Boston Globe reports: Biolab & ebola

Two recent Boston Globe items of note:

Local hospitals prep for ebola

emergencyIn response to the West African outbreak of the deadly Ebola virus, some Boston hospitals are instructing clinical staff to ask patients as soon as they arrive about their travel histories, and reminding doctors and nurses of the symptoms.

But hospital officials say they would be ready to quickly identify the illness and prevent its spread if an infected patient showed up, using protocols and equipment already in place.

Column : Local biolab sits mostly empty as the CDC copes with its own lab safety crisis.

Over a decade of community protests, Boston University has beaten back lawsuits aimed at closing the lab and won City Council backing. Final approvals are still pending from the Boston Public Health Commission and the federal Centers for Disease Control and Prevention.

Its critics, though, have been given fresh ammunition: The CDC confessed earlier this month to sloppy handling of anthrax and avian flu at its laboratories elsewhere, exposing dozens of employees to the deadly bacteria. The mistake was the kind that proponents of the Albany Street lab had called nearly impossible.

“The CDC example is a wake-up call, if you needed a wake-up call,” said David Ozonoff, a Boston University professor and the longtime dean of its department of environmental health who opposes the lab.

In today’s Globe: Stem cells, retractions, cystic fibrosis and lung transplants.


Two items of note, including one from obit writer Bryan Marquard on a patient who survived Mass General’s first living-donor double-lung transplant  which was “so new that no one could venture odds for long-term survival.Mr. Bean was 20 that July day as he lay on the operating table, helping advance science as much as he hoped to extend his life. He was 38 when he died in Mass. General on April 14, several months after his body began to reject the transplanted lungs and complications set in.”


And from Carolyn Y. Johnson’s always solid but hard-to- find science blog. Read it inside the Monday business section. Good luck finding it online.  Here’s some help:

Retracted stem cell papers get public, private scrutiny

Something would turn out to be wrong with both papers. Where these two tales diverge is how these problems have been handled.

In the weeks since the paper describing the acid bath technique was published in the journal Nature, it has been thoroughly — and publicly — picked apart. Several of its Japanese authors have held press conferences. The president of the RIKEN research institution in Tokyo, where many of the authors work, has apologized to the scientific community, prefacing his public remarks with a deep bow. RIKEN has released detailed reports and been specific about what portions of the paper it was investigating and what was found. It publicly accused a young scientist named Haruko Obokata of fraud, a finding she is appealing.

The incident has sparked a national discussion about the state of science in Japan and the need to ensure high standards in order not to lose the world’s trust.

In contrast, the 2012 paper was withdrawn in April without fanfare: a barebones retraction notice posted by the journal Circulation stated an institutional review had found that the paper contains unspecified “compromised” data. No details were provided about what was wrong with the data.

HIV, gone after marrow transplant, returns to Boston’s “Berlin” patients

Update: Health News Review used this story as an example of overuse of the term “cure.” HNR also pointed out how the “cure” got a lot of coverage and the news that it wasn’t a cure did not.

The Globe’s story is behind the paywall. Here is the nut.

Or here

Boston researchers are reporting the return of the HIV virus in two patients who had become virus-free after undergoing bone marrow transplants, dashing hopes of a possible cure that had generated widespread excitement

The story reports that doctors detected the return of the virus in one patient in August. The second patient chose to continue in the study, but in November, doctors found traces of HIV and he went back on his medication

Some background here from Nature Boston. 

More on the meeting where this was reported here.

As pointed out above in HNR, the overuse of the term “cure” often leads to disappointment? Here’s what the Google search looks like:

ssniOr here.

Genetics and autism: One study, one story

Two Boston-linked stories today on the genetics of Autism.

ss sciFrom the Scientist Last year a team of Australian scientists claimed to have developed a genetic test that predicts risk for autism spectrum disorder (ASD) with “72 percent accuracy.”y night at a Boston fundraiser in support of his research into the functioning of brain synapses in autism

The Scientists reports that they said the test  “may provide a tool for screening at birth or during infancy to provide an index of at-risk status.”

