August 6, 1999

Legislators on Beacon Hill soon will decide whether certain patients across the state will benefit from a radioactive imaging agent manufactured at the MGH for the detection of some cancers and other diseases.

For the past 10 years, the MGH has produced and used a radiopharmaceutical known as F-18 fluorodeoxyglucose (FDG), which is a diagnostic imaging agent used to detect cancerous lesions by Positron Emission Tomography (PET) scanning. Because the equipment required to produce FDG is highly specialized, the MGH is the only facility in the region that produces it. Now that smaller hospitals in the state have equipment capable of imaging with FDG, there are numerous requests to the MGH for this drug.

To begin the process leading to commercial distribution of the drug, the MGH applied for a license from the Department of Public Health and the Massachusetts Board of Registration in Pharmacy in November 1997. The state Board of Registration in Pharmacy indicated, however, that for the licensing process to move forward, the Nuclear Pharmacy Act of 1985 must be amended by the state legislature.

The act contains language that requires a nuclear pharmacy to be independent from any other business. This language is similar to wording in the retail pharmacy laws that prohibited supermarkets and department stores from operating retail pharmacies. Following a lawsuit against the Board of Registration in Pharmacy, that language was eliminated from the retail pharmacy laws but not from the nuclear pharmacy laws. As the law currently stands, the MGH is prohibited from distributing these drugs because the MGH Nuclear Pharmacy is not independent and separate from the hospital.

At the request of the MGH, Rep. Salvatore DiMasi (D-Boston) and Sen. Mark Montigny (D-New Bedford) introduced legislation, H-2512 and S-478, to remedy this problem. Ronald J. Callahan, PhD, of MGH Radiology, testified June 29 on behalf of these identical bills at a hearing of the Joint Committee on Health Care.

According to Callahan, the physical half-life – the amount of time necessary for the radioactivity to decrease to half of the initial activity – of fluorine 18, the radioactive element in FDG, is only 109 minutes. "This means that, for effective use of this radiopharmaceutical, it must be produced close to where it will be administered to patients," he says. "So the key to making this drug widely available is a combination of regional production facilities, like the one at the MGH, and in-house imaging equipment at community hospitals and clinics."

On July 1, the committee consolidated the two bills and issued a favorable report on S-478, which is now in the Senate Ways and Means Committee. "Getting this bill out of the Health Care Committee and into Ways and Means is an important step in the process, and we will continue working with the legislature to move this bill forward," says Jeff Lockwood of Partners Government Relations.

Callahan adds that, as soon as the legislature approves the bill, the MGH can begin dispensing FDG throughout the region. "FDG is a very important diagnostic imaging agent," he says, "and as soon as we can make this procedure more widely available, the better it will be for patients who need it."