29 May 2008
Information Quality and Peer Review:
Are disclaimers in draft documents effective?
by Richard Belzer
in Information Quality
Since 2002, federal information quality guidelines have required agencies to avoid disseminating scientific information that is not objective, and to have effective administrative systems for managing requests for the correction of information that a petitioner believes is incorrect. The burden of proof of error rests with the petitioner.
All information that is "disseminated" is covered by these rules, but information that is made public solely for the purpose of scientific peer review or public comment is exempt from the definition -- provided that it is accompanied with a specified disclaimer (p. 8):
The purpose of this disclaimer is to deter people from relying on draft documents. An empirical question is whether the prescribed language is strong enough.
An interesting test case has arisen with respect to the industrial chemical bisphenol A (BPA). More...
21 Feb 2008
How Not to Estimate Benefits:
The case of Avastin
by Richard Belzer
in Regulatory Economics, Regulatory Policy
The Wall Street Journal editorializes today against a longstanding Food and Drug Administration policy that values the benefits of drugs for terminal cancer patients solely in terms of life extension. Some visual aids may help make the issues easier to understand. More...
19 Feb 2008
The Precautionary Principle in Action:
Is taking or not taking Vytorin 'precautionary'?
by Richard Belzer
in Regulatory Policy, Regulatory Science
A recent study raised doubt about the benefits of Vytorin, a patented combination of two anti-cholesterol drugs, ezetimibe and simvastatin. Some cardiologists say the study is sufficient evidence to stop prescribing it as widely; others disagree.
The decision whether to take Vytorin or its component drugs rests with patients, but they rely heavily on the advice of their doctors? How can patients makes sense of this debate? More...
6 Feb 2008
The Perils of Regulatory Policymaking by Opinion Poll:
Consumer Reports on "health care reform"
by Richard Belzer
in Regulatory Economics, Regulatory Policy
Consumer Reports has sponsored a poll on health care that yielded results characterized as "revealing a significant disconnect." But there is no disconnect at all if elementary economic analysis is applied. More...
3 Jan 2008
Where to Have a Cardiac Arrest?
Answer: not in the hospital
by Richard Belzer
in Information Quality, People & Institutions, Regulatory Science
New York Times reporter Denise Grady previews a research report due to be published in today's New England Journal of Medicine that says many hospitals do not respond quickly enough to cardiac arrest. Leslie Saxon, who wrote an accompanying editorial, delivered the money quote: “You’re better off having your arrest at Nordstrom, where I’m standing right now, because there are 15 people around me.” More...
5 Dec 2007
Why Is Blood In Short Supply?
Anecdotal evidence of highly precautionary (but discretionary) donation policies
by Richard Belzer
in Regulatory Economics, Regulatory Policy, Regulatory Science
Recently Neutral Source managing editor Richard Belzer attempted to donate blood, but was declined. Although the story is anecdotal and not empirical, it suggests good reasons why this particular blood bank seems to always be in short supply. More...
20 Aug 2007
Health Insurance and Incentives:
Ending reimbursements for certain hospital-acquired conditions
by Richard Belzer
in Regulatory Economics
For most Americans, third-party insurance companies reimburse health care providers based on the diagnosis-related group codes (DRGs) originally established by Medicare. When Medicare changes policies, it is likely that private health insurance companies will follow. Recently, the Centers for Medicare & Medicaid Services announced a policy change on reimbursements for "hospital-acquired conditions" -- a bureaucratic term for medical errors.
Until now, a hospital could be reimbursed for the costs of treating Medicare patients will ailments resulting from hospital mistakes. Under the new regulation, if a surgeon amputates the wrong limb or leaves an object behind after surgery, or hospital staff administer an incompatible blood type or permit an air embolism, CMS will not reimburse the added cost of subsequent treatment. The policy change is intended to give health care providers a financial incentive to avoid committing these errors.
In our discussion below, be analyze one specific medical error of special interest: mediastinitis.
More...27 Jul 2007
Who Pays the Cost of Regulation?
Insights from corporate income tax incidence
by Richard Belzer
in Regulatory Economics
Regulation is widely understood as a tax on the activity or person being regulated. Where these activities repair genuine market failures, benefits from regulation may result. If there are benefits from, say, automobile safety regulation, one would expect the beneficiaries to be persons who otherwise would have been killed or injured at the pre-regulatory safety level.
But what about the costs of regulation? Who bears them? More...
