Northwestern scientists to meet with EPA to request important changes in guidelines
October 16, 2012 | by Marla Paul
CHICAGO — A team of Northwestern University scientists will meet with Environmental Protection Agency (EPA) administrators in Washington D.C. Oct. 18 to advocate for important changes in the agency’s guidelines for reproductive health research.
“The problem is current research assessing the risk of toxins on reproductive health is not being uniformly investigated in both sexes and across the lifespan,” said Kate Timmerman, program director of the Oncofertility Consortium of Northwestern University, who will be one of the scientists meeting with the EPA. The reproductive health guidelines have not been updated since 1996 and need to be revised to reflect new research findings.
The Northwestern team will ask the EPA to expand the definition of reproductive health beyond pregnancy to include the lifespan of an individual.
“Reproductive health is important across the entire lifespan because your endocrine system affects your bone health, cardiovascular health and other systems in the body,” Timmerman said. Endocrine disrupters, sometimes triggered by environmental factors, can lead to increased risk for stroke and heart attack as well as osteoporosis.
The Northwestern scientists also will request that all EPA-sponsored research require appropriate testing in both sexes. Currently many toxicity studies are only conducted in male animal models with the assumption that females are affected the same way, but that isn’t necessarily true.
“What happens now is if researchers don’t see an effect in males, they won’t look in females,” Timmerman said. “But we know certain toxins in the environment can have a significant effect on females and not males and vice versa.”
Timmerman and colleagues will present a white paper to the EPA on how to improve and update the guidelines.
In addition to Timmerman, other Northwestern scientists meeting with the EPA
include Kimberly Gray, professor of civil and environmental engineering at Northwestern’s McCormick School of Engineering and Applied Science; Mary Ellen Pavone, M.D., assistant
professor of obstetrics and gynecology at Northwestern’s Feinberg School of Medicine and a physician at Northwestern Memorial Hospital; and Francesca Duncan, reproductive scientist/research associate in the lab of Teresa Woodruff, chief of fertility preservation at the Feinberg School and director of the Oncofertility Consortium. Woodruff also is a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
- Scientists to EPA: Include women in reproductive health research (sciencedaily.com)
Some edits made, and new items added, late the same evening.
I’ve recently learned of some well-intentioned medical research that disturbs me so deeply that I think it’s time to get formal about teaching e-patients and their partners how to detect research that misses its target, even if it’s well intentioned.
Doing this responsibly requires a deep understanding of the purpose of research and its methods. So this is the start of a series in which I’ll lay out what I’ve learned so far, describe the problems and challenges and opportunities that I see, and invite dialog on where I’m wrong and your own experiences as patient or clinician or researcher.
If this succeeds we’ll have a new basis for considering questions of what to do and how to prioritize it, in this era of change in medicine – not just in research but in all of medicine, as we work on reducing our spend. My goal in the series will be to be as clear in my writing as I can, while being as verifiably accurate as I can, given that I’m no PhD or Pulitzer laureate. Critique and correction are welcome.
This first post is an introduction, with background reading.
Context: Patient Engagement
The context for this series is patient engagement: patients shifting from being “compliant” cars in a medical car wash to being responsible and engaged.
Empowered, engaged patients take responsibility for their health and their care. One aspect is being responsible for understanding, as best we can, the evidence that a recommended treatment is right for us. Sometimes it’s pretty simple, sometimes not; but the higher the stakes get, the more important it is.
With respect to research, there’s a big challenge: sometimes the published evidence sucks – even though it got through the peer review process and was approved by a big-name journal.
Of course not all evidence sucks. But if you’re considering whether to be cut open or eat chemicals (meds), you have a choice: trust blindly (“whatever you say, doc”) or take responsibility for understanding as much as you can.
As we’ll discuss, one big reason blind trust fails is that the evidence your doctor gets isn’t necessarily great, and most clinicians aren’t rigorously trained in how to scrutinize it. (They too are largely trained to trust the journal process.) So this is for them too.
