1. $788,000 paid to doctor accused of faking study
Medtronic said on Wednesday that it had paid nearly $800,000 over an eight-year period to a former military surgeon who has been accused by the Army of falsifying a medical journal study involving one of the company’s products. The surgeon, Dr. Timothy R. Kuklo, claimed in the study that the use of a Medtronic bone growth product called Infuse had proved highly beneficial in treating leg injuries suffered by American soldiers in Iraq. The British medical journal that published the article retracted it this year after an internal Army investigation found that Dr. Kuklo had forged the names of four other doctors on the study and had cited data that did not match military records. Other doctors at Walter Reed Army Medical Center, where Dr. Kuklo worked until August 2006, said that he had also overstated the benefits of the Medtronic product. Dr. Kuklo, who now works as an assistant medical professor at Washington University in St. Louis, has repeatedly declined to comment on the situation. Medtronic has said it was not involved in any way with the challenged report. The company is under investigation by the Justice Department and Senator Charles E. Grassley, Republican of Iowa, in connection with possibly illegally marketing of Infuse through outside physicians like Dr. Kuklo who work for it as consultants. The company has denied doing so. Last month, it suspended Dr. Kuklo’s consulting contract.
The New York Times by Barry Meier, June 18, 2009
2. Are you doing all you can to spot medical errors?
Earlier this month, the 185-bed Doctors Community Hospital, located outside of Washington, DC, in suburban Prince George's County, MD, was fined by state health regulators who said the hospital failed to notify them that a patient had died and that at least seven others suffered serious injuries last year because of medical staff mistakes. The fine was stiff: $95,000. However, the state officials agreed to reduce the penalty to $30,000, with the remaining $65,000 to be used to develop a patient safety program. Administrators at the hospital have subsequently acknowledged their failure to comply with the law and called the state's action a wake up call to examine patient safety procedures at their hospital, according to an article in the Washington Post. In its survey for the 2009 report of 622 hospitals with 196,462 respondents, AHRQ found several areas that hospitals could consider in improving their patient safety efforts:
Number of events reported. On average, most of the respondents within hospitals (52%) reported no adverse events in their hospitals in the past 12 months. It is likely that events were being underreported, AHRQ said.
Teamwork within units. This is the extent to which staff support each other, treat each other with respect, and work together as a team. It also was the area that had the highest positive responses (79%), which indicates it is a strength for most hospitals, the report noted. In addition, 86% agreed with the statement that when a lot of work needs to be done, everyone works together as a team.
Nonpunitive response to errors. This is an area with the most potential for improvement, the report noted
Handoffs and transitions. This area also created some concerns, according to AHRQ. Only 41% disagreed or strongly disagreed with the statement that things fall between the cracks when patients are transferred.
HealthLeaders Media by Janice Simmons, June 25, 2009
3. Docs don’t tell 7% of patients about abnormal tests
When patients' test results are abnormal, their doctors failed to tell them the bad news more than 7% of the time, and in practices that used a combination of paper and electronic medical records, the failure rate was as high as 26%, according to a new report. Some patients were given a false sense of security in that they were told if they didn't hear anything, the test result was fine. Some patients were told, "No news is good news." "Failures to inform patients of clinically significant abnormal test results or to document that they have been informed appear to be relatively common, occurring in 1 of every 14 tests," the researchers wrote. The study, by Lawrence Casalino, MD, of the Weill Cornell Medical College in New York, and colleagues in Chicago and Los Angeles, was published in the Archives of Internal Medicine yesterday. The researchers said theirs is the first to document a failure rate for a broad set of tests for a large and varied group of physician practices. Medical records from 5,434 patients between the ages of 50 to 69 were examined from the files of nearly 200 volunteering primary care physicians in PPOs in the West and Midwest. The researchers discovered 1,889 abnormal results, but 135 of those findings were never conveyed to the patients. The project selected only patients who had undergone any of 11 blood tests, such as cholesterol or hemoglobin, or three screening tests, such as mammography, Pap smear, or fecal occult blood. A failure to notify the patient was counted when the abnormal result was deemed clinically significant, in that the outcome could have indicated a lethal disease process. Perhaps a surprising result from the study was that when an electronic medical record system was used in combination with a paper record system, it made the process worse. In the four practices that used both, the failure rate was 5.4%, 8.7%, 21.5%, and 26.2% (the last two were the worst scores in the study). Practices that used only paper records were almost as good as practices that had transitioned completely to an electronic medical record system.
