Latest Drugwonks' Blog

Redlining Vaccines

  • 02.01.2012

If the people who make the decisions are the people who will also bear the consequences of those decisions, perhaps better decisions will result.

-- John Adams

On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.

(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)

And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:

“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.” 

Not so fast.

Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients.  That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).

ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”

The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.

In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.

The FDA recognized the importance of the adult indication for Prevnar 13 (currently the only vaccine for pneumococcal bacteria approved in the United States for adults 50 years of age or older is Pneumovax which is only effective against invasive pneumonia and not effective on the more common, pneumococcal pneumonia. Prevnar 13 is a conjugate which means it contains a pneumococcal bacteria bound to a protein to help the body’s immune system recognize the bacteria and will have a longer lasting immune response), but at the upcoming ACIP meeting (February 22-23), there is only a discussion of 13-valent pneumococcal conjugate vaccine. Just discussion.  That’s important – but a positive recommendation is crucial.  Otherwise it is, in many unfortunate respects, just talk.

The need for this patient population exists.  The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.

The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia.

As the saying goes, “Truth fears no questions.”

Remember when Obamacare was topic in chief in Washington?  Today, the administration and single payer supporters are avoiding the subject like the proverbial plague.

Hence,  Ken Abramowitz, our guest blogger reminds us of the pitfalls (and pluses) of Obamacare.   Ken is a co-founder and Managing General Partner of NGN Capital. He joined NGN Capital from The Carlyle Group in New York where he was Managing Director from 2001 to 2003, focused on U.S. buyout opportunities in the healthcare industry. Beginning July 2003, he transitioned to Senior Advisor at Carlyle in order to devote the time necessary to create a dedicated healthcare fund on behalf of Carlyle. Prior to joining Carlyle, Mr. Abramowitz worked as an Analyst at Sanford C. Bernstein & Co. where he covered the medical-supply, hospital-management and HMO industries for 23 years, after which he was an EGS Securities Healthcare Fund Manager. 

We look forward to his future posts on health care reform and medical innovation.

ObamaCare imposes European socialism “lite” on the U.S.  The plan involves 2,800 pages of legislation and, soon, 10,000-15,000 pages of regulation.  It is a massively underfunded $900 billion program that relies on stealing $500 billion from a grossly underfunded Medicare program and it does not recognize the $200 billion cost of offsetting the 21% Medicare physician cut.

Rather than making medicine more affordable, It will bend the cost curve upward by taxing insurance carriers, medical device companies, and pharmaceutical companies.  It also raises costs in the individual market by imposing insurance mandates (guaranteed issue, narrow underwriting bands, no lifetime benefit limits).

Worse it sets up grossly underfunded individual insurance exchanges that will quickly exceed projected spending.  therefore they eventually seek to control cost under dysfunctional price controls.  Thereafter insurance carriers will exit the market, tempting the government to take over as it did after the collapse of the housing market. These exchanges offer a costly defined benefit that is 65% subsidized by Federal and State governments, but should have been financed by a more affordable defined contribution.

On the positive side, the bill does provide genuine subsidies to finance and facilitate the “meaningful” use of EMRs and IT integration.  On the really positive side, the massive government overreach we will see voters continue to reject Obamacare as they did in 2010.   Hence, while the plan is guaranteed to blow up by 2015 fortunately 50% of the bill will be repealed before then. Though no one knows which 50%.


Former Obamacare czar Zeke Emanuel boldly predicts that health insurance companies will be obsolete in 2020 and be replaced by ACOs that focus on managing disease and health outcomes

Didn't we hear that in the 1970s when people like Emanuel were predicting insurance companies would become obsolete and be replaced by HMOs that would manage health and improve outcomes?

The faith in administrative changes or addition of regulation to improve, shape, control human behavior is particularly strong among health care policy experts of all stripes.   I believe that it is technological progress that makes certain types of care --  fee driven, intermediate or palliative treatments produced through hardware or in hospitals -- obsolete.   Think of how infectious diseases were generally treated less than 50 years ago,  the use of medicines instead of institutions for people with mental illness, same day surgery vs. the 5 day stay.   

ACOs were designed to be conduits for government produced guidelines that are biased against new technology.  They are organized against innovation, not to capitalize on it.  

