Philip Alcabes discusses myths of health, disease and risk.

HIV, Contraception, and (More) Unethical Conduct by U.S. Researchers

Brava! to Caitlin Gerdts and Divya Vohra at Daily Beast for a superb, and much-needed, dissection of the flaws in this week’s heavily hyped Lancet study by Heffron et al.  The study purported to show elevated HIV risk associated with hormonal contraceptive use among women in parts of Africa (abstract here, subscription needed for full text).  The NY Times ran a front-page story, claiming that

[t]he most popular contraceptive for women in eastern and southern Africa, a hormone shot given every three months, appears to double the risk the women will become infected with H.I.V.

and almost everybody else (as diversely situated in newsworld as the Atlantic, CNN health blog, Catholic News Agency, and Voice of America) joined the NYT in failing to examine it critically.

Gerdts and Vohra add the essential context that was missed by the newsmedia:  about a half-million women die during or because of childbirth each year, almost all of them in poor countries.

At RH Reality Check, Jodi Jacobson summarizes the main cautions about the Heffron study, and points to a Guttmacher Institute white paper.  She takes into account concerns about high maternal and infant mortality in parts of Africa, the harms associated with complications of pregnancy and unsafe abortions, and, of course, the substantial possibility of vertical transmission of HIV in places where antiretroviral therapy isn’t universally available.

To claim that poor women should give more weight to the rather remote risk of acquiring a virus that might cause serious illness years down the road than to the dangers of pregnancy itself in the near term is to reduce real women to automata.  Facing dire straits they might be, but they’re supposed to be reasoning machines, programmed to engage in the AIDS industry’s preferred calculus, risk.

A quick summary of the shortcomings of the Heffron et al. research:  comparing users of hormonal contraception to nonusers, the difference in actual risk of acquiring or transmitting HIV was very small, amounting to 1 to 3 new infections per one hundred contraceptive users over and above the infection rate for nonusers.  And it’s impossible to say that these excess infections were actually attributable to the contraceptive — because the study wasn’t a clinical trial.  A great many aspects of social setting, relationships, health, and welfare of the study subjects would have been different between contraception users and nonusers, some of which would undoubtedly account for differences in rate of HIV transmission.

And since all of the subjects were in so-called discordant couples — one partner infected with HIV, the other not — it would be unusual to expect no HIV transmission at all.

Unless, of course, the subjects had been offered antiretroviral therapy, ART.  But this the researchers did not do.  They referred eligible subjects to HIV clinics.  They seem not to have checked whether people who needed ART were getting it.  They seem not to have offered ART to women who got pregnant, either.  Certainly, their Lancet article makes no report of doing so.

I wondered if this was too much to expect of researchers — so I asked the students taking my course on global AIDS and human rights.  Undergraduates, I find, generally have a clearer sense of ethics than most medical researchers.

Even the students who felt that the Heffron study was worth doing and basically sound were troubled by the researchers’ lack of curiosity as to whether HIV-infected subjects were getting the ART drugs they needed.  And most of the students thought this was a disabling ethical fault, which should have caused human subjects committees to make the researchers redesign the study.  One student pointed out that the Bill and Melinda Gates Foundation, one of the study’s funding sources, could easily afford to pay for antiretroviral therapy for all of the roughly 2,000 HIV-infected people in the study.

In the end, my students had the questions that Marcia Angell raised in her editorial in the New England Journal of Medicine in 2011 (PDF at this link angell editorial nejm 2000 ):  Don’t physician researchers have the same responsibility to study subjects that they do to their own patients?  And therefore, when their subjects lack resources to obtain effective therapy for treatable conditions, don’t the researchers have a moral obligation to make the therapies available?

Heffron et al. didn’t do this.  They watched HIV-infected people transmit HIV to their partners (the researchers provided HIV testing and counseling about avoiding transmission — but they don’t make clear whether they notified uninfected partners that they might be in harm’s way).  They did little to prevent transmission.  Notably, they didn’t offer ART to people with low CD4 counts.  Nor did they offer post-exposure prophylaxis to uninfected people who had had intercourse with an infected partner.  They just watched.

