BIG PHARMA? BIG DEAL…

Those of us who trust scientific methods to evaluate medical treatments are frequently faced with challenges that take the form of the “argumentum ad big pharma”, which claims that since the pharmaceutical industry funded a given study it cannot be trusted.

Some dismiss this immediately as a fallacy, a form of argumentum ad hominem, that is, the argument is invalid because it disqualifies the source, and not the proposition itself.

Not so fast; this critique applies when propositions have a standing on their own. If, using a comic book reference, the Joker said that 2 + 2 equals 4, the fact that the Joker said it shouldn’t come into consideration, the discussion should be exclusively whether 2 + 2 indeed equals 4.

But there are situations when the source is relevant, and the proposition cannot be evaluated without it, or at least it has to be weighed against the trustworthiness of the source. If someone says that she witnessed a given happening, whether one accepts or not that proposition as true depends on how much the person saying it can be trusted.

Additionally, we live in a complex society, with many different specialized forms of expertise being called into action for all kinds of purposes, and no matter how well educated, trained or informed one is, there are many more areas in which we are incompetent than not. A Nobel winner in chemistry can be a complete ignoramus in matters of plumbing, for instance, and thus will have to rely on a trusted expert when fixing a leak in her house.

When it comes to the scientific evaluation of medical treatments, those are available in articles published in biomedical journals. Although anyone can read what is in there (in terms; although there are many good open access journals, unfortunately for a large number of the main publications one still has to pay dearly for getting access to them if they are not lucky enough to be an institution that is capable to provide for this, but that’s yet another problem), actually being able to criticize what is being presented requires a level of expertise that usually involves a lot of time and dedication, something that will not be achieved by a few minutes of internet searching. And here lies the rub; the whole scientific publishing enterprise relies on assumptions of trust, and unfortunately we have had evidence in many occasions of manipulations of drug assessments, for instance, due to commercial reasons.

Acknowledging that this might constitute a problem, the International Committee of Medical Journal Editors instituted a long time ago standard policies requiring that any potential conflict of interest should be declared by authors and made public by journals. Unfortunately what was conceived as a means to curb excesses ended up normalizing them (Chalmers I. From optimism to disillusion about commitment to transparency in the medico-industrial complex. J R Soc Med. 2006;99(7):337-41. DOI:10.1258/jrsm.99.7.337). Numerous authors have been documenting the contemptible practices of some companies in the health sector which distort the procedures of science in order to promote their products (McGarity, T. D., & Wagner, W. E. Bending science: How special interests corrupt public health research. Cambridge, Mass. & London, UK: Harvard University Press, 2010), and the pharmaceutical industry is no exception (see for instance Goldacre B. Bad pharma: how drug companies mislead doctors and harm patients. New York: HarperCollins, 2012), in fact, a study based on a narrative review of internal documents of a specific company uncovered in the course of a legal process concluded that “Research, publications, and educational programs (including ‘independent’ events) were used as marketing opportunities, augmented by opinion leaders and local physician champions to engage their physician colleagues. Since the promotional intent of these activities may not have been widely recognized, their impact on physicians was probably greater than interactions with known commercial intent, which are typically approached with greater skepticism.” (Steinman MA et al. Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents. Annals of Internal Medicine 2006;145(4):284-93. DOI: 10.7326/0003-4819-145-4-200608150-00008).

As another, more serious example, there has been much hay made about the deplorable rofecoxib fiasco. There is no room here to go through the whole thing, but basically a new anti-inflammatory drug was found to increase the risk of cardiovascular mortality and there are signs that the clinical research had shown that, but these results were suppressed (Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. Jama. 2008 Apr 16;299(15):1813-7; more information on that here: The danger of drugs … and data).

Although this is something that should never have happened and point out to serious flaws in the current regulatory model for registering new drugs, the moral of the story is that it was further research that uncovered the problem.

