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.

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?

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?

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.

Why Vaccinate Children Against Flu?

Scientists shill for vaccine manufacturers in doing routine research.  This week, HealthDay reports that University of Rochester researchers found lower flu-immunization coverage in states with less Medicaid coverage for vaccination.   Instead of asking whether pediatric flu immunization has any public health value, research like this assumes that flu immunization is useful.  It helps make sure the vaccine manufacturers sell more flu vaccine.

What is the value of mass immunization of children against flu?

CDC claims that flu is dangerous for children and recommends immunization.  This claim seems to be based on the 50 to 150 pediatric deaths attributed to flu each year.  Preventing children’s deaths is a good reason to immunize those who might get very sick were they to be exposed to influenza.

But to translate a small number of possibly preventable deaths into a national policy of mass immunization?  That takes a special relationship with the vaccine manufacturers (see here and here and here and here for my comments on the collusion of officials with pharmaceutical interests).

The evidence that flu vaccine is effective in children is shaky, as Dr. Tom Jefferson’s exhaustive scrutiny of study data reveals.  Immunization of children seems to be weakly effective at reducing influenza-like illnesses in a general population, as Ritzwoller et al. showed in a study published in Pediatrics in 2005.  Partial immunization was ineffective — an issue worth considering if more than a single dose is required.

A few studies suggest that mass immunization of children is a way to prevent flu among young adults.

A community trial of immunization of children against flu, published in Vaccine in 2005, showed the ineffectiveness of immunizing children:  there was no reduction in acute respiratory illnesses among children in the concurrent or subsequent flu seasons, compared to communities where kids were not immunized.  There were slight reductions in ARI incidences among adults in the community where children were immunized — but this study wasn’t designed to show whether it was the immunizing of kids that protected the adults, or something else.

Similarly, a 2000 study published in JAMA by Hurwitz et al. showed that flu immunization of children in day care had the effect of reducing acute febrile illnesses among household contacts, compared to household contacts of daycare attenders who were not immunized (abstract here, full article requires subscription).  So immunizing children in daycare might help their parents to avoid getting sick.

In general, there’s suggestive evidence that mass immunization of small children against flu lessens the impact of flu outbreaks among young adults.

But few young adults die of flu.  It’s an annoying and sometimes serious illness.  The reason the public health authorities are interested in preventing flu among young adults isn’t to reduce suffering; it’s to keep them from staying out of work.  Should we immunize children so that the nation’s economic machine doesn’t slow down?

To put it a little differently:  should we shift large amounts of taxpayer money into the hands of pharmaceutical and vaccine manufacturers for the purchase of flu vaccine for children, basically in order to spare employers the loss in profits that would arise when workers stay home?

The news from ProPublica this week, that they and associated journalists found many cases of physicians taking money from big pharmaceutical companies, is alarming but comes as no surprise.  ProPublica’s new searchable database shows that the seven pharmaceutical companies (collectively accounting for 36% of market share) that provided data together made $257.8 million in payments to physicians.

What’s more alarming is that pharmaceutical companies often don’t even have to bother paying to push their products.  That’s especially true when the product is a vaccine.  Even flu vaccine, despite its limited and highly variable effectiveness.  Policy decisions made by the Advisory Committee on Immunization Practices and CDC, practice decisions by medical organizations, research-grant funding, and so on are thoroughly organized around immunization.  Despite the evidence.