Just a cost of doing business

Sidney Wolfe, who was head of Ralph Nader's health research group back when I was a 21 year old office assistant for Mr. Nader and is still at it, provides an interesting analysis to BMJ. Why, you may well ask, is an American activist reporting research on enforcement actions against drug companies by U.S. authorities publishing his results in a British journal? That's an interesting question. I'm sure it's irrelevant that New England Journal of Medicine takes in a million dollars or more a year in advertising from drug companies.

Anyway, as background, when the government fines a drug company for ripping off the government or poisoning patients, it makes them sign what's called a Corporate Integrity Agreement (yes, a CIA) which supposedly subjects them to special monitoring for some period of years. Dr. Wolfe finds that in spite of hundreds of millions of dollars in penalties and serial CIAs, drug companies keep on doing the same evil over and over again.

From 1991 through 2012, drug companies have paid $30.2 billion in civil and criminal penalties to the federal and state governments. GlaxoSmithKline has paid the most: $7.56 billion. Pfizer comes in second at about $3 billion.

For example, GSK paid $87 million in 2003 for ripping off Medicaid, and signed a CIA supposedly lasting till 2008. Didn't do any good, apparently. GSK paid another $150 million in 2005, again for ripping off the government, and signed a new CIA lasting through 2010. Whoops! Another $150 million in criminal penalties, and $600 million in civil penalties, for ripping off the government, this time by selling adulterated drugs. Then in 2012, GSK paid $3 billion in criminal and civil penalties for various nefarious schemes including off-label promotion, paying kickbacks to doctors for prescribing, and concealing evidence of the risks of one of its products.

So why does this keep happening? Well, GSK's profit in 2012 was $7.7 billion, more than the entire amount of the penalties they have paid in 20 years. Wolfe:

We are forced to conclude that neither the current level of penalties nor corporate integrity agreements are effective and that there is a pathological lack of corporate integrity in many drug companies.

Yep. If you are morally depraved, it's just a financial calculation. If you make more money by stealing and murdering and paying the fine than you would by honesty, go ahead and murder and steal. 

American Exceptionalism

I hope everyone is enjoying their holidays, to whatever extent you have them. I'm actually at work today but I'm all by myself. Just some things I needed to get done. Anyway . . .

Like a whole lot of nonplussed observers, I find the American habit -- nay, the ironclad requirement of acceptable public discourse -- of insisting that the United States is uniquely great, the best at everything, and exempt from the moral standards that apply to other nations not only epistemologically warped, but factually preposterous. Even our exceptional wealth, derived first from the exploitation of a sparsely populated by well-resourced continent, then enhanced by our triumph in World War II and post-war hegemony, is well on the way to depletion.

But that's the least of it. Even at the height of our national wealth and power, our welfare as a people was exceptional only for our failures. Throughout the post-war era, despite our greater total wealth, we have had less equality, more want, and worse health than western Europeans, and now even more countries are catching up to us and exceeding us in measures of social welfare. The military empire is financially unsustainable and brings us no evident benefit, yet we seem determined to squander everything it takes to maintain it. Our physical infrastructure is rotting before our eyes and out leadership in scientific and technological innovation eroding. As everyone knows, the material standard of living of most of the population has been declining for two decades, as whatever increased wealth we generate is hoovered up by the very wealthy. And yet our political discourse is dominated by an axiomatic belief that the greatest threat to our future is the possibility that we will spend the resources needed to fix these problems.

The issue of health care costs is one I think about professionally, so I'll present it as an exemplar of our broader malaise. Spending half again to twice as much as comparable nations on health care gets us worse health, which is I suppose the major theme of this blog. But why does this happen?

1. Inequitable access. For all we spend on people lucky enough to have health care coverage, there is a good 15 to 30% of the population, depending on who you count and what you consider inadequate, that can't obtain the full benefit because they can't pay for it. That doesn't happen anywhere else among the wealthy countries. It's one thing about us that is exceptional.
2. Overpayment. All the other countries have, one way or another, bargaining power with the suppliers of medical goods and services that keeps prices low. Note that this does not, as free market fundamentalists claim contrary to all evidence, result in inadequate supply or lower quality. Because of the way medical markets work, which I won't go into right now but will be happy to discuss (yet again) on request, an unregulated market results in overpriced inputs. We also have powerful vested interests, such as certain medical specialties, that essentially extract rents.
3. Overuse. About 1/3 of medical intervention is unnecessary, useless or harmful. Again, that doesn't happen in countries with rational health care systems.

