Posted On: March 29, 2011

Two simple ways to cut medication errors

Medication errors in a hospital’s psychiatric unit were cut drastically with two techniques: an electronic prescription drug ordering system and a computerized method to report adverse events, according to new research from Johns Hopkins University.

The leader of the study, Geetha Jayaram, MD, MBA, an associate professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, says that “with the use of electronic ordering, training of personnel and standardized information technology systems, it is possible to eliminate dangerous medication errors” altogether.

The findings published in the March issue of the Journal of Psychiatric Practice illustrate how the psychiatric unit at The Johns Hopkins Hospital in Baltimore went from a medication error rate of 27.89 per 1,000 patient days in 2003 to 3.43 per 1,000 patient days in 2007. And none of the medication errors during the study period caused death or serious, permanent harm, Javaram notes.

“Having something typed eliminates bad writing — and most errors — immediately,” she says. “It’s a good reason for going electronic.” Medication errors, which can be lethal, are known to be caused by illegible handwriting, misinterpretation of orders, fatigue on the part of medical personnel, pharmacy dispensing errors and administration mistakes. A pharmacy may misread what a physician has written or give the wrong medication or the wrong drug dose to a patient.

The computer program used in the psychiatric department also includes integrated decision support for drug dosage selection, drug allergy alerts, drug interactions, patient identifiers and monitoring — things that can be lost with a manual system that relies on layers of human beings to ensure the correct decisions are made, Jayaram says. The more the number of steps involved in the process, the greater the likelihood of mistakes.

Source: Scienceblog

You can read the complete study here.

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Posted On: March 28, 2011

States fail to discipline rogue doctors whose own hospitals find them guilty of serial malpractice

State medical boards responsible for disciplining physicians have failed to do so in more than half of cases where hospitals have revoked or restricted a physician’s privileges.

A study conducted by Public Citizen, a non-profit consumer advocacy group, found that 63% of the doctors whose hospital privileges were restricted or revoked were not disciplined by the state's Board of Medicine, and 32 states didn’t even reprimand more than half of the offending physicians.

"Either state medical boards are receiving this disturbing information from hospitals but not acting upon it or, much less likely, they are not receiving the information at all,” says study overseer Dr. Sidney Wolfe, adding that either scenario is alarming.

The report was based on data from the National Practitioner Data Bank from 1990 to 2009. It examined the number of doctors whose hospitals barred — or put restrictions on — their practicing medicine there. Of the 10,672 U.S. physicians who faced hospital sanctions, 55 percent escaped any licensing action or discipline from their state medical board.

"In 20 years, only 10,000 doctors have ever been disciplined — which is an indictment of hospitals," Wolfe says. "But once hospitals take action, it's pretty serious. Of those, 5,800 were thrown off the staff of the hospital."

Yet in many cases, the state medical board did not discipline the doctor any further, and as a result, many are still practicing medicine, he says.

"It's a real indictment of medical boards," Wolfe says, because these cases are the most egregious and already have been investigated by the hospital. "It's like handing you a case on a silver platter. The investigation has been done."

State medical boards and hospital peer review are considered two of the three "legs" of the three-legged stool of patient safety and doctor discipline. The third leg that holds doctors and hospitals accountable is the availability of medical malpractice lawsuits for injured patients.

But that leg is under continual threat from medical industry advocates who complain, without good evidence, that the industry could do a better job of policing itself if state laws could make it harder for advocates for injured patients -- trial lawyers -- to file lawsuits.

Other Public Citizen report highlights include:

Of the 5,887 physicians who the state medical boards failed to discipline — many of whom also had a history of medical malpractice payments — 1,119 were disciplined for incompetence, negligence or malpractice; 605 were disciplined for substandard care; and 220 were identified as an immediate threat to health or safety.

Other categories of serious deviations of physician behavior and/or performance that resulted in the loss of hospital privileges included sexual misconduct; inability to practice safely; fraud including insurance fraud, fraud obtaining a license and fraud against health care programs; and narcotics violations. A total of 2,071 physicians were disciplined by their hospital employers for one or more of these violations.

3,218 physicians in the study lost their clinical privileges permanently, and an additional 389 physicians lost privileges for more than one year.

Source: The Los Angeles Times

You can read the complete study here.

