Category Archives: Health

Economist article about end of life planning

One of my students today just sent me this link to an article in this week’s Economist about end-of-life planning.

How to have a better death

http://www.economist.com/news/leaders/21721371-death-inevitable-bad-death-not-how-have-better-death

It led me to also view its link about conversations about serious illness by one of my favorite authors.

“Serious Illness Conversation Guide” drawn up by Atul Gawande

I also found these slides targeting providers informative as well.

Using the Serious Illness Conversation Guide – HealthInsight

I found it informative that CMS (Medicare) created two new Advance Care Planning (ACP) codes. It will be interesting to see how often they are used.

Two new codes created in 2015, allowed for payment by Medicare in 2016.

  • 99497 ACP 30 minutes $85.99
  • 99498 ACP additional 30 minutes $74.88

CPT describes eligible services as being performed by a physician or “other qualified health professional” which means a physician, NP or PA.

We could save a lot of money and improve happiness and quality of life if more doctors, nurses, families and patients talked about these issues.

 

#stupideconomics and Healthcare Triage on the AHCA

Two interesting links related to the recent Republican health care proposal called the AHCA.

The first is a serious but also humorous Forbes article by my BU colleague Larry Kotlikoff in his series about Stupid Economics, this one targeting Tom Price and the AHCA bill. (A 3-minute read.)

Tom Price's Liver And 'The Coverage They Want'

The second is an excellent Youtube summary of the CBO forecasts (called “scoring”) of the effects of the AHCA by pediatrician Aaron Carroll.

Healthcare Triage: Results Are In! Congressional Budget Office Scores the American Health Care Act

Posted: 17 Mar 2017 06:09 AM PDT  Text of the report here.

(Broadcast is eight minutes.)

Facts about Tom Price, HHS nominee

Health economists and every concerned citizen should disseminate the facts in this NEJM article about Donald Trump’s nominee of Tom Price to be the next secretary of HHS.
Coauthor Richard Frank is also a BU Ph.D. alum!

Randy Ellis

 

Care for the Vulnerable vs. Cash for the Powerful — Trump’s Pick for HHS

Sherry A. Glied, Ph.D., and Richard G. Frank, Ph.D.

New England Journal of Medicine

December 21, 2016DOI: 10.1056/NEJMp1615714

http://www.nejm.org/doi/full/10.1056/NEJMp1615714#t=article

 

Since there is no abstract, here are the first two paragraphs.

Representative Tom Price of Georgia, an orthopedic surgeon, will be President-elect Donald Trump’s nominee for secretary of health and human services (HHS). In the 63-year history of the HHS Department and its predecessor, the Department of Health, Education, and Welfare, only two previous secretaries have been physicians. Otis Bowen, President Ronald Reagan’s second HHS secretary, engineered the first major expansion of Medicare, championed comparative effectiveness research and, with Surgeon General C. Everett Koop, led the fight against HIV–AIDS.1 Louis Sullivan, HHS secretary under President George H.W. Bush, focused his attention on care for vulnerable populations, campaigned against tobacco use, led the development of federally sponsored clinical guidelines,2 and introduced President Bush’s health insurance plan, which incorporated income-related tax credits3 and a system of risk adjustment. In their work at HHS, both men, serving in Republican administrations, drew on a long tradition of physicians as advocates for the most vulnerable, defenders of public health, and enthusiastic proponents of scientific approaches to clinical care.

Tom Price represents a different tradition. Ostensibly, he emphasizes the importance of making our health care system “more responsive and affordable to meet the needs of America’s patients and those who care for them.”4 But as compared with his predecessors’ actions, Price’s record demonstrates less concern for the sick, the poor, and the health of the public and much greater concern for the economic well-being of their physician caregivers.

Since the NEJM full article  requires a subscription, here is a summary what they document:

Price has sponsored legislation that

  • supports making armor-piercing bullets more accessible
  • opposes regulations on cigars
  • Repeals and replaces the ACA (see details below)

Voted  

  • Against the Affordable Care Act (ACA)
  • Against regulating tobacco as a drug
  • Against the Domenici–Wellstone Mental Health Parity and Addiction Equity Act
  • Against funding for combating AIDS, malaria, and tuberculosis
  • Against expansion of the State Children’s Health Insurance Program
  • In favor of allowing hospitals to turn away Medicaid and Medicare patients seeking nonemergency care if they could not afford copayments
  • Against reauthorization of the Violence Against Women Act
  • Against legislation prohibiting job discrimination against lesbian, gay, bisexual, and transgender (LGBT) people
  • Against enforcement of laws against anti-LGBT hate crimes.
  • Against expanding the NIH budget
  • Against the recently enacted 21st Century Cures Act

Price stated views:

  • Favors converting Medicare to a premium-support system
  • Favors changing the structure of Medicaid to a block grant program
  • Favors amending the Constitution to outlaw same-sex marriage
  • Opposes stem-cell research
  • Inconsistent in supporting investments in biomedical science.

His proposal for repealing and replacing the ACA is H.R. 2300, the Empowering Patients First Act,5 which would

  • Eliminate the ACA’s Medicaid expansion and
  • Replace ACA subsidies with flat tax credits based on age, not income
  • Be regressive, with larger subsidies for high than low incomes.
  • Credits would pay only about one third of the premium of a low-cost plan
  • Credits proposed are smaller than those proposed by President Bush in 1992, and will not be sufficient to get most people to buy health insurance
  • Eliminate the guaranteed-issue and community-rating requirements in the ACA, with ineffective substitutes.
  • Withdraw almost all the ACA’s federal consumer-protection regulations, including limits on insurer profits and requirements that plans cover essential health benefits.
  • Allow the sale of health insurance across state lines, effectively eliminating all state regulation of health insurance plans
  • Fund his plan by capping the tax exclusion for employer-sponsored health insurance at $8,000 per individual or $20,000 per family, caps that are lower than the unpopular Cadillac tax in the ACA, which Price himself has voted to repeal, and hence is unlikely to ever be approved
  • Directly advance physicians’ economic interests by permitting them to bill Medicare patients for amounts above those covered by the Medicare fee schedule and allowing them to join together and negotiate with insurance carriers without violating antitrust statutes.
  • Oppose strategies for value-based purchasing and guideline development,
  • Oppose the use of bundled payments for lower-extremity joint replacements and
  • Propose that physician specialty societies hold veto power over the release of comparative effectiveness findings.

Consider what you can do to make sure that these facts are widely known. Perhaps ask your legislators which of these views they support.

Wondering about 2.5%

I can’t help wondering how the election outcome would have been different if the headline that was prominently featured in the news for the last month had been the one we just received in the email message from the Boston University Human Resources Department that said:

  • Contribution rates for 2017 – we are pleased to inform you that the health plan rates are increasing by only 2.5% for 2017

This sure paints a different picture of the ACA than “it’s a disaster” and rates are going to increase at double digit rates.

And this is more typical of premium increases for the past four years.

Fact: The average real increase in per enrollee spending in the private sector from 2010 to 2014 was 1%, and it was negative for Medicare and Medicaid. (Obama, JAMA, 2016)

(This is my last blog on politics and health policy for a while. Too distracting.)

