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The American Cancer Society’s new mammography guidelines: Déjà vu all over again

The American Cancer Society’s new mammography guidelines: <em>Déjà vu</em> all over again

One of the things that feels the weirdest about having done the same job, having been in the same specialty, for a longer and longer time is that you frequently feel, as the late, great Yogi Berra would have put it, déjà vu all over again. This is particularly true in science and medicine, where the same issues come up again and again and again, often with the same arguments on either side. Sometimes the same players are even involved. So it is with mammography recommendations. Indeed, I’m feeling déjà vu all over again right now, as I read headlines like “Women advised to get mammograms later, less often“, “American Cancer Society, in a Shift, Recommends Fewer Mammograms“, and “ACS: Breast cancer screening should begin at age 45“. What provoked these headlines was a major revision in the American Cancer Society’s recommendation for mammographic screening for breast cancer in women at average risk of the disease. In a seeming replay from 2009, when the United States Preventative Services Taskforce (USPSTF) sent shockwaves through the breast cancer world by recommending that most women not start mammography until age 50 and then only to have it done every two years instead of every year, the American Cancer Society (ACS) has now just similarly ratcheted back its recommendations for screening mammography, just not as much as the USPSTF did. The new recommendations were communicated in a special communication published by JAMA on Tuesday.

What changed regarding mammography recommendations

Before we get to the issues, how, specifically, did the ACS change its mammography recommendations? Before this change, the ACS basically recommended the same thing that most other American professional societies dealing with breast cancer did: yearly mammography starting at age 40 for the rest of a woman’s life. The new guidelines now recommend that women with an average risk of breast cancer should undergo regular screening mammography starting at age 45 years and continuing annually until age 54. From age 55 and older, the ACS recommends that women transition to every two years. (More details below.) As I Tweeted when I saw these recommendations, basically it appears that the ACS has more or less split the difference between the old recommendations and the USPSTF recommendations.

So why is the ACS changing its recommendations? And what does this say about the science and our values regarding cancer screening? If you’ve been reading this blog, you know that over the last several years there has been a steady drip, drip, drip of studies that range from highlighting the downside of widespread mammographic screening to downright questioning the value of mammography. That’s why I’ve been discussing rethinking screening for breast cancer since at least 2008. Basically, you can go back and read my old posts and, if you have a lot of time and are enough of a glutton for punishment to read them all, watch the evolution of my thinking about breast cancer screening over the last seven years.

Back in the day, I used to fully support breast cancer screening beginning at age 40 and proceeding yearly throughout. As I examined more and more of the evidence, I became less enthusiastic about screening so intensely and started to believe that starting at 40 was too young for most women. Indeed, I was probably the only breast cancer doctor at my cancer center in 2009 who supported the USPSTF recommendations when they were announced, which led to some—shall we say?—interesting discussions about what should be said to the press and what a press release our cancer center wanted to release ASAP should actually say. I also got myself into a little…trouble…for criticizing colleagues in radiology—not from my institution, I hasten to add!—for some rather blatant turf protection. Let’s just say that a prominent radiologist, one who’s achieved far more renown in his field than I ever have in mine, was most displeased with some of my commentary and let me know about it. I found this displeasure odd, given that I am most definitely not a nihilist with respect to mammography screening (and, make no mistake, there are quite a few of those out there these days). I’m just a lot more balanced and aware of its limitations than I used to be. On the other hand, I did call him out for some of his more obnoxious comments that implied that those who question mammography are cackling gleefully at the thought of more women dying of breast cancer. Interestingly, I don’t seem to get asked to contribute to such press releases that much anymore, but in fairness neither do most of the other breast cancer clinicians I work with; so I probably can’t blame it on my previous outspokenness.

What brought me to this point is an increasing understanding of the concepts of overdiagnosis and lead time bias, coupled with a string of studies that show more modest benefits (and, in one case, no benefit) from screening mammography. To be honest, the attack dog reaction by some mammography supporters to some of these negative studies also set my skeptical antennae a’twitchin’ as well.

