MGH editor threatens retraction after lung study consent problems

The NYTimes reports that the doctors who conducted the 50,000 patient lung cancer screening trials “were unable to locate 90 percent of the consent forms.”

The finding casts further doubt on a clinical trial that made headlines in 2006 when it concluded that fully 80 percent of lung cancer deaths could be prevented through wide use of CT scans.

That trial, led by Dr. Claudia I. Henschke at Weill Cornell Medical College in New York City, drew sharp criticism from skeptics of cancer screening; the criticism intensified when The Times reported in March 2008 that the research was being financed in part by $3.6 million in grants from the parent company of the Liggett Group, a cigarette maker.

The confidential report on patient consent, dated Oct. 7, 2008, recommended that the trial be stopped. But it continues to this day, although not at Weill Cornell.

The Cancer Letter also reports extensively on the case.

The story further reports:

Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chief of The Oncologist journal, said he would ask Weill Cornell for an explanation of the problems outlined in the 2008 scientific review, as well as a follow-up to the report. His journal has published research by Dr. Henschke, and “if we find there was no informed consent for those patients, the paper would have to retracted,” he said.

Finally, the story also quotes Dr. P. Pearl O’Rourke, director of human research affairs at Partners HealthCare.

Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chi

The responsible conduct of a study requires that informed consent documents be kept on file,” said Dr. P. Pearl O’Rourke, director of human research affairs at Partners HealthCare, part of Harvard University. “There should be a system so that every consent form can be found no matter if individuals were enrolled at a single site or multiple sites.”

John D. Rodgers, a spokesman for Weill Cornell, wrote in an e-mail that the medical school followed federal research regulations “and there were no issues regarding the safety of the research subjects.”

Lots of biomedicine at the Cambridge Science festival

Starting tomorrow and carrying on for ten days, the Cambridge Science Festival offers over 170 events. But don’t dawdle. There’s a preview talk tonight at the ultra-hip Lab @ Harvard and tomorrow’s events dovetails with MIT’s campus wide open house.

 John Durant, the director of the MIT Museum, a key event sponsor, said he noticed the need for a festival here as soon as he arrived from England in 2006. Science festivals are common in Europe and it was clear that Cambridge had all the raw materials for one.

“But, I could also see that it wasn’t obvious to someone who wasn’t plugged in,” he said in an NNB interview. The city’s scientific community needed more visibility. “Instead of facing inward to itself, it could face outward.”

Since then, Philadelphia, San Diego, New York and other cities have launched science festivals.

“Many of the events will be taking place in venues not usually associated with science, like the new public library, along the banks of the Charles or at the Hooper-Lee-Nichols House, a home built in 1685 that houses the city’s historical society.

“There is a kind of playfulness about what you do with science in public places,” Durant said.

So, come play. And while there are a ton of family events, those who would rather not swarm with squealing tykes can find plenty to do. In fact, one event comes with this WARNING: Do not come to this event if you are easily offended by anything

“Improbable Research After Dark” SATURDAY NIGHT, May 7, 11:00 pm. Central Square Theater, Cambridge, MA.

TICKETS are on sale at the Central Square Theater and online. This will be a benefit for the Catalyst Collaborative@MIT Science Theater Project and Improbable Research.

Dramatic, two-minute-long readings from studies and patents that have won Ig Nobel Prizes, performed by some of the Boston area’s leading scientists, actors, and journalists. “NOTE: For details on our other–very different (it’s scientists and friends singing funny songs about science, on Monday night, May 2– event at the Cambridge Science Festival, see the Improbable events listing page.</em

Globe’s White Coat Notes is back

The Globe’s White Coat Notes blog  is back. It never really went away but it has been limping along since Liz Cooney left a few months back. Newcomer and former Philly Inquirer health writer Chelsea Conaboy is cranking out the posts while covering breaking news.  

WCNotes looks at health policy, business and news of interest to anyone involved in the state’s biggest industry — health care. That means all of us –either as employers or consumers. Along with the consumer news from the paper’s newish wellness blog — Daily Dose – the Globe is offering an online “Health and Wellness ” page. The actual hard copy of the section morphed into a chunk of the Monday G section.