But a new study, led by Benjamin Neale from Massachusetts General Hospital, suggests that those claims were overblown. Neale’s team replicated the Australian group’s research in a larger sample, and found that the proposed panel of markers did not accurately predict ASDs.

“The claims in the original manuscript were quite bold. If they were true, it really would have been quite a major advance for the field, with serious ramifications for patients and other risk populations,” said Neale. “I think it’s important to ensure that this kind of work is of the highest quality.”

More here from SciBlogger Emily Willingham. 

And, this from WBUR

BOSTON — For Timmy and Stuart Supple, a pool is one of the best places to be. That’s where their mother thought the boys, who are 8 and 10 years old and severely autistic, would be the most calm and least stressed for a very important introduction.

“We, we, we go see the doctor?” 10-year-old Stuart asked his mother.

His mother, Kate Supple, tells him the man standing in front of him by the pool is the doctor. Dr. Thomas Sudhof has never met the boys, but he wants to see their autism unchecked.

Sudhof isn’t a pediatrician or one of the myriad of therapists trying to get into their world and bring them out. The Stanford University neuroscientist — who this year shared the Nobel Prize in medicine for his decades of study into how brain cells communicate — has been studying Tommy and Stuart’s genes, specifically an alteration in one gene, for five years. The Supples hosted Sudhof Wednesda

From the Scientist Last year a team of Australian scientists claimed to have developed a genetic test that predicts risk for autism spectrum disorder (ASD) with “72 percent accuracy.”y night at a Boston fundraiser in support of his research into the functioning of brain synapses in autism

The Scientists reports that they said the test  “may provide a tool for screening at birth or during infancy to provide an index of at-risk status.”

But a new study, led by Benjamin Neale from Massachusetts General Hospital, suggests that those claims were overblown. Neale’s team replicated the Australian group’s research in a larger sample, and found that the proposed panel of markers did not accurately predict ASDs.

“The claims in the original manuscript were quite bold. If they were true, it really would have been quite a major advance for the field, with serious ramifications for patients and other risk populations,” said Neale. “I think it’s important to ensure that this kind of work is of the highest quality.”

Therapeutic misconception: Reporting on the Cape Cod clinical trial participant

images nihA WBUR host on fundraising duty this morning talked about how NIH has figured out a way around the federal shutdown to get a so-called life-saving treatment to a Cape Cod man in a drug study.

The fact is, if you are in a clinical trial, no one can promise that you are getting a life-saving drug. The purpose of a clinical trial is to prove or disprove that experimental drugs are life saving.

The patient on the Cape is in a study to test whether a drug approved for thyroid cancer  will work on his metastatic bile duct cancer. For him, it’s hope. But it’s research. The “therapeutic misconception” is the notion that clinical trials offer  teatment. In randomized trials, you’re not even guaranteed to get a drug — you might get a placebo.

A researcher from the psychiatry department at UMass Medical puts it this way: “The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research.”

The Globe:

Cape Cod man’s last-chance treatment for cancer…father of three is now unlikely to receive an experimental drug 

.. cabozantinib, a drug approved for thyroid cancer but still experimental to treat other cancers….

expected to be treated in research studies over the next few weeks. via from AP :

NIH director Francis Collins told the Associated Press that each week the shutdown continues, the NIH hospital will have to turn away 200 patients, 30 of them children, seeking to enroll in new studies—often for last-resort treatments after they’ve exhausted all other options.

Just saying.

Don’t have a hot attack: Framingham Heart Study carries on

fhsWhat is up with the Framingham Heart Study? That long-running research project has been tracking the cardiac health of hundreds of local folk for decades.  (The algorithm used to estimate the 10-year risk of heart disease is called the “The Framingham Risk Score.”)

A story and a blog post recently reported woefully about a 40 percent sequester cut to the study’s National Institutes of Health funding.  Neither quoted anyone from NIH.

So, both pieces failed to note that the cut is to the study’s administrative grant from the National Heart Lung and Blood Institute, not its research grants.  According to BU, the study receives an estimated $5.4 million in NIH grants for research. This funding is not impacted by the 40 percent cut.

