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5-Star Friday • Informed patients & uninformed President? These journalists nail it!

5-Star Friday • Informed patients & uninformed President? These journalists nail it!

5-Star Friday

It’s been a month since Punxsutawney Phil saw his shadow and I’m beginning to think it meant we were in for 6 weeks of great health care journalism (rather than 6 more weeks of winter).

5 Star FridayLast week was inspiring and this week had more excellent articles than we could write about. So don’t miss the links down at the bottom of the page. That’s where we highlight a pair of 5-star reviews from the Philadelphia Inquirer and STAT.

There were four articles we didn’t review but felt we should pass along because they address two important topics quite well. First, President Trump’s appeal to congress this week that the Food and Drug Administration (FDA) needs to become less restrictive and speed up its approval process. Second, the challenges of encouraging patients to be more involved and informed in medical decisions about their health.

The “F” in FDA stands for “fast” • a Vox article by Julia Belluz and a Forbes article by Matthew Herper both ask if the President’s arguments hold up

Both the Vox and the Forbes articles jump right in and take issue with the President using a young woman’s inspiring story of benefiting from the fast-track release of a drug that saved her life. A drug her father helped develop for a rare genetic disease that affects roughly one in 100,000 people.

Both journalists take the fact-check approach to Trump’s allegation that the FDA’s approval process is so cumbersome that it is stifling innovation, preventing “miracles,” and even raising the price of drugs. Matthew Herper of Forbes frames the issue well:

“But is it true? Are lifesaving drugs being kept from patients by insensitive bureaucrats? Or, as the FDA’s defenders would argue, are selfless public servants preventing companies from bilking sick people and their families with false hope and broken promises, while protecting the public from deadly side effects? The answer, like so much in healthcare, is complicated. “

The Vox article rightly points out that the FDA is “already the fastest drug regulatory agency in the world.” Belluz interviews one pharmaceutical scientist who, over a nearly 30 year career, has never brought a drug to market. In fact, less than one percent of drugs evaluated by the FDA even make it to human testing. Even fewer to our pharmacies. Is this simply a reflection of stringent regulations or does it underscore the inherent challenges of developing targeted therapies for complex biological processes?

Belluz goes on to point out that even though the FDA continues to fast-track more and more drugs — roughly 2 percent more each year — several studies show that for every 10 drugs that hit the market, 8 or 9 of them aren’t any better than medications already available. This doesn’t sound like innovation.

And as for a deregulated FDA leading to cheaper medicines, that is highly unlikely. It is simplistic to think that money saved on the front end by accelerating a drug’s approval will have anything to do with its ultimate market price. Likewise, the forces that cultivate innovation (and may lead to cures) have much more to do with meticulous science than accelerated science.

Patient participation in health care decisions • a NY Times opinion by Drs. Mikkael Sekeres & Timothy Gilligan and a Wall Street Journal article by Laura Landro

Do you prefer Android 4.1 Jelly Bean or 4.0 Ice Cream? Do you know the difference between bit-rate, bitcoin and bittorrent? Care to discuss saturation and pixelation options with AMOLED?

Don’t have a clue? Me neither.

How about if a cardiologist asks: “We’re recommending a stent for your left main coronary artery. There’s a small risk the procedure could lead to an intimal tear, arrhythmias, anaphylactic shock from the contrast dye, myocardial infarction, stroke … but probably just a mild hematoma where we insert the catheter. Do you understand these risks and are you ready to proceed?”

For many of us the answers to these last two questions — if we really stopped and thought about it — would be “not really” and “I’m not sure.” But is this what we answer with the doctor right in front of us? Probably not. Welcome to the intimidating, overwhelming, and imperfect world of informed consent. It’s a world Drs. Mikkael Sekeres and Timothy Gilligan of the Cleveland Clinic know well. And, in an opinion piece in the New York Times, they say there’s a secret involved:

“The secret is that informed consent in health care is commonly not-so-well informed. It might be a document we ask you to sign, at the behest of our lawyers, in case we end up in court if a bad outcome happens. Unfortunately, it’s often not really about informing you … A fundamental challenge with this process is that it is often unrealistic to think that you actually could be fully informed of what you’re about to undergo. How can we explain to you the experience of having your chest cracked open, or what it feels like when you go through chemotherapy? Neither of us has undergone heart surgery, or treatment for cancer, and we don’t kid ourselves that any depiction of the experience we provide will be enough.”

Sekeres and Gilligan want people to stop feeling intimidated and overwhelmed and offer advice that I would argue every patient should follow when faced with a tough health care choice:

Ask doctors to use language YOU understand. Not jargon.
Summarize back to your doctor what you heard
Request background materials that help you learn at your pace
Ask for best-case, worst-case, and most likely scenarios.
Ask to talk to another patient who has faced this decision
Ask for alternatives
Take notes

These suggestions may seem simplistic, self-evident really, but if you stop and think about how they might have helped you the last time you made a major medical decision (or watched a friend or family member do so) then you can appreciate their power ….

And it is power, or more accurately empowerment, that is the focus of this thoughtful Wall Street Journal article by Laura Landro looking at new approaches gaining popularity in shared decision making. Landro not only clearly outlines the research behind how shared decision making can improve a variety of health outcomes, but also focuses on three approaches:

Decision Aids – usually interactive media that rely heavily on graphics to clearly illustrate benefits and harms in understandable ways
Teaching doctors how to incorporate shared decision making into their patient interactions
Improving patient access to their own medical records.

Although the concept of shared decision making is not a new one, this article shows it is one that is gaining credibility through growing research. As one source in the WSJ article says:

“The most important goal is to avoid a situation where the patient doesn’t have a voice or gets so overwhelmed by the decision that in the end they just say ‘what should I do doc?’.”

5-Star Review for STAT news in intravenous vitamin story

We appreciated STAT’s evidence-based approach to a burgeoning fad fueled more by celebrity endorsements than data.

The article was well-sourced, provided real costs, and gave readers their own way to check on the credibility of the claims of “evidence” in this highly unregulated industry. Our reviewers would have liked to see more about potential harms.

5-Star Review for the Philadelphia Inquirer story on testosterone therapy

A balanced and detailed look at the risks and benefits of both approved and off-label uses of testosterone in older men.

The article appropriately raises the issue of overprescribing, employs credible sources, and expresses concern over manufacturers promoting the expanded use of testosterone in untested ways.

Have you come across some health care writing that you found particularly illuminating or inspiring? If so, we’d love to hear about it. Just include it in the comment section below. Maybe it will find its way into 5-Star Friday. Have a good weekend!


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