Too bad the site gets almost no play on Boston.com. You have to click on an ad or the “lifestyle” tab or scroll  down to find the health link. It doesn’t get much play on the actual Globe page either, where you need to look hard to find the tiny link under the flag (newspaper jargon for the title) or a larger link in special features.

And even though we’ve claimed the title and url, Boston Health News doesn’t try to be health news site of record. We try to offer a little bit something different here, so we’re not too worried about the competition. (Our motto should be – “From DRGs and HCFA to ACOs and CMS.”  Except no one outside health care would get it. Let’s just say we’ve been on the acronym-laden beat for a while.  )  

So, please forgive us for not working the royal wedding into the this space.

And, as we said when WBUR’s Commonhealth went up: more for us to aggregate. You’ll find links to best of what they have to offer here. Today? Commonhealth’s reporting on AARP’s objections to the repeal of a law that limits drug companies from marketing  to doctors via travel junkets and four-star meals. Two years ago, the state essentially decided the “gifts” were bribes and banned them.  This week, the Senate voted to repeal the law, which also requires companies to report speaking fee payments to doctors. Commonhealth tells us who AARP called out for giving in to the argument that the ban is bad for business. All these people voted for it; now they are against it. Might be worth checking out their campaign donors.

Paul Adams (R-Andover, 17th Essex District)
Richard Bastien (R-Gardner, 2nd Worcester)
Paul Brodeur (D-Melrose, 32nd Middlesex)
Edward Coppinger (D-Boston, 10th Suffolk)
Gloria Fox (D-Roxbury, 7th Suffolk)
Anne Gobi (D-Spencer, 5th Worcester)
Steven Levy (R-Marlborough, 4th Middlesex)
John Mahoney (D-Worcester, 13th Worcester)
Paul Mark (D-Hancock, 2nd Berkshire)
Tom Sannicandro (D-Ashland, 7th Middlesex District)
Paul Schmid (D-Westport, 8th Bristol District)
Ellen Story (D-Amherst, 3rd Hampshire District)
Benjamin Swan (D-Springfield, 11th Hampden District)
Cleon Turner (D-Dennis, 1st Barnstable District)

Cambridge meeting: Using health information tech to transform patient care #NEHC #HIT

The Harvard School of Public Health held its annual conference Tuesday ”Enabling the Adoption of HIT to Transform Patient Care”

We weren’t there, but the speaker’s powerpoints are posted online. See #NEHC for tweets.

From the program:

The next five years will bear witness to major changes in our nation’s healthcare system. These changes will be expensive, expansive, painful to implement and yet, entire-ly necessary. A key component of the overhaul will be through the implementation of health information technology, most notably the Electronic Health Record and Per-sonal Health Record.

The focus of today’s conference, “Enabling the Adoption of HIT to Transform Patient Care”, is on supporting the adoption of EHRs to deliver better care at a lower cost and emerging technologies to engage patients in care.

 2011 Conference Program

Karen Bell – Presentation

Karen Bell, MD, MMS, is Chair of the Certification Commission for Health Information Technology (CCHIT®), effective April 26, 2010.

Dr. Bell brings to the Commission wide and varied expertise in health information technology (HIT), quality assurance and clinical practice, in both the private and public sectors. Most recently, she served as Senior Vice President, HIT Services, Masspro, the federally-contracted Quality Improvement Organization within Massachusetts, where she oversaw the development, implementation and distribution of products and services to support adoption of electronic health records (EHRs) within the health care system

Ashish Jha – Presentation

 

 Ashish Jha, M.D., M.P.H. is associate professor of Health Policy and Management in the Department of Health Policy and Management at the Harvard School of Public HealthDr. Jha is a practicing general internist with a clinical focus on hospital care. The major themes of his research include: 1) Quality of care provided by health care systems with a focus on safety, efficiency, and effectiveness; 2) Health information technology as a tool to reduce disparities and improve the quality, efficiency, and safety of care; 3) Disparities in care, with a focus on the quality of care provided by minority-serving providers; and 4) Hospital governance and its impact on quality of care.

