This post was written by Maggie Mahar and Niko Karvounis

Despite all of the talk about medical errors and patient safety, almost no one likes to talk about diagnostic errors. Yet doctors misdiagnose patients more often than we would like to think. Sometimes they diagnose patients with illnesses they don’t have. Other times, the true condition is missed.  All in all, diagnostic errors account for 17 percent of adverse events in hospitals according to the “Harvard Medical Practice Study,” a landmark study that looks at medical errors.

Traditionally, these errors have not received much attention from researchers or the public.  This is understandable. Thinking about missed diagnosis and wrong diagnosis makes everyone—patients as well as doctors—queasy. Especially because there is no obvious solution.  But this past weekend the American Medical Informatics Association (AMIA) made a brave effort to spotlight the problem, holding its first-ever “Diagnostic Error in Medicine” conference. 

Hats off to Bob Wachter, Associate Chairman of the Department of Medicine at the University of California, San Francisco, and the keynote speaker at the conference. On Monday, Wachter shared some thoughts on diagnostic errors through his blog, “Wachter’s World.”

Wachter begins by pointing out that a misdiagnosis lacks the concentrated shock value that is needed to grab the public imagination. Diagnostic mistakes “often have complex causal pathways, take time to play out, and may not kill for hours [i.e., if a doctor misses myocardial infarction in a patient], days (missed meningitis) or even years (missed cancers).” In short, to understand diagnostic errors you need to pay attention for a longer period of time—not something that’s easy to do in today’s sound-bite driven culture.

Diagnostic errors just aren’t media friendly. When someone is prescribed the wrong medication and they die, the sequence of events is usually rapid enough that the story can be told soon after the tragedy occurs. But the consequences of a mistaken diagnosis are too diffuse to make a nice, punchy story. As Wachter puts it: “They don’t pack the same visceral wallop as wrong-site surgery.”

Continue reading →

“False Hopes, Unwarranted Fears: The Trouble with Medical News Stories.” If you find the headline alarming, you should read the editorial, published just last week in PLoS Medicine. There, the journal’s editors summarize  what the Health News Review has discovered over the past two years while evaluating medical stories about new products and procedures throughout the mainstream media.

“It’s not a pretty picture,” says Gary Schwitzer, the University of Minnesota School of Journalism professor who publishes the online project.

In a video linked to the Health News Review website,  Schwitzer points out that “about 65% of the time” major news organization are not telling viewers and readers how “big the potential harms” of new treatments are–or “how small the potential benefits.”

Meanwhile, about three-quarters of the stories about a new product or procedure fail to talk about how much the idea costs.  “At a time when the U.S. is spending 16 percent of GDP on healthcare, I find this unfathomable,” says Schwitzer. “No one is asking: ‘How are we going to pay for it?’; ‘Who will have access to these things’?; ‘Who’s to say that we even need some of these things?  This is what we need to discuss.”

Ultimately, “these stories are painting a ‘kid in the candy-store’ picture of US health care,” Schwitzer charges, “whereby everything is made to look terrific, risk-free, and without a price tag. Nothing could be further from the truth.”

Health News Review is supported by a grant from the nonprofit Foundation for Informed Decision Making, which was founded in 1989 by Dr. Jack Wennberg and colleagues. Its mission is to assure “that people understand their choices and have the information they need to make sound decisions affecting their health and wellbeing.”

Continue reading →

How often have I said: “There is no Consumer Reports guide to healthcare—and with good reason”? Often I add that “rating refrigerators is a lot easier than measuring the quality of care provided by a hospital or doctor.”

Guess what?

Consumer Reports has just launched a new online “compare your hospital” tool  (Thanks to Gary Schwitzer, who reported this on Schwitzer Health News Blog over the week-end.)

And where did Consumer Reports get their information?  They’ve taken it from the Dartmouth research on treatment, overtreatment and outcomes that I cite so frequently.

I have always liked Consumer Reports–ever since I was a young bride buying my first air-conditioner. It didn’t let me down then, and, I’m glad to say, it hasn’t let me down now.

Continue reading →

Kenneth Raske, president of the Greater New York Hospital Association…attributed the aggressiveness of private hospitals in New York simply to the sophistication of the patients and their families…"that’s a reflection of the New York culture that we have.” –The New York Times

All together now: when it comes to medical care, more is not necessarily better. This is a point we’ve driven home here on Health Beat, but a JAMA study published this week adds a new dimension to the discussion by showing that even patients feel that more is not better.

The research, authored by experts from UMass Boston, the Foundation for Informed Medical Decision Making, and Dartmouth, surveyed 2,515 Medicare patients across the nation to find out how they felt about the medical care that they received over the past year. The survey specifically asked whether patients felt that their needs were met, how they perceived the quality of ambulatory care, and how they perceived the  quality of overall care.

Continue reading →

In HealthCare, Guaranteed, Dr. Ezekiel Emanuel proposes a bold plan for health care reform that offers free, high quality health care to all Americans. No premiums. No deductibles. Low-co-pays. Under this plan, the government insists that all insurers offer the same comprehensive benefits to everyone, including: office and home visits, hospitalization, preventive screening tests, prescription drugs, some dental care, inpatient and outpatient mental health care and physical and occupational therapy. These benefits are more generous than Medicare’s and more comprehensive than what 85 percent of all employers offer their employees. 