Posted in: Cancer, Public Health

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Choosing Wisely: Changing medical practice is hard

OK, so Choosing Wisely isn't quite like this, but it's still very important.

OK, so Choosing Wisely isn’t quite like this, but it’s still very important.

We here at Science-Based Medicine like to point out that arguably the most striking difference between science-based medicine (and the evidence-based medicine from which we distinguish it) and alternative medicine, “complementary and alternative medicine” (CAM), or (as it’s called now) “integrative medicine” is a concerted effort to change for the better. In other words, in SBM, we are continually doing studies to improve practice. These studies take on two general forms: Comparing new treatments with old to determine if the new treatments work better and, as has become an imperative over the last several years supported by more research dollars, comparing existing treatments in order to determine which ones work better. In the case of the former, we are trying to add to our knowledge and thereby add more effective treatments, while in the case of the latter we are trying to weed out treatments that are less effective and/or less safe or that cost more money to produce the same results. Indeed, the rise of an explicit framework, evidence-based medicine, is a result of the desire of medicine as a profession to improve what it is doing. (Yes, I know this blog frequently criticizes EBM, but in the case of treatments that have science behind them EBM and SBM should be—and usually are—synonymous.) This is in marked contrast to CAM, where treatments based on prescientific vitalism never, ever go away, no matter how many clinical trials show them to be no better than placebo and basic science shows them to be ludicrously disconnected from reality.

An example of this imperative to make things better is Choosing Wisely. This is an initiative launched in 2012 in which the American Board of Internal Medicine (ABIM) Foundation challenged specialty societies to produce lists of tests and interventions that doctors in their specialty routinely use but that are not supported by evidence. The explicit goal of Choosing Wisely was to identify and promote care that is (1) supported by evidence; (2) not duplicative of other tests or procedures already received; (3) free from harm; and (4) truly necessary. In response to this challenge, medical specialty societies asked their members to “choose wisely” by identifying tests or procedures commonly used in their field whose necessity should be questioned and discussed. The resulting lists of “Things Providers and Patients Should Question” was designed to spark discussion about the need—or lack thereof—for many frequently ordered tests or treatments.

Posted in: Clinical Trials, Politics and Regulation, Quality Improvement

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“Safe” dietary supplements can land you in the emergency room

Dietary supplements
If there’s one thing I’ve been consistent about, it’s that, however ridiculous all the other woo I routinely discuss here is—homeopathy, reiki, reflexology, I’m talking to you and your friends—herbal medicine and supplements might have value because they might have a physiological effect that is beneficial in treating or preventing disease. Of course, if that’s the case, it’s because the herb or supplement contains chemicals that act as drugs. They’re “dirty” drugs in that they are mixed with all sorts of other substances in the herb or supplement that might or might not have effects, which means that different lots of the herbs or supplements often have different activity, but they are drugs nonetheless. That’s why, for instance, doctors don’t tell patients to chew on foxglove leaves when they want a patient to get digoxin. Digoxin is a powerful drug with a relatively narrow “therapeutic window,” meaning that the difference between the levels of the drug in the blood needed for therapeutic effect are not very far from toxic levels; so predictable, reliable drug content is essential. I just learned a while ago that within the living memory of some older physicians digoxin actually was prescribed as crude extracts, which was very difficult and dangerous, hence the necessity of purification. In other cases, (such as Artemisinin, for which Youyou Tu was recently awarded the Nobel Prize in Physiology or Medicine), crude plant extracts do not contain sufficient quantities of the active component, necessitating its isolation, purification, and, in some cases, chemical modification to increase its absorption, stability, or activity.

One thing that proponents of herbal medicine and supplements often forget, though, is that if herbs or supplements can have potentially beneficial effects (albeit difficult to regulate effects due to the crude, impure nature of the extracts often used) because they contain drugs, then herbs and supplements can also produce adverse events, again, because they contain drugs. You can overdose on herbs and supplements. This point was recently reinforced by a new study by Geller et al. published last week in the New England Journal of Medicine (NEJM), entitled “Emergency Department Visits for Adverse Events Related to Dietary Supplements.” It was carried out by investigators from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, and Chenega Government Consulting; and the Center for Food Safety and Applied Nutrition and the Division of Public Health Informatics and Analytics and the Division of Dietary Supplement Programs, Food and Drug Administration. The title pretty much tells you what the study is about, and what the study is about is that dietary supplements cause a lot of visits to the emergency room every year; 23,005 (95% confidence interval [CI], 18,611 to 27,398) emergency department visits per year can be attributed to adverse events related to dietary supplements.

