When Lewis Blackman, a healthy, gifted 15-year-old, underwent elective surgery at the Medical University of South Carolina– one of the state's most modern hospitals–he was in good health. Over the next four days, he bled to death.
 

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Lewis Blackman’s mother, Helen Haskell, founder of Mothers against Medical Error, sent me this article, first published in The State (Columbia, South Carolina). Her story serves as an extreme example of the dangers that hospital patients can encounter when residents are working without more experienced doctors supervising them. I’m posting the story and commenting on it  [in brackets] because too often, patients suffer when residents are working without a net.

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Yesterday, I commented on a New York Times story that appeared Wednesday, June 2, attacking the Dartmouth Research.  The work that Dartmouth has done over the past two decades suggests that hospitals in some parts of the country are over-treating patients. Overtreatment means that patients who didn’t need to be in the hospital in the first place are exposed to the side effects of treatment as well as gruesome hospital- acquired infections, medication mix-ups and a host of other medical errors. Thus unnecessary care puts patients at risk while helping to drive health care bills heavenward— and suggests that we could rein in Medicare spending by squeezing some of that hazardous waste out of the system.  But according to the Times: “Data [from Dartmouth] Used to Justify Health Savings Effort is Sometimes Shaky.”

In Part 1 of this post I discussed what two of the Times’ sources told me about how the Times’ reporters misrepresented what they said. Both Harvard economist David Cutler and Yale’s Dr. Harlan M. Krumholz complained that the story made it seem that they are critics of the research, when in fact they agree with Dartmouth on the basic message of the data, and see the work as, in Krumholz’ words “pivotal to moving us forward  . . . we all agree that there is lots of waste and it is unevenly distributed across the country.”

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Today, the New York Times published a piece about the Dartmouth research that is raising eyebrows– in part because there are so many factual mistakes in the story, in part because the tone is so personal.

“It sounds as if it were written by someone’s ex-spouse,” a source who is very familiar with Dartmouth’s work told me in a phone conversation earlier today.

“Harris and Abelson were determined to write a story that would ‘take down Dartmouth,’”  confides a second source in Washington who spoke with the Times reporters.

This is the second critical piece that Times’ reporter Gardiner
Harris has written about Dartmouth’s highly-respected work in just four
months. I wrote about the first story here
noting  that the article “garbled the facts” about the research, and
quoted Dr. Elliott Fisher, the senior researcher, out of context.

Others quoted in today’s story indicate that the Times’ piece distorted what they said:
“Every word is clearly accurate, but the implication is wrong,” says
David Cutler, a Harvard economist health care policy expert who has
advised President Obama on healthcare.

Dr. Harlan M. Krumholz, a professor of medicine and health policy
expert at Yale also was quoted as if he doubted the basic thrust of
Dartmouth’s work. The Times’ reporters  used  just one line 
from his interview:  “It may be that some places that are spending more
are actually getting better results.”

Today, Krumholz explained:
“What I spent most of the interview trying to convey is that a lot of
the back and forth [about bits and pieces of Dartmouth’s data ] is
inside baseball stuff – and we are all working hard to figure out how
to gauge costs and value better . But Dartmouth’s work on variation is
pivotal to moving us forward – and we all agree that there is lots of
waste and it is unevenly distributed across the country.

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Summary: Most hospital patients have no idea that the resident treating them could be coming to the end of a 30-hour shift. If he is exhausted, the resident’s judgment may be impaired. Yesterday, the union that represents some 13,000  residents and interns nationwide (CIRSEIU),  the American Medical Student Association (AMSA)  Public Citizen, the consumer advocacy organization based in Washington DC, , as well as sleep scientists at the Harvard Medical School’s Division of Sleep, announced the results of survey published in BMC Medicine, revealing how little the public knows about residents’ hours. 

Sleep deprivation is likely to lead to errors; residents themselves acknowledge that lack of sleep has caused them to make mistakes that harm, and sometimes even kill patients.  Exhaustion also affects how they feel about their patients.In 2008, the Institute of Medicine (IOM) recommended capping shifts at 16 hours, saying that longer shifts are unsafe for patients and residents themselves. The Accreditation Council on Graduate Medical Education (ACGME), the group that oversees the training of physicians in the U.S currently allows resident physicians to work for 30 consecutive hours up to twice per week.  The ACGME has been reviewing the IOM recommendations and is expected to announce its decision later this month.