In other words, the cuts come from the money used to run the program – office staff, data collection and the management of study subjects, not the scientific research projects that fall under the program’s umbrella. The data collected from the locals helps researcher understand the mechanics and, more recently, the genetics of heart disease as it impacts the rest of us.

In total, NIH says it will spend $21 million this year contracts for the FHS study infrastructure – including a study looking for biomarkers for heart disease. In addition to funding the BU research, NIH says its grants cover 17 FHS related studies at eight different organizations and universities. In addition to the Heart Lung and Blood institute, that money comes from five other NIH institutes and centers, including the National Institute on Aging, The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Neurological Disorders and Stroke.

None of this was clear in this first, July 20 story from the Metro West Daily:

The Framingham Heart Study expects to lose $4 million in funding as part of the federal budget cuts known as sequestration, study officials confirmed Friday in a statement. The $4 million cut takes effect Aug. 1 and represents 40 percent of funding it receives from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health, the statement said.

 The story quotes a spokeswoman from Boston University, which is home to the study.

The cut with “result in a reduction in workforce affecting 19 staff from a variety of clinical and administrative areas, as well as reductions in clinic exams and lab operations.”

Then it quotes from a statement about NIH cuts in general from new Sen. Ed Markey:

“Slashing critical federal investment in medical research jeopardizes the health of many Massachusetts residents, while putting at risk tens of thousands of jobs in the commonwealth’s innovation economy and the industries they support,” Markey said. 

Then it quotes from Karen LaChance, a Framingham resident and president of the Friends of the Framingham Heart Study.

“We just hate to see any cut. It delays hopefully finding whatever the magic bullet might be to prevent heart disease.

Then it doesn’t quote anyone from NIH.

In a post on the Metro West Daily story,  WBUR’s CommonHealth blog offers the headline “Famed Framingham Heart Study Faces Deep Cuts From Federal Sequester.”

It was a “Say it isn’t so” moment this morning when I saw this MetroWest Daily News headline: Framingham Heart Study Faces $4 Million Cut. “Heart disease is the country’s number 1 killer, and chances are whatever you do to prevent it or treat it was influenced by the Framingham Heart Study, a venerable epidemiological gem right here in our own Boston suburbia….”

But, you could argue that it ain’t so.

As far as the impact of the cuts, Metro West Daily quote  BU as noting that “This loss of funding will result in a reduction in workforce affecting 19 staff from a variety of clinical and administrative areas, as well as reductions in clinic exams and lab operations.”

BU tells us that approximately 80 people work at the FHS. “The affected staff will see a reduction in hours beginning Aug. 19; if alternative funding sources are not identified, a layoff would occur Nov. 1. “

The FHS site was a little clearer on all this, with note on its home page:

New Information for FHS Participants edited July 20 2013

Q. Is the FHS closing?
A. No. The current Offspring and Omni Group 1 exams are continuing to Oct. 31, 2013. Ancillary studies are continuing as planned. Medical history updates are being collected on the regular schedule. Please respond to calls for FHS participation as usual.

By Wednesday August 1, BU had posted its own story on the BU Today website with the headline: “Framingham Heart Study Carries on, Despite Budget Cuts: 65-year-old core contract loses 40 percent of funding.”

Storify: Coverage of the UMass #Down syndrome/gene silencing study #genetics

BHN Likes Storify but WordPress doesn’t. Click on the picture to go to the full collection of stories on the UMass Down syndrome study.

ss down s

How to predict suicide risk: A Harvard researcher proposes a test



The New York Times Magazine profiles the work of Harvard psychologist Matthew K. Nock, the director of Harvard University’s Laboratory for Clinical and Developmental Research. Word association begins to describe, but probably oversimplifies, his approach.

The story calls 39-year-old Nock, as “one of the most original and influential suicide researchers in the world.”

The inscrutability of suicide has not kept most psychologists who study it from theorizing about why people kill themselves. Nock, however, tends to approach theories from a different angle. “I think it’s easy to generate explanations,” he said recently. “It’s much harder to test out these different explanations and see whether the data support them or not.”

