Map of life expectancy at birth from Global Education Project.

Thursday, August 25, 2016

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.

Monday, August 22, 2016

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.

Thursday, August 18, 2016

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. 

Wednesday, August 17, 2016

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.

Thursday, August 11, 2016

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.

Tuesday, August 09, 2016

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.

Thursday, August 04, 2016

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.

Monday, August 01, 2016

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.

Tuesday, July 26, 2016

This is incredible

I don't know if anyone remembers Fat Al Gore, but back in 1998 he proposed stationing a satellite at the Earth-Sun L1 point to continuously photograph the earth from deep space. Flaky, no?

The L1 point is one of five locations called Lagrange points, which exist in any system of two orbiting bodies, where a smaller body can remain stably. L1 is nearly 1 million miles from the earth, well outside the orbit of the moon. Somehow I missed it, but NASA actually did it! The satellite is now called the Deep Space Climate Observatory, or DSCOVR (get it?) and it was launched by SpaceX in 2015. Now it gives us this amazing image:

That is the moon transiting the earth. We're seeing the side of the moon which can never be seen from earth. Although it's called the "dark" side of the moon it isn't really dark - it is illuminated just as often as the near side. Since we're seeing the lighted side of the earth (L1 is in a direct line between earth and sun, so you always see the day side), we're also seeing the far side illuminated. You can see the transit in motion here, courtesy of your tax dollars at work.

That's everything we have, folks. There's no place else to go, and nothing else to live on.

Monday, July 25, 2016

When ideology trumps reality

(I took a few days off to rest my brain. Results are mixed, but I'm back.)

You may have heard about the HIV outbreak in Scott County, Indiana. (Not sure how much of this the grand poobahs at New England Journal of Medicine will let you read, but I'll run it down for you.)

This is a rural area, almost entirely white, with high unemployment and poverty. The governor of Indiana, Mike Pence, is now the Vice Presidential candidate of the Republican party. Prior to 2015, with Pence's backing, Indiana outlawed needle exchange programs. Needle exchange has been shown to substantially reduce the risk of transmission of HIV and Hepatitis C virus (HCV); and it does not increase the prevalence of injection drug use. On the contrary, by bringing users into contact with service providers, it increases the chance that people will enter treatment. However, conservatives have succeeded in banning the practice in many states using the argument that it "enables" illicit drug use. Of course, addicts will inject any way they have to, and if they can't get clean needles, they'll share.

One more thing -- free HIV testing had not been available in Scott County since the Planned Parenthood clinic closed in 2013.

Early in 2015, a disease intervention specialist (DIS) discovered a cluster of 11 HIV infections in Scott County. A DIS is a public health worker who interviews people diagnosed with an infectious disease such as HIV and tracks down people they have potentially infected, or who potentially infected them, in order to diagnose additional cases and gain an understanding of transmission networks. Previously, there had only been 5 HIV infections identified in Scott County since 2004. All of the infected persons had crushed, dissolved and injected extended release oxymorphone.

As a result, the CDC and Indiana state government declared a public health emergency, and began intensive contact tracing and population screening. Ultimately they found 181 people with HIV in the county, nearly all of whom reported injection drug use. As a result, Pence relented and allowed needle exchange in April, 2015, after which the cumulative diagnoses leveled off and finally stabilized. As the authors also write:

A lack of health insurance could have been a barrier to the response to this outbreak, but fortuitously, in January 2015, Indiana received a waiver to provide Medicaid insurance [which] helped to ensure health care coverage in the largely underinsured and impoverished community . . . and facilitated the immediate enrollment, coverage and access to critical health care services.

I might note that people who are effectively treated for HIV are essentially non-infectious, meaning that treatment for all can stop the epidemic in its tracks.

Is there a lesson here? Yes. We were right and Mike Pence was wrong. But who do you think the good citizens of Scott County are going to vote for?

Tuesday, July 19, 2016

An informed perspective on the ACA

Former law professor and current federal employee Barack H. Obama offers an assessment of the Affordable Care Act in last week's JAMA. While I don't know if we can count on him to be an entirely disinterested observer, this does have some fair and balanced elements.

He rightly notes that the law has resulted in a huge decline in the proportion of people who lack health insurance, and is plausibly linked to observable improvements in beneficiaries' health status and financial security. He also gives credit to the ACA for slowing the growth of spending on health care, which is a big more speculative at this point.

But he also observes that affordability is a problem for some people. Fixing this would require increasing the funding for subsidies and changing the structure of subsidies to fix some quirks.

The big news, however, is that he notes that the ACA has not succeeded in creating competitive insurance markets in all parts of the country. Therefore, he embraces a publicly sponsored insurance option, a Medicare for all style program, where competition is lacking. This goes part of the way toward Bernie Sanders, who of course wants that everywhere. It's a pretty kludgy fix -- it would need an on/off switch depending on the current competitiveness of the market in a given region, which doesn't seem very workable.

Biggest problem, of course, is that there is no way in the Delta quadrant of the galaxy that a Republican House would ever pass this. But, it does give Hillary something to campaign on.

Side Note: That the major scandal to come out of last night's hate fest on the lake is that Melania Trumps speech contained some purloined words tells us everything we need to know about the corporate media. Blatant ugly lies; bigotry; depraved fear mongering: all okay worthy only of stenography. Non-politician given ghost written speech that contains a bit of borrowing -- that's your screaming headline. Bring on the giant meteorite.

Thursday, July 14, 2016

It doesn't take a genius . . .