And, taking a step back in the causal chain, why are we so dysfunctional? It's because of our political culture which enables rentiers and thieves to win in the legislature. They have much of the public bamboozled into thinking that solving national problems and producing some modicum of justice will, by some unexplained mechanism, make people not be "free"; and that it will mean stealing from them to benefit the unworthy. Racism has a lot to do with this, and so does our frontier history and our puritan heritage and a whole lot else I'm sure.

But if the medical-industrial complex continues to rob the public as it is doing, and medical costs grow in the future as many fear they will, national and local government will find it increasingly difficult to pay for education, physical infrastructure, sustainable energy and other critical investments, and social welfare. Our economy will be hollowed out, and our future bleak. Yes, it would be good to stop squandering money on useless military hardware and soldiers with nothing good to do, but that is actually a much smaller problem on a purely cost basis.

What is to be done? Many say the Republicans have become too extreme to be credible, yet they continue to win elections. The consensus prediction is that they keep the House and maybe even grab the Senate next November. There is no penalty for lying to the public, the corporate media just transmit it, and even amplify it by running with whatever conventional narrative the liars manage to establish. Oceans of unaccountable, anonymous money will continue to drown the electorate.

What is to be done? I have always believed we need to organize. Old models of organization, through labor unions and traditional issue based and identity politics, aren't working well any more. We need to innovate. I will continue to think about this, I hope you will too.

Recommended Reading

Sorry for erratic blogging of late, family responsibilities have intervened. Anyway . . .

Your Intertubes have somewhat degraded the world of print magazines, obviously, and made it harder for good writers and thinkers to get paid for all that verbiage production. But it also means there's a lot of good free stuff out there and I commend your attention to Democracy: A Journal of Ideas.

There's a lot that's worth your attention this month but I'm going to assign Hanauer and Beinhocker with a critical look at capitalist ideology. (Oh nooo! Are they commies?) This is not actually at all original, it's an accessible review of your basic social democratic thinking. However, it is sad that this very compelling and human-centered view of the economic world is pushed to the furthest margins in our mass discourse.

The essential critique of GDP as a measure of economic health is one I've made here. I should probably get over the fetish of not repeating myself because that's buried somewhere in the archives and forgotten. But here's a money quote from H&B:

How can it be that great wealth is created on Wall Street with products like credit-default swaps that destroyed the wealth of ordinary Americans—and yet we count this activity as growth? Likewise, fortunes are made manufacturing food products that make Americans fatter, sicker, and shorter-lived. And yet we count this as growth too—including the massive extra costs of health care. Global warming creates more frequent hurricanes, which destroy cities and lives. Yet the economic activity to repair the damage ends up getting counted as growth as well.

Yep. More and more money flowing through the pipes is not what makes for a better human condition. We need to radically wrench the discourse away from this deeply evil idea. Or we are doomed.

If this is really true, words are inadequate

Dahr Jamail takes a walk on the dark side of climate science -- that minority, but a substantial and credible minority, of scientists who are staring into the abyss. These are the ones who foresee strong positive feedback effects on climate as melting permafrost causes massive releases of methane into the atmosphere. They believe it is possible that global average temperatures will jump by 3 or 4 degrees centigrade on the time scale of a couple of decades. They foresee acceleration of the ongoing mass extinction, and the destruction of life support for the vast majority of the human species. Seriously folks, they're talking about remnant populations in the arctic and Antarctica.

And no, these people are not on the fringe. The point is, the forecasts we generally see are consensus forecasts -- they're somewhere down the middle, in fact somewhat conservative.

How about this prediction? Climate change will not be an important issue in the 2014 or 2016 political seasons. We aren't going to pull our collective heads out of the sand until it's so hot our eyebrows burn off. This must be our relentless focus, our most important political demand. Stop burning fossil fuel.

Situational Ethics and Eric Snowden

I haven't said much about the national surveillance state and the man who showed it to us because I haven't felt I had much to add to the most excellent commentary of many others. But now that the NSA is undertaking a PR blitz, aided and abetted by the formerly journalistic enterprise 60 Minutes, I finally feel moved to toss in my tuppence.

