DC Medical Malpractice & Patient Safety Blog

Anyone who watches TV has been bewildered/amused/confused/annoyed by pharmaceutical ads that begin by explaining how your life can be perfect if you take this drug, and end with a rushed recitation of all the things that can go wrong if in fact you do take the drug.

Drug companies, of course, are obliged by the FDA to include potential side effects when they’re trying to sell you their products. But as proved by a recent study in PLoS ONE (a journal for peer-reviewed scientific and medical research), Big Pharma pretty much thumbs its nose at the FDA when it advertises in medical journals, where it's trying to sell its wares to doctors.

Among the nine publications reviewed by researchers were such mainstream journals as Annals of Internal Medicine, New England Journal of Medicine and Journal of the American Medical Association. About half of the ads reviewed violated at least one FDA rule, and about one-third were “possibly” out of compliance because of missing information. More than half of the drug ads failed to quantify serious risks. Fewer than 1 in 5 adhered to all FDA guidelines.

As explained by MedPage Today, the pharmaceutical industry spends $58 billion on marketing; the FDA’s division of marketing and advertising has $9 million. So what are the chances a miscreant marketer will get caught?

To help bridge the budget gap, the FDA recently implemented the “Bad Ad” program, asking physicians to report nonadherent or misleading ads. But that’s like asking the playground monitor to report bad behavior – what’s bad to one monitor is just kids being kids to another. As the researchers noted, the guidelines are difficult to enforce, don't emphasize transparency and ignore basic information relevant to prescribing.

The most common breaches or possible breaches of rules were:

• misused references to the scientific literature;


• misleading use of graphics;


• failure to cite references;


• overrepresentation of the experience with the drug.

By medical specialty, at least one FDA rule was broken by ads for:

• 6 in 10 hematology/oncology products;


• 5 in 10 cardiovascular and diabetes products;


• more than 4 in 10 psychiatric products.

As the researchers wrote, “Advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks.”

Despite their concerns, they said that “most advertisements we reviewed satisfied the majority of FDA guidelines.” It makes you wonder, though, about the squishy nature of the guidelines – the researchers also noted that an ad that makes no specific claim about efficacy and does not quantify drug safety is still in compliance.

The study recommends that the FDA update and simplify ad regulations, and require ads to explain risks clearly, offer information on absolute benefits and verifiable references and identify the appropriate population for the drug’s use.

All of that seems like a no-brainer. And another reason why, when your doctor prescribes a drug, you should ask what are the potential side effects and risks, and why he or she has chosen it over others. Read the patient information that’s included in the drug packaging.

It’s an unfunny truism that if you want to avoid getting sick, stay out of the hospital. But that may be starting to change for the better.

The unacceptably high number of hospital patients who contract an infection after admission has long been in the news. We have covered the topic frequently.

According to federal estimates, 1 in 20 people admitted to a U.S. hospital develops an infection – or about 1.7 million people every year. Such infections represent a top 10 cause of death in this country; approximately 99,000 people die annually from hospital infections, at a health-care cost of $33 billion.

Scrutiny of this problem has generated policy changes – Medicare, for example, no longer foots the bill when inpatients are infected by microbes from catheters and intravenous lines. And, per the new federal health-care legislation (the Affordable Care Act), soon subsidies will be withheld to hospitals that fail to reduce their infection rates.

In a bit of good news from this patient safety front, many hospitals have committed to solving the problem and boast demonstrable results. As reported in the Los Angeles Times, a three-year campaign to reduce the incidence of hospital infections in California has saved lives, cut costs and institutionalized best practices to ensure continued vigilance and good results.

At the midway point of the campaign, the program has seen reductions of:

• ventilator-associated pneumonia by 41%;


• catheter-related urinary tract infections by 24%;


• blood poisoning by 11%.

About $11 million has been saved, and about 800 lives.

The health threat is particularly acute these days, thanks to the increasing use of outpatient clinics. That means hospitals are reserved for the sickest patients, and the sicker the patient, the more vulnerable he or she is to infection.

In California, Anthem Blue Cross is often the target of consumer and health advocates who have challenged its substantial health-care premium increases and its history of questionable recissions (dropping policyholders from coverage after the discovery of an expensive medical condition). But even this often soulless corporate entity acknowledges the unacceptable cost of hospital infections, and has funded the statewide Patient Safety First program with $6 million.

The company says it has recouped nearly double its investment in the program through reduced health-care spending. And its corporate parent, WellPoint, Inc., says it won’t increase payments to hospitals in 14 states that don’t meet its standards of infection control, readmission rates and other practices.

Some of the program elements employed by hospitals are:

• establishing and following safety checklists and documenting every step;


• frequent hand-washing by staff;


• more frequent brushing of patients’ teeth;


• enlisting respiratory therapists to swab the mouths of patients on ventilators several times a day;


• eliminating unnecessary procedures.

If you or a loved one is to be admitted to a hospital, ask if it has an infection-control checklist, and if so, ask to see it. After admission, make sure staff members wash their hands before they tend to you or your loved one. Ask when catheters and ventilators were last sanitized. Hospitals that care about your safety should not object to such scrutiny

As Dr. James Cleeman, an expert on health-care quality, told the L.A. Times, “Nobody should go into a hospital and wind up sicker than when they went in.”

Another clarion call to simplify a program so critical to the welfare of so many Americans was sounded earlier this month in a report published online by Health Affairs. It concluded that when faced with numerous Medicare Advantage plans, older Americans were less likely to enroll than if their choice of plans was more limited. It also found that seniors whose mental faculties were impaired were less likely to enroll than others when the Advantage plans offered more generous benefits.

Medicare Advantage plans, a form of supplemental insurance administered by private companies, pay providers more for treating Medicare beneficiaries. They frequently offer more generous drug benefits than those that are available in Medicare Part D plans.

The findings suggest that many Medicare beneficiaries are unable to access or process information, so if they’re faced with numerous, complicated insurance plans, they make enrollment decisions that aren’t in their best interests.

The three-year study looked at 21,815 enrollment decisions made by 6,672 participants. In comparing enrollment decisions among participants with different mental capabilities and plan offerings, if 15 or fewer plans were available, there was usually an increase in Medicare Advantage enrollment. When the number of options surpassed 30, as it did in one-quarter of U.S. counties, enrollment in the program decreased.