The problem: residents represent cheap labor. Some say that the ACGME faces an inherent conflict of interest because its board is dominated by the trade associations for hospitals, doctors and medical schools that benefit from the residents’ long hours. Is this true?

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In 2007, a book by Phillip Longman sent lasting ripples through the U.S. health care establishment. The title was audacious: Best Care Anywhere. But it was the subtitle that shocked: Why VA Healthcare is Better than Yours.

Was Longman suggesting that the Veterans’ Health Administration provides better care than the treatment that millions of well-insured Americans typically receive in the private sector?  Yes.

Longman had uncovered what one reviewer called “the biggest untold story of the past decade,” the quality revolution that Dr. Ken Kizer launched when he took over the VA health system in 1994. And Longman had eye-popping evidence to back up his claims: overwhelming hard-core data from the most prestigious peer-reviewed medical journals. The research revealed that when it comes to everything from outcomes to patient satisfaction, and patient safety, the VA outperforms.

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Summary: It is hard to imagine fire engulfing a patient on the operating table.  But it does happen—even at highly respected medical centers. An electrical device is turned on while the patient is receiving oxygen . . . Or, electricity meet an alcohol-based solution that was used to clean a patient’s skin before making an incision .

Rarely is a patient  severely burned in an OR.  Although the Cleveland Clinic experienced six surgical fires last year,  only three patients were hurt and they suffered minor burns.  Yet it is amazing that there were six surgical fires at the widely respected Cleveland Clinic –and that the Clinic didn’t report the fires. In Ohio, as in many other states, hospitals are not required to tell anyone about these adverse events.  And patients who receive compensation are often asked to sign confidentiality agreements. (To be fair, when Medicare inspectors came in March, the  Clinic voluntarily talked about the fires  that had occurred over the previous 12 months. It is not at all clear that the Clinic was trying to bury the information. It just didn't have anyone to tell. That is the problem. )

Surgical fires, like many accidents that hospitals call “adverse advents” could be prevented.  If more errors and accidents were made public, medical professionals could analyze causes and publish guidelines that would make patients safer, not only at one hospital, but nationwide.

Under the new reform legislation, regulation is all about transparency. Medicare will insist that hospitals report infection rates. And my guess is that more and more states are going to require that hospitals publicly disclose accidents and errors.

Meanwhile, groups such as  the Empowered Patient Coalition and the Consumers Union Safe Patient Project are providing new channels for patients to report these accidents.

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Did you know that if there is a fire in the OR during surgery
hospitals in some states don’t have to report the event to anyone?

When I read a recent story in the Cleveland Plain Dealer headlined, “Reporting Surgical Fires Could Improve Patient Safety in Ohio, Experts Say, I was stunned. (Many thanks to Helen Haskell, founder of Mothers Against Medical Error, for sending the piece my way).

The piece begins:

“When
fire breaks out and burns a patient during surgery in Pennsylvania, the
hospital is required by law to report the incident to the state Patient
Safety Authority.

“If a similar surgical fire ignites in New York or California, the hospital must notify the state health departments there.

“And if the same thing happens in Ohio?

“The hospital doesn't have to tell any state agency . . . .

“On April 30, officials at the Cleveland Clinic confirmed that
six fires had broken out in Clinic operating rooms in the 12-month
period that ended in March.

“Patients suffered ‘superficial burns’ in three of the fires,” they said. "And no one was harmed in the other three.”

“The
Clinic didn't report the incidents to any outside agency immediately
after it happened because it wasn't required to,” said Dr. Michael
Henderson, the Clinic's chief quality officer.

“But when
health officials showed up in late April to conduct an inspection for
the Centers for Medicare & Medicaid Services (CMS),  the Cleveland Plain Dealer’s Diane Suchetka reports, “the Clinic told them about the fires.”

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When I posted about Rick Scott in March of 2009,  I was surprised that he had survived the fall of HCA-Columbia to become a major figure in the debate over health care reform. HCA-Columbia was a for-profit hospital chain that got into of trouble while he served as its CEO. First, came the FBI raid in seven states A few days later, the Board of Directors ousted Scott.  Ultimately the company pled guilty to no fewer than 14 felonies and paid a total of $1.7 billion in criminal and civil fines. It was the biggest Medicare fraud case in U.S. history.

Scott was never charged with wrong-doing—perhaps he knew too much.

