Among the thousands of research abstracts released to the public on Wednesday by the American Society of Clinical Oncology (ASCO), just six were selected to be highlighted in a news conference with journalists.
Of those six, one was an analysis showing only about 2% of heavy smokers are screened for lung cancer despite a recommendation from the United States Preventative Services Task Force (USPSTF).
At least three mainstream news organizations picked it up, including two wire services whose stories were carried by the New York Times, WebMD, and other outlets:
Such is the power of ASCO — the world’s largest organization of cancer doctors — to influence coverage by promoting particular abstracts and framing their importance in news releases, as we pointed out earlier this week.
ASCO releases these abstracts en masse every year, two weeks before its giant scientific conference and well before the full study results will be published and peer reviewed.
But can advocacy groups like ASCO be counted on to provide all the information that the public needs to know about a complicated topic such as lung-cancer screening? Or will their inherent biases shape the message?
Coverage misses harms
ASCO’s news release about the screening study laments the “unfortunate” low rate of lung cancer screening and calls for an awareness campaign to encourage more smokers to get screened.
Missing is discussion of legitimate reasons smokers might have to decline screening including substantial harms and a modest benefit.
Following ASCO’s lead, Bloomberg and HealthDay both echoed dramatic language about the finding without providing any perspective from independent experts who might voice reservations about screening.
For example, Bloomberg quoted the lead researcher calling the screening rate “truly abysmal” and grounds for a “call to action.”
Both of those news organizations also reported that lung-cancer screening could save thousands of lives a year without the caveat that the data came from a modeling estimate that assumed 100% adherence to screening and extrapolated from short-term trial results, among other limitations.
No numbers people can use
None of the coverage provided numbers that an individual could use to actually make a decision about cancer screening. This Agency for Healthcare Research and Quality decision aid notes that there are three lung cancer deaths prevented for every thousand people screened annually and followed for seven years, at a cost of 356 false positives leading to 18 unnecessary and invasive lung biopsies. Such biopsies carry risks of infection and other harms.
With the substantial drawbacks of screening in mind, the USPSTF stated that a decision to begin screening “should be the result of a thorough discussion of the possible benefits, limitations, and known and uncertain harms.”
It cited “substantial harms, most notably the risk for false-positive results and incidental findings that lead to a cascade of testing and treatment that may result in more harms, including the anxiety of living with a lesion that may be cancer.”
A more balanced view
The AP gave a more balanced view, mentioning “worries about false alarms and follow-up tests” high in the story and interviewing both patients who support screening and experts who expressed doubts:
But screening has a dark side: research shows that over three years of annual scans, 40 percent of people will have an abnormal finding that often leads to follow-up tests such as a lung biopsy, and complications of those can be fatal, said Dr. Otis Brawley, the American Cancer Society’s chief medical officer.
“I’m committed to telling people the truth and letting people decide for themselves,” Brawley said, but added that if he were a candidate for screening, “I don’t think I would do it.”
Dr. Kenneth Lin, a Georgetown family physician and former staff doctor for the government task force that advised screening, also isn’t a fan.
“There’s been a lot of skepticism” about its value, and the American Academy of Family Physicians has not endorsed it, Lin said. Many doctors feel the effort is better spent trying to get smokers to quit, he said.
The AP was also the only news outlet to report financial conflicts. The analysis was funded by a foundation of Bristol-Myers Squibb, which makes the $150,000-a-year lung cancer drug Opdivo. Bristol is also sponsoring a lung cancer education track of the ASCO meeting.
Limitations weren’t mentioned
There were important limitations with this analysis that went unmentioned in the news release and in the coverage, some experts said.
For example, the analysis didn’t count patients who might have been screened outside of the American College of Radiology registry, noted Richard Hoffman, MD, director of the Division of General Internal Medicine for the University of Iowa Carver College of Medicine.
Some people who met criteria for age and smoking status might not have been screened because they had already had a CT scan for another reason or were too sick to undergo surgical treatment, said Tanner Caverly, MD, a general internist at the Ann Arbor VA Medical Center.
“More complicated” reasons for small uptake
The news release doesn’t adequately discuss possible reasons for the low screening rates. While it cited “low provider referral or perhaps patient psychological barriers,” Hoffman, a HealthNewsReview.org contributor, said “the actual list is far longer and more complicated.”
For example, there are concerns about the quality of evidence around screening, safety, availability of treatment, costs of follow-up procedures, and evidence that resources might be better directed at smoking cessation efforts.
Is there a disparity?
All of the news stories reported ASCO’s comparison of lung cancer screening with other cancers such as breast and colon, for which screening rates are higher. The lead researcher called it a “disparity.”
But is that a fair comparison?
“(Colorectal) and breast cancer (screening) rates are higher, but we also have far longer follow-up data (6.8 years for lung, up to 20 for other cancers) supporting their use—and multiple positive studies,” Hoffman said.
Linda Kinsinger, MD, MPH, retired chief consultant for preventive medicine in the Veterans Health Administration, also has doubts.
“Although there’s some uncertainty about the mortality reduction from either breast or colon cancer screening, the mortality reduction from lung cancer screening is almost certainly less. So trying to equate them implies that the benefits are about equal, which is likely not true. It also implies that the harms are also similar, again probably not true,” she said.
“Strong case” for a screening campaign?
ASCO’s news release framed this analysis as making a “strong case” for a campaign to encourage lung cancer screening. That called to mind the American Lung Association’s problematic “Saved by the Scan” campaign, which we wrote about last year.
The ALA campaign was based on net benefits shown in the National Lung Cancer Screening Trial, but there are doubts those positive results extend to wider screening efforts. For example, more than half of patients screened in a Veterans Affairs demonstration project had false alarms that resulted in follow-up testing and other potential harms.
Unmentioned were numerous potential drawbacks to screening campaigns, including attracting people who won’t benefit, burdening some patients with high out-of-pocket costs, and thrusting procedures onto community physicians whose skills might fall short.
Caverly said while screening “can be an important intervention for heavy smokers,” it should be an individualized decision.
And Kinsinger said it’s “extremely difficult to communicate” all pros and cons of screening in a public service campaign.
