November 16th, 2013
A Critical Time for Health Research?
Siqin Ye, MD
Several Cardiology Fellows who are attending AHA.13 in Dallas this week are blogging for CardioExchange. The Fellows include Vimal Ramjee, Siqin Ye, Seth Martin, Reva Balakrishnan, and Saurav Chatterjee. You can read the next fellowship post here. For more of our AHA.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our AHA.13 Headquarters.
I’m excited to be part of the blogging team for CardioExchange’s coverage of the American Heart Association 2013 Scientific Sessions!
On my flight to Dallas this morning, as is my habit, I caught up on the stack of magazines and journals that were accumulating on my desk. As it happens, one of them was this week’s JAMA special issue, “Critical Issues in US Health Care.”
The articles inside were riveting. In a Viewpoint piece, “Toward a New Social Compact for Health Research,” Dr. Harvey Fineberg talks about the retrenchment of US investment in health research, as evidenced by declining NIH and overall funding in the last decade. In a separate Viewpoint, Dr. Donald Berwick discusses the “toxic politics” of healthcare. “Public trust in science is eroding”, he points out, while healthcare professions have largely been silent and have not vigorously advocated for needed reforms.
I think Dr. Berwick’s points also apply to the pressures faced by health researchers. Many of us engage in research because we believe that the advancement of medical science is a worthwhile pursuit and a societal good. But we don’t do a good job advocating for our beliefs in the public arena, so that there are far more members of Congress willing to fight against cuts in fighter plane orders than those who fight against cuts in the NIH budget. On this point, Dr. Fineberg writes:
“Perhaps no young physician scientists embark on a research career thinking it is a position in sales, but they quickly learn how necessary it is to convince others of the value and promise of their own research ideas. Today, it is equally important for health researchers to gain public confidence and trust in the value and promise of the whole of the scientific research enterprise for health.”
In my mind, this process of engaging the public can start with small steps: sharing on my Facebook feed an article debunking anti-vaccination myths, or, as my research shop has decided to do, prominently displaying the NIH logo on our posters and presentations. As I explore the scientific offerings at this year’s AHA meeting, I am also excited to see the AHA exploring new ways to engage the public, such as the mobile app that allows attendees to easily share the sessions they find interesting on social media.
But I also wonder about what more we can do. For instance, the American College of Cardiology recently added an “Ask-An-Expert” feature to their patient website to directly connect the public to ACC members. This inspired me to wonder: what if we also built an “Ask-A-Researcher” forum, featuring prominent researchers taking questions directly from the general public, similar to a Reddit AMA?
What do you think? How can we, as researchers and healthcare professionals, better engage the public?
perspective of 25 years in medicine:
Over recent years, the presentation of clinical research in the medical publications I have been reading has improved considerably . In the Annals of Internal Medicine, conclusions which were broad generalizations have been replace with appropriate summaries of the data with the target population identified. The Annals has also added an editors’ boxed summary with Context, Contribution , Caution and Implication added (always on the second page). Under Catherine de Angelis, MD, formerly editor in chief of JAMA, unsupported judgements in conclusions of study abstracts largely disappeared. In Journal Watch, the entries in “Comment” such as “now we know” have been replaced by “Here is stronger evidence”, or “this study shows that” by ” in this study ” and “we should” by “the findings support”.
The improved writing is more accurate and logical. Perhaps more important, it instructs the physician reading the article on the appropriate interpretation of the research. If the physician community is accepting unwarranted conclusions from published research, we can hardly expect reporters and the general public to do better. The published reports may be viewed by practicing physicians as being poorly written, but they are viewed by the public as authoritative.
The write-ups are better but could be better still. The Jupiter Trial write-up and the response in the June 28, 2010 issue of the Archives of Internal Medicine, are a case in point. The Jupiter trial, for which Dr. Ridker was the lead author, is a major clinical study supporting use of statins for primary prevention. The June 28, 2010 Archives of Internal Medicine has four articles addressing the Jupiter study with many questions about the way it was conducted, prematurely terminated, and interpreted by the lead authors. Data needed to make sense of the reported findings was not available in the reports. The reported findings did not appear consistent with previously reported epidemiological data. The reported findings did not appear to support the judgement to terminate the study prematurely. The move to have all study data freely accessible to everyone would reduce the problems. Supporting this movement is critical to eliminating the accusations of economic influence on interpretation of data as well as to eliminating the opportunity to hide such deliberate skewed interpretation if it does occur. This was a major problem in the writing available to the public about the Jupiter study.