Does this mean that the “argumentum ad big pharma” is correct? No. Although the pharmaceutic industry may be an uncomfortable ally at times, the benefits of modern pharmacotherapy (and science-based medicine in general) cannot be overstated. Just consider the case of aids; thanks to an unprecedented effort, in a relatively short time we managed to identify a causal agent, develop increasingly sophisticated and accurate means of identifying its presence and, finally, whole new families of drugs that transformed the panorama of the fight against the disease.

So, are there problems in the system? Undoubtedly so. But those derive from malice, not inherent flaws in the research methodology, and the scientific enterprise does have this kind of self-correcting mechanism that gives us reason to trust it. The solution is more, not less, science; just as an example, provided by the same Goldacre cited before (see Funnel Vision), a relatively simple device, called a funnel plot, can evidence the practice of hiding bad results.

As two sociologists of science put it, “Science may be wrong (…) but this does not make the opposite view right. In the absence of careful research about the opposite view, science is probably the way to bet. This is even more likely to be the case if science is continually put under scrutiny.” (Colins H & Pinch T. Dr. Golem: How To Think About Medicine. Chicago:The University of Chicago Press, 2005).

And, last but not least, it should be pointed out that conflicting interests due to commercial interference are not a privilege of any specific sector of the health care industry at large. This is not about a fight pitching crooked physicians and a corrupt industry versus pure disinterested individuals; just to give an example, the NIH estimates that “The $14.8 billion spent on nonvitamin, nonmineral, natural products is equivalent to approximately one-third of total out-of-pocket spending on prescription drugs ($47.6 billion)”. In other words, big money is being made in “alternative ways”; pot, kettle, black. Which is not to say that there are not well-meant people on both sides of this divide. The problem is that meaning well is not enough to take responsibility to care for other people’s lives.

Shoah

Berlin Holocaust memorial, January 27th 2017, Holocaust Remembrance Day.

As I stand at the edge of the monument, I am deeply touched by its somber austerity. My eye is caught by a solitary rose standing on one of the concrete prisms. I walk towards it and take some pictures. An elder man sees that, approaches me and says: "I put that rose there. I would appreciate if you could send me the photo". He hands me a handmade business card with his address, phone and email. Richard Lehmann. I try to say something, but tears start to well up, and I barely blurt out the words "thank you".
I sent him the photo, finished the message with "peace". He thanked me for the tears and the word.

We must remember.

EPIGENETICS

Scientific advances can be at the same time interesting and incomprehensible for those who do not have the necessary knowledge basis to understand what the fuss is all about. And given the extraordinary complexity of current scientific knowledge, everyone – even scientists themselves – is bound to be ignorant in many more subjects than they are experts on.

Scientific journalism is not always capable of keeping up the pace with everything that goes on in the many areas of advanced research, especially in the current climate, in which media companies are undergoing a major crisis. And specialized journalists in science are probably more expensive than the bean counters are willing to pay.

So it is not uncommon to have important scientific hallmarks to be announced in newspapers and TV newscasts in a way that generates much more confusion that understanding – just consider recent examples, such as the brouhaha about the Higgs boson, unfortunately nicknamed “the god particle”.

On top of that, scientific lingo is often appropriated by all kinds of quacks and cranks to lend credibility to their particular brand of insanity, and more often than not as part of a sales pitch. Just consider how much abuse poor quantum mechanics has suffered in the last decades, being invoked to “explain” everything, from homeopathy to the “soul”…

As in many SciFi TV shows, a patchwork of sciencey sounding words are strung together to create an impression of highly sophisticated science – with the difference that TVs technobabble is harmless. Mostly, anyway.

And now to the case in point: epigenetics. There are many interesting things in that field that contribute to a better understanding of biological processes. But it certainly does not mean that memories are transmitted generationally or anything remotely like that. And, inevitably, it is being hijacked by the usual suspects to support their brand of woo.