HealthLeaders Media by Cheryl Clark, June 23, 2009
4. Synthes’ relationship with surgeons questioned
Synthes Inc. handpicked the surgeons. The West Chester maker of orthopedic products also paid for the doctors' travel to training sessions in San Diego and Charlotte, N.C. There, company employees explained how to use their new bone-mending cement to fix a type of spinal fracture that afflicts hundreds of thousands of people yearly, most of them elderly. Federal prosecutors alleged in an indictment of the company last week that these training sessions were a dangerous, illegal, and less expensive substitute for clinical trials required by the Food and Drug Administration. Synthes has said it acted properly and will defend itself against the charges. The indictment casts a spotlight on the cozy and lucrative relationships between doctors and makers of drugs and medical devices. The allegations, if true, also illustrate how a company can exploit regulatory gray areas to boost sales while undermining patient safety. Synthes Inc. allegedly marketed Norian XR for surgeries to treat vertebral compression fractures, a use not approved by the FDA. That promotion led to 200 surgeries in which three people died, although prosecutors said they could not determine what role, if any, the bone cement played.
Philly.com by Mirian Hill, June 23, 2009
5. Hospital worker may have exposed patients to hepatitis
A former hospital employee may have exposed hundreds, or even thousands, of surgical patients to hepatitis C after taking their fentanyl injections and replacing them with used syringes filled with saline solution, authorities say. Kristen Diane Parker, who worked at Rose Medical Center in Denver, has admitted to secretly injecting herself in a bathroom and using unclean syringes as replacements for patients, investigators say. She had hepatitis C, which she believes she contracted through using heroin and sharing dirty needles while she lived in New Jersey in 2008, authorities say. She was a surgical technician at Rose from October 2008 to April 2009. Nine patients who had surgery there during that time have tested positive for hepatitis C. Investigators are looking into whether they contracted the virus from Parker. According to an affidavit filed by an investigator with the Food and Drug Administration, Rose Medical Center knew Parker tested positive for hepatitis C. She was counseled on how to limit her exposure to patients. Parker quit after she was found in an operating room where she was not allowed to be. She subsequently tested positive for fentanyl. Hospital officials then contacted the DEA. Parker is in federal custody facing three drug-related charges. If she is found to have done serious harm to a patient, she could face up to 20 years in prison. If a patient dies due to her actions, she could face life in prison.
CNN by Jim Spellman, July 3, 2009
6. Unsung heroes work hard to cut hospital-acquired infections
For years, Alfonso Torress-Cook followed the rules in his quest to eliminate hospital-acquired infections. Patients at his hospital received large doses of antibiotics and were scrubbed down with alcohol-based soaps, as he and his colleagues aimed to kill every bacterium possible. Torress-Cook eventually joined Pacific Hospital of Long Beach, in California, where as director of epidemiology and patient safety, he changed the rules and slashed the number of patients who become infected. Torress-Cook is part of a growing movement in medicine that no longer accepts hospital-acquired infections as inevitable complications. Every year, such infections sicken 1.7 million and kill 99,000 people in the United States. At Pacific Hospital, Torress-Cook doesn't go after all bacteria, just the dangerous ones. The staff members at the 184-bed hospital use antibiotics sparingly, feed patients yogurt to replenish healthy bacteria in the gut and bathe patients daily, using a soap that maintains the natural pH of the patient's skin, killing only bacteria that don't belong there. Torress-Cook is also obsessive about hygiene: Nurses clean under patients' fingernails and brush their teeth daily. He also enlisted the hospital's cleaning crew as part of the infection-fighting team. Rooms receive a thorough cleaning every day -- more than simply emptying the trash and mopping the floor, he says. Approximately one out of every 22 patients who checks into a U.S. hospital acquires a bacterial infection, adding more than $28 billion to health care costs, according to a 2009 report from the Centers for Disease Control and Prevention. But there are signs of improvement. Pennsylvania, which requires the most extensive reporting of hospital-acquired infections, saw the annual rate for all infections drop 8 percent, according to the most recent figures available from the Pennsylvania Health Care Cost Containment Council. And there are other signs of progress. The development and use of a simple checklist for a common procedure that threads a so-called central line to supply medicine directly to the bloodstream has been extraordinarily effective.
