Yuck

Clostridium dificile is a bacterium which is an opportunistic pathogen in humans. Specifically, it infects the intestines and causes severe diarrhea, which can be fatal but is always indescribably unpleasant. Much C. dificile is now antibiotic  resistant as well.

For the medical industry, additional bad news is that it is mostly iatrogenic. While community acquisition occurs, the most likely way to get C. dficile disease is to be in the hospital, wherein it lurks, and to receive a massive antibiotic bomb that wipes out our normal intestinal microbia. C. dificile then moves into the abandoned territory.

What to do? How about restore the intestinal microbia. How to do that? Well, don't think about it too hard. What you need is a shit enema. So that's what they are doing, and it works. Adding to the unpleasantness, if you have recurrent infection it works much better to use donor poop than your own, which obviously has not been up to the task. (You may only be able to read the first paragraph.)

I note this not to gross you out, particularly, but because it points as dramatically as possible to our evolving understanding of ourselves not simply as clonal colonies of eukaryotic cells derived from a single zygote, but as ecosystems including not just those, but also a much larger number of prokaryotic organisms. Our eukaryotic genome has co-evolved with the rest of the ecosystem such that it supports beneficial  symbionts that not only are essential to digesting our food but also protect us from unfriendly organisms and quite possibly do other stuff we don't yet understand.

That doesn't mean that the stuff you buy at the GNC that purports to be probiotic will actually do you any good. We're still just beginning to figure this out and  come up with evidence based interventions. But it will become a bigger deal in coming years, I hereby predict.

Have I ever mentioned that drug companies are evil?

They aren't really of course -- corporations aren't people nor are they moral agents. But human beings do act on their behalf. With price gouging by pharmaceutical manufacturers all of a sudden in the news (despite it has been going on forever), some of our friends from Hahvahd, aka World's Greatest University, explain some of the ins and outs of drug pricing wonkery (and wankery).

Some of the main points are:

• The U.S. grants long periods of monopoly over new drugs, and let's companies use various loopholes and fancy tricks to extend their monopolies.

• Even when they lose legal monopolies, they often have practical monopolies for various structural reasons in the industry. The simplest is that if you are in a competitive market for generic drugs, there isn't much profit there in many cases, so you don't get a lot of competition.

• Medicare is not allowed to negotiate drug prices, and drugs can't be imported, even though they're cheaper everywhere else in the world.

The companies claim they need to haul in the big bucks to pay for R&D, but that's a total crock. They conclude:

High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability; providing greater opportunities for meaningful price negotiation by governmental payers; generating more evidence about comparative cost-effectiveness of therapeutic alternatives; and more effectively educating patients, prescribers, payers, and policy makers about these choices.

The problem is, of course, that the companies own congress, so none of this is going to happen.

The Party of Ignorance

A United States senator says that there is no need for college professors, students can just watch documentaries. He specifically proposes watching the Ken Burns documentary instead of paying some egghead to teach Civil War history.

By the way, this clown has a college degree.

Burns is a Republican, He is not from the South, but I presume he must know that many of his colleagues and their constituents actually wouldn't like that proposal because they think the Civil War was actually the War of Northern Aggression and it was all about state's rights and the preservation of heritage and tradition. How do universities deal with these differences in point of view?

Unless they are Liberty or Bob Jones university, we expose people to basic facts, often in the form of a textbook; and to various interpretations and viewpoints on those facts through diverse reading assignments. We then encourage them to discuss and debate the issues, along the way teaching critical thinking skills and the technique and etiquette of adversarial dialogue. Then we ask them to express their own ideas and conclusions through written essays, which we evaluate and critique.

In other words, we don't just stuff them full of single viewpoints on complex issues. We develop the capacity to learn and think for oneself. A capacity sadly lacking in Ron Johnson.

The Chrono-Synclastic Infundibulum

Vonnegut fans will recognize the title of this post as a singularity in the space-time continuum where all possible opinions are true. That is perhaps not quite the same as saying that there are no facts. Peter Pomerantsev, in Granta, finds that we are living in a post-factual society, a development for which he blames a combination of mendacious politicians, Your Intertubes, and post-modern philosophers.

I don't think our situation is as yet quite that bad. In Putin's Russia, it probably is, but that's because he controls all of the mass media and can maintain a fact-free environment. Pomerantsev invokes the counterfactual, emotion-driven Brexit campaign, but as we know the Brits woke up from their dream the following morning to find themselves doused in the ice water of reality. Karl Rove mocked the Reality Based Community but ultimately, he discovered that he could not create the new realities of his imagination: the Weapons of Mass Destruction™ weren't there, and Iraq did not become a bourgeois republic allied with the West. Donald Trump's fans are impervious to facts but they will discover on November 9 that they are in the minority and their hero is a loser.

