DC Medical Malpractice & Patient Safety Blog

Cortisone shots seem almost miraculous in their pain-banishing properties for sore tendons and joints. But a major new review article says they actually make tennis elbow worse and have long-term consequences when used for other tendon injuries too like Achilles tendon and sore shoulders.

For tendonitis, especially, cortisone seems to change the short-term biology of pain, but doesn't heal the underlying structural damage, which is usually due to overuse and not inflammation.

Patients who take cortisone tend to have higher rates of relapse and also are less likely to return to their baseline than patients who do nothing or take physical therapy, according to the review article in the Lancet, a prominent British medical journal. The findings were reported in the New York Times.

Read more here.

As we near the end of Breast Cancer Awareness Month, it's time to speak the truth about how the cancer advocacy industry overly hypes and scares the American public about this disease. The much bandied number "one in eight" gives a good window into this.

When I tuned in CBS 60 Minutes the other night, the first advertisement after the opening teasers said:

Marg Helgenberger (CSI: Crime Scene Investigation): "You know what's a real crime, one in eight women will be diagnosed with breast cancer this year. We don't know how to solve it yet, but this "Warriors in Pink" scarf was created to help." Narrator: "You can make a difference in the fight against breast cancer, visit Fordcares.com"

One in eight this year! The reality is more like one in 813 - a hundred-fold less.

(The National Cancer Institute's SEER program puts out these figures. You can see the table for all cancers here. The numbers are expressed in new diagnosed cases per 100,000 women, and the estimate of 123 new cases per 100,000 translates to one in 813.)

Cancer advocates who are a little more careful than the CSI actor say that the one in eight number means "lifetime risk" of a woman getting cancer. That number is sort of accurate -- but also wildly misleading. If a woman reaches age 85, her cumulative lifetime risk of getting breast cancer (not dying of it) is one in eight. But it's not a number that is useful to anyone.

By age 85, a woman has escaped the risk of early death from breast cancer that so worries everyone. So what is the point of even talking about what an 85-year-old's risk is? Maybe because it's an arresting number, and a lot scarier than the real age-related numbers that count.

Here's a table of the risk of being diagnosed with cancer depending on a woman's age (also from the National Cancer Institute ):

A woman's chance of being diagnosed with breast cancer is:
• from age 30 through age 39 . .. 1 in 233
• from age 40 through age 49 . . .1 in 69
• from age 50 through age 59 . . .1 in 42
• from age 60 through age 69 . . .1 in 29

The chance of dying prematurely from breast cancer is, fortunately, even less. Here's a table giving those odds by age: (these are in five-year increments, also from the government SEER data; click here to see the source data)

• from age 35 through age 39 . .. 1 in 12,987
• from age 40 through age 44 . . .1 in 6,993
• from age 45 through age 49 . . .1 in 4,348
• from age 50 through age 54 . . .1 in 2,980
• from age 55 through age 59 . . .1 in 2,062
• from age 60 through age 64 . . .1 in 1,618
• from age 65 through age 69 . . .1 in 1,372

So the death risk is nowhere close to one in eight.

When you compare breast cancer to the other major killers, you can calculate the likelihood of death in any given year by type of disease.

A woman's chance of dying in any one year (combining women of all ages) is:

• All causes: 1 in 155
• Heart diseases: 1 in 475
• All cancers: 1 in 661
• Lung cancer: 1 in 2,500
• Chronic obstructive lung disease: 1 in 2,777
• Accidents: 1 in 3,876
• Alzheimer's: 1 in 4,016
• Breast cancer: 1 in 4,367
• Diabetes: 1 in 5,128
• Colon cancer: 1 in 6,944
• Pneumonia: 1 in 7,092

(This is based on government "age-adjusted" data from the CDC's last report earlier this year. Here is the table.)

None of this is to say that breast cancer isn't an important worthy target of research and education. It just should not be blown out of proportion with statistics that are very, very far off the mark.

Responsible cancer advocates never use the one-in-eight number because they know how misleading it is. Dr. Susan G. Love says flatly on her website: "The one in eight statistic doesn't accurately reflect breast cancer risk."

Others, however, print up T-shirts with the number, name websites with it, and use it in many other ways, like the PSA on 60 Minutes the other evening.

So maybe it's time to bury this overly scary, misleading number.

Most consumers are shocked when they learn the reality of the early warning system for defective medical devices and drugs in the United States. Unlike Europe and most other advanced countries, there is no systematic, mandatory national registry of failures to provide an early warning system.

Manufacturers are required to send to the FDA reports of drug adverse reactions and device failures. But the manufacturers have no legal obligation to collect such data in the first place, except in the rare instances when the FDA uses its power to require such on a case-by-case basis.

