THCB

First, Do Net Harm?

Recently, the US Preventative Services Task Force reiterated its recommendation that women not undergo routine screening for ovarian cancer. This was remarkable, not simply because it was a recommendation against screening, but because the task force was making the recommendation again, and this time even stronger.

The motivation for the recommendation was simple: a review of years’ worth of data indicates that most women are more likely to suffer harm because of false alarms than they are to benefit from early detection. These screenings are a hallmark of population medicine—an archetypal form of medicine that does not attempt to distinguish one individual from another. Moving beyond the ritualistic screening procedures could help reduce the toll of at least $765 billion of wasted health care costs per year.

We already know the common changes in the DNA sequence that identify people who have higher risk of developing ovarian, breast or prostate cancer and most other types of cancer. Consumers can now readily obtain this information via personal genomic companies like 23andMe or Pathway Genomics. But we need to do much more DNA sequencing to find the less common yet even more important variations—those which carry the highest risk of a particular cancer. Such research would be easy to accomplish if it were given top priority and it would likely lead to precision screening. Only a small fraction of individuals would need to have any medical screening. What’s more, it will protect hundreds of thousands of Americans from being unnecessarily harmed each year.

Three of the most common mass screening tests are mammography for breast cancer, prostate specific antigen (PSA) for prostate cancer, and the CA-125 blood test for ovarian cancer. All recent data indicates net harm. Take mammography: for every 2,500 women screened over a ten-year period, only one death is avoided but there are six to eight individuals who are harmed with unnecessary surgery, radiation, chemotherapy or some combination of these misinformed treatments. For every 1,000 men, aged 50 or older, screened for PSA, there are no differences in deaths versus an equally large group of unscreened men. However, 180 screened men have a false positive result and undergo a series of prostate biopsy procedures, with at least twenty having an unnecessary treatment.  Ovarian screening has been shown to produce a 10 percent false-positive rate with five out of every 100 women enduring unnecessary surgery to remove their ovaries.

Screening tests are only one category of population medicine. At least $110 billion per year is spent on useless prescription medications, wasted because physicians treat patients as if everyone’s biology were precisely the same. For example, the three drugs with the largest sales today—Humira, Enbrel, and Remicade—are all used for rheumatoid arthritis and autoimmune disorders and cost nearly $30 billion per year. However, only 40 percent of patients have a response. To date, nothing has been done by the life-science industry to understand why the majority of patients will not derive benefit or to develop alternative treatments for them. Instead, the industry wastes their $18 billion and squanders their hopes.

There are common threads for why we are so slow to let go of population medicine. The current way of doing things is simple—the same tests, the same drugs, the same dose for all Homo sapiens. It makes for solid revenue for hospitals and doctors, who derive unintended benefits from the additional operations, procedures, and radiation treatments provoked by false positives. And ditto for the pharmaceutical and biotech industries whose preferential target, from a marketing and sales perspective, would be all people on the planet.

But we have the tools today to make the switch from population to individualized, precision medicine. Just recently in 1 week the Encyclopedia of DNA Elements group published thirty-five papers in leading medical journals that took our understanding of the genome to new heights.  We already have remarkable data describing incontrovertible interactions between one’s genome and many commonly used drugs, including Plavix for blood clots, interferon for hepatitis C, Tegretol for seizures, statins for heart disease, steroid inhalers for asthma, and many more. But we’re not using the information, and so the warnings about population-based medicine must be sounded again and again.

With all the talk and legislation on health-care reform, hardly a word has been uttered about seizing this opportunity. It isn’t just about new ways to save costs, for which we are certainly desperate enough. It’s about avoiding the harm of mass screening and treatments. The term net benefit has been one used in medical circles for the past few decades, but now we must address net harm—and there is evidence that there is plenty of it going on with the way medicine is practiced today.

It is time for the public to demand a better way forward. When a screening test is ordered, patients should question why and demand the data to justify it. When a medication is prescribed, they should ask about the data for how the drug will interact with their genome. It’s time for the government to seize the opportunity to advance the research with tools that zoom in on each individual’s biology and physiology—be it via the genome or wireless sensors—to promote precision of testing and treatment in the future. And, with its pipeline of new drugs drying up and innovation running on empty, it’s time for the life science industry to markedly narrow its target for drug development.

We are at a unique time in medicine, a veritable inflection point that can transcend mass medicine and bring us to one that takes each individual’s distinct properties into account. There is no such thing as an average human being. But the average medicine that is being practiced today is obsolete and intolerable. How long must we accept mass numbers of individuals experiencing unnecessary harm before deliberate action takes hold?

Eric Topol is chief academic officer at Scripps Health, a professor of genomics at The Scripps Research Institute and the author of The Creative Destruction of Medicine.

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DeeannadonbruceSeth KaplanDoctor BobLizzy Recent comment authors
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Deeanna
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Hi there to every one, as I am truly keen of reading this weblog?s post to be updated daily. It carries fastidious data.

donbruce
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donbruce

Eric: Just finished your book. Nice and interesting. I am a bit concerned about the unintended consequence of VSCAN devices used for routine evaluation. We all acknowledge the primitive aspect of traditional physical exams and for sure VSCAN will likely pick up more pathology than standard physical exams….however…given the limited back ground in ultrasound of most internists, there is an equal if not greater liklihood of numerous false positives, necessitating full fledged Ultrasound exams, CT and MRI exams simply to assure the internist that the findings were innocuous….Such a spin off of testing is just what we do not need… Read more »

Seth Kaplan
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Seth Kaplan

You are correct about the drug interactions, especially statins, which are very harmful and provide no benefit. However, big pharma will work hard to stop anyone from changing the current situation.
In terms of screenings, all I can say is, when it’s your cancer, and you weren’t screened, let’s see if you feel the same way.