Posted in: Herbs & Supplements, Politics and Regulation

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Sarah Hershberger: “Health freedom” and parental rights vs. child welfare

Sarah Hershberger, pictured with her family in a 2014 video.

Sarah Hershberger, pictured with her family in a screenshot from a 2014 video.

One of the more depressing topics that I regularly write about on this blog includes of analyses of news stories of children with cancer whose parents decided to stop science-based treatment (usually the chemotherapy) and use quackery instead. There are, of course, variations on this theme, but these stories take form that generally resembles this outline: A child is diagnosed with a highly treatable cancer with an excellent cure rate. Standard science-based treatment is begun, but the child suffers severe side effects from the chemotherapy. After an incomplete course of chemotherapy, the parents, alarmed at their child’s suffering, start balking at further chemotherapy, either because the child refuses further treatment or because they do. At some point in this process the parents become aware of the claims of practitioners of this or that alternative medicine, who tell them that their child’s cancer can be cured without toxic chemotherapy, and, wooed by the siren song of a promise of a cure without suffering, the parents choose that instead. At this point, physicians, alarmed at the parents’ choice, call in their state’s child protective services team, and a court battle ensues. Sometimes the court battle results in an order that the child complete conventional therapy, as it did with, for example, Daniel Hauser or Cassandra Callender. Sometimes it ends with a compromise in which the child and/or parents can choose an unconventional practitioner, as in the case of Abraham Cherrix. All too often the courts utterly fail to protect children with cancer, as the Canadian courts did in the cases of Makayla Sault and JJ. Not infrequently, if the court rules against the parents, the parents flee with their child to avoid treatment, as happened with Daniel Hauser, Abraham Cherrix, and Sarah Hershberger. Usually, they ultimately come back.

However they turn out, over the years of looking into them I’ve found that these stories tend to bear a depressing similarity and predictability. For example, if the child does well, it is always attributed to the alternative treatment, even when the child received a significant amount of conventional therapy. This attribution derives from a fundamental misunderstanding of how the treatment of cancer works in that the problem with incomplete cancer treatment is not that it can’t cure the cancer but that it has less of a chance of doing so. As I’ve explained many times, the reason that treatment regimens for many pediatric cancers involve two years’ worth of chemotherapy is that over time pediatric oncologists learned the hard way that, although the first cycle of chemotherapy (usually called induction chemotherapy) can lead to remission, without the additional cycles the chances of recurrence are very high—unacceptably so. Consequently, children who stop chemotherapy early can be in remission; they’ve just been put at a high risk of recurrence.

Posted in: Cancer, Herbs & Supplements, Naturopathy, Politics and Regulation

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Presidential candidate Ben Carson: Shilling for Mannatech with his very own alternative cancer cure testimonial?

Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.

Ben Carson fires up the Mannatech faithful by telling them how it helped him cure his prostate cancer. Well, that and the nerve-sparing prostatectomy he underwent and the fact that the spine lesions he thought to be metastases were really not metastases at all.

Over the years, mainly at my not-so-super-secret other blog, I’ve frequently made the points that the vast majority of physicians are not scientists and, in fact, that many of them suffer from a severe case of Dunning-Kruger when it comes to science outside of biomedical sciences—or even biomedical sciences outside of their medical field of expertise. The most common science I’ve seen physicians embarrass themselves attacking has generally been evolution, with a disturbingly high number of physicians denying evolution and embracing creationism. Of these, the doctor I wrote about most frequently back in the day was the creationist neurosurgeon Michael Egnor, but with the onset of the 2016 Presidential race there’s been a new creationist neurosurgeon in town with arguably even more ignorant attacks on evolution. I’m referring, of course, to noted neurosurgeon Ben Carson, whose creationist stylings have been so bad that I had to use him as a poster child to demonstrate how the vast majority of physicians are not scientists and all too many of us have an inordinate and unjustified confidence in medicine as a “check on BS.”

