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The problem with preclinical research? Or: A former pharma exec discovers the nature of science

If there’s one thing about quacks, it’s that they are profoundly hostile to science. Actually, they have a seriously mixed up view of science in that they hate it because it doesn’t support what they believe. Yet at the same time they very much crave the imprimatur that science provides. When science tells them they are wrong, they therefore often try to attack the scientific method itself or claim that they are the true scientists. We see this behavior not just in quackery but any time scientific findings collide with entrenched belief systems, for example, medicine, evolution, anthropogenic global warming, and many others. So it was not surprising that a rant I saw a few weeks ago by a well-known supporter of pseudoscience who blogs under the pseudonym of Vox Day caught my interest. Basically, he saw a news report about an article in Nature condemning the quality of current preclinical research. From it, he draws exactly the wrong conclusions about what this article means for medical science:

Fascinating. That’s an 88.6 percent unreliability rate for landmark, gold-standard science. Imagine how bad it is in the stuff that is only peer-reviewed and isn’t even theoretically replicable, like evolutionary biology. Keep that figure in mind the next time some secularist is claiming that we should structure society around scientific technocracy; they are arguing for the foundation of society upon something that has a reliability rate of 11 percent.

Now, I’ve noted previously that atheists often attempt to compare ideal science with real theology and noted that in a fair comparison, ideal theology trumps ideal science. But as we gather more evidence about the true reliability of science, it is becoming increasingly obvious that real theology also trumps real science. The selling point of science is supposed to be its replicability… so what is the value of science that cannot be repeated?

No, a problem with science as it is carried out by scientists in the real world doesn’t mean that religion is true or that a crank like Vox is somehow the “real” intellectual defender of science. Later, Vox doubles down on his misunderstanding by trying to argue that the problem in this article means that science is not, in fact, “self-correcting.” This is, of course, nonsense in that the very article Vox is touting is an example of science trying to correct itself. Be that at it may, none of this is surprising, given that Vox has demonstrated considerable crank magnetism, being antivaccine, anti-evolution, an anthropogenic global warming denialist, and just in general anti-science, but he’s not alone. Quackery supporters of all stripes are jumping on the bandwagon to imply that this study somehow “proves” that the scientific basis of medicine is invalid. A writer at Mike Adams’ wretched hive of scum and quackery, NaturalNews.com, crows:

Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid.

But does this study show this? I must admit that it was a topic of conversation at the recent AACR meeting, given that the article was published shortly before the meeting. It’s also been a topic of e-mail conversations and debates at my very own institution. But do the findings reported in this article mean that the scientific basis of cancer treatment is so off-base that quackery of the sort championed by Mike Adams is a viable alternative or that science-based medicine is irrevocably broken?

Not so fast there, pardner…
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Posted in: Basic Science, Cancer, Clinical Trials

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Cancer care in the U.S. versus Europe: Is more necessarily better?

The U.S. is widely known to have the highest health care expenditures per capita in the world, and not just by a little, but by a lot. I’m not going to go into the reasons for this so much, other than to point out that how to rein in these costs has long been a flashpoint for debate. Indeed, most of the resistance to the Patient Protection and Affordable Care Act (PPACA), otherwise known in popular parlance as “Obamacare,” has been fueled by two things: (1) resistance to the mandate that everyone has to buy health insurance, and (2) the parts of the law designed to control the rise in health care costs. This later aspect of the PPACA has inspired cries of “Rationing!” and “Death panels!” Whenever science-based recommendations are made that suggest ways to decrease costs by reevaluating screening tests or decreasing various tests and interventions in situations where their use is not supported by scientific and clinical evidence, whether by the government or professional societies, you can count on it not being long before these cries go up, often from doctors themselves.

My perspective on this issue is that we already “ration” care. It’s just that government-controlled single payer plans and hybrid private-public universal health care plans use different criteria to ration care than our current system does. In the case of government-run health care systems, what will and will not be reimbursed is generally chosen based on evidence, politics, and cost, while in a system like the U.S. system what will and will not be reimbursed tends to be decided by insurance companies based on evidence leavened heavily with business considerations that involve appealing to the largest number of employers (who, let’s face it, are the primary customers of health insurance companies, not individuals insured by their health insurance plans). So what the debate is really about is, when boiled down to its essence, how to ration care and by how much, not whether care will be rationed. Ideally, how funding allocations are decided would be based on the best scientific evidence in a transparent fashion.