CNN by David S. Martin, July 9, 2009
7. When doctors make mistakes
In the years since, I have worked with other doctors who have had similar experiences. And while the discussions at disciplinary meetings and at morbidity and mortality conferences tend to focus (and rightly so) on the effects of these physicians’ errors on patients, there is rarely any time devoted to how such errors affect doctors and their subsequent interactions with patients. I called Dr. Colin P. West recently, a practicing general internist and the associate director of the internal medicine residency training program at the Mayo Clinic in Rochester, Minn. About three years ago, Dr. West and his colleagues published an article in The Journal of the American Medical Association on the effect of errors on physicians-in-training and on the outcomes of their future patients. The researchers found that self-perceived errors not only increased the risk of burnout and depression but also adversely affected subsequent patient care. Over time, young doctors who believed they had made errors in the past felt less and less empathy toward their patients, which then led to an even greater risk of subsequent errors. While doctors should strive for as few errors as possible, “you can’t go through training without making an error unless you are not taking care of patients,” Dr. West said. “And if you are really invested in the care of patients, there’s a personal cost when things don’t go well.” That cost can extend to patients. Doctors who are depressed are as much as two times more likely to make subsequent errors than doctors who are not. “From the point of view of the patient,” Dr. West observed, “it’s important whether the doctor treating you is experiencing symptoms of depression or burnout.” Greater support for doctors from both the training process and patients could help to improve patient outcomes and strengthen the patient-doctor relationship.
The New York Times by Pauline W. Chen, M.D., July 9, 2009
8. On national scale, New York hospitals fare poorly on readmissions
9. Surgeon faces probe of research
Hospitals in New York State are significantly worse than those elsewhere in the nation at limiting patients from having to return shortly after being treated for a major illness, according to federal data released on Thursday. The new data come amid a national debate over how to reduce the rate of hospital readmissions, which cost the federal government billions of dollars a year in Medicare reimbursements. The stakes are high for hospitals: Congress and the Obama administration are considering financial penalties for hospitals with high rates of readmissions and incentives for those with low rates. Critics of hospitals with high readmission rates have long accused the institutions of having a financial motive for creating what they call a revolving door for patients. Generally, hospitals are paid for each admission, regardless of how long the patient stays in the hospital. So when patients return, the hospital is paid again for the new treatment.
New York Times by Anemona Hartocollis July 9, 2009
10. New 30-day readmission rates listed at HHS hospital compare web site
Hospital readmission rates that occur within 30 days after discharge for Medicare patients with heart attacks, heart failure, or pneumonia are now available for viewing for the first time on the Hospital Compare Web site. The readmission rates are being added to information already available at the site on how often hospitals take guided steps to provide care for these patients, as well as updated information on mortality rates. The information is offered by the Centers for Medicare and Medicaid Services and is supported by the Hospital Quality Alliance, a national public/private collaboration. More than 4,000 hospitals—including almost all acute care hospitals—have voluntarily submitted quality information to share with the public through the Web site.
Healthleaders Media by Janice Simmons July 9, 2009
11. Surgeon Faces Probe of Research
A top surgeon at the University of California, Los Angeles, has lost his position as executive director of its spine center and faces an investigation by the school into his research after allegedly failing to disclose he was being paid by several companies whose products he was studying. Between 2002 and 2008, Jeffrey Wang repeatedly failed to report on forms filed with the state and with the medical school that he was receiving consulting payments, stock options and royalties from five companies on whose products he was conducting research, according to the university. The failure to report these relationships "violated university guidelines," the school said. "UCLA regrets that in the case of Dr. Jeffrey Wang, associate professor of orthopedic surgery, a pattern of non-disclosure could have persisted without our knowledge," the school said in a statement. "We are committed to examining our processes to determine how, as an institution, we will prevent similar problems in the future." UCLA has appointed a committee to investigate Dr. Wang's work and determine whether the payments affected his research and "if there are any mitigating actions needed to ensure the integrity of the research results."