Over the last couple of weeks since my post on the second Republican debate, in which Donald Trump spewed antivaccine nonsense and Ben Carson pandered to antivaccine views, even though past statements by him demonstrate that he knows better, unfortunately Carson has continued to spew statements that are nothing but downright embarrassing, be they his statement in the wake of the Oregon mass shooting that it would be better to attack an armed gunman during a mass shooting “because he can’t get us all” (complete with a seeming attitude that those who died were cowardly), his doubling down on that by claiming that if the Jews had been armed maybe things would have turned out differently in the Holocaust (neglecting the fact that Jews did resist), or his many other statements that make me wonder how someone with so little critical thinking skills could get through medical school and a neurosurgery residency to become such a respected surgeon.

Posted in: Cancer, Herbs & Supplements, Nutrition, Politics and Regulation

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Antivaccine activists fund a study to show vaccines cause autism. It backfires spectacularly.

You want to inject me with vaccines and then dissect my brain? Why? We already know vaccines don't cause autism!

You want to inject me with vaccines and then dissect my brain? Why? We already know vaccines don’t cause autism!

Having written about pseudoscience and quackery continuously for over a decade and having engaged in conversations about it online for over 15 years, I’ve come to recognize a number of traits that are virtually the sine qua non of quacks and pseudoscientists and their believers. Obviously, one of them is a severe case of the Dunning-Kruger effect, a tendency of those with low expertise in a topic to overestimate their expertise and express far more confidence in their conclusions than warranted while those with high expertise know enough to know how much they don’t know about a topic and thus tend to express more uncertainty and caveats. Basically, the Dunning-Kruger effect describes how unskilled individuals express an illusory superiority, mistakenly believing their knowledge, competence, and ability to be much higher than it really is.

As a result of the Dunning-Kruger effect, coupled with other cognitive shortcomings suffered by all human beings (but seemingly amplified in believers in quackery and pseudoscience) that lead them to believe in pseudoscience, such as confusing correlation with causation, motivated reasoning, and the like, believers in pseudoscience are often so absolutely rock-solid in their beliefs that they are virtually impossible to reason with. It is incredibly difficult to change their minds, and disconfirming evidence often causes them to dig in all the more deeply to defend their beliefs. Not uncommonly, this leads them to commission studies designed to support their beliefs. But what happens when such a study does not actually support their belief? What happens when such a study backfires spectacularly and not only fails to support their belief, but emphatically so? Skeptics were re-treated to just such a spectacle last week when SafeMinds and other antivaccinationists were burned by a study they funded (subscription required):

Between 2003 and 2013, SafeMinds provided scientists from the University of Texas Southwestern School of Medicine, the University of Washington, the Johnson Center for Child Health & Development and other research institutions with approximately $250,000 to conduct a long-term investigation evaluating behavioral and brain changes of baby rhesus macaques that were administered a standard course of childhood vaccines. (The National Autism Association, another organization that has questioned vaccine safety, also provided financial support for this research.) The latest paper in the multiyear project was published Monday in the Proceedings of the National Academy of Sciences (PNAS). In it, the researchers concluded that vaccines did not cause any brain or behavioral changes in the primates.

Astute readers will recognize that I’ve written about similar papers before reporting that pediatric vaccines cause changes in behavior and/or brain structure in macaque monkeys. Specifically, way back in 2008, I noted the initial report of this ongoing study, first when preliminary results were reported as a poster presentation and then later another publication from the same group published in 2009. Steve Novella and a certain well-known friend of the blog have also described how poor experiments published from these studies in 2010 were, the latter of whom cited several other major criticisms of the study, not the least of which was some reporting of changes in the size of a part of the brain known as the amygdala that were…hard to believe. There were also a lot of issues with the control group chosen.

