Philip Alcabes discusses myths of health, disease and risk.

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.

By Philip Alcabes | April 22nd, 2011 | Categories: Disease, epidemics, flu, Outbreaks, public health | Tags: , , , , , | 1 comment

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?

By Philip Alcabes | March 25th, 2011 | Categories: Behavior, Health Professions, obesity, public health, Risk | Tags: , , , , , , , , , | 8 comments

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.

By Philip Alcabes | February 13th, 2011 | Categories: public health, Uncategorized | Tags: , , | Comments Off on USPHS Back in Bed with Big Pharma

Vaccine Crusaders Arm for Battle

I’m not sure I want to feel sorry for Andrew Wakefield — a nudnik, possibly even a charlatan.   And although I worry that MMR vaccine, especially as part of the intense dosing schedule for childhood vaccination overall, might have bad effects on some kids’ immune systems,  I’m not categorically opposed to immunization.

Still, it’s hard to avoid wondering:  is Wakefield right when he alleges that he’s being persecuted by the vaccine industry?

Last week, I discussed the BMJ article by Brian Deer asserting that Wakefield’s research was fraudulent, and the accompanying editorial supporting immunization.  At that point, I thought that the BMJ pieces were, together,  a one-off.

I was wrong.  In fact, it looks this week like the vaccine industry has armed some of its main warriors and sent them out to do battle.

The Battle Against Anti-Vaccinationism

In the Jan. 13th issue of the New England Journal of Medicine, two powerful chiefs, Gregory Poland and Robert M. Jacobson, claim that there’s an “age-old struggle” to make vaccines available.  Their aim is to vilify the “antivaccinationists” who “have done significant harm to the public health.” [Note the use of the holy article in this phrase, to signal just how sacred these warrior-priests hold “the” public health to be.]

The Poland-Jacobson piece is pure propaganda.  Theirs is a tale of heroic struggle on the part of ever-embattled Believers against the satanic forces of Antivaccationism — who have been trying “since the 18th century” to shake people’s faith in the vaccine gospel.  And nowadays the nasty antivaccinationists are using scarily modern forms of communications, such as TV and the Internet, in order “to sway public opinion and distract attention from scientific evidence.”

Wow:  TV and the web.  Sounds satanic alright.

I guess I shouldn’t be surprised that a couple of crusaders make their own work sound salvationist.  What troubles me is that they make it sound like they’re disinterested do-good-ers.

In fact, Poland and Jacobson are in bed with Big Pharma.  Poland runs the Mayo Clinic’s Vaccine Research Group.  Although as far as I can tell, Poland and Jacobson are not currently in the direct pay of the vaccine manufacturers, they and the VRG have benefited handsomely from vaccine makers’ largesse.

For instance, Poland’s and Jacobson’s work on human papillomavirus vaccine, as they acknowledge in a 2005 Mayo Clinic Proceedings paper, was funded by Merck, and their co-workers were Merck employees.  Later, in conjunction with a continuing medical education module on meningococcal vaccine in 2009, Poland disclosed the following ties:

Sources of Funding for Research: Merck & Co, Inc, Novavax, Inc, Protein Sciences Corp; Consulting Agreements: Avianax, LLC, CSL Biotherapies, CSL Limited, Emergent Biosolutions Inc, GlaxoSmithKline, Merck & Co, Inc, Novartis Vaccines, Novavax, Inc, PowderMed Ltd

And on his disclosure form for this week’s NEJM article Poland acknowledges funding from Pfizer and Novartis for vaccine studies.

So when Poland and Jacobson write that our society “must continue to fund and publish high-quality studies to investigate concerns about vaccine safety,” they’re really talking about preserving their livelihood.  It’s very much in their interest to ensure a steady flow of such funding.

And when they say that “society must recognize that science is not a democracy in which the side with the most votes or the loudest voices gets to decide what is right,” they’re being completely disingenuous.  Because Poland and Jacobson know quite well why science is not a democracy:  in the type of research they do, it’s the big money that decides what is right.

A High Priest of Vaccine “Science”

Then there’s Paul Offit making the rounds.  Offit has been the subject of lots of attention by Age of Autism, most recently as a “denialist.” Offit probably profited somewhat from the licensing of Rota Teq vaccine, which he helped invent — although AofA’s allegation that he is therefore beholden to Merck seems unsubstantiated.