 

 

I am sorry

Dear BUHealth friends, alumni, students and colleagues.

Like most of the people I know, I am immensely saddened by the results of the US presidential elections, which have elected Donald Trump as president and elected republicans to run both houses of congress.

My view is that hate and party loyalty won out in the end over any reasoned comparisons of the two presidential candidates.

I hope to try harder to understand the views of the those who voted for Donald Trump and why they fell for such a clever salesman.

A good place to start is to reread the blogs I posted by and about Scott Adams who alone was consistently supporting and predicting the victory of Donald Trump for over a year. Sadly, Adams was right and the rest of us, driven by incorrect polling predictions, were wrong.

http://blogs.bu.edu/ellisrp/2016/09/why-trump-is-going-to-win-the-us-presidency/

Austin Frakt (at TheIncidentalEconomist.com) has already posted a very useful blog on what health reforms and directions are mostly likely under Donald Trump.  It is linked here if you are interested or if you are asked to discuss this with your family or colleagues..

The next health reform

http://theincidentaleconomist.com/wordpress/the-next-health-reform/

I am lucky that I live and work in a state and occupation that hopefully will not experience the brunt of the pain that I predict is ahead.

Some people may take solace in the fact that Marijuana was legalized for possession, home growing, and recreational use in Massachusetts starting this December 15 2016 (although not to be legally sold in dispensaries for another year).

I for one plan to try to add to our sadly lacking civility by calling him Donald Trump, or president-elect Trump, rather than simply Trump.

Randy

Recent Marketplace Premium Increases are No Big Deal

By Randall P. Ellis, Boston University, Department of Economics October 28, 2016

A great deal has been made recently about the large increases in certain Health Insurance Marketplace premiums  announced for 2017. I present here five arguments for why these increases are no big deal, and are not the right thing to focus on when evaluating the success of the 2010 Affordable Care Act (ACA).

Argument 1: The Marketplace exchanges in which premiums are increasing are very small part of the US Health Care Market. 97% of Americans are not in them. And 80% of the enrollees who are in the Marketplace get government subsidies for their premiums. (Thomas G. McGuire, unpublished figure).

TM US Market Composition 2014

Argument #2: When the ACA Marketplace was started in 2014, its premiums were unexpectedly low, not high, in most markets. Everyone commented on this. The same thing happened when Medicare Part D was introduced. Many economists believe this was because health plans were trying to capture market share by offering low premiums. Such low premiums were not sustainable. Two years into the Marketplace, plans are trying to catch up with the much higher employer sponsored premiums. This should not be treated as a failure of Obamacare.

Argument #3: Many health insurance markets in the US are already highly concentrated. For example Blue Cross Blue Shield of Alabama has a 90 percent market share. (kff.org, 2014)  We cannot expect competitive premium pricing with such market power. As I discuss in Ellis (2012): Leemore Dafny, Mark Duggan, and Subramaniam Ramanarayanan in the American Economic Review 2012, using data from the American Medical Association (AMA), show that 94% of 314 US market areas have “highly concentrated” insurance markets. This concentration cannot be blamed on the ACA, since it predated it.

Argument #4: The main goal and achievement of the ACA has been that it has reduced the number of uninsured. The data clearly show this, and the largest percentage increase has been in private insurance, not government insurance programs.

Recent Health Insurance coverage

Argument 5: The unexpected wonderful cost impact of the ACA has been favorable: lowering the average rate of increase in health care spending throughout the country. (Barack Obama, JAMA, 2016)

obamatrend2

This has been particularly true for the Medicare program. US government statistics (CBO and OMB) show enormous savings in Medicare since 2010.

2016_EllisMcGuire_UpdateonUS_RA_20161005_Page_09

While the ACA has not eliminated uninsurance or solved the US cost containment problem, it has made important improvements in both directions. Recent large premium increases in the Health Insurance Marketplace, which happen all the time in the employer sector without much attention, are part of a bigger problem still in need of solutions.

The US Should Ban or Heavily Tax Weapons Designed for Mass Shootings

Boston University Working Paper

Randall P. Ellis
Boston University,
Department of Economics
August 22, 2016
Abstract

This paper presents four arguments for why the US should ban or at least heavily tax the sale or transfer to civilians of weapons designed for mass shootings (WDMS), which would include most semi-automatic guns and weapons with large capacity magazines.

  1. The Supreme Court has repeatedly validated that second amendment protections of the right to bear arms do not apply to particularly dangerous weapons where protection of public safety overrides constitutional protections; this exclusion should apply to WDMS just as it does to machine guns and short-barreled shotguns.
  1. To make gun owners pay for the annual cost of deaths in the US due to guns, we should be taxing each gun owned at $1000 per year, or tax all gun sales (new or used) at $15,000 per gun sold. Given their higher killing power we should tax WDMS at $60,000 per gun sold. Or just ban them.
  1. In the last 36 months, there have been 5,399 people in the US killed or injured at mass shootings (where four or more people are shot, although not necessarily killed). Unless action is taken, the most recent trends suggest that there will be twice as many mass shootings in the US in five years.
  1. Current federal law for duck hunting bans the use of shotguns that hold more than three shells. If we care enough to ban four-bullet capacity guns to preserve ducks, then we should be willing to ban even higher capacity guns designed to kill people.

The full paper is linked here.

http://blogs.bu.edu/ellisrp/files/2016/08/Banning-or-heavily-taxing-WDMS-20160822.pdf

Obama’s JAMA article is a must read for all professionals

There is a very important  article in this week’s JAMA - Internal Medicine, written by Barach Obama.

It highlights the effects of the ACA/Obamacare.  It is free on-line.

United States Health Care Reform: Progress to Date and Next Steps

http://jama.jamanetwork.com/article.aspx?articleid=2533698

If you are short on time, then the following link to just the figures provides many of the key results.

http://jama.jamanetwork.com/article.aspx?articleid=2533698

To me the highlights of the article are that it documents:

The decline in the uninsured (no surprise, but well presented) now down to 9.1 percent from over 16
Declines in teen smoking from 19.5% to 10.8% due to the Tobacco Control Act of 2009 (Wow)
Much slower rates of decline in the uninsured in states that refused the Medicaid expansion (no surprise)
The decline in the underinsured among privately insured as measured by the near disappeance of unlimited exposure (new to me)
Lower rates of individual debt sent to a collection agency (great to see)
Negative rates of real cost growth in Medicare and Medicaid since 2010, with drastically lower growth in privately Insured
Constant share of out of pocket spending as a fraction of total spending among the employer based insurance
(new to me, he cites increases in deductibles offset by decreases in copays and coinsurance.)
Forecast Medicare spending in 2019 is now 20% LOWER than when he took office.
Decline in Medicare 30 day, all hospital readmission rates as well as improvements in other measures.
This information is important to understand to counter the repeated false claims that Obamacare is a failure, or has increased health care spending, or is bankrupting the government, all of which are shown to be false in the evidence presented here.