On this account, the Heffron study wasn’t only flawed — it was so questionable on ethical grounds that the Lancet should be ashamed to have published it.  And the funders — the NIH as well as the Bill & Melinda Gates foundation — censured.

 

 

Life Expectancy Goes Up but Risk-reduction lectures Continue

Bravo! to Rob Lyons at Spiked. Since it’s now apparent that life expectancy has increased almost everywhere and is at historic high levels in much of the developed world, Lyons asks the logical question:  why is the public health system still scolding everyone about what people eat and how fat the average person is?

A paper by David Leon in this month’s International Journal of Epidemiology showed the dramatic increase in life expectancy — the median age at death, that is.  It has reached over 85 years for women in Japan, but it’s high even in countries where longevity was relatively low a generation ago.  Cheeringly, US life expectancy at birth is now 78 years; in the UK it’s 80.  And it’s even higher in some countries of western continental Europe.  Here are the graphs for different parts of the world from Leon’s paper, showing trends since 1970:

Life expectancy since 1970

Lyons has gone after the anti-obesity crusaders before (as well as related topics at his smart blog on contemporary food confusion, Panic On A Plate).  Now, he’s particularly disturbed by the sermonizing about eating. “You can’t even have a pie and a pint without someone telling you it will kill you, it seems,” Lyons writes at Spiked.

And, really, it’s even worse than that — because it’s not just eating that’s the subject of the lecturing.  It might be true that you will live longer if you give up smoking, cut your salt intake, drop your BMI down to 24.99, exercise four times per week for at least 20 minutes each time, get immunized against flu and human papillomavirus, drink in moderation, and take naps.  But unfortunately there’s not a bit of evidence that any of that — apart from the decline in smoking — has contributed to increasing longevity.

And of course, even with smoking cessation, there’s no telling whether it would make any difference to you — only on average.

So why are the public health messages so far away from what really matters — basically, prenatal care, postnatal care, and wealth (with its concomitant, standard of living)?  Well, there’s a puzzle.

What’s the point of having an industry whose main aim is to make sure that people are constantly in fear that they are doing something that will kill them — even as it becomes apparent that most of what people do is only making us live longer?   Lyons calls it Good News Omission Mentality Syndrome (GNOMES).

I ask you:  could it have something to do with control?  And the desire to sell products?

Nuclear Energy and Risk

Elizabeth Kolbert is a fine science writer.  Her explanations of the complicated mechanisms — geothermal, marine chemical, atmospheric, and so forth — underlying climate change are clear and compelling.

But I confess I’m no fan of her work.  Kolbert’s sky-is-falling! rhetoric is a little too florid, and her criticism of people who don’t act environmentally a little too pointed.

Yet, her short piece in this week’s New Yorker, “The Nuclear Risk,” is terrific.  It’s worth reading.   She gets at a central lesson of the radioactivity crisis that followed on the earthquake + tsunami disaster:  you can only plan for the disasters you’re able to conceive of.  The Japanese catastrophe, she writes

illustrates, so starkly and so tragically, [that] people have a hard time planning for events that they don’t want to imagine happening. But these are precisely the events that must be taken into account in a realistic assessment of risk. We’ve more or less pretended that our nuclear plants are safe, and so far we have got away with it. The Japanese have not.

That the nuclear crisis is supposedly under control now, or might be under control if some new problems are dealt with, doesn’t change the planning problem (and have a look at this blog post by Evan Osnos for a worrying take on what happens to people who are facing such a triplex disaster scenario).

Kolbert relates the problem of nuclear planning in the U.S. to corporate interference with regulatory agencies, quoting the Government Accountability Office’s finding that the Nuclear Regulatory Commission has based its policies

on what the industry considered reasonable and feasible to defend against rather than on an assessment of the terrorist threat itself.

It’s disturbing that industry and regulators are on intimate terms, but it isn’t exactly news — not in regard to energy policy, nor health policy (for example, consider the CDC’s Advisory Committee on Immunization Practices, which I wrote about a year ago).   The comfortable collusion between corporations and government agencies is an issue — but it’s not the most troubling lesson of the Japanese crisis.

Rather, the main event is the inevitability of unforeseen and unforeseeable disasters.  And the simple impossibility of making plans to avoid what can’t be imagined.

