Quality

This is a guest post from independent medical investigative journalist Jeanne Lenzer. She is a former Knight Science Journalism Fellow and a frequent contributor to BMJ, and has published works in  The Atlantic, The New York Times Magazine, Discover, The New Republic, and other outlets.

When doctors recommend tests, drugs or surgeries to prevent bad outcomes (think cholesterol-lowering agents to prevent strokes or cardiac stents to prevent heart attacks) they tap into our deepest sense of what constitutes commonsense: An ounce of prevention. Catch it early. A stitch in time.

It can’t be a bad thing to catch problems early, can it?

Unfortunately, one of the toughest things to explain is why detecting some illnesses at their earliest stages can cause more harm than good. Take this example: Since elevated cholesterol is associated with a higher risk of cardiovascular disease, doctors often prescribe drugs known as statins to people with elevated cholesterol levels in the hopes of reducing their risk of a heart attack or stroke.

Here comes the part that’s tough to explain – because it is so counterintuitive: Statins only help individuals who already have had a heart attack or stroke (with a few exceptions, and more on that later).

Of course, this makes no sense to most people. Isn’t the whole point of taking cholesterol-lowering agents to prevent a heart attack? Why should anyone wait until after a heart attack or stroke to begin taking a drug designed to prevent a heart attack or stroke?

The answer rests with disease creep and the simple statistical quirks that come with it. In the past, doctors treated diseases that caused symptoms. But now we have tests and imaging machines that can detect risk factors and illnesses in their earliest stages. Like cholesterol. Elevated cholesterol is not a disease. It doesn’t cause symptoms. It is a risk factor. People with high cholesterol levels are somewhat more likely to develop a heart attack or stroke, but they are at far less risk than individuals who already have cardiovascular disease. This is the definition of disease creep: when pre-conditions or risk factors are treated as if they are the same as the actual disease state.

Here’s a thought experiment (with purposefully exaggerated numbers) to help understand this puzzle: Imagine a group of people who have the rare but awful Disease A, which is so terrible that all of its victims will die. Now imagine the discovery of Wonder Drug X, which cures half of the patients with Disease A. Unfortunately, Wonder Drug X does have a pretty bad side effect profile – it’s a very powerful drug, after all – and 10 percent of people who take it will die from liver failure. Despite this worrisome side effect, Wonder Drug X is truly an advance for patients with Disease A: For every 200 patients with the disease who are treated, 100 will now survive and only 10 of the 100 survivors will die of the drug’s side effects. That means 90 more people out of 200 will survive thanks to Wonder Drug X.

But now imagine a different group of 200 people, who don’t actually have disease A, but instead have a genetic marker which “is associated with” Disease A. In this scenario only 1 in a million people in the general population will get disease A. If you have the genetic marker, the risk is much higher, such that 2 of these 200 people will develop the disease at some time in the future. The genetic test gets highly promoted – “find out your risk early, because we now have a treatment that works, and the sooner you’re treated, the better!” There is a tiny grain of truth to this – of the 2 people identified by the genetic test, 1 (50%) will now be saved by Wonder Drug A.   This might sound just as good as before; here’s a group of people with 10,000 times (!) the risk of the general population to develop a uniformly fatal disease. Surely it’s worth taking a drug that can cure that disease in half the cases, isn’t it?

But it really isn’t the same. Because saving that one life isn’t remotely worth the harm caused by Wonder Drug X in these 200 people. For while each individual is at a 10,000 fold risk of the disease, only 2 are destined to die from it. On the other hand, if they take Wonder Drug X, roughly 20 (10 percent of the 199 survivors) will die unnecessarily of liver failure.

The FDA did the right thing last week when it removed its seal of approval from the use of Avastin in treating advanced breast cancer. The decision is a long time coming, given that its own expert panel recommended against approval in the first place, and that another panel recommended removing the breast cancer indication nearly a year and a half ago.

Still, this is an important and courageous move for the FDA: important because it implicitly acknowledges the FDA's duty to only approve drugs that are safe and effective; courageous because the agency will undoubtedly be raked over the coals for the decision. Members of the breast cancer advocacy community, like most other people, have a bias toward preferring action over inaction. Their frustration is understandable, as advanced breast cancer is a terrible diagnosis. For advocates of evidence-based medicine, however, it's time to stand behind the FDA. They're doing their job, and doing it well.

Several other blogs have made important points about the decision. The Incidental Economist provided an excellent list of all the things the FDA didn't do, including:

• "Pulling Avastin from the market;
• Banning use of Avastin for metastatic breast cancer;
• Punishing doctors who use it off-label;
• Banning reimbursement for off-label use; or
• Making a death panel decision based on inadequate scientific evidence."