Here is the link again.

http://jama.jamanetwork.com/article.aspx?articleid=2533698

Insurers are doing well under ObamaCare

Much was made recently about how UnitedHealth decided to drop out of the ACA Federal Exchange in several states. It is important to realize that far from being a failure to large insurers (UnitedHealth is the largest insurer in the US), health insurance remains extremely profitably under ObamaCare. Below is a bar chart of the percentage change in stock prices of the five largest publicly traded health insurers in the US from March 23, 2010 when the ACA was signed to today (6/6/2016).

Top Five Health Insurer Stock Prices under ObamaCare

 

Obamacare reality: It is working

At a time in the US when all of the Republicans presidential candidates are declaring Obamacare a failure which needs to be undone, it is worth noting the REALITY that it is succeeding in its primary purpose of covering more American with health insurance. It does not mandate insurance coverage, but the subsidies and tax penalties for not having insurance are motivating more people to get insurance. 20 million more people now have health insurance than did before. (Click on graphs for a clearer image.)

 20 Million Gained Health Insurance From Obamacare, President Says
The Huffington Post

Uninsured rate Gallop-HealthwaysEven though cost containment was not its primary goal, Obamacare is also reducing, not increasing, costs of health care.
Since many people don’t trust the government, here are some private sector slides.
PriceWaterhouseCoopers, an actuary firm not known for being political, forecasts that health expenditure
cost growth in 2016 will continue to slow down.

http://www.pwc.com/us/en/health-industries/behind-the-numbers/assets/pwc-hri-medical-cost-trend-chart-pack-2016.pdf

Here are my two favorite slides from their chart pack. Note the changes since 2010.

pwc trends gdpand nhe

My view is that the above figure is misleading, since the decline in rates of growth did not start in 1961, but still the slow growth since 2010 is clearly evident.

 

spending growth rate PWC 2016

Obamacare is working. We just don’t have enough leaders and media telling us this.

 

Note: I sent this blog to my BUHealth email list.

Let me know if you would like to be added as a BUHealthFriends subscriber by emailing ellisrp at bu.edu

Tax to rise on the uninsured next year.

This is why enrollment in health insurance will continue to rise in the US from the ACA.

For 2016: Max of  $695 or 2.5 percent of taxable income if uninsured.

http://www.bostonglobe.com/news/nation/2015/10/19/health-law-fine-uninsured-will-more-than-double/76FbuARARxAmaT9H4nN66K/story.html

Full text is below.

Health law fine for uninsured to rise

Boston Globe

Associated Press  October 19, 2015

WASHINGTON — The federal penalty for having no health insurance is set to jump to $695, and the Obama administration is being urged to highlight that fact in its new pitch for health law signups.

That means the 2016 signup season starting Nov. 1 could see penalties become a bigger focus for millions of people who have remained eligible for coverage but uninsured. They’re said to be squeezed for money and skeptical about spending what they have on health insurance.

Until now, health overhaul supporters have stressed the benefits: taxpayer subsidies that pay about 70 percent of the monthly premium, financial protection against sudden illness or an accident, and access to regular preventive and follow-up medical care.

But in 2016, the penalty for being uninsured will rise to the greater of either $695 or 2.5 percent of taxable income. That’s for someone without coverage for a full 12 months. This year the comparable numbers are $325, or 2 percent of income.

Marketing usually involves stressing the positive. Rising penalties meet no one’s definition of good news. Still, that may create a new pitch:

The math is pretty clear. A consumer would be able to get six months or more of coverage for $695, instead of owing that amount to the IRS as a tax penalty. (That is based on subsidized customers now putting in an average of about $100 a month of their own money.)”

#6 Raise the minimum wage for jobs not offering health insurance

Time to change the policy discussion.

Congress has been unwilling to raise the minimum wage despite strong public support for doing so. This blog suggests a concrete approach for getting even broader public support and potentially reducing the need for federal taxes.

As of January 1, 2015 29 states and DC have minimum wages above the Federal minimum wage, which is still only $7.25 per hour. For a worker working 40 hours per week 50 weeks per year, the minimum wage yields only $14,500 per year, which is below the federal poverty level ($15,730) for a  family of two in 2014 in all states and DC. At these low income levels, even full time employees still cannot afford health insurance and will mostly be relying on large subsidies for health insurance  and the employee earned tax credit (EIT).  The insurance subsidy for a minimum wage worker enrolling in a private silver plan is currently at least $4,237 per year for an adult with one child, while the EIT is currently $3,359 for a single worker with one child if earning the minimum wage. Hence an employer paying only the minimum wage is counting on a subsidy from the government of at least $7596 per year for a worker with one child, which is $3.80 per hour.

A simple approach that will encourage more firms to offer health insurance is to raise the minimum wage required for any position that does not include any offer of subsidized health insurance. For concreteness I propose a minimum wage of $12 per hour without health insurance, versus $8 per hour with a job that includes subsidies for health insurance. (Those age 21 and under would also be eligible for the $8 per hour rate.) Whether the job is for 10, 30 or 40 hours per week does not matter, only whether there is subsidized health insurance. This four dollar per hour increment will encourage firms to bear the full cost of their workers, and reduce the burden on federal tax revenue and the budget.

In Massachusetts, the minimum wage just increased on January 1, 2015 from $8 to $9 per hour. The State's economy continues to do well, and I still see signs in retail windows showing help is still wanted. Plus we still have lots of low-cost food and retail stores and services. Reduced employment is not visible, and would likely be more than offset by the stimulatory effects of reduced taxes. I see no reason why we couldn't leave it up to states to decide whether they want to use the same or higher minimum wages for jobs with or without health insurance as long as the two minimums are reached.

In Australia, the minimum wage is US$ 13.84 (16.87 Australian dollars), everyone has national health insurance, and the unemployment rate is comparable to the US at 6.2 percent (November, 2014). We rather liked it when we were there in 2011 that our gardener and most restaurant workers were Australian citizens, who spoke English well, not low-paid foreigners and recent immigrants, as they are in the US.

As I write this blog, the US congress is debating whether to partially undo the employer mandate provisions of the Affordable Care Act by allowing firms to not have to pay any penalty for not offering health insurance for employees working less than 40 hours per week. The current standard is 30 hours per week. This would have a potentially disastrous effect since so many workers work about 40 hours and it would be easy for employers  to avoid the (modest) ACA penalties by reducing worker hours. Plus, without the employer mandate, many workers will remain uninsured. Having a higher minimum wage for jobs not offered health insurance will greatly weaken the incentive for firms to drop employee hours to avoid offering insurance coverage and eliminate the 40 versus 30 hours as an issue. In fact it would encourage firms to offer full- rather than part-time jobs with health insurance, reducing the need for public subsidies.

This minimum wage policy particularly makes sense if it is combined with the proposal in my next (future) blog #7 to eliminate all family health insurance policies, insure individuals not households, and have all children under age 21 be covered independently of their parent's insurance policy. Making all children eligible for the exchange coverage options regardless of their (parent's) income would be one possible approach.

Here are links to my four previous blogs from 2013 on Taxes and fiscal policies. Still the right direction.