The study I’m about to discuss is anything but the best scientific evidence.
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Posted in: Cancer, Diagnostic tests & procedures, Politics and Regulation, Science and the Media

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Why haven’t we cured cancer yet? (Revisited): Personalized medicine versus evolution

About a year ago, I addressed what might seem to the average reader to be a very simple question: Why haven’t we cured cancer yet? As I pointed out at the time, it’s a question that I sometimes even ask myself, particularly given that cancer has touched my life. Three years ago, my mother-in-law died of a particularly nasty form of breast cancer. Even though I am a breast cancer surgeon, I still wonder why there was nothing that could save her (and there still is nothing that could have saved her, if it existed then) from a decline over several months followed by an unpleasant death. Yet, as a cancer researcher, I do understand somewhat. A couple of years ago, I wrote in depth about the complexity of cancer from a science-based viewpoint, as compared, of course, to the incredibly simplistic view that many purveyors of alternative medicine quackery promote as being The One True Cause of Cancer. As I put it at the time, shamelessly stealing from Douglas Adams: Cancer is complicated. You just won’t believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think algebra is complicated, but that’s just peanuts to cancer.

I saw more evidence of that at the American Association for Cancer Research meeting last week. In fact, if there’s anything I’ve learned, it’s that developing personalized therapy for cancer is going to be a hell of a lot more difficult than we had ever suspected. Actually, it wasn’t just the AACR meeting that taught me this, but it’s as good a pretext as any to discuss some cool new science. I only wish it was science that pointed an obvious path forward to the development of personalized therapy. On the other hand, if it were easy then anyone could do the “personalized therapy for dummies” approach that, for example, Stanislaw Burzynski takes. Then there’s the even more ridiculously simplistic approach that certain practitioners of “complementary and alternative medicine” (CAM) take.

So why haven’t we cured cancer yet? Again? One reason that I discussed last time I covered this topic concerns a study that used the latest next generation sequencing (NGS) techniques to sequence seven aggressive and advanced prostate cancers. I described the results as these genomes looking like someone threw a miniature grenade into the nucleus of a prostate epithelial cell. In other words, these are some really messed up genomes. (I wanted to use another word to describe it, but this is a family blog—sort of, anyway.) I used this example to explain once again that cancer is not a single disease. It’s hundreds of diseases. Although there are common themes in how cells become cancerous, such as loss of responsiveness to growth signals with a resultant ability to grow unchecked, evasion of programmed cell death (apoptosis), inducing the surrounding tissue to provide a blood supply (angiogenesis), evading the immune system, and invading the blood or lymphatic systems to travel elsewhere in the body and take up shop in other organs, such as liver, lung, or bone, individual cancers acquire these necessary (to the cancer) abilities through many different mechanisms. For this reason, it’s completely ridiculous to speak of a “cure for cancer.”

It’s also the reason I expressed skepticism when Steve Novella discussed a potential universal anti-cancer drug. Ditto when the press breathlessly reports studies suggesting a “universal cancer vaccine.” While these sorts of research findings are promising, they need to be put into perspective. We’ve seen their like many times before, and various cancers are still deadly diseases. In fact, my career intersected with this sort of hype back in the 1990s, when I studied combining angiogenesis inhibitors with radiation therapy in experimental models of cancer in mice. For a period of time in the late 1990s, I lived the hype. Then reality, as it always does, brought us all down to earth. Now, 15 years later, we know that angiogenesis inhibitors, although useful, are not any sort of “magic bullet” cure for all solid tumors. Like many advances before, they have now taken their place in the armamentarium of anticancer drugs, more important than some but not as important as others.

It’s even more complicated than that.

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Posted in: Basic Science, Cancer, Evolution

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Autism prevalence: Now estimated to be one in 88, and the antivaccine movement goes wild

Editor’s Note: Some of you might have seen this before, but it’s an important (and timely) enough topic that I figure it’s worth exposing to a different audience. It’s been updated and edited to style for SBM. Enjoy.