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Posted On: March 24, 2011

Time cushion sought in Nevada malpractice cases

Backers of a Nevada bill that would give plaintiffs a 45-day “time cushion” to obtain and file an expert witness affidavit call it an issue of fairness. At a hearing before the state’s Assembly Judiciary Committee, witnesses noted that in some cases, affidavits become separated from lawsuits or cannot be obtained within the 1-year statute of limitations.

Opponents of the bill say that if the time cushion became law, it would erode provisions of a 2004 initiative passed by voters to cap malpractice awards and reduce so-called frivolous litigation. They maintain that 1-year statute of limitations allows enough time for those with meritorious claims to find an attorney, secure medical records and a medical expert affidavit..

However, the Committee heard differently from witness Sandra Payan, who testified that her mother’s death following a hernia operation was later determined to have been caused by a punctured colon which then ruptured. After more than 2 years, the malpractice suit filed by the family was dismissed just weeks before trial after defense attorneys successfully argued the affidavit was not filed along with the suit but instead was filed separately a few days later.

After Payan’s testimony, one member of the Assembly agreed that dismissing a suit because an affidavit may have gotten lost in a clerical error was a harsh penalty and said the 45-day window would be “beneficial to both parties.”

Source: Businessweek

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Posted On: March 23, 2011

“Alarm fatigue” endangers hospital patients

“Alarm fatigue” caused by the rising use of monitors is distracting and numbing hospital personnel with deadly results, the Boston Globe reports.

An investigation by the newspaper reveals that more than 200 hospital patient deaths in the U.S. between January 2005 and June 2010 are linked to problems with alarms on patient monitors that track heart function, breathing, and other vital signs.

Typically, the problem isn’t the equipment, but rather the failure by medical personnel to react with urgency or notice the alarm. As monitor use continues to increase, the audible beeps from the machines can become so relentless that nurses become desensitized. How relentless? At a 15-bed unit at Johns Hopkins Hospital in Baltimore, staff documented an average of 942 alarms per day — about 1 critical alarm every 90 seconds.

Nurses said the number of alarms can be so overwhelming that they turn into background noise — although a dozen nurses interviewed by the Globe said they have never seen a nurse purposely ignore an alarm. The problem, says one nurse, is that “everyone who walks in the door gets a monitor. We have 17 [types of] alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes . . . background.’’

In addition, the devices themselves have flaws that contribute to alarm fatigue. For example, monitors can be so sensitive that alarms go off when patients sit up, turn over or cough. Some studies have found more than 85 percent of alarms are false (i.e. they go off when the patient isn't in danger. Over time this can make nurses less and less likely to respond urgently to the sound.

In many cases, of course, nurses miss alarms warning of problems that aren’t life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, also may go unheeded.

In one extreme case, a cardiac monitor blared 19 dangerous arrhythmia alarms for nearly 2 hours before staff silenced the alarms temporarily without treating the patient, who died. In other instances, staff have misprogrammed complicated monitors or forgotten to turn them on.

Hospitals that have experienced alarm-related deaths have aggressively addressed the issue, hiring nurses and technicians whose sole job is to monitor the monitors and modifying monitors to make them less sensitive to unimportant changes and less prone to false alarms. But overall, hospitals and the medical device industry have yet to seriously tackle the issue.

Source: The Boston Globe

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Posted On: March 19, 2011

George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group

If you wanted to lobby for a law that wipes out the rights of patients to hold hospitals, drug manufacturers and doctors accountable when they hurt people by carelessness and wrongful conduct, what would you call your group?

"Protect Patients Now!" It has a nice ring, doesn't it?

However, the people behind this campaign, which was launched in Washington to advocate for the H.R. 5 "tort reform" bill in Congress, are anything but patient advocates.

The campaign comes from a group called the Health Coalition on Liability and Access. A list of the coalition's members can be found on its website, and includes:

* Major medical malpractice insurance carriers (Pro Assurance, The Doctors' Company, Medical Protective);

* Doctors' lobbying organizations, especially those who have been active in political efforts to curb lawsuits (the AMA, plus neurosurgeons' and orthopedic surgeons' societies and others);

* Long-time "players" in the legal "reform" space, particularly the American Tort Reform Association, which got much of its seed money from the tobacco industry.