#1 All Taxes and Budgets Should be Expressed as Dollars per Person

#2. Include Social Security and Medicare taxes when discussing tax burdens

#3 Tax Bads (or at least don’t subsidize them!)

#4 State Tax Rates are Not Related to State Income or Growth

#5 “Let the Children and Grandchildren Pay?”

 

 

 

Recommended book on US health care system

I highly recommend this book as a useful summary of the US Health Care System. I have made it required reading (as a reference) for my classes at BU.

The Health Care Handbook: A Clear and Concise Guide to the United States Health Care System, 2nd Edition Paperback – November 15, 2014

by Elisabeth Askin (Author), Nathan Moore (Author)

 

Paper:  $15.99

http://www.amazon.com/gp/product/0692244735

Electronic: $8.99

http://www.amazon.com/Health-Care-Handbook-Concise-United-ebook/dp/B00PWQ93M8/

 

Useful Data Links to US Government data

Websites for Federal Administrative Data sets:

US Administration for International Development:
Foreign aid from the U.S: Data and Tools

Department of Agriculture:
Economic Research Services: Supplemental Nutrition Assistance Program (SNAP) Data System
Food and Nutrition Services: Commodity Supplemental Food Program Data
Food Safety Inspection Services: Recalls and Quarterly Enforcement Reports
Forest Inventory Data
National Agricultural Statistics Service: Cropland Data
Natural Resource Conservation Service: Conservation Financial Assistance Programs' Enrollment Data
Risk Management Agency (RMA): Program Costs and Outlays Data
RMA: Actuarial Data
Web Based Supply Chain Management Reports Data

US Army:
Army Corps of Engineers: U.S. Waterborne Commerce Data

Department of Commerce:
Bureau of Economic Analysis (BEA): Foreign Direct Investments Data in the US
BEA: US National Income and Product Account (NIPA) Data
Economic Development Administration: Program Data
Census: Business Register Data and Longitudinal Business Database
Census: Longitudinal Employer-Household Dynamics
Census: County and Zip Code Business Patterns
International Trade Administration (ITA): U.S. Exporting Companies Data
ITA: Export-Supported Employment Data
ITA: Visitors Arrivals Program (Form I-94) Data
ITA: International Air Travel Statistics ( Form I-92) Program Data
National Climate Data Center: National climate and historic weather data
National Marine Fisheries Service: Recreational Fisheries statistics or Commercial Fisheries Statistics

Commodities Futures Trading Commission:
Filings, transactions, and other data
Market Report Data

Consumer Financial Protection Bureau:
Credit Card Agreement Database
Consumer Complaint Database

Consumer Product Safety Commission:
Injury Statistics

Department of Education:
Civil Rights Data for Public Schools
EDFacts Data for K-12 Educational Programs
National Center for Education Statistics: Common Core of Data on Public School
Federal Student Aid Data
National Reporting System Data for Adult Education
Nation’s Report Card System Data

Department of Energy:
Energy Information Administration (EIA): Energy Prices Data
EIA: Renewable Energy Market Data
EIA: Crude Oil Production and Stocks Data

Environmental Protection Agency:
Air Quality Data
Enforcement Dockets data
National Pollutant Discharge Elimination System (NPDES) permits and compliance data
Toxic Substances Control Act Chemical Substance Inventory
Superfund Sites (CERCLIS database)

Equal Employment Opportunity Commission
Enforcement and Litigation Statistics on Employment Discrimination

Federal Court System:
Bankruptcy Statistics

Federal Deposit Insurance Corporation:
Industry Data
Failed Bank Data

Federal Emergency Management Agency:
Assistance Record Data

Federal Financial Institutions Examination Council:
Financial and Structural Data for FDIC-insured Institution
Home mortgage loans data
Reinvestment Act Data

The Federal Reserve:
Consumer Credit data
Finance Companies Data
Foreign exchange rates
Government Receipts for Expenditures and Investments
Money Stock Measures
Treasury Account Series data

Federal Trade Commission:
Fraud and Identity Theft aggregates (Consumer Sentinel Network)

Fish and Wildlife Services:
Wetlands Data

General Services Administration:
Federal Procurement Report Data
FFATA Sub-award Reporting System (Data Reporting)
Small Business Goaling Report

Department of Health and Human Services:
Agency for Substances and Disease Registry (ASTDR): Environmental Health Webmap Data
ASTDR: Hazardous Substances Emergency Events Surveillance Report Data
ASTDR: National Toxic Substance Incidents Program Data
Center for Disease Control and Prevention (CDC): Community Water Fluoridation Statistics 
CDC: National Program of Cancer Registries Data
CDC: Surveillance Data
Center for Medicare and Medicaid Services (CMS): Medicare Claims Data or Microdata
CMS: National Health Expenditures Data
CMS: Provider of Service Data
National Directory of New Hires Data
National Center for Health Statistics: Vital Statistics: Births, Deaths, Marriages, Divorces
Temporary Assistance to Needy Families Administrative Records

Department of Homeland Security:
Immigration Statistics

Department of Housing and Urban Development:
Community Development Block Grants Expenditures Data
Family Data on Public and Indian Housing and Microdata
Fair Market Rents Data
Government Sponsored Enterprise Data
Metropolitan Area Quarterly Residential and Business Vacancy Report Data
National Low Income Housing Tax Credit Database
Neighborhood Stabilization Program Data
Program Income Limits Data

Department of Interior:
US Geological Survey (USGS): Biodiversity, Species data
USGS: Land Cover and Land Use data
USGS: Water Resources data
USGS: Water Quality Data

International Trade Commission:
Tariffs Databases

Department of Justice:
Bureau of Prison: Inmate, Population, and Staff Statistics
Bureau of Justice Statistics(BJS): Court Statistics Project Data
BJS: Federal Justice Statistics Program Data
BJS: Law Enforcement Management and Administrative Statistics
BJS: National Corrections Reporting Program Data
BJS: National Incident-Based Reporting System Data
BJS: National Prisoner Statistics Program Data
Federal Bureau of Investigation: Uniform Crime Reports Data

Department of Labor:
Bureau of Labor Statistics: Quarterly Census of Employment and Wages
Foreign Labor Certification Office: H-1B Data
Labor Retirement and Welfare Benefit Plan Data Set
(Form 5500)
Occupational Safety and Health Administration (OSHA): Work-Related Injury or Illness Data
OSHA: Enforcement Data (Inspection Data)
OSHA: Worker Fatalities/Catastrophes Report (FAT/CAT) 

National Aeronautics and Space Administration:
Urban Landsat

Patent and Trademark Office:
U.S. Patent and Trademark Office patent data

Department of Transportation:
Bureau of Transportation (BTS): Air Carrier Statistics
BTS: Intermodal Passenger Connectivity Database
Maritime Administration: Maritime Travel and Transportation Statistics

Department of Treasury:
Bureau of Fiscal Service: Public Debt Report
Financial Crime Enforcement Network: Mortgage and Real Estate Fraud Data Set
Interest Rate Statistics
Internal Revenue Service (IRS): Corporate Tax Statistics (Form 1120)
IRS: Employee Benefit Plans (Form 5500)
IRS: Individual Tax Statistics (Form 1040)
IRS: Quarterly Payroll Taxes (Form 941)