Last November, the FDA ruled that tobacco manufacturers must include on their packaging graphic depictions of the horrors smoking can wreak. The new packaging was to take effect in autumn 2012.

Five tobacco companies now have taken the FDA to federal court, challenging the regulations. Among other things, they claim that the depictions:

• would unfairly dissuade adults from using a legal product;


• would cost millions;


• violate the First Amendment;


• “do not further any compelling governmental purpose”; and


• “would have few if any benefits.”

In case you're feeling the slightest twinge of sympathy for the tobacco makers, here's what Dr. Howard K. Koh, writing in the New England Journal of Medicine, says.

“A decade of experience in more than 30 other countries has demonstrated that such graphic warnings lead to an array of public health benefits. The warnings are more likely to be noticed than text-only labels, are viewed as more effective in communicating health risks to smokers and are associated with increased motivation on the part of smokers to quit smoking.”

Dr. Koh is assistant secretary for health in the U.S. Department of Health and Human Services. So he's defending his own decision. But knowing what we know about how tobacco poisons work throughout the human body, is this even a close question?

To see a slide show of the text and images for the new packaging, click here.

And if you want to harken back to the olden days before we had any warnings on cigarette packs, and when the manufacturers liked to use doctors to promote their smoky poisons, check out this tour through nostalgia.

When a previously healthy unborn baby dies from a medical error during birth, what should the grieving mother be paid for her suffering?

That is the difficult but necessary calculation that must be made in any malpractice lawsuit where the clock cannot be turned backwards to restore the baby to life, and the only justice the legal system can measure out is money compensation for a tragedy that should have been prevented.

There is no doubt that the emotional injury to the mother and father of the stillborn child can endure for many years, even when no malpractice has occurred and there is no one to blame but fate. A recent letter writer in the New York Times explained:

My husband and I lost our son in 2008. We arrived at the hospital one evening, me in labor and giddy with anticipation. The news of our baby’s death was delivered to us before I delivered him. The loss is devastating. The silence hurts just as much: the empty crib in the waiting nursery; the friends and co-workers who avoid conversation and eye contact; family afraid to acknowledge our loss.

Another story in the Times talks about how lawyers and judges grope to calculate fair numbers for a stillbirth that should not have happened.

On top of the hurt of losing a baby is the pain of being let down by health care providers whom the patient has trusted with her own health and the health of her baby. Many patients need therapy to get past the sense of betrayal they feel about their doctors and nurses.

Another issue in stillbirth malpractice is the desire to see that this kind of problem doesn't happen to other patients. Our firm worked on a recent case on behalf of a couple in northern Virginia. The core issue was the hospital's failure to adequately staff its labor and delivery unit, leading the nurse who was supposed to be working one-on-one with our mother to over-extend herself with other patients. You can read more about this case on our firm's website, at this link.

The Food and Drug Administration has received more complaints about defective metal-on-metal hip implants in the last six months than in the total previous four years combined, according to a report in the New York Times.

The defect complaints mainly concern the DePuy (Johnson & Johnson) A.S.R. hip implant device but also include the Zimmer Durom cup.

Reader comments to the Times include many who raise these questions:

* Why is there no national registry of devices implanted in the human body, to make it easier to catch up with defect issues before they become widespread? Other countries have this.

* Why does the FDA not mandate independent testing of permanent devices like hip implants before they are marketed? Why do the manufacturers control all the testing?

* Why couldn't the FDA foresee the issues with metal-on-metal hip implants which had been forecast in the medical literature for many years?

My take: Our system of regulating medical devices is badly flawed and in need of a big overhaul. This is the same conclusion reached recently by an independent panel of the Institute of Medicine.

In 1999, the FDA approved the drug Actos for Type 2 diabetes. Its popularity grew substantially after its primary competitor, Avandia, was linked to increased risk of heart attack. In 2010, the drug generated $3.4 billion in sales for its manufacturer, Takeda Pharmaceuticals.

Now, Actos is under fire, too.

The drug was recalled this summer in France and Germany in the wake of increased incidents of bladder cancer among people who took Actos. Similar reports have occurred in the U.S., where the FDA has allowed the drug to remain on the market provided warning labels are added to the packaging.

Earlier this month, the first lawsuits over Actos’ alleged role in bladder cancer were filed in the U.S., and many more are expected to be forthcoming. The lawsuits charge that Takeda failed to disclose data showing an increased bladder cancer risk.

If you are a diabetic who takes this drug, notify your doctor immediately if you develop:

• blood in your urine;


• an urgent need to urinate;


• pain during urination; or


• pain in the back of lower abdomen.

In an AP story published by the Atlanta Constitution, Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, said it wasn’t clear if the bladder cancer risk is real, but that Actos and Avandia both are linked to heart risks, weight gain and possibly bone loss and fractures.

“The consensus,” he said, “already is that (Actos) should only be considered ... after patients have exhausted all other options."

The news that health insurers will be required to cover contraception and related counseling, courtesy of the Affordable Care Act (ACA) passed last year, received a lot of media attention and political blowback.

Because some people find that provision of preventive care for women objectionable, it overshadowed other elements of the new guidelines, which pertain to insurance policies whose plan years begin on or after Aug. 1, 2012. Such policies are referred to as “nongrandfathered” because they represent only new plans; a health plan in effect now cannot be “grandfathered” into this coverage, although some might include it anyway.

As defined by the U.S. Department of Health and Human Services, the mission of the ACA is to promote prevention of health problems in the hope of reducing the need to treat them. It also aims to make care affordable and accessible for everybody by requiring health plans to cover preventive services and eliminating cost sharing.

Although “preventive services” covers a lot of territory that can include marginally appropriate, cost-inflating measures, those required by HHS demonstrate strong scientific evidence of their health benefits, per research conducted by the Institute of Medicine (IOM). Not only must plans cover them, they may not charge a copayment, coinsurance or deductible if the services are delivered by a network provider.

