DC Medical Malpractice & Patient Safety Blog

In October, we reported that the U.S. Preventive Services Task Force was recommending that routine screening for prostate cancer be suspended for most men. Last week, after six months of reviewing nearly 3,000 public comments, the task force confirmed its initial finding.

The discussion of prostate screening for cancer, as well as that of routine mammography, have helped raised consciousness that overtesting and overtreatment compromise the quality of health care.

The task force’s study was published in the Annals of Internal Medicine.

The PSA test, in which blood is tested for the presence of elevated levels of an enzyme that helps liquefy semen, exposes men to far more harm than it helps. Although elevated levels can indicate the presence of a cancer, research studies have shown that, at best, one life is saved for every 1,000 people screened over a 10-year period. But more than 100 of those 1,000 men will produce suspicious results when there is either no cancer or a cancer that is growing so slowly (or not at all) as to produce no threat. Forty of those 1,000 patients will become impotent or suffer urinary incontinence.

For most men, a positive test means having a biopsy, which carries its own risks such as pain, fever, bleeding, infection and hospitalization. If cancer is detected, 9 in 10 men will be treated surgically or by radiation even when the tumors are not life-threatening. The possible side effects are impotence, urinary incontinence, blood clots and other harms that the panel concluded are overwhelmingly persuasive in removing the PSA test from routine care.

Men concerned about prostate health and age-related problems such as reduced or intermittent urinary flow, should discuss them with their doctor for diagnosis and treatment other than PSA testing. The scientific evidence is overwhelming that it causes more harm than good -- for most men, and that means it's still worth a discussion to find out if you're in the group that may need closer watching.

In their youth, baby boomers were perceived as the luckiest generation yet of Americans. But thanks to their unprecedented freedom and the boundary-pushing nature of post-World War II America, boomers disproportionately suffer from something nobody wants: hepatitis C.

As a result, the Centers for Disease Control and Prevention (CDC) is recommending that all baby boomers be tested to see if they are harboring the virus that causes problems, or if they already have been compromised by its presence.

Hepatitis is inflammation of the liver. It also refers to viral infections that affect the liver, most commonly hepatitis A, hepatitis B and hepatitis C. Hepatitis C can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Read more about hepatitis here, and about the threat it presents when caregivers are careless.

Hepatitis usually spreads when blood from someone infected with the hepatitis C virus is transferred into the body of someone who is not, most commonly by sharing needles or other equipment to inject drugs. It used to be spread through blood transfusions and organ transplants, but now the blood supply is more thoroughly screened.

According to the CDC, hepatitis infects 1 in 30 baby boomers (the generation born between 1945 and 1965), or 2 million people. It’s the fastest-rising cause of cancer-related death and the leading cause of liver transplants in the U.S.

Most of the boomers infected with hepatitis C are unaware of it—except for ambiguous problems such as fatigue, it remains asymptomatic until the diseased liver is seriously compromised.

So the CDC has issued guidelines proposing that all baby boomers in the U.S. be tested for the virus with a simple, one-time blood test. If it’s positive, treatment can be available before the virus becomes life-threatening. The CDC says newly available therapies can cure as many as 3 in 4 infections.

Baby boomers represent 3 in 4 U.S. adults infected with hepatitis C, and are five times more likely to be infected than other adults; 15,000 die every year from related illnesses, such as cirrhosis and liver cancer.

The CDC estimates that testing could identify more than 800,000 people who otherwise don’t know they have a life-threatening condition. The agency estimates that testing could save more than 120,000 lives.

Hepatitis C can be either “acute” or “chronic”; the former viral infection is a short-term illness that occurs within six months after someone is exposed to the virus. Usually, acute infection leads to chronic infection. That can result in long-term health problems, or death.

There’s no vaccine, so the best way to prevent hepatitis C is by avoiding behaviors that can spread the disease, especially injecting “recreational” drugs.

To take the CDC’s hepatitis C risk assessment, link here. If your risk is moderate to high, or if you are a baby boomer, ask your doctor for the blood test.

To learn more about the CDC's hepatitis initiative, link here.

The concept of coordinated care is considered a best practice, but in light of a recent survey and story by NPR, the Robert Wood Johnson Foundation and Harvard School of Public Health, it’s hardly a widespread one.

A few years ago, we wrote about what happens to hospital patients when the facility’s right hand doesn’t know what the left hand is doing. The story told how the lack of coordinated care resulted in 1 in 5 Medicare patients being readmitted to the hospital within 30 days.

Earlier this year, we reported that some health insurers are beginning to appreciate the wisdom of coordinating patient care in terms of both health outcomes and cost savings.

Coordinated care involves a therapeutic plan that integrates the efforts of all of the patient’s medical and social service providers. It might designate a single person to manage all of the collaborators or simply might be an understanding they share to ensure efficiency and communication. The point is to maximize resources, minimize duplicate procedures, reduce costs and, ideally, prevent harm.

That didn’t happen for Andrew Dasenbrock, one of the subjects detailed in the NPR story.

A 32-year-old a self-employed IT consultant, Dasenbrock says he can't afford health insurance. When he woke one night with intense stomach pain — "like shards of glass traveling through me," he said—he went to an urgent care center nearby. Doctors ran several tests, couldn’t settle on a diagnosis and sent him to the hospital.

The hospital was part of the same system, but its staff was not alerted to Dasenbrock’s arrival, nor were his records transferred. He was forced to fill out the same questionnaires and repeat all the same diagnostic tests. He remained in excruciating pain.

