Mary Chris Jaklevic is a reporter-editor at HealthNewsReview.org. She tweets as @mcjaklevic.
A recent New York Times story decrying limited uptake of a clot-busting drug for stroke pigeonholed skeptics of the treatment as ill-informed “naysayers” while deeming the drug’s boosters to be “experts.”
At the same time, the story didn’t acknowledge the heavy hand of industry funding that has influenced discourse about the drug, tissue plasminogen activator (tPA), which may open blocked vessels after a stroke.
Those biases are among an array of problems we found with the story, For Many Strokes, There’s an Effective Treatment. Why Aren’t Some Doctors Offering It?
It also neglected to provide readers with data about the magnitude of purported benefits and harms, explore the costs of administering tPA, or delve deeply enough into the quality of the evidence.
Most egregiously, according to experts we talked to, it portrayed this as an area of settled science rather than one of lingering uncertainty. Patients and their families, who must decide quickly whether to opt for tPA in the first few hours following a suspected stroke, aren’t served by this kind of imbalanced, incomplete coverage.
Dan Mayer, MD, a HealthNewsReview.org contributor and retired professor of emergency medicine at the Albany Medical College, wrote in an email:
Having had a stroke, I often wonder: if 99% of my symptoms hadn’t cleared before I got to the hospital (60 minutes or well within the time for t-PA), would I have opted for t-PA? This is an area for shared decision making rather than doctrinaire pronouncements on either side.
The story was framed around a vignette about an emergency room doctor who was a researcher in a 1990s trial that the story said “proved (tPA) could prevent brain injury after a stroke.”
That doctor, Christopher Lewandowski, MD, expressed dismay that the drug he thought would “change medicine” hasn’t become universally accepted by his fellow emergency room physicians more than two decades after the findings were published.
It seems that premise would warrant a deep dive into the quality of the data, but that’s not what happened here.
Rather, the story makes sweeping proclamations about the effectiveness of tPA.
It quotes Gregg C. Fonarow, MD, a cardiologist at the University of California, Los Angeles, warning that without tPA patients can end up disabled and facing “devastating consequences.”
It asserts that around 700,000 people in the U.S. who have strokes caused by blood clots each year “could be helped by tPA. Yet up to 30 percent of the stroke victims who arrive at hospitals on time and are prefect candidates for the clost-buster do not receive it.
“The result: paralysis and muscle weakness; impaired cognition, speech or vision; emotional and behavioral dysfunction; and many other permanent neurological injuries.”
One physician researcher pointed out on Twitter just how alarming that sounds:
The story didn’t explain where that 30% figure came from, and it didn’t acknowledge that patients might opt not to be treated after a careful consideration of the evidence.
It went on to state that “in most stroke patients [tPA] prevents brain injury,” which is contradicted even by the study that reported the most favorable outcomes for treatment with tPA.
In fact, that trial showed a very modest benefit. While at best one in five stroke patients are candidates for the drug, only one in eight of those were helped by it, with improved neurological function.
And as the story did mention, a reanalysis of that trial data showed those positive results could be explained by the fact that those who received tPA in the study had less severe symptoms.
The story waved off 11 other studies that didn’t show a benefit, citing tPA proponents’ contention that the failed trials don’t mean tPA “cannot help patients like those in the original clinical trials.”
Also not mentioned: no study conducted on tPA has found it saves lives, and some showed it increased mortality.
The story stated that tPA can present “a real risk” of bleeding in the brain, but didn’t say it can cause serious injury or death, which is the consequence that many ER docs worry about. That risk can be exacerbated by misdiagnoses, since stroke symptoms can resemble those of other maladies such as migraine headaches, infections, and tumors.
The story also stated that “rates of cerebral hemorrhage have declined as doctors have gained experience over the years.” Again, there’s no data given on what those rates are and what evidence shows that brain bleeding is becoming less common.
Mayer believes patients should be informed that the number needed to harm is 18, meaning that for every 18 patients treated with tPA, one additional patient will have a brain hemorrhage that can lead to serious injury or death.
The story never acknowledged that some physicians advocating tPA and their hospitals stand to profit from administering the drug.