As a result, I believe by 2020 not only will the current form of underwriting be obsolete -- because of advances in personalized medicine and direct to consumer delivery of healthcare --  but so will ACO's and Obamacare.   If you think it was surprisingly easy to overthrow Arab dictators wait till you and I know more about our health sooner than government bureaucrats who produce outdated guidelines and mandates. 

Here's a link to Zeke's article:

http://opinionator.blogs.nytimes.com/2012/01/30/the-end-of-health-insurance-companies/?nl=opinion&emc=tya1
Why does Roche want Illumina?

It's true that the cost of sequencing continues to follow Moore's law --  exponential decline in material and equipment costs and increased computing power -- so that what Illumina does with supercomputers is something that doctors and patients will be able to do with smartphones.   But Roche is not interesting in the hardware of sequencing.  If it did, it could just buy a bunch of machines for a lot less that $5.7 billion.

In fact, Roche knows that sequencing will become commonplace.  I think it wants Illumina because of it's partnerships with clinical labs worldwide to perform sequencing.  Distribution for Roche diagnostics and products -- as the firm focuses on targeted therapy -- is more valuable than equipment or sequencing.  Roche also sells glucose kits too and find that marketplace pretty lucractive. 

Should Illumina sell?  I don't know and have no opinion.  However, I remember when Yahoo snubbed a Microsoft acquisition for a hefty premium over it's share price.  Now Yahoo is scrambling to find a buy at a share price far below that offer.   Information is quickly becoming a commodity in health care.   In 10 years drug companies will be delivering individual content directly to consumers to treat illness.   Perhaps Roche believes it can be a source of revenue growth.  In any event, acquiring Illumina is about how medical care will be organized in the future, not about it's microarrays now.

Update on the Office of the Center Director and Office of Drug Evaluation1

CDER Staff:

I want to update you on recent changes in my Immediate Office to further enhance medical and scientific decision-making across CDER.  These changes also affect the Office of Drug Evaluation 1 (ODE1), Office of New Drugs.

I have asked Robert (Bob) Temple, M.D., to give up his role as the Acting Director of ODE1, so that he can devote more of his time and vast expertise to his other role as the Deputy Center Director for Clinical Science.  Ellis Unger, M.D., currently the Deputy Director of ODE1, will serve as Acting Director of ODE1.  Bob will continue as Acting Deputy Director of ODEI and plans to maintain substantial (but somewhat less) involvement in ODEI activities.

In November 2009, due to the growth of the Center’s responsibilities, I appointed Bob as the Deputy Center Director for Clinical Science with primary responsibility for high level initiatives and programs related to clinical science and clinical trial methodology issues.  At that time, Bob agreed to wear two hats and continue as Acting Director of ODE1.

As Deputy Center Director for Clinical Science, Bob has played and continues to play a major role in directing and executing many cross-cutting CDER functions, which enhance the quality and consistency of our operations.  Now he will have more time to further provide valuable regulatory input and methodological assistance across the Center.

I am grateful to Bob for serving ODE1 with excellence and superb leadership. I also am grateful that we have someone like Ellis to step in and assume the Office Director position on an Acting basis.  Ellis has been with CDER since 2004, serving in various leadership roles, and in the ODE1 Deputy Director capacity since August 2008.  I am confident that he will continue to serve ODE1 exceptionally well.

Janet Woodcock

Really interesting issue brief from CBO regarding approaches taken in various projects that help in attainment of demonstration goals:

Gather timely data on the use of care, especially hospital admissions. Programs that collected timely data on when their patients’ health problems developed or became exacerbated and where they were treated seemed better able to coordinate and manage their patients’ care. Those efforts could be strengthened if CMS improved its capability to provide programs with timely data on their patients’ use of services.

Focus on transitions in care settings. Programs that smoothed transitions (for example, by providing additional education and support to patients moving from a hospital to a nursing facility or between a primary care provider and a specialist) tended to have fewer hospital admissions.

Use team-based care. Demonstrations that provided close collaboration between care managers and physicians -- especially those with larger teams that included pharmacists, who could help patients manage their medications-- appeared to have fewer hospital admissions.

Target interventions toward high-risk enrollees. Programs that targeted interventions to beneficiaries they identified as being at greatest risk of being hospitalized—on the basis of medical condition, prior hospitalization, or predictive modeling—appeared to have fewer hospital admissions.