In 2003,  Nock approached his colleague about the Implicit Association Test, “famous for its ability to measure biases that subjects either don’t care to acknowledge or don’t realize they have on topics like race, sexuality, gender and age. Nock wondered if the I.A.T. could be configured to measure people’s bias for and against being alive and being dead, and Banaji thought it was worth a try. They experimented with several versions in Nock’s lab and at the psychiatric-emergency department at Mass General. Then they put their best one on a laptop and offered it to Mass General patients, many of whom had recently threatened or attempted suicide; 157 agreed to take it. Hunched in plastic waiting-room chairs or propped up in cots as they waited for a clinician to admit or discharge them, they were often grateful for a distraction…The I.A.T., it seemed, was picking up a heightened signal of suicidal tendencies that the most commonly used method for assessing risk — a clinical interview — had been powerless to detect.

More from The Washington Post.

Update 7/10: Knight Science Tracker knocks this as a single source story.



AAAS Boston science meeting: Genomics, bioengineering, stroke research and more

aaas logoThe annual meeting of the American Association for the Advancement of Science (aka Triple-A-S) is coming to Boston in February.They offer plenty of sessions on health topics in between panels on chemistry, astrophysics and robotics.

It’s not exactly an academic meeting and not exactly for the general public. Unless you’re s student, the registration fees start at $235 and go up. But, we’ll be reporting on some of the below events  here and elsewhere.  This is just a selection from the program

The Science of Uncertainty in Genomic Medicine

Friday, 15 February 10:00AM-11:30AM

Organized by: Reed E. Pyeritz, University of Pennsylvania, Philadelphia; Shili Lin, Ohio State University, Columbus


Giovanni Parmigiani, Harvard Medical School, Boston, MA

How Useful Is It to Know Your Genome?

James P. Evans, University of North Carolina, Chapel Hill

Genomics in Clinical Medicine: Navigating the Spectrum from Certainty to Uncertainty

Robert C. Green, Partners Center for Personalized Genetic Medicine, Boston, MA

A Data-Driven Pathway to Genomic Medicine

Between Science, Society, and Policy

Saturday, 16 February 8:30AM-11:30AM

Organized by: Peter Yang, Brenna Krieger, and Kevin Bonham, Harvard University, Boston, MA


Ting Wu, Harvard University, Boston, MA

Personal Genetics and Education

Mary Carmichael, Boston Globe, Malden, MA

The Media and the Personal Genetics Revolution

Brian Naughton, 23andMe Inc., New York City

Commercialization of Personal Genomics: Promise and Potential Pitfalls

Mira Irons, Children’s Hospital Boston, MA

Personal Genomic Medicine: How Physicians Can Adapt to a Genomic World

Sheila Jasanoff, Harvard University, Cambridge, MA

Societal and Ethical Dimensions of the Personal Genomics Revolution

Jonathan Gitlin, National Human Genome Research Institute, Bethesda, MD

Personal Genomics and Science Policy


Interfacing with the Body Using Implants and Prostheses

Sunday, 17 February 8:00AM-9:30AM

Organized by: Erin Heath, AAAS Office of Government Relations, Washington, DC


Leigh Hochberg, Massachusetts General Hospital, Boston

Restoring Communication and Mobility Through Neurotechnology

*Hugh Herr, Massachusetts Institute of Technology (MIT) Media Lab, Cambridge, MA

Perfecting the Prosthetic Limb

Joseph F. Rizzo III, Harvard Medical School, Boston, MA

Creating a Retinal Implant


Biotechnology and Nanotechnology

Monday, 18 February 9:45AM-12:45PM

Organized by: Elicia M.A. Maine, Simon Fraser University, Vancouver, BC, Canada; James M. Utterback, MIT, Cambridge, MA


Robert S. Langer, MIT, Cambridge, MA

Challenges and Opportunities at the Confluence of Biotechnology and Nanomaterials

Nathan Lewis, California Institute of Technology, Pasadena

Clean Energy Innovation from the Confluence of Technologies

Sarah Kaplan, University of Toronto, ON, Canada

The Process and Practice of Interdisciplinary Research

Elicia M.A. Maine, Simon Fraser University, Vancouver, BC, Canada

Global Bio-Nano Firms: Exploiting the Confluence of Technologies

Han Cao, BioNano Genomics Inc., San Diego, CA

Commercializing Innovation: Applying Nanotechnology to Genomics


Why is Living Healthily So Difficult?