Basically, these abstracts and papers reported the results of an ongoing study looking at infant vaccines in macaque monkeys to see if there was an effect on socialization or changes in brain anatomy, the key hypothesis seeming to be that thimerosal-containing vaccines cause autism. (The investigators even added thimerosal to some of the vaccines because they weren’t being made with thimerosal anymore!) You can read the links I cited just now if you want the gory details; suffice to say that these were not good studies and not particularly good evidence that vaccines cause autism, as shown by the fact that homeopaths loved the study, and ultimately the paper examining hepatitis B specifically was withdrawn. Yet these reports were flogged for quite a while by the antivaccine movement as proof positive primate data that vaccines are Evil.

Fast forward to 2015. Now we have a much larger, much better study. It’s even by the same people. And guess what? It’s as negative as negative can be. No wonder SafeMinds and other antivaccinationists are unhappy. Let’s take a look. (more…)

Posted in: Science and Medicine

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“Liquid biopsies” for cancer screening: Life-saving tests, or overdiagnosis and overtreatment taken to a new level?

Could a blood draw be all you need to diagnose cancer and identify the best treatment for it? Not so fast...

Could a blood draw be all you need to diagnose cancer and identify the best treatment for it? Not so fast…

I’ve written many times about how the relationship between the early detection of cancer and decreased mortality from cancer is not nearly as straightforward as the average person—even the average doctor—thinks, the first time being in the very first year of this blog’s existence. Since then, the complexities and overpromising of various screening modalities designed to detect disease at an early, asymptomatic phase have become a relatively frequent topic on this blog. Before that, on my not-so-super-secret other blog, I noted that screening MRI for breast cancer and whole body CT scans intended to detect other cancers early were not scientifically supported and thus were far more likely to cause harm than good. That was well over ten years ago. Now we have a company offering what it refers to as a “liquid biopsy” for the early detection of cancer. I fear that this is the recipe for the ultimate in overdiagnosis. I will explain.

The problem, of course, is that disease progression, including cancer progression, is not always a linear process, in which the disease progresses relentlessly through its preclinical, asymptomatic phase to symptoms to complications to (depending on the disease) death. There is such a thing as disease that remains asymptomatic and never progresses (at which point it’s hard to justify actually calling it a disease). As I pointed out in my first SBM post on the topic, at least three-quarters of men over 80 have evidence of prostate cancer in autopsy series. Yet nowhere near three-quarters of men in their 80s die of prostate cancer—or ever manifest symptoms from it. This is what is meant by overdiagnosis, the diagnosis of disease that doesn’t need to be treated, that would never cause a patient problems.

When teaching medical students and residents, I frequently emphasize that overdiagnosis is different from a false positive because overdiagnosis does diagnose an actual abnormality or disease. For example, ductal carcinoma in situ (DCIS) diagnosed by mammography leading to a biopsy is a real pathological abnormality; it is not a false positive. We just do not know which cases of DCIS will progress to cancer and which will not, leading to a question of how DCIS should be treated or at the very least whether we should treat it as aggressively as we do now, particularly given that the apparent incidence of DCIS has increased 16-fold since the 1970s, all of it due to mammographic screening programs and the increased diagnosis of DCIS and early stage breast cancer has not resulted in nearly as much of a decrease in the diagnosis of advanced stage breast cancer as one would expect if early diagnosis were having an impact in reducing the diagnosis of late stage disease.

Overdiagnosis would not be such an issue if it didn’t inevitably lead to overtreatment. DCIS, for instance, is treated with surgery, radiation, and anti-estrogen drugs. Early stage prostate cancer used to be treated with radical prostatectomy, but now more frequently with radiation. Many of these men and women didn’t actually need treatment. We just don’t know which ones. This is why over the last six or seven years a significant rethinking of screening for breast and prostate cancer has occurred. There has been a backlash, of course, but the rethinking seems to have taken hold.