Which is where I part company with Kolbert.   Would better planning (or stricter regulation of industry) have avoided the near-catastrophic radioactive release at Daichii?  Yes, perhaps.  But nobody could have foreseen an earthquake of this magnitude, or infrastructure so destabilized by a tsunami as fast-moving and destructive as this one, or the double-punch effect occurring where it did and how it did.  There’s only so much you can plan because there’s only so much you can envisage.

And that’s the problem with the idea of planning to reduce risk.  You plan for what you know. Maybe you plan for something a little worse than what you’ve seen before — but even that is basically what you know, with a little juicing to make it livelier.   Even the pure-fantasy regulatory agency — the one with firewall immunity from influence by industry, perfectly competent engineering of its plans, and state-of-the-art technology — can’t foresee every eventuality.  Therefore, even the best planning won’t eliminate risk.

In the end, the question isn’t just how to keep the energy industry away from the regulators.   It’s how to live in a universe that isn’t completely predictable, no matter how good you think your “science” is.   And is ruled by random, implacable, and sometimes highly destructive nature.

Public Health: Childhood is a Dangerous Place

Is there a Department of Scare Creation at Case Western?  This week, we have research reported by their Dr. Scott Frank and colleagues: “Hyper-texting and Hyper-networking Pose New Health Risks for Teens.”  Frank says,

The startling results of this study suggest that when left unchecked texting and other widely popular methods of staying connected can have dangerous health effects on teenagers.

(Aside to Dr. Frank:  C’mon, doc.  Do you not know that “hyper text” is already a term in wide usage? Do you know how sometimes there are underlined words, most often in blue, that, if you click on them with your mouse then you are magically transported to another website?  That’s it.  Do you realize that any teens who aren’t already laughing at you for your transparently hysterical research agenda have cause to snicker over your misuse of contemporary language?  But back to my point…)

The subject of a press release by the American Public Health Association, the study claims that teens who text  more than 120 times a day are, compared to light texters:

  • 41% more likely to have used illicit drugs
  • Nearly 3.5 times more likely to have had sex
  • 90% more likely to report having had four or more sexual partners

The results were based on a survey of over 4,000 high school students in the midwest.

The paper, presented at the annual meeting of the APHA, is yet another indicator of the association’s redirection — from promoting social reform to becoming the Popular Front for the Promotion of Family Values.   The news media complied with the APHA’s mongering by publicizing Frank et al.’s findings, for instance here, and so did the usually serious WebMD.

Research like this is meant to say both “childhood is deadly” and “children are dangerous.”  Teenagers have sex, it says, and you grownups shouldn’t take that lightly.

The connection of teen sex and teen drug use to cell phones, iPhones, or the Internet appeals to people who think there is something new, and terrifying, about modernity.  As Carl Phillips notes over at ep-ology, it’s a way of saying “Beware the scary new technology!  It is causing teens to interact.”

Of course, there’s also a race, class, and sex angle:  The study reported that excessive texting (along with what the authors call “hyper-networking,” meaning excessive use of social network sites) is more common among girls, racial minorities, and kids whose parents have less education. One more reason to be suspicious of the poor and the dark-of-skin, says the Popular Front.

Especially, the APHA wants us to beware of girls.  The public health industry — the folks who reminded your grandparents that female sexual desire spreads disease with posters like this one, from the ’40s:

US Government VD Poster, ca. 1940

Source: U. of Minnesota, Social Welfare History Archives

… now tell us to watch out for girls who text.

Mike Stobbe at AP, covering the report, did a (typically) good job of looking deeper into the question.  About half of kids between the ages of 8 and 18 text each day, and the ones who do average 118 texts per day. While texting while driving is a really bad idea, texting about sex isn’t uncommon (Stobbe points out).  Unlike texting while driving, nobody dies from it.

Public heath shouldn’t be a matter of, as the Frank report put it, wake-up calls for parents.   Childhood really is dangerous in some places (Somalia, Congo, and Haiti come to mind, in case physician-researchers currently obsessed with sex amongst American teenagers are looking for something useful to do with their medical skills).  But it isn’t in America.   Sex, even between teenagers, really isn’t very scary.   There are a lot of things we adults could do to make the country and the world less miserable, but spying on our kids isn’t among them.

