Misleading to the point of deception, this news release ignores all primary and secondary analyses of the study it ostensibly reports on — which were uniformly negative and showed no benefit — and instead treats a positive subgroup analysis as if it were the main finding of the study. It also failed to mention the potential for serious harm from the drug, and wasn’t transparent about the financial interests that might bias the opinions of one of the study authors. This is just not an acceptable practice.
Yet it appears that journalists and other web producers bit on the bait and followed the lead of the news release unquestioningly. That’s where avoidable harm occurs.
Since the drugs used in combination in this study (Lupron and acetylcholinesterase inhibitors) are already on the market, it’s conceivable that desperate family members and caregivers of Alzheimer’s patients will demand treatment based on these hyped results. (A broadcast television news story even encourages patient family members to “ask their doctors to consider putting them on the drug.”) The benefits touted by the release were seen only in a smaller subgroup of patients — not the main study — and subgroups need to be treated very carefully for a variety of reasons. Most importantly, the randomization of patient characteristics in the various groups of the study may not have been maintained in the subgroup analysis. If the patients in the subgroup who received Lupron were less severely ill or had other differences compared with those in the control group, then the treatment may appear to be beneficial, when in fact the result is due to confounding. This release doesn’t address such important limitations, and that’s unfortunate.
The press release does not provide any indication of this drug combination cost. Since both drugs are on the market, some estimate should be possible.
We realize that university news releases may not be accustomed to being judged by a standard that calls for cost information. But 70% of ~2,000 health care news stories we’ve reviewed over the past 9 years were judged unsatisfactory on cost information. So we’re certainly not going to lower the bar for news releases, which could help to turn that trend around.
Although we appreciate the release’s attempt to quantify benefits in terms of ADAS-cog scores, these numbers lack any significance for those who are not familiar this particular scale. Is this a 10-point scale or a 100-point scale? The importance of the 3 and 4-point drops described in the release will be judged differently depending on this crucial context.
In addition, while the benefits were corroborated by mention of another study that showed a reduction in the risk of developing Alzheimer’s disease among men who receive Lupron, there is an important clinical difference between reducing risk of developing Alzheimer’s disease and slowing progression of the cognitive deficits of Alzheimer’s disease. The release didn’t make this clear.
While the news release does note that the study population was limited to post-menopausal women due to the effect of Lupron on sex steroid production, it does not mention potential harms associated with the drug combination among post-menopausal women or possible interactions with other drugs that may be used by this population. The study itself found that 77 of 109 patients or (71%) experienced at least one adverse event. Three serious adverse events (2 cases of gastrointestinal hemorrhage and one case of deep vein thrombosis) were judged to be potentially related to the drug.
Emphasis on or exaggeration of potential benefits, coupled with minimizing or totally ignoring harms, have been hallmarks of a majority of the ~2,000 news stories that we’ve reviewed in the past 9 years. News releases could help turn news stories in a different, more helpful, more complete direction. That’s our hope and expectation with this new feature of reviewing health care news releases.
The news release doesn’t accurately describe the study design and, as noted above, neglects to inform us of some important limitations. First, the positive findings about the benefits of Lupron came from a subgroup analysis of the study — not the primary analysis. The main test of the study was to compare two different doses of Lupron with a placebo, and the results of that test were negative. The release glosses over this detail entirely and highlights the results of a much less definitive subgroup analysis. It focuses on the subgroup of patients who were already taking an acetylcholinesterase inhibitor (AChEI), and noted that those who received the high dose of Lupron had stable cognitive function while the other two groups declined. That’s certainly an interesting finding and one that may warrant additional research, especially since the researchers planned to analyze that subgroup beforehand — which makes the result stronger than if they’d merely stumbled across it after the fact. Then again, the finding could well be biased for several reasons. And since the study was already small to begin with, the results of an even smaller subgroup should be treated very carefully. The release offered none of this context, and tried to paint the results of the study as unequivocally positive. As a result, many readers may be deceived as to the importance of these findings and how “promising” this drug combination really is.
The release did not exaggerate the impact of Alzheimer’s disease.
The news release clearly states the study was initiated by Dr. Richard Bowen, an employee of the (now bankrupt) Voyager Pharmaceutical Corporation, and that the company performed the study. But it doesn’t disclose that Bowen also reported owning stock in Voyager (he’s previously been described as a “major shareholder”), which holds a patent covering the use of Lupron for the treatment of Alzheimer’s. Though apparently now in bankruptcy, the company would likely still stand to benefit if this treatment approach gained new attention from researchers or was championed by new investors — and Bowen might well share in that reward. The news release wasn’t transparent about this.
The news release notes that “This is the first time any therapy has been shown to stabilize memory loss over a year.” That’s all well and good, but how do the results compare with other FDA approved treatments for Alzheimer’s disease or others that may be on the horizon? The release doesn’t address this issue.
It’s clear from the release that both medications in this combination therapy (AChEI and Lupron) are currently available. We appreciate that the news release ends by noting the preliminary nature of the findings, and the uncertainty as to whether additional studies of this combination will be conducted. But unfortunately, the release’s mischaracterization of the results will likely overpower this note of caution.
The news release notes that there is previous research suggesting that Lupron may be beneficial for the prevention of Alzheimer’s disease. It establishes that this is the first drug combination that could maintain stability in cognitive function for Alzheimer’s patients over the course of a year.
No unjustifiable language identified.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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