Medical Device Daily Washington Editor

The Agency for Healthcare Research and Quality announced Monday that a review of studies that examined correlations between two genes and a patient's propensity to develop deep-vein thromboses (DVTs) offered at best only skimpy support for the notion of the predictive power of gene tests, leading the authors of the study to conclude that randomized, controlled studies are needed to establish whether doctors can make care recommendations based on the results of those tests.

However clich d the recommendation of "further studies indicated" may seem, the matter is of intense interest, given that DVTs can send chunks of clots to the lungs to form pulmonary embolisms, which the AHRQ statement says is responsible for at least 20,000 deaths in the U.S. each year. Still, a firm that makes genetic testing for the two genes in question is of the view that the results of such tests are not particularly meaningful outside the context of a clinical visit during which a provider can talk to a patient about lifestyle risks that exacerbate any inherited propensity toward DVTs.

Medical Device Daily spoke with Martin Munzer, President/CEO of Cygene Labs (Coral Springs, Florida), a firm that makes gene-testing equipment, as well as with the company's director of product development, Keith Zucker, PhD.

Zucker said that the two genes named in the AHRQ statement, Factor V Leiden (FVL) and prothrombin G20210A, "are two of the four we have on the Cygene panel" for DVT risk.

Zucker also noted that "there are hundreds of articles on both those genes," examining their risk independently and jointly, and that despite the cautiousness expressed in the AHRQ statement, there is "no question that they do increase the risk and significantly."

As for the report's attempt to develop a large-scale validation of the joint predictive power of FVL and G20210A, Zucker stated that Cygene's equipment is not sold for "testing in that manner. We're using the [genes] as a risk factor. In that respect, there's no question that the science is very strong."

Martin also said "this is an area of genetics that is very well understood." He acknowledged that the rates of incidence "are not as high as a statistician would like to see," but observed that the mortality level in connection with DVTs is too high to ignore. He characterized the test, which he said the company sells for $89, as a preventive measure. "This is the kind of seat belt you would want to wear" to help avoid DVTs, he said.

The AHRQ report notes that "as many as 600,000 Americans each year may have" DVTs and that hospitals report almost 260,000 pulmonary embolisms annually. AHRQ director Carolyn Clancy, MD, said in the statement that "while genetic testing shows great promise to improve treatment and prevent disease, this report clearly shows that we need more research and evidence to achieve its full potential." Clancy also said that patients "can help reduce their likelihood of developing a blood clot by talking with their doctor about precautions."

House looks at orthopedic registry bill

The House of Representatives is examining a bill that would require the formation of a registry for hip and knee replacements with the intent of determining which replacement devices and procedures offer the best outcomes with an eye toward reducing medical costs.

The Knee and Hip Replacement Registry Act of 2009 (H.R. 2813) is sponsored by Rep. Lloyd Doggett (D-Texas) and Bill Pascrell (D-New Jersey) and would require AHRQ to assemble the registry within three years of the bill's passage and file registry data within another two years. The data would have to be sent to a comparative effectiveness research entity at the Department of Health and Human Services, but the bill specifies neither a specific amount of funding nor a funding source.

In a June 12 statement, Pascrell said the registry "would reduce the number of costly and complicated do-over surgeries and save taxpayers billions of dollars." He also described as "outrageous" the fact that "medical devices are being made available in America that are so lousy they have been withdrawn in markets overseas," adding that as Congress and the White House work "to reform healthcare and reduce Medicare costs, bringing higher standards to the medical device industry would be a good place to start."

The bill has been referred to the House Energy and Commerce and the Ways and Means Committees.

Senate eyes CE institute legislation

Not to be outdone by the House of Representatives, the Senate Finance Committee announced a bill that would formally create a comparative effectiveness institute. In a June 9 statement announcing the bill, the chairs of the Senate Finance and Senate Budget Committees stated that the objective of the Patient-Centered Outcomes Research Act of 2009 would be a "private, non-profit corporation" that could be funded to the tune of $600 million a year within five years.

Senate Finance Committee chairman Max Baucus (D-Montana) said in the statement that physicians and patients "don't have enough information on which treatments work best for which patients, and that increases waste."

The research institute would focus on both primary research and reviews of existing data and would be answerable to "a multi-stakeholder board of governors," to be composed of the Secretary of Health and Human Services, the director of AHRQ, and "18 additional members representing diverse public and private sector expertise and interests," the statement noted. These 18 members would be appointed by the director of the Government Accountability Office under the terms of the proposed legislation.

As for how to finance such an entity, the statement by Baucus and Kent Conrad, the chairman of the Senate Budget Committee, notes that a fee of $2 would be levied on Medicare beneficiaries and on enrollees in private plans in 2013, after which the funding source is expected to "reach nearly $600 million."