What’s obvious about Offit is that he is contemptuous of people who don’t agree with his version of truth.

Offit appeared on Lenny Lopate’s radio show in New York yesterday, and presumably will be appearing elsewhere.  His aim is to explain the “grave public health problem of vaccine avoidance.”  The “anti-vaccine movement threatens us all,” he says.  In fact, that’s the subtitle of his new book, Deadly Choices.

Where Poland and Jacobson are militant and sanctimonious, Offit sounds a note at once sentimental and officious.  It’s “tragic” that there have been measles outbreaks because of parents refusing to have their kids vaccinated, he says.  And the problem is that people just don’t understand science.  In fact, Dan Olmsted at AofA gets it quite right when he critique’s Offit’s blinkered version of science:

Anyone concerned about [possible harms of vaccination] fits Offit’s definition of anti-vaccine, because vaccines don’t cause any of them, because Paul Offit says so, a solipsism that is really quite breathtaking: “[B]ecause anti-vaccine activists today define safe as free from side effects such as autism, learning disabilities, attention deficit disorder, multiple sclerosis, diabetes, strokes, heart attacks, and blood clots — conditions that aren’t caused by vaccines — safer vaccines, using their definition, can never be made.”

I had the same reaction to Offit’s self-important — and, to my mind, unscientific — claims.  Offit shows no interest in the open inquiry that marks science.  People who don’t agree with him are uneducated, poorly informed, maybe just stupid.  And, of course, dangerous.

“Tragic” Consequences of Unbelief

On the Lopate show, Offit resorted to the now-common formula of the “tragic” consequences of parents’ belief in Andrew Wakefield.

What’s the tragedy, exactly?   It’s true that there have been outbreaks of measles in the British Isles that have been traced to parents’ refusal to have their children immunized.  An excellent review in BMJ in 2006 provided some of the data for the U.K. — including that one child died in a 2006 measles outbreak that was related to poor immunization coverage.  A few children died in Ireland in 2000.  A CDC account of a measles outbreak in California in 2008 reports that it hospitalized a few children, although none died.

It would be great if nobody ever died from an infection that could be prevented in any way.  It’s surely tragic to the parents of a child who dies from a preventable infection.   The sympathies of each of us should go out to such parents, as to those whose kids are killed by bad drivers, sports injuries, or infections for which there’s no vaccine.

But in what sense is one child’s death more of a collective “tragedy” for all of us than the other deaths that go unremarked every day?   Why is it tragic when one child dies of a vaccine-preventable infection and not when a lot of them die of poorly regulated handguns or as troops fighting wars that never endanger our leaders, only our young?

The Ramp-up of Aggression by the Vaccine Crusaders

Why are the vaccine warriors rampant now?  Perhaps the vaccine makers are terrified that the low uptake of H1N1 flu vaccine despite all the hype in 2009, along with low MMR compliance in some places (the U.K. especially), means that their profits are going to slide.  Maybe their friends, like Offit and Poland, are worried that reduced uptake of vaccines will translate into diminished research funding or fewer conferences in delicious places.

Or maybe the vaccine industry finds Wakefield so obstreperous that they can’t rest until he is destroyed. Wakefield’s no choir boy, but he might not have realized just how much control the pharmaceutical industry can exert in the U.K.

In a review essay in last week’s New York Review of Books, Simon Head points out that Big Pharma is “the only major segment of the British economy that is both world-class and an intensive user of university research,” and implies that it exerts control over both the substance and volume of U.K. research productivity, especially in medicine.  Head sees reason to believe that Pharma will “tighten its hold over scientific research in the UK” in the future.

It’s Not a War

There need be no either-or about vaccines.  If our society can live with guns and automobiles (together accounting for roughly 50,000 American deaths a year), if we tolerate alcohol, processed foods, acetaminophen, high-rise construction, and all the other things that occasionally cause harm but mostly contribute to the way of life we prefer — then we can stop calling it “tragic” when a few parents don’t have their kids immunized.

Because to call one measles death “tragic” is to further the vaccine warriors’ campaign — the campaign that pretends to be on behalf of science or healthy kids, but is really fought to protect the fortunes of vaccine makers.

The campaign protects the power of shiftless public officials who claim to be protecting the public from harm when they serve up millions of taxpayer dollars to vaccine manufacturers for barely useful vaccines (H1N1 2009), or for vaccines that are undoubtedly helpful but might be harmful in some cases and haven’t been thoroughly examined (HPV vaccine).  And who, to this day, won’t even consider the very good question that Andrew Wakefield posed in the 1990s:  is it a good idea to give kids three immunizations in a single preparation?

