Philip Alcabes discusses myths of health, disease and risk.

W.H.O. and the Medical Industry

At EP-ology, Carl Phillips has a new post on the World Health Organization’s failure to care about suffering.   It’s worth reading — especially if you (still) believe that the WHO’s main aim is promoting health.

Phillips’s focus in that post is on a new WHO Atlas on headaches

and the problem that headaches cause people to stay home from work, or work less productively.   The agency estimates that Europe-wide, the lost productivity from migraines alone is worth 155 billion euros each year.  It isn’t that you feel crummy when your head hurts, and that chronic headache makes your life miserable.  It’s that you might not perform your expected per-capita service to the expansion of wealth.

Here’s how EP-ology assesses the agency:

The WHO is not the humanitarian organization that many people might think it is.  It is a special-interest medical-industry-oriented organization with an emphasis on the interests of governments, not people.  Its emphasis on productivity in looking at headaches … ignores people’s welfare…

Now, I can’t agree with Phillips’s analysis that the WHO’s ethical system is either “communist” or “fascist.”  For self-described public health agencies like the WHO to be concerned primarily with productivity and the generation of wealth — and only secondarily, if at all, with suffering — has been a hallmark of capitalism since the British Parliament passed the world’s first Public Health Act in 1848.

In fact, the laws institutionalizing public health in Britain in the late 1840s were passed by the Whig (liberal, more or less) government of Lord John Russell.  Public health was a legacy of efforts not by the nascent socialist and communist movements, but by radical capitalists — who sought to secure a moderately hale labor force to serve British industry with little cost to the factory owners.  And aimed to blame individuals for their own misery.

But it’s impossible to disagree with the main point of Phillips’s post:  WHO’s aim is to serve industry.

As further evidence, consider this follow-up note on Tamiflu by Helen Epstein, published in the May 26th issue of NY Review of Books (I discussed Epstein’s main article in a post last month).  It seems more and more apparent that potential dangers of Tamiflu (oseltamivir) in children were ignored.  Epstein reports that

the risks of delirium and unconscious episodes were indeed significantly elevated in children who took Tamiflu, especially if they took the drug during the first day or so after influenza symptoms appeared….  If these results are confirmed, they are especially worrying, since the World Health Organization and the US Centers for Disease Control both recommend that Tamiflu be taken as soon as possible after symptoms appear.

I was not the only one unaware of this important study; neither, apparently, were the World Health Organization, the US Food and Drug Administration, and the US Centers for Disease Control. When I contacted these agencies in January and February 2011, their spokespeople assured me that there was no evidence that Tamiflu causes neuropsychiatric side effects in children. [emphasis added]

In the rush to move taxpayer monies into the hands of wealthy private corporations, the WHO (with CDC and other agencies) proclaimed a flu emergency in 2009.  And ignored evidence on possible dangers of the products they were touting as part of the “preparedness” response.

Profiting from Preparedness

Don’t miss Helen Epstein’s brilliant exposé in the latest issue of The New York Review of Books. She shows how the profit motive shapes the “preparedness” industry — worth $10 billion worldwide in 2009 (the year of the Flu Pandemic That Wasn’t).

I’ve covered the profit-motivated thinking behind vaccine recommendations generally and specifically with regard to flu immunization.  Epstein’s main interest is in the role of pharmaceutical companies in promoting oseltamivir (Tamiflu®) and other neuraminidase inhibitors as public health responses to flu fears.  Her story features the brilliant work of Tom Jefferson and colleagues, and the shady behavior of the global biotech firm Roche in trying to block Jefferson et al.’s efforts to investigate the safety of neuraminidase-blocking agents.

Jefferson was lead author on the Cochrane Collaborations’ main paper on neuraminidase inhibitors for flu prevention and treatment.   But when reports of adverse effects of these drugs emerged and he and colleagues tried to re-assess the underlying reports on which the effectiveness of oseltamivir and similar drugs was based, Jefferson was stymied.  His colleague, Peter Doshi, related the story in BMJ.   The journal’s editor-in-chief, Fiona Godlee, along with Cochrane director Mike Clarke, wrote in an accompanying editorial:

The review and a linked investigation undertaken jointly by the BMJ and Channel 4 News cast doubt not only on the effectiveness and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted.

The take-home message is that while there is evidence that Tamiflu can be effective in treating flu, the evidence is shakier than it seems, and troubling reports point to potentially serious adverse effects.

How does a questionable medication get to be the basis (or part of the basis) for public health policy?  The answer is that the policy makers and the money makers work hand in hand.

Maryann Napoli at Center for Medical Consumers tried to point out the troubling links between WHO and big pharma last year, and Steven Novella at Science-Based Medicine brought it up around the same time.

But most of the coverage focuses on the involvement of individual scientists and/or physicians who are receiving payments or other forms of remuneration directly from drug companies.  It’s not hard to police such straightforward conflicts — and so it was easy for Margaret Chan, WHO Director-General, to say last year that “at no time, not for one second, did commercial interests enter my decision-making.”