The hospital diagnosed an ailment that, while painful, wasn’t serious and required only that Dasenbrock ingest a lot of fluid. He went home. Two days later he received two bills totaling thousands of dollars.

"I laid the two bills next to each other and it was literally word for word, letter for letter and line item by line item the same charges ... for all the tests I had gone through," Dasenbrock said. He had to pay double what he should have for his care.

Another tale was told by Jacki Bronicki, whose father was 80. He had Parkinson’s disease, but the retired engineer and physics teacher was mentally acute and responding well to his treatment.

Last year he fell, broke three ribs and was admitted to the hospital. His mental state began to deteriorate by the second day. "He wasn't even coherent by the third day," Bronicki said.

Bronicki said that the parade of doctors who saw him seemed to assume that his confusion was, for him, normal, and reflected his age and condition. Bronicki said she had to explain to each new doctor that he had Parkinson's, that his mental deterioration was not his normal, that he usually was coherent.

Finally, a neurologist finally figured out that all the different doctors had prescribed different pain medications, and the drugs were interfering with Brown's Parkinson's medication. That caused his mental deterioration and made his limbs rigid.

His prescriptions were realigned, and he improved. But Bronicki and her sisters felt they had to remain at his hospital bedside 24 hours a day to prevent another medication error. And, she reported, "He has a lot more dementia than he had a year before. He can't walk anymore. And I'm not sure if it would have normally progressed like this, or if we really sped it up."

It wasn’t they who sped it up; more likely, it was the lack of communication and coordination among all of his caregivers.

Certainly, many of the survey respondents were pleased with their care. But of people hospitalized in the last 12 months:

• 30 percent said doctors, nurses and other health-care professionals communicated poorly with each other;


• 24 percent said doctors, nurses and other health-care professionals didn’t communicate information about their condition or treatment.

To prevent mistakes and unnecessary costs that result from uncoordinated care, ensure that in advance of your need for care by multiple parties, you and your loved ones have a patient advocate (read our article “Bring an Ally with You to the Doctor's Office”). Get and maintain a complete patient history, and make sure all of your care providers have it.

The list of medical procedures no one welcomes is long and varied, but pretty much everyone would opt never to have a colonoscopy if it weren’t necessary.

It’s not so much the procedure that’s a problem, it’s the preparation—a diet restricted to clear liquids for 24 hours, and the ingestion of a nasty bowel-clearing drink no one will ever confuse with refreshment.

We recently wrote about the mixed messages that surround colon cancer scans, but they’re advisable for many people. Thanks to recent research, things could be looking up for the colonoscopy crowd.

As reported on MedPage Today, virtual colonoscopy, in which the lower intestine and colon are scanned externally by CT technology instead of viewed with an invasive probe, correctly identified 9 in 10 patients with larger adenomas—masses, or polyps, that aren’t cancerous but carry that potential. Standard optical colonscopy generally detects 9½ out of 10 such polyps.

Smaller masses, however, might not be be detected as successfully with virtual colonoscopy.

The study results were published in the Annals of Internal Medicine.

The less invasive procedure eliminates the need for the laxative that precedes traditional colonoscopy, but patients still ingest a solution; it contrasts stool on the image as different from other bowel contents. The interpretive software digitally erases the stool from anything a radiologist needs to see.

Although virtual technology does not appear to depict polyps smaller than 10 mm as reliably as larger masses, the vast majority of polyps that lead to cancer and affect survival outcomes are larger than 10 mm. For people who can’t—or won’t—tolerate the laxative bowel preparation, the CT scan might be the only way they get screened.

The study involved multiple facilities and 605 adults 50 to 85 years old who were at average to moderate risk for colon cancer. All were screened by both methods. Only four of the 26 lesions detected were smaller than 10 mm. All of the confirmed cancers were larger than 10 mm.

More than 6 in 10 study subjects said they’d opt for the virtual procedure over standard colonoscopy in the future. About 5 in 100 received additional diagnostic tests because something other than suspicious polyps were detected.

In addition to the loathsome preparation, traditional colonoscopy has inherent risks, primarily perforation of the bowel. Some people also might react to the sedative.

If you’re scheduled for a colonoscopy, discuss the pros and cons of each type of screening, including sigmoidoscopy, which is invasive, but requires less preparation than colonoscopy and usually no sedation. But it views only the lower part of the colon instead of the whole thing. So a lot of specialists liken it to undergoing mammography of just one breast.

Despite the news on virtual colonoscopy, for most people, conventional colonoscopy remains what doctors call the "gold standard."

For approximately 1 million Americans every year, kidney stones easily outrank childbirth, migraine headaches and other kinds of hurt for the booby prize of “most pain I’ve ever had.”

Now those victims have some good news—new research by scientists at the Washington University School of Medicine in St. Louis has yielded information to explain why some people are more likely to develop kidney stones than others. That’s critical to developing tests for kidney stone risk and effective treatments.

The research was conducted on mice and the results published in The EMBO Journal, (the European Molecular Biology Organization). Human kidney function is similar to mouse kidney function.

Most kidney stones form when minerals in urine, such as calcium, crystallize and stick together. Risk increases with a diet lacking sufficient water and/or too much salt, which binds to calcium; the risk of developing stones also increases with age.

But the identification of a genetic component has been linked to an increased risk of as much as 65 percent.