How do we fund it? Emanuel, who is the Director of the Clinical Bioethics Department at the U.S. National Institutes of Health, proposes a 10 percent Value-Added Tax (VAT) on consumption. For a median-income family earning $50,000 a year and spending virtually every penny, this means that they would pay $5,000 a year (10 percent of $50,000) in taxes on their purchases. But in return, they would receive health care benefits worth more than $12,500 (the current average price for comprehensive insurance that covers a family.)  In addition, because The Guaranteed HealthCare Access Plan would replace employer-based coverage, many workers could expect a raise roughly equivalent to what their employer now pays toward their premiums.

Here is how the plan works: Every American would receive a voucher for individual or family coverage. The vouchers would be of equal value and all insurers would be required to offer the same comprehensive benefits package to anyone who applied—young or old, sick or healthy.

Insures would report to 12 Regional Health Boards.  Each Board would have a Center for Patient Safety and Dispute Resolution staffed by patients, physicians and lawyers that would receive and adjudicate patient complaints, compensate patients, discipline and disqualify physicians responsible for repeatedly injuring patients, and fund and develop patient safety programs.  (Patients not satisfied with the Board’s resolution of their complaint still could sue for malpractice).

The Guaranteed HealthCare Access Plan pledges to cover the 257 million Americans who are not now on Medicare at a cost of nearly $1 trillion. This number includes what we now spend on employer-based insurance, Medicaid and SCHIP –plus what it would cost if the uninsured had employer-based coverage.

People who are now enrolled in Medicaid, SCHIP or Medicare would not be forced to switch to the new Guaranteed HealthCare Access Plan, but if they chose to, they could. For the time being, probably most seniors on Medicare would stay put.  But over 15 years, these three plans would be phased out.

Continue reading →

Most plans for health care reform that stress “choice” give families the opportunity to choose from a menu of plans that offer insurance at different prices. In effect, families are “free to choose” the health care plan that they can afford. (More accurately, they are “forced to choose” the plan they can afford.)

Imagine, instead, a proposal for health care reform that guarantees free, high quality health care for all Americans. No premiums. No deductibles. Under this plan, the government insists that all insurers offer the same comprehensive benefits to everyone including: office and home visits, hospitalization, preventive screening tests, prescription drugs, some dental care, inpatient and outpatient mental health care and physical and occupational therapy.

These benefits are more generous than Medicare’s and more comprehensive than what 85 percent of all employers offer their employees. (Individuals who want to purchase coverage for additional services like concierge medicine, experimental drugs for serious conditions, complementary medicines or more mental health benefits could do so.)

If this all sounds too good to be true, you need to read Health Care, Guaranteed by Dr. Ezekiel Emanuel. Published this month, Health Care, Guaranteed offers a bold, refreshing plan for health care in America. The charm of the proposal is four-fold:  It faces up to the fact that reform won’t pay for itself, and it offers a funding mechanism that is fair, efficient and could deliver high quality care nationwide. It regulates insurers, forcing them to concentrate on quality.  Finally, and perhaps most importantly, this plan insulates our health care system from the lobbyists who, today, have far too much control over our health care system.

Dr. Emanuel has the background and experience needed to help draft a blueprint for health care reform. An oncologist who also has a Ph.D. in political science and now serves as Chair of the Department of Bioethics at the Clinical Center of the National Institutes of Health, Emanuel is attuned to the ethics as well as the politics of medicine, and he understands the needs of seriously ill patients.

Continue reading →

In last week’s JAMA, distinguished legal and public health scholar Lawrence Gostin, affiliated with both Georgetown Law and Johns Hopkins, takes on the Supreme Court decision on the case of Riegel v Medtronic Inc. The case, decided in February, established that federal law preempts state law when it comes to medical devices. What this means is that, once the FDA approves of a medical device, consumers cannot use state liability laws to sue device-makers should they fall victim to device malfunctions or problems.

When the Riegel decision was first announced, I slammed it for expecting way too much of the FDA—which is under-funded, under-staffed, and often reliant on industry for financial support. In saying that federal law trumps all, the Supreme Court is giving final say in consumer safety to an agency that can barely do its job. As Gostin puts it so succinctly, “the court’s confidence that the agency has the expertise, resources, and information necessary to ensure the safety of food, drugs, and medical devices is misplaced.”

I don’t want to replay the nitty gritty about how the FDA has declined in this post—you can check out previous posts for more details. But suffice to say, it’s incredibly wrong-headed to claim that the FDA is “rigorous” (as did the court) in its approval process, and that this approval is enough to preempt legal recourse on the part of patients who suffer harm thanks to a poorly designed device.

Gostin, however, doesn’t stop here. He also asks some tough questions about how the Riegel decision changes the rulesof the game when it comes to approval and accountability. Gostin asks: what if a medical device is approved by the FDA because “a corporation…deceived the agency into granting that approval”? Is it fair to allow device manufacturers to “use FDA approval as a shield against litigation” if they can scam their way into approval? Of course not—but this is exactly what can happen today. 