. . . to figure out that the entire basis of the Republican presidential candidates appeal is racism. Kevin Drum gives us a more opionated discussion of this obvious fact.

As a friend just ranted at me, however, the corporate media for the most part (Confessore piece above obviously excepted) and even, it seems, many Democratic politicians have at best tip-toed around this. Hillary Clinton obviously doesn't have nice things to say about him, but just calling him a con artist and a fraud is not mentioning the elephant in the room.

For the teevee news, of course, the candidate is good for ratings and that's all they care about. That's what made him the Republican nominee, his ubiquity on cable news. They obviously don't want to alienate his fans.

But the same goes for many Democratic politicians. The Bill Clinton presidency was largely about trying to win back the Reagan Democrats by pandering to their racism. Hillary knows that accusing racists of being racist is the best way to make them feel offended. Telling the country that racism is foundational to white working class culture would be the truth, but it would also be an excellent way to make sure you could not be elected to office outside of Berkeley or Jamaica Plain.

How worried am I? Not very worried about hearing the Marine Band playing Hail to the Cheetoh Dusted Thief, but disturbed by the weakness and corruption of our institutions. Donald Trump may be too vain and undisciplined to carry his schtick over the finish line, but somebody smarter and emotionally stable might come along and carry off a more successful version of the act. In the meantime, we could see a lot of unpleasantness.  

Tuesday, July 12, 2016

Anybody who isn't paranoid is nuts

One of my research projects was to develop a questionnaire assessing the knowledge and beliefs of people living with HIV about the disease and treatment. I did qualitative interviews first to harvest the kinds of ideas people have and then translated those into structured questions. One of them is:

 "Some doctors are paid by drug companies to prescribe certain HIV medications."
People can call that correct, partly correct, or not at all  correct, but I didn't score this question when I calculated their overall accuracy because it's not exactly true and it's not exactly false.

Susan Chimonas, in the journal Democracy (which I very much commend to you as a most excellent freebie)  uses this recent study in JAMA Internal Medicine as the occasion to write about the problem of pharmaceutical industry influence on prescribers. I say she uses it as the occasion because we already know all this. Even very small gifts can have a substantial influence. They talk about $20 meals but even pens and sticky note pads have been shown to have an effect. My old office at Tufts Medical Center had boxes of office supplies stamped with the pharmaceutical brand names. The drug companies obviously wouldn't waste their money on this if it didn't work.

Now, there isn't any stated quid pro quo. You don't actually have to prescribe Toxovan to get the free lunch or the triangular pen. This is actually a weird trick about human psychology. It's surprising how well it works. Transparency is often touted as the solution -- drug companies should have to disclose their gifts to prescribers, prescribers should have to disclose the gifts they accept. But that doesn't work. The only solution is to ban the practice. Drug companies should not be permitted to give anything to prescribers. The information they need is in the so-called "label" (actually a substantial pamphlet) approved by the FDA. The docs should read it. That is the only interaction between prescribers and drug companies that should be permitted.

Friday, July 08, 2016

What rough beast . . . slouches toward Bethlehem to be born?

I'm kind of an old guy now, and I lived through the '60s -- the Civil Rights Movement and massive police and KKK violence in response, the Vietnam War protests and the Chicago convention, the assassinations, the urban riots, the Weather Underground, the Black Panthers . . .

It seemed as though everything was spinning out of control. People got scared enough to nominate Barry Goldwater,  and then elect Richard Nixon, but eventually everything calmed down and the country held together. The truth is though, the underlying fractures in our society didn't heal, they just got painted over for a while. Is this historical moment more dangerous, or do we have more cultural resources now to overcome the turmoil and fear?

I'm not sure yet. Has progress been an illusion, or are we just seeing the one step back after two steps forward? We'll just have to stay tuned.

Thursday, July 07, 2016

Opioid Prescribing Policy

A major political deal in my former home state of Massachusetts has been reform of opioid prescribing regulations, and you can read all about it here. This law had strong bipartisan support from the Democratic legislature and Republican governor as well as the Massachusetts Medical Society. The opioid abuse epidemic has gotten the attention of lots of state governments and many of them had passed laws like this a few years ago.

Speaking of the Massachusetts Medical Society, they publish the New England Journal of Medicine which today has this from Ellen Meara and colleagues. Alas, they can't find any evidence that these laws do much good at all, if any. Their data came from people under 65 who receive Medicare benefits because of disability. That's obviously not representative of the general population but on the other hand they have high rates of receiving opioid prescriptions and account for a highly disproportionate share of related adverse events. Furthermore, there is no obvious reason why these state laws would not affect opioid prescribing to them as much as it would to others.

There are several sorts of provisions they looked at, many of which are components of the Massachusetts law. These include limiting the quantity of initial prescriptions, requiring prescribers to consult a Prescription Drug Monitoring Program (which tells them if patients are also getting prescriptions somewhere else), and various other provisions. But it turns out that there is no meaningful difference in long-term prescribing, high levels of prescribing consistent with addiction and overdose risk, multiple prescribers, or actual overdose, when states adopt these laws.

Now maybe they take more effect over more years, maybe they have a small effect that the study couldn't detect, and maybe non-disabled people are different. But the takeaway seems to be that this problem is not solved by trying to impose restrictions on physicians. We need to change the culture and practice of medicine, and that means for one thing doctors' skills to communicate with patients and manage pain without overusing opioids. The legislature doesn't have any magic bullets.