Here’s the good news: academic detailing is becoming so widely accepted that everyone wants to help provide the evidence that is disseminated. That’s also the bad news; worrisome examples range from the grotesque to the sinister. One eminent health policy expert wanted to know how much it would cost to put together a nationwide academic detailing program (my heart leaped) that would be underwritten by the pharmaceutical industry (dammit).
Prescription drug management (PBM) companies now offer so-called academic detailing services as part of their contracts with payors to oversee drug choices and spending. Sounds good until one realizes that a large chunk of PBM revenue come from payments by manufacturers to move market share to their products. So much for communicating evidence that is neutral, unbiased, and non-commercial.
You’d think we’d have learned our lesson by now. Do universities or insurers or government fail to offer enough continuing education about prescribing? No problem, drugmakers will be more than happy to fill the gap, either for free or at amazingly low cost…. often with really great food. That local clinical expert who shows up at Grand Rounds to provide an overview of all the new treatments for diabetes, at no cost to the hospital? Don’t ask who’s paying him to be there. And those convenient smartphone apps that provide so much handy dosing information for any drug you can think of? All you have to do is read the commercial messages that pop up on your way to the data, as the vendor promises its pharmaceutical sponsors the chance to "embed your brand message at multiple points across the care continuum."
There is a solution to the concern about who’s providing the content for academic detailing programs, and it’s much easier than figuring out whether a particular Facebook ad is brought to you by a Russian bot. Just expect that any purveyor of AD information will reveal clearly all the financial ties it and its authors have with any drug or device maker, in relation to program sponsorship as well as the creation and editing of the clinical content. After years of being misled about hidden data on adverse events or failed studies, we’ve developed a higher set of expectations about disclosing all information about clinical trials, and the need to reveal authors’ financial ties for published studies.
Those same higher standards must also be applied to academic detailing programs, so that its audiences will know whether the material is the carefully vetted work of a team of unconflicted reviewers who don’t work for any manufacturers, or is instead yet another terribly sophisticated new way to market particular products.
Want more? Peruse the archive of Jerry's pieces here on DETAILS.
Jerry Avorn, MD | NaRCAD Co-Director
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist, geriatrician, and drug epidemiologist, he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use, particularly in the elderly. Read more.
Navigating a Disorienting Healthcare Landscape | Jerry Avorn, MD, NaRCAD Co-Director
Tags: Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications
First, about the grammar. Readers under 65 will be forgiven if they never heard of the daytime television quiz show “Who Do You Trust?” that aired from 1957 to 1963. In it, male contestants were asked if they wanted to answer a question or whether they ‘trusted’ their wife to do so. Concerns by snarky little kids like me that it really should have been “Whom Do You Trust?” did not diminish the show’s popular appeal. Gender issues went totally undiscussed.
All grown up now and confronting a changing health care landscape, that still-sometimes-snarky little boy often wonders, as do many of my clinician colleagues, who can be trusted in the world of medical information, especially in relation to prescription drugs. Gone are the simpler times when one had to worry only about whether the drug ads and sales reps were really presenting a balanced picture of all the evidence, which was a hard enough challenge.
We now know that we also have to be concerned about off-label marketing campaigns offering impermissible (and often downright deceptive) statements about efficacy – excesses for which over $16 billion has now been paid to state attorneys general in legal penalties and settlements.
As I’ve noted previously, the courts and the FDA are also moving toward much more permissiveness with company claims about efficacy and safety. And in last year’s 21st Century Cures Act, Congress instructed the FDA to be more open to accepting lower standards for drug approval.
Then there are newer sources of information whose trustworthiness is not always clear. More and more, this includes the prescription benefit management (PBM) companies, which seem to be holding on to an ever-larger fraction of the funds flowing through their rich payment pipelines, yet provide little transparency about who gets to keep what rebate dollars, and for what reason. Once billed as cost-savings protectors and comparative effectiveness gurus, the PBMs are under increasing scrutiny, and asked to make their financial data transparent and to clarify just who’s saving what for whom (or is it ‘for who?’).
Nor can we always be sure what angle the payors are playing. Why is Drug A on the formulary, but not its sibling Drug B? It may be an astute purchasing decision, or just the result of a rebate hack. And how much are prior authorization rules and growing co-payments designed to promote evidence-based care, or other less worthy goals? Even clinical guidelines put out by third parties vary from the most rigorous to pretty sketchy.