Normally, kidneys process essential minerals from blood for transport back to the cells that perform the basic functions of life. Typically, the gene of note, claudin-14, is not active in the kidney, and when it is, appears to be the source of the problem. The new research shows that it can be neutralized by specific molecules, thereby enabling the kidney’s filtering system to work as it’s designed.

When people eat a diet high in calcium or salt and don’t drink enough water, claudin-14 prevents the calcium from re-entering the bloodstream. The excess calcium is expressed in urine, which leads to the formation of stones in the kidneys or bladder. When a stone gets stuck in the bladder, ureter or urethra, it can block the flow of urine and cause intense, seeing-stars pain.

Drugs that mimic the activity of the molecules that “turn off” claudin-14 could significantly reduce the likelihood that people with this genetic makeup would form stones. And a test could be developed to measure levels of claudin-14 in urine. If they are elevated, dietary modifications would be the first line of defense against developing stones.

Until treatment catches up with science, you should ensure sufficient hydration to help prevent the formation of kidney stones. The amount required depends on an individual’s activity level and the climate. The National Institutes of Health say that different kinds of kidney stones require different dietary modification. In general:

• If you’ve had a kidney stone, drink enough water and other fluids to produce at least 2 quarts of urine a day (eating fruit with a high water content, such as melon, can boost your fluid intake).


• If you work or exercise in hot weather, drink more to replace fluids lost through sweat.


• Avoid grapefruit and cranberry juices and dark colas, which have been found to increase the risk of stone formation.


• Ask your doctor about eating protein. Meat (especially organ meat such as liver), eggs and fish contain substances that break down into uric acid in the urine. Nonanimal protein (nuts, beans, etc.) can increase the excretion of calcium. Both encourage stone formation in some people.

Here's another tale of Big Pharma insinuating itself into places it doesn't belong, to the detriment of quality care and patient safety.

Established to support patients with chronic pain, their families and the health-care professionals who serve them, the American Pain Foundation claimed to be the pain community’s largest advocacy group. Early this month, it abruptly shuttered its operation, attributing its demise to economic circumstances.

As several news organizations reported, that’s hardly the whole story.

Given the boom in prescription pain medicine—according to Marketplace.org, prescriptions for painkillers such as Oxycontin and Vicodin have quadrupled in the last decade—Americans clearly are hurting. You’d think there would be plenty of support for an organization that salved the pain.

But as explained in an investigative report by ProPublica, the foundation shutdown had to do with a U.S. Senate committee investigation into makers of narcotic painkillers and groups that champion them. According to ProPublica, 9 of every 10 dollars of the foundation’s funding in 2010 came from the drug and medical-device industry.

And—surprise!—its guidelines for patients, journalists and policymakers had minimized the risks associated with opioid painkillers and had exaggerated their benefits.

Senators Max Baucus, D-Mont., and Charles Grassley, R-Iowa, sent letters to the foundation and drug companies citing an "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers."

Drug companies, they wrote, "may be responsible, at least in part, for this epidemic by promoting misleading information about the drugs' safety and effectiveness."

The senators are looking into the whole pain-control industry and medical oversight agencies to expose the financial connections among them. In addition to the American Pain Foundation and drug makers, recipients of the letters included the American Academy of Pain Medicine, American Pain Society, the Federation of State Medical Boards (the trade group for agencies that license doctors) and The Joint Commission (an independent nonprofit that accredits hospitals).

The U.S. Government Accountability Office (GAO) reported in 2003 that the Joint Commission had partnered with Purdue Pharma, the maker of Oxycontin, to distribute pain educational materials. In 2007, Purdue had pleaded guilty to federal criminal charges that it misled regulators, physicians and consumers about Oxycontin's risk of addiction.

No one denies that opioids might be appropriate for people in serious pain. But like any other drug, their benefits must be measured against their potential harm, and you can’t do that when manufacturers and so-called “advocates” supply inaccurate or incomplete information.

As quoted in the ProPublica story, Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn, N.Y., and president of Physicians for Responsible Opioid Prescribing, said, "These groups, these pain organizations … helped usher in an epidemic that's killed 100,000 people by promoting aggressive use of opioids. What makes this especially disturbing is that despite overwhelming evidence that their effort created a public health crisis, they're continuing to minimize the risk of addiction."

Sales of these potent drugs have risen 300 percent since 1999. And opioids were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. In 2009, the use and misuse of the drugs were cited in more than 475,000 emergency department visits, nearly doubling the 2004 number. The figures come from the Centers for Disease Control and Prevention (CDC).

One in 8 high school seniors surveyed for a research paper in the Archives of Pediatrics & Adolescent Medicine said they had used prescription opioids for nonmedical reasons.

Another report in the Journal of the American Medical Association found that the rate of newborns diagnosed with drug withdrawal jumped threefold from 2000 to 2009. The rate of mothers using opioids at the time of delivery was five times higher in 2009.

Typically, medical professionals and patient advocacy groups acknowledge that drug overdoses are a legitimate concern, but say that most deaths involve illegally obtained drugs. They also say that patients' risk is low if they do not have addictive personalities, and people who suffer from serious pain should not be deprived of relief.

No, they shouldn’t. But narcotic manufacturers also shouldn’t be bankrolling advocacy groups whose job is to provide objective and complete information about drugs.

Beauty’s only skin deep, they say, but ugly cuts to the bone.