In addition to the birth control measures, from which plans are exempt for certain religious employers, the following preventive services for women are mandatory and must be provided by insurers without cost sharing to policyholders for policies beginning on or after Aug. 1, 2012:

• well-woman visits;


• screening for gestational high blood sugar;


• human papilloma virus (HPV) DNA testing for women 30 and older;


• sexually transmitted disease counseling;


• human immunodeficiency virus (HIV) screening and counseling;


• breastfeeding support, supplies and counseling; and


• family violence screening and counseling.

If your health insurance plan or insurance policy began on or after Sept. 23, 2010, it is also subject to mandatory preventive services for which you are not supposed to be charged a copayment or coinsurance, or for which you must meet your deductible if services are delivered by a network provider. To find out what’s on the list, link here.

The U.S. faces a growing shortage of the low-profit but vital generic drugs that cancer patients and other desperate folks rely on. These drugs are made in places like India and China in plants that the Food and Drug Administration lacks power to inspect.

Meantime, Big Pharma focuses on new high-profit but low-benefit drugs. The latest examples of new FDA approvals: Provenge, a drug for prostate cancer which on average extends life by four months at a cost of $93,000, and Yervoy, a melanoma drug with a price tag of $120,000 for a similar average benefit of four more months of life.

As reported by Gardiner Harris in the New York Times, a lot of solutions are being proposed to the crisis that has been brewing for the last few years, ranging from creation of a government stockpile of drugs to a requirement that drug makers give an early warning to the FDA of inability to keep up with demand for drugs.

Good luck getting any of these passed by a Congress whose loudest members reflexively say the government is the problem, not the solution. But as many Times readers noted in comments on the new article, this story is another example of why we need smart government, not no government, to address the many failures of the free market when it comes to vital services like health care.

No surgical patient wants to experience, or remember, the details of their operation, and the drugs given to put patients to sleep generally work nicely to create a blank slate in the mind for anything that happened after the anesthesiologist told the patient to start counting backward. But not always.

As many as 1 in 100 patients reports afterward that he or she was awake during the surgery, and can recount details of what was heard that make it clear it wasn't a dream. The psychic injury is worse because the paralysis that accompanies anesthesia usually means that aware patients can do nothing to signal to the doctor that they can hear what is going on.

Sometimes these patients are psychologically traumatized enough (with post-traumatic stress disorder) that they end up in the office of a malpractice lawyer like me, asking if they have a legitimate claim against the anesthesiologist or the surgeon.

The answer to that question is "Probably not," according to the latest research.

The problem is that while anesthesiologists have a rough idea of which patients are at high risk, nobody knows how to guarantee, or even improve the odds, that "intra-operative awareness" will not occur.

A study published this week in the New England Journal of Medicine assessed two possible ways of cutting the risk of intra-op awareness. One involved monitoring brain waves. The other involved measuring the concentration of anesthetic gases being exhaled by the patient. The study found that neither clearly worked, although there were fewer reports of intra-op awareness in the patients whose anesthetic gas levels were monitored.

You would think that if someone is awake by mistake during surgery, it means they weren't given enough anesthesia. But you would be wrong, according to the experts. Despite decades of research, we don't know that much about consciousness and memory, and their relationship to general anesthesia. And the ability to figure out during surgery who might still be awake when they look asleep is surprisingly rudimentary.

Here's the conclusion of an editorial on the subject that was also published in the NEJM, written by Gregory Crosby, M.D., an anesthesiologist at Brigham & Women's Hospital in Boston:

Monitors are meant to supplement, not supplant, clinical decision making, and depth-of-anesthesia monitors that reduce complex neurobiology to simple numbers are no exception. It is unreasonable to expect any such monitor to unfailingly detect conscious awareness — a specific and still mysterious property of the brain and mind — and neither patients nor physicians should think otherwise. Notwithstanding this and other weaknesses of current devices, a window into the anesthetized brain, albeit a foggy one, may still be useful, in conjunction with information from other monitors ... as a generic, all-purpose index of the brain's response to powerfully sedating drugs. Whether these devices add value in this way remains to be seen, but when minding the mind during sedation and general anesthesia, a little insight into how the brain is reacting is apt to be better than none, especially if it challenges historical ways of gauging anesthetic depth and catalyzes the search for something better.

Article first published as Awake by Mistake During Surgery: A Patient's Nightmare on Technorati.

Who runs a hospital better, a physician or a businessperson? And which is better for patient safety and healthy outcomes?

As reported in the New York Times, the conventional wisdom that doctors should focus on patient care and managers should run the infrastructure was challenged by a study in the journal Social Science & Medicine.

Of the nearly 6,500 hospitals in the U.S., only 235 are run by physician administrators.

In a review of 300 top-ranked U.S. hospitals specializing in a variety of disorders, "overall hospital quality scores were about 25% higher when doctors ran the hospital, compared with other hospitals," The Times said. "For cancer care, doctor-run hospitals posted scores 33% higher.

Study author Dr. Amanda Goodall said the finding was consistent with corollary research showing that research universities perform better when led by outstanding scholars and that basketball teams perform better when led by former top players.

Goodall said the results may reflect the fact that doctors truly understand “the core business of health. ... M.D. CEOs are more likely to prioritize patients because patient care is at the heart of their education and working life as a physician. When it comes to making hard budgetary decisions or rationing choices, M.D. CEOs may be able to make more informed decisions.”

The study results, Goodall pointed out, show only an association between high hospital scores and doctor CEOs; they do not prove that doctors make better leaders. Maybe top hospitals are more likely to seek out doctor leaders; maybe top doctor managers seek out the best hospitals.

Bottom line: The best hospitals seem to choose physician executives, and lower-ranked hospitals usually have managers with a business or administrative background.

That's something for patients to consider if they have a choice of hospital facilities.

In a stark reminder that the practice of medicine is a business as well as a service, a new study has proved what doctors have been saying for years: Meeting the paperwork needs of insurance companies costs U.S. doctors in a big way.

According to the study published in Health Affairs, U.S. docs pay an average of nearly $83,000 per year "in time and labor interacting with multiple insurance plans about claims, coverage, and billing for patient care and prescription drugs."

These costs, the study concludes, hit hardest at practices with only one or two physicians.

