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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Last week I wrote about the President’s Cancer Panel Report which highlighted the “grievous harm” caused by environmental carcinogens and urged action that included removing the toxins from our food, water, and air that “devastate American lives.”

Achieving this is will be no easy task for a nation whose primary tool for regulating chemicals, the Toxic Substances Control Act (TSCA), was added last year to a list of government programs at “high risk” of failure by the Government Accounting Office. The Cancer Panel authors write that TSCA, passed in 1976, is a weak law that doesn’t provide the Environmental Protection Agency with enough authority and “may be the most egregious example of ineffective regulation of environmental contaminants.”

When the Act was passed, some 62,000 chemicals already on the market were declared “safe”, even though there was little or no data to support this policy. Every year another 1,000 chemicals are introduced onto the market—usually with little toxicity testing. The net result: Only 2% of the 80,000 to 100,000 chemicals currently in use have been tested for carcinogenicity and other toxicity.

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Summary:  A startling study published in the New England Journal of Medicine reveals that just as doctors in some towns are more aggressive in treating their patients, physicians in some places are more likely to send patients for tests, and to subspecialists. As a result, their patients are diagnosed with more diseases. Thus, if a Medicare patient who was living in Phoenix (and feeling perfectly healthy), moves to Miami, he may suddenly discover that he suffers from two or three chronic conditions.  
This creates a problem, not only for the patient (am I really sicker?), but for health care reformers who hope to pay hospitals and doctors more for higher quality care. To do that they have to adjust for risk: Providers caring for sicker patients should still be eligible for bonuses, even if their outcomes  aren’t as stellar as the results achieved by hospitals that treat more robust patients. But if the majority of Medicare patients in Miami have been diagnosed with one disease or another, does that mean that Medicare should pay Miami’s hospitals more than hospitals in Phoenix because their patients appear more vulnerable– at least on paper? The researchers conclude: “risk-adjustment is going to be tougher than we thought.”
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At a dinner party in Manhattan, someone mentions the problems he has been having with his sinuses, and his doctor’s diagnosis. Since everyone at the table is over 40, his comment quickly leads to a lively discussion of back pain, rotator cuffs, high blood pressure, skin cancer, and diverticulitis. It seems that everyone in the room has been diagnosed with something. Finally, someone asks “Are we really that old? Can’t we talk about something else?” Everyone laughs and the conversation turns to politics.

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Over on Kevin M.D. Dr. Vineet Arora  writes about what she learned while touring hospitals and a med school in China: http://www.kevinmd.com/blog/2010/05/china-medical-school-residency-training.html

“My husband and I recently traveled to Wuhan Medical School in the Hubei Province in central China,” she reports. “Our medical school [University of Chicago] has partnered with Wuhan to help inform their curricular reform efforts. We spent 4 days touring the hospitals and teaching facilities, meeting students and faculty, going on rounds, and giving talks. Although the language barrier was challenging, we had incredible translators who worked to translate every slide we spoke into Chinese. We also had the opportunity to observe and talk to students, residents, and faculty through translators to better understand their experiences.”

Unfortunately, Chinese medical students are getting a somewhat skewed view of medical education in the U.S.  “The preclinical students told me they watch Grey’s Anatomy and House, MD and wonder if that is what medicine is like. I told them that U.S. medical students and premeds have wondered that too!”

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