PodMed Double T 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. A transcript of the podcast is below the summary.
This week's topics include crowdfunding for stem cell therapies, USPSTF recommendations for prostate cancer screening, MRI guided biopsy of the prostate, and testing blood for Zika virus.
Program notes:
0:31 Zika virus screening of blood donations
1:31 Cost of about $1 million to prevent one case
2:31 Traveled into the US and gave blood
3:15 PSA screening recommendations
4:15 Screening 1,000 men
5:14 Appropriate strategy to follow
5:26 Utility of MRI for targeted biopsy of prostate
6:27 Have a sonogram
7:15 Crowdfunding for stem cell therapy
8:15 How many soliciting?
9:15 FDA now looking
10:20 End
Transcript:
Elizabeth Tracey: Should we screen blood donations for Zika virus?
Rick Lange, MD: Crowdfunding and stem cell therapy.
Elizabeth: Should MRI be used when the prostate needs a biopsy?
Rick: Prostate cancer screening.
Elizabeth: That's what we're talking about this week on PodMed Double T, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso, posted on May 11th, 2018. I'm Elizabeth Tracey, a medical journalist at Johns Hopkins.
Rick: I'm Rick Lange, President of Texas Tech University Health Sciences Center in El Paso and Dean of the Paul L. Foster School of Medicine.
Elizabeth: Rick, let's turn right to the New England Journal of Medicine, the study that I served up as "Should we be screening blood donations for Zika virus?" As we know, there is a worldwide furor, really, when Zika emerged as an infection, lots of, really, pretty tragic consequences as a result of that, especially during pregnancy. They instituted a blood-screening program for testing for the virus.
In this study, they looked at over 4 million blood donations. They pooled a bunch of those things together trying to find out, "Well, all right, where are the reactive ones in here? Are we actually finding any of these?" They found 160 that were initially reactive and nine that were confirmed positive. In total -- and this is the thing that I find absolutely startling - they found that in order to prevent one potential case of Zika virus transmission via blood transfusion, it would be a cost of about $1 million. That's a lot of money in order to potentially prevent one single case of infection.
Rick: Elizabeth, if I read that study right, if they screened over 4 million individuals and found nine with infection, that means it's about 1 per 500,000 or 1 per half a million in the United States. Now in the areas that had endemic infections -- that is in French Polynesia and also in certain parts of South America -- during active infection, routine blood donations were infected about 1% to 2% of the time. In the United States, it's much less, and as you alluded to, very expensive. In fact, to screen for an entire year would cost the American Red Cross an extra $137 million. It tells me that we all want safe blood products. There's no question about it, but can we be smarter about this?
Well, if you dig down a little bit more into the study, the individuals that were infected here were primarily those that received the infection outside the U.S. and traveled into the U.S. and gave blood. If you wait for 180 days after you've been to those areas, even if you were infected, it clears. One of the things we could do is say, "If you've traveled to one of these endemic areas, you can't donate." The second is instead of testing the samples individually you can pool some of the samples. There are ways we can use this data to become more effective in screening for Zika virus.
Elizabeth: I think this is especially important because, of course, we're always seeing new, emerging infectious diseases that can be transmitted via the blood.
Rick: The other issue is if you look at last year, there were 200 infections in the United States. This year only two, so you could also change your screening or when you do it, or how you do it, based upon whether you're in an epidemic area or not.
Elizabeth: Speaking of screening, then, let's turn to the Journal of the American Medical Association. Should men undergo PSA screening for prostate cancer?
Rick: What they did was they looked at over 63 studies and 104 publications that included almost 2 million men. Based upon that, the recommendation was for men over the age of 70, there's no evidence that screening for prostate cancer actually lowers prostate cancer mortality. What it does is it detects a lot of cancer that otherwise wouldn't have been clinically relevant and men get treated for it, and it subjects them to the harm. For example, if a man has a radical prostatectomy, his risk of having urinary incontinence is 20% and of having erectile dysfunction is 67% to 70%.
Between the ages of 55 to 69, the USPSTF recommends individual testing should be done only after there's been a discussion of the potential benefits and harms of screening. If you screen a thousand men over a 13-year period, you'll prevent 1.3 prostate-cancer-related deaths. However, during that time, you will detect about 40 cases of prostate cancer that otherwise would have been clinically irrelevant and subject the men to the harms that I mentioned. So these are the kind of discussions that one has to have.
Now there are two groups in which prostate cancer screening should be done. Men that have first-degree relatives that have a history of prostate cancer or other adenocarcinomas in the GI tract or in the lung or [in] women, in the ovaries. Then it appears that African American men are about twice as likely to die of prostate cancer than non-African American men. Those groups, perhaps, should have prostate cancer screening in the ages of 55 to 69, but not over the age of 70.