Researchers compared U.S. medical practices with those in Ontario, Canada. "We estimated physician practices in Ontario spent $22,205 per physician per year interacting with Canada’s single-payer agency — just 27% of the $82,975 per physician per year spent in the United States," they wrote. "U.S. nursing staff, including medical assistants, spent 20.6 hours per physician per week interacting with health plans — nearly 10 times that of their Ontario counterparts."

Canada, of course, has a single-payer health-care system; U.S. medical practices often must secure prior authorizations and deal with several insurers with different billing requirements, requiring a greater investment of staff resources as well as time.

Of course, sometimes preliminary measures save money and guard against inappropriate care. And the U.S. system affords consumers more choices.

But the researchers said if administrative costs for U.S. physicians were the same as the Canadians, collectively they would save as much as $27.6 billion a year. They concluded that electronic filing would make the U.S. process more efficient.

If you follow patient safety news, you've seen this headline before. Why should you care? Apart from retaining an attorney to represent you in the event of medical malpractice, what stands most prominently between medical consumers and the bad behavior of health-care providers is their states' medical boards.

These government agencies are charged with licensing medical practitioners, monitoring their practices and punishing those who make serious mistakes or who commit crimes. Sometimes, this oversight is lacking. We’ve written here before about states that fail to discipline doctors whose own hospitals find their behavior wanting, and about how one state—Washington—took the lead in addressing its board’s deficiencies.

A recent study by consumer watchdog Public Citizen has ranked states’ effectiveness in protecting their citizens from substandard physicians. Thanks primarily to shrinking budgets and also to flagging political will and leadership, residents of many states have a lot to be concerned about.

Most states, the study concludes, do not live up to their obligations to protect patients from doctors who practice substandard medicine.

The report analyzed data from the Federation of State Medical Boards on all disciplinary actions taken against doctors in 2010. It calculated the rate of serious disciplinary actions (revocations and surrenders of licenses, suspensions and probation/restrictions) taken by state medical boards. The rate was slightly lower than that in 2009 and “significantly” lower than the peak for the last 10 years.

Some of the worst states have been consistently poor performers. Nationally, in 2010 state medical boards took 2.97 serious actions per 1,000 physicians – down 3% from the last period and 20% from the peak rate of discipline in 2004 of 3.72 per 1,000 physicians.

Had the national rate of doctor discipline repeated the 2004 peak rate, there would have been 745 additional serious disciplinary actions in 2010 against U.S. physicians. “With a typical doctor having between 500 and 1,000 or more patients in their practice,” the report reads, “the positive impact of this on the large number of patients going to these doctors would be enormous.”

Minnesota was the worst state when it came to disciplining doctors. South Carolina and Wisconsin also have been consistently among the bottom 10 states for each of the last eight rankings. Connecticut has been in the bottom 10 for the last five rankings, and for the third consecutive ranking, Florida, at no. 7, is among the 10 states with the lowest rates of serious disciplinary actions. It’s a highly populated state with a lot of older people who use more health-care services than other demographic segments.

Filling out the bottom 10 are: Massachusetts, Rhode Island, New Hampshire, Utah and Vermont.

States whose rank has declined the most since their peak are: Vermont (8 to 42), Utah (10 to 43), Massachusetts (23 to 47), Montana (8 to 32) and Georgia (15 to 40).

Louisiana ranked highest in disciplining doctors, taking 5.98 serious actions per 1,000 physicians. Five states – Alaska, Arizona, Colorado, Ohio and Oklahoma – have been in the top 10 for all eight rankings. Other states in the top 10 are: Wyoming, North Dakota, New Mexico and Nebraska.

States whose rank has improved the most since their nadir: Hawaii (51 to 11), Delaware (50 to 13), Maine (46 to 19), North Carolina (41 to 16), Washington (42 to 18) and Arkansas (45 to 23). There are 51 rankings because the District of Columbia was also included (no. 37).

“One reason for medical boards’ declining rate of discipline is likely tighter state budgets,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The ability of certain states to rapidly increase or decrease their rankings … can only be due to changes in practices at the board level. The prevalence of physicians eligible for discipline cannot possibly change so rapidly.”

Most boards do not perform satisfactorily in disciplining physicians. Public Citizen called for legislative action and public pressure to kick them into action and, by extension, improve patient protection.

The organization said medical boards are more likely to address physician misbehavior if:

• they receive adequate funding (all money from license fees going to fund board activities instead of into the state’s general fund);


• they have adequate staffing;


• they engage in proactive investigations, rather than only reacting to complaints;


• they use all available/reliable data from other sources such as Medicare and Medicaid sanctions, hospital sanctions and malpractice payouts;


• they have excellent leadership;


• they have independence from state medical societies;


• they are independent from other state agencies; and


• a reasonable legal framework exists for disciplining doctors (the “preponderance of the evidence” rather than “beyond reasonable doubt” or “clear and convincing evidence” as the legal standard for discipline).

Another episode in the if-you-build-it-they-will-come (and pay) story of medical technology has been written recently by hospital emergency rooms. In 1996, about 3 in 100 ER patients were given a CT scan; by 2007, the figure had grown nearly fivefold, to 1 in 7 ER patients, according to a new study in the Annals of Emergency Medicine.

Does this greater diagnostic investment result in fewer people being admitted to the hospital — which is a good thing — or are CTs being overused, and padding the health-care bill without much payoff?

The hospitalization rate following a CT scan was 26% in 1996, and 12% percent in 2007. During that period, the overall hospitalization rate of ER patients rose from about 11% to about 13%.

The cost-benefit issue was examined recently by Kaiser Health News, not only in the context of cost, but because CT scans — which render a three-dimensional image by coordinating a series of X-rays taken from multiple angles — can subject patients to excess radiation.

The researchers, from the University of Michigan Health System, said the radiation risk could be higher for children, patients receiving multiple scans and those who develop complications from the intravenous dyes the imaging often requires.

The American College of Emergency Physicians claimed that fewer patients being admitted to the hospital can be attributed partly to the diagnostic tool.

Hard to argue with a technology that appears to help cut hospital admissions by half, but the study also finds that this positive effect of CT scanning “appeared to diminish after 2003” when the rate “flattened and stabilized” as CT use continued to rise.