And by “ugly” we’re talking about the potential for cosmetics to have unattractive consequences. At least that’s the thinking behind the push for more accurate product labeling on makeup, sunscreen, bath and other personal products.

As explained in a story by the Detroit Free Press, the chemicals, minerals and unknowns that are constituents of these lotions and soaps and hair applications do not undergo routine review by the FDA or USDA or any other regulatory agency. Only when consumer problems necessitate attention are these products scrutinized.

Between the fundamental human desire to look good and the overwhelming marketing hype characteristic of the cosmetics industry, consumers are hard-pressed to get accurate, helpful information about the ingredients with which they have such a close, personal relationship.

That’s not acceptable to U.S. Rep. John Dingell, D-MI. He’s conducting the first congressional hearings in decades about cosmetics safety. Several pieces of legislation have been introduced to give the FDA the power to register cosmetics and enable recalls if products prove unsafe.

Last year we wrote about one risky product, Brazilian Blowout, a hair-straightening formula that was found to contain dangerous levels of formaldehyde. Consumers suffered respiratory problems and skin rashes, and now Brazilian Blowout labels carry a warning. But it’s still a legal product and the FDA has no further authority to regulate it.

Lack of research into the long-term effects of low-level exposure to cosmetic chemicals makes clear harm uncertain. In the cosmetics industry, according to the co-founder of a cosmetics company quoted by the Free Press, "everyone's intentions are safe levels. But then, everyone is using 20 products a day. It's this geometric explosion of chemicals in our lives. ... It's not one thing."

"The question is whether the occasional application on the skin is really dangerous," said Dr. Scott Ramsey, director of the Cancer Prevention Program at the Seattle-based Fred Hutchinson Cancer Research Center.

Years ago paraben -- a preservative used in cosmetics and deodorant – was suspect in breast tumors. People dumped these products, but it’s still unclear if paraben is harmful. Preservatives prevent the growth of harmful bacteria in a product that sits on a bathroom shelf or at the bottom of a purse, and it’s impossible to completely escape exposure to toxins. Even antibacterial soap, a product that’s supposed to confer protection, has been host to a chemical suspected of causing hormonal issues.

But consumer safety advocates at least want to cut down on exposure you can control. One salon customer interviewed by the Free Press put it concisely: "Better health is not a science problem; it's an information problem."

Don’t use a product without reading the label. If ingredients are not listed, Google the manufacturer for more information or opt for a product you can vet. Search for information about the safety of a given product on the Consumer Products Safety Commission’s Safer Products (CPSC) site.

If a product causes problems—anything from minor skin irritation to more serious issues such as swelling or breathing problems—contact the FDA’s cosmetic topics website, the CPSC and the manufacturer.

If you want the federal government to improve cosmetic product oversight, contact your congressional representative.

The hospital’s emergency room is filled with patients representing a range of urgent problems. The kid with a broken ankle, courtesy a bumpy slide at second base. The woman wearing dark sunglasses and cradling her migrained head. The guy pressing a towel into the web of his hand to stanch the blood from a knife meant to cut a bagel. The hyperactive, foot-tapping college student who alternates between nonstop chatter and low, howling moans, in the throes of an anxiety attack, schizophrenia or who knows what.

Who will be seen first, who will get treated quickly, how long will it take to admit someone who should be an inpatient?

This is a hypothetical example. But it’s pretty certain not to be the patient with the mental disorder. A study published in the Annals of Emergency Medicine showed people presenting at hospital emergency departments and trauma centers with psychiatric problems spent more than 11 hours in the ER, and that they wait even longer if they must be transferred for admission.

If the psych patient is older, intoxicated or uninsured, according the study, the wait is even longer. The time doubled if the patient was discharged not home but to an outside facility.

As reported on MedPageToday, the conclusions highlight how interrelated is mental health care, and how much room there is for improvement for to coordinate care.

This isn’t news. National Center for Health Statistics showed that the average wait for mental health services in an emergency department was 42 percent greater than the wait for other health issues.

In a survey by the American College of Emergency Physicians, 40 percent of emergency department medical directors said psychiatric patients waited more than eight hours from disposition decision to discharge from the ED. Only 7 percent of the directors said medical patients had to wait that long.

In addition to being inconvenient and distressing, waiting too long in an ER can be harmful. See our post, “ER delays cause patients to skip care.”

Some ERs are better able to process psych patients than others.

"Emergency departments (EDs) that are embedded within a larger system of care and have ready access to various levels of after care options,” the researchers wrote, “are likely to be better positioned to more rapidly transition patients through the ED."

There’s still not much authoritative data about just how much psychiatric patients are penalized in the ER because their disorder isn’t visible or exciting or … what? So the latest research was aimed at identifying patient-related and clinical management factors associated with longer ED waits.

Psychiatric patients seeking emergency consultation at five urban hospitals—two academic and three community—were studied. More than 1,000 patients were included. The median age was 39, and the gender representation was equal. About 7 in 10 were non-Hispanic white; two-thirds had public insurance; 13 percent were homeless.

The most common complaints were depression or anxiety (37 percent) and suicidal thoughts or nonlethal self-harm (33 percent). One in 3 showed evidence of alcohol use, with or without other drugs.

On discharge, the most common diagnoses were mood disorder (69 percent) and substance use disorder (41 percent). Nearly 300 patients were discharged to home and nearly 600 were admitted to the hospital or transferred to a psychiatric unit.

