TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, 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 an inactivated SARS-CoV-2 vaccine in Chile, cytisine for smoking cessation, generic drug costs at Costco, and muscle relaxants for low back pain.
0:35 Inactivated COVID-19 vaccine in Chile
1:35 86% against death
2:35 Needed against variants
3:35 Ongoing in children
3:40 Using muscle relaxants in low back pain
4:40 Over 6,000 participants
5:45 Disappointing in short-term treatment
6:36 Generic drug costs at Costco versus Medicare
7:40 Medicare overspent
8:45 Intermediaries are reaping costs
10:21 Varenicline less complex regimen
11:22 Cytisine better than placebo and nicotine patches
Elizabeth Tracey: Are muscle relaxants any good in treating low back pain?
Rick Lange, MD: Is the Chinese COVID vaccine effective?
Elizabeth: Is there another agent that may help people quit smoking cigarettes?
Rick: And generic drugs, are they cheaper at Costco or via Medicare?
Elizabeth: That’s what we’re talking about this week on TT HealthWatch, 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.
Elizabeth: Rick, why don’t we turn right to the New England Journal of Medicine? This is an early… we, in fact, only were able to look at the abstract report that they’re publishing, but on a vaccine that’s been under development clearly for quite a long time and the impact of that vaccine in Chile.
Rick: This is a vaccine made by a Chinese company called Sinovac and it’s an inactivated viral vaccine. What they do is that they grow the virus up in monkey kidney cells and then they put in a compound that denatures, so it can no longer replicate. They have the virus with all the protein and they can inject that into individuals to elicit an immune response. How effective is that particular vaccine?
This is a large study. This is a study conducted in the country of Chile where they were 10.2 million people vaccinated with this particular vaccine between February 2nd through May 1st of this year. What they discovered — and, again, it was administered to people 16 years of age or older — is that the vaccine was 66% effective in preventing COVID-19 infection, but more importantly it was about 86% to 90% effective in preventing hospitalization, ICU admission, and COVID-related deaths.
Well, you say, “Why do we need a new vaccine?” If we are going to immunize the entire world, if there are 7 or 8 billion vaccines we need, we need all the companies to be able to contribute. This particular company is ready to ramp up to produce 3 billion doses this next year. The second thing is that this is less expensive than some of the vaccines, but not all of them.
For example, the Moderna vaccine costs about $33 per dose; it requires two doses. The Pfizer, about $20 per dose. This also requires two doses. It looks like it’s going to cost about $13, so less expensive than the mRNAs, but not as inexpensive as the AstraZeneca vaccine, which costs about $3 or $4.
This will have an important role in helping us meet the global viral infection. And by the way, it’s important even for the U.S. for it to be addressed globally because the more it circulates around the world the more likely we are to have variants that our current vaccines may not cover.
Elizabeth: Well, clearly, just today the CDC reported that the Delta variant is the predominant variant that is creating infections here in the United States. And as long as this infection is rampant all over the world, those variants are going to continue to develop, and so there is this urgent need for us to develop and disseminate vaccines.
The other thing that I would like to bring out is this notion that is increasingly being supported in the literature that the utility of using more than one type of vaccine in individuals also elicits a more robust response and could potentially meet this variant issue.
Rick: And maybe particularly important for using different types of vaccines as, again, this is an inactivated viral vaccine and combining that with a second dose with an mRNA vaccine as well. There are some studies already ongoing to show how effective that might be.
Elizabeth: I would also note that in Chile they are also doing a study right now using this vaccine in children, so there should be some data relative to that coming out pretty soon.
Let’s turn from here to another global issue and that’s the issue of low back pain. This is in the BMJ and this is taking a look at efficacy, acceptability, and safety of muscle relaxants for adults with nonspecific low back pain.
This is just an enormous issue, with many people saying that almost everybody in their lifetime is going to have some episode of nonspecific low back pain. It can be persistent and very disabling.
It turns out that muscle relaxants are the third most commonly prescribed medicine for this particular condition. And of course, being the nerd I am, I had to go out and look up what are the first two, which they did not cite in this study.
The first of them is acetaminophen or paracetamol, if we are going to give our nod to the folks across the pond, and the second one are NSAIDs. After that, then, it’s these muscle relaxants.
This is a meta-analysis including 31 trials encompassing some 6,505 participants that were quantitatively analyzed. They took a look at, “Well, all right, how well did it work if you were given a non-benzodiazepine antispasmodic for your low back pain?” What they found at only 2 weeks is that there was a modest reduction in pain intensity, but not a reduction in disability, and really calls into question whether these things ought to be used at all, because there really isn’t much evidence for them.
Rick: This modest benefit you say is statistically significant, but clinically not, and it was on a scale of 0 to 100. There was a decrease in pain of 8 points, which overall is not even considered clinically significant.
Elizabeth, as you mentioned, this is a pretty significant issue to address. There were 30 million prescriptions written in the United States in 2016 for these muscle relaxants. Treating low back pain is responsible for the highest total expenditure in healthcare in 2016. We spent $134 billion in the United States alone.
So on the one hand, it’s disappointing to know that these haven’t been shown to be effective. By the way, that’s in the short term. We have not had long-term trials, but this information we need to know so that we can actually stop prescribing medicine that’s not beneficial. Why spend time or money, or experience the adverse effects that occur with these things, like dizziness, headache, and nausea if they’re not going to be effective?