Doctor Bob
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Doctor Bob

THCB should have preceded this by a paragraph indicating Dr. Topol’s financial interest in getting people to have DNA testing at public expense. At a time when many conservatives keep pitching “patient centered health care”, i.e. trust the patient to decide how to spend public funds, we have massive propaganda about medical issues and profound medical ignorance by many physicians who figure that it’s easiest if they just order what the patient wants. It’s schizophrenic to push for extensive genomic screening as the solution to the problems of other “clumsy screening” such as mammography & PSA testing. Life expectancy for… Read more »

Lizzy
Guest

I’m not sure I understand why they are recommending so strongly against getting screened.

john
Editor

Before slamming ET for being “obsessed” with wireless sensors and questioning his agenda, you should probably consider his contributions. http://en.wikipedia.org/wiki/Eric_Topol A cardiologist obsessed with wireless technology? How completely and utterly shocking. A researcher looking for funding? What are you obsessed with? Anything? Eric J. Topol, M.D. is an American cardiologist, geneticist, and researcher. Much of Topol’s career was spent at the Cleveland Clinic, where he served as chairman of cardiovascular medicine and founded the Cleveland Clinic Lerner College of Medicine. Topol was one of the first researchers to question the cardiovascular safety of rofecoxib (Vioxx),[1] culminating in the drug’s ultimate… Read more »

rbaer
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rbaer

I wouldn’t say shocking, rather amusing. And by the way, I have nothing against him obtaining funding if his projects are worthwhile, but I don’t think that blogposts are particularly effective. I also don’t know what ETs (considerable) accomplishments have to do with anything I wrote. If you want to write: if someone as smart as ET is obsessed with wireless sensors, there must be something to it, fine. But arguments should stand on their own, and he still could make a better and more realistic case. Just writing that everyone’s genome should be sequenced and as much physiology as… Read more »

sm2012
Guest

@rbaer, I appreciate the cynicism, but I don’t think he’s being obsessive or biased. The points around individualizing population statistics and medicine are actually very fair and interesting ones. The problem is that they are largely irrelevant currently in the day-to-day practice of medicine. How many people really walk in with a fully sequenced 23andme genome?? The government is trying to get their hands around some very rudimentary cost, quality and access issues. While individualized medicine is going to certainly improve how we can tailor care (and yes, this will impact cost, quality and access), it won’t happen for some… Read more »

rbaer
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rbaer

Not sure what you disagree with – I wrote that there does not appear to be much actionable data … who knows, maybe there is some change coming. This is all in the realms of ordinary medical progress (i.e. research/grants, papers, commercial applications, changing practice, guidelines etc.) Obsession: Read the other post I linked to. IMHO, there can be little doubt that ET likes the thought of putting probes into human beings. There is nothing new to that (implantable loop recorders/holter, esophagoeal pH monitoring, ambulatory EEG) except maybe for his emphasis of the wireless part, but ET apparently expects some… Read more »

rbaer
Guest
rbaer

“But we have the tools today to make the switch from population to individualized, precision medicine. Just recently in 1 week the Encyclopedia of DNA Elements group published thirty-five papers in leading medical journals that took our understanding of the genome to new heights. We already have remarkable data describing incontrovertible interactions between one’s genome and many commonly used drugs, including Plavix for blood clots, interferon for hepatitis C, Tegretol for seizures, statins for heart disease, steroid inhalers for asthma, and many more. But we’re not using the information, and so the warnings about population-based medicine must be sounded again… Read more »

Vikram C
Guest
Vikram C

Trying to summarize problem that seems at many levels. 1. Biopsy are sampling exercises. They may not capture malignancy or capture it late for some folks. 2. Then there are false signals leading to treatment not needed. Doesn’t seem logical. I would assume there would be multiple tests to confirm malignancy before starting treatment. 3. Even when correctly identified, there are treatments prescibed that are not effective. Once again seems strange though not suprising. One would assume physicians use their experience to determine efficacy during prescription. Then these medicines also pass through FDA evaluation. Are these evaluation not effective? Evidence… Read more »

BobbyG
Guest

1 & 2:

Bayes 101. Relative assay error rates are, among other factors (like stage), contingent on prevalence.

Margalit Gur-Arie
Guest

If that’s the case, why are we defining “quality” as a bunch of population based screenings, as in the Weill Cornell study that “proves” (based on 2008 data!) that EHRs improve “quality” of care because docs with EHRs ordered more screenings for breast cancer, chlamydia, colorectal cancer and A1c (thrown in there for good measure)?
Is “quality” independent on “net harm”?

southern doc
Guest
southern doc

“why are we defining “quality” as a bunch of population based screenings?”

Because it’s easy and “we” can?

(Of course, the word “easy” is relative. I have one insurer that regularly dings me for not ordering PSAs on two female patients in their 80s)