If there’s one thing that I’ve learned that I can always—and I do mean always—rely on from the antivaccine movement, it’s that its members will always be all over any new study regarding vaccines and/or autism in an effort to preemptively put their pseudoscientific spin on the results. It’s much the same way that they frequently storm into discussion threads after stories and posts about vaccines and autism like the proverbial flying monkeys, dropping their antivaccine poo hither and yon all over science-based discussions.

In any case, antivaxers are also known for not respecting embargoes. They infiltrate their way into mailing lists for journalists in which newsworthy new studies are released to the press before they actually see print and then flood their propaganda websites with their spin on the studies, either attacking the ones they don’t like or trying to imprint their interpretation on ones on which they can, all before the skeptical blogosophere—or even the mainstream press—has a chance to report. So it was late last week, when vaccine-autism cranks jumped the embargo on a CDC study that announced new autism prevalence numbers. This is nothing new; it’s the antivaccine movement’s modus operandi, which makes me wonder why the various journals don’t shut off the flow. The study, of course, was announced in press conferences and a number of news stories. No doubt by now many of you have seen them. The stories I’ve seen thus far have focused on the key finding of the CDC study, which is that the prevalence of autism in the U.S. has risen to approximately 1 in 88, a finding reported in the CDC’s Morbidity and Mortality Weekly Report.

This is how the CDC came up with the new prevalence:
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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California Bill AB 2109: The Antivaccine Movement Attacks School Vaccine Mandates Again

Of all the preventative treatments ever developed through science- and evidence-based medicine, vaccines have arguably saved more lives, prevented more illness and disability, and in general alleviated more suffering than any single class of treatments or preventative measures throughout history. Given the obvious and incredible success of vaccines at decreasing the incidence of infectious diseases that used to ravage populations, it seems incredible that there would be such a thing as an antivaccine movement, but there is. Indeed, when I first encountered antivaccine zealots on the Usenet newsgroup misc.health.alternative about ten or twelve years ago, as a physician I really had a hard time wrapping my head around the fact that such people existed. No doubt the same is true of many physicians, who take the scientific evidence for the safety and efficacy for vaccines for granted. However, I am a cancer surgeon, and I do not treat children; so until I discovered antivaccine rhetoric on the Internet I was blissfully ignorant that such views even existed. Other health care professionals knew better. Pediatricians, nurses, and any health care professionals who deal with children and the issue of vaccinations know better, because they face antivaccine views on a daily basis. It is because of the incredible importance of vaccination and the danger to public health the antivaccine movement represents that we at Science-Based Medicine write so frequently about vaccines and the antiscientific, pseudoscientific, and misinformation-packed fear mongering about vaccines that is so prevalent today.

The success of vaccination campaigns has recently been endangered by a number of factors, in particular the antivaccine movement. Because of various groups opposed to vaccination, either for philosophical reasons or because they incorrectly believe that vaccines cause autism, neurodevelopmental disorders, sudden infant death syndrome, and autoimmune diseases, among others, one of the most potent tools for encouraging high rates of vaccine uptake, school vaccine mandates, have come under attack. Alternatively, increasing numbers of parents have taken advantage of religious or philosophical exemptions in order to avoid the requirement to have their children vaccinated prior to entry to school. As a result, of late some states with lax vaccination requirements have begun to try to tighten up requirement for non-medical vaccine exemptions. The arguments used by the antivaccine movement against such legislation are highly revealing about their mindset, in particular their attitude towards issues of informed consent, which I will discuss a bit. But first, here’s a little background.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Keeping the customer satisfied

One thing about blogging once a week or so compared to my other blogging gig, which is usually close to every day, occasionally more often, is that I really can’t cover everything I want to cover for this blog. Even more so than at my not-so-super-secret other blogging gig, I have to pass on topics that could be fodder for what could be excellent to even awesome posts—or, self-congratulating hyperbole aside, at least reasonably interesting to the readers of this blog. When that happens, I can only hope that one of my co-bloggers picks up on it and gives the subject matter the treatment it cries out for. Or, sometimes, such subject matter just has to be dealth with elsewhere by me—or not at all. Even a hypercaffeinated blogger like myself has limits.

