A Medical Device Daily

The FDA last week issued a statement saying that it will convene a meeting “in the near future“ to evaluate research concerning the possible link between new wireless communication systems and brain cancers. The purpose, it said, will be to “identify gaps in knowledge that warrant additional research.“

The statement is a response to what the FDA said were “numerous inquiries“ about a recently published paper – “Pooled analysis of two case-control studies on use of cellular and cordless telephones and the risk for malignant brain tumors diagnosed in 1997-2003, by Hardell et al“ – associating increased risk of malignant brain tumor with long term use (more than 10 years) of cell phones and cordless phones.

The study found that these “heavy“ users of cell phones had a 240% increase in brain tumors on the side of the head where the phone was normally used. The study defined heavy use as more than 2,000 total hours, or about one hour of use per workday for 10 years.

The FDA said that this study is not new but rather a combined analysis of two studies published in 2005 and 2003.

“Both the 2005 and 2003 studies were population-based, case-control studies,“ based on histopathological diagnoses submitted to regional cancer registries in the Uppsala/Örebro and Linköping regions of Sweden, the FDA said. Control subjects were taken from a population registry covering the whole population in Sweden.

It said exposure assessment was conducted using mailed questionnaires with a few follow-up telephone interviews. The only statistical adjustment made was to avoid bias for year of diagnosis.

The agency said that a number of studies have recently been published looking at the risk of long term cell phone use and brain cancer and that the results reported by Hardell are inconsistent with results obtained in the other long-term studies.“

Also, it said the use of mailed questionnaires for exposure assessment and lack of adjustments for confounding factors other than time of diagnosis makes the Hardell study design “significantly different from the other studies.“

It said the Hardell study was “difficult to interpret“ because of a lack of “an established mechanism of action“ or “supporting animal data.“

The FDA said it also continues to monitor studies looking at the possible health effects of exposure to radio frequency energy.

Maryland to fund stem cell research

Lack of federal funding for embryonic stem cell research is stimulating state efforts to take up the task of researching the therapeutic value of stem cells, with Maryland the latest to join the state stem cell cadre.

With SB 144, the Maryland legislature determined that the state, which has a significant biotech industry base, will bypass the impasse in Washington to push this branch of medical science forward. The three states that preceded Maryland are California, New Jersey and Connecticut.

An unofficial copy of the bill states that the annual allocation would be “non-lapsing“ and calls for “certain earnings“ to be paid into a fund that would amount to “at least“ $25 million per year starting in FY 2008. Maryland Governor Robert Ehrlich proposed funding of $20 million for such efforts in January, but the legislature trimmed that amount to $15 million in the final version of the bill.

A March 31 New York Times editorial commented that a state-by-state approach to stem cell research is “an absurd way to conduct research that may have extraordinary importance if it pans out,“ and described the Maryland effort as a “small program“ that would employ “only embryos that would otherwise be discarded by fertility clinics.“

In 2001, the White House slapped a moratorium on funding for embryonic stem cell research using cell lines not already established, pending a closer look at the ethics of cloning. The moratorium provoked outrage among bioresearchers and kudos from right-to-life advocates and some medical ethicists. Efforts on Capitol Hill to advance the discussion have bogged down, but the Senate's support for the president's position may be eroding.

According to the March 7 edition of The Hill, Republican Senators Arlen Specter (Pennsylvania) and Orrin Hatch (Utah) plan to reintroduce S 471 with the backing of a number of GOPers and the bulk of the Democratic Party. Minority leader Harry Reid (D-Nevada) will assist his GOP counterparts in prodding the Senate's majority leader, Bill Frist (R-Tennessee), to hold time for a debate on the bill. The House passed a similar measure in 2005, but the Senate version has yet to make it to the floor.

FDA releases investigations operations manual

The FDA has released the latest iteration of its Investigations Operations Manual, available via the National Technical Information Service (NTIS). Running eight chapters, an appendix and an index, the document is available as 10 separate PDF documents at the agency's web site.

The NTIS web site indicates the need to pay a fee of $100 for the hardcopy edition, but the downloadable version is available at FDA's site at no cost. The press release accompanying the 2006 edition states that the latest version employs a “new numbering system utilized by International Standards organizations“ and reorganizes the content to make it more user friendly. The index is expanded from earlier versions and chapters are reorganized into shorter sections, thus improving readability.

Sections that are new or revised include those for selective sampling, reporting requirements for observations of new human tissue, approach to drug inspections and administrative detention.