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CYA TMI? Drug Label Warnings List Dizzying Number Of Adverse Events

Drug labels warn about a mean of 70 adverse events per medication, leading researchers to conclude that the glut of information is confusing patients.

Jon Duke, MD, an ACP Member, and other researchers extracted 534,125 adverse drug events from 5,602 product labels. There was a mean of nearly 70 events per label. They found 588 with more than 150 adverse drug events and 84 with more than 300, with the top offender having 525 events listed. This top group included selective serotonin reuptake inhibitors, anti-virals, and restless leg syndrome drugs.

Labels for the 200 most commonly dispensed medications contained significantly more adverse drug events than others (median, 79 vs. 47; P<.001). By specialty, there were more adverse drug events listed in the fields of neurology (n=168), psychiatry (n=116), and rheumatology (n=111).

Drugs approved during the 1980s and 1990s had the highest overall number of adverse drug events, while newer medications had significantly more labeled adverse drug events than older medications.

“The findings aren’t unexpected,” wrote Dr. Duke and colleagues in the Archives of Internal Medicine. Newer drugs face more rigorous clinical trials and postmarketing surveillance than older medications. More commonly prescribed drugs are more likely to generate more reports of adverse events. The high volume of events in neuropsychiatric medications “may relate as much to patient population as to the effects of the drugs themselves.”

But, Dr. Duke and colleagues concluded, “The presence of such excess data still may induce information overload and reduce physician comprehension of important safety warnings.”

While the Food and Drug Administration tried to revamp warning labels in 2006, labels have grown more complex since then. “This finding underscores the tremendous challenge faced by the FDA in reversing the long-standing trend toward overwarning.”

*This blog post was originally published at ACP Internist*

The AMA And Congress: How To Cross The Cultural Divide

The AMA’s communications department kindly sent me a copy of a letter that they (and 9 other professional society CEOs or Presidents) recently sent to Barack Obama and 12 members of congress. I’ve been blogging about the fact that healthcare providers in general, and physicians in particular, do not seem to have much of a voice in healthcare policy. In fact, from what I can tell, Dr. Nancy Nielsen is carrying the torch almost exclusively. I don’t mean to belittle anyone’s efforts, it’s just that I’ve noticed that she is often the only physician at the highest level policy meetings.

So it was with great interest that I read the group letter to Obama et al., wondering what collective message our physician leaders were trying to get across. The writing was academic – using terminology familiar to those heavily steeped in medicine – and emphasized the creation of a patient-centered culture supported by evidence based medicine.

However, the letter raised an interesting question in my mind: Will members of congress read and understand it? I believe that the most effective letters to congress are likely to share three qualities: 1) they must be emotionally provocative 2) they must be written at about the 6th grade reading level 3) they must be brief.

Why Letters Must Appeal To Emotion (“Cultural Competency”)

Dr. Nielsen said at a recent Medicare Policy Summit that speaking with Senators can be “pure theatre.” That has been my observation as well. Decades of experience speaking in large committee meetings have taught them that amusing sound bites or emotional outbursts get attention. In fact, it may be the best way to get things done in congress. For example, did you know that the reason why kidney care is the only disease-based eligibility under Medicare is that Shep Glazer testified before congress during one of his dialysis sessions?

Washington , D.C. , Nov. 4, 1971 – In the most dramatic plea ever made on behalf of kidney patients, Shep Glazer, Vice-President of NAPH, testified before the House Ways and Means Committee while attached to a fully functioning artificial kidney machine.

Minutes before, in the corridor outside the hearing room, Shep told reporters from the AP, UPI, and the Washington Post, “Gentlemen, I am going to tell the Committee that if dialysis can be performed on the floor of Congress, it can be performed anywhere.” As his wife, Charlotte , connected him to the machine, he continued, “Kidney patients don’t have to be confined to hospitals, where expenses are $25,000 a year and more per patient. It’s much cheaper in a satellite unit or at home. I want to show the Committee what dialysis is really like. I want them to remember us.”

My point is that in congress, as opposed to medical meetings, emotion is king. Physicians have a hard time speaking from the gut, since we’re trained to speak from data – because we know that the gut can be misleading. However, my plea to physician groups is this: let’s collect our data, understand the science behind our point of view, and then present our advice in a way that is persuasive to congress. That means we’d probably benefit from a few theatre classes (can we get CME credit for them?) I’m not suggesting that we become undignified in any way – I’m just saying that personal stories, case studies, and appeals to emotion are the currency on the Hill. If we want attention, we’ll need to find a way to make our points in their own language.

For example, I was listening in to a recent Senate hearing on healthcare finance, when a Republican senator began his introductory remarks about “out of control spending” with this:

I must tell you that I have major concerns about our current approach to spending. We’ve already sunk billions of dollars into all kinds of bailouts and programs without any clear benefits. But every time I bring up the excessive spending issue, you’d think I was a skunk at a picnic…

An amusing analogy, and one that resonated with his peers. This Senator understood the culture to which he was speaking. In other words, he had a “culturally competent” message.

Why Letters Should Be Written At About The 6th Grade Reading Level (Health Literacy)

Dr. Richard Carmona told me that one of the first things he learned as Surgeon General was that the American people understand health information at a 6th grade reading level. Thus, there is no point in making a 100+ page medical report on the health hazards of smoking the corner stone of a public smoking cessation campaign.

Health information must be written in a clear, and actionable manner – but it must also be delivered in such a way that it resonates with diverse communities. Letters to congress are no different – many of our congressmen and women do not have advanced medical or science degrees. We must be sensitive to that and write to them in a way that makes it easy for them to understand what we’re hoping to accomplish.

Why Letters Must Be Very Brief

Much has been made of the fact that many people who signed the recent 1000+ page stimulus bill hadn’t actually reviewed it. In fact, it is estimated that 306 members of Congress voted for a bill they had not read.

Of the 535 members of the United States House and Senate,  246 House members and 60 members of the august Senate voted for the $787 billion  stimulus bill without having read a single one of the bill’s 1,071 pages or having any idea of where all of this money borrowed from our grandchildren is going to be spent.

So if our members of Congress don’t read the stimulus bill, will they take the time to read long letters from professional societies? I think you know the answer.


The AMA should be applauded for their lobbying efforts on the part of physicians in Washington. However, my personal view is that letters to congress may be more effective if they are written in a concise, jargon-free, compelling way that respects the “culture” of congress. We physicians hear a lot about “health literacy” and “cultural competency” – and must remember to apply those principles to letter-writing campaigns.

Will any letter influence congressional decision-making? It’s hard to measure the “ROI” of group letters to congress – and certainly they’re only one part of a larger strategy. However, it behooves us physicians to find ways to reach across the cultural divide to speak to congress about the issues that trouble us all: the fate of patients. Letters may be helpful, but an increased presence in Washington, along with some heartfelt reasoning, may be our best shot. Perhaps the Broadway actors affected by the economic recession could help us out?

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