Saturday, 16 February 1:00PM-2:30PM

Organized by: Benedikt Herrmann, Joint Research Center, European Commission, Ispra, Italy; Geraldine Barry, Joint Research Center, European Commission, Brussels, Belgium


David Laibson, Harvard University, Cambridge, MA

Behavioral Economics and Health Behaviors

Todd Hare, University of Zürich, Switzerland

Neurobiological Mechanisms of Self-Control in Value-Based Choices

Benedikt Herrmann, Joint Research Center, European Commission, Ispra, Italy

How Much Do Social Norms Influence Our Ambitions To Live Healthily?


The Toxicological Impact of the Gulf of Mexico Oil Spill on Human and Wildlife Health

Saturday, 16 February 8:30AM-11:30AM

Organized by: John Pierce Wise Sr., University of Southern Maine, Portland; R. Joseph Griffitt, University of Southern Mississippi, Ocean Springs


Iain Kerr, Ocean Alliance, Gloucester, MA

Introduction to the Deepwater Horizon Accident

Samantha B. Joye, University of Georgia, Athens

Impact of the Gulf Oil Crisis on the Sea Floor

Carys Mitchelmore, University of Maryland Center for Environmental Science, Solomons, MD

Laboratory Studies to Assess the Effects of Oil Spill Chemical Dispersants on Corals

R. Joseph Griffitt, University of Southern Mississippi, Ocean Springs

Effects of Dispersed Oil on Larval Sheepshead Minnows

Greg Mayer, Texas Tech University, Lubbock

Weathering and Dispersion of Crude Oil Alter Its Toxicity in Fundulus Grandis

John Pierce Wise Sr., University of Southern Maine, Portland, ME

The Gulf of Mexico Offshore Toxicology Study


A 50 Year Legacy: Why does Rachel Carson Matter?

Sunday, 17 February 10:00AM-11:30AM

Organized by: Jane Maienschein and Gregg Zachary, Arizona State University, Tempe, AZ


Sharon Kingsland, Johns Hopkins University, Baltimore, MD

Bridging Two Cultures: Rachel Carson as Scientist and Humanist

Gregg Zachary, Arizona State University, Tempe, AZ

Back to the Future: The Rachel Carson “Model” as a Response to the Crisis in Science

Jane Lubchenco, NOAA, Washington, DC

Rachel Carson and Responsible Science Policy


The Benefits of Randomized Experiments for Science and Society

Friday, 15 February 1:00PM-2:30PM

Organized by: Daniel McCaffrey, RAND Corp., Pittsburgh, PA


Arthur Lupia, University of Michigan, Ann Arbor

Experimenting with Politics

Michael Kremer, Harvard University, Cambridge, MA

Experimenting with Public Health and Education in the Developing World

Susan Murphy, University of Michigan, Ann Arbor

Experimenting to Improve Clinical Practice


Stroke Research: New Concepts and Innovative Solutions

Friday, 15 February 3:00PM-4:30PM

Organized by: Virginija Dambrauskaite and Ruxandra Draghia-Akli, European Commission, Directorate General for Research and Innovation, Brussels, Belgium


Costantino Iadecola, Weill Cornell Medical College, New York City

Great Expectations: The Promise of the Neurovascular Unit for Stroke Therapy

Molly Shoichet, University of Toronto, ON, Canada

Engineering Meets Medicine: Innovative Strategies To Overcome Stroke

Stephen Meairs, University Medical Center Mannheim, University of Heidelberg, Germany

The European Stroke Network: A Platform for Overcoming the Translational Roadblock


