Philip Alcabes discusses myths of health, disease and risk.

Influenza, Epidemics, and Science

Back in March, thinking about the controversy over Gain of Function (GOF) research on influenza viruses, I suggested that the debate isn’t really about science, nor

about morals, no matter what some self-important researchers claim.   The debate is about who will be able to control scientific research and who will benefit from the consequences (including, presumably, vaccines or other marketable preventive agents).  Don’t be misled by assertions that the debate over GOF research is about public health, or ethics.  It’s about the usual:  political power and profit making.

Now that a new flu virus, H7N9, has caused over 130 human flu cases in the far east, with 37 deaths (per WHO’s summary of 29 May 2013), the questions on GOF studies might seem to take on new significance.

The insightful Guenther Stertenbrink brought me up on my assertions about GOF research, saying

I don’t see that connection and motivation, how they  (signatories) might benefit from flu-research reduction politically or financially,  the “marketable agents”…  And don’t you think this should be discussed by hearing both sides,  giving them the opportunity to reply, with links etc. to support the claims  ? Have you contacted them ?
I’m trying to estimate the pandemic risks and I’m in the process of contacting them to see the letter to the ethics commission, how the signatories and 200 nonflu researchers were selected and approached, what their expertise is to judge and weigh and assess and quantify flu-specific benefits and risks.

Stertenbrink is working assiduously to assess both real pandemic risks and the scientific issues involved in the GOF research debate.  He is hosting a useful colloquy  and has also posted a timeline of commentary and findings.

But I’m sticking to my guns.  Guenther is perfectly correct when he intimates that many of the complainants who ask that GOF flu research be controlled or curtailed have nothing financial to gain.  But it’s not true that they have nothing at all to gain.  In science, and especially in science that bears on public health, controlling the narrative is of nonpareil importance.

The only reason why external commissions should be convened to assess the possible dangers of success of GOF  experiments is to make sure that the “right” people get to control the narrative.  Because, really, to claim that the actual danger to humans arising from transfering genes in flu virions is knowable and predictable is to misrepresent the deep uncertainty in assessing risk. 

There are three consequences of indulging in this misapprehended risk assessment.

First, it creates a false voice of authority.  “We know that bad things are likely to happen with probability X if experiment Y succeeds” implies that “we” (the experts?) have knowledge beyond what is actually available.  People who have claimed to have exceptional knowledge have done some very, very bad things to the world.  All claims of extraordinary knowledge of the future are to be rejected, on moral grounds, in a civil society.

Second, the claim to be able to assess the risks of successful experiments works against the inspired tinkering of science.  If our civilization want to have science — and I think it should — we are going to have to live with some unwanted disasters, and with some people (scientists, I mean) doing unseemly things.  We may reasonably regulate what they do, in order to prevent animals from being tortured or people killed for the sake of science.  But we can’t expect that science will always be “well behaved,” in the sense of a well-behaved mathematical function.

Third, claims that GOF experiments are unethical are really assertions that some other kind of science is ethical.  Some other science, in other words, is closer to an imaginary Platonic sort of correctness.  Science, as Paul Feyerabend argued, is anarchic.  Properly so.  But that means there are no hard-and-fast rules of Truth.

As a result, Truth in science is usually the thing that the most vocal and powerful people agree on. If certain kinds of science (GOF research, in this case) are declared off limits because the powerful people, such as those who are doing other kinds of research and think GOF research should stop, deem it to be “unethical,” then it is a sure thing that the truths of the powerful will be the only Truth.  But why shouldn’t everybody  have their chance at Truth?

I stand by my assertion.  The debates over GOF research, just like debates over “ownership” of the MERS coronavirus sequence or the carefully constructed fear  over whether the world is  sufficiently frightened about MERS, aren’t about science, or public health, or ethics.  They are about who controls the narrative.


Further Feuding on Flu

My stand on prohibiting flu-virus research hasn’t changed: as I told the NY Times last year, even if flu experimentation is overseen by a group of so-called experts, it’s just not clear who should keep an eye on the experts.

And the question about minding the experts just got more complicated.

The issue has been whether researchers should be allowed to conduct experiments with modified strains of H5N1 (avian) influenza virus, in order to find out more about the potential for bird flu to spread among humans.  Concerned about possible dangers of experimenting with extra-transmissible bird ful, a moratorium on such research was declared.  The moratorium ended in late January of this year.