“Even if the message is ‘Talk to your doctor about screening,” that assumes that providers are knowledgeable enough to be able to explain it all and have a program available for managing the screening process,” she said.
A “most egregious” message
The “most egregious” message in the abstract, in Hoffman’s view, was its conclusion that that lung cancer screening should be mandated as a national quality measure, which would incorporate it into quality-reporting, accountability, and payment programs for doctors.
“Given that this is a preference-sensitive decision, the only acceptable measure would be whether eligible patients were provided information about screening,” Hoffman said. “One lesson that we’ve learned over the years is that screening programs have small absolute benefits and have many downside harms.”
An image from a U.S. News story on “12 Things to Know Before Your First Mammogram.”
While more doctors embrace the idea that women should make their own informed decisions about when and how often to get screened for breast cancer, news reporting doesn’t always reflect that nuanced approach.
Instead, it conveyed a misleading and one-sided message that annual screening starting at age 40 “saves the most lives.”
The lead said women turning 40 have a choice “to start regular screening for breast cancer or to push off commencing this annual or bi-annual wellness ritual.”
But the story that followed suggested there’s really only one sane option, and that’s to screen, screen, screen:
Although the recommendation of when to start varies based on personal risk and which agency’s guidelines you’re using, the fact remains that mammographic screenings have been shown to detect breast cancer at earlier stages when it’s more treatable.
Two ardent screening proponents backed up that assertion:
Breast surgeon Kristi Funk, MD is quoted saying she advises her patients who are at normal risk of developing breast cancer to “begin at age 40. Do it every single year, and don’t stop or don’t skip a year until you plan to die in the next five years.”
Radiologist Elizabeth Arleo, MD, offered: “Most women – those at average risk – should start annual screening mammography at age 40, as per the recommendations of the American College of Radiology and the Society of Breast Imaging.”
‘Just do it’ tone
HealthNewsReview.org contributor and breast surgeon Deanna Attai, MD, took issue with the “just do it” mantra.
“I think that women deserve a balanced discussion, and just a few comments about the possible downsides to screening mammography could go a long way to even out the information presented and could help women make informed choices about screening,” she said via email.
“Mammography isn’t perfect and in fact readers should be aware of the risks,” said another HealthNewsReview.org contributor, Mandy Stahre, PhD, who noted that rates of false-positives and overdiagnosis were among the many data points that went unmentioned.
This story stands in contrast to recent coverage of United States Preventive Services Task Force (USPSTF) guidelines calling for personalized decision-making around prostate cancer screening. Those stories generally did a good job of recognizing the complexity of screening decisions.
Saying all women should get screened starting at age 40, as the U.S. News article does, “takes away the realization that this is a human being who ought to be able to make choices about what is right for them,” said Otis Brawley, MD, chief medical officer of the American Cancer Society (ACS).
He’s concerned giving patients incomplete data perpetuates distrust, whether the message is from doctors or from the news media. “As people start learning there are two sides of the story, they’re going to wonder why they didn’t get both sides,” he said.
A shift in approach
Recent years have brought increasing recognition of the pitfalls of mammography. In 2009 the USPSTF — an independent panel of experts — recommended against routine screens for women aged 40 to 49 years, as had been common practice, stating that the decision to start regular mammography before age 50 should be an individual one that takes into account how each patient weighs specific benefits and harms.
The USPSTF recommended that women start mammogram screening at age 50 and get a mammogram every two years thereafter up to age 74, and reiterated that recommendation in 2016.
The ACS has also moved toward a more individualized approach, while recommending that women ages 45 to 54 be screened annually and those older than 55 be screened every two years.
A woman’s right to decide
“We try not to make a woman feel that we’re ordering her to do it,” Brawley said. “We are encouraging her to do it, but we’re trying to respect a woman’s right to say, ‘this is my body and I don’t want that.'”
Nancy Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, said the article could generate confusion at a time when doctors should be shifting screening decisions to patients and equipping them with data.
“For too long we’ve been teaching women that all they need to do is get a mammogram every year and they won’t die of breast cancer. But the real story is much more complicated than that,” Keating said. “It’s going to be a lot of work to take back years and years of messaging that everyone needs a mammogram every year.”
In the article, radiologist Arleo, an associate professor of radiology at New York-Presbyterian/Weill Cornell Medical Center, quoted her own modeling study showing “the greatest mortality reduction is achieved with annual screening starting at age 40 – a nearly 40 percent decrease in breast-cancer-specific mortality compared with only a 23 percent decrease in breast-cancer-specific mortality associated with the U.S. Preventive Services Task Force recommendation of biennially screening women 50 to 74.”
But there are problems with that data.
For one thing, the 40% figure appears to be greater than real-world experience, Brawley said.
Further, those numbers leave out the drawbacks. In fact, women in their 40s might want to proceed cautiously before deciding to be screened, since they are far more likely to be harmed than helped due to false positives, unnecessary biopsies and overdiagnosis.
Keating offered this reality check: “Most women who get breast cancer won’t die of breast cancer whether or not they had a mammogram. A small number of women who get aggressive forms of breast cancer will die of breast cancer even if they had been getting regular mammograms. And then there is a very small number of women for whom the mammogram may make a difference.”
Looking at the numbers
Overdiagnosis is particularly worrisome. It refers to cancers found through screening that would never have become life threatening but get treated anyway because doctors can’t tell whether a cancer is life-threatening or not. Women who are overdiagnosed have treatment such as surgery and chemotherapy that they would never had needed if they hadn’t been screened, potentially leading to harmful side effects and anxiety.
Keating and Lydia Pace, MD, MPH, director of women’s health policy and advocacy at Brigham and Women’s Hospital, co-wrote a recent article in the Journal of the American Medical Association calling for individualized decision-making.
According to data presented in their article, for every 10,000 women in their 40s screened annually for 10 years, 32 women will die despite being screened and just three deaths will be averted. More than half of those women — 6,130 — will get a false positive result and 700 will get an unnecessary biopsy. Twenty-eight will be overdiagnosed and thus treated for a cancer that wasn’t going to kill them.