Anti-Tobacco Crusaders

It’s hard to understand why the public health industry is so irrational about tobacco use.  Yes, it’s dangerous  to inhale the fumes of burning tobacco.  Smoking can be very bad for people.  But why vilify tobacco use in all its forms?

The anti-tobacco crusade is a modern-day version of Revivalist religious fervor.  It sure isn’t science.  And it isn’t about protecting people’s health.

The CDC estimates that 442,000 Americans die from tobacco smoking each year.  These estimates are slippery; they’re based on a fairly loose definition of what it means to die “from” a behavior — but let’s agree that a lot of people die sooner than they otherwise would because they smoke cigarettes.

Alternative ways of self-administering nicotine allow users to avoid the disastrously harmful drug-delivery device, the cigarette.  You’d think that Big Public Health, 45 years into a campaign to get people to stop smoking, would be promoting all sorts of safe methods of nicotine delivery.

That’s not what happens.  Instead, the industry pours anathema on light cigarettes, smokeless tobacco, and other safer-than-cigarettes products.

The latest sermon is an article in this month’s The Nation’s Health — the newsletter of the American Public Health Association (APHA, which has turned into the High Synod of Public Health Religion).  The article  claims that “New Types of Smokeless Tobacco Present Growing Risks for Youth.”

The title is a double rhetorical turn now (alas) typical of APHA:  (1) your kids are going to die, and (2) the “risk” to them is increasing.  The piece would seem silly if the author, named Kim Krisberg, weren’t so serious.  After all, it isn’t kids who die from smoking, and the risk of smoking-related death isn’t increasing at all.  But we’re not in the realm of truth here.

Since Big Public Health isn’t dealing in truth when it comes to tobacco, evidence isn’t part of the story.   The head of the Campaign for Tobacco-Free Kids can say “the time to stop the spread of dangerous products is before they become the fad of today,” insouciantly sidestepping the fact that smokeless tobacco products aren’t dangerous.  Brad Rodu’s invaluable website Tobacco Truth explains — see Brad’s June 16th post, for instance.  Or go to this page at the excellent resource TobaccoHarmReduction, or see this article published in Cancer Epidemiology, Biomarkers & Prevention in 2004.

The public health industry’s animus for tobacco leads it to label as harmful something that is really a boon to public health — the increasing use of products that provide nicotine without burning tobacco.  Surely it’s better to have people chewing nicotine-containing products that won’t harm them than to allow them to continue smoking tobacco in order to get a nicotine dose.

Moralistic fervor makes you stupid.  Stupid enough to write, as two physicians with FDA’s Center for Tobacco Products did,

As state and local communities across the United States adopt indoor clean-air laws that restrict smoking in public areas and workplaces, the tobacco industry seems increasingly focused on the development and introduction of novel smokeless tobacco products

… as if the tobacco industry were magically making Americans who would otherwise stop smoking suddenly crave smokeless tobacco — and as if that would be bad for them.  Drs. Deyton and Cruz, you should know better.

But Matthew Myer with Tobacco-Free Kids isn’t unintelligent.  Nor, I assume, are Deyton and Cruz.  And I can’t imagine they really want people to suffer.

Still, do they really think that safe non-smoked tobacco products are going to bewitch our kids?  Do they believe that apocalypse comes in a package of smokeless tobacco?

Are they just so obsessed with battling tobacco companies that they’ve lost sight of the aim of public health, i.e., to reduce suffering?

Or is it simpler?  Has the public health industry’s big-money anti-tobacco campaign allowed too many people to make too good a living by saying stupid things about tobacco?

The cigarette manufacturers have been scurrilous, dastardly, and sometimes appallingly inured to the misery and death their products have hastened.  Maybe they deserve the Myerses of the world.

But the public health industry could be a lot more focused on helping people to live less painful lives, and less obsessed with its private demons.

As Carl V. Phillips suggests in a post this week, the FDA will have to break with the public health industry’s moralism if people who use nicotine are going to protect themselves from cigarettes.

If the FDA can’t overcome Big Public Health’s obsession with satanic tobacco rituals, re-introduce truth into the discussion, and re-focus on making real people’s lives less miserable, the zealots are going to turn stupidity into bad policy.