Life Science Compliance Update

June 22, 2016

JAMA Internal Medicine Bias – Now You See Me

Merlin the Magician would be proud of a recent study published in JAMA Internal Medicine attempting to prove that doctors who receive small gifts of food are more likely to prescribe a branded drug than generic drugs. The authors linked two national data sets in an attempt to quantity the association between industry payments and physician prescribing patterns.

The "researchers" utilized the most-prescribed brand-name drugs in four categories according to Medicare Part D information from 2013. They then cross-referenced those prescribing rates to the five months of data in the Open Payments database available for the year 2013. According to the authors, physicians who received only one meal promoting one of the four target drugs had higher rates of prescribing those medications.

The conclusion and relevance of the study in the abstract reads: Industry payments to physicians are associated with higher rates of prescribing brand-name statins. As the United States seeks to rein in the costs of prescription drugs and make them less expensive for patients, our findings are concerning.

However, once one digs a little deeper, it is clear that the investigation lauded by the press as evidence does not meet the scientific rigor that one would expect from a JAMA publication.

The Problems (Not an Exhaustive List)

First, the media reports all focused on the propensity of physicians to prescribe brand-name drugs when cheaper alternatives were available, not at all taking into consideration weather the patient may actually be better off on the branded drugs. In their main argument around statin use, many patients tolerate one statin and not another.

Second, when looking at the table of financial payments types and their association with brand name prescribing rates for statins, (the only table with actual numbers) food payments which was the source of many media stories did not meet statistical significance of .05 or 5%. The confidence intervals on meals actually skewed toward fewer prescriptions with a range of -2.56 to +.42. We recommend that the authors and the JAMA internal medicine editors review the Wikipedia definition of statistical significance, to help them understand that drawing inferences on data that does not meet the null hypothesis may not be in the best interest of their journal. But then again, pharmascolds hold to the believe to never let facts get in the way of a good narrative. Unfortunately, their allies in the media hold that same view.

Third, if one looks closely at Figures 1 and 2, out of almost 2,500 physicians analyzed, only a handful are creating the upward slopes between the covariates. The relationship is non-existent for physicians who receive less than $2,000, and for those who receive above $2,000, there are a few data points. Overall, the actual change listed at the end of their article was less than .1% increased prescribing per $1,000 increase in the open payments database.

Fourth, all the media mentions that the study looked at three therapeutic areas, lipids, hypertension and depression, yet their paper only discusses statins.  The editing and peer review process takes many months.  The authors would have had ample time to know what was actually being published.  So where is the "study showing even small meals influencing physicians."

Fifth, we have made clear time and time again that the Open Payments data made available through the Affordable Care Act can be misused. Once again, we see opponents of marketing using the national registry as a stepping stone in their ultimate goal of eliminating any and all payments to physicians. As we have noted before, the data available through Open Payments has minimal pre-release vetting by the physicians, and can contain de-identified and disputed payments.

Sixth, some physicians may choose to attend industry events where information is provided about drugs they already prefer to prescribe. Such a choice would have little to no effect on their prescribing patterns. The authors of the study failed to take that into account.

The authors of the study recognized that there were several limitations, including equating five months of payment data to twelve months of prescription data. Comparing an entire year of prescribing patterns to five months of payment data should almost be considered malpractice: the five months of payment data is more than likely not representative of a full year.

Further, the study did not differentiate between new prescriptions and refills. By failing to take into account whether a prescription was a refill, the number of prescriptions written could very easily be inflated for each physician.

Media

The media absolutely missed it on this one headlines included:

Wall Street Journal

Free Meals Influence Doctors' Drug Prescriptions, Study Suggests

"Doctors who received a single free meal from a drug company were more likely to prescribe the drug the company was promoting than doctors who received no such meals, according to a study."

New York Times

Drug Company Lunches Have Big Payoffs

A free lunch may be all it takes to persuade a doctor to prescribe a brand-name drug instead of a cheaper generic, a new study suggests.

ProPublica

Feed Me, Pharma: More Evidence That Industry Meals Are Linked to Costlier Prescribing

A study published online Monday in JAMA Internal Medicine found significant evidence that doctors who received meals tied to specific drugs prescribed a higher proportion of those products than their peers. And the more meals they received, the greater share of those drugs they tended to prescribe relative to other medications in the same category.