 

David Bates – Presentation

Dr. Bates is an internationally renowned expert in using information technology to improve clinical decision-making, patient safety, quality-of-care, cost-effectiveness, and outcomes assessment in medical practice.
A practicing general internist, Dr. Bates is Chief of the Division of General Internal Medicine at Brigham and Women’s Hospital in Boston. At a time when patient safety has become a key driver for focusing national attention on health-care quality, Dr. Bates’ work has not only shown the magnitude of the problem but also provided a blueprint for helping solve it. He led a seminal study on the epidemiology of drug-related injuries, demonstrating that the most effective way to prevent serious medication errors is to focus on improving the systems. He has also performed many studies on how computerized, evidence-based guidelines can improve quality and efficiency.

 

Big ideas in five minutes at the ten-day Cambridge Science Festival

I’ve been busy over at Nature Network Boston, where I’ll be posting steady coverage of the Cambridge Science Festival. Check it out

The first event is Big Ideas for Busy People, 10 five-minute talks. Speakers include: Jack Szostak, The Origin of Life Professor of Genetics, Harvard Medical School; Colleen Cavanaugh, The Human Microbiome: We Are Not Alone biologist, Harvard University; Dr. Donald Elliott Ingber, Human Organs-on-Chips: No More Animal Studies for Drug Development?Director, Wyss Institute for Biologically Inspired Engineering at Harvard and Robert Desimone, Shedding Light in the Brain Director, MIT McGovern Institute for Brain Research.

Friday, April 29, 2011
7:30-9:30 pm
Big Ideas for Busy People
The Laboratory at Harvard, Northwest Building, 52 Oxford Street

Pictures from last year here on Flickr.

Also over at NNB:

• A post on Vertex, expensive new drugs and top shelf corporate digs: Hepatitis C: The kind of cure $4 billion buys
• A report from the Association of Healthcare  Journalists meeting in Philly: Surgeon describes details of Gabrielle Giffords’ trauma care
• Also, news that Cambridge-based Patients Like Me has published patient-generated data to refute 2008 report lithium slows the progression of the, amyotrophic lateral sclerosis or ALS. Expect more of this kind of research — which uses data extracted from online patient communities

Link to PLM
Link to Commonhealth story
Link to Nature Biotech paper

Yoga classes/workshops for Parkinson’s and stroke

Or, Yoga for Gimps as Renee Le Verrier puts in in her blog. Here’s how she describes herself:

A yoga instructor in my forties and parent of a third grader, mine is not the expected face of Parkinson’s disease (PD). This incurable, degenerative neurological disease is no longer one affecting only the aged…She ‘focuses on creating adaptations and modifications for individuals who find it challenging to move with ease. As a stroke survivor and a person living with Parkinson’s disease, I know that physical limitations can cause a sense of disconnection not only with our bodies but also within ourselves. For me, yoga gently smoothes the way and leads to greater fluidity and balance in my body as well as in my spirit.

In Boston, she writes, American Parkinson Disease Association (APDA) includes members in their 50s, 60s and early 70s, with a he Younger Young Onset group is made up of people in their 20s, 30s, and 40s. Among these groups are individuals who lead dance programs, are qualified runners in the Boston Marathon, are avid cyclists who ride in 50- and 100-mile research fundraising events

 Le Verrier runs class at Mass General on Mondays at noon: Each class begins with a period of coming to stillness before asana practice. Poses are demonstrated with chair support, beginning with seated warmups and moving into standing and mat postures. The class closes with an extended guided relaxation.

I am a certified yoga instructor who focuses on creating adaptations and modifications for individuals who find it challenging to move with ease. As a stroke survivor and a person living with Parkinson’s disease, I know that physical limitations can cause a sense of disconnection not only with our bodies but also within ourselves. For me, yoga gently smoothes the way and leads to greater fluidity and balance in my body as well as in my spirit. Through teaching, writing and presenting about yoga, I hope to share this path to strength and grace.

She runs class at Mass General on Monday at 10 am. She’ll also be part of this workshop on the North Shore in June:

The Parkinson’s Summer Arts & Movement Weekend (June 24 – 26, 2011) offers the first program of its kind in New England. Rather than dwelling on the losses experienced with this disease, this weekend of workshops in art, dance, music, photography, tai chi and yoga celebrates what we can do and skills we can gain. Professionals in each field, many of whom live with PD, facilitate the workshops throughout the weekend. (Detailed information is online on the APDA web site This nonprofit event is sponsored in part by the Massachusetts Chapter of the American Parkinson Disease Association (APDA). The weekend is open to anyone affected by the disease, including individuals and family members or friends who may want to join in.