The DePuy hip replacement recall in August 2010 repeats a familiar pattern. Hip replacement surgeons knew they were experiencing a lot of failures with the DePuy hips, but no one had systematic data, and everyone assumed the manufacturer knew what was up and would report promptly.

In March 2010, the company warned doctors there might be a high failure rate. Then in August, it issued the recall. Now many patients have hired lawyers to pursue lawsuits, but a better warning system might have prevented many of them from getting the defective device installed in the first place.

The New York Times has more here.

Infectious disease specialists are raising the alarm over a variant of the e.coli bacteria that is resistant to most of the antibiotics used to treat bladder infections and could be responsible for more than 3,000 deaths a year.

E.coli ST131, an aggressive strain of multi-drug-resistant e.coli bacteria, may be responsible for as many as 1 million bladder infections a year, according to a recent study conducted by Dr. James Johnson, an infectious disease expert at the Veterans Affairs Medical Center in Minneapolis.

E.coli ST131 is one resistance gene away from being untreatable, Johnson warns. “I think it’s high time to worry. Before, resistant strains were wimpy. Now, we have a winner,” he says.

Although e.coli is best known as the intestinal bacteria that causes diarrhea when people eat tainted meat or vegetables, such as spinach, it actually occurs more often outside the intestines, causing far more infection and death. Extra-intestinal e.coli is responsible for about 80 percent to 90 percent of the urinary tract infections that occur annually.

Most e.coli variants respond to common treatments: guzzling gallons of water, swilling quarts of cranberry juice, and, if all else fails, heading to the doctor for a quick course of antibiotics. However, Dr. Johnson’s study determined that although the e.coli ST131 strain accounted for only about 17 percent of e.coli isolates overall, it accounted for more than 50 percent of bacteria resistant to more than one antibiotic, including the top two types used to treat most urinary tract infections, or UTIs, and also was responsible for nearly 70 percent of resistance to the biggest guns of mainline UTI treatment, fluoroquinolones and extended-spectrum cephalosporins.

E.coli ST131 probably caused the most significant multi-drug resistant e.coli infections in the U.S. in 2007, the year Johnson studied, constituting a serious public health threat.

Dr. Johnson’s findings add to the growing concerns about drug-resistance in common infections such as UTIs. New UTI guidelines that will restrict the use of fluoroquinolones for large infections are expected to be issued by the Infectious Diseases Society of America this fall.

Source: MSNBC
You can read an abstract of Dr. Johnson’s study here.

Until a terrible injury happens to you or a family member because of someone else's carelessness, you probably give little thought to the civil justice system that holds wrongdoers accountable in American courts. Except for a nagging thought that maybe there are a lot of frivolous lawsuits out there.

That anti-lawsuit thought is planted in people's brains courtesy of the massive public relations machine of the U.S. Chamber of Commerce (which happens to be a few blocks from my own office in downtown Washington).

Now a new report documents how the Chamber really feels about lawsuits: They love them! WIth one qualifier: The Chamber aggressively uses lawsuits to cow government agencies or otherwise implement the agenda of the big corporations that fund the Chamber. They never side with the little people who get injured by indifferent or careless corporate activity.

One of the items on the Chamber's agenda is restricting the rights of patients to file malpractice actions against doctors and hospitals.

Here's an excerpt from the new report from the American Association for Justice:

On one hand, the Chamber spends an unrivaled amount of money lobbying to restrict access to the courts for ordinary Americans. On the other, it files copious lawsuits and briefs in defense of the likes of AIG, Wal-Mart, Firestone and a slew of pharmaceutical and insurance companies.

In almost every case, the Chamber’s litigation on behalf of corporations has come at the
expense of Americans’ health or financial security. The Chamber has:

• justified the actions of Wall Street banks that drove the country’s economy into
turmoil;

• defended the most conceited and worst behaved CEOs and their most extravagant
excesses;

• tried to force workers, instead of employers, to pay for their own safety equipment;

• filed numerous actions opposing any move to combat climate change;

• sought to shield pharmaceutical executives who skirted safety procedures that
ultimately killed 11 children;

• opposed measures allowing workers to receive a rest period during a full work day;

• fought on behalf of lead paint manufacturers found to have poisoned thousands of
children;

• defended corporations that discriminated on the basis of race and disability;

• and spent years defending big tobacco, asbestos companies and chemical companies
found to have contaminated water and air.

Read the whole report here.

The frequency of malpractice claims against hospitals has declined slightly and the severity of those claims is leveling off, according to a report from Zurich, the insurance company.