The coalition calls itself a "grassroots advocacy organization" but conspicuously absent from its membership are any of the consumer groups — Consumers Union and Public Citizen, to name two — who have been pushing the medical industry to make health care safer (and thereby solve its lawsuit problem).

H.R. 5 was sent to the floor of the U.S. House of Representatives this week by a party line vote of the House Judiciary Committee. The bill gives special breaks in the form of damage "caps" and other special treatment not only to all physicians, nurses and other individual caregivers, but also to drug manufacturers, nursing homes and hospitals.

The idea of H.R. 5 is that by making the medical industry less legally accountable for the harms it causes, Congress will free up the industry to become safer and provide cheaper care to more Americans.

I did not make that up.

The American Association for Justice (of which I am a member) has an online petition for concerned consumers to send a message to their Member of Congress about this bill.

Article first published as George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group on Technorati.

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Posted On: March 17, 2011

Mandated use of unproven screening practices drives up medical costs with little patient benefit

A new Texas law that mandates insurance coverage for coronary artery calcium scanning and carotid artery ultrasound was “premature” and will have major ramifications for public health, a noted Texas cardiologist says.

In a commentary published in the Archives of Internal Medicine, Dr. Amit Khera, a cardiologist at the University of Texas Southwestern Medical Center in Dallas, says that although some of these tests may be right for some patients, mandating their use via legislation goes far beyond what the evidence to date supports.

"I'm not against this technology – I use it myself," Khera says. "But when you go from an individual doctor and a patient making a decision about a test to a statement like 'we should apply this to an entire population, and the evidence is so strong that we need a law,' I think then you need a much higher level of evidence and a more detailed look at all the ramifications."

Neither screening test has been proven in adequately powered trials to lead to diagnoses or preventive measures that translate into reduced adverse cardiovascular events. There is also no real consensus as to which patients might benefit from screening, what level of baseline risk would warrant further screening or what steps should be taken as a result of any given finding.

In terms of calcium screenings alone, Khera calculates that approximately 285,000 individuals in Texas who would be eligible for insurance coverage of screening based on criteria set out in the bill would be found to have calcium scores over 400, and many of these people would already have another indication for taking statin therapy. And, he notes, a one-time screen could be expected to result in 190 new cancers and find 190,000 incidental findings of "minimal consequence" that would inevitably be followed with further, possibly unnecessary tests.

In an editorial note accompanying Dr. Khera’s commentary, Archives editor Dr Rita Redberg commented that “at a time when states are facing crises in health insurance spending and cutting lifesaving treatments, and when Texas leads the nation in the percentage of residents without health insurance, it is remarkable that Texas has chosen this path."

A new bill modeled on the Texas legislation is also set for consideration in Florida.

Source: TheHeart.org

You can read an extract of Dr. Khera's original commentary in the Archives of Internal Medicine here.

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Posted On: March 16, 2011

'Apology' legislation could inhibit medical malpractice suits

Recently passed legislation in the Pennsylvania General Assembly that would prohibit malpractice plaintiffs from using apologies in lawsuits could hurt victims of malpractice seeking restitution in the courts. If the bill becomes law, it would make inadmissible “any benevolent gesture or admission of fault made prior to the commencement of a medical professional liability action” concerning an “unexpected outcome.”

Republican State Rep. Keith Gillespie, the main sponsor of the bill, says words like “I’m sorry” can come back to haunt medical professionals when used to allege that a physician has admitted fault. Gillespie maintains that the bill does nothing to prevent lawsuits from being filed, and simply allows medical professionals in hospitals and nursing homes to have “frank, open conversation” after a bad outcome. Similar “apology” legislation has already been passed in 35 other states.

But Harrisburg attorney Scott Cooper, vice president of the trial lawyers organization Pennsylvania Association for Justice, warns that the legislation could take away power from people pursuing a legitimate claim in court. "It's the devil in the details," Cooper said.

For example, it's one thing to bar the patient from using a mere apology by the doctor. But what if the doctor admits exactly what went wrong? And what if the patient has no other way to prove what happened other than what the doctor said in the apology?

The legislation is part of an overall tort reform package pushed by Pennsylvania Gov. Tom Corbett, who also is proposing a cap on non-economic damages in malpractice suits.

Source: York Daily Record

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Posted On: March 11, 2011

"When you're a hammer, everything looks like a nail"

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’

...