- Patients and caregivers – the people on the receiving end of the treatment; the ones who make the decision to accept treatment.
- Clinicians, for two reasons:
- In a participatory relationship, the patient and clinician need to be on the same page regarding the basis for decisions, or one will think the other’s crazy
- As I said, in my experience most clinicians haven’t been rigorously schooled in the weakness of the info they were taught to trust. (This isn’t an insult; see homework below.)
- Health policy people (government and non-profits), because they need to be firmly grounded in reality, or they can’t possibly make policies that work in reality (eh?)
- Insurance companies (commonly euphemized as “care plans” or just “the plans”), who decide what will get paid for. (I know some insurance companies don’t mind paying for stuff that doesn’t work; they basically get a commission on all spending. But others do care what works and what doesn’t – some even have staff who help patients understand the options! They need to be well informed too.)
- Others, I’m sure.
This will make some people unhappy.
It’s the unhappiness that comes from realizing the world isn’t what you thought it was. And the unhappiness that comes from realizing you have to adjust.
But ladies and germs, disconnects like that are what keep a dysfunction in place and make problems intractable. So, comfortable or not, let’s get on with it. The unhappiness I anticipate:
- Some clinicians don’t welcome questions from their patients. (Others do.) In my personal experience most of the ones who object don’t realize how weak the evidence is.
- I hope they’ll remember what I learned in school: all science must be open to new information. (As SPM co-founder and ACOR founder Gilles Frydman said in 2010, “All knowledge is in constant beta.”)
- I know clinicians have many pressures including short appointments. This doesn’t have to be done by an MD; in my view of the future, every “medical home” will have coaches who can help assess published material.
- Some patients really don’t want to hear that the science they depend on – which has indeed produced miracles – has also produced crap sometimes. They especially don’t want to hear that clinicians – their clinicians, who they know are good people – aren’t perfect.
- In general, everyone wants certainty – doctors and patients alike – so it’s unsettling to know you can’t have it. (Even the best science has a chance of errors, and all science is subject to correction.)
Important: This is not a “we reject science” series.
- I love science. I personally am alive because of great medical research that created a harsh treatment delivered brilliantly by great clinicians at Beth Israel Deaconess in Boston. I love the training and clinical experience that made them able to save my life!
- It included great laparoscopic surgery and orthopedic surgery developed by great skilled scientists and delivered by skilled, adroit surgeons & teams. Hooray for science!
- But in the end, science knows that there is no certainty. They’re doing the best they can amid uncertainty. Heck, I myself live in uncertainty:
- The best evidence (which is not great) says there’s a 50% chance my cancer will return, which would likely kill me
- At diagnosis the evidence said I had 24 week median survival
- On the flip side, the treatment that did cure me usually doesn’t work.
Bottom line: There Is No Certainty.
The art of designing, conducting and reporting research includes dealing accurately with this issue.Whatever you read, there’s always a chance it’s wrong.
In my view, the ultimate responsible patient understands this, accepts the uncertainty (as best a human can), and responds by saying “Okay, what are the options? And what are the chances they’ll work?”
If you fully understand that much research is shaky and deserves questioning, you can skip to the end and wait for round 2. If not, read these past posts, because if you don’t realize there’s weakness, you have no reason to learn what comes next.
Here’s your homework.
Past posts establishing the need to be responsible for our decisions
These posts are from e-patients.net………
Click here for the rest of the post
- Is there hope for clinicians in the digital age? (guardian.co.uk)
- Martine Ehrenclou and “The Take-Charge Patient” (digitaldoorway.blogspot.com)
- Regular patient/clinician interaction can help increase follow-up cancer screening (medicalxpress.com)
- Helping Patients Communicate More Effectively About their Health (thielst.typepad.com)
A good overview of how improved data analysis and presentation is improving health care delivery.
I especially liked the slideshare presentation found below in Related Articles.
