Michael Joyce is a writer-producer with HealthNewsReview.org and tweets as @mlmjoyce
There is a delay of about 300 days from the time a drug company issues a news release about a new study of a cancer drug, to the time the complete results of the study are published in a peer-reviewed journal.
This according to a study published last week in JAMA Oncology.
This certainly raises the question of why does it take so long?
But it also raises some very different questions touching on issues we see frequently:
It creates a disconcerting limbo period — nearly a year in some cases — during which this incomplete and often imbalanced information dangles out there for interested doctors and patients, even though it has yet to be vetted for publication or even presented at a medical conference.
That’s a set-up for misleading both doctors and patients, and potentially leading to significant harms.
First, is it even ethical to claim benefits of a drug (very often to the exclusion of noteworthy harms) and publicly release them without supporting data?
Second, which matters more if the goal is fostering innovation and improving patient outcomes? Completeness or speed?
“In theory, rapid and early dissemination of new research findings — both to the medical community and the lay public — may get appropriate care to patients sooner, and help important ideas spread,” said Michael Hochman MD when I spoke to him last summer.
Hochman is an internist and director of the Gehr Family Center for Implementation Science. I had turned to him for insights regarding the accelerated dissemination of research findings — commonly seen in news releases and medical meetings — that had not yet been peer-reviewed or meticulously vetted for publication. He added:
In practice, however, it seems that the dissemination of early stage research findings often leads to the cart getting out ahead of the horse. It’s hard to know where the optimal balance lies. There are clearly benefits to immediate communication, but there are also real risks that preliminary, un-adjudicated results will be taken out of context. And there are countless examples of new medical treatments and tests becoming widely disseminated before the data support their widespread dissemination.
But do preliminary and un-adjudicated results (including from Phase III cancer trials) find their way to the public? And are they taken out of context?
Yes and yes. Here are some examples from Phase III cancer trials we’ve recently written about:
“The headline of the story, ‘Roche’s Tecentriq cocktail adds to lung cander survival success,’ asks readers to take Roche’s word for it, because neither it nor Roche offers any quantitative data to support the claim.”
” … the story should have explained that since the data are unpublished and not available for review by anyone, we have no way of knowing if what the drug company says is accurate”
In both cases the burden of proof — which is the defining aim (and responsibility) of a clinical trial — is now shifted to to the reader (doctor or patient) who is now hamstrung by incomplete — and prematurely released –information. Do they have what they need to make a shared and informed decision?
It’s worth mentioning that the Securities Exchange Commission (SEC) requires companies to release research results as quickly as possible so their investors can — ironically enough — make “informed decisions.”
At issue is whether that information can be presented more responsibly, and whether news organizations can do a better job reporting on such announcements. Clearly, some companies use this as an opportunity to hype their results, hoping to move the stock price, months before anyone will have a chance to verify the claims.
As you might expect companies will very often lean toward framing these preliminary results in a way that encourages investment. The problem is this framing is often echoed in news releases, which is then often parroted by reporters, and eventually makes its way to the public.
We followed a classic example of this last spring with Amgen’s cholesterol-lowering drug Repatha. Amgen dubbed it a “landmark study,” the news release provided no data to back up this claim, but this didn’t stop some breathless coverage.
So who was better served — investors or patients?
Delays in publishing aren’t unique to medicine. As noted in this 2016 Nature article, it’s a growing problem across many scientific disciplines.
A short list of guesses on why it’s happening includes:
The list goes on but the fact remains that the delays are real, are frustrating for those involved, and percolate down to affect doctors and patients.
“These delays can matter. We all want to offer treatment options in which benefits outweigh harms,” says Andrae Vandross, MD, a hematology-oncology specialist at UCLA.
“But it’s tricky. If the reason for the delay is peer review and careful analysis, presumably this will improve our own analysis in deciding if the intervention is appropriate for our patients. If the reason for delay is strategic marketing, journal downloads, etc., this makes it hard to justify when juxtaposed to patient care considerations.
“All in all, I would prioritize a well done study that would provide a viable treatment option, even if the perception is that it’s delayed.”
Dr. Matt Katz is a radiation oncologist based in Massachusetts who brings up another point.
“Delays in publishing can slow implementation, especially since 70% of patients receive their cancer care outside of academic medical centers. Oncologists in the community setting are unlikely to make major changes in practice before publication. It’s peer-reviewed publication — not abstracts from meetings or press releases from for-profit companies — that dictate changes in policy, practice guidelines, and my own discussions of treatment options with patients.
I’ve heard it said “we don’t need more books, we need more good writers.” I’ve also heard many doctors say something analogous about clinical studies: “we don’t need more clinical studies, we need more well designed ones.”
But once we have such well designed studies, and the potentially meaningful results that come with them, our next priority should be how do we pass this information along to the doctors and patients who need it most. Do we rely on for-profit drug companies to package that information for the concerned public or concerned investors? And should we demand that negative results and study limitations be included alongside the touted benefits?
I guess the answers to those questions depend on who you think the research is for.