Epstein’s great contribution is in showing that obvious conflicts of interest aren’t the main way that for-profit companies influence policy.  It’s done through stonewalling, as Jefferson encountered when he tried to examine Roche’s data.  It’s done through widely accepted collusions.

For instance, the CDC Foundation — “Helping CDC Do More, Faster” is its motto — is a nonprofit organization, created by the U.S. Congress, whose job is to

connect the Centers for Disease Control and Prevention (CDC) with private-sector organizations and individuals to build public health programs that make our world healthier and safer.

Of course, calling them “private-sector organizations” suggests that these are not-for-profits — and some, like the District of Columbia Department of Health, the Medical College of South Carolina, and UNICEF, really are.  But most of the private-sector collaborators who are linked with CDC’s policy makers by the CDC Foundation are big corporations.  They include all the giants of Pharma world:  Merck, Pfizer, Roche, Sanofi-Pasteur, etc.  (They also include some who are just giants:  Google, Dell, YUM! Brands, and IBM, to name a few.)

So when CDC’s updated flu response plan now recommends antiviral (i.e., neuraminidase-inhibitor) treatment “as soon as possible,” it’s worth asking whether this is because it has any public health value (answer:  no) or just because CDC is cozy with companies that make money when people get sick.

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.

USPHS Back in Bed with Big Pharma

Just in case you thought that the U.S. Public Health Service’s main interest is the public’s health:

Recently, Paul Sax reported at The Body on a plan to issue guidelines on the use of pre-exposure HIV prophylaxis (PrEP) using a combination of antiretroviral drugs, announced in the January 28 issue of CDC’s Morbidity and Mortality Weekly Report. The effect of issuing guidelines is to endorse the procedure, which will help enrich pharmaceutical companies — the first being Gilead, which makes Truvada (combination of tenofovir + emtricitabine).

Here’s the CDC’s rationale for issuing interim guidelines now, with formal guidelines to follow:

CDC and other U.S. Public Health Service (PHS) agencies have begun to develop PHS guidelines on the use of PrEP for MSM at high risk for HIV acquisition in the United States as part of a comprehensive set of HIV prevention services…  [W]ithout early guidance, various unsafe and potentially less effective PrEP-related practices could develop among health-care providers and MSM … [including]

1) use of other antiretrovirals than those so far proven safe for uninfected persons;

2) use of dosing schedules of unproven efficacy;

3) not screening for acute infection before beginning PrEP or long intervals without retesting for HIV infection; and

4) providing prescriptions without other HIV prevention support (e.g., condom access and risk-reduction counseling).

Translation:  if  CDC or another USPHS agency doesn’t do something now, homosexual men might not buy  as much medication as they could.

What’s the impetus for this guidance?   Results of the iPrEx study, which was supported by the National Institute of Allergy and Infectious Diseases at NIH, were published in the New England Journal of Medicine in December.  The study purported to show a 44% reduction in HIV incidence among men who had sex with men who were taking Truvada prior to sexual exposure.  But the study was so deeply flawed, and the authors so cagey about their methods, that it’s  impossible to conclude that Truvada makes any difference to the chances of acquiring HIV.

As the iPrEx trial’s logo implies

iPrEx

it was multinational, involving almost 2500 HIV-negative people who were male (at birth) and adjudged to be at high risk of acquiring HIV because of their pattern of sexual activity.  It involved sites in Peru, Brazil, Ecuador, South Africa, Thailand, and the U.S. The comparison was between subjects taking Truvada and subjects taking a placebo.

The famous 44% reduction, however, was clearly not obtained in each site — and the authors don’t state which sites showed more effect.  More importantly, the reduced HIV incidence among those taking Truvada occurred only for a small subset of subjects who stayed on the drug for more than a year without becoming infected.  And it only lasted for about one additional year.

In other words, in the iPrEx study, people who took Truvada and remained HIV-negative for a year were slightly less likely to acquire HIV in the following year than were those who took placebo and remained HIV-negative.

Finally, even the small, second-year-only effect of Truvada is of questionable use to men in the U.S.  Because the study was based on men living in places with extremely HIV prevalences — higher than those in much of the U.S. — and involved men having a large number of partners, it provided essentially no evidence for any utility in the U.S.

As other trials of pre-exposure chemoprophylaxis are going on now, other companies’ products are likely to be included in the final version of the CDC guidelines.  So more corporations can benefit from the largesse of the Public Health Service.

Condoms are very effective at interrupting HIV transmission.  Obviously, you have to use them (properly) in order to benefit from that effect.  Because people don’t like them very much, condom promotion is a poor public-health strategy.

But as a matter of guidance for men who have sex with men, in what way is it better for the USPHS to suggest Truvada, which has to be used consistently even when you’re not having sex, probably won’t take effect for a year or so, and even then will only give you a minor reduction in the chances of acquiring HIV — rather than condoms?

Answer:  it is if you’re trying to promote profits for the pharmaceutical industry.