The fifth annual Zurich benchmarking report on claims trends in the healthcare industry, which collected data from 1,600 U.S. hospitals between 1997 and 2007, indicates that claims severity, or the average amount per claim, has stabilized over the past several years, with an average annual rise over the past 11 years of 4%.

Zurich also reports that teaching and children’s hospitals have higher claim severity than acute care community hospitals and outpatient facilities. Non-profit hospitals have the lowest severity; and among non-profits, faith-based institutions have the lowest severity of all.

Leo Carroll, head of Health Specialty Products, Zurich North America Commercial, says:

“It’s interesting to note that severity does continue to rise among claims valued under $1 million, which are the claims considered more typical within an institution's loss experience, while the most severe claims (those valued above $1 million and $5 million) have stabilized overall, the frequency of those large losses has increased slightly.”

Carroll also noted that the most severity prone states continue to be New York, Illinois and Pennsylvania. Meanwhile, in Pennsylvania, Gov. Edward G. Rendell has vetoed a bill that would have frozen primary medical malpractice insurance limits for 7 years, saying the bill would destabilize the medical malpractice insurance marketplace and undermine the state’s ability to attract and retain medical providers. According to Rendell:

“We have worked very hard in the last eight years to get to this new, improved place in which medical malpractice claims are down, insurance coverage is more available and affordable, and the number of medical providers is increasing. I vetoed Senate Bill 1280 because I do not want to impede that progress or put our doctors at risk. Further study, analysis and public input are warranted before implementing the changes contemplated in this bill."

Source: Insurancenewsnet.com

You'll find the complete Zurich report here.

Here's a new research finding that is encouraging but discouraging at the same time for patient safety.

After 16 Michigan hospitals began to share patient safety information, surgical complication rates dropped by nearly 10 percent, according to a recent study.

That's encouraging, of course. The disquieting piece is why it would take a major research study to reach such an intuitively obvious result, and why sharing of data doesn't already happen on a wide and routine scale.

The University of Michigan study followed a program called the Michigan Surgical Quality Collaborative, which involved 300,000 patients who had general or vascular surgery between 2005 and 2007.

The greatest reductions were seen in blood infections, septic shock, prolonged ventilator use and cardiac arrest. Death rates remained the same.

According to the study’s author, Darrell A. Campbell Jr., MD, a professor of surgery and chief medical officer of the University of Michigan Health System, “the collaboration of hospitals in terms of identifying and disseminating information about best practices is actually a much more effective way of improving quality than just relying on each hospital alone to come up with what they think is a way to improve quality. In other words, sharing ideas is important and it's effective." He added that this type of program could help achieve the health care reform goals of improving quality and reducing costs.

“Surgical complications are very expensive,” Campbell says. “Once something bad happens following surgery, it takes a lot of resources for the patient to recover.”

A preventable surgical complication can add weeks to a hospital stay and thousands in added costs. Contracting pneumonia from prolonged ventilator use following a surgical procedure, for example, can add $50,000 to a hospital bill.

Given the high cost of surgical complications, authors estimate that it would take only a 1.8 percent reduction in complications a year for three years to offset the cost of supporting the pay for participation program.

“If this system was adopted nationally, not just in Michigan, I think you would find a greatly accelerated pace of surgical quality improvement,” Campbell says.

Inspired by the Michigan group, surgeons in Tennessee and upper New York have launched collaboratives. Similar ones are in the works in Pennsylvania, Virginia and Illinois.

Source: University of Michigan press release.

You can view an abstract of the study in Archives of Surgery here.

Today's news has two reminders of why statisticians are our friends and allies when it comes to getting the right health care and avoiding dangerous and over-hyped treatments.

The headlines:

* Hormone replacement therapy after menopause not only increases the risk of getting breast cancer, but also makes the cancer more deadly. Details here.

* Taking a daily fish oil supplement in pregnancy doesn't make babies any smarter. Details here.

The arc of both stories is similar, and that's no coincidence.

Act One: Medical scientists develop a new treatment that, based on then current knowledge, should work.

In hormone therapy, the idea was that estrogen protected women from heart and blood vessel disease. This was based on a statistical notion -- since proven false -- that there was a big jump in heart attacks and similar disease after menopause, which must mean (so it was thought) that the drying up of estrogen in the body with menopause was depriving the body of a natural protectant.

In fish oil, the idea came from observations that DHA, a key fish oil ingredient, is naturally transmitted to a fetus in the last half of pregnancy and is important to brain development. And premature babies, born with low supplies of DHA, did better in some studies if they received DHA supplements in the first few months of life.

Act Two: Hopeful "observational" studies are published. These involve dozens to hundreds of patients and have very favorable results for the treatment in question.