Dr. Keith Kocher, the study’s lead author, said, “There are risks to overuse of CT scans … so if they’re done for marginal reasons you have to question why. For example, patients who complained of flank pain (pain in the side) had an almost 1 in 2 chance of getting a CT scan by the end of the study period. Usually most physicians are doing that to look for a kidney stone, but it’s not clear if it’s necessary to use a CT scan for that purpose.”

“Also, during the study period, [emergency department] visits increased by about 30 percent,” Kocher said, “while CT use increased 330 percent, meaning the rate of CT use grew 11 times faster than the rate of ED visits.”

Several factors contribute to the increased use of CT scans:

• the greater availability of the equipment;


• doctors’ fear of being sued for malpractice;


• a perception that patients want the test; and


• financial pressure to make use of the machine.

A handful of symptoms accounted for a disproportionate use of CT scans in the ER — impairments of nerve, spinal cord or brain function; flank pain; convulsions; vertigo; headache; abdominal pain; and general weakness. Approximately 1 in 4 CT scans performed in the U.S. is done in an emergency department, the study found.

If CT scans are overused, figuring out how to reduce their use is tricky, noted Dr. Robert Wears, an emergency medicine doctor who wrote an editorial accompanying the study. Such decisions, he said, are made on a case-by-case basis.

“What is acceptable and appropriate use or nonuse of CT imaging is not an entirely objective question that can be neatly resolved by empirical data and formal analysis,” he wrote, “but rather a tangled, socially constructed issue involving competing views of risk, benefit and obligation, and the elusive question of how much certainty we must have.”

The last thing an injured or ill person wants to do is engage in a protracted discussion about the suitability of care — he just wants to stop hurting. Still, when a CT scan is prescribed, Kocher advises patients to ask if it’s truly necessary. Or ask this: If the CT comes out one way, how will the care be different from how it would be if it comes out another way? Here's where the doctor may hem and haw. The doctor will probably still want to do the scan, and maybe she’s right. But the greater the awareness of the issue, the sooner a reasonable and appropriate standard of care can be determined.

Article first published as Why is Use of CT Scans Soaring in Emergency Rooms? on Technorati.

No one wants to be treated in a hospital by a doctor at the tail end of a 36-hour shift who is falling asleep on his or her feet. So the organization that supervises training programs for resident doctors mandated an 80-hour work week limit.

A provocative piece in the New York Times Magazine makes the case that shorter hours for residents hasn't made hospitals any safer. Why?

• Handoff errors -- poor communications about patients between the doctor leaving a shift and the new doctor arriving -- are still rampant in hospitals, because of lack of systematic training in how to do a proper handoff.
• Lack of supervision, leaving residents to make decisions with little experience and no guidance.
• Many hospitals flout the new rules, and residents work longer than they should.

It's an issue that resists easy answers, as shown by the many comments to the article, which you can click here to read.

We have a good discussion of how handoff errors can lead to malpractice and preventable harm to patients on our firm's website.

In 2007, the FDA proposed guidelines for gluten-free labeling. The gluten component of foods is important to people with celiac disease, a disorder in which essential nutrients can’t be metabolized when gluten is consumed. Gluten is a constituent of many grains, such as wheat, barley and rye.

Now, the FDA-approved definition of "gluten-free" is up for review, and the agency is reopening the comment period. Rules for what can be deemed gluten-free were never adopted.

As reported in Food Safety News, last week Michael Taylor of the FDA said, "We want to get the most up-to-date information and data from affected consumers, from the food industry, researchers and others to ensure that we're making the right public health call in defining gluten-free."

Approximately 3 million Americans suffer from celiac disease. "We want to make sure that those suffering from celiac disease avoid adverse health consequences from being exposed to food that may trigger the symptoms and cause long-term health effects," said Taylor.

The proposed language requires any food with the gluten-free label to contain fewer than 20 parts per million of gluten -- the equivalent of, roughly, about 2 grains of salt in a piece of bread. That recommendation includes a peer-reviewed assessment of the existing literature on gluten safety.

Some people believe that any amount of gluten is unacceptable in a product labeled “gluten-free.”

The rules are expected to be finalized next year.

To view the FDA documents related to the discussion, link here and here. The proposed regulations for gluten-free labeling are in the Federal Register, docket no. FDA-2005-N-0404 at www.regulations.gov.

As reported in the journal Health Affairs, antidepressant drugs are the third most commonly prescribed class of medications in the U.S. Much of the growth of these drugs has been fueled by prescriptions written by nonpsychiatrist caregivers, and are not accompanied by a psychiatric diagnosis.

Between 1996 and 2007, the proportion of doctor visits at which antidepressants were prescribed but no psychiatric diagnoses were noted increased from 59.5% to 72.7%.

Researchers aren’t saying that this remarkable growth necessarily represents inappropriate use of antidepressants, and depression is underdiagnosed and undertreated in this country. But the rapid and marked increase of such prescribing habits have prompted researchers to call for scrutiny of the pattern to better understand the factors driving the trend and to develop “effective policy responses.”

Ramin Mojtabai, one of the study’s authors and a professor in the department of mental health at Johns Hopkins in Baltimore, said to WebMD, “What we are observing is that Americans are increasingly viewing psychiatric medications as a solution for a wide range of social and interpersonal problems and for dealing with daily stress [and] general medical providers appear to be going along with this trend. The irony is that many patients with major depression or anxiety disorders who could potentially benefit from treatment with antidepressant medications do not receive these treatments.”

Another source told WebMD that there may be another story line here. Doctors often get reimbursed at lower rates for treating psychiatric conditions, so they might be motivated to prescribe antidepressants but record them in patient charts as treatment for a nonpsychiatric problem. And there’s still a stigma attached to psychiatric illnesses, which could skew diagnoses.

The study authors suggest that if antidepressants are being prescribed for uses not supported by clinical evidence, there might be a need to improve providers’ prescribing practices, revamp drug formularies or vigorously pursue implementation of broad reforms of the health-care system. The point is to improve communication between primary care providers and mental health specialists.