I do share Pomerantsev's contempt for post-modernism and it's bizarre claim that truth is the servant of power, that scientific claims are arbitrary, and that denial of intersubjective reality is liberating. And I am as frustrated as anyone by the power of confirmation bias and motivated reasoning, which has indeed been amplified by the instant availability of whatever congenial bullshit you are looking for at the click of a mouse.

Nevertheless, sitting here in a university, I know that we still have the tools to recognize truth and a large corps of people who live by them. We may go down the infundibulum soon, but not today. 

Fat Al told you so

With California burning  and Louisiana drowning, NASA informs us that we've just lived through the hottest month in recorded history. If you go to the last link, to Joe Romm's blog, you'll see a graphic that ought to terrify you.

What appears to be happening is a long-anticipated step up in global temperature -- with 2016 landing close to .2 degrees centigrade hotter than last year, which was already the all-time hottest year by a lot. The Middle East is literally becoming uninhabitable -- Baghdad has had temperatures above 109 Fahrenheit every day since June 19, and other places in the region are even hotter. In case you didn't know, the collapse of agriculture in Syria due to climate change was the main reason why Syrian society disintegrated, leading to the greatest humanitarian catastrophe since WWII.

One of the presidential candidates says this is not actually happening, it's a hoax perpetrated by the Chinese. The other one never mentions it. It is the single most important thing that is happening on earth.

Yep, they're still evil

That would be the drug companies. Boston University School of Public Health prof. Alan Sager (with whom I am acquainted) runs down their profiteering at society's expense. I would say, do read the whole thing because it takes him 11 pages to properly debunk all of the prevalent falsehoods about this. I'll just offer you this excerpt which reiterates stuff I keep saying here, which is that the mythological and non-existent "free market" bears absolutely no resemblance to the reality of pharmaceutical development, manufacture and selling:

Unfortunately, functioning free markets are simply unattainable in health care, and the drug sector is no exception. That’s because not one of the six requirements for a competitive free market is met, or can be met, in the realm of pharmaceuticals. A market of small buyers and sellers doesn’t make the price; drug makers with patents or market power are dominant. Price competition among generics, biosimilars, and me-too brand name drugs does little to cut U.S. drug spending. Sovereign consumers don’t make decisions; they rely on physicians who are often swayed by drug makers’ marketing or detailers. Entry of new competitors can be hard; drug makers merge with competitors or acquire them to reduce competition; big vertically-integrated drug makers often finance smaller ones or buy up their discoveries. Information is asymmetric; patients lack it and doctors and drug makers have lots of it. Subtly, but importantly, the price of drugs doesn’t remotely track the cost of production. And the injunction that buyers should beware and mistrustful carries little weight in the absence of good information about which drugs are needed or valuable.

There are actually additional reasons why the fictitious "free market" doesn't come near this reality, but those are probably enough for now. As Sager explains, it is the immense political power of the drug companies, along with our generally brainwashed population, that let's them keep ripping us off.

Sager is an advocate of single payer national health care, but given that isn't happening any time soon, he offers some interim measures. Not on Hillary's docket, however, at least not so far.

Down the Rabbit Hole

John Ioannidis is what I would call a science critic. I don't mean that he's anti-science. On the contrary. He's a science critic in the same sense that a movie critic or a literary critic likes movies or books, but has something to say about which ones are better than others, and how they are composed and achieve or fail to achieve their artistic objectives.

He joins colleagues in critiquing the Big Science initiatives of NIH, which has been directing more than half of its funding to genomic and stem cell research. Contrary to early expectations, it turns out that the relationship between the genome and specific diseases is far too complex to provide targets for prevention or treatment. Even when a specific genetic cause of a disease is known, as in sickle cell anemia, the knowledge doesn't necessarily translate into a therapeutic target.

Similarly (and relevant to the cancer "moon shot,") the extremely diverse mutations associated with cancer, and the adaptive nature of tumors (they evolve in response to selection pressure from treatments), mean that understanding the specific mutations associated with cancers is of limited value for treatment. Stem cells have also so far failed to yield any approved treatments.

The writers call for a redirection of NIH funding away from these "big ideas," and to more strictly evaluate proposals in these areas. The challenge is that right now, these fields are academically prestigious, and yield high impact publications, promotions and tenure, and awards. Furthermore, scientists get pigeonholed in their narrow programs of research, and proposal review committees generally don't like it when they try to step out in a new direction. So there are vested interests which are difficult to overcome.

I actually think that there is more to be gained by what they call translational science -- getting doctors to do what we already know is best for patients -- and investment in social determinants of health, than by the "blue sky" biomedical research Ioannidis and friends call for. Sure, we should do some of that, but we can save lives and improve the health of billions of people just by putting what we already know to work. But that isn't very glamorous.