Those statistics vary for women in their 50s and 60s, when rates of diagnosis and death increase.
The radiation paradox
The U.S. News piece mentioned women may be told to return to have more imaging done, but didn’t explore the full extent of the potential harms.
It also portrays 3-dimensional mammography as superior to older 2-dimensional technology without explaining that the two haven’t been compared in clinical trials.
What is known, Brawley said, is that 3D mammography delivers more radiation, and that gets at another big drawback that isn’t mentioned: the accumulated harm of radiation exposure from repeated breast x-rays.
Radiation increases the risk for cancer, particularly for women who have BRCA gene mutations that impair the body’s ability to fix breaks in DNA. Brawley called that “a real paradox” of screening.
“This is something that drives the radiologists who are very pro-mammography absolutely bonkers,” he said.
A narrow range of sources
Keating also noted that radiologists — two of whom are quoted in the U.S. News article — “have been slow to acknowledge the limitations of mammography.”
The story’s other source, Funk, runs a practice in Los Angeles that provides screening and treatment of breast cancer.
Breast surgeon Kristi Funk made unsupported claims about her “cancer-kicking” smoothie on The Doctors TV show.
While she’s won fame for treating Angelina Jolie and Sheryl Crow, Funk doesn’t exactly come across as a stickler for evidence-based practices. She’s been promoting a newly published book with a smoothie recipe that she says contains “cancer-kicking” compounds. She also markets a supplement she says can counteract the bad effects of drinking alcohol.
“I think it would be nice to see evidence of a benefit before I spend my money on their products,” Keating said.
Brawley said of the supposed cancer-fighting smoothie: “I think we would have tremendous difficulty finding clinical trial data to support that claim.”
(In a weird coincidence, the ACS recently introduced its own smoothie, but the organization doesn’t claim it can prevent cancer. Rather, it’s a high-calorie version designed for cancer patients who have difficulty keeping their calorie intake up.)
Undercovered breast cancer stories
All in all, Brawley said he’d like to see more journalists focus on the need for better screening tests and on the opportunity to save more lives by making sure women get proper treatment.
“Every time I hear people argue about when we should start screening or how often we should start screening, I ask how come they don’t talk about the 30 to 40% of women who are currently diagnosed who get less than optimal treatment?” he said.
Later today the American Society of Clinical Oncology (ASCO) will hold a virtual “presscast” giving journalists a sneak preview into a handful of “new, high-impact studies” that will be presented at their annual meeting two weeks from now.
Just six out of 2,500 abstracts were selected for the preview.
“Many medical meetings do this and I’ll have to say I think ASCO does a fairly good job of this Herculean task,” said Len Lichtenfeld, MD, a Deputy Chief Medical Officer at the American Cancer Society.
Len Lichtenfeld, MD
“But there are problems with less savvy journalists writing articles based on abstracts that haven’t even been presented yet.
“This is incomplete information that hasn’t been vetted or peer-reviewed. Most journalists — and the public — don’t know the limitations of these highly promoted data. They don’t know the context of how these results fit into the larger cancer picture. Not only are the abstract results usually skewed toward highlighting benefits, but they often generate more interest from investors than they do from the medical community. Not infrequently the stories based on these early, embargoed abstracts will be imbalanced.”
A potential for harm
Lichtenfeld — like other doctors I spoke with in researching this topic — points out that promoting what is essentially pre-reporting on preliminary, pre-published findings is worrisome.
“I’ll often have people coming to me for my expert opinion on these pre-published abstracts, but I have to tell them I can’t thoughtfully comment without the full picture. The meeting presentation hasn’t even occurred and the data are often proprietary. This not only puts commenting experts in a difficult position, but it can be potentially harmful to patients who are understandably eager for new treatments. On the one hand, they can be enticed by new treatments where the harms aren’t yet fully known or disclosed; on the other, they may be diverted away from choosing established treatments that have been shown to be effective.”
Who benefits here?
Vince Kiernan, PhD
If, indeed, there is a potential for harm then it raises the question of who stands to benefit from what really amounts to pre-pre-coverage? That is, media coverage not just before the preliminary data is presented at a meeting, but also coverage long before it’s deemed worthy of publication.
“It’s almost a rhetorical question isn’t it?” said Vince Kiernan, PhD of the Catholic University of America in Washington, D.C.. Kiernan has a special interest in science journalism embargoes (ie. an agreement that exists between journalists and those in control of the research findings, which the media won’t publish until an agreed-upon date, as with today’s embargo by ASCO).
“In this case both the organizers of the conference and the scientists gain prestige. People will see all the attention and think: ‘This must be an important discovery or an important conference’.”
But proponents of such embargoes argue the heads up helps journalists to be more accurate; they’ll have more time to seek out expert opinions and do in-depth research.
“I don’t buy that,” said Kiernan. “Journalists have habituated to embargoes. They simply yoke journalists into a pack, and that usually results in homogenous coverage. Do they really have freedom of action? Are they really free when the timing and the content are selected for them?”
And Kiernan said he has other concerns.
“Our culture has this folklore of the ‘marketplace of ideas.’ That journalists are competing with one another to get the story out quickly, accurately, and all in the public interest. But that isn’t really true is it? Medical meetings, journals, and institutions can use embargoes to shape journalist’s behavior — and their stories — to serve their ends, not necessarily the interests of the public.”
In short, medical conferences like ASCO’s that do this are cherry-picking content they consider newsworthy; essentially dictating when journalists can publish their stories, and topping it off by providing incomplete, preliminary, and often skewed results with little to no context. Also, when journalists write as a pack — about the same topic, at the same time — it tends to amplify the seeming importance of those findings, even though they may not be any more likely than previous studies to reflect the “true” answer to the research question.
“It warps the public’s understanding of how science works,” he said. “One new study can’t overturn the consensus in the field. And in many cases, the newest study is just the one most likely to be disproven in the future. Readers can often learn more from the history of a scientific question than they can from just the latest stab at answering that question.”
This sentiment is echoed by Adam Cifu, MD, an internist at the University of Chicago. Cifu specializes in evidence-based medicine and has written a book about what happens when research findings are adopted prematurely, only to be reversed when ineffectiveness — or harms — become impossible to ignore.