This leads to one good answer to the ungrammatical question in our title. With these galloping changes in an ever-more marketplace-oriented health care system, every prescriber needs and deserves a smart, superbly informed colleague to rely on to get the best possible syntheses of the clinical evidence – someone who has no other agenda or motivation other than getting the facts right and transmitting them faithfully.
Each year, we can take less comfort in counting only on FDA-approved indications, or payor policies, or PBM choices, or advertised claims. The more compromised each of these sources becomes, the more we’ll need ‘honest brokers’ like well-trained and un-conflicted academic detailers, whose only duty is to communicate the fairest evidence summaries as effectively as possible. Like lightweight clothing in an era of global warming, it’s a need that’s only going to increase.
Thoughts? Reactions? Sound off below.
Jerry Avorn, MD, Co-Director, NaRCAD
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist and drug epidemiologist, he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use. Read more.
Tags: Evidence-Based Medicine, Health Policy, Jerry Avorn, Medications
Listen closely, and you’ll hear the other shoe dropping.
For several years FDA has been besieged by litigation brought by drug makers and their supporters which argued that the agency’s limiting companies’ promotional claims violated those corporations’ First Amendment-protected rights to ‘commercial free speech.’
Then the 21st Century Cures Act signed by still-President Obama in December of 2016 authorized FDA to consider less demanding standards in approving medications. 2017 began with a new administration vowing to free the pharmaceutical industry from the onerous regulatory burdens of the FDA. Now all these forces are coming together in a worrisome confluence of regulatory derangement.
The House Energy and Commerce committee in mid-July held hearings on how best to implement the Congressionally mandated loosening of drug approval standards set forth in the “Cures” act. At the same time, the new FDA Commissioner has argued that FDA’s “public health mandate” should be met by relieving manufacturers of some of those troublesome requirements to demonstrate clinical benefit, in order to get drugs to the public more easily. At the same time, he noted, as FDA reduces the complexity and duration of the drug approval process, this speeding of new drugs onto the market will help contain their high prices.
Nevermind that FDA’s approval process is already the swiftest in the world, clocking in at a mere 6 months for priority decisions.
And nevermind that the cost of the regulatory process accounts for only a small portion of medication prices.
And just ignore the fact that worrying about cost never has been part of that agency’s mandate.
Justifying the reduction of FDA’s regulatory standards to meet its “public health mandate” is a troubling Orwellian development that is likely to have exactly the opposite effect. It is eerily reminiscent of the notorious Vietnam-era claim by the military that a village “had to be destroyed in order to save it.” Invoking FDA’s public health mission to justify approving drugs that have not been adequately shown to help patients is both bizarre and irrational.
These developments raise the ante for evidence-based prescribing in general, and for academic detailing in particular. Most clinicians and health care systems are not yet aware that FDA approval may become an eroded imprimatur to guide medication decisions, and most people will continue to believe that pharmaceutical company claims have to pass muster with FDA for their accuracy, even as this becomes less and less true in the coming years.
Even if we cannot stop these disturbing developments, we must at least make sure that they are understood by our colleagues in medicine, so that academic detailing services – by definition rigorously evidence-based and non-commercial – can play an increasingly large role in informing prescribing decisions, as an antidote to these worrisome ongoing developments.
Share your thoughts in our discussion forum below.
Biography. Jerry Avorn, MD, Co-Director, NaRCAD
Dr. Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics (DoPE) at Brigham & Women's Hospital. A general internist and drug epidemiologist, he pioneered the concept of academic detailing and is recognized internationally as a leading expert on this topic and on optimal medication use.
Sharing the History & Origins of AD via Jerry Avorn's 2017 NEJM Article
Tags: Evidence-Based Medicine, Jerry Avorn
Thirty-eight years ago, a US federal research agency issued a request for proposals on “Improving the Quality and Economy of Prescription Drug Use.” Recently out of my residency and concerned about the mismatch I was seeing between the best evidence and prevailing patterns of prescribing, I suspected that the problem might result in part from an imbalance in the effectiveness of communication coming from commercial vs academic sources.
The pharmaceutical industry was impressively adept at sending well-trained change agents (drug “detailers”) to provide information about company products engagingly and interactively to physicians in their offices, in order to increase product sales. Academics, by contrast, who may have had a more impartial and thorough understanding of the evidence, tended to be passive and inelegant communicators, standing behind podiums in optional continuing education courses, delivering one-way didactic presentations in darkened rooms, often doing little to change actual practice. Click here to read the whole article at NEJM's "Piece of My Mind" Archive.