1 Jul 2007
Markets vs. Governments:
Contaminated Chinese imports
by Richard Belzer
in Regulatory Economics, Regulatory Policy
Over the past several months increasing evidence has arisen indicating that products manufactured by Chinese firms and exported to the U.S. often do not adhere to U.S. health and safety standards.
Does the federal government need to enact new regulations to deal with these threats? More...
21 Jun 2007
The Power of Incentives:
Health care and physician behavior
by Richard Belzer
in Regulatory Economics
In a Wall Street Journal commentary, Peter Bach explains succinctly why heath care in the United States is lower in quality than it should be given the resources devoted to it. It comes down to incentives. Physicians are compensated based on outputs, not outcomes. Therefore, they are motivated to increase outputs and not motivated to improve outcomes. More...
29 May 2007
Journal Peer Review and Objectivity:
The case of Avandia (rosiglitazone) and the New England Journal of Medicine
by Richard Belzer
in Information Quality, Regulatory Science
We've been a consistent supporter of high standards for information quality, especially for federal agencies that disseminate influential information in the support of regulatory objectives. We've also been consistently concerned about one particular aspect of the information quality and peer review guidelines issued by the Office of Management and Budget: the rebuttable presumption that scientific, technical, economic or statistical information published in peer reviewed journals satisfies the guidelines' standard for objectivity.
In the past week, the New England Journal of Medicine published online an article by Steven Nissen and Kathy Wolski claiming that Avandia, GlaxoSmithKilne's blockbuster drug for type 2 diabetes mellitus, "is associated with a significant increase in the risk of myocardial infarction [heart attack] and with an increase in the risk of death from cardiovascular causes that had borderline significance."
The Nissen & Wolski study has received enormous press attention. In today's Wall Street Journal former Food and Drug deputy commissioner Scott Gottlieb asserts that the NEJM has political motives for subjecting the study to inadequate peer review and publishing the study with excessive fanfare. Though not directed at federal information quality law and policy, Gottlieb's commentary suggests circumstances when OMB's rebuttable presumption of objectivity ought to be replaced with a rebuttable presumption of bias. More...
10 May 2007
When Science Becomes Advocacy:
Childhood obesity in Somerville, Massachusetts
by Richard Belzer
in Peer Review, Regulatory Policy
Wall Street Journal health columnist Tara Parker Pope has a Page One article about a recent program intended to reduce the incidence of childhood obesity in Somerville, Massachusetts. The occasion for the story is publication of a scientific review of the program.
Pope's article, and the journal article on which it is based, raise troubling questions about scientists and journalists behaving as advocates. It also exposes problems inherent to scientific peer review. More...
22 Dec 2006
How is "Big Oil" a Lot Like "Big Pharma"?
The economics of uncertainty in large-scale investments
by Richard Belzer
in Regulatory Economics
The pharmaceutical industry and the oil industry have a lot in common besides being the target for criticism. Recent news stories suggest that they have other important economic similarities:
- It takes billions of of R&D dollars to develop new drugs or develop new oil fields.
- Many of their investments don't yield salable products or marketable fuels.
- Both industries operate in regulatory regimes in which success may lead to asset expropriation.
20 Dec 2006
"Generic HAACP Plans for Regulatory Analysis"
Do federal HACCP regulations meet HACCP standards?
by Richard Belzer
in Regulatory Economics
An important element of Monday's post on E. coli and irradiation was the recognition that years of federal regulations had failed to significantly reduce foodborne illness risks. Conducting research for the post brought back memories of having reviewed the Food and Drug Administration's and Food Safety Inspection Service's initial regulations implementing the Hazard Analysis and Critical Control Points (HACCP) inspection regime.
Those reviews led to a presentation and a food safety conference, and the presentation led to a paper that was published as a chapter in a book on the economics of HACCP. (Amazon ranks the book #2,020,211, but hurry: as of Monday night they had one copy left.)
More...18 Dec 2006
E. coli and Irradiation
Would irradiation have prevented the recent outbreaks?
by Richard Belzer
in Regulatory Policy, Regulatory Science
Last fall's E. coli O157:H7 outbreak in spinach has now been followed by an outbreak in lettuce used by certain fast food enterprises. Today's Wall Street Journal includes an editorial criticizing "E. Coli's Enablers," by which they mean activists who oppose irradiation.
Would irradiation of produce intended to be consumed raw have prevented these outbreaks?
More...