The 42 slides in Big data – a brief overview outlines what big data is, its sources and processes, how it is analyzed, current “players”,examples, market analysis, future, and opportunities.
Slowly but surely, health care is becoming a killer app for big data. Whether it’s Hadoop, machine learning, natural-language processing or some other technique, folks in the worlds of medicine and hospital administration understand that new types of data analysis are the key to helping them take their fields to the next level.
Here are some of the interesting use cases we’ve written about over the past year or so, and a few others I’ve just come across recently. If you have a cool one — or a suggestion for a new use of big data within the healthcare space — share it in the comments:Genomics. This is the epitomic case for big data and health care. Genome sequencing isgetting cheaper by the day and produces mountains of data. Companies such asDNAnexus, Bina Technologies, Appistry and NextBio want to make analyzing that data to discover cures for diseases faster, easier and cheaper than ever using lots cutting-edge algorithms and lots of cloud computing cores.BI[definition of business intelligence] for doctors. Doctors and staff at Seattle Children’s Hospital are using Tableau to analyze and visualize terabytes of data dispersed across the institution’s servers and databases. Not only does visualizing the data help reduce medical errors and help the hospital plan trials but, as of this time last year, its focus on data had saved the hospital $3 million on supply chain costs…...Semantic search. Imagine you’re a doctor trying to learn about a new patient or figure out who among your patients might benenfit from a new technique. But patient records have been scattered throughout departments, vary in format and, perhaps worst of all, all use the ontologies of the department that created the record. A startup called Apixio is trying to fix this by centralizing records in the cloud and applying semantic analysis to uncover everything doctors need, regardless who wrote it…..Getting ahead of disease. It’s always good if you figure out how to diagnose diseases early without expensive tests, and that’s just what Seton Healthcare was able to dothanks to its big data efforts…
- Better medicine, brought to you by big data [GigaOM] (gigaom.com)
- Intel and NextBio seek Big Data upgrades in genomics (fiercebiotechit.com)
- Big Changes Are Ahead For The Health Care Industry, Courtesy Of Big Data (fastcompany.com)
Big data – a brief overview (slideshare.net) [a slide presentation, 42 slides]
- Oracle adopts the popular R language for the enterprise and big data. (oracle.com)
- Presentation: Scalability Challenges in Big Data Science (architects.dzone.com)
- Salesforce intros Radian6 Insights for social big data (zdnet.com)
- Big Data Modeling – Part I – Defining “Big Data” and “Data Modeling” (infocus.emc.com)
- NextBio and Intel Announce Collaboration to Optimize Use of Hadoop Stack And Move Forward With Big Data Technologies in Genomics (ducknetweb.blogspot.com)
- A Beautiful Friendship: Big Data and Social Media (blogs.sap.com)
- Stanford rides Big Data wave in medical research (fiercebiotechit.com)
- Big Data? Big Deal! (clean-clouds.com)
he most over-used and under-analyzed statement in the academic vocabulary is surely “more research is needed”.
These four words, occasionally justified when they appear as the last sentence in a Masters dissertation, are as often to be found as the coda for a mega-trial that consumed the lion’s share of a national research budget, or that of a Cochrane review which began with dozens or even hundreds of primary studies and progressively excluded most of them on the grounds that they were “methodologically flawed”.
Yet however large the trial or however comprehensive the review, the answer always seems to lie just around the next empirical corner.
With due respect to all those who have used “more research is needed” to sum up months or years of their own work on a topic, this ultimate academic cliché is usually an indicator that serious scholarly thinking on the topic has ceased. It is almost never the only logical conclusion that can be drawn from a set of negative, ambiguous, incomplete or contradictory data…
- Understanding the nuances of evidence-informed healthcare (thehindu.com)
Looking for historical biomedical information? Try the redesigned IndexCat, a product of the US National Library of Medicine
In my last position as a medical librarian, IndexCat was the first place to go for finding historical biomedical articles and related information. Searches on IndexCat can find in minutes what took up to an hour or more in the print version, providing access to over 3.7 million items as information about books, journal articlesd,issertations, pamphlets, reports, newspaper clippings, case studies, obituary notices, letters, portraits, as well as rare books and manuscripts.