One of my favourite references on the internet, PZ Myers’ blog Pharyngula, has featured many posts on the subject, including the takedown of one of the most egregious offenders, Deepak Chopra. As can be seen below, he even “prophesized” this was going to happen. I encourage anyone interested in the subject to read all the posts I link to below. Just to give a taste of each post, I copied a small quote from each of them. I hope you enjoy reading them.

Epigenetics

“Epigenetics is the study of heritable traits that are not dependent on the primary sequence of DNA. That’s a short, simple definition, and it’s also largely unsatisfactory. For one, the inclusion of the word ‘heritable’ excludes some significant players — the differentiation of neurons requires major epigenetic shaping, but these cells have undergone a terminal division and will never divide again — but at the same time, the heritability of traits that aren’t defined by the primary sequence is probably the first thing that comes to mind in any discussion of epigenetics. Another problem is the vague, open-endedness of the definition: it basically includes everything. Gene regulation, physiological adaptation, disease responses…they all fall into the catch-all of epigenetics.”

The magical world of epigenetics

“Let me tell you the hard part about writing about epigenetics: most of your audience has no idea what you’re talking about, but is pretty sure that they can use it, whatever it is, to justify every bit of folk wisdom/nonsensical assumption that they have. So while you’re explaining how it’s a very real and important biological process that is essential for development and learning and behavior, half your readers are using the biology to confirm their biases about evolution and inheritance, and the other half already know all the basic stuff and want to get to the Evisceration of the Wrong, which is always the fun part anyway.”

The sure-fire, simple way to tell if an article about epigenetics is full of crap

“It’s easy. If it uses the word ‘Lamarckian’ without boldly prefixing it with ‘not’, you can just stop reading. Likewise if the word is prefixed with ‘pseudo-’, ‘semi-’, or ‘quasi-’. Just skip it. It’s too confused to bother with.”

Take the epigenome, please

“The thing to watch out for next is revealed at about 4:00 in the video, where he talks about using diet and behavior to give yourself a “healthy epigenome”, whatever that is. I’m sure some unscrupulous, dishonest someone, somewhere is writing a diet book about super-foods to super-charge your epigenome for you and your baby. I’m calling it. There are already plenty of pseudoscientific books that mangle the concept of epigenetics. I’m sure the ones that will turn it into a marketing fad are coming up soon. We’ve already got a lot of books touting the microbiome as the cure-all for everything — I can easily imagine the fusion of the epigenome and microbiome hype machines popping up on Amazon.”

But of course @DeepakChopra is incorporating epigenetics into his quackery

“No, ma’am, you can’t make a cancer disappear by consciously modifying your epigenome. The proper approach is to go to a real doctor or two, not Chopra, and listen to their recommendations. Cancers are not acts of will, punishments for sins, or subject to thoughtful consideration. But Deepak Chopra has made a lot of money by implying that they are, and drawing in desperate, sick people who will grab onto any glimmer of hope, no matter how false.”

Evolutionary Psychology, yet again

Georges Canguilhem proposed the concept of scientific ideology for certain types of discourse that seem to mimic the trappings of proper science but are, in his words, "hyperbolic with regard to its objects", that is, make unwarranted claims that are not reasonably supported by any scientifically sound procedure.

I am always reminded of this when I read certain claims of the "evolutionary psychologists". In the last few months I collected a number of posts by an evolutionary biologist and a psychologist that tear down the enterprise on the two fronts. The EP folks do provide easy targets a lot of time, though, see the last link below for an example.

That the brain we possess is a result of evolution is, at this point, an indisputable assertion. That we have plenty of examples of innate, inherited behaviour, in many species is also quite unproblematic. That some aspects of human behaviour are probably at least partly inherited is at least quite likely. When specific characteristics of human interactions are attributed to evolutionarily selected, inherited genetic stuff, though, things start to get a little frisky. Little or no support from the neurosciences is offered, and all the work done by cultural anthropologists is practically ignored. It has been said that the "natural human state" described by EP is strikingly similar to American middle class mores of the 1950s…

Anyway, just check what I found:

Critique of Evolutionary Psychology

“Yet it is argued here that evolutionary psychology’s assumptions regarding the mind are often inconsistent with the neurobiological evidence; biological constraints may place limits on the kinds of hypotheses that can be made within a theoretical framework that wants to remain true to the known properties and functions of the human nervous system. Evolutionary psychology’s assumptions regarding our innate biology also shape their treatment of culture and learning in ways that may inaccurately reflect true experience–neurodevelopmental interactions.”

