TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine in Baltimore, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.
This week's topics include sodium levels and health outcomes, profits from inhalers, HIV meds and ethnicity, and conspiracy theorists and cancer beliefs.
Program notes:
0:52 Race and ethnicity and initial antiretroviral therapy
1:50 Who ended up with INSTIs
2:52 Uninsured had lower rates
3:52 Effective therapy for treatment and prevention
4:30 Cancer beliefs among anti vaxxers and others
5:33 Only got the right answer about 60%
6:33 Covid vaccination rates relationship
7:04 Middle-age high normal serum sodium and health issues
8:02 Serum sodium and proxy for hydration
9:08 Will hydration help?
10:04 No dose response evident
11:03 At best is ask about water
11:15 Inhalers and profits for manufacturers
12:15 Most profits with secondary patents
13:14 End
Transcript:
Elizabeth: Do race and ethnicity have anything to do with what type of medicine is given to people with HIV?
Rick: Cancer beliefs among anti-vaxxers, flat-Earthers, and reptilian conspiracists.
Elizabeth: It's a little scary, Rick. To go on then, do sodium levels in the blood have anything to do with chronic disease and mortality in older folks?
Rick: And revenue on inhaler therapies before and after patent expiration.
Elizabeth: That's what we're talking about this week on TTHealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I'm Elizabeth Tracey, a Baltimore-based medical journalist.
Rick: And I'm Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I'm also Dean of the Paul L. Foster School of Medicine. I want to wish all of our listeners a Happy New Year.
Elizabeth: Let's turn to something that's good news and that's in JAMA. Does race or ethnicity have anything to do with initial prescription of antiretroviral therapy among people with HIV in the United States?
This is actually quite a large study. It's a retrospective observational study of just shy of 43,000 adults entering HIV care from October 12th, 2007, which is when a type of antiretroviral therapy that's called an INSTI -- and that's for integrase strand transfer inhibitor -- was first approved by the FDA, to April 30th, 2019 where this is considered to be standard therapy and is guideline recommended.
What these investigators were examining was whether, at the initiation of this particular type of medicine, there was variation in race, ethnicity, and also sex in who ended up getting these cutting-edge drugs, versus now that these things are guideline-recommended. It's somewhat unsurprising to note that these INSTIs were more common among White patients and also, interestingly, among males at the beginning. But now that they have become part of the guideline-recommended initial therapy for most people with HIV, those things have largely disappeared. So in my mind, this is a "good news" study.
Rick: I would agree with you. One of the things that was surprising to me is that it not only looked at this particular therapy, but also looked at the initiation of therapy. Within 1 month of making the diagnosis, how likely was it that antiretroviral therapy was prescribed? There was no difference among the races. I found that very encouraging as well. Also, the fact that a large number of patients are getting guideline-directed medical therapy. That's not true in other diseases -- for example, in hepatitis or even heart disease.
It was interesting, however, there was a difference with regard to their insurance. The uninsured tended to have lower rates than the privately insured. When you looked at things from 2017 to 2019, there were a larger group of Hispanic and Blacks who received guideline-directed medical therapy rather than Whites. Again, I think this is all a good news story as you've highlighted.
Elizabeth: I think both of us would agree with the notion that people with HIV have always comprised kind of a special group. The reason I'm saying that is because very early on, when HIV came over the transom, and people became aware of the cause of it there was a tremendous amount of advocacy for patients and a lot of cohesion in this group, saying, "Look, we want to try new therapies. We want to be involved in what's happening with us." I'm wondering if that's got something to do with why this appears to be so good.
Rick: I think it's a combination of two things. One is national treatment guidelines and then secondly, as you've mentioned, the advocacy as well. I can remember back before we had therapy and it was of the essence -- the initiation of both effective therapy for treating it and preventing the spread of it as well ended up being really a national focus.
Elizabeth: I would ask you to reflect on this guideline-recommended therapy and how it might be implemented in other chronic diseases so that we would see the same kinds of benefits.
Rick: There are several parts of this. Obviously, one is establishing what are national guidelines and then communicating them effectively both to patients and to physicians. I think it's easier to do with a disease that you know is deadly. It's harder to do with a disease that it's a little bit more indolent. I think sometimes we don't have the advocacy and we don't see the urgency of making sure the national guidelines get instituted as quickly as possible.
Elizabeth: That's a great point. How about if we turn to the BMJ? This is one that's kind of amusing, a little tongue-in-cheek.
Rick: This was a really unusual study, attitudes or beliefs of cancer prevention among anti-vaxxers, flat-Earthers and reptilian conspiracists. The thought being is that these are individuals that are oftentimes exposed to misinformation. Oftentimes because of the way social media works, it aggregates these individuals together and so they can reinforce each other's beliefs.
They took almost 1,500 responders to a survey and they asked them about their beliefs. Were they anti-vaxxers? Were they flat-Earthers? Or do they believe in reptilian conspiracy -- that is, that reptiles morphed to humans and back and forth?
Then they asked them about cancer beliefs. We know that there are some things that are associated with cancer. Cigarette smoking -- whether it be active or passive -- consuming alcohol, low levels of physical activity, getting sunburned as a child, family history of cancer, HPV infection, being overweight, all known to cause cancer. They asked individuals whether they believe this and they only got the answer right about 60% of the time.
Then they asked them about perceptions that have never been associated with the development of cancer. Things like drinking from plastic bottles, or eating foods containing artificial sweeteners, use of microwave ovens, mobile phones, cleaning products, living near power lines. Forty percent of the time these individuals identified that they were associated with cancer.