Not everywhere, of course. (more…)

Posted in: Basic Science, Cancer, Diagnostic tests & procedures, Public Health

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Donald Trump and the dangerous vaccine politics of the 2016 Presidential race

Republican candidates Ben Carson and Donald Trump during the CNN Republican presidential debate at the Ronald Reagan Presidential Library and Museum on Wednesday, Sept. 16, 2015,

Republican candidates Ben Carson and Donald Trump during the CNN Republican presidential debate at the Ronald Reagan Presidential Library and Museum on Wednesday, Sept. 16, 2015

I’ve been writing about vaccines and the antivaccine movement since the turn of the millennium, first in discussion forums on Usenet, then, beginning in 2004, on my first blog (a.k.a. the still existing not-so-super-secret other blog), and finally right here on Science-Based Medicine (SBM) since 2008. Vaccines are one of the most important, if not the most important, topics on a blog like this because (1) arguably no medical intervention has prevented more deaths and suffering throughout history than vaccines; (2) few medical interventions are as safe and effective as vaccines; and (3) there is a vocal and sometimes effective contingent of people who don’t believe (1) and (2), blaming vaccines for all sorts of diseases and conditions to which science, despite many years of study, has failed to link them. The most prominent condition falsely linked to vaccines is, of course, autism, but over the years I’ve written about a host of others, including sudden infant death syndrome, shaken baby syndrome, autoimmune diseases, and even cancer. In a similar vein, antivaccine activists will try to claim that vaccines are loaded with “toxins” or even tainted with fetal “parts” or cells because some vaccines’ manufacturing process involves growing virus in two cell lines that were derived from aborted fetuses many decades ago. Even the Catholic Church doesn’t say that Catholics shouldn’t use these vaccines, but that doesn’t prevent some antivaccine groups from portraying vaccines as virtually being made by scientists cackling evilly as they grind up aborted fetuses to make vaccines. (I exaggerate, but not by much.)

On a strictly scientific, medical level, antivaccine claims such as the ones described above are fringe, crank viewpoints. There is no serious scientific support for any of them and lots of scientific evidence against them, particularly the most persistent myth, namely that vaccines cause autism. It also used to be the case that, politically, antivaccine views tended to be those of the fringe. Unfortunately, in the current election cycle, those fringe views seem to be coming to the fore among prominent candidates for the Republican Presidential nomination. This was most evident at the second Republican Presidential debate last week, where Donald Trump spewed antivaccine tropes and neither of the two physicians also running for the Republican nomination mounted a vigorous defense of vaccines. Even candidates who have previously issued strong statements defending vaccines (Senator Marco Rubio and Louisiana Governor Bobby Jindal) remained silent.

(Video of the exchange can be found here.)

How did we get to this point? And why is it that antivaccine views, which in the past were stereotypically associated with crunchy lefties in the mind of the public, seem now to have found another comfortable home among small government conservatives, including the man who currently appears to be the frontrunner for the Republican nomination? In the days that followed the debate, there have been many discussions of Donald Trump’s antivaccine views, but none that take the long view. All seem to flow from the idea that it’s mainly just Donald Trump and his wacky views, rather than Trump being part of a more widespread phenomenon. I’ve frequently said that antivaccine beliefs tend to be the pseudoscience that knows no political boundaries, occurring with roughly equal frequency on the left and the right. However, it’s virtually inarguable that right now, in 2015, the loudest political voices expressing antivaccine views (or at least antivaccine-sympathetic views) are in the Republican Party. Yes, Robert F. Kennedy, Jr. is back in a big way, partying like it’s 1999 with Bill Maher over thimerosal-containing vaccines and autism, but neither he nor Bill Maher holds public office or is currently running for office. The über-liberal website The Huffington Post might have been promoting antivaccine propaganda since its inception, but its writers are not running for office, either, and of late it seems to be much less antivaccine than before. (more…)

Posted in: Neuroscience/Mental Health, Politics and Regulation, Vaccines

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The Federal Trade Commission takes on homeopathy—maybe

FTC vs. homeopathy: Cage match?

FTC vs. homeopathy: Cage match?

Well, I’m back.