You have lupus, the chronic inflammatory disease in which the body's immune system attacks its tissues and organs. Sometimes the symptoms resemble the joint stiffness and swelling of arthritis; sometimes they present as skin rashes; sometimes your kidneys malfunction. There are four different kinds of lupus whose treatment might involve a variety of behavioral interventions and so many drug options you need a scorecard to keep track.

Even medical professionals specializing in auto-immune disorders can’t keep up with the research and vast body of knowledge required to be expert in such a complicated disease, not to mention scores of other disorders whose treatment is situational and varied.

In these days of government that can seem to do no right, one federal program is planning to improve access to the body of medical research knowledge. Established by Congress via the 2010 Patient Protection and Affordable Care Act, the Patient-Centered Outcomes Research Institute (PCORI) is tasked with identifying the best available information to help patients and their health-care providers make informed decisions about their care.

PCORI, an independent, nonprofit entity, is all about the science.

As noted by Kaiser Health News in collaboration with Philly.com, "'comparative effectiveness research'" is a relatively new concept in the United States. In fact, the U.S. health system, which largely follows a model that pays doctors and hospitals for any service provided, generally has not embraced comparative effective research.”

If PCORI brings a much-needed objective, science-based standard to the health-care landscape, that doesn’t mean there aren’t challenges to its success. After all, it was created by the political process, and when does that ever yield a purely feel-good result?

KHN/Philly.com enumerates several obstacles for the new agency:

• identifying research priorities for patients based on the study of hundreds of medical conditions and the questions they pose;


• avoiding political criticism from opponents who argue that PCORI will ration care, some even calling it a "death panel";


• maintaining support from medical device makers and drug companies concerned that the institute will be simply a cost-control mechanism; and


• devising strategies for conducting studies to provide meaningful results.

PCORI is reviewing past comparative effectiveness research in the hope of making several grants by the end of this year to identify what it needs to find out from patients. For example, should it use social media to ask people what kind of information they want to have before making decisions?

It also wants to warm up the cold, bureaucratic face public programs often present. “[I]in addition to enhancing the quality of the research,” said KHN/Philly.com, “reaching out to patients can help the institute shed concerns about rationing that were raised by opponents in the health care debate.”

To protect its objectivity, PCORI is forbidden to consider the cost of different treatments as part of setting its research agenda or drawing conclusions. That makes medical device manufacturers and drug companies, who always are concerned about discussions of cost, more comfortable.

PCORI leaders are highly and widely respected, which also helps solidify its neutrality and depth. The nonpartisan Government Accountability Office selected most of its board members; directors of the National Institutes of Health and the Agency for Healthcare Research and Quality chose the others. The board chairman is vice chancellor health sciences at UCLA and dean of its medical school.

“The basic mission is to insure that patients are well-informed and can have informed conversations with doctors,” Dr. Harold C. Sox, former editor of the Annals of Internal Medicine told KNH/Philly.com . “Shared decision-making is not a blue-red issue.”

PCORI wants and needs consumer input throughout its mission. This month, it’s soliciting input from the public about initial topics for pilot projects. To learn more, link here. To stay informed about what PCORI wants to know from consumers, and to contribute to the conversation, link here.

In the 1990s, a new medical specialty emerged whose purpose was to help control the cost of hospital care and improve the outcome for hospital patients. “Hospitalists” are physicians who care only for inpatients; generally, they do not have a private patient practice. As noted in a recent report on NPR, the growing popularity of hospitalists does not appear to be reaping either the hoped for financial or health benefits.

The notion that hospitalist care is superior to that of a personal physician derives from the expertise a hospitalist develops because he or she practices solely within that setting. Dr. James Goodwin of the University of Texas, who studied the impact of hospitalist care among a large cohort of Medicare recipients, said these patients tended to be released sooner than those under the care of their personal physicians. He pegged the population of inpatients under hospitalist care at 30%-40%.

The sooner you leave the hospital, of course, the lower the cost of care. But the complication arises after release. The objective of Goodwin’s study, published in the Annals of Internal Medicine, was “to assess the relationship of hospitalist care with hospital length of stay, hospital charges, and medical utilization and Medicare costs after discharge.” It concluded that patients under hospitalist care were more likely either to be readmitted within 30 days, or to visit an emergency room than patients cared for by their regular doctor.

That represents, Goodwin concluded, additional costs for Medicare of more than $1 billion every year.

Hospitalists, it seems, are more likely to discharge their patients to a convalescent or rehabilitation facility than they are to their homes. And that’s expensive.

Dr. Joseph Li of the Society of Hospital Medicine, an organization that represents hospitalists, raised the possibility that patients who go home directly from the hospital might not be receiving adequate follow-up care, an issue we addressed last week in our discussion of care transition from hospital to home. Li also suggested that hospital patients who transition into a secondary care facility might be receiving the more appropriate treatment than if they had been discharged to their homes.

“These patients are being monitored 24/seven by health-care providers,” he told NPR. “Many of these patients being sent back are being appropriately sent back to the hospital for evaluation.”

Of course, it’s in his organization’s interest to draw that conclusion. That doesn’t mean it’s wrong, but clearly, the study indicates a need for hospitalists and the doctors of individual patients to coordinate care better to meet the needs of both budgets and health.

Pharmaceutical companies love dish about doctors and patients almost as much as they love drug profits. One source of information they like to plunder to expand their markets is doctors’ prescribing histories. These “who,” “what,” “why” reports are one component of so-called “data mining” that has gotten much attention lately as a sometimes sneaky way to unearth potentially sensitive information.

The companies buy the reports from prescription drug intermediary (PDI) agencies that, as explained in an article in the New England Journal of Medicine, collect the prescription records from pharmacies and link them to physician information purchased from the American Medical Association.

Pharma sales representatives crunch the numbers in order to refine their sales pitches when they visit doctors’ offices. Critics of this process, known as “detailing,” claim that it:

• raises costs by increasing the use of brand-name drugs;


• jeopardizes patient safety through wider uses of drugs that haven't been studied appropriately; and


• compromises the privacy of doctors and their patients.

As the NEJM writers note, several states have passed laws to curtail detailing and restrict PDIs from providing prescribing information that identifies physicians. One PDI/pharma effort challenged a law in Vermont that prohibited pharmacies and PDIs from selling/licensing/exchanging prescriber-identifiable prescription information and from permitting its use for drug promotion. The case ended up in the U.S. Supreme Court on the claim that it unconstitutionally restricted free speech.