Securities and Exchange Commission:
Filings
Mutual Fund Fees and Expenses
Program and Market Data
Short Sale Volume Data 

Small Business Administration:
Small Business Lender and Loan Data
Social Security Administration:
Social Security Programs Data
Earnings and Employment Data for Workers Covered under Social Security and Medicare

Department of Veteran's Affairs:
Veterans Benefits Administration Reports
National Pollutant Discharge Elimination System (NPDES) permits and compliance data

Websites for Agency Procedures on Access to Restricted-Use Administrative Data Sets:

Bureau of Labor Statistics Confidential Data Sets Access
Census Bureau Restricted Restricted Data Sets Access
Agency for Healthcare Research and Quality Restricted Use Data Access
National Center for Health Statistics Restricted Use Data Access
National Center for Education Statistics Restricted Use Data Licenses
Bureau of Transportation Statistics Restricted-Release Airline Data Access
USDA's Economic Research Service Agriculture Resource Management Survey Data Access
National Institute on Aging Restricted Data Access
Center for Medicare and Medicaid Limited Data Access
Social Security Administration Health and Retirement Study Data Access
National Science Foundation/National Center for Science and Engineering Statistics Restricted-Use Data Access
Substance Abuse and Mental Health Data Archive

Re-envisioning Ebola, including updated story about Nigeria from Kas Nwuke

Arlene Ash, Professor and Division Chief, Biostatistics and Health Services Research, at UMass Medical School, has compiled a useful series of original thoughts, emails, and links about Ebola which I am broadcasting and reposting on my blog site here.

This posting repeats some of the information already posted in my earlier blog:

Ebola is being contained in Nigeria

The original article by Kas Nwuke is now linked (with permission) as a pdf and includes linked references on my web site. (It is 6 pages – updated to include two pages of references.)

Containing Ebola: A success story from an “unexpected” place?

From Arlene Ash:

Friends and Colleagues,

Here’s what I [Arlene Ash] sent previously with some updates.

I now have Mead Over’s permission to circulate his text that is included below, plus sharing the link to his Twitter log: @MeadOver.

Also, I have added the text from yesterday’s NYT editorial “Cuba’s Impressive Role on Ebola,” since non-subscribers may not be able to get it themselves on-line.  The full text, with links and commentary, is very interesting, and I think important.

These are, indeed, extraordinary times – and, I firmly believe, they offer an extraordinary opportunity to discard old, dysfunctional paradigms – if only we can seize it.

Arlene

_

Last weekend I [Arlene Ash] wrote:

Re-envisioning Ebola as an opportunity

Friends, If you like this idea as well as I do, perhaps you can help make it “go viral.”

  •  I believe it would be cheaper to stop Ebola in Africa than to try to seal our borders against it as it spreads unchecked.
  • I believe that taking a leadership role in stopping Ebola would do a great deal for our self-esteem as a nation, and for our regard in the world.
  • I believe that cost-effectiveness calculations could make a strong case for a “war on Ebola” as the best kind of war that we could wage. I propose we could do more to combat ISIS and protect America by working with the world community to prevent the spread of Ebola in Africa than by any level of commitment of troops and weapons to the enflamed Middle East.

I want America to re-envision Ebola as an opportunity to demonstrate what great things we can do when we bend ourselves to the task.

Of course we are all busy, but perhaps it takes only a little help from many people to spread a really good idea.

Thought for the day. Please grow it and pass it along.

_

I got back some very interesting feedback which I would like to share:

From Randy Ellis (a success story in Nigeria, with lessons for the rest of the world):

Amid so much negative and scary news about Ebola, this research paper on the experience of Nigeria where it has not spread widely after arriving by airplane gives great hope. I recommend it if you have time (It is 6 pages).

Containing Ebola: A success story from an “unexpected” place? [Now linked instead of attached as a pdf]

The author, Kasirim Nwuke  is a BU Ph.D. Here is his bio from one web site.

http://www.elearning-africa.com/profiles/profile_popup.php?address_id=595692&lang=4

_

Then a follow-on from Mead Over, author of a World Bank report (Twitter log  @MeadOver):

This is indeed a good story with details that go beyond the information our World Bank report (in the box on page 29) on the efforts of Senegal and Nigeria that I co-authored on October 7 and blogged on Friday:

http://www.cgdev.org/blog/understanding-world-banks-estimate-economic-damage-ebola-west-africa

http://documents.worldbank.org/curated/en/2014/10/20270083/economic-impact-2014-ebola-epidemic-short-medium-term-estimates-west-africa

The box on page 29 of the WB report was requested by JYK after he sat next to Goodluck Jonathan at the UNGA meeting last week and President Jonathan told him that 1,000 Nigerian public health workers were involved in the contact tracing including almost 300 Nigerian doctors.  This is remarkable not only for the level of effort, but also in comparison to Liberia, Sierra Leone and Guinea each of which had fewer than 100 doctors before the crisis.  In Nigeria I have heard that the polio eradication workers are the ones who were redeployed to do the Ebola contact tracing.  Other countries don’t have the polio program because they don’t have polio.  So even a relatively wealthy country like Ghana may have trouble emulating Nigeria’s success.

I like the point made in the article that Nigeria showed courage in announcing the danger far and wide and rolling out a massive public health effort to contain it.  This was before the rest of the world was taking the epidemic as seriously as they are today, and thus the measures could well have been opposed by economic interests.  (Parallel to HIV:  In the early days of the HIV epidemic, business interests in Thailand opposed the admission that HIV was a problem.  In “Confronting AIDS” we attribute Thailand’s energetic and remarkably successful “100% condom program” partly to the fact that the country was under a military dictatorship for 6 months and the “benevolent dictator” saw the wisdom of opposing the economic interests in order to start that program.)

When I spoke on Ebola at American University the other evening, one of the other panelists was an anthropologist who had recently returned from Sierra Leone.  She also reported the “Ebola handshake” and other “self-isolation behavior from that country.  Epidemiologists are hoping that such behavior, developing in response to the news and the public information campaign, will reduce the reproductive rate of the epidemic.  But we have not seen a deceleration in Liberia or Sierra Leone yet.

Another implication of the author’s account and of the Nigerian and Senegalese public health expenditure amounts reported in the box of the World Bank report is that several West African countries are increasing government spending in response to the outbreak (as is the US).  Our World Bank report does not include the possible stimulus effect of this spending on national economies.  This spending may offset some of the reduction in aggregate demand due to aversion behavior, and thus reduce the economic impact below our estimates.  However, as I say at the end of my blog, unless the epidemic begins to decelerate soon, our “High Ebola” estimate may fall short of estimating the total impact.  And I hope that when Charles Kenny and I join CDC and others in asserting this is still a small problem inside the US, we are not being overly optimistic.  As here:

https://www.youtube.com/watch?v=_jCWkDYwN2g; https://www.youtube.com/watch?v=113kLL3pZQQ

One frustrating aspect of the report by Kasirim Nwuke is the lack of references or hyperlinks [AA: they are now attached in a separate file.]  Even our World Bank report did better.  I agree totally with his conclusion that Nigeria is not yet “safe”.  Each day is another roll of the dice.  In one sense, Nigeria was lucky that they detected the first case on entry.  Next time they may not be so lucky.