Act Three: Manufacturers make big bucks pumping the treatment in question.

Act Four: Medical scientists do the hard work of large-scale studies where patients are "randomized" to the real treatment versus a dummy (placebo) treatment.

This takes years of carefully following patients and comparing outcomes.

Act Five: Enter the statisticians.

They come in, crunch the numbers and discover: It doesn't work (see today's fish oil study) or worse, it causes a lot of harm too (today's hormone story).

What's the lesson for the rest of us? As I wrote a few days ago on this blog, it pays to be skeptical of medical research findings, particularly when hyped by commercial interests.

Most people hear about research in the Act One, Two or Three stages.

If you wait till the story plays out in Acts Four and Five, you'll be less disillusioned, and safer and wiser too.

There are no simple diagnostic tests for sepsis - an out-of-control reaction to infection that can start shutting down organs in mere hours - but there are warning signs if healthcare providers pay close enough attention, according to Dr. James O’Brien, a critical care specialist at Ohio State University Medical Center.

“Minutes matter,” O'Brien says, noting that delays are too often simply a case of “not treating this like a medical emergency.” Millions of people around the world die from sepsis each year, and 30% of sepsis cases in the U.S. result in death.

The early symptoms of sepsis can be vague: confusion, shortness of breath, an increase in the heart rate, falling blood pressure and weakness, all of which could be caused for many other reasons. But the combination of symptoms without a clear benign cause is reason for aggressive care.

Sepsis occurs when the body overreacts while fighting an infection and damages its own tissues, which in turn can lead to shock and organ failure. Complex interactions between the microbe and the immune system cause the immune system to overreact to the point that even if the bacteria is eradicated, the damage continues to spread due to the toxic reaction of the immune system.

To better combat this deadly reaction, international sepsis experts recently formed a Global Sepsis Alliance to urge more aggressive care. The alliance wants hospitals to start antibiotics and intravenous fluids within an hour of suspicion of sepsis, as every hour of delay lowers survival by nearly 8 percent. Currently, many hospitals don’t begin appropriate care for four or even six hours, O’Brien says.

Scientists in Portugal, meanwhile, may have found an important clue as to what fuels sepsis, which is estimated to kill more than 200,000 Americans annually. During sepsis, red blood cells can become injured and leak an iron-based substance called heme that's normally part of the hemoglobin that carries oxygen.

But when it leaks into the bloodstream at the same time the body is experiencing lots of inflammation — a given during sepsis — the heme becomes toxic to organs. In a series of experiments with infected mice, the researchers showed that extrame heme leads to more deaths.

Although the body manufactures a molecule called hemopexin to clean up leaky heme, the level of hemopexin dropped as heme levels rose. When the researchers injected more hemopexin, more mice survived.

More research is needed to confirm the findings, the study authors say.

Source: Associated Press

To learn more about the global sepsis alliance, go here:

That's the provocative headline on an article by an internationally regarded skeptic of medical research. And the striking thing is that many researchers agree their field is badly flawed.

Dr. John Ioannidis bolstered his contention about the wrongness of most published research with an elaborate mathematical proof published in the on-line journal PLoS Medicine.

Anyone who follows the medical headlines even casually and has a decent memory knows that Dr. Ioannidis is right. Whether the issue is cancer screening with PSA or mammograms, or nutritional research on the value of fish oil, or a hundred other subjects, the arc of medical knowledge follows a predictable path: from excitement to widespread adoption to more careful research to disillusionment.

Here's Dr. Ioannidis's own summary of the factors that go into the wrongness of most published research, in his PLoS Medicine essay:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.

A more accessible discussion of Dr. Ioannidis's work is published in The Atlantic this month, by David Freedman. An excerpt:

Studies have gone back and forth on the cancer-preventing powers of vitamins A, D, and E; on the heart-health benefits of eating fat and carbs; and even on the question of whether being overweight is more likely to extend or shorten your life. How should we choose among these dueling, high-profile nutritional findings? Ioannidis suggests a simple approach: ignore them all.

For starters, he explains, the odds are that in any large database of many nutritional and health factors, there will be a few apparent connections that are in fact merely flukes, not real health effects—it’s a bit like combing through long, random strings of letters and claiming there’s an important message in any words that happen to turn up. ...

Even if changing that one factor does bring on the claimed improvement, there’s still a good chance that it won’t do you much good in the long run, because these studies rarely go on long enough to track the decades-long course of disease and ultimately death. Instead, they track easily measurable health “markers” such as cholesterol levels, blood pressure, and blood-sugar levels, and meta-experts have shown that changes in these markers often don’t correlate as well with long-term health as we have been led to believe.