Elizabeth: I have to conclude that all of this points to the clear need for something that is a good deal more predictive of prostate cancer rather than PSA.
Rick: I totally agree. Probably what should be done is routine monitoring, not just a single PSA that's elevated -- because there are a lot of things besides prostate cancer that do that -- but an appropriate strategy where you're following it over a long period of time to see what that PSA is doing, and then having better tests to determine whether prostate cancer is there or not. That leads to our next study, one that you're going to talk about in the New England Journal of Medicine.
Elizabeth: It sure does. This is a look at the utility of MRI for targeted biopsy of the prostate. In general, men undergo ultrasonography and that frequently is used to guide the prostate biopsy when a prostate biopsy is indicated, and in this study, they took a look at 500 men who underwent randomization to either the MRI biopsy group or not. The MRI was able to actually take some of those men out of the group because it suggested that, "Guess what? We don't really think you have prostate cancer, so you don't even need to have a biopsy."
The men who did have the biopsy via MRI, it was a good deal more predictive and there's a lot of other advantages to it. In total, then, this study suggests to me that MRI-guided biopsy is the way to go and ought to be the standard of care for men who are going to undergo a biopsy of their prostate gland when prostate cancer is highly suspected.
Rick: Currently, Elizabeth, if your PSA is elevated, if it's over 4, as you suggest, men oftentimes have a sonogram and that directs the biopsy. Now the biopsy, there are 6 to 12 pieces of biopsy tissue taken just indiscriminately around the prostate. What that means is you're going to detect clinically low-grade cancer in some men who otherwise it really wouldn't be relevant. What MRI does, as you mentioned, is it tells you if there is an abnormality, and in those in which there is an abnormality, they take only three pieces of tissue. They're more likely to detect a higher-grade cancer and less likely to have false positives. This suggests it should be the standard of care in most men with an elevated PSA.
Elizabeth: Let's talk about availability of this technique nationwide.
Rick: In large urban settings, it's certainly available. It's standard MRI equipment. It just requires a special coil to look at the prostate because it's a small gland, but it's routinely available.
Elizabeth: Okay, let's turn to our final one. This is a research letter in the Journal of the American Medical Association taking a look at something that's very much in the news, "Hey, what about these stem cell clinics that have reported benefits?" and an interesting aspect to that.
Rick: Elizabeth, you found this particular study and I appreciate you bringing it to my attention. The long and the short is that these crowdfunding campaigns for stem cell therapy are helping to spread inaccurate information. Stem cell therapy, there are over 351 different U.S.-based companies offering stem cell therapy, everything from curing someone's poor vision to treating their arthritis. Unfortunately, they're unproven therapies, but there's direct-to-consumer marketing of these therapies. Because they're unproven, the insurance companies don't pay for them. That means the individual pays for them or has to raise money, and one of the ways to do that is with crowdfunding.
What these investigators did was they looked over about a 5-month period at the two most popular crowdfunding platforms -- that is, GoFundMe or YouCaring -- and they asked a simple question. How many individuals were soliciting funds for stem cell therapy? They found 408 different campaigns requesting over $7.5 million. People contributed $1.5 million from about 13,000 different donors. Seventy-five percent of the time, the individuals presented the stem cell therapy as it was definitely proven and going to be helpful or likely to be helpful, and in very few of the times did they ever say it wasn't going to be beneficial. In 36 of them, they represented there was going to be no risk at all involved with it and we know that's not the case. This is an interesting study in that it shows that the crowdfunding, which was accessed by over 111,000 people that looked at the advertisements, conflated the results, and we know that it's unproven therapy.
Elizabeth: This is something that just sends me over the deep end because it's just so, frankly, manipulative. It really trades on people's desperation with regard to their particular health conditions, and I think speaks loudly for the need for federal regulation.
Rick: Absolutely. The FDA has not entered into this field previously, but it's now in their crosshairs because it's caused specific harm. There are instances where stem cell therapy has been injected into people's eyes and they've lost their vision completely. Again, what I want our listeners to know is that these U.S.-based stem cell therapy centers, this direct-to-consumer marketing is for a therapy that is unproven at this time.
Elizabeth: Per that, in the Journal of Physiology this week, a study that we are not actually talking about in greater detail, but really points to the kinds of studies that need to be done in order to demonstrate the efficacy of this. This was a study taking a look at stem cell utility after heart attack and whether it was able to repair the heart. This is the kind of thing that has to be done, closely scrutinized and peer reviewed.
Rick: I totally agree.
Elizabeth: Okay. On that note, I'm going to talk about the USPSTF's recommendations regarding prostate cancer screening on the blog this week. That's a look at this week's medical headlines from Texas Tech. I'm Elizabeth Tracey.
Rick: I'm Rick Lange. Y'all listen up and make healthy choices.