But now some distinguished scientists are calling for fuller constraints on this kind of research — called gain-of-function (GOF) experimentation, because it involves creating novel strains of viruses with capabilities not known to occur in nature.  The ostensible purpose of such research is to figure out how to prevent harm associated with inevitable genetic changes in viruses.  Think of it as creating disaster scenarios at the molecular level, so as to determine how to avert damage if the disaster comes to pass.

CIDRAP gives a nice summary of the new controversy, reporting that the Foundation for Vaccine Research, an advocacy group, has written to Dr. Amy Guttman, chair of the Presidential Commission for the Study of Bioethical Issues, raising what the Foundation says are “moral and ethical” concerns about GOF research.

An editorial by Simon Wain-Hobson in Nature the other day advances reasons why scientists should get together to limit GOF research.  Wain-Hobson questions the scientific validity of the predictions such research makes (since natural selection in the real world might produce changes in viruses quite unlike those manufactured in the lab), and criticizes WHO for failing to generate a broad discussion on the dangers of GOF research.

Then, he asks what will happen if the viruses created in GOF research leak out of a lab.  Who will take responsibility, who should make decisions, who should own the information arising from the research?  He says,

The global ramifications of GOF research have simply not been sufficiently explored and discussed. Influenza virologists are going down a blind alley and the powers that be are blindly letting them go down that alley, which is tantamount to acquiescing. So let’s be clear: the end game could be viruses more dangerous than the Spanish flu strain.

And Wain-Hobson goes on to propose a suspension of all GOF research until

virologists open up and engage in public discussion of their work and the issues it raises. Given that the flu community failed utterly to use the year-long hiatus to good effect, it is clear that an independent risk–benefit assessment of GOF work is needed.

Here is where it gets complicated.  One group of scientists (Wain-Hobson and the FVR) is angry with another group (the so-called flu community, basically those influenza researchers who conducted the 2011 H5N1 experiments and their defenders).

At the same time, both groups are unwilling to have government regulate research. In fact, Wain-Hobson worries because

Officials in Washington DC are putting the finishing touches to new guidelines for the review, regulation and oversight of this kind of research. The chill winds that we can anticipate blowing from policy-makers as a result could affect all of us who research viruses and their pathology.

The terms of the debate aren’t scientific, that is.  And they surely aren’t about morals, no matter what some self-important researchers claim.   The debate is about who will be able to control scientific research and who will benefit from the consequences (including, presumably, vaccines or other marketable preventive agents).  

Don’t be misled by assertions that the debate over GOF research is about public health, or ethics.  It’s about the usual:  political power and profit making.

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.



Vaccines & Autism: News?

Fascinating.  You can’t look at a newspaper or news feed without seeing today’s AP story on the finding of fraud in Andrew Wakefield’s vaccine-autism study.  CNN is into this story in a big wayHuffington Post ran the AP report.  Amanda Gardner at HealthDay picked it up, which means it will go into further syndication.  I can’t help wondering why it’s so important to put another nail in Wakefield’s professional coffin.

Or is it the vaccine-autism connection that’s supposedly being interred?

Probably both.

The BMJ opened the proceedings this week by publishing journalist Brian Deer’s investigative piece on the original Wakefield study of MMR vaccine and autism (Wakefield’s study was published in Lancet in February 1998).   That report had already been repudiated by Wakefield’s coauthors, and retracted in 2010 by the Lancet‘s editors after investigation of Wakefield’s procedures.  Wakefield is no longer allowed to practice medicine in the UK.   The Deer article was a parting shot.

An accompanying editorial by Fiona Godlee, Jane Smith, and Harvey Marcovitch, BMJ editors, was a well-taken and circumspect attempt at restoring confidence in measles immunization — on which, in their view, the work of Wakefield and colleagues had cast a shadow.  The editors might not be right in blaming the 1998 Wakefield study for contemporary parents’ reluctance to get their kids immunized, but their aim is to make a reasonable, if arguable, public health point.   To my reading, they haven’t got much of an axe to grind.

But then the whetstones began to turn.  Jonathan Adler at Volokh cheers, wondering if now the “vaccine-autism charade” will end.  Nick Gillespie is also celebratory, albeit more sedately, at Reason‘s blog.   