Continue reading →

Yesterday, while scouring KevinMD, I stumbled across a post from “Respectful Insolence,” a blog authored by an academic surgeon/scientist who dubs himself “Orac.” In the post, Orac  reports that this Wednesday at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting,researchers from the Mayo Clinic will be reporting on a disturbing correlation between the use of breast magnetic resonance imaging (MRI) and a rise in the number of women having mastectomies. In this context, Orac offers a cogent, compelling perspective on why too much cancer screening can harm patients.

Orac’s worries specifically relate to using MRI scans to detect breast cancer. Advocates of the procedure rightly claim that MRI scans can detect more growths than other techniques, including mammography [i.e. an x-ray] and a clinical examination. The MRI technology detects so much that, as the New York Times put it last year, the scans reveal “all sorts of suspicious growths in the breast, leading to many repeat scans and biopsies for things that turn out to be benign.”

In other words, breast MRI scans are so sensitive that if you have breast cancer, there’s an almost 100 percent chance that they’ll detect it; but the technology produces many  false positives because it’s not as good at distinguishing between malignant and benign growths. As Orac puts it: “…MRI [scans] now routinely "section" people into "slices" much thinner than 1 cm, making our imaging sensitivity considerably higher than it was 14 years ago.

The problem is that while many people undergo malignant changes in various organs as they grow older than most will never actually develop “clinically apparent cancer.” In fact, some studies have shown that MRI scans accurately detect breast cancer just 30 percent of the time. Though most studies place this rate at a higher level, they also show that mammographies (using x-rays to examine the breast) lead to fewer false positives than MRI scans.

Continue reading →

Most malpractice suits are not frivolous. Take a close look at a large sample of claims and you’ll discover that the patient died or suffered a significant disability roughly 80 percent of the time. But when researchers at Harvard’s School of Public Health scrutinized cases involving some 33,000 physicians, 61 acute care hospitals and 428 outpatient facilities nationwide, they discovered that only sixty-three percent of the injuries were caused by medical error or negligence.

In other words, 37 percent of the claims were unfounded. But most plaintiffs had no way of knowing that there was no basis for the suit because once they began to ask questions, both doctors and the hospital clammed up. Traditionally hospital lawyers have told medical personnel that if the patient or his relatives are unhappy with the outcome, don’t say anything. Keep in mind, “anything you say could be used against you in court.”

As a result, the Harvard researchers explained, “our findings underscore how difficult it may be for plaintiffs and their attorneys to discern what has happened before the initiation of a claim and the acquisition of knowledge that comes from the investigations, consultation with experts, and sharing of information that litigation triggers.”

In other words, the only way to find out that you have no reason to sue is by suing—and triggering the costly and time-consuming process of legal “discovery” that will give you access to all of the facts.

As I explained in part 1 of this post, The New York Times recently reported   that a few hospitals are now experimenting with candor: rather than denying, they are revealing what happened, and apologizing. But this violates the received wisdom that a doctor who says “I’m sorry” to a patient will soon find himself saying “I’m sorry” to a jury. And, as some physicians who have been dragged through the process warn, that doctor will never have a chance to explain that while he wishes every day that things had gone differently, the situation was a little more complicated that the plaintiff’s attorney would have you believe…

Continue reading →

This post was written by Maggie Mahar and Niko Karvounis

Medical device makers are taking direct-to-consumer (DTC) advertising to a perilous new level. In a piece titled “Crossing the Line in Consumer Education?” that will appear in the May 22 issue of The New England Journal of Medicine (NEJM), Drs. William E. Boden, and George A. Diamond tackle the issue, arguing that a new campaign to peddle medical devices directly to patients warrants close scrutiny. Manufacturers are inviting consumers to decide not only what is best for them, but what is best for their surgeons. This is “consumer-driven medicine” at its most dangerous.

Boden and Diamond focus on a 60-second television spot for Johnson & Johnson’s drug-eluting coronary stent, “the Cypher,” which debuted during last year’s Thanksgiving match-up between the Dallas Cowboys and the New York Jets. (Click here to view the advertisement in question).

The commercial has all of the hallmarks of the drug industry’s highly polished DTC advertising: First, we’re introduced to “the tough guy” – a once-powerful man who now is “cornered by chest pains” and sits slumped in his arm chair. Then, we are shown how he can reclaim his life in a montage of joyous physical activity accompanied by upbeat music. Of course, “this product isn’t for everyone,” we’re told. But “life is wide open. It all depends on what you’ve got inside.” 

In the campaign to put the health care “consumer” in the driver’s seat, where he can have “control” and “choice,” J&J is breaking new ground.  This ad isn’t for a pill that you buy in a pharmacy but rather for a coronary stent, a wire mesh device that is placed in an artery which has been blocked by fatty deposits. Doctors first thread a tiny balloon into the artery and inflate it to clear the blockage; then they insert a stent into the artery, and a second balloon expands the stent to keep the newly cleared blood vessel wide open.

Continue reading →