Of course, the FDA can't do many of these things, but many advocates seem to forget that Avastin is still available, and it will surely still be used off-label. But at least oncologists and patients will be on notice that the risks of the drug are not worth taking, at least for most, perhaps even all patients. (There might be a small sub-population of women who benefit from the drug -- and maybe not. Genentech, the manufacturer, would have to do further study to identify those women.) We echo the Incidental Economist's exhortation to journalists: please don't make these mistakes again. Don't even imply them. No excuses.

GoozNews also pointed out that insurers are unlikely to drop coverage of Avastin for breast cancer, even without the FDA's word:

"most insurance companies and Medicare will continue to follow the National Comprehensive Cancer Network guidelines. NCCN’s guideline writing committee, a third of whom have financial ties to Roche/Genentech, has said it will not withdraw Avastin’s use in metastatic patients." (emphasis added)

Evidence-based medicine is critical to improving the effectiveness (and cost-effectiveness) of our medical system. In order to do expand its reach, we need doctors who understand medical evidence. Unfortunately, as recent debates about PSA testing and mammograms for women under 50 have shown, many doctors have (at best) a fuzzy grasp of statistical reasoning. Without a good understanding of statistics, physicians are as vulnerable as any other "man on the street" to serious statistical mistakes--mistakes that affect their clinical judgment.

Some of that can be reformed in medical schools: the medical curriculum reform movement, which often focuses on improving teamwork and coordination of care, has also incorporated calls to teach med students about medical evidence and how to properly interpret it when making clinical decisions.

What can we do, though, about the doctors already out there practicing medicine? PharmedOut, a project of the Georgetown Department of Pharmacology, is offering a new "5-Minute Fast Stats" powerpoint that provides information about a few critical concepts in medical statistics: the difference between absolute and relative risk (and between absolute and relative risk reduction), the number needed to treat (NNT), and the number needed to harm (NNH). The powerpoint is quite good for understanding the critical difference between absolute and relative risk--and most importantly, it points out the ways that drug manufacturers use the different numbers to emphasize benefits and minimize risk. The section on NNT and NNH is slightly more confusing--we would have focused more on interpreting the numbers and what they mean for patients, rather than computing them--but the concepts remain important.

We certainly hope that doctors will take advantage of the presentation (and the other resources on PharmedOut's website), and take the time to share it with their colleagues (download here). The more our doctors understand the messages they're getting from medical research and pharmaceutical marketing, the better off we'll be.

About a year ago, I accompanied my 80-year-old mother on a visit to the cardiologist’s office. She had been having unexplained dizzy spells and a rapid, irregular heart beat and was in for tests to see what the problem was. After the first test, we sat with the electrophysiologist, who explained Mom’s results.

While the partisan gap in Washington is wider than it’s been at any time in living memory, the two parties do have one remarkable agenda in common. Both have proposed cuts in Medicare so drastic that they would have been politically suicidal a decade ago and may still be. Yet neither party is backing off.

Here’s a list of the recent fibs, misdirections, misstatements and outright lies uttered by a wide variety of opinionmongers in reaction to the new guidelines on prostate cancer screening with the PSA test issued by the U.S. Preventive Services Task Force.

CLAIM 1:

“There weren’t any urologists on the task force!” This was uttered by none other than Newt Gingrich, former Speaker of the House and now-presidential candidate, during the Republican debate at Dartmouth College this week. The charge was also leveled by Dr. Patrick Walsh, University Distinguished Professor of Urology at Johns Hopkins Medical Institutions. (Walsh also pioneered “nerve sparing surgery,” a technique for removing the prostate that helps preserve a man’s ability to get an erection.)

They’re right: there were no urologists on the task force. Instead, there were 15 experts, all of whom have advanced degrees in addition to their medical training, and the statistical knowledge to parse medical evidence. You don’t need to be a urologist to dissect a scientific study, and there are plenty of urologists out there who wouldn’t know the first thing about doing so.

Perhaps Paul Goldberg, publisher of The Cancer Letter, said it best when describing the urologist Gingrich cited: “I wouldn’t call him an expert in prevention; I would call him a urologist.”

Whenever a deeply held belief comes into conflict with evidence, the stage is set for the sort of pitched battle we’re now seeing over the U.S. Preventive Services Task Force (USPSTF) guidelines for prostate cancer screening. We’ve got headlines proclaiming “Men Can't Afford to Skip the PSA Test,” letters to Congress saying “the U.S. Government is putting the lives of thousands at risk,” and a doctor telling the New York Times, “We will not allow patients to die, which is what will happen if this recommendation is accepted.”