I lost track of Scott after I wrote about him in Money-Driven Medicine  (2006).  But last year, he surfaced, running a multimillion-dollar campaign for a group that called itself “Conservatives for Patients’ Rights.” Its goal was to kill health care reform. Scott had seeded the effort with $5 million of his own cash.

One might think that the HCA debacle would have undermined  Scott’s credibility as a health care leader. One would be wrong.

In 2009, I was startled to find Scott back in the news. Now I’m thunder-struck: Rick Scott is a Republican candidate for governor in Florida.  And he is considered a viable contender. As Roy Poses puts it on Health Care Renewal: “This one fits into the 'you just can't make this stuff up' category." 

Poses fleshes out Scott’s story. He cites a book by John Schilling, a Medicare reimbursement supervisor in Fort Myers who blew the whistle on HCA. Schiller later wrote that: “Joe Ford, the FBI agent who led the Columbia/HCA investigation and then took on corporate fraud at Enron, retired from the bureau and lives near San Francisco. He declined to comment for this story, but was quoted in a 2008 book by Schilling (Undercover: How I Went from Company Man to FBI Spy – and Exposed the Worst Healthcare Fraud in U.S. History.) saying that his biggest regret in the Columbia/HCA case was not charging corporate executives.

“'After Columbia/HCA, I realized people, individual corporate officers, had to be held accountable for the actions of their companies,' Ford said . 'Instead of just giving us [the government] money, people need to go to jail,' he added.  'I learn from my mistakes, and this was my first big one.'”

Poses, who is without question, the premiere blogger on health care fraud, has long argued that fines are not enough. If we want to deter crime, management at hospitals, drug-makers, device-makers and insurers –as well as rogue doctors—should  know that they will face prison terms.

Summary: President Obama has tapped Dr. Donald Berwick to lead the Centers for Medicare and Medicaid. Senate Finance Committee chairman Max Baucus has said that he hopes to hold confirmation hearings before the July 4 recess, though he is making no promises.

Conservatives have begun their attack on the president’s choice, bashing him for having said some positive things about the health care system in the UK, and claiming that he plans to “ration care.”  But most health care insiders understand that Berwick won’t be cutting needed benefits; his goal is to eliminate the fraud and waste that clog our health care system. 

Industry insiders understand that as Berwick reins in unnecessary spending, their revenues will be trimmed. Nevertheless Berwick’s reputation for integrity, wisdom and success in protecting patients is such that the health care industry stands behind him, endorsing the president’s choice.

As for Berwick, he doesn’t think that the UK’s National Health Service is perfect—far from it. But he understands that there is much that we can learn from many countries, as we design a “patient-centered” system that is both more affordable, and safer.
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Last week Francis Collins, the director of the National Institutes of Health proposed important new rule changes for federally-funded investigators that are designed to increase transparency and remove many of the conflicts of interest that abound in biomedical research.

The proposed NIH rules, which are open for comment and expected to go into effect before the end of the year, represent the first time financial reporting requirements have been overhauled since 1995. The rules require investigators to disclose to their institutions all payments they receive from industry above $5,000, as well as any equity position they hold in a company. Research funding, speaking fees, paid authorship and travel expenses all must be part of this accounting. The previous limit was $10,000. The new regulations, which are aimed at reducing or removing industry bias from academic research, also require the academic medical centers to come up with a plan to manage investigator’s conflicts of interest—for example, university officials might insist that an investigator sell stock he owns in a company that helps pay for his research. Institutions will also be required to post all relevant payments (along with names of individual investigators) on a public website.

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Summary:  When it comes to regulating drugs and devices, FDA Deputy Commissioner Joshua Sharfstein is the agency’s point man. Recently, he co-authored a “Perspective” for the New England Journal of Medicine which outlines the FDA’s proposal for greater transparency, both within the drug and device industry, and at the FDA.

When Sharfstein was tapped for the job, his critics described him as “hostile” to industry. But when you consider who his critics are, you recognize that they are “hostile” to virtually any form of government regulation, even when it is designed to protect the innocent. By requiring manufacturers to disclose details about their clinical trials—their failures as well as their successes—the FDA aims to make sure that these companies are not hiding information about risks. Moreover, the FDA argues, if device-makers and drug-makers share what they know, they can learn from each other.

The FDA proposal signals that this administration is serious about regulating the health care industry. The time has come to implement reform, and this means insisting that stake-holders collaborate to create a health care system that is patient-centered, not profit-centered.

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