Australian state tightens CT screening rules

August 6, 2003

Owners of CT screening clinics in Australia's oldest and most populous state risk finding themselves in court if they continue to offer whole-body scans to healthy walk-in clients.The New South Wales government has introduced a new set of conditions

Owners of CT screening clinics in Australia's oldest and most populous state risk finding themselves in court if they continue to offer whole-body scans to healthy walk-in clients.

The New South Wales government has introduced a new set of conditions for CT scanning, aimed at controlling the number of speculative "lifestyle" exams being performed. This follows the appearance of Australia's first U.S.-style CT screening clinics in Sydney.

The regulations make it illegal to perform whole-body CT on members of the public in NSW unless imagers do the following:

? see a written referral from an independent doctor
? explain to the client the level of radiation dose involved, the possible associated health risks, and the higher risk for anyone under the age of 50
? obtain written, informed consent from the client

Individuals who breach these conditions could face fines up to $A27,500 (US$18,000) and/or the prospect of up to two years in jail. Corporations found to be in violation could be fined $A165,000 (US$110,000).

Government officials claim that the new rules will protect the public from unnecessary exposure to ionizing radiation. A report issued by the NSW Environment Protection Authority in November 2002 acknowledged the potential value of targeted CT in diagnostic medicine but emphasized the high levels of radiation associated with whole-body exams.

Dr. Paul Condoleon, a GP and director of the Total Health Screening clinic in Sydney, objects to the emphasis on radiation risks in publicity surrounding the regulations. Not surprisingly, demand for whole-body CT has dropped following the government's announcement. Yet the average 7-mSv dose to which clients are exposed during the exam is comparable to other medical x-ray procedures such as barium enema and cardiac stress tests, he said.

"They are trying to use radiation as a scare tactic," Condoleon said. "The regulations are an overreaction by a government that doesn't agree with the philosophy of whole-body CT scanning."

The new conditions actually make little difference to working practices at Total Health Screening. The clinic has always required clients to see a doctor prior to having a scan and has always used consent forms, he said.

Visitors to the Total Health Screening Web site are advised to consider a full-body scan if they have a family history of cancer or heart disease, have ever smoked, live a sedentary or stressful life, or are older than 40. They are also invited to consider buying a CT scan as a "thoughtful gift" for family and friends. The site cautions pregnant women and anyone younger than 20 not to undergo CT screening.

"We have a very high level of patient satisfaction," Condoleon said. "We have found pathology in a significant proportion of our patients. This is life-saving, preventative healthcare, rather than reactive healthcare."

The Royal Australian and New Zealand College of Radiologists (RANZCR) does not support the CT screening clinics that advertise their services in Sydney's newspapers. These centers offer head-to-toe scanning at a cost of up to $A900 ($600), with the promise that the exam will show early signs of cancer or heart disease, said Dr. Derek Glenn, a radiologist and RANZCR spokesperson. But the scientific evidence supporting the use of CT as a screening tool is just not there, he said.

"These scans are not cheap," Glenn said. "The issue is whether people selling them are over-promising. They are not quoting the false-positive and false-negative figures, and we all know that any medical imaging exam has false positives and false negatives."

The American College of Radiology is similarly unimpressed by entrepreneurs who promote whole-body CT as a medical checkup. The college's policy statement, renewed in September 2002, emphasizes the difference between screening high-risk patient groups for specific disease, an application that may prove clinically valid, and whole-body scanning of apparently healthy people.

Dr. Jim Borgstede, vice chair of the ACR board of chancellors responsible for developing the policy statement, criticized owners of walk-in scanning centers for using targeted CT research data to justify whole-body screening. Although the NSW government's attempt to clamp down on the clinics is welcome, he said, the merit of using consent forms as a means of regulation is questionable.

"How do patients give their informed consent to a procedure we have no data about?" he said.

The results of whole-body CT screening could actually do more harm than good, according to Borgstede. People may be falsely reassured when the signs of early-stage cancer are simply too small to be seen on the scan. And unusual but harmless findings may be misinterpreted, leading to needless worry, additional invasive tests, and unnecessary financial outlay.

"The biggest concern of all in this CT screening situation is that there are going to be a great many false-positive diagnoses," he said. "It will cause tremendous expense to healthcare budgets to prove that they are negative."