 

Alzheimer’s and the dark side of early detection

After reading today’s reports on the new Alzheimer’s disease guidelines, see my post at Nature Network Boston on overdiagnosis, drug compnay marketing and the downside of early detection. Also, check out the comments on the Globe story. While some stray into the area of conspiracy theories, readers do seem aware of these issue.

…(W)hile the quest to prevent disease before it becomes disabling is worthwhile, it also opens the door to marginal, expensive and potentially toxic drugs and overdiagnosis – defining the well as sick.

In other words, primary prevention has a dark side.

So with that in mind, we decided to check into the current sponsors of the Alzheimer’s Association, which worked with NIH on the news guidelines.

Non-profit group that promote research into a particular disease are heavily dependent on donation from drug companies. And drug companies use these relationships as a way to market their drugs. That’s not to say that pharma execs don’t care about preventing AD. But connecting with patients groups is as much about sales as it is about cures.

More here.

Tweeting from the #healthwriters meeting

Nature Network Boston ( @natnetboston) and Boston Health News (@tinkerrr)  have been tweeting from the Association of Health Care Journalists meeting in Philly.#ahcj11 for full tweet stream.

 

NatNetBostonNature Network

 

McGee – Uses Patients Like Me to research her MS. On new drug “The patients on the thread…knew a lot more than doctors.” #ahcj11 #natnet

Lobbying docs and what they want

The Mass Medical Society tweets to ask  — are we signed up for doctors day at the state house?

Join Your Colleagues at the State House for Doctors’ Day: Monday, May 9, 2011

The Massachusetts Medical Society is fighting for physicians on many fronts. This is your opportunity to meet with your local legislators and speak to them on such important issues as: Physician tiering and health care quality Physician payment reform Defensive medicine Tobacco control State budget priorities WBUR’s Commonhealth reports on some of the doctor’s priorities: The Massachusetts Medical Society was busy today trying to block a slew of health bills that would give certain providers, ranging from naturopaths to nurse midwives and physician assistants, greater authority and scope in their practices. (And thereby, theoretically, diminish the power of physicians).

Study: Overuse of antibiotics in RI nursing homes

A recently published study out of Brown documented antibiotic overuse for urinary tract infection in nursing homes and came up with this understated conclusion: Opportunities exist to improve provider practice related to the appropriate treatment of urinary tract infections in the nursing home.

 More here from Reuters.

Two out of every five residents with urinary problems got inappropriate drugs, researchers found, which in turn increased their chance of getting a bacterial infection.

“We tend to over-utilize antibiotics, many times if family or the nursing home requests them,” said Dr. David Dosa of Brown University in Providence, Rhode Island, who worked on the study.

Why is this a problem? See the CDC’s “Fast Facts” on antibiotic resistance. For example:

 

 More here from NYTimes “New Old Age” column.

“One of the most important findings, and other studies show similar results, is that undertreatment didn’t hurt anybody,” Dr. Dosa said. “Nobody in our sample who didn’t get an antibiotic had a bad outcome,” like a kidney infection, hospitalization or death. But those patients who were overtreated — that is, given antibiotics when their symptoms didn’t fit the criteria — were far more likely to be struck by the virulent and dangerous C. difficile bacterium, which flourishes in the gut when patients’ own competing bacteria have been eliminated by potent drugs.

“That allows some of these superbugs to take over, and they’re much harder to eradicate,” Dr. Dosa said. “It’s become an epidemic over the course of the last decade.”

Moreover, bacteria that develop resistance to antibiotics can plague not only old people but, despite infection control measures, their visitors and caregivers and the patient down the hall.

• Antibiotic resistance has been called one of the world’s most pressing public health problems.
• The number of bacteria resistant to antibiotics has increased in the last decade. Many bacterial infections are becoming resistant to the most commonly prescribed antibiotic treatments.
• Every time a person takes antibiotics, sensitive bacteria are killed, but resistant germs may be left to grow and multiply. Repeated and improper uses of antibiotics are primary causes of the increase in drug-resistant bacteria.