On the relatively rare occasions when a study does go on long enough to track mortality, the findings frequently upend those of the shorter studies.
...

And so it goes for all medical studies, he says. Indeed, nutritional studies aren’t the worst. Drug studies have the added corruptive force of financial conflict of interest.

Doctors and nurses bring different values, different training, and different snapshots of patients to the process of care, so it's no wonder they can disagree. Often the disagreements are not about technical issues but about basic human values where there is no clear right and wrong.

Theresa Brown, R.N., has an excellent column in the New York Times about how she agonized when a terminal cancer patient cried out in protest against the painful chemotherapy treatments he was getting. The doctor pushed the patient to carry on the treatment, and so the patient agreed, only to die shortly later with extra pain from bleeding in his bladder that the aggressive treatment had caused.

When she was criticized by another physician for speaking out against what she saw as unnecessary and unwise care, here is how she responded:

So is the doctor-patient relationship really more sacrosanct than the nurse-patient relationship? I don’t think so. Physicians have the ultimate responsibility for treatment decisions, but because nurses spend so much more time with hospital patients than doctors do, we have a unique view of how the patient is really doing. And at times, patients present very different faces to nurses and to doctors — complaining to a nurse in a way they never would to a doctor.

And while my physician colleague said that nurses only see a snapshot, that picture is often one the doctor does not see.

Later, I had another chance to talk to the doctor who raised this issue in the first place. I told him that I was planning to write about our discussion of the role of doctors and nurses. “Yes,’’ he said. “We never got to finish our conversation.”

So we finished it. He shared difficulties he’d had with nurses criticizing treatment decisions when they had only known the patient for a few hours. I nodded. Then I said that physicians can have blinders on, too, and he nodded as well.

In the end he said, “The point is, it needs to be a conversation.” And we both agreed on that.

But when in doubt, I will err on the side of aggressive advocacy for my patients. Nurses have a professional obligation to make sure that patients receive the best care possible and to insure that all care given in hospitals is safe. For better or for worse, patients who come into our hospital are the responsibility of the nurses, even if the patient has been admitted by a doctor of her own choosing. A good nurse will share his or her opinions with the medical staff — sometimes loudly — because that’s part of our job, even if we ruffle a few feathers in the process.

I agree that there has to be a conversation. But I think the central actor in the conversation is the patient, or if the patient is incompetent, then the family. We lawyers call this "informed consent." But it's really about the fundamental human right to determine what is done to our own bodies.

When Trevor Roberts' leg bones snapped during a high school football game near Wichita, Kansas, he received the standard orthopedic treatment: a resetting of the bones with a titanium rod to hold them in place. So why did he have to have an above-the-knee amputation because of gangrene six days later?

The surgeon who had to remove most of the boy's leg, Dr. Archie Heddings at the University of Kansas Medical Center in Kansas City, told USA Today he thought the health care system had failed Roberts in some way.

Dr. Heddings told the newspaper:

"To me, in all honesty, I think this is a failure of the doctor-hospital system. I don't want to impugn anybody. But ... one of the first things you're supposed to do when there's an open fracture is get tetanus and antibiotics. Then, you take that person to the operating room and you get out all the dirt, you get out all the bone that doesn't have soft tissue attached to it — that's dead bone — and you take out all the dead muscle. And then if there's any question 48 hours later, you take the patient back to the operating room and look at the wound and make sure there's no dead muscle. If there is dead muscle, those bacteria have something they can reproduce in. And they'll ... start wreaking havoc."

From the newspaper's account, the first surgery to put the leg back together occurred at a Wichita hospital on the same Friday night as the injury. The 17-year-old was sent to his home near Lawrence, Kansas on the following Sunday. Then he had a high fever and went to another hospital in Lawrence two days later. It's not clear what happened at that visit, but he didn't get definitive care until two more days when he was back in the Lawrence hospital with another fever and a blistered foot. That brought him to the care of the surgeon in Kansas City who told the young man he had to amputate to save his life.

An investigation is under way to get to the bottom of this sad story.

Read the whole newspaper account by clicking here.

Ambulatory surgery centers (ASCs) that specialize and have high case volumes have better patient outcomes, according to a study by researchers at four U.S. universities.

The researchers found that the more a facility specialized in its services –and the higher its case volume for those services, the higher its patient quality scores. The researchers defined quality performance as the likelihood that an ASC patient undergoing surgery would avoid unplanned hospitalization within 30 days after the procedure.

To perform the study, which examined potential associations among ASCs organizational strategy, structure and quality performance, the researchers obtained claims data for arthroscopy and colonoscopy procedures performed from 1997 to 2004. “Quality performance” was determined by the likelihood that an ASC patient undergoing surgery would avoid unplanned hospitalization within 30 days after the procedure.