The average wait times and average added times were:

• transfer outside the care system, 15 hours;


• transfer within the system, 12.9 hours;


• transfer to psychiatric unit in hospital, 11 hours;


• age: 12.6 hours for ages 60 and older, 11.9 hours for ages 41 to 59, 10.7 hours for ages 18 to 40;


• positive screen for alcohol, more than 6.2 hours;


• diagnostic imaging, more than 3.2 hours;


• use of a restraint, more than 4.2 hours;


• uninsured, more than 4 hours.

Being admitted or transferred resulted in an additional wait of 3.3 to 7.4 hours. The long wait after diagnosis and before admission/transfer, the researchers said, was the single biggest influence on how long a patient would be confined to care.

"Approximately two-thirds of all patients receiving emergency mental health care … were either admitted or transferred to a psychiatric unit. Although these hospitalized patients tended to be seen and assessed more quickly than patients discharged home, they had significantly longer overall length of stay because of the extended wait time between the decision to admit and the ED discharge."

Early in 2009, President Obama signed the American Recovery and Reinvestment Act (ARRA). Commonly known as the Stimulus, or Recovery Act, it was intended to juice the sluggish economy, and it reached into all corners of our culture. One of its effects on health care was the establishment of a national electronic medical record (EMR).

Financial incentives were provided for medical providers to transition to electronic record-keeping. Well-designed and well run e-record programs improve efficiency and enhance patient safety, but they require conscientious attention on the part of designers and providers.

One such provider, a cardiologist and a fan of EMR, recently had an experience that prompted him to wonder if electronic record-keeping systems should be considered medical devices, and therefore subject to all the same kind of regulatory oversight given, say, a heart defibrillator.

Dr. Wes Fisher received a medical record from a major medical center that employed an EMR manufactured by a well-established, billion-dollar corporation. As recounted on KevinMD.com, he saw “one of the better examples of how EMRs are contributing to misinformation and confusion when health-care is delivered.”

The report was an internal medicine consultation of a hospital patient whose “medications” portion of the internist’s notes are posted on the KevinMD website exactly as received in the EMR, and identified as “Active Medications.” All told, 55 entries for medications were listed, and Fisher was “terrified."

Some medications were listed multiple times, sometimes with different dosages. Some drugs lacked dosages, such as warfarin, a blood-thinner that must be carefully dosed and monitored. Meds typically prescribed for outpatients are listed along with those typically prescribed for inpatients, making any reviewer of this record unclear what meds this patient is actually taking.

Fisher in no way excuses the internist, or any other doctor, from responsibility over the quality and accuracy of any medical record, whether it’s confined to an office or disseminated to other providers, facilities and insurance companies. But his overriding concern is that when EMRs are poorly developed and/or hospital administrators buy products capable of providing “useless and potentially lethal information about our patients” (his italics), doctors must speak up.

“So how will we measure problems with EMRs?” he asks. “It seems industry representatives would rather not address these concerns. We should ask ourselves, is anyone thinking about this?”

Fisher suggests the creation of an EMR registry similar to the data repository mandated by the Center for Medicare & Medicaid Services (CMS) for implantable cardioverter defibrillators (the ICD Registry). Its purpose would be to track adverse patient outcomes resulting from software systems and would enable EMR manufacturers to learn and improve from everybody’s mistakes.

To learn more about your rights in compiling, keeping and disseminating your medical records, read our newsletter article, “Why Getting and Reading Your Medical Records Can Save Your Life.”

Here’s another arrow for the quiver of people exasperated with government.

As part of its health-care reform, the Obama Administration proposed that drug companies be made to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. The rationale, as reported by The New York Times, was evidence that such payments can influence treatment decisions and boost costs by encouraging the use of more expensive drugs and medical devices.

Disclosure, the thinking goes, would make doctors more disposed toward making decisions in the best interests of patients instead of their bottom lines. As we’ve reported, drug and device company largess can be ripe for conflicts of interest.

According to The Times, about 1 in 4 doctors takes cash payments from drug or device makers; nearly 2 in 3 accept routine gifts of meals for themselves and their staff. The Times also concluded that doctors who take money from drug makers often practice medicine differently from those who do not—they’re more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Some companies have begun posting some payment information on their web sites, sometimes as the result of legal settlements with the federal government. Under the new proposal, if a company has even one product covered by Medicare or Medicaid, it must disclose all payments to doctors other than its own employees. The federal government will post the information on a public Web site.

The penalty for noncompliance could be $10,000 for failure to report. A company that knowingly fails to report payments could be subject to a $100,000 penalty for each violation, to a maximum of $1 million a year.

Comments about the proposal were accepted until Feb. 17, then Medicare officials were to issue final rules with the force of law.

Here’s where the archers among us start to take aim. As reported on FDA Law Blog, earlier this month the Centers for Medicare & Medicaid Services (CMS) announced “that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before Jan. 1, 2013.”

The regulation requires the first report to be submitted by March 31, 2013 for payments made in this calendar year, but CMS already has exceeded one deadline--under the Patient Protection and Affordable Care Act (ACA), payment-reporting procedures were supposed to be established by of Oct. 1, 2011.

The postponement gives CMS time to review more than 300 comments about the proposed rule, and also affords manufacturers additional time to prepare for the disclosure reports. Although the CMS didn’t expressly say the March deadline was extended, it’s implicit in the delay.