First, Glenn Greenwald talked with ABC News and had something surprising to say:

[Snowden] was very concerned that the government would find out what it was that he was planning on doing before he got a chance to meet with us and turn over the materials. I remember at the time thinking that he was probably a little paranoid in thinking there was this massive surveillance state that would be monitoring what it was that we were doing. Then once I did get the documents, and was able to read through them, and report on them, I realized that actually it was a byproduct of my ignorance, not his paranoia -- that we really do live in a kind of a surveillance state and he was quite right to be that worried.

I don't know if you were familiar with Greenwald's work before Snowden gave him the goods, but I read him regularly for years, ever since he was an independent blogger. And believe me, if Glenn Greenwald did not believe that we were under massive, secret surveillance just about nobody outside of the elect had a clue. And the courts were useless. The courts consistently found that nobody had standing to sue to find out what was going on because nobody could prove that they had been targeted, since it was all a secret. And members of Congress, who knew something about it but who had in fact been lied to about many matters, were forbidden by law to disclose what they knew publicly. So there was no oversight and no accountability, and no possibility of it. Anthony Romero of the ACLU explains this in more detail.

Snowden violated the law, and a specific oath. And he did not accept the penalty for his lawbreaking as is specified in much civil disobedience doctrine, although he has certainly paid a very high price. But this is not a standard set up for civil disobedience either. Jim Crow was not a secret, war is not a secret, and the penalty for sitting down at a lunch counter or throwing blood on a missile is not life-destroying. (Nelson Mandela was an armed insurrectionist, which is not civil disobedience, and he did not willingly accept his penalty, he got caught, with the help of the CIA. Whole different kettle of fish.)

Snowden discovered massive, almost unimaginable violations of the fundamental principles of democracy and individual rights around which there is a very broad, non-partisan and trans-ideological consensus in the United States. The atrocities he revealed would never have been known to the people who were paying for them, form whose benefit it is ostensibly being done, and who believed they enjoyed fundamental rights of protection from such practices, had Snowden not acted as he did. And the only reason this was all secret is because the perpetrators -- including two presidents -- knew damn well that the people would never tolerate it.

So he had no other ethically defensible choice. He had unparalleled courage to do what the truth demanded. Absolutely, he should be given amnesty and the opportunity to rejoin our society as a respected citizen -- and a hero.

"Antidepressants"

I put the title of this post in quotation marks because I believe that even the name of these chemicals is misleading. Alan Frances, who led development of the DSM-IV, pretty much stands by that work but he really, really doesn't like the DSM-V. (I don't particularly like either one of them, but Frances is reasonably up-front about the limitations of psychiatric nosology, and his contribution to the debate over the DSM-V has been largely helpful.) Anyway, in the linked essay Frances and Christopher Dowrick offer the astonishing factoid that 11% of the U.S. population over the age of 11 currently takes an anti-depressant.

Wow. These are drugs that have numerous serious side effects, are essentially addictive for many people in the sense that they can't stop taking them without experiencing intolerable symptoms, and they don't actually treat any known disease. Yep, I meant that. There is absolutely no evidence -- in fact compelling evidence to the contrary -- that a shortage of serotonin in the brain does not cause, and is not even associated with, the collection of symptoms labeled "depressive disorder." The way they get approval for these drugs is to ask people some questions -- from, for example, the Beck Depression Inventory -- feed them antidepressants, and then see if there is a "statistically significant" difference in the amount of change in how they answer the questions, compared to people who take a placebo.

Sample questions (pick the answer that best applies to you)

0 I am not particularly discouraged about the future.
1 I feel discouraged about the future.
2 I feel I have nothing to look forward to.
3 I feel the future is hopeless and that things cannot improve.

0 I don't feel I am being punished.
1 I feel I may be punished.
2 I expect to be punished.
3 I feel I am being punished.

It doesn't matter if you're say, serving a life sentence, or living in Aleppo, if you get a high score on this test you have a disease called depression. It turns out that for people diagnosed with major depressive disorder, clinical trials tend to show that about 15% of them have a response in how they answer these questions that exceeds the response to placebo. Or so it seems based on the data we've been able to see. Selective publication and data massaging are ubiquitous in this field.

Anyway, as Frances and friend tell us, according to the DSM-V if your spouse or parent or child  died two weeks ago, and you're still feeling sad, you have a disease. And you should take pills. That is a) nuts and b) evil. There is indeed terrible suffering that comes upon some people, not necessarily in reaction to any particular unhappy event, and that won't lift. We don't understand why, and for some of these people, antidepressants may give some relief. Others, not. But . . .