Limit the costs of intervention. To achieve federal budgetary savings, a program’s fees or bonuses must be smaller than its reductions in regular Medicare expenditures. There was nearly a threefold difference in the Medicare fees paid to different organizations that combined telephone and in-person contact to coordinate care, an indication that some organizations were able to deliver such interventions much more efficiently than others.

The complete CBO brief can be found here.

First, here's a blog from the Washington Post about two children diagnosed genetic disorders, one of them being Rick Santorum's 3 year old daughter Bella.

Bella Santorum, Amelia Rivera and ‘marginal’ children who prove no child is marginal


Republican presidential candidate Rick Santorum with his wife Karen. (Matt Rourke - AP)
GOP presidential candidate Rick Santorum’s youngest daughter, Isabella, is recovering at Children’s Hospital of Philadelphia after a bout of pneumonia forced her family to rush her to the hospital this weekend and her father to temporarily abandon the campaign trail.

Known as “Bella,” the 3-year-old was born with the genetic disorder Trisomy 18, which is often fatal for infants and leads to physical deformities and cognitive deficiencies.

In a strange coincidence, Bella is being treated at the same hospital that earlier this month made the news for its treatment toward another 3-year-old girl, Amelia (Mia) Rivera, who has the genetic disorder Wolf-Hirschhorn syndrome.

Rivera’s family said Children’s Hospital of Philadelphia officials told them their daughter was not eligible for a life-saving kidney transplant because she was “mentally retarded.” (I wrote about her story in a previous post here.)

Hospital officials will not comment directly on the case, but have said they do not have a policy of denying transplants to children with developmental delays. (Studies have shown such policies are a common, if unspoken and unethical, practice at many transplant centers.)

Hospital officials and the transplant team have also agreed to meet with Mia’s family.

Besides their conditions, ages and the venue in which they are being treated, the little girls share something else: Their stories have touched a public nerve.

In Bella’s case, her story was already well-known. Santorum has said that after she was born, doctors told him and his wife that they should let the girl die because she would never live a normal life. Controversially, he has linked that experience to his criticism of the Democrat-backed healthcare reform.

Santorum critics point out that healthcare reform expands coverage and will, in fact, help families in similar situations.

For Mia, her family’s fight to make her eligible for a transplant has brought her fame. Her plight has prompted tens of thousands to protest both her treatment and also the broader issue of discrimination in medical care.

Politics aside, if that’s possible, what’s most amazing about both these stories and all their similarities is that these two little girls, Bella and Mia, who have both been deemed marginal throughout their lives, are now part of the public discourse.

They are reminding us that children come in all shapes, sizes and forms. That even soft voices have merit. That children cannot be ranked for worth. Marginal? Not them.


The only problem with this beautiful essay is that under health care reform there are people who think that the plight of such children cause, well, a misallocation of resources.  In otherwords, why waste money on screening these kids, especially when they drive up health care costs.

Such is the attitude of Jean Slutsky, who is a senior offical at the Agency for Healthcare Quality and Research (AHRQ) and is on the PCORI methodology committee, which will determine how PCORI should conduct CER and what it should measure.  Slutksy, like other methodology committee members believe CER should be used to control health care costs.   (I will post on these other members in the future.)  Here's Slutsky opining on kids like Bella Santorum:

"Compelling stories of children who died from very rare metabolic disorders that might have been detected with newer, more expensive equipment have created powerful momentum for expanded screening of newborns. But in an era of constrained budgets, state policymakers need to weigh the benefits and costs of new screening programs against those of other equally important programs. Nonetheless, it remains politically risky to frame a health policy decision as being based primarily on cost or cost-effectiveness."

 

http://content.healthaffairs.org/content/24/1/102.full

Maybe it's politically risky because, as Slutsky's statement indicates, such decisions seem to focus on children with rare diseases who would be cheaper to care for if they weren't screened.  Sadly Slutsky's view about rationing care based on cost is shared among PCORI methodology mavens. 

And taxpayers pay for her salary?  Slutsky should resign from PCORI and AHRQ.

 

The Wyden–Ryan proposal—a foundation for realistic Medicare reform

Joseph Antos | The New England Journal of Medicine

The need for significant Medicare reform is increasingly evident, even to policymakers long accustomed to avoiding this politically explosive topic. A host of commissions and expert groups, ranging from the President’s National Commission on Fiscal Responsibility and Reform to the Heritage Foundation, have argued that the United States is on an unsustainable fiscal path. Medicare is at the center of our fiscal crunch, with outlays that have grown about twice as fast as the economy over the past decade, according to the Congressional Budget Office (CBO).