There was a higher amount of beliefs that were incorrect in those that were anti-vaxxers, as opposed to those that were vaxxers, and to those that believed in reptilian conspiracies versus those that didn't, and those that believed in flat earth versus those that didn't.
Elizabeth: It sounds like we need to address this whole thing as a package because it's not a single thing that people are actually believing in.
Rick: No. What the author suggests is that there is a connection between digital misinformation and potential erroneous health decisions. Their concerns were when you have misinformation in one area it folds over into other areas and the potential health consequences are pretty severe.
Elizabeth: Well, this study reminds me a whole lot of the one that we reported looking at COVID vaccination rates among largely Republican versus largely Democratic areas of the country and finding out, oops, there is a political association. This "birds of a feather flock together" notion seems to be true here also.
Rick: We need to do a better job of cultivating true medical education, building trust, using effective health communication, and some social marketing communications as well to tackle a complex problem like this.
Elizabeth: Let's turn now to The Lancet, a study that associates middle-aged high-normal serum sodium as a risk factor for accelerated biological aging, chronic disease, and premature mortality. It is done by the Intramural Research Group as part of the NIH National Heart, Lung, and Blood Institute (NHLBI).
What they noticed some time ago was that when you restrict water to mice they therefore have a higher sodium level in their serum. They are able to show that it shortens their lifespan and promotes degenerative changes. They decided to take a look at this in people by using data from the Atherosclerosis Risk in Communities (ARIC) study. That enrolled people 45 to 66 years, just shy of 16,000 of them, and followed them for 25 years.
They took a look at this serum sodium as a proxy for hydration habits. They calculated a biological age from age-dependent biomarkers and then assessed risks of chronic diseases and premature mortality.
Their analysis showed that middle-aged serum sodium of greater than 142 mmol per liter is associated with a 39% increased risk to develop chronic disease and greater than 144 mmol per liter with a 21% elevated risk of premature mortality.
These folks who had this higher than 142 mmol per liter had up to 50% higher odds to be older than their chronological age when they did this calculation for biological age. Their conclusion is that this could be a marker for folks who are at increased risk for chronic disease and premature mortality, and what we need to find out is whether hydration can really impact on this particular outcome.
Rick: Elizabeth, as you mentioned, it's an association study, and we have talked about the fact that they don't actually prove causation. They are tying this to under-hydration, people that don't drink as much fluid as is recommended. The body's mechanism is to try to conserve fluid and how it does it is conserve sodium to try to draw water in as well and as a result the serum sodium goes up.
It's thought that these hormonal mechanisms that do that include both pro-inflammatory and pro-coagulation changes. It's hard to believe that people are really under-hydrated for a period of 25 years. I don't think there is any harm though in saying that, "Gosh, the Institute of Medicine recommends that men drink about 15 or 16 cups of water or fluid a day and women drink 10 or 11 cups of fluid per day." Regardless of whether you subscribe about whether this study is true or not, I think there is no harm in following the recommendations for normal fluid intake for men and women.
Elizabeth: What is interesting to me is that it does not appear to be what I'm going to call a dose response. The sweet spot of dysfunction is that 137 to 142 mmol, if you have higher levels of sodium in your blood that are higher than 142 or 144, that doesn't shift the curve further over with regard to mortality.
Rick: Either end -- if your sodium is excessively low, that's usually is associated with some bad chronic medical condition like liver disease, heart disease or kidney disease, and your mortality is higher. Also, if your serum sodium is over 144.5, your mortality is worse than if it's between that sweet range of 137 to 143 or so. That's where the sweet range is. Excessively high or excessively low is associated with an increased mortality in this particular study.
Elizabeth: What would you think about a measurement of serum sodium as kind of a health metric for people?
Rick: That's what they are advocating for. At best, what one can do is if someone sees a very high serum sodium is ask individuals, "Are you drinking enough water?" If not, to get that corrected.
Elizabeth: Let's turn to our final one then, and that's this rather daunting look in JAMA at when inhalers go off patent, what happens to manufacturers' profits.
Rick: Inhalers are the cornerstone therapy for people who have asthma and chronic obstructive pulmonary disease. Unfortunately, the brand name manufacturers have continued to sell most inhalers at high prices. They do that because it's unlikely that they have direct generic competition.
Why is that? When the inhalers are first approved, they have patent rights and those patent rights last for a certain period of time. What the drug companies do is when their primary patent goes off, they give a secondary patent. They do that by patenting peripheral aspects of the products.
What this study did was it looked at the revenue that was generated over all of the patented inhalers. They have 18 primary patents and 239 secondary patents. During the time the inhalers were used, the manufacturers earned $178 billion, 38% when primary patents were active -- that's $67 billion -- and $110 billion, or 62%, with the secondary patents, and only $613 million, less than 1%, after all patents had expired.
Elizabeth: I am just so disturbed by this because nobody has got extra money to be spending on these things. They are absolutely critical for many, many people with asthma. The idea that we're just spending so much more money as a result of a manipulation is really troubling to me.
Rick: It is. I would agree. It's not that people can choose a different therapy. There isn't really no alternative therapy for these inhalers. We obviously need substantial reform if we are going to lower the price of medications, both for the insurers but more importantly the patients.
Elizabeth: On that note, Happy New Year again. We look forward to talking with you next week. I'm Elizabeth Tracey.
Rick: And I'm Rick Lange. Y'all listen up and make healthy choices.