“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

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Posted On: March 10, 2011

Female Hormone Injections for Weight Loss: Another Quack Remedy

Some unethical doctors are charging patients big bucks for prescriptions of human chorionic gonadotropin (hCG) for weight loss. Supposedly you can lose fat in just the right places, the belly for one, if you take daily hCG injections in your abdomen. The claims are sheer quackery.

This use of hCG, a pregnancy hormone that is derived from the urine of pregnant women, is "off label," meaning the manufacturer is not allowed to promote its use for weight loss, since it's never been proven to work.

For the doctors who prescribe hCG for weight loss, it's not illegal, just unethical. The use of hCG for weight loss has never been proven to work any better than injections of salt water (placebo).

The injections are prescribed along with an anorexic diet of 500 calories a day. So any claims about weight loss from the hCG are scientifically impossible to prove, since starvation is likely to cut weight anyway.

The hCG weight loss remedy has been exposed as quackery in articles in WebMD, Wikipedia, and other media.

Yet still the New York Times reports that women are lining up to pay up to $1,000 a month for hCG prescriptions and the syringes needed to stick themselves.

As the Times reports:

[t]he F.D.A. has also reiterated a warning, first issued in the mid-1970s, that is required on hCG packaging: It has not been shown to increase weight loss, to cause a more “attractive” distribution of fat or to “decrease hunger and discomfort” from low-calorie diets.

The F.D.A. recently received a report of a patient on the hCG diet who had a pulmonary embolism, said Christopher Kelly, a spokesman for the agency. He said the hormone carried risks of blood clots, depression, headaches and breast tenderness or enlargement.

Dr. Pieter Cohen, an assistant professor at Harvard medical school who researches weight-loss supplements, said that aside from the issue of side effects, the use of hCG as a diet tool was “manipulating people to give them the sense that they’re receiving something that’s powerful and potent and effective, and in fact they’re receiving something that’s nothing better than a placebo.”

But unlike other popular diet supplements, hCG, which is derived from the urine of pregnant women, has acquired an aura of respectability because the injections are available only by prescription.

The promoters of hCG for weight loss throw big dollops of paranoia and conspiracy theory into their pitches. Supposedly this is a "secret" that "they" don't want you to know about.

Well, here's a non-secret: The only way to safely keep a healthy weight has been known for a long time: A well-rounded, balanced diet plus regular exercise. But what could be more boring?

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Posted On: March 10, 2011

Hospital’s comprehensive obstetrics program cuts malpractice claims by 99%

Anyone who believes it's inevitable that some babies will get injured during childbirth may have a change of heart after reading how a New York City hospital dramatically cut staff errors and reduced medical malpractice payouts by 99%.

In a report published in the American Journal of Obstetrics & Gynecology, the head of the obstetrics team at New York Weill Cornell Medical Center describes how the safety initiatives they introduced reduced avoidable deaths and serious injuries to zero in 2008-2009, down from five in 2000.

“Any hospital could do it — it's not about money, it's about changing the culture to make it safer to deliver babies,” says team leader Dr. Amos Grunebaum. The new measures introduced by the team reduced errors and helped ward off lawsuits by clearly documenting everything doctors did right in cases where a bad outcome was not their fault.

Consumer advocates are hailing the report as a breakthrough in patient safety and a better way to curb malpractice costs than so-called tort reform.

Patient safety advocates like me, who represent patients in medical malpractice lawsuits, have said over and over that we would like to see lawyers get less business by making the medical system safer for patients.

The reforms at Weill Cornell resulted in annual medical malpractice payouts dropping from an average of $28 million from 2003 to 2006 to $2.6 million a year from 2007 to 2009. And since there were no sentinel events reported in 2008 and 2009, those numbers are expected to drop even more.

Among the changes were:

* Doing away with the labor and delivery unit's dry-erase whiteboard, which staff used to communicate patients' progress, and replacing it with a new electronic application.

* Not allowing any paper charting.

* Hiring a full-time patient safety nurse to educate staff on new protocols the doctors wanted and to conduct emergency drills.

* Hiring three physician assistants and a “laborist” (an obstetrician who works at the hospital full-time) who works nights and weekends, reducing on-call time for other obstetricians, in order to avoid errors due to sleep deprivation.

Though many aspects of the plan were costly, the authors concluded that the savings in medical malpractice payments "dwarf the incremental cost of the patient safety program.”