Even if the substantial reductions in payments to health care providers included in the Affordable Care Act (ACA) are fully implemented and Congress allows the 27.4% reduction in physician payments required under current law to go through, Medicare spending will continue to grow at unsustainable rates. It is more likely that Congress will not enforce such large reductions in provider payments, making Medicare’s drain on the budget that much greater. With the retirement of 76 million Baby Boomers over the next two decades, the program will consume an ever increasing share of the federal budget unless policies are adopted to bend Medicare’s cost curve.

On December 15, 2011, Senator Ron Wyden (D-OR) and Representative Paul Ryan (R-WI) released a Medicare reform proposal based on the concept of premium support.[1] Under their proposal,

Medicare would be converted from a defined-benefit to a defined contribution program. Instead of guaranteeing to pay for services as they are rendered, as fee-for service Medicare does, the program would give beneficiaries a subsidy (“premium support”) to purchase coverage from one of multiple competing health plans. The motivation behind the approach is to give plans a clear incentive to provide necessary services in a cost-effective manner, which can result in lower premiums or other beneficiary costs, attracting enrollees and increasing the plan’s share of the market.

The new proposal gives minimal bipartisan credibility to a concept that has long been championed by Ryan and that, in various forms, has been supported by experts on both sides of the political aisle.[2] It also represents a considerable compromise from Ryan’s earlier proposal, which was advanced as part of the House budget resolution last spring.[3]

Under the Wyden–Ryan proposal, seniors would have a choice of private plans competing alongside traditional fee-for-service Medicare. All plans, including traditional Medicare, would bid against each other, with premiums based on the plan’s cost of providing the full package of Medicare-covered services. The federal subsidy would be tied to the cost of the second-least-expensive plan in each market, which means that beneficiaries would have the option of enrolling in a less expensive plan and receiving a cash rebate. Anyone choosing a more expensive plan would pay the full additional premium out of pocket.

The subsidy would be greater for beneficiaries with greater health needs or lower incomes, and the average payment would increase with the growth in the gross domestic product (GDP) plus 1%. In addition, low-income beneficiaries who qualify for both Medicare and Medicaid would be protected from premium increases and would receive additional subsidies to cover their out-of-pocket expenses. As has been the approach with other reforms, this premium-support system would not take effect until 2022.

Wyden–Ryan is more realistic in some respects than Ryan’s earlier reform proposal. The most important change is allowing beneficiaries to opt for traditional fee-for-service Medicare if they so choose. Some conservatives criticize this change as backsliding.[4] They correctly see the traditional

Medicare program in its current form as inefficient and anticompetitive. But pretending that the program will disappear in 10 years feeds the worst tendencies of politicians, who would avoid making important but difficult decisions needed to set traditional Medicare on a fiscally sustainable path.

The reality is that traditional fee-for-service Medicare will probably have about 57 million enrollees in 2022, and it could remain a dominant force in the health sector for decades if seniors continue to enroll.[5] That is likely in rural locales and other markets that are dominated by a small number of providers. In such cases, health plans have little bargaining power and thus little ability to compete on price. In other markets where there is less concentration and more competition among providers, health plans should be better able to contract selectively and offer lower-cost options to seniors.

Ryan and Wyden hint at the need for commonsense reforms to traditional Medicare, including a new structure of deductibles and copayments, a cap on catastrophic costs, and a new physician-payment system. They skirt the central problem: a disorganized fee-for-service system and top-down limits on prices paid for services drive the use of more, and more complicated, services. The program’s survival depends on our willingness to make substantial changes over the next few years — before the major reform is implemented — so that traditional Medicare can provide cost-effective care without draining the Treasury.

The current proposal also offers a more politically palatable fiscal target at the cost of achieving fewer “scoreable” savings. Under Ryan’s earlier proposal, the federal subsidy would grow only with general inflation (1.5% in 2012, according to the CBO) instead of the more generous target of GDP plus 1% (a rate projected to total 4.8% in 2012). Not coincidentally, that is the same fiscal target established for the Independent Payment Advisory Board (IPAB) under the ACA.