Ambulatory surgery, or outpatient surgery, is provided for patients requiring less than a 24-hour stay. ASCs have become more common across the country because (a) advances in surgical technology and anesthesia have made surgery easier on patients and so consequently more in demand; and (b) the cost of providing the same procedure in an ASC is often considerably less than hospital outpatient surgery.

According to a KNG study, the specialties with the highest percentage of Medicare-certified ASCs in 2007 were ophthalmology (19%) and gastroenterology (18%), followed by pain management (8%), orthopedics (7%) and dermatology (4%). Multiple specialty ASCs comprised 35% of the total.

Source: Medical Care Research and Review

You can view the KNG study here.

A diet drug which safety advocates called to be withdrawn from public use eight years ago has finally bit the dust. Under pressure from the Food and Drug Administration, the drug’s manufacturer, Abbott Laboratories, voluntarily pulled the drug from the market due to longstanding concerns that it increased the risk of heart attacks and strokes.

“There was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” said John Jenkins, MD, director of the office of new drugs at the FDA. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”

The move was described as “commendable but dangerously too late,” by Sidney Wolfe, MD, a member of the FDA’s Drug Safety and Risk Management Committee and director of the Health Research Group of Public Citizen, a consumer and health advocacy group.

The pressure from the FDA came after results of a clinical trial involving more than 10,000 patients showed that people who took Meridia had a 16% increase in relative risk of heart attacks. The trial also showed that individuals taking Meridia only lost approximately 2.5% more weight than those on placebo and that the weight loss didn't last very long.

Abbott maintained these results weren’t relevant because most of the individuals in the trial had cardiovascular disease and should not have taken the drug in the first place. The company continues to maintaion that for the right patients, the drug is safe.

European regulators took the drug off the market in January 2010. An FDA advisory committee was split on whether to remove the drug, but the ultimately decided to recommend doing so because “there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” Jenkins said, adding that he did not believe Meridia users would have any residual increased risk once they stopped taking the drug.

Source: The New York Times

You can view an abstract of the clinical trial that led to the FDA recommendation here.

It was nearly a year ago that the U.S. Preventive Services Task Force caused a huge uproar with the mildest imaginable recommendation about mammograms, and now two physician researchers say it might be time to point out that certain emperors are wearing no clothes.

In their Sounding Board article in the New England Journal of Medicine, Drs. Kerianne Quanstrum and Rodney Hayward note that some of the harshest cries against the Preventive Services Task Force came from those doctors with the highest vested self-interest in maintaining the importance of mammograms: radiologists with the Society for Breast Imaging. Yet nobody seemed to notice the obvious conflict of interest.

As the authors note:

When a given service is successfully extended to more people with more intensity, the profession providing that service tends to grow in importance and profitability. In the United States, where medical specialists often enjoy an exalted status in the minds of the public, if experts shout loudly that every woman 40 years of age or older must be screened annually for breast cancer, then breast cancer must be important, screening must be a basic human right, and doctors who provide this service must have great value and authority.

But what if those experts are basing their recommendations on more than the interest of patients alone? In any other industry, we accept the idea as natural that those providing a service or product hold their own and their shareholders' interests as a primary objective. Why have we failed to acknowledge that the same phenomenon occurs in health care? Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members' interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool's dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone — to compete on true value when the opportunity to inflate perceived value is readily available.

The objective facts, as Quanstrum and Hayward point out, are that the well known economics law of diminishing marginal returns applies in health care as much as anywhere. In mammograms, as the rareness of the tested condition increases, the hidden costs of the test goes up and the value goes down.

So for women between ages 60 and 69, you can save one life by subjecting only 400 women to mammogram screening (in the process of 5,000 screening visits and 400 false alarms in the same group over 13 years of follow-up). That's enough of a benefit to encourage everybody in the age group to get annual screening.

But in women between ages 40 and 49, the data show that to save a single life, you need to subject 1,900 women to screening and endure 20,000 screening exams with 2,000 false alarm tests during eleven years of follow-up. That puts the risk-benefit equation in more of a gray area where you cannot say definitely that no one should have it, or that no one should not have the screening.

And that was exactly the point of the Preventive Services' recommendation: To put the issue into the hands of individual doctors and patients and let them decide if family history or individual anxiety are enough to make the patient want to have the test. That's not a cop-out, it's a prudent bow to individual self-determination.