On news of the extension, Sen. Charles Grassley, R-Iowa, one of the sponsors of the Physician Payments Sunshine Act, said, “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

We’d like to believe him. But when it comes to excuses in Washington, supply always
seems to exceed demand.

What with the uncertainty of the Obama Administration’s health-care reform and the increasing cost of medical care, few areas of U.S. commerce are as volatile as health insurance. But one segment of that industry is decidedly popular, although it’s fraught with “what-ifs.”

In one year, between January 2010 and January 2011, high-deductible insurance plans grew by more than 1 million customers. According to a story aired on PBS Newshour, in collaboration with Kaiser Health News, last year, nearly 3 in 10 workers covered by employer insurance were offered a high-deductible option. Enrollment in such plans has tripled in five years. A survey by the Kaiser Family Foundation (not affiliated with the health-care provider) showed that half of all covered workers in small businesses (as many as 199 employees) had a high-deductible plan.

Deductibles for these plans range from at least $1,200 for an individual to more than $10,000. Before the insurer begins to cover the costs, the consumer must pay the deductible out of pocket. The tradeoff is that the monthly premiums are lower for both employers and consumers than other plans—they average, for an individual, about $1,000-$2,000 a year.

Many employers offering these plans also create health savings accounts (HSAs), a sort of rainy-day fund to which employers and/or employees may contribute money tax-free for use in medical emergencies. The money accumulates year to year, and can be rolled over into a new employer’s plan.

Thanks to the Patient Protection and Affordable Care Act (ACA), even bare-bones, high-deductible plans must cover certain basic, preventive services for free, such as vaccinations. But they’re still risky, even for the young, healthy people for whom they make the most sense.

The PBS story profiled a young ballet dancer who opted for his dance company’s high-deductible coverage. Dennis Adams, in his mid-20s, had never had surgery, had never broken a bone, had never been in an ambulance, had never been to the hospital. He signed up for a $2,500 deductible plan.

Then he tore a knee ligament during a dance performance. The MRI needed to show the extent of the damage cost $1,600, and the provider required that it be paid up front. Adams didn’t have the money.

Lucky for him, the injury was work related, so workers’ compensation insurance covered his cost.

Whether you’re older, infirm or young and robust, high-deductible plans are designed to make you likelier to take care of yourself, and more attentive to how your health-care dollars are spent. In theory, that’s a good thing—the overuse of medical services has fueled an out-of-control medical industrial industry and increased patient harm.

But there’s a black side here, and it’s not just about lacking the cash to cover your deductible.
It’s about the inability for even the most conscientious consumer to price medical services (see Patrick Malone's newsletter this month on "The Unknowable Cost of Medical Care," and what you can do), and the withholding of even needed care. In the PBS story, Dr. Alison Galbraith of Harvard Medical School said that people in high-deductible plans had “a much higher prevalence of delayed or foregone care due to cost” compared with those in more traditional plans.

People are rationing their own care, which is fine for many people who otherwise would overuse the system. It’s not fine if you’re ill or have a chronic condition that can be managed with regular, sometimes minimal care.

One high-deductible plan member allowed as much. “I do get headaches about once a month,” she said, “and they can get really bad. And I still haven't gone to see a doctor about it. … It's like, I'm kind of trying to cheat the system a little bit, because it's like, if I don't go and it's not really serious, then I'm saving money.”

But at what cost?

As Dr. Drew Altman, President and CEO of the Kaiser Family Foundation, put it, “We really need to have a national discussion about whether this is a good thing or this is a bad thing. … I think what it really means is, this is OK for some people if you are pretty healthy. But we have to worry about what these very high deductibles, $2,000, $3,000, $4,000, $5,000 deductibles, is that really even insurance coverage?”

If you’re considering insurance coverage with a high deductible, remember:

• Out-of-pocket costs generally include the deductible, the patient's co-pay to see a doctor, prescription medicines and/or hospital costs.


• Often, the number of office visits allowed for only the co-pay is limited. If you exceed that number within a calendar year, generally you are expected to pay the caregiver’s out-of-network (or unsubsidized) rate.


• HSAs allow beneficiaries to contribute, tax-free, as much as $3,100 for an individual and $6,250 for a family.


• The plans are problematic for low-income individuals, especially those with chronic conditions, such as diabetes. People with health problems often have the toughest time meeting the high deductible because their illnesses can keep them from working.


• The IRS determines what medical expenses qualify toward the deductible. Recently, the agency dropped over-the-counter medications from its list.

Who doesn’t like a good deal? The popularity of Groupon, the online deal-of-the-hour/day/week service has spawned a whole family of mimics. Unfortunately, suggests Gary Schwitzer on Health News Review, it’s a dysfunctional family when it comes to dubious medical treatments.

In the space of mere days, irresistible deals were available for:

• laser toenail fungus treatment;


• MRI for “headache prevention screening”;


• -lipolaser treatments;


• botox;


• B12 injections or allergy test.

Never mind that the evidence for lasers eradicating toenail fungus is sketchy, that the claim that an MRI can prevent headaches is positively ludicrous and the lipolaser might be performed by a guy with less training than your dentist.

