Philip Alcabes discusses myths of health, disease and risk.

Disaster for Health Care Reform: Supreme Court Upholds Affordable Care Act

Chief Justice Roberts is the diabolical genius of free-market jurisprudence.  Reformers have been sucker-punched.  Any possibility of creating an equitable system for delivering medical care has been postponed for at least a generation.

Yet, liberals are rejoicing at yesterday’s Supreme Court ruling, in which Roberts left the three arch-conservatives (Thomas-Scalia-Alito) and Kennedy, to join the usually liberal wing (Brier-Ginsberg-Kagan-Sotomayor) in order to uphold the Affordable Care Act, the health care financing law of 2010.  Paul Krugman says that the “real winners are ordinary Americans — people like you.”

The celebration is misguided.  After yesterday’s ruling, there will be no national health system.  There will be no single-payer nonprofit insurance plan.  For the foreseeable future, diagnosis, treatment, and corporate profit will remain the inseparable triumvirate of medicine.  Hardly party-worthy.

Sure, there are a few things worth cheering about.  As Josh Levs set forth yesterday in a particularly cogent summary of the new law, insurers won’t be able to deny coverage to people with pre-existing conditions (young people immediately, everyone from 2014 on).   Until you’re 26, you will be able to get health insurance from your parents’ insurance policy, especially useful now with unemployment so high among the young.  Some of the “doughnut hole” in Medicare prescription drug reimbursements will be closed.

But Roberts’s brilliance was revealed in his handling of the vexatious issue of the mandate — the requirement that each non-indigent American purchase health insurance coverage or be fined by the Feds.  The fine would begin at $285 per family or 1% of income, whichever is higher, in 2014 but climb to over $2000 or 2.5% by 2016.  Instead of looking at the mandate and accompanying fine for noncompliance as a regulation, Roberts picked up on the fall-back argument adduced by Solicitor General Donald Verrilli, Jr. — he asserted that it’s really a tax.  And, of course, Congress can levy taxes.

At Slate, Tom Scocca explains that Roberts used his majority opinion on this case to undercut Congress’s right to regulate commercial activity.  For Scocca,

the health care law was, ultimately, a pretext. This was a test case for the long-standing—but previously fringe—campaign to rewrite Congress’ regulatory powers under the Commerce Clause… Roberts’ genius was in pushing this health care decision through without attaching it to the coattails of an ugly, narrow partisan victory. Obama wins on policy, this time. And Roberts rewrites Congress’ power to regulate, opening the door for countless future challenges. In the long term, supporters of curtailing the federal government should be glad to have made that trade.

According to CDC’s summary of the latest Congressional Budget Office estimates, about 30 million uninsured Americans will gain coverage under the ACA in the next few years, leaving about 27 million without health insurance at all.  That’s an estimate, because undocumented immigrants are untouched by the ACA.  Ditto prisoners, who supposedly get health care in their institutions but, by all indications, often don’t.

And, the Roberts ruling opens the door to questions about the Federal government’s capacity to get the states to expand Medicaid coverage.  Roberts and four justices say it’s limited.  Four others say it doesn’t exist at all.  As Charles Ornstein explains at ProPublica, that means that some states might simply refuse to expand Medicaid, which would undercut one of the aims of the ACA.

The final score is hardly a victory for “ordinary” Americans.

  • We now have a Congress that may tell Americans to give money directly to private corporations, or pay a penalty to the Federal government.  At least when Congress can claim that paying private corporations is in our best interest.  In other words, now private insurance companies may collect taxes.
  • We will have insurance companies that may continue to profit from Americans’ suffering.
  • We will still have nearly 10% of the population without access even to primary care.
  • We now have questions about whether Congress may impel the states to indemnify the sick poor.  (Hardly cause for optimism, especially at a time when states are seeking ways to lighten budgetary obligations, for instance by reducing pension benefits for public employees.)

And the Roberts ruling accomplishes this victory for corporate power by upholding the law, not striking it down.  That means that Congress won’t re-consider health care financing anytime soon.  Which means that the single-payer system will rest in its grave for the time being.

Yesterday was no cause for celebration.  It was a dark day for health care reform.

 

 

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.

 

 

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.

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?