Evolutionary Psychology and its Defenders

“Readers of this blog know my thoughts on evolutionary psychology. Quite frankly, I am getting tired of writing about it. However I think this theory of psychology is important to challenge, so I feel some responsibility to stay involved in the discussions. Aside from Rebecca’s sarcastic tone and her choosing some of the most laughable examples from recent evolutionary psychology research, I see little wrong with her talk. There are no serious errors in her logic, and this more entertaining approach is probably just the kind of discussion that needs to be had for laypersons to begin to understand some of the problems with evolutionary psychology.”

Evolutionary Psychology Is Neither

“And finally, I can’t shake the feeling that the methodologies I have encountered in evolutionary psychology would not meet the standards of any other science. For a notable example, it is apparently a revelation to evolutionary psychology that one cannot readily generalize about the human condition from a sample of humans that is Western, Educated, Industrialized, Rich, and Democratic. Perhaps this was news in psychology – creationist, evolutionary, or otherwise – but, sad to say, everybody else who works with cultural diversity knew that a really long time ago.”

I think I evolved and am hardwired to bang my head against the wall when I read this stuff

“Did you know that women might have been driven by evolution to be ‘bitchy’, that is, aggressive, competitive, and insulting towards other women? An article in The Atlantic presents a couple of evo-psych studies — the usual stuff, Western college students given culturally specific choices, and then makes absurd universal conclusions about human nature and evolution. I hated it.”

Panadaptationism strikes again!

“I suppose it’s typical that male traits are explained by their likelihood of holding a weapon, and female traits by baby handling, but again, it makes no sense. I’ve held babies, and I recall holding them on whatever side was convenient at the time. The tricky part to holding a baby or a spear and unbuttoning your shirt is the unbuttoning bit — that requires a bit more dexterity than holding a bulky objects. So both men and women face the problem of unbuttoning while holding an object, and they get completely reversed solutions to the problem?”

Who’s Afraid Of Science Studies?

A very interesting article was published recently on the New England Journal of Medicine, with a historical view of the development and importance of randomized clinical trials in medicine: Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard — Lessons from the History of RCTs. N Engl J Med 2016; 374:2175-2181 DOI: 10.1056/NEJMms1604593

The abstract: “Over the past 70 years, randomized, controlled trials (RCTs) have reshaped medical knowledge and practice. Popularized by mid-20th-century clinical researchers and statisticians aiming to reduce bias and enhance the accuracy of clinical experimentation, RCTs have often functioned well in that role. Yet the past seven decades also bear witness to many limitations of this new ‘gold standard.’ The scientific and political history of RCTs offers lessons regarding the complexity of medicine and disease and the economic and political forces that shape the production and circulation of medical knowledge.”

Three of the authors have medical degrees, I know one of them – Greene – who is a young, brilliant historian of medicine (his book Prescribing by Numbers made me rethink my own considerations on the definition of disease in contemporary medicine), who cannot therefore be accused of ignoring the subject matter they write about. In effect, they produced a solid, scholarly review of the subject. The article seems to me as non-controversial as may be, considering past considerations from mainstream authors about the whole enterprise of conducting clinical trials, such as the proposal by Richard Smith, former editor of the BMJ, of an outright moratorium in publishing their results since they became, in his words, a mere marketing tool for the pharmaceutical industry (see Smith R. Medical journals are an extension of the marketing arm of pharmaceutical companies. PLoS Med. 2005;2(5):138. DOI:10.1371/journal. Pmed.0020138).