How information that is supposed to be private between a doctor and a patient can qualify as free speech seems preposterous on its face, but the court ruled in favor of the commercial interests in a long and carefully parsed finding that Vermont was biased against detailers and their free speech.

The authors of the NEJM article looked at both sides of the issue. “If laws like Vermont’s were to become widespread,” they wrote, “they would undercut pharmaceutical companies’ ability to detail physicians effectively, with the probable consequence that detailing would be greatly reduced. Although this outcome might well reduce the cost of prescription drugs, it would also reduce the amount of information that doctors receive. … detailing can have educational value. For all its problems, detailing — like its troublesome cousin, direct-to-consumer advertising — is probably of some benefit to patients.”

They explain that PDI databases are used to benefit public health as research material, and if PDIs were deprived of data-mining income, they might not invest in keeping such complete records. They also explain that landmark legislation to protect patient privacy remains strong. “[T]he Court defended the patient privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, noting that HIPAA imposed a general ban on disclosure except in ‘a few narrow and well-justified circumstances.’ Although the Court did little to define the boundary between unconstitutional laws such as Vermont’s and sacrosanct ones such as HIPAA, it is clear that some restrictions on data sales will, if tailored finely and fueled by strong governmental interests, survive.”

The writers suggest that data-mining prohibitions could survive judicial scrutiny if they:

• broaden the ban so as not to finger only drug marketers; and


• sharpen the focus on privacy issues.

In other words, the authors found reason for hope that this one decision does not establish an impenetrable precedent for commerce to boost drug costs, pose a threat to public safety and invade private files.

Of course, doctors can always close their doors to sales reps, but that’s more pipe dream than likelihood. Because even if doctors are as loath to open their files to Big Pharma as the industry is hungry for the information, and even if doctors know that a sales pitch is less than objective, they still can learn something new, and they value the free samples.

If you’re concerned about this issue, and your doctor prescribes a drug:

• Ask if there is a generic option, and if it’s suitable for you.


• Ask if he or she embraces the AMA’s Physician Data Restriction Program (PDRP), which allows doctors to withhold prescribing data from sales reps but still share it for research purposes. According the NEJM, only 4% of physicians have signed on, probably because “the AMA’s financial interests cut against strongly promoting the program.”


• Tell him or her that you’re uncomfortable with your drug history being shared, and request that he or she not entertain pharmaceutical sales calls.

These measures alone probably won’t change anybody’s practice, but they will let your caregiver know that you’re informed and concerned. And that you can always find another doctor.

The cost of treating multiple sclerosis (MS) with a certain class of drugs is significantly higher than the cost of addressing the symptoms of MS with other therapies, according to a study in the journal Neurology.

Analyzing data from 844 individuals with early-stage MS and projecting health-care costs, including the cost of the drugs and lost productivity over a 10-year period, the study found that MS patients using disease-modifying drugs experienced modest health gains. But the cost associated with using such drugs is more than eight times higher than what is considered “reasonable” from a cost-effectiveness perspective.

“While it is clear that disease-modifying drugs are beneficial to some MS patients, those gains come at a tremendous economic cost,” said Katia Noyes, Ph.D., M.P.H., associate professor in the Department of Community and Preventive Medicine at the University of Rochester Medical Center and lead author of the study. “These results point to the need to continually evaluate the cost-effectiveness of new treatments in the interest of controlling health care costs.”

MS, a disease of the central nervous system, is the most common cause of neurological disability in young adults, causing muscle weakness, numbness or tingling in arms and legs, difficulty with coordination, balance and walking, blurred vision and slurred speech. The disease first manifests in cycles of acute symptoms followed by periods of remission and recovery. Eventually, the symptoms generally become debilitating.

Several new drugs introduced in the 1990s modified the course of the disease; traditional therapies primarily treat the symptoms of the disease. The drugs have been shown in large clinical studies to slow the progression of the disease and reduce relapses, but are associated with side effects and are very expensive -- as much as $30,000 per year.

The researchers employed a method called quality-adjusted life years (QALY) to evaluate the health effects of the drugs. QALY is a standard tool for evaluating disease burden by estimating the improved quality of life gained over time from a particular medication or course of therapy. Health policy experts generally accept that for an intervention to be judged “cost-effective” it should cost $100,000 or less to produce an extra QALY. According to the study, disease-modifying drugs for MS cost more than $800,000 per QALY.

And that came with only a modest improvement in health, according to the study. For example, MS patients taking one of the drugs gained about two quality-adjusted months over 10 years compared with patients who did not take disease-modifying drugs. They had an average of six out of 10 free of relapses compared with five years for patients not taking the drugs. The authors also found that the benefit to patients was greater if they began taking the drugs early during the onset of the disease.

The latest report from the prestigious Institute of Medicine -- about the nonsensicality of the current system where dangerous medical devices can get approved for sale with a grandfathering process called 510-k -- prompted this letter to the editor that summed it all up:

The problems are not new. They reflect an underfinanced and underpowered Food and Drug Administration, successful efforts by the device industry to block or blunt regulation, and the industry’s relationships with corruptible surgeons and members of Congress.

In the current ideological climate, we will hear a great deal about the dangers of “overregulation.” One must hope that the F.D.A. will be allowed to pay more attention to the Institute of Medicine than the onslaught from industry lawyers and lobbyists.

The author is HENRY GREENSPAN, who teachers ethics, politics and regulation at the University of Michigan, writing in the New York Times.

Blogger Jim Edwards has a list of "10 Weird Health Theories That Just Won't Go Away."

Many of them flower from the backlash to the medical industrial complex's desire to medicalize, and provide a pill for, all slightly different human behaviors. Others underscore how appropriate skepticism about modern medicine can lead to an over-correction and an endorsement of wrongheaded and dangerous ideas (autism being caused by vaccines as a prominent example).