In the Jupiter study, an elevated hsCRP is the basis of determining an increased risk of CAD, and so the criterion for some people that would qualify them for use of a statin. Paul Ridker, MD, a highly respected Cardiologist, is also the co-holder of the patent along with Brigham and Woman’s Hospital for the hsCRP assay. In a Medscape article following the Archives publication, Dr. Ridker makes clear that he believes that he was not influenced and the study was not effected by his potential gain if the hsCRP criterion is adopted. He clearly believes that the Jupiter Study design, execution and write-up is pure rigorous medical science of the highest quality. Whether he is immune from economic influence or not, the articles in the Archives provoked less than scientific responses from Dr. Ridker, e.g., “In this world, no matter how clear and blue the sky is, there will always be people who look up and see nothing but rain.” and “Why are people so unhappy that we saved lives?” Dr. Nissen of the Cleveland Clinic was quoted supporting Dr. Ridker saying, “The de Lorgeril paper is not science. It is more of an assault.” Far more cardiologists have been involved, published in the NYTimes, Time magazine and in Barbara Roberts case, her book, The Truth About Statins. For those of us who are not cardiologists and especially for the lay public, we have to rely on the experts for access to the data. We then use the data, and the presentation of the data to help us gauge how to weigh the judgements offered. In this case, even for the cardiologist researchers, the data and the facts have not been easy to locate, and the judgements have been suspect, leaving accusations of economic motives an understandable response.
These reports and editorial comments about the Jupiter study are particularly important in light of the new AHA/ACC cholesterol management guidelines. On November 18,2013, The NYTimes editorial board decided to warn the public against the recommendations of the AHA/ACC , academic medical institutions previously well respected. “Patients in good cardiovascular health would be well advised to stay away for now from following the cholesterol guidelines issued last week by the nation’s two leading heart organizations.”
The decision of such a major, trusted and influential organization as the NYTimes to take on academic medicine could hardly be a stronger indicator of the loss of trust in the medical establishment. About a week before the editorial, Gina Kolata, one of their main medical writers, wrote about the new guidelines. While the NYTimes editorial undermined confidence, appropriately, for it’s lack of reliability of the risk calculator. Kolata’s article further undermined that trust of medical decision making and inappropriate economic considerations when she wrote about the promotion of Zetia despite lack of evidence of end point benefit. The evidence is only of intermediate end point benefit, i.e lowering of LDL cholesterol level. She also pointed out that Merck earned $4.4 billion in 2012 Zetia plus Vitorin (Zetia combined with a statin), a drug with no proven benefit. This is not a fault of academic medicine alone, or the FDA alone, it is a fault of the medical system in which practicing physicians can be convinced that a drug is useful, and so believe that they should use it, when there is no such evidence. The unavoidable concern is to wonder how many other medical treatments are being prescribed without adequate evidence?
Researchers bear the responsibility not only to make sure that their own research is well designed to eliminate bias as much as possible, and to be written up so as not to be misleading to the hurried physician who may read no further than the title, or the conclusion of the abstract, but you are also responsible for reading your colleagues published studies and writing letters to the editor to point out to practicing physicians who will not be as knowledgable as yourselves, the limitations and errors in design or interpretation of the study and its results.
Sorry this was so long. To those of you who read this, thank you for your time.
Thank you Dr. Vassar for your thoughtful perspective. I also worry about academic medicine losing the trust of the general public, and I agree with you that we have to better manage the relationships between research, industry, and the public interest to maintain/restore that trust. In that we all have a role to play.
That being said, I was taken aback by the reflexive cynicism that can be seen, for example, in the comment section of Gina Kolata’s article. It’s ironic, because the new guidelines actually try to move away from LDL lowering drugs, such as Zetia, that hasn’t demonstrated cardiovascular benefit. These points were well-discussed in places like theheart.org and Dr. Krumholz’s blog, but may not have reached as many people as the initial NYT article. Which makes it all the more important for us to keep doing our best to be responsible researchers and practitioners.