NEW ENGLAND JOURNAL OF MEDICINE...Source of unbiased medical information or political WHORE
1. Journalistic Malpractice
Scott Gottlieb
As medical information is exploding and becoming more accessible, all of us, particularly physicians, need objective sources to interpret data and present a balanced view. Unfortunately, major medical journals that should be filling this role often put more weight on pushing political agendas. Their editorial prejudice has left a troubling void for rigorous and unbiased arbiters of medical evidence who can guide sound medical practice decisions.
The behavior of the New England Journal of Medicine (NEJM) is a case in point, when it rushed onto its Web site a limited and flawed analysis of safety concerns around the diabetes drug Avandia. The publication was timed to get ahead of the Food and Drug Administration's more careful evaluation of the same issues. The journal seemed bent on beating the FDA to the punch. The goal? Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals. The journal's motives were made bare by its own editorial on the matter.
While there are "questions" whether Avandia is associated with certain heart risks -- so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world -- the NEJM study doesn't add much new insight into those issues because of its own limitations. But you wouldn't know that from the way the Journal hyped its analysis to the media or opined about the study's significance. These facts weren't lost on clinicians and even NEJMs competitors. The Lancet, NEJM's British sister-publication, said of the study, "Alarmist headlines and confident declarations help nobody." A top American medical researcher told WebMD, "I can't help but wonder if the NEJM is functioning more like the mainstream press than a scientific journal at this point."
NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's "handling" of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study.
At what cost do political machinations of the medical journals come? NEJM editors have long favored more drug regulation. But medical journals have also historically played a special role in helping to define medical practice standards. Even decisions they make on how prominently to place a study, let alone how they editorialize about it, are seen as strong signals to clinicians on how doctors should weigh the evidence. So when editors pursue a political agenda, it's public health that pays a price. Degrading an institution that doctors depend on for balanced analysis and fair-minded editorial judgments isn't good for anyone.
In the case of the Avandia study, NEJM editors gave short shrift to the study's flaws. The paper, which re-analyzed the results of 42 earlier studies of the drug found on the Internet, revealed that Avandia might cause a small increase in the absolute risk of a heart attack. But the study that the authors did, called a "meta-analysis" because it aggregates results from lots of studies to generate a larger sample, contained a number of serious limitations.
Among other things, the authors of the NEJM study based their conclusions that Avandia caused a higher heart risk on just a handful of cardiac events, none of which they could go back and verify, because, unlike the FDA, the authors didn't have access to confidential patient records. A few heart events either way might have changed the study's findings. The way data was misused by NEJM will give pause to companies that agreed to more transparency around results of medical studies and who now post their clinical trial data online.
These shortcomings didn't stop NEJM from spinning the preliminary data into the conclusion that Avandia was a troubled drug mishandled by the FDA and comparing it to Vioxx, the pain drug withdrawn by Merck two years ago because it increased risk for heart attacks. Vioxx "represented a similar regulatory failure to insist on large trials of public health importance in a timely fashion," NEJM's editorial states.
Absent was any discussion by NEJM of the drug's benefits, or advice from diabetes experts on how doctors should counsel their patients based on the information.
There have now been too many instances where one of the major medical journals has used editorial decisions about publication and placement of bottom-line medical information as a tool to primarily influence political discourse, rather than informing medical practice. Many journals still hold the line and stick to scientific standards in their decision-making, but face political risks themselves in declining politically minded submission tactics. When it comes to the issue du jour, drug safety, no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval. Yet NEJM and other journals have tried on other occasions to upstage FDA investigations through well-timed but much less complete publications.
Nor is this the first time that NEJM timed release of a deceptive publication to influence political debate. Its now-infamous December 2005 editorial on the Vioxx affair, titled "Expression of Concern," advanced factual distortions that internal NEJM emails later revealed were timed to divert attention away from a damaging deposition that one of the NEJM editors had given in a Vioxx trial and, instead, place blame on Merck.
I have worked on the staff of two leading medical journals, the British Medical Journal and the Journal of the American Medical Association. These institutions fill an invaluable role informing clinical practice and maintaining standards for how rigorous clinical research ought to be conducted. There is a problem when some journals let antipathy for business interests and left-leaning views interfere with the medical decisions that they make, bending standards or stepping outside their mandate, using their prestige and influence in ways that distort medical facts in the aim of influencing political outcomes.
Prestigious biomedical journals are important public health tools, provided they stick to their core business of weighing medical evidence and informing physicians of important practice advances. When they use shortcuts and shoddy analysis to fabricate criticism and doubt of drug regulation, they're no better than some politicians they increasingly comport with.
Dr. Gottlieb, a physician, is resident fellow at the American Enterprise Institute and was Deputy Commissioner of the FDA from 2005 to 2007.
*******
2. New England Journal of Politics Part I
Wall Street Journal Jan. 16, 2006
Merck scored a court victory late last month, convincing all but one federal juror that it acted responsibly in developing and marketing its Vioxx painkiller. What makes the outcome more notable is that it came despite the efforts of Merck's latest accuser, the New England Journal of Medicine.
Accusations aren't the usual fare of august medical journals, so it's worth trying to understand the publication's self-insertion into the Merck litigation. Its extraordinary decision to publish a critical statement about a Vioxx study it ran years ago is being hailed by trial lawyers as the best evidence yet that Merck played fast and loose with its data. Another way to say this is that the New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.
The facts and timing of the Merck ambush certainly suggest as much. Late last year the New England Journal published an "Expression of Concern" about a Vioxx study it carried in 2000, baldly accusing researchers of omitting key data to make the painkiller appear more safe. The statement curiously appeared just as jurors began debating the latest Vioxx verdict. In case anyone missed the point, Executive Editor Gregory Curfman followed with his own attack on Merck, telling reporters he was "stunned" that the researchers had "allowed" his journal to publish a "misleading" article. In response to Merck's explanation, Dr. Curfman bluntly noted: "We're not buying into that."
