From Boston — #Sepsis, #ethics and how to waste $5 billion in health dollars.

Not at the same time. Two Boston items.

SEPSIS

Public Citizen argues that a clinical trial of a new approach to sepsis is unethical. One of the lead investigators is at BIDMC. From NPR:

A consumer advocacy organization is asking federal health officials Tuesday to halt a large medical study being conducted at major universities nationwide.

Public Citizen says that the study, involving treatment for sepsis, puts patients at risk and will at best produce confusing results.

The CLOVERS study seeks to answer a key question about sepsis, which is a common and life-threatening response to infection. Sepsis kills more than 250,000 Americans a year, often by triggering the failure of multiple organs. As patients’ blood vessels get leaky as a result of sepsis, it becomes difficult to maintain safe fluid balance and blood pressure.

NPR reports that  Dr. Nathan Shapiro, a professor of Emergency Medicine at Beth Israel Deaconess Medical Center and one of the principal investigators for the CLOVERS study, stands by it.  He declined to talk to the reporter and instead issued a written statement.citing the input of “expert clinicians” who produced a study that “follows a well-accepted design.”

sepsis-cta-question-ig1-small
Centers for Disease Control

Public Citizen also had a written statement on a letter sent to Office for Human Research Protections at HHS.

 An ongoing clinical trial involving seriously ill sepsis patients is deeply flawed, riddled with serious regulatory and ethical lapses, and must be stopped, Public Citizen said today in a letter (PDF) to the federal government.

In the experiment, patients are being given one of two treatments for sepsis, both of which are risky and neither of which is considered standard treatment. Because no other group of patients in the trial is receiving the usual treatment for sepsis, researchers can’t ensure that the experiment isn’t causing increased deaths and organ failure. Sepsis is a life-threatening condition in which bacteria or their toxins get into the bloodstream, causing shock and organ failure.

STAT also has a story on Public Citizen’s action, as well as a great video explaining the hard-to-explain condition.

 

Another item, this one in the Times:

Long-term care hospitals?

This little noticed approach to post-acute care is apparently delivering nearly $5 billion. Amy Finkelstein of MIT was one of the authors of a study that concluded:

There is substantial waste in U.S. healthcare, but little consensus on how to identify or combat it. We identify one specific source of waste: long-term care hospitals (LTCHs). These post-acute care facilities began as a regulatory carve-out for a few dozen specialty hospitals, but have expanded into an industry with over 400 hospitals and $5.4 billion in annual Medicare spending in 2014. We use the entry of LTCHs into local hospital markets and an event study design to estimate LTCHs’ impact. We find that most LTCH patients would have counterfactually received care at Skilled Nursing Facilities (SNFs) – post-acute care facilities that provide medically similar care to LTCHs but are paid significantly less – and that substitution to LTCHs leaves patients unaffected or worse off on all measurable dimensions. Our results imply that Medicare could save about $4.6 billion per year – with no harm to patients – by not allowing for discharge to LTCHs.

The New York times reports on the study here.

 

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If you can’t join them, beat them: BIDMC in takes over Milton hospital

When the Harvard hospitals decided to join forces as Partners, they cut BIDMC out of the deal. So, this story from the Globe  – on Beth Israel Deaconess Hospital-Milton –is worth noting:

partnersdownloadConsolidation in the health care industry has been viewed with suspicion, leaving critics worried that the state’s biggest health care networks want to leverage increased market power into higher rates. Partners HealthCare, the largest health care system in Massachusetts, recently abandoned its bid to acquire South Shore Hospital in Weymouth in the face of such criticism and a ruling from a judge who said Partners’ growth would raise costs for consumers.

…The Milton case shows how consolidation — though it often increases costs to consumers — can also offer a lifeline to a struggling hospital. The brand alone of a big Boston health care network can be a powerful force, analysts said.

 

Globe Q & A : BIDMC doc wins poetry award

A nice Q & A in the Globe today with BIDMC internist Dr. Rafael Campo, who is also a poet. Interview by Karen Weintraub.  He recently won the Hippocrates Prize for Poetry and Medicine.

Campo: When we take care of patients we are immersed in stories, in language, in metaphor. Every encounter is a form of poetry, because I think in poetry, we experience immersion in another person’s voice, in another person’s story.

Here’s the opening of a poem called  “Lost in the Hospital”B0000200

It’s not that I don’t like the hospital.
Those small bouquets of flowers, pert and brave.
The smell of antiseptic cleansers.
The ill, so wistful in their rooms, so true.
My friend, the one who’s dying, took me out
To where the patients go to smoke, IV’s
And oxygen in tanks attached to them—
A tiny patio for skeletons…

BIDMC’s Haider Warraich in the NYTimes on how false hope harms patients

The NY Times offers a piece in the Sunday Review urging doctors to be straight with dying patients. From BIDMC doc (and novelist) Haider Javed Warraich:

bidmc logoA study of cancer patients and their doctors in the Annals of Internal Medicine a year later found that many doctors didn’t quite tell patients the truth about their prognosis. Doctors were up front about their patients’ estimated survival 37 percent of the time; refused to give any estimate 23 percent of the time; and told patients something else 40 percent of the time. Around 70 percent of the discrepant estimates were overly optimistic.