To ProPublica, perhaps you should take that course on statistics as well as the editors.

Several publications took a second look:

Bloomberg actually did a good job laying out the alternative scenario in an article titled: Maybe Pharmaceutical Reps Actually Aren't Bribing Doctors by Megan McArdle where she elegantly outlines how there are many more scenarios that the doctor being bribed as most the media coverage has focused on. In her analysis the physician may be doing this out learning new things about better drugs or perhaps he already writes the scripts.

Forbes in an editorial outlines how the choices of medications is important, and medical decisions are not made in a vacuum. The Way To Doctors' Prescription Pads Is Through Their Stomachs So, once again, the pharmaceutical industry is under attack for coercing physicians to prescribe its drugs. This time the temptation involves food ...

Industry Response

The Coalition for Healthcare Communications issued a statement in response to the "investigation," stating,

Nothing new here.  Information is power.  The more information prescribers obtain, the more they are likely to use a drug safely and effectively. Dinner meetings are regulated by the FDA to ensure that the information is consistent with the basic information about the drug and is not false or misleading in any way. The fact that the doctors have dinner as part of the process does not change the facts of the presentation in any way. Education informs effective prescribing.

 The Pharmaceutical Research and Manufacturers of America also responded, noting that:

This study cherry-picks physician prescribing data for a subset of medicines to advance a false narrative. Manufacturers routinely engage with physicians to share drug safety and efficacy information, new indications for approved medicines and potential side effects of medicines. As the study says, the exchange of this critical information could impact physicians' prescribing decisions in an effort to improve patient care.

Physicians' prescribing patterns are dynamic and based on individual patients' needs. According to a survey of physicians, 91 percent felt that a great deal of their prescribing was influenced by their clinical knowledge and experience. The survey also found that factors such as a patient's particular situation, including drug interactions, side effects and contraindications; articles in peer-reviewed medical journals; and clinical practice guidelines, affected prescribing decisions a great deal.

Normally, an editor and peer reviewers would have had the authors pull back on many of the assumptions made by this article. One has to hope that this lack of checks and balances does not also apply to their clinical articles. Unfortunately, this study will be added to the lexicon and quoted by many opinion papers and journal editorials as fact, adding to the vicious cycle. We encourage the American Medical Association to do a full review on how this paper passed publication.

June 03, 2016

Using Massachusetts Physician Payment Data Prescribing Patterns Under Attack (Again)

Prescribing practices of physicians are once again under attack. And, once again, the attacks leave consumers, patients, and their families feeling confused. This time, the confusion is a result of a study done by researchers from Harvard Medical School and published in JAMA Internal Medicine which found that "medical industry payments to physicians in Massachusetts are associated with higher rates of prescribing brand-name drugs that treat high cholesterol."

Right off the bat, there are some interesting things to note relating to the study. First of all, the study only looked at physicians in Massachusetts, a relatively small state. Second, the study only focused on the prescribing of brand-name drugs for high cholesterol, a relatively small portion of total branded drugs prescribed since the largest players have since gone generic. These are not suggested to discredit the research, but instead, to help put it in perspective.

However, even acknowledging those realities, it is always beneficial to read through the entire study to ascertain the methods, the reasoning, and, if possible, the true results of the study, to best understand the study and the points behind it.

Design, Setting, and Participants

The study used cross-sectional linkage of Part D Medicare prescriptions claims data with the Massachusetts physician payment database. The database includes all licensed Massachusetts physicians who wrote prescriptions for statins that were paid for under the Medicare drug benefit in 2011.

Study Results

Among the 2444 Massachusetts physicians in the Medicare prescribing database in 2011, 899 (36.8%) received some form of industry payments. The most frequent payment was for company sponsored meals, accounting for 71.1% of payments.

Statins accounted for 1,559,003 prescription claims, 22.8% of which were for brand name drugs. According to the study, physicians with no industry payments listed had a median brand name prescribing rate of 17.8%. For every $1,000 received in payments, the brand name statin prescribing rate increased by a statistically insignificant .1%.

