Sunday, December 28, 2008

Hawaii Island of Oahu Without Power

The power company rushed to give Obama an emergency generator to get him though the night. Doesn't this once again illustrate the need to bury our power lines? First New England, now Hawaii. Above ground power lines are a problem everywhere. Let's bury them as we dry to dig out of the financial crisis. Now that Obama has a recent personal taste of the issue, even if quickly ameliorated, maybe he will be motivated to add this to his stimulus package.

Wednesday, December 17, 2008

Ice Storms and Fiscal Stimulus

New England still has 100,000 homes without electricity a week after an ice storm. People are missing work and school and much time and money is going into putting the wires back on the poles. This happens every year, maybe not on this scale, but every year thousands lose power due to winter storms. Why are we not burying the wires?!

There's a job that could employ many now and improve economic efficiency in the future.

Saturday, December 13, 2008

David Wegman, A Moment to Reflect Along the Way


Last night we honored David Wegman's many contributions to Occupational Health including especially his visionary application of the Nordic model to the United States, by creating a Department of Work Environment at the University of Massachusetts Lowell. It was a wonderful evening. With much humor and great stories. Central to it all were the roles played by David and Peggy's children in their presentations, and recognition of the central role Peggy Wegman played in all of this.

An ice storm canceled the afternoon session, so we were not able to formally present the many awards, including citations by the Governor, State Legislature, and even the U. S. Defense Department. But, my favorite story was about that DOD award, from an ergonomics grad of the program, who also sent a picture of he and his comrades waving from an ergonomically designed tank. To which Greg Wagner replied --"Tanks but no tanks."

Thursday, December 11, 2008

Impact Factor

Thanks Greg Mankiw for this.

Conflicts of Interest and IRB Reviews

I'm reading the AAMC document referenced in a conference call yesterday about the case I discussed here a few days ago. The document clearly lays out the rationale for a rebuttable presumption against doing research where there is an individual or institutional COI. Appendix B gives helpful examples of how and when conflicts might be managed and the research allowed to proceed, and when the presumption should prevail. The document does deal with the early stage research issues I raised during the call.

Overall, the document is helpful -- but it only goes so far. I think it misses one of the most important conflicts of interest, the investigator's interest in publishing. This conflict is well known, is a major cause of misconduct in research, and has existed for a very long time.

Eventually, the COI process needs to grapple with the fact that researchers have vested interests in making findings and publishing their work. Publish or perish is well established. Thus, all researchers have a financial interest in making discoveries that they can publish to ensure their own job security. While job security issues apply most acutely to junior faculty, even tenured faculty have an interest in publishing so that they can get future grant funding and increase their social stature. Therefore, the logical extension of the COI recommendations is that there should be a rebuttable presumption against anyone doing any sort of research which they intend to publish. Only research done for purely personal enjoyment, by persons who are independently wealthy, should be allowed without prior approval of the institutional COIC.

Of War and Peace and GDP

Paul Krugman comments on an argument by Mark Thoma, Bob Hall and Susan Woodward, wherein Krugman asserts that the military spending resulted in a one-for-one effect on GDP during WWII because of rationing. But, Thoma et al., also look at the Koren War and see a similar effect. Now, I was born during the Koren War, so I have no direct memory of it. But, as far as I know, there was no rationing during that one. So, maybe there is more to this than Krugman allows.

Still the argument that infrastructure spending is equivalent to military spending seems a big stretch. I don't know of anyone who can use a tank or cluster bomb to increase productivity. Making stuff that is then only useful for destroying things and killing people somehow doesn't seem equivalent to building highways, mass transit, or electric power generation and distribution systems.

Saturday, December 6, 2008

Conflicts of Interest and IRB Reviews

As an IRB Chair, I'm confronting how to deal with conflicts of interest (COI) on the part of a researcher proposing a human subjects study. The physical risks in this case are minimal. But, the population is vulnerable and the main risk is that bad science could be misleading, causing subjects to spend their money on useless products. The project could raise unfounded hopes, or make important discoveries.