Sometimes, however, I actually get a second chance. In other words, I get a chance to revisit a topic that I passed by. Usually, this happens when something new happens that gives me an excuse to revisit the topic. So it was last of week, when I was perusing the New York Times by an oncology nurse named Theresa Brown. Her article was titled, appropriately enough, Hospitals Aren’t Hotels. It will become very apparent very quickly why in a moment. But first, let’s sample Brown’s article a bit, because it brings up an issue that is very pertinent to science-based medicine:
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Posted in: Clinical Trials, Diagnostic tests & procedures, Epidemiology

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An antivaccine tale of two legal actions

I don’t know what it is about the beginning of a year. I don’t know if it’s confirmation bias or real, but it sure seems that something big happens early every year in the antivaccine world. Consider. As I pointed out back in February 2009, in rapid succession Brian Deer reported that Andrew Wakefield had not only had undisclosed conflicts of interest regarding the research that he did for his now infamous 1998 Lancet paper but that he had falsified data. Then, a couple of weeks later the Special Masters weighed in, rejecting the claims of autism causation by vaccines made in three test cases about as resoundingly as is imaginable. Then, in February 2010, in rapid succession Andrew Wakefield, the hero of the antivaccine movement, was struck off the British medical register, saw his 1998 Lancet paper retracted by the editors, and was unceremoniously booted from his medical directorship of Thoughtful House, the autism quack clinic he helped to found after he fled the U.K. for the more friendly confines of Texas. Soon after that, the Special Masters weighed in again, rejecting the claims of autism causation by vaccines in the remaining test cases. Then, in January 2011, Brian Deer struck again, publishing more damaging revelations about Wakefield, referring to his work as Piltdown medicine in the British journal BMJ.

This year, things were different.
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Posted in: Politics and Regulation, Science and the Media, Vaccines

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Help a reader out: Abstracts that misrepresent the content of the paper

Earlier this week, a reader of ours wrote to Steve and me with a request:

First off, I just want to say thank you for everything you gentlemen do. I find that your sites are extremely helpful when trying to figure out what level of information is BS, and what is real.

In short, I was wondering if either of you two would be able to refer me to a scientific or psuedo-scientific article where the abstract completely misrepresents the article or the conclusion doesn’t fit the analysis/data. The reason is that I’m writing is that I’m currently in my third year at [REDACTED], and currently I’m working on my seminar paper so I can graduate. I decided to look at whether there is a reasonable fair use argument in the reproduction of an entire scientific article and at what instances prior precedent would allow it. Inherent in the argument is that a scientific paper can’t be properly excerpted without losing vital information (or that an abstract does not adequately describe the entire paper), so complete reproduction of the article is necessary to properly convey the point.

Sincerely,

A Reader

So…at the risk of being too blatant, I’ll just say that our readers are very informed and scientifically knowledgeable (excepting the odd troll, of course). Can you help another reader out and provide references that fit this reader’s request? I can think of one, but I don’t think it’s as blatant as what he has in mind. Please list your references below. Heck, we might even be able to get a post for SBM out of this if there are some interesting papers that fit the description above.

Posted in: Basic Science, Medical Academia

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A surprising article about “integrative” medicine in The New England Journal of Medicine vs. “patient-centered” care

The New England Journal of Medicine (NEJM) is published on Thursdays. I mention this because this is one of the rare times where my owning Mondays on this blog tends to be a rather large advantage. Fridays are rotated between two or three different bloggers, and, as awesome as they are as writers, bloggers, and friends, they don’t possess the rabbit-like speed (and attention span) that I do that would allow me to see an article published in the NEJM on Thursday and get a post written about it by early Friday morning. This is, of course, a skill I have honed in my not-so-super-secret other blogging identity ; so if I owned the Friday slot I could pull it off. However, the Monday slot is good enough because I’ll almost always have first crack at juicy studies and articles published in the NEJM before my fellow SBM partners in crime, unless Steve Novella managed to crank something out for his own personal blog on Friday, curse him.

My desire to be the firstest with the mostest when it comes to blogging about new articles notwithstanding, as I perused the table of contents of the NEJM this week, I was shocked to see an article that made me wonder whether the editors at NEJM might just be starting to “get it”—just a little bit—regarding “integrative” medicine. As our very own Mark Crislip put it a little more than a week ago:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

Lately, though, I’ve been more fond of a version that doesn’t use fancy words like “instantiate”:

If you integrate fantasy with reality, you don’t make the fantasy more real. You temporarily make your reality seem more fantasy-based, but reality always wins out in the end.