At Age of Autism, John Stone tries to undermine the journalist (Deer) who wrote the fraud story.  Stone is so rabid, and so ad hominem, in his attempts to destroy Deer that he manages to touch on not a single one of the reasons why it remains impossible to rule out a link between vaccines and autism.   Elsewhere at AofA, the UK group CryShame’s response is published; it too focuses on Deer’s methods, not the substance.

Evidently, substance is nobody’s concern here.  It’s about how news gets made.  Gary Schwitzer, a really sharp observer of the journalism scene, notes that journalists made Wakefield’s reports newsworthy back in their day, and are now “playing a key role in uncovering and dismantling” the story.

The vaccine-autism connection is news because it continues to get everyone riled up.

The defenders of vaccination (to judge by their vigorous celebration every time some further insult is visited on Andrew Wakefield) keep hoping that the suspicions of such a connection will go away.

The skeptics about governments’ medical policing of private lives invoke the possibility that vaccines are associated with a really high profile Bad Thing — like autism — to further their case.

The people who are crying out for an explanation for why so many kids function autistically remain unsatisfied.  (It’s not hard to see why they can’t get satisfaction:  policy makers, invested in mass immunization, don’t want to do the studies that would really find out whether or not the multiple vaccinations that kids are supposed to undergo today might be related to neurological changes.)

Of course, all of that has to do with the substance of the problem.  And what we’re seeing here, with Wakefield, with the revocation of his medical license last year, with this week’s fraud charge, and so on, isn’t substance at all.  It’s gloating or it’s grumbling.  Really, it’s not new.  But it’s news.

NYC: Unethical Research by Bloomberg Administration

I had missed this story when the NY Daily News broke it in September, but  the front page of today’s NY Times made it impossible to ignore:  Mayor Mike Bloomberg’s administration is conducting unethical experimentation on human beings.

The News describes the experiment very simply:

[New York City’s] Department of Homeless Services split 400 struggling families into haves and have-nots.

The “haves” get rental assistance, job training and other services through a program called Homebase.

The other half … were dubbed the “control group” and shut out of Homebase for two years. Instead, they were handed a list of 11 agencies and told to hunt for help on their own.

The aim of the experiment, allegedly, is to find out whether Homebase, a $23 million program, is effective.  The city’s Commissioner of Homeless Services told the Times that

When you’re making decisions about millions of dollars and thousands of people’s lives, you have to do this on data, and that is what this is about.

(If you thought that what it’s about, for a commissioner meant to deal with homelessness, is making sure that people have homes — you were so wrong.  Silly you.)

To make matters worse: what’s being tested is a program whose effectiveness the city has already asserted. As Mike, who blogs brilliantly on this and many related topics at SLO Homeless, notes:  the 2010 Mayor’s Management Report, issued in September, claimed that Homebase helped “ninety percent of clients in all populations receiving prevention services to stay in their communities and avoid shelter entry.”

So, to make sure this is clear:  New York City is deliberately denying a couple of hundred families access to an existing homelessness-prevention program that it has already declared to be highly effective.

The scenario is identical to one that kicked up storms of controversy in the medical-research world in the 1990s (neatly contextualized and summarized here):   experiments were conducted in Africa and southeast Asia supposedly to test the effectiveness  of an already-proven preventive regimen, AZT.  Administered during pregnancy, it reduced the likelihood of mother-to-fetus or mother-to-infant transmission of HIV.  In the poor-country experiments, half of the women enrolled got the effective regimen; the other half got placebo.

In other words, if you were pregnant and infected with HIV and you had had the wisdom to live in the U.S., you got a treatment that protected your infant from infection.  If you lived in a poor country you got:  studied.

There’s something about poor people, and especially about poor women with kids, that seems to make them smell like catnip to the always evidence-hungry technocrat cats.

Want to run a placebo-controlled trial?  Find something that already works (antiretrovirals, homelessness prevention, or, in other circumstances, syphilis treatment, TB prevention, etc.), then find a few women with kids who need it — then tell them you’ll flip a coin.  Heads, they get what they need; tails… well, too bad.

I’m a scientist.  I believe that evidence can be helpful.  Sometimes, it’s crucial.  When you’re truly unsure whether to pick prevention A or prevention B, data can help you to choose right and avoid harm.  That’s the great promise of science.

But sometimes the appeal to evidence is baleful — like here in Bloomberg’s New York, where evidence on homelessness is just a way of furthering the aims of the technocracy.  Which always means that some people will avoid harm.  Others will pay the price.

And the others are, so often, poor women with children.