OK, returning from London isn’t nearly as epic as Sam Gamgee’s final words in The Lord of the Rings returning to his wife and daughter after having accompanied Frodo, Gandalf, Bilbo, and key elves of Middle-Earth to the Grey Havens, there to say goodbye to them as they boarded a ship to the undying lands. I just love the quote. It says something to me returning home after a long journey, even if it was just a vacation to J.R.R. Tolkien’s native land. It also suggests a bit of the exhaustion after a long day of traveling, complete with a long-delayed flight, a late arrival, and a state of utter exhaustion that accompanied it, plus an unfortunate lower gastrointestinal issue.

All of this is a way of saying that this post might actually be relatively brief for a post by me…no epics this week. [Addendum: Nope. Even lower GI annoyances and exhaustion couldn’t keep me from going over 2,000 words. At least I didn’t hit 3,000.] In its nearly eight year history, I’ve never missed more than one week at SBM, and I don’t intend to start now. Specifically, with the FTC workshop on homeopathy rapidly approaching, one week from today, I couldn’t resist adding my 2 pence to the mix, now that the agenda and list of participants have been announced.

Posted in: Homeopathy, Politics and Regulation

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“Precision medicine”: Hope, hype, or both?

The cost to sequence a whole genome has been plummeting impressively since 2007.

The cost to sequence a whole genome has been plummeting impressively since 2007.

I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single “gene chip,” and to assess the relative abundance of every RNA transcript, coding and noncoding (such as microRNAs) simultaneously through next generation sequencing (NGS) techniques was considered, if not science fiction, so far off in the future as to be unlikely to impact medicine in my career. Yet here I am, mid-career, and all of these are a reality. The cost of rapidly sequencing a genome has plummeted. Basically, the first human genome cost nearly $3 billion to sequence, while recent developments in sequencing technology have brought that cost down to the point where the “$1,000 genome” is within sight, if not already here, as illustrated in the graph above published by the National Human Genome Research Institute. Whether the “$1,000 genome” is truly here or not, the price is down to a few thousand dollars. Compare that to the cost of, for instance, the OncoType DX 21-gene assay for estrogen receptor-positive breast cancer, which costs nearly $4,000 and is paid for by insurance because its results can spare many women from even more expensive chemotherapy.

So, ready or not, genomic medicine is here, whether we know enough or not to interpret the results in individual patients and use it to benefit them, so much so that President Obama announced a $215 million plan for research in genomic mapping and precision medicine known as the Precision Medicine Initiative. Meanwhile, the deeply flawed yet popular 21st Century Cures bill, which passed the House of Representatives, bets heavily on genomic research and precision medicine. As I mentioned when I discussed the bill, it’s not so much the genomic medicine funding that is the major flaw in the bill but rather its underlying assumption that encouraging the FDA to decrease the burden of evidence to approve new drugs and devices will magically lead to an explosion in “21st century cures,” the same old antiregulatory wine in a slightly new bottle. Be that as it may, one way or the other, the federal government is poised to spend lots of money on precision medicine.

Because I’m a cancer doctor, and, if there’s one area in medicine in which precision medicine is being hyped the hardest, it’s hard for me not to think that the sea change that is going on in medicine really hit the national consciousness four years ago. That was when Walter Isaacson’s biography of Steve Jobs revealed that after his cancer had recurred as metastatic disease in 2010. Jobs had consulted with research teams at Stanford, Johns Hopkins, and the Broad Institute to have the genome of his cancer and normal tissue sequenced, one of the first twenty people in the world to have this information. At the time (2010-2011), each genome sequence cost $100,000, which Jobs could easily afford. Scientists and oncologists looked at this information and used it to choose various targeted therapies for Jobs throughout the remainder of his life, and Jobs met with all his doctors and researchers from the three institutions working on the DNA from his cancer at the Four Seasons Hotel in Palo Alto to discuss the genetic signatures found in Jobs’ cancer and how best to target them. Jobs’ case, as we now know, was a failure. However much Jobs’ team tried to stay one step ahead of his cancer, the cancer caught up and passed whatever they could do. (more…)

Posted in: Basic Science, Cancer, Clinical Trials, Science and the Media

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