Health Topics – Johns Hopkins Medicine Podcasts

Deprescribing is an effort underway among primary care physicians to completely assess all medicines a person is taking, including vitamins, supplements and over the counter medicines, and reduce that number to the fewest possible while still achieving therapeutic goals. Caleb Alexander, an internal medicine expert at Johns Hopkins, explains.

Alexander: It does take time, but it’s time that’s well spent for many patients and it is a process, it’s not an event. You know the thousand mile journey begins with one step. So when it comes to deprescibing, it’s not as if everything has to be achieved in a single office visit. And in fact it’s often only by looking and discussing these matters over time that one gets a very firm sense of the likely value or lack thereof of a given product.  :28

Alexander says patient participation in the process is critical as only you will know whether some medicines are beneficial or not. At Johns Hopkins, I’m Elizabeth Tracey.

If you’re taking a number of medicines your physician may bring up the idea of 

‘deprescribing’ to you. That’s the idea that many of these medicines may no longer be needed, may not be providing enough benefit versus their potential for harm, or may be substituted with a simpler regimen. Caleb Alexander, an internal medicine expert at Johns Hopkins, describes deprescribing.

Alexander: This is a concept that has been long in the making and that is long overdue. We spend billions of dollars trying to figure out when to start medicines and next to nothing trying to figure out when to stop them. It’s just all too easy to stack one medicine on top of another on top of another. There’s a very real phenomenon that happens when many patients come in, especially the elderly, with these long medications lists which is that we need to clean things up.  :28

Alexander says any deprescribing effort must also include any vitamins, supplements and over the counter medicines you may be taking as well. At Johns Hopkins, I’m Elizabeth Tracey.

Implantable recorders, which are placed under the skin and monitor someone’s heart for a prolonged period of time, may help identify a heart condition known as atrial fibrillation in those who’ve had a stroke, two recent studies find. Michele Johansen, a stroke expert at Johns Hopkins, describes the findings.

Johansen: I think that the good question that it does answer is in patients that you really have concern for atrial fibrillation, an implantable loop recorder you shouldn’t give up. An implantable loop recorder is a wonderful mechanism that we now have to monitor patients over time. And that the majority of patients do really well. So I think that thinking about implantable loop recorders, the yield you get from an implantable loop recorder, that is a very viable way by which you can work up patients is a real takeaway from this article. We don’t need to wonder about that anymore.  :28

Johansen notes that correctly identifying the cause of a first stroke is paramount in preventing a second one, and implantable recorders can help. At Johns Hopkins, I’m Elizabeth Tracey.

For people who’ve had a stroke, finding out why will dictate their management going forward, with a pair of new studies showing that an implantable monitor to look for atrial fibrillation, where part of the heart doesn’t beat in synchrony, may help for some patients. Michele Johansen, a stroke expert at Johns Hopkins, explains.

Johansen: Secondary prevention of stroke is where finding the cause of the stroke really matters. And so when you talk about atrial fibrillation, that is the most common cause of what’s called a cardioembolic stroke. So cardioembolic stroke just meaning that the clot came from the heart, broke off and went to the brain. The reason that finding atrial fibrillation is patients that have had strokes, is that the way that you treat patients who have atrial fibrillation is different than the way that you treat other patients who have strokes.  :28

Johansen notes that for those with atrial fibrillation, or a-fib, as it is often abbreviated, certain medicines are indicated that are not used in those with other causes of stroke. At Johns Hopkins, I’m Elizabeth Tracey.

Medicare is poised to spend millions of dollars on aducanumab, a just approved drug for Alzheimer’s disease the FDA’s own advisory panel recommended against approving. Caleb Alexander, a member of the panel and an internal medicine expert at Johns Hopkins, says approval was reached using what’s known as the accelerated pathway.

Alexander: For products that are approved using the accelerated pathway they’re approved on the basis of a surrogate or a biomarker, in this instance brain amyloid levels. So when products are approved using the accelerated pathway the manufacturer is obligated to conduct what’s called a confirmatory study, a study that looks at the outcomes that we really all care about, that is clinical benefit however those types of studies can take several years to perform.  :28

Alexander notes that a confirmatory study could be about nine years in the future, enabling Biogen to market the drug and reap enormous profits in the meantime. At Johns Hopkins, I’m Elizabeth Tracey.

