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. 

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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.

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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…

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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.

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“There are two things to fear in life,” Justice Brandeis once said: “death and litigation.” Most physicians would agree.  Win or lose, the process of being sued for malpractice will forever change the way he views both his profession and his patients. No wonder fear of malpractice drives so much costly and potentially hazardous “defensive medicine.”  Nevertheless, some have argued that malpractice suits protect patients by forcing hospital boards to take a closer look at patient safety issues. Perhaps—but the high administrative costs associated with malpractice suits, combined with the effect they have had on the doctor-patient relationship suggests that there should be a better way to shield the sick.

An article in Sunday’s New York Times points to a new approach. “For decades,” the Times reported, “malpractice lawyers and insurers have counseled doctors and hospitals to ‘deny and defend.’  Many still warn clients that any admission of fault, or even expression of regret, is likely to invite litigation and imperil careers.” But with providers “choking on malpractice costs and consumers demanding action against medical errors,” some of the nation’s leading hospitals are trying out what is, for them, a new strategy—reveal and apologize.  It’s a simple solution: telling the truth. The mounting cost of malpractice claims may finally be having a constructive effect. The evidence suggests that if more hospitals adopt this approach, there could be great benefits, both for physicians and for patients.

Nevertheless, there are risks for health care providers. “Disclosure is the right thing to do,” an article published in Health Affairs last year observed,  but as “pressure mounts on physicians and hospitals to disclose adverse outcomes…and medical injuries” they should be aware that the volume of claims would rise and providers should be ready for “the financial consequences.”

After all, we are, as everyone knows, a litigious society. President Bush has warned us, repeatedly, of “what’s happening all across this country…lawyers are filing baseless suits against hospitals and doctors. That’s just a plain fact. And they’re doing it for a simple reason. They know the medical liability system is tilted in their favor.” In the nation’s “judicial hellholes,” the President of the United States cautions us, “every claim filed by a personal-injury lawyer brings the chance of a huge payoff or a profitable settlement out of court…This liability system of ours is out of control.”

The President is not alone:  you have read the news stories about the multi-million dollar cases, and the op-ed pieces declaring that they are now the norm:  emotional juries and prejudiced courts are persecuting blameless doctors, driving up the cost of health care while forever ruining careers.

As is so often the case, what “everyone knows” just isn’t true. 

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Film-makers who are making a documentary about Money-Driven Medicine have contacted me to ask if I know of anyone who “is suffering  from, has suffered from, or is related to a patient who they believe has suffered from some type of over-treatment.

“It doesn’t have to be a dramatic case – just someone who feels they were pushed through a cascade of needless scans towards some surgery or treatment that they would rather not have had would make the point, too.”

I don’t think we’re looking for a case of malpractice, but rather a case where the patient chose elective surgery or an elective procedure without having the opportunity to fully understand the risks and benefits in the way he or she would have if they had gone through a “shared decision-making” process. (See related post on “consumer-driven” vs. “patient-centered” medicine). It could be a knee replacement or hip surgery; it could be angioplasty or by-pass, it could be treatment for early-stage prostate cancer, another round of chemo, etc. 

If any readers have a suggestion, please comment or e-mail me at mahar@tcf.org.

Your comments on “The Ticking Clock” (below) raise some questions about consumer-driven healthcare that I decided deserve a separate post.

One reader wrote: “We have all been fretting for decades over how to get patients more involved in understanding and buying-in to their health care needs. Consumer-Driven Health Care (CDHC) is the most effective means to that end that has ever come along.”

He added: “Certainly you are right that very often the optimal treatment is unknown or ambiguous. But isn’t that precisely when the patient should be making the final decision? Who else should do it? That does not mean the patient is playing doctor, only that patients will consult with physicians they respect for the best recommendation and will decide on what course of treatment they are most comfortable with. It is, after all, the patient’s life and health that is at stake.”

Another reader responded to my comment that when the patient begins to think of himself as a “consumer” and of the doctor as a “retailer,” this can undermine the trust needed in a doctor-patient relationship. He replied: “As a physician I have to disagree with your comment that ‘Even then, many physicians feel that the consumer vs. seller model undermines the patient doctor relationship.’ If anything it enhances the relationship as only the consumer truly understands their needs and therefore it is best for the consumer to have a good deal of control. Some physicians tend towards protectionism. I also think your opinions regarding the ability of a patient to make [his or her] own decisions [are] a trifle paternalistic, though I can understand how you might have come to that conclusion.”

Let me say first, that I agree with both readers. But I think that what they are describing is not “consumer-driven medicine.” It’s “patient-centered medicine.” There is an enormous difference.

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The most recent issue of Health Affairs focuses on “The Politics of Health Care Reform” and features an article by pollster Celinda Lake, president of Lake Research Partners in Washington.