However, interestingly, payments for educational training were associated with a 4.8% increase in the rate of brand name prescribing. While that percentage is more significant than the overall percentage mentioned above, it is still not that significant. As we have mentioned before, and continue to opine on, we do not believe that physicians becoming more educated about certain drugs is typically a bad thing. The more they learn, they more they know and can understand how individual drugs can help their patients and what kind of side effects they need to be looking for.

Using the foregoing figures, the researchers concluded that industry payments to physicians are associated with higher rates of prescribing brand-name statins.

Analysis

As we have all know, and the Harvard researchers even stated, correlation does not equal causation. Simply because there is a correlation between receiving payments (such as a company sponsored meal) and prescribing rates does not mean that one is caused by the other. Even if it is a true causation, physicians who attend company sponsored meals learn more about the drug, and therefore feel more comfortable prescribing it, than a physician who does not have the benefit of that knowledge. Further, the correlation they are trying to bring to bear is a one in one thousand percent, a statistically insignificant amount.

Most patients likely prefer to have a physician who knows exactly what they are prescribing, and a physician who knows which individual patients may be someone who benefits from the name-brand drug, instead of the generic. In the case of statins not all patients can tolerate all statins some patients who have problems taking one statin often can use another statin and several of those statins that utilize different pathways are still branded products.

The study's limitations included the possible inaccuracy of the reporting of payments and prescriptions covered outside of Medicare. Further, they could not determine "which physicians received payments from a specific company and analyze their prescribing of that company's products."

April 14, 2016

NEJM: What Do I Need to Learn Today – The Evolution of CME

Graham McMahon, MD, MMSc, the President and CEO of the Accreditation Council for Continuing Medical Education, has written an article for the New England Journal of Medicine about the evolution of continuing medical education (CME). The article, "What Do I Need to Learn Today? – The Evolution of CME," asks for clinicians, educators, healthcare institutions, and regulators to contribute to the continuing transformation of CME.  He also suggests that CME be included as a significant asset for regulatory efforts such as MOC and the Merit-Based Incentive Payments System.

Dr. McMahon stated that such a continued transformation will serve to "expand the opportunities for educational innovation that improves physician practice and ultimately benefits patient care and the health of our country." To help the transformation, Dr. McMahon recommends that clinicians become more aware of their individual strengths and weaknesses and choose CME activities that can help them grow and become better clinicians.

In order to meet the learning needs of clinicians in today's healthcare environment, it is imperative for educators to design CME activities that focus on the learners, rather than the teachers, and incorporate opportunities for interaction and reflection. Interprofessional continuing education (IPCE) gives physicians the opportunity to build the competencies needed for team-based practice. Patients should be active in their care and should be viewed as part of the healthcare team; including patients as CME speakers can work to engage physicians' hearts as well as their minds.

Part of the problem today, as outlined in the article by Dr. McMahon, is that information is "ubiquitous," meaning that the simple exchange of information has little value, and that in order to truly learn and understand something, shared wisdom and the opportunity to engage in practice-relevant problem solving is crucial. Dr. McMahon realizes that once physicians see and understand that they are actively (and actually!) learning, they embrace future activities that allow them that same learning opportunity.

As stated by Dr. McMahon,

Education that's inadequate, inefficient, or ineffective, particularly when participation is driven by mandates, irritates physicians who are forced to revert to "box-checking" behavior that's antithetical to durable, useful learning.

It is important that going forward, regulators begin to focus on educational outcomes, not the process, and work to create other conditions that maximize flexibility and innovation in CME. The ACCME's collaboration with the American Board of Internal Medicine (ABIM) to simplify the integration of Maintenance of Certification (MOC) and CME, is an example of regulatory authorities working together to reduce the burden placed on physicians, helping to promote lifelong learning.

Dr. McMahon also points out that "If more regulatory authorities recognize the value of education in driving clinical practice and quality improvement and allow educational activities to count for multiple requirements, they can reduce the burden on physicians and promote lifelong learning. For example, participation in CME could be designated as a method for meeting the clinical practice improvement expectations of Medicare’s new Merit-Based Incentive Payment System."

Each year, the accredited CME community collectively provides nearly 150,000 activities. Accredited CME activities are required to be evidence-based and free of any commercial bias or influence. The more involved healthcare leaders, educators, and learners, become in the process, the more CME can do to promote performance, quality improvement, collegiality, and public health.

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