Adam Cifu MD
“I actually don’t think that abstracts published at meetings do a whole lot to influence actual care. And I’d be pretty concerned about a doctor who changes their practice based on a meeting abstract. I tend to react to these abstracts with a, ‘I find this interesting but I’ll wait to read the actual published research before considering making practice changes.'”
So what’s the rush? Why the pre-pre-publishing of preliminary data? I asked Cifu: Is it because it might give doctors a jump on important findings that could save lives?
“In my entire career I have never read any article that would have changed someone’s life had I read it a couple of weeks earlier.”
Putting these concerns to the test
Over the next few days you’ll likely be coming across news stories generated by today’s ASCO presscast. We’ll take a look at some of them. And we’ll cover another flood of stories once the meeting is underway June 1-5 in Chicago.
We invite you to join us as we follow these stories closely to see just how reporters handle them.
Will the coverage be cautious? Will it be balanced? Or will reporters parrot what is spoon-fed to them?
ASCO is an important meeting with usually about 30,000-40,000 cancer specialists in attendance. As we wrote last year it serves as a barometer for many things … “a shortlist would include emerging technologies, politics, research funding, and the big money that big companies invest in their intense marketing and public relations campaigns.”
I would add to that list it also serves as a barometer for how such meetings influence media coverage. This week we’ll put that to the test.
How likely are you to believe one of the following:
That a study in fish might hold the key to preventing Parkinson’s?
That a study in rabbits might help us prevent HIV from spreading?
A brain scan could pick up mental illness?
I’m betting you’re skeptical. And you should be.
But get this: all three of these textbook examples of clickbait come from university news releases (below). That’s right, ivory towers; otherwise known as institutions of higher learning.
Don’t get me wrong, I’m all for basic research. And animal models and high tech imaging techniques are as good a starting point as any. But that’s not the issue. The issue is how this research is disseminated to the public — whether it be via news releases or news stories — and the potential that exists for misguiding people when the headlines promise much, but the content delivers little.
That’s why we regularly take a look back at the news stories and releases we’ve systematically reviewed to see if the headlines and the content are in synch. This is what we found when we looked back over the past month.
News RELEASE report card: 8 of 14 (57%) headlines overstate evidence(we list 3 examples below)
Headline: Eating more fish could prevent Parkinson’s disease
Study: An in vitro (lab) study only suggests that the fish protein, parvalbumin, binds to a particular human protein called “alpha-synuclein” which has been identified as forming amyloid chains in patients with Parkinson’s disease.
Our review: The news release should have made it clear that a laboratory fish experiment cannot be extrapolated to humans, and further, that no cause and effect relationship has been established between amyloid proteins and the development of any neurologic disease.
Headline: Brain scans may help diagnose neurological, psychiatric disorders
Study: Researchers had 9 people perform a variety of tasks while having functional MRI (fMRI) scans, and found the imaging changed very little from task-to-task, or day-to-day. The news release suggested this stability means these scans could be used to reveal individual traits or diseases.
Our review: “Whereas at present depression, bipolar disorder, and many other mental illnesses can only be diagnosed based on self-reported symptoms or observations of behavior, this release suggests we are on the verge of being able to diagnose these conditions via a particular type of MRI.”
Headline: University of Waterloo develops new way to fight HIV transmission
Study: Evaluates a medicated vaginal implant designed to diminish the T-cell immune response to HIV infection. The active ingredient — hydrochloroquine (HCQ) — may induce a so-called “immune quiescent” state which could theoretically make women more resistant to HIV.
Our review: Although the language in the release repeatedly implies the approach could “prevent women from getting HIV infection,” it fails to mention the study is in rabbits, and can make no claims of efficacy in humans. Furthermore, claims of efficacy, reliability, and affordability are not backed up with any data whatsoever from the study.
News STORY report card: 4 of 13 (30%) headlines overstate study evidence (we list 2 examples below)
Headline: New cure for baldness could be found in existing drug, scientists say
Study: Researchers found that a substance called Cyclosporine A (or, CsA, which has been used to treat immune disorders and transplant rejection) affected a protein that stunts the development of hair follicles. They then identified an osteoporosis drug that has a similar effect on hair follicles in the lab, but could potentially have fewer side effects than CsA. Nothing in this study of lab proteins is ready to be extrapolated to follicularly-challenged humans.
Our review: The story didn’t say anything about the quality of the study, the implications, and “should have explained up front that potential advances are years away, if they come at all.”
Headline: Partial rather than full knee replacements better for many — report
Study: A review of medical records, not a randomized controlled study, that suggests partial knee replacement is associated with better health outcomes and lower lifetime costs than total knee replacement.
Our review: According to our reviewers “the story glosses over how the study was conducted, what was measured, and what the limitations were … and doesn’t make clear what the benefits of the surgery are.” Not only that, this sort of chart review is not rigorous enough to support the sweeping conclusions of the headline.
You can find more from our Headline vs. Study series HERE
When the United States Preventive Services Task Force (USPSTF) issued a statement recommending against prostate cancer screening in 2012, its guidance was met with often vituperative attacks from professional organizations and advocacy groups. The muted response to new recommendations released this past Tuesday supporting personalized decision making for men 55 to 69 must have come as a welcome relief to the Task Force. The response was not surprising; the Task Force had issued a draft recommendation last year that received a similar reception.
The Task Force’s qualified support for screening disarmed some of its most vehement critics, including the American Urological Association (AUA). The AUA commended the Task Force for now being aligned with practice guidelines issued by the AUA and other major physician groups.
With a few exceptions, news stories about the recommendations appropriately recognized the complexity of screening decisions, as reflected in these headlines:
In addition, the AP’s coverage includes some misleading statements from an American Academy of Family Physicians representative, who states that African Americans and men with a family history of prostate cancer are “the best candidates for screening.” In fact, the Task Force recommendations apply to all men and do not indicate that high-risk men would be the best candidates for screening. The Task Force specifically points out that earlier screening of high-risk men is not supported by the evidence—men of African ancestry were not included in large numbers in the supporting studies and those studies did not identify men with family histories.
