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.



Bean Counting HIV Infections

Larry Kramer told the NY Times today that there is no  AIDS policy in the U.S.  To which  Kevin Fenton, the aimless director of CDC’s AIDS efforts, replied, non-sequitur-ly, “CDC is not resting.”

The occasion was CDC’s publication in PLOS One of new figures claiming that the annual number of new HIV infections in the U.S. is only around 50,000.

And if you read the CDC’s new Fact Sheet on HIV infection, just posted, you find out that

The current level of HIV incidence in the United States is likely not sustainable. Prevention efforts in recent years have successfully averted significant increases in new HIV infections, despite the growing number of people living with HIV and AIDS who are able to transmit the virus.

CDC English is a little difficult for native speakers to interpret, but I think that the translation of “likely not sustainable” is:  “we need more money or else the incidence is going to go up.”

Now, 50,000 new HIV infections each year is bad news for 50,000 Americans.  But on a population basis, it’s not a very high number.  The HIV prevention industry will wring its hands, and perhaps Mr. Kramer will, too.  They can all grumble that after 30 years of AIDS there should be no new infections at all.   But that’s ridiculous.  A pipe dream.  HIV is a sexually transmissible infection.  And STIs can’t be eradicated — because, well, people have sex.  No matter what.  And sometimes the kind of sex that isn’t recommended by the experts. With the wrong people.  And so forth.

Really, that there are only 50,000 new infections each year is a sign of (a) the low inherent infectiousness of HIV and (b) Americans’ sharp awareness of how to protect themselves from HIV infection.   It’s not really clear that any new prevention is needed.

What is needed:  get effective treatment into more HIV-infected people.   Obviously, to slow the progression of HIV-based impairment in the individual — but also as a public health measure, to reduce the HIV carrier’s infectivity and thereby reduce the probability of transmission.  It would have medical value and public health value.  But there’s not much policy on that.

CDC officials are bean counters, not policy makers.  That’s why, Mr. Kramer, your expectations are too high.  The CDC’s job is not to do anything about AIDS.  CDC’s job was never to do anything about AIDS.  CDC’s job was, and is, and presumably will always be:  to keep CDC in business.

They’re terrific bean counters, obsessive, scrupulous, punctilious, completely absorbed in their own assumption that their data are a source of truth, committed to deciphering the supposedly unequivocal message the data send.

The message, always, is “CDC needs to do more of what it’s been doing.”

I gave the CDC a hard time in August 2008, when the agency published its estimate that there are 56,000 new HIV infections in the U.S. each year.  That seemed too high, I told the NY Times at the time.  Of course, it was useful for the CDC’s rudderless AIDS division to claim that HIV incidence was higher than everyone thought:  suddenly, lots of people were urging that HIV  prevention programs be beefed up.

Now, the agency has backpedaled. The 2006 incidence wasn’t 56,000 after all, the CDC now figures, it was only 48,000.  And anyway 56,000 is the same as 48,000, the agency now says.

Let me summarize:  Back in 2008, the CDC’s estimate supposedly showed that prevention wasn’t working, so the agency needed to do more of it.  The new estimate, which is almost the same as the old estimate, shows that prevention does work, so the agency needs to do more of it.  All CDC calculations point to the same conclusion:  keep CDC in business.

If CDC were interested in the nation’s health, more so than maintaining its meager status quo, it would be advocating for more treatment (to Donald McNeil’s credit, he makes that point in today’s NYT article).

And if CDC were interested in HIV as a public health problem, and not just in bean counting for the purposes of keeping itself in business, it would stop putting its beans into 30-year-old jars.  What’s the point of the tired “race/ethnicity” breakdown?  Does anybody know anymore how to categorize people into the ancient non-Hispanic-black/Hispanic-including-black/non-Hispanic-white codification?  Does anybody know what it means?

And the famous transmission categories, the MSM-IDU-heterosexual-other breakdown:  that was useful early on, when we weren’t sure that the modes of communication of HIV were fully known.  But that era ended in 1985.

Dear CDC:  Could you please put your beans into some useful jars?

No, it’s asking too much.  Because CDC’s aim isn’t to be useful.  It’s to keep counting beans exactly the way it knows how to count them, and put them into the same jars as always, and keep on concluding that the data — the beans — show that CDC must keep on doing exactly what it has been doing.