A 3.3-percentage-point difference in fiscal targets translates to a 1-year increase in program spending of about $20 billion, or about $300 billion over 10 years. Adopting the weaker target means a substantial loss of budget savings, but only if Congress would actually enforce the stricter limits. That may be unlikely given recent history. Over the past 8 years, Congress has overridden even relatively small reductions in physician payments called for by the sustainable growth rate formula. Clearly, a favorable score from the CBO does not guarantee lower program spending.

Will this premium-support proposal based on full competition among private plans and traditional Medicare work? Some critics argue that premium support simply shifts the cost of care to seniors without improving the efficiency of health care delivery. That would be true only if there were no room to improve health care efficiency or if plans ignored opportunities to cut costs, increase market share, and improve their bottom lines.

Under a premium-support system, each additional test or procedure would not generate additional reimbursement from the government. Most Medicare beneficiaries live on fixed incomes and are not in a position to pay more. That reality will force health plans and providers to coordinate patient care and find other efficiencies rather than perpetuating the current fragmented system.

The Wyden–Ryan proposal offers a safety valve. If its critics are correct, then traditional Medicare, with its price controls and government regulations, will be the low-cost plan in every market. Beneficiaries will shift back to traditional Medicare when the cost differences become apparent, and the competition experiment will be declared a failure.

But one should not be fooled. If the alternative to market incentives is price controls wielded by the IPAB, access to necessary services will inevitably be limited, as providers seek more lucrative business.

Given the serious fiscal problems facing this country, slowing the growth of Medicare spending is no longer optional. The only question is how to do it. The Wyden–Ryan proposal outlines a strategy for Medicare reform that harnesses market forces to control costs. It provides a real alternative to the top-down controls favored in the ACA. Paul Ryan and Ron Wyden have defined the policy parameters that could be the basis for real Medicare reform in 2013.

Antos is the Wilson H. Taylor Scholar in Health Care and Retirement Policy at AEI. He also is a commissioner of the Maryland Health Services Cost Review Commission and a health adviser to the Congressional Budget Office.

[1] Wyden R, Ryan P. Guaranteed choices to strengthen Medicare and health security for all: bipartisan options for the future. December 15, 2011 (http://budget.house.gov/UploadedFiles/WydenRyan.pdf).

[2] The Debt Reduction Task Force. Restoring America’s future: reviving the economy, cutting spending and debt, and creating a simple, pro-growth tax system. Bipartisan Policy Center, November 2010 (http://www.bipartisanpolicy.org/sites/default/files/BPC%20FINAL%20REPORT%20FOR%20PRINTER%2002%2028%2011.pdf).

[3] House Committee on the Budget. The path to prosperity: restoring America’s promise. Fiscal Year 2012 budget resolution (http://budget.house.gov/UploadedFiles/PathToProsperityFY2012.pdf).

[4] Suderman P. Paul Ryan’s Medicare compromise. Reason.com. December 15, 2011 (http://reason.com/blog/2011/12/15/paul-ryans-medicare-compromise).

[5] 2011 Annual report of the boards of trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. May 13, 2011 (https://www.cms.gov/ReportsTrustFunds/downloads/tr2011.pdf).

Yet another example of shoddy 'research' confirming biases that are not established by evidence.

Tax on sugary beverages projected to have broad health benefits
A penny-per-ounce excise tax on beverage makers would mean reduced sales and rates of type 2 diabetes and associated health problems, a study says.

By Carolyne Krupa, amednews staff. Posted Jan. 24, 2012.


From the article reporting on the 'study'

"Forty states have sales taxes on soda, but they are too low to impact sales, said Dr. Y. Claire Wang, lead study author and assistant professor at Columbia University's Mailman School of Public Health in New York. California's tax is the highest at 7.3%. In many states, profits from the taxes are used to benefit health-related programs and low-income families."

Dr. Wang fails to tell us that while California has the tax rate on food as well as soda the prevalence of  kids classified as either obese or overweight (10-17) increased in the state while it decline in other states where the tax on food and soda is non-existent or lower.  

Social engineers like Wang want us to believe -- absent clear evidence -- that raising taxes on soda will reduce obesity and healthcare costs.  A glance at tax rates and obesity prevalence shows that it not so. 

http://archpedi.ama-assn.org/cgi/content/full/164/7/598

And of course every assumes an increase in obesity.  But is that absolutely true?  It turns out the prevalence of obese adults has remained the same from 2003-2008 with differences in the change of prevalence within enthnic and racial groups (as well as within states among similar ethnicities) according to a most recent CDC study that received almost NO media attention.