Any journal has an obligation to demand honest studies. Yet the facts of this case suggest that is exactly what it got. In November 2000 the journal published a Vioxx study funded by Merck, which was ostensibly looking for gastrointestinal problems. In the course of the study, the researchers also discovered that participants showed a somewhat higher risk of heart attack from taking Vioxx as compared to another widely used painkiller, naxopren -- a fact they included in the published results.
What has Dr. Curfman in a dither is the fact that three more participants also suffered heart attacks -- though only after the cutoff date that had been determined by an outside safety panel for the study. The three heart incidents were included in an early draft of the paper, but they had disappeared by the time it went to press. The not-so-subtle accusation is that Merck manipulated the data.
* * *
In fact, as prominent scientists have since attested, the authors were simply following the rules of science. "If the outcomes truly occurred after the close of the study, then they don't belong in the study," Brian Strom, an epidemiologist at the University of Pennsylvania, told Nature magazine. As to a grand Merck cover-up, the company provided the additional information to the Food and Drug Administration, publicly released it not long after the journal's article, and included information about the additional heart attacks when it sent out marketing materials that included the published study.
The New England Journal clearly knew all this, and as an esteemed professional body presumably understood the scientific rationale behind the omission. Yet it nonetheless chose to use the Vioxx trial as an opportunity to join in the latest political and legal tarring of Big Pharma as greedy profiteers.
Dr. Curfman declined to discuss the case on the record, save for the following statement: "The editors of the New England Journal of Medicine expect that a manuscript submitted for publication will provide a complete and accurate description of the study that was done, and that certain data will not be withheld."
Unfortunately this attack on Merck isn't isolated, but is part of a growing trend among scientific journals that have joined business-bashing and other liberal campaigns. Last year a group of medical-journal editors joined in a partisan battle over "disclosure," refusing to publish studies unless companies had first registered at a federal clinical trial Web site.
As FDA Deputy Commissioner Scott Gottlieb noted in a September speech, this is ironic considering that the journals "bottle up" important research in overly long peer-review processes and enforce their own "strict embargoes" on key studies so as to elevate their own publishing franchise. There's also the question of proprietary drug data that no company is eager to share with competitors. "Disclosure," after all, counts for little if no company sees a financial reason to explore a drug in the first place.
* * *
Some of this behavior may, in fairness, be a response to criticism the journals themselves have received from the political left. Many have come under fire as stooges of Big Pharma because they get advertising revenue from drug companies. But in recent years the leadership of these publications has also taken an ideological turn.
Former New England Journal of Medicine Editor Marcia Angell has become a leading advocate of national health care (a la Canada's waiting lines) and drug price controls. Medical journals such as the Lancet bow to environmentalists by running reviews bashing the chemical DDT, despite its proven ability to save lives from malaria. The journal Science has refused to run research from noted academics questioning the theory of manmade global warming. Nature, Science and the Lancet have also declared war on genetically modified food; Nature published one study that was so shoddy it later ran a retraction.
The worry here is that the health community and broader public will soon have one less place to find legitimate "science." These publications have viewed themselves as the gold standard in research, using their peer review processes to build reputations for careful and unbiased science on the leading issues of the day. Any suggestion that these publications have an axe to grind -- whether against corporate America, private markets, or specific drugs -- undermines their standing as neutral arbiters. That in turn makes it that much harder to separate good science from the "junk" version. And that truly warrants an "expression of concern."
3.The New England Journal of Politics, Part II
The Editorial Board Wall Street Journal
The New England Journal of Medicine (NEJM) this week published an editorial denouncing “dangerously incompetent” leadership in Washington on the pandemic and all but endorsing Joe Biden for President. This will go down well in all the right precincts. But then please don’t complain if half of America suspects that science is increasingly politicized.
The editorial recites the government’s well-known failures in managing the coronavirus, such as the initial struggles to roll out testing and hand out enough protective equipment. We can’t disagree with that, but the editors go on to extol China’s virus management, conveniently ignoring its early cover-up and manipulation of the World Health Organization. Why are American elites so enamored of authoritarian command and control? The editors then hit the U.S. for late and inconsistent quarantines, without taking into account the public-health and economic costs of lockdowns.
You might say “the New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.” That’s a line from our 2006 editorial “New England Journal of Politics” describing how the NEJM had waded into a legal dispute over Merck’s painkiller Vioxx. The NEJM also appeared in these pages in 2007 for working to tank a diabetes drug and help Democrats in Congress to regulate treatment approvals more tightly.
Our contributor Scott Gottlieb noted at the time that medical journals have “historically played a special role in helping to define medical practice standards. Even decisions they make on how prominently to place a study, let alone how they editorialize about it, are seen as strong signals to clinicians on how doctors should weigh the evidence. So when editors pursue a political agenda, it’s public health that pays a price.”
Another prominent medical journal, The Lancet, has its own history of political incursions, such as a study on Iraq war casualties funded by anti-George W. Bush partisans. The NEJM’s latest editorial laments that “current leaders” have “undercut trust in science.” The irony is that much of the public distrust of expertise derives from years of scientists behaving like politicians.
WSJ Opinion: The Case For Stopping the Covid-19 Lockdowns
Wonder Land: Leading epidemiologists have come together to write "The Great Barrington Declaration," which urges a “Focused Protection” strategy in managing the coronavirus, and has already been signed by thousands of scientists. \
No comments:
Post a Comment