IndexCat has recently been redesigned for even easier access to the records of historical biomedical information.
IndexCat is “the [free!]online version of The Index-Catalogue of the Library of the Surgeon-General’s Office (Index-Catalogue) [, the]..multi-part printed bibliography or list of items in the Library of the Surgeon-General’s Office, U.S. Army. It contains material dated from the 1400s through 1950 and is an important resource for researchers in the history of medicine, history of science, and for clinical research.”[http://www.nlm.nih.gov/hmd/indexcat/abouticatalogue.html]
While IndexCat does not contain the full text of items, it provides enough information on them so they can be located at libraries.
If you need the full text of the items, the best place to start is your local public or academic library. Ask for a reference librarian.
He or she can help you find the item or assist you in getting a copy through interlibrary loan. And remember, most academic libraries will be happy to help those who are not affiliated with their institution. Just call ahead and ask how they assist the public.
Related blog post
How to obtain free/low cost medical and scientific articles (jflahiff.wordpress.com)
A growing concern with fraud and misconduct in published drug studies has led researchers at the University of Illinois at Chicago’s Center for Pharmacoeconomic Research to investigate the extent and reasons for retractions in the research.
“We were surprised to find the proportion of retractions due to scientific misconduct in the drug literature is higher than in general biomedical literature,” said Simon Pickard, associate professor of pharmacy practice and senior author of a study published in the journalPharmacotherapy.
Nearly three-quarters of the retracted drug studies were attributed to scientific misconduct, he said, “which includes data falsification or fabrication, questionable veracity, unethical author conduct, or plagiarism. While these studies comprise a small percentage of the overall literature, health care professionals may rely on this evidence to make treatment recommendations.”
These studies can affect the treatment of thousands of patients, since scientific publications are often printed months in advance. There is an average lag in time of 39 months between the original publication and a retraction notice, Pickard said.
“Once a health care professional changes treatment options, it’s not easy to reverse,” said Jennifer Samp, a fellow in Pickard’s research group and lead author of the study. “Staying current with new findings in scientific literature is a priority for health care practitioners — especially pharmacists — and it is important for them to know when a study has been retracted, especially those with manipulated data.”…
Evaluating Health Information (links)
- Scientific Lies: Facts in scientific drug literature may not be (talesfromthelou.wordpress.com)
- Ethical and Scientific Issues in Studying the Safety of Approved Drugs (jflahiff.wordpress.com)
- Interpreting the Scientific Literature (randi.org)
- How do you follow the scientific literature? (ketyov.com)
- Following the scientific literature through RSS (xcorr.net)
Every day, there is another medical study in the news. There’s another newspaper or TV story telling us that X can cure depression or make you thinner or cause autism or whatever. And since it’s a medical study, we usually think that it’s true. Why wouldn’t it be?
But what most people don’t realize, let alone really think about, is that there might be other studies that show that X does none of those things — and that some of those studies might never have been published.
Just this week, the journal Pediatricsreleased an article that perfectly demonstrates this problem. There have been a number of studies that have shown that a certain type of medication, selective serotonin reuptake inhibitors (SSRIs), can help stop the repetitive behaviors of autism, like hand-flapping or head-banging. If you were to do a search of the medical literature, as doctors and parents and patients often do, you’d think that using SSRIs is a good idea. But when researchers dug deeper, they found that there were just as many unpublished studies that showed that SSRIs didn’t help. If they had all been published (they were all good enough to be published), that same search of the medical literature would have shown that using SSRIs isn’t a good idea.
This is bad. We rely on studies to guide our decisions. What is going on?