One source in the story has received payments from two companies that market tPA. Edward Jauch, MD, an emergency doctor and professor of neurosciences at the Medical University of South Carolina, received just over $20,000 from Genentech and Boehringer Ingelheim Pharmaceuticals, from 2013-16, according to Open Payments.
All four tPA proponents quoted in the story are affiliated with Joint Commission-accredited stroke centers, which attract patients with a range of services that include offering tPA.
Moreover, as medical journalist Jeanne Lenzer reported, Genentech employees served as “study monitors” in the trial that served as the basis for using tPA in stroke, which means the company exerted control over how data was collected.
The story noted that guidelines of the American Heart Association and its offshoot, the American Stroke Association, “strongly endorse tPA for patients after they’ve been properly evaluated.”
But the AHA also has a significant conflict of interest on this issue.
Lenzer wrote in 2002 that six of the nine members on an AHA committee that strongly recommended tPA for stroke “despite continuing controversy about the safety and efficacy of the treatment” had ties to the manufacturer, Genentech. Further, the association itself had received more than $11 million from Genetech in the decade preceding the recommendation.
The AHA continues to receive funding from companies that make tPA, reporting some $654,000 in cash and pledges from Genentech and Boehringer Ingelheim in the most recent financial report posted on its website, for the fiscal year that ended in 2017.
And there was no mention of the cost of the drug, which varies by hospital. Some hospitals reportedly pay as much as $8,000 per dose, although the costs of administering the drug are higher because patients must first undergo a CT scan to rule out a brain hemorrhage that could be worsened with tPA.
The story cast doubt on the credibility of independent doctors who are concerned this drug is harming patients as a minority of “vocal disbelievers” who get their information from social media.
In the original version of the story, University of California Los Angeles professor and emergency medicine specialist Jerome Hoffman, MD — who has combed the available evidence about tPA and performed the reanalysis of data from the 1995 trial — is described as a “charismatic, riveting speaker” who has “sold information tapes expounding his theory.”
As this blog was about to be published, the Times ran a correction stating Hoffman did not sell tapes.
All that was exacerbated by the use of leading words such as “experts” to describe those who disagree with Hoffman’s analysis and “claims” (rather the standard “said”) in attributing Hoffman’s statement about the quality of evidence.
Lenzer said the portrayal of Hoffman — who is considered an expert in emergency stroke care as well as scientific methodology — and other doctors who question the integrity of the evidence as uninformed is “very disturbing.”
“These doctors have a genuine concern for public safety,” she said.
In fact, Hoffman told HealthNewsReview.org that he’s never accepted industry money and has donated any compensation he’s received for testifying in court cases involving tPA to charity. “I didn’t want anyone to have any way of insinuating that I was saying what I did in order to make $,” he wrote in an email. He said the fact he was painted as the conflicted party in this story is “pretty ironic. I could make a lot of money if I just switched sides.”
Hoffman has spent much of his career educating doctors and medical students about the pitfalls of medical literature. Some of his presentations are available on YouTube, and you can watch him talk about tPA here.
The distorted narrative ended with tPA proponent Lewandowski relating how his own father was refused the drug by another ER physician who said he “doesn’t believe in the drug.”
His father had a facial droop and slurred speech. His right arm and right leg flopped about uselessly. His stroke scale was 7, moderately disabling, but he survived for a few more years.
“It was very difficult for me personally,” Dr. Lewandowski recalled. “I had spent so much of my professional life working on this treatment. It actually worked.”
“I felt like I had let my dad down.”
That dramatic conclusion might have been less compelling had the story explained the evidence that tPA offers a benefit is far from robust.
Hoffman noted the story could have been flipped to say Lewandowski’s father “got lucky because he didn’t get tPa and didn’t get a brain hemorrhage and die.”
But he said it’s wrong to declare a winning side when the evidence isn’t definitive.
“This is sort of a poster child for the way in which information is distorted by proprietary interests. For me, that’s the important message.”
Addendum 4/2/18: After this blog post ran, journalist Jeanne Lenzer wrote a guest post calling on health care journalists to be vigilant in reporting conflicts of interest of their sources.