Is amyloid, a substance that accumulates in the brains of people with Alzheimer’s disease, the cause of the disease or simply a bystander? No one knows, and that’s why an FDA advisory panel voted against approving a new drug to treat Alzheimer’s, because it relies on reducing amyloid. Caleb Alexander, an internal medicine expert at Johns Hopkins and one member of the advisory panel, describes what’s known.

Alexander: There have been more than two dozen studies that have failed that have been focused on trying to reduce amyloid levels. Amyloid is implicated somehow in the disease process but whether or not it’s a valid surrogate is a far different question. And one of the many surprises of the FDA’s recent decision is that they’ve decided to hang their hat on amyloid as a reasonable surrogate. Now Biogen has up to nine years to produce a confirmatory trial.  :31

At Johns Hopkins, I’m Elizabeth Tracey.

The amyloid hypothesis. That’s the idea that accumulation of a material called amyloid in the brain leads to Alzheimer’s disease. Acceptance of this idea has led the FDA to approve aducanumab, which reduces amyloid, but isn’t known to improve any symptoms of the disease. Caleb Alexander, an internal medicine expert at Johns Hopkins and a member of the FDA review panel, which voted against approval, explains.

Alexander: The pathogenesis of Alzheimer’s remains quite opaque. There’s an enormous amount that we don’t understand about the disease process. The amyloid cascade hypothesis for many years has sucked all the oxygen out of the room. There’s been an enormous investment in investigating products that are targeted to amyloid, at the expense of pursuing other potentially quite fruitful avenues of investigation.  :28

For now Alexander is concerned that desperate people will use aducanumab without evidence of its efficacy. At Johns Hopkins, I’m Elizabeth Tracey.

Aducanumab or Aduhelm is a newly approved medicine for treating Alzheimer’s disease, with many experts asserting that it should never have gotten FDA approval. Caleb Alexander, an internal medicine expert at Johns Hopkins and a member of the FDA review panel that recommended against approval, says the agency chose what is known as a ‘surrogate’ endpoint, kind of a midpoint, rather than clinical benefit.

Alexander: Towards the end of the review process the FDA decided rather than approving it based on its demonstrated clinical evidence they approved it based on the product’s ability to lower amyloid in the brain. But there’s a lot of uncertainty as to whether or not amyloid is a valid surrogate. There have been many studies that have been performed that show products that can successfully reduce amyloid, with no improvement in the symptoms that we all care about- language, memory, cognition.   :31

At Johns Hopkins, I’m Elizabeth Tracey.

Aduhelm is the proprietary name for aducanumab, a just approved medication for treatment of Alzheimer’s disease. Caleb Alexander, an internal medicine expert at Johns Hopkins, sat on the FDA review board for this medicine and explains why he voted no regarding its approval.

Alexander: We have a product with very unclear safety and effectiveness for a disease that’s common and often devastating, that affects millions of Americans and their loved ones, and a product that also may cost tens of thousands of dollars a year. The FDA’s decision has been a very contentious one, the product’s safety and effectiveness is so muddled most scientists didn’t expect that it would be approved.  :28

Alexander says so far, three of the experts on the review panel have resigned over this decision on the part of the FDA and there is much controversy among clinicians who treat people with Alzheimer’s disease. At Johns Hopkins, I’m Elizabeth Tracey.

Have you heard of the ‘nicotine hypothesis’? That’s the idea put forward by supposed scientific studies that somehow nicotine helped protect people from severe Covid-19 disease. Michael Blaha, a cardiologist at Johns Hopkins and tobacco cessation advocate, says there’s no evidence nicotine is beneficial.

Blaha: I think we have pretty solid evidence actually on smokers. I haven’t seen as high quality data with novel tobacco products like electronic cigarettes. But certainly there’s no data that they’re beneficial and that’s of course what some of this research of questionable quality was hinting. That some of these tobacco products might actually be protective and that doesn’t make any biologic sense and certainly there’s no strong data to support that. I think that there’s pretty good data and it makes sense that smoking leads to worse outcomes with Covid-19.  :28

Blaha says the tobacco industry is adept at spinning information to show their products in the best possible light, so buyer beware. At Johns Hopkins, I’m Elizabeth Tracey.