_

In response, Kas Nwuke KNwuke@uneca.org wrote (on 10/18/14):

Going through the materials, I have come to know that Nigeria's preparations started much earlier. It started once the outbreak in Guinea and reached full steam after the July ECOWAS Heads of State Summit.  That Summit discussed Ebola in the sub-region and resolved that member States of ECOWAS should be prepared to contain it.  Nigeria according to the Health Minister made, after the Summit, the very first financial donation of $3.5 million US to the three countries.  Back home, the Health Minister briefed the Commissioners for Health in the 36 States of the Federation and asked for increased vigilance.

 

You will find this additional information in the references.

 

In my essay, I had given the number of Nigerians who have volunteered to go to Liberia and Sierra Leone as 200.  I have since learned that the number is actually 591.  In addition, Nigeria is also providing crash courses to health personnel from the three most affected countries.

 

I am sure that lots more will be written about Nigeria experience.  I hope that the lesson can be of value to resource constrained countries on how to handle/tackle epidemics in the future.

 

(I must with regret inform you that Nigeria's election politics has now entered the Ebola debate.  Rivers State and Lagos State are controlled by the opposition.  Electioneering campaign for next year's election has started and the ruling PDP and the opposition APC is each seeking to claim credit for the success in containing the spread of Ebola.  The Rivers State Governor has just disclosed - see the hyperlink - that the state spent N1.106 billion - more than $6 million - to tackle Ebola.)

 

With best wishes,

 

Kas

-

Also, some inspiring information about a UMass colleague (Steven Hatch) now in Liberia:

http://www.nytimes.com/2014/10/17/world/africa/pursuing-a-calling-that-leads-to-west-africa.html

http://www.nytimes.com/2014/10/17/world/africa/ebola-liberia-west-africa-epidemic.html

and a NYT “conspicuous success story” about Senegal, that points to the so far very positive Nigerian experience as well.

-

Also,

NYT, October 19 Op-Ed: “Cuba’s Impressive Role on Ebola” (http://www.nytimes.com/2014/10/20/opinion/cubas-impressive-role-on-ebola.html?_r=0)

Cuba is an impoverished island that remains largely cut off from the world and lies about 4,500 miles from the West African nations where Ebola is spreading at an alarming rate. Yet, having pledged to deploy hundreds of medical professionals to the front lines of the pandemic, Cuba stands to play the most robust role among the nations seeking to contain the virus.

Cuba’s contribution is doubtlessly meant at least in part to bolster its beleaguered international standing. Nonetheless, it should be lauded and emulated.

The global panic over Ebola has not brought forth an adequate response from the nations with the most to offer. While the United States and several other wealthy countries have been happy to pledge funds, only Cuba and a few nongovernmental organizations are offering what is most needed: medical professionals in the field.

The Cuban health sector is aware of the risks of taking on dangerous missions. Cuban doctors assumed the lead role in treating cholera patients in the aftermath of Haiti’s earthquake in 2010. Some returned home sick, and then the island had its first outbreak of cholera in a century. An outbreak of Ebola on the island could pose a far more dangerous risk and increase the odds of a rapid spread in the Western Hemisphere.

Cuba has a long tradition of dispatching doctors and nurses to disaster areas abroad. In the aftermath of Hurricane Katrina in 2005, the Cuban government created a quick-reaction medical corps and offered to send doctors to New Orleans. The United States, unsurprisingly, didn’t take Havana up on that offer. Yet officials in Washington seemed thrilled to learn in recent weeks that Cuba had activated the medical teams for missions in Sierra Leone, Liberia and Guinea.

With technical support from the World Health Organization, the Cuban government trained 460 doctors and nurses on the stringent precautions that must be taken to treat people with the highly contagious virus. The first group of 165 professionals arrived in Sierra Leone in recent days. José Luis Di Fabio, the World Health Organization’s representative in Havana, said Cuban medics were uniquely suited for the mission because many had already worked in Africa. “Cuba has very competent medical professionals,” said Mr. Di Fabio, who is Uruguayan. Mr. Di Fabio said Cuba’s efforts to aid in health emergencies abroad are stymied by the embargo the United States imposes on the island, which struggles to acquire modern equipment and keep medical shelves adequately stocked.

In a column published over the weekend in Cuba’s state-run newspaper, Granma, Fidel Castro argued that the United States and Cuba must put aside their differences, if only temporarily, to combat a deadly scourge. He’s absolutely right.

 

Ebola is being contained in Nigeria

Amid so much negative and scary news about Ebola, this research paper on the experience of Nigeria where it has not spread widely after arriving by airplane gives great hope. I recommend it if you have time (It is 6 pages - updated to include references.).

Containing Ebola: A success story from an "unexpected" place?

The author, Kasirim Nwuke  is a BU Ph.D. Here is his bio from the elearning-aftrica web site.

http://www.elearning-africa.com/profiles/profile_popup.php?address_id=595692&lang=4

Kasirim Nwuke

Kasirim Nwuke is Chief, New Technologies and Innovation at the United Nations Economic Commission for Africa (ECA), Addis Ababa, Ethiopia. He has thought in a number at a number of higher education institutions in the United States of America including Tufts University, Medford, MA; Wellesley College, Wellesley, MA, and Northeastern University, Boston, MA. He been a Research Associate at Harvard University School of Public Health and the a Fellow in African Studies at the African Studies Centre, Boston University. He has held different positions at the United Nations Economic Commission for Africa and as Senior Economic Adviser to the Minister of Finance of the Federal Republic of Nigeria. Kasirim is the author (or lead author) of several research papers and reports and policy briefs on African economic development.  Among books to which he has been a contributing author is "AdricaDotEdu: IT Opportunities and Higher Education in Africa" Maria Beebe et al. Kasirim holds a PhD in Economics from Boston University, Boston, MA.

Former BU professor and World Bank senior economist Mead Over has also been blogging on ebola in west africa. Here is one of his recent blogs.

http://www.cgdev.org/blog/understanding-world-banks-estimate-economic-damage-ebola-west-africa

http://documents.worldbank.org/curated/en/2014/10/20270083/economic-impact-2014-ebola-epidemic-short-medium-term-estimates-west-africa

 

 

 

Important Reposting on Placebo surgery from TIE

I am forwarding this excellent TIE post since every health researcher and indeed every consumer should realize how serious the lack of evidence is on many common surgical procedures. Here are some quotes organized in a succinct way.