Assault and battery for money

NYT's Gina Kolata tells you what all of us health services researchers already know far too well. Surgical procedures don't have to be approved by the FDA or anybody else, and even when they are proven to be useless, surgeons keep doing them. She leads with the most notorious example, spinal fusion.

In fact this goes way back. In the 1990s, what was then called the Agency for Health Care Policy and Research concluded that there was no evidence that spinal fusion was beneficial to patients. So, the spinal surgeons society persuaded the Republican congress to eliminate the agency entirely. Quoth:

AHCPR was also confronted in 1995 with an advocacy organization’s active efforts to get it defunded. The source was an association of back surgeons who disagreed with conclusions reached by the [agency] on low-back pain and with practice guidelines based on that work. . . .

The surgeons found sympathetic ears among House Republicans who, for reasons already discussed, were prepared to believe the worst about the agency. The events of 1995 followed many years of controversy over the merits of surgical procedures for low-back disorders. AHCPR entered this fray when its PORT on low-back pain reviewed the research and concluded that there was no evidence to support spinal fusion surgery and that such surgery commonly had complications.³⁰ The North American Spine Society (NASS) created an ad hoc committee, which attacked the literature review and the subsequent AHCPR practice guideline on acute care of low-back pain. In a letter published in 1994 in the journal Spine, the committee not only criticized the methods used in the literature review and expressed concern that the conclusions might be used by payers or regulators to limit the number and types of spinal fusion procedures, but it also charged that AHCPR had wasted taxpayer dollars on the study.³¹ An entity known as the Center for Patient Advocacy was formed by Neil Kahanovitz, a back surgeon from Arlington, Virginia, to lobby on the issue. It organized a letter-writing campaign to gain congressional support for its attack on AHCPR. Kahanovitz used personal contacts to gain the support of Representatives Bonilla, who had a staffer who was Kahanovitz’s patient; Johnson; Gerald Solomon (R-NY); and Joe Barton (R-TX). Solomon, Bonilla, and Johnson led the effort in the House to end the agency’s funding, energetically promulgating the NASS/Kahanovitz argument that it was supporting unsound research and wasting the taxpayers’ money.

The agency managed to survive, but it endured a 21% budget cut. (It's successor is now known as the Agency for Healthcare Research and Quality.)

Here we are, 20 years later, and surgeons are still doing this procedure, even though, as Kolata reports, randomized controlled trials since then have consistently found no benefit. It's finally stopping now that insurers have decided not to pay for it.

Similar phenomena happen all the time. The hue and cry when the Preventive Services Task Force recommended against routine mammograms for women in their 40s was orchestrated by radiologists, oncologists and surgeons who feared losing business. (Debbie Wasserman Shultz, bless her, was their willing dupe.)  We are finally seeing a movement in medicine to eliminate useless or harmful procedures, as spearheaded by the Choosing Wisely campaign lead by the American Board of Internal Medicine and joined by many other medical specialty societies. Still, physicians' financial incentives work against the goal, and we really need more than voluntarism.

The Cancer Moonshot

I'm not entirely sure how much I've written about this here before, but the cancer moonshot that president Obama recently announced isn't sitting all that well with me. It will apparently re-allocate $1 billion in NIH funding to cancer research. Since congress obviously hasn't appropriated any new money, this is coming out of competing research interests.

The first problem with this idea is that, as the linked NIH fact sheet states quite clearly, cancer is not a disease. It is an umbrella term for hundreds (at least) of diseases -- quite likely it's conceptually impossible to define any finite number of cancers. Cancer means a failure of regulation of cell division such that abnormal cells proliferate. This can happen in innumerable ways to innumerable different kinds of cells. So there can never be one "cure" or one answer. Many different lines of research will lead to better approaches to different sets of people diagnosed with cancer, or to dead ends.  The mission is essentially undefined.

The second problem is that the risk of cancer rises steadily with age. While it's been a high priority (and an astonishing success story already, in fact) to effectively treat cancer in children and young adults, the vast majority of cancers occur in people who are older than 70. This means that people who are successfully treated for cancer are quite likely to come down with another, or to succumb within a relatively short time to some other cause of death. Given that available treatments so far are mostly very burdensome, have terrible side effects, and leave people with shortened life expectancies and, yes, disproportionate risk for recurrence, one has to question the cost effectiveness of making a huge investment without regard to the specific type of cancer, age of onset, or other risk.

There is hope that breakthrough technologies such as immunotherapy may ultimately benefit many people without horrific side effects but that would seem to argue against the scattershot approach of the current effort. I would like to see this discussed much more broadly, and the mission and strategy much better informed and defined. As it stands, it seems like a political stunt.