Source: Crain’s New York Business.com

You can read the article in the American Journal of Obstetrics and Gynecology here.

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Posted On: March 8, 2011

The Coming Cancer Epidemic from Overuse of CT Scans

The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans — used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer.

Even a “routine” CT scan of the abdomen, ordered thousands of times every day in the United States for patients with belly pain, carries a large risk of downstream cancer, just from that single scan.

Dr. Rebecca Smith-Bindman, MD, of the University of California San Francisco, estimates a 20-year-old woman who undergoes a CT scan of the abdomen and pelvis has a one in 250 chance over her lifetime of getting cancer just from that single dose of radiation. This number was in a talk she gave recently at UCSF, as reported by her colleague Bob Wachter, MD, a patient safety expert at UCSF.

More scary statistics are in two articles Dr. Smith-Bindman and her colleagues published in Archives of Internal Medicine in 2009. There, they estimated that a single CT scan of the heart’s arteries (called a CT coronary angiogram, and promoted as being safer than the usual test called a cardiac catheterization) would cause cancer in one in 270 women and one in 600 men who underwent the test at age 40.

One problem is a huge range in the amount of radiation used at different facilities. Dr. Smith-Bindman’s group found a 13-fold variation from the lowest to the highest radiation exposure between scanners running the exact same imaging study.

She blames lax regulation by the Food and Drug Administration and lack of aggressive self-regulation by the medical physicists, working in hospitals, who are supposed to protect patients.

Most patients have no idea of the amount of radiation in one CT scan. It’s estimated to be about 200,000 times more than the radiation you get from going through an airport whole-body scanner, or about 450 times more than a simple chest X-ray.

Once people start to appreciate the risk, they realize that the pretty pictures produces by CT scans can have a very expensive cost down the road. It's something to remember the next time you see a billboard advertising “whole body scans” for healthy checkups, or “virtual colonoscopies” (to pick two examples of the heavily hyped types of CT scans now available).

Article first published as The Coming Cancer Epidemic from Overuse of CT Scans on Technorati.

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Posted On: March 8, 2011

Fewer central line infections in ICU, but not in other wards

The number of bloodstream infections in intensive care units (ICUs) caused by tubes inserted into major blood vessels decreased significantly between 2001 to 2009, but unacceptably high rates of infection are still occurring for patients in other hospital units and for dialysis patients, government researchers say.

Central lines are tubes that are usually placed in the large veins of the neck or chest to deliver medicines and nutrition. Infections of these lines, which are largely preventable, can become serious problems, with death rates of 12-25%.

An estimated 18,000 ICU central-line infections were recorded in 2009, down from 43,000 in 2001, according to a report by the Centers for Disease Control and Prevention (CDC). This 58% decrease means that in 2009, between 3,000 and 6,000 deaths were prevented and as much as $414 million saved. And if the decrease in these ICU infections was steady from 2001 to 2009, as many as 27,000 lives and as much as $1.8 billion may have been saved.

(Note: These numbers are rough estimates. The 2001 figure of 43,000 infections could have been as low as 27,000 and as high as 67,000.)

According to the CDC, much of the decrease resulted from campaigns to improve techniques for managing the lines in ICUs, where they are most frequently used. Infections involving bacteria such as staphylococcus can be avoided with simple measures like washing hands, wearing sterile gowns and drapes, and following the proper techniques for inserting and maintaining the lines.

However, researchers noted that central line infections still occurred far too often, affecting 80,000 patients a year and killing at least 10,000. In addition, of the 350,000 patients who received dialysis in the U.S. in 2008, about 37,000 suffered central-line infections. Such infections are the second leading cause of hospital stays and death in people on dialysis after cardiovascular problems.

Peter Pronovost, MD of Johns Hopkins Hospital, a pioneer in patient safety, developed the simple "checklist" for using central lines in ICU patients, which was proven in a landmark study in the New England Journal of Medicine to cut the infection risk to close to zero.

Source: The New York Times

You can read an abstract of the study here.

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Posted On: March 3, 2011

New "Physician Compare" Website Doesn't Impress

Patient safety advocates like me have long dreamed of cracking open for the public the vast trove of data the government collects on doctors, so patients could figure out who gets the best outcomes and guide their doctor choices accordingly. Medicare was supposed to start down that path with its new "Physician Compare" website, but alas, it has a long way to go.