Engineering the Nervous System: Solutions to Restore Sight, Hearing, and Mobility

Sunday, 17 February 1:30PM-4:30PM

Organized by: Sanna Fowler, Ecole Polytechnique Fédérale de Lausanne, Switzerland


Stephanie P. Lacour, Ecole Polytechnique Fédérale de Lausanne, Switzerland

Flexible Electronics for Interfacing with the Nervous System

Silvestro Micera, Ecole Polytechnique Fédérale de Lausanne, Switzerland

Controlling a Prosthetic Hand with Peripheral Neural Interfaces

Grégoire Courtine, Ecole Polytechnique Fédérale de Lausanne, Switzerland

Walking Again After Spinal Cord Injury

Konstantina M. Stankovic, Harvard Medical School, Boston, MA

Reversing Infant Deafness Through Genetic Engineering

Joan Miller, Harvard Medical School, Boston, MA

Saving Sight in Retinal Disease


Predicting Major Events and Planning for Hazards: An Art or Science?

Friday, 15 February 10:00AM-11:30AM

Organized by: Julia Wilson, Sense About Science, London, United Kingdom; Albert Yuan, San Lian Life Weekly, Beijing, China


Kelin Wang, Geological Survey of Canada, Sidney, BC

Operational Earthquake Prediction: Castles in the Air

Azra Ghani, MRC Center for Outbreak Analysis and Modeling, London, United Kingdom

Disease Scares: Predicting and Preparing for Outbreaks

Peter Webster, Georgia Institute of Technology, Atlanta

Assessing Risk from Climate Change: Scenario Generation Versus Prediction

Can Exposure Science Quell the Furor over Environmental Endocrine Disruption?

Saturday, 16 February 1:30PM-4:30PM

Organized by: Justin G. Teeguarden, Pacific Northwest National Laboratory, Richland, WA


Russ Hauser, Harvard School of Public Health, Boston, MA

BPA and Human Health: Epidemiologic Evidence and Its Interpretation

K. Barry Delclos, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR

Relating Internal BPA Doses to Adverse Effects in Rodent Toxicity Studies

Daniel R. Doerge, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR

BPA Pharmacokinetics in the Adult and Perinatal Periods in Experimental Animals

Justin G. Teeguarden, Pacific Northwest National Laboratory, Richland, WA

Estrogen Receptor Activation Potential of Internal Concentrations of BPA in Humans

Jeffrey Fisher, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR

Estimating Infant and Adult Human Serum Levels of Unconjugated Bisphenol A

Richard M. Sharpe, University of Edinburgh, United Kingdom

Are Causal Associations in Epidemiological Studies of BPA Exposure Plausible?


Global Health and Environmental Impacts of E-Waste Recycling

Friday, 15 February 3:00PM-4:30PM

Organized by: Erica L. Dahl, SafeBridge Consultants Inc., New York City; Bruce A. Fowler, ICF International, Fairfax, VA


Sanmi Areola, Environmental Health Services, Metro Public Health Department, Nashville, TN

The Scope of the Problem: International Regulation and the Basel Treaty

Myrto Petreas, California Department of Toxic Substances Control, Berkeley

Regulated and Unregulated Contaminants in California Waste Streams

Aimin Chen, University of Cincinnati Department of Environmental Health, OH

E-Waste Recycling in Developing Countries: Concerns of Developmental Toxicity

Boston docs on debate over cholesterol screening for kids

A couple of Boston-area docs weigh in on charges of industry influence in the debate over whether to test kids for cholesterol.  From the Globe:

CHICAGO — Should all US children be tested for high cholesterol? Doctors are still debating that question months after a government-appointed panel recommended widespread screening that would lead to prescribing medicine for some kids.

Fresh criticism was published online Monday in the journal Pediatrics by researchers who say the guidelines are too aggressive and were influenced by panel members’ financial ties to drug makers.

Other criticism was published earlier this year in the Journal of the American Medical Association. …JAMA included additional criticism from a dissenting member of the panel that produced the kids’ cholesterol guidelines, Dr. Matthew Gillman of Harvard Medical School. He recommends more narrow screening based on family history of cholesterol problems.