What did the Task Force say and why?
The Task Force emphasized that men could understandably have markedly different perspectives about the same data on benefits and harms, which is why the group supports individualized decision making. The ideal scenario is shared decision making, a collaborative process between patients and clinicians based upon the best available clinical evidence and the values and preferences of an informed patient.
Why did the Task Force revise its 2012 recommendation against screening to this more nuanced, individualized approach? News coverage appropriately highlighted the influence of longer-term follow up of men in the European Randomized Study of Screening for Prostate Cancer (ERSPC). Data published in recent years showed increasing benefits for screening over time in preventing prostate cancer deaths and metastatic spread. News coverage also recognized that the harms of screening related to overdiagnosis and overtreatment were being partly mitigated by the increased uptake of active surveillance—a monitoring strategy for men with a low-risk prostate cancer that defers active treatment (surgery or radiation) in the absence of cancer progression.
Additional context and active surveillance
The stories, though, overlooked a few important details in the Task Force recommendation. Not only did the Task Force factor in the increasingly positive ERPSC results, but it also discounted the negative results of the large American trial, the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO). Previously, the Task Force equally weighted results from both studies, but the PLCO is now widely recognized as a flawed evaluation of screening. The study was supposed to compare the effects of annual PSA testing vs. no testing on prostate cancer mortality. However, it was later shown that over 80% of the men in the control arm received PSA testing either during or before the study. This helped bias the study towards finding no benefit for screening.
Another issue is that active surveillance is primarily described as sparing patients from the harms caused by surgery or radiation. However, the evidence offers an even more compelling rationale for this strategy. The Prostate Testing for Cancer and Treatment (ProtecT) trial, conducted in the United Kingdom, recently showed that men with early-stage prostate cancers who were randomly assigned to surgery, radiation therapy, or active monitoring had the same low risk of dying from prostate cancer after 10 years of follow up. Active surveillance thus prevents treatment harms without increasing the risk of dying from prostate cancer.
More support needed for shared decision making
Finally, coverage about the new guidelines seems to assume that patients can make good decisions if they just talk to their primary care clinicians. This is overly simplistic. Studies have consistently shown that clinicians lack the time and often the expertise to conduct shared decision making visits. When screening is discussed, providers often fail to present both the pros and cons of screening or elicit patient preferences. Men are often poorly informed about the screening decision, markedly overestimating the risks of developing cancer and dying from it. They also tend to overestimate the benefits of screening.
An important missing ingredient from the news coverage—and the Task Force recommendation—is the use of decision aids. These are educational tools that can consistently provide patients with comprehensive and objective information about prostate cancer, the pros and cons of screening, and help patients clarify their values and prepare to discuss screening with clinicians. These tools are readily available, and patients should be encouraged to take responsibility for these decisions, coming into a visit informed about the disease and their options. This preparation can lead to much more efficient and productive discussions. Most people wouldn’t buy a car or a flat-screen TV without first doing some homework, and it should be the same for making cancer screening decisions—which have much higher stakes.
The USPSTF’s critical contribution
While the Task Force’s prostate cancer screening recommendations have been controversial over the past few decades, they have consistently been based on rigorous evidence syntheses—unlike organizations such as the AUA which did not embrace this approach until 2013. Importantly, these guidelines have helped Americans recognize that there are potential benefits and harms from all screening tests, and that patients need to actively participate in screening decisions.
Sometimes a news report proclaims that a treatment or test has been found to be “just as good as” another one.
But is that really the case?
In medicine, a finding that one approach is just as effective as another is often the result of what’s known as a “non-inferiority trial.” Unlike more common and straightforward superiority trials, these studies have designs that can be tricky to interpret.
Technically speaking, they test whether an intervention is “not acceptably worse” in terms of its effectiveness than what’s currently used.
But in fact, non-inferiority trials entail complex statistical maneuvers that experts have compared to the fantastical world of Lewis Carroll’s book, “Through the Looking-Glass,” where everything is reversed.
Researchers are increasingly raising questions about these types of studies, saying they sometimes advance a commercial agenda for drug and device-makers and pose ethical concerns for participants.
Non-inferiority trials have proliferated as drug and device makers devise products they hope work just as well as treatments but with an extra benefit, such as more convenient dosing, lower cost, or fewer side effects.
A new resource for making sense of non-inferiority trials
In it you’ll learn how to explore some key questions that should be asked about non-inferiority trials:
Is the comparison treatment the current gold standard?
What is the margin of non-inferiority?
Are potential trade-offs worthwhile?
You’ll also learn about some real-world examples and this useful analogy from Italian neurologist Stefano Ricci, MD:
Would you buy a car which is definitely less good in terms of safety and durability than the model you had set out to buy, just because the first vehicle is a bit less expensive? The answer to this question obviously depends on the degree of both these differences.
You can find more tips for analyzing studies and health care claims in our TOOLKIT section.
Should you donate to a friend’s or family member’s crowdfunding campaign to help pay for medical costs?
A recent online crowdfunding campaign for a stem cell treatment.
It may seem like an easy answer, but a new study indicates how thorny that decision can be — particularly when people seek money for unproven stem cell treatments that are not covered by health insurance.
By parroting the marketing messages of the clinics they want to utilize, patients’ crowdfunding campaigns often exaggerate the effectiveness of such treatments, according to a research letter published yesterday in JAMA. They also tend to downplay the risks.
HealthNewsReview.org has written about how news stories about crowdfunding campaigns often don’t examine whether there is evidence that the procedures actually work. This new study emphasizes why that matters.
“The exaggerated claims that you find on the stem cell companies’ web sites are basically baked into the crowdfunding campaigns,” said University of Minnesota bioethicist Leigh Turner, PhD, one of the authors.
Turner said while the paper suggests a need for physicians to discuss the evidence around unproven treatments with patients, the findings also bolster the evidence that unproven stem cell clinics are a “predatory marketplace that often exploits people who have quite limited financial means.”
Yet patients and their families may be unaware that they’re falling prey.
“These are people who are highly motivated to think this is something that might work for them,” said co-author Jeremy Snyder, PhD, an associate professor in health sciences at Simon Fraser University. “They’ve bought into the hype.”