Jerry Avorn, MD
Harvard Medical School; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; Co-Director, NaRCAD
JAMA. 2017;317(4):361-362. doi:10.1001/jama.2016.16036
Jerry Avorn, MD, Co-Director of NaRCAD, Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital
Tags: Evidence-Based Medication, Jerry Avorn, Medications
Consider the following recent news development:
A large multinational company is discovered to have purposely hidden the risks of one of its best-selling products by suppressing information about its adverse effects and presenting only a selective set of data about its impact, to cast it in a more favorable light than was accurate. The magnitude of this distortion was so great that it posed health risks for hundreds of thousands of people throughout the industrialized world. The company admitted guilt and said it would try to do better in the future. No criminal charges were pressed, and none may ever be.
I refer, of course, to Volkswagen. Last year, the carmaker was found to have rigged the pollution-control devices in its diesel cars to make it appear they were reducing emissions, but only when the car was being inspected. The rest of the time the autos spewed out pollutants far in excess of the allowed limits. The engineers and executives who perpetrated this enormous hoax were not demons. They were employees of a large corporation who let the need for profit (or shareholder value, a more polite term) push them beyond the limits of accurately presenting data about their products. These things happen in large companies, including drugmakers, who have in the last decade or so had to pay over $15 billion in legal settlements, most of which dealt with such mis-statements of benefits and harms. Nothing personal; it’s just business.
Anyone who is shocked about this should go back to review the imperatives of corporate life, as defined by the Nobel Prize-winning economist Milton Friedman. In a 1970 article, he noted that “There is one and only one social responsibility of business -- to use its resources and engage in activities designed to increase its profits….” Unfortunately, the second half of that sentence is often omitted: “…so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud.” In an era of an overstretched and sometimes overmatched FDA, there’s a greater need than ever to present clinicians with an accurate depiction of the good and harm that medications can do.
Of course, academic detailing is about far more than just correcting the excesses or misstatements of drugmakers. Our job is to present a comprehensive, un-skewed overview of the benefits and risks of medications and other health care decisions. But in doing so, we sometimes have to address misconceptions generated by some drugmakers who are, I suppose, just trying to give their shareholders a good return on their investment. Whether a company makes cars or drugs, its staff at all levels are under tremendous pressure to increase sales. This can often draw otherwise reasonable employees close to – or sometimes over – the line of what’s deceptive.
In academic detailing, we don’t have to worry about sales goals or profit margins. The only currency we need to maximize is accurate evidence; our only “shareholders” are patients and the clinicians who care for them. In a way, that’s the easiest and best part of our jobs.
by Michael Fischer, MD, MS, & Bevin K. Shagoury
Tags: Detailing Visits, Evidence-Based Medicine, Training
Changes in healthcare are accelerating faster than ever, amplified by the immediacy of virtual communication. New research studies or guidelines appear simultaneously in traditional media, online news sites, and social media. Front-line clinicians may not have the time to review the actual data before incorporating new information into their practices. We’ve seen this recently with topics such as managing cholesterol and hypertension, the safety and possible overuse of pain medications, and new treatments for hepatitis C.
These topics present a challenge not only for clinicians and their patients, but for those who work on medical education and quality improvement efforts. Educational messages cannot be static; rather, organizations working to promote change and improvement need to identify new evidence, incorporate it into interventions and bring it to frontline clinicians. Amidst the steady stream of research and new discoveries, along with ongoing debates about those findings, how do organizations work to effectively assess needs, share best evidence, and improve healthcare outcomes?
NaRCAD is uniquely positioned to help address this question, serving as a powerful and integral link between the best evidence and frontline clinicians by supporting academic detailing programs and related outreach interventions. We’re leaders in the field, providing training and support to health care organizations to establish effective academic detailing programs, working with partners to develop academic detailing program templates which can be adopted by others, and sustaining a network of programs sharing best practices in academic detailing to improve patient health outcomes.
Evidence aside, observation and insight tells us that healthcare, like the populations it serves, is organic; constantly changing, growing, and redefining the best next steps to improve the quality of care and patient outcomes. As new medical evidence emerges and new delivery system innovations are introduced, we at NaRCAD look to help those changes enter practice in a way that most benefits patients and public health. Learn more about us, or tell us how we can help you.
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