But Schwitzer was amused most by an offer from Living Social for Colon Hydrotherapy:

“The foliage may be in bloom outside, but if you’re feeling less than fresh inside, today’s deal could help you stem the problem: Pay $35 and get one colon hydrotherapy session (a $75 value). Colon hydrotherapy is a safe, effective method of cleansing the large intestine using water instead of drugs. The gentle infusion of warm filtered water moves naturally through your large intestine, leaving you feeling cleansed and refreshed. The treatment is safe, quick and pain-free. The certified staff uses an advanced state-of-the-art technology to provide you with natural wellness therapies. Don’t be a shrinking violet — nab today’s deal before it goes to seed.”

Commented one guy on the Health News Review site, “Personally, I await the Groupon lobotomy offer…”

Absent pernicious anemia, almost no one needs injections of B12. And no one’s colon is crying out for cleansing. But … got a coupon for hype eradication? We’re in!

Since 2009, when the U.S. Preventive Services Task Force threw a grenade into the “mammograms for everyone” approach to women’s care, researchers, doctors and women have been wondering just who should get a mammogram, when and how frequently.

As widely reported last week, the results of new studies are helping to tease out the variables in this equation. Thanks to a greater appreciation that more tests don’t necessarily render better care, and that such overuse can cause patient harm, people are learning that customized medicine is superior medicine.

As the Los Angeles Times noted, “Of the various recommendations put forth by the U.S. Preventive Services Task Force in 2009, none generated more ire than the suggestion that annual mammograms could do more harm than good for most fortysomething women, who are far less likely than older women to get breast cancer….

“The new research was designed to identify women who could benefit the most from having mammograms early and often.”

The task force, an independent panel of health experts which advises the federal government, suggested more than two years ago that women older than 50 should have a mammogram every two years instead of annually, and that most women in their 40s should bypass the test altogether. Until then, women over 40 routinely were advised to have a mammogram annually.

The new research found that among women 50 to 74, for every breast cancer death averted by screening, 146 women received a false-positive reading -- a false alarm -- on a mammogram. And for every year of life someone gained thanks to a mammogram’s early detection of breast cancer, 8.3 false positives led to unnecessary biopsies, weeks of worry and sometimes surgical complications.

Two markers stood out for researchers as indicators that a 40-year-old should have regular and more frequent mammograms: a woman whose mother or sister was diagnosed with breast cancer, and women with unusually dense breast tissue.

These people, the studies concluded, carry at least twice the average risk of developing breast cancer in their 40s. For such women, according to the study in the Annals of Internal Medicine, routine screening outweighs the risk of false alarms and unnecessary, often invasive and uncomfortable tests.

One of the studies combined and analyzed data from 61 previously published studies. The other employed computer models to predict the health outcomes of approximately 44,000 simulated women who had their first mammogram at 50. The simulation was revised to show their outcomes had they begun screenings at 40. Then it compared the rates of false alarms, breast cancer diagnoses and mortality in both groups.

For the younger group, researchers found that the only ones who stood to benefit to a similar degree were those whose breast cancer risk was roughly double the norm for their age group. Having a first-degree relative — a mother or sister — with a breast cancer diagnosis more than doubles a 40-year-old's own risk of developing the disease. Two or more first-degree relatives with breast cancer bump up the risk nearly fourfold.

Increased risk also was seen in women whose breasts are composed of significantly more glandular than fat tissue. That also doubled the risk of breast cancer risk for someone in her 40s.

The confounding element here is that dense breasts make mammograms harder to read: Cancerous tumors aren’t as apparent within glandular tissue as they are within fat. Radiologists, who review mammograms, and doctors lack established standards to define and grade breast density.

Other risk factors identified in the new studies were:

• biopsies--women whose breast biopsies were benign have an 80 percent greater risk of getting cancer in their 40s;


• oral contraceptives—30 percent greater risk;


• never having given birth—25 percent;


• first child after 30—20 percent increased risk.

As we’ve discussed before, percentages of increased risk don’t necessarily convey an accurate picture. The commonly heard refrain that a woman’s risk of breast cancer is 1 in 8 is misleading. That’s a skewed metric that fails to consider not the risk at age 40, but the lifetime risk for a woman who lives to age 90. The real figure for young adults is more like 1 in 813.

The new studies, of course, help women understand if their risk is higher or lower than average.

As the whys and wherefores of mammograms evolve, women and their doctors should focus on two things: getting an accurate family history, and understanding their individual breast anatomy. The state of the art today makes those the drivers of when to begin and how often to get a mammogram.

If you think the word “blockbuster” is reserved for popular entertainment like “Game of Thrones,” you probably don’t need to take a blood thinner. Such drugs are prescribed to people at risk of stroke from conditions such as atrial fibrillation (irregular, rapid heart rate).

In Pharma Land, the drug Pradaxa is considered a blockbuster, or a drug whose annual sales top $1 billion. It’s touted as superior to other anticoagulant drugs because it requires less monitoring.

But just as a blockbuster movie can be ravaged by critics, a blockbuster drug can collect seriously bad reviews.

Since its U.S. introduction in 2010 by Boehringer Ingelheim as an alternative to Coumadin (warfarin), Pradaxa has engendered hundreds of adverse event reports to the FDA, according to AboutLawsuits.com, concerning hemorrhages and internal bleeding. Lawsuits charging wrongful death have cited Institute for Safe Medication Practices (ISMP) records tallying scores of deaths from bleeding.

Other anticoagulants, such as Coumadin, also pose a risk of bleeding, but patients on warfarin can be given vitamin K as a fast-acting reversal agent to bleeding problems. Pradaxa lacks such an antidote to disaster.