The initial response of the IRB and the institutional committee on COI was to require disclosure. But, this does nothing to protect a desparate patient. Management of the COI is needed. Once that is done, what the subject needs to know is that after considering the management steps, that the IRB approves of the study. I've come across this helpful document on COI from the National Human Research Protections Advisory Committee (NHRPAC) -- a letter from the committee regarding how to deal with COI in human subjects research.

Particularly helpful are the following statements (emphasis added):

NHRPAC would advise that in a research protocol in which an actual conflict of interest has been identified in the financial disclosure process, subjects could be advised in the informed consent process (and/or in the form itself) of the possible conflict and the nature of that conflict, with the terms, conditions and extent of disclosure calibrated by the conflict of interest committee and the IRB to correspond to the level of risk that the possible conflict poses. Conflict management strategies should also be disclosed, so that research subjects have general knowledge of the conflict of interest identification and management processes, and how those apply to the study in which the subjects is considering her enrollment. Conflicts management strategies may include, for example, mandating independent monitoring of informed consent, outside evaluation of subjects’ eligibility for a trial, independent review of adverse events reports and research records, and peer review of data analysis and interpretation.

The NHRPAC gave an example of a disclosure:

Every research scientist and physician at Mercy Hospital, and Mercy Hospital itself, must disclose significant financial interests in private companies or entities that may be related to this research study. Our Hospital committees have reviewed this information and have concluded that there are some financial relationships between the researchers or Mercy itself on the one hand, and the company that is funding this research, on the other. [insert some degree of specific disclosure here, if warranted, as to the interests and the conflicts management strategies]. However, after considering this information, our Hospital committees believe that there are no conflicts of interest that [or no conflicts of interests that, when taken with the conflicts management strategies discussed above] will influence the way you will be treated in this study or the way in which this research study will be conducted. If you would like to have more information about Mercy Hospital’s review process in general, or in regard to this study, please ask the researchers or the research coordinator, and they will assist you. You may also ask Mercy Hospital’s patient advocate, who also can arrange for you to have this information. If, because of this information, you choose not to participate in this study, this will have no effect in your continued health care at Mercy. Participation in all research, including this study, is entirely voluntary, and you may withdraw from participating at any time.

... under NHRPAC’s approach, disclosure of troubling financial relationships or actual conflicts to research subjects is not the preferred methodology for protecting subjects, but is an adjunct method for allowing subjects to have access to information that some may find relevant to their choices to participate in research.

In summary, a majority of NHRPAC preferred the approach of financial disclosure, conflicts analysis, conflicts management, and carefully calibrated "specific" disclosure, or "generic" disclosure, with ready availability to subjects of more specific information upon their request. Under these recommendations, therefore, institutional and researcher disclosure and management of conflicts precedes research approval; and simple disclosure to research subjects is not substituted for the duty of an IRB, institution or researcher aggressively to identify and manage possible conflicts according to their established processes.


The tough part is deciding what is sufficient management of a particular COI.

Wednesday, December 3, 2008

Big Stimulus Programs by Big Debtor Countries Will End in Tears??

The argument that, "Keynes, in the 1930s, advocated that the US make up for the demand loss rather than expecting the US's overindebted European trade partners to continue overconsuming" does not hold water. See for example Brad DeLong's econ 161 course notes. Hjalmar H.G. Schacht, the first central banker and then finance minister under Hitler, pursued deficit spending in a way that no other government did -- including the New Deal. One could argue that Schacht was the only Keynesian finance minister of his time. Although, Germany in 1932 was saddled with extreme debt, the expansionary program was fabulously effective -- Germany's unemployment rate problem was quickly solved -- the only industrialized country to achieve that goal. It is ironic that the insightful financial master, who worked for the devil incarnate, had the middle name Horace Greeley because his parents so admired the 19th century Repubican and Abolitionist.