This optimism is far from harmless. It drives doctors to endorse treatments that most likely won’t save patients’ lives, but may cause them unnecessary suffering and inch their families toward medical bankruptcy.

One source of this optimism is pop culture, which frequently depicts heroic recoveries from seemingly life-threatening situations. Another is the medical school experience. What motivates weary medical students is the hope that one day interventions they perform will save lives, heal families and enact cosmic good.

Haider Warraich also had a piece two weeks ago about witnessing the aftermath of one of the marathon bombs. He had lived through war and violence growing up in Pakistan, he wrote. It did little to prepare him for the Boston blast beyond heightening his fear of looking like a suspect.

More on Warraich and the marathon  from Slate and a bit of audio from The World.

Beth Israel, like other Boston hospitals, sees promise in personalized medicine

Update 10? 21: This Beth Israel Deaconess Medical Center program  got a plug at the Connected Health meeting last week from Kevin Davies, editor Bio-IT World and author of  The $1,000 Genome: The Revolution in DNA Sequencing  and the New Era of Personalized. Davies said it will help make genome sequencing a useful tool for diagnosis and treatment.

Noting that the U.S. Food and Drug Administration [FDA] has approved over 30 drugs with “biomarker guidelines for treatment,” Beth Israel Pathology Department announced yesterday that it is moving into personalized medicine.

The hospital has signed two-year deal with a Westborough-base GenomeQuest, a company that makes DNA analysis software.  The company, according to a joint press release, “will provide whole-genome data management and analysis capabilities for all “next-generation sequencing” projects in BIDMC’s Department of Pathology.” See story on MassDevice.com.

The hospital is already offering staff classes in personalized medicine. Click here for a link to project staff bios. Click here for a link to the course offerings.

To describe the effort, the hospital’s pathology quotes the 2008 report from President’s Council of Advisors on Science and Technology (PCAST) and links to a group called The Personalized Medicine Coalition :  

Personalized medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not.

That last sentence reflect the hope more than the reality, apparently, a lot of start-ups are betting on it as they develop technology hospitals need to offer DNA analysis.  More here  from Xconomy Boston.  And other area hospitals are offering their own versions of  the approach , which is promising but — except in a few cases — still far from well-established as an approach to care.

 Mass General is already advertising it as a service, even though some of the offerings involve clinical trials, not treatment.  Partners has its own “Center for Personalized Medicine.” Dana Farber’s program is also based in its pathology department.

UCSF v. Beth Israel on FDA on heart device safety

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

Docs from BI, working with the Food and Drug Administration, released a study this week suggesting that medical device makers are providing weak evidence to support the efficacy and safety of products, in particular cardiovascular devices like stents and implanted defibrillators.

The study was release earlier to counter a similar study in the Journal of the American Medical Association that faulted the agency for approving devices based on limited and potentially biased data.

Just prior to the release of the new study, FDA officials announced that they would strengthen the device review process.

The New York Times reported that the BIDMC “study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study.”Researchers also concluded that 25 percent of trials had failed to adequately follow patients enrolled in studies.”

Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed.

But, the JAMA study out of the University of California faulted the FDA review process and “concluded that the F.D.A. had approved cardiovascular devices based on data that ‘lacked adequate strength.’”

Their conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias.

According to AP: The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA’s medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

What your doctor is really thinking

Beth Israel Deaconess Medical Center announced their new “Open Notes” project yesterday. According to the hospital new release, the project “will examine the impact of adding new layer of openness to a traditionally one-sided element of the doctor-patient relationship – the notes from patients’ doctors’ visits.”

The Globe sort of scooped them and then some with a story two weeks ago about how some docs are nervous about the project.

Doctors write these one- to two-page comments after every visit, and other physicians who treat the patient read them, too. But the notes usually aren’t readily available to patients because hospitals and doctors’ groups fear that they will misunderstand medical jargon, take offense at a blunt observation, or worry unnecessarily about a precautionary test.

After requesting a copy of my records, I ended up with a two-inch thick pile of paperwork. When I read some of my GI doctor’s notes, I did feel a bit misunderstood. I had just had two-hour long gallstone attack AFTER getting my gall bladder out.  She described me as “very upset,” which was true. On one hand, I appreciated that she recognized my angst. But, somehow, it felt patronizing.