I had my child immunized when she was the right age for that.    But I’m not certain that absolutely everyone has to do the same.  Neither are the courts, which is why they allow exemptions from immunization for personal belief.

I don’t think measles is a menace to civilization.  I know that only a very tiny percentage of children who contract measles get dangerously sick from it, that flu vaccine doesn’t work for everyone (and isn’t an effective public health measure to stop flu outbreaks even though it can protect individuals from illness), and that varicella vaccine can make the problem of shingles worse even though it reduces the problem of chicken pox.  And so forth.

I mean that immunization is complex and fraught.  Not everyone can be expected to agree with every vaccine recommendation.   Even while some people are opposed to vaccination and refuse to immunize their kids, life will go on, and society will continue to thrive, and Paul Offit can continue to say arrogant things about “science.”

So, could someone please call off the crusade?

By Philip Alcabes | January 14th, 2011 | Categories: autism, Disease, epidemics, Health Professions, Outbreaks, Physicians, public health, science | Tags: , , , , , , , , | 2 comments

Cholera: A Shame, Not a Whodunit

Titling Maggie Fox’s article on the source of the Haitian cholera outbreak “Whodunnit?,” Reuters makes distraction the main attraction.

Finger pointing about the “cause” of the outbreak — finger pointing at Nepalese peace keepers, the UN mission, relief workers, or Haitian health workers — is a way of avoiding the fundamental problem:  insufficient political will to create working infrastructure for poor countries.  Haiti being the leading example, the cholera outbreak being the case study.

Given how shaky the living arrangements have been for many Haitians since the January earthquake, given the pre-existing destitution and the anemia of efforts to fix that, it’s a tribute to the Haitian health system that cholera didn’t break out until October.  It might have been much sooner.

But now that cholera is spreading, it seems that more energy is going into using the outbreak to whip up political animus in, and about, Haiti than to figuring out how to make sure it doesn’t happen again.

This week, the politicization of the cholera outbreak seems to get worse by the day (Crawford Kilian’s cholera coverage at H5N1 continues to keep abreast of both the cholera outbreak and the political uses it’s being put to).   I talked to John Hockenberry and Celeste Headlee about this on The Takeaway yesterday, pointing out that the problem is social crisis, not Nepalese troops.  It’s poverty, lack of adequate sanitation, poor access to clean water — not foreigners.

Here’s the segment of The Takeaway:

In contrast to the misleading headline of Reuters’ piece, what Ms. Fox covers is not the (pseudo) mystery of “who brought cholera to Haiti?”  It’s the effort by CDC, the Haitian health ministry, and PAHO to determine whether the outbreak likely started from a single source or multiple ones.

The findings are reported in the Morbidity and Mortality Weekly Report this week:  Haitian cases all carried Vibrio cholerae of the O1 serogroup, serotype Ogawa (a very common strain), with DNA of a single pulse-field gel electrophoresis pattern.  Because of the propensity for mutation or recombination events in the reproduction of bacteria, it would be extremely unlikely for different people to be carrying bacteria with the identical PFGE pattern unless they had all been exposed to an identical strain.  [N.B.  Strictly speaking, cholera is not an infection:  the illness results from poisoning by V. cholera in the intestine, not from actual infection of tissue.  Therefore I write “exposed to” rather than “infected by.”]

Based on the findings so far, CDC and its partners concludes that the outbreak probably began with a single strain.

Did this strain arrive in cholera recently, or has it been around for some time and only recently came to attention as a cause of mass morbidity and mortality?  Did it arrive in a person and contaminate the environment via feces, or arrive in food or water?  Was there a single initiating exposure, or did cholera arrive inside multiple people or food items?  As Fox points out, the study can’t answer these questions.

It makes sense to seek information on how the outbreak got started in order to plan for better systems to prevent future outbreaks.  CDC is on the right track here.

But by calling this a whodunit, Reuters is pandering to people who want to inflame tempers, not spreading information about what can be done to make Haiti healthier.  Shame on you, Reuters.

By Philip Alcabes | November 19th, 2010 | Categories: epidemics, News, Outbreaks, public health | Tags: , , , | Comments Off on Cholera: A Shame, Not a Whodunit

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