy was 1.54.  Results were also insignificant in models examining students who were exposed to the policy for a longer duration or were exposed to a stricter policy.  

Discussion 

Implementation of a policy to restrict the receipt of gifts from the pharmaceutical industry at US medical schools was associated with significantly reduced prescribing of two out of three newly marketed psychotropic medications among students once they reached clinical practice. The odds of prescribing a newly marketed stimulant and a newly introduced antipsychotic medication were reduced among physicians who graduated from a medical school that had an active gift restriction policy.  The propensity to prescribe these two newly introduced medications was further reduced if the students were exposed to the policy for a longer duration or if the policy was relatively stringent.  

While these findings may suggest the ability to reduce prescribing of newly marketed pharmaceuticals, it remains yet to be seen whether such findings will result in only lower costs, or also better patient outcomes.  There is a significant chance, particularly given the complex nature of many of these drugs and the diseases they treat, that failing to prescribe new drugs may only further harm patients. 

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Thanks for your “Policy and Medicine” item today about Marissa King’s BMJ article on the effects of med school gift restriction policies. Your critique seems quite on target, but let me add a minor nit that’s worth picking.

Our institute funds research into the effects of devices and diagnostics, and does not tread into areas involving pharmaceuticals. King at al. would have been well-advised to observe the same distinction. But instead they state as their objective “To examine the effect of attending a medical school with an active policy on restricting gifts from representatives of pharmaceutical and device industries on subsequent prescribing behavior.”

Although med school policies may lump together the influence of pharma and device reps, that doesn’t mean they are really equivalent to one another. It’s too bad that neither the authors nor the editors seemed concerned to notice that this study produced not one shred of evidence about the effects of med school policies on the assessment, adoption, or use of medical devices. Nothing in the article justifies even the slightest mention of the medical device industry.

We don’t really know whether the patterns of conflict of interest that apply to pharmaceuticals also apply to devices. The two industries differ from one another in almost every regard, and they should be studied independently with those differences in mind. Well designed studies along these lines could be very useful for guiding appropriate education and policy decisions.

In addition to the weaknesses you identify, the King article makes the unfortunate mistake of following the example of university policymakers, and lumping the pharma and device industries together without a further thought.

Unfortunately, I’m sure this won’t be the last such occurrence.

In your conclusion you state:
"There is a significant chance, particularly given the complex nature of many of these drugs and the diseases they treat, that failing to prescribe new drugs may only further harm patients. "

I do not believe that conclusion is supported by the data. We just don't know what will happen and need to collect outcomes data also.

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