Lake takes the pulse of public opinion by holding focus groups, and then tries to shape a reform plan that mirrors their hopes and fears. Rather than crafting a blueprint for health care reform and then presenting it to the public for discussion, Lake believes that reformers should begin “by exploring voters’ own perceptions and the core values that shape their views on health care…Leaving aside the base voters at opposite ends of the spectrum who were most strongly in favor of or opposed to universal health care,” she and her group “focused on the large clusters of swing voters whose support for health reform was more conditional. Through segmented focus groups and a national telephone survey in 2006, we identified a set of values that drive these swing voters’ perceptions of reform.”

Lake has little patience with old-fashioned reformers: “Advocates for change in health care would like to think that by using a combination of facts and reason, they could persuade Americans that a progressive, universal health care system would be more effective, efficient, and humane than the current system,” she writes. But that’s simply not true, she asserts: “real changes must be enacted in the world of politics and public opinion, where values and perceptions are more important than facts and reason.”

Lake is not alone. I have heard other progressives express their belief that conservatives have “won” the national political debate in recent years because they are so clever at using memorable memes and slogans to appeal to voters’ values and emotions. And Lake is right that slogans don’t appeal to “fact and reason.”  Slogans are like television ads or bumper stickers: they’re not designed to provoke thought; the goal is to make the mind click shut like a box.

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After being re-elected in 2004, President Bush began touting an ambitious social policy platform, the so-called “ownership society.” Part of this agenda was a strong push for high-deductible health plans (HDHPs) coupled with health savings accounts (HSAs)—tax-free savings accounts to pay for health care expenses.

Like so much else that the Bush Administration attempted, the ownership society flopped, in large part because it called for the privatization of Social Security. With this failure, HDHPs and HSAs fell out of the public spotlight. To the casual observer, the question of whether or not health care reform should move in this direction seemed to have been put to rest.

But even though they are no longer in the political spotlight, HDHPs and HSAs are actually thriving—and in fact penetrating our health care system at a relatively brisk rate. This is problematic. Not only are HDHP/HSA plans poor policy, but their proliferation also weakens the political viability of the health care reform we really need.

Here are the numbers: at the end of last month, the Associated Press reported that the number of Americans enrolled in HDHP/HSA plans has nearly doubled from 2006 estimates, to around 6 million. Admittedly, these plans still have a long way to go before they become a force to be reckoned with.  America’s Health Insurance Plans estimate that enrollment in HDHP/HSA plans comprises just 3.4 percent of the private insurance market in the U.S., and in March, Employee Benefit Research Institute (EBRI) estimates that 42 percent of people who have HDHPs and are eligible for HSAs don’t even use the accounts.

Nevertheless, a doubling of enrollees over two years is nothing to scoff at. And while national rates of enrollment are still meager, the picture’s somewhat different at the state level. The AP reports that in Minnesota, the state with the highest percentage of HDHP enrollees, “about 9.2 percent of the state’s total enrollment in private health insurance comes through high-deductible plans. Following closely behind [are] Louisiana, [at] 9 percent and the District of Columbia, [with] 8.7 percent.”

State governments are also beginning to turn to HDHPs and HSAs as models for reform. Last week, Georgia passed a law—with the support of Newt Gingrich—that will give insurers $146 million in tax breaks for selling HSA plans. In Indiana, Health Affairs reports that HSAs are being coupled with Medicaid to provide high-deductible health insurance to low-income citizens.

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“His heart filled virtually his whole chest,” recalls Dr. Diane Meier describing her very first patient, an 89-year-old suffering from end-stage congestive heart failure. 

It was the first day of Meier’s internship at a hospital in Portland Oregon, and after being assigned 23 patients, she was suddenly told that one of her patients, who had been in the Intensive Care Unit for months, was “coding.” She raced to the ICU where the resident told her to put in a “central line.”

“I didn’t know how,” Meier admits.  “I felt overwhelmed and inadequate. Then, the patient died. . .

“Everyone just walked out of the room,” she remembers.  I stood there. I still sometimes flash back on that scene: the patient, naked, lying on the table, strips of paper everywhere, the room empty. This was my patient. I felt I was supposed to do something—but I didn’t know what.”

Meier left the room and, in the hallway, saw the patient’s wife. “I walked right past her,” she recalls, nearly shuddering at her own cowardice.  I didn’t know what to say. I didn’t even say ‘I’m sorry.’ As a physician, I didn’t think that I was supposed to do that. “

I heard Dr. Diane Meier tell this story at a conference for medical students at  Manhattan’s Mt. Sinai School of Medicine last week. When she finished, she asked her audience, “What is the hidden curriculum here? What does this story tell you?’

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