Elizabeth: They take a look at this thing globally and they say of the 15 physical practice guidelines that they assessed, six did recommend these muscle relaxants to manage low back pain. five did not recommend them and four did not for recommendations, so there is really no consistency worldwide in what people are doing.
Rick: With this information, I hope that the guidelines reveal that muscle relaxants aren’t the answer, but other techniques may be helpful. Things like exercise, physical therapy, and other things we have talked before about.
Elizabeth: Since we’re talking about drugs then, let’s turn to JAMA Internal Medicine looking at the price of drugs that are paid for under Medicare versus what Costco can get those things for.
Rick: Elizabeth, these are specifically common generic drugs. If I asked people when you think of generic drugs, what you think about, they would say, “Low cost” because they’re less expensive than the brand-name medications.
However, what’s happened is we have a complex system that’s highly concentrated intermediaries with proprietary contracts that actually can make artefactually raise their prices, and that is for selling the drugs to Medicare.
Here is what these authors did. They took a look at 184 of the most common generic drugs, how much is spent on these drugs via Medicare, and secondly is how much is spent via Costco. We’re talking about the spending on the drugs. We’re not talking about what they cost patients. Because in Medicare Part D, the median cost-sharing was $1 for preferred generic medications and $6 for non-preferred generic medication. So the patients may not experience the cost, but obviously the system does.
And here is what they discovered. In looking at more than 1.4 billion Medicare Part D claims, Medicare overspent by about 21% in 2018; that amounted to $2.6 billion compared to the exact same drugs that Costco spent.
What happens is that these low out-of-pocket costs with Medicare amounts to the fact that Medicare overpaid on over 43% of the prescriptions for the most common generic medications that year.
Elizabeth: For some of those, the overpayment was even more significant. I mean, it was crazy the variability among these different drugs, how much more they may have overspent.
Rick: They are, and how we just transferred that to Costco instead of Medicare, we could have saved $2.6 billion on these 184 drugs just across the system. The generic medications account for 22% of the Medicare Part D spending.
Elizabeth: Tell me, how optimistic are you that there is going to be a policy change that’s going to help us to rectify the situation?
Rick: Well again, a lot of these costs are in the intermediaries and they are passing that on to either the government or sometimes on to private insurers. That’s one of the major ways we can affect lowering the cost of prescription drugs. I think over the ensuing years there is going to be a lot of pressure to do that, Elizabeth.
Elizabeth: Is that among pharmacy benefits managers then?
Rick: It is. As you said, what are called PBMs is one of those. It’s very complex and what happens is these PBMs raise the price and then they rebate the pharmacies, so the pharmacies get some money back; that kind of keeps them in the intermediary position. Now, obviously, it doesn’t occur with Medicare, but Costco doesn’t go through a PBM.
Elizabeth: We need some more visibility to this issue. Finally, let’s turn to JAMA. This is looking at a medicine that’s called cytisine versus varenicline on smoking cessation. And I thought this was important because varenicline, of course, has been around for a bit, but it’s got a lot of significant side effects for people who would really like to quit smoking. So this particular trial takes at a look at this medicine, cytisine, and examines whether it’s as effective or more effective than varenicline, so noninferiority.
This thing took place in Australia. They recruited 1,452 Australian adult daily smokers, who were willing to make a quit attempt. They randomized them to cytisine — that was 725 of them — with kind of a complicated run-in and also maintenance regimen of 1.5 mg capsules taken six times daily initially and then gradually reduced over a 25-day course, or varenicline, which was a 0.5 milligram tablet titrated to 1 mg daily for 84 days. It sounds a little bit simpler to me to manage that particular regimen.
Their primary outcome was 6 months continuous abstinence that was confirmed using a carbon monoxide breath test at 7 months of follow-up. Just over 76% of these folks completed this trial. The cytisine group, just about 12% of them met that ability to stay smoke-free during that time while it was 13.3% for the varenicline group.
So it didn’t compare well. However, there were way more side effects in the varenicline group than there were in the cytisine group, and so I’m in favor, I think, in this study of doing it again in a larger group and seeing if it’s helpful. But it’s also a bit daunting that only 13.3% of the varenicline group were able to be successful in smoking cessation.
Rick: Yeah. Many people in the U.S. haven’t heard about cytisine. It’s a plant-based alkaloid and it really addresses the same receptor as varenicline. In studies, cytisine was better than placebo and was better than nicotine patches. It’s been approved in Central Europe and Eastern Europe, and actually some Central Asian countries, but it’s not approved in the United States.
Again, this was a noninferiority. I mean, 12% versus 13.3%. To me, that’s not a huge difference. What cytisine doesn’t have is it doesn’t have some of the common side effects — such as bad dreams and nausea — that varenicline has. Only about 13% of them remain abstinent over the 6-month period. I agree with you. That is disappointing.
Elizabeth: Very disappointing and points to me at least for the need to just say, “Look, we shouldn’t have any kind of cigarette smoking to begin with. Let’s just outlaw these things.” Then also there has got to just be a more effective way to intervene in this particular addiction.
Rick: I wish I had the answer to know what that is. Varenicline is the most effective medication we have available right now. And even then, only about 1 in 7 individuals who are motivated end up being successful.
This isn’t available in the U.S., but for those individuals that actually try varenicline and have adverse side effects, it may be that cytisine could be an alternative medication. I would hope that the FDA would take a look at it and see whether it should be approved in the U.S.
Elizabeth: Excellent. On that note then, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.
Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.