A lot of suffering is just the human condition. It comes with the big brain, the curse of consciousness, and the indifference of the universe. Let's all try to love and succor each other. But stop taking the damn pills. Thank you.

And while we're on the subject of the FDA . . .

Steven Nissen in BMJ has a rant that could strip paint, or strip the bark off of both the FDA and GlaxoSmithKline. After all these years, I'm still getting used to the apparently universal psychopathy of pharmaceutical executives. This one makes Charles Manson look like a sweetie pie.

Specifically, in case you didn't know, in 1999 Glaxo got approval for rosiglitazone, a drug to treat diabetes. The approval was based on a so-called secondary endpoint, specifically that it lowers blood sugar. However, even before approval publicly known studies showed that people who took it appeared to have an increased risk of adverse cardiovascular events such as heart attacks. The FDA went ahead and approved it anyway, but the Europeans required a post-marketing study called RECORD.

Under the brand name Avandia, rosiglitazone made huge bucks for GSK, but meanwhile, secretly, the company did a meta-analysis that found that yes, it raised the risk of cardiovascular events substantially. They told the FDA, but both parties kept this information secret from the public.

Nissen got access to the data from rosiglitazone trials through a lawsuit, and he found that the drug increased the risk of death by about 64%. At this point, Nissen writes, "FDA officials were infuriated with me for challenging the drug's safety." When the RECORD trial was published in 2009, it didn't show the increased risk, and the FDA convened an advisory panel which Nissen says was intended to "exonerate" the drug. But the study was garbage. The new Deputy Commissioner appointed by Obama held honest hearings, and the panel voted to remove the drug from the market or tightly restrict its use.  The New York Times later found that GSK had known since 1999 that an alteranative drug was safer, and concealed the information. But the FDA kept trying to reanalyze the data to prove that rosiglitazone was safe after all.

Now let's be clear here. We're talking about killing people for profit, with the collaboration of a federal agency. The common term for killing people for profit is felony murder. That is not very nice. But drug companies have been caught doing it again and again. Sometimes they pay fines, sometimes they just pocket the money and laugh in our faces. These are the "makers," the "job creators," the "builders." That's where we live.

Sorry FDA, not good enough

As you probably already know or would soon even if you hadn't visited here, the FDA has finally issued regulations on feeding antibiotics to livestock. Yes, in three years "farmers" (read: owners of buildings stuffed full of pigs and cows confined in small spaces, gorging on corn and garbage, and discharging millions of gallons of shit into lagoons) won't be able to go to the local feedstore and buy antibiotics by the 80 pound bag.

No, they'll need a prescription from a veterinarian based on the assertion that they're "preventing disease." Big whoop. They'll get one.

Some consumer health advocates were skeptical that the new rules would reduce the amount of antibiotics consumed by animals. They say that a loophole will allow animal producers to keep using the same low doses of antibiotics by contending they are needed to keep animals from getting sick, and evading the new ban on use for growth promotion.

Yep, that will happen. 

Invisible Murder

My colleague Doug Brugge offers a primer on what happens to people who live within 400 meters of major highways. To expand on this a bit, there are a whole lot of pollutants that come out of tailpipes but among the most important health hazards, now that we've put various kinds of emission control devices on cars, are so-called ultrafine particles (UFPs), which are less than 2.5 microns in diameter. That's really, really small. They are completely invisible, and odorless. You could breathe in millions of them with every breath and not know it.

They go right through the lungs into the blood stream and enter cells. They appear to cause generalized inflammatory responses, atherosclerosis, and to be acute triggers of heart attacks. As Doug tells us, the WHO says that something like 3.2 million deaths worldwide are caused by ambient particulate matter, and they're responsible for more lost years of life and healthy life than lots of risks we worry about more, including physical inactivity, high serum cholesterol, and occupational injuries.

But the risk is very localized. They're very highly concentrated close to major highways -- not so much urban arteries, which was counter-intuitive for me. But the point is the vehicles are going fast on the highway, so a lot more fuel is going through the engines than is the case in urban streets no matter how congested. But get 300 or 400 meters away from the interstate, and the level goes down to background.

