Health Newsfeed – Johns Hopkins Medicine Podcasts

“Mind the Gap” is the name of a report undertaken in Maryland to assess what may be missing in the training of nurses to help them be resilient during times such as the Covid-19 pandemic. Cynda Rushton, a professor in the Johns Hopkins School of Nursing and one of the report’s authors, describes the project.

Rushton: We asked them what was it that sustained them during the pandemic, then we asked them what they saw as the gap. What would they want to have had in their training that would help them to meet those challenges. They had some really important solutions. This report is not our report from our resilient nurses initiative. It’s actually meant to give voice  to the real lived experience of students and faculty and nurses who are in practice.  :31

Nurses say they could benefit from formal mentors as well as more exposure to actual nursing practice while training. 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. 

What helps people be less susceptible to Covid-19 infection and severe illness? Several recently published scientific papers appear to support the so-called ‘nicotine hypothesis,’ suggesting that nicotine may be beneficial. Micheal Blaha, a cardiologist at Johns Hopkins and tobacco cessation advocate, says this is part of a trend.

Blaha: There’s no doubt that tobacco companies are still trying to infiltrate research and scientific thinking and trying to pull opinions in their direction. This is happening with traditional combustible cigarettes but it’s also happening quite a bit with the makers of electronic cigarettes, who are trying to recruit scientists, recruit post-doctoral fellows to do research for them, and of course serve the purpose of their tobacco products.  :23

Blaha says before accepting any assertions based on so called scientific studies it is always good to ask yourself if this study really makes sense. Abundant information has established the harms of nicotine delivery methods such as electronic and combustible cigarettes. At Johns Hopkins, I’m Elizabeth Tracey.

If you’ve been diagnosed with cancer of a solid organ, things like prostate or breast, genetic analysis of your tumor may prove to provide important information on the best way to manage your disease, a recent study shows. William Nelson, director of the Kimmel Cancer Center at Johns Hopkins, explains.

Nelson: They did a study of 1138 patients with solid organ cancer. They could get good sequences from 1015 of them. They looked at either the whole genome or the key suspicious genes, there’s about 1700 of them. What was interesting is they found so called ‘actionable’ gene alterations, the kinds of things you were looking for and so would make a difference in treatment, in 817, which is a what 80 plus percent of the folks.  :27

Nelson says there’s also a place for looking at recurrent cancers since genes change, or mutate, and may also have implications for cancer treatment. At Johns Hopkins, I’m Elizabeth Tracey.

Magnetic resonance imaging or MRI is sometimes used to examine the prostate gland when cancer is suspected and a biopsy is being considered. Now a new study demonstrates its benefits. William Nelson, director of the Kimmel Cancer Center at Johns Hopkins, explains.

Nelson: The advantage to the MRI was that there were a significant number of men, a third of them, that you didn’t need to biopsy at all, so that’s an advantage. The difficulties now are the availability of the instrumentation and eyes to examine it. The worry you sometimes get is that are the people who do only the examining of prostates through magnetic resonance imaging all day long every day, are they better at it than people who are more deployed across the country who have to look at many different things? And I think the answer to that is probably yes.  :30

Nelson says for now, men in this situation can ask about having an MRI as well as the volume a center does in this specific application. At Johns Hopkins, I’m Elizabeth Tracey.