JAMA. 2012 Jan 20. [Epub ahead of print]

Prevalence of Obesity and Trends in the Distribution of Body Mass Index Among US Adults, 1999-2010.

Flegal KM, Carroll MD, Kit BK, Ogden CL.



Another question is:  how many kids are like I was.. chunky or overweight until I began in 6th grade to focus on my goal of playing for the New York Yankees. Changes in human development due to better access to food, medicine, safer environments do have changes in utero that can affect the prevalence of metabolic disorders.  Indeed, there is a pretty solid case behind the claim that BMI as a measure fails to take into account physiological improvements in food and other technological advances.   Americans are heavier and taller now than they were a century ago.   We live longer too.  The crusade against soft drinks and obesity fail to adjust for what economist Robert Fogel demonstrates is "a positive effect of stature and BMI on" life expectancy and output. 

Now I am not saying that obesity isn't a problem or not linked to increased morbidity.  What I am suggesting is that the way to keep weight under control is the combination of education, awareness, exercise and diet.  Taxes that target any one food or drink or any amount thereof are not only an invasion of freedom but they will be useless. 

 




In my last post I wrote about heuristic biases that lead to wrong and even dangerous conclusions.  The one bias that runs rampant in media reporting of science, (Gary Schweitzer -- who claims he is objective -- is the worst offender) is relying upon single studies with small sample sizes that claim statistical significance (internal validity) to make a sweeping judgement about the dangers of chemicals, soda, medicines, etc.    

This week a single study, "Serum Vaccine Antibody Concentrations in Children Exposed to Perfluorinated Compounds" was published in JAMA http://jama.ama-assn.org/content/307/4/391 this week claiming that "elevated exposures to PFCs were associated with reduced humoral immune response to routine childhood immunizations in children aged 5 and 7 years. "    The research is the only study to look at PFC levels over time in humans.  The handful of other studies have only looked at the relationship betwee immune suppression in rats at human PFC levels.    Blood samples in this study were  taken to measure PFC levels in maternal pregnancy serums and then at age of 5 and 7.    There was no regular monitoring of serum levels from birth to age 5 or 7 nor from age 5 to 7.   The group was not compared to controls with different serum levels and antibody response.   So the results are just as likely to be random as they are to be suggestive.  

But that didn't stop JAMA or media outlets to sound the alarm using the heuristic of representativeness and small sample sizes to draw conclusions about probablities that are not supported by the evidence:


Chemical Contaminants Linked To Low Immune Response To Vaccines  MedicalNewsToday


Chemicals linked to lower vaccine response in children‎   AFP


Vaccine effectiveness reduced by common environmental toxin .   Boston Globe


However, Liz Szabo at USAToday provides the most balanced evaluation of the study and frames the coverage by calling to the limited sample size and the absence of causality.

http://yourlife.usatoday.com/health/story/2012-01-24/Chemical-exposure-may-compromise-vaccine-response/52774114/1

Chemical exposure may compromise vaccine response

"Children exposed to chemicals called PFCs — used in some non-stick cookware, stain-resistant coatings, fast-food packaging and microwave popcorn bags — have a reduced response to vaccines, raising the possibility that the compounds could prevent children from being adequately protected against disease, a new study shows..."

She goes on to cite Paul Offit, a straight shooter and great guy (even though he is a Phillies fan) and to point out that PFC levels are decreasing:

"Grandjean acknowledges that his study's design doesn't definitively prove that PFCs compromise children's vaccine response. It's possible that something else affected their response, says Paul Offit, chief of infectious disease at Children's Hospital of Philadelphia. For example, it would help to know if children with higher PFC levels have any basic immune system problems, independent of vaccines.

The EPA and chemical industry phased out U.S. production of one of these compounds, PFOS, or perfluorooctane sulfonic acid, in 2002. Since then, blood tests show that exposure to this chemical have declined, Grandjean says. Manufacturers are in the process of phasing out another major compound, called PFOA, or perfluorooctanoic acid.

"But other PFCs may be increasing," Grandjean says. "PFOS is now produced in large amounts in China."


In the past, Ms. Szabo has also been relentless in her coverage about the science behind the public health benefits of vaccines.   Great work then and now.

 

 

More vaccine coverage:

Continuous coverage by health reporter Liz Szabo on the myths and benefits of vaccines.





CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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