"2002... arthroscopic surgery for osteoarthritis of the knee ... Those who had the actual procedures did no better than those who had the sham surgery. " (We still spend $3 billion a year on this procedure)
"2005... percutaneous laser myocardial revascularization, ...  didn’t improve angina better than a placebo"
"2003, 2009, 2009... vertebroplasty — treating back pain by injecting bone cement into fractured vertebrae ... worked no better than faking the procedure."
"2013 ... arthroscopic procedures for tears of the meniscus cartilage in the knee... performed no better than sham surgery" (We do about 700,000 of them with direct costs of about $4 billion.)
"[2014] ... systematic review of migraine prophylaxis [prevention], while 22 percent of patients had a positive response to placebo medications and 38 percent had a positive response to placebo acupuncture, 58 percent had a positive response to placebo surgery.
"2014... 53 randomized controlled trials that included placebo surgery as one option. In more than half of them ... the effect of sham surgery was equivalent to that of the actual procedure."

If you are getting surgery done, do your own research on it and ask questions!

 

-------- Original Message --------

Subject: “The Placebo Effect Doesn’t Apply Just to Pills” plus 1 more
Date: Thu, 9 Oct 2014 11:13:06 +0000
From: The Incidental Economist <tie@theincidentaleconomist.com>
To: <ellisrp@bu.edu>

“The Placebo Effect Doesn’t Apply Just to Pills” plus 1 more


The Placebo Effect Doesn’t Apply Just to PillsPosted: 09 Oct 2014 04:00 AM PDT

The following originally appeared on The Upshot (copyright 2014, The New York Times Company).

For a drug to be approved by the Food and Drug Administration, it must prove itself better than a placebo, or fake drug. This is because of the “placebo effect,” in which patients often improve just because they think they are being treated with something. If we can’t compare a new drug with a placebo, we can’t be sure that the benefit seen from it is anything more than wishful thinking.

But when it comes to medical devices and surgery, the requirements aren’t the same. Placebos aren’t required. That is probably a mistake.

At the turn of this century, arthroscopic surgery for osteoarthritis of the knee was common. Basically, surgeons would clean out the knee usingarthroscopic devices. Another common procedure was lavage, in which a needle would inject saline into the knee to irrigate it. The thought was that these procedures would remove fragments of cartilage and calcium phosphate crystals that were causing inflammation. A number of studieshad shown that people who had these procedures improved more than people who did not.

However, a growing number of people were concerned that this was really no more than a placebo effect. And in 2002, a study was published thatproved it.

A total of 180 patients who had osteoarthritis of the knee were randomly assigned (with their consent) to one of three groups. The first had a standard arthroscopic procedure, and the second had lavage. The third, however, had sham surgery. They had an incision, and a procedure was faked so that they didn’t know that they actually had nothing done. Then the incision was closed.

The results were stunning. Those who had the actual procedures did no better than those who had the sham surgery. They all improved the same amount. The results were all in people’s heads.

Many who heard about the results were angry that this study occurred. They thought it was unethical that people received an incision, and most likely a scar, for no benefit. But, of course, the same was actually true for people who had arthroscopy or lavage: They received no benefit either. Moreover, the results did not make the procedure scarce. Years later, more than a half-million Americans still underwent arthroscopic surgery for osteoarthritis of the knee. They or their insurers spent about $3 billion that year on a procedure that was no better than a placebo.

Sham procedures for research aren’t new. As far back as 1959, the medical literature was reporting on small studies that showed that procedures like internal mammary artery ligation, a surgical procedure used to treat angina, were no better than a fake incision.

In 2005, a study was published in the Journal of the American College of Cardiology proving that percutaneous laser myocardial revascularization, in which a laser is threaded through blood vessels to cut tiny channels in the heart muscle, didn’t improve angina better than a placebo either. We continue to work backward and use placebo-controlled research to try to persuade people not to do procedures, rather than use it to prove conclusively that they work in the first place.

A study published in 2003, without a sham placebo control, showed that vertebroplasty — treating back pain by injecting bone cement into fractured vertebrae — worked better than no procedure at all. From 2001 through 2005, the number of Medicare beneficiaries who underwent vertebroplasty each year almost doubled, from 45 to 87 per 100,000. Some of them had the procedure performed more than once because they failed to achieve relief. In 2009, not one but two placebo-controlled studies were published proving that vertebroplasty for osteoporotic vertebral fractures worked no better than faking the procedure.

Over time, after the 2002 study showing that arthroscopic surgery didn’t work for osteoarthritis of the knee, the number of arthroscopic procedures performed for this condition did begin to go down. But at the same time, the number of arthroscopic procedures for tears of the meniscus cartilage in the knee began to go up fast. Soon, about 700,000 of them were being performed each year, with direct costs of about $4 billion. Less than a year ago, many were shocked when arthroscopic surgery for meniscal tearsperformed no better than sham surgery. This procedure was the most common orthopedic procedure performed in the United States.

The ethical issues aren’t easily dismissed. Theoretically, a sugar pill carries no risk, and a sham procedure does. This is especially true if the procedure requires anesthesia. The surgeon must go out of his or her way to fool the patient. Many would have difficulty doing that.

But we continue to ignore the real potential that many of our surgical procedures and medical devices aren’t doing much good — and might even be doing harm, since real surgery has been shown to pose more risks than sham surgery.

Rita Redberg, in a recent New England Journal of Medicine Perspectives article on sham controls in medical device trials, noted that in a recentsystematic review of migraine prophylaxis, while 22 percent of patients had a positive response to placebo medications and 38 percent had a positive response to placebo acupuncture, 58 percent had a positive response to placebo surgery. The placebo effect of procedures is not to be ignored.

Earlier this year, researchers published a systematic review of placebo controls in surgery. They searched the medical literature from its inception all the way through 2013. In all that time, they could find only 53 randomized controlled trials that included placebo surgery as one option. In more than half of them, though, the effect of sham surgery was equivalent to that of the actual procedure. The authors noted, though, that with the exception to the studies on osteoarthritis of the knee and internal mammary artery ligation noted above, “most of the trials did not result in a major change in practice.”

We have known about the dangers of ignoring the need for placebo controls in research on surgical procedures for some time. When the few studies that are performed are published, we ignore the results and their implications. Too often, this is costing us many, many billions of dollars a year, and potentially harming patients, for no apparent gain.

@aaronecarroll

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Placebo historyPosted: 09 Oct 2014 03:00 AM PDT

Here are my highlights from “Placebos and placebo effects in medicine: historical overview,” by Anton de Craen and colleagues. All are direct quotes.