In some cases, crowdfunding campaigns examined in the study even went beyond the claims made by the stem cell clinics themselves, Snyder said, with messages claiming a treatment would “cure my cancer,” “make me walk again, or “cure my MS,” referring to multiple sclerosis.
Nearly 90% of campaigns made unfounded claims
Researchers looked at campaigns that appeared on crowdfunding web sites GoFundMe or YouCaring between August and December of 2017, which sought donations for stem cell interventions advertised by 50 different companies. Nearly 90% of the campaigns made optimistic or definitive claims that the procedures would work.
The study found that 44% of campaign pages made statements that were “definitive or certain about the intervention’s ability to work,” and another 30% made statements that were “optimistic or hopeful that the intervention would work.” Fifteen percent made statements of both kinds. Only 11% did not make effectiveness claims.
It also found 36 mentions of risks, all of which claimed the intervention had low or no risks compared with alternative treatments.
The campaigns sought more than $7.4 million and received pledges of about $1.4 million from 13,050 donors. The authors said the study likely underestimated the number of crowdfunding campaigns for stem cell interventions, since it looked at only two funding platforms and did not track campaigns for procedures at non-U.S. stem cell clinics or for U.S. providers established after February 2016.
The new findings suggest that crowdfunding campaigns also might have a wider impact than previously appreciated. The 408 campaigns that were studied were shared 111,044 times on social media such as Twitter and Facebook, researchers found.
Need for improving access to good information
The list of conditions for which stem cells offer a proven benefit is small; consumers can find current, evidence-based information about stem cell treatments in this report from the International Society for Stem Cell Research.
University of Wisconsin law professor Alta Charo, who works with the society, said crowdfunding “is certainly capable of exacerbating the problem” of public confusion over the effectiveness of stem cell treatments.
While not speaking for ISSCR, she said via email it is “almost impossible to eliminate bad information in this era of internet erasure of national boundaries,” and there’s a need to increase public access to reliable data.
It can be helped by voluntary cooperation from search engine companies, on-line product purchasing companies, and social media platform companies if they agree to respond promptly to reports of false or misleading items that pose a risk to patients. This can be difficult, of course, as we are learning from observing Facebook’s recent efforts to respond to false news items being planted and disseminated through its service. But that doesn’t mean it isn’t worth trying.
Journalists may also have a role.
While it’s understandable that reporters with local newspapers and TV stations cover crowdfunding campaigns because of the sad stories involved, Turner said, “the problem is they don’t take the step of looking at the businesses themselves. Local reporters will basically take the campaigns at face value. They will basically treat this as an established therapy.”
Are clinics pushing patients to create campaigns?
The researchers said they are working on a longer paper that will describe their findings in detail, including examples of messaging in crowdfunding campaigns.
They also noticed that most crowdfunding campaigns involved treatments at just a handful of clinics, raising further ethical concerns.
“Is that because those clinics are pushing their patients to create crowdfunding campaigns? Future research is going to try to take a close look at that question,” Turner said.
Something huge, expensive, arguably controversial and allegedly revolutionary happened on Sunday to modest fanfare.
Three years after it was announced by President Barack Obama, the ambitious precision health initiative — now rebranded as the “All of Us” research program — was launched by the National Institutes of Health (NIH) in 7 cities across the United States.
The goal? Convince one million Americans to give the NIH access to their electronic medical records (EMRs), blood and urine tests, and answers to lifestyle questionnaires.
Why? Because it could accelerate advances in what’s come to be known as “precision medicine” (aka “personalized” or “individualized” medicine) which we’re told will lead to advances in the prevention, treatment — and even cure — of a host of diseases.
How? Good question. No one, including the NIH, knows the answer to that. Certainly a solid case can be made for using our increasingly sophisticated understanding of genetics, along with EMR’s, to crowdsource as much “human data” as possible to search for an answer.
But it’s not the merits of the $1.5 billion research program critics take issue with. It’s the framing. In other words, how this program is being pitched to the American public. And does it raise expectations beyond what the program can realistically hope to achieve?
An anthem to precision medicine and foregone conclusions
The NIH is expected to be a trusted and neutral arbiter of evidence-based medical research.
But the marketing video for “All of Us” — not unlike the news release from NIH — promises benefits and impacts as almost foregone conclusions. With no supporting evidence this oddly patriotic video — appealing to our “honor and compassion” — calls the research program a “landmark in history” that will “heal the sick and eradicate disease” and promises that “the next great breakthrough will be found in each and every one of us.”
The All of Us Anthem - YouTube
“I’m not against publicizing research, or using innovative and ethically appropriate strategies to recruit research participants,” says Tim Caulfield, a lawyer and professor of health policy and law at the University of Alberta.
Tim Caulfield, LLB, LLM
“But this video contains a lot of extreme language. And if it’s a recruitment tool — and I think it is — one would assume it would need to satisfy the research ethics policies for public advertisements. While most of the institutional review board (IRB) guidelines for recruitment are focused on clinical trials, the general vibe is that advertisements should not overpromise in order to increase recruitment.
“For example, the FDA guidelines explicitly say that ‘any advertisements to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest.’ Clearly, this video goes further than that. Although there is exciting and valuable research happening in this space, this feels more like a commercial for precision medicine. Does the research community think that’s OK? If so, why?”
A perspective from an “All of Us” researcher
It’s a question I posed to Stephen Thibodeau, PhD, co-director of the Molecular Genetics Laboratory at the Mayo Clinic. Two years ago, NIH awarded Mayo $142 million to be the primary biobank for the All of Us blood and urine samples. Thibodeau is one of the leaders of that biobank.
Stephen Thibodeau, PhD
“We certainly don’t want to overpromise, but we do want to capture the imagination of people. We need to enroll a large number of people because it’s definitely a numbers game. The size and scope of this program is novel, and it needs to be large in order to accelerate progress in precision medicine.”
But there are already over 50 such studies around the world that have each enrolled over 100,000 people. Most notably, the Precision Medicine Databank of the Veteran’s Administration that’s enrolled well over 500,000 participants. So what’s different about this $1.5 billion dollar program?