The reality? The report (full version here) says that there is “moderate or high certainty that [routine PSA testing] has no net benefit or that the harms outweigh the benefits,” and thus gives it a “D” rating. “D,” in this case, means “discourage this service.”

Note what the recommendation doesn’t say. It never tells doctors to “deny this service.” Nor does it say to insurers, “don’t pay for this service.” The USPSTF does not ration care, determine what private insurance has to cover, or even determine what Medicare will pay for.* Rather, the task force’s sole purpose is to distill research findings into concise advisory opinions for medical providers.

The effect of all the fearmongering -- in addition to misinforming men about the potential risks and benefits of the PSA test – is to set the stage for some potentially dangerous political theater. Congress has a habit of threatening research agencies when their findings displease some important constituency. The last controversial recommendation from the USPSTF (which said there was no need for women ages 40-49 to have annual mammograms) generated such fallout that the current recommendation was held back for nearly two years – depriving men and their doctors of crucial information about the risks of getting a prostate screening test.

The Dartmouth Atlas has long made a mission of pointing out the variation in medical practice across the US, and in the process, the Atlas has gained a reputation for innovative, incisive research. Among health policy geeks, its maps are legendary.

That explains the general dismay over “After Hospitalization,”  the most recent Atlas report, which came out last Wednesday. According to the report, the hospital community has done a lousy job of making sure patients don’t land right back in a hospital bed after they’re discharged. Preventable readmissions are recognized as a serious problem, taking patients out of their homes and costing billions of dollars each year. Medicare has decided to link hospital payments to success in meeting a readmission standard, and that means a lot of hospitals have a big problem according to the Dartmouth Atlas.

Efforts to reduce readmissions thus far have sputtered. According to the Dartmouth report, surgical and medical readmission rates between 2004 and 2009 were essentially constant. Poor coordination of care between hospitals and post-hospital recovery are the primary reason for readmissions. When chronically ill patients leave the hospital, their medical needs are often far from complete—they require medication, follow-up, and management over an extended period. Even knowing that, many patients still don’t see a primary care doctor within two weeks of their discharge—a step that Dartmouth and others see as crucial to proper care management.

Health Wonk Review, Muppet Edition!

Hello all, and welcome to another exciting episode of Health Wonk Review! (Regular readers will note that yes, I used line last time. I have half a mind to make Alistair Cookie the official HWR mascot, here at New Health Dialogue.) In honor of what would have been Jim Henson’s 75^th birthday last week, I bring you the Muppet Edition of Health Wonk Review!

Now, without further silliness, the articles!

Quality Care

Here at New Health Dialogue, we’re exulting in doctors’ acceptance that yes, they do overtreat patients! Now, getting them to accept that money is part of the reason why…

Jonena Relth of Healthcare Talent Transformation draws attention to the cool new physician payment system being tried at Fairview clinics in Minnesota: payments are based on patient satisfaction and health, rather than by the number services provided.

David Williams draws a parallel between diagnosis and management consulting: experienced clinicians need to be wary of “early closure,” and avoid becoming like the “more experienced managers [who] are satisfied with two data points – after all, that’s enough to make a line, [or the partners who] just need one data point – they can assume the slope.”

Jessie Gruman, at the Prepared Patient Forum, wonders if the collaboration between HHS, the Robert Wood Johnson Foundation, Dr. Oz, and others will help Americans learn to pay attention to their medical care and improve communication with their providers.

Chris Langston points out that there are fewer people entering training for geriatric specialties—a workforce that may be critical in addressing the communications issue Jessie discussed.

The most recent issue of the Archives of Internal Medicine includes a provocative survey of primary care physicians—one that indicates a significant, long-overdue change in how both providers and patients see medical care.

The study surveyed over 600 physicians by mail, and found that 42 percent believe their patients are getting too much medical care. That’s seven times as many as the six percent who believe their patients aren’t getting enough. Further pressing the case, about 30 percent of PCPs surveyed said that their own practice was more aggressive than they’d like.

Think about what this means. Four years ago, when the Health Policy Program’s director, Shannon Brownlee, published her book Overtreated, most Americans, and a lot of providers, legislators and policy experts thought the only real problem in U.S. healthcare was too little care – because nearly 1 in every 6 Americans was uninsured. Now we have a study that shows that physicians are well aware that overtreatment is also a problem