The journals that publish articles certainly play a role. After all, it’s cooler to publish a study that has a grabby headline, that promises an answer or a cure. That’s much more likely to get readers than a study that says that something doesn’t do anything at all. But it turns out that the researchers themselves play a bigger role.
Some researchers don’t even write up their studies or try to publish them. ….
- Medical Research We Never Hear About: The Problem of Unpublished Studies (thehealthcareblog.com)
Credit: Wikipedia Commons
A medical doctor (who himself is a big draw at medical conferences) has recently questioned the motives and utility of medical conferences. [Mythbuster Ioannidis: Are Medical Conferences Really Useful?]
He believes much of the presented research findings are not fully peer-reviewed, and thus cannot fully educate, train, or contribute to evidence-based practice. Often findings at medical conferences are seized upon by the popular press and prematurely promoted as having sound scientific evidence. Quite often these findings change with peer review and are later published with the revisions and modified findings in scientific journals.
Excerpt from the 4 April 2012 JAMA (Journal of the American Medical Association) article
(The full text of this article is by subscription only, these excerpts came from a related posting at HealthNewsReview.org)
An estimate of more than 100 000 medical meetings per year may not be unrealistic, when local meetings are also counted. The cumulative cost of these events worldwide is not possible to fathom.
Do medical conferences serve any purpose? In theory, these meetings aim to disseminate and advance research, train, educate, and set evidence-based policy. Although these are worthy goals, there is virtually no evidence supporting the utility of most conferences. Conversely, some accumulating evidence suggests that medical congresses may serve a specific system of questionable values that may be harmful to medicine and health care.
The availability of a plethora of conferences promotes a mode of scientific citizenship in which a bulk production of abstracts, with no or superficial peer review, leads to mediocre curriculum vita building. Even though most research conferences have adopted peer-review processes, the ability to judge an abstract of 150 to 400 words is limited and the process is more of sentimental value.
Moreover, many abstracts reported at the medical meetings are never published as full-text articles even though abstract presentations can nevertheless communicate to wide audiences premature and sometimes inaccurate results. It has long been documented that several findings change when research reports undergo more extensive peer review and are published as completed articles.* Late-breaker sessions in particular have become extremely attractive prominent venues within medical conferences because seemingly they represent the most notable latest research news. However, it is unclear why these data cannot be released immediately when they are ready and it is unclear why attending a meeting far from home is necessary to hear them. A virtual online late-breaker portal could be established for the timely dissemination of important findings….
…Power and influence appear plentiful in many of these meetings. Not surprisingly, the drug, device, biotechnology, and health care–related industries make full use of such opportunities to engage thousands of practicing physicians. Lush exhibitions and infiltration of the scientific program through satellite meetings or even core sessions are common avenues of engagement. Although many meetings require all speakers to disclose all potential conflicts, the majority of speakers often have numerous conflicts, as is also demonstrated in empirical evaluations of similar groups of experts named on authorship lists of influential professional society guidelines.”
Ioannidis doesn’t discard the entire notion of conferences. In fact, he projects what “repurposed” conferences might be like:
“Repurposed conferences could be designed to be entirely committed to academic detailing (ed. note: drug company “educational” outreach to physicians). All their exhibitions and satellite symposia would deal with how to prescribe specific interventions appropriately and how to favor interventions that are inexpensive, well tested, and safe. Such repurposed conferences could also focus on how to use fewer tests and fewer interventions or even no tests and no interventions, when they are not clearly needed.”
- Tips on Locating Conference Proceedings
Includes advice on searching the Internet, databases, and contacting librarians and conference presentation authors
- Posters from Life Sciences and Medicine Conferences and Meetings
Not comprehensive, but worth checking
- The Missing Outcry – Are the NIH and Its Researchers Shirking Their Obligations? (scholarlykitchen.sspnet.org)
- Lessons for journalists and the public about all the news we hear from medical conferences (HealthNewsReview.org)
- Mythbuster Ioannidis: Are Medical Conferences Really Useful? (Common Health-Reform and Reality)