Here's another quote from Drs. Quanstrum and Hayward:

We must acknowledge that just as in any other profession or industry, self-interest is unavoidably at work in health care. Rather than even acknowledging practice guidelines offered by vested experts, we ought to borrow from the wisdom of sound governance and implement a system of checks and balances when it comes to the interpretation and application of medical evidence. At the same time, we need to recognize that these two tasks are distinct. Although the interpretation of medical evidence is (or ought to be) a scientific exercise, the application of that evidence, as in guideline formation, is ultimately a social exercise.

Decisions regarding practice guidelines can, and certainly should, be informed by evidence. But they will always require value judgments regarding how much evidence is sufficient to dictate care, for example, or whether and to what degree costs should be considered. By separating the processes of evidence review and guideline formation, fair disagreements about the quality or substance of the evidence can occur separately from, and before, disagreements about the implications for clinical care.

LipoDissolve is the brand name for an injectable drug that is supposed to melt fat. The patient gets a series of injections that supposedly dissolve the bonds between fat cells, and the body then flushes the fat away. Sounds great, doesn't it?

Patients who've had these injections have told the Food and Drug Administration that they've developed painful knots under their skin, scarring, deformities and other bad outcomes. What's worse, the drugs used -- chemicals caled phosphatidylcholine (PC) and deoxycholate (DC) -- have never been proven to be effective for these promoted purposes.

The FDA has tried to crack down on these treatments. Last spring, it sent warning letters to various "medspas" -- usually run by well credentialed dermatologists or plastic surgeons -- telling them that they were making false and misleading statements on their websites. For example, here's an excerpt of one letter sent to a dermatologist in the tony Washington suburb of Chevy Chase, Maryland:

Although intravenous phosphatidylcholine has been approved in some countries for the treatment of a variety of conditions, it has not been approved in the U.S. Currently there is no FDA approved injectable PC or DC, and therefore, your claim that PC and DC have been FDA approved individually for medical conditions is false or misleading. In addition, FDA is unaware of evidence to support the safety claims for your Lipodissolve products.

As explained above, the claims made for your Lipodissolve products are false or misleading in that they are not supported by substantial evidence or substantial clinical experience.

Read the full letter here.

Despite the FDA's efforts, LipoDissolve is still widely available. Lots of patients assume that someone in a white coat with an MD behind their name wouldn't offer to inject something into their body unless it was absolutely safe and legal. And the idea that you can lose weight effortlessly, and look better too, makes it all the more irresistable.

A good rule for patients to follow applies in other walks of life too: If it sounds too good to be true, it probably is.

Delays in the emergency room cause some patients to forgo treatment, according to a study by the University of South Florida. The study found that when ER patients have to wait to be admitted to hospital, the waiting time for other ER patients becomes longer, and the more likely it is that some of them will leave the ER and not get the treatment they need.

The problem is referred to as “boarding.” About 30% of ER patients need to be admitted to the hospital for further treatment, but often, they have to wait for inpatient beds to become free. As a result, waiting times for others in the ER increase.

The intent of the study, which monitored the ER at the USF-affiliated Tampa General Hospital, was to determine the number of ER patients that might walk out in frustration. The study determined that the longer those patients wait to be admitted, the more likely it is that other patients waiting behind them will leave the ER.

The research results have already been used to improve patient flow at TGH, which has implemented changes to the way patients are treated and admitted. However, study co-author David Wein, MD, says similar problems to those documented at TGH occur at hospitals across the country.

In 2007, almost 117 million people went to American hospital emergency rooms for medical attention, according to the National Hospital Ambulatory Medical Care Survey. In 2008, the number of visits increased to over 123 million.

Wein notes that the increased demand on emergency departments will be a problem if delays getting patients out of already busy emergency departments are not addressed.

Source: The Tampa Tribune

The Institute of Medicine (IOM) will conduct a year-long study to identify best policies and practices for improving healthcare safety and reducing malpractice when using electronic health records. The study will focus on prevention of health IT-related errors, rapid reporting of patient safety concerns and methods to promote safety-enhancing features of electronic health records.

After reviewing the available evidence about how health information technology (HIT) affects patient safety and care, the study will issue recommendations to maximize the safety of HIT-assisted health care services. In addition, the study will discuss the potential effects of government and private sector HIT efforts.

Highlights of the study are expected to include:

• Summary of existing knowledge of the effects of HIT on patient safety;
• Identifying approaches to promote the safety-enhancing features of HIT while protecting patients from any safety problems associated with HIT;
• Identifying approaches for preventing HIT-related patient safety problems before they occur;
• Identifying approaches for surveillance and reporting activities to bring about rapid detection and correction of patient safety problems;
• Addressing the potential roles of private sector entities such as accrediting and certification bodies as well as patient safety organizations and professional and trade associations; and
• Discussion of existing authorities and potential roles for key federal agencies, including the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), and the Centers for Medicare & Medicaid Services (CMS).