About 4% of Americans live within 150 meters of a major highway, which is already bad news. I would very much want to be quite a bit farther away than that. So wanna guess who those folks are? This CDC report tells us.  Anyway, you know the answer:

The greatest disparities were observed for race/ethnicity, nativity, and language spoken at home; the populations with the highest estimated percentage living within 150 meters of a major highway included members of racial and ethnic minority communities, foreign-born persons, and persons who speak a language other than English at home (Table). The estimated percentage of the population living within 150 meters of a major highway ranged from a low of 2.6% for American Indians/Alaska Natives and 3.1% for non-Hispanic whites to a high of 5.0% for Hispanics and 5.4% for Asians/Pacific Islanders. Likewise, the estimated proportion of the population living near a major highway was 5.1% for foreign-born persons, 5.1% for persons who speak Spanish at home, and 4.9% for persons who speak another non-English language at home.

 Poor people, immigrants. There are a whole lot of reasons why poor people are less healthy and don't live as long, and no it's not because they're irresponsible, lazy moochers. It's because their conditions of life are unfavorable. That's called injustice.

Apocalypse maybe?

I can't remember the guy's name and I can't figure out a way to use your favorite on-line search engine to track it down, but many suns ago -- 20 years or so -- he was a highly controversial microbiologist who claimed it was a certainty -- not if but when -- that the global human population would be decimated by a global pandemic, or maybe several, of emerging infectious diseases.

The controversy was not so much over whether this was true -- a lot of people in the public health field, of various disciplines, tended to think so. The controversy was because he gave the impression he thought this would be a good thing. The human population is already unsustainable and becoming more so. Either we have megadeath by microbe, or by ecosystem collapse, and the former seemed preferable.

I'm not rooting for either eventuality, but I do think we need to stop having so many babies, and fast. Actually the global fertility rate has declined sharply in recent decades but not enough. Nine billion people -- the consensus number expected by demographers -- by 2050 -- all aspiring to the current levels of consumption of Europeans and North Americans -- are not a thing that can possibly work.

But what about doom by emerging infectious disease? CDC certainly worries about it and publishes an open access journal on the subject. HIV is an example of an EID that would indeed have done what the anonymous prophet predicted if it were more easily transmitted. Fortunately it's hard to catch, but it has everything else you need to wipe out much of the species -- long incubation period, so people can be walking around spreading it for a long time before they collapse on the cot -- no vaccine, no recovery, and totally deadly. Despite its wimpiness in getting from one person to another, it spread all over the world very quickly thanks to the shrinking of the planet by air travel.

We've had other episodes -- SARS, which fizzled out, novel influenza which turned out to be, meh. Actually I would say that the flu pandemic hoax of 2009-2010 -- and that's what it was, basically -- shows that yes, there are a lot of people kind of secretly wanting something dramatic to happen. The fact is that global interconnectedness, the very large human population which creates a lot of vessels where bugs can evolve and DNA recombine, and human contact with every sort of animal, does create a real risk of a new Black Death, this time globally, not just in one continent. But it's really totally imponderable. Nobody can say what the probability is that the exactly correctly nasty microbe will appear; and if it does, we'll figure it out quickly and maybe find a way to fight it before the worst happens. So yes, it's possible but I'm going to say not our biggest worry. I'm going to say that.

You kiddies really need to know this

With the outpouring of love for Nelson Mandela from across the political spectrum, you youngsters probably have a very wrong idea about history. Mandela spent 27 years in prison because the CIA handed him over to the South African security service.

The United States was a committed ally and supporter of the apartheid regime in South Africa until 1986, when Congress passed the Comprehensive Anti-Apartheid Act by overriding Ronald Reagan's veto. Reagan did not fully enforce the sanctions in the act although his successor George Bush I finally did so. Mandela was released from prison in 1991, two years after Bush took office.

Before then, Republicans labeled Mandela and the African National Congress terrorists.

Just so you know. 

Update:  Here's a fuller story from Bill Berkowitz.

Anecdotal, but it's very true . . .

Erratic blogging right now because my mother is in the hospital and I'm having to cope with various related problems. She has now been officially "admitted" but she's actually been inside the hospital, on a ward, in a bed, with IV and nurses and the whole thing since Saturday night, and yet not "admitted" until yesterday.