But this well-founded discussion was met with a conniption in some quarters. A blogger wrote a piece criticizing the NEJM for having published it (The NEJM and Clinical Trials: What’s Going On?), from which I would like to quote just a tiny bit: “That, to me, is the social science worldview in a nutshell – that everything, simply everything, is deeply entangled in social conditions, economics, and politics. Take an NMR spectrum? A political act. Weigh out some copper sulfate? Politics. I sometimes think that that’s my vision of Hell. (…) Behind some of this stuff is a worldview that holds that there isn’t such a thing as ‘knowledge’ at all, just power struggles and wishful thinking.”

This is in my opinion as willfuly ignorant as the blogger who stated that she wouldn’t eat anything she could not pronounce. The whole field of science studies is reduced to this ridiculous caricature by someone who clearly refuses to engage seriously with the discussion proposed by those who work in that area. Yes, science does have political and economical underpinnings, and failing to acknowledge that can lead to scientism and excessive medicalization. I really believed that the “Science Wars” of the nineties were over, but apparently not everyone got the memo.

The issue here is not that there is no such a thing as “knowledge”, but that we have to examine what we call “knowledge”, how it is produced, how it circulates among different social groups and what are the consequences of its use. Redefining the threshold for a given clinical parameter, for instance – say, blood cholesterol – is not an act of “pure science” (if that even existed), it is a negotiated process, an idea that seems to give that blogger the heebiejeebies, but that was apparently supported, for instance, even by a relatively conservative author such as Karl Popper, who wrote that “scientific objectivity can be described as the inter-subjectivity of scientific method” (“The sociology of knowledge” in Stehr N, Grundmann R. (orgs) Knowledge: critical concepts. Volume V: Sociology of Knowledge and Science. New York: Routledge, 2005, p. 68).

And that redefinition has very concrete consequences, like almost tripling the number of candidates to be treated with statins, something with obvious economic and political implications, which are present, even if implicitly, in the process of negotiating the “new normal”. At every corner multiple interests intersect in the path of the production of scientific “knowledge”, especially in Medicine, and ignoring this can be naively dangerous. Examples of how clinical trials have been manipulated over time abound, and even when they are done with the appropriate methodological concerns, they are not Revealed Truth, but a relevant guide for clinical action with important limitations. Acknowledging such limitations and the complex interactions that go into making science, on the other hand, does not mean denying that reliable “knowledge” that can be acted upon does not exist, but quite the contrary. Two exponents of the field that was simplistically panned by the author of that blog post, Harry Collins and Trevor Pinch, have a position that I subscribe wholeheartedly (I have been using this citation so much – with due credit, of course – that I fear one of this days they will ask me for copyrights…), expressed as follows: “Science may be wrong (…) but this does not make the opposite view right. In the absence of careful research about the opposite view, science is probably the way to bet. This is even more likely to be the case if science is continually put under scrutiny.” in Colins H & Pinch T. Dr. Golem: How To Think About Medicine. Chicago: The University of Chicago Press, 2005 (p. 202)

And while we are at it, what is “knowledge” anyway? Answering this is in itself a philosophical question of the type clearly despised by our colleague, but I’ll leave that for another day.

POST-SCRIPTUM: After having posted this, I recalled reading a post by PZ Myers that addressed a similar problem, and I found it: Emotionally invested in despising philosophy. He writes “Yet again, people are asking why are so many smart people such idiots about philosophy? I have a different answer than you’ll find at that link. It’s because so many smart people are idiots about psychology. I deal with a lot of atheists, and one of the many flaws in that group that have been coming to the fore lately is the obliviousness they have to their own motivations. Atheists are all about the scienceyness. Good people are rational, objective, and unemotional, which whether they are aware of it or not, is a value judgment built on emotion. There is a lot of self-esteem-building going on, centered around who is smarter than who, who can build the most logical argument, and who is best at being aloofly superior. It’s all very annoying.”