Lawsuits also challenge the rigor with which Boehringer Ingelheim researched its drug and allege that the company promoted it as an alternative to the older, safer warfarin despite failing to warn about the lack of a reversal agent.

More incidents of uncontrollable bleeding with Pradaxa, according to the ISMP, were reported during the first quarter of 2011 than were reported for any other drug monitored by the institute. More than 500 reports were made about Pradaxa versus 176 for warfarin, which ranked second.

Researchers have suggested that Pradaxa drug trials were flawed, and the FDA is investigating the bleeding claims, as are agencies in Europe and Canada.

But if you’re Boehringer Ingleheim you don’t dare argue with success. The company recently boasted that the launch of Pradaxa was “among the most successful market introductions in the pharmaceutical industry in the past few years.”

Not if you’re a Pradaxa patient bleeding to death with no way to stop it.

Although the FDA still considers Pradaxa a worthy drug, it has recommended that Pradaxa patients immediately contact their doctor if they detect signs of bleeding problems. They are:

• unusual bleeding from the gums;


• frequent nose bleeds;


• unusually heavy menstrual or vaginal bleeding;


• severe, uncontrolled bleeding;


• pink or brown urine;


• red or black stool that looks like tar;


• unexplained bruises that grow over time;


• coughing up blood or blood clots; and/or


• vomiting blood or a substance that looks like coffee grounds.

A little knowledge is a dangerous thing.

So said the 18th century’s Alexander Pope in “An Essay on Criticism.” So said, in so many words, the 19th century’s T.H. Huxley in “On Elementary Instruction Physiology.” So said the 20th century’s Albert Einstein, who added a second sentence, “So is a lot.”

Each of these people turned up in a Google search as the author of that expression. If you Googled “dangerous knowledge” in the hope of finding out who who said it first, chances are excellent you would get a misguided result. You can find knowledge on the ‘net, but finding context and fact is a bit more daunting.

According to a Pew Research Center study, more than 6 in 10 adults search for health information online. Nearly 6 in 10:

• read someone else's commentary or experience about health or medical issues online;


• consulted rankings or reviews online of doctors or other providers;


• consulted rankings or reviews online of hospitals or other medical facilities;


• signed up online to receive updates about health or medical issues;


• listened to a podcast about health or medical issues.

Certain topics showed large gains in adult consumer interest over a seven-year period:

• a specific disease or medical problem (49 percent, up from 36 percent);


• a medical treatment or procedure (41 percent, up from 27 percent);


• prescription or over-the-counter drugs (33 percent, up from 19 percent);


• alternative treatments or medicines (26 percent, up from 16 percent);


• depression, anxiety, stress or mental health issues (21 percent, up from 12 percent);


• experimental treatments or medicines (15 percent, up from 10 percent).

We’re big fans of medical consumers informing themselves about health topics and quality of care. But context and and factual information aren’t always found where Googlers are looking.

A recent study published in Psychological Science shed some light on the common consumer habit of matching one’s symptoms with disorders described on the Internet to make wholly misguided self-diagnoses. Got a headache, nausea and fatigue? Websites listing these symptoms prompt far too many people to conclude erroneously that they have brain cancer.

As explained in a story on The Daily Beast, the response is a Web-enabled hypochondria called “cyberchondria,” and it can be as complicating as it is helpful.

The Psychological Science researchers said the brains of cyberchondriacs are like those of gamblers. It’s about pattern recognition, and what can go wrong when the brain tries to impose order on chaos. Cyberchondriacs who see patterns in lists of symptoms make the same mistake as gamblers who see patterns in random events such as consecutive rolls of the dice. The latter might conclude, erroneously, that a positive result on one or two rolls will repeat. The former might conclude that experiencing some symptoms in a list of several means they must have all of the other symptoms as well.

The researchers made up a type of thyroid cancer for which they also made up six symptoms. They composed three differently ordered lists of the same six symptoms. One grouped the milder, more common symptoms (fatigue, shortness of breath) at the top, and the more severe and rarer symptoms (pain in the throat or neck, lump in the throat or neck) at the bottom. One list ordered the more severe symptoms first, followed by the milder ones. The third mixed all the symptoms.

Different groups of healthy subjects were shown one of the lists, told to check off their symptoms, then asked how likely they were to have that cancer relative to the average American. Both groups with the lists of mild symptoms separated from severe symptoms were far more likely to believe themselves at risk for this fake problem than the group with the randomly listed symptoms.

The gift of pattern recognition can undermine the basic logic of probability. Gamblers say they have a “hot hand”; cyberchondriacs believe they have “hot symptoms”—if they hit the first two in a list, they believe they must have the third one as well.

There’s nothing wrong with a little knowledge, but if you get it from the Internet, you must ensure your source is credible. Check out our newsletter, “Essential Tips for Doing Your Own Health-Care Research.” Other solid sources for medical information include scientific journal abstracts, university research summaries and articles from established centers of medical practice such as the Mayo Clinic and reports by government organizations such as the Centers for Disease Control and Prevention and the National Institutes of Health.

Knock yourself out with medical research, but refrain from self-diagnosing until you consult with a medical professional. You might have a brain tumor, but it’s far more likely that your eyeglass prescription has changed, your milk has gone a bit sour and you’re not getting enough sleep.

As Pope said:
“A little learning is a dang’rous thing;/Drink deep, or taste not the Pierian spring:/There shallow draughts intoxicate the brain,/And drinking largely sobers us again.”