… Dr. Sarah De Ferranti, an American Academy of Pediatrics spokeswoman and director of preventive cardiology at Boston Children’s Hospital, said the question should be part of a conversation parents should have with their pediatrician about heart disease risks, including weight, blood pressure, and lifestyle. She said she would have her children tested.

Most of the Peds articles are behind the pay wall. But, UCSF put out a press release on the latest comments. And the NIH guidelines are online.

From NIH: Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents

From UCSF: New lipid screening guidelines for children overly aggressive, UCSF researchers say recommendations fail to weigh benefits against potential harms

Recent guidelines recommending cholesterol tests for children fail to weigh health benefits against potential harms and costs, according to a new commentary authored by three physician-researchers at UCSF.

Moreover, the recommendations are based on expert opinion, rather than solid evidence, the researchers said, which is especially problematic since the guidelines’ authors disclosed extensive potential conflicts of interest.

The guidelines were written by a panel assembled by the National Heart, Lung and Blood Institute (NHLBI) and published in Pediatrics, in November 2011. They also were endorsed by the American Academy of Pediatrics. The guidelines call for universal screening of all 9 to 11-year-old children with a non-fasting lipid panel, and targeted screening of 30 to 40 percent of 2 to 8-year-old and 12 to 16-year old children with two fasting lipid profiles. Previous recommendations called only for children considered at high risk of elevated levels to be screened with a simple non-fasting total cholesterol test.

The call for a dramatic increase in lipid screening has the potential to transform millions of healthy children into patients labeled with so-called dyslipidemia, or bad lipid levels in the blood, according to the commentary by Thomas Newman, MD, MPH, Mark Pletcher, MD, MPH and Stephen Hulley, MD, MPH, of the UCSF Department of Epidemiology and Biostatistics and e-published on July 23 in Pediatrics.

“The panel made no attempt to estimate the magnitude of the health benefits or harms of attaching this diagnosis at this young age,” said Newman. “They acknowledged that costs are important, but then went ahead and made their recommendations without estimating what the cost would be. And it could be billions of dollars.”

Some of the push to do more screening comes from concern about the obesity epidemic in U.S. children. But this concern should not lead to more laboratory testing, said Newman.

“You don’t need a blood test to tell who needs to lose weight. And recommending a healthier diet and exercise is something doctors can do for everybody, not just overweight kids,” he said

The requirement of two fasting lipid panels in 30 to 40 percent of all 2 to 8-year olds and 12 to 16 –year- olds represents a particular burden to families, he said.

“Because these blood tests must be done while fasting, they can’t be done at the time of regularly scheduled ‘well child’ visits like vaccinations can,” said Newman. “This requires getting hungry young children to the doctor’s office to be poked with needles on two additional occasions, generally weekday mornings. Families are going to ask their doctors, ‘Is this really necessary?’ The guidelines provide no strong evidence that it is.”

The authors note that the panel chair and all members who drafted the lipid screening recommendations disclosed an “extensive assortment of financial relationships with companies making lipid lowering drugs and lipid testing instruments.” Some of those relevant relationships include paid consultancies or advisory board memberships with pharmaceuticals that produce cholesterol-lowering drugs such as Merck, Pfizer, Astra Zeneca, Bristol-Myers Squibb, Roche and Sankyo.

“The panel states that they reviewed and graded the evidence objectively,” said Newman. “But a recent Institute of Medicine report recommends that experts with conflicts of interest either be excluded from guideline panels, or, if their expertise is considered essential, should have non-voting, non-leadership, minority roles.”

Evidence is needed to estimate health benefits, risks and costs of these proposed interventions, and experts without conflicts of interest are needed to help synthesize it, according to Newman. He said that “these recommendations fall so far short of this ideal that we hope they will trigger a re-examination of the process by which they were produced.”


Newman and Hulley have no disclosures. Pletcher has NIH funding to support research on targeting of cholesterol-lowering medications to prevent cardiovascular disease.


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