A Medical Device Daily

The doubling of the budget of the National Institutes of Health between 1998 and 2003 raised a lot of hopes for cures of diseases, but the administration of those funds has raised a number of eyebrows at the Office of Inspector General (OIG) at the Department of Health and Human Services.

A recent report published by OIG indicates that NIH is not particularly vigilant about keeping an eye on financial conflict of interest, but is also in favor of allowing grantees to supervise their own conflicts of interest.

However, part of the problem appears to be that NIH is a bit behind the technological curve when it comes to document storage and tracking.

The OIG report, which was published at the OIG’s web site Jan. 17, states that of the NIH appropriation of $29.2 billion in FY07, 80% went to extramural grants and that grantees “must have a written policy for identifying financial conflicts of interest and ensuring that conflicts will be managed, reduced or eliminated.” These organizations must file conflict-of-interest reports with NIH, but the agency nonetheless “could not provide us with all the actual conflict-of-interest reports they receive.”

Part of the problem is apparently one of technology and part of it is sheer volume. The report notes that “because NIH has approximately 40,000 to 50,000 active grant awards at any given time, and each grant file contains thousands of pages of documents, finding every conflict of interest notification would require searching manually each individual grant file.”

OIG stated that the relevant regulations “do not explicitly require the nature of the conflict or other details to be reported.” Predictably, this led to less-than-forthcoming reports by grantees, with “at least 89% of ... reports” not stating “the nature of the conflicts or how they would be managed.” Of the 438 reports OIG reviewed, only 30 included the detailed information sought by OIG. “These reports describe cases ... in which investigators have intellectual property associated with the grant research or financial interests in companies that are subcontractors on the research grants.”

OIG’s position seems to be that self-supervision is no supervision, noting that many of NIH’s grantmaking institutes “rely on the good faith of the grantee to ensure compliance” with regulations and that “the majority of the [NIH] institutes do not have any proactive method for ensuring that grantees have financial conflict-of-interest policies.” OIG recommended increased oversight of grantee institutions and mandatory reporting by those institutions on “the nature of financial conflicts of interest and how they are managed, reduced or eliminated.”

The third recommendation provided the sticking point between NIH and OIG. This recommendation was that each grant-awarding division of NIH forward “to Office of Extramural Research (OER) all financial conflict-of-interest reports they receive from grantee institutions and ensure that” the OER database includes all conflict-of-interest reports filed by grantees.

NIH’s opposition to this is based in part on the proposition that “responsibility for identifying and managing financial conflicts of interest must remain with grantee institutions,” but OIG argued “collection of this information can be accomplished without interfering with grantee institutions’ legal responsibility for managing conflict of interest.”

The problem is not a new one for NIH. Congressional interest surged last year after an investigation undertaken by OIG starting in 2003 disclosed dozens of instances of conflict of interest among NIH grantees. One of the more egregious examples was that of a physician, Trey Sunderland, MD, who allegedly shipped thousands of samples of spinal fluid to Pfizer (New York), which paid Sunderland almost $300,000 in fees (Medical Device Daily, April 3, 2007). Sunderland is said to have pleaded the Fifth Amendment during congressional testimony on the matter, but capitulated with a guilty plea in a December 2006 trial proceeding.

Diuretics best for metabolic syndrome BP

High blood pressure has been known as a bogeyman for heart health for decades, but the treatment for those with specific co-morbidities is not so easy to figure out. A recent report by NIH makes clear, however, that such information is now coming into hand.

The Jan. 28 NIH statement indicates that the results of the ALLHAT (Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial) study shows that diuretics are the most effective initial therapy against hypertension for those with metabolic syndrome. The study, which was underwritten by NIH’s National Heart, Lung and Blood Institute, is the subject of an article appearing in the Jan. 28 edition of the Archives of Internal Medicine.

The news is a twofer for healthcare in that it shows that cheaper, older drugs do the job better. According to NHLBI Director Elizabeth Nabel, MD, “This new analysis shows that diuretics are better at preventing cardiovascular disease and thus does not support the selection of the newer drugs over diuretics for preventing poor health outcomes related to hypertension or for lowering high blood pressure.”

The study did not want for sheer numbers, either, described in the NIH statement as “a randomized, double-blind trial involving 42,418 participants, ages 55 and older with high blood pressure (140/90 mm Hg or greater) and at least one other risk factor for heart disease.” Slightly more than half, or 23,077, “had metabolic syndrome with diabetes or pre-diabetes ... at the time of enrollment.”