“We are capturing a very diverse population that’s historically been underrepresented,” said Thibodeau, alluding to the fact that most research subjects have traditionally been white and male.
“A more diverse population will help us generalize our findings to the larger population. We’ll also have the ability to follow peoples’ health records over time, not just a one-time contact.”
Thibodeau is referring to the fact that volunteers for the study provide what NIH director, Francis Collins, MD, PhD says is: “pre-consent for re-contact for participation in clinical studies of all sorts by industry, by academics … maybe about prevention, maybe about devices, maybe about drugs.” It’s what the NIH news release touts as “a rich and open data resource for traditional academic researchers as well as citizen scientists — and everyone in between.”
Plenty of room for concern
But Mike Joyner, MD — a frequent contributor to HealthNewsReview.org and also a researcher at the Mayo Clinic — is more guarded.
Mike Joyner, MD
“I have three concerns. First, their cohort — which consists of recruited, not randomized subjects — may not be all that representative. Second, there are good studies which support questioning outcomes that come from EMRs. They’re not the same grade as the research results we get from randomized, controlled trials. Finally, I wonder about the claims of using the results to ‘revolutionize’ or ‘transform’ health. What’s going to be their definition of success? Fewer disparities in health care? Increased life expectancy? Decreased health costs? It seems a little vague.”
Leigh Turner, PhD
Leigh Turner, PhD, a bioethicist at the University of Minnesota, shared some similar concerns about the study methodology. But there were other things he found worrisome.
“My primary concern is the hyperbolic claims [the video] makes about precision medicine. We need less hype and more honest accounts of the very serious challenges involved in developing highly tailored therapies for patients. Second, this is a costly program and it’s questionable whether it can achieve its desired results. We need an informed public debate about that, not an ‘anthem’ selling a program. Such a large-scale, high-profile initiative attracts a lot of attention, but that doesn’t mean there will now be an inevitable and swift march toward the development of precision medicine.”
News coverage more measured than the NIH news release
The modest news coverage of the “All of Us” rollout was more cautious — and informative — than the NIH news release.
The Washington Post opted to focus on a very relevant concern: privacy. Something the news release didn’t address at all.
Wired gave a very thorough look into the scale and costs of the project, as well as who will have access to the data, and how.
And Fortune should be commended for using very cautious language in discussing how the project “could theoretically help spur” medical research and treatments.
A fine line
It’s important to acknowledge that the NIH and its partners have embarked on an ambitious project with a legitimate chance of impacting our health care. Trying to recruit one million people to that end is commendable, can not be easy, and most certainly requires some degree of promotion.
However, equally important is its historic reputation as a neutral arbiter focused on evidence-based science. Some might argue that if the video is wildly successful in driving recruitment for this project, than the ends justify the means. But the video and its hyperbolic appeal could also compromise the NIH’s role as a respected scientific organization. Could that lead to an erosion of public trust? Or, at the very least, could their promotional message cross a very fine line and mislead not just a million people, but many more than that?
This is just one little story about one woman reacting to one magazine article that bothered her.
But I think it’s important because it’s a window into the reactions that patients can have when they see stories about their condition. And those reactions and deeply-felt frustrations may not come to the surface very often. This one did only because we had announced the start of our series on patient harms from misleading media at about the same time that thyroid disease patient Donna-Lynne Larson saw a story in Women’s Health magazine.
Larson, in promo for her film, “WALK TALK DANCE SING: unraveling my Hashimoto’s affair”
Since Ms. Larson had taken Synthroid (brand name for levothyroxine) for seven years and stopped because of side effects, it would make sense that this headline would lure her in. She didn’t like what she saw. She called the magazine piece “insulting” and “disrespectful.”
Personally, I was repulsed by the article’s whimsical, light-hearted listicle style. I wouldn’t react kindly if I had a serious, life-impacting illness and if I saw a magazine piece that discussed my condition while throwing in gif images of Brad Pitt, of a woman who can’t walk in tight clothes, of a cartoon character sweating, and scenes from “The Addams Family” and “Schitt’s Creek.”
Up high in the story was this: “Like any medication, Synthroid can have side effects, but for most people, the drug just makes them feel awesome again.”
Only ‘1 percent’ don’t respond?
Awesome is not how Larson would describe how Synthroid made her feel. Her history goes back to 2004 when she felt floored by fatigue, waking up one day unable to move. She was diagnosed with Hashimoto’s disease – an autoimmune form of thyroid disease. She was prescribed Synthroid but it made her feel worse, not better. Not awesome.
The magazine piece then went on to report: “Although there are about 1 percent of patients that won’t respond to Synthroid at all and will need other treatment, the vast majority of people on it feel remarkably better within six weeks of starting it.”
“Wow,” Larson thought after reading the piece, “I’m one of the 1% – there must be something seriously wrong with me.”
But where does this 1% figure come from? “Awesome” and “remarkably better” aren’t descriptions that match what a significant number of patients report after using Synthroid. The People’s Pharmacy offered a layperson’s summary of a 2016 study:
“The authors point out that 10% to 15% of patients treated with standard levothyroxine ‘monotherapy’ are ‘dissatisfied as a result of residual symptoms of hypothyroidism, including neurocognitive impairment…’ In other words, patients often complained of symptoms such as brain fog, confusion, fatigue or depression even after their lab tests appeared to be normalized.”
It’s difficult to pin down how many patients feel “awesome” from Synthroid, as the article states is the case with “most people.” A highly-unscientific poll on WebMD.com asked Synthroid users to rate the drug. More than 1,000 user reviews appear, with “effectiveness” getting about an average rating of 3 stars out of 5, and “satisfaction” getting an average rating less than 3 stars out of 5. That sounds like fair-to-middling at best, not awesome.
‘Sucked into a vortex’
Larson wrote on her Facebook page the same day she saw the Women’s Health magazine article: “It is a shameful advertisement for Synthroid. The message: if you aren’t feeling well, go see your doc, and get your Synthroid meds adjusted again. Cha ching…cha ching….and the beat goes on.”