  • In 1807 Thomas Jefferson, recording what he called the pious fraud, observed that ‘one of the most successful physicians I have ever known has assured me that he used more bread pills, drops of colored water, and powders of hickory ashes, than of all other medicines put together’. About a hundred years later, Richard Cabot, of Harvard Medical School, described how he ‘was brought up, as I suppose every physician is, to use placebo, bread pills, water subcutaneously, and other devices’.
  • The word placebo (Latin, ‘I shall please’) was first used in the 14th century. In that period, it referred to hired mourners at funerals. These individuals often began their wailings with Placebo Domino in regione vivorum, the ninth verse of psalm cxiv, which in the Latin Vulgate translation means ‘I shall please the Lord in the land of the living’. Here, the word placebo carries the connotation of depreciation and substitution, because professional mourners were often stand-ins for members of the family of the deceased.
  • In 1801, John Haygarth reported the results of what may have been the first placebo-controlled trial. A common remedy for many diseases at that time was to apply metallic rods, known as Perkins tractors, to the body. These rods were supposed to relieve symptoms through the electromagnetic influence of the metal. Haygarth treated five with imitation tractors made of wood and patients found that four gained relief. He used the metal tractors on the same five patients the following day and obtained identical results: four of five subjects reported relief.
  • In the 1785 New Medical Dictionary, placebo is described as ‘a commonplace method or medicine’. In 1811, the revised Quincy’s Lexicon-Medicum as ‘an epithet given to any medicine adapted defines placebo more to please than to benefit the patient’.
  • In the 1930s, several important papers were published with regard to the introduction of placebos in clinical research. [... Two] papers assessed the value of drugs used in the treatment of angina pectoris in cross-over experiments and deceptively administered placebos to the ‘no-treatment’ comparison group. [...] In both trials the drugs were judged to exert no specific action that might be useful in the treatment of angina. Gold and colleagues tried to explain why inert interventions might work: their points included ‘confidence aroused in a treatment’, the ‘encouragement afforded a new and ‘a of medical by procedure’ change advisor’.
  • Placebo was a fraud and deception that had the ‘moral effect of a remedy given specially for the disease’, but placebos did not affect the natural course of disease; they were a priori excluded from having such an impact. Placebos were therapeutic duds to manage patients, or, as in the Flint investigation, a camouflage behind which to watch nature take its course.
  • In 1938, the word placebo was first applied in reference to the treatment given to concurrent controls in a trial.
  • The efficacy of cold vaccines was evaluated in several placebo-controlled trials. [...] The conclusion [of one] reads ‘one of the most significant aspects of this study is the great reduction in the number of colds which the members of the control groups reported during the experimental period. In fact these results were as good as many of those reported in uncontrolled studies which recommended the use of cold vaccines’. The placebo effect was born.

@afrakt

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NEJM: Sham Controls in Medical Device Trials

Rita F. Redberg, M.D.

N Engl J Med 2014; 371:892-893September 4, 2014DOI: 10.1056/NEJMp1406388

(Bold emphasis added by RPE)

The problem:

Only 1% of all medical devices reach the market through the premarket-approval route — the only pathway that requires the submission of clinical data. Research has shown that premarket approvals are often based on data from one small trial that used surrogate end points and included only short-term follow-up.1

RCTs are rarely used:

“Blinded, randomized, controlled trials (RCTs), in which the proposed therapy is compared with a placebo or a “sham” (nontherapeutic) intervention, are common for drugs but rare for medical devices.”

Even complex, RCTs with invasive procedures are possible.

“…double-blind trials of fetal-tissue transplantation for Parkinson's disease, discussed by Freeman et al. (1999). The sham procedure involved making twist-drill holes in the patient's forehead and was considered necessary and ethical for determining whether there was an effect of treatment beyond the placebo effect (there was not).”

“Another important lesson on the value of sham controls came from vertebroplasty, a procedure in which bone cement is injected into a fractured vertebra for treatment of a compression fracture. Vertebroplasty became popular in the early 2000s, on the basis of observational studies and a nonrandomized trial. Fueled by position statements from various U.S. radiologic and neurologic surgical societies arguing the benefits of these procedures, the number of vertebroplasties performed in Medicare patients nearly doubled between 2001 and 2005, increasing from 45.0 to 86.8 per 100,000 enrollees.3 In 2009, however, RCTs that included a group assigned to receive a nontherapeutic procedure found that pain relief in the sham-procedure group was no different from that in the group that received the actual procedure.4

Placebo effects are even larger with procedures than with drugs.

“ Researchers at the Institute of Medical Psychology in Munich recently quantified that power for various types of placebo treatments in studies of migraine prophylaxis. They found that 58% of patients had a positive response to sham surgery and 38% had a positive response to sham acupuncture, while only 22% had a positive response to oral pharmacologic placebos.5

Conclusion: More RCTs are needed. But the article does not address the problem that even with RCTs it is hard to change physician practice.

Full article is here.
http://www.nejm.org/doi/full/10.1056/NEJMp1406388?query=TOC

Employer Sponsored Insurance Also Surged in MA in 2007.

There has been a great deal of surprise expressed in the media over the RAND’s latest report suggesting that more people have become insured through employer sponsored insurance (ESI) than through either Medicaid or the Exchanges under the ACA. One example is Adrianna McIntyre on The Incidental Economist who posted on Wednesday:

"I can’t overstate how stunning this finding is if it’s true; CBO expected that ESI gains and losses would pretty much break even in 2014 and that employer coverage would decline modestly in future years (p. 108)."

This result is precisely NOT stunning if you study the Massachusetts health reform.
In Massachusetts the expansion in ESI coverage ALSO led the total increase during the first year and half. Below is a  table summarizing the early returns in MA from a Massachusetts Division of Health Care Finance and Policy study in 2011.

http://www.mass.gov/chia/docs/r/pubs/11/2011-key-indicators-may.pdf

Notice how growth in ESI dominated both Medicaid and the Exchange in the first two years, before being surpassed by these other two.

I speculate that part of the reason so many Massachusetts employers dropped their plans in 2010 was because they knew they were not
compliant with the ACA new higher standard, but that is speculation. There was also a serious recession that affected employment and enrollment.

Massachusetts Health Reform http://www.mass.gov/chia/docs/r/pubs/11/2011-key-indicators-may.pdf
Insured Population by Insurance Types, 2006-2010
Excluding Medicare
Insured Population by Insurance Type, 2006-2010
June 30 2006 Dec 31 2006 Dec 31 2007 Dec 31 2008 Dec 31 2009 Dec 31 2010
Private Group 4,333,014 4,395,136 4,457,157 4,474,466 4,358,867 4,315,040
Individual Purchase 40,184 38,718 65,465 81,073 114,668 117,514
MassHealth 705,179 740,663 764,559 780,727 848,528 898,572
Commonwealth Care 0 18,327 158,194 162,725 150,998 158,973
Total Members 5,078,377 5,192,814 5,445,375 5,498,991 5,473,061 5,490,099
Change since 6/30/2006 June 30 2006 Dec 31 2006 Dec 31 2007 Dec 31 2008 Dec 31 2009 Dec 31 2010
Private Group 62,122 124,143 141,452 25,853 -17,974
Individual Purchase -1,466 25,281 40,889 74,484 77,330
MassHealth 35,484 59,380 75,548 143,349 193,393
Commonwealth Care 18,327 158,194 162,725 150,998 158,973
Total Members 114,437 366,998 420,614 394,684 411,722
Distribution of new enrollment as a fraction of total gains June 30 2006 Dec 31 2006 Dec 31 2007 Dec 31 2008 Dec 31 2009 Dec 31 2010
Private Group 54% 34% 34% 7% -4%
Individual Purchase -1% 7% 10% 19% 19%
MassHealth 31% 16% 18% 36% 47%
Commonwealth Care 16% 43% 39% 38% 39%
Total Members 100% 100% 100% 100% 100%