The study will be carried out under a $989,000 contract announced today by the Office of the National Coordinator for Health Information Technology, the agency charged with coordinating U.S. government HIT efforts.

Source: Earth Times

You'll find more information about the Institute of Medicine’s activities and projects here.

Five hospitals in New York City have joined a 3-year, $3-million program aimed at decreasing medical malpractice costs. The federally funded program will attempt to cut malpractice-related costs at the five hospitals by (a) revealing medical errors quickly; (b) offering early settlements; and (c) using judicial mediators to assist in settlement negotiations as an alternative to having cases go to jury trials.

The program is one of several funded by the federal government to encourage hospitals to acknowledge and reduce medical errors.

Four of the hospitals -- Beth Israel Medical Center, Mount Sinai Medical Center, Maimonides Medical Center, and Montefiore Medical Center – will focus on reducing obstetrical errors, while the fifth – New York Presbyterian Hospital – will try to prevent surgical errors.

Judges working as judicial mediators will help patients negotiate disputes with hospitals, though plaintiffs retain the option of seeking a jury trial. In addition, patients who use the judge mediators can have an attorney present during settlement talks.

However, concerns remain about how the program will protect the rights of patients – in particular, the right to a lawyer. Although participation in mediation is voluntary and patients are to be notified of their right to have an attorney represent them during the mediation, the fact that the patient is not required to have an attorney has led to concerns that hospital attorneys could take advantage of unrepresented injured patients and convince them to accept inadequate compensation. Another concern is that promoting a policy of early disclosure and settlement could allow hospitals to escape full liability

Sources: Renal and Urology News and 24/7 press release

Antipsychotic drugs have now become the top-selling class of prescription drugs in the United States, with $14.6 billion in annual revenue. Quite a trick for a group of drugs approved for one percent or less of the population.

But now you can go into any nursing home or elementary school and find non-psychotic patients taking these anti-psychotic drugs every day. Therein lies a marketing story for pharmaceutical manufacturers, who have danced around FDA regulations intended to keep the drugs marketed for only proven and safe uses.

The names include Abilify, Geodon, Seroquel, Zyprexa -- and the side effects include weight gain, drowsiness, nausea, involuntary body movements, and even diabetes.

The New York Times' Duff Wilson has a long takeout on this marketing story and the many lawsuits that have turned up industry documents showing how regulations are ignored and skirted.

Two quotes from this must-read story hit my eye:

“If you have a lot of money on the table and you have clinical uncertainty over mental health conditions, where you don’t have a blood test or objective test for it, you see it’s kind of a combustible mixture,” says Dr. Mark Olfson, a Columbia University psychiatry professor and researcher.

And this one:

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

If you're a man over age 60, remember this number: 2. That's likely to be the new cutoff number that shows if your PSA test needs followup.

The PSA blood test for screening men with high risk of prostate cancer has come under a lot of criticism for subjecting thousands of men to biopsies and surgeries that cause impotence and incontinence without any proven benefit of longer life expectancy.

But a new research study says that a simple cutoff number on the PSA test predicts quite accurately which men are likely to get aggressive prostate cancers that need to be cut out. The number is 2.0. It's not a perfect predictor, but it does put a man in a much higher risk category if he has that result after age 60.

As reported in the New York Times:

About one in four men will have a P.S.A. score of 2.0 or higher at the age of 60, and most of them will not develop prostate cancer, said the study’s lead author, Andrew Vickers, associate attending research methodologist at Memorial Sloan-Kettering. But the score does put them in a higher-risk group of men who have more to gain from regular screening, he concluded.

The higher the score at age 60, the greater the long-term risk of dying from prostate cancer, Dr. Vickers and his colleagues found. Men with a score of 2.0 or higher at age 60 were 26 times more likely to eventually die of the disease than 60-year-old men with scores below 1.0.

Still, the absolute risks for men with elevated scores were lower than might be expected. A 60-year-old man with a P.S.A. score just over 2.0 had an individual risk of dying from prostate cancer during the next 25 years of about 6 percent, the researchers found. A 60-year-old man with a P.S.A. score of 5 had about a 17 percent risk.

“Most of those men are going to be absolutely fine,” said Dr. Vickers. “But they can be told they are at high risk and they need screening.”

Men with a P.S.A. score of 1.0 or lower at age 60 had a very low individual risk of death from prostate cancer over the next 25 years, the study found: just 0.2 percent.

Now, what if you're in the middle group -- with a PSA between 1.0 and 2.0? That puts you in a low risk group -- but not so low that you never need to worry. The decision to get the PSA test should depend on your family history and your own fears and concerns.