The Wall Street Journal by David Armstrong July 22, 2009
12. Saying ‘sorry’ pays off for U. of Michigan doctors
When a treatment goes wrong at a U.S. hospital, fear of a lawsuit usually means "never daring to say you're sorry." That's not the way it works at the University of Michigan Health System, where lawyers and doctors say admitting mistakes up front and offering compensation before being sued have brought about remarkable savings in money, time and feelings. The estimated $5.8 billion annual cost of malpractice claims nationwide has drawn scrutiny as President Barack Obama and Congress plot an overhaul of the nation's $2.4 trillion health care system. So far, Obama has spoken in broad terms about shielding doctors from unwarranted lawsuits without capping damage awards, but medical malpractice is an issue that deeply divides. Doctors, hospitals, trial lawyers and patient advocates disagree not only on the solution but the problem itself. Officials at the University of Michigan say their approach addresses doctor, patient and public concerns. The willingness to admit mistakes goes well beyond decency and has proven a shrewd business strategy, according to a 2009 article in the "Journal of Health & Life Sciences Law" by Boothman and four colleagues at the Ann Arbor school. According to Boothman, malpractice claims against his health system fell from 121 in 2001 to 61 in 2006, while the backlog of open claims went from 262 in 2001 to 106 in 2006 and 83 in 2007. Between 2001 and 2007, the average time to process a claim fell from about 20 months to about eight months, costs per claim were halved and insurance reserves dropped by two-thirds. The "saying sorry" movement has its skeptics, even among those who agree it's the right thing to do. The right of injured patients to sue health care providers and force them to open up their internal records is a crucial part of reducing medical mistakes and improving care, said Matthew Gaier, co-chairman of the New York State Trial Lawyers Association's medical malpractice committee. For "saying sorry" to work, doctors need protection from having their own honesty used against them in court, said Jim Copland, director of the Manhattan Institute's Center for Legal Policy and an advocate of curbs on damage suits. Protection could take the form of a shield law that would exclude an apology from admission as evidence in a malpractice suit. A number of states have or are considering such laws.
Google by David N. Goodman July 20, 200913. U surgeon’s deals with Medtronic draw fire
A top spine surgeon at the University of Minnesota who has reaped more than $1 million consulting for Medtronic Inc. is facing tough questions from a prominent U.S. senator investigating financial conflicts in medicine. In a July 24 letter, Sen. Charles Grassley, R-Iowa, also asks the university pointed questions about how it monitors potential conflicts of interest involving medical school doctors who receive consulting payments from medical device companies. But the real fire in the 142-page letter is aimed at Dr. David Polly, 52, a nationally known surgeon who heads the spine service at the U's Department of Orthopaedic Surgery. Grassley asserts that Polly testified before a Senate committee without disclosing that he was being paid by Medtronic; alerted Medtronic to the progress of government-sponsored research in violation of an agreement with the university; and may have given inaccurate information to a university ethics committee. In an interview following three spine surgeries Tuesday, Polly said he never hid his relationship with Medtronic and followed all the university's disclosure rules. He defended the role physicians play in working with medical device companies as crucial to improving the quality of medical devices and, by extension, patient care. Medtronic said in a statement late Tuesday that "based on information that has come up in several outside inquiries, Medtronic has decided to investigate Dr. Polly's consulting relationship and activities to our company." The company did not offer specifics on the impending probe. The U's Medical School has approved a new conflict of interest policy that requires more detailed and public disclosure of these relationships, but that document is on hold for the time being.
StarTribune by Janet Moore July 28, 2009
New York Times by Anemona Hartocollis July 9, 2009