What does this mean? It means it's a scam, basically. Here's a somewhat explanation and here's a more formal study from some of my colleagues. Basically, three issues. 1) Hospitals are now penalized by Medicare if hospital patients are re-admitted within 30 days. If they never "admitted" you in the first place, you can't be re-admitted. 2) If you're on "observational status," you aren't an inpatient. That means that instead of being paid the flat Medicare Part A rate for a hospital episode, they can charge for all kinds of specific services and it comes to more money -- often out of pocket from the unsuspecting  victim patient. 3) Medicare can deny payment for a hospital episode altogether if they decide it wasn't actually necessary. The hospitals are trying to avoid this danger.

Problems are not only the possibility of higher out of pocket costs to patients, but compromised care. When she changed from observational status to admitted, my mother had to be moved to a different ward. That's how the hospital is organized. Ergo, different nurses and doctors. Not only is continuity compromised, but for elderly people this can be confusing and stressful.

We need a better way. With Accountable Care Organizations and capitated payment, none of this will happen. After all, it costs somebody more in the end, even if the hospital finds it more economically prudent to do things this way. If a system of care -- primary care, specialists, hospital -- gets one fee to take care of a person, they'll do it the right way. Long story made very short here, but we'll talk more about it.

Meanwhile, if you or your loved one ends up in the hospital, ask if you/they are on "observational status." If so, yell and scream. If they're really in the hospital, and getting inpatient services, insist that they be admitted. Don't take no for an answer.

About that statin controversy

I'm not a cardiologist or an epidemiologist and I don't like to make authoritative noises when I'm really just faking it. However, the recent brouhaha over new guidelines for the use of statins  promulgated by the American College of Cardiology and American Heart Association touches on many issues I do think about with some pretense of expertise, so I feel compelled to comment insofar as I can.

For those who haven't been keeping up, formerly doctors were urged to prescribe these medications with a goal of lowering Low Density Lipoprotein (LDL), the so-called "bad cholesterol." The goal of  prescribing was to get  LDL as low as possible, all the way down to 70. The new guidelines no longer call for trying to meet any particular cholesterol target; rather, the indication for prescribing is a score on a risk algorithm to predict the probability of heart attack or stroke within 10 years.

The controversy centered around three main issues. First, the risk score calculator was said by many to be inaccurate, and to overestimate risk. The whole idea of a risk cutoff in the first place is to try to balance the potential benefits of taking statins against the potential risks and costs. Obviously they cost a bit of money, although they're quite inexpensive on a per-dose basis now that many different generics are available. There are some possible side effects, including an increased risk for diabetes which would largely defeat the purpose. And a lot of people nowadays already take a lot of pills -- nowadays it's commonplace for people to have 5 or 10 prescriptions. When people have that many pills to take, a lot can go wrong, including a low likelihood that they'll take all of them as prescribed. That means statins could crowd out other medications that might be more important for some people. There's also a psychological burden. And we don't really know much of anything about possible interactions between statins and other drugs.

Another problem is that abandonment of the cholesterol target seems perverse. If statins work by reducing LDL, then isn't that the reason for prescribing them and shouldn't LDL levels be our measure of whether they are working? This is a dirty little secret of statins - it isn't clear that's the mechanism by which they reduce risk of cardiovascular disease at all. Adding other medications that further reduce LDL has not been found to provide added benefit. Many people suspect that it's actually an anti-inflammatory effect, or some other unknown mechanism, that's doing the job. But if we don't even know how they work or exactly what they are doing to our bodies, shouldn't we be more cautious?

Finally there are the usual complaints about potential conflicts of interest among the panel members, some of whom have received drug industry money.

I don't have the time or probably the expertise to evaluate all the arguments about how to balance these considerations in the face of uncertainty, but John Ioannidis comes to the rescue. If I can summarize what he seems to be saying, the fact is that nobody has an ironclad case either way. The panel worked through immense amounts of data and in the end, they had to make a best judgment, which might be wrong in either direction. It's obviously worth a lot to reduce the population risk of stroke and heart attack by even a couple of percentage points per year. Many people, including me, have a predisposition to perceive overtreatment but undertreatment is bad too.

What Ioannidis says is that what we need is what we don't have -- large scale randomized controlled trials in representative populations that can definitively answer the risk/benefit question. That would take multi-megabucks over ten or more years. Sadly, people get dug in on their own answers to unanswered questions and waste time yelling at each other when they ought to be looking for definitive evidence. That seems to be the situation here.

This is no doubt a highly unsatisfying blog post but that's the way it is.