One critic says the new site "is confusing and unfriendly to consumers, painfully slow and, worst of all, factually unreliable. Put bluntly, the agency ... has produced a consumer tool that practically shouts, 'We couldn't care less whether any consumer ever uses this.'"

The quotation is from Michael L. Millenson, President of Health Quality Advisors LLC, writing on the Kaiser Health News website.

The Medicare site has basic information about doctors, like their practice address, but misses out on many tidbits that consumers want to know:

* Hospitals they practice at

* Malpractice history

* Where they trained

* Board certification.

Those kinds of things can be found at commercial sites like healthgrades.com for a small fee. Or you can search one of the sites that lists doctors' board certifications, like
the American Board of Internal Medicine, which certifies internists.

The quality information that consumers really crave, such as surgeons' complication rates or incidence of wound infections, lies off in the future somewhere. Medicare says it will begin adding quality data to the site in 2012, with a formal launch date in 2013. Don't hold your breath.

Meantime one surgical specialty group, the Society of Thoracic Surgeons, has collaborated with Consumers Reports to publish quality data on heart and chest surgeons. Read our blog entry on this here.

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Posted On: March 2, 2011

Study takes aim at myth of high cost of drug development

Drug manufacturers claim their products are pricey because of the high cost and high risks involved in getting new drugs to market. But a recent study shows that these high cost estimates have been constructed by industry-supported economists and that R&D costs are not the barrier to drug development the drug companies maintain they are.

The study, by researchers at Stanford and the University of Medicine and Dentistry of New Jersey and published online in Biosocieties journal, also shows that current incentives reward companies for developing new medicines of little advantage that compete for market share at high prices, rather than clinically superior medicines with public funding that would reduce the price of drugs to consumers and actually lower risk to the pharmaceutical companies.

The study takes aim at drug companies’ inflated cost estimates and shows exactly where they are wrong. For example, figures typically bandied about -- $800 million or $1.3 billion to develop a new drug – do not include the 39% contribution made by taxpayers through tax write-offs for R&D. Furthermore, the study shows that the industry-based figures are based on clinical trials (and number of participants) that are much larger than actual trials reported by the FDA and the National Institutes of Health.

Even worse, as much as half of the industry estimates are not real costs, but exaggerated estimates of profits that companies might have made if they put their money in the stock market instead of developing the drug. And even if the notion that foregone profits should be included as a cost – which, according to the study authors, no other industry does – U.S. government guidelines call for using three percent, not the 11 percent used to arrive at the $800 million figure.

In essence, the study argues, pharmaceutical companies “have it both ways,” treating R&D costs as though they were long-term capital investments even though the the taxman treats them like ordinary, fully deductible business expenses.

The study concludes that the real cost per "self-originated" drug product is closer to $180-231 million, noting that “the mythic costs of R&D are but one part of a larger, dysfunctional system that gives us mostly new medicines that have few or no advantages and serious side adverse reactions that have become a leading cause of hospitalization and death.”

Source: Alison Bass blog

You can read the report here.

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Posted On: March 1, 2011

Doctor who botched prostate cancer brachytherapy procedures at VA hospital sanctioned

A physician who gave nearly 100 veterans with prostate cancer incorrect doses of radiation has been sanctioned by the Nuclear Regulatory Commission (NRC). The errors involved the incorrect placement of iodine-125 seeds in patients to treat prostate cancer.

Out of 116 such brachytherapy procedures performed at the facility between 2002 and 2008, the VA reported that 97 were carried out incorrectly. The NRC investigation found that Dr. Gary Kao, a radiation oncologist at the VA Medical Center in Philadelphia, took part in 91 of the 97 incorrect procedures. In several cases, the incorrect doses were caused by Kao having implanted the seeds in nearby organs or surrounding tissue.

As a result, the NRC ruled that Kao cannot take part in agency-related activities without undergoing more training. The NRC also issued a separate order requiring Gregory Desobry, a medical physicist who worked at the same facility, to notify the agency if he accepts employment in that capacity involving NRC-regulated activities within 20 days of beginning such work. Last year, the NRC fined the Philadelphia VA hospital $227,500 over the incidents.

Source: Philadelphia Inquirer

To view a copy of the NRC decision, click here.

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