The part about the cow pie needs no change, although I think ice cream works a bit better than apple pie. Your mileage may vary. Feel free to make up your own metaphor inspired by Mark’s.

In any case, in the Perspective section, I saw three articles about “patient-centered” care:
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Posted in: Cancer, Diagnostic tests & procedures, Medical Academia, Medical Ethics

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Dr. Oz revisited

We here at SBM have been very critical of Dr. Mehmet Oz, who through his relentless self-promotion (and with more than a little help from his patron Oprah Winfrey) has somehow become known as “America’s doctor.” Back in the early days, when he was the regular medical expert on The Oprah Winfrey Show, Dr. Oz was at least tolerable. Much of what he discussed was reasonably science-based and even sensible, mainly advice to eat better and get more exercise, which is what most primary care doctors tell their patients every day. True, he did “integrate” some non-evidence-based therapies in with the evidence-based therapies, which was not good given how a typical viewer wouldn’t be able to tell where the science-based advice ended and the magical thinking began, but for the most part, even on Oprah’s show, he kept his woo somewhat in check. At least, there were boundaries beyond which he wouldn’t pass, even though Dr. Oz’s wife is a reiki master and he has been a fan of reiki (gaining fame for inviting reiki masters into his operating room during cardiac surgery) since at least the 1990s. More recently, Dr. Oz has testified in front of NCCAM patron Senator Tom Harkin’s committee to promote “complementary and alternative medicine” (CAM) or, as its advocates like to call it now, “integrative medicine.” He’s also been the Medical Director for the Integrative Medicine Program at New York-Presbyterian Hospital/Columbia University Medical Center since 2001. (How he does his TV show, holds a job as a professor of surgery at Columbia University, and holds positions as Clinical Trials of New Surgical Technology, Attending Surgeon, and Director, Clinical Perfusion Services at the same hospital, I’ll never know. He must have the most understanding partners ever.)

Be that as it may, even after Dr. Oz landed The Doctor Oz Show, for the first half of his first season he kept it fairly straight and science-based. However, two years ago the mask began to slip when Dr. Oz first aired a credulous feature about reiki under the title Dr. Oz’s Ultimate Alternative Medicine Secrets. Not long after that, Dr. Oz featured a man who is in my opinion arguably the foremost promoter of quackery on the Internet, Dr. Joe Mercola, along with the master of quantum quackery, Dr. Deepak Chopra. It was at that point that one could rightly say that Dr. Oz had “crossed the Woobicon.” Since then, it’s been one thing after another, beginning in earnest about a year ago. For instance, in January 2011, Dr. Oz featured Dr. Mercola again in a completely credulous portrait that painted him a “brave maverick doctor,” only without a hint of irony. A couple of weeks later, he featured a yogi who advocated “detoxing” and a faith healer from my old stomping grounds in Cleveland. Then, just when I thought Oz couldn’t go any lower, he featured psychic scammer John Edward.

Finally, back in April 2011, Dr. Oz’s producers apparently figured out that there was a problem with Dr. Oz’s image, except that they saw it as an opportunity to gin up a little controversy on the show. They invited our very own Dr. Steve Novella on the show as the “skeptic” who criticizes Dr. Oz. I very much admire Steve for going into the lion’s den, where, he knew in advance, he would be the underdog and the audience would be against him. Steve acquitted himself well, and after his appearance, I have to admit, I pretty much stopped paying attention to Dr. Oz for several months. He basically faded into the background of quackery, a prominent voice “integrating” quackery with medicine, pseudoscience with science, in the apparent belief that mixing fantasy with reality somehow improves medicine. Personally, I prefer Mark Crislip’s take and will steal his statement about “integrative medicine”:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

I just learned last week that Dr. Oz, while trying to make the cow pie taste better, is only continuing to succeed in making the apple pie taste worse. Witness an episode from last week featuring a long segment entitled Dr. Mercola’s Most Radical Alternative Cures, or, as the banner on the segment calls it, “Radical Cures Your Doctor Thinks Are Crazy.” Not surprisingly, Dr. Mercola has been bragging about his fourth appearance on Dr. Oz’s show yet again. (Video: Part 1 and Part 2).
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Posted in: Cancer, Energy Medicine, Science and the Media

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