Here's the list of myths:

• "The so-called obesity epidemic is just a scare tactic to make you feel bad"

• "Human growth hormone is the fountain of youth"

• "Women who don't like sex have female sexual dysfunction"

• "Low-dose naltrexone cures everything"

• "Multiple sclerosis is caused by blocked jugular veins"

• "Taking multivitamins can prevent prostate cancer"

• "High cholesterol is not a health risk" [Note from Malone: This one is complicated.]

• "The feds want to microchip you like a pet cat"

• "HIV is not the cause of AIDS"

• "Vaccines cause autism"

As of this autumn, Tylenol is losing part of its punch. Manufacturer Johnson & Johnson is reducing the maximum recommended dosage on products containing acetaminophen, the main ingredient in Tylenol. The risk of liver damage from too much acetaminophen has long been a problem.

Most cases of liver damage occur when consumers take more than the prescribed dose of acetaminophen within a 24-hour period, take more than one acetaminophen product or consume alcohol regularly before taking acetaminophen.

When reformulated, Extra Strength Tylenol's recommended maximum daily dosage will be 3,000 mg per day, down from 4,000 mg per day. Earlier this year, the FDA imposed new limits on acetaminophen in prescription painkillers including Vicodin and Percocet, which contain other pain-killing compounds. Over-the-counter meds with acetaminophen were not affected by the FDA's restriction.

According to AboutLawsuits.com, more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.

We've said it before, and we'll say it again -- being released is only the halfway point of a successful hospital experience. The shift from in- to out-patient status is known as "care transition," and it must be managed carefully to ensure the patient recovers fully.

Two new studies in the Archives of Internal Medicine reinforce the notion that one's chances of being readmitted to the hospital are significantly improved when health-care providers and patients follow a program of care transition.

That term, according to the the Care Transitions Program at the University of Colorado's School of Medicine, "refers to the movement patients make between health care practitioners and settings as their condition and care needs change during the course of a chronic or acute illness."

Although the new studies were small -- it proved difficult to recruit sufficient numbers of people -- real-world applications of what were previously controlled trials showed reduced rates of admission when the hospital discharge process included complete communication.

One program to reinforce post-discharge self-care instructions and the need for a follow-up physician visit reduced 30-day readmissions by 39% among participating Medicare patients in Rhode Island. Another program with different interventions but the same goal for heart failure patients in Dallas showed a 48% reduction in 30-day readmission rates.

A lower incidence of hospital readmission is important not only as a measure of improved care, but reduced cost. Sort of -- reduced for whom? Certainly the patient, but not necessarily the hospital.

In one of the studies, as described in MedPage Today, the advanced practice nurse-led program cost $1,1110 per patient but reduced in-hospital health-care costs by $524 from admission to 30 days afterward. And the hospital lost an average $751 in revenue by preventing readmissions.

No one is suggesting that being in the hospital longer than you need is a good idea, but the numbers do suggest a need for change in how hospitals are reimbursed for care administered but not for preventing adverse outcomes, according to Mitchell H. Katz, M.D., of the Los Angeles County Department of Health Services. He wrote an editorial about the studies.

Another fly in the reduced readmission ointment is patients themselves, who must be willing to participate in a prescribed transition program. That's proving elusive perhaps because people just want to be left alone to recuperate after their hospital experience, and the program can seem intrusive, with home visits and/or phone calls for the purposes of patient and family education and to monitor the patient's condition.

In a nutshell, care transition is about communication. It's an organized way, as CU's Care Transition Program says, to make the "handover from hospital to home go smoothly and to help you stay out of the hospital." Visit its transitions skills page for information about:

• The Personal Health Record;


• The Discharge Preparation Checklist;


• Medications;


• Follow-up Visit with your Primary Care Doctor or Specialist;


• Understanding your Health Conditions;


• Reaching Your Health Goals.

A woman on Medicare who lives in a nursing home is visited by relatives. They are told by facility staff that the resident isn't allowed to leave without her doctor's permission. If she does, she must sign a statement releasing the facility from liability, and that her departure will result in her losing her health-care coverage.

That sounds like a plot from a Kafka novel, but it actually happened to one family. According to the Los Angeles Times, most of what they were told was not only fiction, but the worst kind of medical-hostage bullying.

Categorically, nobody -- not a doctor, not any health-care provider -- has authority to strip someone of his or her health insurance benefits, including Medicare. Of course, certain requirements must be met for Medicare to cover some costs at a skilled nursing facility (SNF). But, as The Times' story noted, if someone is receiving care, she has met the requirements, and it's unlikely that Medicare would be denied if she left against doctor's orders.

Medicare coverage in an SNF is determined by a prior, qualifying three-day hospital stay; by participation in Medicare Part A with days left in the benefit period; and by a doctor's order for the SNF services as part of treatment for a diagnosed condition.

According to Eric Carlson, an attorney with the National Senior Citizens Law Center, nursing home staff has no authority to tell someone he or she can't leave. "The person isn't incarcerated, and doctors are professionals hired to give advice, not to force people to do things against their will," he told The Times.

If someone leaves against a doctor's advice, her choice must be documented, that's all.

And as far as releasing a medical provider from liability for wrongdoing, Carlson says ... don't. "Healthcare people can't [legally] absolve themselves from their own negligence."

Medicare is fraught with complication, so people on both sides of the equation -- patients and providers -- can be forgiven for misunderstanding its terms. The best way to prevent mistakes and misinformation is to be informed of your rights as a Medicare recipient, and to communicate your knowledge to facility staff.

Resources include:

• National Senior Citizens Law Center, www. nsclc.org. Review the free consumer guide, "20 Common Nursing Home Problems and How to Resolve Them."


• The Office of the Medicare Ombudsman. Complaints can be filed with a representative in your state. Find yours through its National Long-Term Care Ombudsman Resource Center, www.ltcombudsman.org/ombudsman.


• Many states have ombudsmen at their departments of health and/or aging. Concerns about a specific nursing facility generally can be filed through a state's Department of Public Health.


• The National Center on Elder Abuse accepts reports about abuse, www.ncea.aoa.gov. Click on "Nursing Home Abuse," then "Where to Report" to find hotlines in your state.


• To find a lawyer at the National Academy of Elder Law Attorneys, visit www.naela.org.


• For information about Medicare benefits, visit the Medicare Rights Center at medicareinteractive.org.