Very annoying, indeed.

“Health” Lunacy On The Internet

Few things piss me off as much as false “cures” or “treatments”, and the advent of the internet made things much worse. I gave some examples a few days ago (Cancer Quackery), but there is a never ending well of BS in the bowels of the network. A lot of this is related to a antiscience streak that underlies a lot of the misinformation that goes around (see another post, The Worrying Growth Of Antiscience Claims). I don’t see many people shopping around for “alternative airplane pilots” to fly them around or “alternative engineers” to design and supervise construction of their apartment, but that’s beside the point.

The proliferation of “detox” and “natural” remedies on the internet would be a laughing matter if it weren’t the very serious consequences they may bring about, either by being harmful, wasteful or simply delaying the beginning of proper care, and for more often than not making victims among the most vulnerable and/or desperate people. I’ll just give a few examples from some quasi-random stuff I came across.

First, the most unbelievable proposition about “cures” I’ve seen in recent times, the idea that industrial bleach is a panacea, especially for autism. Yes, you read it right: ‘Miracle cure’ exposed as bleach. More about it here: Autism: how unorthodox treatments can exploit the vulnerable. “As a rule of thumb, the more desperate and vulnerable you are the easier you are to exploit, with anything from financial advice to lifestyle tips. A diagnosis of an incurable disease; a child with a serious developmental disorder: these are circumstances that see many people seek unorthodox solutions, either as a way of coming to terms with what has happened, or in an attempt to find a treatment that perhaps the mainstream has not yet embraced, but which will give relief or cure. However, some alternative products and techniques are not merely controversial, they are potentially dangerous. Recently in mainland Ireland, a number of parents have been interviewed by police as part of an on-going investigation with the Health Products Regulatory Authority. These parents are thought to have administered a substance known as MMS to their autistic children. MMS has been known variously as Master Mineral Solution, Miracle Mineral Solution and Miracle Mineral Supplement.”

Another favourite is this staple of “natural treatments”, coffee enemas (!). There’s no good reason to squirt coffee up your ass. “Potential side-effects from squirting coffee up your asshole include: ‘electrolyte imbalance, sepsis, colon or rectal perforation, and proctocolitis due to the coffee itself, among others, up to and including death.’ Coffee will not ‘detox’ you because detoxing is bullshit. It wouldn’t matter, except quacks tell cancer patients and other people who are sick and need actual medicine, not coffee enemas, to squirt coffee up their assholes.”

This unfortunately applies to some mainstreamed forms of therapy that apparently either don’t know or don’t want to conduct an honest trial: New Study on Homeopathic Cough Syrup for Children Reveals a Lack of Effectiveness and Ethics. “In case you didn’t catch that, they concluded that the homeopathic cough syrup worked in the current study’s pediatric population because the subjects did as well as the adults in the ‘treatment’ arm of their prior study. The prior study, like the overwhelming majority of homeopathy research, was entirely consistent with the much more plausible conclusion that the minimal clinical effect was a mixture of placebo effects and statistical noise. All the subjects in both studies simply followed the expected course of cough symptoms caused by colds when no treatment is provided.”

This extends to all sorts of diets and concoctions, perfectly satirized by an actual dietitian: Broccoli is bad for you, like, really toxic bad. “The Internet proliferates with opinion pieces quick to vilify particular foods and nutrients as being ‘the cause’ of many of our health problems by over-cooking (see what I did there?) one side of the research evidence. To show you how this is done, I present for you today a masterclass on this art form. I’ll also give you some practical tips on how to spot when it is being done.”

Very dangerous “advice” is being dispensed on the internet, so caveat emptor. In closing, I feel the same way as the author of this post: Distilled nonsense. “Why are ‘health’ sites so full of shit? It’s getting to be the case that when I see ‘health’ (or worse, ‘wellness’) in the title of an article, I have the same aversive reaction I get when I see the word ‘family’. It’s a good word that has been hijacked by loons.”