To Larson, the theme of “if you’re having trouble, your dosage must be off” reinforces the message that Synthroid is a wonder drug for 99% of people who take it. She describes what life is like in the search for relief from the right dose.
“You get sucked into a vortex,” Larson told me. “You dose, re-dose, you start feeling anxious, you develop trouble sleeping, you have achy joints. You see your doctor, who says, ‘Well, try another drug for that. You probably have anxiety disorder or irritable bowel syndrome….’ It’s just: ‘Take this pill, you’ll be fine.'”
She once did a fundraiser for a Canadian thyroid disease advocacy group. “In my naivety,” she said, “I had no idea that the president of the organization was a rep for Abbott, sellers of Synthroid – the very drug that wreaked havoc on my life.”
Larson is an actor, writer and director and she used those skills to write and perform a one-woman play, “Who’s Going to Stop My Hair from Falling Out? A True Tale about Thyroid Disease.” She calls it part of her healing process. Later, she produced what she calls a no-budget film, “WALK TALK DANCE SING: unraveling my hashimoto’s affair.”
She is aghast at American TV drug ads that float via the airwaves over the border into her Canadian living room. “Everybody makes decisions every day from everything they hear from all media,” she told me. “We’re just inundated. When we see something in the media, we have no reason not to believe it.”
Bring us more of your stories
So, to recap, she identified problems with journalism (the Women’s Health magazine piece), with advertising, and with conflicted patient advocacy groups.
“While I was struggling to find my way, there I was drugged like a zombie,” she said. “I was trying to find my voice, to speak up for myself. This was made so much more challenging while lost in the blur of Synthroid.”
Hers is one more little story – the kind that often doesn’t get told or heard by others. We think that stories like hers need a far broader platform. People are being hurt by thoughtless drivel that has far-reaching impact. That’s the reason we’re telling these stories in our series, “Patient harm from misleading media.” Please share any relevant stories with us, at firstname.lastname@example.org.
Trailer from her no-budget film:
"WALK TALK DANCE SING:" FILM TRAILER - Vimeo
Or, if you want to watch the entire movie, click here. When you’re asked for an access code, enter WTDS.
Six years ago, oncologist and bioethicist Ezekiel Emmanuel, MD, wrote that the proliferation of proton beam therapy machines in the U.S. was “crazy medicine and unsustainable public policy.” If that was the case then, it’s even crazier today. And Jay Hancock helps readers track the craziness. He reports that: “There are 27 proton therapy centers now operating in the United States. Nearly as many are being built or planned….Nearly a third of the existing centers lose money, have defaulted on debt, or have had to overhaul their finances.”
The headline clumsily seems to pin this on patients’ “lagging demand.” But Hancock’s reporting points to the supply side of the supply-and-demand equation: hospital administrators buying far too many machines that they hoped to put to work in far too many unproven uses. Hancock wrote: “(proton beam’s) pinpoint precision has not been shown to be more effective against breast, prostate and other common cancers.”
So for Americans who hang on to the chauvinistic belief that U.S. health care is best in the world, proton beam machine proliferation is one achievement for which they may wave the flag and chant, “We’re Number One!” But it may not be one for which they should be especially proud. Kudos to Hancock for keeping us up-to-date on one factor behind another America #1 claim – spending a far greater percentage of our gross domestic product on health care than any other country on earth (often without a return on that investment).
Illustrated like a noir comic, this story lays out the extreme sales-maximizing strategies of opioid maker Insys Therapeutics, detailing its use of well-known pharma tactics (“speaker” fees for prescribing doctors) and some you might not have heard of before (hiring “prior authorization specialists” who mislead insurers about a patient’s condition).
Hughes reveals the mindset behind the operation, drawing on court documents and interviews with former employees. He also visits an addicted vet whose life has devolved to the point of sleeping under a desk and a high-prescribing Sarasota doctor who says the Insys speaker program “suited his ego.” With former company officials now facing criminal and racketeering charges, this story connects the dots between greed and patient harms.
This story shows that stigma against opioid users is everywhere — even in the addiction treatment community. Kudos to reporter Bauer-Reese for including patient voices to reveal a nuanced portrait of people trying to overcome addiction, while also revealing yet another barrier to treatment.
Here’s the news: A new 12-step program has emerged specifically for people taking medication, such as buprenorphine and methadone, to help them recover from their addictions. These folks are snubbed in traditional 12-step programs, overtly or subtly:
One member shared a story of working up the nerve to tell her AA sponsor that she’s on 45 mg of methadone, something that is too often discouraged in the AA model. When she shared, the compassion was audible; this kind of concern is all too common.
The evidence for medication-assisted treatment is strong: the meds reduce opioid deaths by 50%, decrease criminal activity, and increase the number of people who say in treatment. Another member:
“Why should I feel ashamed for doing something that’s saved my life? I was putting a needle in my arm every 10 minutes—methadone saved my life.”
But taking the meds often is framed as substituting one opioid for another. The story brings in an addiction expert to reframe:
“I think it’s heartbreaking because if a person had cancer or had any other chronic illness and they were valiantly managing it, people in their lives would be supporting them and encouraging them to take their medication every day to stay healthy.”
Aschwanden provocatively takes us from the present — where scientists are removed from the EPA advisory panel, and President Trump’s pick to head NASA claims “global temperatures stopped rising 10 years ago” — back to the days when big tobacco usurped a basic tenet of science, uncertainty, to essentially give momentum to doubt.
The end result? The emergence of two brands of science using the same language for very different reasons.
Whereas the “open science” movement aims to make science more reliable, reproducible and robust, proponents of “sound science” have historically worked to amplify uncertainty, create doubt and undermine scientific discoveries that threaten their interests.
If you’re someone fascinated by cherry-picked evidence, “scienceploitation,” the malleability of “fact,” or the interplay between values and fact, then this gem of an article will have you enthralled.
Please Note: These stories have not been subject to our rigorous, 10-criteria systematic review for accuracy, balance, and completeness. Rather, they represent pieces of health care journalism and opinion writing that members of our staff found compelling and wanted to share with others.
5-Star Friday is a regular feature on HealthNewsReview.org. You can find a list of previous installments HERE.